Lithuania

The recommendation states as its basis

In recent years, the number of non-registered producers decreased, however it is still significant, covering some 40% of the total ware potato production area. The number of samples taken from these producers only slightly increased after the audit in 2018. Table 2 below contains the number of samples and the positive results from 2023 in case of registered and non-registered ware potato producers. Only ten percent of the samples were taken from non-registered operators, but 15 percent of these samples were infected by C. sepedonicus, proportionally higher than in the case of registered 6 producers. This difference is similar in most of the years since 2016. Despite the high number of positive samples, the CA decreased the number of samples taken and in the period since 2014, the lowest number of samples were taken from 2022-2024 (see table 3). The design of the annual phytosanitary inspection plan and the number of samples taken did not take into account appropriately the risk that C. sepedonicus occurs in the area covered by each survey contrary to Article 22(2) of Regulation (EU) 2016/2031. The number and origin of the samples were not based on the particular potato production system of Lithuania, contrary to Article 3(2) of Regulation (EU) 2022/1194. Table 2. Samples taken in 2023 from registered and non-registered producers of potatoes other than seed potatoes Crop area in ha Registered producers Non-registered producers production number number of production number number of area (ha) of sam- positive area (ha) of sam- positive ples samples ples samples <1 217.70 115 7 3 733.90 10 4 1-4.99 939.40 137 6 61.25 42 4 5-19.99 1 057.65 90 3 0 1* 0 20-50 1 047.00 42 0 0 - - >50 2 785.51 87 0 0 - - Total 6 047.26 471 16 3 795.15 53 8 Proportion of posi- 3.4 15.1 tive samples (%) * Exact production area was not available

The CAs carry out appropriate surveys on fields of and potato lots produced by registered operators. However, the risk from areas which are not under official supervision is not taken into account appropriately during the annual surveys, as places of production cultivated by non-registered producers who typically plant tubers of undetermined plant health status function as a reservoir for C. sepedonicus and contribute to the spread of the pest. The likelihood that the presence of C. sepedonicus in Lithuania is much higher than detected is significant.

The recommendation states as its basis

Where the CAs establish non-compliances, the operator receives an official warning containing the consequences of further non-compliances or shall pay a penalty of 30- 300. In 2023 and 2024, 23 such warnings were issued for various non-compliances. In the case of repeated infringements, operators shall pay a penalty of 50-550. Only 50% of the penalty shall be paid if it is paid within 14 days. In the last two years, penalties of 15, 25, 50 and 300 were imposed in six cases. However, such penalties are not effective, proportionate and dissuasive when producers knowingly break official eradication measures of an outbreak, such as by planting potatoes in infected or potentially infected fields or by planting uncertified tubers in other sites of a DA (see also finding 30). The applied penalties are not in line with Article 139 of Regulation (EU) 2017/625. The situation did not change since 2018 when the CA had already been recommended to implement dissuasive sanctions in case of infringements with regard to the application of phytosanitary measures. An amendment of the Phytosanitary Act was in public consultation in the beginning of 2025 and this was intended to increase sanctions. 5.1.4 Laboratories

The penalties applied are not effective and dissuasive to prevent the infringement of official measures which decreases the chance of successful eradication of outbreaks.

When inspectors detect non-compliances regarding the official measures, the duration of those measures is extended by one year. At the first time of non-compliance, operators receive an official warning indicating the fines envisaged in case of further occurrences of such infringement. A producer visited who had planted uncertified tubers despite the official order first received an official warning. The following year, the producer had to pay 25 penalty for the same infringement. The measure and penalty applied were not effective, proportionate and dissuasive to prevent further occurrence of such infringements (see also finding 7). The same situation had already been noted during the audit carried out in 2018. Conclusions on controls on eradication measures

