Sweden

The recommendation states as its basis

The SCA uses a list of first-tier suppliers derived from the companies listed in the SCA's product register. The SCA acknowledged that the list is not complete as regards first-tier suppliers as the operators that have registered themselves are not always the operators responsible in Sweden. Moreover, the information collected about the operators´ activities in the PPP register is very basic (only name and address of the headquarters of the company) and limits the planning of controls (see paragraph 64). In addition to the product register, the SCA may also consult the SCA's pesticide register which contains information on all PPPs that are authorised or have been authorised in Sweden.

Regarding marketing and agricultural users, each MUP is responsible for maintaining its own register/list. The audit team visited four MUPs and all stated that they are working with lists. All MUPs acknowledged that the list of operators is a work in progress. It is updated with the information they get from their activities, complaints gathered during 8 visits carried out in the framework of projects intended for other purposes, etc. They acknowledged that the lists may not include all operators relevant for the controls of PPPs. Training for acquiring PPP certificates

The CABs organise training programmes for operators and advisors. This training results in the issuance of certificates that qualify individuals for activities related to the distribution, sale, or use of PPPs. The SBA maintains a list of those who have successfully completed the training. Planning of official controls on marketing and distribution of PPPs

The inspection covered most aspects relevant for the official control of PPPs. The SCA checked the labelling of seven products, asked for the training certificate of staff and verified some of the records kept by the company. However, the warehouse and re-packer facilities, mentioned above, were not part of the inspection (see also paragraph 36). Controls at retailers/distributors of PPPs

The audit team noted good examples of collaborations between the SCA and Customs. Customs sent 11 inquiries to the SCA in 2023, and 3 illegal PPPs were detected as a result. In 2024, 46 inquiries were sent, and 39 illegal PPPs were detected. Conclusions on controls on the marketing of plant protection products

The recommendation states as its basis

MUPs are responsible for controls at non-agricultural users. In one MUP visited, inspections are determined by an assessment following the guidance issued by the Environmental Agency and also on experience gained from previous controls. For example, golf courses are classified as low risk, with a frequency of one visit every 5 years. The MUP stated that due to limited resources, visits do not always cover all aspects relevant for the use of PPPs. Sometimes inspections are part of projects that focus on only one or a few specific aspects. For example, the previous inspection focused on whether the required distances between spots where PPPs were applied and ditches and water courses were respected. In another MUP, golf courses are inspected every other year. Inspections are typically announced in advance.

The audit team found that inspection of farmers has not been consistently conducted in recent years, according to information provided by the MUPs. The MUPs reported difficulties in meeting the inspection frequency recommended by the SCA and the SBA due to resource constraints. In one MUP visited, out of approximately 350 farmers, only three were inspected in 2023, and those inspections were solely for fertilizer controls. In 2024, only 11 farms were inspected, despite an annual target of around 55. Another MUP visited indicated that they do not maintain specific statistics on the controls of PPP users. 10 They can provide numbers for the total inspections conducted, but these may not align with the planned or expected inspections specifically related to PPP use. This approach does not fully comply with Articles 9(1) and 24(1) and (2) of Regulation (EU) 2017/625.

The water framework directive results are taken into account for controls. However, the results of the national pesticide residue programme mentioned are not always taken into account for the planning of inspections. This is not in line with Article 24(2)(a) of Regulation (EU) 2017/625. The audit team considered that the results that show use of unauthorised PPPs, as well as those showing exceedance of maximum residue levels for authorised PPPs would be relevant for follow-up during inspections.

Inspections of users are announced, normally four weeks in advance. Inspections to follow up on problems found previously can be "unannounced" (although warning can be given 24 hours in advance). The CAs stated that the advance notice is necessary, as growers are often not present on farms. This is not in line 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

There is guidance for MUPs to determine inspection frequency based on risk criteria. However, the lack of a well-defined and comprehensive list of operators for control, the currently reduced frequency and limited scope of routine inspections may reduce the general effectiveness of these controls. In addition, the sampling procedure is not in line with the official control regulation.

The recommendation states as its basis

MUPs are in charge of controls of operators marketing PPPs not covered by the SCA controls, i.e. retailers, wholesalers and distributors. The SCA, in collaboration with the SAB has prepared guidance for risk assessment and determining the frequency of the visits. The MUPs may use this guidance but are not obliged to follow it. In principle, inspections carried out by the MUPs of marketing of PPPs are unannounced. 9

Agricultural users are selected for inspections based on risk criteria outlined in the guidance prepared by the SBA. One of the key criteria is farm size. For example, farms smaller than 50 ha must be inspected at least every five years and larger ones every three or four years. The MUPs also consider the results of previous controls, adjusting the frequency accordingly. These criteria mainly apply to arable crops, while different risk criteria apply for other type of users The MUP stated that for inspections of greenhouses, they follow the Swedish Environmental Code, focusing primarily on structural integrity and checking for potential leakages, rather than concentrating on PPP usage. This approach deviates from the primary purpose of these controls, which should be to verify the use of PPPs by operators. This is not in line with Articles 9(1) and 24(1) and (2) of Regulation (EU) 2017/625.

The SCA develops an annual sampling plan based on risk criteria. These criteria follow the EU draft 2018 guidance document, version 1, and include: 50% of the products selected are those with high sales volumes, 25% are high-risk products with, for example, a history of non-compliance, and 25% are chosen randomly. Additionally, the focus is on whether products are intended for professional or private use, with a priority given to products for professional use. The PPPs analysed in 2023 were selected on the basis of the following criteria: all the products contained active substances included in the price list agreed with the laboratory, were approved for professional use in Sweden and were in distributors' stocks. Most of the products had been included in previous programmes due to high sales volumes, and a few of them were among the products that the Nordic countries had agreed to analyse. While products with previous non-compliance issues were considered, they could not be included in the plan.

The tasks related to the authorisation and control on the marketing and use of PPPs have not been delegated and are carried out by the CAs. Conclusions on delegation of certain tasks

The recommendation states as its basis

This approach does not comply with Articles 2(1), 14(h) 24(1) and 34(5) of Regulation (EU) 2017/625, as samples collected and sent by the operators cannot be considered as part of official controls. It is also not correct to allow for a counter sample without meeting all the conditions outlined in Article 35 of the same regulation.

The laboratory reports of the samples analysed in recent years revealed only a few non- compliant results. Apart from a reservation on the independence of the sampling, referred to above, it would provide reasonable assurance that PPPs marketed are those that have 11 been authorised. From 2018 to 2023, analyses were conducted on 19, 50, 20, 19, 24, and 29 products respectively, with only three cases of non-compliance detected during this period.

The laboratory carrying out the analysis for the quality control of PPPs is designated and accredited to ISO/IEC 17025. However, not including analyses for unacceptable co- formulants and regulated impurities in the sampling programme reduces the overall capability of the control system to ensure the safety of the PPPs placed on the market.

The recommendation states as its basis

A Danish laboratory, accredited to ISO/IEC 17025, has been designated for performing tests to analyse the formulation quality of PPPs.

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. This lack of verification had not been detected by CAs, as not all of them had carried out an audit 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 report identified these issues and acknowledged the need for better collaboration and supervision of activities carried out by the MUPs. Conclusions on the competent authorities for official controls

The roles and responsibilities of the CAs are clearly defined, with cooperation between CAs.

The audit team observed three inspections conducted by two MUPs at two retailers/distributors selling PPPs for professional use and at a garden centre selling PPPs for non-professional use.

The inspectors carried out an exhaustive check of the conditions of the storage with the aim to ensure that storage of PPPs is safe and that operators have all measures in place to avoid contamination of the surroundings in case of accident.

The audit team interviewed the customs officials at the border control post and noted that the officials were well-versed in the procedures and authorised to sign import approvals. According to the procedure, Customs carries out controls at the import points of any consignment of PPPs or active substances declared by importers and identified by relevant tariff codes. The SCA presented good examples of collaboration with customs to detect the illegal trade of PPPs. The audit team visited the custom offices and the custom warehouse where a physical check was carried out. The customs officials conduct documentary checks for all imports of PPPs and active substances notified, ensuring all documents in the import approval are reviewed. If there are any uncertainties, customs officials can contact the SCA for clarification.

The inspectors reviewed the application records to confirm that they contained the minimum information required by the checklist, but did not cross-check the accuracy and reliability of these records. They do not request invoices to verify whether PPPs recorded were purchased or if recorded quantities are realistic for use on the corresponding areas where PPPs were used. This lack of verification goes against Article 14(e) of Regulation (EU) 2017/625 and Article 55 of Regulation (EC) No 1107/2009 and prevents a technical evaluation of PPP usage. 16

Inspections do not always include visits to areas where PPPs were used, even when crops are present. Inspectors indicated that their checklists do not prompt visits to areas where PPPs were used. Some inspectors reported they might visit a few areas where PPPs were used, while others do not, as it is not required. The lack of guidance in the inspection procedure is not in line with Article 12(1) of Regulation (EU) 2017/625, and systematically omitting visits to areas where PPPs were used is not in line with Article 14(b)(i) and (d), limiting data collection and reducing the likelihood of detecting unauthorised PPP applications (missing of information about crops and areas cultivated, buffer zones, water courses, etc).

There are some IT programmes developed by the SBA that are very useful for the proper application of PPPs. The farmers visited used such programmes. Another positive aspect that the audit team noted during all their visits to farms, is that measures to limit or avoid the contamination of water courses or ground waters are always checked. Control of non-agricultural users

The audit team examined cases of non-compliances found during MUPs inspections and noted that the follow-up is satisfactory, and sanctions are imposed on the non-compliant operators, including the taking of corrective actions. Evidence of these was provided to the audit team. Conclusions on controls on the use of plant protection products

The recommendation states as its basis

The audit team noted that compliance of professional operators with the requirements of Article 1(b)(d) of Regulation (EU) 2019/827, such as competence to conduct plant health examinations and to apply best practices and measures to prevent the presence and spread of plant pests, is not verified during the authorisation process. This is not in line with Article 89(1) of Regulation (EU) 2016/2031.

For compliance with Article 2 (a)(b)(c) of Regulation (EU) 2019/827, SBA has provided operators some information on their website, mainly for priority pests and for some EU quarantine pests such as regulated potato pests. For other pests, links to the EPPO global database were made available (information is in English only). The CA has not provided operators information on modalities of visual inspections as required by Article (2)(b) of Regulation (EU) 2019/827 and information on best practices and measures to prevent pest presences as required by Article (2)(c) of the same Regulation. 5.3.2 Official supervision of professional operators and verification of their actions

As inspection guidelines and checklists do not require verification of the authorised op- erators' compliance with the requirements of Articles 87 and 90 on the appropriateness of authorised operators' examinations and obligation to keep records on examinations, compliance with these requirements was not included in any of the observed inspections. This is not in line with Article 92(1) of Regulation (EU) 2016/2031. Conclusions on authorisation and supervision of professional operators for issuing plant passports:

The system of authorisation of professional operators to issue plant passports follows rules established in EU legislation. However, the CA has neither provided authorised operators with the information needed to carry out meticulous inspections independent- ly and at critical points, nor has it required them to keep records of such inspections. Moreover, there is no requirement in the guidelines for the CA to verify compliance to the abovementioned criteria. These shortcomings increase the risk that operators do not carry out their inspections meticulously, and that they place plants on the market, in- fested with regulated pests.

Operators met by the audit team stated that they check their plants constantly as they go about their work, even though formally not required to do so by the SBA. However, as operators visited had never documented this activity, as required by Article 87(3)(d) of Regulation (EU) 2016/2031, the audit team could not verify that authorised operators conduct meticulous examinations in line with Article 87(3) of Regulation (EU) 2016/2031 prior to issuing plant passports. In addition, only one of the operators met by 8 the audit team had defined their critical points and the list of pests for monitoring pur- poses as required by Article 90(1) of Regulation (EU) 2016/2031. No records are kept on monitoring by authorised operators. The reason for not undertaking this task is the lack of specific requirements and official controls by the SBA as stated in point 27 in section 5.3.2. 5.4.2 Examinations by competent authorities including the verification of examinations carried out by authorised operators

The lack of evidence that authorised operators carry out meticulous examinations prior to issuing plant passports, and the absence of controls to verify this, provides insuffi- cient assurance that plants for which plant passports have been granted in Sweden are free of relevant pests.

The official controls on sales through distance contracts are undertaken at those opera- tors who had registered this specific activity in the national plant health registry. The of- ficial controls at operators issuing plant passports are undertaken as described under sec- tions 5.3 to 5.5, with the inspection scope focusing mainly on the format and attachment of the plant passports and traceability. Authorised operators' compliance with the re- quirements of Articles 87 and 90 on the appropriateness of authorised operators' exami- nations and obligation to keep records on examinations is not verified by the CA. The inspection frequency for 2022 and 2023 was met and no non-compliances were reported regarding plant passports and traceability. Conclusions on official controls on movement of plants and plant products with plant passports

Similar to the official controls at other operators authorised to issue plant passports, the controls at the operators that sell their products through distance contracts provide in- sufficient assurance that plants for which plant passports have been granted in Sweden are free of relevant pests.

Member state response

The competent authority (SBA) will ensure that the authorised operators and operators seeking authorisation prior to issuing nt passports conduct and properly record the meticulous examinations. The SBA will ensure that those operators identify itor critical points within their production processes. This will be achieved through an amendment of the SBA guidance, instructions and check list for official controls as well as the performance of the official controls themselves, in order to achieve better compliance with the requirements in Article 87(3) and 90(1) of Regulation (EU) 2016/2031. The SBA plans to achieve those adaptations in a phased pproach, as follows: 1 - By the end of the year, the SBA will have developed relevant information with the intention to start disseminating it via the web and through direct communication channels to authorized operators. 2 - By the end of the year the SBA will have adjusted its guidance on controls in order to enable corresponding adjustments of the control instructions and check list for 2025. 3 - The controls will be carried out accordingly after the guidance on controls, control instruction and check list documents are amended, if possible

The recommendation states as its basis

The audit team verified the application of enforcement action for a case where the pro- tected zone pest Bemisia tabaci was found during the annual inspection for plant pass- 12 port purposes in September 2023. Although the operator was ordered to apply insecti- cides and a deadline of approximately 10 days was provided, no follow up inspection was conducted to verify if the pest eradication measures were applied and had been ef- fective. According to the SBA, the follow up as an additional inspection to the annual plant passport inspection was scheduled for February 2024.2 A similar approach was ob- served for the finding of Bemisia tabaci in one of the authorised operator's facilities in September 2022. Although the outbreaks were eventually eradicated, the approach taken by the CA is not fully in line with Article 137(1) of Regulation (EU) 2017/625, that re- quires the CA to give priority for action to be taken to eliminate or contain the plant health risk. Conclusions on enforcement actions

In general, sanctions appear to be effective, proportionate, and dissuasive thereby help- ing to ensure that professional operators comply with their legal obligations. However, in cases where the presence of a pest was confirmed, the long period of time before the implementation of eradication measures applied by the authorised operator is verified increases the risk that plants for which plant passports have been issued in the mean- time are not free of the relevant pests.

Member state response

ate In accordance with Article 137(1) of Regulation (EU) 2017/625, ed the SBA will make sure to prioritize and implement necessary e, or contain, plant health risks in cases of e future. ts guidance on controls and control s, in order to facilitate a faster response both e measures to be undertaken by the authorised -up visits by the SBA. The aim is to ges by the end of 2024. nt of the guidance on controls and control s, the SBA will prioritize all potential d plant pests in a timely manner. Page: 2 2024 Ref. Ares(2024)2976336 - 23/04/2024 port ref. DG(SANTE) 2024-7959 of the audit carried out from 31 January t passport system Page: 3

The recommendation states as its basis

In the other two regions, including the one where all the establishments visited by the audit team were located, no regular or structured on-site monitoring or supervision visits take place to confirm that the OVs carry out their duties satisfactorily, consistently and in accordance with the SFA guidelines and legislation.

Other than in one region of the country (where it is currently being carried out on a trial basis), there is no regular or structured on-site supervision of the establishments' official staff taking place to confirm that the OVs and OAs carry out the controls in the slaughterhouses correctly, consistently and in accordance with the SFA guidelines and legislation. The existing system is based on remote support and analysis of indicators. Although this is useful for identifying trends and differences between regions or even establishments, it is not suitable way to recognise individual deficiencies. As a result of the design of the system, some non-compliances or failures in the delivery of official controls cannot be identified and resolved.

Although the majority of the PMI procedures were conducted satisfactorily, the audit team identified several aspects that were not in compliance with the legislation: 11 · Carcases passed as fit for human consumption by the OV/OA team before the removal of some pathological lesions; this removal/trimming was the responsibility of the FBO's staff and occurred after the PMI was performed by the OV/OA and the carcase was health marked. No further checks were carried out by the OV/OA to ensure that the rectification of the carcase had been performed satisfactorily; · Lack of lockable facilities for the refrigerated storage of detained meat in one of the establishments visited. Post-mortem inspection - poultry

PMI procedures only covered the external surface of the carcases and the offal. Neither the OV nor the FBO staff carried out a cavity inspection of the poultry carcases as required by Article 12 of Regulation (EU) 2019/627. 12 5.3.2 Official controls over food business operators' obligations Food Chain Information (FCI) and animal identification Legal requirements Article 3 of Regulation (EC) No 853/2004 in conjunction with its Annex II Section III and Article 9 and 10, 40, 41 42 and 43.1 of Regulation (EU) 2019/627. Findings

The audit team observed several unhygienic practices taking place during the visits, some of them systematically occurring in several establishments. They included the overuse of drop hoses by operatives to clean themselves and the equipment, causing a risk of cross-contamination to nearby carcases by uncontrolled splashing. It was noted that staff could not make use of apron washes or other suitable alternatives as no apron washing cabinets were available in the majority of the slaughterhouses visited. Also, some water pipes and hand-wash basins on working platforms were not properly ducted, which facilitated the pooling of water and thereby created a risk of contamination of dirty water splashing onto carcases and offal. These two issues had not been identified or enforced by the OVs. Microbiological criteria Legal requirements Articles 35 and 36 of Regulation (EU) 2019/627. Commission Regulation (EC) No 2073/2005. Findings

Member state response

that Reply SFA: We will ensure that we have a suitable procedure in place to monitor and verify that official controls in slaughterhouses are carried out effectively and appropriately in accordance with Article 5(1)(a) of Regulation (EU) 2017/625. Our aim is that this procedure will be in place by September 2025. Our plan is to establish a procedure for monitoring OV and OA on a regular basis. This will include a structured on-site supervision of the establishments to confirm that the OVs and OAs carry out the controls in the slaughterhouses correctly. The procedure will be risk-based and include both a quantitative and qualitative follow-up plan.

The recommendation states as its basis

At the establishments visited, the OVs had already detected some of the non- compliances observed by the audit team and had started taking action to address them. The audit team identified that: · Several of the deficiencies were of a long-standing nature and had been under enforcement for a considerable length of time, without having achieved the required results; · In some cases, the deadlines for the rectification of these issues had expired and a new deadline had been given without indication of further consequences, or the follow-up had been planned/taken place a considerable time after the deadline had expired (at times, a year later, at the time of the next planned audit/inspection). · In other cases, the deadlines originally given were too long and did not take into account the severity of the non-compliance. · Some of the non-compliances seen had been previously classed as resolved. The audit team noted that uncertainty in the identification of the root cause could have been a reason for the recurrence of these issues in some of the follow-up control reports.

Although there is an enforcement system in place, which is clearly designed and could work satisfactorily, some weaknesses in the delivery (mainly linked to the deadlines and follow-ups) limit its impact and undermine its efficacy to ensure that FBOs resolve the identified deficiencies and prevent their recurrence.

Nevertheless, in one of the establishments, the maintenance and cleaning status of some of the wall surfaces near and in one of the chillers were not satisfactory. Although the FBO had begun a refurbishment to remedy the situation, the enforcement process had lasted several years and had not produced suitable and timely results; some areas where refurbishment was in progress (e.g. corridors, buffer areas between cattle and sheep slaughter lines) were not suitably isolated to avoid risks of cross-contamination of carcases and offal intended for human consumption. 13

Member state response

ply SFA: We will ensure that, when a non-compliance is established, the competent authority takes appropriate measures so that the operator concerned remedies the non-compliance and prevents reoccurrence of same as required by Article 138 of Regulation (EU) 2017/625. Our aim is that this will be in place by September 2025. To be able to succeed with this, we will ensure that our enforcement system, that we already have in place, works more satisfactorily and in the same way throughout our organization. We will also make sure that instructions are followed by our personnel involved in controls. This will also be included in the follow-up plan detailed in recommendation 1.

The recommendation states as its basis

There is a system in place for AMI and PMI covering most of the relevant aspects. The performance of AMI by the OVs was considered as fully satisfactory and some establishments showed elements of good practices to ensure that animals were not slaughtered without inspection. PMI was carried out in accordance with the legislation, in the majority of cases. However, the current arrangements in place do not guarantee that the health mark will only be applied to carcases that have undergone full PMI and where there are no grounds for declaring the carcase (or part of it) unfit for human consumption. In the poultry slaughterhouse, the PMI procedures did not include the cavity inspection of the carcases.

Member state response

ses Reply SFA: g The SFA will, by September 2024, have a new instruction in for slaughterhouses to ensure that all carcasses undergo full PMI before health marking. Page: 1 Ref. Ares(2024)2941609 - 22/04/2024 ort ref. DG(SANTE) 2024-8031 of the audit carried out from 26 February ning slaughter hygiene and meat inspection requirements Action Proposed by the competent authority and deadline by which it will be completed l slaughterhouses will be inspected so that they all have lockable facilities for the refrigerated storage of detained meat. The inspections will take place during 2025.

The recommendation states as its basis

According to the information provided by the SFA, the derogation on the timing of PMI in the context of Article 13 of Commission Implementing Regulation (EU) 2019/627, in establishments without permanent official supervision, is applied in 70 red meat slaughterhouses.

At these low-capacity slaughterhouses without permanent official supervision, the delayed PMI is sometimes carried out by OAs and not by OVs. This happened, according to the CA's figures, 22% of the time in 2023.

The delayed PMI in establishments without permanent supervision is frequently carried out by OAs and not by OVs as required by Article 13(1) of EU Regs 2019/ 627

Member state response

Reply SFA: f Earlier, before Regulation (EU) 2019/627 was introduced, the by SFA made the interpretation that delayed inspection could be carried out by Official Auxiliaries (OA). The staffing was adapted to be able to use both Official Veterinarian (OV) and OA for delayed inspection. The SFA has thus interpreted previous legislation as meaning that OA was allowed to carry out delayed inspection, who in many cases are just as competent to carry out PMI inspection as OV. In cases where an OV needs to make PM inspections of carcasses and/or organs for competence reasons, there is an option at the slaughterhouses to put those carcasses aside. The OV is then called to the slaughterhouse or the game handling facility. Adaptation to the conditions in Art. 13.1 of Regulation (EU) 2019/627 is taking place. This adaptation, which has been ongoing in recent years, has resulted in more OVs carrying out the delayed post-slaughter inspection. But this takes time given the situation we have in Sweden with the shortage of veterinarians, and it is expected to take several years before deferred inspections can be carried out by OV at all affected slaughterhouses and game handling facilities. Page:

The recommendation states as its basis

The SBA has a risk-based planning approach for its official inspections. The risk assessment is based on different risk factors (e.g., the type of activity(s) registered, the quantity of production, results of previous official controls). The final score is based on a mathematical formula which converts the risk factors into numerical values and provides the risk class for each of the FeBOs (score between 1 and 7) which determines the inspection frequency for each FeBO. The frequency varies between once every 7 years (very low) to three times per year (high). FeBOs dealing with medicated feed are also included in the risk-based planning. The audit team noted that the planning for the risk assessment of official inspections does not take into account the reliability and results of own controls performed by FeBOs which is not in line with the requirements laid down in Article 9(1)(d) to Regulation (EU) 2017/625.

The planning of inspections is based on several appropriate risk-related factors but the reliability of operators `own controls is not considered and is a notable gap in an otherwise well-functioning risk-based planning process. While official inspections are carried out on all operators with an appropriate frequency, the effectiveness of these inspections, and thus of the overall system governing the production of feed, is weakened by several shortcomings in their execution. These relate to the inspectors' assessment of feed business operators' tests to verify that the measures they have taken to minimise cross contamination has been effective, and checks on the operators' adherence with the requirements for veterinary prescriptions and the labels of medicated feeds. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

risk assessment of FeBOs will include an assessment of the By the end of October reliability and results of operators' own control. The routine document 2024 ed "Rutin erfarenhetsklass DKEs" will be revised so that operators' n controls are considered when assessing if the so-called experience class ("Erfarenhetsklass") should be changed or not.

The recommendation states as its basis

Verification of establishments' tests to assess the measures taken to minimise cross- contamination, required by part 2(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. In two establishments visited, tests to assess the extent of cross contamination were carried out twice per year and the test results were acceptable. However, in one establishment the FeBO`s written instruction on the testing method was unclear and the implementation of the tests was not in line with the scientific requirements (e.g., the place of sampling, the number of samples taken, the mixing of samples and the first mix to be sampled). The other establishment used two different types of coccidiostats. The tests carried out concerned one of the coccidiostats. The feed inspectors met, were able to assess some parts of these test procedures, but experienced difficulties in comprehensively assessing the procedures and the results of the cross-contamination tests.

In one establishment visited the FeBO tested the cleaning (flushing) batch between the production of feed with coccidiostats (narasin) and subsequently without coccidiostats. The FeBO tested the coccidiostat concentration of the first, second and third subsequent mixing following the production of feed with coccidiostats. The concentration of the carry-over of coccidiostats was higher in these mixes than the maximum level described in point 7 of Annex I Section VII of Directive 2002/32/EC. The FeBO did not place these contaminated feeds on the market but used these feeds during the production of complete feeds for broilers containing narasin. Based on the recipe of this type of complete feed, the narasin concentration in the final feed was higher than the maximum limit in Commission Regulation (EC) No 545/2006. This practice was not identified during previous official controls.

The audit team visited two FeBOs authorised to produce medicated feed. In one, tests to determine the extent of cross-contamination were not performed at all. In the second, such tests were performed on the production lines used for production of feed with coccidiostats but not on the production line used for the production of medicated feeds. This absence of regular checks is not in line with the requirements laid down in point 2 of Section 4 of Annex I to Regulation (EU) No 2019/4.

The planning of inspections is based on several appropriate risk-related factors but the reliability of operators `own controls is not considered and is a notable gap in an otherwise well-functioning risk-based planning process. While official inspections are carried out on all operators with an appropriate frequency, the effectiveness of these inspections, and thus of the overall system governing the production of feed, is weakened by several shortcomings in their execution. These relate to the inspectors' assessment of feed business operators' tests to verify that the measures they have taken to minimise cross contamination has been effective, and checks on the operators' adherence with the requirements for veterinary prescriptions and the labels of medicated feeds. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

he guidance document for the inspectors will be updated to clarify the By the end of December- control and verification of the operators' own control and routine 2024. regarding cross contamination. The knowledge gained during the audit regarding verification that the feed business operators meet the requirements for appropriate checks of the effectiveness of measures they have taken to minimise cross-contamination will be disseminated internally to all feed inspectors. Page: 1 the recommendations of report ref. DG(SANTE) 2024-8069 of the audit carried out from 06 May 2024 to n of official controls on feed hygiene ction Proposed by the competent authority Deadline for completion

The recommendation states as its basis

The audit team scrutinised FeBO documentation concerning the manufacture of medicated feeds in two establishments. In general, the prescriptions, recipes and labels of the medicated feeds were available. However, the audit team noted that the assessed prescriptions did not contain information on the diagnosed disease to be treated, the marketing authorisation number of the veterinary medicinal products, the inclusion rate of the medicated premix or active substances and the percentage of medicated feed in the daily ration. These are required by points 5, 6, 8 and 11 of Annex V to Regulation (EU) 2019/4 and these particular non-compliances had not been identified in the reports of the previous official controls.

