Cyprus

The recommendation states as its basis

The VS has an internal audit system, and the fishery sector was covered in 2013. The VS monitors the implementation of the official control plans by receiving the completed checklists and the DVOs' reports every six and twelve months. When serious non- compliances at operators are detected, joint inspections can be carried out, but in these cases, evaluation of the performance of the individual officers is not included. The aforementioned tools are not adequate to allow the CA to have an overview of the effectiveness and appropriateness of the controls as set out in Article 5(1)(a) of Regulation (EU) 2017/625. Additionally, the VS does not have in place control verification procedures in line with Article 12(2) of Regulation (EU) 2017/625. Conclusions on competent authorities

The lack of verification mechanism leaves the VS unaware of the real effectiveness and appropriateness of controls carried out and the compliance level of operators in the fishery sector as identified, among other things, during the previous DG SANTE audits on the same topic.

The audit team reviewed the approvals of several on-land establishments and noted that in general the procedure described above was followed. However, the timelines between conditional and final approvals were not always respected and exceeded a total of six months. This is not in line with Article 148(4) of Regulation (EU) 2017/625. The audit team noted that when new premises were built to replace the old one, in the same location with the same activity, there was not a new approval carried out. According to the CA, the current national approval procedure is not clear in this kind of case.

The procedure described above is not in line with Article 148(4) of Regulation (EU) 2017/625, which requires that after three months, the CA must either extend the conditional approval (for a period not exceeding a total of six months) or issue a final approval. The exception (i.e. the possibility to extend conditional approval to a total of 12 months) applies only to factory and freezer vessels.

The audit team noted that even the current procedure is not always followed with regard to the deadlines set: one of the RVs was conditionally approved in 2020 and has not yet been granted with a final approval.

The procedures adopted to approve operators are broadly in line with the applicable EU legislation, except for RVs. Additionally, the timelines related to conditional approvals are not always respected and may be extended beyond the deadlines foreseen in EU rules allowing operators to carry out activities without not meeting all requirements.

The audit team carried out a desk-based assessment of the documented controls over RVs. The planned inspection frequency has not been respected and was consequently extended to six years instead of four years. The audit team noted that HACCP plans did not cover all relevant areas e.g. temperatures in the holds and fishery product traceability.

HACCP-based procedures are assessed by the central level at the time of approval. The DVO officials explained that they only check recordings and sampling by the operator related to HACCP and they do not review the HACCP plans themselves during inspections. Consequently, none of the reports included remarks of any non-compliances 9 in the operators' HACCP plans (see findings in paragraphs 49 and 50 on HACCP non- compliances).

The audit team noted that in many cases the operators had used external consultants to produce their HACCP plans. When reviewing the plans, the audit team noted discrepancies in relation to current processes and EU legislation. Furthermore, the HACCP plans were not always updated, when changes in activities and/or equipment occurred.

The audit team noted that in many cases HACCP hazard analysis did not include all possible hazards (no physical and chemical hazards included), critical control points had critical limits (temperatures) not in line with EU rules, monitoring of critical limits was not adequately determined, and in case of failures to comply with a critical limit (mainly related to temperatures of frozen fishery products), adequate corrective actions were not defined properly. When questioned, the operators did not have knowledge and ownership over their HACCP plans.

In addition to the findings related to HACCP-based procedures, the audit team noted non- compliances in many other areas, which were either not covered during official controls or, if checked, non-compliances were not detected and/or not recorded in the reports (see below paragraphs 52 - 59). The audit team did not find any evidence of enforcement measures used as defined in Articles 137 and 138 of Regulation (EU) 2017/625. When questioned, the officials explained that due to the good cooperation with the operators, and because the use of enforcement measures is too much workload and time consuming, there has not been willingness to take measures. Unfortunately, many of the findings in this report are a repetition of the findings made during the previous DG SANTE audits in Cyprus for fishery products showing that the official control system has systematically failed to adequately implement official controls contrary to requirements in Article 5(1)(a) and (b) of Regulation (EU) 2017/625.

Regarding non-compliances in the cold chain, the audit team noted the following during the visits: storage temperature records for chambers with frozen fishery products showed consistently temperatures above -18, temperature recording devices were not in place, not properly recording or not in a place where it can be easily read, locations of temperature sensors were unknown or not situated in the area of the highest temperature, temperatures measured from frozen fishery products were above the EU limits (starting from -12) and cold chambers with products stored up to the doors preventing access and proper air circulation. Those non compliances were not identified by the operators and the officials during inspections.

Freezing of fishery products was carried out for whole wrapped fish, such as tuna, in a cold store with no criteria for rapid freezing and/or controlling the freezing process. In another case, fishery products frozen two weeks ago were found to have a core temperature of -12, while the temperature recording display showed -23 (at the time of the visit the blast freezer was used as a storage facility for polystyrene boxes). 10

Significant non-compliances in general hygiene were noted in areas where chilled fresh fish was processed as well as the excessive use of water resulting in spillage to floor instead of being directing to a drain. The audit team noted condensation above unprotected fishery products. In one case, bins used for the transport of farmed fish were dirty and had a bad odour as they were only flushed briefly after use and then stored outside at high ambient temperature waiting to be washed later before use. These bins (washed and filled with some ice), were still dirty. Officials were unaware of this situation.

Maintenance issues, some significant, were detected in several premises. In some cases, it was explained to the audit team that verbal orders have been given, and some corrective actions had been taken by the operators.

Deficiencies in pest control were noted due to the gaps around doors and fans. Live ants and flies were detected in some establishments.

Traceability was not ensured when fishery products were found in cold storage without any labels. During one traceability exercise, the operator was not able to show evidence of the origin of the raw material.

Hygiene of water was not ensured when seawater, added to bins with ice, was taken from the dock. In addition, the ice machine checked by the audit team was rusty, the room had dirty walls and ceiling and the process of loading ice into transport bins was unhygienic. In another case, the water treatment system with an ultraviolet lamp for river water had not been maintained since 2010. In addition, the analysis did not include all relevant chemical parameters.

The audit team identified non-compliances on the labelling of fishery products with regard to identification marking, mandatory information of origin, references to aquaculture/wild catch, latin names of species, storage temperatures, and when relevant, a warning on potential gastrointestinal effects of consuming oilfish (Ruvettus pretiosus). Conclusions on official controls on the production and placing on the market

Official controls as implemented are not identifying and/or recording a range of readily apparent non-compliances in HACCP based plans, maintenance, hygiene, cold chain, pest control, traceability and labelling. Additionally, when non-compliances are detected, the CA is reluctant to use enforcement measures.

In the absence of on-the-spot verification of officials' performance when carrying out official controls, the VS is not aware of the situation described above, and that official 11 controls, as systematically inadequately implemented, cannot ensure the compliance of operators and processing of fishery products with food safety requirements as already noted during the previous DG SANTE audits on the same topic. 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

Vessels below 12 meters in length belonging to categories A and B are currently not included in the annual control plans. This is not in line with Article 67(b) of Implementing Regulation (EU) 2019/627. The VS informed the audit team that they have been excluded 8 from the controls mainly due to lack of resources, difficulty to reach the vessels and they do not need a certificate of compliance to operate. The VS added that they can be inspected on a random basis, if available and if an inspection to a landing site takes place (see paragraph 43). During an on-site visit to one landing site, two such vessels came back from a fishing trip. The DVO official inspected these vessels and detected the same non- compliances noted by the audit team (the reuse of polystyrene boxes, insufficient amount of ice, lack of cleanliness and absence of protection from the sun).

Based on information provided, controls of landing sites have not been planned and consequently not carried out since 2020. This is not in line with Article 67(a) of Implementing Regulation (EU) 2019/627.

The official control system covers land-based establishments, aquaculture farms and to some extent, RVs and primary production fishing vessels above 12 meters in length. Official controls are performed using documented procedures covering the required aspects. However, landing sites and primary production fishing vessels below 12 meters in length are omitted from the official control planning and, thus a significant proportion of the production chain is not subject to official controls.

The recommendation states as its basis

This Law empowers inspectors from the LCS to access any property, including private property, for the implementation of the measures listed in the paragraph above. Access can only be granted following the consent of the owner, according to the Constitution of the Republic of Cyprus. Inspectors of the ADOs are empowered to access private property only when they are accompanied by LCS inspectors. 5.1.2 Laboratories

The Plant Protection Laboratory (PPL) has been officially designated by the CA as the national reference laboratory for plant health in Cyprus. Staff of the PPL informed the audit team that the laboratory has participated in proficiency tests organised by the EU Reference laboratory with positive results. However, it is not accredited in accordance with the EN ISO/IEC 17025 standard. Therefore, the designation is not in line with Article 100(2) of Regulation (EU) 2017/625.

The recommendation states as its basis

In chapter 14 of the action plan, it establishes for the survey of the pest free areas (PFAs), that a sample from five to ten non-adjacent plots of main host plants per municipality/community outside of the DAs shall be taken by each of the LCS and ADO offices. Chapter 15 of the action plan details that in each plot, surveillance shall consist of the visual examination of 10 to 20% of the plants selected in a "zig-zag" pattern. This procedure does not consider surveillance in commercial operators of secondary host plants, non-agricultural plant species (in particular on squirting cucumber plants), nor in non-commercial plots (family orchards), contrary to European Food Safety Authority (EFSA) recommendations for detection surveys for non-EU Tephritidae3 (see paragraph 29). This is not in line with Article 22(1) and (2) of Regulation (EU) 2016/2031 that requires that surveys on Union quarantine pests shall be risk-based, carried out in all appropriate locations used by professional operators and other persons, and based on sound scientific and technical principles. Conclusion on the action plan

Following this initial demarcation, the audit team was informed by LCS and ADO officers that they survey other professional operators in the BZ which was demarcated as the area within 2km distance from this initial IZ. The extent of demarcation for this BZ is in line with the pathways for movement of D. ciliatus as published on the EPPO website4. It is also appropriate in view of the risk of the pest spreading out of the infested zone, in line with Article 18(3) of Regulation (EU) 2016/2031. However, survey activities were carried out neither on non-commercial growers nor on wild plants of squirting cucumber, in most cases. Therefore, the implementation of the delimiting survey is not in line with Article 22 (1) and (2) of Regulation (EU) 2016/2031 which requires that surveys shall be risk-based, carried out in all appropriate locations used by professional operators and other persons, and based on sound scientific and technical principles.

According to the information reported by the CA during the remote meetings of the audit, the total area surveyed in 2024 for the main four host plants were 62.78 ha of which, the presence of D. ciliatus was detected in 25.76 ha. The area surveyed, compared to the average area planted with main host plants (see section 4.3, Table 1), represent less than 10% of the area occupied by cultivated main host of D. ciliatus (see paragraph 29). The CA did not have reliable data on the secondary and wild hosts area surveyed (See paragraph 27). This is not in line with Article 22(1) and (2) of Regulation (EU) 2016/2031 (see paragraphs 18 and 21).

The recommendation states as its basis

According to the information reported by the CA during the remote meetings of the audit, the total area surveyed in 2024 for the main four host plants were 62.78 ha of which, the presence of D. ciliatus was detected in 25.76 ha. The area surveyed, compared to the average area planted with main host plants (see section 4.3, Table 1), represent less than 10% of the area occupied by cultivated main host of D. ciliatus (see paragraph 29). The CA did not have reliable data on the secondary and wild hosts area surveyed (See paragraph 27). This is not in line with Article 22(1) and (2) of Regulation (EU) 2016/2031 (see paragraphs 18 and 21).

During the field assessments, staff from Ammochostos ADO and LCS informed the PHMSAPS that in this district, about 95% of main host producers and many secondary host plots were surveyed during the 2024 season. In the Larnaca District, officials from the ADO and LCS units informed the audit team that out of the five cultivation cycles of cucumbers per year, between two and three of these cycles per professional growers were surveyed in 2024. Officials also implemented some surveys on secondary host crops (see section 4.6) when present in the same professional operator farm.

During discussions between the LCS and ADO in the districts of Ammochostos, Larnaca and Limassol, the audit team verified that some of this information was kept in field books and not uploaded timely during the 2024 season. In the case of Ammochostos district, some of this information was reported by the LCS official to the PHMSAPS office by phone and not transferred to the spread sheets of the CA until the end of the audit (see paragraph 29). These delays in the survey data reporting represent weaknesses in the coordination and cooperation between the Units of the CA. Furthermore, this 9 practice is not in line with the requirements of point 12 (IV) of the action plan against D. ciliatus. The action plan requires that the results of the surveys and trap catches shall be uploaded by the LCS liaison offices on spread sheets located on the IT servers of the PHMSAPS. This task shall be completed before the end of the following working day (see paragraph 13, verification of procedures). This is not in line with Article 5(1)(a) and (5) of Regulation (EU) 2017/625 which, requires that when more than one unit is competent to perform official controls or other official activities, eefficient and effective coordination and cooperation shall be ensured between the different units within a CA.

This lack of up-to-date information concerning the surveys has a strong impact on the capacity of the CA to to immediately communicate the DAs to the Commission and MS.

By the end of the audit and based on the survey information collected by the district Units during 2024, the CA provided the audit team with updated information on the area surveyed for the main host plants during this year. In accordance with this latest information provided by the LCSs, the overall area surveyed of main host plants of D. ciliatus during 2024 was approximately 190 ha, which is equivalent to one quarter of the total area planted with main host crops in 2023 (see section 4.1, table 1). Of this area, D. ciliatus was found in approximately one third of this area (63.8 ha). This data significantly differs from the data reported in update number two of 10 March for Europhyt Outbreak 26245 where, the infested area reported was 25,765 ha. This is neither in line with the immediate establishment of DA as required by Article 18(1) of Regulation (EU) 2016/2031 nor Article 19 (2) of the same which, requires that upon finding the presence of the pest in the buffer zone, the MS concerned shall immediately notify the Commission and the other MS. This practice is not in line either with Article 31(4) of Regulation (EU) 2019/1715 which, requires that contact points shall update the notifications as soon as they have verified any relevant new information that has been made available to them.

According to the EFSA pest survey card6 for Tephritidae, detection surveys should focus mainly on Cucurbitaceae and Solanaceae cultivated as commercial crops and found as ornamentals or cultivated non-commercially in residential areas. Delimiting surveys following a detection could include all Cucurbitaceae and Solanaceae and all other species described as hosts for the detected species, that are found in the surveyed area as crops, ornamentals or naturally occurring wild plants.