The recommendation states as its basis

The majority of outbreaks were detected in fields where producers planted tubers of undetermined plant health status, such as farm saved tubers and ware potatoes which are not tested for the presence of C. sepedonicus. The nature and number of positive findings justifies that for phytosanitary protection it is appropriate to adopt more stringent measures than those required by Regulation (EU) 2022/1194, as provided by Article 31(1) of Regulation (EU) 2016/2031. Based on Annex II Section I (1)(b) of that Regulation, such measure can be a restriction on the cultivation of potatoes grown from tubers of uncertain plant health status. 7 Table 3. Samples taken from 2014 to 2024 from registered and non-registered producers of potatoes including seed potatoes year Registered producers including Non-registered producers 2014 seed potatoes 2015 2016 Number of Number of Proportion Number of Number of Proportion of 2017 samples 2018 samples positive of positive positive positive 2019 2020 samples samples (%) samples samples (%) 2021 2022 987 28 2.8 13 0 0 2023 876 2024 1257 15 1.7 11 0 0 843 890 34 2.7 33 3 9.1 1111 1204 16 1.9 123 13 10.6 1084 707 15 1.7 108 16 14.8 579 651 10 0.9 115 8 7 21 1.7 120 12 10 26 2.4 110 14 12.7 17 2.4 136 22 16.2 16 2.8 53 8 15.1 10 1.5 64 5 7.8 Conclusions on the surveys outside the demarcated areas

The CAs carry out appropriate surveys on fields of and potato lots produced by registered operators. However, the risk from areas which are not under official supervision is not taken into account appropriately during the annual surveys, as places of production cultivated by non-registered producers who typically plant tubers of undetermined plant health status function as a reservoir for C. sepedonicus and contribute to the spread of the pest. The likelihood that the presence of C. sepedonicus in Lithuania is much higher than detected is significant.

The recommendation states as its basis

Verification of an establishment's tests to evaluate measures designed to minimise cross-contamination, as required by point 2(b) of the "Facilities and Equipment" section and point 3 of the "Production" section of Annex II to Regulation (EC) No 183/2005, is an integral component of inspections, when applicable. In all three establishments visited, the operator's test procedures and related test reports were available. In one establishment, the incremental samples collected were pooled and incorrectly sent as one sample to the laboratory for analysis. In another establishment, 15 incremental samples were collected to check the potential cross-contamination, but all these samples were collected from the first mix after cleaning, whilst the production batch contained 10-15 mixes. In another establishment, the results of the cross-contamination tests were higher than the target described in the operational procedure. In two establishments, no evidence was available that the physical attribution of the tracers used during the tests is similar to the coccidiostats used during production. These shortcomings were overlooked during previous official inspections, putting into question the effectiveness of checks carried out on this aspect. The feed inspectors met by the audit team experienced difficulties in comprehensively assessing the procedures and the results of the cross-contamination tests.

The system of planning of inspections is based on appropriate risk-related factors and ensures that the official inspections are carried out regularly, on a risk-basis and with appropriate frequency. While feed inspectors regularly use checklists and guidance documents and official inspections are documented, the effectiveness of these inspections is weakened by shortcomings in the inspectors' assessment of FeBOs tests on cross-contamination. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

The recommendation states as its basis

The audit team observed official sampling in two compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In both cases, the distribution of the potential contamination was heterogeneous in the matrix and inspectors sampled a part of the batch (sampled portion). The audit team identified several shortcomings during the official sampling: · the inaccurate calculation of the number of the incremental samples; · the inappropriate mixing of the aggregate, reduced and final samples; · the inappropriate reduction of aggregate sample to reduced sample and reduced sample to final samples (using dividers); · limited knowledge on the concept and calculation of sampled portion. These are not in line with the legal requirements of Annex I to Regulation (EC) 152/2009.

SFVS officials and local feed inspectors stated that they do not have dividers that could be used during official sampling when the contamination is heterogeneously distributed in the sampled feed. This is not in line with the requirements of point 9.4 of Annex I to Regulation (EC) 152/2009. 5.2.2.3 Testing of official feed samples

Many aspects of the planning and implementation of sampling and testing of official feed samples are positive. A risk-based approach has been adopted for the planning of official sampling, and the interpretation of the analytical results is correct. However, the inappropriate official sampling could adversely affect the legal and technical validity of official feed samples, and the reliability of decisions made on the basis of the corresponding results. 5.2.3 Actions taken on non-compliances

The recommendation states as its basis

The audit team noted in all the establishments visited that they were approved for all the activities carried out. However, one of the establishments visited by the audit team was approved to produce meat products and meat preparations, despite the fact that the production of meat preparations had not been carried out for several years (no facilities, equipment and HACCP plan were available). The CA had not withdrawn the approval for this activity. Conclusions on approval of establishments

Specific procedures for the approval of food business establishments are in place, enabling the competent authorities to maintain oversight and to take appropriate actions when the conditions are no longer met. However, the shortcomings noted during the audit show that they are not always properly implemented, compromising the guarantees that approved establishments comply with the relevant requirements of EU food law.