The audit team assessed labels of the medicated feeds. The assessed labels did not contain information on the added amount of active substances contained in the veterinary medicinal products, information on the adequate disposal of the medicated feed, information on any contra-indications and instructions for use in line with the veterinary prescription. These are not in line with the requirement of points 3, 4, 5, 8 and 10 of Annex III of Regulation (EU) 2019/4. These non-compliances had not been identified in the reports of the previous official controls.

The planning of inspections is based on several appropriate risk-related factors but the reliability of operators `own controls is not considered and is a notable gap in an otherwise well-functioning risk-based planning process. While official inspections are carried out on all operators with an appropriate frequency, the effectiveness of these inspections, and thus of the overall system governing the production of feed, is weakened by several shortcomings in their execution. These relate to the inspectors' assessment of feed business operators' tests to verify that the measures they have taken to minimise cross contamination has been effective, and checks on the operators' adherence with the requirements for veterinary prescriptions and the labels of medicated feeds. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

e guidance for the inspections will be updated to clarify that the By the end of December escriptions for medicated feed and the labels of those medicated 2024 the guidance will is checked during inspections to determine their compliance be updated. ith the relevant legal requirements. By the end of May 2025 the national legislation he Swedish board of Agriculture (SBA) will include a template will be updated. or prescription of medicated feed in national legislation. will inform the FeBOs of the requirements for labelling f medicated feed and the prescription.

The recommendation states as its basis

Regarding the above instructions, the auditors found that moisture analysis, when required, is to be performed by a yet-to-be determined external accredited laboratory. While there have been no positive results to date, the auditors noted the potential impact of the current laboratory procedure in respect of the timeliness of analysis and the impact on sample integrity, as laid down in point 3.3 of part 3 of Chapter II of Annex V to Commission Regulation (EC) No 152/2009, in respect of the possibility for adsorption of water during transit to an external laboratory. Furthermore, the laboratory instructions referred to the use of the `reference sample (unbroken)' for moisture analysis as opposed to the `original analysis sample'. While both sample portions originate from the same aggregate sample, there were no measures in place in the laboratory to guarantee that once prepared, any changes arising between the analysis and reference samples due to handling, storage environment or adsorption of external moisture could be eliminated. The audit team noted that this is problematic in terms of ensuring the legal, scientific and technical validity of the sample as required by Point 5 of Article 34 of Regulation (EU) 2017/625, as the sample portion from which moisture correction to 12% is to be determined is technically different to that from which the content of undesirable substances is to be measured in the absence of such a guarantee. Conclusion on the planning and implementation of sampling and testing of official feed samples

Many aspects of the planning and implementation of sampling and testing of official feed samples are positive. A robust risk-based approach has been adopted for the planning of official sampling, the official sampling procedures are correctly implemented, the laboratories used for testing are appropriately designated, accredited and they have performed satisfactorily in relevant proficiency testing schemes. Notwithstanding the above, the current approach applied by the SVA laboratory to determine moisture analysis could adversely affect the legal and technical validity of samples and the reliability of decisions made on the basis of the corresponding results. 12 5.2.3 Actions taken on non-compliances

Member state response

al feed samples will be homogenised with a mechanical di- By the end of March ider during the sample preparation at SVA. A part of the sample 2025 will be sent to a lab accredited for water content analysis when rrection of water content is required for interpretation, in ac- ordance to point 5 of part C of Annex II in regulation (EC) No 009. s will also be taken to ensure that the sample storage and ransportation is performed in a way that maintains the integrity f the feed sample. SVA has already started to register tempera- ure and air humidity in the sample storage room. Page: 2

The recommendation states as its basis

The implementation of the plan largely meets the NRCP requirements with respect to the minimum sampling frequencies (24) for 2023, covers the full calendar year for most commodities, and is on schedule for 2024. The SFA laboratory staff, aided by sample reception assistants, monitor whether the expected samples have been taken and have arrived at the laboratory and take action if this is not the case. In 2023, there was a greater than 100% achievement rate for some commodities due to a misunderstanding, i.e., samples were taken to match the number of analyses and not the number of planned samples of a specific matrix. The sampling rate for pharmacologically active substances (all commodities) was also greater than 100% at slaughterhouses but ranged from 74- 108% on farms, depending on the commodity, with no explanation having been provided for the 74% sampling achievement rate on pig farms. The sampling achievement rate was 92% at egg collection centres, 84% at fish farms and 78% at honey collection centres. Difficulties in getting the samples from the CABs was provided as the explanation for the shortfall in fish samples. No explanation was provided for the honey sample shortfall. All sampling reports examined by the audit team in situ contained the information required in EU legislation (25). 5.2 Implementation of the national randomised surveillance plan for residues of pharmacologically active substances

The control and surveillance plans for residues of pharmacologically active substances, pesticides and contaminants are generally implemented in line with planned arrangements, EU legal requirements and are effective, underpinning assurances on the (32) Commission Directive 2002/63/EC (33) Parts B and D of Annexes I and II to Regulation (EU) 2022/741 (34) Article 1(2) of Regulation (EU) 2021/1355 (35) Regulation (EC) No 401/2006, Regulation (EC) No 333/2007 and Regulation (EU) 2017/644 (36) Regulations (EU) 2022/931 and (EU) 2022/932 (37) Annex I of Regulation (EU) 2022/931 7 residues status of food of animal origin. Nevertheless, the under-sampling of certain commodities for residues of pharmacologically active substances weakens the effectiveness of the system.

Member state response

r Reply by SFA: issue that we are constantly working with. We've identified the following main problems with keeping the planned arrangements: 1. The follow-up of planned sampling is too slow and lacking in structure. 2. Routines for replanning samples can be improved. 3. The communication between the coordinators at the central SFA and the different organisations/authorities involved in sampling needs improvement. 4. Sampling organisations taking a lot of samples more often lack resources to perform the planned sampling. To correct these issues we are planning the following: - The lab at SFA is switching to a new data system during 2024. End of June 2025. In the new system we will set up better reports for the follow-up of planned sampling at all levels of planning (e.g. overall, by substance group or by place of sampling). At the same time, we will set up better routines for regular follow-up. We intend to ensure that follow-up can be done weekly and that follow-up reports can be sent to organisations/authorities involved in sampling so they can keep track of their planned sampling. - Starting in 2024 a new planning tool will be developed for the End of 2025. programme coordinato

The recommendation states as its basis

The validation reports largely assessed the appropriate validation parameters required by EU legislation (48). However, the following shortcomings were observed: i. Within-laboratory reproducibility in the confirmatory test methods reviewed was only evaluated for a single concentration level, which is not in line with EU requirements (49). ii. For the beta-agonists LC-MS/MS method, the decision limit for confirmation (CC) exceeded the minimum method performance levels recommended by the EURLs (50). iii. Evaluation of the stability of analytes in sample matrix as required (51), was not included in all of the method validation reports reviewed. (48) Chapter 2 of Regulation (EU) 2021/808 (49) Point 1 of Chapter 2.2.1.4 of Annex I to Regulation (EU) 2021/808 (50) EURL guidance on minimum method performance requirements for specific pharmacologically active substances in specific animal matrices. Available here: dbc5a216-7404-4c24-9a81-57ae6fa88890_en (euro- pa.eu) 10

Further to the above validation reports, the audit team found that the method used to test for tetracyclines in muscle (a multiresidues analysis by LC-MS/MS), did not include the 4-epimer, whereas the MRL is set for the sum of parent drug and its 4-epimer (52). The laboratory informed the audit team that the method had been originally developed in 2006 and it had not been possible at the time to resolve the parent and 4-epimer of the tetracyclines with the chromatographic parameters and analytical column used.

Given that both of the national laboratories testing samples for residues of pharmacologically active substances, pesticides and contaminants taken under the various control and surveillance plans are accredited to EN ISO/IEC 17025, operate methods that are largely appropriately validated and have well-functioning quality control systems in place, the competent authority can have confidence in the reliability of results generated. Notwithstanding this positive assessment, the few shortcomings observed concerning the validation of analytical methods, undermine the reliability of results for certain analytes.

Member state response

Reply by SFA: ely i. Despite that we rarely have a finding of the monitored i. nd substances in our national control program, we plan to continue The confirmatory in implementation of Within-laboratory reproducibility in the analytical methods confirmatory test methods utilizing a risk-based approach with a (corresponding to where prioritization strategy based on the frequency of findings in the findings in the national control programs for the last five years. See also additional control programs has comments in separate document. been made during the last five years) will be updated to include the recommendations of report ref. DG(SANTE) 2024-8084 of the audit carried out from 16 to 26 April pharmacologically active substances, pesticides and contaminants in animals and animal products d by the competent authority Deadline by which it will be completed Within-laboratory reproducibility by the end of 2028. ed analytical method for testing of Beta-agonists will ii. according to the referred EURL guidance on The plan is to perform thod performance requirements for specific implementation until gically active substances in specific animal matrices. June 2026. s been communicated by t

The recommendation states as its basis

The audit team followed the work of six inspectors during the visits, who were generally skilled and knowledgeable. However, they were not aware/knowledgeable of specific requirements regarding fishery products, such as temperature criteria (see paragraphs 19.a, 29 and 34). They overlooked unhygienic situations in the FBO (see paragraphs 34, 43 and 44). Inspectors showed gaps in skills regarding the assessment of the FBOs HACCP (see paragraphs 30 and 38). This is not in line with Article 5 (4) of Regulation (EU) 2017/625.

Officials are generally knowledgeable. However, the lack of knowledge of specific fishery product requirements, and the gaps in the skills to assess the HACCP plans, impact the effectiveness of the official controls.

The audit team identified the following issues during the visits to approved establishments: a. The audit team noted that some recently approved establishments did not meet certain approval requirements laid down in Regulations (EC) Nos 852/2004 and 853/2004, such as temperature recording devices for cold chambers, temperature displays or the avoidance of inappropriate product flows. Inspectors were not aware of these requirements. b. During the approval process, relevant information is not recorded, such as blueprints. It is unclear which parts of the premises and which activities are included in the approval. The audit team visited a cold room located in a separate building. The municipality was not able to verify if the cold room was included in the initial approval or was later assessed and added to the approval. This lack of detail may prevent an appropriate review of the approval being carried out during their official controls as required in Article 148(5) of Regulation (EU) 2017/625. c. SFA notifies the municipalities of the transfer or the control of the FBOs, by sending the approval certificate. Municipalities do not receive additional information such as flow-diagrams or HACCP plans. Thus, inspectors can overlook modifications in the FBO approved activities (see paragraph 39). This is not in line with Article 148(5) of Regulation (EU) 2017/625. d. One of the two factory vessels visited during the audit lacked approval. The approval number was "passed" from an old vessel (after it was scrapped), to a new vessel. The approval process was not followed, as the owner kept the same name for both the old and new vessels. This is not in line with Article 4 of Regulation (EC) No 853/2004 and with Article 69 of Regulation (EU) 2019/627.

Officials do not consistently assess HACCP plans, validation studies and/or verification of the production processes. As a result, the CA cannot verify that the HACCP plans are suitable for purpose. This impacts the effectiveness of the official controls.

Inspectors (mainly in municipalities) overlook hygiene situations in the FBOs, that can be a direct risk for ready-to-eat products. This impacts the effectiveness of the official control. 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. (7) In response to the draft report, the CA confirmed that , "Regular checks of the hygiene conditions at landing have been initiated". 11 Findings

Member state response

s carrying out Reply SFA: ific relevant The competence development plan for the SFAs contains ment, in individual plans for every member of staff. Adequate training on HACCP and control of fishery products is in this plan. On a basic level we have an e-learning course on SFAs "Utbildningsportal"(the Education portal) called "Faror och risker"(Hazards and risks) the scope of that course is foodborne hazards and risks, hazards in the production processes, hazard analysis and critical control points, food and feed legislation regarding hazards. We also provide basic and more advanced training courses by external educators and we also send our staff to relevant BTSF courses. At the SFA we also have a cross sectorial "HACCP-group" that gives support and guidance to our staff in particularly difficult questions regarding HACCP related issues. For the staff that perform official controls relevant for this audit (26st) we have a mandatory training course (e-learning) that every inspector and/or veterinarian must undertake before they can perform controls on approved establishments that handle fishery products. The course is called "Processkunskap om fiskprodukter" (Process knowledge of fis

31 Dec 2026 opment plan for the SFAs contains individual plans for every member of staff. HACCP and control of fishery products is in this plan. On a basic level we have on SFAs "Utbildningsportal"(the Education portal) called "Faror och risks) the scope of that course is foodborne hazards and risks, hazards in the zard analysis and critical control points, food and feed legislation regarding asic and more advanced training courses by external educators and we also ant BTSF courses. At the SFA we also have a cross sectorial "HACCP-group" that idance to our staff in particularly difficult questions regarding HACCP related form official controls relevant for this audit (26st) training course (e-learning) that every inspector and/or veterinarian must y can perform controls on approved establishments that handle fishery products. "Processkunskap om fiskprodukter" (Process knowledge of fishery products) and ing official controls on fishery products with the relevant requirements placed on luding HACCP. This course is also on the SFAs "Utbildningsportal". verybody has undertaken this training with sufficient results and only then they can cal knowledge into practice during official contr

The recommendation states as its basis

According to the SFA approval procedures, cold stores can be considered retailers when they supply approved FBOs. According to this procedure, cold stores can be registered instead of being approved. This is not in line with Article 4 of Regulation (EC) No 853/2004. SFA stated during the audit that the approval procedure would be rectified and communicated to municipalities. 5

SFA is responsible for the approval of the establishments. SFA performs an on-site visit and grants full approval before starting the operation, therefore in the absence of HACCP records. Thus, SFA cannot verify that the FBO meets the other relevant requirements of the food law. This is not in line with Article 148(4) of Regulation (EU) 2017/625. Three months after the full approval is granted, SFA performs a new on-site visit, to assess the HACCP records generated during this period. SFA informed the audit team that a new procedure was under development, to grant conditional approval on the first visit and full approval after the three-month visit.

The audit team identified the following issues during the visits to approved establishments: a. The audit team noted that some recently approved establishments did not meet certain approval requirements laid down in Regulations (EC) Nos 852/2004 and 853/2004, such as temperature recording devices for cold chambers, temperature displays or the avoidance of inappropriate product flows. Inspectors were not aware of these requirements. b. During the approval process, relevant information is not recorded, such as blueprints. It is unclear which parts of the premises and which activities are included in the approval. The audit team visited a cold room located in a separate building. The municipality was not able to verify if the cold room was included in the initial approval or was later assessed and added to the approval. This lack of detail may prevent an appropriate review of the approval being carried out during their official controls as required in Article 148(5) of Regulation (EU) 2017/625. c. SFA notifies the municipalities of the transfer or the control of the FBOs, by sending the approval certificate. Municipalities do not receive additional information such as flow-diagrams or HACCP plans. Thus, inspectors can overlook modifications in the FBO approved activities (see paragraph 39). This is not in line with Article 148(5) of Regulation (EU) 2017/625. d. One of the two factory vessels visited during the audit lacked approval. The approval number was "passed" from an old vessel (after it was scrapped), to a new vessel. The approval process was not followed, as the owner kept the same name for both the old and new vessels. This is not in line with Article 4 of Regulation (EC) No 853/2004 and with Article 69 of Regulation (EU) 2019/627.

While SFA approval procedures include provisions for establishments where there have been significative modifications (including activities or equipment), the interpretation of these procedures was unclear for municipality representatives. They were not certain if a reapproval should be carried out in these cases and if it was, by whom (SFA or municipalities). 6 Conclusions on registration/approval of food business operator establishments

SFA applies its documented approval procedures. Nonetheless, there are gaps in the application of these procedures which allow, in certain cases, the approval of establishments without an on-site visit.

The procedure for approval/registration can omit certain cold stores from the approval (these are registered by the municipalities without SFA supervision). While these criteria have been amended during the audit, the CA cannot provide guarantees that all currently registered cold stores are retailers.

Relevant information about the approval is not transferred and the available for further inspections (i.e. plans/blueprints and/or detailed description of the activities). This impacts the effectiveness of the subsequent official controls (notably when establishments are transferred from SFA to municipalities).

Member state response

ment for the Reply SFA: or has demonstrated SFA has a routine for approval of food establishments that fall n particular those of under the scope of the official regulation (EC) 853/2004. As for ith Article 148 2024 all new approvals are conditional which means that a FBO in the approval process must demonstrate compliance with all relevant requirements laid down in (EC) 852/2004 and (EC) 853/2004. If the FBO complies to these requirements during the control for approval they will get a conditional approval. It is only the relevant HACCP requirements that are conditioned in the approval. If an establishment don´t comply with basic hygiene requirements they cannot get a conditional approval. After a maximum of three months, we perform a control of relevant HACCP requirements during production in the FBO. If they comply to all relevant requirements, they will get a permanent approval. This routine for conditional approvals will be reviewed starting in 2024 and improved and then implemented in SFAs handbook with instructions. Ready approximately during 2026. Page: 4 ndations of report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 November control systems in place governing

31 Dec 2026 approval of food establishments that fall under the scope of the official regulation 2024 all new approvals are conditional which means that a FBO in the approval ate compliance with all relevant requirements laid down in (EC) 852/2004 and FBO complies to these requirements during the control for approval they will get nly the relevant HACCP requirements that are conditioned in the approval. mply with basic hygiene requirements they cannot get a conditional approval. s, we perform a control of relevant HACCP requirements during they comply to all relevant requirements, they will get a permanent approval. al approvals will be reviewed starting in 2024 and improved and then ook with instructions. 2026. t in our operative control plan that cold stores supplying fishery products to en, are approved instead of registered. This will be done by the SFA where we Page: 7 ies of Sweden in response to Report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 the food safety control systems in place governing the production and placing on the market of posed by the competent authority Proposed action plan deadline the FBOs in question. E.g. if we receive or get information f

The recommendation states as its basis

The controls of the landing are under the responsibility of CABs. According to CABs, new items were added to the checklist of fishing vessels. After the closing meeting, CABs provided the only available control in which a check on a landing site was included. However, CABs are not in a position to demonstrate the performance of regular checks on the hygiene conditions of landing as indicated in Article 67 of Regulation (EU) 2019/627. Facilities handling fishery products

CABs are not performing regular check on the hygiene conditions at landing as laid down in Article 67 of Regulation (EU) 2019/627. A similar conclusion was detected in the previous audit (ref. DG(SANCO) 2015-7462) leading to the issuance of a specific recommendation (7).

Member state response

ck on the hygiene Reply SFA and CAB´s: plementing Regular checks on the hygiene conditions of landing will be prioritised in the national control planning for primary production from 2025. The guidance document for fishery products will be updated for this control, and available in the autumn 2024. An implementing seminar for inspectors at the CABs will be held in November 2024.

31 Dec 2025 e conditions of landing will be prioritised in the national control planning rom 2025. The guidance document for fishery products will be updated for this the autumn 2024. An implementing seminar for inspectors at the CABs will be n November 2024. Page: 10 ies of Sweden in response to Report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 the food safety control systems in place governing the production and placing on the market of Action Proposed by the competent authority Proposed action plan deadline l planning is our tool for planning the official controls in primary production. The buted though out the CAB based on the number of operators registered in each CAB. to control 47 FBO registered for fishing. The controls are distributed over 10 CABs. Bs and planned number of controls at each CAB is based on number of FBO ing, number of landings and quantities of landed fishery products 2022-2023.

The recommendation states as its basis

However, there is not a systematic approach to guarantee that all control-areas are fully covered over the 3 to 4-year inspection cycle and in accordance with the results of the risk classification, notability in the municipalities. Therefore, the CA cannot verify that the approval conditions are kept under review and that official controls include verification of compliance according to Article 67 of Regulation (EU) 2019/627.

Factory vessels produce fresh and cooked shrimp. The fishing association developed "guidelines for shrimp operation" in 2007. SFA inspectors accept the guidelines as appropriate to comply with Article 5 of Regulation (EC) No 852/2004. Inspectors verify that they are adhered to by the FBO during inspections.

The approval conditions are not consistently kept under review. The verification of FBO's documents by officials is partially missing, as it relies on the FBO's verbal statements. This impacts the effectiveness and consistency of the official controls to verify compliance with EU rules.

Officials do not consistently assess HACCP plans, validation studies and/or verification of the production processes. As a result, the CA cannot verify that the HACCP plans are suitable for purpose. This impacts the effectiveness of the official controls.

SFA cannot verify that factory vessels implement and maintain permanent procedures based on HACCP principles and that they comply with the specific requirements for cooking shrimp on board. This impacts the effectiveness, and consistency of the official controls.

Inspectors (mainly in municipalities) overlook hygiene situations in the FBOs, that can be a direct risk for ready-to-eat products. This impacts the effectiveness of the official control. 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. (7) In response to the draft report, the CA confirmed that , "Regular checks of the hygiene conditions at landing have been initiated". 11 Findings

Member state response

nditions under Reply SFA: s as per SFA is during 2024 going to start to review and improve the g official routine and working methods for keeping FBOs approval EU) 2017/625. conditions consistently under review. Verification of FBOs 1. documents e g. HACCP plans, validation studies and/or 45. verification of the production processes will be mandatory for all FBOs and verbal statements is not regarded to be an acceptable option. This will be implemented in a handbook with instructions and in our operational control plan. Ready approximately 2026. Reply Gothenburg and Stockholm (MUP): The municipalities of Gothenburg and Stockholm will improve the routine and working methods in the same way as mentioned above.

31 Dec 2026 going to start to review and improve the routine and working methods for keeping tions consistently under review. Verification of FBOs documents e g. HACCP tudies and/or verification of the production processes will be mandatory for all FBOs ts is not regarded to be an acceptable option. This will be implemented in a handbook nd in our operational control plan. Ready approximately 2026. d Stockholm (MUP): of Gothenburg and Stockholm will improve the routine and working methods in the . 3 Page: 11 ies of Sweden in response to Report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 the food safety control systems in place governing the production and placing on the market of t authority Proposed action plan deadline of 2025 a review of our own routine and working methods for keeping all nsistently under review is done by SFA. That is for all the FBOs where We are now during 2024 implementing in our operational control plan reas that it is compulsory for our staff to perform this in the official controls we will start to improve the routine and our working methods where it´s During 2024 and the e controls performed in 2024 and the first half of 2025 on these first

The recommendation states as its basis

During the audit, SFA, municipalities or CABs did not provide evidence of official sampling for PAHs. This is not in line with Article 70 of Regulation (EU) 2019/627. Conclusion on official controls of fishery products

Official controls of fishery products include all the relevant elements, except for PAHs. This impacts the capacity of the CA to monitor certain risks associated with smoking activities.

Member state response

controls are Reply SFA: official controls of SFA has already implemented in our operational control plan a 0 and 71 of yearly control on the requirements in (EC) 2019/627 regarding PAH with starting point in the FBOs HACCP-plan. It is done in establishments that handle fishery products and that perform the process of direct smoking. Starting under 2024 we will review Page: 5 ndations of report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 November control systems in place governing the production and placing on the market of fishery ority and deadline by our staffs individual the controls and follow ups hlight that this type of controls national control plan smoking fishery products be focused upon those re the freshly generated dust immediately d yields a higher ompared to the indirect by a pipe to the smoke the Swedish National pling program on PAHs weden during 2006-2010. CODEX COP CAC/RCP ation on foods with ) from smoking and 3/917 grants a derogation itionally smoked fish and aximum levels of PAH Sweden shall continue to tionally smoked fish and ion is to be fulfilled by the raditionally smoked ndations of report ref. DG(SANTE) 2023-7718 of the audit carried out f

31 Dec 2026 lemented in our operational control plan a yearly control on the requirements in ding PAH with starting point in the FBOs HACCP-plan. It is done in establishments products and that perform the process of direct smoking. Starting under 2024 we will our internal routines for our staffs individual planning of controls, performance of llow ups on this type of control to better highlight that this type of controls is esults thereof. Ready approximately during 2026. and multi -annual national control plan on contaminants rol of enterprises smoking fishery products by traditionally smoking methods will be enterprises using a smoke chamber where the freshly generated smoke from growing ust immediately reaches the foods. This smoking method yields a higher Hs in the foods, compared to the indirect smoking method where the smoke is led oke chamber. This conclusion was made by the Swedish National Food Agency by sampling program on PAHs in smoked fish and meat products in Sweden during 2006- Page: 13 ies of Sweden in response to Report ref. DG(SANTE) 2023-7718 of the audit carried out from 20 the food safety control systems in place governing the production and placing on the mark

The recommendation states as its basis

During the visit to the port BCP Gothenburg, the audit team noted that the samples of consignments selected for identity and physical checks were routinely taken from the rear of the transport container without the consignments being partially or fully unloaded from the means of transport in order to have full access to the whole consignment for the purpose of those checks, and the authorities did not thereby ensure that samples were representative of the entire consignment, which is not in line with Articles 3 and 4 and Point 4(c) of Annex II to Regulation (EU) 2019/2130, and documented procedures. The SBA stated that consignments were partially or fully unloaded only if a risk assessment indicated that such unloading was necessary. 5.2.4.3 Checks on consignments of goods of non-animal origin

However, shortcomings were noted regarding the performance of identity and physical checks on goods of animal origin and the frequency of identity and physical checks on food of non-animal origin, which reduce the overall effectiveness of the official control system.

Member state response

checks on consignments of Answer from the Swedish Food Agency (SFA) and the Swedish cordance with the detailed Board of Agriculture (SBA): The Swedish Food Agency and the Swedish Board of of Annex II to Regulation Agriculture aim at an efficient and risk-based border control that ensures that the objectives of the official controls regulation (EU) 2017/625 are met. We have initiated an investigation to ascertain that samples for identity and physical checks are taken according to the legal requirements in Commission Implementing Regulation (EU) 2019/2130. Consignments shall be subject to partial or full unloading, whenever necessary to have full access of the whole consignment. A risk-based approach will continue to be applied, where factors such as e.g. new operators or commodities and previous compliance of the operator will be considered. Identity and physical checks shall not routinely be taken only from the rear of containers or trailers, including for consignments with lower risk. During this investigation, we will review, clarify, and improve the methods to practically unload consignments, including both the use of our own BCP staff and increased availability of harbour pers

The recommendation states as its basis

However, the audit team noted that the identity and physical checks on consignments of food of non-animal origin subject to temporary or emergency measures had not been carried out in line with the minimum frequency rates required by Articles 6 and 8 and Annexes I and II to Regulation (EU) 2019/1793. The competent authority was aware of this shortcoming and had recruited additional staff to address it (see Section 5.1.1).

However, shortcomings were noted regarding the performance of identity and physical checks on goods of animal origin and the frequency of identity and physical checks on food of non-animal origin, which reduce the overall effectiveness of the official control system.

Member state response

ical checks on consignments of Answer from the Swedish Food Agency (SFA): at the minimum frequencies The latest changes in regulation (EU) 2019/1793 has caused a es I and II to Regulation (EU) large increase in consignments of food of non-animal origin imported to Sweden from 2021-2022, continuing in 2022-2023. To address this, several new employees, both official veterinarians and official inspectors, have been recruited to the Border Control Team at the Swedish Food Agency during 2023. The movement to the new BCP facility in Gothenburg Port during 2023 has been a time-consuming process for the colleagues in Gothenburg, which is now completed. As already stated in recommendation 1, the competent authorities are working on the routines to improve the methods to unload consignments in a more efficient way. The central authority has introduced quarterly reconciliation meetings with representatives from the Swedish BCP:s to confirm that the sampling is in phase with the requirements in regulation (EU) 2019/1793. The effect of these measures is already visible, the minimum frequencies will be met to a larger extent in the end of 2023, compared to the statistics in september. Our assess

The recommendation states as its basis

Cases of non-compliances in relation to raw milk quality (PC, SCC or antibiotic residues/inhibitory substances) notified monthly by dairy establishments are usually followed up during the next planned inspection, and not immediately after the county veterinarians receive the reports from the CAB unit dealing with controls over the primary sector. This practice hampers the CAs efforts to take action to determine the origin and extent of the non-compliance in line with Article 138.1 of Regulation (EU) 2017/625. The immediate measures are left to the dairy establishments and comprise an immediate stop of further deliveries in case of antibiotic residues. Milk payment reduction is also used by 13 the dairy establishments. The situation varied between the CABs reviewed. The CAB Västra Götaland has established a routine where the county official veterinarian carries out an unplanned check on-site as soon as work planning allows. In relation to PC and SCC exceeding values, a risk assessment is made. If there is a sale of small quantities of raw milk from the farm, an unplanned check is carried out on the farm as soon as work planning allows. Otherwise, the plant will be placed on a priority list for targeted planned controls in the coming control year. The CAB of Västernorrland stated that usually there would be no follow-up inspection. Thus, positive cases for residues of inhibitory substances in raw milk are, in general, not timely followed up at holding level as part of official controls. Conclusions on controls over milk and colostrum production holdings

The reporting by FBO to CABs of non-compliances concerning the quality of raw milk (PC and/or SCC), and detection of residues of antibiotics in raw milk, on a monthly basis only, hinders effective follow-up, which is further impacted by systemic delays at the level of the CAB. Equally, positive findings for residues of antibiotics/inhibitory substances are, in general, not timely followed up with official controls at holding level. This is not in line with Article 138.1 of Regulation (EU) 2017/625 and Article 50.2 of Regulation (EU) 2019/627.