The recommendation states as its basis

The eradication measures are listed in Annex III to the action plan and include; · prohibition of movement of infested fruits outside the IZ and their disposal in black plastic bags, 7 https://gd.eppo.int/taxon/DACUCI/datasheet 11 · application of contact insecticides in the plots and weeds in the area up to 10 meters around the infested plot, and · placements of yellow sticky traps or feed traps for mass trapping.

Prior to the issuance of the action plan, LCS and ADO officials provided verbal instructions to professional operators affected by D. ciliatus. The audit team could verify this information during the field assessments and were informed by the professional operators visited that the measures listed in the action plan were immediately implemented in 2024.

The CA stated that all exports of host plants of D. ciliatus are subject to 100% phytosanitary controls by the CA before being exported, and trade to EU destinations outside the island. No non-compliances due to the presence of this pest were reported by the importing country or another MS.

The recommendation states as its basis

Control verification procedure is carried out by two means. Firstly, by the PHMSAPS by remotely checking the information provided by the liaison officers of each LCSs on the CA shared IT files. Secondly, for the on-site control verification procedures of LCS and ADO officials which is to be carried out jointly by the Heads of the PHMSAPS and LCS. However, no such verification has been implemented yet. This is not fully in line with Article 12(2) of Regulation (EU) 2017/625.

During discussions between the LCS and ADO in the districts of Ammochostos, Larnaca and Limassol, the audit team verified that some of this information was kept in field books and not uploaded timely during the 2024 season. In the case of Ammochostos district, some of this information was reported by the LCS official to the PHMSAPS office by phone and not transferred to the spread sheets of the CA until the end of the audit (see paragraph 29). These delays in the survey data reporting represent weaknesses in the coordination and cooperation between the Units of the CA. Furthermore, this 9 practice is not in line with the requirements of point 12 (IV) of the action plan against D. ciliatus. The action plan requires that the results of the surveys and trap catches shall be uploaded by the LCS liaison offices on spread sheets located on the IT servers of the PHMSAPS. This task shall be completed before the end of the following working day (see paragraph 13, verification of procedures). This is not in line with Article 5(1)(a) and (5) of Regulation (EU) 2017/625 which, requires that when more than one unit is competent to perform official controls or other official activities, eefficient and effective coordination and cooperation shall be ensured between the different units within a CA.

The recommendation states as its basis

In cases where PPPs contain candidates for substitution, the CA does not perform comparative assessments, relying instead on evaluations conducted by the MS that authorised the reference PPP product. The audit team expressed concerns that relying on the other MS evaluation is not correct, as safer, equally suitable alternatives may be available in Cyprus, that were not available in the MS that conducted the evaluation. The fact that the CA does not consider performing the comparative assessments, even at the renewal phase, is not in line with article 50(4) of Regulation (EC) No 1107/2009.

However, the authorisation process does not include conducting comparative assessments for PPPs that contain candidates for substitution against alternatives with potentially safer active substances, and emergency authorisations are not immediately notified to the Commission and MSs.

The recommendation states as its basis

However, there was a delay in notifying the Commission and MSs about the granted emergency authorisations. In some instances, notifications were sent several months after the authorisations had been issued, or even after their expiration. This delay is not in 2 https://food.ec.europa.eu/system/files/2023- 03/pesticides_aas_guidance_comparative_assessment_substitution_rev_1107-2009.pdf 7 compliance with article 53 of Regulation (EC) No. 1107/2009. The CA identified the issue as a lack of formal procedure and assigned personnel for this task and has committed to ensuring prompt notification for such decisions in the future. Conclusions on authorisation of plant protection products

However, the authorisation process does not include conducting comparative assessments for PPPs that contain candidates for substitution against alternatives with potentially safer active substances, and emergency authorisations are not immediately notified to the Commission and MSs.

The recommendation states as its basis

Re-packaging activities may involve PPPs imported from non-EU countries for re-export or PPPs from other EU MSs marketed in Cyprus under parallel-trade permits. The CA considers parallel trade a high-risk activity and requires distributors to obtain approval for each movement of PPPs. Additionally, distributors must notify the CA at least three days in advance of any intended re-packaging. The audit team considered this a good practice, as it provides insight into the volume of products entering the Cypriot market and the proportion subject to re-packaging. However, at the time of the audit, this information was not being used to plan controls for re-packaging operators. The absence of regular inspections for an activity considered high-risk is not in accordance with Articles 9(1) and 11 24(1) of Regulation (EU) 2017/625. Planning of official controls on use of PPPs

The results from previous inspections and samples collected by LCS inspectors serve to identify the high-risk crops for the upcoming year's inspection planning. However, there is no specific criteria for selecting operators who grow these high-risk crops, leading to a random selection process. This approach does not fully comply with Articles 9(1) and 24(1) and (2) of Regulation (EU) 2017/625. Moreover, with the low number of inspections, it becomes more important to target operators who may pose the higher risk.

The results of the national pesticide residue programme mentioned in paragraph 27 are not taken into account for the planning of inspections. This is not in line with Article 24(2)(b) of Regulation (EU) 2017/625. The audit team considered that the results that show exceedance of maximum residue levels for authorised PPPs would be relevant for follow-up during inspections, as growers might have either use an excessive amount of PPPs or applied them too close to harvest. Results showing unauthorised use of PPPs are taken into account for the sampling programme, see below.

The relatively high non-compliance rate of samples taken by the LCS (18 out of 79 in 2024) compared to favourable results from formulation analysis (see paragraph 51) suggests that there is a higher risk associated with the misuse of authorised products by growers or the use of illegally traded PPPs (see paragraph 26) than with the marketing of unauthorised PPPs. This is not adequately considered by the CAs when determining the number of inspections at growers, which is significantly less representative than the number carried out at market level.

The recommendation states as its basis

While market operator inspections are generally conducted unannounced, all grower inspections are announced, with growers receiving 3-4 days' notice. The DoA stated that this advance notice is necessary, as growers are often not present on farms. Yet, the audit team found no evidence in the inspection reports to support this necessity, and the CA confirmed that announcements are standard practice rather than exceptions. This is inconsistent with Article 9(4) of Regulation (EU) 2017/625. Moreover, advance notice could compromise inspection effectiveness by allowing operators ample time to alter conditions at their premises, such as removing unauthorised PPPs. Planning of sampling for formulation analyses of PPPs

Official controls at market level are carried out unannounced. However, prior notice is given to growers in all cases, with no justified reason, and long time in advance. This undermines the effectiveness of the inspections.

The recommendation states as its basis

The national legislation includes provisions for the potential withdrawal of certificates. However, at the time of the audit, no procedures were defined for the conditions under which certificates might be withdrawn, and no certificates had yet been withdrawn since the system's implementation. This lack of defined procedures is not in compliance with Article 5(2) of Directive 2009/128/EC, which mandates that certification include criteria and processes for granting, renewing, and withdrawing certificates. Planning of official controls on marketing and distribution of PPPs

There is a certification system implemented to provide training to users, distributors and advisors that overall works well. However, there are no measures foreseen for the withdrawal of certificates as necessary. 5.2.3. Delegation of certain tasks Findings

The recommendation states as its basis

However, at the time of the audit, the laboratory had not yet been accredited to ISO/IEC 17025, which according to article 37(1) and 37(4)(e) of Regulation (EU) 2017/625 is a requirement for the designation of laboratories to carry out analysis of samples of goods taken during official controls.

Furthermore, the laboratory's analysis focuses solely on active substances, without considering unacceptable co-formulants and regulated impurities. This prevents the CA from fully complying with Article 24(1) of Regulation (EU) 2017/625. The CA noted that currently, there are accredited methods for only a few impurities, and this poses a 14 common challenge across all Member States, suggesting that this issue requires discussion and resolution at EU level. Conclusions on laboratories used for formulation analysis of plant protection products as part of official controls

The recommendation states as its basis

The audit team noted that the primary aim of inspections, both at market and user levels, is to verify basic compliance aspects without further thorough verification (see paragraphs 70, 73 and 90). These weaknesses had not been detected by the central CA, as there was no supervision of inspectors' work at the time of this audit. This oversight deficiency does not comply with Articles 5(1) (a) and (b) of Regulation (EU) 2017/625. The CA indicated that a recent internal audit identified this issue and announced plans to initiate supervision activities shortly. Conclusions on the competent authorities

As described in paragraph 42, at the time of the audit, re-packers were not subject to regular inspections. As part of the audit, a visit was made to a re-packer of PPPs for demonstration purposes, allowing the CA to discuss with the audit team the key areas inspectors would focus on during their inspections. The audit team noted that the checklist designed for inspecting this activity generally provides sufficient guidance for ensuring compliance with relevant legislation. However, some aspects, such as the process inspectors should follow to verify the source and quantities of PPPs through invoices, or whether they need to take samples, may require further clarification.

The audit team noted that the checklist used for this inspection contained only one point related to the control of PPPs, specifically the verification of input/output flow. All other checklist items pertained to structural and storage conditions. Inspectors are not required to verify whether the purchased and stored PPPs were authorised or whether operators maintain records of these products for at least five years. The checklist also lacked items related to verifying stocks or ensuring that stored PPPs were labelled in accordance with their authorised conditions. This lack of comprehensive guidance for inspections is not in line with Article 12(1) of Regulation (EU) 2017/625. Additionally, the failure to verify these compliance aspects contravenes Articles 14(b)(i), (ii), (iv), and (e) of Regulation (EU) 2017/625, as well as Articles 65 and 67 of Regulation (EC) No. 1107/2009. Controls at retailers of PPPs

The audit team noted that the basic checks done during the inspections where no samples are taken, are often ineffective in identifying non-compliance issues such as incorrect labelling. For example, inspectors failed to notice errors on the labels of two PPPs. One product´s label lacked usage instructions, while the other, in some packages, had unclear or missing instructions related to a recent restriction of usage only in greenhouses. These superficial checks are not sufficient as to meet the requirement of article 14 (b)(iv) of Regulation (EU) 2017/625, and to verify that the PPPs labels meet the requirement of Article 65 of Regulation (EC) No. 1107/2009.

The recommendation states as its basis

However, the inspectors were not adequately trained and provided with specific tools to properly identify all non-compliances and to register them in the official reports (see paragraphs 52 to 55). PHS

However, the inspectors were not adequately trained and provided with specific tools to properly identify all non-compliances and thus enforce the EU Legislation (see para- graphs 61 to 64). Audit / Supervision

The training systems are not able to deliver specific competency to staff, which has an impact on the implementation of official controls.

Member state response

2024 : 17/6/2024 / . : Page: 1 ref. DG(SANTE) 2024-8038 of the audit carried out from 09 April 2024 to icrobial safety of food of non-animal origin y

Member state response

he PPL is implementing the requirements of the ISO 17025 and is working towards accreditation. The laboratory follows the EPPO protocols for S. frugiperda, D. citri and C. Liberibacter, applies the proper procedures as required by the ISO 17025 and participates in all Proficiency Tests conducted by the European Reference Laboratories.

PPL is implementing the 31 Dec 2024 requirements of the ISO 17025 and is The PPL is working towards accreditation for working towards accreditation. The Xylella fastidiosa on olive tree (matrix) at laboratory follows the EPPO protocols the moment with expected approval date of for S. frugiperda, D. citri and C. accreditation in 2025. However, the Liberibacter, applies the proper laboratory follows the EPPO protocols for procedures as required by the ISO 17025 both Spodoptera frugiperda and HLB, and applies the proper procedures as required by the ISO 17025 and participates in all and participates in all Proficiency Tests Proficiency Tests conducted by the European Reference Laboratories. conducted by the European Reference The DA has prepared an Action Plan for Laboratories. Spodoptera frugiperda. In this action plan eradication measures are detailed.

The recommendation states as its basis

The Plant Protection Laboratory (PPL) is the national reference laboratory (NRL) for plant health for Cyprus. The PPL exchanges information with the CA on the sampling procedure and carries out the examination and analysis of samples required for the identification of S. frugiperda, D. citri and C. Liberibacter. PPL is accredited in accordance with EN ISO/IEC 17025 standard, however methods used for testing for these pests are not within the scope of the accreditation, as required by Article 100(2) of Regulation (EU) 2017/625. The initial positive results concerning both pests presence was confirmed by an EU reference laboratory (EURL). All subsequent testing is carried out by the NRL. 7

Member state response

The CA will reevaluate the actions taken for S. frugiperda, efore the end of the year 2024.

he CA will reevaluate the actions taken 30 Sep 2024 ts for S. frugiperda, before the end of the __ (1) year 2024. Attachment: _ SPODOPTERA F 46, Page: 1 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report ref. DG(SANTE) 2023-7924 of 023 in order to evaluate the situation and controls of plant pest outbreaks on Proposed by the competent authority Proposed action Updated Action Proposed by the competent plan deadline authority

The recommendation states as its basis

The "Contingency plan for the control of C. Liberibacter", is currently in draft format. According to the CA, this document is also considered to serve as the action plan for its control, should the pest be detected in the future. The document includes details about the biology and vectors of the pest, the measures to be taken in case of suspected or confirmed findings of C. Liberibacter and the establishment of DAs and measures to be taken within i.e. destruction of all host plants in nurseries and garden centres and orchards. However, this is not fully in line with the requirements of Article 25 (1), (2) and (4) of Regulation (EU) 2016/2031, requiring contingency plans for priority pests to be adopted by 1 August 2023.

Member state response

A contingency plan for C. Liberibacter has been drawn up in accordance with Article 25 (1) ad (2) of Regulation (EU) 2016/2031. It is currently in the process of being adopted in the form of Order according to national legislation. (estimated date of adoption, summer 2024)

ntingency plan for C. Liberibacter 31 Aug 2024 been drawn up in accordance with A contingency plan for C. liberibacter has cle 25 (1) ad (2) of Regulation (EU) been prepared. It is awaiting approval by the /2031. It is currently in the process Minister to include in relevant Order. eing adopted in the form of Order rding to national legislation. __ imated date of adoption, summer Attachment: _CANDIDATU ) See reply in Recommendation No.:1

The recommendation states as its basis

Following the first confirmed finding of S. frugiperda in January 2023, the CA did not immediately establish a demarcated area, as the first finding was found in a light trap on the property of a private citizen and was not associated with a growing crop or located near host species. On 14 March 2023, the CA issued instructions in the form of an action plan to delimit an area of 5 km around the site where the pests was found. However, the CA did carry out intensive surveys assisted by trapping to detect the pest in the vicinity of the outbreak, in accordance with the action plan.

