Italy

The recommendation states as its basis

While all analysed inspection reports and corresponding checklists assessed prescriptions as compliant, the audit team noted that prescriptions regularly missed some mandatory information set out in Annex V to Regulation 2019/4 in accordance with Article 16(6) to the said Regulation. Missing information concerned: a) the category and age of animals, or where appropriate, weight of the animals (identification), b) the name of the active substance (designation), c) inclusion rate of the active substance (or substances), and d) the mention: `This prescription shall not be re-used'. In addition, the REV system does not allow for the possibility of inserting the prescription expiry date in case it would be shorter than that referred in Article 16(8) to the said Regulation. 7

The prescriptions also missed the information that can be added to a prescription only after a medicated feed is produced, namely the information set out in Annex V to Regulation 2019/4, in particular its: a) Point 15: With respect to supplier of the medicated feed, its name or business name and address, date of delivery, and the batch number of medicated feed delivered under the veterinary prescription, and b) Point 16: Signature of the supplier to the animal keeper or of on-farm mixer. However, the audit team noted that the medicated feed producers regularly inserted this information directly in the REV system, and once inserted, this information could not be altered.

The competent authorities' representatives explained that REV system may hold some of the missing information and in case it does not, a veterinarian issuing the prescription could insert the required information using a dedicated field or a box for entering a `free text'. The audit team confirmed that, for some missing information, such possibilities indeed exist but veterinarians issuing prescriptions did not use them or they very seldom used them. In response to the audit findings on prescriptions, yet during the audit, DGAH launched an update aiming at adding all missing information into prescription.

The vast majority of FeBOs manufacturing medicated feed complied with the requirement laid down in Article 16(8) Regulation 2019/4 on validity of prescription issued for manufacturing medicated feed containing VMP with antimicrobial(s). However, there were situations where FeBOs split the production in different days and manufactured the prescribed amount of medicated feed with few days' intervals, eventually exceeding the five-day limit of the prescription validity. Except in one feed mill visited, official controls did not consider such practice as a non-compliance.

DGAH explained that such a practice happens occasionally and mainly concerns situations where an animal keeper cannot store the full prescribed amount at once due to inadequate storage capacity. As a result, the FeBO produces the first batch of feed within the five-day validity period, with the remaining produced a few days later. To support this explanation, DGAH provided data (6) showing that in 2025, out of 23 174 prescriptions for medicated feed containing antimicrobials, 529 involved multiple shipments. Among these, only 75 prescriptions involved shipments produced and delivered beyond the five-day validity period, even though the first shipment was made within those 5 days. The audit team noted that the situation affected about 0.32% of all prescriptions for medicated feed in 2025. Despite the incidental nature of this split manufacturing practice, DGAH has committed to issue a national instruction on this aspect to ensure that the production of medicated feed takes place within the period the prescription is valid, even in case of multiple shipments. Moreover, DGAH would improve control checklists to harmonise official controls on this aspect.

Official controls verifying requirements applicable to prescriptions, overlooked that prescriptions missed some of the obligatory information and that the manufacturing of some medicated feed containing antimicrobials had taken place outside the 5 days of the prescription validity. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

The recommendation states as its basis

However, these registers do not include relevant information on the crops being grown. Different strategies have been followed by the regional CAs to overcome the lack of detailed information in the register: · In some cases, regional CAs have got access to the data bases of the Chambers of Commerce. These databases only provide for general activity groups, which in the case of primary production comprises permanent crops and other general activities such as "cereals", or "horticulture". · In Sicily, there are 53 000 farms dedicated to primary production of FNAO, including permanent and non-permanent crops. The regional CAs of Sicily indicated that 8 000 farms were dedicated to horticulture. In Campania, CAs indicated that there were 39 000 farms of non-permanent crops. These systems do not provide enough information to CAs to identify growers producing crops with a higher microbiological risk. Therefore, recommendations No 4 and 5 of the DG(SANTE) 2021-7175 audit report have not been addressed. · In other cases, as for example in Veneto and Emilia Romagna, CAs have an agreement with the Department of Agriculture which provides accurate information on the type of crops grown in the farms. The information provided is updated around every 18 months. CAs of Veneto indicated that this frequency of exchanges will be increased to every six months. The information of the register of the Department of Agriculture indicates the type of crop except for seeds for sprouting, which are not identified as such. 7

There are procedures in place to ensure that FBOs of FNAO are registered and are known to CAs which have the possibility to access to different sources of registers. However, the lack of direct access to relevant information and proper coordination between CAs prevents regional and therefore, local CAs to avail updated information of farms growing crops potentially posing higher microbial risk, thus limiting the adequate prioritisation of official controls in accordance with Article 9(1)(a) of Regulation (EU) 2017/625.

The recommendation states as its basis

Regarding seeds for sprouting, the current available registers do not provide information on the farms producing this type of product. To overcome this lack of information, one local SIAN has requested to a FBO placing seeds for sprouting in the market the list of farms supplying seeds for sprouting located in the territory under the remit of the SIAN. However, this was an initiative of the local SIAN that it has not been systematically taken by the rest of local, regional or central CAs to identify the farms producing seeds for sprouting. Processors

The lack of information on farms growing seeds for sprouting, together with the fact that CAs do not enforce the registration of such FBOs, hinders the capacity of CAs to prioritise official controls to these FBOs in accordance with Article 9(1)(a) of Regulation (EU) 2017/625 to verify compliance with applicable hygiene rules during primary production pre-during and post-harvest. 8

There is not a reliable official system to identify growers producing seeds for sprouting, and therefore they are not subject to official controls to verify compliance with hygiene requirements to address microbiological risks. In some cases, this lack of official control is mitigated by controls carried out by the downstream FBO (the one who place the seeds on the 14 market) on its suppliers of seeds for sprouting.

The recommendation states as its basis

Regarding operators placing seeds for sprouting on the market, MoH has incorporated this type of FBOs in the SINTESIS database (Integrated System for Trade, Imports and Structures - Sistema Integrato per gli Scambi, le Importazioni e le Strutture). SINTESIS is the register of Italian establishments for the production of food of animal origin which in 2013 was extended to other categories of establishments to cover, among others, sprout-producing establishments, and FBOs producing seeds for sprouting. At the time of the audit, there were nine FBOs registered as producers of seeds for sprouting. However, the audit gathered evidence demonstrating that there are other FBOs placing seeds for sprouting on the market that are not included in the SINTESIS register (see paragraphs 53 and 57). Approval of sprout-producing establishments

During visits to the sprout-producing establishments, inspectors overlooked some aspects: · The health certificate associated to a batch of seeds of mungo beans (Vigna radiata) was not authentic, as the stamp and signature was not from CAs but from the exporter. · CAs have requested the FBO to conduct a preliminary test of a new batch of seed before resuming production. Instead, at the time of the visit the production was at full capacity and inspectors accepted a sample from the production as valid for the preliminary test. · The testing reports of sprouts provided by the FBO shows that only one subsample has been taken for STEC. This is not in line with point 1.29 of chapter 1 on food safety criteria of Annex I to Regulation (EC) No. 2073/2005. · Final product and seeds stored in the same room · Some of the suppliers of seeds for sprouting were not included in the official list issued by MoH in the SINTESIS data base. This did not trigger any reaction of the inspectors. · To verify that the chlorine used to wash sprouts was suitable for food. · The official testing of final product was cancelled because the label indicates that sprouts were not ready to eat (RTE) and should be cooked before consumption. However, analysis for STEC in sprouts (point 1.29 of Chapter 1 of Annex I to Regulation (EC) 2073/2005) is not linked to whether the sprouts are considered RTE products or not. · Inspectors did not immediately request the FBO to remove a product affected by dripping condensation. 12 · Inspectors did not further investigate if preliminary testing was done by the FBO in line with point 3.3 of Annex I to Regulation (EC) 2073/2005, as the bags of a large batch of seeds apparently were not opened to take samples.

The audit team visited one FBO placing seeds for sprouting in the market. This FBO has an internal system in place for controlling growers producing seeds. Farms producing seeds for sprouting are bounded by contracts to the FBO placing seeds for sprouting on the market. All his growers, both producing seeds for sowing and for sprouting, are required to comply with hygiene requirements of Annex I of Regulation (EC) No 852/2004. The company also purchases seeds from another Italian FBO that places seeds for sprouting on the market, which is not included in the SINTESIS list. The authorities were made aware of this "non-listed" company in previous official inspections.

CAs have not taken actions when they were aware of FBOs supplying seeds for sprouting which were not included in the official register. This, in combination with the lack of cooperation with CCA and regional CAs have prevented effective official controls in the production chain of seeds for sprouting.

The recommendation states as its basis

However, these registers do not include relevant information on the crops being grown. Different strategies have been followed by the regional CAs to overcome the lack of detailed information in the register: · In some cases, regional CAs have got access to the data bases of the Chambers of Commerce. These databases only provide for general activity groups, which in the case of primary production comprises permanent crops and other general activities such as "cereals", or "horticulture". · In Sicily, there are 53 000 farms dedicated to primary production of FNAO, including permanent and non-permanent crops. The regional CAs of Sicily indicated that 8 000 farms were dedicated to horticulture. In Campania, CAs indicated that there were 39 000 farms of non-permanent crops. These systems do not provide enough information to CAs to identify growers producing crops with a higher microbiological risk. Therefore, recommendations No 4 and 5 of the DG(SANTE) 2021-7175 audit report have not been addressed. · In other cases, as for example in Veneto and Emilia Romagna, CAs have an agreement with the Department of Agriculture which provides accurate information on the type of crops grown in the farms. The information provided is updated around every 18 months. CAs of Veneto indicated that this frequency of exchanges will be increased to every six months. The information of the register of the Department of Agriculture indicates the type of crop except for seeds for sprouting, which are not identified as such. 7

There are procedures in place to ensure that FBOs of FNAO are registered and are known to CAs which have the possibility to access to different sources of registers. However, the lack of direct access to relevant information and proper coordination between CAs prevents regional and therefore, local CAs to avail updated information of farms growing crops potentially posing higher microbial risk, thus limiting the adequate prioritisation of official controls in accordance with Article 9(1)(a) of Regulation (EU) 2017/625.

Sicily has communicated to the local ASLs the plan for official controls on primary production of FNAO for 2025. A total of 38 official controls are planned for one ASL (at the time of the audit, 2 had been carried out), and 45 (of which 41 should be greenhouses) for a second ASL. According to the regional CAs, these controls are to be carried out to crops posing a higher microbial risk, as for EFSA opinions.

In Campania, there are 39 000 classified as non-permanent crops (therefore including cereals, fruits and vegetables). There is not in place a plan for official controls related to microbial risk on FNAO primary production. The new checklist including microbial risks was introduced in October 2024 to be used for the planned controls on chemical risks (around 40 controls per year, equivalent to 0,1% of the number of farms). However, a low number of inspections have taken place using this new checklist, and mainly related to farms involved in RASFF notifications.

For primary production, there is no uniformity in the planning and implementation of official controls. In some regions CAs addressed adequately the recommendations of the 2021 DG Health and Food Safety audit report allowing them to conduct appropriate risk-based controls following clear guidelines and checklists. The delay in implementing the necessary measures in other regions, compromises the risk-based official controls system and hinders the effectiveness of such controls.

The recommendation states as its basis

Regions are responsible for planning and organising training of staff, both for regions and their ASLs. Regarding specific training on primary production of FNAO, the audit team observed significant differences in the visited regions. In Veneto, since the previous audit, specific courses on official controls of primary production have been organised every year. The courses included an on-site component to conduct inspections on production farms, and attendees were subject to a written test at the end of the course to assess the acquired capacities of staff.

Opposite to this situation, in Sicily or Campania, no training has taken place regarding official controls in primary production of FNAO. In Sicily, the first training in the matter is planned for September 2025. As seen in paragraphs 42, 44 and 46, both regions had started to conduct inspections at primary production including microbiological risks in October 2024 (Campania) and from May 2025 in Sicily. This absence of training for staff is not in line with the Article 5(4) of Regulation (EU) 2017/625, and calls into question the effectiveness of the implementation of the action plan submitted to address recommendation No 6 of the DG (SANTE) 2021-7175 audit report.

During official inspections witnessed by the audit team, inspectors and their supervisors overlooked some critical deficiencies (e.g., risk of cross-contamination, lack of hygiene and staff misconduct). Official staff acknowledged that these deficiencies represent a risk for food safety (see paragraphs 47, 53, 59 and 62). Audit / Supervision

The level of training provided to staff performing official controls on FNAO varies significantly between regions. While some regions offer thorough and specialised training to cover new areas of official controls for Cas, other provides little to no training. This disparity in training levels compromise the effectiveness of official controls in several regions.

During the inspections witnessed by the audit team, inspectors used the new checklist and followed the guideline for primary production of FNAO. They assessed various factors, including water used for irrigation and irrigation methods, enquired about the sources of manure, and evaluated the availability of toilets, hand washing facilities for staff and hygiene protocols. However, regarding some aspects that may present a microbiological risk, the inspectors: · did not address to the presence of crates used for harvesting kept outside the greenhouses, even though harvest was not occurring at that time; · did not respond to the presence of crates for harvested products placed directly on the soil; · did not raise concerns about the FBO parking vehicles inside a warehouse where empty crates ready for packing harvested product were stored; · did not challenge the FBO to demonstrate the quantities of "certified" manure used, nor were they aware of the appropriate quantities for the size of the farm; · explained that samples had been taken for microbiological testing from living plants, rather than from products already harvested. 11

During visits to the sprout-producing establishments, inspectors overlooked some aspects: · The health certificate associated to a batch of seeds of mungo beans (Vigna radiata) was not authentic, as the stamp and signature was not from CAs but from the exporter. · CAs have requested the FBO to conduct a preliminary test of a new batch of seed before resuming production. Instead, at the time of the visit the production was at full capacity and inspectors accepted a sample from the production as valid for the preliminary test. · The testing reports of sprouts provided by the FBO shows that only one subsample has been taken for STEC. This is not in line with point 1.29 of chapter 1 on food safety criteria of Annex I to Regulation (EC) No. 2073/2005. · Final product and seeds stored in the same room · Some of the suppliers of seeds for sprouting were not included in the official list issued by MoH in the SINTESIS data base. This did not trigger any reaction of the inspectors. · To verify that the chlorine used to wash sprouts was suitable for food. · The official testing of final product was cancelled because the label indicates that sprouts were not ready to eat (RTE) and should be cooked before consumption. However, analysis for STEC in sprouts (point 1.29 of Chapter 1 of Annex I to Regulation (EC) 2073/2005) is not linked to whether the sprouts are considered RTE products or not. · Inspectors did not immediately request the FBO to remove a product affected by dripping condensation. 12 · Inspectors did not further investigate if preliminary testing was done by the FBO in line with point 3.3 of Annex I to Regulation (EC) 2073/2005, as the bags of a large batch of seeds apparently were not opened to take samples.

During the visit to the pre-cut establishment, inspectors overlooked some aspects, which were not identified in previous inspections: · Although there were designated high risk areas, there were no adequate access areas with adequate hygienic procedures to prevent contamination from dirty areas. · Staff touched a pipe on the floor and did not wash their hands before returning to handle lettuce. · Despite there were three cooling devices over the production lines, CAs have only required isolation to prevent condensation dripping from one of the devices above one line, but not the for the other two cooling units. Condensation dripping was evident over the production lines without triggering any reaction from the inspectors. · The company was cleaning the automatic weighting equipment prior to packing with high pressure water.

For primary production, there is no uniformity in the planning and implementation of official controls. In some regions CAs addressed adequately the recommendations of the 2021 DG Health and Food Safety audit report allowing them to conduct appropriate risk-based controls following clear guidelines and checklists. The delay in implementing the necessary measures in other regions, compromises the risk-based official controls system and hinders the effectiveness of such controls.

The low number of sprout-producing establishments, along with the territorial organisation of the official controls hinders the capacity of the staff conducting official controls to gain sufficient know-how and experience with the relevant requirements to this type of FBOs. This compromises the effectiveness of the official controls.

The recommendation states as its basis

Examples of planned audit reports were provided to the audit team: Friuli Venezia Giulia in November 2021, Sicily in 2022, Lombardy in June 2023 and Sardinia in May 2024. In general, the main shortcomings identified were lack of internal audits by regions due to the lack of auditors; failure to use the checklists proposed by MoH for official controls in primary production; insufficient training of staff; low number of inspections on primary production level and difficulties of inspectors in identifying non-compliances. However, the audit team could not find evidence that regions had implemented measures to address key non- compliances identified by MoH during its internal audits (see paragraphs 13, 14, 42, 47, 53, 59 and 62). 5

The audit team was provided with examples of audits carried out by MoH related to RASFF notifications, such as draft reports for audits carried out in Sicily in November 2024 and in Emilia Romagna in February 2025. In addition to the shortcomings mentioned in the previous point, weaknesses were also identified in the management of a RASFF notification related to Salmonella in cherry tomatoes: the report highlights that regional CAs did not take measures to manage the emergency situation.

MoH has implemented an internal audit system which covers the official controls in FNAO. This has allowed to identify organisational problems and shortcomings which, if addressed (and it was not the case) by regional CAs, could allow to improve the effectiveness of official controls in the area of concern.

In some regions, the lack of a supervisory system to assess, on-the-spot, the performance of (4) European Centre for Disease Prevention and Control, European Food Safety Authority, 2025. Prolonged cross- border multi-serovar Salmonella outbreak linked to consumption of sprouted seeds ­ 6 March 2025. ISBN 978-92- 9498-782-2; doi: 10.2900/7051610; Catalogue number TQ-01-25-013-EN-N 6 staff during official controls and, in regions where such a system exists, the failure to identify shortcomings in official controls, has a negative impact on the effectiveness of the implementation and enforcement of EU legislation.

During the inspections witnessed by the audit team, inspectors used the new checklist and followed the guideline for primary production of FNAO. They assessed various factors, including water used for irrigation and irrigation methods, enquired about the sources of manure, and evaluated the availability of toilets, hand washing facilities for staff and hygiene protocols. However, regarding some aspects that may present a microbiological risk, the inspectors: · did not address to the presence of crates used for harvesting kept outside the greenhouses, even though harvest was not occurring at that time; · did not respond to the presence of crates for harvested products placed directly on the soil; · did not raise concerns about the FBO parking vehicles inside a warehouse where empty crates ready for packing harvested product were stored; · did not challenge the FBO to demonstrate the quantities of "certified" manure used, nor were they aware of the appropriate quantities for the size of the farm; · explained that samples had been taken for microbiological testing from living plants, rather than from products already harvested. 11

During visits to the sprout-producing establishments, inspectors overlooked some aspects: · The health certificate associated to a batch of seeds of mungo beans (Vigna radiata) was not authentic, as the stamp and signature was not from CAs but from the exporter. · CAs have requested the FBO to conduct a preliminary test of a new batch of seed before resuming production. Instead, at the time of the visit the production was at full capacity and inspectors accepted a sample from the production as valid for the preliminary test. · The testing reports of sprouts provided by the FBO shows that only one subsample has been taken for STEC. This is not in line with point 1.29 of chapter 1 on food safety criteria of Annex I to Regulation (EC) No. 2073/2005. · Final product and seeds stored in the same room · Some of the suppliers of seeds for sprouting were not included in the official list issued by MoH in the SINTESIS data base. This did not trigger any reaction of the inspectors. · To verify that the chlorine used to wash sprouts was suitable for food. · The official testing of final product was cancelled because the label indicates that sprouts were not ready to eat (RTE) and should be cooked before consumption. However, analysis for STEC in sprouts (point 1.29 of Chapter 1 of Annex I to Regulation (EC) 2073/2005) is not linked to whether the sprouts are considered RTE products or not. · Inspectors did not immediately request the FBO to remove a product affected by dripping condensation. 12 · Inspectors did not further investigate if preliminary testing was done by the FBO in line with point 3.3 of Annex I to Regulation (EC) 2073/2005, as the bags of a large batch of seeds apparently were not opened to take samples.

During the visit to the pre-cut establishment, inspectors overlooked some aspects, which were not identified in previous inspections: · Although there were designated high risk areas, there were no adequate access areas with adequate hygienic procedures to prevent contamination from dirty areas. · Staff touched a pipe on the floor and did not wash their hands before returning to handle lettuce. · Despite there were three cooling devices over the production lines, CAs have only required isolation to prevent condensation dripping from one of the devices above one line, but not the for the other two cooling units. Condensation dripping was evident over the production lines without triggering any reaction from the inspectors. · The company was cleaning the automatic weighting equipment prior to packing with high pressure water.

The recommendation states as its basis

Nonetheless, the audit team observed shortcomings in the cooperation between ASL, region and MoH (see paragraphs 18, 20, 30, 32, 42 and 57). Official staff and Training

Despite several RASFF notifications on seeds for sprouting (4) mentioning both FBOs placing seeds for sprouting on the market and farms producing seeds for sprouting, none of them were included by the Italian CAs in the national list of FBOs producing seeds for sprouting. MoH informed the audit team that this was due to poor cooperation between local and central CAs. This is not in line with Article 4(2)(a) of Regulation (EU) 2017/625.

However, these registers do not include relevant information on the crops being grown. Different strategies have been followed by the regional CAs to overcome the lack of detailed information in the register: · In some cases, regional CAs have got access to the data bases of the Chambers of Commerce. These databases only provide for general activity groups, which in the case of primary production comprises permanent crops and other general activities such as "cereals", or "horticulture". · In Sicily, there are 53 000 farms dedicated to primary production of FNAO, including permanent and non-permanent crops. The regional CAs of Sicily indicated that 8 000 farms were dedicated to horticulture. In Campania, CAs indicated that there were 39 000 farms of non-permanent crops. These systems do not provide enough information to CAs to identify growers producing crops with a higher microbiological risk. Therefore, recommendations No 4 and 5 of the DG(SANTE) 2021-7175 audit report have not been addressed. · In other cases, as for example in Veneto and Emilia Romagna, CAs have an agreement with the Department of Agriculture which provides accurate information on the type of crops grown in the farms. The information provided is updated around every 18 months. CAs of Veneto indicated that this frequency of exchanges will be increased to every six months. The information of the register of the Department of Agriculture indicates the type of crop except for seeds for sprouting, which are not identified as such. 7

Regarding operators placing seeds for sprouting on the market, MoH has incorporated this type of FBOs in the SINTESIS database (Integrated System for Trade, Imports and Structures - Sistema Integrato per gli Scambi, le Importazioni e le Strutture). SINTESIS is the register of Italian establishments for the production of food of animal origin which in 2013 was extended to other categories of establishments to cover, among others, sprout-producing establishments, and FBOs producing seeds for sprouting. At the time of the audit, there were nine FBOs registered as producers of seeds for sprouting. However, the audit gathered evidence demonstrating that there are other FBOs placing seeds for sprouting on the market that are not included in the SINTESIS register (see paragraphs 53 and 57). Approval of sprout-producing establishments

In the absence of a register detailing the crops, the staff indicates that different strategies have been adopted to select high risk farms, for example by searching in internet websites of FBOs. However, due to the high number of farms in the region (around 8 000 registered as horticulture production, without distinction between products that are consumed raw and others consumed after cooking such as potatoes, aubergines, etc.), and the limited staff resources, this approach does not constitute an effective method to characterise the universe of farms that should be subject to controls.

CAs have not taken actions when they were aware of FBOs supplying seeds for sprouting which were not included in the official register. This, in combination with the lack of cooperation with CCA and regional CAs have prevented effective official controls in the production chain of seeds for sprouting.

The recommendation states as its basis

In the context of surveys, the CAs do not have appropriate and properly maintained facilities and equipment to perform surveys efficiently and effectively as required by Article 5(1)(f) of Regulation (EU) 2017/625. The National Plant Health Service uses the Monitoring of Harmful Pests (MORGANA) IT system to plan and record surveys, to send samples to laboratories, and to manage the resultant data. Sixteen of the 21 RPSs input survey data directly into MORGANA, while the remaining five use their own systems and transfer relevant data into MORGANA periodically throughout the year. The MAFF explained that deficiencies in MORGANA make it very difficult to extract data from the system. As a practical example, the MAFF are unable to monitor the implementation of surveys on an ongoing basis to check progress towards annual targets or to check that 5 surveys are being done at the appropriate times of the year as required by Article 22(2) of Regulation (EU) 2016/2031 due to these deficiencies.

At an operational level, there is clear, legally binding guidance for the planning and implementation of surveys, but deficiencies in the IT system used means that the central competent authority is unable to monitor the implementation of surveys by the regions.

The recommendation states as its basis

The three RPSs met by the audit team stated that they propose survey numbers for risk- based surveys for all Union quarantine pests (including priority pests) and pests provisionally qualifying as Union quarantine pests based on available resources, rather than phytosanitary risks. The MAFF acknowledged that the majority of RPSs follow this same approach. The MAFF and CREA-DC stated that they do not have the human resources to critically analyse the survey proposals of the RPSs (in terms of numbers of planned surveys, locations for surveys and survey methodology) as foreseen under the structures described in findings 4 and 5, with the result that the proposals of the RPSs are aggregated to form the multi-annual and annual survey programmes, without any analysis to determine if the resultant national programmes comply with Article 22(2) (for Union quarantine pests) and Article 24(1) (for priority pests) of Regulation (EU) 2016/2031.

The system for planning the multi-annual and annual survey programmes, as currently in operation, does not ensure that the resultant plans comprise a sufficient number of risk- based surveys, to be carried out in all appropriate locations, and based on sound scientific and technical principles, to ensure the timely detection of any outbreaks of these pests.

The multi-annual risk-based survey programme is drawn up by the CREA-DC based on proposals from the RPSs. CREA-DC explained that annual survey plans are also drawn up using this approach. Due to the weaknesses described in finding 9, the resultant risk- based (as distinct from statistically-based) survey programmes for Union quarantine pests and pests provisionally qualifying as Union quarantine pests are not risk-based, not carried out in all appropriate locations, nor based on sound scientific and technical principles as required by Article 22(2) of Regulation (EU) 2016/2031. In addition, in the case of priority pests, surveys do not include a sufficiently high number of visual examinations, sampling and testing, to ensure, as far as it is possible given the respective biology of each priority pest and the ecoclimatic conditions, with a high degree of confidence, the timely detection of those pests as required by Article 24(1) of Regulation (EU) 2016/2031, and are not conducted in line with pest-specific legislation.

The number of planned and completed visual examinations and traps under the S. frugiperda risk-based survey programme in Italy (as recorded in MORGANA) are summarised in Table 1. CREA-DC and the three RPSs met by the audit team stated that visual examinations refer exclusively to examining plants, rather than examining the contents of traps. The planned numbers and types (visual examinations or traps) of surveys are based on the proposals of the RPSs. The three RPSs met by the audit team acknowledged that their proposed survey numbers for S. frugiperda are based on the available resources as described in finding 9. Table 1. Number of planned and completed visual examinations and traps for S. frugiperda in Italy Year Planned no. of Completed no. of Planned no. of Established visual visual no. of traps traps examinations examinations 2021 540 1 759 166 202 2022 688 1 714 220 246 2023 1 038 2 568 211 281 2024 1 001 3 979 217 282 2025 1 070 - 221 -

Surveys are not planned (and subsequently implemented) based on risk as required by Article 22(2) of Regulation (EU) 2016/2031 and by Article 3(2)(a) of Implementing Regulation (EU) 2023/1134. Article 3(2)(a) of Implementing Regulation (EU) 2023/1134 requires MS to conduct risk-based surveys in line with the the EFSA pest survey card, in particular at areas where host plants enter the EU, where they are handled and repacked, and where their waste is disposed of, at airports and seaports, and at nurseries, garden centres and retail shops, as appropriate. The EFSA pest survey card suggests placing traps in fields of host plants and at storage and handling facilities dealing with host plants. The EFSA pest survey card indicates that S. frugiperda can establish in four regions of Italy ­ Calabria, Campania, Sardinia and Sicily, with transient populations possible in other regions. In total, 217 traps were planned in Italy in 2024, but just 35 of these, were in the four regions of Italy where the pest can establish. Sardinia planned 30 traps, Campania planned five, and both Calabria and Sicily planned zero traps. On the other hand, some regions such as Emilia-Romagna (30), Lombardy (42), Piedmont (20), Tuscany (10) and 12 Veneto (10) have relatively higher numbers of traps given that the EFSA pest survey card indicates that the pest cannot establish in these regions. The MAFF explained that these disparities are due to the limited human resources to conduct surveys in some regions, and the lack of resources in MAFF/CREA-DC to analyse the data and seek changes to the RPSs proposals to ensure a consistent distribution of surveys based on phytosanitary risk.

Sicily has 4 000 ha of tomatoes and 1 400 ha of peppers and aubergines. Solanum lycopersicum L. (tomatoes) are listed as host plants in Annex I, while Capsicum L. (peppers) are listed as specified plants in Article 2 of Regulation (EU) 2023/1134. It has approximately 5 000 nurseries. It also has five international airports (four civilian and one military) and four commercial seaports. The RPS in Sicily has not determined the number of traps needed, but in July 2025, it established two traps and had conducted three visual examinations at the time of the audit in September. Calabria has 1 500 ha of tomatoes and almost 400 nurseries. It has three international airports and four commercial seaports. In the 2021-2025 multi-annual survey programme, Calabria planned no surveys of any type for S. frugiperda, despite being one of the four regions of Italy where the pest can establish. In 2025, the RPS in Calabria noted this omission and had installed five traps and completed 10 visual examinations by the time of the audit but had not yet determined the number of traps needed based on risk. Lazio grows about 9 500 ha of Zea maize L. (maize) (a specified plant) and about 24 000 ha of vegetables, which include Solanum melongena L. (aubergines) (a specified plant) and peppers. Lazio has about 450 nurseries, two international airports and one seaport. In both 2024 and 2025, the RPS installed three traps for S. frugiperda. In all three cases, the RPSs acknowledged that this level of trapping is not sufficient to address the phytosanitary risk as required by Article 22(2) of Regulation (EU) 2016/2031 and by Article 3(2)(a) of Implementing Regulation (EU) 2023/1134.

Surveys for S. frugiperda are not planned based on the scientific and technical information referred to in the EFSA pest survey card as required by Article 3(1) of Regulation (EU) 2023/1134. The EFSA pest survey card for S. frugiperda clearly states that "detection surveys to substantiate pest freedom should be based on a trapping strategy" while Article 3(3) of Implementing Regulation (EU) 2023/1134 states that surveys shall consists of traps, and where appropriate, visual examinations. In both 2024 and 2025, approximately 1 000 - 1 100 visual examinations and 220 traps were planned throughout Italy for S. frugiperda. The three RPSs met by the audit team explained that they prioritise visual examinations during which inspectors can observe multiple pests during a single visit, instead of traps which are pest specific and require monitoring on an ongoing basis. This overall approach of focusing on visual examinations rather than traps is in conflict with the EFSA Pest Survey Card (which MS are obliged to follow under Article 3(1) of Implementing Regulation (EU) 2023/1134) and Article 3(3) of Implementing Regulation (EU) 2023/1134. 13 Planning annual risk-based survey programmes for A. ludens, B. dorsalis, B. zonata and R. pomonella

Surveys for B. dorsalis and B. zonata are not planned based on "the scientific and technical information" in the EFSA pest survey cards as required by Article 3(1) of Regulation (EU) 2025/311. Both pest survey cards clearly state that "trapping is the recommended method for surveillance and detection". In addition, Article 3(2)(c) of Implementing Regulation (EU) 2025/311 states that surveys for B. dorsalis and B. zonata shall be conducted by trapping and makes no reference to visual examinations in the case of routine surveys. Finally, the OTSS guidance documents for B. dorsalis and B. zonata state that surveys should be predominantly based on monitoring with traps.

In the 2021-2024 period, the ratio of traps to visual examinations for B. dorsalis (detailed in Table 2) ranged from 1:6 to 1:10 at national level. The ratio of traps to visual examinations is broadly similar for B. zonata and for other years. The three RPSs met by the audit team explained that they prioritise visual inspections due to a lack of staff. They explained that inspectors can observe up to 30 pests in fruit orchards in a single visit. On 14 the other hand, traps are pest specific, and they plan to check them every 7-10 days, which is much more demanding on staff resources. However, they acknowledged that it is not possible to identify the four relevant species of fruit flies by visual examination in the field but explained that these visual examinations are useful to assess the general health status of the plants.

Article 3(1) of Regulation (EU) 2025/311 requires surveys for B. dorsalis and B. zonata to be based on EFSA's General guidelines for statistically sound and risk-based surveys and the scientific and technical information referred to in relevant EFSA pest survey cards. The EFSA pest survey card for B. dorsalis identifies citrus and prunus species (particularly peach and nectarine) as the primary host species for detection surveys (these are also listed as host plants in Annex I to Regulation (EU) 2025/311). Sicily has about 70 000 ha of these host plants (62 000 ha citrus and 7 000 ha of peaches and nectarine). Calabria has about 35 000 ha (32 000 ha citrus and 3 200 ha of peaches and nectarines). Finally, Lazio has about 1 500 ha (800 ha citrus, 600 ha peaches and 50 ha nectarines). The EFSA pest survey card for B. dorsalis refers to the International Standard for Phytosanitary measures - ISPM 26 on Establishment of pest free areas for fruit flies in terms of trapping density. ISPM 26 recommends 0.25-1trap/100 ha in production areas, with higher trap densities in higher risk areas. The OTSS for B. dorsalis also uses the values in ISPM 26 for recommended trap densities. The mid-point value in this range of 1 trap/200ha is used in Table 3. The data shows that both Sicily and Calabria establish approximately 10% of the recommended number of traps, whereas Lazio region establishes a sufficient number of traps based on the EFSA pest survey card. Table 3. Numbers of traps for B. dorsalis Area of primary Recommended No. of traps No. of traps host species (ha) no. of traps in established in established in production areas 2024 2025 Sicily 70 000 350 20 29 Calabria 35 000 175 25 19 Lazio 1 500 8 20 12

The EFSA pest survey card for B. zonata identifies Prunus persica (peaches and nectarines) as the primary host species for detection surveys (these are also listed as host plants in Annex I to Regulation (EU) 2025/311). Sicily has about 7 000 ha of peaches and nectarines. Calabria has about 3 200 ha of peaches and nectarines and Lazio has about 600 ha peaches and 50 ha nectarines. The EFSA pest survey card for B. zonata refers to the ISPM 26, and on that basis, recommends 1 trap/100 ha in production areas, with higher trap densities in higher risk areas. The OTSS for B. zonata also uses the values in ISPM 26 for recommended trap densities. 15 Table 4. Numbers of traps for B. zonata Area of Recommended No. of traps No. of traps primary host species (ha) no. of traps in established in established in production areas 2024 2025 Sicily 7 000 70 20 29 Calabria 3 200 32 25 19 Lazio 650 6 20 12

In the case of A. ludens, surveys should be risk-based, carried out in all appropriate locations, and based on sound scientific and technical principles as required by Article 22(2) of Regulation (EU) 2016/2031. In addition, surveys should include a sufficiently high number of visual examinations, sampling and testing, to ensure, as far as it is possible given the respective biology of each priority pest and the ecoclimatic conditions, with a high degree of confidence, the timely detection of the pest as required by Article 24(1) of Regulation (EU) 2016/2031. The OTSS for A. ludens identifies citrus species as the primary host species for surveys and recommends 0.25-1trap/100 ha in production areas, with higher trap densities in higher risk areas. Sicily has about 62 000 ha of citrus, Calabria has about 32 000 ha and Lazio has about 800 ha. The mid-point value in this range of 1 trap/200ha is used in Table 5. Table 5. Numbers of traps for A. ludens Area of Recommended No. of traps No. of traps primary host species (ha) no. of traps in established in established in production areas 2024 2025 Sicily 62 000 310 10 10 Calabria 32 000 160 6 6 Lazio 800 4 2 2

The huge variation between regions in the intensity of surveys for specific pests is a result of the weakness in risk-based planning under Article 22(2) of Regulation (EU) 2016/2031. 16 This results in an inconsistent approach to surveys in different regions which can be seen by comparing Lazio to Sicily and Calabria in Tables 3, 4 and 5.

While Italy's multi-annual survey programme includes all (approximately 400) relevant pests, significant weaknesses in the planning (and subsequent implementation) of the annual risk-based survey programme, including for priority pests, means that the resultant surveys do not provide a reasonable level of assurance that these pests have not established in Italy.

The recommendation states as its basis

The multi-annual risk-based survey programme is drawn up by the CREA-DC based on proposals from the RPSs. CREA-DC explained that annual survey plans are also drawn up using this approach. Due to the weaknesses described in finding 9, the resultant risk- based (as distinct from statistically-based) survey programmes for Union quarantine pests and pests provisionally qualifying as Union quarantine pests are not risk-based, not carried out in all appropriate locations, nor based on sound scientific and technical principles as required by Article 22(2) of Regulation (EU) 2016/2031. In addition, in the case of priority pests, surveys do not include a sufficiently high number of visual examinations, sampling and testing, to ensure, as far as it is possible given the respective biology of each priority pest and the ecoclimatic conditions, with a high degree of confidence, the timely detection of those pests as required by Article 24(1) of Regulation (EU) 2016/2031, and are not conducted in line with pest-specific legislation.

While Italy's multi-annual survey programme includes all (approximately 400) relevant pests, significant weaknesses in the planning (and subsequent implementation) of the annual risk-based survey programme, including for priority pests, means that the resultant surveys do not provide a reasonable level of assurance that these pests have not established in Italy.

The recommendation states as its basis

At the time of the audit in September 2025, Italy had finished the process of drawing up contingency plans for just four of the 20 priority pests which are capable of entering into and becoming established in its territory on the basis of Article 25(1) and (4) of Regulation (EU) 2016/2031, Article 3 of Implementing Regulation (EU) 2020/1201 (X. fastidiosa), Article 4 of Implementing Regulation (EU) 2023/1584 (P. japonica) and Article 4 of Implementing Regulation (EU) 2025/311 (B. dorsalis and B. zonata). The finalised contingency plans relate to X. fastidiosa, P. japonica and a combined contingency plan for B. dorsalis and B. zonata. (In all cases, Italy has outbreaks of the pests).

In the case of the contingency plans for the remaining 16 pests, CREA-DC had drawn up 15 of these plans, which had subsequently been approved by the NPC. The MAFF stated that the final step of the process, a series of Decrees of the MAFF to formally adopt these plans were under preparation. The NPC was working on the contingency plan for S. frugiperda, with a view to finalising it by the end of 2025.

At the time of the audit in September 2025, the four completed contingency plans were published at https://www.protezionedellepiante.it/. However, these plans had not been communicated to the Commission and to other MS, as requested by the Commission in a letter to Italy in March 2024, by uploading them to the internet Rapid Alert System for Food and Feed (iRASFF) plant health portal, as required by Article 25(5) of Regulation (EU) 2016/2031.

The failure to finalise three quarters of the required contingency plans almost two years after the legal deadline means that Italy has yet to establish a solid starting point to deal with outbreaks for the majority of priority pests.

The recommendation states as its basis

MS are not required to carry out simulation exercises in cases where they have recently taken measures to eradicate the pest(s) concerned, given what they have learned from the practical experiences gained ­ this applies to six of the 20 priority pests in the case of Italy. Therefore, Italy is obliged to carry out simulation exercises for 14 priority pests. The MAFF stated that Italy has not completed any simulation exercises to date and has no documented plans to conduct such exercises, which is not in line with Article 26(1) of Regulation (EU) 2016/2031. 23 Conclusions on contingency plans

In the absence of contingency plans, the CAs have not conducted simulation exercises for relevant pests and therefore cannot demonstrate that they will be able to eradicate or, where appropriate, contain outbreaks of these priority pests, if and when they are detected.

The recommendation states as its basis

There are insufficient procedures and arrangements in place to ensure the effectiveness and appropriateness of official controls in the areas of feed and seed contrary to Article 5(1)(a) of Regulation (EU) 2017/625. The MH has developed detailed checklists for conducting official controls on feed operators. The NCPAN provides sampling guidelines and sampling report templates based on the requirements laid down in Annex I to Regulation (EC) No 152/2009. All controls on feed operators are recorded in a harmonised manner in the Veterinary Information system for food safety (SINVSA), a national Information Technology (IT) system used by all regions. However, the checklists used for controls on feed mills do not include any specific references to controls relating to labelling and traceability of feeds containing GMOs, or the requirement for operators to have a system to avoid the adventitious presence of GMOs in non-GM feeds. Consequently, the MH could provide no documentary evidence that these requirements are systematically controlled during inspections at feed business 4 operators. The guidance/instructions for taking seed samples for GMO analysis is deficient in a number of areas as described in findings 38 and 40. Conclusions on the organisation of official controls on GMOs

The procedures and arrangements on which controls on trials and food are based provide a sound basis for ensuring the consistent implementation of legislation on GMOs in these areas. Deficiencies in the checklists used by inspectors in the feed area mean that there is no documentary evidence that controls relating to labelling, traceability and the requirement for operators to have a system to avoid the adventitious presence of GMOs in non-GM feeds are performed.

Sampling of seed lots, which forms the basis of the control system for seeds, is not performed consistently due to significant deficiencies in the procedures provided to inspectors, which compromises the reliability of the control system on seeds.

The audit team observed official sampling of a lot of maize seed by ICQRF inspectors at a seed distribution premises; · There was no single guidance document to guide the inspectors. They used an International Seed Testing Association (ISTA) guidance document to determine the number of incremental samples to take from the seed lot, and four different ICQRF documents (a Ministerial Decree of 22 December 1992 on seed sampling, the Ministerial Decree of 27 November 2003 on controlling GMOs, a Circular Letter and an ICQRF handbook) to determine how to take the sample, · The inspectors acknowledged that they used the ISTA guidance based on their own initiative, and that this guidance was not specifically referred to in any of the other guidance documents, · The seed lot comprised 1.1 tonnes (65 bags x 17kg), and the inspectors decided to take 30 incremental samples based on the ISTA guidance, · The aggregate sample was not homogenised in a methodical manner as this is not covered in any guidance provided to the inspectors. (Homogenisation of the 10 aggregate sample is a critically important step in the process as any GM seeds present are likely to be heterogeneously distributed at low levels), · The inspectors took five final samples from the aggregate sample and weighed all five samples to ensure that they were at least 1.2kg, which equates to 3 000 seeds, in line with ICQRF guidance, · The samples were sealed and the sampling recorded in a national IT system, with one of the final samples and a copy of the sample report form provided to the operator, · Of the five final samples, two go to CREA-DC, one to the operator, one is kept for expert analysis if required by a judicial authority and one is kept for analysis by CREA Bergamo, in case of a dispute on the result of the first sample.

The audit team did not observe inspectors from CREA-DC sample a seed lot, but in the course of meetings during the audit, CREA-DC stated that it follows the same procedures and takes seed samples in the same way as the ICQRF.

The audit team was unable to observe official sampling of a seed lot at the point of import as there had been no consignment imported in the few days prior to the audit. It met with the Regional Phytosanitary Services of Tuscany, which shares responsibility for taking samples of soya seed imports at Livorno port with Customs. The Regional Phytosanitary Services explained that in practice, it controls every second import of soya seeds, with Customs controlling the other 50%. The Regional Phytosanitary Services explained how it had taken a sample from a recent import of soya seeds, and based on these discussions, the audit team noted that; · The Regional Phytosanitary Services determined the number of incremental samples solely based on a Ministerial Decree of 22 December 1992, whereas ICQRF determined this based on ISTA guidance, · It had taken 24 incremental samples from a 12-tonne consignment of soya seeds packaged in 10 bulk bags. The Ministerial Decree of 22 December 1992 requires one incremental sample per 500kg, and no fewer than ten incremental samples regardless of the lot size. (This approach results in a sampling intensity which is significantly lower than when using the ISTA guidance), · The inspectors took five final samples from the aggregate sample. Of these five samples, two go to a private laboratory for analysis and three are kept in a Customs warehouse to be used if the initial sample tests positive, · In all cases where the initial sample tests positive, rather than in cases where the operator challenges the result, the Regional Phytosanitary Services of Tuscany sends two of the remaining three final samples to CREA Bergamo for confirmatory analysis. 11

There are insufficient procedures and arrangements in place to ensure the effectiveness and appropriateness of official controls in the seed area as required by Article 5(1)(a) of Regulation (EU) 2017/625 as demonstrated by deficiencies and inconsistencies in the sampling methodologies implemented by the ICQRF and the Regional Phytosanitary Services of Tuscany as described above.

The deficiencies in checklists described in finding 11 means that there is no documentary evidence that controls determine if feed business operators comply with traceability and labelling requirements in line with Articles 24 and 25 of Regulation (EC) No 1829/2003 and Article 4 of Regulation (EC) No 1830/2003 and the obligation to have a system in place to avoid adventitious presence of GMOs in non-GM feeds in line with Article 24(3) of Regulation (EC) No 1829/2003.

While considerable operational resources are invested in controlling seeds, there are significant weaknesses relating to sampling and analysis, with the result that the control system does not provide reasonable assurances that seeds sown in Italy are free from GMOs. The importance of establishing an effective control system is demonstrated by the fact that in 2024, notwithstanding the weaknesses in controls, 3% of samples of imported soya seeds and almost 4% of soya seed samples tested under own-controls contained GMOs.

The system of official controls in feed is weakened by the failure to satisfactorily address risks linked to imported feed materials, the failure to test all samples for all relevant GM events, and the absence of documentary evidence demonstrating controls on labelling and traceability requirements, and the requirement for operators to have a system to avoid the adventitious presence of GMOs in non-GM feeds. Consequently, official controls do not provide a satisfactory level of assurance that feed marketed in Italy complies with EU requirements regarding GMOs.

The recommendation states as its basis

The NCPAN requires that at least 3% of imported feed consignments are sampled and analysed, but there are no specific targets for sampling and analysis related to GMOs, with one exception. The BCPs are instructed to sample all consignments of linseed from Canada and wheat from the United States of America (USA) due to previous detections of unauthorised GM events in these commodities from these countries. The NCPAN notes the low numbers of controls on imported feed materials in previous years and the risks associated with these products, given that GM crops are grown in many of the countries of origin. However, it does not establish targets for sampling and analysis for these materials, either at the point of entry, or during controls on the internal market. Given that Italy imports six to seven million tonnes of maize and maize derived products and about 2.5 million tonnes of soya and soya derived products each year, the failure to prioritise the sampling and analysis of imported feed materials for GMOs linked to the country of origin is not in line with Article 9 of Regulation (EU) 2017/625, which requires official controls to be carried out on a risk basis.

The planned official controls for GMOs in feed fail to address risks related to imported feed materials and organic feed, thereby weakening the assurance that animal feed marketed in Italy complies with legislation on GMOs.

In 2023, ASLs took 546 samples (99% of the planned number) of animal feed (comprising 155 feed materials and 391 compound feeds) which were analysed for GMOs. In the first nine months of 2024, 246 samples (86% of the planned number up to that point of the year) of animal feeds (comprising 79 feed materials and 197 compound feeds) were sampled and analysed for GMOs. While the NCPAN clearly states that at least 50% of samples should be feed materials, in both years, less than 30% of feed samples were feed materials, thereby failing to fully implement the planned risk-based programme as required by Article 9 of Regulation (EU) No 2017/625.

The BCPs sampled just four consignments of imported feed materials for GMO analysis in 2023, which is broadly in line with other years. While the risk arising from imported feed materials is identified in the NCPAN, samples of specific matrixes from specific countries are not prioritised for sampling and analysis for GMOs, as explained in finding 19.