Although the presence of antibiotic residues was deemed a critical control point (CCP) in the HACCP plan of the third larger dairy plant visited by the audit team, the milk trucks were only tested once weekly randomly for inhibitory substances/antibiotic residues, and the test result of the raw milk silo was used to decide if the milk was fit for human consumption. This practice was in line with the branch guidelines. In addition, the use by FBOs of rapid tests that detect beta-lactams and tetracyclines only, implies that other possible antibiotic residues in raw milk would remain undetected.

The FBOs' systems in place in relation to SCC and PC in raw co milk is generally implemented in line with the requirements with Section IX of Annex III, Regulation (EC) No 853/2004, whereas the verification and enforcement action by the CAs after notification of non-compliances in relation to these parameters and/or after detecting antibiotic residues in raw milk is not in line with Article 138.1 of Regulation (EU) 2017/625 and Article 50.2 of Regulation (EU) 2019/627 as it is done with a delay.

Member state response

gue with the dairy industry, through the farming organisation LRF, regarding the required changes to the current industry guidelines has begun. The plan is to agree on the changes that needs to be made during a scheduled meeting on 2022-11-23 so that the changes can begin to be implemented during the beginning of 2023.A guidance document for CABs follow up at the farm of instances of raw milk containing residues of antibiotics detected by food business operators will be implemented from January 2023. An implanting seminar for inspectors at the CABs will be held in January 2023. The developed procedure will be followed up in 2024. Response 2023-04-05 after Commission services´ assessment: The industry guidelines were updated as planned and links to them are found on the SFA webpage for national guides. Branschriktlinjer (livsmedelsverket.se) Control of raw milk: https://www.lrf.se/media/jlzdbpxf/branschriktlinjer-f%C3%B6r-kontroll-av-obehandlad- mj%C3%B6lk-2022-11-23.pdf Hygienic production of milk products: https://www.lrf.se/media/ehupgow4/branschriktlinje-f%C3%B6r-hygienisk-produktion- av-mj%C3%B6lkprodukter-p%C3%A5-mejeri-2022-11-23.pdf A guidance document regarding raw milk con

The recommendation states as its basis

The CA have accepted the branch approach that the raw milk reception silo is the control point for inhibitory substances/antibiotic residues in raw milk (in combination with the system that milk from each holding is tested for antibiotic residues at least once monthly and testing of the raw milk from at least 3 trucks monthly) to determine if it can be processed for human consumption. At silo sampling stage, any possible antibiotic residue in raw milk is largely diluted and the probability of detecting it is very low. One of the dairy establishments visited (part of a chain) had chosen not to test the trucks for inhibitory substances, which is not in line with the industry guideline.

Although the presence of antibiotic residues was deemed a critical control point (CCP) in the HACCP plan of the third larger dairy plant visited by the audit team, the milk trucks were only tested once weekly randomly for inhibitory substances/antibiotic residues, and the test result of the raw milk silo was used to decide if the milk was fit for human consumption. This practice was in line with the branch guidelines. In addition, the use by FBOs of rapid tests that detect beta-lactams and tetracyclines only, implies that other possible antibiotic residues in raw milk would remain undetected.

The delays in the FBOs reporting of incidents where raw milk has tested positive of residues of VMPs, combined with the situation that allows the FBOs to use the raw milk silo as a testing point for antibiotic residues to determine if the milk is fit to be processed for human consumption, leads to situations where raw milk containing antibiotic residues could be processed into products for human consumption.

Member state response

ee part one of action proposed in recommendation number 1. hanges will be made in the guideline. Information regarding the changes will be ommunicated to the inspectors performing official controls at the SFA during the eginning of year 2023, and official controls will be performed during 2023 esponse 2023-04-05 after Commission services´ assessment: he industry guideline on Hygienic production of milk products (see answer on rec 1) has een updated and published. See section 2.14.1 which now states that every incoming ruck has to be tested.

The recommendation states as its basis

The control system does not ensure the same frequency checks for goat and sheep milk as for cow milk in order to verify if FBOs comply with their obligations.

Member state response

ontrol of sheep and goat farms and that the raw milk is tested in line with Chapter I, Annex III of Regulation (EC) No 853/2004 and will be prioritised in the national control Page: 2 ommission services' assessment of the action plan submitted by the competent authorities of the audit carried out from 07 March 2022 to 22 March 2022 in order to evaluate the official ction Proposed by the competent authority lanning for primary production from 2023. A guidance document for this control will be vailable from 2023 and an implementing seminar for inspectors at the CABs will be held n January 2023. esponse 2023-04-05 after Commission services´ assessment: special focus of control the farmers own control of raw milk from sheep and goats is mplemented in the national control planning for primary production 2023. See page 5 in ttached document. The plan is part of the MANCP and can be find on this webpage: ttps://www.livsmedelsverket.se/foretagande-regler-kontroll/sa-kontrolleras-ditt- oretag/nkp-webben/overgripande-mal-och-prioriteringar . webinar, including guidance how to perform the control, was held on February 3, 2023. 8 participants attended the online webinar (including the organize

The recommendation states as its basis

In one cheese plant "industrial products" (e.g. cheese rest pieces, cheeses with some molds) destined to be sold as an raw material for other dairy processing establishments were not properly covered in the HACCP plans and not stored correctly and in line with the EUCALAIT/EDA guideline on cheese as raw material in the manufacture of food products, a guidance document the FBO stated to be using. The vat for cheese with molds contained some cheeses that were utterly covered with mold and were not fit for human consumption. The FBO stated the raw material was according to the client's specification. However, the only criteria used was to sort the raw material according to the fat percentage (3 categories) in addition to the category of the cheeses with molds. In addition, there was a written statement of the client stating that they were aware that the raw material was as such not fit for sale to consumers and would be used for further processing.

The audit team noted that in another establishment processing cheeses, belonging to another dairy chain, industrial products were delivered to the same clients; also in this plant the products were not covered properly by the HACCP.

Some controls areas have received limited attention - the audit team noted systematic shortcomings in relation on to controls on industrial dairy products targeted as raw materials for the food industry and in relation to controls on ABP.

Member state response

d The SFA will include the control of industrial food products in all establishments handling ilk products in the control plan for 2023 and thereafter with regular intervals. e 2023-04-05 after Commission services´ assessment: see attached control plan and reports. Page: 3 ommission services' assessment of the action plan submitted by the competent authorities of the audit carried out from 07 March 2022 to 22 March 2022 in order to evaluate the official Action Proposed by the competent authority

Member state response

See part one of action proposed in recommendation number 1. n hanges in the guideline regarding sampling of products for and analysis of L. monocytogenes and Salmonella in line with Chapter I, Annex I to Regulation (EC) No 2073/2005 has been communicated with LRF and Eldrimner. Eldrimner, a national food craft centre, plans to review the national guidelines for small-scale dairy products in 2023. Information to the inspectors performing official controls at the SFA during the beginning of year 2023. Control of microbiological criteria is included in the control plan for SFA for 2023. Response 2023-04-05 after Commission services´ assessment: The industry guideline on Hygienic production of milk products (see answer on rec 1) has been updated accordingly and published. In December 2022 the SFA informed the "branschorganisationer ­ Gårdsmejeristerna och Eldrimner" which represent the artisan milk- and dairy producers that audits and inspections will be carried out to control that producers take listeria monocytogenes samples in ready-to-eat products in compliance with regulation (EC) 2073/2011. Food inspectors and veterinarians has been instructed to carry out such inspections and au

The recommendation states as its basis

The monitoring of HPAI in wild birds is based on reporting and sampling of fallen, or sick and killed animals. Prior to the epizootics, the SVA and the SBA reminded the public and ornithologists of the importance to report those findings to enhance 6 surveillance for HPAI in wild birds. Reports of observed morbidity and mortality in wild birds are analysed on a daily basis and a subset of the birds are submitted to SVA for analysis. As a result, between 400 and 500 wild birds are surveyed annually. However, neither the risk assessments of the SVA, nor the SBA, identified the relevance of adapting and strengthening that surveillance in certain areas of the country in close vicinity to some of the HPAI outbreaks confirmed, where there was a significant presence of species of wild waterfowl that do not regularly show obvious clinical signs of HPAI or increased mortality (e.g. wild geese). This could have provided them with additional epidemiological evidence to reinforce disease preventive activities in the area and to confirm their hypotheses on the local introduction of the HPAI virus from these wild birds into domestic poultry (i.e., carrying out phylogenetic studies).

Therefore, that sub-optimal effectiveness of the surveillance in wild birds cannot be considered in line with provisions laid down in Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429, on the need to design and apply surveillance in a way that is appropriate and proportionate to the objectives pursued and to the risk factors involved in order to ensure the timely detection of the presence of the targeted disease. In doing that, the competent authority shall as well comply with EU requirements establishing the Union surveillance programme for HPAI, as laid down in Articles 3(1)(a) and (b)(i), 4(1)(b)(i) and 10(2) of, and Annex II to Delegated Regulation (EU) 2020/689.

Although the authorities have made efforts to increase the sensitivity of surveillance in both wild birds and domestic poultry, surveillance in the former was only partially effective as an early warning system to better prevent the outbreaks in both epizootics and to confirm epidemiological hypothesis on the source of infection in affected establishments.

Member state response

rogramme for surveillance of HPAI in wild birds is in place. rly In relation to monitoring of HPAI in wild birds, reported mortality is already used as a source of information, and far more dead birds are reported than the subset of birds examined. Surveillance programmes are revised annually, and possible improvements are discussed, for HPAI a more systematic reporting of observations of morbidity or mortality in wild birds ing discussed as well as active monitoring of apparently healthy wild birds in poultry dense areas. When it comes to sampling of wild birds in proximity to an outbreak, as mentioned in the (draft) report the causal relation is neither given nor evident to prove. Wild birds can also be exposed to virus from infected poultry farms. Having positive cases in poultry will result in information in media and direct to farms in proximity, thus additional findings in wild birds are not needed as a basis for activities to raise awareness and increase biosecurity.

The recommendation states as its basis

However, the audit team saw two cases where the private veterinary practitioner had not done that on the establishment infected in both epizootics and there had been delays in passing the information to the SVA or to district veterinarians of the SBA in both instances. Representatives of the SBA indicated that it had happened during the 2020/21 epizootic because some operators were not yet familiar with the high risk related to HPAI; however, 7 one of the above-mentioned cases happened during the 2021/22 epizootic. That is not in line with requirements laid down in Articles 12(1) and 18(1)(a) and (c) of Regulation (EU) 2016/429.

The efforts to raise and maintain public awareness on the risks associated with HPAI contributed to the prompt notification of suspect cases and limited the spread of the disease. Some delays in certain cases to notify suspect cases had a limited impact since they occurred in areas with a low density of poultry.

Member state response

The authorities and the industry are continuously working with keeping the knowledge of the symptoms of HPAI up-to-date, and how to act in case of a suspicion high and fresh in mind. We mean that the results of these activities are sufficient. The SBA will however continue working on information initiatives ensuring that veterinarians and stakeholders fulfil their responsibilities to immediately notify the competent authority where there is any reason to suspect the presence of HPAI in accordance with Article 18(1)(a) of Regulation (EU) 2016/429. SBA will spread this information by information on our website, targeted information campaigns to animal holders, veterinarians Page: 1 023 port ref. DG(SANTE) 2022-7502 of the audit carried out from 21 November r the prevention and control of avian influenza Action Proposed by the competent authority and others who can come into contact with animals exposed for HPAI. In addition, we will highlight the importance of clinical signs ensuring that the animal holders and veterinarians are aware and has knowledge of how to act and to whom they should notify any suspicions of HPAI.

The recommendation states as its basis

When reviewing one of the HPAI outbreaks, confirmed on 2 March 2021 in an establishment keeping pheasants for game re-stocking, the audit team noted that in January, i.e., once the SBA had raised the alert concerning the high risk of incursion of the disease, the business operator responsible for the establishment had re-captured previously released birds from the wild. The district veterinarians who dealt with the outbreak were aware of this practice, as they confirmed that it is common during that period of the year in several establishments from the area. However, neither them or other staff of the SBA had investigated the potential risk associated with that activity, and they had not taken either any action to prevent additional outbreaks in these specific establishments.

The SBA delegated inspections on biosecurity in establishments to the poultry meat and eggs sectoral associations. However, examples like the one explained in the previous point prove that at least some parts of the poultry industry had not adapted disease preventive measures properly to mitigate the specific risks associated with the presence of HPAI in wild birds in accordance with the requirements established by the SBA, as required until 20 April 2021 by Commission Decision 2018/1136 and, since that date, by provisions laid down in Articles 10(1)(a)(iii), (b) and (c), (4) and (5), and 11(1)(b) of Regulation (EU) 2016/429.

In addition, the competent authorities had not adapted their official controls, or their procedures and/or arrangements to verify their effectiveness, to ensure that the biosecurity measures applied by the industry were suitable, implemented in compliance with their instructions, and that the inspections carried out by the sector itself were effective to achieve that. This is not line with Articles 5(1)(a), 9(1) and 33(a) of Regulation (EU) 2017/625. Surveillance

The results of most of the epidemiological enquiries indicated that the outbreaks were very likely caused by a separate primary introduction of the HPAI virus from wild birds. This was confirmed later by the SVA with phylogenetic analyses. Some epidemiological enquiries underlined weaknesses related to the application of biosecurity measures to prevent the introduction of HPAI. However, the SBA had not adequately investigated the possible influence of those weaknesses as a cause of infection, even recurrent in both epizootics, in certain establishments (e.g., in the turkey production sector).

The lack of a system to adequately verify compliance of poultry establishments with HPAI preventive measures precludes that the SBA obtains accurate and up-to-date information on the actual implementation and effectiveness of their HPAI preventive policy. Despite evidence on the inappropriate application of, and insufficient compliance with national requirements on biosecurity in poultry establishments affected by the HPAI epizootics, the SBA failed to correct those shortcomings. This resulted in an unmitigated high risk of infection in certain types of establishments, which contributed to some of the outbreaks and, in certain cases, to recurrent infections in the same establishments in both epizootics.

The SBA allowed repopulation in affected establishments only after the final cleaning and disinfection was carried out. SBA staff verified establishments' compliance with 20 national requirements on biosecurity measures and that they were suitable to minimise the risks of introduction of HPAI. The audit team saw some examples where they gave recommendations to operators to address weaknesses identified in that respect. In one of the cases checked, an establishment that was infected in both epizootics, at the time of the second outbreak the operator had not addressed some of the recommendations given by SBA staff after the checks carried out after the first one. Representatives of both the SBA and the SVA acknowledged that shortcoming. The SBA informed the audit team that they were in the process of evaluating and reinforcing those checks on biosecurity in poultry establishments (see section 5.1.1.1, and the associated conclusion, on weaknesses related to application and verification of preventive measures).

Member state response

There is an ongoing project reviewing our official control system for animal health including official control on biosecurity measures on poultry. The project will be finished by the end of 2023. The conclusions from the project together with this audit ill feed into adjustments to the official controls ensuring that fy appropriate biosecurity measures on poultry are applied in high risk areas, in restriction zones as well as during the normal tion control of biosecurity. We will in addition improve the documentation on performed controls ensuring that the official control is adequate and risk based.

The recommendation states as its basis

The district veterinarians responsible for the areas where the suspect cases were notified initiated the epidemiological enquiries at the time of suspicion. In most cases, they finished with them shortly after the disease had been confirmed. But some of them were incomplete, not providing all relevant epidemiological information/data, e.g., they did not include information on other establishments of the same owner, often sharing their machinery, which they did not identify as contact holdings. In addition, they had not considered properly the risk of virus transmission associated with some relevant contacts and epidemiological links (e.g., delivery of feed, trucks from a rendering plant and trucks collecting table eggs), which they did not follow to identify contact establishments and place them under supervision to rule out the potential spread of the disease. Therefore, although those enquiries aimed to obtain the relevant information required by Article 57(2) of Regulation (EU) 2016/429, they did not achieve that consistently.

District veterinarians provided the collected information to the SBA. The SBA frequently relayed it to the SVA, which analysed it promptly in some cases. SBA and SVA experts visited most of the outbreaks to further evaluate the epidemiological situation on site, but they did that only once the establishments had been depopulated and the carcasses dispatched for their disposal5. That precluded that those experts could obtain important information on the routine operation of the establishment and from their own evaluation of the evolution of the disease in the affected poultry present in the establishment.

In some cases, the outcome of the analyses carried out by the SVA and the SBA served to establish the most likely time window for the infection of the flocks, the duration of the incubation period, and to obtain other relevant epidemiological information. However, those results had not been adequately documented to show how the SBA and/or the SVA used them for a complete analysis of the likely routes of introduction of 5 In their response to the draft report the CA stated that these HPAI outbreaks occurred during a time when there were national restrictions on movements due to the Covid-19 pandemic, therefore it was not possible to visit the outbreaks to an extent that otherwise would have been done. 8 the virus in the affected establishments and of its possible spread, and to identify quickly contact establishments. Therefore, the authorities could not fulfil all the objectives of the epidemiological enquiries to inform their decisions on the application of control measures to contain the HPAI outbreaks, as provided for in Articles 55(1)(e) and (f), 56(a)(ii), 57(2), and 62(1) of Regulation (EU) 2016/429, and Articles 14(1), 17 and 18(2) of Delegated Regulation (EU) 2020/687.

There were cases where district veterinarians had to prioritise other official tasks, for example, preparation and performing of killing of poultry and disposal of carcasses in affected establishments. That delayed often completion of the epidemiological inquiries for the same establishments. The audit team confirmed that in a large laying hen establishment infected at the beginning of 2021, as the district veterinarian could only complete the epidemiological enquiry 18 days after confirmation of the disease. That establishment had multiple houses, some separated by considerable distance (e.g., separating the area with houses keeping pullets from those keeping laying hens). The SBA had decided after an evaluation carried out months before the outbreak that, considering the husbandry practices applied, there were multiple epidemiological units6 in the establishment. At the time of the outbreak, the SBA decided to grant accordingly a derogation as provided for in Article 14 of Council Directive 2005/94/EC, applicable at the time, to not kill the poultry from the epidemiological units not affected initially (since 21 April 2021, this derogation is provided by Article 13 of Delegated Regulation (EU) 2020/687).

In that case, the district veterinarian was in constant contact with the SBA and provided initially some epidemiologically relevant information on the establishment, but the fact that the full enquiry was delayed precluded that both the SBA and the SVA obtained all the necessary information to fully analyse the situation and adapt accordingly the measures taken (e.g. testing of other epidemiological units, further restrictions in their movements). The SBA did not consider necessary consulting the SVA before deciding on granting that derogation.

However, as mentioned before (section 5.1.1.2), not all contact establishments were identified or duly followed up. That is not in line with EU requirements laid down in Article 62(1) of Regulation (EU) 2016/429, and Article 18(2) of Delegated Regulation 11 (EU) 2020/687. Conclusions on early detection, handling of suspicion and confirmation of HPAI

The inconsistent and slow analysis in many cases of the data and information collected by district veterinarians during the epidemiological enquiries, alongside the often inadequate documentation of its outcome, made it difficult for the SBA to take timely and appropriate risk-based control measures (e.g., identifying contact establishments, granting of derogations for separate epidemiological units and for movements in restricted zones). That slowed down the response to the disease, which was not as effective as it should have been to limit the impact of the outbreaks.

However, as described in sections 5.1.1.2 to 4, certain limitations in the provision of quick and adequate epidemiological information from the affected establishments precluded that both the expert group and the national disease control centre could analyse all necessary data to advice on the application of some disease control measures (e.g., handling of separate epidemiological units in some establishments, granting of some derogations).

District veterinarians demonstrated good knowledge about the measures they had to apply to respond to HPAI outbreaks, with some exceptions related to carrying out and evaluating epidemiological enquiries. In general, they carried out their tasks timely; however, there were instances where due to overload they had to prioritise some activities over other and they could not apply some of the required disease control measures (e.g., prioritise killing over epidemiological enquiries, which resulted in delays to perform the latter, they could not visit hobby/non-commercial establishments situated in some protection zones, they could not supervise cleaning and disinfection activities in some cases). The SBA did not have flexible arrangements and sufficient human resources to react quickly and address those gaps. That was not in line with requirements laid down in Articles 13(1)(a) and 43(2)(c)(iv) of Regulation (EU) 2016/429 on responsibilities of the competent authorities to have an effective organisation and access to personnel to apply disease control measures timely and effectively, and on application of the contingency plan for HPAI. 5.2.5 Availability of equipment and materials

Member state response

have reviewed our routines to strengthen the initial pidemiological enquiries. As of now we offer the official veterinarians further support in the epidemiological enquiries with the aim of enhancing the collection of adequate information from the farms at the initial stage. Please see the attached ) documents. In addition, the SVA performs visits or online meetings with the erator and the official veterinarian at the infected holding at an earlier stage in order to identify and collect crucial information.

The recommendation states as its basis

The Swedish national accreditation body has accredited the laboratory in accordance with the standard EN ISO/IEC 17025. However, the molecular methods used by the SVA for the investigation of suspect cases of HPAI, and for confirming them, are not within the scope of accreditation (e.g., the matrix gene PCR, and the PCRs used for H5 and H7 subtyping and pathotyping). This is not in line with requirements laid down in Article 37(5)(a) and in the first paragraph of Article 100(2) of Regulation (EU) 2017/625. Representatives of the SVA confirmed that they had started the accreditation process for those diagnostic methods and informed the audit team that, in that context, there was an audit of the national accreditation body envisaged for May 2023.

The NRL for avian influenza has adequate diagnostic standards and provides the competent authorities with rapid technical support for the detection and control of HPAI. However, despite the satisfactory performance of the laboratory in the inter- laboratory proficiency tests organised by the EU reference laboratory for the disease, the molecular methods routinely used to detect and confirm cases of HPAI are not yet within its scope of accreditation. That undermines the soundness and reliability of the results it delivers in those situations. 5.1.3 General measures in relation to protection and surveillance zones 5.1.3.1 Establishment of protection and surveillance zones

Member state response

SVA has had the PCR-method for detection of influenza A viruses accredited on 16 January 2023. Page: 2 023 port ref. DG(SANTE) 2022-7502 of the audit carried out from 21 November r the prevention and control of avian influenza Action Proposed by the competent authority he Regarding the method for subtyping and pathotyping of avian influenza H5 and H7, the method is ready for accreditation and SWEDAC will perform an audit in May 2023 for this accreditation. During the audit, SWEDAC will also perform audits for accreditation for other methods. The decisions made by SWEDAC are joint decisions for all methods audited and it can therefore take some time before final decisions, but SVA expects the decision to come during 2023.

The recommendation states as its basis

There were cases where district veterinarians had to prioritise other official tasks, for example, preparation and performing of killing of poultry and disposal of carcasses in affected establishments. That delayed often completion of the epidemiological inquiries for the same establishments. The audit team confirmed that in a large laying hen establishment infected at the beginning of 2021, as the district veterinarian could only complete the epidemiological enquiry 18 days after confirmation of the disease. That establishment had multiple houses, some separated by considerable distance (e.g., separating the area with houses keeping pullets from those keeping laying hens). The SBA had decided after an evaluation carried out months before the outbreak that, considering the husbandry practices applied, there were multiple epidemiological units6 in the establishment. At the time of the outbreak, the SBA decided to grant accordingly a derogation as provided for in Article 14 of Council Directive 2005/94/EC, applicable at the time, to not kill the poultry from the epidemiological units not affected initially (since 21 April 2021, this derogation is provided by Article 13 of Delegated Regulation (EU) 2020/687).

In that case, the district veterinarian was in constant contact with the SBA and provided initially some epidemiologically relevant information on the establishment, but the fact that the full enquiry was delayed precluded that both the SBA and the SVA obtained all the necessary information to fully analyse the situation and adapt accordingly the measures taken (e.g. testing of other epidemiological units, further restrictions in their movements). The SBA did not consider necessary consulting the SVA before deciding on granting that derogation.

As indicated in the previous section, at the beginning of 2021, when some large establishments with several poultry houses got infected, the SBA granted a derogation from immediate killing of birds to some of them, in which the disease had not been confirmed, and that were considered separate production/epidemiological units. However, in doing that, the SBA did not carry out a proper risk assessment at the time of the outbreak, taking into account the results of the epidemiological enquiry (which was not yet done at the time of the decision) and the possibility to obtain first favourable results in laboratory examinations to exclude the circulation of the HPAI virus in still asymptomatic poultry.

In addition, the lack of updated relevant epidemiological information from the first infected unit precluded excluding that at least during the monitoring period of 21 days before the confirmation of the disease, the epidemiological units in which the disease had 7 See for example: Grant M, Bröjer C, Zohari S, Nöremark M, Uhlhorn H, Jansson DS. Highly Pathogenic Avian Influenza (HPAI H5Nx, Clade 2.3.4.4.b) in Poultry and Wild Birds in Sweden: Synopsis of the 2020­ 2021 Season. Veterinary Sciences. 2022; 9(7):344. https://doi.org/10.3390/vetsci9070344 10 not been confirmed were kept completely separated and handled by different personnel, which is a basic conclusion to extract from such risk assessment.

In addition, still during the 2020/21 epizootic, the SBA applied the same approach in another establishment keeping breeding poultry, considering some of the houses as separate epidemiological units, after the disease was confirmed in one of the units. They did not only grant the derogation to not kill the poultry from the not (yet) affected units, but also allowed the dispatch of several consignments of hatching eggs from them to other establishments in Sweden (see also section 5.1.3.4 concerning that derogation). Those decisions were taken without carrying out a proper risk assessment and without considering either the epidemiological and laboratory analysis information mentioned in the previous point to exclude the possible circulation of the HPAI virus in the other units of the establishment.

In the above cases, the disease was detected eventually in other epidemiological units, and all birds remaining on the establishments were subsequently killed. The few remaining units not yet clinically affected were preventively culled. However, the SBA did not take any samples to rule out the infection in those units, as required at the time by Article 10(3) of Directive 2005/94/EC and point 8.2 in Chapter IV of the Annex to Commission Decision 2006/437/EC. Nor did the SBA take any action to trace and destroy hatching eggs already dispatched to hatcheries in non-affected areas of the country from these preventively killed birds. All in all, the process to grant those derogations was not in line with requirements laid down in Article 14 of Directive 2005/94/EC, which are since 21 April 2021 laid down and reinforced in Article 13(1) of Delegated Regulation (EU) 2020/687.

The measures applied immediately upon confirmation of HPAI outbreaks during both epizootics were adequate in most cases and helped to contain the spread of the disease. However, during the 2020/21 epizootic, the SBA granted certain derogations that postponed the killing of poultry in epidemiological units of affected establishments considered as separate. Those decisions proved to be not only unjustified, as most of those units got eventually infected by the same HPAI virus, but were also not based on a proper risk assessment to exclude any risk of spread of the disease, as required by EU legislation. Despite that, there was no evidence that those situations had contributed to spread HPAI from the relevant establishments. 5.1.2 Diagnosis of HPAI

Before they could grant the derogation for those movements, district veterinarians performed checks on the health status of the poultry kept in the relevant establishments. 15 Beyond that, the SBA did not require any pre-movement sampling and laboratory testing since they did not consider it necessary. They argued that the HPAI viruses circulating in Sweden during both epizootics caused obvious clinical symptoms and high mortality in the poultry species kept, and thus, that they were easily and quickly detectable during the clinical examinations and checks on production records their staff carried out (e.g., no establishments with ducks or geese involved).