In July 2023, the second finding occurred, where one S. frugiperda larva was detected in a maize crop in Larnaca district and then again in September 2023, the CA reported the third official detection of the pest in a maize crop in Nicosia. According to the first Europhyt update (ref: 01/2023-07-26) on the outbreak, the CA stated that they demarcated a 100 m infested area and a 100 km buffer zone around the outbreak site, and in effect demarcating the entire island. Contrary to the Europhyt update, the audit team noted during the site visits, that the infested zones were considered to be the field or plot of land where the infestation occurred but did not include a radius of 100 m around the infestation. Furthermore, host plants such as potatoes and brassicas growing in plots immediately adjacent to the infested ones or within the 100 m radius, were not included in the infested zone (see paragraph 22 and 27). This is not in line with Article 5(1)(a) of Regulation (EU) 2023/11345, requiring that the infested zone is to include the infested plants and all plants which are liable to become infested within a 100 m radius around the finding of S. frugiperda.

According to the CA, maize, peppers and aubergines are considered to be a risk among those specified plants referred to in Commission Implementing Decision (EU) 2018/638, which was in force up until 30 June 2023. Furthermore, the CA stated, that at the time, it did not consider other host plants listed in the ESFA pest survey card for S. frugiperda (June 2020) to be a risk, even though according to the document, they are liable to become infested. Crops such as potatoes, certain cereal crops and brassicas which are grown throughout Cyprus where the pest is not known to occur are excluded. 5.3.2 Establishment of DAs due to the presence of Diaphorina citri

Member state response

he CA will amend the Action Plan (see recommendation no. 2) accordingly and will; (a) Include clear reference to the demarcated area (infected zone, including 100 m radius around the infestation and buffer zone). (b) Host plants around the infested zone within a 100m radius will be included in the infested zone

CA will amend the Action Plan (see 30 Sep 2024 mmendation no. 2) accordingly and ; clude clear reference to the demar- d area (infected zone, including 100 dius around the infestation and buffer ). Host plants around the infested zone Page: 2 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report ref. DG(SANTE) 2023-7924 of 023 in order to evaluate the situation and controls of plant pest outbreaks tion Proposed by the competent authority Proposed action Updated Action Proposed by the competent plan deadline authority thin a 100m radius will be included in e infested zone

The recommendation states as its basis

Similar to the procedure for S. frugiperda, the CA established the infested zone to be the citrus orchard or plot infested with D. citri, without taking into consideration other citrus orchards in close proximity to the source of infestation. The audit team visited a number of outbreak sites, where there were other citrus orchards adjacent to the infested plots. According to the CA, since there was no evidence of infestation in these plots, they did not include them in the infested zone. This is not in line with the requirements of Article 5 The requirement for a DA to comply with Article 5 (1) (a) of Regulation (EU) 2023/1134 entered into force on 12 June 2023. 10 18(2)(c) of Regulation (EU) 2016/2031, which requires that the infested zone shall include plants liable to become infested due to their susceptibility to that pest and their close proximity to infested plants or common source of production.

The area outside the infested zone was considered to be the buffer zone, however in practice, no formal delimitation takes place, contrary to their "Contingency plan for D.citri" (see paragraph 8(e)), which requires that the buffer zone shall extend to a 3 km radius beyond and around the infested zone. If established, the buffer zone can form the basis for measures such as surveys and restrictions on movement of plants or additional controls. The CA stated that orchards adjacent to the infested orchards were considered to be outside the infested zone, because no buffer zone was defined in the DA due to the uncertainty about the presence of the pest in the adjacent citrus orchards. This is not in line with Article 18(1) and (3) of Regulation (EU) 2016/2031, which provides for the immediate establishment of a demarcated area consisting of an infested zone and a buffer zone, adjacent and surrounding the infested zone.

Member state response

An Action Plan for D.citri has been drafted in accordance with Article 27 of Regulation (EU) 2016/2031. It is currently in the ess of being adopted. (estimated date of adoption, summer 2024). Page: 1 rt ref. DG(SANTE) 2023-7924 of the audit carried out from 01 December ant pest outbreaks Action Proposed by the competent authority and deadline by which it will be completed Regarding the Demarcated area, the following applies: - The infected zone consists of the plot or plots (in case they are adjacent) in which the insect has been detected on the host plants and the space surrounded by a radius of five meters from them (immediately adjacent space). - The buffer zone consists of the municipalities and communities that either in whole or part of them fall within a radius of three Km from the borders of the infected zone. In the safety zone regular surveys will be carried out for a period of at least two years. With respect to lots falling within the two zones, measured will be applied the entire lot, and will be based on the measures applied in the infected zone. The CA will carry out regular surveys for a period of two years to determine and update the demarcated area, based on the r

Action Plan for D.citri has been 31 Jul 2024 afted in accordance with Article 27 of The infested zone as outlined in the Action gulation (EU) 2016/2031. It is Plan is considered the field where the D.citri rrently in the process of being adopted. is detected. Based on the surveys we stimated date of adoption, summer implemented so far, there were several cases 24). where in the same field certain plants were infected whereas others were pest free. Also, in many cases -possibly depending of garding the Demarcated area, the fol- the species, variety and growth period- plots wing applies: adjacent to infested plots were found pest free. We kindly offer that this phenomenon was witnessed also by the auditors. The The infected zone consists of the plot or referenced flight ability of the pest has been ots (in case they are adjacent) in which considered by the 3 km buffer zone, through e insect has been detected on the host the planning of intensive surveys. _ ants and the space surrounded by a ra- _.C us of five meters from them (immedi- ely adjacent space). Page: 3 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report

The recommendation states as its basis

Following the first finding of S. frugiperda, the CA conducted intensive surveys with the assistance of trapping in the vicinity of this finding, focusing their efforts on production sites of host plants of maize, peppers and aubergines considered to be a risk for the presence of the pest (see paragraph 22). However, according to the EFSA pest survey card, delimiting surveys should cover all host species in the survey area. Surveys are not carried out in line with Articles 19(1) and 22(2) of Regulation (EU) 2016/2031, which requires that surveys shall take account of scientific and technical evidence, and any other appropriate information, concerning the presence of the pests concerned.

At the time of the second finding in a maize crop, Article 7 of Regulation (EU) 2023/1134 applied, with regards to the requirements for surveys in demarcated areas. According to the action plan of 14 March 2023, surveillance and sampling for the presence of S. frugiperda, a mix of seven funnel and delta pheromone traps were to be placed within the 5 km buffer zone. These were checked once or twice a week, 11 respectively, and the insect samples were sent to the PPL for analysis. In the update to the action plan (12 September 2023), it provided instructions for the placement of a further 17 funnel and delta traps in the Nicosia, Limassol, Larnaca, and the Paphos areas, which were to be checked every 15 days.

On 12 June 2023, Annex 1 to Regulation (EU) 2023/1134, provided an extended list of host plants, including certain Solanum spp. and Brassicaceae. However, following the second finding of the pest, the CA maintained their survey focus on the three crops referred to in paragraph 27, without full consideration for the other hosts listed in the annex to the above Regulation or the EFSA pest survey card. This is not fully in line with Article 7(b) of Regulation (EU) 2023/1134, which requires scouting in sites of production where host plants are grown.

In the update to the action plan (12 September 2023) when Regulation (EU) 2023/1134 applied, there was no survey design or sampling scheme developed, which should provide guidelines on being able to identify with at least a 95 % level of confidence, a 1 % a level of presence of the specified pest. This is not in line with the requirements of Article 7(c) of Regulation (EU) 2023/1134.

As a result of the surveys and trapping, the pest was detected in multiple locations across the island. According to the CA, there are 16 infested production sites spread across the whole island. As a result of these findings the CA demarcated the whole island (see section 4.3). The audit team noted that ADOs staff displayed good knowledge for recognising the late larval stages of the pest and signs or symptoms for their presence, particularly on maize crops. 5.4.2 Surveys for Diaphorina citri

Member state response

he CA will amend the Action Plan accordingly (see reply for recommendation No. 2): - information intended for the Inspectors on the revised list of hosts to be included in the surveys re t Page: 2 rt ref. DG(SANTE) 2023-7924 of the audit carried out from 01 December ant pest outbreaks Action Proposed by the competent authority and deadline by which it will be completed s

CA will amend the Action Plan ac- 30 Sep 2024 ngly (see reply for recommendation See reply on recommendation no. 1 . 2): information intended for the Inspectors the revised list of hosts to be included the surveys Page: 5 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report ref. DG(SANTE) 2023-7924 of 023 in order to evaluate the situation and controls of plant pest outbreaks ction Proposed by the competent authority Proposed action Updated Action Proposed by the competent plan deadline authority

The recommendation states as its basis

The CA carries out regular surveys in the demarcated areas for D. citri in parallel with the survey for C. Liberibacter. These surveys are focused on production sites of citrus fruit, nurseries and garden centres with host plants including citrus and Murraya spp. plants. However, as a result of the buffer zone not being clearly defined (see paragraphs 23 and 24), these surveys were conducted all over Cyprus.

The audit team noted that citrus trees were abundant all over Cyprus however, abandoned orchards, private properties and urban areas with bitter orange (Citrus aurantium) trees growing on the footpaths, are not included in the scope of the survey. According to the CA, this was due to the lack of resources. Furthermore, the CA requires permission to access private properties and if refused it would require a court order to gain access, which was too complicated, so it was not done. This is not in line with Articles 19(1) and 22(2) of Regulation (EU) 2016/2031, which requires that the survey shall be carried out in all appropriate locations and be based on sound scientific and technical principles.

The ADO staff informed the audit team that surveys are in general based on visual examination of plant material of trees grown in orchards, for detecting symptoms caused by D. citri adults or nymphs. They also stated that as a result of the information 12 campaign raised by the Department of Agriculture for D. citri, the producers frequently report suspicious symptoms concerning its presence.

ADO staff have been instructed to focus the survey on citrus trees in places of production at the time of new flushing, in spring, mid-summer and late autumn. The ADO staff follow an "S-shape" course within the citrus orchards and focus on the recently developed flushes of young stems and leaves of trees. However, this is not always possible, in particular for the developing upper parts of the tree canopy and surveillance efforts are mostly limited to leaves growing within the lower interior central part of the trees.

According to the statement of the ADOs staff, one yellow sticky trap is deployed per citrus orchard regardless of its size. However, out of the six citrus orchards visited, only one yellow sticky trap was spotted by the audit team in an orchard located in the Asomatos Limassol area where the presence of D. citri was first reported. Also, in the nurseries and garden centres visited, close to infested zones, the audit team noted that yellow sticky traps were not deployed for the detection of D. citri, as there was no requirement or recommendation to do so.

Member state response

on Intensive surveys will continue in sites of production where 1) host plants are grown and orchards. Surveys will include urban areas and abandoned orchards. Survey design will be based on EFSA's system sensitivity tool RiBESS+.

tensive surveys will continue in sites of 31 Jul 2024 oduction where host plants are grown See reply on recommendation no.5. See reply on recommendation no.5. d orchards. urveys will include urban areas and oned orchards. urvey design will be based on EFSA's ystem sensitivity tool RiBESS+.

The recommendation states as its basis

The CA carries out regular surveys in the demarcated areas for D. citri in parallel with the survey for C. Liberibacter. These surveys are focused on production sites of citrus fruit, nurseries and garden centres with host plants including citrus and Murraya spp. plants. However, as a result of the buffer zone not being clearly defined (see paragraphs 23 and 24), these surveys were conducted all over Cyprus.

The audit team noted that citrus trees were abundant all over Cyprus however, abandoned orchards, private properties and urban areas with bitter orange (Citrus aurantium) trees growing on the footpaths, are not included in the scope of the survey. According to the CA, this was due to the lack of resources. Furthermore, the CA requires permission to access private properties and if refused it would require a court order to gain access, which was too complicated, so it was not done. This is not in line with Articles 19(1) and 22(2) of Regulation (EU) 2016/2031, which requires that the survey shall be carried out in all appropriate locations and be based on sound scientific and technical principles.

The CA informed the audit team that the strategy applied for the detection of C. Liberibacter, has mainly involved the laboratory analysis of D. citri specimens. According to the CA, this is where the bacteria will be detected first, as the identification of C. Liberibacter in plant tissues is not possible during the period in which the presence of the pest is latent. This is in agreement with the EFSA pest survey card (2019) for C. Liberibacter 6, which states the areas where the psyllids are present can be prioritised for the purpose of Huanglongbing detection surveys. According to the inspectors, during their survey for D.citri they also carry out visual examinations for symptoms of C. Liberibacter in citrus leaves. At the time of the audit, C. Liberibacter had not been detected in the 71 samples of D. citri. Sampling of plant material is only taken when there is a suspicion of the presence of the bacteria and is accompanied by the samples analysed for D. citri. According to the CA, since the first outbreak of D. citri, only two 6 EFSA pest survey card on Huanglongbing and its vectors 13 symptomatic samples of leaves were analysed for the presence of C. Liberibacter, which yielded negative results.

According to the EFSA pest survey card, visual inspection of leaves is of limited use for early detection of the disease as it can be confused with nutrient deficiencies of citrus trees. However, the document recommends that visual examinations for C. Liberibacter should be complemented with a sampling programme for symptomatic and asymptomatic plant material.