The system of official controls in feed is weakened by the failure to satisfactorily address risks linked to imported feed materials, the failure to test all samples for all relevant GM events, and the absence of documentary evidence demonstrating controls on labelling and traceability requirements, and the requirement for operators to have a system to avoid the adventitious presence of GMOs in non-GM feeds. Consequently, official controls do not provide a satisfactory level of assurance that feed marketed in Italy complies with EU requirements regarding GMOs.

The recommendation states as its basis

Sixteen Environmental Protection Agency (Aziende provinciale per la Protezione Ambientale and Aziende Regionali per la Protezione Ambientale) (APPA and ARPA), IZS and ASL laboratories (including the NRL) are designated to do all official analysis on GMOs in food and comprise the Italian Network of Official GMO Laboratories. Ten of the sixteen laboratories are designated to do all official analysis on GMOs in feed. These laboratories are designated by the regions and autonomous provinces, rather than the MH. The audit team examined the designation provided by the two regions visited in the course of the audit. In neither case did it include a detailed description of the tasks to be carried out and the conditions under which these should be carried out as required by Article 37(4) of Regulation (EU) 2017/625.

Whereas the NRL is accredited for the analysis of 178 GM events, seven of the 16 designated official laboratories are accredited for less than 20 GM events, with a further four accredited for less than 40 GM events. The designation of these laboratories is not in line with Article 37(4) of Regulation (EU) 2017/625 which states that CAs may only designate official laboratories which have the expertise, equipment and infrastructure 16 required to carry out the required analyses. This weakness has been highlighted by the MH over several years, particularly at the regional coordination committee on GMOs.

The NRL explained that while many of the designated laboratories are accredited for a limited range of analysis, the network of laboratories can analyse for all relevant events. The NRL explained that the rationale in adopting this approach was that laboratories would focus on screening, and in case of a positive screening result, they either undertake quantitative analysis in-house or forward the sample to the NRL for further analysis. The NRL stated that approach, while ensuring all GM events are analysed, results in delays in completing analysis. In 2023, a quarter of feed samples and 10% of food samples were forwarded to the NRL following initial screening analysis by another laboratory in the network.

The NRL did not have detailed data on turnaround times for all laboratories in the network, but provided data for the NRL. This data showed an average turnaround time from sampling to the final analytical result of 39 days for GMO analysis in food and feed samples in 2023. This increased to an average of almost 80 days for positive samples. Turnaround times of this magnitude are not in line with Article 37(4)(d) of Regulation (EU) 2017/625 which requires official laboratories to deliver analysis results in a timely manner.

Seed samples are analysed for the presence of GMOs in five laboratories. While these laboratories have been designated, the designations do not systematically include a detailed description of the tasks to be carried out and the conditions under which these should be carried out as required by Article 37(4) of Regulation (EU) 2017/625. · All samples taken on the internal market, either by CREA-DC or the ICQRF, are analysed in the CREA-DC laboratory in Tavazzano. This accounts for about 50% of all seed samples tested under official controls each year. The laboratory is ISTA accredited for 13 GM events. It is not accredited for analysis of GMOs in accordance with the EN ISO/IEC 17025 standard as required by Article 37(4)(e) of Regulation (EU) 2017/625. The laboratory plans to seek this accreditation in 2025. The laboratory screens samples for the 35S promoter and the Tnos terminator, techniques which are capable of detecting 80% of GM events in maize and 33% of GM events in soya, · All samples taken by the regional Plant Health Services of Tuscany (i.e. samples of 50% of lots of imported soya seeds) are analysed in a private laboratory. (In December 2024, the CA changed to use a different private laboratory). In both cases, the laboratory was chosen by the seed industry and subsequently designated by the CA following a check to determine if it was accredited in accordance with the EN ISO/IEC 17025 to analyse for the presence of the 35S promoter. The operator pays for the analysis even though it is conducted as part of an official control. Both laboratories test samples by screening for the 35S promoter, which 17 can be used to detect 66% of GM events in maize and less one third of GM events in soya. · All samples taken by Customs (i.e. samples of imported soya and maize seeds) are analysed by the Customs laboratory in Genoa. This laboratory is accredited for analysis of GMOs (20 methods) in accordance with the EN ISO/IEC 17025 standard as required by Article 37(4)(e) of Regulation (EU) 2017/625. · All samples taken by the regional Plant Health Services of Friuli-Venezia Giulia (i.e. samples of imported maize seeds) are analysed by the Phytopathology and biotechnology laboratory of the region. This laboratory is accredited in accordance with the EN ISO/IEC 17025 for screening analysis for the 35S promoter, which can be used to detect 66% of GM events in maize and less one third of GM events in soya, · Finally, in cases where the initial laboratory result indicates the presence of GM material at, or greater than, a level of 0.1%, if the operator challenges the initial laboratory result, the sample is analysed by CREA Bergamo to get the definitive result. By exception, the regional Plant Health Services of Tuscany forwards all positive samples to CREA Bergamo for confirmatory analysis.

The CREA Bergamo laboratory is explicitly named as the laboratory for confirmatory analysis of GMOs in seeds under Ministerial Decree 27 November 2003. It is only capable of analysing samples for the presence of the 35S promoter. The laboratory is not accredited for analysis of GMOs in accordance with the EN ISO/IEC 17025 standard as required by Article 37(4)(e) of Regulation (EU) 2017/625 and does not participate in proficiency tests as required by Article 38(2) of Regulation (EU) 2017/625.

CREA-DC uses both analytical methods validated by the EU Reference Laboratory (EURL) and internally validated methods. The CREA Bergamo laboratory uses commercial test kits for its analysis. This approach is not in line with Article 34(2)(a) of Regulation (EU) 2017/625 which states that official laboratories should only use methods complying with internationally recognised rules or protocols or methods developed or recommended by the EURL, where these methods exist.

The deficiencies relating to designation, accreditation and the limited analytical scope of laboratories used for official controls of GMOs in seeds means that controls do not satisfy Article 4(5) of Directive 2001/18/EC, i.e. that seeds sown in Italy are free of GMOs. 18 Conclusions on the implementation of official controls

While considerable operational resources are invested in controlling seeds, there are significant weaknesses relating to sampling and analysis, with the result that the control system does not provide reasonable assurances that seeds sown in Italy are free from GMOs. The importance of establishing an effective control system is demonstrated by the fact that in 2024, notwithstanding the weaknesses in controls, 3% of samples of imported soya seeds and almost 4% of soya seed samples tested under own-controls contained GMOs.

The continued designation of official laboratories which are not capable of conducting the required analysis has resulted in significant delays in processing food and feed samples, with the result that non-compliances are not detected in a timely manner.

The recommendation states as its basis

Under the NCPAN for the period 2021-2023, 549 feed samples were planned for GMO analysis each year. Under the NCPAN for the period 2024-2026, this has been reduced to 380 samples per year. The MH explained that under the 2021-2023 plan, 389 samples were tested for authorised GMOs only, with the remaining 160 samples tested for unauthorised GMOs only. Under the 2024-2026 plan, all samples of conventional feed are being tested for both authorised and unauthorised events, with organic samples (which typically comprise about 10-12% of samples) being tested for unauthorised 5 GMOs only. This approach of analysing organic feed samples for unauthorised events only is sufficient to meet the requirements of Article 4(5) of Directive 2001/18/EC, but it is not sufficient to meet the requirements of Article 4 of Regulation (EC) No 1830/2003, as authorised GM events may be present at levels greater than 0.9%, (which requires the feed to be labelled as GM, and its marketing as conventional feed), but this non-compliance would not be detected if the analysis is only for unauthorised events.

The planned official controls for GMOs in feed fail to address risks related to imported feed materials and organic feed, thereby weakening the assurance that animal feed marketed in Italy complies with legislation on GMOs.

The recommendation states as its basis

While maize and soya are the two most widely grown crops in Italy which have been subject to genetic modification, the MAFF acknowledged that the sampling and analysis programme for GMOs in seeds has not been reviewed, and revised as necessary, since its inception in 2003 to reflect all identified risks as required by Article 9(1)(a) of Regulation (EU) 2017/625. Therefore, the programme does not meet the requirements of Article 4(5) of Directive 2001/18/EC, as other seeds which may be subject to GM modification, e.g. tomato, are not included in the scope of the control programme. 7 Conclusions on the planning of official controls

Official controls on seeds are based on an outdated plan that does not reflect all known risks, thereby failing to provide sufficient assurance that seeds sown in Italy are free from GMOs.

The MAFF stated that a Ministerial Decree of 27 November 2003 specifies the legal criteria for a seed sample to be deemed to contain GMOs, i.e. the sample is considered positive if the 35S promoter is detected at, or greater than, a level of 0.1%. The MAFF acknowledged that this criterion is outdated and does not meet the requirements of Article 4(5) of Directive 2001/18/EC as screening for 35S will not detect all GM events. It clarified that in practice, if any GM material is found in a seed lot at, or greater than, a level of 0.1%, it is deemed to be non-compliant. There is no tolerance for GM material in seeds in EU legislation, and therefore the presence of GM material at or above the limited of detection is a non-compliance. The operational criteria of 0.1% for all GM material adopted by MAFF is not in line with Article 4(5) of Directive 2001/18/EC, as CREA-DC, in which 50% of seed samples are tested, confirmed that its LOD is considerably lower than 0.1%.

The overall control system on seeds has not evolved to reflect new risks over the last 20 years and to define appropriate criteria to determine compliance. Finally, all available information is not used to target official controls on a risk basis.

The recommendation states as its basis

In cases where GMOs are detected in imported seeds, the seed lot is either sent abroad or destroyed at the expense of the importer. When GMOs are detected in seeds produced in Italy, the seed lot is destroyed at the expense of the operator by incineration or exported outside the EU. The ICQRF are satisfied that the destruction of seed lots is effectively a financial penalty, and on that basis, no further sanctions applied to the operator. Neither the ICQRF nor CREA-DC undertake any action to determine the origin and extent of the non-compliance as required by Article 138(1) of Regulation (EU) 2017/625, and do not prioritise sampling and analysis of associated seeds lots or further seeds lots from the same operator in line with Article 9 of Regulation (EU) 2017/625.

The failure to investigate the origin and extent of these breaches is a missed opportunity to gain information which could subsequently be used to improve the effectiveness of the control system.

The recommendation states as its basis

It confirmed that in the case of this private sampling and analysis it uses the same sampling methodology and analytical scope as for samples under official controls. The results showed that in 2023 and 2024 just 0.3% of all maize seed lots tested positive for GMOs, but almost 4% of soya seed lots tested positive, i.e. greater than 0.1% GM material. CREA-DC reports the results of these private samples to the relevant operator. It does not report these results to ICQRF or to the MAFF, and the operator is not obliged to inform the CAs of these results under national legislation. Neither MAFF in the context of the overall planning of controls, nor CREA-DC and ICQRF in the context of determining which operators and seed lots to target for sampling under their official controls seek, and take account of this data, which is not in line with Article 9(1)(d) of Regulation (EU) No 2017/625. 5.3.3 Controls on GMOs in food and feed Legal requirements Articles 4(2), 12, 13, 16(2), 24 and 25 of Regulation (EC) No 1829/2003 Article 4 of Regulation (EC) No 1830/2003 Article 4 and Annex I to Commission Regulation (EU) No 619/2011 Annex I to Regulation (EC) No 152/2009 Article 4(5) of Directive 2001/18/EC Articles 9 and 13 of Regulation (EU) No 2017/625 12 Findings

The overall control system on seeds has not evolved to reflect new risks over the last 20 years and to define appropriate criteria to determine compliance. Finally, all available information is not used to target official controls on a risk basis.

The recommendation states as its basis

However, the designation of the remaining eight laboratories, including the designated regional laboratory of Friuli Venezia Giulia, is not in line with Articles 38 and 40 of Regulation (EU) 2017/625, as they have not been accredited to EN/ISO 17025 for the diagnosis of insects and have not taken part in proficiency tests organised by the NRL for the specific determination of P. japonica or A. spiniferus, as required by Article 40 (1) (b) (iii) of Regulation (EU) 2017/625. Conclusions on the organisational aspects of the plant health controls

The lack of proficiency testing for these pests in some of the designated non-accredited laboratories increases the risk that the results are not sound and reliable.

The recommendation states as its basis

Thirty eight of the 40 relevant regions implement visual examinations in the BZs in line with Article 5(3)(a) of Commission Implementing Regulation (EU) 2022/1927. Only Abruzzo and Lazio reported they had not carried out any visual inspections in the BZs of their outbreaks.

Calabria and Umbria are the only regions which stated the use of traps for surveys in the BZs. The rest of the regions reported that trapping was not used due to the lack of specific traps for this pest. This is not in line with the requirements of Article 5(3)(b) of Commission Implementing Regulation (EU) 2022/1927 which specifies that, surveys shall include traps in the buffer zones of the DAs for containment. 5.4.6 . Awareness campaigns for A. spiniferus

For A. spiniferus, the implementation of measures in most DAs and the lack of verification of these measures cannot effectively prevent the spread of the pest from most of the IZs. This is further compromised by the absence of traps in most BZs and by the objective for containment rather than eradication in most recent DAs. The generally good implementation of awareness campaigns can help in identifying the eventual presence of A. spiniferus outside the IZs. 5.5 CONTROLS ON MOVEMENT OF SPECIFIED PLANTS AND PLANT PRODUCTS WITHIN THE EU Legal requirements Article 5 of Regulation (EU) 2016/2031. Article 9 of Commission Implementing Regulation (EU) 2023/1584. Findings 5.5.1 Inspections at the places of production for P. japonica

The recommendation states as its basis

The national level also developed guidelines on the interpretation and application of Regulations (EC) Nos 852/2004 and 853/2004. This guidance is directed at both operators and official controls officials. The audit team noted certain unalignments of the guidelines with the EU requirements, which is described under paragraph 33 below. 10

Based on the requirements of the applicable EU food law and the guidance issued by the national competent authority, each region issues several documented procedures covering the registration/approval of establishments, development of the control plan of operators (inspections and audits), the control plan of fishery products (see paragraphs 69 and 70 below), supporting documents for the official controls (risk-based matrices, checklists, reports, follow-ups, non-conformity notices, etc.) and reporting procedures (to report the control numbers and results to the national authority). The audit team noted a shortcoming in the implementation of the procedures for registration/approval, which is described in section 5.2 below.

The official controls are carried out supported by, in general, adequate documented procedures. Certain shortcomings were noted concerning the implementation of the procedures for registration/approval and the interpretation of Regulation (EC) No 852/2004.

In respect of registration of establishments and activities subject to registration, the audit team noted that the guidance document on Regulations (EC) Nos 852/2004 and 853/2004, issued by the national competent authority both to assist operators requesting registration/approval of their facilities and to assist officials in the performance of their official tasks, is not aligned with the EU rules, as follows: a. Contrary to point 4(b) of Section VIII of Annex III to Regulation (EC) No 853/2004, Italy considers the removal of skin of the fish (Selachii species) as an operation (associated operation) included in the primary production sector. This type of activity should only be allowed on approved vessels/establishments. b. Contrary to point 4(b) of Section VIII of Annex III to Regulation (EC) No 853/2004, Italy considers that the associated operations allowed on board fishing vessels can also be carried out in an establishment of an aquaculture farm as a primary production activity and covered solely by the registration of the aquaculture farm. An establishment of an aquaculture farm can perform this type of activities only if that establishment has been approved as required by Article 4(1)(b) of Regulation (EC) No 853/2004. Conclusions on registration/approval of food business operator establishments

The procedures adopted to register/approve establishments are broadly in line with the applicable rules of the EU food law. Nevertheless, the guidance issued by the national competent authority allows registered vessels to perform activities that can only be carried out in approved vessels and allows establishments of aquaculture farms to operate without the necessary approval (only being registered).

The recommendation states as its basis

The different levels of the authorities indicated that, in general, the number of staff available for the control tasks is adequate. However, in certain cases not all tasks are carried out as per the defined deadlines (in particular, those related to the approval of establishments and vessels, and official controls of approved vessels), mainly due to work overload linked with certification for exports and the displacement to international ports (for approved vessels).

Based on the requirements of the applicable EU food law and the guidance issued by the national competent authority, each region issues several documented procedures covering the registration/approval of establishments, development of the control plan of operators (inspections and audits), the control plan of fishery products (see paragraphs 69 and 70 below), supporting documents for the official controls (risk-based matrices, checklists, reports, follow-ups, non-conformity notices, etc.) and reporting procedures (to report the control numbers and results to the national authority). The audit team noted a shortcoming in the implementation of the procedures for registration/approval, which is described in section 5.2 below.

The official controls are carried out supported by, in general, adequate documented procedures. Certain shortcomings were noted concerning the implementation of the procedures for registration/approval and the interpretation of Regulation (EC) No 852/2004.

In this regard, the audit team noted that the information in S.Inte.S.I.S. shows that there are several establishments/vessels for which a conditional approval has been issued ­ according to the table provided there are currently 2 factory vessels, 52 freezer vessels, and 80 establishments on land which have a conditional approval. In 57 cases (establishment on land), those conditional approvals were issued more than 6 months ago. For 53 approved vessels, the conditional approval was granted more than one year ago. Therefore, the information existing in S.Inte.S.I.S. suggests that the deadlines applicable to the conditional approval to establishments on land and vessels were not respected.

The procedures related to the approval of establishments are not implemented as required by Article 148(4) of Regulation (EU) 2017/625 in respect of the renewal of the period of time for conditional approval and in terms of respecting the maximum period of time for that conditional approval. 13

The recommendation states as its basis

The audit team also reviewed the information provided by the national competent authority with regard to controls carried out (annual report on official controls ­ see section 4.2 above). The global figures for Italy show that overall 19% of the primary production fishing fleet was controlled in 2022 (1 148 out of 5 964 registered fishing operators (mainly fishing vessels)), which can be considered as being equivalent to one control every 5 years). 15 However, taking also into account the EUROSTAT figures, this percentage of cover drops to less than 10%.

Overall, the control system is implemented as planned, except for fishing (primary production) and freezer vessels.

The recommendation states as its basis

With regard to the addition of sulphites on board primary production fishing vessels, the audit team noted that the guidance document on Regulations Nos 852/2004 and 853/2004 (see paragraph 19 above) allows this practice under certain conditions: recording by the fisherman of the use of the additive; indication on the landing document of the use of the additive; and, existence of a label, or a specific indication, to be kept up to retail and sale to the final consumer.

The control procedures, on the use of sulphites by operators of primary production fishing vessels, do not cover all the relevant EU rules, in particular with regard to the maximum admissible levels for such additives, and are therefore not adequately checked by the competent authorities.

The recommendation states as its basis

The different levels of the authorities indicated that, in general, the number of staff available for the control tasks is adequate. However, in certain cases not all tasks are carried out as per the defined deadlines (in particular, those related to the approval of establishments and vessels, and official controls of approved vessels), mainly due to work overload linked with certification for exports and the displacement to international ports (for approved vessels).

The national competent authority indicated that the frequency for the controls of certain approved vessels (mainly freezer) is not respected due to the shortage of staff available for those controls, the remote location of the ports where the vessels may land, and the unpredictable working pattern of the vessels.

The national competent authority did not control this freezer vessel as required by the Italian procedures and by Article 67(b)(i) of Regulation (EU) 2019/627. Moreover, this vessel changed ownership in 2020 and the approval was transferred to the new owner 16 without an on-the-spot visit to ascertain that the initial approval conditions are still respected and have not been changed.

The national competent authority indicated that the situation, described in paragraph 51 above, is shared by many operators of crustacean freezer vessels and that the Italian rules will preclude the option to suspend the approval. According to these rules, a suspension of the approval is limited to a certain amount of time, after which the approval is either reinstated or is withdrawn. While understanding the limitations of the Italian provision, the audit team also considers that the current situation is not in line with the EU rules, namely Article 67 of Regulation (EU) 2019/627 and Article 148 of Regulation (EU) 2017/625. Landing operations, landing and first sales sites (auction hall)

Overall, the control system is implemented as planned, except for fishing (primary production) and freezer vessels.

The recommendation states as its basis

Despite good implementation of the official controls, the audit team found shortcomings with regards to the drafting and implementation by the operators of shelf-life studies for ready-to-eat products that are able to support the growth of Listeria monocytogenes, as required by Article 3 of Regulation (EC) No 2073/2005. At the same time, the different local authorities did not take the same approach for assessing those studies (see below). 17

The control system, covering the establishments on land, presents gaps in relation to the ability to assess that operators have in place adequate shelf-life studies for ready-to-eat products that are able to support the growth of Listeria monocytogenes. 18 5.3.2 Official controls of fishery products Legal requirements Council Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EU) 2023/915. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Implementing Regulation (EU) 2019/627. Findings

The recommendation states as its basis

This annual plan determines the total number of tests that each region must carry out on fishery products. The total number of tests is divided as follows: 45% of tests performed from samples taken from the production sector and 45% from the distribution sector. The remaining 10% are, by default, to be taken from the distribution sector, but each region decides the best allocation of these 10%.

The competent authority of the region visited provided the audit team with the regional sampling plan stemming from the national plan. The samples assigned to the region are then distributed by the different ASLs. The audit team noted that, in cases that could not be justified by the small number of samples, or the specificity of the parameter (e.g. environmental contaminants), the national instruction to distribute 45% of the samples at production and 45% at distribution, has not been followed. As examples, testing for histamine is only carried out on samples from the distribution sector, and the same for testing for Listeria monocytogenes in ready-to-eat food. Conclusions on official controls of fishery products

However, the non-adherence by the regional authorities to the distribution of samples defined by the national authority casts doubt on the complete adequacy of the regional control plan to achieve the objectives of the official controls set in the EU food law (verification of compliance with the applicable rules).

The recommendation states as its basis

With regard to the analytical methods for testing official control samples for the quantification of the level of heavy metals, the audit team noted that for one IZS the limit of detection of the method for cadmium does not respect the EU rules, in particular table 5 of point C.3.3.1 of Part C of the Annex to Regulation (EC) No 333/2007. The same finding was noted for another IZS in the case of the limit of detection for the method for lead.

However, and specifically for the testing of fishery products for cadmium in one IZS and for lead in one IZS, that reliability can be compromised by EU rules not being respected in relation to the EU rules on the limits of detection of the analytical methods used for that testing. (12) The initial information provided was supplemented with the information from the Italian accreditation body, Accredia, which is available at: https://services.accredia.it/accredia_labsearch.jsp?ID_LINK=1734&area= 310&dipartimento=L&desc=Laboratori. 22

The recommendation states as its basis

The audit team noted that the national list of approved and registered petfood plants published on the Ministry of Health website did not contain information on the product types placed on the market, contrary to the Commission technical specifications (4) and the requirements of Article 20a(a) of Regulation (EU) No 142/2011.

The list of Italian petfood plants on the Commission's Trade Control and Expert System (TRACES NT) was not up to date; 125 plants were listed vs. 184 on the website of the Ministry of Health. Thus, the requirements of Article 20a(b) of Regulation (EU) No 142/2011 are not met.

Based on the review of documents submitted by the Ministry of Health, the audit team noted that, in several regions, petfood plants that had stopped their activities for a long while were still present on the published list of petfood plants, despite several reminders sent by the Ministry of Health to RVS to ensure the timely removal of inactive operators from the national lists. Therefore, it cannot be considered that the list of petfood plant is kept up-to-date as required by Article 47(1) of Regulation (EC) No 1069/2009. Conclusions on registration, approval, and listing

There are arrangements in place for the registration, approval, and listing which should provide assurances that the operators active along the chain of petfood production are known and thus facilitate the implementation of official controls throughout this supply chain. However, the fact that the registration/approval data are not kept up to date (as evidenced by the disparity between the data in the national list and TRACES-NT), weakens an otherwise satisfactory system for approval and registration. 5.2.2 Planning of official controls

The recommendation states as its basis

In both of the raw petfood plants, the operators had received (and accepted) incomplete commercial documents for incoming Category 3 materials. These documents did not contain information demonstrating that, as required by Article 35(aa)(iii) of Regulation (EC) No 1069/2009, the ABP consisted of exclusively Category 3 material of the sub- categories defined in Article 10(a),(b)(i) and/or (ii) of the said Regulation, which are the only sub-categories allowed for the production of raw petfood in the EU.

The internal procedures of both operators did not mention any restrictions on the sub- categories of Category 3 material that could be used for production of raw petfood.

In one of the raw petfood plants, some raw materials of animal origin were not accom- panied by any ABP commercial documentation, contrary to the requirements of Article 21(2) of Regulation (EC) No 1069/2009. The operator stated that such raw materials were considered food and, in its opinion, ABP documentation was not necessary. How- ever, by definition, in accordance with Article 3(1) of Regulation (EC) No 1069/2009, these raw materials are ABP and must be accompanied by ABP commercial documents.

The incompleteness and absence of commercial documentation for ABP dispatched from food establishments (such as slaughterhouses and cutting plants) is also an indica- tion that official controls at food business operators where these ABP originate have not effectively verified compliance with ABP requirements. 5.2.3.2 Official controls in ABP plants

Firstly, storage conditions for PAP destined for use in petfood were unhygienic. Before bagging or dispatch in bulk, PAP were stored on an unclean and damaged concrete floor contrary to the requirements of Article 25(a) of Regulation (EC) No 1069/2009 and point C of Section I of Chapter II of Annex X to Regulation (EU) No 142/2011.

Secondly, Category 3 material used for the production of PAP were stored on the floor before processing, mixed with dirt from cleaning operations. Pits in which these materi- als were subsequently placed prior to their processing, were unclean and with remains of ABP from previous days. The raw materials used in production during the visit were highly contaminated with foreign bodies and therefore they should have been catego- rised as Category 2 material (Article 9 of Regulation (EC) No 1069/2009) and not used for production of PAP (Article 31(1)(a) of Regulation (EC) No 1069/2009). Company staff were removing foreign bodies from the raw materials before their shredding but, in spite of these measures, foreign bodies were still present in the shredded material sent to 8 cookers for their processing into PAP. Foreign bodies were also present in the final product (PAP). Representatives of the Ministry of Health informed the audit team that instructions regarding the need to monitor (and ensure absence of) foreign bodies in ABP from the food sector had been circulated to the RVS and ASL, and also to the in- dustry, on several occasions.

Thirdly, materials recovered from cleaning the processing equipment were recycled into processing. Such materials included sludge and remains of spoiled ABP that stayed in the unclean processing equipment for several days. Such materials should have been categorised as Category 2 material (Article 9 of Regulation (EC) No 1069/2009) and not used for production of PAP (Article 31(1)(a) of Regulation (EC) No 1069/2009).

In the raw petfood plants visited, the reports of the inspections reviewed by the audit team made no reference to the following serious non-compliances. In one of the plants, the operator did not carry out own testing for Enterobacteriaceae (hygiene criteria). On- ly a subset of this family of microorganisms was tested for. Testing by operator of raw petfood for Enterobacteriaceae is a requirement under EU rules (Point 6 of Chapter II of Annex XIII to Regulation (EU) No 142/2011) as it provides an assessment of the overall hygienic conditions at the plant. The same operator carried out analyses for Salmonella in raw petfood but only on one sample, instead of five, contrary to the aforementioned requirements of Regulation (EU) No 142/2011.

In the other plant, the audit team reviewed the operator's own-check Enterobacteriaceae results from 2023 to date. Several results were non-compliant (there were three or more samples with a bacterial count between 500 and 5000 colony forming units in 1 gramme of raw petfood). However, the operator did not consider the results to be non-compliant and therefore did not take any corrective actions to improve the hygienic conditions of the process, contrary to the requirement of Point 6 of Chapter II of Annex XIII to Regu- lation (EU) No 142/2011. This was not detected during official inspections carried out in that plant.

Notwithstanding these positive aspects, the official controls are not effective in verify- ing operator compliance with some of the applicable requirements as evidenced by the serious non-compliances identified by the audit team in establishments and plants visit- ed. These concerned the unsuitability of raw material used for the production of petfood (including lack of or incomplete commercial documents for any such raw material used), serious breaches of hygiene rules and absence of required own-testing of final product or absence of corrective actions by the operators following non-compliant own- testing results.

The recommendation states as its basis

The audit team noted that ABP consisting of raw fish were used for production of raw petfood in the two petfood plants visited. In January 2024, the Ministry of Health made use of a derogation laid down in Article 16(g) of Regulation (EC) No 1069/2009 to au- thorise the use of raw fish and other fish derived ABP, under specific conditions and on- ly for direct sale to the final consumer within the territory of Italy. ABP from raw fish to 9 be used in the manufacture of raw petfood must not show signs of alterations (from an organoleptic point of view) and be subjected to freezing at -20°C for at least 24 hours.

For petfood placed on the market, Article 35(a)(iii) of Regulation (EC) No 1069/2009 states that raw petfood must derive only from material referred to in Article 10(a) and (b)(i) and (ii) of that Regulation. As fish-derived ABP fall under Article 10(i) and (j), they cannot be used for the production of raw petfood in an approved petfood plant. 5.2.3.3 Actions taken in the event of non-compliance and follow-up

The competent authority has allowed the use of raw fish and ABP derived from fish for the manufacture of raw petfood at approved petfood plants, contrary to the EU require- ments.

The recommendation states as its basis

The audit team evaluated selected CHEDs validated for consignments in transit to ap- proved warehouses and CHEDs issued consequently for consignments split after storage in transit to BCPs of exit. The audit team noted that in some of those CHEDs, the goods have been described with the customs nomenclature (CN) code 9930 for goods delivered to vessels and aircraft rather than the relevant CN code for each of the commodities men- tioned in the accompanying official certificate according to the model referred to in Part I of the Annex to Commission Implementing Regulation (EU) 2019/2128.

The audit team further noted that, based on data in TRACES-NT for 2023 and 2024, the majority of CHEDs issued for non-conforming goods intended either for storage in ap- proved warehouses, ship supply vessels leaving the EU, or exit at BCPs for ship supply vessels located in a third country port relied on the use of the CN code 9930, which is not 10 in line with Article 40(1) and Part I of Annex II to Commission Implementing Regula- tion (EU) 2019/1715 and does not allow traceability of goods in transit.

Whilst the Ministry of Health stated that identity checks are full checks or limited to a checks on the seals on containers or means of transport, the audit team noted that, at the BCP with the highest throughput of consignments of goods of animal origin, identity checks are being carried out digitally based on information provided by the terminal op- erator on such consignments, which is not in line with Article 3(2) of Implementing Regulation (EU) 2019/2130. The Ministry of Health was not able to explain to the audit team how this digital control system operated. The Ministry of Health took action during the audit to discontinue this method and resume visual seal checks by staff at the BCP, albeit with stated reservations on its ability to fully implement those identity checks with current staff resources given the volume of containers arriving at this port.

During the visit to the one port BCP, the audit team noted that the minimum number of items or packages in a consignment selected for identity checks and physical checks of goods of animal origin intended for human consumption were not in line with Articles 3(2) and 4(4) and point 4(b) of Annex II to Implementing Regulation (EU) 2019/2130 and documented procedures.

The audit team evaluated five CHEDs for consignment of goods of animal origin re- entering the EU, of which three consignments were authorised to re-enter in compliance with Articles 2 and 3 of Commission Delegated Regulation (EU) 2019/2074. The re- maining two consignments were not accompanied by the official declaration referred to in Article 3(2)(b) of the same Regulation. In addition, both consignments underwent identity checks by means of a seal check in the absence of an official seal, which is not in line with Article 3(2) of Implementing Regulation (EU) 2019/2130. 5.2.4.3 Checks on consignments of goods of non-animal origin and food contact materials

The audit team identified that for several consignments of goods of animal origin evalu- ated, the CHEDs were not completed correctly in Part II by the competent authority, which is not in line with Article 40(2)(b)(ii) of Implementing Regulation (EU) 2019/1715. In six cases, the type of identity check was not indicated, in a further two cases the documentary check was considered satisfactory whilst the documentation ac- companying the consignment was not, in another case the physical check was considered satisfactory whilst the laboratory test results of a suspect sample were unfavourable, and the laboratory test results were only partly entered for another suspect sample. Conclusions on the implementation of official controls on animals and goods entering the EU

The official controls on consignments of categories of animals and goods entering the EU through BCPs in Italy are generally carried out in line with relevant EU legislation, documented procedures and planned arrangements. However, shortcomings were identi- fied in the performance of official controls on consignments of goods of animal origin, of which the digital seal checks at one BCP was the most significant, and in decisions taken on consignments of goods of animal origin. In addition, for certain products of non- animal origin, the required frequency rate of identity and physical checks was not im- plemented at a small number of BCPs. These shortcomings collectively undermine the overall effectiveness and appropriateness of official controls to ensure that only compli- ant consignments of animals and goods enter the EU.

The recommendation states as its basis

However, the audit team further noted, based on the same data, that the identity and physical checks on consignments of certain goods of non-animal origin subject to tempo- rary or emergency measures set out in Implementing Regulation (EU) 2019/1793 had, in some cases, not been carried out in line with the minimum frequency rates required by Articles 6 and 8 and Annexes I and II to that Regulation. The majority of the shortfalls in implementation of the required frequency rates concerned a small number of BCPs only. 5.2.5 Decisions on consignments and follow-up

The official controls on consignments of categories of animals and goods entering the EU through BCPs in Italy are generally carried out in line with relevant EU legislation, documented procedures and planned arrangements. However, shortcomings were identi- fied in the performance of official controls on consignments of goods of animal origin, of which the digital seal checks at one BCP was the most significant, and in decisions taken on consignments of goods of animal origin. In addition, for certain products of non- animal origin, the required frequency rate of identity and physical checks was not im- plemented at a small number of BCPs. These shortcomings collectively undermine the overall effectiveness and appropriateness of official controls to ensure that only compli- ant consignments of animals and goods enter the EU.

The recommendation states as its basis

The audit team noted that the port BCPs Livorno, La Spezia, Genova and Vado Ligure Savona, including seven inspection centres thereof visited, were not compliant with cer- tain minimum requirements for BCPs laid down in Article 64(3) of the OCR and Articles 3, 4, 6 and 8 of Implementing Regulation (EU) 2019/1014, for the categories of goods for which they had been designated.

The audit team noted the following non-compliances at the four port BCPs Livorno, La Spezia, Genova and Vado Ligure Savona, including seven inspection centres thereof vis- ited, designated for categories of goods of animal and non-animal origin: · the unloading facilities at the BCP La Spezia port, the inspection centres Calata San- ità (Terminal Sech) and Calata Massaua (Terminal Rebora) at the BCP Genova port and the inspection centre Terminal Lorenzini at the BCP Livorno port were con- structed in such a way that containers with consignments of goods cannot be appro- priately placed with handling equipment and consequently unloaded under a roof, which is not in line with Article 3(1)(a) of Implementing Regulation (EU) 2019/1014. · the unloading and storage rooms of the inspection centre Terminal Lorenzini at the BCP Livorno port were poorly maintained and consequently, not easy to clean or disinfect, which is not in line with Article 3(2) of Implementing Regulation (EU) 2019/1014. In addition, the inspection rooms at that centre were not appropriately equipped to examine and sample consignments, which is not in line with Article 4(2) of that Regulation. · the inspection centre PNAO at the BCP Livorno port did not have adequate drainage in the unloading, inspection and storage areas or rooms, which is not in line with Ar- ticle 3(2) and (3) of Implementing Regulation (EU) 2019/1014. · at the inspection centre Terminal San Giorgio at the BCP Genova port, the inspec- tion room did not have a supply of hot and cold running water, which is not in line with Article 3(1)(b) of Implementing Regulation (EU) 2019/1014. The BCP staff confirmed that inspection of goods takes place in part of the unloading area adjacent to the inspection room which does have these facilities. The Ministry of Health took action during the audit and modified the layout to include the area adjacent to the in- spection room as part of the inspection facilities. · in the case of the BCP Vado Ligure Savona port, shortcomings were identified by the Ministry of Health at the facilities for controls on consignments of goods of ani- 16 mal and non-animal origin. Its control report concluded that the facilities were non- compliant for serious health reasons, but the Ministry of Health had not taken any corrective actions such as the withdrawal or suspension of designation of the BCP in line with Articles 62(1) and 63(1) of the OCR respectively. The audit team con- firmed that the facilities were not compliant with the requirements laid down in Ar- ticles 3, 4, 6 and 8 of Implementing Regulation (EU) 2019/1014. The audit team vis- ited the new facilities at this BCP intended for goods of animal origin, which were not yet equipped, and which were found not to meet the minimum requirements for BCPs mainly due to the fitting of some walls, floors and ceilings which were not easy to clean and disinfect, which is not in line with Article 3(2) of that Regulation.

The audit team visited two control points designated by the competent authority for the performance of identity and physical checks on consignments of non-animal origin and noted that neither control points were compliant with the minimum requirements for BCPs, which is not in line with Articles 53(1)(a) of the OCR. In particular: · at one control point, part of the storage area adjacent to the inspection room is also used for the inspection of goods and did not have a supply of hot and cold running water and facilities for washing and drying hands which is not in line with Article 3(1)(b) of Implementing Regulation (EU) 2019/1014. · at the second control point, the audit team noted that part of the unloading area was rusty with flaking paint and there were cracks in the floors, and storage rooms were not maintained. The floors, walls, ceilings and fittings of the unloading area and storage rooms were dirty. The unloading area had pooled water in one part and was used to store cleaning and other equipment which was visibly soiled. The audit team noted that these facilities were therefore not easy to clean or disinfect, which is not in line with Article 3(2) and (3) of Implementing Regulation (EU) 2019/1014. In addition, two uncovered waste containers were present at one open unloading bay with decomposing fruit which had attracted fruit flies and other insects which were consequently also present in the internal facilities. Evidence of rodents was also not- ed in one storage room. The audit team therefore noted that the arrangements in place do not ensure compliance with relevant biosecurity standards required by Arti- cle 64(3)(i) of the OCR. The Ministry of Health took action during the audit and suspended the designation of this control point.

The BCPs, including inspection centres thereof, and two control points visited were found to be not compliant with certain minimum requirements for BCPs for the categories of goods for which they had been designated.

The recommendation states as its basis

A recent Ministerial decree in 2022 has consolidated biosecurity rules for pig establishments, taking into account requirements of the EU ASF Regulation and strengthening protection of establishments against the infection. A new dedicated IT tool is available for categorisation of establishments and selection for official controls. The system is however still under development, and the frequency of regular official controls to verify operators' compliance is not clear yet, even for restricted and infected zones. Hence results from the above efforts to increase biosecurity are yet to yield.

The laboratory network provides reliable and consistent support for the implementation of the ASF control programme. The competent authorities need to ensure that all regional laboratories which carry out confirmatory tests are accredited for the test method used as required by Regulation (EU) 2017/625.

Audits of the Regional authorities on the implementation of control measures take place but focus more on procedures rather than on operational activities, thus not fully ensuring that official controls ensure compliance with animal health regulations.

Data submitted on the inspections carried out show that the competent authorities followed so far in general the 1 % approach which is the same as 11 Repopulation will for official controls on registration and identification. One Region only be allowed (Piedmonte) visited had increased it to 3% in the free zone, other Regions when biosecurity reportedly apply still higher frequencies. In the restricted zones, the competent requirements are authorities had carried out inspections on biosecurity in all establishments, as adhered to. requested by the decrees of the Ministry of Health, without delay. It remained unclear however, at the time of the audit what the system of regular official controls, in particular in restricted zone I and in the free area, would be in the future.

The results of the biosecurity inspections varied in the Regions visited, some local health units (ASLs) reported a high number of non-compliances in 2022, following the new rules, but also in 2023. The audit team visited one newly registered establishment, and one existing, located in restricted zone II, which had upgraded their biosecurity measures to the standard as requested following official controls. In both cases, the authorities had approved the biosecurity plans before the establishments could start or continue their activities; the audit team assessed that both plans were generally in compliance with Annex III of Regulation (EU) 2023/594.

Member state response

ds controls in the infected area and in the restriction zones II and III, article 3, letter b), point iv of the Ordinance no. 5/2023 of the Special Commissioner for ASF, provides that any continuation or resumption of the commercial activity of farms is subject to the favorable outcome of the check performed by the official veterinarian of the local competent veterinary service. In addition, the enhanced biosecurity measures referred to in Annex 3 to the Implementing Regulation (EU) 2023/594 as amended must be adopted and the biosecurity levels referred to in the Ministerial Decree of 28 June 2022 must be ensured. In order to be considered valid, the results of the official control must be uploaded in the Classyfarm.it information system by specific checklists. Also for restriction zone I, article 4 of the Ordinance provides for the official control of all commercial farms to check the presence of enhanced biosecurity measures, again by the checklists of the Classyfarm.it system. The system is currently fully operating and where some mandatory requirements set by national or community legislation are not met by the operator, the system records an unfavorable outcome of the official

The recommendation states as its basis

Several components of disease surveillance in wild and kept porcine animals, particularly on larger commercial establishments, strengthen early detection of disease. The commencement of pre-movement testing for movement derogations presents an opportunity for further enhancement. However, operators of smaller family establishments, do not always report dead pigs and therefore increase a risk of a delayed detection and uncontrolled spread of ASF.

The order of the Commissioner 02/2023 of April 2023 further enhances the Clinical surveillance with compulsory sampling and testing of each dead pig to be examinations of carried out in restricted zone II, and of certain casualties (e.g. all boars and pigs during sows found dead) in restricted zone I. depopulation activities, home 33. As the authorities granted basically very few movement derogations for slaughter under movement of pigs from restricted zones under Regulation (EU) 2021/605 or veterinary Regulation (EU) 2023/594, the number of samples taken as pre-movement supervision. tests is very low.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

al authority monitors the progress of passive surveillance tic animals through the level of power and ation of SINVSA, simultaneously recommending to the and Public Administrations to meet the surveillance s set out in the National Plan. In addition, in accordance current Ordinance of the Special Commissioner for ASF, eas subject to restrictions both as part of the control in the infected area and in areas II and III, the local authority provides for immediate slaughter of the pigs n family farms, on semi-wild farms with commercial and on mixed farms that keep pigs, wild boars or their ds intended for food production, and provides for a ban lation. From the beginning of application of the Plan, it that the passive surveillance activities envisaged for c pigs were difficult to carry out, both for operators and inary services. For this reason, the Ministry of Health some tools to fill the gap, including risk analysis, in order fy high-risk farms (based on different parameters) and to n optimal allocation of resources. At the same time, courses and communication activities were carried out by rinary services throughout their territories, as well as by nal Reference Center for Pests in

The recommendation states as its basis

Regional authorities failed in implementing adequately the national action plan for wild porcine animals which included an objective to reduce the wild porcine animal population. The abundance of wild porcine animals undermines efforts of authorities and hunters to slow down the spreading of infection. Furthermore, the authorities' effort to confine infected wild porcine animal population and limit their contact with healthy animals in adjacent areas (fencing of infected zones) was unsuccessful.

Since 2022, the disease-free regions have issued urgent intervention plans for In Regions visited the management, control and eradication of ASF in kept and wild porcine targets for animals, with a view to reducing the risk of introduction and improving the reduction have management of wild porcine animal population. The competent authorities not been reached. were planning to draft further plans for trapping, killing and disposal of wild porcine animals and actions strategies for eradication plans in the areas of ASF restrictions to be approved by the regions, with a view to establish a national action plan according to Art. 56 of Regulation (EU) 2023/594. Reluctance of 17. The traditional way of hunting wild porcine animals in Italy is group hunting hunters to with groups of 20 ­ 40 hunters, with packs of dogs, only on dedicated days participate in (twice per week). depopulation activities. 18. Hunting in the infected area is in general prohibited, but selective/sanitary individual shooting to reduce the wild porcine animal population has been Incentives for allowed. In general, the competent authorities reported a reluctance of hunters carcass search to shoot wild porcine animals in restricted zone II, as the meat is not eligible and hunting have for human consumption, but also in restricted zone I due to limitation to use not proven to be meat only for own consumption (ban on placing on the market). In natural effective. reserves, e.g. in parks in Rome where hunting is not possible, authorities use different traps and tele-anaesthesia with further euthanising of animals. The authorities reported sabotage from animal rights activists, and therefore it is only possible to place traps on private ground which reduces the effectiveness of these measures. The above have undermined efforts to reduce wild boar populations.

The citation could not be resolved to a numbered paragraph in the report.

Therefore, the authorities have envisaged to pay higher incentives, e.g. 90 or 100 for the hunting of each female adult/subadult in restricted zone I, and at least 20 for wild porcine animal reported in restriction zone I or II. Funding for these incentives is secured by regional programmes and the Commissioner. Fencing was 20. Fencing as an effective measure to contain ASF in wild porcine animals was delayed, existing planned from the beginning, according to the eradication plans, but could be barriers such as implemented only with a considerable delay. In one Region, due to long motorways need lasting tender procedures, administrative burdens and problems in securing to be reinforced funding, a partial closure of an infected area wase reached five months after by additional the detection of first cases; by that time, the cases of ASF were detected fencing. outside of fenced area. In general, the difficult terrain in mountainous regions hampers fencing, but the authorities also encountered reluctance of municipalities to build fences and resistance of the population. ASLs also reported that local knowledge was not considered for the best routing of the fences.

The citation could not be resolved to a numbered paragraph in the report.

The authorities also took efforts to reinforce existing fences along motorways 13 which are considered a barrier against the spread of ASF, and to close gaps such as bridges and underpasses. In Lazio, the ring motorway around Rome is considered such an existing barrier, but not all of its many bridges and underpasses can be closed (e.g. along railway tracks and rivers). Currently the authorities managed to close around 60%, which still leaves gaps for wild porcine animals to pass through. Recently a first positive wild porcine animal has been detected outside of the ring motorway. Level of Biosecurity during hunting structural biosecurity during 22. The authorities have provided regular information to hunters, e.g., via leaflets hunting has been or specific training related to biosecurity during hunting. IZS provided upgraded training on how to take samples from hunted wild porcine animals in restricted considerably. zone I. Adequate 23. In restricted zone I, where own consumption of wild porcine animals hunted is measures are in allowed following a negative ASF test, the authorities initiated the installing place for of dedicated places for evisceration and dressing which must also be equipped collection of with chillers and have arrangements for disposal of carcasses and animal by- carcasses and products in place. They carry out official controls to ensure compliance with sampling from these requirements before hunting is allowed to hunting companies. These restricted zone II. installations were funded by the Regions, additional funding will be granted by new Commissioner decree.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

g and Disposal of Wild Boars (Sus Scrofa) and Strategic r the Development of Eradication Plans in ASF -year period 028. The Plan applies throughout the national territory, he exception of Sardinia Region. onal plans for urgent actions enforce the afore-mentioned rdinary capture and culling plan throughout the national ory free from ASF, with the exception of Sardinia Region. ovisions of the Eradication Plans and the Ordinances of the rdinary Commissioner for ASF apply in the restriction s were divided into criticality classes, based on: t; age annual economic extent of damage to agriculture ed between 2019 and 2021; Page: 5 G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever ere the % he and te ns G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever s. nt cuum; d area he tion curity. he act em. boar e, G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever ng boar the nt ote ffective ies ive ed ze l plan e nd safe e of G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever lpine vene in . on d in G(SANTE) 2023-7733 of the audit

The recommendation states as its basis

In the restricted zones, the competent authorities applied depopulation of pig establishments 8 rapidly, facilitated by the small number of holdings managing to keep the infection outside of domestic pig establishments. Derogations for movements of porcine animals and pig meat/products were granted only for movements within restricted zones II, under certain conditions which could however not fully ensure that pig meat/pig products would not circulate outside the restricted zones.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

2023, the two competent Directorates General for Health and Food Safety developed guidelines and ion-making schemes for the issue of special authorizations nt to Regulation (EU) 2023/594. This allowed to support petent authorities in issuing derogations to the movement , products and by-products of animal origin from the ASF tion zones, as well as to ensure clearer and more uniform res for designating plants, marking, certification and tion of the products above in accordance with the general cific requirements set out in Regulation (EU) 2023/594. 0 G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever he EU) as ent he ast y e e d e s efore t G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever al ry e . y- n cle s for le must ts for d to tent ions G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever osed by the competent authority rators in the slaughter sector. Furthermore, unlike 2021/605 in force in the audit reference period, 2023/594 covers the movements of pigs within the zones. In Piedmont Region, the slaughterhouses located were attached to retail stores a

The recommendation states as its basis

In the restricted zones, the competent authorities applied depopulation of pig establishments 8 rapidly, facilitated by the small number of holdings managing to keep the infection outside of domestic pig establishments. Derogations for movements of porcine animals and pig meat/products were granted only for movements within restricted zones II, under certain conditions which could however not fully ensure that pig meat/pig products would not circulate outside the restricted zones.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

o standardize compliance and adoption throughout the territory of the conditions referred to in Regulation ll official veterinarians in charge of the supervision ontrol of slaughterhouses and plants for subsequent cutting ing received the documents and decision-making erred to in recommendation no. 3. These also include ditions that the animals must meet to access the use of destination and that must be documented by the g document and the other information systems o the official veterinarians. ents also specify the cases when the common mark on meat and products and those when the special mark lied, as well as the cases requiring health certification here the exemptions provided for by article 18 of 2023/594 can be applied.