The audit team reviewed several examples where a derogation was granted. One of them, happening before 21 April 2021, involved dispatching hatching eggs from units of breeding establishments where a case of HPAI was confirmed, that the SBA considered as separate epidemiological units (see more details in section 5.1.1.3). However, they did that without taking and analyse first the standard samples from each of the production units involved in that activity, as required by point 8.10(c) of Chapter IV of the Annex to Commission Decision (EC) 2006/437, in accordance with the requirements of Article 26(1)(a) of Directive 2005/94/EC (applicable at the time of the outbreak).

In another case, happening in December 2021, the SBA granted a derogation to move poultry to a slaughterhouse from two establishments belonging to the same operator, in whose third establishment they had just confirmed an outbreak of HPAI (two days before). One of those two establishments was located in the protection zone established after the outbreak, less than two kilometres from the affected one, whereas the second one was within the surveillance zone. All three establishments shared some machinery, and the operator visited them regularly. Although all that evidence indicated that those movements could represent a high risk of spreading the disease, the SBA allowed them without carrying out a proper risk assessment and applying additional risk mitigating measures, e.g., laboratory examination with favourable results of samples taken from poultry kept in those establishments, including from the animals to be moved.

The competent authority granted some derogations to move animals and products of animal origin from restricted zones without adequately ensuring that they would not endanger disease control, as required by EU legislation. Nevertheless, there was no evidence that those situations had any impact on the further spread of the disease or in delaying its containment. 5.1.4 Animal depopulation for the purpose of disease control 5.1.4.1 Animal welfare considerations

However, as described in sections 5.1.1.2 to 4, certain limitations in the provision of quick and adequate epidemiological information from the affected establishments precluded that both the expert group and the national disease control centre could analyse all necessary data to advice on the application of some disease control measures (e.g., handling of separate epidemiological units in some establishments, granting of some derogations).

The disease control centres established at national and local level during the epizootics, in particular during the one in 2020/21, coordinated the response to most of the outbreaks effectively. However, they lacked some necessary information to take important decisions related to specific outbreaks. Although those decisions could have had important consequences (e.g., transmission of the disease locally, or elsewhere in the country via derogated movements), the low density of poultry in the affected areas and the low risk associated with commodities allowed to leave the restricted zones, helped to prevent the spread of the disease.

Member state response

On 15 February 2023 the SBA implemented an electronic application service which follows here: E-tjänst för ansökan om tillstånd för förflyttning till, från eller inom en restriktionszon - Jordbruksverket.se where operators such as animal owners, receivers, and transporters can apply for exemptions from ovement restrictions from restriction zones. In this application the operator must state all the relevant information regarding the . A risk assessment is carried out by SVA prior to the uthority's granting of approval for the transport. The risk assessment must demonstrate that spread of infection is negligible for the transport to be carried out. Veterinary visits and, if necessary, sampling, is undertaken prior to movements. Sampling and laboratory testing of animals is performed in consultation with SVA prior to moving animals to slaughter from a contact facility. If the SBA decides on preventive culling, this will be preceded by diagnostic testing at the NRL (SVA). In all normal circumstances a facility which is infected by a category A disease is viewed upon as one single epidemiological unit. Only in exceptional cases separate epidemiological units Page: 3 023 port ref. DG(SAN

The recommendation states as its basis

In most cases, collection and disposal of killed poultry operated swiftly and without delay. However, in the case of a large establishment affected by an outbreak in 2021, the authorities lacked sufficient collection and processing capacity. This was due to the exceptionally large number of poultry carcasses and an exceptionally large number of eggs. To cope with the situation and keep on killing the poultry, the SBA opted for the temporary storage of those ABP in specially designed big bags on the establishment until they were collected and processed as described above along the following four months. During that time, the SBA paid special attention to the application of biosecurity measures to prevent the spread of infection from the material stored in the establishment, which was situated in an area with low density of establishments, e.g., the closest one was 7 km apart.

The shortcomings highlighted in the previous point are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429, on the responsibilities of the competent authorities to have access to adequate facilities to take the necessary disease control measures, including disposal of animals that may contribute to the spread of a category A disease in the event of an animal health crisis, such as the 2020/21 HPAI epizootic.

At the time of the audit, and despite the lessons learnt from the case mentioned above, the contingency plan for HPAI had not yet been updated to anticipate and deal with such exceptional situation. However, the SBA amended their procedures to speed up the disposal of ABP from the average poultry establishment affected by a HPAI outbreak, e.g., starting preparations for collection and disposal of carcasses already at the time of suspicion. Furthermore, they intend to explore other options to strengthen their preparedness, e.g., to transfer partially the responsibility for disposal of carcasses to business operators, who should develop a specific contingency plan for their establishments with that purpose. Conclusions on animal depopulation for the purpose of disease control

The authorities had taken adequate steps and made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases of dead and killed poultry in the event of outbreaks of HPAI affecting establishments of average size and not occurring in spatiotemporal clusters. However, that preparedness did not factor in the possibility of an outbreak in some exceptionally large establishments, where significant delays in applying those measures increased for weeks the risk of spread of the disease. Although the low density of poultry in the affected area mitigated that risk and no additional outbreak was confirmed in it, the authorities have not yet upscaled their preparedness to address that shortcoming. 5.1.5 Cleaning and disinfection

The SBA externalised the application of the preliminary cleaning and disinfection in affected establishments to private contractors, who, in most cases, did it within short deadlines once the poultry were killed and the carcasses disposed of. There were cases where the authorities had to postpone the application of both preliminary and final cleaning and disinfection because of the limited capacity of some of those contractors or as a consequence of delays in removal of dead bodies or killed animals. Thus, in some instances, because of those delays, the SBA lifted the restrictions in surveillance zones without having applied first the final cleaning and disinfection (see also section 5.1.6).

In a large establishment affected by an outbreak at the beginning of 2021, the SBA initially questioned the efficacy of applying the preliminary disinfection due to unfavourable weather conditions (low temperatures and snow fall), as they considered that the biocidal available was not going to be effective. After further consultation with the SVA, they decided to proceed with the disinfection. In addition, the final cleaning and disinfection was delayed for more than four months due to the presence of contaminated materials (for more see section 5.1.4.2).

Staff from the SBA at central level and some of the district veterinarians met confirmed that they had not supervised implementation of cleaning and disinfection activities in all affected establishments, as required by Article 48(a) of Directive 2005/94/EC (before 21 April 2021) and Article 57(2) of Delegated Regulation (EU) 2020/687 (since 21 April 2021). Conclusions on cleaning and disinfection

The competent authorities ensured that adequate cleaning and disinfection of most affected establishments contributed to the elimination of residual infection, except where the presence of contaminated materials precluded them to do so and caused delays, and when they could not supervise application of those measures. Although those 19 shortcomings increased temporarily the risk of spreading the infection in certain areas, there was no evidence that it had happened. 5.1.6 Lifting of restrictions

The fact that the SBA decided in several cases to lift the restrictions in surveillance zones before having implemented and/or supervised the final cleaning and disinfection on establishments affected by HPAI outbreaks was not in line with Article 68(1)(b) of Regulation (EU) 2016/429. Conclusions on lifting of restrictions

The SBA did not ensure that the objective of applying the final cleaning and disinfection on establishments affected by HPAI outbreaks, i.e., to minimise the risk of spread of the disease, was achieved in all cases before discontinuing the application of control measures in restricted zones. Although that non-compliance with EU rules increased temporarily that risk, there was no evidence that it had materialised in further outbreaks of the disease. 5.1.7 Repopulation of affected holdings

The arrangements made by the competent authorities and operators to procure the equipment and services they needed for the killing of poultry in affected establishments and for the disposal of contaminated materials proved to be fit for purpose in most circumstances, except for an outbreak in a very large poultry establishment during the 2020/21 epizootic, which exposed some weaknesses of the preparedness system, e.g., inadequate capacity for disposal of a large amount of carcasses and subsequent delays in conducting cleaning and disinfection. 5.2.6 Diagnostic capacity in case of an emergency

Member state response

This specific case was a large establishment where the collection disposal of carcases took longer time than it normally should and have done. This was due to other contributing factors than merely limitation in capacity. The HPAI outbreak happened ng the Covid-19 pandemic. The handling was consequently limited due to imposed Covid-19 restrictions. In our view we nd solved the issue in an adequate way given the unusual situation that had arisen. ess, SBA will continue to develop the capacity to apply tion and disposal of the carcases and of other contaminated products. We will also analyse further alternatives for disposal, such as suitable incineration plants and burial of carcasses. As of 1st January 2023, the SBA has introduced a routine for how the responsible veterinarian must monitor and certify that the cleaning and disinfection have been carried out correctly. Please refer to the example attached. Bilaga 4, intyg Rutin för preldes.docx preliminärdesinfekti Page: 4 023 port ref. DG(SANTE) 2022-7502 of the audit carried out from 21 November r the prevention and control of avian influenza Action Proposed by the competent authority However, SBA disagrees with recommendation no.

The recommendation states as its basis

The SBA has not fully updated the contingency plan for HPAI in recent years, despite the recent epizootics and the recurrent risk of incursion via wild birds of HPAI in EU Member States. They have been developing for several years a new version of that contingency plan trying to adapt it to the one they developed for foot-and-mouth disease, but several parts still need to be amended and further developed, including some operational manuals.

In the last three years, there has been no simulation exercise on HPAI to test the emergency preparedness system. Nevertheless, the authorities provided evidence on several actions introduced in their animal health emergency preparedness system as a result of the lessons learnt from the 2020/2021 and 2021/2022 HPAI epizootics. Those 21 actions aim to increase the effectiveness of their system, e.g., on conducting of epidemiological enquiries, new arrangements for disposal of carcasses, on killing of poultry, including provisions on preventive killing, on raising awareness, and to streamline certain administrative procedures.

The improvements mentioned in the previous point go in the right direction, but the situation found at the time of both epizootics cannot be considered in line with EU requirements laid down in Article 62 of Directive 2005/94/EC (before 21 April 2021) and Article 43(2) of Regulation (EU) 2016/429 (since 21 April 2021), on the matters that contingency plans should at least cover. The persistent delay in updating the plan is not in line with EU requirements laid down in Article 62(5) of the said directive (before 21 April 2021) Article 43(1) of the said regulation (since 21 April 2021), and precluded the competent authorities to apply all necessary disease control measures during both HPAI epizootics in accordance with Chapter II to IV of Directive 2005/94/EC (before 21 April 2021) and Article 4 of Delegated Regulation (EU) 2020/687 (since 21 April 2021). 5.2.2 Registration of poultry holdings ­ Areas with high density of poultry

District veterinarians demonstrated good knowledge about the measures they had to apply to respond to HPAI outbreaks, with some exceptions related to carrying out and evaluating epidemiological enquiries. In general, they carried out their tasks timely; however, there were instances where due to overload they had to prioritise some activities over other and they could not apply some of the required disease control measures (e.g., prioritise killing over epidemiological enquiries, which resulted in delays to perform the latter, they could not visit hobby/non-commercial establishments situated in some protection zones, they could not supervise cleaning and disinfection activities in some cases). The SBA did not have flexible arrangements and sufficient human resources to react quickly and address those gaps. That was not in line with requirements laid down in Articles 13(1)(a) and 43(2)(c)(iv) of Regulation (EU) 2016/429 on responsibilities of the competent authorities to have an effective organisation and access to personnel to apply disease control measures timely and effectively, and on application of the contingency plan for HPAI. 5.2.5 Availability of equipment and materials

The authorities have not fully updated and verified the functionality of the contingency plan and related operational manuals for HPAI in recent years, despite the recent epizootics and the recurrent risk of incursion via wild birds of HPAI. That missed opportunity to adequately reinforce all important components of their emergency preparedness system, including up-to-date training of district veterinarians, had a detrimental effect on the timeliness, selection and effectiveness of some of the measures applied to control the disease outbreaks, and could have had worse consequences resulting in the further spread of HPAI.

Member state response

e SBA is in the process of updating documents in the national ng contingency plan for HPAI. The plan is scheduled to be completed by the end of 2023. A plan for how the contingency plan should be updated is established. Changes to the plan can be hen necessary, e.g. due to change in legislation, change in routines or updated contact details. A comprehensive review and review of all documents in the contingency plans must take place every fifth year as a minimum according to the internally shed routine dated 2 September 2020. It is our view that we have access to sufficient qualified personnel resources. According to the ordinance on state authorities'prepardness and contingency planning Förordning Page: 6 023 port ref. DG(SANTE) 2022-7502 of the audit carried out from 21 November r the prevention and control of avian influenza Action Proposed by the competent authority (2022:524) om statliga myndigheters beredskap https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk- forfattningssamling/forordning-2022524-om-statliga- myndigheters_sfs-2022-524 Please refer to §9 where it is mentioned that all authorities must cooperate and support each other in the event of a crisis situation

The recommendation states as its basis

The long-standing ban on beak trimming and consumer's demand, supported by the egg labelling rules, has driven the continuous reduction of cage systems and thus led to better conditions for hens to express their normal behaviours.

Member state response

guidance for the inspections will be updated to clarify that derogations below the minimum requirements in the Directive can be accepted. uidance will be updated by the end of December 2022.

The recommendation states as its basis

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

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

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

Member state response

The Board of Agriculture will develop procedures and arrangements to ensure the effectiveness, appropriateness, quality and consistency of official activities. A draft plan to address these issues will provided by 30th of November 2020. e coordinated with the work on the Animal Health Law.

rd of Agriculture will develop The Swedish Board of Agriculture perform procedures and arrangements to ensure the inspections of official veterinarians' activities. effectiveness, appropriateness, quality and Experiences drawn from these inspections will be consistency of official activities. A draft plan used in the development of training programmes for to address these issues will provided by 30th official veterinarians. This has already started during of November 2020. 2020. It will continue to be part of future inspections. This will be coordinated with the work on the The inspections will also cover the official Animal Health Law. veterinarians' management of suspicions and outbreaks of epizootics. The SBA will assess whether both the veterinarians are carrying out public activities as expected and that they have the necessary competence to do so. The plan is to develop this process during 2021, implemented and evaluated in the beginning of 2022. The SBA will in future exercises or inspections evaluate whether there are further developments that can be employed. A plan for the implementation of these must be drawn up within 6 months after the exercise/inspection of the area i

The recommendation states as its basis

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

Member state response

oard of Agriculture will develop templates to be used in the epidemiological investigations including a final report that will summarise the conclusions thereof. There may also be a need to clarify SVA's role in the epidemiological investigation to t epidemiological expertise is used to the extent needed e epidemiological assessments are documented in a systematic and traceable manner. By 30th November 2020 SBA and SVA will present a draft plan for developing these templates and routines. This will be coordinated with the work on the Animal Health Law. Page: 1

he Board of Agriculture will develop Templates to be used in the epidemiological emplates to be used in the epidemiological investigations during outbreaks of African Swine nvestigations including a final report that Fever, Newcastle disease, Avian Influenza and West ill summarise the conclusions thereof. Nile Fever are being drafted. These will be tested here may also be a need to clarify SVA's and evaluated during the first half of 2021, to be ole in the epidemiological investigation to finalised and in place by 15 September 2021. nsure that epidemiological expertise is used The templates will include a final report that o the extent needed and that the pidemiological assessments are documented summarises the conclusions thereof. n a systematic and traceable manner. y 30th November 2020 SBA and SVA will resent a draft plan for developing these and routines. This will be oordinated with the work on the Animal Law. Page: 2

The recommendation states as its basis

The SBA procedure for approvals determines the administrative steps for handling approval applications. The audit team noted that the procedure does not explain how to 9 evaluate the applications and how to check the validation of the ABP processing method carried out by the plant operator (5).

The audit team examined the approval files of five establishments and noted that: a. Contrary to Point 1, Section 2, Chapter I of Annex XVI to Regulation (EU) No 142/2011, the SBA had granted approval to five ABP processing plants using processing method 7 without verifying that all operators had demonstrated that the samples of the final product, on a daily basis over a period of 30 production days, complied with the microbiological standards, as required by Point 1(c) of Part G, Chapter III of Annex IV to Regulation (EU) No 142/2011. The SBA explained that it had granted approval based on the fact that another ABP processing plant which it had approved some years ago had also used method 7 applying the same parameters. The SBA did not take into account the fact that the various operators used different processing technologies and raw materials (6) . b. The SBA did not repeat the checks on the operators' validation of the ABP treatment process when significant alterations had been made to the process, such as modifications of the machinery or changes of raw materials. This is not in line with the requirements of Point 4, Section 2, Chapter I of Annex XVI to Regulation (EU) No 142/2011. (7) c. For two of the processing plants, approvals were issued before the 04/03/2011, when Regulation (EC) No 1774/2002 was in force. For both plants, the competent authority could not present any documentation regarding the fulfilment of the validation requirements indicated in Chapter V of Annex V of that Regulation.

The arrangements in place for the approval of ABP establishments and plants are not effective in ensuring that approval is granted only to those operators who adequately demonstrated their ability to produce and place on the market safe products.

The recommendation states as its basis

The SBA plans official controls without taking into account certain criteria of those listed in Article 9(1) of Regulation (EU) 2017/625. In particular, the identified risks associated with the activities under the control of operators, operators' past records as regards the outcome of official controls and the reliability and results of own controls that have been performed by the operators, were not considered for establishing the frequency of official controls.

The SFA and all CABs, MUPs and Association of Municipalities develop their own control plans based on different factors linked to the characteristics and main activity of the establishment (farm activity, food production). The control frequency is fixed without taking into consideration certain criteria listed in Article 9(1) of Regulation (EU) 2017/625, namely the risks associated with the location of the operator and the operators' past record of compliance. adjacent approved storage plant to receive PAP under Article 48. The pet food plant has recently been formally approved according to Regulation (EC) No 1069/2009. (9) In its response to the draft report, the competent authority noted, in relation to transporters, the current routine is to immediately delist an establishment that is no longer approved. In addition and without undue delay, plants and operators are delisted as soon as they inform the SBA that they should no longer be registered. The operator is obliged to report to the SBA according to Art. 23 in Regulation (EC) No 1069/2009 when they should be delisted. There are approximately 450 registered transporters that only occasionally transport ABP or DP and they often prefer to be on the list as registered rather than registering whenever necessary. 11 Conclusion on the planning of official controls

Planning of official controls conducted by the various competent authorities does not take into account all relevant risk criteria and thus ABP establishments, plants and operators are not subject to competent authority controls on an appropriate risk basis. 5.2.3 Implementation of official controls

The recommendation states as its basis

The SBA is responsible for the listing of registered and approved ABP plants, establishments and operators, and for the maintenance of the lists. The lists are publicly available. The audit team noted that while in most cases newly registered or approved establishments were included in the lists shortly after their registration/approval, the delisting of the establishments that had stopped their activity or had lost their approval was not carried out in a timely fashion with delays in updating the lists ranging from a few months to a few years (9). This is not in line with Article 47(1) of Regulation (EC) No 1069/2009. Conclusions on registration, approval and listing of ABP plants, establishments and operators

Although the lists of registered and approved ABP operators, plants and establishments are available to the public, these are outdated and can neither be used as a reliable basis for planning of official controls nor for informing the public, including authorities from other Member States, on the operators active along the ABP chain. 5.2.2 Planning of official controls

The recommendation states as its basis

The audit team analysed examples of consignments recorded in TRACES and noted that, contrary to the requirements of Article 48(3) of Regulation (EC) No 1069/2009, the SBA does not inform the competent authorities of other Member States in TRACES on: a) the dispatch of consignments of PAP derived from Category 3 material, and; b) the arrival of each consignment of Category 1 and Category 2 materials, and meat-and-bone meal or animal fat derived from Category 1 and Category 2 materials (10). The written procedure presented during the audit included instructions on how to use Traces for performing documentary checks. At the time of the audit, it was not explained in the document how SBA officials should notify dispatched consignments. 5.2.7 Actions in case of non-compliance and follow-up

The absence of TRACES notifications on arriving and dispatched ABP and DP consignments weakens the system of EU-wide traceability of movements of such consignments.

The recommendation states as its basis

The Board of Agriculture monitors whether the county administrative boards achieve these operational objectives. As a result of this monitoring, the Board of Agriculture stated that all counties now use the risk classification model. The county visited by the audit team used the risk classification model but pointed out several problems with the data provided and therefore they used their own local knowledge to some degree when selecting farms for controls. The Board of Agriculture have not evaluated how the risk classification model performs in practice and how effective it is in identifying risk.

The Swedish Board of Agriculture has developed a quality assurance system in 2010 called Animal Welfare declaration (Djurskyddsdeklaration). Herd veterinarians in Sweden working in pig farms who can allow pig farmers the right to administer certain medicines, conditional on a visit every five weeks from their private veterinarian where this quality assurance system is used at farm level. These veterinarians have received training and make a declaration after every visit on compliance with certain animal welfare criteria. The Farm and animal health organisation (Gård & Djurhälsan) employs many such veterinarians. The farmer has to provide an action plan to address any deficiencies, and if the deficiencies persist then the veterinarian must notify the county administrative board. No cases were notified to the county visited. The county administrative board agreed that this was a potentially valuable source of information for risk based planning of official controls. However this lack of notifications presented a very different picture of the level of compliance compared to the result of official controls.

Both the Ministry and the Board of Agriculture work on the premise that the higher level objectives will be met if they ensure compliance with the legislation. The Multi-Annual National Control Plan also contains operational objectives which are specific and measurable and which the Board of Agriculture use to measure the performance of the county administrative boards. This has been successful in ensuring that the 21 county administrative boards work in a more consistent way; however, the evaluation has been more on doing things in the correct manner, rather than evaluating if the control system leads to doing the correct things. So although all counties now use the risk classification model, the objective for "a good risk based" control has not been measured as the Board of Agriculture has not reviewed or evaluated the effectiveness or efficiency of the implementation of the risk classification model.

The recommendation states as its basis

The Annual Report on the implementation of the MANCP in 2017 was submitted to the Commission. However, this report did not include specific sections on PDO/PGI/TSG agricultural products and foodstuffs or GI spirit drinks control activities. This is not in line with Article 40 of Regulation (EU) No 1151/2012. The 2018 annual report is under preparation. The CA informed the audit team that it does not contain reference to controls carried out of PDO/PGI/TSG agricultural products and foodstuffs and GI spirit drinks.

The 2017 annual reports submitted by MUPs and CABs to the NFA did not contain any specific data related to controls on GIs. The procedure has changed, and from 2018, CABs and MUPs report on activities carried out on GIs. However, the information provided is very basic and only relates to the number of controls carried out. It does not include specific information on the operators and GIs subject to controls. Therefore, the NFA cannot have an accurate overview of the inspections carried out or monitor that the CAs involved achieve the frequency of controls planned. This is not in line with Section 3 of Ordinance 1425/2009.

CAs are designated for the official controls of PDO/PGI/TSG agricultural products and foodstuffs and GI spirit drinks and the distribution of tasks is clearly defined. Training has been provided to official staff. However, the level of information provided by regional/local authorities to the NFA is not sufficient to properly monitor and coordinate their control activities. The CAs control activities are not included in the annual report as established in Article 40 of Regulation (EC) No 1151/2012. 5.2.2 Verification of compliance prior to placing on the market Legal requirements Article 37(1) of Regulation (EU) No 1151/2012 Articles 22(1) and 24 of Regulation (EC) No 110/2008 Findings

Furthermore the reporting from MUPs to the NFA does not provide clear information on the type and number of products and operators covered by controls and the NFA does therefore not have an overview of the controls carried out by the MUPs. So while ad-hoc controls are carried out, Sweden cannot ensure that risk-based controls take place in a systematic manner in the country as there is no coordination among the CAs involved at market level. This is not in line with Article 4.3 of Regulation (EC) No 882/2004 and with Article 38 of Regulation (EU) No 1151/2012

Member state response

In connection with Sweden's transition to the new reporting required by Regulation (EU) 2019/723 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States, the national reporting will be changed and new information will be obtained from all control authorities. The new model includes reporting of controls of Regulation 1151/2012. Sweden intends to report according to the new annual report model in 2022.

Previous answer 2019-09-30 all In connection with Sweden's transition to the new reporting required by Regulation (EU) the 2019/723 laying down rules for the h application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States, the national reporting will be changed t in and new information will be obtained from all control authorities. The new model includes reporting of controls of Regulation 1/2012. Sweden intends to report according to the new annual report model in 2022. Answer 2019-12-xx Changing the reporting system to obtain more detailed information from the control authorities takes time, but the developing will start during next year (2020). Next year we at the SFA will also start to collect more information about which producers there are in Sweden that produce products with PDO/PGI/TSG and GI-spirit drinks. The current annual reporting model contains all Page: 1 eived 10 Dece;ber 2019 (updated) Ref. Ares(2019)7002440 ­ 10/12/2019 ion Plan submitted by the competent authorities of Sweden in response to Report ref. 1 June 2019 to 19 June 2019 in order to eval

The recommendation states as its basis

The facilities, equipment and hygiene of the BIPs/DPEs visited, are in general adequate for undertaking controls on imported consignments. The facilities of BIP/DPE Göteborg have not been adequately maintained which may compromise the hygiene standards applied during the checks on imported goods.

Member state response

SBA and NFA have had a meeting with the port of Göteborg. At the meeting, an action plan including a timetable was decided for the measures to be taken by the port of Göteborg to ensure that the facilities of the BIP/DPE Göteborg are maintained and kept in compliance with the requirements of Decision 2001/812/EC, Directive 97/78/EC and Regulation (EC) No 669/2009. The noticed deficiencies in the maintenance of the facilities shall all be rectified at the latest before the end of the 1st semester 2019. In addition the port of Göteborg has confirmed that there are currently no plans to move the facilities of the BIP/DPE during 2019. Page: 1

The recommendation states as its basis

From the data obtained by NFA from the CABs, in 2017 there were 1,371 primary producers of FNAO registered in PRIMÖR, in the scope of this audit. At CAB level it is estimated that 13.5% of all primary producers are not registered yet, including primary producers of FNAO. The CABs stated that mainly small producers are not registered. The NFA informed the audit team that missing registrations are caused by uncertainty of the CABs which primary producers would need to be registered or not. Therefore, NFA plans to improve current guidance regarding registration of primary producers and make it more detailed.

The NFA confirmed that internet sellers of seeds for sprouting and garden centres selling seeds for sprouting are obliged to be registered as FBOs. The NFA has made an investigation regarding current registrations at the level of MUP. Currently 21 out of 26 identified sellers of seeds for sprouting are registered. 5.2.2.2 Approval of Sprout-Producing Establishments

Procedures are in place for the registration of primary producers in a national electronic database at CAB level and for the registration of all other food establishments at MUP level. However, by estimation on a national level, at least 13.5% of primary producers, including FNAO, are not registered and not all garden centres selling seeds for sprouting are registered yet. Thus, not all FBOs are under official controls.

Member state response

for spouting has been followed up. Two of the unregistered operators have stopped selling seeds for sprouting. All garden centres concerned are registered now, except for one where it is under investigation. Garden centres registration_status 2019-02-15 ill update and clarify current guidance document overing approval and control of sprout producers. This will be lised in September 2019. A new checklist for approval and control of sprout producers has been sent directly to the CA:s concerned and will be published on

The recommendation states as its basis

The audit team was informed that in order to ensure that controls are carried out adequately, the following measures were put in place: On a regular basis, in each region a verification is undertaken to check that, at team level, planned controls are being carried out, non-compliances are followed-up within deadlines set, and that control reports are sent to FBOs within 14 days. Starting from 2018 all CAs (CABs, regional NFA and MCAs) must report to the central NAF office on the controls performed, which establishments have been controlled, the legislative scope of the controls, and on the non-compliances found. The intention is to collect better data in order to support determining the focus of controls for the following year. In order to ensure consistency, senior officials at regional level review reports and documented enforcement actions. In addition, on-site supervisory visits are carried out either by these senior staff, alone or jointly with the officials that routinely carry out controls. Joint visits between different OVs also take place. A minimum of two joint official controls per year are required to be carried out by each local CA carrying out visits on the spot. In some cases, as a result of these joint visits where one OV observes other OV's control performance, recommendations for improvements of the controls were made . Nonetheless, these supervisory activities did not identify certain occasions where official controls failed to identify certain non-compliances(see Sections 5.3.3 and 5.3.4) An overall quality management system will be developed during 2018.