Surveys for C. Liberibacter are not carried out in line with Article 24 of Regulation (EU) 2016/2031, which requires that surveys of priority pests shall include a sufficiently high number of visual examinations, sampling and testing, as appropriate for its timely detection. Conclusions on specific surveys for S. frugiperda, D. citri and C. Liberibacter

Member state response

The CA will amend the sampling plan for C. Liberibacter in order to address the recommendation. There will be an increase of the number of visual inspections as well as the number of insects sampled and tested for Citrus Greening Bacterium. Although EPPO Standard describing a diagnostic protocol for `Candidatus Liberibacter spp. notes that detection of C. Liberibacter in asymptomatic plants can be very erratic due to the patchy distribution and low concentration of bacteria in the plant, and EFSA Pest survey card on Huanglongbing and its vectors notes that mainly on non-symptomatic plants, due to the uneven distribution of the bacteria in the plants, the high levels of `false negative' result in a low test sensitivity , the CA decided to include random sampling of symptomatic and asymptomatic leaves in the surveys. Page: 3 rt ref. DG(SANTE) 2023-7924 of the audit carried out from 01 December ant pest outbreaks Action Proposed by the competent authority and deadline by which it will be completed

e CA will amend the sampling plan for 31 Jul 2024 Liberibacter in order to address the commendation. will be an increase of the number f visual inspections as well as the num- er of insects sampled and tested for Cit- us Greening Bacterium. Page: 6 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report ref. DG(SANTE) 2023-7924 of 023 in order to evaluate the situation and controls of plant pest outbreaks ction Proposed by the competent authority Proposed action Updated Action Proposed by the competent plan deadline authority lthough EPPO Standard describing a iagnostic protocol or `Candidatus Liberibacter spp. notes hat detection of C. Liberibacter in symptomatic plants can be very erratic ue to the patchy distribution and low oncentration of bacteria in the plant, and FSA Pest survey card on Huanglong- ing and its vectors notes that mainly on on-symptomatic plants, due to the une- en distribution of the bacteria in the lants, the high levels of `false negative' esult in a low test sensitivity , the CA ecided to include random sampling of ymptomatic and asymptomatic leaves in he surveys. age: 7 recommendations (upda

The recommendation states as its basis

Where the pest is found to be present, operators are instructed to implement increased frequency of pesticide applications by spraying for the control of S. frugiperda. According to the CA, at the stage when larvae were detected, it was largely ineffective due to inappropriate timing of applications as the caterpillar was already protected in the plant. According to the CA, the option of burning of the crops is not possible during the hot summer months due to the risk of wildfires.

The EFSA pest risk assessment for S. frugiperda (section 4.2)7 states that "if this pest were to arrive and become a pest of maize in Europe, it is likely that the existing available tools could be used to control it effectively". However, the CA has not defined official procedures for treatment against the pest (see paragraph 13). Treatment methods, such as the use of chemical pesticides at other growth stages (flight season of adult moths, young larvae stages), the use of biological control agents, destruction or deep burial of infested material and other host plants, burning of plant material in other seasons, soil cultivation, have not been assessed or defined as official treatment procedures by the CA. This is not in line with Article 17(1) of Regulation (EU) 2016/2031, which requires the CA to immediately take all the necessary phytosanitary measures for the eradication of the pest, and Article 9(a) of Regulation (EU) 2023/1134, which requires appropriate treatments against the specified pest, in all the stages of its development, where the migratory nature of the adult pests, the distribution of host plants and the feeding habits of its larvae shall be considered. Point 14, Article 2 of Regulation (EU) 2016/2031 and ISPM 5 defines treatment as an "official or non-official procedure for the killing, inactivation or removal of pests, or for rendering pests infertile or for devitalization".

Operators are advised that the movement of the upper layer of soil from infested plots is prohibited and they are to apply strict hygiene measures with regards to the movement of machinery and equipment in and out of infested areas. However, the implementation of these measures is not supervised or verified by the CA.

Furthermore, the CA have not introduced restrictions on the cultivation, harvesting or movement of possibly infested plant material from infested plots. Maize cobs for human consumption and plant material for animal feed are permitted to move out of these infested plots and are traded all over Cyprus.

Risk management measures targeting prevention and elimination of infestation are outlined in Annex II, section 1 point 1 (b) and (c) to Regulation (EU) 2016/2031 as provided for in Article 17(1) in the same Regulation. This provides for measures regarding restrictions on the cultivation and use of the infested plants and movement of machinery in order to limit the spread of the pest. Furthermore, EPPO standard on guidelines on the design and implementation of a bufferzone (PM 5/10), recommends to restrict the spread of the pest by preventing the movement out of the infested area and buffer zone. 7 EFSA PRA Spodoptera.pdf 15 5.5.2 Measures for eradication of Diaphorina citri

Member state response

See reply for recommendation No. 2

e reply for recommendation No. 2 30 Sep 2024 See reply on recommendation No. 1 See reply on Recommendation No. 5 Also, please be informed that the DoA prepared a Ministerial Proposal to provide subsidies to the Citrus farmers for the application of pesticides against Diaphorina citri. This Decision is under evaluation by the Ministerial Council. Draft of the Ministerial Proposal is attached

Member state response

The CA amended the Action Plan accordingly outlining measures that must be taken by growers, places of production, importers/exporters/traders, municipalities and he general public. Additionally, since April, 2024 the CA in collaboration with Agricultural Research Institute and Cyprus University of Technology is carrying out releases of the biological control agent (BCA), Tamarixia radiata. Releases of the BCA will initially take place in orchards and will gradually continue in urban areas and abandoned orchards. Page: 4

e CA amended the Action Plan accord- 31 Jul 2024 y outlining measures that must be ken by growers, places of production, porters/exporters/traders, municipali- es and general public. ditionally, since April, 2024 the CA in llaboration with Agricultural Research ge: 8 recommendations (updated) received 10/10/2024 plan submitted by the competent authorities of Cyprus in response to Report ref. DG(SANTE) 2023-7924 of 023 in order to evaluate the situation and controls of plant pest outbreaks n Proposed by the competent authority Proposed action Updated Action Proposed by the competent plan deadline authority tute and Cyprus University of Tech- 20240723 y is carrying out releases of the bio- __. al control agent (BCA), Tamarixia ta. Releases of the BCA will initially place in orchards and will gradually nue in urban areas and abandoned rds. 9

The recommendation states as its basis

While the audit team did not carry out a comprehensive review of these guidelines, it was noted that they cover all of the food chain and controls related to the production of beef. However, the audit team noted that the "Instruction on procedures to be followed in slaughterhouses" does not provide sufficient information for the OVs on how to act appropriately in case of bovine animals with traceability issues (e.g. lost ear tags) detected at AMI. This has a negative impact on the official controls on bovine traceability. (See also paragraphs 79 and 81).

The CAs have issued national legislation and guidelines necessary to ensure the implementation and/or enforcement of EU requirements applicable to the bovine meat sector. From a summary analysis, they are in line with EU legislation and mostly adequate, with the exception of those dealing with cases of bovine animals with traceability issues. 3

As part of the AMI, the OV verifies the identification of animals in the bovine database (see paragraph 72). If any non-compliances are detected in relation to the traceability of animals, the OV should follow the procedures laid down in the relevant VS instruction (see paragraph 4). The audit team noted that this instruction refers to the provisions of Regulation (EC) No 1053/2010, which requires that if the keeper of an animal cannot prove its identification and traceability, the CA shall, where appropriate, on the basis of an assessment of the animal health and food safety risks, order the destruction of the animal without compensation.

One of the OVs interviewed explained that where the traceability of a bovine animal is not established (e.g. lost ear tag(s)), it will be slaughtered and the carcass will be detained and tested for antibiotic residues. If the result of the analysis is negative, the meat is declared fit for human consumption. The audit team noted that these actions were the initiatives of the OV, as they are not included in the VS instruction. The audit team was provided with examples of such cases and noted that a 400 fine was imposed on the farmers in each case.

In addition, the audit team reviewed a case when a bovine animal arrived at the slaughterhouse with one ear tag. After verification of the identification of this animal in the CBD, the OV ascertained that this ear tag belonged to an animal which, according to the data in the CBD, had already been declared dead. Despite the fact that the traceability of this animal was clearly not established, its meat was released for human consumption by the OV. The CA imposed a 400 fine on the farmer. A representative from the VPHD informed the audit team that the procedure included in the instruction does not provide sufficient information to direct OVs to act appropriately in such situations and that the VS plan to revise this instruction (see also paragraph 79).

The recommendation states as its basis

The prerequisites for private veterinarians to be contracted as OVs are previous experience and training. The audit team was informed by the VPHD that the last training sessions, provided by the VS for contracted staff, were in 2019. These included, among others, training on AMI, PMI and slaughterhouse inspection. However, the audit team also noted that the contracted OVs are not included in the CA`s training plan, therefore the VS do not provide them with regular training.

Cooperation and coordination arrangements between and within the CAs involved in the controls for the areas covered by this audit are in place. The mechanisms in place (such as documented procedures and training) give the CAs a reasonable level of assurance that controls are carried out uniformly and consistently. However, the contracted OVs are not included in the CAs' training system, which could have an impact on the sustained level of competence of contracted staff responsible for official controls of the bovine sector.

The recommendation states as its basis

The VPHD inspectors collect official samples to verify the reliability of results obtained by operators in their own-checks programmes. The VS designated official laboratory carries out analyses for microbiological standards, and uses official laboratory located in another Member State for carrying out analyses for glyceroltriheptanoate (GTH) content. The audit team noted that: a. Both laboratories analysing official samples are accredited to ISO 17025. The VS laboratory has the methods used for analyses of official samples within the scope of its accreditation. The laboratory from the other Member State does not. The latter is not in line with Article 37(5) of Regulation (EU) 2017/625. The VPHD representative stated that the external laboratory in question regularly participates in the inter-laboratory tests organised by the EU Reference Laboratory for detection and quantification of GTH, with successful outcomes. Nonetheless, in response to this finding, during this audit, the VS representatives declared they would seek a laboratory with an accredited method for GTH. b. Despite the absence of written guidelines on official sampling explaining `what', `where' and `how' to sample, official samples were properly targeted to relevant operators (processing Category 1 and Category 2 material) and properly reflected the scope of examination (GTH content and microbiological standards). c. In 2019 and 2020, with some exceptions, inspectors collected all of the planned samples. Exceptions concerned a few situations resulting from COVID-19 related restrictions and cases where operators had suspended or ceased their activity. d. The sampling protocols and results of laboratory analyses contained a unique serial number. The VPHD inspectors stated that they record the number in DVO (5) sampling logs and put it on a disposable bag (sealed with tamperproof seal) containing the sample. The number allows linking the sample, the place of sampling and examination result, thus ensuring legal, scientific and technical validity required by Article 34(5) of Regulation (EU) 2017/625.

Whilst official samples were collected and tested as planned in accredited official laboratories, the fact that one of the designated laboratories does not have the analytical method used for GTH analysis included in the scope of its accreditation as required by EU law, may compromise the competent authority in taking enforcement action in the event of a non-compliant result being found.

The recommendation states as its basis

The audit team noted that the BIP Manual had not been updated as appropriate, as required by Article 12(3)(b) of the OCR. It also noted that no documented procedures or arrangements were in place for the official controls of live animals, which is not in line with article 12(1) of the same Regulation.

The Department of Agriculture informed the audit team that it has issued an Inspectors Manual and Sampling Manual, which include documented procedures for the official control of products of non-animal origin. The audit team noted that the manuals were updated as appropriate, in January 2020 and December 2019 respectively, and reflected changes introduced by the OCR and relevant implementing and delegated acts.

However, the lack of documented procedures and necessary arrangements, updated as appropriate, including a monitoring plan for products of animal origin, have an adverse impact on both the effectiveness of the organisation of official controls on imports of animals and goods, and its compliance with Union legislation. The lack of recent internal audits or verification checks of the official controls for such imports, represent possible missed opportunities to identify and address those issues. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

Member state response

P manual is being updated and it is expected to be finalized by the end of 2022.

The BCP manual is being updated and it is expected to be finalized by the middle 023. he amendment of the BCP Manual will include procedures for the official controls on live animals.

The recommendation states as its basis

The Veterinary Services stated that they have not established a monitoring plan, required by Article 4(5) and point 5 of Annex II to Commission Implementing Regulation (EU) 2019/2130. 6

However, the lack of documented procedures and necessary arrangements, updated as appropriate, including a monitoring plan for products of animal origin, have an adverse impact on both the effectiveness of the organisation of official controls on imports of animals and goods, and its compliance with Union legislation. The lack of recent internal audits or verification checks of the official controls for such imports, represent possible missed opportunities to identify and address those issues. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

Member state response

monitoring plan is being developed and it is expected to be alized by the end of September.

hed is the monitoring plan.

The recommendation states as its basis

The audit team noted that a small number of documentary checks had not identified certain errors in the entry documents accompanying 2/5 consignments of animals and 4/22 of products of animal and non-animal goods. Although those checks were therefore not completed in line with the requirements set in Article 2(2) of Regulation (EU) 2019/2130, the errors were not sufficient to affect the validity of the decision to allow entry of the animals or goods concerned. Conclusions on the implementation of official controls on animals and goods entering the EU

While consignments of animals and goods entering the EU are presented for official controls, which are generally carried out in line relevant EU legislation, certain shortcomings were identified, including the late notification of arrival of consignments, the performance of documentary checks and the movement of non-compliant consignments from BCPs, which undermine the appropriateness of official controls and their overall compliance with Union legislation.

Member state response

levant information will be included in the BCP manual. ever, the VS have informed the operators responsible for a consignment about a) the list of animals and products subject to official controls at BCPs, b) the presence of the appropriate accompanying official certificates and / or official attestations for the above animals and products in order the consignment to be released and c) the operators' obligation of prior notification (attached letter 07 07 21). Page: 1 t ref. DG(SANTE) 2021-7218 of the audit carried out from 23 September n imports of animals and goods and verification of compliance of border ction Proposed by the competent authority dditionally, the VS informed the operators about a) the ppropriate information to be recorded in a private attestation ccompanying shelf-stable composite products not containing rocessed meat, b) the presence of the appropriate accompanying fficial certificates and / or official attestations for animals and roducts subject to official controls at BCPs in order the onsignment to be released and c) the operators' obligation of rior notification (attached letter 05 04 22).

Page: 1 response to Report ref. DG(SANTE) 2021-7218 of the audit carried out from 23 September 2021 icial controls on imports of animals and goods and verification of compliance of border control sponse to Commission Services' assessment of the competent authority's sponse

The recommendation states as its basis

The competent authorities have made available on the internet, a list of the BCPs and Control Points that it has designated on its territory, in line with Article 60(1) of the OCR. The audit team noted however, that the TRACES NT contact point has not maintained and kept up to date in TRACES the list of BCPs that have been designated, which is not in line with Article 44 (1) of Regulation (EU) 2019/1715. In particular, the Department of Agriculture informed the audit team that BCP Vassiliko Port is no longer used for the importation or trade of any kind of feed, and that BCP Larnaca port is used for bulk consignments of feed of non-animal origin, which is in contrast to the information in TRACES NT at the time of the audit.