Concerning the situation described above, the audit team noted that the problem arose from the fact that the premises were not adequate for the volume of production of the establishment (according to the FBO the current throughput of RTE products was 423 tons per month). To confirm if this was the case, the audit team requested from the CA the production capacity that was declared by the FBO at the time of approval of the establishment, as this aspect should also be checked during the controls (see paragraphs 25 and 29). The SFVS was unable to provide this information and acknowledged that these data are not easily available from the database to the CA staff and may therefore cause difficulties to the staff to perform their verification during inspections/audits.

The recommendation states as its basis

Evidence was provided to the audit team of staff participation in training sessions that are particularly relevant for carrying out official controls on production of meat preparations and meat products in all the regions visited. However, in certain areas - mainly in relation to Hazard Analysis and Critical Control Point (HACCP) requirements and some of the requirements of Regulation (EC) No 2073/2005, which have an impact on the effectiveness of official controls over the production of ready-to-eat (RTE) food - the audit team found gaps in CA inspection staff knowledge (see also paragraphs 50 and 52).

Although a training system is in place, covering topics pertinent to the sector audited, the observed gaps in the CA's knowledge of HACCP requirements and to the applicable microbiological criteria for Listeria monocytogenes in RTE meat products raise doubts about its effectiveness, thus jeopardizing the quality of the official controls.

The audit team noted that the non-compliances detected by the CA auditors were mainly related to the pre-requisite programmes of the establishments (e.g. to maintenance and hygiene issues). This was confirmed by the data provided by the SFVS on the summary of the non-compliances detected in establishments during the HACCP audits in 2024. However, significant non-compliances, not detected during HACCP audits, were observed in the establishments visited: · Concerning the physico-chemical characterisation of a RTE product, which is fundamental to deciding whether it supports or does not support the growth of Listeria monocytogenes. In some establishments, there were no specifications for physico-chemical characteristics of the products and in others, the "product characterisation" was not correct as the FBOs did not consider the inherent variability linked to the product: e.g. intra- and inter-batch variability when testing for pH or water activity (aw). In this regard, it was noted that the guidance document issued by the European Union Reference Laboratory on Listeria monocytogenes (EURL Lm), providing guidance (see: EURL Lm technical guidance document on challenge tests and durability studies for assessing shelf- life of RTE foods related to Listeria monocytogenes) to FBOs and the CAs on how to carry out shelf-life studies, was not known, or in any event, was not taken into account by the CA auditors when assessing FBOs' compliance with the requirements of Regulation (EC) No 2073/2005. · In some establishments, the FBOs used the weight loss of the product during the drying process to demonstrate that the required aw is reached. However, there was no proper validation study to establish correlation between the two values (weight loss and the aw). When available, the validation was based only on one sample or on one product and the result was used for the entire product group (i.e. intra- and inter-batch variability was not taken into account). · In one establishment the FBO could not provide the validation of the cooking step to prove that all the products reached the critical limit temperature.

Listeria monocytogenes sampling and testing included both final products and environmental samples. However, in several establishments visited producing RTE meat products able to support the growth of Listeria monocytogenes, it was noted the following: · Samples from the processing area and equipment were taken mostly after cleaning and disinfection. The EURL Guidelines on sampling the food processing area and equipment for the detection of Listeria monocytogenes recommends that the sampling should be carried out during processing (in order to increase the probability of detecting a persistent strain). Sampling only after cleaning and disinfection makes the detection of the pathogen difficult and can lead to a false sense of security. These aspects were not noted during official controls. Nevertheless, in one of the meat products establishments visited, where the above- mentioned samples were taken also during processing, the audit team noted that the FBO recently, and after the identification of Listeria monocytogenes in the marketplace, participated in a relevant training session provided by a third-party company. · The FBOs tested their products in accordance with the food safety criterion of point 1.2, Chapter 1, Annex I to Regulation (EC) No 2073/2005 using both limits: enumeration with the limit of 100 cfu/g, although no shelf-life studies had been carried out, and for absence/presence in 25g. Footnotes 5 and 7 of Chapter I of Annex I to Regulation (EC) No 2073/2005 does not provide for the simultaneous application of both limits. Nonetheless, in the FBOs' interpretation both criteria should apply (100 cfu/g when the product is placed on the market and absence in 25g before the food leaves the immediate control of the FBO). The SFVS confirmed to the audit team that this interpretation is generally used in Lithuania. The audit team noted that FBOs used the limit of 100 cfu/g during and at the end of the indicated shelf life for RTE meat products able to support the growth of Listeria monocytogenes kept under the control of the FBO in the absence of shelf- life studies proving to the satisfaction of the CA that the product will not exceed the above limit.