The system in place also includes reporting of and supervision over the activities carried out by official staff with the objective of verifying the implementation of official controls and the performance of the OV of the official controls. However, this system was not fully effective in detecting certain gaps in the controls, and therefore not capable of prompting appropriate corrective action in these instances.

The control staff organise the work, including how often to go on-the-spot, depending on the number of hours assigned to each establishment. The frequency of controls is related to the number of allocated hours (e.g. a registered cold store receives one hour per year which results in visits on the spot every few years when sufficient hours have accumulated, while a stand-alone meat establishment which receives more hours, may receive several control visits per year). These hours include preparation for the control, carrying out the on-site control and drafting the report (one third of the allocated time for each of these activities), which are then charged directly to the FBO concerned. 5

The hours allocated to perform certain controls might not support an in-depth evaluation in all situations. For example, a large meat products establishment with several production lines received 15 hours/year for controls, of which five hours occur on the spot; for one the biggest cutting plants, also producing meat preparations and minced meat, 39 hours for controls per year had been allocated; while for a medium sized meat preparations and meat product establishment ­ 20 hours had been assigned for the year.

All establishments visited had established HACCP-based systems. Official controls include as part of the routine controls and/or during audits the verification of these systems and the evidence available showed that the controls had been carried out as described and, in general, did identify very few shortcomings. The official controls also covered checks on pre-requisite programmes such as potable water, cleaning, disinfection and pest control.

Official controls are in general organised in line with EU requirements, their frequency 15 is risk-based and they follow specific documented procedures including those related to enforcement. However, the lack of resources, the time limitations to perform in-depth checks, the lack of details in the reports and the delegation of certain tasks to the FBOs without effective oversight, affects the overall efficiency of the official controls.

While the system of official controls includes checks on FCI and animal identification, these are not fully reliable and are not sufficient to guarantee that any non-compliances are detected.

CAs follow-up on identified non-compliances, but the measures taken did not address the cause in some cases.

Member state response

way so Specialisation of the meat control The management at the NFA have, since 2016, been working on specialisation of the meat control starting with the staff in the regional control departments at the NFA. One of the outcomes of all this project has been the Groups of specific competence where there are, among other groups, groups for both red meat and animal welfare (which are both areas covered in the audit). The main goal for specialisation of the staff at the NFA is to increase the knowledge of the OVs and the OAs which will lead to better and more effective controls. In 2018 the specialisation will target the organisation. There will be a systematic overview during the fall of 2018. The result of the overview and the changes to the organisation will be implemented starting spring 2019. Changing the risk classification system The NFA, has been reviewing the current risk classification system during 2017 and 2018. In 2019 there will be a proposal for a new model for the risk classification of all establishments (including the controls done in slaughter houses). The current risk classification system allocates the time for the controls done at the establishments. The new model

The recommendation states as its basis

The audit team was informed that in order to ensure that controls are carried out adequately, the following measures were put in place: On a regular basis, in each region a verification is undertaken to check that, at team level, planned controls are being carried out, non-compliances are followed-up within deadlines set, and that control reports are sent to FBOs within 14 days. Starting from 2018 all CAs (CABs, regional NFA and MCAs) must report to the central NAF office on the controls performed, which establishments have been controlled, the legislative scope of the controls, and on the non-compliances found. The intention is to collect better data in order to support determining the focus of controls for the following year. In order to ensure consistency, senior officials at regional level review reports and documented enforcement actions. In addition, on-site supervisory visits are carried out either by these senior staff, alone or jointly with the officials that routinely carry out controls. Joint visits between different OVs also take place. A minimum of two joint official controls per year are required to be carried out by each local CA carrying out visits on the spot. In some cases, as a result of these joint visits where one OV observes other OV's control performance, recommendations for improvements of the controls were made . Nonetheless, these supervisory activities did not identify certain occasions where official controls failed to identify certain non-compliances(see Sections 5.3.3 and 5.3.4) An overall quality management system will be developed during 2018.

The system in place also includes reporting of and supervision over the activities carried out by official staff with the objective of verifying the implementation of official controls and the performance of the OV of the official controls. However, this system was not fully effective in detecting certain gaps in the controls, and therefore not capable of prompting appropriate corrective action in these instances.

Reports had been drafted after controls, entered in the database and provided to the controlled FBOs in all cases reviewed by the audit team. However the team noted that the description of the deficiencies noted remains occasionally limited. 5.3.3 Specific requirements for slaughterhouses 5.3.3.1 Food Chain Information (FCI) and animal identification Legal requirements Article 3 of Regulation (EC) No 853/2004 and Article 5 of Regulation (EC) No 854/2004. Findings

Official controls are in general organised in line with EU requirements, their frequency 15 is risk-based and they follow specific documented procedures including those related to enforcement. However, the lack of resources, the time limitations to perform in-depth checks, the lack of details in the reports and the delegation of certain tasks to the FBOs without effective oversight, affects the overall efficiency of the official controls.

CAs follow-up on identified non-compliances, but the measures taken did not address the cause in some cases.

Member state response

n- Increased actions since 2014 This recommendation remains since the audit in the same area in of 2014. The NFA has, between 2014 and 2018, increased the enforcement actions taken in establishments where non- compliances have been found. According to the routines for NFA control staff, a non-compliance which is not remedied by an FBO after the first follow-up inspection will result in actions according to art 54 of Regulation (EC) No 882/2004. The NFA management is monitoring that this routine is followed by all NFA staff performing official controls. Specialisation of the meat control The main goal for specialisation of the staff at the NFA is to increase the knowledge of the staff performing official controls in certain areas such as meat control. By increasing the knowledge, the staff performing official controls will also be able to better detect non-compliances and take actions if the non-compliances are not remedied. Implementing the new control report When implementing the new control report at the NFA; all NFA staff will get an education (a course) on how to write reports and also how to best describe non-compliances in the report. An education involving the documentation

The recommendation states as its basis

The approval procedure foresees that establishments are given a conditional/provisional approval. In practice, however, and due to the system related to the recovery of costs for official controls through fees, de facto approval is granted without actually seeing an establishment in operation and without eg. the verification of the implementation of the Hazard Analysis Critical Control Points (HACCP) system; subsequent controls/routine inspection may only take place the following year. The CA informed the audit team that the legislation on fees is under review. 4

An effort has been made to keep the establishment list published on the NFA website, and fewer discrepancies -compared to the situation during the previous audit- were noted. Nonetheless, some differences were still found between the approved activities and the information appearing on the establishment lists published on the NFA website: The list of approved establishment indicates in some cases the postal address of the business which differs from the geographical location of the establishments. Two meat product establishments visited had been approved for activities, e.g. re- wrapping, that were not included in the published establishment lists. This deficiency has also been identified during the previous audit. Approval covers also the obligation to have a separate place with appropriate facilities for cleaning, washing and disinfection of means of transport for livestock. However, the Swedish legislation on controls does not cover the control of the use of these facilities. The verification of the cleaning and disinfection of trucks for live animals in the slaughterhouses is not included in the official verification by the NFA, OV, or CAB. Conclusion on registration/approval of establishments

While detailed procedures exist for the approval of establishments, in practice new establishments are approved without their compliance having been verified under operational conditions.

Member state response

The National Food Agency will, as a first step, revise the instructions dealing with the approval process for our own staff (these can be found in Kontrollwiki). These instructions are binding for the NFA:s own staff. In these instructions, we will clarify that controls should be done in the starting phase of a new FBO in order to ensure that the FBO:s meet the requirements according to article 5 in Reg 852/2004. Another reason for this recommendation is the current Swedish national regulation on control fees which needs to be changed so that the competent authorities may collect the fees needed for the control the first year of approval. This has been addressed to the government who are currently reviewing these regulations.

The recommendation states as its basis

For each of the areas of controls assessed, instruction and guidance for controls had been issued by the NFA and made available by NFA both on their website in the "Kontrollportalen", which is available to all control authorities, as well as in "Kontrollwiki" which is also available to FBOs and consumers. For the areas assessed, the control staff is made aware of the legislation relevant to the area of control, and suggestions for questions to the FBOs are prepared.

National instructions on the identification of animals for slaughter (2015-09-04/BMODA) lay down the responsibilities of animal keepers, transporters, FBOs and the OVs. However, the verification of the identification of animals is done by the FBO after slaughter and not on the live animals, which is not in line with EU requirements or with point 5, third paragraph, of this instruction. Implementation of controls and resources

In the majority of the cases, official controls had been carried out according to the plan, with an exception for the region Central-North which continues to encounter difficulties with staff recruitment despite efforts to improve manpower levels. In this region, and depending on the time of year, a shortfall of up to 10 % in required numbers was noted for 2017;there is a need to employ nine additional staff in 2018. One additional staff member was recruited in 2018. As a result of staff shortage, not all the planned controls can or have been done. e.g. in one large establishment packing products for consumers, only 40% of the attributed and planned hours for 2017 for official controls (20.5 hours of controls instead of 47 hours) had been used. This establishment was already under reduced frequency of controls due to CA staff shortages.

In the northern part of the country, the CAs faces challenges for the implementation of the controls due to the great distances between establishments, the concentration of the slaughter in certain times of the year and the lack of internet connection (all CA documents are in electronic format).

In the same region, it is planned that staff working in slaughterhouses carry out other controls in the months of the year with low slaughter activity. A system is in place to 7 appoint OVs on a temporary basis for the times of the year with higher volumes. These veterinarians, already employed by the SBA, are appointed by the NFA on a yearly or once every two years basis. For new temporary recruits a permanently employed OV from NFA provides induction training, all the required information and on-the-job training related to OV's specific duties. It is only when the latter is satisfied that the temporary OV is allowed to carry out his assigned official tasks independently. 5.3.2 Reporting of official control results

Starting from 2018 a new report template is in use in several MCAs, including Gothenburg and Stockholm. The use of the new template by all NFA staff is delayed pending the organisation of training courses on how to write the reports. The template provides for the inclusion of all items checked during the controls - the previous system reported only on identified non-compliances- and includes details on the FBO's corrective actions in response to non-compliances from previous controls.

While the system of official controls includes checks on FCI and animal identification, these are not fully reliable and are not sufficient to guarantee that any non-compliances are detected.

Although official controls related to identification marking, labelling and traceability had been carried out in line with EU requirements, these controls did not identify the types of shortcomings that were identified by the audit team during the on-site visits.

Member state response

n The NFA will perform a control project in 2019 with the scope of increasing the knowledge of the NFA staff when it comes to official controls on FCI and animal identification. The project will Page: 4 Ref. Ares(2018)3016851 - 08/06/2018 port ref. DG(SANTE)/2018-6454-MR of the audit carried out from 06 March ntrols related to the safety of food of animal origin, in particular fresh meat and Action Proposed by the competent authority increase the amount of controls performed to verify that the compliance of the information is in order with the animal identification.

The recommendation states as its basis

In response to recommendation No 5 of report 2014-7229 relating to delayed post-mortem inspections in low through-put slaughterhouses, the CCA stated that the NFA has chosen not to proceed with the adoption of national measures in accordance with Article 17(3) of Regulation (EC) No 854/2004.

Ante-mortem and post-mortem inspection are generally carried out and documented in a satisfactory way. However, the CA does not ensure that post-mortem inspection in low throughput slaughterhouses is done without delay as required in Chapter II, Section I (D,1) of Annex I to Regulation (EC) No 854/2004. In addition, the final check of absence of contamination prior to health marking is still not considered the responsibility of the OV, which is not in line with Chapter V, 1.(s) Section II of Annex I to Regulation (EC) No 854/2004.

Member state response

es The NFA is hoping that the new EU-legislation, which soon will nnex replace Reg. No. 854/2004, is going to make it possible for the PM at some slaughterhouses to take place within up until 24 hours. The new legislation will probably be published in the EUT in the first quarter of 2019 at the latest. This taken into account, and considering that the Swedish practice doesn't pose a problem concerning food safety (this according to the NFA), the NFA is therefore not planning any new measures ­ the NFA awaits the new legislation.

The recommendation states as its basis

The system in place to guarantee absence of contamination on carcasses is still not in line with Chapter V, 1.(s) Section II of Annex I to Regulation (EC) No 854/2004 indicating that "soiling, faecal or other contamination" are reasons to declare meat unfit for human consumption. The NFA considers it to be the responsibility of the FBO to verify absence of contamination and takes no responsibility prior to the health marking as part of the post 9 mortem decision. Checks for contamination of carcasses are not part of the CA's post- mortem inspection before health marking. The OV checks every day a random sample of carcasses, depending on slaughter volume. e.g. in a slaughterhouse processing 1,000 animals per week, the instruction foresees that in order to verify the efficiency of the controls and action taken by the FBO, the OV (or auxiliaries) checks daily 6 carcasses in the cold store after health marking by the FBO. If during a month visual contamination of more than 12 carcasses is seen, than a fine can be imposed. In practice that means that if out of 120 carcasses seen on a monthly basis 12 have remaining contamination (which is 10% of the carcasses seen), no fine is issued.

Ante-mortem and post-mortem inspection are generally carried out and documented in a satisfactory way. However, the CA does not ensure that post-mortem inspection in low throughput slaughterhouses is done without delay as required in Chapter II, Section I (D,1) of Annex I to Regulation (EC) No 854/2004. In addition, the final check of absence of contamination prior to health marking is still not considered the responsibility of the OV, which is not in line with Chapter V, 1.(s) Section II of Annex I to Regulation (EC) No 854/2004.

Member state response

The NFA will issue instructions that clearly points out the e responsibility of the official veterinarian for faecal contamination before health marking including to take necessary decisions concerning meat in line with Chapter V, 1.(s) Section II of Annex I to Regulation (EC) No 854/2004

The recommendation states as its basis

Non-compliant working practices were noted by the audit team and not identified by the CA in some of the establishments visited, e.g.: In all three establishments, where checked, the requirements to produce minced meat were not respected: e.g. exceeding period of use of meat, starting counting from packing date instead of slaughter date, combining specifications for unpacked and vacuum packed meat. Regulation (EC) No 853/2004 lays down that fresh meat has to be frozen without undue delay. However, it is national policy to allow freezing at the end of the best before date of fresh product. This practice was seen in a cold store visited with products that were later sold to restaurants and catering businesses. In addition in another establishment, products to be frozen were the day after the indicated freezing date still not frozen. This may jeopardise the reliability of the traceability of the products if related to the production or freezing date. 5.3.4.1 HACCP-based systems Legal requirements Article 5 of Regulation (EC) No 852/2004 and Article 4 of Regulation (EC) No 854/2004). Findings

Official controls are in general organised in line with EU requirements, their frequency 15 is risk-based and they follow specific documented procedures including those related to enforcement. However, the lack of resources, the time limitations to perform in-depth checks, the lack of details in the reports and the delegation of certain tasks to the FBOs without effective oversight, affects the overall efficiency of the official controls.

Member state response

of The specialization of the staff with the goal to increase the knowledge mentioned under recommendation 1 and recommendation 2 will contribute to a better control and to ensure that the requirements to produce mincemeat are in line with Regulation (EU) 882/2004 Chapter VII.4, annex III Reg. No 853/2004 states that for meat from domestic ungulates, the "meat intended for freezing must be frozen without undue delay". Page: 5 port ref. DG(SANTE)/2018-6454-MR of the audit carried out from 06 March ntrols related to the safety of food of animal origin, in particular fresh meat and try or r meat ezing at article 4 in that at first is er stage in the th a use by- f the , the freezing for human or freezing, he food chain. when the FBO hen that delay. In order FBO has the /the meat on s. stated in the rigin to another t if the retail requirements requirement to not such a he way of he food chain is port ref. DG(SANTE)/2018-6454-MR of the audit carried out from 06 March ntrols related to the safety of food of animal origin, in particular fresh meat and ts must date). If the an be frozen for human FBO:s to sell

The recommendation states as its basis

The instructions on sampling stipulate that the sample taken from 'mixed consignments' should be constituted of units from the different regulated commodities within the consignment, based on an ad hoc risk assessment by the inspector, to make up the minimum sample of 200 units. The sample unit is defined as the 'minimum single part of the commodity', e.g. a single cut flower stem, a stem of leafy vegetables, an individual piece of fruit or vegetable, or an individual plant intended for planting. The audit team noted from inspection data supplied by the SBA, that a significant proportion of consignments imported into Sweden are 'mixed', including around 50 consignments per year of aquarium plants of mixed genera from Southeast Asia.

The audit team observed inspections of mixed consignments containing fruits and vegetables from Uganda and Thailand at Arlanda airport and noted that the work instructions were followed, and that sampling for visual checks was based on the consignment and not on the individual, constituent lots. The number of units of each regulated article taken to form the sample varied significantly (see section 5.4.4 below). Inspections are not therefore carried out on the entirety or a representative sample of at least each lot declared to consist of, or to contain, plants or plant products referred to in Article 13(1), (2) or (3) of Directive 2000/29/EC. This is not in line with Article 13a(1)(a)(ii) or 13a(1)(b)(ii) or (iii) of the same Directive.

However, in line with the work instructions, inspections of mixed consignments are not carried out on a representative sample of each constituent lot. These checks do not therefore provide an appropriate level of confidence or probability of detecting any harmful organisms that may be present.

The audit team noted that, with respect to sampling: Inspectors selected the sample for inspection themselves and were free from interference from third parties; The size of samples taken for inspection was in line with the work instructions (see section 5.1.4 above); At Frihamnen Stockholm, the inspector could only access the rearmost pallets of the container to collect a sample for visual checks, and so it could not be ensured that the samples was representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; At the other inspection posts visited, inspectors had access to the entire consignment and samples were collected from a range of packages selected at random from different areas within the consignment. In the case of homogenous consignments, the sample could therefore be considered representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; The audit team observed three inspections of mixed consignments. For one of these consignments, the PCU inspectors explained that they had selected one box of each regulated commodity, from which they would inspect 200 units in total. In practice, the sample was constituted as follows (the figures are approximate as the number of units varied slightly between packages): six fruits of bitter melon (Momordica charantia) from a total of 20 fruit; 50 stems of basil (Ocimum basilicum) from a total of 4 500 stems; 40 fruits of aubergine (Solanum melongena) from a total of 400 fruit; 20 fruits of mango (Mangifera indica) from a total of 280 fruit; 50 stems of celery (Apium graveolens) from a total of 1 000 stems; and more than 200 fruits of chillies (Capsicum frutescens) ­ 2.5 kilograms from a total of 34.5 kilograms. In some cases, these sample sizes provide a confidence level significantly below 80% of detecting even a 5% level of infestation according to ISPM 31, and this reduced level of confidence was not justified based on risk.

Other than at Frihamnen Stockholm, import inspections in Sweden are carried out meticulously, and other than mixed consignments, the samples taken for inspection can be considered representative, in line with EU legislation.

Member state response

The attached work instruction for mixed consignments was amended on 20 June 2018 (see Annex I to AP_2018-6482). Section 5.1.2 now includes a reference to ISPM 31. The selected sampling method provides a 95% level of confidence detecting a % level of infestation. A "lot" is defined as a single article.

The recommendation states as its basis

Sweden has established an exemption from the requirement for a phytosanitary certificate for certain imports from European third countries only, under Section 17 of the Plant Health Ordinance. The exemption is detailed on the SBA's8 website. The scope of the exemption is as follows: Passengers travelling from European third countries (including the Canary Islands) may import 2 kilograms of plants and plant products in their hand luggage, without a phytosanitary certificate. Private persons moving home, from European third countries (including the Canary Islands) may import any quantity of plants and plant products without a phytosanitary certificate. Neither of these exemptions applies to potatoes, citrus plants, or endangered species.

The exemption for passengers' luggage, concerns only small quantities and is in line with Article 13(3)(b) of Directive 2000/29/EC. However, the exemption for persons moving home, which the SBA stated is intended to reduce the administrative burden of such relocations, is not limited and does not therefore apply only to small quantities, which is not in line with the same article.

However, the unlimited exemption for most plants and plant products imported into Sweden from European third countries by individuals moving home, presents an unmitigated phytosanitary risk.

Member state response

The Swedish government has initiated the revision of the plant ordinance (2006:817) in the context of the new EU regulations 2016/2031 and 2017/625. During this process the ption for individuals moving home from a European third country will be removed.

The recommendation states as its basis

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

The audit team noted that, with respect to sampling: Inspectors selected the sample for inspection themselves and were free from interference from third parties; The size of samples taken for inspection was in line with the work instructions (see section 5.1.4 above); At Frihamnen Stockholm, the inspector could only access the rearmost pallets of the container to collect a sample for visual checks, and so it could not be ensured that the samples was representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; At the other inspection posts visited, inspectors had access to the entire consignment and samples were collected from a range of packages selected at random from different areas within the consignment. In the case of homogenous consignments, the sample could therefore be considered representative of the consignment, as required by Article 13a(1)(b)(iii) of Directive 2000/29/EC; The audit team observed three inspections of mixed consignments. For one of these consignments, the PCU inspectors explained that they had selected one box of each regulated commodity, from which they would inspect 200 units in total. In practice, the sample was constituted as follows (the figures are approximate as the number of units varied slightly between packages): six fruits of bitter melon (Momordica charantia) from a total of 20 fruit; 50 stems of basil (Ocimum basilicum) from a total of 4 500 stems; 40 fruits of aubergine (Solanum melongena) from a total of 400 fruit; 20 fruits of mango (Mangifera indica) from a total of 280 fruit; 50 stems of celery (Apium graveolens) from a total of 1 000 stems; and more than 200 fruits of chillies (Capsicum frutescens) ­ 2.5 kilograms from a total of 34.5 kilograms. In some cases, these sample sizes provide a confidence level significantly below 80% of detecting even a 5% level of infestation according to ISPM 31, and this reduced level of confidence was not justified based on risk.

The audit team noted that, with respect to the implementation of the checks: Inspectors had a good knowledge of the different harmful organisms which the commodities they were inspecting were most likely to host; At Frihamnen Stockholm, due to the lack of facilities enabling access to consignments, the inspector selected individual fruit for visual checks one-by-one, returning the fruit each time to the bulk bin. It could not therefore be ensured that the same unit was not inspected more than once. The checks could not therefore be considered meticulous, which is not in line with Article 13a(1)(a) of Directive 2000/29/EC; Other than at Frihamnen Stockholm, the checks observed by the audit team included a thorough visual examination of the entire sample and units which 17 exhibited any signs or symptoms of the presence of harmful organisms were studied carefully using a stereo microscope, and/or destructively sampled. The checks were considered by the audit team to be meticulous, in line with Article 13a(1)(a) of Directive 2000/29/EC.

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

Member state response

PRU has initiated the process to ensure that the places where we carry out plant health checks will meet the minimum requirements. The relevant actors have been invited to a dialogue out how to fulfil the minimum requirements. We have also informed them that unless these requirements are fulfilled, we will not perform plant health checks there from October 1st 2018.

The recommendation states as its basis

The PCU stated that they rely on the Swedish postal service to identify any postal packets containing regulated articles, and refer them to the PCU at Arlanda. During 2017, there were 25 such referrals, 7 of which were rejected due to the absence of an accompanying phytosanitary certificate. The PCU informed the audit team that interceptions of postal or courier imports are not notified through EUROPHYT- Interceptions, which is not in line with Article 2 of Directive 94/3/EC.

The audit team noted that the notification procedures laid down in Commission Directive 94/3/EC are generally complied with. However, the SBA do not notify interceptions related to postal or courier imports (see section 5.3.4 above), which is not in line with the requirements of Article 2 of Directive 94/3/EC.

Interceptions involving postal and courier imports, are not notified to the Commission and other Member States. This does not enable the Commission and other Member States to evaluate and potentially mitigate the risk posed by such imports.

Member state response

w routine was implemented at the end of April 2018. It now includes notification of interceptions of postal and courier parcels. Please see an example attached of such notification (see Annex II to AP_2018-6482). Page: 1 Ref. Ares(2018)2552358 - 16/05/2018 . DG(SANTE)/2018-6482-MR of the audit carried out from 17 April ealth tion Proposed by the competent authority Page: 2

The recommendation states as its basis

The NAO concluded in their 2014 review of arrangements for food controls that NAO audits did not satisfy the requirement for independent scrutiny. The NFA has subsequently worked together with colleagues in the other countries of the Nordic Council (Denmark, Sweden, Finland, Norway and Iceland) on a project "The Nordic cooperation on independent scrutiny". This project has not yet been carried out in Sweden. The NFA hopes that the project may give rise to a permanent arrangement for independent scrutiny.

The SBA Internal Audit Unit carries out an annual evaluation with an external evaluation every fifth year, following the International Professional Practices Framework (IPPF). This also includes areas outside Regulation (EC) No 882/2004 for which this Unit is responsible. The unit is scrutinised on the basis of international auditing practices, national rules for agencies to do internal audits and its obligations under Regulation (EC) No 882/2004. The external audit, which takes several weeks, includes verification of a self-evaluation report through review of certain audits of official controls, including working documents and interviews with auditees (heads of unit).

The SBA's animal control has an arrangement for self-evaluation by reviewing audits of official controls, including the working documents. However, the unit has no arrangement for independent scrutiny. Conclusions

Independent scrutiny is not in place for two audit bodies while the third has a satisfactory arrangement through an annual external audit. The Nordic cooperation project could provide the basis for a permanent arrangement for the other two audit bodies to fulfil this requirement. 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: 11 generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, specific technical knowledge and skills, personal attributes, education, work experience, auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

The recommendation states as its basis

A number of arrangements have been put in place to facilitate the communication between and within CAs, CtrlAs and CBs. The audit team saw several minutes of biannual meetings between the CAs (including Customs) and the CBs aimed at improving and harmonising official controls in the organic sector. Moreover, the NFA has recently launched an electronic platform to facilitate the communication with other CAs, CtrlAs and CBs. However, it was observed that the NFA does not have sufficient information on whether and how the MUNs implement controls to verify the conditions for exclusion of certain retailers from the obligation to be subject to controls by the CBs, because, as stated by representatives from the NFA, these types of checks are not reported by the MUNs in their annual reports to the NFA. This is not in line with Article 92(5) of Regulation (EC) No 889/2008 as far as the exchange of information between CtrlAs and CAs is concerned. 3

The control system in place clearly assigns tasks and responsibilities to the actors involved. However, its effectiveness is partly undermined by poor communication between the MUNs and central level on the implementation of the necessary checks to verify the condition for the exemption of certain retailers from official controls. 5.2.2 Control Bodies: Approval, Supervision and Withdrawal Legal Requirements Article 27(5) to (9) and Article 27(14) of Regulation (EC) No 834/2007. Article 5(2) and 5(3) of Regulation (EC) No 882/2004. Articles 92c and 92e of Commission Regulation (EC) No 889/2008. Findings

Member state response

The Swedish Board of Agriculture (SBA), the National Food ired Agency (NFA), the municipalities; the County Administrative Boards, the Customs Service and Consumers Agency are according to the Control of organic production act and ordinance pointed out as control authorities. None of these have a code number or the right to issue certificates. These have now been notified in OFIS in line with 35 of Regulation No 834/2007. The information regarding the competent authorities was updated during the audit. This was done via e-mail to the Commission since OFIS did not allow for this added information. When the annual transmission of information on CBs according to article 94(1) b was done on 31 March 2016, the SBA also repeated the notification on all competent authorities in OFIS. All three authorities involved in approving CB:s or delegation of control will review the routines for notifications ensuring that relevant notifications are done appropriately. In addition all competent authorities now have access to OFIS.