While (former) Border Inspection Posts have been re-designated following the introduction of the OCR, the list of designated BCPs has not been kept-up-to date, which undermines the ability of the competent authorities and importers to ensure that only consignments of goods for which appropriate facilities and arrangements are in place, are presented for official controls.

Member state response

email was sent to sante-traces@ec.europa.eu on Wednesday, ay 4, 2022 9:57 AM, informing the commission on the esignation of BCPs in Cyprus with the relevant responsibilities nd changes. Among them was the designation of the ports of arnaca and Limassol and Larnaca Airport as BCPs for FNAO- HC(feed). ctions To be taken: Based on the above, the competent uthority (DoA) considers that no more action is required to e taken.

swer from DA. e relevant Veterinary BCPs are published at: tps://food.ec.europa.eu/system/files/2019-12/bcps_contact_cyprus.pdf and tp://www.moa.gov.cy/moa/vs/vs.nsf/All/0851BD37F3C0E820C2258722001 203/$file/vetetrinary%20border%20control%20posts.pdf

The recommendation states as its basis

As detailed in section 5.3 below, there are no arrangements in place at the BCPs for the Public Health Services to apply measures as provided for by Articles 65, 66 and 67 of the OCR for non-compliant consignments of food of non-animal origin, which is not in line with Article 64(3)(d) and (e) of that Regulation. The Public Health Services stated that such consignments would be transferred to a designated Control Point, where measures, including re-dispatch or rejection would be applied. Such movements are not in line with Article 66(1) of the OCR, or the rules in Article 2 of Commission Delegated Regulation (EU) 2019/2123.

While consignments of animals and goods entering the EU are presented for official controls, which are generally carried out in line relevant EU legislation, certain shortcomings were identified, including the late notification of arrival of consignments, the performance of documentary checks and the movement of non-compliant consignments from BCPs, which undermine the appropriateness of official controls and their overall compliance with Union legislation.

The audit team noted however that there was a lack of the required inspection and storage facilities at those BCPs for the categories of products of non-animal origin for which they had been designated by the Department of Agriculture and the Public Health Services.

The Public Health Services confirmed that they do not have access to facilities to detain consignments at the BCPs in case of unsatisfactory documentary checks. Those BCPs therefore do not comply with the minimum requirements for BCPs, in particular Article 64(3)(c) and (d) of the OCR and Article 3(1)(b) and (c) of Regulation (EU) 2019/1014.

The Department of Agriculture stated that there were no consignments of feed of non- animal origin under the emergency measures in 2020 and 2021. In the event that such consignments would arrive, the Department of Agriculture staff would carry out official controls in the facilities designated for products of plant origin (plants, plant products and wood packaging materials). However, no arrangements and risk-analyses were in place in this respect at the time of audit. Conclusions on minimum requirements for border control posts

The BCPs evaluated satisfy the minimum requirements for BCPs for the categories of animals and goods of animal origin for which they had been designated. However, there 14 are significant shortcomings in the facilities for performing official controls and in particular for storing non-compliant consignments of products of non-animal origin, which has an adverse impact on the capacity to implement of official controls and ensure the appropriate handling of such products for which those BCPs were designated.

Member state response

A aken into consideration that no consignment has been ever imported to Cyprus that fell in the scope of (EC) 669/2009 or (EU) 2019/1793, so a risk based control program/ risk analyses based on/ for/ that includes these materials cannot be performed. . No other control points are approved besides the BCPs regarding Feed Page: 2 t ref. DG(SANTE) 2021-7218 of the audit carried out from 23 September n imports of animals and goods and verification of compliance of border 3. The materials refer to in the abovementioned regulation are expected to arrive in containers, by ship, and not by any other way e.g. plane or in bulk. So the facilities in Limassol BCP (Limassol Port) is expected to examine any consignment arriving and falling in the scope of this regulation. 4. The appropriate written procedures (for inspection and sampling) are in place for any consignment that falls in the category of high risk that these materials are included in, and the inspectors at the BCP are informed about them. 5. In the case that a consignment that falls in the scope of the above mentioned regulation is imported, then the relevant provisions will be applied as also the sampling frequency with the first o

from DA. nswer from PHS: order for the PHS to comply with the relevant legislation regarding the m requirements of a BCP, a request was submitted to the DA, based on ticle 3(9) of Reg. 2019/1014, so as to share the same facilities to be used for e dedicated controls. bsequently and for the efficient and effective coordination and cooperation he two Departments (PHS ­ DA), a relevant Code of Practice is rrently being developed, based on article 3(9) of Reg. 2019/1014. Page: 2

Member state response

/ . , . 3. : 2022.

The recommendation states as its basis

For vessels less than 12 meters in length inspections are executed at random during landing site inspections. The VPHD has no register of such vessels to their disposal. After a request of the audit team, the VPHD gathered the information from the Fisheries Department demonstrating that in 2019 745 small vessels were registered by MARDE. In 2019 the total volume of landing from small coastal fishing vessels (up to 12 meters long) was 500 tons. Of these 500 tonnes unloaded, 216 tonnes were sold directly to final consumers and 284 tonnes were sold to registered buyers (fish markets, restaurants, etc.) who then sell them for commercial use. The CA stated that efforts to do more stringent controls for this category would be disproportional to the work force needed.

The list of vessels more than 12 meters in length is provided at the beginning of a calendar year by the Department of Fisheries to the VPHD. This is in accordance with the protocol of cooperation. These vessels require an annual inspection and the issuance of a "certificate of compliance". The audit team reviewed the inspection report of such a vessel inspected in 2020. The new check-list with more detailed requirements was used.

However, they are not fully effective as regards controls of vessels less than 12 meters in length because the VPHD has very limited access to an updated register. RECOMMENDATION NO 2 AUDIT REPORT DG(SANTE) 2019-6663 - COLD STORES The CA should ensure that the approval requirements in Article 4 of Regulation (EC) No 7 853/2004 for FBOs (in relation to cold stores) are followed in all cases, and in compliance with Article 31(2)(c) of Regulation (EC) No 882/2004. To note: the requirements contained in Article 31(2)(c) of Regulation (EC) No 882/2004 have been carried over into Article 10 (2) of the Official Control Regulation (EU) No 2017/625. The main finding that prompted this recommendation was the fact that the audit team had noted that the presence of a continuous recording device in cold stores was not obligatory, which was due to a misinterpretation of the EU legal requirements. Action plan proposed by the CA Letters were sent to all those establishments that were inspected during the mission and found to be non-compliant as regards temperature recording in cold stores, asking them to take corrective measures. The FBOs were then re-inspected by the DVOs and found to be compliant. The DVOs have been instructed as to how establishments should calibrate the measurements and record the temperature at different points of the cold store. The thermometer's temperature sensor must be located at the point of the storage room with the highest temperature, the temperature of the refrigerators must be monitored by an automatic recording system and continuous readings must be taken at least once an hour. Findings regarding the implementation of the action plan for this recommendation

Primary production vessels less than12 meters in length. During the present audit, the VPHD (central and local) was not aware of the number of vessels registered in Cyprus in this category. The transfer of the information from the Department of Fisheries to the VPHD is not included in the Protocol of Collaboration signed in 2020.

The CA has implemented corrective actions to list correctly refer vessels and primary production fishing vessels (more than 12 meter). Smaller vessels, however are not included which is not in line with Article 10 (2) of the Regulation 2017/625. RECOMMENDATION NO 4 AUDIT REPORT DG(SANTE) 2019-6663 ­ OPERATIONS ON VESSELS The CA should ensure that primary production vessels limit their operations to those permitted in Section VIII, Point 4(b) of Annex III to Regulation (EC) No 853/2004) and to this end, consider revising the current vessel checklist to provide more guidance to the inspector on the conditions for permitted operations, along with the relevant structural and equipment requirements. The main finding that prompted this recommendation was that the vessel visited during the audit showed poor maintenance and general hygiene conditions: the refrigerated hold had a strong fish odour, was poorly maintained, dirty, and presented wooden surfaces (in contact with fish) with peeling paint. Furthermore, there was ice build-up, rusty cooling pipes and condensation falling on the fishery products; no suitable containers available to store large fish (e.g. grouper) with ice; plastic containers used to store fish with ice, were dirty and not designed to prevent melt water coming in contact with the container below (Section VIII, Chapter III, point A(4) of Annex III to Regulation (EC) No 853/2004); some fish had been skinned and cut to smaller pieces on board, operations, which are excluded from the associated operations on primary production vessels (Section VIII, Point 4(b) of Annex III to Regulation (EC) No 853/2004). Action plan proposed by the CA The operator of the fishing vessel was sent a letter and the FBO then proceeded with corrective actions on 8 August 2019. VPHD provided written evidence of this. Findings regarding the implementation of the action plan for this recommendation

The recommendation states as its basis

The LCS has a list of 33 registered food operators supplying food by-products to animal holdings for feeding of farmed animals. Whilst four of these operators have been included in the DoA's annual control programme, the remaining 29 operators have not and these include flour or carobs mills, breweries/distilleries, producers of fruit juice or other beverages, dairy plants, olive oil and pasta producers. The audit team noted that: a. As these 29 operators were not included in the DoA control programme, the LCS has not carried out a risk assessment for them, and had not established a risk category to determine the frequency for official controls thereon. The LCS representative explained that, in principle, such operators would be controlled every five years when their registration expires. b. According to the information from the ABP Section of the Veterinary Services, there are 19 dairy plants supplying by-products to animal holdings for feeding purposes (see finding 33). These plants were not included in the LCS list above and therefore have not been subject to official control in this area by the DoA. The above is not in line with Article 9(1) of Regulation (EU) 2017/625, which requires competent authorities to carry out, on operators, official controls which are regular, risk-based and with appropriate frequency.

With the exception of food business operators supplying food and food by-products for feeding of farmed animals, both the DoA and Veterinary Services carry out their controls ­ inspections and sampling ­ regularly and along the entire feed chain, even though the controls on operators handling medicated feed are not risk-based. On the evidence of the records seen by the audit team and the situation on the spot in the establishments visited, the controls are capable of, and have, with the exception of operators' obligations to have procedures in place to verify the correct functioning of their HACCP systems, correctly identified non-compliances in operators' performances.

Member state response

ther services will take place so that all the operators are included in the future action plans. Actions have already be taken and will be completed by the beginning or mid 2021. Verification will be ongoing. `CVS-SOP-701' « / ». 5.2 , 5.2.1 , 2 ,

The recommendation states as its basis

The VMPS has a written procedure on how to select feed operators manufacturing and/or using medicated feed for inspections to ensure that all of them are subject to regular controls. Operators for official controls are selected from those handling medicated feed, and the frequency of controls depends whether an operator manufactures medicated feed for commercial reasons or to for the use on its own farm (see finding 36.d). This is not entirely in line with Article 9(1) of Regulation (EU) 2017/625 requiring that official controls are also risk-based.

Although the control system is working now, the absence of a defined risk-based approach for selecting for inspections operators manufacturing and/or using medicated feed may hinder the functioning of the system in the future; namely that these presenting higher risks would not be controlled, as they should be. 7

The audit team noted that: a. With the exception of food business operators supplying their products to the feed chain (see finding 45), the DoA official controls, including sampling, apply 9 across the feed sector and cover traders/importers of feedingstuffs, feed manufacturers ­ both commercial feed mills and for own on-farm use, manufacturers of premix/mineral and complementary feed, primary producers and farmers and, since January 2020, also transporters. b. All of the operators visited by the audit team, subjected to the DoA controls, had been classified following risk assessment. c. The DoA official controls prioritise feed business operators handling imported/traded feedstuffs - which represent almost 100% of all feedingstuffs placed on the domestic market being preferentially selected for controls, based on risk. d. Every year the VMPS coordinator establishes a list of operators handling medicated feed (including medicated feedstuffs) and subject to official controls. The VMPS representative stated that all feed business operators manufacturing medicated feed are inspected on an annual basis. However, in accordance with the procedure CVS-SOP-701, those feed business operators who manufacture medicated feed for their own use are subject to inspection once every two years. The number of controls carried out mostly matched those planned. 5.3.2 Planning of official sampling and testing programmes

With the exception of food business operators supplying food and food by-products for feeding of farmed animals, both the DoA and Veterinary Services carry out their controls ­ inspections and sampling ­ regularly and along the entire feed chain, even though the controls on operators handling medicated feed are not risk-based. On the evidence of the records seen by the audit team and the situation on the spot in the establishments visited, the controls are capable of, and have, with the exception of operators' obligations to have procedures in place to verify the correct functioning of their HACCP systems, correctly identified non-compliances in operators' performances.

Member state response

. . , . () 2 . . . e Department of Agriculture will take the following actions to ensure e compliance with the requirements of Article 6(2)(f) of (EC) 183/2005: Further train the inspectors on the verification processes based on ed the guidelines published by DG SANCO (2005) and the Commission (Commission Notice on the implementation of food safety management systems covering prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses - 2016) related to food and the way to be applied in

The recommendation states as its basis

Notwithstanding the above, the audit team noted that none of the operators had established the procedures required by Article 6(2)(f) of Regulation (EC) No 183/2005 12 to verify that the measures on HACCP outlined in points (a) to (e) of the cited Article 6(2) were complete and working effectively. The operators and the authorities met explained that absence of such procedures resulted from their collective misinterpretation of this requirement. Thus, these had neither been put in place by operators nor requested by the authorities.

With the exception of food business operators supplying food and food by-products for feeding of farmed animals, both the DoA and Veterinary Services carry out their controls ­ inspections and sampling ­ regularly and along the entire feed chain, even though the controls on operators handling medicated feed are not risk-based. On the evidence of the records seen by the audit team and the situation on the spot in the establishments visited, the controls are capable of, and have, with the exception of operators' obligations to have procedures in place to verify the correct functioning of their HACCP systems, correctly identified non-compliances in operators' performances.

Member state response

feed. Modification of the instruction manuals to be clearer on the subject of HACCP principles verification processes. During inspections, more attention will be given on the verification of the procedures and, if required, appropriate corrective actions will be given to emphasize the operator's attention to the verification process. Actions to commence immediately and be finalized by October of 2020 and the verification will be on going

The recommendation states as its basis

Every sample is taken as a single item, as there are no provisions to sample in duplicate or to divide the collected sample. Operators are not asked if they want to waive this right. In this context, the competent authority fails to guarantee the right of feed and food business operators whose products are subject to sampling and analysis to obtain a legally valid sample in case they want to apply for a supplementary expert opinion, as required by EU legislation 13.