In addition, the audit team saw examples, when reviewing the CA's follow up actions 11 after RASFF notifications (i.e. when Listeria monocytogenes was detected in RTE meat products), that when another batch of the product concerned was tested for Listeria monocytogenes to prove the safety of the product, the FBO used enumeration with the 100 cfu/g criterion without the FBO's adequate demonstration (i.e. without a shelf-life study) to the satisfaction of the CA that the product will not exceed the limit 100 cfu/g throughout its shelf-life. This is not in line with point 1.2, (in particular the provisions laid down in footnote 5) of Chapter 1, Annex I to Regulation (EC) No 2073/2005.

The FBOs visited by the audit team did not perform any shelf-life studies for Listeria monocytogenes. The CA highlighted that they only were aware that FBOs in Lithuania in the fish sector carried out shelf-life studies. When discussing the above reported issues with the CA staff and FBOs, the audit team found gaps in their knowledge regarding the requirements of Regulation (EC) No 2073/2005, in particular related to the studies (including the shelf-life studies) referred to in Annex II to the mentioned Regulation. The SFVS explained that in the SFVS strategic plan 2025-2027, it is foreseen to strengthen communication with FBOs and conduct training/seminars on important topics.

Concerning the frequency of own-check sampling of RTE meat products, the audit team noted large discrepancies: in a large capacity meat products establishment producing over 30 tonnes of meat products on a daily basis, including RTE meat products, the frequency of own-check testing for Listeria monocytogenes is one product from a product group on a quarterly basis while, in a smaller capacity establishment, this frequency was once a month. These frequencies had been accepted, or were not noted, by the CA without assessing how the FBOs made the sampling frequency decision in the context of their procedures based on HACCP principles and good hygiene practice, taking into account the instructions for use of the foodstuff. In this regard, the SFVS informed the audit team that there is no specific guidance available on how to assess the FBOs' own-check sampling plans.

It was also noted that the sampling frequency, for both product and environmental sampling, was not changed (i.e. was not increased by the FBO or the increase was not requested by the CA when the risk changed) even after a RASFF notification related to the detection of Listeria monocytogenes in 25g of one of the RTE meat products.

The audit team noted that during the last years in the establishments visited the own checks meat product and environmental laboratory tests did not identify any Listeria monocytogenes or Salmonella.

The recommendation states as its basis

In relation to categorisation and handling of ABP, past inspections carried out at the two slaughterhouses visited (one for poultry and one for ungulates) overlooked the following: (a) categorisation of unemptied pig digestive tracts and material collected from unclean sections (floor) of slaughterhouses as Category 3 material, contrary to the requirements of Article 9 of Regulation (EC) No 1069/2009, (b) disposal of large amount of pig blood through the waste water treatment, contrary to the requirements of Article 14 of Regulation (EC) No 1069/2009 and, (c) absence of traps with mesh size of no more than 6 mm in areas where specified risk material (SRM) is removed and more generally for the pre-treatment of wastewater from the slaughtering process contrary to the requirement of point 1 of Section 2 of Annex IV to Regulation (EU) No 142/2011.

Whilst official controls on food business operators include verification of compliance with ABP requirements, they are not effective in verifying said operators' compliance with the requirements concerning the correct categorisation and disposal of ABP.