The recommendation states as its basis

The laboratory network provides reliable and consistent support for the implementation of the ASF control programme. The competent authorities need to ensure that all regional laboratories which carry out confirmatory tests are accredited for the test method used as required by Regulation (EU) 2017/625.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

tion ensures that testing laboratories, including the , fulfill all the requirements of the standards to onformity assessment activities. Istituti Zooprofilattici Page: 13 G(SANTE) 2023-7733 of the audit carried out from 15 June 2023 to 27 n to African swine fever n Proposed by the competent authority mentali (IIZZSS) labs, in charge for one/two or three regions, ublic labs, operating under an accreditation scheme (UNI CEI O/IEC 17025), whereas the diagnostic tests to be accredited stablished by each IZS, based on the strategic directions of ZS Directorates. In Italy the sole Accreditation Body nted by the Government is Accredia. DIA: the steps of the accreditation path for diagnostic rocess of accreditation for a diagnostic test runs from the cation to the granting of accreditation, as follows: plication pplication must be made in the original form, clearly and , according to the specific activities required by the lab. It include also all the documents requested and be signed by an rised representative of the IZS. It is examined by the ical Officer of the relevant Accredia department for iance with all the above requirements. If the outcome of this is positive Accredia informs th

The recommendation states as its basis

Audits of the Regional authorities on the implementation of control measures take place but focus more on procedures rather than on operational activities, thus not fully ensuring that official controls ensure compliance with animal health regulations.

In addition, the audit team noted a few weak points in the carcass collection centres in restricted zone II visited. In one case, the refrigerated container for the storage of carcasses until collection for disposal was located outside the premises, though accessible only from the premise, and in another case the newly installed wheel wash for disinfection of transport vehicles did not 14 appear fully fit for purpose.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

dit activity by the central authority was carried out as a the audit referred to in these recommendations to check and effectiveness of the measures and procedures d by the Regions subject to ASF restrictions. as specified above, the two competent Directorates e Ministry of Health developed specific guidelines on-making schemes for the issue of special ions pursuant to Regulation (EU) 2023/594. This support the competent authorities in issuing s to the movement of pigs, products and by-products of gin from the ASF restriction zones, as well as to ensure d more uniform procedures for designating plants, ertification and destination of the products above in with the general and specific requirements set out in (EU) 2023/594. Page: 16

The recommendation states as its basis

Of the 44 designated laboratories, 24 are accredited to EN/ISO 17025, while the remaining 20 laboratories are designated under the derogation in Article 40 of Regulation (EU) 2017/625. Although required by Article 40 (1)(iv) of Regulation (EU) 2017/625, no proficiency tests on OFF have been organised by the NRL for the non- accredited laboratories. The NRL stated that this is scheduled for early 2024. 5 Conclusions on the organisational aspects of the plant health controls

The combination of a clear legal framework, CAs with clearly defined responsibilities and allocation of resources provides a solid foundation for the eradication of the outbreaks of OFF in Italy. The lack of verification of the work of non-accredited laboratories via proficiency tests organised by the NRL increases the risk of incorrect diagnostics of OFF.

Member state response

The provisions of article 10, paragraph 2, of Ministerial Decree 169819 of 04/13/2022 "Characteristics, areas of competence, structures and methods of recognition of laboratories operating in the field of plant protection" will be implemented. In 2024 a specific PT will be carried out for the recognition of adults of Bactrocera dorsalis and B. zonata as officially planned by the National Phytosanitary Committee in the session of 5/02/2024. Deadline: December 2024

The provisions of article 10, paragraph 2, of nisterial Decree 169819 of 04/13/2022 "Characteristics, areas of competence, structures and methods of recognition of as laboratories operating in the field of plant protection" will be implemented. In 2024 a specific PT will be carried out for e recognition of adults of Bactrocera dorsalis and B. zonata as officially planned by the National Phytosanitary Committee in the session of 5/02/2024. Deadline: December 2024

The recommendation states as its basis

In 2021-2022 the NRL organized a proficiency test for the designated laboratories. Each of the 31 laboratories, designated by MIPAAF for Xf analysis, participated. The NRL stated that: · The scope included testing the presence of Xf subspecies pauca and multiplex in a matrix of DNA extracts of plant samples of Lavandula sp., Olea europaea, Prunus dulcis, Salvia rosmarinus and Vitis vinifera. · The laboratories were asked to analyse the samples with the method(s) they commonly used for Xf detection. Each laboratory used at least one of the molecular methods listed in Annex IV to Regulation (EU) 2020/1201; · The performance of 29 laboratories was assessed as fully satisfactory. Two laboratories had issues with the detection of Xf subspecies multiplex in the DNA extract of lavender plants. The NRL recommended corrective actions, which have already been implemented by the two laboratories.

The Xf proficiency tests organised by the NRL provide limited reassurance on the activities of the official laboratories as the DNA extraction part of the procedure was not assessed. The ISO/EN 17025 accreditation of the official laboratories, once finalised, will also provide additional guarantees for the appropriateness of the tests.

Member state response

s are In 2023, a test performance study will be organized are by the National Reference Laboratory which will Response of Lazio: include, on plant and insect samples, the application Until DAFNE laboratory obtains Accredia of the entire procedure including DNA extraction in certification, tests for the investigative order to guarantee a global assessment of the activities in the demarcated and free areas sis. performance of the official laboratories. Currently, (except at registered operators), as considered ere are 9 accredited laboratories for Xylella "other official activities" as defined by Article fastidiosa (art. 37 OCR), while for bacteria in 2 of Regulation (EU) 2017/625, are carried out general there are 11 accredited laboratories + by DAFNE pursuant to article 40 of Reg. (EU) CREA. On 20/5/2022 CREA-DC organized a PT on 2017/625. the diagnosis of Xylella fastidiosa with the official methods ex Reg. (EU) 2020/1201, where 28 RPS laboratory took part: Response of Apulia: Following the MIPAAF Decree N° 0422185 of Tuscany: 13/09/2022 granatini financial contributions The RPS laboratory of Tuscany Region was to accredited on 22/4/2022 for two tests in qPCR for Xylella fastidios

The recommendation states as its basis

The audit team noted that in 2021, compared to the 2020 surveys, which were assessed by the 2021 audit report: · The total number of plant samples increased by 8% while those of the vector increased by 94%. For plant surveys the share of samples from nurseries increased, while the share of symptomatic samples decreased. The majority of insect samples was collected in orchards and other green areas; · The issues highlighted in the 2021 audit report concerning the organisation and coordination of the surveys remained unaddressed. There were significant differences among the regions in the number of survey sites and samples. MIPAAF had only general information about the surveys, in the form of figures according to the reporting templates required by the Commission services. MIPAAF was not aware of the details of the activities and not of the detailed risk criteria, established by each region; 9 · Similarly to the 2020 situation, the scope of the surveys, the number of samples collected and the range of host plants checked remained limited in certain regions neighbouring the DAs, which may not reflect the existing plant health risk.

The national contingency plan for Xf was published in the form of a MIPAAF decree of 24 January 2022. The audit team checked that the plan was prepared in line with the relevant provisions of Regulations (EU) 2017/625 and 2020/1201 and contains nearly all required elements. However, the provisions in relation to the requirements on the minimum resources to be made available in case of a confirmed and suspected presence of Xf are too general and not mandatory for the regions. Therefore, the proper and timely implementation of the necessary actions is not ensured.

Member state response

a in In general, Italy carries out an extensive national esent, survey for Xylella fastidiosa, the largest in the The 2023 monitoring plan with the required red by Union in terms of inspections and analysis. All information has been forwarded to the regions are involved and the level of investigation Commission and is attached to this communication. is related to the characteristics of the region, the cultivated areas and the nursery activity. The official surveys are planned and carried out on the basis of national guidelines for monitoring, which defines the main risk factors to be taken into account. In carrying-out out the investigations in free areas, the plant species most sensitive to severe subspecies of the bacterium are more submitted to sampling for laboratory analysis. The large number of host plants listed in the regulation is not presented in the various survey sites. The new mandate of the Ministerial working group for the National Survey plan, which defines the composition, roles and responsibilities (in which all the regions and CREA participants), has implemented the activities to improve this aspect too. In 2023, the new survey campaign in the free areas will be

The recommendation states as its basis

The national contingency plan for Xf was published in the form of a MIPAAF decree of 24 January 2022. The audit team checked that the plan was prepared in line with the relevant provisions of Regulations (EU) 2017/625 and 2020/1201 and contains nearly all required elements. However, the provisions in relation to the requirements on the minimum resources to be made available in case of a confirmed and suspected presence of Xf are too general and not mandatory for the regions. Therefore, the proper and timely implementation of the necessary actions is not ensured.

The National Contingency Plan is generally in line with EU requirements, however, despite the possibility of central funding, it is not ensured that the regions would make available the minimum resources necessary to deal with a possible future outbreak of Xf.

Member state response

a Discussions are continued at the level of the National Phytosanitary Committee, in order to provide for an annual allocation by the Regions of a w percentage share (to be defined) of the regions ies of Italy in response to Report ref. DG(SANTE) 2022-7401 of the audit carried out from 13 June and controls for Xylella fastidiosa Action Proposed by the competent authority Updated Action Proposed by the Competent Authority ng through the plant protection fund. The National Plant Protection Fund, under ne In particular, DM 19/11/2021, No 0607484, has the article 57 of Legislative Decree 19/2021, U) defined the criteria for the use of the phytosanitary provide every year financial resources to the fund, with a specific amount for the implementation Regional Phytosanitary Services in order to of the activities of the RPS. performe phytosanitary activities according to the criteria established by Ministerial Decree No. 0607484 of 19/11/2021 (article 6). Every year, the Strategic Activities Plan that is approved by the National Phytosanitary Committee provides in detail the phytosanitary interventions to be carried out in the current year by allocating resources from the Fund to each Regi

The recommendation states as its basis

The audit team noted that: · As the 2020 surveys were carried out with a non-statistical, square based approach, the direct comparison of the results with the 2021 survey results is not possible; · The statistical surveys were designed in line with the relevant provisions of the EU legislation. The higher risk category was correctly applied for the first 400m parts of the BZs and for the epidemiological units with olive groves and Prunus sp. orchards; · The repeated detection of Xf in certain parts of the containment area indicates the presence of the inoculum in that area. Consequently, the categorisation as high risk of the first 400m part of the area from the border of the BZ instead of the rest of the IZ could have enhanced the chance of the detection of any positive there and so reassure the protective function of the BZ; · Only the first 50m part of the 400m circles around the positive plants, removed earlier in the containment area, were considered as high risk, which is not in line with the EFSA guidelines; · With the number of inspections and samples the level of confidence and targeted prevalence of the pathogen, required by the relevant provisions of Regulation (EU) 2020/1201 were met or exceeded in each part of the DAs; · The number of samples taken from each square was in line with the requirements of the statistical method. However, the presence of symptomatic specified and other plants in the square was not taken into consideration as a risk factor for selecting the plants for sampling; · The surveys were carried out in a period which is appropriate for the detection of the infection of the specified plants; · In the central database, information is available about the individual plants which were sampled during the previous surveys. This information was not made available for the ARIF agents, although it could have been a useful asset for the selection of plants to be sampled; · ARIF agents implemented the surveys fully in line with the RPS guidance documents. The relevant data are thoroughly registered in the IT system, which ensures full traceability; · The applied pooling system enables the analysis of higher numbers of samples with the existing laboratory capacities, however, it increases the time needed for the confirmation of positive results by 5-10 days on average; · The figures for the 2021 surveys clearly indicate the considerable efforts made by the authorities. Although the number of positives is relatively small compared to the total 16 number of samples, their territorial distribution indicates certain patterns of the distribution of the disease in the DAs, which necessitates the fine-tuning of the 2022 surveys according to the identified risk. · Except for the Alberobello outbreak, Xf was not detected in the Salento BZ during the 2021 surveys. In the Salento containment area there are outbreak hot spots, which require particular attention and quick actions. · The high number of positives in the Monopoli DA indicates the strong presence of bacterial inoculum and the associated risk of spread.

The 2021 statistical surveys were planned and implemented generally in line with requirements of the EU legislation and the achieved level of compliance and targeted prevalence exceeded the minimum required by the EU legislation. Although a generally risk-based approach was used for targeting the specified plant population with the surveys, not all existing risk factors were taken into consideration. Therefore, the achieved results may not reflect entirely the actual spread of the disease in the DAs.

The audit team noted that: · The planning of the statistical surveys was in line with provisions of Regulation (EU) 2020/1201. The fine-tuned design of the 2021 took into consideration sufficiently the risk factors, including those which were identified during the 2020 surveys; · The implementation of the statistically sound inspections and sampling was compromised, as access to some parts of the squares was impossible or limited (hilly landscape, impenetrable forests, holiday properties); · Due to high number of plant species tested positive in the IZs, which are all present in each of the established epidemiological units, the pragmatic approach used for the distribution of the samples among host species may not provide comprehensive feedback about the actual spread of the disease; · The number of positive tested plants and vectors indicate that the bacterial inoculum is present in the BZ, mainly in its promontory part. 26 5.7.3 Surveillance in the infected zone

Significant efforts were made to implement the surveys in the DA and in its vicinity in line with the EU rules. The existing risk factors were correctly considered for the planning, however access issues to certain parts of the Monte Argentario promontory and to private properties and the very high number of host species present compromised the possibility to obtain a full picture about the spread of the disease.

Member state response

tely Apulia: ased In the application of Ribess + software, were scribed 3 different levels of risk and defined the lative areas: gh Risk (HR) - Risk Value 2 400 m wide area (50 to 450 m) sited around the m radius buffer of each plant found to be fected in the 2021 monitoring; 400 m wide area sited between the Salento ntainment area and the remaining Salento fected area running from the Ionian Sea to the riatic Sea; 400 m wide area sited between the Salento ntainment area and the Salento buffer zone nning from the Ionian Sea to the Adriatic Sea; dium risk (MR) - Risk value 1.5 400 m wide area (450 to 850 m) close to the area ported in point 1 in High Risk (HR); sic risk (BR) - Risk value 1 The remaining area of each single delimitated area which is known the present of specified plants. nsequently at the identification of numerous ies of Italy in response to Report ref. DG(SANTE) 2022-7401 of the audit carried out from 13 June and controls for Xylella fastidiosa thority Updated Action Proposed by the Competent Authority of Monopoli and in the agri of: Response of Apulia: astellana In the Action Plan adopted in 2022, for the t No. 67 of application of RIBESS +, the 400m wide area ced

The recommendation states as its basis

The RPS published the following mandatory measures for the landowners in the DA: In spring ­ destruction of herbaceous vegetation, where the juvenile stages of the vector live, by soil tillage or shredding. From May to October ­ control of the vector population with 23 insecticides authorised for the crop. The RPS stated that the implementation of the measures is verified by random checks at selected growers.

The audit team noted that the level of implementation of the vector controls was not satisfactory, as in the IZ, and along the roadsides in the BZ, herbaceous vegetation with juvenile stages of the vectors was present. The high number of vector catches (see section 5.7.2) also indicates the limited effectiveness of the vector controls. Conclusions on the controls applied in the Region Lazio in relation to the Xf outbreak

The quick removal of the positive tested plant eliminated the risk of spread from that tree. The positive impact may be compromised by the incomplete inventory of specified plants and the non-compliant vector controls.

Member state response

es for Lazio: ted In July 2022, an awareness meeting was organised al with the stakeholders of the Canino area in which f the measures for the control of Xylella vectors indicated in Article 8 of Regulation (EU) ies of Italy in response to Report ref. DG(SANTE) 2022-7401 of the audit carried out from 13 June and controls for Xylella fastidiosa ction Proposed by the competent authority Updated Action Proposed by the Competent Authority 020/1201 were explained. These measures had Response of Lazio: een ready to be the subject of phytosanitary From November, the verification of the rescriptions to the owners and tenants of the land carrying out of the treatments for the control alling in the infected area and in the buffer area. of the vectors by the companies falling within n addition, a specific meeting was held with the the delimited area will be initiated. echnicians of the main producer organisations The checks will be carried out by: resent in the area in which the list of authorised - Intensification of control of the ctive ingredients for the control of vectors that is company book of phytosanitary uthorised on the main crops present was defined in treatments that the farms ar

The recommendation states as its basis

The RPS stated that: · Since the 2021 audit each plant which tested positive during the 2021 surveys was removed, i.e., 19 plants in the seven IZs established in 2021 and 92 in the IZs established earlier; · In the newly established IZ in the municipality of Orbetello, which is on the connection area of the mainland to the promontory, all specified plants were identified 27 and removed. In the other, newly established, and already existing IZs, on the territory of the Monte Argentario promontory, the specified plants were removed only in the 5 m vicinity of the positive tested ones. Altogether 2,220 specified plants were removed, in addition to the 111 positives; · Due to the existing environmental and forest fire protection rules the removals were carried out during the winter and spring, and were completed in May 2022, before the start of the flight period of the vectors. The plants were destroyed, and vector controls were applied in line with the relevant provisions of the EU legislation; · In the IZs in the promontory part of the DA the full implementation of the relevant provisions of Regulation (EU) 2020/1201 is not possible as the territory is characterized either by steep slopes and cliffs, which are inaccessible or covered by impenetrable Mediterranean vegetation, making any plant removal impossible or very dangerous. Most of the flora in the IZs is composed of specified plants and their removal would cause environmental, hydrogeological, landscape and forestry constraints. In the costal parts of the promontory, there are swamps and abandoned private areas, where finding the owner or obtaining access is very difficult.

The number of positive tested plants and vectors indicates a strong presence of the bacterial inoculum in the IZs and many parts of the BZ in the promontory. It is also an indication that the current practice of the plant removals, which is not in line with the provisions of the EU legislation. Although the BZ was established in line with the minimum requirements of the EU legislation, due to the inappropriate plant removals it may not protect sufficiently the spread of the disease from the DA.

Member state response

to (e) of As provided for the art.7 par.1 from a) to e) of Reg (EU) 2020/1201, the removal of plants in a radius Response of Tuscany: f 50 m from the infected plants, has been A survey is currently underway on all the ompletely done, in all the IZs inside Orbetello infected areas located in the territory of the unicipality. Specified plants never found positive Municipality of Monte Argentario where the o Xf in the Tuscany outbreak, located in the IZs, infected plants and all the specified plants ere analysed, as provide for letter e) of the art. 7. present within five meters of them have been ll of these were negative and were not felled. The removed to verify the technical and economic emoval activity in municipality of Orbetello is feasibility of complete removal within 50m. onsidered more important and pressing because Also on the basis of the outcome of this survey, he IZs are closer to the free zone. The other IZs are a definitive decision on the strategy to be n Monte Argentario promontory far away from free applied in that part of the infected area will be one. Such areas are subject to constraints that taken. revent rapid execution of felling activity (closed rivate proper

The recommendation states as its basis

The RPS stated that: · Since the 2021 audit each plant which tested positive during the 2021 surveys was removed, i.e., 19 plants in the seven IZs established in 2021 and 92 in the IZs established earlier; · In the newly established IZ in the municipality of Orbetello, which is on the connection area of the mainland to the promontory, all specified plants were identified 27 and removed. In the other, newly established, and already existing IZs, on the territory of the Monte Argentario promontory, the specified plants were removed only in the 5 m vicinity of the positive tested ones. Altogether 2,220 specified plants were removed, in addition to the 111 positives; · Due to the existing environmental and forest fire protection rules the removals were carried out during the winter and spring, and were completed in May 2022, before the start of the flight period of the vectors. The plants were destroyed, and vector controls were applied in line with the relevant provisions of the EU legislation; · In the IZs in the promontory part of the DA the full implementation of the relevant provisions of Regulation (EU) 2020/1201 is not possible as the territory is characterized either by steep slopes and cliffs, which are inaccessible or covered by impenetrable Mediterranean vegetation, making any plant removal impossible or very dangerous. Most of the flora in the IZs is composed of specified plants and their removal would cause environmental, hydrogeological, landscape and forestry constraints. In the costal parts of the promontory, there are swamps and abandoned private areas, where finding the owner or obtaining access is very difficult.

The audit team noted that: · The plant removals, in line with provisions of Regulation (EU) 2020/1201 were fully implemented only in one IZ, established in 2021 on the connecting area of the promontory; · In the other IZs, the majority of the specified plants were not removed, which is not in-line with the provisions of Article 7(1) of Regulation (EU) 2020/1201; · Although the works were completed before the next flight season of the vectors, some positive tested and specified plants were removed with significant delays, while Article 7(1) of Regulation (EU) 2020/1201 requires immediate actions; · The RPS statement that the full implementation of the relevant provisions of Regulation (EU) 2020/1201 is not feasible in the promontory part is justified given the conditions there. 5.7.5 Agricultural practices to control insect vectors

Significant efforts were made to implement the surveys in the DA and in its vicinity in line with the EU rules. The existing risk factors were correctly considered for the planning, however access issues to certain parts of the Monte Argentario promontory and to private properties and the very high number of host species present compromised the possibility to obtain a full picture about the spread of the disease.

The number of positive tested plants and vectors indicates a strong presence of the bacterial inoculum in the IZs and many parts of the BZ in the promontory. It is also an indication that the current practice of the plant removals, which is not in line with the provisions of the EU legislation. Although the BZ was established in line with the minimum requirements of the EU legislation, due to the inappropriate plant removals it may not protect sufficiently the spread of the disease from the DA.

The high number of IZs, the incomplete information about the spread and the fact that EU requirements for eradication cannot be fully implemented mean that the eradication of the bacterium is not feasible in the promontory part of the DA and the applied measures only reduce the speed of the spread.

Member state response

(2) Actually the procedures adopted seem to have stopped the spread of the pest in the territory; in Response of Tuscany: fact the infected zone is set back 4 km, moving Actually, the procedures adopted seem to have he away from the free zone. Number and size of IZ are stopped the spread of the pest in the territory; increased from the beginning of the outbreak, but in fact, number and size of IZ are increased the boundaries of the DA have not increased. from the beginning of the outbreak, but the Furthermore, the annual survey from 2018 till 2021 boundaries of the DA have not enlarged. indicate a decrease of the number of positive plants Furthermore, the annual surveys from 2018 to per year. In fact, in 2020, 232 plants were tested 2021 indicate a decrease of the number of positive, with a positive rate of 5,5 %, although in positive plants per year. 2021 111 were tested positive, with a positive rate of 3,8%; this seems to indicate a decrease of the infestation level in DA. In 2022 a new survey campaign is ongoing based on statistic model RiBESS+. The end of this activity is expected in January 2023, when the possibility of modifying the strategy will be evaluated. If in the next

The recommendation states as its basis

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

A new working group on animal welfare during transport, with representative from Regions, ired UVAC and IZS, will be created during 2023, with the objective to find possible solutions and address the inadequate procedures on the official controls pointed out. The programm would also include: - updates in relation to checks at transport mentioned in the PNBA, as establish a minimum percentage of welfare checks at farm for either departure or arrival; welfare checks for unweaned calves; - central level official guidelines (findings n.15-16) for verification and homogenous procedures (findings n.42-43) at local level on checks on trucks (also related to unweaned calves, finding n.44), transporters approval and emergency plan; - supporting instructions on the checklist for inspection at control posts, including also information on drivers contact and address (finding n.22). Page: 1 8 January 2023 mendations of report ref. DG(SANTE) 2022-7504 of the audit carried out from 07 February 2022 ned calves during long journeys Action Proposed by the competent authority Regarding finding n.49, a Note from the Ministry of Health, with instructions to local veterinary services to insert the types

A new working group on animal welfare during transport, with representative from egions, UVAC and IZS, will be created during 2023, with the objective to find possible as solutions and address the inadequate procedures on the official controls pointed out. The programm would also include: - updates in relation to checks at transport mentioned in the PNBA, as establish a minimum percentage of welfare checks at farm for either departure or arrival; welfare checks for unweaned calves; - central level official guidelines (findings n.15-16) for verification and homogenous procedures (findings n.42-43) at local level on checks on trucks (also related to unweaned calves, finding n.44), transporters approval and emergency plan; - supporting instructions on the checklist for inspection at control posts, including also information on drivers contact and address (finding n.22). Regarding finding n.49, a Note from the Ministry of Health, with instructions to local veterinary services to insert the types of animals into transporter certificates of authorisation, has been issued from our office in 2022. Updated CA response 6 April 2023: - The working group has already met on line on 8th.3.2023an

The recommendation states as its basis

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

In order to ensure that documented control ) verification procedures are developed and applied, on 4th-6th October 2022 a first audit on animal welfare during transport has taken place (findings n.38-39-48) in northern Italy and in two control posts in the competent area. Two other Audit in different regions are in project for 2023. Other Control posts would be also checked in the next months (finding n.53). Page: 2

order to ensure that documented control verification procedures are developed and lied, on 4th-6th October 2022 a first audit on animal welfare during transport has en place (findings n.38-39-48) in northern Italy and in two control posts in the petent area. Two other Audit in different regions are in project for 2023. Other trol posts would be also checked in the next months (finding n.53). ated CA response 6 April 2023: estimated timeline to start and finalise the drafting of the documented control ification procedures is about a year in the framework of the working group Page: 2

The recommendation states as its basis

The inability of the surveillance to detect promptly the virus in wild birds (detection in wild birds happened after outbreaks in poultry establishments) contrasts with the fact that all competent authorities considered circulation of the virus in wild birds as the main cause for most of the initial outbreaks of the disease in both regions. The NRL confirmed this a posteriori by virus phylogenetic studies. That sub-optimal effectiveness cannot be considered in line with provisions laid down in Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429, on the need to design and apply surveillance in a way that is appropriate and proportionate to the objectives pursued and to the risk factors involved in order to ensure the timely detection of the presence of the targeted disease.

Although the competent authorities have made considerable efforts to increase the sensitivity of surveillance for HPAI in wild birds, the tool however was not effective as an early warning system. That raises questions about the suitability of the design, the proper application, and the cost-effectiveness of that surveillance, as there is consensus among all relevant parties that the HPAI virus was circulating in wild birds in the affected areas before it was detected in poultry.

Member state response

To design and implement surveillance for early detection of HPAI in wild birds in a way that is appropriate and proportionate to the objectives pursued and to the risk factors involved to provide an early warning for the possible introduction of the disease in poultry so that operators can apply reinforced preventive measures without delay. Article 26(2) and (4), and 27 of Regulation (EU) 2016/429. Articles 4(a)(b) and 10(2) of, and Annex II (Section 4) to Delegated Regulation (EU) 2020/689. Based on conclusion 37 and associated finding 15.

Italy apply a passive surveillance plan in wild birds in the whole country. This plan provides the testing of all wild birds found dead. e Furthermore, in accordance with the the Ministerial provision n° 20885 of 01/09/2022 and further provision which will last until March 2023 and as well as according to criteria of Annex II (Section 4) of Delegated Regulation (EU) 2020/689, in addition to, and on to complement the early detection activities (passive surveillance) foreseen under the national surveillance plan for AI, active surveillance measures including the sampling and testing of hunted healthy water birds, live decoy and birds trapped belonging to the orders Anseriformes and Charadriformes, have been implemented at the beginning of autumn migration period in the Italian Regions most frequently affected by AI circulation (Friuli- Venezia Giulia, Veneto, Lombardia, Emilia- Romagna, Umbria and Lazio). Sampling should be carried out according to a prevalence set by epidemiological observatory of each region. Avifauna recovery centres are also included in the plan and controls should be carried out at the moment of entry of wild birds in the centres. Traps has been also activated o

The recommendation states as its basis

In the cases checked by the audit team, turkey producers notified suspect cases of HPAI quickly, in most cases timely. In contrast, the audit team saw examples of affected layer hen establishments where the operator had not notified the authorities despite experiencing mortality rates of four or five times the usual daily average for a few days, or of other significant deviations in other production parameters. That is not in line with 10 requirements laid down in Article 18(1)(a) and (c) of Regulation (EU) 2016/429.

The effective systems to raise and maintain public awareness and the good laboratory support helped the authorities to identify and confirm most cases of HPAI in poultry quickly. The delayed notification of suspect cases by certain operators is still a cause for concern as it may facilitate the spread of the disease in areas with a high density of 13 poultry.

Member state response

Page: 1

ties Epidemiological analysis related to 2021-22 epidemic showed that early warning could be in enhanced if turkeys and laying hens are tested at the beginning of a slightly rise of mortality (which might happens in one shed only). In this regard, by means of Directorial decree already in force, criteria of suspect mortality were provided for turkeys and laying hens together with particular abnormal behaviours, which should trigger a compulsory communication from the farmer to a veterinarian for laboratory investigation. For instance, for turkeys this happens when there is a slight changing of standard parameters of production and increase in daily mortality of at least 0.2%. For laying hens communication should be provided when there is a rise of mortality of 2-3 folds in limited area oh the establishment. As for broiler, sampling of dead birds is carried out even without increase of mortality. This procedure falls within article 18 point 1 letter c) of regulation 2016/429. This implies that the veterinarian should take samples and communicate the abnormal parameters observed (i.e. increase in mortality, or drop in production) to the official ort, received 11 July 2023 Action Prop

The recommendation states as its basis

According to representatives of the field epidemiology teams and to SVL staff who performed those enquiries, the current model of epidemiological enquiry is too burdensome, and it requires gathering too much information, especially in the face of multiple outbreaks, and thus, it was not a suitable tool to inform quickly on the best possible measures mentioned above. That is not in line with general requirements laid down in Articles 5(1)(a) and 12(2) and (3) (read with point 5 in Chapter II of Annex II thereto) of Regulation (EU) 2017/625, for the competent authorities to have procedures and/or arrangements in place to ensure the effectiveness of official controls and other 11 official activities, to verify them, and to take corrective action and update them as appropriate when they identify shortcomings with their application.

The shortcomings mentioned above did not allow the competent authorities to analyse quickly a sufficient number of records and information to ascertain quickly the likely spread of the disease and determine which preliminary disease control measures they had to take to prevent it. Thus, they could not fulfil the fundamental objectives of the epidemiological enquiries to inform decisions on application of control measures as provided for in Articles 55(1)(e) and (f), 56(a)(ii), 57(2)(e), 62(1) and 64(1)(f) and (2)(b) of Regulation (EU) 2016/429, and Articles 8(3), 9, 21(1)(c) and 23(a) of Delegated Regulation (EU) 2020/687.

The competent authorities did not obtain timely the necessary information from the analysis of the epidemiological enquiries carried out in affected establishments to understand the likely spread of the disease, notably in areas with a high density of susceptible establishments exposed to a high level of environmental infection and frequency of contacts between them. Hence, they could not take the right decisions and adopt preliminary restrictions and additional control measures rapidly to contain the spread of the disease, as they had undertaken in response to a previous recommendation of the Commission services.

The competent authorities were aware of the dense and frequent network of contacts occurring between many of those establishments, especially because most of them belong to the same few companies. The fast evolution of the disease confirmed that those circumstances were not properly considered in accordance with Article 64(2)(b) of Regulation (EU) 2016/429 and Article 21(1)(c) of Delegated Regulation (EU) 2020/687, when the authorities delimitated the boundaries and size of the restricted zones to contain the spread of the disease and did not establish a further restricted zone immediately, precisely to prevent that.

The competent authorities did not evaluate swiftly all relevant epidemiological criteria and establish immediately a further restricted zone in the area of Veneto where the epizootic began and which they considered of very high risk for the spread of HPAI. That delay undermined the effectiveness of the additional control measures they applied, which therefore were not sufficient to stop the spread of the disease before it reached epizootic proportions and expanded far beyond the initially affected area.

However, certain shortcomings, such as a) the lack of adequate epidemiological expertise to analyse the dynamics of the disease quickly, anticipate its evolution, and advice appropriately on actions to curtail its spread, b) the delays during the initial stages of the epizootic to decide on establishing a further restricted zone, and c) the incapability to find quickly adequate solutions to the problems experienced with application of animal depopulation, indicate that the operation of the national and regional disease control centres was not fully operational, which is not in line with Article 43(2)(a) and (d) of Regulation (EU) 2016/429.

The disease control centres established at national, regional, and local level during the epizootic coordinated application of the main control measures in the affected areas effectively. However, they all failed to take certain important decisions at critical times, and thus, they did not prevent the spread of the disease effectively.

Member state response

Page: 2 f. DG(SANTE) 2022-7586 of the audit carried out from 07 March 2022 to avian influenza Action Proposed by the competent authority

A novel epidemiological enquiry form has been es developed by the epidemiology laboratory that upport the National Reference Laboratory, in collaboration with a dedicated working group that encompasses the local vet services of the on Veneto Region. of The new form allows collecting in less time more detailed information on the biosecurity (1) measures at the infected farms, providing data for more focussed analyses. Local veterinary services in the northeastern Italian regions have been trained in compiling m the form; however. Further training programs for the official veterinarians are planned t 5 throughout 2023. The direct involvement of the local veterinary services will contribute in reducing the direct involvement of the al epidemiological lab at the NRL, which will be them, dedicated at providing technical support in decision-making. Outcomes of epidemiological analysis are also evaluated by experts, during the National crisis ­ Unit, which convene on regularly basis. s

The recommendation states as its basis

According to the analysis of the competent authorities, local airborne spread played a significant role in transmitting the infection in areas with a very high density of establishments (e.g., facilitated by the proximity between establishments and by the use of force ventilation), together with the risk of environmental infection associated with wild birds. However, the industry had not adapted disease preventive measures properly to mitigate the impact of those critical risk factors, and the competent authorities had not adapted their verification activities to ensure that the measures applied by the industry were suitable for that purpose. Therefore, all that evidence had not been properly considered to guarantee that operators in the poultry industry can fulfil their responsibilities to minimise the risks of spread of HPAI applying appropriate biosecurity rules in line with the requirements laid down in Articles 10(1)(a)(iii), (b) and (c), (4) and (5), and 11(1)(b) of Regulation (EU) 2016/429.

The official controls, despite their extensive application and largely positive outcome, did not contribute sufficiently to correct the shortcomings related to biosecurity that likely facilitated the spread of the disease during the 2021-2022 epizootic. This is not in line with Article 5(1)(a) of Regulation (EU) 2017/625. 5.2.3Operation of the national and local disease control centres ­ Information management tools and data analysis

The competent authorities have repeatedly underlined the significant risk that the very high density of poultry represents for the areas affected by the 2021-2022 HPAI epizootic, but they have not acted accordingly to reduce it. Moreover, evidence confirms that that density has even increased in some of those areas. This, coupled with the sub-optimal application of biosecurity measures at times unsuitable to mitigate the prevailing risks of HPAI introduction and spread, raises concerns about their capability to prevent and control new HPAI epizootics.

Member state response

ed n

A new decree according to the provision of by article 10 of regulation 2016/429 is underway for the poultry sector and as well as for captive iling birds. The new decree will update biosecurity measures introducing new requirements to mitigate the risk of lateral spread of the disease. Some new physical means as well as tion, new revised procedures will be introduced. Furthermore criteria would be introduced for the new poultry establishment taking into f account the distance between farms. Criteria would change in new establishment shoul be established in risk area or not. and The decree provides also compulsory controls in the establishments in order to evaluate the level of application of biosecurity measures with particular regard to turkeys and layer hens farms. The results of official control will o be inserted in the"classyfarm" system, which present a specific tool to rank the risk for each establishment and therefore prioritize the official control. ort, received 11 July 2023 Action Proposed by the competent authority Furthermore, another decree is under way which provide according to article 13 point 2 of Regulation 2016/429 compulsory training course for breeders, and an

The recommendation states as its basis

According to representatives of the field epidemiology teams and to SVL staff who performed those enquiries, the current model of epidemiological enquiry is too burdensome, and it requires gathering too much information, especially in the face of multiple outbreaks, and thus, it was not a suitable tool to inform quickly on the best possible measures mentioned above. That is not in line with general requirements laid down in Articles 5(1)(a) and 12(2) and (3) (read with point 5 in Chapter II of Annex II thereto) of Regulation (EU) 2017/625, for the competent authorities to have procedures and/or arrangements in place to ensure the effectiveness of official controls and other 11 official activities, to verify them, and to take corrective action and update them as appropriate when they identify shortcomings with their application.

The shortcomings mentioned above did not allow the competent authorities to analyse quickly a sufficient number of records and information to ascertain quickly the likely spread of the disease and determine which preliminary disease control measures they had to take to prevent it. Thus, they could not fulfil the fundamental objectives of the epidemiological enquiries to inform decisions on application of control measures as provided for in Articles 55(1)(e) and (f), 56(a)(ii), 57(2)(e), 62(1) and 64(1)(f) and (2)(b) of Regulation (EU) 2016/429, and Articles 8(3), 9, 21(1)(c) and 23(a) of Delegated Regulation (EU) 2020/687.

The competent authorities did not obtain timely the necessary information from the analysis of the epidemiological enquiries carried out in affected establishments to understand the likely spread of the disease, notably in areas with a high density of susceptible establishments exposed to a high level of environmental infection and frequency of contacts between them. Hence, they could not take the right decisions and adopt preliminary restrictions and additional control measures rapidly to contain the spread of the disease, as they had undertaken in response to a previous recommendation of the Commission services.

The competent authorities were aware of the dense and frequent network of contacts occurring between many of those establishments, especially because most of them belong to the same few companies. The fast evolution of the disease confirmed that those circumstances were not properly considered in accordance with Article 64(2)(b) of Regulation (EU) 2016/429 and Article 21(1)(c) of Delegated Regulation (EU) 2020/687, when the authorities delimitated the boundaries and size of the restricted zones to contain the spread of the disease and did not establish a further restricted zone immediately, precisely to prevent that.

The competent authorities did not evaluate swiftly all relevant epidemiological criteria and establish immediately a further restricted zone in the area of Veneto where the epizootic began and which they considered of very high risk for the spread of HPAI. That delay undermined the effectiveness of the additional control measures they applied, which therefore were not sufficient to stop the spread of the disease before it reached epizootic proportions and expanded far beyond the initially affected area.

Member state response

To take full consideration of all appropriate criteria that should be analysed in the context of a potential HPAI epizootic to decide quickly on the establishment of a further restricted zone to prevent the spread of the disease in areas where the risk of transmission is especially high. Articles 64(2)(b) and 71(2) and (3) of Regulation (EU) 2016/429, and Articles 21(1)(c) and 23(a) of Delegated Regulation (EU) 2020/687. Article 43(2)(a), (b) and (d)(i) and (ii) of Regulation (EU) 2016/429 ­ on the application of the contingency plan for HPAI Based on conclusions 38 and 74, and associated findings 25, 27 and 58.

eria New criteria for establishing a further ial restriction zone has been evaluated and in particular the first confirmation of an outbreak ent in DPPA as well as the results of the of surveillance in wild birds. In this respect in October 2022 Italy enforced swifltly Further Restricted Zones (FRZ) after the confirmation of the first outbreak in a meat turkeys flock located in DPPA of Veneto ation region. The FRZ encompasses part of Veneto e Lombardia region with high density of turkeys, broilers and layer hens. Rapid risk assessment (RRA) procedures are being developed at the epidemiological laboratory working with the NRL, and will be finalised by the end of January. The RRA is aimed to qualitatively assess the risk of AI introduction via migratory bird movements, and will provide the basis of an Early Warning System (EWS) to activate a series of preventive measures for limiting the risk of AI introduction in the domestic sector. A qualitative risk assessment was conducted in all of the Italian regions, accounting for a base set of risk factors delineated by the NRL. Such analyses led to the definition of three areas (limited risk, risk of introduction, and risk of introduction

The recommendation states as its basis

According to representatives of the field epidemiology teams and to SVL staff who performed those enquiries, the current model of epidemiological enquiry is too burdensome, and it requires gathering too much information, especially in the face of multiple outbreaks, and thus, it was not a suitable tool to inform quickly on the best possible measures mentioned above. That is not in line with general requirements laid down in Articles 5(1)(a) and 12(2) and (3) (read with point 5 in Chapter II of Annex II thereto) of Regulation (EU) 2017/625, for the competent authorities to have procedures and/or arrangements in place to ensure the effectiveness of official controls and other 11 official activities, to verify them, and to take corrective action and update them as appropriate when they identify shortcomings with their application.

The shortcomings mentioned above did not allow the competent authorities to analyse quickly a sufficient number of records and information to ascertain quickly the likely spread of the disease and determine which preliminary disease control measures they had to take to prevent it. Thus, they could not fulfil the fundamental objectives of the epidemiological enquiries to inform decisions on application of control measures as provided for in Articles 55(1)(e) and (f), 56(a)(ii), 57(2)(e), 62(1) and 64(1)(f) and (2)(b) of Regulation (EU) 2016/429, and Articles 8(3), 9, 21(1)(c) and 23(a) of Delegated Regulation (EU) 2020/687.

In both regions, however, given the size and evolution of the epizootic, there were important delays (several days and even weeks) in the process of killing of poultry in infected establishments and, in removing the carcasses of killed or dead poultry and of other contaminated products (e.g., feed and litter) from affected establishments. The preliminary studies carried out by the national reference centre for the epidemiology of avian influenza seem to demonstrate that those delays contributed to the local spread of the disease. Those studies indicated as well that the risk of transmission was exacerbated by force ventilation, in particular between establishments keeping turkeys, that used it, and other situated nearby keeping mainly broilers and layer hens. These shortcomings are not in compliance with EU requirements laid down in Article 61(1)(b) and (c) of Regulation (EU) 2016/429 and Article 12(1) of Delegated Regulation (EU) 2020/687. 5.1.1.4 Contact (epidemiologically linked) establishments ­ Specific measures

The competent authorities did not obtain timely the necessary information from the analysis of the epidemiological enquiries carried out in affected establishments to understand the likely spread of the disease, notably in areas with a high density of susceptible establishments exposed to a high level of environmental infection and frequency of contacts between them. Hence, they could not take the right decisions and adopt preliminary restrictions and additional control measures rapidly to contain the spread of the disease, as they had undertaken in response to a previous recommendation of the Commission services.

The increasing delays in the killing and disposal of animals and of other products that may be contaminated, gradually undermined the effectiveness of other containment measures and was one of the main drivers of the further spread of the disease during the worst of the epizootic. 5.1.2Diagnosis of HPAI

The impossibility to apply targeted preventive killing in protection zones in some of the high-risk affected areas did not allow the competent authorities to reduce the density of susceptible poultry as quickly within those zones as the epidemiological situation required. Considering that that was the preferred choice of the competent authorities based on their experience and the analysis of the situation, that cannot be considered fully in line with provisions of Article 61(1)(b) of Regulation (EU) 2016/429 and Article 22(2) of Regulation (EU) 2020/687. 5.1.3.3 Further restricted zones

Although the competent authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, other shortcomings, such as the limited availability of means to apply animal depopulation and carcass disposal and the shortage of personnel to visit quickly high-risk establishments within those zones, undermined the quick application of measures to contain the disease and the prevention of its spread.

The application of preventive killing to sufficiently reduce the poultry population in high-risk areas quickly and stop the spread of the disease was not possible due to resource constraints as all animal depopulation capacity was compromised by the numerous affected establishments the. The impact of that shortcoming was partially mitigated by the decisive action of the competent authorities and the cooperation of the industry to send for slaughter as many poultry as possible from establishments situated within restricted zones.

The shortcomings highlighted in the previous points are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429 on the responsibilities of the competent authorities to have access to adequate facilities and equipment and to have an effective organisation to be capable to take the necessary disease control measures, including disposal of animals that may be contaminated or contribute to the spread of the disease, in the event of an animal health crisis like the recent HPAI epizootic.

The competent authorities had not taken adequate administrative steps and made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases of dead and killed poultry in establishments where the presence of HPAI was confirmed or as a preventive measure in areas affected by the disease. This was even more evident in the region of Veneto and caused significant delays in the depopulation of establishments and accumulation of carcases, which significantly undermined the effectiveness of other measures to contain the spread of the disease. 5.1.5Cleaning and disinfection

However, certain shortcomings, such as a) the lack of adequate epidemiological expertise to analyse the dynamics of the disease quickly, anticipate its evolution, and advice appropriately on actions to curtail its spread, b) the delays during the initial stages of the epizootic to decide on establishing a further restricted zone, and c) the incapability to find quickly adequate solutions to the problems experienced with application of animal depopulation, indicate that the operation of the national and regional disease control centres was not fully operational, which is not in line with Article 43(2)(a) and (d) of Regulation (EU) 2016/429.

Neither the national nor the regional disease control centres reacted quickly enough to make available sufficient additional staff to attend the demands of that SVL during the worst weeks of the epizootic. That was not in line with requirements laid down in Articles 13(1)(a) and 43(2)(c)(iv) of Regulation (EU) 2016/429 on responsibilities of the competent authorities to have qualified personnel and an effective organisation to apply disease control measures effectively, and on application of the contingency plan for HPAI. 5.2.5 Availability of equipment and materials

The shortcomings described above are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429 on the responsibilities of the competent authorities to have access to adequate facilities and equipment and to have an effective organisation to be capable to take the necessary disease control measures, including the rapid killing of animals from affected establishments, in the event of an animal health crisis like the recent HPAI epizootic. They are not in line either with provisions on the application of the contingency plan for HPAI laid down in Article 43(2)(c)(iii), (v) and (vi) of the said Regulation to make available all appropriate materials and resources necessary for the rapid and efficient eradication of the disease. 5.2.6Diagnostic capacity in case of an emergency

The competent authorities counted on well-developed and up-to-date contingency plans and operational manuals to respond to outbreaks of HPAI. However, some authorities responsible for some of the high-risk areas more affected by the 2021-2022 epizootic, had not taken adequate action to make sure that they could avail timely of adequate human, 30 technical and material resources to contain the disease rapidly and effectively. Those shortcomings were instrumental in facilitating the spread and long duration of the epizootic in those areas, and thus contributed to its high economic impact.