The implementation of the residue monitoring plan follows planned arrangements but does not guarantee the operators right to a second expert opinion. Its effectiveness is reduced by errors in targeting animals for sampling at slaughter and by not ensuring sample integrity (lack of tamper-proof seals) and traceability. 5.1.4. Other residue monitoring programmes Legal Requirements Articles 9 and 11 of Directive 96/23/EC; Articles 8 and 10 of Regulation (EC) No 882/2004. 13 Article 11(5) and 11(6) of Regulation (EU) No 882/2004. 14 Article 11.7 of Regulation (EU) No 882/2004. 15 Section 2.6 of the Annex to Commission Decision 98/179/EC. 16 Security seals are mechanisms used to seal containers in a way that provides tamper evidence and some level of security. Seals help to detect tampering, either accidental or deliberate. 17 Article 8(3) of Regulation 882/2004. 6 Findings

Member state response

eceived 6 August 2019 A letter was sent on the 23/10/2019 to all District Veterinary With a clear circular to the District Officers, Rural Veterinary Stations and Veterinary Officers placed at the red meat slaughterhouses in order to ensure that Veterinary Officers, the Regional the operator could exercise his right for a second expert Veterinary Officers, the Veterinary Officers opinion. of the Veterinary Stations, as well as the In case that the operator waives this right it should be done in responsible officials in the Slaughterhouses, written form. please note that if during the sampling it is (attachment no. 1) requested by the operator of the Food Business (FBO), a second sample (control sample) be taken, identified and duly kept by the competent authority, in order to ensure that the FBO could exercise his right to carry out the second expert's report by his own expert (at the expense of the FBO). the samples will be kept by the Veterinary Services (Veterinary Public Health Division).

The recommendation states as its basis

EU legislation 14 provides that samples must be handled and labelled in such a way as to guarantee both their legal and analytical validity. Whilst in Cyprus samples are collected in containers as required by EU legislation,15 , those containers, however, do not bear an individual identification mark to maintain sample traceability. The container is placed into a lightweight plastic bag that is then sealed. The seal 16 attaches the carton label to the bag. Plastic bags observed were fragile and easily damaged in the freezer, and the seals could be easily removed without breaking the bag. If a sample were to fall out of the bag, or the carton label were to be damaged, the traceability of the sample could not be ensured.

The implementation of the residue monitoring plan follows planned arrangements but does not guarantee the operators right to a second expert opinion. Its effectiveness is reduced by errors in targeting animals for sampling at slaughter and by not ensuring sample integrity (lack of tamper-proof seals) and traceability. 5.1.4. Other residue monitoring programmes Legal Requirements Articles 9 and 11 of Directive 96/23/EC; Articles 8 and 10 of Regulation (EC) No 882/2004. 13 Article 11(5) and 11(6) of Regulation (EU) No 882/2004. 14 Article 11.7 of Regulation (EU) No 882/2004. 15 Section 2.6 of the Annex to Commission Decision 98/179/EC. 16 Security seals are mechanisms used to seal containers in a way that provides tamper evidence and some level of security. Seals help to detect tampering, either accidental or deliberate. 17 Article 8(3) of Regulation 882/2004. 6 Findings

Member state response

Received 6 August 2019 A letter was sent on the 23/10/2019 to all District Veterinary Officers, Rural Veterinary Stations and Veterinary Officers By means of a clarifying circular to the placed at the red meat slaughterhouses to address this district veterinary officials, the Veterinary recommendation. Stations, as well as those responsible for (attachment no. 2) Slaughterhouses, they should be pointed out that, when samples are taken, they must Page: 1 authorities of Cyprus in response to Report ref. DG(SANTE)/2019-6652-MR of the audit carried out from 29 aluate the control of residues and contaminants in live animals and animal products including controls on Action Proposed by the competent Updated action plan received on 7 December 2019 authority ensure that, in order to ensure that traceability is maintained, the sequence number of the sample must be entered in each sample container. The samples are correctly sealed, maintained in more durable bags to ensure their integrity, and sealed with adhesive tape where the Veterinary Services logo is printed.

The recommendation states as its basis

Recommendation 7 of the 2014 audit report requested the competent authority to ensure effective coordination between and within the competent authorities 20, particularly in case of non-compliances (potentially) related to feed. In its action plan, the competent authority proposed to use (inter alia) a cooperation protocol and the checklist used by the inspectors to investigate non-compliances covers some information on the feed production and use on farm. However, despite the otherwise fluent communication between these services, during the investigation on the detection of semicarbazide in poultry muscle there was no consultation with the services in charge of controls on feed even though this residue could have been related to feed (either as a result of illegal treatment with nitrofurazone or as a contamination). The origin of the residue could not be determined.

The follow-up of non-compliant test results largely meets EU requirements but its effectiveness is reduced by delays in communicating the results after testing, and sometimes incomplete investigation (in cases where feed could be the origin).

Member state response

Received 6 August 2019 Amended Cooperation Protocol and letter (attachment no. 3) Date of entry into force: Immediate application In cooperation with the Office responsible for Feed Control of the Department of Agriculture, the Veterinary Services will proceed to an amendment to the Cooperation Protocol in order to inform both the Department of Agriculture, as the competent body, of its individual actions concerning the control of the feed used in this case, and the Veterinary Sector of the VS as the competent body for medicated feed, a body with which there is direct cooperation, when identifying a non- compliant result in animal products.

The recommendation states as its basis

In the slaughterhouse, the official veterinarian explained that carcasses with screening positive results for antibiotics were detained, but this detention was not always reflected in a report 21 to the operator. In the cases where the screening results were confirmed or when the owner declined a confirmatory analysis, the carcasses were sent to the rendering plant. However, not all of the commercial documents from the rendering plant were available for the non-compliant carcasses, and at least one bovine carcass went as Category 3 animal by-product material 22 19 Article 16 of Directive 96/23/EC. 20 Article 4(3) and (5) of Regulation 882/2004. 21 Article 9(2) of Reguslation (EC) No 882/2004. 22 Article 10 of Regulation (EC) No 1069/2009. 8 while it should have been classified as Category 2 23 animal by-product material (and processed accordingly). In practice, the Category 3 material can be used for the manufacturing of feed for farmed animals 24.

In a fish farm where residues of malachite green were confirmed, the initial sample was taken on 9 May 2017, and tested on 15 June. Follow-up samples were taken in July, August, October, and November with repeated non-compliances found in fish muscle. Samples taken in January 2018 were compliant. However, the detention of the animals was only documented since 9 August 2017. The ban on movementwas lifted on 23 February 2018. Between June and August 2017, fish from this farm had been placed on the market. The competent authority failed to ensure that, following the illegal treatment 25, the animals concerned were immediately placed under official control 26 and did not leave the farm. After the date of the ban there were no movements recorded.

The follow-up of non-compliant test results largely meets EU requirements but its effectiveness is reduced by delays in communicating the results after testing, and sometimes incomplete investigation (in cases where feed could be the origin).

Member state response

Received 6 August 2019 A letter was sent on the 29/10/2019 to all District Veterinary Officers, Rural Veterinary Stations and Veterinary Officers Page: 2 authorities of Cyprus in response to Report ref. DG(SANTE)/2019-6652-MR of the audit carried out from 29 aluate the control of residues and contaminants in live animals and animal products including controls on Action Proposed by the competent Updated action plan received on 7 December 2019 authority Instructions were given to staff of the placed at the red meat slaughterhouses informing them that in Veterinary Services, which are located in order to ensure that the detained carcasses will not leave the the slaughterhouses of ungulates, for each establishments, a copy of the detention form should be given to case of freezing of carcasses and viscera, to the FBO (both red meat slaughterhouses, poultry and rabbit provide the slaughterhouse operator with a slaughterhouses). copy of the form of commitment of all the slaughtered and eviscerated carcases, in For the ungulates slaughterhouses, a book with duplicated order to ensure that the slaughterhouse detention forms is being printed at the Government Printing Office (please see rele

The recommendation states as its basis

In the slaughterhouse, the official veterinarian explained that carcasses with screening positive results for antibiotics were detained, but this detention was not always reflected in a report 21 to the operator. In the cases where the screening results were confirmed or when the owner declined a confirmatory analysis, the carcasses were sent to the rendering plant. However, not all of the commercial documents from the rendering plant were available for the non-compliant carcasses, and at least one bovine carcass went as Category 3 animal by-product material 22 19 Article 16 of Directive 96/23/EC. 20 Article 4(3) and (5) of Regulation 882/2004. 21 Article 9(2) of Reguslation (EC) No 882/2004. 22 Article 10 of Regulation (EC) No 1069/2009. 8 while it should have been classified as Category 2 23 animal by-product material (and processed accordingly). In practice, the Category 3 material can be used for the manufacturing of feed for farmed animals 24.

The delayed detention of suspect animals on farm after an illegal treatment, the non-documented detention of carcasses at the slaughterhouse and errors in the categorisation of carcasses which had been confirmed not fit for human consumption, open the possibility to erroneously place unsafe products on the market.

Member state response

Received 6 August 2019 On the 6th August, a letter was sent to the District Veterinary Officers and to the OVs at the red meat slaughterhouses in Instructions were given to staff in the which the procedures for classifying the products according to Veterinary Services to correctly classify the Reg. (EC) No. 1069/2009 were being reminded, for the products which, in accordance with products that are not conformed to the residues requirements Regulation (EC) No 1069/2009 are not (please see attached letter). intended for human consumption. The Page: 3 authorities of Cyprus in response to Report ref. DG(SANTE)/2019-6652-MR of the audit carried out from 29 aluate the control of residues and contaminants in live animals and animal products including controls on the competent Updated action plan received on 7 December 2019 a holistic approach in In order for the Veterinary Services to address the procedure ossible for products for for the efficient detention of suspected carcasses and the tolerated. correct classification of the carcasses in case they do not comply with the residues legislation, three (3) forms have been sent to the Government Printing Office so they are printed as duplic

The recommendation states as its basis

With regard to method validation/verification, the audit team noted that: a. the multiresidue method for antibacterials (B1) has been validated for bovine milk and porcine muscle. If these substances have to be quantified in other matrices, a matrix-matched calibration curve is prepared in the relevant matrix and the recovery of the quality control sample spiked at the Maximum Residue Limit (MRL) is included in the control chart maintained for bovine milk or porcine muscle, respectively. This practice eliminates the matrix effect for matrices from species other than bovine/porcine and allows to assess the matrix effect of muscle/milk samples from other species. The control chart for pork muscle seen by the audit team demonstrated the lack of matrix effect for muscle samples from different animal species. b. so far the method has not been validated for amoxicillin, cefazolin, cefquinome, cephalexin, sulphachlorpyridazine and neomycin in muscle, though these analytes are tested for in routine samples; c. the performance of screening methods for antibacterial substances has been verified in bovine, broiler, pork and fish muscle but not in eggs which are also tested in this laboratory; d. at the VSL, methods for aflatoxin M1 in milk (screening and confirmation) have been validated in bovine milk whilst milk samples of other species (sheep, goats) are also tested for in this laboratory; e. the ELISA method used for screening aflatoxin M1 in milk has been validated as a quantitative method according to Decision 2002/657/EC. Therefore the cut- off level, as required by EU legislation applicable for mycotoxin analysis 30 has neither been calculated, nor verified annually; f. all other methods checked by the audit team have been validated in line with the relevant EU requirements 31. 30 Article 2 and Annex II to Regulation (EC) No 401/2006 31 Article 3 and 4 of Decision 2002/657/EC, Article 2 and Annex II to Regulation (EC) No 401/2006 11

Although not all analytical methods in use have been validated/verified for all substance/matrix combinations, the quality controls in place combined with frequent and satisfactory participation in proficiency tests support the reliability of the results generated under the residue monitoring plan.

Member state response

e Received 6 August 2019 The analytical methods used at the General Chemical Laboratory of the State Chemical Laboratory will be verified/validated for all matrix material by 2021. Namely the multi-residue method for antibacterial (B1): (a) is to be validated for amoxicillin, cefazolin, cefzoline, cefalexin, sulfachchloridazine and neomycin in muscle and (b) the method performance of the eggs will be verified Page: 5 authorities of Cyprus in response to Report ref. DG(SANTE)/2019-6652-MR of the audit carried out from 29 aluate the control of residues and contaminants in live animals and animal products including controls on Action Proposed by the competent Updated action plan received on 7 December 2019 authority 44.c: The Laboratory for the Control of Food of Animal Origin (LCFAO) of VS will in 2019 validate the screening method for antimicrobials and eggs. 44.d: The LCFAO of VS will validate and verify the confirmatory method and method of detection respectively in the goat and sheep milk in 2019. 44.e: The LCFAO of VS has already calculated the cut-off level.

The recommendation states as its basis

Recommendation 3 of the 2014 audit report requested the competent authority to ensure that food chain information included data on all veterinary medicinal products or other treatments administered within a relevant period and with withdrawal periods greater than zero days 51. The food chain information form for the animals slaughtered was available at the slaughterhouse visited, as required. Food chain information should include data on the veterinary medicinal products or other treatments administered within a relevant period and with withdrawal periods greater than zero days.