Member state response

that food business 1. To conduct training for veterinary inspectors of territorial units of VMVT responsible for control of animal food 1069/2009, entities and official veterinarians of animal slaughterhouses. No 142/2011 In the training, present the deficiencies in the management of the ABPs identified during the audit, the conclusions and recommendations presented, and present the measures planned by the SFVS to implement the audit recommendations. Deadline: 30/11/2023. 2. The SFVS will provide an information notice to the operators of animal slaughterhouses regarding the violations of the management of ABPs identified during the audit, in order to review and, if necessary, supplement the ABPs management procedures, especially regarding the correct classification into categories, handling of blood and waste water, conducting briefings for responsible employees and preparing visual instructions. Deadline: 31/12/2023. 3. To supplement the SFVS Quality System work instructions PZ-1-6-D1 "Verification of official food, veterinary control and permanent official veterinary supervision", the verification questionnaire of official veterinarian performing permanent state veterinary superv

The recommendation states as its basis

Controls on removal and disposal of SRM are in place. However, contrary to the operator's procedures, in one of the slaughterhouses visited, SRM were not stained with a dye or otherwise marked following their removal. SFVS representatives informed the audit team that the current guidelines for slaughterhouses and instructions for carrying out inspections at slaughterhouses do not require staining or marking of SRM. According to these instructions, placing of SRM in containers labelled as Category 1 material is considered sufficient. The absence of staining of SRM with a dye or, as appropriate, marking (with another marker) is not in line with the requirements of point 3 of Annex V to Regulation (EC) No 999/2001. 5.2.3.2 Official controls in ABP plants

Contrary to EU requirements, SRM is not stained or otherwise marked after its removal, thus limiting the ability of the competent authority (and the operator) to identify possible unintentional or deliberate cases of contamination of food or other categories of ABP by SRM.

Member state response

th a dye or 1. To conduct training for veterinary inspectors of territorial T responsible for control of animal food o 999/2001 entities and official veterinarians of animal slaughterhouses. ing, present the deficiencies in the management identified during the audit, the conclusions and ons presented, and present the measures he SFVS to implement the audit ons. /11/2023. will provide an information notice to the animal slaughterhouses regarding the violations ement of SRM found during the audit, in order d, if necessary, supplement the SRM rocedures, especially regarding the correct marking by dye or otherwise of SRM, riefings for the responsible employees. Page: 2 e recommendations of report ref. DG(SANTE) 2023-7710 of the audit carried out from 22 May 2023 of official controls on animal by-products (ABP) and derived products (DP) Action Proposed by the competent authority Deadline: 31/12/2023. 3. To supplement the SFVS Quality System work instructions PZ-1-6-D1 "Verification of official food, veterinary control and permanent official veterinary supervision", obliging official veterinarians in slaughterhouses to assess whether SRMs are properly removed and immediately stained by d

The recommendation states as its basis

In the ABP plants visited, official controls overlooked shortcomings in the implementation of HACCP-based procedures. These procedures were in place but often incorrectly implemented and thus not in compliance with the requirements of Article 29(2) of Regulation (EC) No 1069/2009. Deficiencies noted by the audit team concerned: (a) process flow diagrams not reflecting all processing steps (petfood plant), (b) incorrect definition of critical control points (biogas plants and processing plant for Category 2 material) and, (c) absence or inadequate monitoring arrangements for critical control points (petfood plant, biogas plant and processing plant for Category 2 material).

Official controls at ABP plants where EU rules require that HACCP-based procedures are implemented are not adequate to verify the operators' level of compliance with all of the key requirements of these procedures.

Member state response

tation of 1. The CA will prepare training for official veterinarians h responsible for HACCP control. Deadline: 30/11/2023 training for official veterinarians. 9/2009 Deadline: 30/06/2024 training for ABP working group official veterinarians. 2. The CA will organise cross-checks to assess HACCP- based procedures whether the operators are implementing the implementation of the legislation governing the handling of animal by-products and/or derived products. Deadline: 30/06/2024. Page: 3 e recommendations of report ref. DG(SANTE) 2023-7710 of the audit carried out from 22 May 2023 of official controls on animal by-products (ABP) and derived products (DP) Action Proposed by the competent authority