The recommendation states as its basis

The national legislation on organic production indicates the SBA and the NFA as the CAs in charge of the delegation of official controls to the CBs. This legislation stipulates that delegation can be granted once the conditions laid down by Article 27(5) to (7) of Regulation (EC) No 834/2007 are met and can be withdrawn when these conditions are no longer met. From the information provided by the CAs, four out of the six delegated CBs, representing about 98% of the total number of operators in Sweden(1), had been delegated independently by the NFA and the SBA. The remaining two CBs had been delegated only by the NFA. However, the audit team noted that, although the SBA has a written procedure for the verification of the conditions for such a delegation, this is not yet the case for the NFA. Therefore, these arrangements are not yet fully in line with Article 92c(4) of Regulation (EC) No 889/2008.

In general, despite the lack of written procedures, there is an effective system for the approval of CBs, the delegation of controls on organic production to the CBs, and for their supervision. However, some requirements in force from January 2014, namely the requirements for additional, unannounced visits and the number of annual samples to be taken by the CBs, had been overlooked during the supervisory activities in 2014 and, partly, in 2015. The plan of the SBA and NFA to be more actively involved in such activities should strengthen the supervision process. 5.2.3 Registration of operators Legal Requirements Articles 28(1), 28(2) and 28(5) of Council Regulation (EC) No 834/2007. Article 92b of Commission Regulation (EC) No 889/2008. Article 63(2) of Regulation (EC) No 889/2008. Findings

Member state response

From the first of April 2016, the National Food Agency (NFA) el, as has a new national regulation (Livsmedelsverkets föreskrifter (LIVSFS 2016:1) om kontroll av ekologisk produktion) regulating organic food control. The regulation stipulates the conditions for an actor to be exempted from the requirement to notify its activity to a control body. It also stipulates that the municipality immediately must inform the NFA when they find an actor which had not notified their activity to a control body, in cases when the actor should have done that. The NFA has informed the municipalities twice in March about the new regulation This was done through the electronic platform which is used for communication between the NFA and the municipalities. There was also a press release about this issue at the NFA website in Page: 1 Report ref. DG(SANTE)/2015-7360-MR of the audit carried out from 14 ems for organic production and labelling of organic products March. The NFA started in 2015 to inform the municipalities at the regional meetings (Länsmöten), which are held twice a year in each county, about the rules in organic food. NFA also informed the municipalities about the new regulation and clari

The recommendation states as its basis

From the information gathered by the audit team, Swedac has procedures in place and sufficient and qualified staff to carry out the surveillance of the CBs in line with the guidelines for accreditation bodies, the European co-operation for Accreditation (EA) Policy (EA-3/12 M: 2013. Comprehensive checklists are also used by Swedac during their supervisory activities to verify relevant requirements of the organic legislation. However, it was noted that certain requirements of the organic legislation were overlooked, notably, the provisions related to the number of additional and unannounced inspections, as laid down by Article 92c of Regulation (EC) No 889/2008, and the provision related to the number of annual samples as laid down by Article 65(2) of the same Regulation (see finding 37).

In general, despite the lack of written procedures, there is an effective system for the approval of CBs, the delegation of controls on organic production to the CBs, and for their supervision. However, some requirements in force from January 2014, namely the requirements for additional, unannounced visits and the number of annual samples to be taken by the CBs, had been overlooked during the supervisory activities in 2014 and, partly, in 2015. The plan of the SBA and NFA to be more actively involved in such activities should strengthen the supervision process. 5.2.3 Registration of operators Legal Requirements Articles 28(1), 28(2) and 28(5) of Council Regulation (EC) No 834/2007. Article 92b of Commission Regulation (EC) No 889/2008. Article 63(2) of Regulation (EC) No 889/2008. Findings

Member state response

National Food Agency has recently finished a paper on y documented procedures for the delegation of tasks to control bodies, (a copy will be forwarded).

The recommendation states as its basis

The audit team noted that the delegation decisions issued by the CAs require the CBs to ensure that operators (wishing to produce, prepare, store or import organic products or placing on the market such products) notify their activity to them. In both the CBs visited, the audit team noted that this was clearly described in their websites. However, it was noted that, although an amendment of the legislation is in the pipeline, the current legislation does not include the obligation of these operators to notify their activities to the CAs. This is not in line with Article 28(1) of Regulation (EC) No 834/2007.

There is a system which is partly effective in ensuring that operators which produce, prepare, store or import organic products or who place on the market such products are registered and subject to controls. In particular, operators are neither yet obliged to notify their activity to the CAs, nor are included in a publicly available list and this might hamper the traceability of the organic products. Moreover, the operators' commitment to follow the applicable provisions of the organic legislation and the information concerning the description of their activities and the relevant precautionary measures, are not consistently required by the CBs when the operators are first included in the system. This might impact the overall effectiveness of official controls (see conclusion 31). 6 5.2.4 Planning and Prioritisation of Controls Legal Requirements Article 27(3) of Regulation (EC) No 834/2007. Articles 65(4), 92c(2) and 92f of Commission Regulation (EC) No 889/2008. Articles 3 of Regulation (EC) No 882/2004 Article 41 of Regulation (EC) No 882/2004. Findings

Member state response

In November 2015, the SBA and the NFA began joint supervisory activities on three of the control bodies (CBs). In all cases SBA and NFA did a follow up on the annual number of samples and out additional visits for 2014 including checks of the status for the n sampling and the additional visits performed 2015. This follow up is part of the office audit routines for SBA and NFA. Moreover, when the CBs report their control activities for the national annual control report, this information will be used for a desk evaluation of how the control bodies perform. During the assessments that Swedac performed in 2015, it was observed that control bodies were experiencing some difficulties when it came to calculating the number of operators to be subject for sampling, additional and unannounced controls. This is mainly due to the fact that some operators have certifications which include several areas at the same time, e.g. primary production Page: 3 Report ref. DG(SANTE)/2015-7360-MR of the audit carried out from 14 ems for organic production and labelling of organic products and food processing. Since the control bodies in many cases do not calculate such operators as a single operator but

The recommendation states as its basis

According to representatives from both the CBs visited, during the first control, the inspector is requested to check, among other things, the appropriateness of the relevant precautionary measures put in place by the operator and the outcome of this evaluation is indicated in the report which is left with the operator. However, the audit team noted that CB1 does not require the operator to sign the declaration containing the operator's commitment to follow the applicable provisions of the organic legislation, the description of its activities and the relevant precautionary measures, contrary to the provisions laid down by Article 63(2) of Regulation (EC) No 889/2008.

There is a system which is partly effective in ensuring that operators which produce, prepare, store or import organic products or who place on the market such products are registered and subject to controls. In particular, operators are neither yet obliged to notify their activity to the CAs, nor are included in a publicly available list and this might hamper the traceability of the organic products. Moreover, the operators' commitment to follow the applicable provisions of the organic legislation and the information concerning the description of their activities and the relevant precautionary measures, are not consistently required by the CBs when the operators are first included in the system. This might impact the overall effectiveness of official controls (see conclusion 31). 6 5.2.4 Planning and Prioritisation of Controls Legal Requirements Article 27(3) of Regulation (EC) No 834/2007. Articles 65(4), 92c(2) and 92f of Commission Regulation (EC) No 889/2008. Articles 3 of Regulation (EC) No 882/2004 Article 41 of Regulation (EC) No 882/2004. Findings

Member state response

Member States shall according to article 28(3) of Regulation (EC) no 834/2007 designate an authority or approve a body for the reception of the notifications referred to in Article 28(1). SBA and NFA are pointed out as both competent and control authorities. All control tasks are delegated to private CBs. Sweden considers the notification as a part of the control. Therefore, both the SBA and the NFA have designated the CBs as the bodies to which the notification shall be done.

The recommendation states as its basis

According to the information provided by the CAs, no lists of operators are publicly available yet. The audit team noted that every CB has its own list of operators but such lists are not accessible to the public. This is not in line with Article 92b of Regulation (EC) No 889/2008. An amendment of the national organic legislation is in the pipeline in order to facilitate the publication of these lists. According to the information provided by the CAs, its publication is expected by the end of 2015.

There is a system which is partly effective in ensuring that operators which produce, prepare, store or import organic products or who place on the market such products are registered and subject to controls. In particular, operators are neither yet obliged to notify their activity to the CAs, nor are included in a publicly available list and this might hamper the traceability of the organic products. Moreover, the operators' commitment to follow the applicable provisions of the organic legislation and the information concerning the description of their activities and the relevant precautionary measures, are not consistently required by the CBs when the operators are first included in the system. This might impact the overall effectiveness of official controls (see conclusion 31). 6 5.2.4 Planning and Prioritisation of Controls Legal Requirements Article 27(3) of Regulation (EC) No 834/2007. Articles 65(4), 92c(2) and 92f of Commission Regulation (EC) No 889/2008. Articles 3 of Regulation (EC) No 882/2004 Article 41 of Regulation (EC) No 882/2004. Findings

Member state response

CB1 is developing a new reporting system and in the system a Page: 4 Report ref. DG(SANTE)/2015-7360-MR of the audit carried out from 14 ems for organic production and labelling of organic products s portal for the customers is developed. When a new customer elevant applies for control it agrees to commit to follow the organic legislation. In the new system the customer will also get a link to the portal to insert the description of the company and its activities together with a description with the risks in the production and related precautionary measures. The input in the portal includes signing. The description will be updated before every audit and the company can update it anytime between the audits. When a control body applies for delegation of control tasks, the SBA and the NFA require relevant documents from the CB. Amongst other things, CB1 request to see the form for the agreement between the CB and the operator.The declarations in article 63.2 are usually included in that form or attached as an Annex.

The recommendation states as its basis

Representatives of the CBs visited stated that the aforementioned unannounced visits are in general carried out without prior warning to the operator, although, in both cases, a prior notification of not more than 24 hours is allowed in case of particular circumstances. In this regard, the CAs have slightly different positions: according to representatives from the NFA and Swedac, no exceptions are allowed for the "unannounced" visit; on the other hand, the SBA's position allows a prior notification (of not more than 24 hours) when this notification could not jeopardise the possible outcome of the control. The audit team noted that this is not fully in line with Article 92c of Regulation (EC) No 889/2008 which requires that at least 10% of all visits to be carried out unannounced. Moreover, no information about the number of these "unannounced" visits with prior notification is available to the CAs. 7 Conclusion on the planning and prioritisation of controls

The measures put in place by the CBs for the planning and the prioritisation of controls are, in general, effective, although the new requirements related to the additional and unannounced visits, in force from January 2014, have been implemented by the CBs with a delay and they do not always carry out unannounced visits as required. 5.2.5 Controls of operators Legal Requirements Titles II and III of Regulation (EC) No 834/2007. Titles II and IV and Article 65(1) and 65(3) of Regulation (EC) No 889/2008. Articles 8 and 9 of Regulation (EC) No 882/2004. Findings

Member state response

th Sweden will as soon as possible take measures in order to ensure hat operators are included in publicly available list.

The recommendation states as its basis

The audit team noted that the operators visited were largely in line with the relevant organic production rules. In a number of cases the inspectors of the CBs rightly identified a number of non-compliances (e.g. expired certificates of suppliers and the lack of notification to the CB of the conventional production, in the case of the farm). However, the audit team noted that the food processors visited, certified by CB1, were not required to document a risk analysis indicating the critical steps for the production of organic food and relevant precautionary measures (see finding 18). This is not in line with Article 26(2) of Regulation (EC) No 889/2008. 8 Conclusion on the controls of operators

The CBs have set up broadly adequate systems to ensure effective controls of operators. However, the provision for food and feed processors to carry out a risk analysis to identify the critical steps and relevant precautionary measures for the production of organic food/feed is not regularly required by the CBs. This may affect the overall performance of the controls since additional efforts are required for the CBs to identify the areas which require more attention during their controls. 5.2.6 Controls on Labelling and Traceability Legal Requirements Articles 23, 24 and 27(13) of Regulation (EC) No 834/2007. Title III of Commission Regulation (EC) No 889/2008. Findings

Member state response

odies Se answer to recommendation 4. Page: 5 Report ref. DG(SANTE)/2015-7360-MR of the audit carried out from 14 ems for organic production and labelling of organic products

The recommendation states as its basis

The audit team noted that although most of the non-compliances reviewed during the visits to the CBs had been addressed with largely appropriate measures and had been followed up, none of the CBs had issued a comprehensive catalogue of measures in case of infringements and irregularities in order to harmonise their controls. Moreover, no national catalogue of measures in case of irregularities and infringements, as required by Article 92d of Regulation (EC) No 889/2008 has yet been adopted in Sweden. According to representatives from the CAs, work is in progress to set this up and a national catalogue of measures is expected to be finalised before the end of 2015. Conclusion on measures in cases of irregularities or infringements

Various measures have been put in place by the CAs, CtrlAs and CBs to manage irregularities and infringements. Those related to the obligations of communication between CBs and CAs are effective. However, the lack of a national harmonised sanction catalogue negatively affects the effectiveness and consistency of the measures taken in case of irregularities and infringements throughout the country.

Member state response

y In the new reporting system of CB1 the customer also will get a tionary link to the portal to carry out a risk analysis of the production to le identify critical steps and related precautionary measures. This provides for the information needed for CB1´s risk evaluation of the company and for the audit. The description will be updated before each audit and the company can update it anytime between the audits.

The recommendation states as its basis

The CCA and the FBO's concerned were able to provide the complete set of documents relating to the qualitative traceability for 8 of the 14 samples identified. In the other six cases, elements of the documentation, sometimes significant, were missing. 4

All the establishments mentioned above were subject to official controls as described in point 3. In most cases, the traceability controls carried out did not cover the quantitative aspects and the deficiencies/weaknesses, identified by the FVO audit team, had not been identified by the CA in charge

Member state response

In the autumn of 2015, 200 inspectors will participate in a course on food fraud given by the NFA. These courses will, among other things, go through the inspection methods for qualitative and quantitative traceability. The course also contains actual traceability exercises. After these training sessions, the gathered experiences from these courses and of the traceability projects that have already been completed and that are now being implemented by the NFA and various municipalities will be assessed. After this the process of developing a new control manual on the work against food fraud commences. The control manual is expected to be completed by the first half of 2017 and will also include the inspection methods for qualitative and quantitative traceability. NFA will in 2018 further develop the "management review" and the systematic monitoring / verification of the agency's inspection activities which today are made in all teams. In June 2015 the NFA published a new control manual Control Manual-perform official food control. This new control manual includes inspection methods for traceability of deceptive practices as well as the verification of "mass balance checks on the inp

The recommendation states as its basis

In one establishment, the FBO archived incoming and outgoing documentation without any additional registration regarding the different origins, quantities of raw materials received and processed and quantities of final products. A batch number was created per day of production. The quantities of the pigs' heads received and the approval number of the establishment that had delivered the meat were not recorded. No specific batch number was created when organic cutting production was carried out. The dates of production of organic meat were not recorded. No information concerning the quantities of meat of different batches delivered to the clients was available. As a consequence the establishments could not carry out any quantitative exercise or any reconciliation. No documented traceability system was in place to allow a recall to be adequately carried out.

Another establishment was directly importing Halal meat from Third Countries. The establishment did not have the Common Veterinary Entry Documents available relating to the consignments evaluated by the FVO audit team. Halal meat was also coming from Member States. The FBO had decided to implement, on a voluntary basis, the Swedish requirement that animals should be stunned before being Halal slaughtered for any meat imported or traded. This requirement could not be documented for deliveries coming from Member States and Third Countries. The traceability system was based on the recording of the date of slaughter at slaughterhouse level, but the FBO could not provide data concerning the quantities of meat present in the establishment for each of the slaughter dates. The storage was made by article number. As a consequence, different slaughter dates were mixed on the same pallet and the owner had no documented system in place for retrieving the meat belonging to different incoming consignments. Neither quantitative traceability nor reconciliation could be carried out by the FVO audit team.

In a third establishment, delivery notes accompanying the incoming deliveries were archived in a binder. The quantities of meat arriving at the establishment were not documented in another way. The traceability system was based on the packing date which was used as batch number. Nevertheless, the internal traceability could not be demonstrated. The quantities used at production level were not registered. The 5 labelling of the bovine meat in consumer packs was not in line with Regulation (EC) No 1760/2000, although the information to allow for a correct labelling was available.

A fourth establishment had a system in place foreseeing the manual recording of the quantities of ingredients received and the references/approval number of the slaughterhouses having produced the incoming meat. However this did not provide the reference of the establishment directly delivering the meat. A lot number specific to the establishment visited was attributed for each entering consignment based on the approval number of the slaughterhouse having produced the meat. A batch number was created for each new production. No recording of the final production quantities was carried out except when the FBO carried out internal reconciliation exercises. The exact quantities of each production batch for the goods delivered to the clients were not recorded.

In a fifth establishment, a batch number was automatically generated for each pallet or group of pallets belonging to the same purchase order and arriving on the same day. All the batch numbers were recorded in the business system of the company. Once identified and registered, each pallet could be allocated to the production departments where a new batch number was created for any given production carried out. This new batch number was created using the week, the day within the week and an increasing chronological number during the week. Reworks were taken into consideration in the traceability system, but not the timing for these reworks to be processed. At present, there is no system in place for carrying out reconciliation exercises. No system was in place for detecting anomalies between the quantities of meat in store and the quantities of meat used for the production. Also no documented evidence existed linking the production of the batch to the packing date. The batch number was not present on the goods sold to the consumers, but only on the trays sold to the supermarket.

In a sixth establishment, the FBO put a traceability system in place including the bar coding of the incoming raw material and outgoing meat products. All consignments of ingredients (e.g. meat, offal, spices) entering the establishment were checked and attributed a bar code. A batch number was created for the production of a given product on any given day. This batch could include one or more recipes. The preparation of each recipe included the scanning of the bar code of all ingredients used and it was explained that the system could automatically deduct the quantities of ingredient picked up from the stock. Nevertheless there was no physical validation of the real weight used for each ingredient used. On the day of the FVO visit, the system was also not able to provide the quantities of meat products produced for each batch, making any reconciliation impossible between the data relating to the initial ingredients and the final products. The FBO explained that no reconciliation system for the final products was in place. Anomalies were detected between the percentage of meat physically present in the recipe of a given meat product and the percentage of meat mentioned on the label.

A seventh establishment had a sophisticated traceability system in place: the batch numbers allocated were based on the date of production of the products, the article 6 number and the internal number of the establishment within the group of companies they belong to. The batch number was present on the trays sent to supermarket but not on the consumer packs. A new batch number was created for any movement of raw material, ingredients, half products or products. Nevertheless, in one of the two cases evaluated by the FVO audit team the data recorded in the company system did not match what the company claimed as being the physical reality, e.g. a production of the 18/03/2015 was recorded as being produced on the 19/03/2015, making the traceability exercise impossible. A consignment note of organic livers received in this establishment mentioned an article number which, after verification by the NFA, proved to be the same for organic and non-organic livers. The FBO gave a commitment to create a specific article number for organic livers.

The only cold store visited had a robust system in place based on the bar coding of any single entering pallet of meat. This bar code is scanned and registered in the system as well as the physical location of any bar coded pallet. As soon as an order is received for exiting goods, the system designates the palettes to be extracted from the cold store using the first in first out principle. The exiting goods are scanned allowing the cold store to have an ongoing permanent state of play of all goods stored. The exercises carried out by the FVO team revealed only one minor deficiency relating to one tray of meat.

In all the establishments visited, the FBOs stated that a traceability system was in place. However, the evaluation of these systems revealed a less positive picture concerning traceability in general and quantitative traceability in particular. In one cold store a robust system was in place. Two establishments were making good progress towards implementing a good system but the others still had significant progress to make. Two establishments had yet to start work on implementing a traceability system.

Member state response

he autumn of 2015, 200 inspectors will participate in urse on food fraud given by the NFA. These courses , among other things, concern inspection methods for itative and quantitative traceability. The course also ains actual traceability exercises. After these training ions the gathered experiences from these courses and he on-going traceability projects that have already completed and that are now being implemented by NFA and various municipalities will be examined. r this the process of developing a new control al on the work against food fraud commences. The rol manual is expected to be completed by the first of 2017 and will also include inspection methods for itative and quantitative traceability. will in 2018 further develop the "management ew" and the systematic monitoring / verification of agency's inspection activities which today are made ll teams. une 2015 the NFA published a new control manual rol Manual-perform official food control. new control manual includes inspection methods for eability of deceptive practices as well as the fication of "mass balance checks on the input and ut flows" (as it is mentioned in the EU report on the crisis, fraud in the food chain and t

The recommendation states as its basis

In one establishment, the FBO archived incoming and outgoing documentation without any additional registration regarding the different origins, quantities of raw materials received and processed and quantities of final products. A batch number was created per day of production. The quantities of the pigs' heads received and the approval number of the establishment that had delivered the meat were not recorded. No specific batch number was created when organic cutting production was carried out. The dates of production of organic meat were not recorded. No information concerning the quantities of meat of different batches delivered to the clients was available. As a consequence the establishments could not carry out any quantitative exercise or any reconciliation. No documented traceability system was in place to allow a recall to be adequately carried out.

Another establishment was directly importing Halal meat from Third Countries. The establishment did not have the Common Veterinary Entry Documents available relating to the consignments evaluated by the FVO audit team. Halal meat was also coming from Member States. The FBO had decided to implement, on a voluntary basis, the Swedish requirement that animals should be stunned before being Halal slaughtered for any meat imported or traded. This requirement could not be documented for deliveries coming from Member States and Third Countries. The traceability system was based on the recording of the date of slaughter at slaughterhouse level, but the FBO could not provide data concerning the quantities of meat present in the establishment for each of the slaughter dates. The storage was made by article number. As a consequence, different slaughter dates were mixed on the same pallet and the owner had no documented system in place for retrieving the meat belonging to different incoming consignments. Neither quantitative traceability nor reconciliation could be carried out by the FVO audit team.

In a third establishment, delivery notes accompanying the incoming deliveries were archived in a binder. The quantities of meat arriving at the establishment were not documented in another way. The traceability system was based on the packing date which was used as batch number. Nevertheless, the internal traceability could not be demonstrated. The quantities used at production level were not registered. The 5 labelling of the bovine meat in consumer packs was not in line with Regulation (EC) No 1760/2000, although the information to allow for a correct labelling was available.

A fourth establishment had a system in place foreseeing the manual recording of the quantities of ingredients received and the references/approval number of the slaughterhouses having produced the incoming meat. However this did not provide the reference of the establishment directly delivering the meat. A lot number specific to the establishment visited was attributed for each entering consignment based on the approval number of the slaughterhouse having produced the meat. A batch number was created for each new production. No recording of the final production quantities was carried out except when the FBO carried out internal reconciliation exercises. The exact quantities of each production batch for the goods delivered to the clients were not recorded.

In a fifth establishment, a batch number was automatically generated for each pallet or group of pallets belonging to the same purchase order and arriving on the same day. All the batch numbers were recorded in the business system of the company. Once identified and registered, each pallet could be allocated to the production departments where a new batch number was created for any given production carried out. This new batch number was created using the week, the day within the week and an increasing chronological number during the week. Reworks were taken into consideration in the traceability system, but not the timing for these reworks to be processed. At present, there is no system in place for carrying out reconciliation exercises. No system was in place for detecting anomalies between the quantities of meat in store and the quantities of meat used for the production. Also no documented evidence existed linking the production of the batch to the packing date. The batch number was not present on the goods sold to the consumers, but only on the trays sold to the supermarket.

In a sixth establishment, the FBO put a traceability system in place including the bar coding of the incoming raw material and outgoing meat products. All consignments of ingredients (e.g. meat, offal, spices) entering the establishment were checked and attributed a bar code. A batch number was created for the production of a given product on any given day. This batch could include one or more recipes. The preparation of each recipe included the scanning of the bar code of all ingredients used and it was explained that the system could automatically deduct the quantities of ingredient picked up from the stock. Nevertheless there was no physical validation of the real weight used for each ingredient used. On the day of the FVO visit, the system was also not able to provide the quantities of meat products produced for each batch, making any reconciliation impossible between the data relating to the initial ingredients and the final products. The FBO explained that no reconciliation system for the final products was in place. Anomalies were detected between the percentage of meat physically present in the recipe of a given meat product and the percentage of meat mentioned on the label.

A seventh establishment had a sophisticated traceability system in place: the batch numbers allocated were based on the date of production of the products, the article 6 number and the internal number of the establishment within the group of companies they belong to. The batch number was present on the trays sent to supermarket but not on the consumer packs. A new batch number was created for any movement of raw material, ingredients, half products or products. Nevertheless, in one of the two cases evaluated by the FVO audit team the data recorded in the company system did not match what the company claimed as being the physical reality, e.g. a production of the 18/03/2015 was recorded as being produced on the 19/03/2015, making the traceability exercise impossible. A consignment note of organic livers received in this establishment mentioned an article number which, after verification by the NFA, proved to be the same for organic and non-organic livers. The FBO gave a commitment to create a specific article number for organic livers.

The only cold store visited had a robust system in place based on the bar coding of any single entering pallet of meat. This bar code is scanned and registered in the system as well as the physical location of any bar coded pallet. As soon as an order is received for exiting goods, the system designates the palettes to be extracted from the cold store using the first in first out principle. The exiting goods are scanned allowing the cold store to have an ongoing permanent state of play of all goods stored. The exercises carried out by the FVO team revealed only one minor deficiency relating to one tray of meat.

In all the establishments visited, the FBOs stated that a traceability system was in place. However, the evaluation of these systems revealed a less positive picture concerning traceability in general and quantitative traceability in particular. In one cold store a robust system was in place. Two establishments were making good progress towards implementing a good system but the others still had significant progress to make. Two establishments had yet to start work on implementing a traceability system.

Member state response

he autumn of 2015, 200 inspectors will participate in urse on food fraud given by the NFA. These courses , among other things, concern inspection methods for itative and quantitative traceability. The course also ains actual traceability exercises. After these training ions the gathered experiences from these courses and he on-going traceability projects that have already completed and that are now being implemented by NFA and various municipalities will be examined. r this the process of developing a new control al on the work against food fraud commences. The rol manual is expected to be completed by the first of 2017 and will also include the inspection methods qualitative and quantitative traceability. will in 2018 further develop the "management ew" and the systematic monitoring / verification of agency's inspection activities which today are made ll teams. une 2015 the NFA published a new control manual rol Manual-perform official food control . new control manual includes inspection methods for eability of deceptive practices as well as the fication of "mass balance checks on the input and ut flows" (as it is mentioned in the EU report on the crisis, fraud in the food chain

The recommendation states as its basis

The CA controls in relation to food additives are not included in the five year plan of controls. However according to the CA, this topic may be covered during controls. No evidence of controls in relation to food additives was included in the official control reports presented to the FVO audit team.

The CA controls in relation to food additives are not included in the five year plan of controls.

Member state response

ditives as a specific control area, is currently not rated in the annual control that is to be reported NFA on a yearly basis. It is being considered to a separate control area in the on-going review of trol areas. This review is expected to be ed 2019. autumn of 2015, the NFA will start working on a trol manual on the control of food additives, s due to be completed in 2016. In anticipation of iew of the control areas, the control of food es will be performed through specific control s. A NFA control project on food additives is ly planned for 2017 the project then be nted in collaboration with various alities. Stockholm municipality carries out a project on food additives during 2015. Page: 4

Member state response

f Regulation The Government has, in the appropriation for 2016, ordered NFA to develop the control of foodstuffs on the internet on a national level. In the report to the Government the NFA shall demonstrate how the CCA coordinates, supports and guides the regional and local authorities in the area of control of foodstuffs on the internet. NFA is to report to the Government before 30 June 2016.NFA will develop a strategy to meet the demands from the government. 1. As regards sales on the internet of seeds for sprouting, the strategy will entail information to relevant FBOs that they are obliged to register the company with the relevant CA. This information will be finalised and sent to all major garden centres before summer 2016. 2. This information will in its relevant parts also be put on the extranet Livsteck.net, thus made available to all relevant CA, recommending them to adjust their registration forms accordingly. This will also be done before summer 2016. 3. Guidance about surveillance and control of food business operators that trade with food on the internet will be produced and put on the extranet Livsteck.net before summer 2016. 4. When an FBO is registered they will gi

Member state response

equired by The three sprouting establishments not approved at the time of the audit are expected to be approved at 31th of March, provided that . the companies by that time have taken all corrective actions needed.