Following the 2014 report, the competent authority informed the Commission that the VPHS had revised the form for food chain information for animals for slaughter. In particular, point 7 of the form was revised and now includes space for up to seven veterinary medicines which were administered to animals in the two months prior to slaughter by any route of administration, and all stakeholders had been informed. The forms were used and presented to the slaughterhouse, except for one animal slaughtered on the day of the audit. The completed forms were forwarded to the Veterinary Service 52 and were systematically accepted by the official veterinarian, even though the following was remarked during the audit: the revised form was not always used for ruminants and pigs. Some (old versions) forms still in use required the reporting of treatments administered in the two months prior to slaughter, while other forms did not specify a period. In the first scenario, the reporting period would not be sufficient for authorised products with a withdrawal period longer than 60 days (at least eight such cases were noted at the time of the audit). In the second case, it was left to the farmer to decide the period for which treatments were declared. 51 Annex II, Section III, point 3c of Regulation (EC) No 853/2004. 52 Points 2, 5 and 7 of Section III, Annex II to Regulation 853/2004. 16 most of the forms were not filled in, except for the identification of the farm, and did not indicate the individual or group of animals covered by the information. The section on the treatments was neither filled in nor crossed out, giving rise to doubts as to whether it was left empty by error. The signature of the owner of the animals was missing on the most of forms checked by the audit team. the dairy farm did not keep copies of the food chain information forms, so it was not possible to reconcile during the audit the food chain information provided with the treatment records available. At the pig farm visited the owner explained that he kept copies but those were not available on the spot. Conclusions on authorisation, distribution and use

Requirements of food chain information are not enforced and the information accessible at the slaughterhouses does not support the guarantees that animals sent for slaughter, if treated with veterinary medicinal products, have been subject to the appropriate withdrawal period. 5.3.3. Official controls Legal Requirements Article 3, 4 and 8 of Regulation (EC) No 882/2004; Article 80 of Directive 2001/82/EC; Article 4(2) of Regulation (EC) No 854/2004. Findings

Member state response

Received 6 August 2019 On the 16/4/2019, an electronic letter was sent to the OVs at the Red meat slaughterhouses, with orders to better validate the new food chain form was prepared to be food chain information form and also place an announcement sent to the breed societies for distribution to for the breeders at the red meat slaughterhouses for informing their members for use. This form will them on measures in case the food chain information was not c replace the old versions of food chain forms according to the Reg. (EC) No. 853/2004 (attachment no. 7) and provide for a longer waiting time for medicines on the Cypriot market. On the 5/7/2019, an electronic letter had been sent to the Chief of the Cow breeders' association informing him on the new In addition, strict recommendations were food chain information form in order for him to publish the made to their managers in order to allow form to all of his members (attachment no. 8). them to accept only correctly completed On the 9/7/2019 and 10/7/2019, letters had been sent to the forms when assessing the food chain OVs placed at the red meat slaughterhouses, in order for them information. The matter is followed up by to validat

The recommendation states as its basis

Farmers in Cyprus are required to keep an inventory of medicinal products purchased and used. Such inventories were kept at the farms visited, but contrary to the requirements in EU legislation 49 (where keepers of food-producing animals need to maintain treatment records for a period of five years after the treatment), the registration of use of veterinary medicinal products (treatment records) presented deficiencies as follows: at the dairy farm the treatment records detailed the individual animals, the dates and the withdrawal periods. Withdrawal periods for milk were reflected in days, and did not permit a verification of whether the cow was excluded from commercial production for a sufficient number of milkings (withdrawal periods should be indicated in whole days, except for milk withdrawal periods, which may be more appropriately expressed in whole hours 50). The farmer stated that he always extended the withdrawal period by two days but this was not reflected in the records. at the pig farm, the farmer applied routine prophylactic treatments for the different age groups, through feed. Injectable medicines were in stock and the farmer confirmed that they were used when necessary. There were no records of these treatments. at the poultry farm, routine treatments of antibiotics used as prophylaxis after vaccinations were recorded for every shed, but the use of colistin (that had been prescribed by a veterinarian) was not recorded and could not be traced to any batch of animals (the prescription did not include this information). 48 Article 67 of Directive 2001/82/EC. 49 Directive 96/23/EC (Article 10), Directive 2001/82/EC (Article 69) and Regulation (EC) No 852/2004 (Annex I, Part A, III, 8(b)). 50 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-6/c/spcpharmaceuticals_10-07- 2006_en.pdf 15 At the aquaculture farm some treatments were recorded but the treatment with malachite green (see finding 32) that had led to the detection of residues in food had not been recorded. The operator explained that the malachite green was found in a storage room and used without recording the treatments. at the bee farm records of treatments were not kept; the reason provided by the beekeeper was that only veterinary medicinal products with zero withdrawal days were used and their administration was seasonal. There is no derogation for keeping treatment records in this respect.

The standard of record-keeping of treatments on farms was not in line with EU requirements, with the potential consequence of an increased risk of placing on the market animal products within the withdrawal periods. In the event that such violations would occur, the incompleteness of the records hampers the effectiveness of any follow-up investigations.

Member state response

eceived 6 August 2019 The individual veterinarians and farmers will be given a definitive indication of their individual obligation to carry out a strict application of measures and energy in order to ensure that the registration forms/registers of veterinary medicinal products for food producing animals are complied with in accordance with the legislation [Directive 96/23/EC (Article 10), Directive 2001/82/EC (Article 69) and Regulation 852/2004 (Annex I, Part A, III, 8 (b)). The staff of the VS will confirm any compliance through the on-site inspections that it will carry out on livestock facilities. In this context, a conference will be organised by the educational services of a conference which will be invited to follow as many parties as possible.

Member state response

Received 6 August 2019 With the implementation of the two new regulations will take place in January 2022 - 2019/6 for veterinary medicines and Veterinary Services will take the ced 2019/4 for medicated feed - will change the existing Page: 8 authorities of Cyprus in response to Report ref. DG(SANTE)/2019-6652-MR of the audit carried out from 29 aluate the control of residues and contaminants in live animals and animal products including controls on ion Proposed by the competent Updated action plan received on 7 December 2019 hority lowing remedial action. prescription system for the manufacture of medicated feed, Only one veterinary prescription will be which in the case there will be only one recipe. ued both for the preparation of a icated feed and for the purchase/supply medicated pre-mixes (veterinary icinal products) that will be used in the ufacturing of medicated feed. hitherto two recipes -- one for the paration of the medicated feed and 1 for purchase/supply of the veterinary icinal products (pre-mixes) orporated in the medicated feed -- will o cease to be issued. The level of control of veterinary scriptions will be intensified. The specifications have been set up and ef

The recommendation states as its basis

The Animal Health and Welfare Division (AHWD) of the VS is responsible for aquaculture farms (animal health issues).

Since the 2013 financial crisis, the number of VOs has been reduced by approximately 50% and 30% for Veterinary Inspectors.

Overtime is limited, making inspection visits out of working hours problematic. This is particularly relevant for inspections on vessels where operations such as landing of fishery products, may be outside normal office hours. 5.1.4 Training and knowledge of staff performing official controls

The audit team noted that: The checklists for aquaculture farms are restricted to animal health issues to the exclusion of public health issues. The vessel checklist in use (form for the unloading of fishery products) focusses on the general hygiene and organoleptic characteristics of fishery products at the time of unloading and onward transport. It does not make reference to the detailed vessel requirements laid down in Section VII, Chapter 1 of Annex III to Regulation (EC) No 853/2004. A new VS manual of staff instructions is under development containing operational guidelines, instructions and procedures to better guide inspectors. 5.1.7 Control activities, methods and techniques

There is a procedure for risk categorization of land-based establishments producing food, which are subject to inspection (including an inspection report template). This procedure is used by the officials when determining the frequency of inspections. In practice, official controls are carried out twice/year but sometimes more frequently, if the risk assessment requires this. Larger vessels (i.e. more than 12 meters in length and fishing for more than eight hours) are now inspected annually (previously up to four times per year) and there is a proposal (not yet adopted) to inspect RVs once every four years. Smaller vessels (less than 12 meters in length) and their associated landing sites are not included in this exercise as they and their landing operations/sites are not subject to inspection, as required under EU law.

The CAs are designated for the official controls throughout the whole production chain (including those at the "green line"). The structures, organisation, powers, staff knowledge and procedures in place (with the exception of those for landing sites and associated operations, small fishing vessels and public health aspects of aquaculture 6 farming), support the implementation of official controls and provide a good basis for meeting EU requirements.

The lack of on-the-spot oversight of district VS inspection staff, resource constraints and lack of efficient and effective co-operation (which is not compliant with Article 4(3) of Regulation (EC) No 882/2004) between services impair the effectiveness of the official controls that do take place.

Inspections are performed once per year by VS staff (more often if farms are co-located with a processing premises) and this is based upon animal health obligations using the checklist for "businesses producing aquaculture products" according to Council Directive 2006/88. They primarily look at veterinary medicinal products' residues, biosecurity and animal movements. VS officials have generally not been present at the slaughter/harvesting of fish.

Vessels between 10 to 12 meters in length and those with derogation (up to 15 meters) are not obliged to land in ports or fishing shelters. No pre-notification of landing is required. Operators must submit a paper landing return to DFMR within 48 hours.

Vessels less than 10 meters in length make monthly landing reports to DFMR by the 5th of the following month. These vessels can supply directly 30kg of fishery products 5 In their response to the draft report the CA stated that in response to a suspicion of fungal infection raised by the audit team, they sampled rainbow trout on 12/9/2019. Specimens were tested in the Veterinary Pathology, Bacteriology and Parasitology Laboratory (bacterial and fungal culture) with negative results. A letter was sent to the FBO for corrective action taking into account the behavioural characteristics of this fish species and the negative laboratory results. 11 (maximum of 50) per consumer/day. DFMR estimates that approximately 30% of their catch is sold this way.

The official control system is implemented in land-based establishments, RVs and certain fishing vessels but excludes smaller primary production fishing vessels, most landing sites/fishing shelters and harvesting of aquaculture products (public health aspects) which is not in compliance with EU requirements.

The recommendation states as its basis

The CAs had a system in place for undertaking initial verification of compliance prior to placing on the market for producers of PDO/PGI/TSG agricultural products and foodstuffs and GI spirit drinks. 5.2.3 Prioritisation of Official Controls Legal requirements Articles 37(1) and 38 of Regulation (EU) No 1151/2012. Articles 22(1) and 24 of Regulation (EC) No 110/2008. Article 3 of Regulation (EC) No 882/2004. Findings Agricultural products and foodstuffs

Official controls at producers/processors are announced which could reduce the effectiveness of the control system.

Member state response

Page: 1

The recommendation states as its basis

The VS established an internal audit system in 2007. In mid-2016 a decision was taken to reorganise the internal audit arrangements and to suspend the internal audit system until new arrangements could be put in place. Therefore, no audits were carried out between mid-2016 and 2017 and no audits are planned for 2018. 3 3 In their response to the draft report the VS provided information on the reasons for the suspension of their audit system. 7 Conclusions

Responsibility for auditing of official controls has been clearly allocated and all competent authorities carrying out official controls have put internal audit arrangements in place with the exception of the VS, which have temporarily suspended their audit system. Therefore, VS has currently no internal audit system in place as required by Article 4(6) of Regulation (EC) No 882/2004.

Member state response

Due to certain issues which have been raised in relation to the proper function of both the Confirmatory Checks auditor's Pool (CCaP) and the realization of the Confirmatory Checks (CCs), the VS management has decided to review and reconsider, the Confirmatory Checks auditor's Pool (CCaP) membership issue; their terms of reference, their level of authority/competencies, the organization format of the CCaP and the realization of the CCs. As a result it is expected that the VS's CCs review and reorganization will be finalized and the CCs reinitiated, by the end of 2019.

Member state response

ine 1 717 2 228 .docx 2004 2002 99.pd2004 96 93.pdf 3.pdf 4 229 2004 97 78.pdf

The recommendation states as its basis

GMO controls of feed mills are part of hazard analysis and critical control points (HACCP) inspections. The inspection frequency is subject to the risk profile of the company for aspects other than GMO, such as the production of medicated feed, the use of proteins of animal origin and production volume. The audit team observed at the feed mill visited that there was potential risk of contamination as GM and non GM feed were manufactured on the same line. However, the risk of GM cross-contamination in feed mills manufacturing compound feeds both with and without GMO and potential non- compliance with labelling requirements in that regard has not been covered by the CAs in the framework of official controls (see also paragraph 45 below).

Controls for GMOs in feed do not verify compliance with labelling requirements in relation to potential cross-contamination. Therefore official controls can overlook that such requirements are not implemented by feed business operators.

The audit team visited a seaport and one feed mill and observed a sampling demonstration and noted that: The feed mill was inspected once a year as confirmed by the feed inspector. Although the company produced compound feed containing GM soya bean (labelled as GM) and compound feed without it (not labelled as GM) on the same production 10 line, HACCP based procedures did not consider the risks posed by cross- contamination of non-GM products by GM soya bean. As stated by the feed mill, they carry out flushing of the production lines when producing different products, however, the company has never assessed that this flushing procedure was effective in preventing the risk of cross-contamination with GMOs. Thus there is a potential risk that non-GM products contain GMOs above threshold level for labelling. This is not in line with Article 24(3) of Regulation (EC) 1829/2003 which requires that operators take appropriate steps to avoid the presence of GMOs in non-GM products. The feed inspectors stated that as part of inspections to feed mills they did not verify that there were measures in place to avoid cross-contamination of non-GM products. The feed inspector in the seaport confirmed his presence during unloading of the feed and explained the controls and sampling he conducts. The feed inspectors confirmed the training they received for sampling and were equipped with the appropriate sampling tools and guidelines. The feed sampling demonstration observed was appropriate (see also chapter 5.3.4 below). Conclusions on controls of GMOs in food and feed

The implementation of the control system in food and feed is generally appropriate. However, there is a lack of verification during official controls on the labelling requirements in relation to potential risk of cross-contamination from GM products. 5.3.3 Controls of specific import requirements Legal requirements Articles 3, 4, 5 and 6 of Commission Implementing Decision 2011/884/EU. Findings

Member state response

epartment of Agriculture will promptly send a relevant letter to all Commercial Feed Mills, with the following recommendations: 1. At the label of all the feed that do not contain GM material, a disclaimer that: "This feed may contain traces of genetically modified soya" should be stated. 2. Obligation of Feed Business Operators to Reply from the DA: perform own checks to ensure that there is no 1. The letter to the Commercial Feed cross contamination. Mills and Cyprus Association of Feed Manufacturers sent on 6th July Finally, the Competent Authority in the 2017. A signed letter is attached. context of official controls on commercial 2. Special checks at Feed Mills will feed mills will also carry out special checks carried out by Competent Authority on the subject, including sampling, to ensure in the context of official controls until the end of 2017. compliance with the provisions of the legislation regarding cross-contamination.