Member state response

implementation 1. The CA will prepare training for official veterinarians g compliance responsible for official controls at processing plants. nd pressure Deadline: 30/11/2023 training for official veterinarians. Deadline: 30/06/2024 training for ABP working group IV to official veterinarians. d point 3 of U) No 2. The CA will organise cross-checks at processing plants to XVI to assess whether the operators are implementing the implementation of the legislation governing the handling of animal by-products and/or derived products. Deadline: 30/06/2024. Page: 4

The recommendation states as its basis

Due to reduced fishing catch quotas for the Baltic Sea the Lithuanian fishing fleet is reduced from 22 in 2018 to 5 vessels in 2023. The vessels land their fish in neighbouring countries. This is a challenge for the CA to conduct the inspections within the stipulated frequency of once in three years. Due to Covid restriction no inspections were carried out since 2020. Aquaculture farms

Nonetheless, such effectiveness and the reliability of official controls is undermined by: a. the cessation of controls on Baltic Sea fishing vessels; b. lack of controls regarding some aspects of public health at aquaculture farms; c. the absence of temperature-recording devices in cold stores; d. ineffective own-controls on Listeria monocytogenes. 5.3.5 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Commission Regulation (EC) No 2023/915. Commission Regulation (EC) No 1881/2006. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

lanned inspections of Baltic Sea primary production fishing vessels will be carried out by the end of the 2nd quarter of 2024.

The recommendation states as its basis

The checklist for stand-alone aquaculture farms does not list the requirements for food safety, e.g. on training of staff for food safety. The CCA stated in the final meeting that they will add these public health items to the checklist. 34.1.1.1 Landing operation, landing sites and first sales

Nonetheless, such effectiveness and the reliability of official controls is undermined by: a. the cessation of controls on Baltic Sea fishing vessels; b. lack of controls regarding some aspects of public health at aquaculture farms; c. the absence of temperature-recording devices in cold stores; d. ineffective own-controls on Listeria monocytogenes. 5.3.5 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Commission Regulation (EC) No 2023/915. Commission Regulation (EC) No 1881/2006. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

Checklist on aquaculture farms under quality control programme T-2-4-9 amended to include food business operator obligations, and in particular the hygiene provisions laid down in Annex I, Part A(II) of Regulation (EC) No 852/2004.

The recommendation states as its basis

The audit team detected more serious findings in one of the establishments visited. In this establishment, one cold store had temperatures above minus 18°C. The fishery products stored were checked for temperature and showed temperatures around minus 14°C. The CA intervened immediately requiring the operators to remedy the non-compliance detected.

The audit team noted in several establishments that the temperature recording during storage of frozen fishery products were done manually. The cold stores were not equipped with temperature-recording devices as required in point C(2), part I, Chapter I, Section VIII of Annex III to Regulation (EC) No 853/2004. The CA stated that the Lithuanian version of the EU legislation was ambiguous, and this obligation was not spotted. The CCA took immediate action and wrote a letter to the territorial units to require automatic temperature registration in cold stores for fishery products.

Nonetheless, such effectiveness and the reliability of official controls is undermined by: a. the cessation of controls on Baltic Sea fishing vessels; b. lack of controls regarding some aspects of public health at aquaculture farms; c. the absence of temperature-recording devices in cold stores; d. ineffective own-controls on Listeria monocytogenes. 5.3.5 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Commission Regulation (EC) No 2023/915. Commission Regulation (EC) No 1881/2006. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

The CA will supplement the SFVS Quality System work I instruction KT-2-2-8-D1 "State veterinary control of fishery product handling establishments" checklists of fishery products clearly indicating with a question that establishments on land must have temperature-recording devices and the temperature sensor of the reader in storage holds. Deadline: 31/12/2023 During the audit the SFVS wrote a letter to the SFVS territorial departments about the need to install automatic temperature registration devices in cold stores for fishery products.