The disease control centres established at national, regional, and local level during the epizootic coordinated application of the main control measures in the affected areas effectively. However, they all failed to take certain important decisions at critical times, and thus, they did not prevent the spread of the disease effectively.

Member state response

Page: 3 f. DG(SANTE) 2022-7586 of the audit carried out from 07 March 2022 to avian influenza Action Proposed by the competent authority

l y A re-organisation has been planned for the epidemiology lab at the NRL, focussing on: (i) supporting the NRL and the MoH in defining control/prevention measures, sampling as schemes, and decision making; (ii) providing ort, received 11 July 2023 Action Proposed by the competent authority more detailed and deep epidemiological ling analyses using novel methods to provide evidence-based information for scheduled . revision of the control/prevention measures 19,

The recommendation states as its basis

Once the number of outbreaks in the main affected areas became very high, some of the SVL in both regions could not carry out the quick official visits to all poultry establishments situated in the protection zones, as required by provisions laid down in Article 26(1) of Delegated Regulation (EU) 2020/687. The main reason for that was the temporary shortage of staff (see also 5.2.4).

The lack of checks in those establishments situated in protection zones, by definition at a high-risk of infection, precluded verification that they were applying proper biosecurity measures and implementing additional surveillance to identify the further spread of the disease from affected establishments quickly. This is not in line with the provisions laid down in Article 25(1)(b), (d) and (e) of Delegated Regulation (EU) 2020/687. Those limitations also applied to large establishments situated in some of those protection zones.

Although the competent authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, other shortcomings, such as the limited availability of means to apply animal depopulation and carcass disposal and the shortage of personnel to visit quickly high-risk establishments within those zones, undermined the quick application of measures to contain the disease and the prevention of its spread.

The competent authorities counted on well-developed and up-to-date contingency plans and operational manuals to respond to outbreaks of HPAI. However, some authorities responsible for some of the high-risk areas more affected by the 2021-2022 epizootic, had not taken adequate action to make sure that they could avail timely of adequate human, 30 technical and material resources to contain the disease rapidly and effectively. Those shortcomings were instrumental in facilitating the spread and long duration of the epizootic in those areas, and thus contributed to its high economic impact.

The competent authorities counted on well-developed and up-to-date contingency plans and operational manuals to respond to outbreaks of HPAI. However, some authorities responsible for some of the high-risk areas more affected by the 2021-2022 epizootic, had not taken adequate action to make sure that they could avail timely of adequate human, 30 technical and material resources to contain the disease rapidly and effectively. Those shortcomings were instrumental in facilitating the spread and long duration of the epizootic in those areas, and thus contributed to its high economic impact.

Member state response

To make adequate arrangements to ensure that the competent authorities responsible for controlling outbreaks of HPAI have access to sufficient human resources to take all the necessary and appropriate measures, including visits to establishments situated within the restricted zone, to do that effectively and without unjustified delay. Articles 13(1)(a) and 43(2)(a), (b) and (c)(iv) of Regulation (EU) 2016/429 ­ on responsibilities of the competent authorities to have an effective organisation and a contingency plan for HPAI that allow them to have access to personnel. Articles 25(1)(b), (d) and (e), and 26(1) of Delegated Regulation (EU) 2020/687 ­ on visits to establishments in protection zones. Based on conclusions 73 and 129, and associated findings 51, 52 and 129.

eneto region has set up a group of veterinary officials with expertise with Avian flu outbreaks. This team could be moved in case e of needs between the different Local ted veterinary units in case of request of and insufficient personnel on the ground

The recommendation states as its basis

In both regions, however, given the size and evolution of the epizootic, there were important delays (several days and even weeks) in the process of killing of poultry in infected establishments and, in removing the carcasses of killed or dead poultry and of other contaminated products (e.g., feed and litter) from affected establishments. The preliminary studies carried out by the national reference centre for the epidemiology of avian influenza seem to demonstrate that those delays contributed to the local spread of the disease. Those studies indicated as well that the risk of transmission was exacerbated by force ventilation, in particular between establishments keeping turkeys, that used it, and other situated nearby keeping mainly broilers and layer hens. These shortcomings are not in compliance with EU requirements laid down in Article 61(1)(b) and (c) of Regulation (EU) 2016/429 and Article 12(1) of Delegated Regulation (EU) 2020/687. 5.1.1.4 Contact (epidemiologically linked) establishments ­ Specific measures

The increasing delays in the killing and disposal of animals and of other products that may be contaminated, gradually undermined the effectiveness of other containment measures and was one of the main drivers of the further spread of the disease during the worst of the epizootic. 5.1.2Diagnosis of HPAI

The impossibility to apply targeted preventive killing in protection zones in some of the high-risk affected areas did not allow the competent authorities to reduce the density of susceptible poultry as quickly within those zones as the epidemiological situation required. Considering that that was the preferred choice of the competent authorities based on their experience and the analysis of the situation, that cannot be considered fully in line with provisions of Article 61(1)(b) of Regulation (EU) 2016/429 and Article 22(2) of Regulation (EU) 2020/687. 5.1.3.3 Further restricted zones

Although the competent authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, other shortcomings, such as the limited availability of means to apply animal depopulation and carcass disposal and the shortage of personnel to visit quickly high-risk establishments within those zones, undermined the quick application of measures to contain the disease and the prevention of its spread.

The application of preventive killing to sufficiently reduce the poultry population in high-risk areas quickly and stop the spread of the disease was not possible due to resource constraints as all animal depopulation capacity was compromised by the numerous affected establishments the. The impact of that shortcoming was partially mitigated by the decisive action of the competent authorities and the cooperation of the industry to send for slaughter as many poultry as possible from establishments situated within restricted zones.

The shortcomings highlighted in the previous points are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429 on the responsibilities of the competent authorities to have access to adequate facilities and equipment and to have an effective organisation to be capable to take the necessary disease control measures, including disposal of animals that may be contaminated or contribute to the spread of the disease, in the event of an animal health crisis like the recent HPAI epizootic.

The competent authorities had not taken adequate administrative steps and made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases of dead and killed poultry in establishments where the presence of HPAI was confirmed or as a preventive measure in areas affected by the disease. This was even more evident in the region of Veneto and caused significant delays in the depopulation of establishments and accumulation of carcases, which significantly undermined the effectiveness of other measures to contain the spread of the disease. 5.1.5Cleaning and disinfection

The shortcomings described above are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429 on the responsibilities of the competent authorities to have access to adequate facilities and equipment and to have an effective organisation to be capable to take the necessary disease control measures, including the rapid killing of animals from affected establishments, in the event of an animal health crisis like the recent HPAI epizootic. They are not in line either with provisions on the application of the contingency plan for HPAI laid down in Article 43(2)(c)(iii), (v) and (vi) of the said Regulation to make available all appropriate materials and resources necessary for the rapid and efficient eradication of the disease. 5.2.6Diagnostic capacity in case of an emergency

The competent authorities counted on well-developed and up-to-date contingency plans and operational manuals to respond to outbreaks of HPAI. However, some authorities responsible for some of the high-risk areas more affected by the 2021-2022 epizootic, had not taken adequate action to make sure that they could avail timely of adequate human, 30 technical and material resources to contain the disease rapidly and effectively. Those shortcomings were instrumental in facilitating the spread and long duration of the epizootic in those areas, and thus contributed to its high economic impact.

Member state response

n Page: 4 f. DG(SANTE) 2022-7586 of the audit carried out from 07 March 2022 to avian influenza Action Proposed by the competent authority

Regione Veneto which was the only region lacking an administrative contract for the r killing and collection of carcasses has finalized the tender to recruit teams dedicated to this y purpose. The eligible companies, should assure the intervention of killing and collection within 24-48 h after a confirmation of an outbreak of HPAI. The tender allows different companies to )(b) participate which will be recruited step by step taking into account the request of the LVU ave The Veneto region has also authorized biogas facilities for the disposal of animal carcasses ke in order to solve some deficiencies of encountered during the epidemic of HPAI in 021-22. These plants could accept the carcasses which cannot go to rendering plants

The recommendation states as its basis

Although the competent authorities have made considerable efforts to increase the sensitivity of surveillance for HPAI in wild birds, the tool however was not effective as an early warning system. That raises questions about the suitability of the design, the proper application, and the cost-effectiveness of that surveillance, as there is consensus among all relevant parties that the HPAI virus was circulating in wild birds in the affected areas before it was detected in poultry.

The competent authorities did not obtain timely the necessary information from the analysis of the epidemiological enquiries carried out in affected establishments to understand the likely spread of the disease, notably in areas with a high density of susceptible establishments exposed to a high level of environmental infection and frequency of contacts between them. Hence, they could not take the right decisions and adopt preliminary restrictions and additional control measures rapidly to contain the spread of the disease, as they had undertaken in response to a previous recommendation of the Commission services.

The increasing delays in the killing and disposal of animals and of other products that may be contaminated, gradually undermined the effectiveness of other containment measures and was one of the main drivers of the further spread of the disease during the worst of the epizootic. 5.1.2Diagnosis of HPAI

Although the competent authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, other shortcomings, such as the limited availability of means to apply animal depopulation and carcass disposal and the shortage of personnel to visit quickly high-risk establishments within those zones, undermined the quick application of measures to contain the disease and the prevention of its spread.

The application of preventive killing to sufficiently reduce the poultry population in high-risk areas quickly and stop the spread of the disease was not possible due to resource constraints as all animal depopulation capacity was compromised by the numerous affected establishments the. The impact of that shortcoming was partially mitigated by the decisive action of the competent authorities and the cooperation of the industry to send for slaughter as many poultry as possible from establishments situated within restricted zones.

The competent authorities had not taken adequate administrative steps and made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases of dead and killed poultry in establishments where the presence of HPAI was confirmed or as a preventive measure in areas affected by the disease. This was even more evident in the region of Veneto and caused significant delays in the depopulation of establishments and accumulation of carcases, which significantly undermined the effectiveness of other measures to contain the spread of the disease. 5.1.5Cleaning and disinfection

The competent authorities counted on well-developed and up-to-date contingency plans and operational manuals to respond to outbreaks of HPAI. However, some authorities responsible for some of the high-risk areas more affected by the 2021-2022 epizootic, had not taken adequate action to make sure that they could avail timely of adequate human, 30 technical and material resources to contain the disease rapidly and effectively. Those shortcomings were instrumental in facilitating the spread and long duration of the epizootic in those areas, and thus contributed to its high economic impact.

The absence of internal audits to check the compliance and suitability of the animal health emergency preparedness systems in the regions repeatedly affected by HPAI epizootics favoured the persistence of shortcomings in those systems, notably in Veneto. The existing shortcoming undermined the effectiveness of disease control and contributed to the size of the epizootic.

Member state response

Page: 5

An Audit by the Ministry of health-veterinary services is scheduled in June 2023 in Veneto egion dly ort, received 11 July 2023 Action Proposed by the competent authority 1,

The recommendation states as its basis

Italy has issued national and regional legislation and guidelines necessary to ensure implementation and/or enforcement of the EU requirements applicable to the bovine meat sector and, from a summary analysis, they are largely in line with EU legislation. However, certain procedures/guidelines were not up-to-date and, as a result, contrary to certain provisions in the EU legislation.

Member state response

Si allega la procedura operative aggiornata per le macellazioni d to d'urgenza predisposta dal Ministero e allo stato attuale in fase di ) approvazione dal Coordinamento tecnico interregionale. Page: 1

The recommendation states as its basis

For the establishments listed in section 2 of this report, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on the assessment of operators' HACCP plans. The audit team noted that the assessment of the hazard identification part of the HACCP-plan by the inspectors was deficient in five establishments out of the nine visited: 1) In general, the hazard identification part of the HACCP plans seen was either absent or was very generic without the level of detail necessary for proper hazard identification and subsequent risk assessment. Notwithstanding that one inspector met could notice this deficiency during the interview, the failure of the operators to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was not reflected in any of the most recent inspection reports seen. 4 2) During the interviews, the inspectors experienced difficulties to identify relevant hazards for calcium carbonate, amino acids produced by fermentation, and the feed additives butylated hydroxyanisole and propyl gallate. In relation to pesticides, only those referred to in section IV of Annex I to Directive 2002/32/EC (banned substances) had been taken into consideration while authorised pesticides referred to in Annexes II, III and V to Regulation (EC) No 396/2005 were largely not considered for the purposes of the hazard identification.

Planning of inspections is based on appropriate risk-related factors and thus ensures that official controls are carried out on all operators, on a risk basis and with appropriate frequency. However, the effectiveness of the inspections is weakened by shortcomings in the competent authority's assessment of (i) operators' HACCP plans, (ii) appropriateness of operators' tests on homogeneity of mixing and cross-contamination, and (iii) operators' traceability systems. The fact that these issues were often not identified in the inspection reports meant that operators were unaware that they were not operating in compliance with legislation. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

Information will be provided for the official veterinarian in charge of the establishment to periodically verify HACCP compliance with the appropriate hazard identification in relation to the production processes and the raw materials/additives used, also with respect to the non-compliances found during the inspection. Appropriate training activities will be scheduled during the year. Expected deadline: 30 working days.

The recommendation states as its basis

Verification of establishments' tests on homogeneity of mixing and minimisation of cross- contamination, required by part 2(b) and 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. In three compound feed manufacturers visited, the audit team scrutinised operators' documentation on the related testing and interviewed the inspectors normally controlling those establishments. The following observations were made: 1) For the controls on homogeneity of mixing, all three operators used naturally occurring markers (e.g., nutritional constituents or salt) which does not provide sufficient information on the homogeneity since the markers are already homogeneously distributed in the matrix. In addition, the number of samples taken (1-3 at two establishments) was statistically inadequate. The operators' written procedures did not contain a comprehensive description of all the steps necessary for the assessment of homogeneity of mixing. 2) For the controls on cross-contamination, the operators' documentation seen did not contain clear procedures for sampling which is critical due to heterogeneous distribution of analytes in non-target feed. In one case, the sensitivity of the analytical method used was not sufficient to detect the presence of the analyte at the levels deemed acceptable for unavoidable transfer of the substance to non-target feed. The deficiencies identified by the audit team were not reflected in any of the most recent inspection reports seen. Thus, combined, the official controls examined by the audit team only partly verified that the operators met the requirements laid down in part 2(b) and 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005.

Planning of inspections is based on appropriate risk-related factors and thus ensures that official controls are carried out on all operators, on a risk basis and with appropriate frequency. However, the effectiveness of the inspections is weakened by shortcomings in the competent authority's assessment of (i) operators' HACCP plans, (ii) appropriateness of operators' tests on homogeneity of mixing and cross-contamination, and (iii) operators' traceability systems. The fact that these issues were often not identified in the inspection reports meant that operators were unaware that they were not operating in compliance with legislation. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

Information will be provided for the official veterinarian in charge of the establishment to that the operator performs inimize cross- contamination and that is equipped with procedures to check the homogeneity of the feed produced. Appropriate training activities will be scheduled during the year. Expected deadline: 30 working days.

The recommendation states as its basis

Routine inspections include the verification of operators' traceability systems, including the operators' obligation to take samples of ingredients and from each batch of products manufactured and placed on the market, or from each specific portion of production (in the case of continuous production) in sufficient quantities, using a procedure pre-established by the manufacturer (hereinafter retained samples), as required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised this verification and noted that neither of the two food business operators visited had taken and kept the retained samples of the feed materials produced. All three compound feed manufactures did not take retained samples from packaged feed additives/premixtures (the representative of one operator stated that those were kept at the headquarters, which could not be verified by the audit team). In two compound feed producers, the retained samples were not sealed. These observations are not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and were not recorded in any of the most recent inspection reports seen.

Planning of inspections is based on appropriate risk-related factors and thus ensures that official controls are carried out on all operators, on a risk basis and with appropriate frequency. However, the effectiveness of the inspections is weakened by shortcomings in the competent authority's assessment of (i) operators' HACCP plans, (ii) appropriateness of operators' tests on homogeneity of mixing and cross-contamination, and (iii) operators' traceability systems. The fact that these issues were often not identified in the inspection reports meant that operators were unaware that they were not operating in compliance with legislation. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

The official veterinarian in charge of the establishment will have to pay particular attention to the check of feed traceability, implementation by the FBO of specific procedures for taking and keeping samples. This aspect will be highlighted in the Addendum that will be published shortly. Expected deadline: 30 working days.

The recommendation states as its basis

The audit team observed official sampling at the three compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In addition, a number of sampling records from 2018 and onwards were scrutinised. Based on these, the following observations were made by the audit team: 1) Due to the absence of mechanical or automatic dividers, the samplers prepared all of the final samples by quartering, which for the purpose of measuring constituents or substances likely to be distributed in a non-uniform way in feed, cannot ensure a representative sample (e.g., in case of control for cross-contamination in compound feed ­ as clearly outlined in the PNAA). This is not in line with the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009. However, this deficiency is mitigated in case of controls for mycotoxins and GMOs in unprocessed feed materials (grains) where the whole aggregate sample is sent to the respective official laboratory (see findings 26 and 35). 2) In one sampling observed, the collection of the material was performed by the operator's staff, using the operator's equipment. A similar approach was suggested in another sampling exercise (which did not eventually happen after discussion with the audit team which did not endorse the sampler's suggestion). This methodology is not in line with the requirement that official samples shall be taken by persons authorised for that purpose by the competent authority, see part 3 of Annex I to Regulation (EC) No 152/2009. 3) In another sampling observed, the size of the sampled portion recorded in the sampling protocol was not consistent with the sampled portion actually sampled. Moreover, in a number of sampling reports seen, no sampling portion was recorded ­ this is not in line with the requirements laid down in part 10 of Annex I to Regulation (EC) No 152/2009. 4) In several sampling reports seen for the control of cross-contamination, the distribution pattern of the analyte was erroneously determined as uniform thus leading to taking considerably fewer incremental samples than required in part 5.2 of Annex I to Regulation (EC) No 152/2009. Collectively, the above deficiencies seen by the audit team undermine the utility and legal validity of the official feed samples taken. 7 5.2.2.3 Testing of official feed samples

Notwithstanding the risk-based approach adopted for the planning of official sampling, significant shortcomings in its implementation (both at the sampling sites and in the laboratories), including the absence of suitable sampling equipment, undermines the legal 8 and technical validity of the samples, weakening the overall effectiveness of official controls in verifying operator compliance with this aspect of feed law. 5.2.3 Actions taken on non-compliances

Member state response

Information will be provided throughout the territory for the purchase of a mechanical or automatic divider, where the number of such as to justify the financial The sampling Guidelines (Annex 8 to the National Animal Nutrition Plan - PNAA) will be fect with the Addendum that will be published shortly. Expected deadline: 30 working days.

The recommendation states as its basis

In the two official laboratories visited, the audit team scrutinised the system of preparation of the aggregate samples of unprocessed feed materials (grains) provided by the ASLs' samplers for testing on mycotoxins and GMOs (see finding 26), and following division into final and laboratory samples. The audit team noted that in neither laboratory was there documentary evidence that the procedure applied achieved complete homogenisation of the aggregate samples required in part 9.4 of Annex I to Regulation (EC) No 152/2009 (control of constituents, including GMOs, or substances likely to be distributed non-uniformly in feed materials). In one laboratory, there was no standard operating procedure on the preparation of pertinent aggregate samples. The laboratory representative explained that the laboratory had no responsibility for the handling of aggregate samples even though they were prepared in the laboratory premises, by laboratory staff, and using laboratory equipment.

Notwithstanding the risk-based approach adopted for the planning of official sampling, significant shortcomings in its implementation (both at the sampling sites and in the laboratories), including the absence of suitable sampling equipment, undermines the legal 8 and technical validity of the samples, weakening the overall effectiveness of official controls in verifying operator compliance with this aspect of feed law. 5.2.3 Actions taken on non-compliances

Member state response

lattico Sperimentale of , Liguria and Valle d'Aosta and the Health Institute have been officially ith preparing procedures to be to all Istituti Zooprofilattici tali. . 4668 of 23 February 2022. ication that manages the whole

The recommendation states as its basis

The audit team scrutinised a number of non-compliances identified in official controls. The examples included an erroneous inclusion rate of an active pharmacological substance, persistent occurrence of vermin, unacceptable carry-over of a coccidiostat into a non-target feed, labelling deficiencies, etc. The audit team noted that in the vast majority of these cases there was clear notification to the operator requesting rectification of the issue(s) within a timeframe. However, in most cases, the competent authority had not verified that the operators had remedied the non-compliance(s) and prevented reoccurrences (e.g., in the case of the erroneous inclusion rate of the active pharmacological substance, the use of digital prescriptions could not guarantee that the operator would ensure the correct inclusion rate; in the vermin case, the quotation for a relevant extermination service submitted by the operator could not be considered as sufficient evidence that the operator had remedied the issue). Conclusion on the actions taken on non-compliances

Notwithstanding clear communication to the feed business operators when non-compliances are identified during official controls, the fact that the competent authorities do not effectively verify that the feed business operators satisfactorily rectify those non- compliances and prevent their further occurrences, weakens the effectiveness of the overall control system.

Member state response

on activity in a computerized manner is available on the SINVSA information In the event of non-compliance, this llows the veterinary service to indicate requirements for resolution. This ion provides for the mandatory by which the operator must solve the liances. At the end of that period, the ry service is automatically informed so rry out a follow-up inspection. Where ow-up inspection is not carried out, the on is not completed but remains "in ".

Member state response

s In riferimento alla bozza del report di Audit DG(SANTE)/2021-7250 svolto da remoto nel periodo 12-23 aprile 2021 e nello specifico alla raccomandazione relativa a: "Garantire che le procedure in atto assicurino che i controlli ufficiali sui nidi negli allevamenti di galline ovaiole siano appropriati e coerenti. Raccomandazione basata sulla conclusione principale n. 4. Risultati associati: n. 47, 48 e 52. Riferimento giuridico: articolo 5, paragrafo 1, lettere a) e b), del regolamento (UE) 2017/625." L'art. 4 della Direttiva 98/58/CE stabilisce "che gli stati membri provvedono affinché le condizioni di allevamento o di custodia degli animali siano conformi alle disposizioni che figurano in allegato" Dall'esame dell'allegato alla citata direttiva non risulta alcuna citazione relativa a caratteristiche dettagliate relative ai nidi e nessun riferimento che possa avere connessioni con la bibliografia scientifica in tal senso. In relazione ai nidi, la direttiva 1999/74/CE del Consiglio del 19 luglio 1999 fornisce la definizione di nido dando indicazioni sul dimensionamento e pavimentazione dei nidi, singoli o di gruppo, nulla citando in ordine alla presenza e tipologia delle pareti di

The recommendation states as its basis

Up until the time of the audit, the NRL provided technical and scientific assistance on request. However, it has not organised inter-laboratory comparative testing or proficiency tests between the official laboratories, although this is appropriate and therefore required by Article 101(1)(c) of Regulation (EU) 2017/625.

Almost each RPS has their own official laboratory where initial tests and the vast majority of confirmatory tests are carried out. The regional laboratories have experienced staff for working with molecular methods, and have already performed analysis with at least one of the methods listed in the Annex to Regulation (EU) 2020/1191. The RPS laboratory is nominated as Regional Reference Laboratory in those regions where more than one laboratory carries out the tests of official samples. However, the proficiency of the official laboratories' ToBRFV analysis with the listed methods has never been assessed by ring tests.

There is an established laboratory network for the implementation of official controls. However, the performance of the official testing for ToBRFV in official laboratories is not verified by the NRL, who does not organise ring tests for this purpose. The official laboratories do not participate either in ring tests, organised by other entities, to achieve the same verification. As a consequence, the CA has no information on how reliable these tests are in detecting the presence of the virus. Any 7 measure based on an unreliable laboratory result has negative influence on the controls.

Member state response

The proficiency test (PT) for ToBRFV was organized by the NRL in June 2021. In particular, 12 official laboratories took part to this PT. On 21st June, a panel of 11 blind samples were sent to each , laboratory for testing according to the Annex of Reg. 2020/1191. The final report was set up in September 2021 (please, find attached).

The proficiency test (PT) for ToBRFV was In order to cope with the unsatisfactory organized by the NRL in June 2021. In performance and to guarantee the particular, 12 official laboratories took part to participation of all the laboratories this PT. On 21st June, a panel of 11 blind designated for the analysis of official samples were sent to each laboratory for samples for ToBRFV, we established testing according to the Annex of Reg. specific provisions within the draft of the 2020/1191. The final report was set up in Ministerial Decree "Characteristics, areas of competence, structures and methods for the September 2021. recognition of laboratories operating in the field of plant protection". This decree was Five laboratories achieved 100% accuracy. approved by the National Phytosanitary The other laboratories mainly had false Committee in January 2022 and has positive results but two of them had false undertaken the official approval process for negatives as well in the case of leaf samples, the issue. their accuracy was 73%. In any case, pending the entry into force of the Decree, the official laboratories with non-performing results were supported with a follow-up to identify t

Member state response

Proficiency Test for the Xylella fastidiosa analysis will be organized within March 2022 by the National Reference Laboratory (NRL) that will involve all nnex designated reference laboratories that perform Xylella fastidiosa official analysis. e This activity will allow to collect information about technical details of the s methods used for Xylella fastidiosa detection, verifying if these are in line with methods listed in Annex IV to Regulation (EU) 2020/1201 and also to assess the actual test performance of each laboratory. Finally, NRL will provide technical assistance and training to the designated regional laboratories.

roficiency Test for the Xylella fastidiosa nalysis will be organized within March 2022 by The PT on Xylella fastidiosa is currently under he National Reference Laboratory (NRL) that execution. The number of participating laboratories ill involve all designated reference laboratories is 31. Each laboratory received 12 blind samples of hat perform Xylella fastidiosa official analysis. different plant matrices (lavender, olive, almond, his activity will allow to collect information rosemary, vine), three PAC and one NAC. The bout technical details of the methods used for deadline for the submitting of the overall results is ylella fastidiosa detection, verifying if these are April 22. The other information will be available n line with methods listed in Annex IV to when the overall data will be processed (deadline egulation (EU) 2020/1201 and also to assess the for the delivery of the report 22 June). ctual test performance of each laboratory. inally, NRL will provide technical assistance and raining to the designated regional laboratories.

The recommendation states as its basis

There are general documented procedures in place, but there are none regarding the application of the eradication and containment measures to be taken following official controls against A. chinensis, A. glabripennis and P. japonica, contrary to Article 12 (1) of Regulation 2017/625. This has contributed to the different implementation of the eradication measures in the regions (see also sections 5.5 and 5.6).

The official controls and other official activities of the RPS regarding the application of the eradication and containment measures against A. chinensis, A. glabripennis and P. japonica are not sufficiently coordinated and there is a lack of procedures, which lead to inconsistent application of the control measures and decreases their effectiveness.

Member state response

noplophora chinensis and Anoplophora glabripennis onized national procedures will be drawn up for the application and verification of he eradication and containment measures, based on the existing regional procedures. These rocedures will be included in the National Contingency Plan for Anoplophora, which is ted to be adopted by 2022. opillia japonica he procedures for official controls are already available, as presented during the Audit. hey have been approved by the National technical-scientific Panel on Popillia japonica, stablished by the Ministry of Agriculture in 2016, and already applied by the involved egions. he composition of the Panel was extended in October 2021 in order to include all the egions involved and neighboring ones, favoring the harmonization of procedures. hese procedures will be included in the National Contingency Plan for Popillia japonica, hich is expected to be adopted by 2022.

Anoplophora chinensis and Anoplophora glabripennis Harmonized national procedures will be drawn up for the application and verification of the eradication and containment measures, based on the existing regional procedures. These procedures will be included in the National Contingency Plan for Anoplophora, which is expected to be adopted by 2022. Popillia japonica The procedures for official controls are already available, as presented during the Audit. They have been approved by the National technical-scientific Panel on Popillia japonica, established by the Ministry of Agriculture in 2016, and already applied by the involved Regions. The composition of the Panel was extended in October 2021 in order to include all the regions involved and neighboring ones, favoring the harmonization of procedures. Page: 1 ted by the competent authorities of Italy in response to Report ref. DG(SANTE) 2021-7283 of the 21 in order to evaluate the situation and controls for Anoplophora glabripennis, Anoplophora Action Proposed by the competent authority These procedures will be included in the authorityaaututhority National Contingency Plan for Popillia japonica, which is expected to be adopted by 20

The recommendation states as its basis

The authorities continue tackling the problems of illegal free-range pigs and under- registration of domestic piglets. Although to a lesser degree than before, both problems still remain and they amplify the risk of persistence and spread of ASF virus.

The epidemiological investigations of the most recent outbreaks were incomplete and/or incorrectly estimated the time during which ASF virus may have existed on the holding. This could negatively affect the ability to identify the possible sources of disease and to implement forward and backward tracing correctly.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

competent authority will take the following measures: a) In application to the Recommendation based on conclusion No. REF _Ref88820651 \r \h 2., a new procedure has been implemented in addition to the records of the new-born of pigs in the holding registers. The procedure is included in the II provision of the Extraordinary ASF Eradication Program (https://www.regione.sardegna.it/j/v/2644?s=1&v=9&c=390&c1=13680 &id=98492), containing rules about the control of the disease in pigs and pig meat productions for the 2022-2023. The provision has been issued on 11/03/2022 by the ASF Project Unit (UdP) and provides for: - The farmers are required to register the new-born of pigs in the National Database (BDN), at least three times per year (Art. 6, par. 5 of the II provision) (phase 1: census registration in BDN). - Every six months, the Veterinary Epidemiological Regional Observatory (OEVR) will performs appropriate checks aimed at highlight, measuring and monitoring any discrepancies in pig reproductive parameters. This phase requires the implementation of a specific algorithm with the official data from BDN by the OEVR (phase 2: assessment of conformity of the reproductive parameters)

The recommendation states as its basis

The effectiveness of ASF surveillance varies across the island, but data demonstrates a decline in the presence of ASF in the wild boar population and of seropositive pigs in farms. There is an under-reporting to the Commission and member states on ASF outbreaks, as Italian authorities do not consider seropositive pigs on holdings as confirmed cases. The temporal and spatial clustering of passive surveillance creates a risk of new cases not being detected quickly, in particular outside the defined infected area.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

onsidering the observations arising from the dialogue between the Auditors, the the regional and national competent authorities during the audit of 9-19 vember 2021, the Recommendation 2 has been already transposed and the ant legislation has been applied starting from December 2021, as can be seen m the notification of the ASF outbreaks in SIMAN and ADIS.

The recommendation states as its basis

The epidemiological investigations of the most recent outbreaks were incomplete and/or incorrectly estimated the time during which ASF virus may have existed on the holding. This could negatively affect the ability to identify the possible sources of disease and to implement forward and backward tracing correctly.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

stated in the II provision of the Extraordinary ASF Eradication Program (Art. , par. 6), the OEVR in collaboration with of the National Reference Centre for SF, supports the veterinary services in carrying out the epidemiological vestigation, evaluating its completeness, timeliness and exhaustiveness. rthermore, the digital compilation of the epidemiological investigations on the base (via input screen) allows the official veterinarians to highlight y discrepancy with the official health data sources. addition, specific training courses will be planned and organized for the staff the veterinary services.

The recommendation states as its basis

The effectiveness of ASF surveillance varies across the island, but data demonstrates a decline in the presence of ASF in the wild boar population and of seropositive pigs in farms. There is an under-reporting to the Commission and member states on ASF outbreaks, as Italian authorities do not consider seropositive pigs on holdings as confirmed cases. The temporal and spatial clustering of passive surveillance creates a risk of new cases not being detected quickly, in particular outside the defined infected area.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

he new procedure on passive surveillance in domestic pigs was adopted with UdP note prot. 77 del 09/02/2022 (Annex 2) and is included in the II provision f the Extraordinary ASF Eradication Program. Base on this, the national and gional informative systems have been lined up. e procedure is aim at ensure adequate and uniform passive surveillance all over . The procedure is based on a sample size representative of the expected ad pigs population, aim at detect a disease prevalence less than 0.5% onfidence level 95%). rticularly, the procedure provides for: The UdP notifies to the ASLs the yearly expected number of dead pigs be tested for ASF, by the note prot. 77 del 09/02/2022 (phase 1: mple size assignment and notification). Page: 3 ived 16 March 2022 of report ref. DG (SANTE) 2021-7344 of the audit carried out from 09 November nimal health controls in relation to African swine fever the IZS local laboratories rms, to perform the ASF specific data sheet (phase . data about farm (i.e., practice, municipality, d pig, date of death, sample data sheet and upload on surveillance (SINVSA) ta upload) ata mining on ASF out the samples tested for directly extracted from ance datacollection

The recommendation states as its basis

The effectiveness of ASF surveillance varies across the island, but data demonstrates a decline in the presence of ASF in the wild boar population and of seropositive pigs in farms. There is an under-reporting to the Commission and member states on ASF outbreaks, as Italian authorities do not consider seropositive pigs on holdings as confirmed cases. The temporal and spatial clustering of passive surveillance creates a risk of new cases not being detected quickly, in particular outside the defined infected area.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

Member state response

The wild boar passive surveillance is already in place throughout the region and be ensured and strengthened. The OEVR has already delivered a specific ocedure for implementing the EFSA Exit strategy for Sardinia, on which the ed. The UdP is implementing a Page: 4 ived 16 March 2022 of report ref. DG (SANTE) 2021-7344 of the audit carried out from 09 November nimal health controls in relation to African swine fever he competent authority ific intervention plan, in collaboration with the Veterinary Services, the IZS, al agency of Forestas, and the hunting and dog associations. ossible to enhance the search for wild boar carcasses n, according to EFSA guidelines, in order to provide a e view of the health status of the entire wild boar population, inside considered infected by the competent authorities of Sardinia, rotected areas where the hunt is forbidden. assive surveillance plan includes the following phases: lans the wild boar passive surveillance goals, based ategy (phase 1: planning of the wild boar passive of the on field inspections aimed at actively searching rcasses throughout the region (infected and non-infected protected areas where the hunt is forbidden). The OEVR ecif

Member state response

, laid down in the Law La legge n.120 del 2020 ha previsto che tutti gli organismi di rry out official controllo (OdC) entro il 15 marzo 2021 siano accreditati. uired by Article 90(3) Successivamente, tale scadenza è stata prorogata al 31 dicembre 2021 dal decreto legge n. 183 del 31 dicembre 2020. Si segnala che con nota n. 9146344 del 18/9/2020, l'ufficio competente VICO I ha richiesto l'accreditamento di tutti gli OdC pubblici operanti nel settore vitivinicolo; mentre con nota 9195716 del 01/10/2020 sia i Consorzi che le Regioni sono state sollecitate ad attivarsi al fine di garantire la continuità delle attività di controllo e certificazione delle rispettive produzioni protette (Ad oggi, 12 febbraio 2021, dei 18 OdC pubblici autorizzati, 4 sono già accreditati e 7 hanno comunicato di volersi accreditare) ***** With Law 120/2020, the Italian State has provided that all CBs must be accredited by March 15, 2021. This date has been subsequently extended to 31 December 2021 by article 10 of Law Decree No. 183 of 31 December 2020 It should be noted that with note no. 9146344 of 18/9/2020, the competent VICO I office requested the accreditation of all public CBs operating in the wine

The recommendation states as its basis

At the time of the audit there were eight private and 18 public CBs approved by MiPAAF for the control and certification of PDO/PGI wines. In the case of private bodies, accreditation to ISO/IEC 17065 is a pre-requisite for approval. The approval procedure for public CBs includes the checking by MiPAAF of all relevant aspects necessary to confirm the CB's competence. However, at the time of the audit only two public CBs were accredited as it was not a pre-requisite for the approval of public CBs. This is not in line with Article 90(3) of Regulation (EU) No 1306/2013.

Member state response

nlawful use of PDO/PGI L'ICQRF nelle linee guida per la programmazione annuale dell'attività di controllo per il 2021 ha previsto di dedicare una percentuale variabile, non superiore al 3% dei controlli e al 5% dei of their origin, as campioni, ai prodotti ad indicazione geografica non italiani. (EU) 2017/625 by Article 16 of La percentuale dei controlli, dedicati alle IG estere, sarà determinata da ciascun Ufficio territoriale in funzione delle 3 importazioni e introduzioni di tali prodotti nel territorio nazionale, oltre che dalla penetrazione commerciale di tali prodotti nel mercato del proprio territorio di competenza. Si allegano le linee guida della programmazione 2021 ******** The ICQRF in the guidelines for the annual planning of control activities for 2021 has planned to dedicate a variable percentage, not exceeding 3% of the controls and 5% of the samples, to non- Italian geographical indication products. The percentage of controls, allocated to foreign GIs, will be determined by each local office according to the imports and introductions of these products in the national territory, as well as by the commercial penetration of these products in the market of its own terri

Member state response

e delays in the analysis and transmission of the information relating to the different epidemiological vestigations are certainly attributable to the high number of reaks that occurred in a short period of time and in ely populated areas. For this reason, during the emergency, the competent Authorities have regarded eradication measures as a priority. Based on the critical issues arisen and thanks to the experience gained, in 2018 and 2019 steps were taken to address the risk factors regarded as crucial in the spread of the disease in the s involved. - Ministerial Decree of 14 March 2018: specific funds ( 10,000,000.00) have been allocated for: the improvement of bio-security measures in poultry farms in high-risk Regions, the increase of passive surveillance in domestic and wild populations, field simulation activities, the collection and analysis of data on the ecology of wild birds and their interaction with domestic birds, the creation of adequate stocks of material for managing interventions during epidemics including disinfectants, personal protective equipment (PPE) and materials for sampling, the implementation of an interregional network and systems for killing, destructio

Member state response

h is continuing its awareness-raising hich has already given the first results in some ons. It will be the responsibility of the Ministry of Health rovide the deficient Regions with this recommendation, as as to adopt more strict verification measures. Page: 3

The recommendation states as its basis

FINDINGS AND CONCLUSIONS Legal acts quoted in this report are provided in Annex I and refer, where applicable, to the last amended version in force at the time of the audit. Relevant provisions of those legal acts that are audited against in the chapters of this report are specified in the appendix.

Neither of the two ports visited have the necessary infrastructure for implementing biosecurity measures, i.e. facilities for the inspection, cleansing and disinfection of livestock vehicles. Whilst the competent authorities at the port of Palermo could provide a short list of companies able to carry out such disinfection either on-the-spot or in the vicinity of the port, these companies are not listed in the Memorandum of Understanding and the audit team did not see evidence of any formal agreement or contract in place to procure these services. The Memorandum of Understanding between the Ministry of Health and Customs at Civitavecchia Port names the cleansing and disinfection company, located within the port area, to be used if required, although the only equipment they have are sprays and nebulisers. Poor cooperation on the Civitavecchia port authority's side, despite repeated requests by Customs (seen by the audit team) to set up an appropriate area on the quay where cleansing and disinfection of vehicles could take place, means that such facilities have not yet been established. The Memorandum of Understanding at Livorno port mentions that the cleansing and disinfection should be carried out by authorised companies and in specifically identified areas of the terminals but does not go so far as to identify either the companies concerned or the areas of the terminals where cleansing and disinfection should take place. This means that the competent authorities cannot confidently avail of the option provided for in Article 3(4)(a) or Article 3(4)(b)(ii) of Decision (EU) 2017/675. 5.1.4. Designation of crossing points

Ports where livestock vehicles or vessels could enter Italy are limited by the current shipping routes. In theory, all Italian ports are a potential point of entry for livestock vehicles or vessels. Although not legally required to do so, the fact that the competent authorities have not designated specific ports for the entry of livestock vehicles means that they are obliged to ensure that the requirements of Articles 2 and 3 of Decision (EU) 2017/675 are respected at all entry points, including those without a BIP. The audit team 4 only saw evidence of local procedures (Memoranda of Understanding) in place at 3 out of 110 sea border entry points notified to the European Commission under Article 39(1)(b) of Regulation (EU) 2016/399 (Schengen Borders Code) and published in the Official Journal of the European Union, (4) and 17 of these sea borders are ports with BIPs. Whilst the Ministry of Health has requested Customs to carry out checks on returning livestock vehicles and on the drivers' declarations (see findings 1 and 3) as part of their routine duties in all ports of entry, it has not provided any detailed instructions to Customs on how these checks should be done to ensure that only compliant vehicles may be allowed to enter. 5.1.5. Administrative provisions implementing EU rules

The instructions for checks on livestock vehicles provided in these memoranda are not sufficiently detailed with regard to the provisions laid down in Articles 2 and 3 of Decision (EU) 2017/675 regarding documentary checks, visual checks, disinfection, action to be taken in case of non-conformity and requirements for record-keeping, to be fully in line with the requirements of Article 8(1) of Regulation (EC) No 882/2004 (5) (see also findings 5 and 8). 5.1.6. Use of databases

Whilst local Memoranda of Understanding between the Ministry of Health and Customs have been formalised recently for three ports, these are insufficiently clear or detailed as regards responsibilities (who does what, when and how). Lack of harmonisation of these memoranda, lack of specific training of staff and information on how to identify livestock vehicles and on those disinfectants/active ingredients which are effective against Foot and Mouth Disease, collectively undermine confidence in the effectiveness and consistency of official controls, were such controls carried out. These weaknesses are mitigated by the fact that the competent authorities stated that there has been no traffic in livestock or feed vehicles for several years.

The placing of responsibility on the shipping companies for ensuring that livestock vehicles entering Italy are notified to the authorities in advance and making the companies liable for the costs of disinfection should such vehicles arrive without having been appropriately cleaned, mitigates the risk of unclean and non-disinfected 6 vehicles entering the EU. However, should the competent authority decide to carry out disinfection on-the-spot or in the vicinity of the port, the memoranda do not provide sufficient practical guidance to officials on how to arrange this, especially given that no formal agreements or contracts have been concluded with companies capable of carrying out the cleaning and disinfection in appropriate premises.

The recommendation states as its basis

At Milano-Malpensa Airport BIP, the facilities for animals (categories U and E) were visited only. In response to a recommendation of a previous audit report (DG(SANTE)/2016-8874), the facilities have been adapted to accommodate ungulates (category U). However, the facilities lacked maintenance, in particular the roof was leaking at different places. This was identified during recent internal verification visits, but BIP staff could not provide evidence that corrective action was underway (see related finding point 73). In addition, BIP staff did not identify damaged floor surfaces and the absence of restraining equipment for animals, categories U and E. Furthermore, the housing facilities for these categories of animals were not appropriately cleaned. The facilities for animals, categories U and E do not meet the minimum requirements laid down in Annex A to Directive 91/496/EEC.

All facilities visited with the exception of the BIP facilities at Venezia Port, did not meet the operational hygiene standards resulting from either lack of maintenance and/or inappropriate cleansing and disinfection. Whilst some facilities are being reconstructed to comply with Regulations (EU) 2017/625 and (EU) 2019/1014 there is, however, no plan to upgrade the substandard facilities and equipment at Civitavecchia Port BIP.

In relation to import controls on food of non-animal origin, DGISAN has not made available to the public a list of points of entry with suitable designated DPE/DPI facilities. The list of DPEs only erroneously refers to local offices of DGISAN and the published list has not been updated since 2016. DGISAN does not ensure that documentary checks are done at the DPE and that physical checks, including sampling, are carried out at the DPE/DPIs.

Member state response

petent authority response received on /03/2020 With reference to official controls on imports of animals and products of animal origin, appropriate measures have been implemented in some cases and planned in others to make the facilities and equipment comply with the requirements of the reference legislation (Reg (EU) 2017/625 and Reg (EU) 2019/1014). In particular, at Civitavecchia Port BCP meetings were held with Port Authority of Civitavecchia. after that, the works aimed at removing most of the deficiencies of the structure (floors, walls, cells) has been started. the works will be completed by mid- March 2020. the cleaning and disinfection program have also been improved. At the new Inspection Centre SPRESS of Fiumicino Airport BCP the shortcomings have been already removed. At the Inspection Centre ALHA Airport MXP SpA of Milano Malpensa Airport BCP Page: 1 s of Italy in response to Report ref. DG(SANTE) 2019-6640 of the audit carried out from 26 e system of official controls on imports of animals and goods ority ove the over, a r ection work in progress e end of the basis been rding t transport he , central ures. e structure ity Page: 2 s of Italy in response to Report ref.

The recommendation states as its basis

The controls on food of non-animal origin subject to special import conditions were not implemented in line with EU rules in several cases below.

At Venice port, documentary checks on food of non-animal origin subject to special import conditions took place at the local USMAF-SASN office instead of in the port of (2) In its response to the draft report the competent authority noted that the BIP staff of Civitavecchia carry out the identity checks of the containerised frozen and chilled goods and collect the packages selected for physical checks at the BCP facilities. 12 entry where physical facilities are in place (see related finding point 82). This arrangement is not in line with the requirements laid down in Article 8(1)(a) of Regulation (EC) No 669/2009, Article 9(2) of Regulation (EU) No 884/2014 and Article 8(1) of Regulation (EU) 2015/175.

USMAF-SASN staff carry out documentary controls based on copies of original certificates and/or laboratory test results. This hinders the verification of the authenticity of the health certificates, declarations and the laboratory results due to the reliance on copies. This procedure is not in line with the requirements laid down in Articles 4, 5 and 9(2) of Regulation (EU) No 884/2014 and Articles 4, 5 and 8(1) of Regulation (EU) 2015/175.

In addition, in one port visited, DPE/DPI staff could not provide copies of the certificates and laboratory test results for one out of three consignments of peanuts from Egypt and one consignment of guar gum from India verified in order to demonstrate that the requirements laid down in Articles 4 and 5 of Regulations (EU) No 884/2014 and (EU) 2015/175 respectively were met.

The official samples, taken by DPE/DPI staff are sent to the designated laboratories for analyses. The consignments were detained awaiting results. The results of the laboratory tests were available in all cases verified, but in one case there was no link between the sampling and the consignment due to absence of the lot/batch number. 5.2.5 Decision on consignment and its follow-up

USMAF-SASN do not check the originals of certificates or other relevant documents and therefore are not in a position to ascertain their authenticity. Furthermore, the way in which the system for documentary checks on consignments of food of non-animal origin subject to special import conditions has been set up at the designated point of entry in Venice Port (checks are being carried out at local office level instead of at the entry point at the border) is contrary to EU requirements.

In case consignments are selected for official sampling, the consignments are forwarded to the inspection facilities for food of non-animal origin, which are located in the port of entry. In Venice port, physical checks and sampling takes also place in customs warehouses, which are not designated by DGISAN as DPIs. Carrying out physical checks at these warehouses is not in line with Article 9(2) of Regulation EC) No 669/2009, Article 8(1)(b) of Regulation (EU) No 884/2014 and Article 8(2) of Regulation (EU) 2015/175.

In relation to import controls on food of non-animal origin, DGISAN has not made available to the public a list of points of entry with suitable designated DPE/DPI facilities. The list of DPEs only erroneously refers to local offices of DGISAN and the published list has not been updated since 2016. DGISAN does not ensure that documentary checks are done at the DPE and that physical checks, including sampling, are carried out at the DPE/DPIs.