Member state response

certification Information on official controls including traceability and ntended for certification requirements for imports of sprouts and seeds for 211/2013 sprouting as required by Regulation (EU) No 211/2013 and Regulation (EU) No 208/2013 will be provided to the CA on the . NFA's extranet Livsteck.net by 31 of March 2016. The NFA will also provide the information at the regular meetings with the CA organised by the county administrative boards during 2016.

Member state response

be NFA will issue a guidance document latest by 31th of March 2016. ria for seeds Annex 1, . be 31, 32.)

Member state response

n NRL as Article 33.2b: National reference laboratories shall coordinate, Page: 2 ed 22/02/2016 ions of Report ref. DG(SANTE)/2015-7459-MR of the audit carried out from 29 of official controls relating to microbial safety of primary production of food of non- for their area of competence, the activities of official laboratories . responsible for the analysis of samples in accordance with Article 11. NRL for pathogenic E. coli including STEC in food in Sweden (NFA) shall: 1. Contact the official laboratories (two laboratories at the moment) that perform analysis of STEC in official control. Inform the laboratories of the: a. Requirements for analysis of samples within official control and by what criteria laboratories can be appointed official laboratories. b. Requirements of accreditation certificate for the laboratories that do analysis of STEC and that it must cover all relevant matrices. c. Requirements of communicating the results from PTs and the evaluation/follow-up of the results to the NRL. 2. Visit the current official laboratories for STEC during the spring of 2016. The laboratories must send accreditation certificate and results and evaluations from PTs on annual basis.

The recommendation states as its basis

Sampling is spread over the year or carried out in key production periods for all species and commodities, with the exception of horses, which, while slaughtered throughout the year are only sampled during a two month period. Thus the requirements laid down in point 2.1. of the Annex to Commission Decision 98/179/EC are not respected for all species/commodities.

The planning of residue monitoring is timely and comprehensive, and contributes to the effectiveness of controls on residues. However it is weakened by deficiencies in the sampling of horses, the absence of registration information on honey collection centres which may result in sampling not being targeted upon the most appropriate food business operators.2 5.1.3. Implementation of the residue monitoring plan Legal Requirements Directive 96/23/EC; Regulation (EC) No 882/2004; Commission Decision 97/747/EC; Commission Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation (EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission Regulation (EC) No 401/2006; Directive 2001/82/EC; Regulation (EC) No 852/2004 of the European Parliament and of the Council; Regulation (EC) No 853/2004 of the European Parliament and of the Council; Regulation (EC) No 854/2004 of the European Parliament and of the Council; Commission Regulation (EC) No 504/2008. Findings

Member state response

he year for horses in line with the The sampling of horses has, up to now, been carried out during a the Annex to Commission limited period of the year which has been shifted between years. However, the analytical methods used have now been improved making it possible for the laboratory to analyse horse samples at the same time as samples from other animal species. Therefore sampling of horses will be carried out in variable intervals over the entire year starting from 2016.

he year for horses in line with the The sampling of horses has, up to now, been carried out during a the Annex to Commission limited period of the year which has been shifted between years. However, the analytical methods used have now been improved making it possible for the laboratory to analyse horse samples at the same time as samples from other animal species. Therefore sampling of horses will be carried out in variable intervals over the entire year starting from 2016.

The recommendation states as its basis

NFA staff met by the audit team stated that they have not been provided with a register of all honey collection centres and honey traders physically receiving and dispatching honey. Thus the NFA does not possess information on all honey collection centres/traders which could be subject to sampling activities.1 Prior to 2015 all 100 RMP honey samples were planned to be taken from one large collection centre receiving honey from some parts of Sweden. In order to better plan and choose future RMP honey samples, while not knowing all honey collection centres, the NFA used data from a national beekeeping association representing beekeepers and several collection centres to create a three year sampling plan which foresees to take samples from several collection centres throughout Sweden. 1 In their response to the draft report the competent authority noted that there is no national register since honey collection centres and honey traders physically receiving and dispatching honey are to be registered at the municipality where the establishment is located. 3 Conclusions on planning of residue monitoring

The planning of residue monitoring is timely and comprehensive, and contributes to the effectiveness of controls on residues. However it is weakened by deficiencies in the sampling of horses, the absence of registration information on honey collection centres which may result in sampling not being targeted upon the most appropriate food business operators.2 5.1.3. Implementation of the residue monitoring plan Legal Requirements Directive 96/23/EC; Regulation (EC) No 882/2004; Commission Decision 97/747/EC; Commission Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation (EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission Regulation (EC) No 401/2006; Directive 2001/82/EC; Regulation (EC) No 852/2004 of the European Parliament and of the Council; Regulation (EC) No 853/2004 of the European Parliament and of the Council; Regulation (EC) No 854/2004 of the European Parliament and of the Council; Commission Regulation (EC) No 504/2008. Findings

Member state response

nsure that all beekeepers In Sweden must all undertakings that are food business operators d honey collection centres and according the definition of FBO in Regulation (EC) No 852/2004 hing honey are registered in line and recital 9 in same regulation notify their establishment for 2/2004 and Article 6 of registration. Food business operators producing honey must be registered at the County Administrative Boards regardless if they deliver honey direct to consumers, to establishments delivering direct to consumers or to other establishments in food chain. Collection centres and traders receiving and dispatching honey must be registered by the local municipal competent authority if they are food business operators according to recital 9 and the definition in Regulation (EC) No 852/2004. Actors whose activities are deemed to have to little continuity and/or organisation to be considered to be undertakings are not to be registered (recital 9). The Swedish residue control programme for honey 2016 will be based on information about all honey establishments which are FBOs, registered by the CABs and municipalities respectively. There is approximately 80 000 primary producers in total in S

nsure that all beekeepers In Sweden must all undertakings that are food business operators d honey collection centres and according the definition of FBO in Regulation (EC) No 852/2004 hing honey are registered in line and recital 9 in same regulation notify their establishment for 2/2004 and Article 6 of registration. Food business operators producing honey must be registered at the County Administrative Boards regardless if they deliver honey direct to consumers, to establishments delivering direct to consumers or to other establishments in food chain. Collection centres and traders receiving and dispatching honey must be registered by the local municipal competent authority if they are food business operators according to recital 9 and the definition in Regulation (EC) No 852/2004. Actors whose activities are deemed to have to little continuity and/or organisation to be considered to be undertakings are not to be registered (recital 9). The Swedish residue control programme for honey 2016 will be based on information about all honey establishments which are FBOs, registered by the CABs and municipalities respectively. There is approximately 80 000 primary producers in total in S

The recommendation states as its basis

Sampling is carried out without prior warning by NFA staff and by SBA district veterinarians. Sampling at aquaculture farms by the CABs on behalf of the NFA should, according to an NFA/CAB agreement, also be unannounced. However, 2 In their response to the draft report the competent authority noted that the registration of food business operators with primary production is an ongoing process. A task given to the CABs by the Government is to have all known food business operators in primary production registered at 30th June 2016. 4 CAB staff take RMP samples during routine inspections from freshwater aquaculture farms that are accessible and staffed all year round. These routine inspections are announced 24 hours in advance. CAB sampling of such farms is not in line with requirements of Point 2 of Article 3 of Regulation (EC) No 882/2004.

Whilst the residue monitoring plan is generally implemented in accordance with planned arrangements, its effectiveness is potentially weakened by pre-announced controls at certain types of aquaculture farms. 5.1.4. Other residue monitoring programmes Legal Requirements Directive 96/23/EC. Findings

Controls on farms with regards to veterinary medicinal products are carried out through two different types of inspections. CAB inspections on behalf of the NFA focus on the requirements of Regulation (EC) No 853/2004 but also include checks on the presence and correctness of veterinary medicinal product records. These controls are carried out without prior warning. CAB inspections on behalf of the SBA focus solely on controls on the use of veterinary medicinal products, but in contrast to the NFA controls, are carried out with 24 hours advance notice without a 11 justification as to why this is necessary. This is not in line with requirements Article 3(2) of Regulation (EC) No 882/2004.

Official controls are carried out at all levels of veterinary medicinal product distribution. However, these control systems are weakened by the fact that national inspection control targets for veterinary practices and farms are largely not met and that inspections are regularly carried out at farm level with prior notice, which could reduce their potential effectiveness.

Member state response

s are carried out without prior Whether or not an official control is announced depends on its id down in point 2 of Article 3 of purpose. Announced controls increases the efficiency and the quality of the control especially considering that someone with 62 knowledge about the enterprise in question will be present. Inspections based on previous experiences and intelligence are unannounced. The SBA will assess the need for reviewing the guideline to clarify this aspect.

s are carried out without prior Whether or not an official control is announced depends on its id down in point 2 of Article 3 of purpose. Announced controls increases the efficiency and the quality of the control especially considering that someone with 62 knowledge about the enterprise in question will be present. Inspections based on previous experiences and intelligence are unannounced. The SBA will assess the need for reviewing the guideline to clarify this aspect. Updated response received 22 April 2016 Whether or not an official control is announced depends on its purpose. Announced controls increases the efficiency and the quality of the control especially considering that someone with knowledge about the enterprise in question will be present. SBA will continue to evaluate the effectiveness of the official control system to ensure that it is not weakened.

The recommendation states as its basis

The responsibility for providing instructions on taking of samples in case of suspicion at slaughterhouses and supervision of same was transferred from the Strategic Control planning group to the NFA control support group of the Food Control Division in 2013. To date no such instructions have been prepared. The audit team noted that findings such as mastitis and peritonitis recorded in post- mortem inspection reports at the two slaughterhouses, which would have supported a suspicion of prior treatment with veterinary medicinal substances, had not resulted in samples being taken. This is not in line with the requirements laid down in Article 24 of Directive 96/23/EC.

While training on how to conduct follow-up investigations took place after the 2010 audit, NFA staff informed the audit team that newer staff at the CABs had not received training on this topic. The audit team found in the two counties visited that the CAB staff responsible for follow-up investigations were neither aware of any instructions or documented procedures to follow in the event of a non-compliance, nor were they able to describe what measures to take in such cases in line with requirements outlined in Article 17 to 23 of Directive 96/23/EC. This gap in knowledge and absence of appropriate training is not in line with Article 6(a) of Regulation (EC) No 882/2004. Thus recommendation No 3 of the 2010 Audit report, in the context of the current audit, has not been addressed. 6 Conclusions on follow-up of non-compliant results

The follow-up of the relatively few non-compliant results to date has been done in a timely and effective manner. Nevertheless, the low numbers of samples taken in case of suspicion, in spite of justifiable evidence supporting such sampling, and the absence of training for newer CAB staff, collectively have the potential to undermine the effectiveness of residue controls. 5.1.6. Laboratories Legal Requirements Regulation (EC) No 882/2004; Directive 96/23/EC; Decision 2002/657/EC; Regulation (EU) No 589/2014; Regulation (EC) No 333/2007; Regulation (EC) No 401/2006. Findings

Member state response

ary training to undertake their Training will be given to staff carrying out follow-up e 6 of Regulation (EC) No investigations of noncompliant results regularly, with start 2016. effective follow-up The topic will be included in the program at training and n line with the requirements of information days for control staff organized by the central 3/EC. competent authorities. Training will also be presented at NFA website for e-learning. The SBA will provide necessary advice and support to the CABs, to ensure that all inspection staff has sufficient competence to control the use of veterinary medicinal products on farm, including information on inspection of horse passport. The CABs have started a project concerning competence within the control areas that are linked to Regulation (EC) No 882/2004. The aim is to ensure that competence gaps are identified and taken care of in the long term. As an immediate measure, the CABs will ensure that all inspection staff is aware of the instructions concerning Page: 2 ion Plan received from the competent authority on 23 October 2015 Ref. Ares(2015)3344898 - 11/08/2015 o the recommendations of Report ref. DG(SANTE)/2015-7512-MR of the audit ca

ary training to undertake their Training will be given to staff carrying out follow-up e 6 of Regulation (EC) No investigations of noncompliant results regularly, with start 2016. effective follow-up The topic will be included in the program at training and n line with the requirements of information days for control staff organized by the central 3/EC. competent authorities. Training will also be presented at NFA website for e-learning. The SBA will provide necessary advice and support to the CABs, to ensure that all inspection staff has sufficient competence to control the use of veterinary medicinal products on farm, including information on inspection of horse passport. Page: 2 eceived from the Competent Authority on 22 April 2016 o the recommendations of Report ref. DG(SANTE)/2015-7512-MR of the audit carried out from 09 to 18 idues and contaminants in live animals and animal products including controls on veterinary medicinal The CABs have started a project concerning competence within the control areas that are linked to Regulation (EC) No 882/2004. The aim is to ensure that competence gaps are identified and taken care of in the long term. As an immediate measure, the CABs

The recommendation states as its basis

The audit team was informed by the food business operator and official veterinarian in the slaughterhouse that they check that the horse presented matches the markings/identity of the accompanying documentation and but do not check section IX of the passport indicating whether or not the horse has been signed out of the food chain. This is not fully in line with Articles 6 and 8 of Regulation (EC) No 882/2004 and Article 20 of Regulation (EC) No 504/2008. Thus, in this respect, this aspect of recommendation No 9 of the 2010 audit report has not been addressed.

Several controls at veterinary practices treating horses were conducted in the second county visited by the audit team, to check the use of phenylbutazone and if the horse had been correctly signed out of the food chain in the passport. In six cases horses had been treated with phenylbutazone but the responsible veterinary practitioners had not marked the animal´s status as not intended for slaughter for human consumption, as set out in Part II of Section IX of the identification document and as required by Article 20 of Regulation (EC) No 504/2008. In 2014, the CAB sent an information letter to all veterinarians in the county highlighting the need to record treatments correctly in the equine passport and to sign horses out of the food chain if required.

The SBA and NFA officials met by the audit team stated that so far no verification of the effectiveness of controls on food chain information or of controls on equine passport requirements (e.g. to verify that horses were fit for human consumption), were conducted. This is not in line with requirements of Article 8(3) of Regulation (EC) No 882/2004.

Shortcomings in both the implementation of the equine passport system and the controls thereon, as well as controls on food chain information for horses, increase the risk that horses, ineligible for human consumption, enter the food chain. 14

Member state response

r food-producing animals, It is NFA's opinion that the term `relevant information' in with the requirements stipulated regulation (EC) no 854/2004, annex I, section I, chapter II, point (EC) 853/2004 and that the A1 shall be interpreted as such information the operator, at the line with Article 8 of Regulation operators own control of FCI according to regulation (EC) no 853/2004, annex II, section III, identifies as unsatisfactory or 77 information the operator does not consider itself able to assess due to eg. lack of knowledge. According to the same section, point 5 it's also the operators' responsibility to notify the official veterinarian (OV) of any information that gives rise to health concerns before ante-mortem inspection. This means that operators with the OV must communicate the relevant information as well as any official certificates or declarations made by veterinarians that may be included in the FCI received. NFA believes that it is in line with the legislation that the OVs then 1) check this communicated, and not all, FCI and 2) perform inspections and audits, both planned, extra (when non compliances) and ad hoc, to ensure that the operators' procedures for receivi

r food-producing animals, It is NFA's opinion that the term `relevant information' in with the requirements stipulated regulation (EC) no 854/2004, annex I, section I, chapter II, point (EC) 853/2004 and that the A1 shall be interpreted as such information the operator, at the line with Article 8 of Regulation operators own control of FCI according to regulation (EC) no 853/2004, annex II, section III, identifies as unsatisfactory or 77 information the operator does not consider itself able to assess due to eg. lack of knowledge. According to the same section, point 5 it's also the operators' responsibility to notify the official veterinarian (OV) of any information that gives rise to health concerns before ante-mortem inspection. This means that operators with the OV must communicate the relevant information as well as any official certificates or declarations made by veterinarians that may be included in the FCI received. NFA believes that it is in line with the legislation that the OVs then 1) check this communicated, and not all, FCI and 2) perform inspections and audits, both planned, extra (when non compliances) and ad hoc, to ensure that the operators' procedures for receivi

Member state response

The inspectors at KEMI, the Swedish Chemicals Agency, are specialised in pesticides. An assessment of needs and follow-up of training is done and documented annually according to established operating procedures (in the quality management system, ISO 9001 certified). The agency is also the CA for 1107/2009 and in- house training is provided as needed by legal advisers and officers participating in technical committees and the authorisation process. The Swedish Chemicals Agency offers a two-day course for MUP/CAB inspectors on enforcement of chemical legislation regarding placing on the market. The training includes a two-hour session specifically aimed at pesticide controls, but other parts are also relevant for PPPs (e.g. classification and labelling, SDS). The training is free of charge and takes place five times during 2014 in different locations. Furthermore, training on PPP enforcement is provided in joint projects with Swedish Chemicals Agency, Swedish Board of agriculture (SBA) and MUP/CAB. Such a project was done in 2011 and another is planned for 2015. There will be seminars for the MUP inspectors with guidance on how to do inspections according to the new legislation, esp

The inspectors at KEMI, the Swedish Chemicals Agency, are specialised in pesticides. An assessment of needs and follow-up of training is done and documented annually according to established operating procedures (in the quality management system, ISO 9001 certified). The agency is also the CA for 1107/2009 and in-house training is provided as needed by legal advisers and officers participating in technical committees and the authorisation process. The Swedish Chemicals Agency offers a two- day course for MUP/CAB inspectors on enforcement of chemical legislation regarding placing on the market. The training includes a two-hour session specifically aimed at pesticide controls, but other parts are also relevant for PPPs (e.g. classification and labelling, SDS). The training is free of charge and takes place five times during 2014 in different locations. ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. nforcement is h Swedish d of Such a nother is e seminars for ce on how to e new here will also be uss how to which areas he ject there will nd publication cussion

Member state response

lines The Swedish Chemicals Agency is taking measures in order to ensure that the re-authorizations of PPPs are in accordance with the relevant deadlines. Resources - The Swedish government is paying extra attention to the work on pesticides by allocating a special budget (beginning with 2013) and by following the work carefully in annual follow ups. The Agency submitted a proposal for higher fees for the authorization of pesticides to the Swedish government which has led to a new ordinance which entered into force 2013. Prioritization - The Swedish Chemicals Agency has objectives and actions in the annual working plan which is focused on prioritizing and streamlining the PPP work. This prioritizing will continue during 2015. Performance Management ­ The Swedish Chemicals Agency implemented a new organization 2013 with the intention to increase the efficiency of the work of the agency. Routines, competencies, and processes are systematically developed in order to streamline the case flow.

e Swedish Chemicals Agency is taking asures in order to ensure that the re- thorizations of PPPs are in accordance with e relevant deadlines. sources - The Swedish government is ying extra attention to the work on sticides by allocating a special budget eginning with 2013) and by following the rk carefully in annual follow ups. The ency submitted a proposal for higher fees r the authorization of pesticides to the edish government which has led to a new dinance which entered into force 2013. ioritization - The Swedish Chemicals ency has objectives and actions in the nual working plan which is focused on ioritizing and streamlining the PPP work. is prioritizing will continue during 2015. ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. formance Management ­ The Swedish micals Agency implemented a new anization 2013 with the intention to rease the efficiency of the work of the ncy. Routines, competencies, and cesses are systematically developed in er to streamline the case flow.

Member state response

nd The Swedish Chemicals Agency is reviewing this process to be further ensure that authorisations are only for limited and ) of controlled use. The review will be documented in an internal guidance that will be implemented during 2015. The guidance will include how to evaluate factors such as time-period of authorisations, scale of use, and the use of emergency Page: 2 Report ref. DG(SANCO)/2014-7182 -MR of a/an audit carried out from 13 authorisations for PPPs for which authorisations have been refused following evaluation. The industry will also be informed of the results of the review.

Swedish Chemicals Agency is reviewing this process to further ensure that horisations are only for limited and trolled use. The review will be umented in an internal guidance that will implemented during 2015. The guidance l include how to evaluate factors such as e-period of authorisations, scale of use, the use of emergency authorisations for s for which authorisations have been used following evaluation. The industry l also be informed of the results of the iew.

Member state response

for A routine for informing the Commission will be developed and included in the quality management system. This routine will be C) in place at the latest at the end of 2014.

outine for informing the Commission will e developed and included in the quality ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. management system. This routine will be in lace at the latest at the end of 2014.

Member state response

e the The existing database available on the public website llowing www.kemi.se includes information on: 6 of · The date of the first authorization of a product · The date of renewal of the authorization of a product · The expiry date of the current authorization · The date when the product is withdrawn from the market The existing database available on the public website www.kemi.se also includes dates for grace periods · for the authorization holder, · for distributors other than the authorization holder, and · for use. The decisions of period of grace are published in the Code of statute of the Swedish Chemicals Agency. It is important that the website also includes information on use areas which are no longer authorized, following re-authorisation where the GAP has changed. The Swedish Chemicals Agency is currently investigating how this can be achieved. The reviewed system will be in place at the latest during 2015. The effectiveness of accessing and using the database in the field during inspections will be highlighted in the guidance on enforcement to the municipalities. Page: 3 Report ref. DG(SANCO)/2014-7182 -MR of a/an audit carried out from 13

he existing database available on the public ebsite www.kemi.se includes information n: The date of the first authorization of a product The date of renewal of the authorization of a product The expiry date of the current authorization The date when the product is withdrawn from the market he existing database available on the public ebsite www.kemi.se also includes dates for race periods for the authorization holder, for distributors other than the authorization holder, and for use. he decisions of period of grace are ublished in the Code of statute of the wedish Chemicals Agency. ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. It is important that the website also includes information on use areas which are no longer authorized, following re-authorisation where the GAP has changed. The Swedish Chemicals Agency is currently investigating how this can be achieved. The reviewed system will be in place at the latest during 2015. The effectiveness of accessing and using the database in the field during inspections will be highlighted in the guidance on enforce

Member state response

of PPP According to the government Ordinance on Pesticides (SFS 2014:425) all distributors should no later than November 2015, have a sufficient number of employees which have received training. The training programme for distributors will be available no later than January 2015. A training programme for users is already in place and will form the basis for the new training system.

ng and According to the government Ordinance on by Pesticides (SFS 2014:425) all distributors should no later than November 2015, have a sufficient number of employees which have received training. The training programme for distributors will be available no later than January 2015. A training programme for users is already in place and will form the basis for the new training system.

Member state response

o The Swedish Chemicals Agency is responsible for controlling operators supplying PPPs for the first time on the Swedish market e and registration holders. There are approximately 70 registration ith holders. Selection of operators to control is determined annually according to a documented procedure with defined parameters such as risk, findings in previous controls and ensuring an appropriate frequency of controls. Municipalities are responsible for controlling operators further down the supply chain. Selection of operators to control is determined by each municipality. Also at the municipal level the selection of operators to control is determined based on risk, findings in previous controls and ensuring an appropriate frequency of controls. During 2015 the guidance on enforcement will be reviewed and recommended frequency of controls for different types of operators will be included. The enforcement of the requirement for training and certification of PPP distributors will also be included in the guidance, including recommendations to establish a register of PPP distributors at local level if this is not already in place. Legal requirement: Under the Swedish Environmental Code,

of Relevant excerpts from a lengthy response: rs The Swedish Chemicals Agency is ly responsible for controlling operators d are supplying PPPs for the first time on the f Swedish market and registration holders. Municipalities are responsible for controlling ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. r down the supply chain. rators to control is ch municipality. guidance on enforcement and recommended trols for different types of e included. The enforcement nt for training and PPP distributors will also be guidance, including to establish a register of at local level if this is not . ervisory authorities shall of all operators which need ision. rcement: Detailed practical to control specifically PPPs the Swedish Chemicals e document for supervision etaljhandeltillsyn ­ Kemiska kämpningsmedel; Tillsyn , available at www.kemi.se). to municipalities and CABs irect contact, in seminars, via a ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pes

Member state response

Control activities including formulation analysis are planned by the Swedish Chemicals Agency for the autumn of 2014, see tion annual plan `Tillsynsplan 2014' (in Swedish) available from www.kemi.se. The project includes inspection of the operator's internal controls of the final product and analysis of 5 to 10 PPPs. Information as a basis for the project has been sought from neighbouring MS CA as well as from the chemists working in the authorisation process. Based on the result of this activity and other information, further formulation analyses will be included in the annual enforcement plan for 2015 and future years as appropriate.

as Control activities including formulation t PPPs analysis are planned by the Swedish d Chemicals Agency for the autumn of 2014, see annual plan `Tillsynsplan 2014' (in Swedish) available from www.kemi.se. The ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. project includes inspection of the operator's internal controls of the final product and analysis of 5 to 10 PPPs. Information as a basis for the project has been sought from neighbouring MS CA as well as from the chemists working in the authorisation process. Based on the result of this activity and other information, further formulation analyses will be included in the annual enforcement plan for 2015 and future years as appropriate.

Member state response

trols The regional and local authorities have a responsibility to perform inspections according to Article 68 of Regulation (EC) No 1107/2009 and the Swedish Environmental Inspection Regulation 2011:13. In 2015 the focus for the SBA will be guidance and information to inspectors on IPM in agriculture. In the following year the focus will be on IPM in the remaining cultivation areas e.g. PPP use in green house. The guidance document will also contain guidance on selection criteria and frequency to assist the local authorities. The legal requirement to keep a register of all operators which need recurrent supervision will be emphasized in the guidance.

The regional and local authorities have a e responsibility to perform inspections according to Article 68 of Regulation (EC) No 1107/2009 and the Swedish Environmental Inspection Regulation 2011:13. In 2015 the focus for the SBA will be guidance and information to inspectors on IPM in agriculture. In the following year the focus will be on IPM in the remaining cultivation areas e.g. PPP use in green house. The guidance document will also contain guidance on selection criteria and frequency ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. to assist the local authorities. The legal requirement to keep a register of all operators which need recurrent supervision will be emphasized in the guidance.

Member state response

The requirements on how to keep records will be further clarified in a SBA Regulation that will be in place in the first quarter of 2015. At the same time guidance documents will be finished. Due on to that and the new Ordinance, the central CAs will provide targeted information to inspectors and users in 2015 and 2016. The guidance documents will be further developed including ways Page: 6 Report ref. DG(SANCO)/2014-7182 -MR of a/an audit carried out from 13 to control these new requirements also including existing requirements.

The requirements on how to keep records will be further clarified in a SBA Regulation that will be in place in the first quarter of 2015. At the same time guidance documents will be finished. Due to that and the new Ordinance, the central CAs will provide targeted . information to inspectors and users in 2015 and 2016. The guidance documents will be further developed including ways to control these new requirements also including existing requirements. Amendment: In the guidance document it will be clarified that it is essential to have access to the KEMI register during the inspection. This could be accomplished for example by having a tablet with Internet access. All relevant information on authorisations and the specific conditions for use of a particular product is available in that register. ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides.

Member state response

The Swedish Chemicals Agency is responsible for controlling in operators supplying PPPs for the first time on the Swedish market and registration holders. There are approximately 70 registration holders. Selection of operators to control is determined annually according to a documented procedure with defined parameters such as risk, findings in previous controls and ensuring an appropriate frequency of controls. Municipalities are responsible for controlling operators further down the supply chain. Selection of operators to control is determined by each municipality. During 2015 the guidance on enforcement will be reviewed and recommended frequency of controls for different types of operators will be included. The enforcement of the requirement for training and certification of PPP distributors will also be included in the guidance. Furthermore, it will be emphasized in the new guidance that the supervisory authorities are required to keep a register of all operators which need recurrent supervision and that this requirement also covers PPP distributors at local level. The Actions proposed under point 7 above are also relevant for this point.

of The Swedish Chemicals Agency is and responsible for controlling operators icle supplying PPPs for the first time on the market and registration holders. e approximately 70 registration Selection of operators to control is ed annually according to a ed procedure with defined rs such as risk, findings in previous and ensuring an appropriate y of controls. lities are responsible for controlling s further down the supply chain. n of operators to control is ed by each municipality. During guidance on enforcement will be and recommended frequency of for different types of operators will ded. The enforcement of the ent for training and certification of ributors will also be included in the . Furthermore, it will be emphasized ew guidance that the supervisory ies are required to keep a register of ators which need recurrent ion and that this requirement also ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. covers PPP distributors at local level. The Actions proposed under point 7 above are also relevant for this point.