The recommendation states as its basis

The audit team noted in several establishments that the own checks regarding Listeria monocytogenes for ready to eat products were not planned and executed effectively (e.g. wrong tools for swabbing used, no swabs taken during production. The CA's inspection procedures in place are not sufficiently detailed to check such own-controls effectively. Conclusions on official controls of production and placing on the market

Nonetheless, such effectiveness and the reliability of official controls is undermined by: a. the cessation of controls on Baltic Sea fishing vessels; b. lack of controls regarding some aspects of public health at aquaculture farms; c. the absence of temperature-recording devices in cold stores; d. ineffective own-controls on Listeria monocytogenes. 5.3.5 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Commission Regulation (EC) No 2023/915. Commission Regulation (EC) No 1881/2006. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

e The CA will prepare training for inspectors responsible for official controls at processing plants about food business operators own- checks assessment regarding the detection of Listeria monocytogenes, especially bringing attention to sampling areas and sampling equipment for the detection of Listeria monocytogenes. Deadline: 30/06/2024 Page: 1

The recommendation states as its basis

The certification of pigs from establishments not complying with the relevant requirements for movement derogations and located in restricted zones II and III, leads to meat which should be restricted to the national market being marked with an oval stamp and considered suitable for the EU market.

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

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

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

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

The recommendation states as its basis

The absence of planned checks to ensure the suitability of biosecurity measures on hunting grounds prevent the competent authority to properly identify and address potential sources of infection, to adequately assess risk and monitor disease transmission, to check the level of understanding of the hunting community regarding ASF and to control the pathways of ASF transmission.

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 recommendation states as its basis

The absence of effective verification of the implementation of the official controls related to the certification of pigs from establishments in restricted zones II and III prevents the competent authority to demonstrate the quality, consistency and effectiveness of controls and to ensure that movement of pigs occurs as intended and in line with the rules. In this context, the absence of effective verification lead to incorrect certification of compliance with Regulation 2021/605 not being detected.

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 recommendation states as its basis

The SFVS stated that consignments of bovine animals in transit are not partially or fully unloaded for identity and physical checks at the BCP of arrival, but that they conduct a visual check of the animals on the means of transport, using fixed platforms. The audit team noted that this does not allow an appropriate clinical examination of the selected 10 animals to be performed, which is not in line with Article 4(3) and Part II of Annex I to Regulation (EU) 2019/2130.

The system in place ensures that consignments of animals and goods entering the EU are presented for official controls, and that those controls are, generally carried out in line with guidelines, documented procedures and Union legislation. A limited number of shortcomings were identified, the most significant of which related to the performance of physical checks on consignments of animals in transit, which are based on a visual check rather than a clinical examination as required.

Member state response

he State Food and Veterinary Service of the Republic of Lithuania acknowledges the recommendations of the Audit team and is committed to taking immediate action to ensure live animal checks, as stipulated in Article 4(3) of Regulation (EU) 2019/2130. We would like to address the following issues brought to our attention: According to Regulation (EU) 2019/2130, the same control procedures are required for live animals entering EU Member States as well as for transit through the EU territory. However, in our case, we have consignments of live bovine animals in transit from Russia to Russia, and the unloading process takes longer than the transit itself. Typically, road transport from Kaliningrad region crossing Lithuania takes approx. 4 hours, while unloading and reloading the animals onto the trucks take no less than 6 hours. Moreover, there is a high risk of injury to animals during unloading, especially when transporting free-range meat species bovine animals. In 2022 over 600 live bovine animal consignments crossed the Kybartu Road BCP for live bovine animals transit purposes, as permitted by the derogation outlined in Article 34 of the Commission Delegated Regulation (EU) 2019/2