Member state response

Competent authority response received on /03/2020 pecific instructions have been provided to the offices concerned in order to ensure that all official controls on food of non-animal origin are carried out at the designated structures (current BCP). As regards the performing of the documentary checks on the original certificates issued by third countries, specific Page: 7 s of Italy in response to Report ref. DG(SANTE) 2019-6640 of the audit carried out from 26 e system of official controls on imports of animals and goods on Proposed by the competent authority ructions for the concerned offices are g prepared. tands firm that since the TRACES-NT uter system is in use, the documentation cquired in electronic format. her information: specific instructions for carrying out the mentary checks have been implemented he USMAF. Currently, however, due to the ical issues for the COVID 19 emergency, documentary checks are carried out on the s of article 4 of Regulation (EU) 2020/466 the copy of the documentation sent tronically or through TRACES with aration by the operator to bring the inal documentation at the end of the gency).

The recommendation states as its basis

Regarding records of supplies of goods from the customs warehouse to cross border means of sea transport checked by the audit team, the certificate referred to in Article 1(3) of Decision 2000/571/EC (the model certificate being laid down in the Annex thereto) was issued by the BIP staff. However, the audit team noted that in a few cases, operators had not provided the BIP staff with the completed certificate confirming the delivery of goods on board the vessel within the deadline of 30 days, which is not in line with Article 2 of that Decision.

The BIP staff issued a similar document for delivery of goods from the warehouse to NATO/US army bases, and validated thereafter the CVEDs in TRACES. The proportion of cases where confirmation of arrival at NATO/US army bases within the deadline of 30 days varies significantly between bases, ranging from 99,6% to as little as 13.4 % confirmed. DGSAF stated that further action is still needed to ensure that this legal obligation is satisfied in all cases. 5.2.4 Documentary, identity and physical checks 5.2.4.1 Checks on animals

The audit team carried out a desk review of 50 consignments of animal origin which were allowed entry and must be channelled to their destination in line with the requirements of Articles 8(4), 12(1) or 15(1) of Directive 97/78/EC. DGSAF and BIP staff provided evidence that the local veterinary units had been informed of the dispatch and had reported the arrival of such consignments at destination. However, local veterinary units did not enter in TRACES the completion of part III of the CVEDs in 16 of the cases, but used instead other means to report the arrival e.g. by email. This is not in line with the requirements laid down in article 3(2) of Decision 2004/292/EC. 13 Furthermore, audit report DG(SANCO)/2013-6899 had made a recommendation on this subject to which DGSAF had provided a satisfactory action plan. 5.2.6 Use of TRACES and other databases in relation to import controls and transit

The guarantees in response to recommendation 1 of a previous audit report in relation to entering required data into TRACES by the local veterinary units, confirming the arrival of consignments at destination have not been effectively implemented.

Member state response

etent authority response received on 3/2020 obligation to confirm the arrival of ignments at destination through the Page: 8 s of Italy in response to Report ref. DG(SANTE) 2019-6640 of the audit carried out from 26 e system of official controls on imports of animals and goods ction Proposed by the competent authority RACES information system (in cases where U legilsation provides for it) will be furhter emarked to the territorially competent egions/UVL through a special letter from he CCA. At the same time, instructions will e given to the PCF to intervene on the UVL n every single situation of non-confirmation f arrival of the consignments at destination nd to report to the CCA the cases in which his obligation is not respected, also for any onsignments in transit, so that to analyse the ecurring cases and report them to the ompetent offices that carry out the audits on he regions (measures by 15 March 2020). Page: 9

The recommendation states as its basis

There is no common checklist or guidance at national level to control FBOs regarding FIA use, hence the local authorities using different approaches for these controls (documents to be requested, aspects to be covered, controlling FIA either during inspection or audit). In one of the Regions visited, the local authorities prepared a detailed checklist which acts as guidance for those controls. In the other Region, officials are advised to use a checklist prepared for the controls of FIA in approved establishments handling food of animal origin, also in controls at registered establishments. The depth of the controls also depends on the expertise and knowledge of the individual inspectors. Different levels of knowledge on FIA requirements were noted amongst the inspectors.

Regarding the FIA users, local authorities in the first Region visited explained that they have recently prepared a pilot checklist which will allow them to cover the aspects not covered to date. The audit team noted that, since this is a relatively new development, inspectors do not follow a structured approach, and sometimes rely solely on the information provided by the FBOs. Some of the elements that the inspectors omitted to examine were: the specifications of raw materials for possible presence of FIA, the recipe of the product examined (which should be the starting point of such controls), the identification of the correct food category; in addition, no requests were made for additional clarification as to why certain additives were not added on the label of the final product although found present in one of the ingredients (carry-over principle).

With regard to FIA users, as indicated at regional level, there is no specific checklist for registered establishments. The approach followed by the inspectors during controls of FIA users was, in the majority of the cases, not consistent (as to what, when and how to 10 check) and not well structured. Some of the inspections were detailed and complete (checking specific requirement for labelling, knowledge of Aluminium-lakes requirements for colours) whereas in others certain elements were not addressed.

Some of the omissions observed by the audit team were: absence of checks of the specifications of the different ingredients to see if some additives could be present, and which of these additives could have a technological function in the final product; failure to note that the specifications regarding purity criteria were incomplete; and conduct of calculations using the weight of the intermediate product (dough) and not of the final product, as appropriate. Nevertheless, when asked by the audit team, in all cases the inspectors were able to re-evaluate or seek for more information for those aspects.

In the second Region visited the audit team was informed that inspectors cover the topic of FIA at FIA users' level during audits. Only in one case the inspectors confirmed that they would start using the dedicated checklist for approved establishments, also for registered establishments as recommended by the regional authority.

Official controls at FIA users' level are lacking in completeness and depth resulting in an insufficient verification of the compliance with FIA legislation. The absence of specific guidance or instructions creates inconsistencies in the approach followed by the inspectors (i.e. omission to ask for the recipe of the product being examined in relation to FIA used, define the product category and examine the specifications of all the raw materials used in the production of a that product). Adding to that, the limited hands-on experience of the inspectors leads to the oversight of certain issues regarding FIA during such controls. 16

Member state response

Il Ministero della salute ha il 9 gennaio 2020 trasmesso alle gioni ai laboratori nazionali di riferimento una nota allegata con l'invito a dare seguito alle raccomandazioni contenute in questo t documento. La regione Lombardia ha dato le seguenti indicazioni ai laboratori del controllo ufficiale con la delibera con DGR n. XI/2633 del 16/12/2019 "RETE DEI LABORATORI DI PREVENZIONE - CATALOGO GENERALE E TARIFFARIO DELLE PRESTAZIONI ANALITICHE OFFERTE - AGGIORNAMENTO DELLA DGR N° X/4761 DEL 28/01/2016" I laboratori, nello svolgimento della loro attività, devono attenersi al documento SANTE/11813/2017 "Guidance document on analytical quality control and method validation procedures for pesticide residues and analysis in food and feed" e devono partecipare agli EURL Proficiency test relativi alle "commodities" erogate. I risultati dei Proficiency test dovranno essere inviati alla UO Prevenzione entro 1 mese dalla ricezione. I laboratori di riferimento per l'analisi dei residui di fitosanitari in alimenti vegetali dovranno accreditare entro il 2020 almeno l'80% dei 175 principi attivi previsti dal Piano Coordinato Comunitario per ogni matrice alimentare (commodity), quale prerequisito p

The recommendation states as its basis

The RPS-Apulia stated that the 2018 annual survey started on 5 November 2018, and ended in May 2019. The RPS-Apulia further stated that the reason for the late start in 2018 was due to waiting for the new AP to come into effect.

As in previous years, the method applied during the 2018 survey in the DA in Apulia was largely in line with the Decision. However, as also noted from previous years, part of the visual inspections were carried out in periods not suitable for the detection of the key symptoms appearing on the leaves of deciduous and herbaceous hosts, which may inadvertently exclude many infected plants during the exercise.

Member state response

, in During 2019, this recommendation was taken into account, as the monitoring of 2019 ed zone started in August 2019 and is now being finalized. propriate For 2020, the Action Plan currently being prepared envisages that monitoring will be cified plants carried out from May to October 2020. (EU)

uring 2019, this recommendation was taken into account, as the monitoring of 2019 started in August 2019 and is now being finalized. For 2020, the Action Plan currently being prepared envisages that monitoring will be carried out from May to October 2020.

During 2019, this recommendation was taken into account, as the monitoring of 2019 started in August 2019 and is now being finalized. For 2020, the Action Plan currently being prepared envisages that nitoring will be carried out from May to October 2020.

The recommendation states as its basis

Substantial resources have been allocated for research purposes particularly for understanding the parameters of A. bungii biology such as behaviour and host acceptance of young trees with trunks of less than 6-7 cm diameter or tree species other than Prunus through artificial diet and oviposition trials. The studies have been carried out on Olea europaea, Punica granatum, Diospyros kaki, Populus alba, as well as on the ornamental Prunus cerasifera cv. pissardii. Despite historical data indicating the opposite, Prunus cerasifera cv. pissardii cannot be excluded from being a potential host as A. bungii females are capable of laying eggs on this species in the absence of other more suitable hosts of Prunus.

The RPS stated that at the time of the audit, coinciding with the beginning of the A. bungii adult flight period in Lombardy, all infested plants had already been felled. The audit team visited a public green site with Prunus cerasifera cv. pissardii, a private backyard garden and a disposal site of felled and chipped plants located in one of the municipalities of the demarcated area and noted that: Ornamental plants of Prunus cerasifera cv. pissardii in both public and private green sites although not excluded from surveillance are not subject to systematic 12 inspections. The RPS stated that of the 1,156 cherry plum trees checked during 2018, they never came across infested trees of Prunus cerasifera cv. pissardii and that from the statistical point of view the intensive surveillance required by the legislation does not necessarily require the compulsory inspection of all trees located within the demarcated area (see also section 5.3.1); In early 2019, the RPS inspectors found exit holes of A. bungii in one out of two trees of Prunus domestica located in a private garden. Both trees under suspicion were felled. The second non-symptomatic tree was felled due to its proximity to the symptomatic one; it was proved not to be infested. However, not all Prunus plants were felled within a 100m radius of the infested sites, which under the Decision was not compliant with the eradication approach in place at the time of the audit; Felled Prunus plants had been chipped by using a tree trunk grinder and were ready for dispatch in an energy producing plant outside the demarcated area. In general, the size of many chips was more than 2.5cm thickness and width, which is not compliant with Article 8.3(b) of the Decision. The RPS stated that the risk of A. bungii larvae surviving to adulthood is minimal as there are no records or scientific evidence that the pest is capable of completing its development under adverse environmental conditions outside tree trunks.

Both RPSs carry out intensive surveillance for the detection of new outbreaks of A. bungii on Prunus plants. However, the exclusion of Prunus cerasifera cv. pissardii from the systematic inspections is based mainly on observations and not on justified scientific evidence.

Member state response

The Associated findings 43 bullet point 1 do not reflect what is actually he done by the Regional Services of Campania and Lombardy. Inspections on Prunus cerasifera cv. pissardii is regularly carried out in public and private areas. In Lombardia, in 2018, 1,156 plants of Prunus cerasifera cv. pissardii were checked. In Campania, to date, 255 inspections have been carried out on Prunus cerasifera cv. pissardii, corresponding to 6,149 checked plants. However, this point will be strengthened with the next revision of the regional action plan.

The recommendation states as its basis

The control of primary production fishing vessels is carried out by ASL/ASP staff and all vessels should be inspected within five years meaning that 20% of vessels should be assessed every year according to the current plan.

The audit team was informed by one ASL of one region that due to staff issues vessel inspections were not performed. In the other region visited, the frequency had been reduced to 10% of vessels to be inspected also due to lack of staff. The disrespect of the defined frequency does not allow the CA to provide the assurances required under Article 3(1) of Regulation (EC) No 882/2004.

However, the audit team noted that vessel inspections had not followed the set plan's frequency.

The recommendation states as its basis

The audit team visited two fishing vessels. One of them was considered as broadly compliant with the EU requirements, but the other one was not considered compliant due to the ice machine being installed inside the toilet facility, which had not been identified at previous controls. Landing operations, landing sites

However, one of them did not have a temperature recording device in a cold store and the temperature in the room did not reach -18°C. The display on the outside showed -8°C when the audit team arrived, -2.8°C during the visit inside and -6.5°C when rechecked after the tour around the establishment. This non-compliance had not been previously noted by the official control staff. In this regard, the local CA informed the audit team that the cold store was equipped with a functional temperature recording device at the time of the approval 2 January 2018. An inspection report dated 14 March 2018 contained no remarks at all.

In another establishment the audit team noted that the original best-before-dates of products packed in modified atmosphere was used for re-packed products in vacuum packages after opening and portioning. Shelf-life studies to support this practice had not been performed, which does not allow the food business operator to demonstrate compliance with Regulation (EC) No 2073/2005. The procedures had not been noted by the official control staff.

Moreover, the control system was not fully effective as certain non-compliances were unnoticed and/or not recorded: a. A cold store not meeting temperature requirements for frozen products (-18°C; temperature recording device) b. Setup of best-before-dates without supporting evidence. c. Food business operators not implementing and maintaining adequate procedures based on the HACCP principles. d. EU requirements for histamine testing are not always applied to food business operators' own control plans. 5.3.2 Official control of the products Legal requirements Article 17(2) of Regulation (EC) No 178/2002, Articles 4 and 7 of Regulation (EC) No 854/2004, Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

The recommendation states as its basis

Moreover, the control system was not fully effective as certain non-compliances were unnoticed and/or not recorded: a. A cold store not meeting temperature requirements for frozen products (-18°C; temperature recording device) b. Setup of best-before-dates without supporting evidence. c. Food business operators not implementing and maintaining adequate procedures based on the HACCP principles. d. EU requirements for histamine testing are not always applied to food business operators' own control plans. 5.3.2 Official control of the products Legal requirements Article 17(2) of Regulation (EC) No 178/2002, Articles 4 and 7 of Regulation (EC) No 854/2004, Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

The recommendation states as its basis

Moreover, the control system was not fully effective as certain non-compliances were unnoticed and/or not recorded: a. A cold store not meeting temperature requirements for frozen products (-18°C; temperature recording device) b. Setup of best-before-dates without supporting evidence. c. Food business operators not implementing and maintaining adequate procedures based on the HACCP principles. d. EU requirements for histamine testing are not always applied to food business operators' own control plans. 5.3.2 Official control of the products Legal requirements Article 17(2) of Regulation (EC) No 178/2002, Articles 4 and 7 of Regulation (EC) No 854/2004, Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

The recommendation states as its basis

The activities of the sectoral offices in relation to planning and development of programmes of official controls are not covered.

The internal procedure requires an annual programme be drawn up based on available documentation and new alerts. All Territorial Offices must be audited at least once every five years. On-site audits include all relevant official control activities and specific sectors are not targeted. The activities of the central office responsible for planning and development of programmes of official controls are not covered. No annual audit programme was provided to the DG SANTE audit team.

In relation to the MH cascade audit system The programming ensures that all RPHSs and ASLs receive multiple audits within each audit cycle. The degree to which sectors are covered varies according to the planning of the sectoral offices and the RPHSs and efforts are made to prioritise according to risk; While the coverage of audits is intense, in common with the situation seen by DG Health and Food Safety in a number of other Member States, there is a gap 3 In their comments on the draft report the Veterinary and Prevention Service of the Region of Lombardy stated that they will formalize, in the next planning documents, the criteria on which to define the priorities for sector audit activities. They will take into account the relevant risk factors emerging from results of previous verification activities, as well as any other documented evidence that leads to identify possible critical areas and/or areas for improvement. 4 In their comments on the draft report the ICQRF informed the Commission services that actions had been taken, following this audit, to ensure they had access to NAS Network reference documents. 19 in coverage of the planning and programming activities carried out at the central level; The RPHSs vary in their approaches. Examples seen demonstrated that relevant risk factors were considered but final selection of topics is very much based on professional judgement of auditors and other experts. Risk-based prioritisation processes/methodologies were not transparently defined and/or documented; There is effective coordination between the Ministry and the RPHSs, and this is attributable in large measure to the co-ordination efforts of Office III and the various structures put into place.

In relation to the ICQRF, audit programming is based on covering the full range of official control activities of each Territorial Office within a five-year cycle rather than on a risk-basis. In common with the situation for MH (and in a number of other Member States), there is a gap in coverage of the planning and programming activities carried out at the central level.

Member state response

lready stated to the team of audit, the Ministry of Health and the Ministry of Agriculture, Foodstuff, Forestry Policies and of Tourism, as part of the Italian public administration, are subject to several assessment on planning and scheduling activities. In fact, both are provided for: - An annual assessment of the achievement of the strategic and operational goals, assigned with "a cascade" process, which starting from the political directions dictated by the Minister arrives at the operational planning tasks to be carried out by the executive levels. These strategic and general objectives, in particular those assigned to DGISAN, DGSAF and ICQRF, also concern the planning and programming of official control activities. In this context, planning of the competent central authorities and programming at central level of official control activities is carried out through the various ministerial decision- making levels, with special measures referred to, as appropriate, "I, II and III level" Directive. These decisional levels establish, and "a cascade" decline, the strategic and operational objectives for the central and territorial offices, starting from political direction dictated b

The recommendation states as its basis

The audit team noted some inaccuracies in the official lists of plants along the chain of production of non-ruminant PAP to be used in the aquaculture sector, as follows: a. The list of food plants contained a very limited number of plants and in one case a plant approved for cutting bovine, ovine and caprine meat was wrongly listed in such list. b. The list of ABP processing plants did not contain several plants which were included in another official list containing ABP processing plants eligible to export non-ruminant PAP (see finding 16). c. The competent authorities confirmed that the above-mentioned lists could not be considered realistic, although in July 2017 the DGAHVM and DGFHFSN reminded the RVS in a joint letter to list the relevant establishments. This is not in line with the requirements laid down in Section A, Chapter V of Annex IV to Regulation (EC) No 999/2001

As a consequence of the previous finding (No 15), whenever an export/trade certificate of non-ruminant PAP has to be issued, or an ABP operator wants to have confidence that his suppliers are eligible for the production of non-ruminant PAP, it is necessary to contact the authority in charge of controls on the supplier and request an official declaration. The Ministry of Health keeps a list of operators, mainly processing plants, 6 which are eligible for the export of non-ruminant PAP, but this list does not cover all types of establishments covered in Section A, Chapter V of Annex IV to Regulation (EC) No 999/2001 (see also finding 35). 5.1.3 Planning of official controls Legal requirements Articles 4(3) and 45 of Regulation (EC) No 1069/2009 Article 32 of Commission Regulation (EU) No 142/2011 Article 7 of, and Annex IV to, Regulation (EC) No 999/2001 Article 3, 4 and 8 of Regulation (EC) No 882/2004 Findings 5.1.3.1 Planning of inspections

However, the lists of plants in the chain of production and use of non-ruminant PAP for the aquaculture sector are not sufficiently accurate. This weakness hampers the competent authority's overview and has resource implications for officials who have to investigate each case when a decision on the presence of ruminant protein in a given consignment of PAP has to be taken. Moreover, certain inaccuracies identified in the approval and registration of some ABP plants and operators partly undermine the overall effectiveness of official controls. 8

Member state response

uction Office 2 DGFHFSN issued a new document addressed to Regional competent authorities in order to ensure the accuracy of the lists of plants in the chain of production and use of feed containing PAP derived from non-ruminants for aquaculture. The guideline concerns instructions in order to give full application to Section A, Chapter V of Annex IV to Regulation (EC) No 999/2001. Verification of compliance with the requirements will also be carried out during the audits of the central competent authority on the regional authorities (please find attached to the mail the document).

on Office 2 DGFHFSN issued a new document addressed to Regional competent authorities in order to ensure the accuracy of the lists of plants in the chain of production and use of feed containing PAP derived from non-ruminants for aquaculture. The guideline concerns instructions in order to give full application to Section A, Chapter V of Annex IV to Regulation (EC) No 999/2001. Verification of compliance with the requirements will also be carried out during the audits of the central competent authority on the regional authorities. (please see the attached document).

The recommendation states as its basis

FINDINGS AND CONCLUSIONS Legal acts quoted in this report are provided in Annex I and refer, where applicable, to the last amended version. Relevant articles or sections of the legislation cited in Annex I are referred to in the individual findings in this section of the report.

Residue monitoring plan samples from farmed game were planned to be taken from farmed game birds and not from farmed cervidae like red or fellow deer, for which farms and primary processing establishments exist in Italy. This is not in line with point 2.3.3.1 of Commission Decision 98/179/EC which requires considering the species when selecting targeted samples from animal carcasses at primary processing establishments. 80% of samples from wild boar to be tested for heavy metals were planned to be taken in one region, while wild boar is also plentiful in other regions. Representatives of the Directorate-General for Food Hygiene, Food Safety and Nutrition (DGFHFSN) met by the audit team, stated their intention to amend the residue monitoring plan for wild and farmed game to rectify above mentioned shortcomings.

Notwithstanding certain shortcomings noted for not including all animals sent for direct slaughter to Italy from other Member States in the calculation of samples to be taken, not subjecting equidae sent from other Member States for direct slaughter to residue monitoring and sampling of farmed and wild game, the timely and largely comprehensive planning contributes to the effectiveness of controls on residues. 5.1.3. Implementation of the residue monitoring plan Legal Requirements Articles 3, 4, 10 and 12 of Directive 96/23/EC; Articles 3, 4, 6 and 8 of Regulation (EC) No 882/2004; Commission Decision 97/747/EC; Commission Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation (EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission Regulation (EC) No 401/2006; Article 69 of Directive 2001/82/EC; Annex I, Part A III, point 8(b) to Regulation (EC) No 852/2004 of the European Parliament and of the Council; Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004 of the European Parliament and of the Council; Article 5 and Annex I, Section I, chapter IIA, point 1 of Regulation (EC) No 854/2004 of the European Parliament and of the Council; Commission Implementing Regulation (EU) 2015/262. 3 Findings

Member state response

Nel Piano Nazionale Residui 2019 verranno introdotte le seguenti modifiche: ) Introduzione di campionamenti su animali (bovini, suini, equini e ovi- caprini) provenienti da altri Stati Membri direttamente in Italia per la macellazione, sulla base del numero di capi arrivati l'anno precedente e destinati al macello. In merito ai risultati riportati al punto n. 5, infatti, si rileva che anche per i suini il campionamento è attualmente effettuato solo sui capi nazionali; 2) Introduzione di altre specie nella selvaggina allevata, oltre i volatili, sulla base dei dati relativi agli allevamenti presenti (es cervidi). Relativamente alla ripartizione dei campioni di cinghiali tra le diverse Regioni (risultato n. 6), nella fase di programmazione del PNR 2019 si effettuerà una ricognizione puntuale dei dati di produzione delle Regioni/P.A.

The recommendation states as its basis

The national residue monitoring plan stipulates that the sample analysis turnaround time is 10 working days for Group A substances and 30 working days for Group B substances . The audit team noted that these turnaround times count from the moment the sample arrives at the laboratory which analyses the sample. In many cases IZS laboratories (IZSs) sent samples to another IZS laboratory for analysis (see also findings 32 and 45), which leads to the fact that the turnaround times from sampling to finalising the laboratory report are longer than 10 or 30 days.

The audit team was provided with sample analysis turnaround time statistics. These showed that 80% of all samples analysed by the IZS laboratory were processed within the required turnaround time. However, 49% of the samples to be analysed for beta-lactam antimicrobials exceeded the 30 day turnaround time and were analysed within 70 days, and one sample within 165 days. Samples sent by the visited IZS to other IZS laboratories exceeded the 30 day deadline for 81.4% of all samples and 4.2% of samples had a turnaround time of 91 to 218 days. The long processing times may affect the analytes' stability and sample integrity (in particular for beta-lactam antimicrobials), which is not in line with the requirements laid down by part 2.9 of the Annex to Decision 98/179/EC. In addition, the delay with the samples' analysis may hinder the timely implementation of the follow-up measures required by Articles 15-19 of Directive 96/23/EC.

The competent authority can largely have confidence in the laboratory performance and the reliability of analytical results as all laboratories are accredited, methods are generally appropriately validated and staff well-trained. However, a few factors weaken the system, such as the long sample analysis turnaround times, the non- adequate validation for a few rare matrices/species combinations and the fact that the NRL for residues of veterinary medicinal products does not completely meet its NRL obligations and has deficiencies in its quality assurance procedures.

Member state response

merito ai risultati riportati al punto n. 46, si rileva che le procedure del Piano prevedono che per le sostanze appartenenti alla categoria B, i tempi analitici non debbano superare i 30 giorni lavorativi, ad eccezione di quei pioni che necessitano il trasferimento ad altro laboratorio. ivamente alla stabilità degli analiti e all'integrità del campione, il Ministero della salute ha inviato al LNR una nota, di seguito allegata (prot. 23005 del 31/5/2018), con cui è stato chiesto di esprimersi sulla adeguatezza dei tempi di analisi previsti dal Piano Nazionale Residui in relazione alla degradabilità di alcune classi di molecole, come gli antibiotici beta-lattamici. Nota per ISS.pdf Il Laboratorio Nazionale di Riferimento per i residui di farmaci veterinari in Page: 1 ons of report ref. DG(SANTE)/2018-6343-MR of the audit carried out from 06 February ues and contaminants in live animals and animal products including controls on veterinary tent authority (LNR) valuterà la stabilità di farmaci previsti dal no fenomeni di instabilità, ad esempio i composti , attraverso i dati di letteratura ed il ricorso ad una tà di controllo (confronto tra gli esiti di analisi prima ne), anche prevede

The recommendation states as its basis

The Italian laboratory network comprises five NRLs and 10 regional laboratories. Four NRLs belong to the National Health Institute (ISS) (residues of veterinary medicinal products, mycotoxins, heavy metals and pesticides) and one NRL (dioxins/Polychlorinated Biphenyls (PCBs)) plus the 10 regional laboratories belong to the Experimental Animal Health Research Institute (IZS). All the laboratories are accredited to ISO 17025 by the Italian accreditation body Accredia.

The NRL has created and maintains a database which includes the information on, inter alia, CC-alphas and CC-betas of the methods applied by the IZSs. The information provided in the database is periodically evaluated and discussed within the IZS laboratory network, which was demonstrated in the form of minutes from two recent annual workshops between the NRL and the IZSs.

The competent authority can largely have confidence in the laboratory performance and the reliability of analytical results as all laboratories are accredited, methods are generally appropriately validated and staff well-trained. However, a few factors weaken the system, such as the long sample analysis turnaround times, the non- adequate validation for a few rare matrices/species combinations and the fact that the NRL for residues of veterinary medicinal products does not completely meet its NRL obligations and has deficiencies in its quality assurance procedures.

Member state response

LNR, a seguito di periodiche valutazioni attraverso la Banca Dati dei arametri di prestazione dei metodi analitici utilizzati dagli Istituti oprofilattici Sperimentali (II.ZZ.SS.) per la determinazione di principi acologicamente attivi nell'ambito del Piano Nazionale Residui, o di non rispetto dei limiti richiesti a livello europeo Residuo e Concentrazioni Raccomandate), a comunicare ormale al laboratorio e al Ministero della Salute al fine il LNR ha convocato una riunione con gli Istituti rimentali e il Ministero della Salute il 20 e 21 settembre esenterà la valutazione dei parametri di prestazione dei viati dai Laboratori ad aprile 2018 su richiesta del LNR. zione riunione ISS - II.ZZ.SS.- Ministero della Salute ALL4.pdf ogni anno un Proficiency Test (PT) rivolto agli II.ZZ.SS. o di molecole e della matrice/specie sarà effettuata a gnizione dei PT ai quali gli II.ZZ.SS partecipano erso le informazioni riportate nella Banca Dati, valutazione del follow-up degli esiti. A tal fine il LNR ha one con gli Istituti Zooprofilattici Sperimentali e il ute il 20 e 21 settembre 2018 nella quale presenterà la nformazioni che i Laboratori invieranno al LNR entro il 10 Page: 3 ons of report ref

The recommendation states as its basis

The audit team observed the standard operating procedure for the validation of methods and found that it was in line with the relevant provisions of Commission 8 Decision 2002/657/EC. Staff of the NRL stated that a software-based validation protocol will in future be applied for all method validations. The envisaged validation protocol is based on the approach outlined in part 3.1.3 of the Annex I to Decision 2002/657/EC.

The audit team examined the validation files and reports for the analysis of chloramphenicol in muscles and found that the validation plan was adequate and included all relevant provisions laid down by Decision 2002/657/EC. The validation process was adequately presented in the validation report. However, quality assurance documentation for routine samples was not available, which is not in line with the requirements laid down in Article 5 of Decision 2002/657/EC.

The competent authority can largely have confidence in the laboratory performance and the reliability of analytical results as all laboratories are accredited, methods are generally appropriately validated and staff well-trained. However, a few factors weaken the system, such as the long sample analysis turnaround times, the non- adequate validation for a few rare matrices/species combinations and the fact that the NRL for residues of veterinary medicinal products does not completely meet its NRL obligations and has deficiencies in its quality assurance procedures.

Member state response

l LNR effettuerà una revisione dei metodi analitici utilizzati nell'ambito del R in conformità alle richieste comunitarie (Articolo 3, Decisione (CE) 7/2002). Il LNR non esegue analisi di routine. Sarà comunque implementato il controllo di qualità interno per i metodi di analisi (Articolo 5, Decisione (CE) 7/2002) utilizzati nell'ambito del PNR entro il 30 giugno 2019. legato 1: nota interna ai referenti per gli EU-RL (vedi risposta alla ccomandazione n. 2). IZS-ME verificherà, entro il 30 agosto 2018, la corrispondenza delle sociazioni matrice/analita dei propri metodi di prova rispetto a quanto evisto nel PNR 2018 e ne darà comunicazione al Laboratorio Nazionale di ferimento. Nei casi in cui tale corrispondenza non sia completa, il boratorio provvederà a pianificare l'integrazione del relativo piano di lidazione ed attuare la revisione del metodo di prova in conformità alla rmativa comunitaria (Articolo 3, Decisione (CE) 657/2002) entro giugno 19. legato 2: incarico piano di validazione (vedi risposta alla Raccomandazione 2). merito a quanto riportato nella conclusione n. 44, si rileva che nel PNR la cerca di clenbuterolo in equini, conigli e selvaggina di allevamento non è evist

The recommendation states as its basis

Staff from the Ministry of Health informed the audit team that the provisions of Commission Implementing Regulation (EU) 2015/262 have not yet been implemented, and that those of Commission Regulation (EC) No 504/2008 are still applied. This is not in line with the entry into force date of Regulation (EU) 2015/262, which was 1 January 2016.

The audit team was further informed that the overall responsibility for the system of equine identification and registration had been transferred as of 20 November 2017 from the Ministry of Agriculture, Food and Forestry Policy (MIPAAF) to the Ministry of Health by national law No 167. Staff from the Ministry of Health stated that the provisions of Regulation (EU) 2015/262 will be implemented as of May 2018, thus 180 days after the Law number 167 entered into force. They stated further that the `Guidelines for the managing of equidae register' (ministerial decree, 29 December 2009), the related 'Operating manual' (ministerial decree No 20318, 26 September 2011) and newly issued equine passports, which are still based on requirements of Regulation (EC) No 504/2008, will be updated by May 2018 to those of Regulation (EU) 2015/262.

A representative of the Ministry of Health informed the audit team that Italy, to comply with the single equine identification database requirement of Article 39(1) of Regulation (EU) 2015/262, intends in future to require that all equine registration data are directly inserted into the existing national animal database (BDN). Staff from the DGFHFSN met by the audit team stated that their aim is to complete this task by the end of 2019.

The MIPAAF has delegated the responsibility of supervision of the equine identification for all ANA passport issuing bodies and AIA registered equines to the representatives of the AIA. One representative of AIA met by the audit team stated 14 that he had access to all databases of ANA as well as to the AIA database in which he could see whether an equine was registered or not, alive or not and whether the equine was allowed for human consumption or not. A representative from the Ministry of Health informed the audit team that ASL staff responsible for controls at slaughterhouses and farms with regards to equidae have full access to the databases of all equine passport issuing bodies, the BDE and the BDN database. The audit team checked the validity of several living and slaughtered equines in the BDE database and found that these had been correctly reflected. In one case the information in the BDE stated the horse was stolen when accessed by the AIA official, while the publicly available data of the BDE stated that the equine was dead.

Five percent of all holdings with equidae shall be annually controlled to verify the correct application of the equidae identification and registration system, as outlined in point 31 of the operating manual for the management of the equidae register. The selection of these holdings is risk-based using clearly defined criteria. The above is in line with Article 3(4) of Regulation (EU) 2015/262. However, the audit team found, based on information provided by the MIPAAF, that out of the 19 regions and 2 autonomous provinces, 5 had met this target, 5 achieved between 4% and 5%, 1 between 3% and 4%, 3 between 2% and 3%, 3 between 1% and 2% and 4 less than 1% of the required controls. This is not in line with nationally established inspection frequencies targets.

A checklist has been developed, to check the relevant equine identification and registration requirements of Regulation (EC) No 504/2008 at holdings. This had been used during official controls on the horse farm visited by the audit team confirming compliance with equine passport and registration requirements. The audit team found at this farm, that the national requirements for the register of equidae and the equine passports requirements of Regulation (EC) No 504/2008 were fulfilled, but not yet of the equine passport content structure as foreseen by Annex 1 to Regulation (EU) 2015/262. The audit team randomly selected several 15 horses and confirmed that they had been provided with a microchip as indicated in the passport.

Current EU rules governing the equine passport system have not yet been implemented and the control system based on previous EU rules demonstrates several weaknesses with regards to controls on equine identification requirements. Notwithstanding this, documented guidance on how to assess equine passport and food chain information in slaughterhouses decreases the risk that equines, ineligible for human consumption, enter the food chain.

Member state response

stante l'attuazione del regolamento (UE) n. 2015/262 abbia subìto un Page: 4 ons of report ref. DG(SANTE)/2018-6343-MR of the audit carried out from 06 February ues and contaminants in live animals and animal products including controls on veterinary tion Proposed by the competent authority tardo a causa sia del trasferimento di competenze per la gestione ll'anagrafe degli equidi dal MIPAAF al Ministero della salute, disposto dalla gge 20 novembre 2017, n. 167, sia dell'attività di revisione della normativa materia di identificazione e registrazione degli equidi tuttora in corso in de europea, si ribadisce che gran parte delle disposizioni previste dal golamento in questione sono soddisfatte dall'impianto normativo vigente ecreto MIPAAF 29 dicembre 2009 Linee guida e principi per organizzazione e la gestione dell'anagrafe degli equidi da parte dell'UNIRE e creto MIPAAF 26 settembre 2011 Approvazione del manuale operativo per gestione dell'anagrafe degli equidi). emesso quanto sopra, si informa che il nuovo decreto che definisce le ocedure tecnico-operative per la gestione e il funzionamento dell'anagrafe gli equidi da parte del Ministero della salute in corso di definizione (vedi c

The recommendation states as its basis

In 2012, the MIPPAF audited in three equine passport issuing bodies for the correct implementation of equine identification and registration requirements and found several deficiencies. The audit team was informed that no follow-up had been implemented to see if corrective action had been taken. This not in line with Article 5(3) of Regulation (EU) 2015/262. The audit team was further informed that since 2012, no other such audits at issuing bodies had been conducted by MIPAAF. This is not in line with the requirements laid down in Article 3(4) of Regulation (EU) 2015/262. Neither did the MIPAAF verify if issuing bodies: a) issue identification documents in line with requirements laid down in Article 7 of Regulation (EU) 2015/262 or have a system in place to verify that identification documents are unique, genuine and authentic and have a unique serial number. This is not in line with the requirements laid down in Article 8 of Regulation (EU) 2015/262; b) enter identification information of all equines for which they issued a passport into one of the databases in line with the requirements of Article 21 of Regulation (EC) No 504/2008 or Article 28(d) and Article 40 of Regulation (EU) 2015/262).

Current EU rules governing the equine passport system have not yet been implemented and the control system based on previous EU rules demonstrates several weaknesses with regards to controls on equine identification requirements. Notwithstanding this, documented guidance on how to assess equine passport and food chain information in slaughterhouses decreases the risk that equines, ineligible for human consumption, enter the food chain.

Member state response

lla bozza di decreto (vedi punto precedente), che definisce le procedure tecnico-operative per la gestione e il funzionamento dell'anagrafe degli equidi parte del Ministero della salute, a seguito del trasferimento di competenze lla stessa anagrafe dal MIPAAF al Ministero della salute disposto dalla legge 20 novembre 2017, n. 167 - Disposizioni per l'adempimento degli blighi derivanti dall'appartenenza dell'Italia all'Unione europea - Legge ropea 2017, sono stati introdotti i seguenti elementi: Il Ministero della salute e le regioni e le province autonome e le aziende nitarie locali, ai sensi del regolamento (CE) 882/2004, programmano in do coordinato, evitando duplicazioni ed in collaborazione con il Page: 5 ons of report ref. DG(SANTE)/2018-6343-MR of the audit carried out from 06 February ues and contaminants in live animals and animal products including controls on veterinary Action Proposed by the competent authority MIPAAF per gli aspetti di competenza, controlli ufficiali per la verifica della conformità alle prescrizioni sulla identificazione degli equidi previste dal presente decreto e dalle relative norme europee. 2. Il Ministero della salute e le regioni e le province au

The recommendation states as its basis

The audit team was informed by staff from the competent authorities that measures are not yet in place to notify deficiencies in the identification of foreign equidae to the competent authority of the Member State of dispatch as required by Article 38 of Regulation (EC) No 882/2004. Thus recommendation No 8 of the 2010 audit report has not been fully addressed.

Current EU rules governing the equine passport system have not yet been implemented and the control system based on previous EU rules demonstrates several weaknesses with regards to controls on equine identification requirements. Notwithstanding this, documented guidance on how to assess equine passport and food chain information in slaughterhouses decreases the risk that equines, ineligible for human consumption, enter the food chain.

Member state response

Il Servizio veterinario che effettua il controllo comunica il riscontro della non conformità direttamente all'UVAC competente che contatta l'autorità del Page: 6 ons of report ref. DG(SANTE)/2018-6343-MR of the audit carried out from 06 February ues and contaminants in live animals and animal products including controls on veterinary Proposed by the competent authority embro di provenienza degli animali per la regolarizzazione tale o, qualora la stessa non sia possibile, per la rispedizione degli o l'abbattimento e la distruzione degli stessi. i più rilevanti l'Ufficio centrale competente, informato dall'UVAC, e a rappresentare direttamente la non conformità riscontrata orità del paese membro di provenienza degli animali. ocedura è attuata in primis in applicazione sia della direttiva CEE del Consiglio del 21 novembre 1989, relativa alla mutua nza tra le autorità amministrative degli Stati membri e alla razione tra queste e la Commissione per assicurare la corretta zione delle legislazioni veterinaria e zootecnica, e sia della direttiva CEE del Consiglio del 26 giugno 1990 relativa ai controlli veterinari e ici applicabili negli scambi intracomunitari di taluni animali vivi e i di

The recommendation states as its basis

However, the audit team noted that although documentary evidence issued by CBs overall contains all information required, it does not always follow the model provided for in Annex XII of Regulation (EC) No 889/2008, as required by Articles 68 and 92b of the same Regulation. The fact that the model required by EU Regulation is not used makes more difficult the verification of the documentary evidence when controls are carried out outside Italy. Conclusions

Member state response

ctions and visits as referred Dall'anno 2015 gli Organismi di controllo delegati per il controllo is communicated to the sugli operatori biologici in Italia sono tenuti a registrare e caricare f Regulation (EC) No nella Banca Dati Vigilanza (BDV) presente sul Sistema Informativo Agricolo Nazionale (SIAN), le informazioni sui risultati delle ispezioni e delle visite di cui all'articolo 65 del Regolamento (CE) n. 889/2008 (Decreto dipartimentale n. 271/2015). I risultati delle ispezioni e delle visite sono messi a disposizione degli Organismi pagatori. Per le 13 regioni di competenza AGEA, dal luglio 2017 è attivo un sistema di cooperazione e interscambio di dati tramite il quale sono rese disponibili all'Organismo pagatore le informazioni inserite nella BDV e relative alle non conformità emesse a carico degli operatori biologici ai fini della riduzione dei premi derivanti dagli impegni assunti con la Misura 11 del PSR. Allo stesso modo, per le rimanenti 8 Regioni, che dispongono di un proprio Organismo pagatore, è attivo un flusso informativo tra le Autorità competenti regionali (o Provincie autonome), che accedono alla BDV e l'Organismo pagatore regionale. Si riportano i seguenti e

The Ministry will give updated La Commissione UE ­ DG AGRI guidance to all control bodies ha avviato con gli Stati Membri, sia as soon as the requirements in ambito del Committee on provided for in the new Organic Production (COP) che les legislative framework based on dell'Expert Group on Organic Regulation (EC) No 848/2018, Production, una discussione sui which introduces a whole contenuti di dettaglio e sul modello range of innovations, become di certificato previsto dal nuovo known. Reg. (UE) 2018/848. However, it should be noted Si ritiene, pertanto, opportuno per that the model form adopted un aggiornamento della for documentary evidence in documentazione di sistema, Italy contains all the attendere il 1° gennaio 2021 information provided for in quando entrerà in vigore la nuova Annex XII to Regulation (EC) normativa europea. No 889/2008. The Italian Si ribadisce che il modello di model, in addition to documento giustificativo containing all the mandatory attualmente utilizzato in Italia information, also goes into contiene tutte le informazioni more detail. On the other hand, previste dall'allegato XII del Reg. the need to improve Annex XII (CE) n. 889/2009. has been recogni

The recommendation states as its basis

The audit team noted that The method of grid based visual inspection and the associated sampling is in line with requirements of Article 3(1) of the Decision; In both annual surveys, a considerable percentage of the grid squares in the BZ and '20km zone' were inspected during winter months. This period may be adequate for the visual inspection of olive trees and other evergreen species, but is not suitable for the detection of the key symptoms appearing on the leaves of deciduous and herbaceous plants; This survey practice does not therefore take sufficiently into consideration the biology of the specified plants, although it is required by Article 3(1) of the Decision. Therefore the effectiveness of the visual inspections as a means of identifying symptomatic plants and suspected cases was compromised. The report of the 2016 audit recommended to Italy to ensure that annual monitoring is carried out at times, which are appropriate for the detection of Xf in all specified plants in the BZ and in the '20km zone', as required by Articles 6(7) and 7(7) of the Decision (Recommendation No 1). The recommendation was not addressed. 5.2.1 Surveys in the buffer zone

The survey method applied in the DA during the 2016 and 2017 annual campaigns was generally in line with the Decision. However, as a part of the visual inspections were carried out in periods not suitable for the detection of the key symptoms appearing on the leaves of deciduous and herbaceous hosts, many infected plants could remain undetected.

The recommendation states as its basis

The Single Authority stated that the concession applies to all 'non-commercial' imports, which includes imports by passengers, by post and courier. Due to the relatively large quantity of plants to which the concession applies, most non-commercial imports fall within its scope, and do not therefore need to be accompanied by a phytosanitary certificate or be subjected to systematic inspection.

In addition, the Single Authority, and the RPS visited by the audit team, stated that the small quantity concession prevented the effective control of passenger, postal and courier imports. They elaborated that this was because the scope of the concession, in terms of both maximum weight and modes of entry it applies to, means that it effectively captures all such non-commercial consignments. Consequently, the controls of these modes of entry were focused almost exclusively on detecting prohibited articles, rather than controlling regulated commodities.

Furthermore, the Single Authority stated that the scope of the concession was historic and that they were not aware of any risk-assessment used to arrive at the maximum quantities or the modes of entry it applies to. It has therefore not been established that there is no risk of harmful organisms spreading in the Community as a result of this concession, which is not in line with Article 13b(3) of Directive 2000/29/EC.

The extent of the small quantity concession, in terms of the maximum quantities covered and the modes of entry it applies to, means that most non-commercial imports of regulated articles are effectively excluded from the scope of systematic plant health checks. As such, the imports which take place under the concession present a potential risk of introducing harmful organisms into the Community. 14

Member state response

L'autorità competente con il supporto del gruppo di lavoro "porti y aeroporti" nell''ambito dell'applicativo "importfito" procederà ad una revisione dei quantitativi massimi consentititi relativo ai the piccoli quantitativi (passeggeri) tenendo in considerazione il rischio fitosanitario della suddetta tipologia alla luce di nuove emergenze fitosanitarie.

ompetent authority, supported by the Ports/Airports Working Party, will use the "importfito" application software to review the maximum permitted quantities relative to small quantities (passengers), taking into account the risk to plant health of the said type of goods in the light of new plant health emergencies.

The recommendation states as its basis

During their visit to the inspection post at Livorno port, which is the fourth busiest seaport in Italy, the audit team noted that: There were no inspection facilities, including suitable areas for inspection, adequate lighting, or basic shelter. The inspection post does not therefore meet the minimum conditions specified in the Annex to Directive 98/22/EC, specifically those listed in paragraph 3. This is not in line with Article 1 of the same Directive; There were no facilities or equipment available to enable access to consignments whilst performing checks. This is not specifically required by Directive 98/22/EC, however, as detailed in section 5.4.4 below, the lack of access means that it cannot be ensured that checks can be, and are, carried out on the entirety or a representative sample of consignments, which is not in line with Article 13a(1)(b)(ii) or (iii) of Directive 2000/29/EC.

The lack of inspection facilities at Livorno port means that it is not possible for inspectors to carry out meticulous inspections of representative samples of imported 17 consignments. These checks cannot therefore be considered reliable.

Member state response

meet In considerazione della carenza infrastrutturale del punto di entrata del porto di Livorno, l'Autorità portuale, come previsto dal Reg 2017/625, ha progettato la costruzione di un punto di ed out ispezione frontaliero per tutti gli Enti di controllo nel terminal Darsena Toscana, dotato di spazi e attrezzature adeguate per svolgere i controlli in maniera meticolosa. Il progetto esecutivo del punto di ispezione frontaliero è stato presentato ai membri del team di audit

iew of the infrastructural deficiencies of point of entry at the Port of Livorno, the Port Authority, in accordance with Regulation (EU) No 2017/625, plans to construct a border inspection point for all inspection bodies in Darsena Toscana Terminal, which has space and appropriate equipment allowing precise checks to be carried out. The executive plan for the border inspection point was shown to the members of the audit team. Additional comments from the Tuscany Page: 1 tions received 5 June 2019 ted by the competent authorities of Italy in response to Report ref. DG(SANTE)/2018-6551-MR er 2018 in order to evaluate the system of import controls for plant health authority and the would point inspected by are country, as ctive inspectors ve-mentioned to be removed ble in every torage rooms r trolleys on e goods and special d with the plant health glass, seals, o which a uploaded, Page: 2 tions received 5 June 2019 ted by the competent authorities of Italy in response to Report ref. DG(SANTE)/2018-6551-MR er 2018 in order to evaluate the system of import controls for plant health authority nt health ompliant with rective s, who ment, can f the goods (b)(ii) or out on a y be ince the u

The recommendation states as its basis

The audit team observed an inspection of WPM carried out by the Customs service and noted that: The Customs officer was only looking for the presence of an ISPM 15 mark, and not any signs or symptoms of the presence of harmful organisms. The officer had little if any knowledge of the different harmful organisms likely to be associated with WPM or the different signs and symptoms which might indicate their presence; Half of the pallets were unloaded from the container so that the Customs officer could check for the presence of an ISPM 15 mark, although the officer stated that this would not be necessary if the marks were visible from the rear doors of the container; The emptied containers were not checked for any evidence of pest activity, such as frass; The pallets were not checked for the presence of bark.