The recommendation states as its basis

The CAs have access to a broad scope of GMO analytical capability, but have assured 14 the reliability of test results only for a minority of the analytical methods used for official controls. 5.3.6 Enforcement measures Legal requirements Articles 4(5) and 33 of Directive 2001/18/EC. Articles 45 of Regulation (EC) No 1829/2003. Article 11 of Regulation (EC) No 1830/2003. Findings

Member state response

he Department of Agriculture, when preparing the new contract with the Analytical Laboratory of the Department of Agriculture, will include the following requirement: "All methods applied to the analysis of samples taken in the context of official Page: 1 s (updated) received 4/8/2017 ted by the competent authorities of Cyprus in response to Report ref. DG(SANTE)/2017-6177-MR of the audit der to assess the official controls of genetically modified organisms including their deliberate release into the ority Updated Action proposed by the Competent Authority scope ther as Reply from the DA: 1. The implementation of the action will be after done in January 2018 when the new contract with the Analytical Laboratory of the DA the will be prepared. ts for another 2.Already in action re no y: ble ody e methods or official the ory. edited ements. Page: 2

The recommendation states as its basis

The audit team noted that the officials met during the visits in the dairy processing establishments had a limited knowledge with regard to evaluation of FBOs' HACCP- based procedures (see paragraph No 60); The CCA stated that no specific training on HACCP-based procedures has been provided so far. Conclusions on training

A system for training of officials and for keeping their competence up-to-date is in place and the knowledge of the officials met was in general satisfactory, with the exception of HACCP-based programmes. 5.1.9 Enforcement measures Legal requirements Article 54 of Regulation (EC) No 882/2004. Findings

The documented official controls seen by the audit team showed that, in some cases, non-conformities such as non-updated procedures, absence of action thresholds for certain microbiological criteria to be set by the FBO, corrective actions not reflected in the real activity of the establishment (e.g. acceptance of raw milk exceeding the limits for TPC/SCC and notification to the CA, potable water treatment, etc.), were not properly identified and evaluated by the CA.

The evaluation of FBOs' HACCP-based systems is included in the inspection checklist for processing establishments. However, the checklist includes a generic reference to the existence of HACCP-based systems and to their evaluation. No instructions on how to evaluate HACCP-based programmes had been provided to official staff at the time of the audit. The audit team noted that some of the official staff interviewed had a limited knowledge in the matter. Conclusions on HACCP based systems

Official controls do not sufficiently verify the implementation of HACCP-based procedures by the FBOs, thus possibly overlooking incompletely designed and implemented HACCP-based procedures. 5.2.3 Microbiological criteria for foodstuffs Legal requirements Article 4 of Regulation (EC) No 854/2004 and Regulation (EC) No 2073/2005. Findings

The recommendation states as its basis

Control of incoming raw materials: In two establishments visited the FBOs did not follow their own procedures for incoming raw materials. In several establishments several incoming carcasses were found with illegible health marks. None of the FBOs had taken corrective actions on receipt of these carcasses. In two establishments, for several carcasses arriving from the same slaughterhouse, the post-mortem inspection was not completed (not all lymph nodes were properly inspected). Some carcasses displayed faecal contamination. In one establishment visited, records for incoming raw materials were not up to date. In two establishments visited, there was no documented evidence regarding the origin and identification of the incoming carcasses (these establishments were supplied from the slaughterhouse mentioned in the next bullet point). In one of the two establishments, raw material was seen without an identification mark or a label. In the same establishment, the origin of other ingredients such as herbs and spices could also not be ascertained through documented evidence. In one slaughterhouse visited, the FBO did not provide all the necessary information for carcasses at the point of dispatch. This is not in line with the requirement of Regulation (EU) No 931/2011. In this establishment there was also some unidentified cut meat present in the cold store. Many carcasses had illegible health marks. 7

However, in several cases, official controls were performed in a perfunctory way, without identifying systemic deficiencies regarding traceability and labelling. In addition at one slaughterhouse visited the post-mortem inspection was incomplete and many carcasses had illegible health marks. The follow up of the deficiencies identified by the CA is not efficient.

The recommendation states as its basis

Control of incoming raw materials: In two establishments visited the FBOs did not follow their own procedures for incoming raw materials. In several establishments several incoming carcasses were found with illegible health marks. None of the FBOs had taken corrective actions on receipt of these carcasses. In two establishments, for several carcasses arriving from the same slaughterhouse, the post-mortem inspection was not completed (not all lymph nodes were properly inspected). Some carcasses displayed faecal contamination. In one establishment visited, records for incoming raw materials were not up to date. In two establishments visited, there was no documented evidence regarding the origin and identification of the incoming carcasses (these establishments were supplied from the slaughterhouse mentioned in the next bullet point). In one of the two establishments, raw material was seen without an identification mark or a label. In the same establishment, the origin of other ingredients such as herbs and spices could also not be ascertained through documented evidence. In one slaughterhouse visited, the FBO did not provide all the necessary information for carcasses at the point of dispatch. This is not in line with the requirement of Regulation (EU) No 931/2011. In this establishment there was also some unidentified cut meat present in the cold store. Many carcasses had illegible health marks. 7

Traceability: In all establishments visited, the FBOs have in place traceability systems for incoming raw materials, intermediate and final products, however, in several establishments these procedures were applied with varying levels of quality. In most establishments, the traceability systems were not reliable and were dependent on individual staff members' knowledge of the physical movement of products within the establishment rather than on an official procedure.

However, in several cases, official controls were performed in a perfunctory way, without identifying systemic deficiencies regarding traceability and labelling. In addition at one slaughterhouse visited the post-mortem inspection was incomplete and many carcasses had illegible health marks. The follow up of the deficiencies identified by the CA is not efficient.

Member state response

ervations: 7,8,9,10,18,30,31,33 / , , , / / [Directive 96/23/EC (Article 10), Directive 2001/82/EC (Article 69) and Regulation 852/2004 (Annex I, Part A, III, 8(b)]. , . / .

Member state response

Observations: 9,10,18,30,31,33 / / . FVO , . , ' Page: 1 2014 ref. DG(SANCO)/2014-7028 -MR of a/an audit carried out from 18 icinal products and coccidiostats and the monitoring of residues and Page: 2 hority on 29 July 2014 ref. DG(SANCO)/2014-7028 -MR of a/an audit carried out from 18 icinal products and coccidiostats and the monitoring of residues and . .

The recommendation states as its basis

There is a standard form for food chain information for bovines, sheep and goats. According to the instruction on the form the veterinary medicinal products to be declared are only those delivered parenterally or in feed. It is thus not clear whether other routes of administration (e.g. by pour-on, bolus or via drinking water) should be mentioned. The period for which the use of medicines should be declared was unspecified in the instructions and the audit team observed that this was interpreted in different ways by farmers. Annex II Section III point 3c of Regulation 853/2004, requires that food chain information includes data on the veterinary medicinal products or other treatments administered within a relevant period and with withdrawal periods greater than zero days.

Member state response

bservations: 11,18 () : . , 7 (7. 2 .

The recommendation states as its basis

Although official staff interviewed by the audit team at the slaughterhouse and DVO/RVS visited were knowledgeable about targeting criteria, all samples (both for group A and group B substances) from slaughtered and live animals were taken randomly. Food chain information and carcase conformation were not considered in relation to the substance(s) the samples would be tested for, although the latter was clearly indicated in the sampling order. Overall there was no evidence that producers linked to non-compliant results had been targeted in subsequent years. Annex III (section 2) to Directive 96/23/EC stipulates that for group substances A samples must be targeted. The same Annex III indicates under section 3 that group B substances samples must be targeted unless random sampling can be justified by the Member State when presenting its residue monitoring plan. The 2013 residue monitoring plan submitted by the VS to the European Commission contains however clear targeting criteria in line with Decision 98/179/EC.

Member state response

Observations: 45,49 , , » , . , .

The recommendation states as its basis

Sampling containers, their sealing, and standardised sampling reports were in accordance with the requirements of section 2.6 and 2.7 of the Annex to Commission Decision 98/179/EC. Nevertheless, the audit team noted that for feed samples taken on farm the product was not adequately identified on the sampling forms (required by 8th indent of 9 section 2.7). There was no batch number of the feed or sampling spot on the farm (shed, silo, trough) indicated.

Member state response

ervations: 46,49 Page: 3 on 29 July 2014 ref. DG(SANCO)/2014-7028 -MR of a/an audit carried out from 18 icinal products and coccidiostats and the monitoring of residues and

The recommendation states as its basis

Storage and transport conditions have been specified in the sampling instruction in accordance with section 2.9 of the Annex to Decision 98/179/EC. However, the temperatures at which samples were stored in the fridge/freezer of the VS in the slaughterhouse visited were not controlled. In line with the sampling instruction, samples which would be transported the same day were stored in a refrigerator and samples which would be transported later in a freezer. The fridge did not have a temperature measuring device, for which reason it could not be verified whether the temperature specifications of the sampling instruction were met. The (un-calibrated) thermometer of the freezer showed a temperature of -11°C at the time of the visit and there was no temperature log. According to the instruction (which was available on-the-spot) samples should be kept between -15 and -20°C.

Member state response

Observations: 47,49

The recommendation states as its basis

Approximately half of the non-compliances reported from the residue monitoring plan and other residue programmes in the period 2011 to 2013 were directly or potentially related to feed. In these cases the Department of Agriculture and the VMPS were often not informed by the VPHS. Consequently, the supplying feed mills were not investigated and feed samples of the original batch retained by the mills or farms were not analysed in order to establish whether contamination of the feed took place on the farm, in the feed mill or during transport. This should have been feasible if the sampling form had contained more detailed information (see also finding 46). In some cases follow-up samples were taken from livestock as part of the investigation, but at least six weeks after the initial monitoring samples. Residues could have washed out in the meantime and broilers or rabbits sampled could have been animals from a different unit or a subsequent production round. Article 4(2(a)) of Regulation 882/2004 requires competent authorities to ensure that official 11 controls are effective an appropriate and Article 4(3) and (5) requires competent authorities to ensure effective coordination between and within the competent authorities. Recommendations 6 and 7 of the 2009 FVO report have not been fully addressed in this regard. Conclusions on follow-up of non-compliant results

Member state response

tions: 58,59 Page: 4

Member state response

re strengthening the quality control of pesticides from with the implementation of an annual plan of control that 5% of the products on the market.

Member state response

y authorised PPPs are used as required by Article 28 of C) No 1107/2009, the CA will increase the number of rols on the use of PPPs from 2014 onwards and strengthen the Police and the Customs in order to avoid illegal tering the Republic of Cyprus. The LC/MS/MS will be used amples to detect unexpected active substances and

Member state response

nsure strengthening official controls on the use of PPPs s. Information kept by the District Offices of the DA g Agency with regards to the number of growers, the crops tivated, will be evaluated in order to increase the number ontrols by at least 50%.

Member state response

of the LC/MS/MS system for the determination of has already broadened the analytical scope of the laboratory at the DA and shall continue in this way, in that, until the end of 2014, the full range of PPPs r use in Cyprus are covered as well as illegal pesticides. Page: 1 NCO)/2013-6635-MR of an audit carried out ion Proposed by the Competent Authority

Member state response

e already given to inspectors in order to describe in their ified measures to be undertaken by the operator, in case

Member state response

on the scope and the results of official controls on the use will be timely transmitted to the Commission from

Member state response

e Paying Agency have already agreed to exchange n controls and infringements concerning PPP legislation. e procedures in order to ensure an efficient and ion from 2013 onwards. Page: 2

Member state response

VETERINARY SERVICES 1. The check lists used for the official controls have been reviewed by the VPHD. The check lists included the requirements mentioned in Reg. (EC) No 2073/2005 and the control of HACCP system used by FBOs. (VS- Attachment 1). 2. Instructions have been given either to DVOs or FBOs as regards the implementation of the above requirements. (VS- Attachments 3-7, 9-15a) 3. Instruction has been given to the private laboratories for the validation of the alternative methods based on internationally accepted protocols. (VS- Attachment 2) 4. Instruction has been send by the NRL of VS to the SGL for the coordination as regards the obligations of the NRLs for Salmonella & E.coli (VS- Attachment 8) PUBLIC HEALTH SERVICES 1. Inclusion in the current Code of Practice for the Official Controls of Food Businesses a separate chapter in relation to the enforcement of the Regulation. Deadline: 30/9/2013 2. Preparation of a Guidance Document for the FBOs which will include all necessary information as regards the implementation of the Regulation. Deadline: 30/9/2013 3. Training of all the involved staff for the provisions of the Regulation as well as for its enforcement. Deadline: 3

Member state response

ination VETERINARY SERVICES as 1. Instruction has been send by the NRL of VS to the SGL for the coordination as regards Page: 1 CA response received 31 May 2013 ities of Cyprus on 04 July in response to Report ref. DG(SANCO)/2013-6867-MR of an audit in order to evaluate the official controls on food safety and process hygiene criteria ction Proposed by the Competent Authority (EC) No the obligations of the NRLs for Salmonella & E.coli (VS- Attachment 8) . A letter has been sent from VPHD to PHS to send directly the information by fax, and iant verify the receiving by phone, in order to avoid the delays of taking the adequate corrective EC) No action in due time. (VS- Attachment 6) UBLIC HEALTH SERVICES . As regards the co-ordination within the Public Health Services, the Public Health nspectors in charge of each District were re-informed, in writing, on their obligation, in ases where they receive non-compliant results from the State General Laboratory of amples of food that fall in the responsibility of the Veterinary Services, to send, mmediately, by fax, these results to the Director of the Veterinary Services. Deadline: one ENERAL STATE LABATORY t has already been agreed that a

Member state response

1a) The Veterinary Public Health Division · In order to verify the effectiveness of the official controls, the (VPHD) drafted the 2012 audit program for coordinators of the VPHD with the OV of the DVO, during the audit of e District Veterinary Offices (DVOs) which the DVOs, perform an on-spot inspection at one establishment chosen s sent to the DVOs on 1 February 2012. The by the coordinators. During this inspection, the OV of the DVO t will be carried out by the VPHDcoordinators who completes a checklist with his observations. The coordinator of the will inspect the DVOs inorder to verify that the VPHD also writes separately his observations about the OV's appropriate measures aretaken and that the objectives inspection and after discussing them with him, he writes them on the of Regulation (EC)No 882/2004 are achieved. The DVOs' audit checklist. program was given to the FVO inspectors during · Additional training has been provided to the Coordinators of the theinspection. Please note that an on-the-spotcheck of VPHD by the CVO if VS, who was the head of the Unit of Internal Audit. the establishments producing food ofanimal origin will The training took place in March. also be car