Member state response

Sweden is of the opinion that Regulation (EC) No 882/2004 is not applicable for control of Regulation (EC) No 1107/2009. The Swedish Environmental Inspection Regulation 2011:13 do not prescribe a corresponding requirement to article 3(2). Whether or not a control is announced depends on the purpose with the inspection. Announced inspections increases the Page: 7 Report ref. DG(SANCO)/2014-7182 -MR of a/an audit carried out from 13 fficiency and quality of the inspection especially considering that omeone with knowledge about the enterprise in question will be resent. Follow-up inspections, inspections based on previous xperiences and intelligence are always unannounced.

users Sweden is of the opinion that Regulation (EC) No 882/2004 is not applicable for control of Regulation (EC) No 1107/2009. The Swedish Environmental Inspection Regulation 2011:13 do not prescribe a corresponding requirement to article 3(2). Whether or not a control is announced depends on the purpose with the inspection. Announced inspections increases the efficiency and quality of the inspection especially considering that someone with knowledge about the enterprise in question will be present. Follow-up inspections, inspections based on previous experiences and intelligence are always unannounced. Amendment: Sweden maintains the legal opinion that Regulation (EC) No 882/2004 is not applicable for control of sale and use of PPPs. We take note, however, of the differing interpretation made by the Commission services. It is in any case our ambition that ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. the control of sale and use of PPPs in Sweden should assure that all actors fulfil their obligations. Control of residues of PPPs in food and feed is within

Member state response

e, and Improved instructions (e.g. to reply even if no controls have been r the made) and a new tool for reporting (in use since 2013) have been eveloped. This has led to an increase in the number of rtaken municipalities replying from 120 in 2011 to 212 in 2012 and 231 n 2013 (out of a total of 290). Further actions with direct contact ith the municipality in the case on non-reporting will be mplemented in 2015.

entral Improved instructions (e.g. to reply even if no rols controls have been made) and a new tool for reporting (in use since 2013) have been developed. This has led to an increase in the ide a number of municipalities replying from 120 ional in 2011 to 212 in 2012 and 231 in 2013 (out of a total of 290). Further actions with direct contact with the municipality in the case on non-reporting will be implemented in 2015

Member state response

ved Sweden recognizes that improvements in this area can be done. gulation A recent survey of the environmental control system by the wedish Agency for Public Management have addressed this issue nd suggested improvements in the system. The Swedish overnment is presently considering these proposals. n anticipation of that, due to the new legislation, new guidance ocuments will be written and will among other issues contain hecklists that the local authorities may use. These will be inished by 31st of December 2014. We will also recommend an xchange of the results of control between controls authorities in o far as there are deviations. Such results should be part of the election criteria when choosing control objects.

ion Sweden recognizes that improvements in this s area can be done. on A recent survey of the environmental control system by the Swedish Agency for Public ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. Management have addressed this issue and suggested improvements in the system. The Swedish Government is presently considering these proposals. In anticipation of that, due to the new legislation, new guidance documents will be written and will among other issues contain checklists that the local authorities may use. These will be finished by 31st of December 2014. We will also recommend an exchange of the results of control between controls authorities in so far as there are deviations. Such results should be part of the selection criteria when choosing control objects.

Member state response

uasive The administrative sanctions in place, which are applicable to nfringements of the PPP legislation, are effective, proportionate nd dissuasive. owever, when it comes to the criminal sanctions, Sweden Page: 8 Report ref. DG(SANCO)/2014-7182 -MR of a/an audit carried out from 13 recognizes that there is a need to increase the proportion of reports to the police or the prosecution authorities that result in criminal penalties for infringement of the PPP legislation. As a first step the Swedish Chemicals Agency will initiate discussions with the prosecution authorities and the municipalities in order to analyse appropriate measures. The government offices plan to review the penalties for violating the chemical legislation during 2015. One purpose of the review is to analyse to what extent rules imposing criminal penalties could be replaced by rules on environmental sanctions charges, which is an administrative charge. The environmental sanction charge is considered as an effective means of sanctioning violations of the environmental legislation.

administrative sanctions in place, which le are applicable to infringements of the PPP islation, are effective, proportionate and suasive. ever, when it comes to the criminal ctions, Sweden recognizes that there is a d to increase the proportion of reports to police or the prosecution authorities that ity, 22 December 2014 mpetent Authorities of Sweden on 12 September 2014 in response to Report ref. DG(SANCO)/2014- o 20 May 2014 in order to evaluate controls of pesticides. result in criminal penalties for infringement of the PPP legislation. As a first step the Swedish Chemicals Agency will initiate discussions with the prosecution authorities and the municipalities in order to analyse appropriate measures. The government offices plan to review the penalties for violating the chemical legislation during 2015. One purpose of the review is to analyse to what extent rules imposing criminal penalties could be replaced by rules on environmental sanctions charges, which is an administrative charge. The environmental sanction charge is considered as an effective means of sanctioning violations of the environmental legislation.

Member state response

ents The NFA control personnel are to carry out official control in accordance with the instruction "Implementation of official control of food business operators". According to the instruction approvals shall be reviewed at each audit (at least once a year) in order to ensure that approvals are up to date and that only activities covered by the approval of an establishment is in fact carried out at the establishment. It is at the moment not stipulated when/how often approvals of establishments not subject to audits shall be reviewed. Approvals are in practice however reviewed once a year, during inspection, at such establishments. The instruction "Implementation of official control of food business operators" will be amended accordingly. In addition control personnel should always pay attention to and, when necessary, react upon any change in activity at establishments. According to Regulation (EC) No 852/2004 FBOs are required to report significant changes in activity to the CA. When such changes are reported to the NFA they are handled in accordance with the instruction "Approval and registration of food establishments". The NFA will amend the instruction in order to clarify how

Member state response

t 1 a Motion for clearer national legislation has been prepared. se include requirements for labeling of batches of fish which is expected to exceed the EU's maximum permitted levels of dioxins and PCBs. Such batches must be labelled already at the first receiver stage indicating that the fish can only be sold on the Swedish market. These changes in the legislations will be in force in autumn 2014. 1b Companies that export fatty fish from the Baltic sea to other member states than Finland, herring above 17 cm from congested zones or salmon, may do so if they have scientific data that shows that the batches comply with Community requirements. NFA will specifically examine these companies to ensure that there is evidence that shows that the batches sent to other member countries has acceptable levels of dioxins and PCBs. This control will start in spring 2014.

ctive official control system in order to ensure that 1 a The National Food Agency is preparing a draft regarding region exceeding EU MLs for dioxins and PCBs is changes in the ordinance LIVSFS 2011:19 in order to facilitate the Member States as required in Article 7 of Regulation official control system. The changes include requirements for labeling of batches of fish which falls within the derogation in article 7 in regulation (EC) 1881/2006. Such batches must be labelled at the first receiver stage and through the food chain indicating that the fish is only to be sold on the Swedish market. The changes in the ordinance will be in force in late autumn/winter 2014, after due consultation with the parties concerned, and if required, being notified according to directive 98/34/EC. 1b Companies that export fatty fish from the Baltic sea to other member states than Finland, herring above 17 cm from congested zones or salmon, may do so if they can provide data from sampling and analysis that shows that the batches complies with the requirements in the regulation (EC) 1881/2006. The results have to accompany the batch of such fish. NFA will specifically examine these companies to ensure

Member state response

2.a The NFA guidance for additional labeling of fisheries products ered by consumer information under Regulation (EC) 1379/2013 will be redrafted so it more clearly address the fishery products that are covered by this legislation. The changes will be made in January 2014 2.b Control instructions will be developed for NFA personnel who is responsible to carry on official audits on fish establishments that handle fish covered by the Swedish National derogation. The instructions for this control will be in place in April 2014. 2.c A traceability project is to be conducted annually in co- operation with the county administration, Swedish agency for marine and water management, municipalities and NFA inspectors in order to track individual batches of salmon and Page: 1 Action Plan received from the Competent Authority on 31 January 2014 port ref. DG(SANCO)/2013-6767 -MR of a/an audit carried out from 09 ins, furans and PCBs in fish from the Baltic region. herring sold on the Swedish market and make sure that no parts of such fish is exported to other member states without credible data that show acceptable levels of dioxins and PCBs. The results of the project will be included in the a

Member state response

The means available for allowing access to facilities etc. are legal powers and deals and contracts with authorities and companies. The legal powers, through the Epizootic Diseases Act, are far reaching. According to 9 § in this act the SBA has the power to decide the following: - Proprietors of slaughter houses and other facilities handling different types of products and animal bi- products have to make these facilities and their equipment and personnel available for any needs in case of an outbreak of epizootic disease. - Proprietors of tools and equipment essential in case of an outbreak of an epizootic disease must provide this when needed during an outbreak. CPs by themselves are not legal acts, but refer to relevant legislation. CPs provide detailed information concerning facilities, equipment and personnel. The CPs will be updated within the SBA project on contingency planning to ensure even more detailed information. The project is running 2013-2015, (see draft report of the audit 5.2.1 last paragraph). A letter of intent has been set up between the Nordic and Baltic countries, in which personnel and equipment may be available from neighbouring countries.

Member state response

SBA is leading an ongoing project, in cooperation with the National Veterinary Institute (SVA), on further developing of the edish contingency planning of epizootic diseases, 2013-2015, Page: 1 ref. DG(SANCO)/2013-6780 -MR of a/an audit carried out from 15 ngency plans in relation to animal health, including provisions on the see draft report of the audit 5.2.1 last paragraph) where, among any other things, a worst case scenario for FMD in Sweden will e analysed and planned for, including a plan for emergency accination.

Member state response

weden has already planned for, but not fully implemented, a system for following up cases where keepers have not been active n the databases for a certain period of time, and cases where one eeper has notified the database concerning the movement of an ng animal but the other involved party has not. The result for un- omplying keepers will be penalty fees. weden will also commit to revise the system for notifying the entral databases concerning animals going to a rendering plant, ncluding assigning the rendering plants holding numbers and bliging them to report received animals to the databases, making ross-checks possible. The Swedish Board of Agriculture plans or these measures to be implemented mid-year 2015.

Member state response

he SBA is leading an ongoing project, in cooperation with the e National Veterinary Institute, on further developing of the Swedish contingency planning of epizootic diseases, 2013-2015, draft report of the audit 5.2.1 last paragraph) where, among many other things, different scenarios for FMD in Sweden will be nalysed and planned for. Further and more detailed information ccording to Art 18 will be put into the CPs during the work of his project.

Member state response

rom 2015 a form will be available to support correct reports on depopulation operations from the responsible veterinarian to the Page: 2 ref. DG(SANCO)/2013-6780 -MR of a/an audit carried out from 15 ngency plans in relation to animal health, including provisions on the Swedish Board of Agriculture. This will ensure reporting to the EC commission according to article 18(4).

Member state response

Legislation on epizootic diseases as well as the CPs for epizootic diseases already contain a lot of information on parameters to be taken into account when identifying burial sites. The primary option is burial on the premises on which the carcases originate, or as close as possible to this site. CPs will be updated to ensure that all measures to be taken into account when choosing a location for burial of carcases are stated, and to ensure updated contact information to all authorities that may be involved. The crisis management at the SBA is responsible for cooperating with other authorities during an outbreak and to find the best possible solution for any issue that may arise considering human and animal health, environmental issues, communication, economy etc. CABs are responsible of having contact information to regional contractors to assist such operations. The policy of "lex specialis" in Sweden will ensure that the best location from an animal health and human health perspective will override concerns on other environmental issues if necessary. Page: 3

Member state response

The Swedish Customs endeavors to continuously improve the processes and the systems. In this ongoing work, we take into account the handling y of restricted goods, including how to identify consignments for veterinary checks and if it is possible within the framework of our activities and resources we adapt and amend the functionality. Within the framework of the implementation of the Union Customs Code there is an ongoing review and development of the future customs procedures, on EU-level. The Swedish Customs plans to develop a new computer system for import / export, a project that will probably last for several years. As the incidents, with consignments which have been released for free circulation without veterinary checks, are related to the functionality of the present Customs computer system, the Swedish Customs will take into account, if possible, the needs of the handling of restricted goods in the developing work in this area. In addition, the incidents are related to operators for which Customs has issued authorizations for simplified declarations. In the area of the follow up work of granted authorizations the Swedish Customs takes into account such incidents. Page: 1

The Swedish Customs endeavors to continuously improve the processes and the systems. In this ongoing work, we take into account the handling y of restricted goods, including how to identify consignments for veterinary checks and if it is possible within the framework of our activities and resources we adapt and amend the functionality. Within the framework of the implementation of the Union Customs Code there is an ongoing review and development of the future customs procedures, on EU-level. The Swedish Customs plans to develop a new computer system for import / export, a project that will probably last for several years. As the incidents, with consignments which have been released for free circulation without veterinary checks, are related to the functionality of the present Customs computer system, the Swedish Customs will take into account, if possible, the needs of the handling of restricted goods in the developing work in this area. In addition, the incidents are related to operators for which Customs has issued authorizations for simplified declarations. In the area of the follow up work of granted authorizations the Swedish Customs takes into account such incidents. Updated

Member state response

present information about accreditated laboratories rtified analysis of contaminants at the NFA website. This nted during 2014

at The NFA will present information about ted in accreditated laboratories performing certified analysis of contaminants at the NFA website. This will be implemented during 2014 Additional Action cle The action proposed is changed. The guidance documents "Offentlig kontroll av livsmedelsanläggningar" and "Upphandling av analystjänster för offentlig kontroll av livsmedel och för föreskriven regelbunden kontroll av dricksvatten" clarifies requirements on laboratories used for official control, including requirements on accreditation, designated laboratories, analysis, methods, parameters to be specified (food, substance, etc). Laboratories hired through procurement are considered as designated laboratories. During 2013 The NFA will revise the guidance documents and publics a control handbook for sampling. The handbook will include requirements on designated laboratories used for analysis of contaminants. Information about accredited laboratories in Sweden and scope of Page: 1 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food Action Proposed by the Competent Authority the

Member state response

stablished instructions for the inspectors appointed to take the various monitoring programmes. These sampling will be revised and published on the website for inspectors at and local level to use. The instructions contain n adequate sampling equipment. This will be implemented he NFA have a special mission to develop skills in the control. The aim is to create an efficient and risk-based ed vision of the audit. Competence raising efforts are ncluding in terms of systematics and methodology in dling of deviations and penalties, risk assessment and monitoring and control in the area of probity. This ling as a part of methodology. - winter 2011-2012, a number of two-day conference ed at inspectors, managers and politicians. The aim is to on picture of the audit, as a platform for further work. The Page: 1 DG(SANCO)/2012-6280-MR of an audit carried out the Competent Authority d up during 2012-2014 with an additional three tors to focus on methodology, including interviewing to develop the vocational technical skills ls - essential to the effective, efficient and risk-based 2014: pplication of risk assessment, control methods and rol process for hygiene, labeling and traceability (2012

The NFA has established instructions for the inspectors appointed to take samples within the various monitoring programmes. These ampling instructions will be revised and published on the website for inspectors at central, regional and local level to use. The instructions contain information on adequate and sampling equipment. This will be implemented during 2013 ion During 2011-2014, the NFA have a special mission to develop skills in the official food control. The aim is to create an efficient and risk-based control with a shared vision of the audit. Competence raising efforts are being ate made including in terms of systematics and le methodology in monitoring and handling of Page: 2 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food Action Proposed by the Competent Authority deviations and penalties, risk assessment and s management in monitoring and control in the by area of probity. This includes sampling as a part of methodology. In the autumn - winter 2011-2012, a number of two-day conference organized aimed at inspectors, managers and politicians. The aim is to

Member state response

ure preparatory work with riskbased monitoring DG(SANCO)/2012-6280-MR of an audit carried out ion Proposed by the Competent Authority contaminants, documenting the factors that have affected the focus of the program. This task will be done in collaboration al departments at the NFA, even other authorities may also be This will be implemented during 2013

NFA will in the future preparatory work with risk based monitoring program of contaminants, documenting the factors that have affected the 4. scope and focus of the program. This task will be done in collaboration with several departments at the NFA, even other authorities may also be consulted. This will be implemented during 2013

Member state response

on about this issue has been presented at a conference for erinarians in May 2012. (See attachement 4-1) c was included in one-day training of CAB's inspectors ut food control in primary production and cross . The training was held in May 2012 (See attachment NFA coordinated control projects have started.or are r. These projects includes assessment of procedures in article 10.2.d and, when motivated from the , sampling for contaminants a project for control of fruits and berries in the primary is running. Such projects are thought of as a kick-off for authorities to exchange information, be taught about a special area, and serve as an blueprint for future control a. nated projects that includes all control methods and Page: 3 DG(SANCO)/2012-6280-MR of an audit carried out Action Proposed by the Competent Authority hall eventually cover most important food areas but rt the areas which is considered to include high ks will be prioritized. This will be implemented during

ood · Information about this issue has been ng presented at a conference for county n veterinarians in May 2012. (See attachment 4- 1) s · The topic was included in one-day training of e CAB's inspectors carrying out food control in primary production and cross compliance. The training was held in May 2012 (See attachment 4-2). · Several NFA coordinated control projects have started or are planned for. These projects Page: 6 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food ion Proposed by the Competent Authority ludes assessment of procedures mentioned in icle 10.2.d and, when motivated from the essment, sampling for contaminants rently a project for control of fruits and ries in the primary production is running. h projects are thought of as a kick-off for local authorities to exchange information, taught about control in a special area, and ve as an blueprint for future control in the a. coordinated projects that include all trol methods and techniques shall eventually er most important food areas but from the rt the areas which are considered to include h hygienic

Member state response

ng instruction that is used by the NFA for its rograms will be made available by publishing them ebsite. This information is detailed and can be actical control information at different levels of the inated NFA projects will be published at the website cial forum available only for control personal. A on forum were control personal can ask specific s regarding details about e.g.. sampling will be hed. al NFA guidance document "Livsmedelsprovtagning i g kontroll och mikrobiologisk bedömning av lsprov -vägledning" about sampling will be updated ude a broader scope of sampling. l be implemented during 2013

g · All sampling instruction that is used by the NFA for its monitoring programs will be made e available by publishing them at the NFA he website. This information is detailed and can be ood served as practical control information at different levels of the food chain. · Each coordinated NFA projects will be published at the website in a special forum available only for control personal. A discussion forum where control personal can ask specific questions regarding details about e.g. sampling will be established. · A horizontal NFA guidance document "Livsmedelsprovtagning i offentlig kontroll och mikrobiologisk bedömning av livsmedelsprov - vägledning" about sampling will be updated and include a broader scope of sampling. Page: 8 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food ion Proposed by the Competent Authority s will be implemented during 2013. itional Action guidance document will be revised to a trol handbook containing chemical risk essment, incl. contaminant, principles for pling and evaluation of analysis results cus will be contaminants with stated limi

Member state response

instruction and training of samplers underline the Page: 4 DG(SANCO)/2012-6280-MR of an audit carried out Action Proposed by the Competent Authority forming an accurate sampling according to the current ement between client and provider of analytical services ory should controll and report any deficiencies with the , moreover to avoid too long storage time for nitrate late reporting times for the analytical result will also be agreement. plemented during 2013

NFA will in the instruction and training of nd samplers underline the importance of ity performing an accurate sampling according to the current regulations. By written agreement between client and provider of analytical services the laboratory s to should control and report any deficiencies with onger the incoming sample, moreover to avoid too long storage time for nitrate samples a stipulate reporting times for the analytical result will also be governed by the agreement. This will be implemented during 2013

Member state response

ible purchaser of analyzes for official controls will only use hat are accredited for the required analyzes and this will be d in the written agreement mentioned in recommendation 6. lemented during 2013.

ed The responsible purchaser of analyzes for official controls will only use laboratories that Page: 10 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food Action Proposed by the Competent Authority are accredited for the required analyzes and this will be clearly stated in the written agreement in mentioned in recommendation 6. on This will be implemented during 2013. Additional Action The responsible purchaser of analyzes for official controls will only use laboratories that are accredited for the required analyzes and the method used fulfill the criteria stipulated in relevant sampling regulation or according to Annex III in Regulation (EC) 882/2004. The laboratory must be able to document the above requirements. This will be clearly stated in the written agreement mentioned in recommendation 6. This will be implemented during 2013.

Member state response

s for reporting analytical results will be revised so that all in accordance with the time required by law or under entioned in recommendation 6. uncertainty of analytical methods for mycotoxins will ing to EURL: s guidelines. plemented December 31, 2012.

ly The instructions for reporting analytical results will be revised so that all results are reported in ordance with the time required by law or U under agreement mentioned in recommendation 6. he measurement uncertainty of analytical thods for mycotoxins will be adjusted Page: 11 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food Action Proposed by the Competent Authority according to EURL: s guidelines. This will be implemented December 31, 2012.

Member state response

l NFA instruction for RASFF will be updated to include more Page: 5 DG(SANCO)/2012-6280-MR of an audit carried out osed by the Competent Authority ollow up procedures, se also rec nr 10 e implemented during 2012

w up The internal NFA instruction for RASFF will be updated to include more stringent follow up procedures, see also rec nr 10 This will be implemented during 2012

Member state response

s will be developed to clarify how the overruns will be up measures of non-compliance results are a key will be included in the instruction. e implemented December 31, 2012. Page: 6

ants Instructions will be developed to clarify how - the overruns will be handled. Follow-up measures of non-compliance results are a key element that will be included in the instruction. This will be implemented December 31, 2012. e he area Additional Action h the NFA have several internal systems for verification. The national control programs for contaminants as well as non-complaints and follow-up actions are followed-up on a regular basis by the coordinator for the monitoring programs. Indicators are followed up in the NFA management system (IT-system) LINUS on a regularly basis and deviations from the sampling plan are reported and followed-up. Page: 12 by the Competent Authorities of Sweden on 11 September in response to Report ref. ut from 20 to 28 March 2012 in order to evaluate controls for contaminants in food ion Proposed by the Competent Authority m 1st January 2013 all samples taken within monitoring program will be documented in ew database (LinCon) which enables easy low-up and reporting of results. also Rec no. 5. Page: 13

Member state response

is planned that the work will start in 2013 and will be finished within years for all production areas. The NFA has informed the Swedish ent that additional resources are needed in order to progress rther sanitary surveys in the rest of the production areas.

Member state response

moment there are two parallel systems for monitoring. For three eas sanitary survey has been done and sampling is performed ng to EC recommendations. In the other areas it´s not until a y survey has been performed that they will fully comply with the ommendations. See the answer to recommendation nr 1 for a time

Member state response

´s procedures classification of a production area will be iewed and put into force in February 2013.

Member state response

monitoring program for toxic plankton the official sampling points lankton will be connected to additional classification areas. In ases when algae samples show presence of toxin producing ton and at elevated levels the frequencies of sampling for analysis ns in mussel meat shall be increased. The modified procedures in force no later than 31 of march 2013.

Member state response

uation of data from the monitoring program for presence of toxins different species of bivalves in relation to the toxin levels in blue Page: 1 ort ref. DG(SANCO)/2012-6545-MR of an audit carried out governing the production and placing on the market of bivalve Action Proposed by the Competent Authority ussels since this species is used as an indicator species in the program. hen toxins in the blue mussel exceed the regulatory limits the NFA hall increase the sampling of other species such as oysters, if the roduction area is still open for other species then blue mussels. egarding the monitoring of AST, the NFA shall start a study in order to ry to include AST in the same multi-method that is used to analyze ipophilic shellfish toxins. In that way AST will be analyzed at least very week in a monitored area. AST is planned to be included in the ulti-method and put in in force in the control system with start January 014.

Member state response

n official sampling plan shall be developed for each establishment. plans will be put in force in 2013.

Member state response

ng official inspection and revision of the purification centers the A personal shall on a regular basis audit the establishment routines data that show that they comply with the legislation. Should be tarted in 2013. Page: 2 ort ref. DG(SANCO)/2012-6545-MR of an audit carried out governing the production and placing on the market of bivalve Action Proposed by the Competent Authority

Member state response

connection with the NFA inspections of the establishments for ext year a review of their HACCP ­plans shall be done for all erent processes.

Member state response

nection with the NFA inspections of the establishments for s next year a review shall be done in connection with e of their premises. Page: 3

Member state response

uard decision, as drafted, is that allows customs authorities blocks on CN-codes indicated in annex 1 of the draft. Thus, consignments will not be released by customs until the import controls are finished and results of analyses turned out to be favorable. Furthermore, NFA decided to transfer all controls (documentation, ID, physical / sampling) to designated points of entry (DPE's) instead of using municipalities. Thereby official import control of rice products from China will follow the same control procedure as import controls of products of non-animal origin under other safeguard measures. DPE-personnel were instructed on controls under the new safeguard decision at BIP / DPE training days held in November 2011. Page: 1 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority

Member state response

oes acknowledge that the inspector ve information on all the safety sent holder shall apply, and other conditions that apply to practical ng cultivation and handling of the GMOs. However, the conditions concerning administrative requirements, for example the annual report, are not relevant for the inspector because these requirements are controlled by the Regulatory unit. In time for the coming growth season (spring/summer 2012) the checklists for the inspector will be updated to reflect all relevant safety measures and conditions. Thereby, the inspector will be able to verify further conditions, when applicable, depending on the timing of the inspection. One of the conditions in all consents for field trials is that the consent holder shall apply all safety measures stated in the application. The safety measures cover handling during transport, sowing, cultivation, harvest and storage. If all these safety measures were to be Page: 2 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority controlled for each trial, the frequency of the inspections wou

Member state response

roducts from China, Sweden sampling protocols that are laid down in the Commission Decision The designated points of entry will carry out the samplings. When carrying out GMO-controls for approved GMOs, the inspectors should control the documentation of traceability, results from analyses from the companies or their suppliers according to the NFA checklist. NFA regards that this controls together with the official samplings are appropriate and insure the compliance with article 9.1 in Regulation (EG) 1830/2003. Page: 3 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority However, NFA will in 2012 investigate the possibility of including the sampling recommendations for food, according to SIS- CEN/TS 15568:2007, in the sampling instruction.

Member state response

dure used at present, a follow-up is Swedish Board of Agriculture, if elow 0.9 % is detected in the the feed samples from the official n that follow-up, the outcome of the y the feed inspector at that particular feed plant is taken into account that relates to precautions of the company to avoid GM- material. The Swedish Board of Agriculture plans to go through the questions in the checklist and the guidance in order to make clarifications in time for the control year 2012. That is, to clarify the existing parts that concerns adventitious or technically unavoidable presence of GMO in feed in relation to the labeling requirements. Page: 4 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority The subject will also be covered in the planned training meeting for the feed inspectors which is planned to take place on the 17-18 January 2012. NFA guidelines describe the controls regarding presence of adventitious or technically unavoidable GMO. However, NFA plan to review the guidelines and the checklist for GMO-controls in 2012 to assess whether the docume

Member state response

trol 2011, the Swedish Board of Agriculture has taken out samples of feed materials of soya, maize and rapeseed for a qualitative analysis of GMO. The GMO:s on the list which was established by the Commission in relation to Regulation (EU) No 619/2011 were already checked for by the Board in that analysis. There were two Page: 5 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority exceptions though, 281-24-236/3006-210-23 cotton was not checked for as cotton is not used as a feed material in Sweden. In addition, MON87701 soya was not included in the analysis in 2011 as the method was not validated then. MON87701 will be covered in 2012. The Swedish Board of Agriculture does not foresee any necessary changes in the analytical methods used at present in order to implement Regulation (EU) No 619/2011. Concerning the sampling methods, those will be adopted and the regulation will be fully implemented from the control year 2012. The list of GMOs which are covered by the Regulation will be taken into account.

Member state response

The SBA has initiated a review of the cerning GM control in seeds. delines will be updated and further be developed that specify the practical performances of seed control. The seed control will continue to be risk based while Page: 6 Authorities of Sweden on 11 January in response to Report ref. August 2011 in order to assess the official controls of genetically modified nment Action Proposed by the Competent Authority the criteria for such risk assessment will be updated and clarified. The guidance document will cover inspection according to Regulation (EC) 1830/2003. Similar guidelines will be developed for detection of unauthorised GMOs. This task will be finalised by May 1st 2012. Page: 7