The audit team found that plant health checks of WPM under the new emergency measures, are not capable of confirming that the WPM meets the requirements laid down in point 2 of Section 1 of Part A of Annex IV to Directive 2000/29/EC, which is not in line with Article 4 of Decision 2018/1137/EU. Conclusions on checks of wood packaging material

Checks of WPM under Decision 2018/1137/EU, carried out by the Customs service, are not capable of confirming that such high risk material is compliant with EU import requirements. 19

Member state response

In riferimento alla raccomandazione 78 alla conclusione 81 l'autorità unica rafforzerà i rapporti con l'agenzia delle Dogane al IV fine di fornire maggiori indicazioni sul rilevamento di eventuali non conformità ai sensi della Decisione 2018/1137/EU fatto salvo che i controlli fitosanitari sono di competenza dei SFR. Page: 1

As regards finding No. 78, relating to conclusion No. 81, the single authority will strengthen its cooperation with the customs agency with a view to providing more comprehensive information on the detection of non-conformities within the meaning of Decision 2018/1137/EU, although plant health checks will remain the responsibility of the Regional Plant Health Services. Page: 5

The recommendation states as its basis

The audit team noted that in 2016 over 90% of sampling was completed for all categories. The achievement of the targets set in the sampling plan improved from 2014 when only 83% and 66% of the planned caecal samples were achieved for broilers and turkeys respectively. Regarding 2015, the competent authorities achieved over 95% for all categories except for bovines under 1 year of age where only 74% was achieved.

The central competent authority has introduced in the 2017 AMR monitoring plan a new supervisory element that consists of the obligation for the regional authorities to submit the regional sampling plans for review to central level. Nevertheless, the audit team noted that the instruction does not specify the different elements to be included in the information provided in order to verify effectively compliance with certain elements of 2 In their response to the draft report the competent authority provided information on actions taken after the audit to address this issue. For more information please see the action plan presented by the competent authority to address the recommendations made in this report. 3 the requirements such as percentage of the population covered and even monthly distribution of samples throughout the year which have undermined sample representativeness in the past (see points 23 and 24) 3.

The competent authorities responsible for the monitoring of AMR are clearly designated and have the necessary powers for the implementation of the harmonised monitoring of AMR. Recent improvements in the coordination between the competent authorities have had a positive impact on the achievement of the objectives of Decision 2013/652/EU, although there are still gaps in in this respect which limit the number of Salmonella isolates available for AST (when the minimum numbers are not achieved), and in the supervision of the implementation of the sampling plan, which negatively affect sample representativeness 2,3.

The audit team noted that the central competent authority did not verify if the slaughterhouses included by the regions in their sampling plans covered at least 60% of the domestic population which is the minimum percentage required by point 2.3 Part A of the Annex to Decision 2013/652/EU. During the audit and at the request of the audit team, the competent authority performed an evaluation of the 2015 sampling plan concluding that for bovines under 1 year of age 69.2% of the population was covered by the regional sampling plans while for pigs the figure amounted only to 47.1%. The data available did not enable the competent authority to perform the same exercise for poultry for 2014 and 2016 5.

The requirement set out in point 2.3.1 of Part A of the Annex to Decision 2013/652/EU that caecal samples collected at slaughterhouses shall be distributed evenly over each month of the year was not adhered to in 2014 and 2015 when sampling took place from May to December. The situation improved for 2016 and 2017 with sampling commencing in February and January respectively. The audit team noted the following: The time of approval of the AMR monitoring plans, which for 2014 and 2015 was March and for 2016 and 2017 late December of the previous year, did not allow the regions to design and issue the plans at regional level early enough to ensure that all months of the year were covered evenly. As an example, in the two regions visited the 2016 plan was issued to the local health units in February/March. Also in 2016, in the Veneto region two major poultry slaughterhouses only received the plan in May. The assignment of samples by the regions visited to the local health units did not include a monthly distribution. As a consequence the audit team noted that, in the local health units visited, sampling was not evenly distributed. 5 In their response to the draft report the competent authority noted the introduction of the updated procedure referred to in footnote 3 and confirmed that for 2017 the sampling plan has covered 71.8% and 72.5% for fattening pigs and bovines under 1 year of age. 6 The regions visited did not supervise the design and implementation of the sampling plan by the local health units to ensure both an even distribution of sampling and the successful completion of the plan 6. The competent authority have committed to approving the next sampling plans by November in order to allow the regions and the local level to implement sampling early in the subsequent year.

In the two regions visited, samples were generally taken on a Monday and Tuesday and on a few occasions on a Wednesday. This approach reduced the randomisation of the sampling days. The audit team noted that the NRL for AMR accepted samples until Friday which implies, with the sample delivery service available, that sampling could be routinely randomised from Monday to Thursday to fulfil the requirements of point 2.3 of Part A of the Annex to Decision 2013/652/EU and the EFSA guidance document 2014 9.

In the bovine slaughterhouse visited, samples were taken randomly selecting the day, with the constraints described above, and the animals to be sampled using an IT programme. In the poultry slaughterhouse visited, on the selected sampling dates most of the available lots were sampled in order to fulfil the required number of samples. In the pig slaughterhouse the sampling days and the carcasses to be sampled were selected by the sampling officer for reasons of convenience, which is not fully random 9.

The documented procedures and instructions in place could ensure adequate implementation of most of the provisions laid down in the legislation. The competent authorities have over time improved the design and implementation of the sampling plan addressing some issues that weakened this plan in the past. However, the gathering of AMR monitoring data in Italy is still not fully comparable with those obtained by other Member States. This is because further strengthening of the procedures is necessary, notably to verify that the minimum required slaughtered population is covered by the sampling and that an even distribution of sampling takes place during all months of the year.

Member state response

The central competent authority sent additional recommendations and specifications (Annex III-Letter 0003440-09/02/2017- DGSAF-MDS-P) to the regions in order to improve the sampling design and the implementation of the AMR Plan. The letter considers: - sampling strategy; - proportional allocation; - monthly distribution; - random sampling; - Salmonella isolates forward. It has already allowed to better verify the right implementation of the percentage of the population covered, the monthly distribution of samples at local level, the random sampling of day, batch(es) of carcasses. See comments in points No 8, 10, 13, 23, 24, 38 and 39.

Member state response

al competent authority sent additional recommendations specifications (Annex II - Letter 11501-08/05/2017­ S-P) to the laboratories from food business erators in order to improve the gathering of Salmonella isolates. to

Member state response

17, 39, 4, 26, 27, 28, 34. A redefinition of the revised farm checklists (IZSLER), along with an explanation manual, is already y and will be integrated taking into account the indications mentioned in the audit report. A National action plan to improve controls on the prevention of tail biting and avoidance of tail docking is also being finalized: please see letter from this Ministry n. 0006793-P-16/03/2018 in response to the Commission's clarification request Ref. Ares (2018) 162648. 38. As indicated by Region 1, the Commission experts haven't acquired or evaluated the checklists used for official controls or the documentation regarding training programs related to Legislative Decree 122/2011 for official veterinarians. Annex II: ref Competition for food and space: " Inspectors measure floor surface and surface occupied by feeders to assess unobstructed floor area. Guidance would appear to permit overstocking in one out of every three pens assessed. (manual d73-87)": current information from this Ministry 22766-P-12/12/2012 regards guidance calculation for available space for sows and gilts only. In particular, it is possible to consider feeders, to assess unobstructed floor area

Member state response

Page: 1 ref. DG(SANTE)/2017-6257-MR of the audit carried out from 13 November t tail-biting and avoid routine tail-docking of pigs Action Proposed by the competent authority ed

Member state response

The competent authority should provide instructions and guidance (compliance criteria) for inspectors to enable them to assess if the requirements on the provision of enrichment material as laid down in point 4 of Chapter I of Annex I of Directive 2008/120/EC regarding the suitability ("proper manipulation and investigation activities") and sufficiency ("permanent access to a sufficient quantity of material") of enrichment materials have been fulfilled for all pigs on farms. Assessment methods for checking access to enrichment materials should include checks based on the guidance given in point 7 of Commission Recommendation (EU) 2016/336 and/or other suitable best practice. Conclusions 17, 38 and 39. Findings 4, 26, 27, 28 and Annex II.

The recommendation states as its basis

However, official controls overlooked some weaknesses in relation to risk assessments, which may result in some relevant hazards not being considered in food business operators' HACCP-based procedures. 5.3.2 Official control of fishery products Legal requirements Article 7 of Regulation (EC) No 854/2004, Chapter II and III of Annex III to Regulation (EC) No 854/2004. Findings

Member state response

Il Ministero della salute ha organizzato per l'anno 2017 un percorso formativo di 50 ore in e-learning, certificato con il relevant rilascio di 50 crediti ECM( Educazione Continua in Medicina) corso di formazione a distanza, la cui realizzazione è stata affidata da questo Ministero all'Istituto Superiore di Sanità. Il corso coinvolgerà almeno 5000 operatori addetti al controllo ufficiale. Nel corso è stata inserita una apposita sezione formativa che prevede una parte teorica e una parte pratica allineata agli orientamenti del Codex Alimentarius e alla recente comunicazione della Commissione europea: CAC/RCP 1-1969 «General principles of food hygiene» COMUNICAZIONE DELLA COMMISSIONE relativa all'attuazione dei sistemi di gestione per la sicurezza alimentare riguardanti i programmi di prerequisiti (PRP) e le procedure basate sui principi del sistema HACCP, compresa l'agevolazione/la flessibilità in materia di attuazione in determinate imprese alimentari (2016/C 278/01) Per ISS affido Progetto corso corso.pdf FAD_17_11.docx

The recommendation states as its basis

There is a system in place to carry out official controls of fishery products that in general is in accordance with EU requirements. However, there is no official sampling in place in the regions visited for controls of PAH levels in smoked fishery products.

Member state response

s of Le nuove linee guida 882 per il controllo ufficiale ai sensi dei n (EC) regolamenti (CE) 882/2004 e 854/2004 approvate in Conferenza Stato Regioni il 10 novembre 2016 ( vedi allegato o link sotto Page: 1 of report ref. DG(SANTE)/2016-8686-MR of the audit carried out from 21 November systems in place governing the production and placing on the market of fishery 6, pagina 75, prevedono la controlli analitici per i prodotti della mbito della parte chimica la ricerca dei A. zione regionale dei controlli analitici. one e.xlsx /Documenti/DOC_055632_Rep.%20212 0odg.pdf Page: 2

The recommendation states as its basis

The CCA does not have an up-to-date list of all the holdings and keepers which keep pigs in Sardinia, which is not in line with Article 3(1)(a) of Directive 2008/71/EC. The authorities provided data on pig farms and number of pigs (see Annex II). Those data do not describe the full pig population because a number of pigs are still kept uncontrolled in some parts of Sardinia, which is illegal according to national law. The regional authority estimates that there are still "3000 to 4000 uncontrolled pigs in nine to ten municipalities, and may be on a few more locations". The majority of such pigs are in the ASF infected area. There is no estimation of the number of keepers of such pigs. 5

A significant number of pig movements are not notified and registered in the national pig database (Banca Dati Nazionale dell'Anagrafe Zootecnica), contrary to the requirement of Article 18(c) of Directive 1964/432/EEC. Pig movements are not registered into the database within seven days. The audit team visited two provinces and selected movement documents randomly in the ASL. In one, all movements were registered in the database; in the other, none of the movements selected for verification were registered in the database (the movements took place in June and August 2016 - two to four months before the audit). Slaughterhouses do not always notify the slaughter of pigs within 7 days. In one province, consignments of pigs which arrived at the slaughterhouse in June and August 2016 had not been registered in the database at the time of the audit. The regional authority identified non-compliances during the annual desk-top verification of registration of movements in the database in 2016, including: number of pigs slaughtered not in line with the number of pigs sent to the slaughterhouse, notification of slaughtered animals for which no movement to a slaughterhouse was registered and notification of consignments sent to a slaughterhouse for which the slaughter was not registered in the database. The regional authority has no insight into movements of uncontrolled pigs.

The existence of uncontrolled pigs in some parts of Sardinia compromises the reliability of pig population data and undermines the traceability of pig movements on the island.

Under-registration/under-notification of the number of piglets and movements of pigs, hampers the confidence in the data stored in the database. As a consequence, the pig identification and movement registration system does not fully support planning and implementation of ASF eradication measures. It also does not fully allow for reliable/targeted planning of official controls, taking into account risks associated with, for example, movements of pigs from infected to non-infected parts of the island.

The recommendation states as its basis

Although EU and Italian legislation established the current BZ in May 2016 (see chapter 5.1.2) the full scale 2016 surveys started there only in August after the Prosecutor's ban was revoked (see chapter 4.2) and the necessary financial and human resources were put into place including the training of the surveillance staff.. The work was being carried out by ARIF, based on a 100m x 100m grid approach, as required by the EU legislation. It was decided to start the work at the northern border of the BZ and to move progressively southward in order to first detect any infection situated farthest from the IZ (see figure II).

After recruiting and training the necessary personnel, the survey started on 29 August 2016 and full capacity was reached in September, involving 172 ARIF agents working in 86 teams. ARIF agents have the status of public agents and Ministerial Decree 2014/2005 gives them the right to enter private property. Each team has an average capacity of 20 squares per day enabling ARIF to check around 1,500 squares and collect 2,000-2,500 samples daily. A complex and sophisticated IT system supports the activity.

The visual inspection and the sampling are carried out following a very detailed guideline. ARIF regularly controls the quality of the work of its agents. The guideline lists the main elements of the methodology as follows: The survey team shall identify the physical borders of each grid square with the help of orthophotos, high resolution satellite images and by using GPS coordinates. The system ensures that there is no overlap of the inspected squares and that no gaps are left uninspected in the territory; The entire area of the square shall be scouted and checked visually. The host and specified plants shall be identified with particular attention to visible symptoms. As the first symptoms of Xf, in particular on olive trees are very similar to the damages caused by other common mechanical and environmental impacts, each possibly symptomatic plant shall be meticulously checked; Each specified plant with symptoms shall be sampled. If no visible symptoms are observed, at least one sample shall be taken from a host plant with a high share in the flora of the square. In the BZ, this shall be generally olive, however some samples shall be taken from other asymptomatic hosts also; At least eight sub-samples must be taken from an olive or other host tree from each cardinal and from the middle and upper parts of the canopy. Small twigs may be cut with the help of high reach pruning poles. Fresh leaves and twig tops shall be taken for samples. The agent carefully checks the leaves and ensures that no vectors are on them before packing into plastic sample bags; The precise position of the sampled plant shall be identified by GPS and the coordinates together with a picture of the plant are automatically recorded by a mobile device used by the agents; Before leaving the inspection site, an electronic report shall be prepared, which is filed together with the unique identification code and GPS data of the square. The 10 report shall include information about the specified plants, their share in the vegetation, any symptoms observed and details of the sampling; The mobile device issues a unique alphanumeric sample identification code and indicates the testing laboratory. A sample label shall be prepared with the identification number and relevant information for identification and trace-back. It shall be attached to the sealed sample bag. The logistics system shall ensure that the samples arrive at the laboratory on the same day and they are cooled during transport; All data is uploaded to a central database after the inspection as soon as the agents have internet access. The laboratories receive a daily extract of the sample data stored in the system and they cross-check this with information on the label. Figure II. Xf monitoring in 2016 in Apulia, in the BZ and in the "20km zone", until 11 November Source: RPS Apulia

The audit team observed a survey carried out by an ARIF team and noted that: The agents were experienced and had good knowledge about the legislation and about the host and specified plants; ARIF organises the sampling properly; the activity of the teams and the logistics of the samples are fully coordinated; The IT system used ensures the proper identification of the squares and the host and specified plants present. The electronic report, which is prepared according to a template, contains all information necessary for the authorities and for other statistical and analytical purposes; The agents carried out the visual checks and the sampling fully in line with the provisions of the guideline. In particular, the possible origin of the symptoms (e.g. mechanical damage) was meticulously checked in order to select those, which could be caused by Xf infection; In the square surveyed, no symptomatic plant was identified. Nevertheless in line with the protocol, a sample was taken from an olive tree as this was the most representative host plant of the site; At the time of the audit (late autumn), visual symptoms could be observed on olive trees, on oleander, on other evergreen plants and on certain herbaceous specified plants. However, olive trees have already dropped a part of their leaves, which were dried up during the vegetation season. Therefore this period was not considered as the most appropriate for surveying olives; At the time of the audit, the majority of the deciduous plants were dropping their leaves, the remaining leaves changed in colour and some herbaceous species also changed their appearance preventing the detection of symptoms, caused by Xf. Therefore the time of the surveys for these plants was inappropriate for visual inspections and requirements of Article 6(7) of the Decision were not met in this respect; The intensity and coverage of the surveys goes beyond the requirements of the Decision. Practically the entire area of each square is subject to meticulous visual check. Sampling and testing is not limited symptomatic plants or to cases of any suspicion of infection. Instead at least one sample is taken in in each square even in the absence of symptoms or suspicion. This could, to an extent, mitigate the negative impact of doing the survey at a time, which is inappropriate for inspection and sampling of certain specified plants. 5.2.3 Surveys in the "20km zone"

From September 2016 onwards, ARIF started its activity also in the "20km zone". First they checked some high risk spots while the systematic survey with the method described in chapter 5.2.2 started in October after the work in the BZ was largely completed. At the time of the audit, in the "20km zone" 11.6% of the area had been checked and sampled. The work started at the border of the BZ and was to continue at the rate of 1,500 squares a day until completed. RPS expects the completion of the work in January 2017 (see table III). For the same reasons as set out in relation to the BZ (see paragraph 36), the audit team considers that the timing of the survey was inappropriate or not the most appropriate in the "20 km zone". Table III. Surveys in the "20km zone" in 2016, as of 11 November Total area (ha*) Grid squares Total number of Laboratory samples from Positive inspected** laboratory samples symptomatic plants samples 106,764 12,333 12,816 447 18 Source: RPS Apulia * Equal to the number of 100m x 100m grid squares ** The Decision requires annual surveys, based on a grid split into 100m x 100m squares in the "20km zone"

The surveys were carried out at times not being the most appropriate for certain specified plants or even inappropriate for some other specified plants. Therefore the effectiveness of the visual inspections as a means of identifying symptomatic plants and suspected cases of infection were compromised. The impact of this could be mitigated to some extent by the 2016 sampling and testing regime, which goes beyond EU requirements.

Member state response

Ensure that regular proficiency tests are carried out for Xylella fastidiosa detection, in particular with participation of each laboratory testing samples from the demarcated area of Apulia. The recommendation is based on conclusion No. 27. Associated findings No.19 and 21.

The recommendation states as its basis

Visual inspections were concentrated in the areas not infested by Japanese beetle, i.e. the buffer zone, and were carried out between mid June and mid August 2016. The three km buffer zone is subdivided in three concentric bands of one km in width within which a 1000 m square matrix grid is used and the sites for inspection were as equally distributed as possible. This density of survey points is significantly lower than that required in EU legislation in other outbreaks, e.g. for buffer zone surveillance for Xylella fastidiosa (100 x 100 m), however, the RPSs performs more dense visual inspections in the area closer to the infested zone. The sites contained preferred host plants on which the adults 9 were found in 2014 and 2015. These included: Rubus, Urtica, Ulmaria, Oenothera, Humulus lupulus, Vitis spp., Rumex, Salix, Ulmus, Corylus, Prunus avium, Robinia, Centaurea phrygia, Tilia, Hibiscus and Rosa. Both RPSs informed the audit team that private persons are contacting them regularly about potential findings of the pest which have been systematically followed up.

In 2016 the RPS in Lombardy carried out 1 825 visual inspections and the RPS in Piedmont 430. With the recent update of the demarcated area in the summer 2016, the area of the buffer zone was extended and is very large. As mentioned above, a 1 000 m x 1 000 m survey grid is not very dense for a secure delimitation of the infestation and the number of inspections indicates that Piedmont in 2016 was far from achieving even that coverage. Thus the authorities might not obtain sufficient information on the current distribution of the pest and may not delimit the outbreak adequately. This is not in line with the requirements of Article 16(1) of Directive 2000/29/EC that all necessary measures must be taken to eradicate, or if that is impossible, inhibit the spread of the pest.

The surveys for Japanese beetle in Italy are organised appropriately, however, they are unevenly distributed between both affected regions and the implemented intensity does not provide sufficient information about the actual distribution of the pest.

Member state response

It is stressed that: 1. The measures taken are aimed at containing Pj; the insect eradication is not considered feasible. 2. The many updates of the demarcated areas show the implementation of an intensive survey of the buffer zone and a constantly monitoring of the outbreak's evolution. 3. The criteria by which the monitoring of the area have been carried out took into account the biological characteristics and the knowledge related to Pj. As there are plant species very attractive for Pj adults (eg: rose, vine, oenothera) by checking such plants in the course of the visual inspection there will be a high probability of intercepting the presence of any adults also in the case of a grid (mesh) 1000 x 1000 m. The detection of even a single insect in the buffer zone has led to the immediate expansion of the outbreak area with inclusion of the entire territory of the municipality object of the new detection and the rapid installation of a number of traps for mass trapping in relation to the consistency of the observed population. 4. For Pj an intensification of the control points (30) is not functional to a greater knowledge of the insect's spread. The methodological approach of a bac

It is stressed that: 1. The measures taken are aimed at containing Pj; The survey in the buffer zone has been carried out the insect eradication is not considered feasible. according to the standard EPPO PM9/21 (1), drawn up by the EPPO working group held in March, 2016 2. The many updates of the demarcated areas in collaboration with the two regional Phytosanitary show the implementation of an intensive survey of Services. the buffer zone and a constantly monitoring of the outbreak's evolution. From the current season, greater attention will be given to ensure a uniform survey intensity 3. The criteria by which the monitoring of the area throughout the demarcated area. have been carried out took into account the biological characteristics and the knowledge With the aim to get a greater control of the territory related to Pj. As there are plant species very and a more reliable knowledge of the population attractive for Pj adults (eg: rose, vine, oenothera) dynamics, it was decided to extend the surveillance by checking such plants in the course of the visual over a larger area, increasing the buffer zone from 3 inspection there will be a high probability of to 10 km. intercepting t

is stressed that: In the first inner 3 km wide band: 2 checks in 1. The measures taken are aimed at the season for each square kilometre, where taining Pj; the insect eradication is not a suitable environment is present, for a total considered feasible. of 938 visual inspections (144 positive); in the second 3 km wide band: 1 check for 2. The many updates of the demarcated areas each square kilometer for a total of 1088 show the implementation of an intensive visual inspections (157 positive); survey of the buffer zone and a constantly in the third 4 km wide band: 1 check for each monitoring of the outbreak's evolution. square kilometer for a total of 960 visual inspections (60 positive). 3. The criteria by which the monitoring of the 2017, total visual inspections 2986 area have been carried out took into account the biological characteristics and the knowledge related to Pj. As there are plant species very attractive for Pj adults (eg: rose, vine, oenothera) by checking such plants in the course of the visual inspection there will be a high probability of intercepting the presence of any adults also in the case of a grid (mesh) 1000 x 1000 m. The detection of even a single insect

The recommendation states as its basis

The containment control measures taken are considered to be appropriate to suppress the population and slow the natural spread of the pest. However, since the measures aimed at eradication are not applied in the buffer zone, containment of the pest is unlikely.

Member state response

j is a very polyphagous insect and is not associated with a single host species that can e eliminated. he ISPM 5 standard defines the buffer as: an area surrounding or adjacent to an area officially delimited for phytosanitary purposes in order to minimize the probability of spread of the target pest into or out of the delimited area, and subject to phytosanitary or other control measures, if appropriate [ISPM 10, 1999; revised ISPM 22, 2005; revised CPM, 2007] he application of preventive control measures in the buffer zone, where the insect is ot present, has to be assessed depending on the applicable measures and the risk of the est spreading. n the case of Pj, is not considered appropriate for the typology itself of measures that an be applied (positioning of the traps for mass trapping or treatments for larval ontrol). n particular, it is stressed that: the positioning of traps, given their high attractiveness, may be counterproductive because it is likely to encourage the spread of adults. In fact in case of new findings, the traps are placed at 1 km towards the outbreak center to reduce the risk of spread of populations; the execution of larvicide treatments during the expan

is a very polyphagous insect and is not ssociated with a single host species that can be minated. ISPM 5 standard defines the buffer as: ommendations (updated) received 15 June 2017 Plan submitted by the competent authorities of Italy on 10 Jan 2017in response to Report ref. t from 12 September 2016 to 23 September 2016in order to evaluate the situation and control of Japanese ea surrounding or adjacent to an area lly delimited for phytosanitary purposes in o minimize the probability of spread of the pest into or out of the delimited area, and to phytosanitary or other control measures, opriate [ISPM 10, 1999; revised ISPM 22, evised CPM, 2007] lication of preventive control measures in fer zone, where the insect is not present, be assessed depending on the applicable s and the risk of the pest spreading. case of Pj, is not considered appropriate for ology itself of measures that can be applied oning of the traps for mass trapping or nts for larval control). icular, it is stressed that: ositioning of traps, given their high iveness, may be counterproductive because ikely to encourage the spread of adults. In case of new findings, the traps are placed at wards the outbreak center to

is a very polyphagous insect and is not Following the first visual inspections in June associated with a single host species that can and July, the infested area was expanded in be eliminated. July and 94 new municipalities were included. In the second update, in October, The ISPM 5 standard defines the buffer as: 20 more municipalities were added. Very few insects were found in positive - an area surrounding or adjacent to an area visual inspections, therefore, they were officially delimited for phytosanitary collected manually, by trapping where purposes in order to minimize the probability appropriate and if necessary insecticide of spread of the target pest into or out of the treatments were used. delimited area, and subject to phytosanitary or other control measures, if appropriate [ISPM 10, 1999; revised ISPM 22, 2005; revised CPM, 2007] The application of preventive control measures in the buffer zone, where the insect is not present, has to be assessed depending on the applicable measures and the risk of the pest spreading. In the case of Pj, is not considered appropriate for the typology itself of Page: 6 (updated), received 1 December 2017 d by the competent authorities o

The recommendation states as its basis

Movement of plants for planting and lawn turf is adequately regulated. However, the prohibition on selling plants outside of the demarcated area is not officially enforced and there is potential risk of spreading the pest outside demarcated area. This is not in line with the requirements of Article 16(1) of Directive 2000/29/EC that all necessary measures must be taken to eradicate, or if that is impossible, inhibit the spread of the pest.

Member state response

he movement of plants from the delimited area is regulated in compliance with the rovisions of other recent emergency Decisions taken at EU level: the production site is registered at the SFR; the production site is subject to two annual inspections by the SFR before andling; the production site must comply with the requirements imposed by the national Decree; t is considered that the conformity of production sites to the aforementioned equirements ensures that the plant material handled by nurseries is free from Pj. roposed action n order to further reduce plant health risks, the measures planned for the infested Page: 3 received 9 January 2017 endations of report ref. DG(SANTE)/2016-8795-MR of the audit carried out from 12 September and control of Japanese beetle (Popillia japonica) zone will be extended also to the production sites located in the buffer zone. Appropriate levels of control on the application of the prescribed measures will be guaranteed.

The movement of plants from the delimited area is regulated in compliance with the provisions of other recent emergency Decisions taken at EU level: - the production site is registered at the SFR; - the production site is subject to two annual ons by the SFR before handling; - the production site must comply with the requirements imposed by the national Decree; It is considered that the conformity of production sites to the aforementioned requirements ensures that the plant material handled by nurseries is free 5 ommendations (updated) received 15 June 2017 Plan submitted by the competent authorities of Italy on 10 Jan 2017in response to Report ref. t from 12 September 2016 to 23 September 2016in order to evaluate the situation and control of Japanese from Pj. Proposed action In order to further reduce plant health risks, the measures planned for the infested zone will be extended also to the production sites located in the buffer zone. Appropriate levels of control on the application of the prescribed measures will be guaranteed. 6

The movement of plants from the delimited Production sites in the demarcated area t area is regulated in compliance with the (nurseries and lawn turf growers*): provisions of other recent emergency Infested zone: n. 333 (of which 156 garden) Buffer zone: n. 393 (of which 230 garden) Page: 9 (updated), received 1 December 2017 d by the competent authorities of Italyin response to Report ref. DG(SANTE)/2016-8795-MR of 2016in order toevaluate the situation and control of Japanese beetle (Popillia japonica) oposed by the competent authority Updated Action proposed by the Competent Authority isions taken at EU level: Ordinances issued n. 632 Inspections: n. 601 duction site is registered at the SFR; Non-compliances: n. 19. Infestations: n. 9 In these cases the movement of plants duction site is subject to two annual outside the infested zone was banned. ns by the SFR before handling; * five lawn turf growers in the demarcated duction site must comply with the area nts imposed by the national Decree; sidered that the conformity of n sites to the aforementioned nts ensures that the plant material y nurseries is free from Pj. action to further reduce plant health risks, res planned for the

The recommendation states as its basis

Despite a high degree of homogeneity with respect to the monitoring approach and overall surveillance strategy, the level of monitoring intensity varies between regions but, in each case, is considered insufficient to reliably delimit the presence of Thousand canker disease and provide for the protective measures required by Article 16(2) of Directive 2000/29/EC (see paragraphs 40 to 52). Veneto

Veneto manages a total of 50 strategically positioned monitoring sites across its region. Identified from the public nursery database (of Veneto Agricultura) and the regional register (see also paragraph 33), the sites are also selected, as much as is practically possible, to a defined geometrical grid.

Trees at all 50 sites are subject to visual inspection. Thirty of the sites are complemented with a pheromone trap. Sites are inspected on a monthly basis.

In addition, the RPS stated that one trap is positioned in one plantation which is also subjected to monitoring. No Thousand canker disease has been observed there to date. Furthermore, both producers and an industry association met during the audit stated they have never witnessed Thousand canker disease, nor the vector, in their plantations. Piedmont

Piedmont has a total of 15 strategic monitoring sites across its region. Of the four pheromone trap deployments, two are located at each of the notified outbreak sites. Eleven other sites are subject to visual monitoring only. Sites, as well as traps, are inspected on a monthly basis.

From their observations, Piedmont stated that no Thousand canker disease has been observed on varieties of J. regia for walnut fruit production. Therefore, the commercial walnut fruit plantations to the South east and south west of the region have not been included in their monitoring regime.

Lombardy monitors 10 strategically selected sites with pheromone traps within its region each year. Each site typically comprises up to 20 trees. Each site is visited on a monthly basis during which the traps and trees are checked for the vector and 12 Thousand canker disease, respectively. This regime, in place since 2014, was preceded by a less stringent preliminary monitoring approach in 2013 following notification of the first outbreak case in Veneto. The location of some of the monitoring sites are changed each year.

In addition to selected sites for visual inspections, Friuli Venezia Giulia originally deployed 21 pheromone traps in 2016 (on loan from the University of Padua), 16 of which are currently operational as five were removed for operational reasons. Deployment is partially random, but some are strategically positioned close to road and railway lines, the others in small young commercial timber plantations of typically 0.5 to 1 Ha. Sites are visited once per month.

As commercial walnut fruit plantations of J. regia are limited in Friuli Venezia Giulia they are not included in the RPS monitoring regime. 5.2.5 Commercial availability of Thousand canker disease pheromone

However, given the relative low level presence of the host, particularly in Piedmont and Lombardy, where outbreaks have occurred, the variation in susceptibility, as well as the issue of latency with respect to delayed symptom expression, the current level of monitoring intensity of timber producing trees is inadequate to reliably delimit for the presence of Thousand canker disease.

Similarly, in Veneto, despite a higher presence of host trees, predominantly plantations of J. nigra, and based on the same issues with respect to susceptibility and latency, the current level of monitoring intensity there is also inadequate to reliably delimit the disease.

Insufficient monitoring is carried out for mono-cultures of J. regia in commercial walnut fruit production in all of the regions, and for which no contingency plan exists. Such absences pose particular potential challenges with respect to disease management and further control should Thousand canker disease enter the fruit production industry.

Member state response

In line with the application of protective measures under Article 16(2) of Directive 2000/29/EC, a more reliable and accurate delimitation of the presence of Thousand canker disease, should be conducted via increased monitoring intensity in all regions. Recommendation based on conclusions 55, 56 and 57 Associated findings 39, 40, 41, 43, 44, 45, 47, 49, and 52

The recommendation states as its basis

In the three DPEs/DPIs for food of non-animal origin visited, the audit team noted non-compliances concerning the structure of the facilities that negatively impact on the hygienic handling and storage of the consignments, contrary to requirements of Article 4 of Commission Regulation (EC) No 669/2009, Article 8 of Commission Implementing Regulation (EU) No 884/2014 and Article 16(3) of Regulation (EC) No 882/2004.

In the DPE/DPI Genova, the DGISAN informed the audit team that they have accepted plans for new DPE/DPI facilities. The current facilities are of a non- permanent nature (a marquee located in a customs warehouse) and are not appropriate to undertake the necessary checks and to handle the food hygienically. It is foreseen that the new facilities will be in place by March 2017.

In the DPE/DPI Ravenna, the competent authorities gave a very short deadline to the operators of the DPE/DPI to rectify the non-compliances identified during official controls in order to ensure that the facilities have the basic structures for the hygienic handling and storage of the consignments. At the time of the audit, the shortcomings had only been partly addressed, and based on the letter of the 6 operator to the competent authorities, the audit team considered that the guarantees provided by the operator that a permanent solution would be in place in spring 2017, were not sufficient. Conclusions on the general requirements regarding the control system

The current facilities at the DPEs/DPIs visited are not appropriate to undertake the necessary checks and to handle food of non-animal origin hygienically, leading to a risk of contamination or spoilage.

Member state response

There is a Central Operational Instruction, issued in 2011, that od contains all requirements and hygienic rules for PED facilities. A ut recommendation is being sent to all USMAFs to ensure that COI consignments and food of non animal origin handling and storage, are in line with requirements set out in Regulations (EC) 669/2009 and 884/2014. Furthermore CCA planned an Audit program on USMAFs to insure that the above mentioned requirements are met. In 2016 were audited 2 USMAFs/PEDs and in 2017, 2 PEDS and 3 USMAFs are being audited.

There is a Central Operational Instruction (COI), issued in 2011 contains all requirements and hygienic rules for DPE facilities. A recommendation is being sent to all USMAFs to ensure that COI instructions and handling and storage of food of non animal origin are in line with requirements set out in Regulation (EC) No 669/2009 and Regulation (EC) No 884/2014. Furthermore CCA planned an Audit program on USMAFs to insure that the above mentioned requirements are met. In 2016 were audited 2 USMAFs/DPEs and in 2017, 2 DPEs and 3 USMAFs are being audited. Updated action plan received on 21 July 2017 All Italian USMAFs, replying to Central Competent Authority request, provided DPEs/DPIs general situation undertaking that any deficiencies detected during their controls is being rectified within June 2018 or at most December 2018. In the meantime Central Competent Authority, is performing audits on DPEs/DPIs in order to verily itself compliance of facilities with European Regulations requirements. This program is planned to be completed by February 2018. Further audits will be performed on those DPEs/DPIs that compliance works is planned to be completed by June or December 2018. Some USMA

The recommendation states as its basis

The person responsible for the load submits to the BIP staff part 1 of the CVED for food and feed of animal origin using TRACES as well as in hard copy to notify the consignments prior to their physical arrival. However, the audit team identified that a significant number of consignments subject to enhanced controls are not notified prior to the physical arrival in the BIPs visited. Out of 36 files verified, 9 were not notified before physical arrival (25%), which is not in compliance with the requirements of Article 3(3) of Directive 97/78/EC and Article 2(1) of Commission Regulation (EC) No 136/2004. The audit team noted that for the files assessed, official controls were performed as required by the legislation.

The competent authority at the DPEs/DPIs visited received prior notification of the physical arrival of food of non-animal origin in the form of part I of the CED from the food business operators or their representatives through the database NSIS as well as in hard copy. However, the audit team identified that a significant number of consignments subject to enhanced controls are not notified at all prior to the physical arrival in the DPEs/DPIs visited. Out of 24 files verified, 18 are not notified before physical arrival (66%), which is not in compliance with the 8 requirements of Article 17(1) of Regulation (EC) No 882/2004, Article 6 of Commission Regulation (EC) No 669/2009, Article 7 of Commission Implementing Regulation (EU) No 884/2014, Article 7 of Commission Implementing Regulation (EU) No 885/2014 and Article 7 of Commission Implementing Regulation (EU) No 2015/175. The audit team noted that for the files assessed, official controls were performed as required by the legislation.

In BIP Genova, the competent authorities stated that they took some measures to discourage the late prenotifications of the consignments but with partial success. Conclusion on the mechanisms to ensure that consignments are presented for import controls

There is an adequate mechanism (including good cooperation with Customs) to ensure that consignments requiring enhanced controls are presented for official controls. However, the competent authorities do not systematically implement measures to ensure that food and feed business operators or their representatives provide prior notification before physical arrival of the consignments in the BIPs and DPEs, which potentially can have an impact on the planning and organisation of the official controls.

Member state response

A recommendation will be sent to all USMAFs in order to ensure rd that consignments of article 6 of Commission regulation the 669/2009 and article 7 of Commission Implementing regulation 884/2014 are met. Furthermore the same recommendation will be included in the update of S.O.P. 11, that is under General ager approval and it should be issued within the month of 2017. With reference to the respect of the times of prenotification of the consignments at BIPs, DGSAF provided instructions to all BIPs ( Letter 0008588-03/04/2017 - Annex)in order to checks systematically the correct prenotification procedures done by economic operators and to point out them the obligations laid down by EU veterinary legislation.

A recommendation will be sent to all USMAFs in order to ensure that consignments of article 6 of Commission Regulation 669/2009 and article 7 of Commission Implementing Regulation 884/2014 are met. Furthermore the same recommendation will be included in the update of S.O.P. 11, that is under General manager approval and it should be issued within the month of May Page: 1 Ares(2017)3689413-21/07/2017 itted by the competent authorities of Italy in response to Report ref. DG(SANTE)/2016-8874-MR vember 2016 in order to evaluate the systems for enhanced import controls Action Proposed by the competent authority 2017. reference to the respect of the times of pre notification of the consignments at BIPs, DGSAF provided instructions to all BIPs ( Letter 0008588- 03/04/2017)in order to checks systematically the correct pre notification procedures done by economic operators and to point out them the obligations laid down by EU veterinary legislation.

The recommendation states as its basis

Following the information provided by the competent authority the recommendation No 2 of the audit report DG(SANCO) 2012-6501 is partially addressed in relation of the BIP facilities at Ancona port and Milano Malpensa airport. The competent authority took corrective measures in BIP Milano Malpensa ­inspection centre "ALHA Airport MXP SpA" to rectify the deficiencies identified during the audit in 2012.

The facility visited (BIP Milano Malpensa ­ facilities of the inspection centre "ALHA Airport MXP SpA", currently approved for categories "U" and "E") fulfil the requirements laid down in the legislation for registered equidae ("E"), enabling the implementation of effective controls, but not for ungulates ("U").

Member state response

Further interventions will be put in place in order to guarantee the complete suitability of facilities authorized for categories "E" of Inspection Centre "ALHA Airport MXP SpA" also for category "U", in complying with point. 2 of Annex A to Council Directive Page: 1 report ref. DG(SANTE)/2016-8874-MR of the audit carried out from 14 November port controls hority already established by in the installation of mobile tructure in order to assure the s. The equipment will be put edures have been put in place; equipment for sanitary checks nimals (E and U) and also of different species of animals. rantee the safety of animal in suffering. ly 2017.

Further interventions will be put in place in order to guarantee the complete suitability of facilities authorized for categories "E" of Inspection Centre "ALHA Airport MXP SpA" also for category "U", in complying with point. 2 of Annex A to Council Directive 91/496/EC, in addition to procedures already established by Malpensa BIP. In particular, such measures will consist in the installation of a mobile equipment of different size in the structure in order to assure the watering and feeding of the ungulates. The equipment will be put also in isolation and housing area. In relation to checks, specific procedures have been put in place; such procedures establish different equipment for sanitary checks of the two different categories of animals (E and U) and also suitable equipment for the restraint of different species of animals. Such interventions will allow to guarantee the safety of animal in the structure and avoid injuring and suffering. Interventions will be realized by July 2017. Page: 2

The recommendation states as its basis

The SA stated that a new Decree would need to be adopted, to establish the necessary legal framework for the application of CID 2015/789/EU. They stated that it is intended that the new Decree will contain additional requirements, beyond those in CID 2015/789/EU. A new AP will be issued following the adoption of the Decree. The SA was not able to provide a timeline for completion of the process. In the interim period though, the Decree of 26 September 2014 remains in force, i.e. the measures introduced by CID 2015/789/EU will not be implemented (with the exception of the revision to the demarcation of the area, detailed in paragraph 10 above).

The legal framework to enable the full implementation of the revised measures introduced by CID 2015/789/EU, and the approval of the revised AP, was not in place at the time of the audit. There is no timeline for its adoption by the MIPAAF, or implementation, although all of the measures in that CID were applicable from 21 May 2015.

The recommendation states as its basis

The RPS Apulia informed the FVO audit team that there is continuous regional media coverage of Xf. The media in other regions and at national level deal with the outbreak periodically. Articles, reports and documentaries broadly reflect the opinion and arguments of those circles, who oppose the cutting of olive trees for eradication or who doubt the existence of Xf in Apulia and its role in the quick decline of the olive trees. The opinion of the RPS and scientific institutions gains limited or very limited coverage and it is usually presented in an unconvincing manner in response to the arguments of opponents to eradication measures. This in not in line with Art. 7 of CID 2015/789/EU.

The audit team found very limited direct engagement with stakeholders in particular following a finding of Xf, see sections 5.8.3 and 5.9.1. Conclusions on communication and information

There is considerable communication to the stakeholders and the public regarding Xf. However, there is limited direct engagement with stakeholders and the message that, in the absence of concerted control measures, the disease has, and will, continue to spread rapidly with the resultant significant loss of olive trees and other host plants, is often not conveyed effectively. This undermines the ability for an effective implementation of the necessary control measures for Xf.

The recommendation states as its basis

There is currently no reference laboratory for Xf in Italy, however, the SA informed the FVO team that MIPAAF intends to nominate the Agricultural Research Council-Rome 7 to act as the national reference laboratory for this purpose. No timeline for the nomination was available.

MIPAAF informed the FVO team that it has commissioned the Institute of Plant Virology of the University of Bari (IPV) to carry out ring tests to assess the proficiency of the RPS laboratories, who analyse samples, using ELISA and/or PCR tests. The SA stated that the ring test would be completed by end of August 2015. 5.4.2 Laboratories testing official samples for Xylella fastidiosa in Apulia

The FVO team was informed that the RPS laboratory of Tuscany uses PCR for testing plant and insect samples and for confirmation, while the RPS laboratory of Liguria uses ELISA for plant sample testing and PCR for insect samples and for confirmatory purposes. There are no MIPAAF recommendations for RPS laboratories concerning the methodology of mass and confirmatory Xf tests.

The FVO team visited the RPS laboratory of Liguria and noted that The laboratory is involved in testing of a wide-range of pathogens of import control and plant health monitoring samples. The number of samples depends on the import volume and timing of the surveys. They apply different, pathogen specific methods. There are peaks in test needs, which regularly create a workload which is difficult to manage for the laboratory staff; The laboratory has facilities for ELISA and PCR, however due to limited possibilities for physical separation of the test steps, the laboratory staff confirmed that extra care is needed for avoiding sample contamination during the tests; 9 The laboratory staff has work experience in serological and molecular tests, however less experience in Xf testing. They did not have any training related to PCR and to Xf analysis; The laboratory does not apply a comprehensive sample and test result administration system, only certain individual records are taken; The Xf tests for samples processed in the laboratory in Liguria are not fully reliable as required by point 3 of Art 2, Art. 3, Art. 4 and Art 6 of CID 2015/789/EU.

The FVO team noted that: The RPS laboratory in Liguria performed the ELISA and PCR tests broadly following the IPV protocols, however with some adaptation, including the application of certain elements of the relevant EPPO protocols which, according to the experts is quite outdated; During the ELISA test for the repetition of the same sample, two plates were used rather than two wells of the same plate. As the laboratory has no photometric facilities the results were evaluated visually. The plant sample gave colour reaction on both of the plates, however the colour was slightly different from that of the positive controls (brownish, instead of yellow). The laboratory considered that the sample was positive and the colour difference was the result of additional reactions, caused by the plant extract. The ELISA test of the same sample was not repeated; For the confirmatory test, different leaves of the same sample were used. The test was performed according to the IPV protocol. The FVO team found that the electrophoretic pattern of the sample was misinterpreted, as an unidentified DNA fragment was considered as Xf DNA; After the confirmatory test both the original leaf sample and the plant, which was assessed as Xf positive were destroyed. 10 Conclusions on laboratories and testing

In contrast, the facilities and expertise available to other RPS has not been established. The ring test being carried out by the IPV should provide at least an indication of the proficiency of these laboratories at detecting Xf in samples, however, until that becomes available, the reliability of the confirmation analysis referred in point 3 of Art 2, Art. 3, Art. 4 and Art 6 of CID 2015/789/EU is not ensured. Therefore, there are no full guarantees that the surveys carried out clearly identify Xf in the pest free areas.

The recommendation states as its basis

The system for official controls at exit BIPs for consignments in transit leaving the EU is not effective at identifying all relevant consignments and therefore implementing the required controls which ensure that consignments have not been manipulated during transit.

Member state response

ACC provided instructions to all BIPs on implementation of the article 3 of Commission Decision 2000/208/EC. articular it was recommended: - to confirm that the consignments in transit correspond to those shipped from the entry BIP, - to check that such consignments are conform to the information reported on the CVED, - to confirm the exit of such consignments by TRACES. Please see Letter ref.. DGSAF 29477 of 25/11/2015 part 2), a ) - pag 3) [annex 1]

ACC provided instructions to all BIPs on implementation of the article 3 of mmission Decision 2000/208/EC. In particular it was recommended: nfirm that the consignments in transit correspond to those shipped from the entry BIP, - to check that such consignments are conform to the information reported on the CVED, - to confirm the exit of such consignments by TRACES. Please see Letter ref.. DGSAF 29477 of 25/11/2015 part 2), a ) - page 3) [annex 1]

The recommendation states as its basis

Article 11(2) of Directive 97/78/EC requires BIP staff to ensure that they receive confirmation of arrival (from an approved warehouse) or confirmation of exit from the EU (from the exit BIP) within 30 days after a transit consignment leaves their BIP. If no confirmation is received within 30 days then official staff should seek confirmation either by contacting the officials in charge of controls at the warehouse or the BIP), or by asking Customs. The audit team noted that: At one of the BIPs, confirmation from destination was received for the vast majority of consignments. However, the system to promptly identify when confirmation of receipt was not received within the 30 day legal time limit was not effective. The system to identify such consignments was paper-based and the BIP was considering the introduction of an electronic register to identify consignments requiring follow-up. At the other BIP, an electronic register was maintained to follow-up the consignments and the follow-up worked well. For consignments destined for approved warehouses, BIP staff stated that all consignments were followed up if required and confirmed as being received at destination via telephone contact with official staff responsible for the warehouse. There was no evidence of this follow- up kept on file. Documentary evidence on file of confirmation of receipt was the completion of box 41 of the CVED by the destination, and in some cases was six months after the consignment had left the entry BIP. (see finding 20)

All consignments in transit entering Italy are checked at BIPs although not all requirements related to pre-notification are enforced. Veterinary checks are carried out in line with the requirements of EU legislation ensuring that only eligible consignments are accepted for transit. 7 The system to promptly identify and follow-up consignments for which no confirmation of receipt at destination has been received by the entry BIP is not effective, reducing the ability of the system to identify non-conforming consignments that have not left the Union as planned. 5.2.2 Controls at approved warehouses 5.2.2.1 Approval and listing

Before non-conforming consignments can leave the approved warehouses, the operator must submit a request to the competent authority who subsequently checks the consignment, seals the means of transport after loading and issues the CVED (linked with the original CVED via box 24) or the document for the Captain's Declaration. The audit team noted the following at the two approved warehouses visited: Approved warehouse A ­ for ship supplies, a register is in place to verify that confirmation of receipt by the ship is received back, and that follow-up action is implemented if required. The warehouse had only issued two CVEDs during 2014 for which box 41 was completed for one within 30 days and for the other after 55 days. For consignments accompanied by a CVED, there is no system in place to ensure that appropriate follow-up is triggered if confirmation of receipt from the destination was not received within 30 days, contrary to the requirements of Article 2 of Commission Decision 2000/571/EC. Approved warehouse B ­ an effective system was in place to ensure that confirmation of receipt was obtained or appropriate follow-up action was implemented if necessary for all consignments. Conclusion on the official controls at approved warehouses

Official controls on transiting consignments stored in warehouses are implemented but their compliance with EU legislation is compromised by the decision of the competent authority to issue single CVEDs for consolidated consignments, which does not permit effective traceability of the goods and cannot ensure the effectiveness of the controls up to the point of delivery. 10 5.2.3 Controls at the exit Border Inspection Posts 5.2.3.1 Documentary, identity and physical checks

Member state response

All BIPs and BIPs responsible of approved warehouses were provided y ACC with relevant instructions. In particular it was recommended that in case the confirmation of receipt/exit of consignments is not received within 30 days the entry BIP/approved warehouses must implement an appropriate follow up. Please, see Letter ref. DGSAF 29477 of 25/11/2015 part 1), c) and 3), c) [annex 1]

l BIPs and BIPs responsible of approved warehouses were provided by ACC th relevant instructions. In particular it was recommended that in case the confirmation of receipt/exit of consignments is not received within 30 days the entry BIP/approved warehouses must implement an appropriate follow up. Please, see Letter ref. DGSAF 29477 of 25/11/2015 part 1), c) and 3), c) [annex 1]

The recommendation states as its basis

Approved warehouses are currently not included within the scope of internal audits by the central competent authority. One of the warehouses visited had an internal audit by the regional level in 2013, but there is no formalised plan for internal audits at approved warehouses at any level.

The main elements of the performance reporting system with relevance for transits is the requirement to check the compliance of a percentage of the certificates that are issued. The overall target was 5% at both BIPs visited due to a high throughput of consignments. The audit team noted that: Genoa Port BIP: checked no transit related documents based on a risk assessment (these were regarded as low risk consignments because they were not destined for EU market). Livorno Port BIP: checked 100% of transit related documents based on a risk assessment (these were regarded as high-risk consignments which should be prevented from reaching the EU market). These checks had identified similar issues to those described in finding 10. At one warehouse visited, the review of 15% of documents issued identified the issue of hand-written CVEDs (see finding 21) but no corrective action was requested. At the other warehouse visited, there was no verification on the compliance of the certificates issued.

The audit team noted that the following issues identified during the FVO audit were not identified by the national verification system: issues with pre-notification (as described in finding 8); issues at entry BIPs with confirmation of receipt at destination (finding 15); issues with exit controls (finding 26). The current performance reporting system checks a percentage of the documents issued by the location being assessed. Recording the controls referred to in findings 15 and 26 usually involves completing box 41 in TRACES on a CVED issued by a location other than the one carrying out the follow-up control. Therefore these controls are not checked as part of the current performance reporting system. 12 Conclusion on the verification and review

The verification system of official controls related to non-conforming transit consignments is based on a combination of internal audits and a performance reporting system. The detection and correction of shortcomings is not ensured because official controls at approved warehouses are not covered by internal audit and not all types of transit controls are checked within the performance reporting system.

Verification of the official import controls is implemented in recent years by the Ministry of Health via a system which evaluates its activities and objectives in accordance with Public Administration rules, i.e. "System for measuring and evaluating the performance". This system is implemented at BIPs and according to the competent authority, verifies official import controls by amongst other things, setting the following objectives for each BIP: to plan and carry out inspections of the structures of the BIP/Inspection centre; to respect the sampling activities for laboratory checks according to the percentages established by monitoring plan (3%); to verify the compliance of the certificates issued by the BIP on a percentage basis based on throughput of the BIP; to respect the percentage physical checks of consignments as set out in Commission Decision 1994/360/EC. The audit team verified that for the BIPs visited, all of the above objectives were reported on and the targets were achieved or exceeded, e.g. the quantitative target of checking 5% of the documents issued by each BIP was confirmed in the database. 13 The table below summarises the follow-up to recommendation number 1 from FVO report DG(SANCO)/2012-6501: Number Recommendation Assessment 1 "To ensure that appropriate actions are taken when Partially addressed needed to correct the deficiencies detected at BIPs in order to ensure that all operating BIPs maintain compliance with approval requirements of See findings No 35 and 36 Commission Decision 2001/812/EC and Directive 91/496/EEC."

Member state response

ial Starting from 2016 also the audit at approved warehouses art. 12 and 13 of Directive 97/78/EC will be included in the planning of the audit of ACC. Moreover, instructions were given by ACC to the BIPs recommending: - to carry out internal audit on the approved warehouses falling under their responsibility. - to verify by internal check also all issued certificates of non conforming consignments, with particular regards to the prescribed deadline for confirm by TRACES the arrival at destination of consignments. Please, see Letter ref. DGSAF 29477 of 25/11/2015, part 4 and part 1, b) [annex 1] Page: 1

tarting from 2016 also the audit at approved warehouses art. 12 and 13 of Directive 97/78/EC will be included in the planning of the audit of ACC. er, instructions were given by ACC to the BIPs recommending: arry out internal audit on the approved warehouses falling under their sibility. erify by internal check also all issued certificates of non-conforming nments, with particular regards to the prescribed deadline for confirm by the arrival at destination of consignments. , see Letter ref. DGSAF 29477 of 25/11/2015, part 4 and part 1, b) [annex er to covers official controls of all BIP, ACC carries out verification TRACES system by e ach BIP as suggested by FVO. ieve this purpose ACC decided to use QlickView program but, the tests some problems that prevent the achievement of the ive were detected. The situation was reported to the Commission in to find a solution.

The recommendation states as its basis

The monitoring plan is implemented in accordance with the planned arrangements. In general, staff at BIPs use TRACES correctly. However, the exchange of information in TRACES is compromised by officials not filling in all results of laboratory testing in a timely and complete manner. Thus correct and relevant information is not provided on time to other Member States and the Commission. Equipment for handling of samples is not calibrated and monitored regularly. 7

Member state response

Instructions were given by ACC to all Italian BIPs recommending at the results of laboratory checks, positive and negative, must be entered completely in TRACES immediately after they are d available. Moreover ACC will carry out a monthly verification on the completeness of data entered in TRACES by QlikView. If a result will not be available in due time (e.g. test that require long laboratory procedures, samples taken at the end of the month, etc.) an explanation must be provided by BIP to ACC. Afterwards, such data will be transmitted by ACC to the European Commission according to Annex II of Regulation EC No 136/2004. Please see letter ref. DGSAF 0028085 of 06/11/2015 [annex 2].

The recommendation states as its basis

The risk ranking set out in the EFSA scientific opinion was not taken into account in the framework of the above-mentioned exercise. This negatively affects the effectiveness of official controls as the major risks identified in EFSA scientific opinion do not contribute to the risk basis for those controls, contrary to Article 3.1(a) and 4.2(a) of Regulation (EC) No 882/2004. However, the CCA, regional CAs and local CAs informed the audit team that microbiological hazards will be considered in the risk based planning for 2016. The CAs are planning to evaluate the risk assessments by the end of this year in order to take into account the microbiological risks identified in scientific opinions of EFSA and probably increase the frequency of inspections regarding microbiological risks in relation to certain produce.

In addition, in September 2015 the regional authorities in Calabria started to develop a new procedure for the official control on primary production of FNAO with relevant checklists containing certain microbiological risks. In 2015, the authorities were responsible for controls on approximately 2400 farms producing FNAO and they carried out approximately 200 inspections at those FBOs. However, at the time of the audit, inspections did not consider any microbiological risks except for contamination of water used at primary producers. Moreover, at the time of the audit, microbiological risks (other than relating to water) identified by EFSA concerning FNAO were not included in the risk-based planning of official controls nor were the inspections targeting high risk crops prone to the microbiological contamination identified by EFSA.

While official controls on primary producers of FNAO cover the risk of microbiological contamination of irrigation water, the remaining major microbiological risks identified by EFSA are not considered (with the exception of one region visited) in the planning of official controls. This circumstance, coupled with the fact that the design of official controls does not make specific provision for targeting the high priority crops identified by EFSA as particularly prone to microbiological contamination, weakens the effectiveness of official controls in this area. 5.2.4 Implementation of Official Controls over Food Business Operators Obligations Legal requirements Article 10(2)(b)(i), Article 10(2)(c), Article 10(2)(d) and Article 15(1) of Regulation (EC) No 882/2004, Article 4(1), Article 7, Article 8 and Part B of Annex I of Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Commission Implementing Regulation (EU) No 208/2013, Regulation (EU) No 211/2013 and Annex I of Commission Regulation (EC) No 2073/2005 Findings

Member state response

With reference to the recommendation laid down in November 2015 report audit on "Reference number: DG(SANTE)/2015-7455 -MR Audit in Italy from 03 November 2015 to 13 November 2015 in order to evaluate the system of official controls relating to microbial safety of primary production of food of non-animal origin", we inform you that we developed a specific guideline on the frequency of official controls, according to Reg. (CE) 882/2004; the guideline was discussed and approved at a meeting of inter-Regional technical group on the 2nd of March 2016. We are now waiting for the approval by State-Regions conference. In order to harmonize all official controls in Italy, guideline establishes frequency of official controls on primary production of non-animal origin products as well, paying particular attention on controls on sprouts and sprouts seeds. After the final approval, guideline will be sent to all Regions; anyway in the meantime we are sending to all Regions a specific planning document for primary production, in which we invite all Competent Autorities to respect recommendation before guideline approval.

Member state response

Competent Authority: ICQRF To ensure that ICQRF inspectors receive, for their area of competence, appropriate training ICQRF provides, in compliance with art. 6 of Reg. 882/2004, specific training courses and updating courses about PPP legislation and procedures for ing out controls on marketing. Last of these courses was held in the 2012. Starting from 2015, update courses on these topics will be provided yearly.

Member state response

To ensure that contingency plans and staff operation manuals are drawn up and kept updated for the diseases listed in Annex I to Council Directive 92/119/EEC as required by EU legislation. Specific EU legal requirements laid down for each exotic disease listed in Appendix to this report (specifically those related to chapters 5.1.1 and 5.1.2). Based on conclusions (21) and associated findings (1), (4) and (8).

Member state response

To ensure that a swift and coordinated response could be given in the event of a widespread disease outbreak of FMD or AI affecting more than one region by having an overview of the level of preparedness available in all RVS and ASLs ­ i.e. that their plans and manuals are fully fit for purpose and applicable. Article 4 (2)(f) of Regulation (EC) No 882/2004; criteria for contingency planning listed in Appendix to this report. Based on conclusions (22) and (62), and associated findings (5), (39), (54) and (55).

Member state response

Page: 1 DG(SANTE)/2015-7569-MR of the audit carried out from 13 October in relation to animal health, including provisions on the protection of

Member state response

To ensure that, on the basis of the various possible scenarios for the size and location of exotic disease outbreaks, staff at the RVS and ASLs are capable of preparing adequate action plans for depopulation operations in order to safeguard the welfare of the animals. Article 18 of Regulation (EC) No 1099/2009. Based on conclusions (23), and associated findings (14), (15) (53) and (55).

Member state response

age: 2

The recommendation states as its basis

The previous FVO audit in June 2015 found that no surveys had been carried out in the buffer zone or surveillance zone in 2014, or to that date, in 2015. The results of the surveys carried out in each zone of the demarcated area and the surveillance zone since June 2015, are detailed in table 6 below. Table 6: Monitoring carried out within the demarcated area and Surveillance Zone from 5 June to 11 November 2015 No of 100m x No of grids No of samples No of positive 100m grids monitored samples Surveillance zone 122 578 171 200 0 Buffer zone 83 637 8 515 9 117 157 Containment zone 78 430 254 14 256 2 924 Containment area 175 593 76 213 53

While the guidelines for monitoring in the demarcated area and surveillance zone are in line with Decision 2015/789/EU, the level of inspections carried out in the buffer zone and surveillance zone is very substantially below that required by Articles 6(7) and 8(2) of that Decision.

Member state response

Ensure that the monitoring for Xyllela fastidiosa in the buffer zone is implemented in line with Article 6 (7) of Decision 2015/789/EU. Recommendation based on conclusions 72 to 77 Associated findings 67 to 71

The recommendation states as its basis

The previous FVO audit in June 2015 found that no surveys had been carried out in the buffer zone or surveillance zone in 2014, or to that date, in 2015. The results of the surveys carried out in each zone of the demarcated area and the surveillance zone since June 2015, are detailed in table 6 below. Table 6: Monitoring carried out within the demarcated area and Surveillance Zone from 5 June to 11 November 2015 No of 100m x No of grids No of samples No of positive 100m grids monitored samples Surveillance zone 122 578 171 200 0 Buffer zone 83 637 8 515 9 117 157 Containment zone 78 430 254 14 256 2 924 Containment area 175 593 76 213 53

While the guidelines for monitoring in the demarcated area and surveillance zone are in line with Decision 2015/789/EU, the level of inspections carried out in the buffer zone and surveillance zone is very substantially below that required by Articles 6(7) and 8(2) of that Decision.

Member state response

Ensure that the monitoring for Xyllela fastidiosa in the surveillance zone is implemented in line with Article 8(2) of Decision 2015/789/EU. Recommendation based on conclusions 72 to 77 Associated findings 67 to 71

The recommendation states as its basis

The RPS and Commissioner record data on infected plants and the estimated number of plants within the 100m clear-cut, separately. The RPS provided a detailed table ('Focolai12novembre aggiornato punti protocolli') which presented the situation in the demarcated area as of 12 November 2015. The FVO team prepared a table (table 7 below) summarising the data provided by the two services. This was presented by the FVO services to the Italian Authorities at the closing meeting of the FVO audit on 20 November 2015, who confirmed the accuracy of the table.

Action is now being taken in response to findings of X. fastidiosa in the demarcated area. The felling programme, which is subject to a number of significant constraints, is ongoing, however there is a very substantial number of infected plants and host plants within 100m radius of such plants, still to be removed outside of the Province of Lecce. The very limited removal of such plants means that Article 6(2) of Decision 2015/789/EU, which requires that such plants are immediately removed and destroyed, cannot be complied with.

The legal provisions regarding the removal of plants as laid down in Articles 6(2) and 7(2) of Decision 2015/789/EU have not been fully implemented in the demarcated area. In the light of the very limited removal of plants, and the resultant risks for the ongoing spread of the disease, this is a significant non-compliance with the Decision.

Member state response

Ensure that eradication measures are implemented immediately following confirmation of the presence of Xylella fastidiosa as required by Article 6(2) of Decision 2015/789/EU. Recommendation based on conclusions 109 to 112 Associated findings 92 to 94

The recommendation states as its basis

The RPS and Commissioner record data on infected plants and the estimated number of plants within the 100m clear-cut, separately. The RPS provided a detailed table ('Focolai12novembre aggiornato punti protocolli') which presented the situation in the demarcated area as of 12 November 2015. The FVO team prepared a table (table 7 below) summarising the data provided by the two services. This was presented by the FVO services to the Italian Authorities at the closing meeting of the FVO audit on 20 November 2015, who confirmed the accuracy of the table.

There is a similarly substantial number of infected plants in the containment zone, within a distance of 20km from the border of the Province of Lecce, which have also not been removed and destroyed immediately, as required by Article 7(2)(c) of the Decision.

Member state response

Ensure that containment measures are implemented immediately following confirmation of the presence of Xylella fastidiosa within 20 km from the border of the containment area as required by Article 7(2)(c) of Decision 2015/789/EU, and in particular that at least all plants that have been found to be infected by Xylella fastidiosa, are immediately removed. Recommendation based on conclusions 110 to 112 Associated findings 92 to 94 Date: 22 January 2016

The recommendation states as its basis

The audit team noted that: 6 At Marghera, Salerno and Gioia Tauro ports, no commodity specific instructions were available for inspectors to carry out import checks of consignments representing high plant health risk. The newly recruited staff at Malpensa Airport received a comprehensive induction training of three months, involving external institutes. The ERSAF had developed a training programme and a programme to ensure that the professional competence of staff performing checks is maintained, as part of its preparation for its application for International Organisation for Standardisation (ISO) 17020 accreditation. The staff present during the visit by the audit team was competent to perform plant health checks, which is an improvement compared to the previous audit in 2013. In Veneto, a newly recruited inspector received on-the-job training from the regional chief inspector. In Campania, RPS staff is provided with 150 hours/year training on plant health issues, most of which, however, does not relate directly to import controls. In the case of new trade (e.g. potatoes in Veneto) training is received from colleagues from other import points with experience of that trade.

There are no commodity specific instructions available at the sea ports reviewed for performing import checks of high-risk consignments. The roll-out of the national manual of procedures has a significant potential to address this shortcoming.

Member state response

Make commodity specific instructions available to ensure that inspectors performing import checks of consignments representing high plant health risk obtain technical competence especially in the detection of harmful organisms as required in paragraph 2 of the Annex to Directive 98/22/EC. Recommendation based on Conclusion No. 20 Associated findings No. 11

The recommendation states as its basis

During the audit visits the audit team noted that: An inspection facility for plant health checks, including binocular microscope, a kit to detect nematodes and a desk-top computer, was available at the Venice- Marghera sea port but not used for other than documentary work and checks of cereals. Inspections are carried out outdoor and in the warehouse on the floor. The warehouse had a recently allocated room dedicated for plant health inspections which had an inspection table. This was intended to be used to inspect potatoes, however, none had yet been imported. At Malpensa airport a dedicated plant health inspection post was available with suitable equipment including magnifying glasses, binocular microscope for performing visual examination of samples and an inspection table with adequate lighting. At Salerno port, inspections of citrus fruits were carried out in a container which was covered but open on the sides. An inspection table was available but the inspector did not use it to spread out the produce to carry out the visual inspection. The inspectors were exposed to sun and high temperature while inspecting refrigerated commodities such as citrus fruits. A different inspection facility was used for another inspection, which the audit team considered as adequate. The port has a container office for RPS which has an inspection table, binocular microscope and tools necessary for phytosanitary inspection. The office facilities are generally not used. Conclusions on points of entry, inspection posts and approved places of inspection

Recommendation 10 of report 2013-6790 was to "Ensure that plant health checks are always meticulous as required in Article 13a(1) of Directive 2000/29/EC. In particular for those commodities where the frequency of interceptions of harmful organisms is significantly lower in Italy than in the EU, the method for inspection should be appropriate." In response to this recommendation, the Single Authority stated that: 15 The NPHC is planned to identify non-regulated commodities which will be subject to random checks on the basis of EUROPHYT interceptions and the EPPO alert list. Specific control procedures are planned to be provided for goods with a low ratio of interceptions to the volume of import compared to the EU average. The above actions are in line with the Action Plan of the Single Authority submitted to address this recommendation. These measures are to be linked with the SIAN system and the deadline for implementation is by end of 2016. The plant health inspection facilities were described in section 5.4.2.

The audit team witnessed plant health checks and examined PCs that had already been considered compliant by the RPS/ERSAF at Venice-Marghera and Salerno ports, and Malpensa airport and noted that: There were significant differences in the sampling procedures followed by the RPSs visted. At Venice-Marghera port, the inspector explained that they use 80% confidence level and 5% detection level to determine the size of the sample to be taken. Although these are minimum values in ISPM31, the RPS stated that the sample size was too large to implement in practice. However, the RPS could not explain what was meant by this, or what the actual sample size applied was. At Malpensa Airport the audit team observed an inspection of orchids from Thailand. The inspector explained that it was considered to be a medium risk commodity as such commodity had not been subject to interceptions for a long time. He picked a confidence level of 90% and used the smallest unit declared on the phytosanitary certificate, in this case stems, to calculate the size of the sample, in stems. In practice the inspector applied the suggested sample size to bunches to increase the number of sampled units. In this case the sample was taken from 20% of 16 the boxes of the consignments. The inspection observed was carried out thoroughly using a standard inspection technic for such products. At Salerno port the audit team witnessed inspections of citrus fruits. A fixed sample size of 200 fruit was taken regardless of the origin. The RPS stated that the fixed sample size is based on the minimum sample size specified in Decision 2014/422/EU for citrus fruits from South Africa considered to be a high risk of citrus black spot. The conditions and the way the visual checks observed by the audit team were carried out were not ideal to detect quarantine harmful organisms (see section 5.4.2). 5.5.4 Reduced frequency of checks Legal requirements Article 13a(2), last sub-paragraph of Directive 2000/29/EC and Commission Regulation (EC) No 1756/2004 apply regarding reduced frequency checks. Findings

Plant health checks carried out at the sea ports visited are not in line with Directive 2000/29/EC as adequate facilities are not used and the conditions do not ensure that the plant health inspection is meticulous enough to detect pests.

Member state response

Ensure that plant health checks are always meticulous as required in Article 13a(1) of Directive 2000/29/EC. In particular for those commodities where the frequency of interceptions of harmful organisms is significantly lower in Italy than in the EU, the method for inspection should be appropriate. Recommendation based on Conclusion No. 58 Associated findings No. 35, 43 and 45

The recommendation states as its basis

The audit team witnessed plant health checks and examined PCs that had already been considered compliant by the RPS/ERSAF at Venice-Marghera and Salerno ports, and Malpensa airport and noted that: There were significant differences in the sampling procedures followed by the RPSs visted. At Venice-Marghera port, the inspector explained that they use 80% confidence level and 5% detection level to determine the size of the sample to be taken. Although these are minimum values in ISPM31, the RPS stated that the sample size was too large to implement in practice. However, the RPS could not explain what was meant by this, or what the actual sample size applied was. At Malpensa Airport the audit team observed an inspection of orchids from Thailand. The inspector explained that it was considered to be a medium risk commodity as such commodity had not been subject to interceptions for a long time. He picked a confidence level of 90% and used the smallest unit declared on the phytosanitary certificate, in this case stems, to calculate the size of the sample, in stems. In practice the inspector applied the suggested sample size to bunches to increase the number of sampled units. In this case the sample was taken from 20% of 16 the boxes of the consignments. The inspection observed was carried out thoroughly using a standard inspection technic for such products. At Salerno port the audit team witnessed inspections of citrus fruits. A fixed sample size of 200 fruit was taken regardless of the origin. The RPS stated that the fixed sample size is based on the minimum sample size specified in Decision 2014/422/EU for citrus fruits from South Africa considered to be a high risk of citrus black spot. The conditions and the way the visual checks observed by the audit team were carried out were not ideal to detect quarantine harmful organisms (see section 5.4.2). 5.5.4 Reduced frequency of checks Legal requirements Article 13a(2), last sub-paragraph of Directive 2000/29/EC and Commission Regulation (EC) No 1756/2004 apply regarding reduced frequency checks. Findings

Currently, the sample size is determined differently by the regions visited. At the sea ports visited, it is not determined taking into account the sampling guidance in ISPM 31 for large lots, therefore, the necessary probability for finding pests in accordance with ISPM 31 and Directive 2000/29/EC is not ensured.

Member state response

Ensure that plant health checks are always based on a representative sample as required in Article 13a(1)(b)(iii) of Directive 2000/29/EC. In particular the minimum sample size should take into account the phytosanitary risk presented by the commodities and should result in a satisfactory probability for finding pests in accordance with ISPM 31. Recommendation based on Conclusion No. 59 Associated findings No.45

The recommendation states as its basis

Although Italy has major sea ports and large volumes of import the authorities report a low number of WPM interceptions. This is also referred to in the EUROPHYT Annual report 2014. Conclusions on checks of wood packaging materials

However, the number of interceptions of WPM originating in all Third Countries is low compared to the volume of import.

Member state response

Page: 1 mendations has been received. Please check back again later to see ref. DG(SANTE)/2015-7603-MR of the audit carried out from 08 September r plant health

The recommendation states as its basis

Recommendation 14 of report 2013-6790 was to "Ensure that notification of an interception is only made in the event of an action taken as required by Article 2 of Directive 94/3/EC. In particular, attention should be paid to the Commission guidelines for submitting notifications in EUROPHYT." In response to this recommendation, the Single Authority stated that: The Single Authority stated that the system for the submission of notifications has been revised since the previous audit. The RPS are responsible for submitting a draft notification in EUROPHYT, this is then verified and validated at central level, at which point it is submitted in the EUROPHYT system. The Single Authority confirmed that notifications are only approved in the event that action is taken by the RPS. The EUROPHYT Annual Report for 2014 includes an analysis of the time taken by Member States and Switzerland to submit notifications of interception. For 2014, Italy notified interceptions of harmful organisms on average within 8 working days; interceptions for other reasons were notified on average within 10 working days. Although the time taken to notify interceptions is in line with the EU average (of 10 and 9 working days respectively) for 2014, it is considerably longer than the two working days or preferably sooner, specified in Directive 94/3/EC for interceptions of harmful organisms. In the event that a consignment is found to be infested with a harmful organism, or is accompanied by incorrect documents, the RPS either refuses entry or destroys the consignment. The audit team noted that in such cases, the RPS endorses the phytosanitary certificate with a triangular stamp in red, marked `certificate cancelled', in line with Article 13(c)7 of Directive 2000/29/EC. 22 The Single Authority and the RPSs visited informed the audit team that they do not adapt their established programme of checks in light of new plant health risks associated with non-regulated material. However new risks associated with regulated materials are taken into account during the import checks. Conclusions on notifications of interception, and action taken

However, the average time taken to notify interceptions of harmful organisms is considerably more than the two working days, required by Article 2(1) of Directive 94/3/EC.

Member state response

an

The recommendation states as its basis

Recommendation 14 of report 2013-6790 was to "Ensure that notification of an interception is only made in the event of an action taken as required by Article 2 of Directive 94/3/EC. In particular, attention should be paid to the Commission guidelines for submitting notifications in EUROPHYT." In response to this recommendation, the Single Authority stated that: The Single Authority stated that the system for the submission of notifications has been revised since the previous audit. The RPS are responsible for submitting a draft notification in EUROPHYT, this is then verified and validated at central level, at which point it is submitted in the EUROPHYT system. The Single Authority confirmed that notifications are only approved in the event that action is taken by the RPS. The EUROPHYT Annual Report for 2014 includes an analysis of the time taken by Member States and Switzerland to submit notifications of interception. For 2014, Italy notified interceptions of harmful organisms on average within 8 working days; interceptions for other reasons were notified on average within 10 working days. Although the time taken to notify interceptions is in line with the EU average (of 10 and 9 working days respectively) for 2014, it is considerably longer than the two working days or preferably sooner, specified in Directive 94/3/EC for interceptions of harmful organisms. In the event that a consignment is found to be infested with a harmful organism, or is accompanied by incorrect documents, the RPS either refuses entry or destroys the consignment. The audit team noted that in such cases, the RPS endorses the phytosanitary certificate with a triangular stamp in red, marked `certificate cancelled', in line with Article 13(c)7 of Directive 2000/29/EC. 22 The Single Authority and the RPSs visited informed the audit team that they do not adapt their established programme of checks in light of new plant health risks associated with non-regulated material. However new risks associated with regulated materials are taken into account during the import checks. Conclusions on notifications of interception, and action taken

The established programme of inspections is adapted in light of new plant health risks associated with regulated material, which are already subject to import checks, but not to non-regulated material. This is not fully in line Article 16(2) second subparagraph of Council Directive 2000/29/EC, and means that known and emerging risks on such material are not addressed during the import checks in Italy.

Member state response

h Page: 2

The recommendation states as its basis

The audit team visited two establishments, located in two different Regions, which required an authorisation because they were handling ruminant and non-ruminant materials, and noted the following: In one case the establishment is a processing plant producing blood products of porcine origin to be used for the manufacture of feed for aquaculture. It was noted that, although the establishment largely fulfilled the necessary conditions to obtain 4 an authorisation, there was no evidence available to demonstrate that these conditions had been actually checked during official controls (see paragraph 16). In the second case the establishment is a feed manufacturer (see paragraph 19). It was noted that a report with a favourable opinion was issued by the local inspector and most of the relevant conditions were mentioned. This was followed by a clearance issued by the local competent authority. In both cases the authorisation required by the relevant Section of Chapter IV of Annex IV to Regulation (EC) No 999/2001 had not been issued.

Slaughterhouses/cutting plants, processing plants handling ABP destined to be used in the aquaculture feed and transporters of ABP and derived products are subject to inspections according to risk-based frequencies which are determined taking into account the recommended frequencies decided at central level and the specific risks identified at local level. In the feed sector, the PNAA valid from 2015 to 2017, highlights the need to inspect all feed business operators according to risk criteria and provides comprehensive explanations on, among other things, the risk factors to take into account. In both sectors (i.e. the ABP and the feed sector) guidelines and checklists to carry out official controls have been issued by the central competent authority. However, although a draft document with explanations and clarifications was about to be issued by Office VII (hence, for the feed part of the chain), the audit team noted that, in general, no checklists/guidelines for official controls currently contain the new provisions on the feed ban. This is not in line with Article 8 of Regulation (EC) No 882/2004 because it results in inspectors paying limited attention to the new provisions (e.g. authorisation of establishments handling ruminant products and cross-contamination during transport) and in a lack of records of relevant checks (see paragraphs 15, 16, 17 and 18). Sampling plans:

Business operators, establishments and plants along the chain are subject to risk-based official controls; however, the competent authorities have not yet put in place the necessary arrangements (notably, updated checklists/guidelines) to ensure that: a) the checks along the chain of the production and use of PAP for aquaculture purposes are carried out and recorded on a regular basis, and b) that the process for the authorisation of operators handling products of ruminant origin is followed in a consistent manner. Although no sampling plans to detect the presence of ruminant proteins in PAP and aquaculture feed containing such PAP were organised in 2013 and 2014, a plan has been developed for 2015 onwards and relevant analyses will be carried out by an accredited network of laboratories.

The audit team visited a processing plant supplying PAP of poultry origin in big-bags or bulk for aquaculture feed. The operator had devised a largely comprehensive own-control system based on Hazard Analysis and Critical Control Point (HACCP) principles and regular samples from the final products are analysed to detect the presence of ruminant DNA (always resulted negative). However, the audit team noted that the risk of cross- contamination during the transport of incoming ABP was not considered in the hazard analysis and had not been included in the agreements with outsourced transporters even 6 though it is one of the conditions laid down in Section D of Chapter IV of Annex IV to Regulation (EC) No 999/2011. This weakness had not been identified by the inspector in charge.

In the second processing plant visited the products placed on the market for aquaculture consist of whole dried blood and dried haemoglobin both of porcine origin, dispatched in big-bags or in bulk. The whole blood is processed in a dedicated production line physically separated from another line which processes blood of other species (including ruminants), whereas the haemoglobin is purchased, as such, stored in dedicated silos and dispatched. Although satisfactory arrangements were in place to avoid the risk of cross- contamination and these were verified by sampling final products, there was no evidence these had been checked during official controls, as the checklist used does not yet include the relevant new feed ban requirements. This is not in line with the requirements on official controls laid down in Section F, Chapter V of Annex IV to Regulation (EC) No 999/2001.

The audit team visited two transporters, located in two different Regions, one handling ABP and the other PAP, both of poultry origin, for aquaculture. Both of them had been authorised as transporters of ABP or derived products, according to a national rule and were subject to planned official controls (although in one of the three Regions visited the competent authorities declared that no checks of transporters were planned due to the lack of resources). According to the aforementioned national rule, the authorisation is granted by the local competent authority for each individual truck owned by the transporter and the transport of ABP/DP and feed in the same truck is prohibited. The audit team noted that although none of the transporters were active in the transport of products of ruminant origin, the authorisation given by the competent authority did not indicate any restrictions or conditions (e.g. use of authorised cleaning procedures) which would apply to the transport of such products and the own-control measures put in place by both the transporters did not refer to the risk of cross-contamination with products of ruminant origin. This shortcoming had not been identified during official controls, although a recent inspection of one of the transporters identified a number of deficiencies (related to the cleaning and commercial documents). This is not fully in line with the requirements on official controls laid down in Section F, Chapter V of Annex IV to Regulation (EC) No 999/2001. 5.2.2 Use of processed animal protein to produce compound feed Findings

The audit team visited a trader of, among other things, PAP, and two feed manufacturers producing feed for aquaculture using PAP as raw material, one of which produced for both aquaculture and other farmed animals (including ruminants). All of them had largely comprehensive own-control systems and were subject to official controls (once or twice per year) according to the risk-based criteria set up by the central competent authority. However, the audit team noted that no evidence of the official checks on the relevant feed ban requirements, as required by Section F, Chapter V of Annex IV to Regulation (EC) No 999/2001, could be provided by the local competent authorities.

Operators along the chain are mostly checked according to the planned frequencies and non-compliances are followed in a structured and systematic manner. However, the absence of evidence of checks on the relevant feed ban requirements (notably, when an authorisation is required) and a low attention paid to the risk of cross-contamination during transport, undermines the overall reliability of the official controls. This weakness is mitigated by largely comprehensive own-control systems put in in place by the operators. 8

Member state response

A new guideline, amending and updating the previous one, has een drafted and submitted to the Regional authorities, in order to are the content and receive comments and suggestions. (please find attached to the mail the draft). The guideline concerns instructions and specific requirements on the production and use of PAP and aquaculture feed containing such PAP, and the authorisation process of those business operators, which handle products of ruminant origin. Moreover, all other derogations to the feedban are included in order to give full application to the Reg,(EC) 999/01. In the document, there are also two tables: one regarding the updated overview of the feedban and its derogations, and the other with the specific requirements of production and storage of PAPs intended to farmed animals. The finalised text will be officially sent as soon as possible. Page: 1

The recommendation states as its basis

Three of the milk processing establishments visited exhibited structural and maintenance deficiencies which meant that they did not fulfil the approval requirements as laid down in Regulations (EC) No 852/2004 and (EC) No 853/2004.

The SINTESIS system provides a single list of approved establishments. In addition, it records the various approved activities of individual establishments1

In one Region an establishment was suspended two years ago on the Sistema INTEgrato per gli Scambi, le Importazioni e le Strutture (SINTESIS) list. The CA explained that this was a consequence of the earthquake which took place in Abruzzo in 2009 when damaged establishments were waiting for aid from the authorities to renovate their premises. During the period of suspension, the establishment was visited four times per year to confirm that no activity was taking place. The establishment was delisted on the day the FVO audit team requested to visit it.

In another Region, the CA stated that an establishment is delisted after six months suspension. 1 Paragraphs 21-24 inclusive have been re-ordered for clarity. 5

One establishment was on the list of heat treatment (liquid milk establishment). However, based on the information provided by the FBO, this establishment has never produced liquid milk.

No standardised criteria have been developed in relation to suspended establishments with the result that establishments can remain suspended for an indefinite time. Some minor errors in the lists of establishment activities were noted. 5.1.5 Prioritisation of official controls

Member state response

feed operators An official note to regional competent Authorities (see the Regulation attached document A) has been issued to invite such Authorities to ructions, as define procedures/instructions to carry out controls, at establishments requesting for the approval according to art.10(3) of Regulation EC 183/2005, to be compliant with the instructions already supplied by the Ministry of Health (check-list as in addendum 1/2003, other provisions in addendum 1/2003, circular letters n.24036 on 16 December 2013 and n.0017029 on 19 September 2012). Moreover, the audit to be carried out by the Ministry of Health are going to evaluate all the provisions adopted by regional/local Authorities to guarantee that all the requirements of legislation are verified before the adoption/refusal of approval according to art.10(3) of regulation EC 183/2005. Moreover, a representative of the Ministry of Health has already carried out two training courses about the implementation of Regulation EU n.225/2012 in one of the three Regions involved in the audit addressed to local Authorities (15 May, 12 June; see the attached documents B) and one training course for FBOs (Assalzoo seminar, on 8 May 2014; se

Member state response

e establishments The above-mentioned note (see the attached document A) Regulation recommends the regional Authorities to describe, in the s are met, inspection report, in a detailed way the verifications and the pertinent results to prove the compliance with the requirements of regulation EU n.225/2012. The note indicates also a reference to review the approvals, in relation to par.5.1.5 of the draft report where it has been Page: 1 4 - documents mentioned therein are published as a separate annex and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3316 ecommendations of Report ref. DG(SANCO)/2014-7037 -MR of a/an audit carried out from 18 the implementation of the specific requirements for production, storage, transport and dioxin testing highlighted that, in some specific cases, the pertinent requirements of the regulation EU n.225/2012 were not evaluated by the official inspectors. Moreover, a competent regional Authority, not directly involved in this community audit, has retired an approval provision (prot. n. 180463 on 24.04.2014; see the attached document E) following a request for clarification by the Ministry of Health (see the attachment D n.00073

Member state response

information The above-mentioned note see the attached document A) has egulation (EC) established that, by September 2014, the public establishment lists and the activities that are carried out shall be liance with annex II, section Facilities and 0 of Regulation EC n.183/2005.

Member state response

official In fact, addendum 1/2013 establishes maximum 30 days for the the issue of the analytical certificate. id down in In cooperation with Italian NRL and official control laboratories issue of the analytical certificates have been re than 10 working days from the sample ssue of the analytical certificate. note (prot. n. 13849, 2nd July 2014; see the F) following the meeting with NRL and laboratories involved in dioxins official controls. e-mentioned note prot. N 13846 (see the attached he regional Authorities.

Member state response

ntended to be The above-mentioned note prot. n. 13846 (see the attached Article 5(2) document A) clarifies that where feeds and other products (not for ufactured/stored for marketing, these last ones Page: 2 4 - documents mentioned therein are published as a separate annex and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3316 ecommendations of Report ref. DG(SANCO)/2014-7037 -MR of a/an audit carried out from 18 the implementation of the specific requirements for production, storage, transport and dioxin testing (not for feed use) shall be clearly labelled for the other purposes.

Member state response

Il Centro di Referenza Nazionale per il benessere animale si è attivato per effettuare le opportune attività di modifica del tware nazionale di registrazione che verranno programmate per il mese di settembre e completate per il mese di ottobre. Risoluzione racc. 1-Brescia.pdf

27/08/2014 Centro di Referenza Nazionale per il benessere animale si è attivato per effettuare le opportune attività di modifica del are nazionale di registrazione che verranno programmate per il mese di settembre e completate per il mese di ottobre. Risoluzione racc. 1-Brescia.pdf

Member state response

Ensure that the appearance or suspected appearance of a harmful organisms as referred to in Article 16(1) of Directive 2000/29/EC is notified immediately, in line with Article 16(1) of Directive 2000/29/EC.

Member state response

Regarding Anoplophora glabripennis, ensure that all necessary measures to eradicate or, if that is impossible, inhibit the spread of the pest are taken, in line with Article 16(1) of Directive 2000/29/EC, in particular that the list of host plants is harmonised based on experience in Italy to avoid compromising the control activities for eradication of the pest.

Member state response

Regarding Anoplophora glabripennis, ensure that all necessary measures to eradicate or, if that is impossible, inhibit the spread of the pest are taken, in line with Article 16(1) of Directive 2000/29/EC, and as provided for in the EPPO standard PM 9/15 (1), in particular to ensure appropriate survey strategy for inspection of plants taking into consideration the biology of the pest where inspection from the ground is not sufficient.

Member state response

Regarding Anoplophora glabripennis, ensure that all necessary measures to eradicate or, if that is impossible, inhibit the spread of the pest are taken, in line with Article 16(1) of Directive 2000/29/EC, and as provided for in the EPPO standard PM 9/15 (1), in particular (a) immediate felling and destruction of symptomatic trees found during the flying period; (b) implement preventive felling of asymptomatic host plants in a wider radius around infested trees in outbreaks with a high infestation rate of the pest and the presence of large number of highly infested host plants; (c) perform systematic investigation of preventively felled asymptomatic host plants.

Member state response

Page: 1 14). Please check back later. ref. DG(SANCO)/2014-7192 -MR of a/an audit carried out from 04 March rn beetles (Cerambycidae).

Member state response

ed

Member state response

Page: 2

Member state response

The local and national authorities have always notified promptly he situation of Xylella fastidiosa in Apulia and any changes occurred. In the monthly meetings of the Standing Committee on Plant Health were carried out in near real time updates on the evolution of the investigation and the scientific research results.

Member state response

Implementation of the ELISA and PCR assays was done by g a larger number of samples collected in the contaminated area. Specifically, 400 samples of citrus, 146 samples of ctaceae, 226 samples of conifers, 86 samples of Arecaceae, were double checked by ELISA and PCR between March and April 2014. Validation of the tests was possible. Positive controls were represented by sap extracts, of the different matrices, spiked with aliquots of the suspension of the pure culture recently (March, 2014) obtained on BCYE and PWG media (Cariddi et al., 2014- doi: 10.4454/JPP.V96I2.024). In both tests the positive controls were correctly identified in all plant matrices, suggesting that no cross-reaction or PCR-inhibition occurred. In addition, more investigations have been done on almond trees. The identification of the bacterium in this host plant was limited to few samples tested in October 2013, using leaf-petioles of senescent leaves. Starting in January 2014, the leaves from the new shoots have been tested monthly, along with the xylem tissues recovered from 1-2y old branches. The results so far gathered consistently showed that leaf tissues (young leaves) have not been colonized by the bac

Member state response

rain' The surveys began in November - December, period in which e some species had winter rest. A group of reliable plant species was selected to avoid that the analysis would give an unreliable result and to be definitely able to detect the presence of the bacterium in the territory. In the first phase of survey, in fact , the activities were mainly focused in checking the spread of X. fastidiosa in the territory of the Apulia region in order to understand the territorial extent in the province of Lecce but also the entire region. It was necessary to detect and demarcate the infected areas in order to take the necessary measures. A different assessment was made in relation to grapevine, for which the protocols already provided for the possibility of being able to make reliable analyzes of material in quiescence excluding cases of infection of grapevine. Page: 2 ref. DG(SANCO)/2014-7260 -MR of a/an audit carried out from 10 l controls for Xylella fastidiosa.. In any case, we have already made specific investigation in infected areas on different species such as citrus fruits, Cactaceae, Arecaceae, Coniferales and other species listed in Annex 1 of the Decision 2014/87. The activiti

Member state response

the end of the first phase of survey of the entire region and in ticular the Province of Lecce, demarcated areas were identified icially established with the Regional Agriculture Service Act no. 157 of April 18, 2014, a copy of which is attached.

Member state response

er to ensure official controls on movement of plants ded for planting, the regional authority has reorganized the trol procedures of nurseries by phytosanitary inspectors and intensified inspections on movement of all species and in ticular on the known host species of X. fastidiosa. same procedure is used for the garden centers. information and continuous updates provided to the serymen are frequent and therefore they have the full aware of procedures to be followed.

Member state response

order to ensure compliance with paragraph 1 of Art. 16 ective 2000/29/EC, specific monitoring are constantly carried out at the sites of production of woody plants, with particular erence to Vitis, Citrus and ornamentals. pections at the sites of production of Vitis and Citrus have been ensified in order to obtain further evidence on their exclusion m the list of host plants. roximately 400 samples of Citrus and about 200 samples of pevine taken from the most infected area (Gallipoli) were ted in order to verify the presence of X. fastidiosa.

Member state response

dies to determine the distribution of the bacterium in the olive done by ELISA and quantitative PCR assays. The dies included trees with different ages and different symptoms erity. Page: 4 ref. DG(SANCO)/2014-7260 -MR of a/an audit carried out from 10 l controls for Xylella fastidiosa.. The bacterium was consistently detected in symptomatic or asymptomatic leaves collected from branches showing withering and dieback. While in the samples collected from branches without symptoms, the % of the infected samples varied. Based on this evidence, inspectors were instructed to inspect the trees prior sampling, and to collect cuttings (with alive tissues) maily from the branches showing suspicious or clear dieback symptoms and in any case also from asymptomatic plants and branches. The sample usually consists of 4-5 cuttings taken from different parts of the same plant from which is extracted the sample for laboratory analysis. The amount of branches collected has been determined on the basis of experimental tests, in order to have a representative sample allowing a high reliability.

Member state response

d During the period of the FVO audit, the inspectors of the regional Service were concluding the investigation of sales and the results e been communicated in a note dated February 19, 2014 n. prot. 142014 to the Central Plant Health Service and to the other Regional Plant Health Services. The Central Plant Health Service sent the communication to the Member States concerned on 20-26/02/2014).

Member state response

The Implementing Decision 2014/87 is dated February 13, 2014 and was published on February 15, so later than FVO audit and therefore it was not possible to adapt the regional legislation. This adjustment was made by an act of the Regional Agricultural Service n. 31 of 27.2.2014, copy of which is attached.

Member state response

the The finding of X. fastidiosa was made in October 2013, so the first investigations were carried out to immediately ascertain the presence and spread of the pathogen. In any case, the analysis of Page: 5 ref. DG(SANCO)/2014-7260 -MR of a/an audit carried out from 10 l controls for Xylella fastidiosa.. some species such as olive and oleander allowed to detect the presence of the pest even in this period. With the preparation of the Action Plan have been defined the procedures and criteria by which the monitoring activities will be carried out in 2014 in accordance with article 2 of the Decision 2014/87/EU and certainly in the most appropriate period for the detection of Xylella fastidiosa.

Member state response

Ensure that, Italian national and regional legislation implements provisions that are fully in line with the Decision 2014/497/EU.

Member state response

Ensure that, if the presence of Xylella fastidiosa is confirmed outside the Infected Zone, the delimitation of the Infected Zone and Buffer Zone shall be reviewed and changed accordingly, in line with point 4 of Section 1 of Annex III of Decision 2014/497/EU.

Member state response

Ensure that, all garden centres located in the Demarcated Area are immediately identified and included in the official control regime, in order to prevent any movement of plants for planting outside the Demarcated Area, that do not fulfil the requirements of Annex II of Decision 2014/497/EU.

Member state response

Ensure that, in the Infected Zone, measures are taken in line with Article 7 (3) and section 2 of Annex III of Decision 2014/497/EU.

Member state response

Page: 1

Member state response

nel mese di settembre del corrente anno si terrà una ulteriore iniziativa di uale sarà prevista una specifica sessione per i controlli doganali ti biologici che sarà impostata sulla nuova Circolare dell'Agenzia delle Dogane atori che "a cascata" erogheranno la successiva formazione nelle strutture dipendenti della Regione Emilia-Romagna è volta allo sviluppo di competenze menti relativi alle materie di competenza vengono gestiti a livello di singoli ficio che si occupa di vigilanza è composto da personale con un profilo formativo e risorse disponibili, l'aggiornamento formativo per le materie relative alle egolamentate, tuttavia, è possibile un potenziamento dell'attività di cifico. sto delle giornate di formazione/aggiornamento interno per il personale addetto rsi entro marzo 2014, e attività di vigilanza in affiancamento con personale già

Member state response

o di interazione tra le autorità competenti, nell'ambito del Comitato a lavorando per: sa partecipazione al sistema da parte di tutte le autorità competenti. li accordi bilaterali Stato -Regioni. amenti operativi. riunito il Comitato nazionale di Vigilanza per condividere gli esiti on direttamente coinvolte e, in particolare, per assicurare il rispetto della Page: 1 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products ompetent Authority disporre uno schema tipo di accordo che, previa a sostituire i differenti accordi esistenti. territoriali ICQRF sono stati invitati a prendere i politici regionali per sensibilizzarli sulla necessità di a svolgere un ruolo attivo nel sistema. La somma costituirà il Programma nazionale di vigilanza 2014. sa ai rappresentanti del Comitato nazionale di na check-list per lo svolgimento degli audit presso le iformare i comportamenti operativi delle diverse

Member state response

cazione dell'art. 92bis del Reg. (CE) n. 889/08 in Italia è stato adottato il Decreto braio 2012 che, all'art. 8, ha previsto che l'elenco degli operatori sotto se caricato dagli Organismi di controllo sul SIB (Sistema Informativo Biologico) documenti giustificativi fossero inviati successivamente. o al 31/12/2011, completo del documento giustificativo, è stato corso della visita. isponibile online al seguente indirizzo: oAziende.do selezionando come "Tipologia Elenco" la e per la vigilanza con nota n. 11988 del 7 agosto 2013 tutti i trollo sono presenti. 013 il MiPAAF ha sollecitato il rilascio del documento Page: 2 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products Proposed by the Competent Authority rganismi di controllo e il successivo caricamento dello stesso sul SIB. È tifiche informatizzate potrà essere superiore al numero di notifiche attese a eratori nel sistema. è stata richiamata l'attenzione delle suindicate Regioni sulla necessità di le informazioni gestite. Solo dopo la trasmissione di tali dati su SIB gli caricare i relativi documenti giustificativi. Ciò potrebbe ritardare il nale aggiornato. ne si adopererà, attraverso tutti gli strumen

Member state response

444 del 22 agosto 2013 l'Amministrazione ha invitato gli Organismi di controllo estivamente ai rilievi formulati dal gruppo di audit nel corso delle verifiche lmente, gli Uffici territoriali dell'ICQRF, competenti della supervisone degli o, sono stati sollecitati a verificare l'adeguata e puntuale applicazione di quanto successive attività di vigilanza. 2013, l'Amministrazione ha raccomandato a tutti gli Uffici territoriali 'espletamento dell'attività di vigilanza di quanto osservato dal gruppo di anto di specifico rilevato a carico dei due Organismi di controllo non fosse i controllo adottato dagli altri Organismi operanti in Italia e, in caso di gli opportuni rilievi e a valutare le azioni correttive proposte dalle strutture di

Member state response

azionale alla raccomandazione formulata sarà adottato un apposito isteriale), nel quale saranno individuati i requisiti che i laboratori debbono come previsto dalla normativa europea. In particolare, i laboratori delegati a tore biologico dovranno fornire alla Direzione Generale per la Promozione della Page: 3 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products ompetent Authority /IEC 17025; tificazione e/o di rilevabilità inferiori o uguali azionale; sso omogenato del campione di laboratorio con rova ripetuta. siano identificate le prove accreditate e in cui , il dato dell'incertezza delle misure; e dell'Autorità competente. mpetenti e sulla base dell'esame positivo il amite internet. Gli Organismi di controllo i laboratori inclusi nell'elenco. ome e con gli stakeholders nel corso del della Conferenza permanente per i rapporti zano. La procedura di acquisizione rollo preventivo di legittimità da parte blicato nella Gazzetta Ufficiale della enire alla fine del mese di febbraio 2014. consentire ai laboratori, già accreditati, di con la conseguente pubblicazione ti con gli stakeholders e con le Regioni.

Member state response

riguardo. 09 del 13 gennaio 2011 l'Autorità competente ha chiarito alcuni di eventuali residui di sostanze non elencate nell'allegato II del Reg. Page: 4 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products ompetent Authority ologici. reto Ministeriale è stata individuata una soglia numerica critica di di prodotti fitosanitari oltre la quale il prodotto con è certificabile come a presenza sia accidentale o tecnicamente inevitabile. L'individuazione della dispensabile per fornire agli Organismi di controllo criteri uniformi per lo opria attività che prevede, tra l'altro, l'interpretazione dei dati analitici forniti alisi che eseguono per loro conto le analisi sui campioni di prodotto biologico.

Member state response

dell'operatore che ha etichettato il vino non in conformità con quanto previsto comma del Reg. (CE) n. 834/07, ha emesso nei confronti dello stesso un azione correttiva consistente nella richiesta da parte ione delle etichette utilizzate. La suddetta non conformità è stata e di seguito riportato: are la dicitura "AGRICOLTURA ITALIA", riporta semplicemente la icare il solo paese d'origine delle materie prime utilizzate era r Manual Logo", a pag. 20, pubblicato nel sito ufficiale della culture/organic/eu-policy/logo_en). La Linea Guida ICEA per l' stata redatta sulla base di tale documento e sulla base di questa ichette in questione. La revisione della Linea Guida ICEA per in conformità alla seconda versione dell' User Manual Logo che d'origine accanto al termine "AGRICOLTURA". ver sentito le Associazioni, le Regioni e le altre autorità coinvolte tende dare agli addetti al settore indicazioni precise sull'etichettatura della normativa specifica dell'agricoltura biologica che di quella Page: 5 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products the Competent Authority

Member state response

atiche di cui all'art.18 del Reg. (CE) n.889/08 siano monitorate dagli Direzione generale per il riconoscimento degli organismi di controllo e (VICO) con nota n. 10705 del 13 maggio 2013 ha richiamato medesimi sul mantenimento di un adeguato sistema di gestione delle pratiche tà di garantire la rendicontazione dei dati delle stesse qualora questa venga enerale VICO assicurerà la verifica della direttiva ha modificato i propri strumenti per la i di controllo al fine di effettuare un sistematico per garantire il rispetto di questa specifica norma. ota informativa da inviare agli Uffici veterinari delle e altre Regioni e Province autonome di provvedere della pratica in deroga e il puntuale rispetto della

Member state response

assicura che le autorizzazioni legate a circostanze calamitose circoscritte ratori. assicura la puntuale applicazione dell'articolo 47 del regolamento (CE) 889/2008. sce che l'uso di mangimi non biologici da parte di singoli operatori sarà mpetenti solo per un periodo di tempo limitato e, in particolare, in ttera c), del regolamento (CE) n. 889/2008 della

Member state response

o dei prodotti biologici in libera pratica sono descritte compiutamente nella dell'Agenzia delle Dogane (Allegato 1) che ha sostituito la precedente della stessa si evince che le procedure di controllo per l'immissione in ologici importati dai Paesi terzi sono state rafforzate e adeguate a quanto Page: 6 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products d by the Competent Authority 89/08 e n. 834/07. sa circolare, a decorrere dal 17 giugno 2013 è stato introdotto l'uso (CADD), da indicare nella casella 33 del DAU, che permetterà il da quelli non biologici (Z041). L'introduzione del merci di cui alle seguenti voci: li di e fecole; inulina; glutine di frumento to o dal frumento segalato ti, schiacciati, in fiocchi, perlati, tagliati o so della voce 1006; germi di cereali, interi, schiacciati, in fiocchi o frutti diversi; piante industriali o medicinali; paglie e tti della loro scissione; grassi alimentari lavorati; cere di a non modificati chimicamente Page: 7 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products roposed by the Competent Authority ichi il CADD Z040 nella casella 33 dovrà, altresì, indicare il codice C644 nella

Member state response

o in quanto le procedure di importazione attualmente adottate in Italia nel territorio UE di prodotti per i quali l'importatore fornisce prove sufficienti cui all'articolo 33, paragrafo 1, lettere a) e b) del regolamento (CE) n. Page: 8 (SANCO)/2013-6650-MR of an audit carried out n and labelling of organic products ompetent Authority

Member state response

ntato alla raccomandazione 4, in ordine agli indebiti preavvisi l'Autorità scontro da utilizzare per l'espletamento di office audit presso la sede o, in fase di predisposizione, ha previsto un'apposita sezione che, tenendo conto ntrodotte dal regolamento (UE) n. 392/ 2013, è finalizzata alla verifica di i controllo. -ICQRF) ha definito apposite misure ripetute ofis, sequestri, notizie di reato, recidive egli ordinari piani di controllo. Page: 9

Member state response

I PNCS prevedono controlli regolari sugli allevamenti di pollame per int verificarne l'attuazione, ai sensi dell'articolo 3, punto 2 (c) - Regolamento (CE) n 2160/2003. La necessità di relazioni su tali controlli ufficiali è già stata riaffermata nei vigenti PNSC, in note ministeriali e durante corsi di formazione (da ultimo durante il corso "Questioni attuali nel settore avicolo" del 25 marzo 2014). Entro luglio 2014 sarà emanato dalla ACC un nuovo documento per confermare e richiamare tale necessità, oltre che quella di rilevare e correggere eventuali non conformità degli OSA.

Member state response

Nel Piano 2015 non sarà più previsto il campionamento ufficiale di conferma a seguito di positività in autocontrollo. I tempi tra prelievo del campione, ricezione del campione e inizio delle analisi fissati dalla normativa comunitaria sono indicati nei PNCS. Entro luglio 2014 sarà emanato dalla ACC un nuovo documento per confermare e richiamare tale necessità, oltre che quella di rilevare e correggere eventuali non conformità degli OSA.

Member state response

I PNCS vigenti prevedono l'applicazione rapida di misure restrittive per gruppi di ovaiole sospetti di positività a S. rilevanti, come da specifica normativa UE. Nel Piano 2015 saranno previste ulteriori garanzie per assicurare l'applicazione rapida di misure restrittive per gruppi di ovaiole sospetti di positività a S. rilevanti. Entro luglio 2014 sarà emanato dalla ACC un nuovo documento per confermare e richiamare la necessità di tali urgenti misure, oltre che quella di rilevare e correggere eventuali non conformità degli O Il campionamento di conferma, nel Piano ovaiole 2015, sarà previsto in ottemperanza al Regolamento 1237/2007. Page: 1 ref. DG(SANCO)/2013-6695 -MR of a/an audit carried out from 03 ontrol Programmes in particular poultry populations (breeders, laying

Member state response

Entro ottobre 2014 sarà emanato dalla ACC, in collaborazione col CRN n line e con l'Ente di accreditamento nazionale, un nuovo documento per est confermare e richiamare tale necessità.

Member state response

m I PNCS prevedono la sierotipizzazione degli isolati di Salmonella spp in autocontrollo, come previsto dalla specifica normativa UE. La necessità di tali analisi è già stata riaffermata nel vigente PNSC, in note ministeriali e durante corsi di formazione (da ultimo durante il corso "Questioni attuali nel settore avicolo" del 25 marzo 2014). Entro luglio 2014 sarà emanato dalla ACC un nuovo documento per confermare e richiamare tale necessità. Page: 2

Member state response

In materia di controlli ufficiali ex Reg. (CE) n.882/2004, nello specifico uanto attiene le funzioni di coordinamento e cooperazione tra i i livelli istituzionali coinvolti nella gestione della PSA, a far data e luglio 2012, è stata ridefinita la linea di comando a livello regionale. La i modifica dell'assetto regionale si è resa necessaria a fronte involuzione della situazione epidemiologica a partire dall'evento pidemico del 2011, perpetratasi fino ad ora, impegnando tutte le AC ad e coinvolgimento, una maggiore attenzione ai risultati ed ad più consapevole responsabilizzazione nello svolgere i propri tato istituito un "Organismo di Coordinamento Centrale e un Lavoro", il quale sotto la supervisione del Ministero della , dovrebbe sovraintendere alle attività di contrasto alla malattia di ai Piani ordinari e straordinari approvati dalla Commissione europea, uanto prescritto dal Piano di azione della DGSANCO di cui a nota del 3 maggio 20132, integrata con la nota del 13 agosto u.s. 12, con la DPGR. 56/2012, era stato istituito il Tavolo di erassessoriale con la previsione di un delegato del Presidente one Sardegna, Dott. Ugo Cappellacci, soggetto responsabile sioni e della messa in

Member state response

a 2008/71/CE è stata recepita con il decreto legislativo n. a 200/2010. Allo stato attuale è stato previsto di introdurre un sistema di zione suppletiva dei capi suini, a prescindere dall'ordinaria cazione e dalla tipologia di cute dei soggetti, che prevede ione del marchio auricolare in aggiunta al previsto tatuaggio. nto attiene alla registrazione delle aziende, i Servizi veterinari egistrano in BDN ogni nuova azienda suina, previo sopralluogo e a delle condizioni igienico-sanitarie e di biosicurezza previste colo 9 del DAIS n. 69/2012, assegnando il codice aziendale di cui n. 317/1996; tale codice è riportato sul tatuaggio nel padiglione icolare sinistro sui suini entro i 70 giorni dalla nascita o comunque, i ogni movimentazione sia per vita che per il macello. ziende ricadenti nelle zone di restrizione per focolaio di PSA nel co e/o nel selvatico la marca va applicata entro 45 giorni di vita e i ogni movimentazione. i ogni movimentazione dall'azienda deve essere introdotta una cazione sanitaria obbligatoria da allegare al modello IV che attesti: ntificazione e la registrazione di tutti gli animali ienda; spetto dei parametri riproduttivi dell'azienda; mpilazione del registro az

Member state response

Italia è attivo il sistema informativo nazionale per la notifica dei Page: 4 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the tion Proposed by the Competent Authority spetti e delle conferme delle malattie animali soggette a denuncia IMAN). Tutti i servizi veterinari delle ASL hanno un referente putato all'immissione dei dati relativi al sospetto, nella prima fase, e ccessivamente alla eventuale conferma o all'esclusione del sospetto. sistema SIMAN, grazie alla connessione con la banca dati nazionale otecnica, garantisce l'univocità e la correttezza di tutti i dati anagrafici, i dati relativi alle coordinate geografiche, consente inoltre di inserire e indi visualizzare tutte le misure sanitarie messe in atto in occasione del colaio, le metodiche diagnostiche utilizzate e tutte le informazioni utili fini dell'eventuale notifica in ADNS, piattaforma con cui il SIMAN è mpatibile. L'autorità centrale può costantemente visualizzare quanto serito nel sistema, ivi compresi la data, l'orario e il nominativo del sponsabile dell'immissione dei dati nel sistema.

Member state response

specificato, nel SIMAN sono reperibili tutte le informazioni te ai fini dell'assolvimento degli obblighi informativi dell'autorità ntrale in termini di notifica dei focolai.

Member state response

ase delle inefficienze riscontrate nel corso delle attività ispettive dal Ministero della salute di concerto anche con il Comando nieri per la tutela della salute e del Centro di referenza per le pesti è stata imposta la revisione della scheda di indagine emiologica nei contenuti e nella tempistica di redazione e invio al inistero della salute. Infatti la scheda attualmente in uso deve essere Page: 5 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the Action Proposed by the Competent Authority ilata entro le 48 dalla conferma di focolaio e completata non oltre dall'avvenuto abbattimento dei capi. Tale scheda è finalizzata gliore valutazione degli elementi e dei fattori che possono aver to l'ingresso del virus. Tutte le informazioni che scaturiscono ndagine, sono strategiche ai fini della gestione dei focolai e sere immediatamente rese disponibili, in modo da rendere tutti gli eventuali provvedimenti necessari ad impedire la e dell'infezione.

Member state response

Come previsto dai Piani straordinari comunitari 2012 e 2013 approvati, è sta l'effettuazione di un controllo una volta l'anno sul 100% ende suine, ivi comprese le aziende da autoconsumo. Durante i ene verificata la regolarità anagrafica dell'azienda e dei oggetti, ex dPR del 30 aprile 1996, n.317 e decreto legislativo n. 00/2010, anche mediante la compilazione di un'apposita check list di AIS 69/2012, rivista in forza delle attività ispettive di cui sopra. r quanto riguarda le condizioni per la movimentazione per vita, la stessa è consentita solo tra aziende con qualifica sanitaria "Controllata ta", ovvero con doppio controllo annuale. ltre a quanto descritto alla raccomandazione n. 2, i Servizi veterinari i verificano il rispetto delle condizioni igienico sanitarie, di benessere mali e di biosicurezza. re attenzione è posta per le aziende della tipologia semibrado Page: 6 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the ent Authority le cui recinzioni esterne devono garantire iretto con altri suini domestici o selvatici, essere doppie ed inamovibili (ancoraggio tezza minima di 1.5 mt.). allo stato clinico, all'anagrafe

Member state response

cedure di notifica dei sospetti e delle conferme di focolai PSA nei ici sono le medesime applicate a quelle dei focolai nel domestico. rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the Action Proposed by the Competent Authority anto anche in questo caso si procede tramite il sistema SIMAN. ltre in Sardegna è in vigore un piano di controllo dei selvatici, che ede la collaborazione delle compagnie di caccia per il prelevamento i, nonché il supporto del corpo Forestale e delle associazioni te alla tutela dei Parchi naturali, in merito all'avvistamento dei ali, alla delimitazione delle aree infette del selvatico, etc.. emente la Commissione europea ha caldeggiato il potenziamento misure di cui al vigente Piano dei Selvatici redatto all'Osservatorio Epidemiologico Veterinario Regionale di concerto con Centro di Referenza Nazionale per le Pesti suine.

Member state response

Regione Sardegna ha assicurato che l'IZS della Sardegna, entro il se di febbraio 2014, provvederà ad inoltrare la richiesta per le prove SA non ancora accreditate all'Organismo italiano di accreditamento DIA).

Member state response

Regione Sardegna ha assicurato che l'IZS della Sardegna partecipa nte ai circuiti interlaboratorio organizzati dal Centro di za comunitario di Madrid (CISA-INIA) e il Centro di referenza e (CEREP). Page: 10 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the roposed by the Competent Authority

Member state response

dall'articolo 7(b) della decisione 2005/363 la lista degli limenti autorizzati all'esportazione di carni fresche al di fuori della degna viene aggiornata due volte l'anno dal Ministero della te, e viene inviata alla Commissione Europea. Nell'ambito della sione di tutte le misure di cui ai Piani degli ultimi due anni, è stata ta una procedura di verifica della sussistenza dei requisiti di tutti ilimenti autorizzati all'esportazione, nonché della sussistenza ività di esportazione, procedendo ad eventuale sospensione orizzazione o alla revoca della stessa.

Member state response

dell'adozione della decisione 2011/852/CE di modifica della one 2005/363/CE, con la quale l'intero territorio della Sardegna è o classificato ad alto rischio per PSA, gli stabilimenti autorizzati che vano proseguire la propria attività di esportazione, hanno vveduto ad approvvigionarsi esclusivamente di suini e di carni nti dal territorio continentale. Relativamente ai prodotti in lavorati in data antecedente la modifica della norma ria (dicembre 2011), su disposizione del Ministero della salute, rovveduto ad informare la Commissione e nel rispetto di quanto dalle norme vigenti, tali prodotti sono stati ammessi rtazione, previa ricognizione delle tipologie e quantità, data di ne e lavorazione a partire dal mese di novembre 2011. ente, è stata predisposta una procedura di verifica circa la Page: 11 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the ent Authority elle materie prime utilizzate, con particolare dei lotti ottenuti da carni sarde e da carni le spedizioni effettuate al di fuori della di novembre 2011. ella salute di procedere ad una sospensione ni rilasciate in caso di interruzione dei zione, ed è stata disposta

Member state response

lo autonoma C:\Users\Bessi\ C:\Users\Bessi\ Desktop\Nuovo PianoDesktop\Nuovo Piano

Member state response

egione Sardegna ha fornito gli elementi di risposta (vedi allegato 74 del 17/09/2013) dichiarando di aver formalizzato allo stabilimento escrizioni finalizzate al procedimento di revoca di revisione del riconoscimento e di essere in attesa della formale valutazione delle rocedure della ditta da parte delle autorità locali. C:\Users\Bessi\ Desktop\Nuovo Piano

Member state response

Regione Sardegna ha fornito elementi di risposta (vedi allegato 23474 el 17/09/2013). DGISAN, con nota prot. n. 39272 del 25/09/2013, ha invitato la gione ad intensificare i controlli ufficiali su tutta la filiera dei SOA andone l'attività con cadenza trimestrale. C:\Documents and C:\Documents and Settings\gaglioner\DeSettings\gaglioner\De operatori ai Page: 13 rt ref. DG(SANCO)/2013-6788-MR of an audit carried out controls on African swine fever and the operation of the n Proposed by the Competent Authority 14

Member state response

di una nota alle Regioni e le Provincie non U.I. con cui verrà iesto di procedere ad una più razionale utilizzazione del rsonale veterinario delle ASL sulla base delle specifiche piano di risanamento per la brucellosi.

Member state response

nto della direttiva 2009/128/CE è stato già ri e l' adozione definitiva è prevista entro il 17 di e del piano di azione entro il 26 novembre

Member state response

nota alle Amministrazioni coinvolte i per la tutela della salute e Ispettorato per la dei prodotti agroalimentari) con l'invito a tenza, che il personale addetto ai controlli guata per l'espletamento dei propri compiti con icolo 6 del Regolamento CE n. 882/2004).

Member state response

nota alle Amministrazioni coinvolte eri per la tutela della salute e Ispettorato per la frodi dei prodotti agroalimentari), con l'invito a mpetenza, che il personale addetto ai controlli menti per la verifica di tutti gli elementi che sono l fine di garantire l' efficacia e l'efficienza dei nto CE n. 882/2004). Page: 1 -6277-MR of an audit carried out Action Proposed by the Competent Authority

Member state response

nota alle Regioni/Province con l'invito ad ievo vengano effettuate da tutte e a garantire che le udano le sostanze attive riportate nell'etichetta e le cluse nell'etichetta che sono state oggetto di non sono più autorizzate ma vi è per esse interesse a quelli che saranno compresi nella lista di cui N 1107/2009 ( articolo 68 Regolamento CE

Member state response

nota alle Regioni/Province con l'invito a iego dei PPP siano eseguiti verificando in particolare e e sui registri dei trattamenti (articolo 4(2)(a)

Member state response

na nota alle Regioni/Province con l'invito a dei PPP siano eseguiti con frequenza ento CE n. 882/2004). Page: 2 -6277-MR of an audit carried out Action Proposed by the Competent Authority

Member state response

nota alle Regioni/Province con l'invito a del controllo ufficiale siano in grado di analizzare ri elencati nel programma comunitario coordinato l Regolamento CE 396/2005).

Member state response

ota alle Regioni/Province con l'invito a del controllo ufficiale tengano conto delle di e le procedure di controllo della qualità per fitosanitari in alimenti e mangimi (linea guida già provveduto, con nota del 19 maggio lle Regioni/Province, dell'Istituto superiore di ento nazionale sull'applicazione della suddetta

Member state response

nota alle Regioni/Province con l'invito a ego dei PPP vengano effettuati in base ad una egolamento (CE) n.882/2004) e in particolare ei propri controlli effettuati presso gli utilizzatori zione che indichi un'eventuale non conformità, ivi Page: 3 -6277-MR of an audit carried out Action Proposed by the Competent Authority eseguiti nel quadro dei regimi di sostegno nel settore.

Member state response

ite azioni per garantire un migliore involte (Regioni/Province, il Comando lute e l'Ispettorato centrale della tutela della qualità ri) affinché i controlli siano più ili (articolo 4 del Regolamento CE n. 882/2004). una nota al "Coordinamento Gruppo di tà veterinaria e sicurezza alimentare". Page: 4 -6277-MR of an audit carried out ction Proposed by the Competent Authority

Member state response

4 (6)] adottato dalle AC, è stato sviluppato in 677/CE, non vincolante per gli stati ssi dalla Commissione nel corso degli specifici ella necessità di assicurare una adeguata copertura isto dalla suddetta Decisione, senza ritenere di dover si dell'art. 4 (6) per ognuna di esse, tenuto conto ta un vincolo in tal senso. he nel contesto della soddisfazione dei requisiti /2004 l'attività di audit svolta dall'ACC sui n sanità pubblica veterinaria e sicurezza degli ha registrato un deciso incremento interessando 16 iò è stato dovuto sostanzialmente alla nanziarie, procedure e check-lists per tale attività, ivi di aggiornamento per gli auditor, alla attività di in merito all'attuazione del programma annuale di t svolta dalle Regioni, l'Ufficio IX DGSAF ha lusso informativo per la rilevazione di tale attività di ordinamento ed il monitoraggio di detta attività. venute abbiamo registrato un incremento e Regioni, raggiungendo un buon livello di attuazione 4(6) Regolamento(CE) 882/2004. Page: 5 -6277-MR of an audit carried out Action Proposed by the Competent Authority lo di audit, ed in particolare negli audit di sistema, l sistema di controllo ufficiale delle autorità ca della ricognizione

Member state response

er to ensure that the list of establishments approved under the SINTESI system is constantly updated: The CCA sent the category associations an official communication about the main non- onformities identified and the "technical details with a bearing on the main list and the lists of establishments approved for the production of foods of animal origin with a view to providing a reference instrument with a for correct notification of activities for which approval is required. See the enclosed e-mails. 2) The CCA will send an official communication to the Regions by 31 January 2013, asking them to put regional procedures in place or, where appropriate, to review existing procedures, for the official control of the areas covered by the recommendation to be made by June 2013 (e.g. checklist for the supervision and verification of correct updating of SINTESI, the checklist for correct sampling and use of the method provided for in Regulation (EC) No 2073, checklist for verifying the match between the labelling of MSM and the ingredients used). 3) The CCA will verify these aspects in the course of the audits planned for 2013;

Member state response

CCA will send an official communication asking the Regions to transpose and implement the guidelines on the criteria for identifying non-conformities in establishment sin the meat and milk sector and checks on the completeness and effectiveness of the corrective measures adopted by the food business operator" approved in CSR on 25 July 2012. These guidelines are designed to provide the Regions with uniform instructions for identifying non- ormities and dealing with them (corrective and prescriptive measures, sanctions). In particular, the non-conformities which came to light in the course of the mission on MSM by FVO inspectors were taken into consideration in the various chapters of the guidelines. Page: 1 esponse received 7 January 2013 e Competent Authorities of Italy on 20 February in response to Report ref. om 03 to 11 September 2012 in order to evaluate the control system in place governing y 31 January 2013, Emilia Romagna intends to develop a regional plan for improving rvisory activities by local health units (ASLs) in order to ensure that official controls sfy the appropriateness and effectiveness required by Article 8 (3) of Regulation 2004.

Member state response

e NC encountered in the establishments which were visited as part of the FVO audit subject of appropriate orders by the CA at local level and their resolution within the deadlines has been documented. See the enclosed e-mails. See the reply to Recommendation No 3

Member state response

measure proposed in Recommendation No 1, points 2 and 3.

Member state response

13, the CCA (the Central Inspectorate for Quality and the Fight Against Contraband F) of the Ministry of Agricultural, Food and Forest Policies), which, among other ngs, is responsible for labelling, will carry out official controls, at retail level, on arations based on fresh pork and chicken (hamburgers, fresh sausages, etc.) in order to k the match with the labelling systems, partly with a view to ascertaining the thresholds fat and connective tissue. ee the proposed measure in Recommendation No 1, points 2 and 3. Page: 2

Member state response

dendum 2013" to the PNAA a specific paragraph on feed establishments will be added. It will focus on ttribution of a risk score to FBO in order to ls and to optimize the human and financial ragraph regarding the risk rating of farmers, in ill be inserted together with a practical tool for high, medium and low risk). isk-rating of the feed establishment will be a tion to be evaluated in the AUDITs planned f Reg.(EC) 882/04, on the regional competent l controls on feed.

In the coming "Addendum 2013" to the PNAA 05/04/2013: ols on a specific paragraph on the risk rating of the Please specify the date of entry into force of -based, feed establishments will be added. It will focus the content of the Addendum 2013. n (EC) on the importance of the attribution of a risk score to FBO in order to perform official The Addendum 2013 came into force on 28 controls and to optimize the human and May 2013. financial resources. Relevant amendments in relation to Rec.1 Moreover, a specific paragraph regarding the are: risk rating of farmers, in relation to the feed, 1. Amendment to paragraph will be inserted together with a practical tool for "Sopralluoghi ispettivi o ispezioni" attributing the score (high, medium and low on pag 6 of the Addendum 1/2013 risk). 2. New entry of annex 9- bis " The completion of the risk-rating of the feed "Potenziamento del controllo establishment will be a point of specific ufficiale nelle aziende zootecniche" attention to be evaluated in the AUDITs on page 56 of the Addendum 1/2013 planned according to art.4.6. of Reg.(EC) 882/04, on the regional competent authorities for official controls on feed.

Member state response

ndum 2013" to the PNAA will be inserted a specific ed drying process and to the risk criteria linked to this or not); he complete drying; ipments and burners. tion check list of the PNAA, for activity other , will be implemented with the evaluation of or the dryers of feed regarding maintenance, Page: 1 document can be found as an annex at: p_details_en.cfm?rep_id=3061 )/2012-6492-MR of an audit carried out hazards and management of risks along the feed Action Proposed by the Competent Authority f the parameters of the process

ys take In the coming "Addendum 2013" to the PNAA 05/04/2013: ties and will be inserted a specific reference to the feed Please specify the date of entry into force of: of feed drying process and to the risk criteria linked to a) the content of the Addendum 2013 and b) ed by this specific activity. the updated check-list. 004. · Drying process (direct or not); Page: 1 Action Plan received from CA 14 June 2013 - documents referred to can be found in a separate annex at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3061 d by the Competent Authorities of Italy on 08 April in response to Report ref. DG(SANCO)/2012- 30 November 2012 in order to evaluate measures in place for the identification of hazards and Action Proposed by the Competent Authority FVO Comment · Quality of the fuel; The Addendum 2013came into force on 28 · Ability to guarantee the complete drying; May 2013. · Maintenance of the equipments and burners. Relevant amendments in relation to Rec.2 Furthermore, the inspection check list of the are: PNAA, for activity other than primary 1. Amendment to paragraph production, will be implemented with the "Sopralluoghi ispettivi o ispezioni" evaluation of specific requ

Member state response

udit 2012/6492 the MH issued a specific egions and Autonomous Provinces (prot.309 ng measures for managing carry-over and cross hese procedures by the officials. hat, in order to verify the possible y drugs in non ­ target feed, the argeted on the fist batch of feed of coccidiostats. " to the PNAA, will focus of FBOs to be selected for the sporting or storing medicated

er takes Following the FVO audit 2012/6492 the MH Satisfactory n by issued a specific 004, instructions to the Regions and Autonomous esidues Provinces (prot.309 et 09/01/2013), regarding measures for managing carry-over and cross-contamination and the verification of these procedures by the officials. In this instruction is clearly stated that, in order to verify the possible presence of coccidiostats Page: 2 Action Plan received from CA 14 June 2013 - documents referred to can be found in a separate annex at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3061 d by the Competent Authorities of Italy on 08 April in response to Report ref. DG(SANCO)/2012- 30 November 2012 in order to evaluate measures in place for the identification of hazards and Action Proposed by the Competent Authority FVO Comment and veterinary drugs in non - target feed, the official sampling has to be correctly targeted on the fist batch of feed produced after a medication/integration of coccidiostats. In addiction, the coming "Addendum 2013" to the PNAA, will focus also on this issue and to the typology of FBOs to be selected for the official sampling (FBOs producing, transporting or storing medicat

Member state response

tivity will be planned on managing of carry over and m veterinary drugs and coccidiostats in feed. rovided by the CCA in cooperation with the . Page: 2 document can be found as an annex at: _details_en.cfm?rep_id=3061 )/2012-6492-MR of an audit carried out hazards and management of risks along the feed Action Proposed by the Competent Authority ming "Addendum 2013" to the PNAA will give the egions to organize specific training activity at or both officials and FBOs e verified in the AUDITs planned according to 882/04, on the regional competent authorities for feed.

place Specific training activity will be planned on 05/04/2013: of managing of carry over and cross- Please note that the operators visited, in to a) contamination from veterinary drugs and particular one of them, were already aware of els coccidiostats in feed. This activity will be the situation concerning carry-over in their rning provided by the CCA in cooperation with the plants, including the different options to for official laboratories. manage it, i.e. measures to reduce it ross- In addiction, the coming "Addendum 2013" to sufficiently to comply with the relevant legal the PNAA will give the instruction to the requirements. The problem detected during Regions to organize specific training activity at the audit concerned rather the lack of territorial level, for both officials and FBOs implementation of the said measures by This activity will be verified in the AUDITs operators and the lack of enforcement thereof planned according to by official services. Please propose measures art.4.6. of Reg.(EC) 882/04, on the regional and deadlines to address the said problem. Page: 3 Action Plan received from CA 14 June 2013 - documents referred to can be found in a separate annex at:

Member state response

2013" to the PNAA will give the instruction to ize specific training activity at territorial level, for BOs e verified in the AUDITs planned according to 882/04, on the regional competent authorities for feed.

down The coming "Addendum 2013" to the PNAA 05/04/2013: Page: 5 Action Plan received from CA 14 June 2013 - documents referred to can be found in a separate annex at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3061 d by the Competent Authorities of Italy on 08 April in response to Report ref. DG(SANCO)/2012- 30 November 2012 in order to evaluate measures in place for the identification of hazards and Action Proposed by the Competent Authority FVO Comment will give the instruction to the Regions to Please specify the proposed date for such organize specific training activity at territorial training. ith level, for both officials and FBOs. This activity will be verified in the AUDITs Please see letter DGSAF 8957 of 3/05/2013: planned according to attached. art.4.6. of Reg.(EC) 882/04, on the regional Whit this document the MH has given competent authorities for official controls on emphasis to the shortcoming detected during feed. the AUDIT 2012/6492, also in relation to undesirable substances (Dir. 2002/32) and their monitoring in the feed business. Moreover, it has forced the Regions/PA to organize within the year 2013, (if necessary in cooperation with the MH), specifi

Member state response

2013" to the PNAA will be integrated with a hazard analysis and its link to the internal l measures. on check list of the PNAA, for activity other ion, will be implemented with the evaluation of this the HACCP based procedures. Page: 3 rom CA on 5 April 2013 - embedded document can be found as an annex at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3061 )/2012-6492-MR of an audit carried out hazards and management of risks along the feed nclusions page 9), the coming "Addendum 2013" to the ke corrective actions in case of non-compliances in ria to be evaluated during the inspections in the feed mean of the Addendum 2013. ed by the Regions and autonomous Provinces to the icinal effect, icated in the relevant authorising legal act or in the

with The coming "Addendum 2013" to the PNAA 05/04/2013: s will be integrated with a specific mention to the Please specify the date of entry into force of: d hazard analysis and its link to the internal a) the content of the Addendum 2013 and b) n sampling plans and control measures. the updated check-list. gards Furthermore, the inspection check list of the PN to AA, for activity other than primary production, The Addendum 2013 came into force on 28 wed will be implemented with the evaluation of this May 2013. specific criteria of the HACCP based Relevant amendments in relation to Rec. 6 procedures. are: 3. Amendment of paragraph "L'autocontrollo nel settore mangimistico" pag 10 of the Addendum 1/2013 4. Amendment of the check list: Activity 7 - Attività diverse dalla produzione primaria di mangimi e attività correlate (art. 5 comma 2 Reg.(CE) n. 183/05) at pages 43- 45 of the Addendum 1/2013 Page: 7 Action Plan received from CA 14 June 2013 - documents referred to can be found in a separate annex at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3061 d by the Competent Authorities of Italy on 08 April in response to Report ref. DG(SANCO)/2012- 30 November 2012 in order t

Member state response

e taken The Competent Authority has requested to all Update received 7 September 2012 es BIPs where non compliance have been found hat all out to forward an action plan aimed at removing A verification procedure has been th all criticalities found out. Consequently all BIPs implemented: it is based on a specific have activated at local level involving also spreadsheet of all deficiencies found during inerested institutions and have carried out the FVO/ACC audit with automatic function meetings where proposal for the adjustment of of warning when the time is exceeded facilities have been created. It has been shown (attached file). the intention to remove all deficiencies found Monitoring of implementing actions will take out in any BIP and any specific cases and the place every two months or quarterly keeping possibility to build new operative and as reference point the timing established by multifuncional structures ( related to Single Commission Decision 2001/812/EC. Window)have been evaluated. At central level In case of ascertained failure by the involved the monitoring of proposal at BIPs and the agencies, according to the procedure, an timetable for their implementation is ong

Member state response

The central CA should ensure that official controls Con l'Accordo Stato Regioni del 7 febbraio 2013 sono state Entro dicembre 2013 of live bivalve molluscs are properly implemented approvate le "linee guida per il funzionamento ed il istituzione del "Tavolo by the regional CAs in all Italian regions. The miglioramento dell'attività di controllo ufficiale da parte del tecnico di central CA should also ensure efficient and effective Ministero della salute, delle Regioni e Province autonome e coordinamento" Ministero coordination and cooperation between CAs as delle AASSLL in materia di sicurezza degli alimenti e sanità -Regioni required under Article 4.5 of Regulation (EC) No pubblica veterinaria." Con dette linee guida si forniscono, tra 882/2004 l'altro, istruzioni per lo svolgimento di audit da parte di tutte Organizzazione della le Regioni. prima riunione tecnica entro giugno 2013 Al fine di monitorare l'attuazione dell'Accordo e di migliorare il coordinamento e la cooperazione tra le Autorità competenti verrà istuito formalmente, presso il Ministero della salute, un "Tavolo tecnico di coordinamento" composto Valutazione piani entro dicembre 2013 da 3 rappresentanti del Ministero

Member state response

The CAs should ensure that the requirements Il ministero ha diramato in data 07 novembre 2012 che si regarding sanitary surveys of Point A.6. of Chapter allega una nota alle regioni sulle principali criticità II of Annex II to Regulation (EC) No 854/2004 are evidenziate nel corso dell'audit FVO. taken into account in newly classified areas and when necessary for reclassification of areas Annex 1. Controllo ufficiale in atto sulla produzione e l'immissione sul mercato dei molluschi bivalvi i gastropodi In data 19 marzo 2013 il ministero ha convocato le regioni per discutere delle criticità del controllo ufficiale sul settore Page: 2 ANNEX Response of the Competent Authorities of Italy to the recommendations of Report ref. DG(SANCO)/2012-6542-MR of an audit carried out from 16 to 26 October 2012 in order to evaluate the control systems in place governing the production and placing on the market of bivalve molluscs N°. Recommendation Piano d'azione Tempistica MBV e delle raccomandazioni formulate dall'FVO, come già segnalato alla Commissione (nota allegata). Annex 2. Missione SANCO/2012-6542 ­ Sistemi di controllo che disciplinano la produzione e la commercializzazione di molluschi bi

Member state response

The CAs should ensure that, when classifying a Nella riunione del 19 marzo 2013 le regioni si sono Con comunicazione al production area, the geographical distribution of the impegnate a verificare che in tutte le aree classificate i punti ministero entro il mese di sampling points ensures that the results of the di campionamento siano rappresentativi e correttamente gennaio 2014 analysis are as representative as possible for the area identificati con coordinate geografiche. concerned in accordance with the requirements established in Point A.6. (d) of Chapter II of Annex II to Regulation (EC) No 854/2004

Member state response

The CAs should ensure that, when monitoring a Le regioni sono state sollecitate con nota n. 37208 del 07 Entro il mese di gennaio production area, the geographical distribution of the novembre 2012 a verificare il rispetto da parte delle Autorità 2014 le regioni sampling points and the sampling frequency ensures Competenti Locali (ACL) delle frequenze previste dai piani comunicano al Ministero that the results of the analysis are as representative di monitoraggio regionali e dalla normativa comunitaria. della Salute i risultati della as possible for the area concerned in accordance Vedi nota allegata a raccomandazione 2. supervisione sulle ACL. with the requirements established in Point B.2 of Chapter II of Annex II to Regulation (EC) No Le regioni verificheranno trimestralmente il rispetto da parte Audit ministeriali per la 854/2004 dell'ACL delle frequenze stabilite. verifica di quanto stabilito Il ministero con l'ausilio del gruppo tecnico per la valutazione dei piani di monitoraggio costituito dai centri di referenza Tutti i piani entro il 2013 nazionali valuterà tutti i piani delle regioni. Annex 3 Valutazione dei piani regionali di monitoraggio Page: 4 ANNEX Response of the C

Member state response

The CAs should ensure that, when monitoring L'esperienza acquisita dimostra che il numero di cellule di classified production areas, the sampling plan to fitoplancton potenzialmente tossico non sempre è check for the presence of toxin-producing plankton direttamente correlato con la presenza di biotossine marine in production water must take particular account of nei molluschi bivalvi. Dati storici relativi ai monitoraggi nelle possible variations in the presence of plankton aree di produzione italiane dimostrano infatti che a volte si containing marine biotoxins and that when changes possono rilevare concentrazioni elevate di microalghe in the composition of plankton containing toxins potenzialmente tossiche nelle acque, ma non viene riscontrata suggest an accumulation of toxins in molluscan contaminazione nei molluschi e viceversa, data anche la flesh, the sampling frequency of molluscs is to be persistenza di alcune biotossine nella polpa dei molluschi (1). increased, as established in Point B.4 and 7 of Anche la disomogenea distribuzione spazio-temporale delle Chapter II of Annex II to Regulation (EC) No specie fitoplanctoniche tossiche può esercitare un ruolo 854/2004 importan

Member state response

The CAs should ensure that, the sampling frequency Le regioni verificheranno con audit e flusso dati trimestrale il for biotoxins analyses in all species of molluscs and rispetto delle frequenze di campionamento per biotossine. marine gastropods is in line with Point B.5 of Il ministero nel tavolo tecnico di valutazione dei piani di Chapter II of Annex II to Regulation (EC) No monitoraggio e con audit di settore verificherà il rispetto di 854/2004 quanto previsto dalla norma.

Member state response

d Regarding the procedures to verify the effectiveness of official controls as required by article 8 (3) of Regulation (EC) 882/2004, a joint initiative of the Ministry and the Regions is being adopted. In the context of the in document on Operational Standards for Competent Authorities and related audit systems ("Criteria for the operation and the improvement of official control activities carried out by Ministry of health, the Regions and Autonomous Provinces and AASSLL on Food Safety and Veterinary Public Health") the national procedure has been defined to verify the effectiveness of official controls in all areas of activity (food and feed safety, animal health and welfare). This procedure is expected to ensure uniform actions throughout the national territory and the various areas of activity. Currently this document is pending approval.

Member state response

Il Ministero della salute, con l'ausilio del Centro di Referenza Nazionale g di Brescia, provvederà a formulare entro la fine di ottobre del corrente , can anno procedure documentate per effettuare una valutazione dei posatoi per le galline ovaiole, a norma dell'articolo 4, paragrafo1, lettera d) e articolo 6, paragrafo1, lettera d) della direttiva 1999/74/CE.

Member state response

ella Legge Comunitaria 2011, in fase di approvazione, è stato inserito , un emendamento che conferisce al governo la delega per il riordino della disciplina sanzionatoria in materia di protezione delle galline ovaiole, con il quale si provvederà ad attuare la modifica dell'articolo 7 del Decreto Legislativo 267/2003 con cui si rafforza l'apparato sanzionatorio per renderlo più efficace, proporzionato e dissuasivo ed il cui schema di modifica è già stato condiviso con le Regioni. Page: 1 ons of Report ref. DG(SANCO)/2011-6048-MR of an audit carried out n of controls for animal welfare on farms and during transport Action Proposed by the Competent Authority

Member state response

Il Ministero della salute in qualità di ACC ha immediatamente adottato by un programma d'ispezione che ha previsto nel periodo 01/01/2012- 29/02/2012 la ricognizione di tutti gli allevamenti di galline ovaiole sul territorio nazionale da parte dei veterinari ufficiali delle AUSL. I dati di tale programma ispettivo sono stati assemblati ed analizzati a fine marzo del corrente anno e già trasmessi ala Commissione europea nell'ambito delle "osservazioni" alla procedura d'infrazione 2231/2011. Un secondo ciclo ispettivo è previsto che inizi a fine luglio 2012 e nel contempo sta per essere emanata una nota circolare che chiarisce l'illegittimità assoluta degli accasamenti in gabbie non arricchite e chiarisce altresì che il programma di adeguamento adottato dal MIPAAF non estende in alcun modo la data ultima di divieto per le gabbie non arricchite.

Member state response

Il Ministero della salute in collaborazione con il Centro di Referenza Nazionale sul Benessere Animale di Brescia metterà a punto, entro w. ottobre del corrente anno, un piano d'azione per scoraggiare la pratica e della muta forzata. ve

Member state response

trols In order to ensure the verification of the ut in controls performed at Italian BIPs. It is currently in progress the improvement of the ation system of verification by ACC. In particular the the ACC has analyzed the deficiencies found out are and has taken actions to promote the to implementation of a documented procedure for om the verification of crisis points in control activities, included those regarding training. Office VIII will collect the procedures of the single BIPs and they will be evaluated and used as focus in a WG with the main BIPs for the writing of a national procedure that will be enclosed in the guidelines. Implementation time: end of July 2012

Member state response

taken Verifications of critical points and corrective Update received from CA 6 September 2012 s actions carried out by the single BIPs in all b) of controls fields will be quarterly collected and Risposta ai commenti FVO evaluated by ACC through an evaluation Il Dipartimento del Ministero della salute sta udits questionnaire. During the periodical audits valutando come intervenire per dare una tion carried out by the ACC at BIPs the answers coerente applicazione all'art.4(6) del hat provided in the questionnaire will be subject to reg.882/04, come richiesto dagli ispettori Page: 1 Updated Action Plan received from CA 6 September 2012 by the Competent Authorities of Italy on 10 April in response to Report ref. DG(SANCO)/2011- ember to 02 December 2011 in order to evaluate the follow-up action taken by the Competent it control system and border inspection posts Action Proposed by the Competent Authority Updated Action Proposed by the Competent Authority t with verification. comunitari, permanendo ancora dei dubbi di Implementation time: end of July 2012 natura giuridica sull'interpretazione del Please note that concrete options for addressing medesimo articolo. Sarà cura del indepen

Member state response

surveillance system that establishes some specific audit and inspection missions to carry in out at BIPs facilities has been already e implemented. Moreover, following the last taly. mission that FVO has carried out at the BIP (DG SANCO) 2011-8964, it is currently in progress the improvement of a verification system on equipment and procedures to be implemented at BIPs local level. Monitoring of the maintenance of requirements for specific categories of authorization will be added in the evaluation questionnaire. Since 2011 the system of performance Page: 3 Updated Action Plan received from CA 6 September 2012 by the Competent Authorities of Italy on 10 April in response to Report ref. DG(SANCO)/2011- ember to 02 December 2011 in order to evaluate the follow-up action taken by the Competent it control system and border inspection posts oposed by the Competent Authority Updated Action Proposed by the Competent Authority n of technical and administrative of the Ministry of Health also includes indicators of quality for staff employed with particular regar to the sampling s of the for laboratory checks tion of compliance with percentages ed by monitoring plan) and the proper maintenan