The recommendation states as its basis

The following observations were made on the videos of the inspections at Medininkai BCP: a. During the inspection of the mixed consignment of WPM and sawn wood, the side curtains of the trailer were pulled back to enable the inspector to examine the sides of the consignment. The rear doors were also opened to facilitate another angle of examination. It was noted by the audit team that while it was necessary to fully or partially unload the consignment, no items were removed from the trailer to enable the inspector to conduct a more detailed examination. The inspector said that this was a typical example of how they would carry out these inspections as the inspector had access to all the sides of the consignment, which was deemed sufficient. The CA stated that this was how the inspector met the requirements of ISPM 31. However, this is not in line with Article 4(2) and (6) of Regulation (EU) 2019/2031, where consignments shall be fully or partially unloaded from the means of transport where it is necessary to have access to the whole consignment for the purpose of physical checks. This enables the inspector to examine the appropriate number of units in each lot and therefore meet the requirements of ISPM 31. Work instructions received in a presentation given to the audit team also requires consignments of WPM to be unloaded when conducting an inspection therefore, official controls are not carried out fully in accordance with Article 12(1) of Regulation (EU) 2017/625. b. According to the same video, the audit team noted clear evidence of nematode and wood boring pest damage on the WPM. The CA stated that samples of the "blue stained" WPM were taken for laboratory analysis. The inspector stated that `blue stain' was an indicator of the presence of nematodes. He also stated that they look for exit holes, galleries and dust, which is also an indicator of presence of a pest. c. The WPM was also checked for the ISPM 15 stamp as part of the inspection procedure5. d. The CA stated that Bursaphelenchus mucronatus was detected by the laboratory in this consignment, which was then refused entry and returned to the country of origin. e. The audit team observed that the consignment of Picea abies sawn wood from the Russian Federation was not unloaded and only examined from the back and sides. It was noted that no consideration was made for the ISPM 15 requirements for the dunnage or WPM separating the lengths of wood or was the consignment unloaded to enable the inspector to examine the appropriate number of units to enable them to meet the requirements of ISPM 31. See finding 30(a) for the same non-compliance. 5 In their response to the draft report, the Lithuanian Competent Authority clarified that WPM and dunnage are being checked regularly, including loose dunnage pieces as well. Training material as well as verbal explanation has been provided. For the specific case which was analysed during audit, the dunnage was not unloaded as the WPM was non-compliant therefore regardless of the dunnage all the consignment was returned to the consignee. 13

Documentary and identity checks are carried out in line with EU requirements. However, physical inspections of some consignments of WPM6 and sawn wood are carried out without them being fully or partially unloaded where necessary, which reduces their ability to detect pests.

The recommendation states as its basis

The audit team met with a representative from Customs, who stated that they have been delegated the task for checks on items contained in passenger luggage, private imports through postal and courier services in line with Article 28 of Regulation (EU) 2017/625. They carry out their checks at the 13 BCPs, the 23 border crossings (where there are no BCPs) and at the facilities of the postal and courier companies. At the border crossings, Customs work with the border guards when carrying out their controls. The audit team was provided with a copy of the co-operation agreement with Customs and the SPSMoA, which outlines their responsibilities. Customs also have a dedicated plant health liaison officer to help co-ordinate day-to-day activities with the SPSMoA, which is an example of good practice. The audit team was also provided with a copy of the equipment and facilities sharing agreement that the SPSMoA have with Customs dated 2022. 5.1.2Audits and verification of procedures

The representative from Customs stated that it is the Customs official's responsibility to check for the presence of a phytosanitary certificate (PC) when carrying out checks on plants, plant products and other objects. Furthermore, it is the responsibility of the SPSMoA to carry out the checks on any items of plants for planting contained in passenger luggage and in postal and courier consignments. According to the documented procedures, any non-compliances found by the Customs services are rejected, returned to the country of origin/sender or destroyed. The Customs officer stated that in the majority of cases there is no PC accompanying these goods, so they are confiscated and destroyed. It was also stated that there is no detailed record of these checks, the number of checks carried out or the number of non-compliances, however a 9 total of 1 500 kg of plant products were destroyed by incineration in 2021 (see section

Non-compliances found by Customs in relation to passenger luggage, postal and courier packages are not reported on IMSOC in line with the requirements of Articles 40(4) and 41(4) of Regulation (EU) 2016/2031. See also section 5.2.4

The actions taken in event of a non-compliance are generally in line with the EU requirements. However, interceptions on imports by private individuals are not reported in line with EU requirements. This influences planning arrangements in other MS by not sharing the available information regarding non-compliant goods coming into the EU.

The recommendation states as its basis

The CA has not designated any laboratory as an official laboratory to carry out PPP formulation analysis. This is not in line with Article 37 (1) of Regulation (EU) 2017/625.

While the laboratories utilised by the CA are accredited, participate in inter-laboratory testing and standardised proficiency tests, and are capable of conducting the wide range of analysis required, the laboratories used for formulation analysis are not officially designated, as required by Article 37 of Regulation (EU) 2017/625.

Member state response

ysis of PPPs as required by Taking into account the recommendation, the State Plant Service under the Ministry of Agriculture will designate an official laboratory for the analysis of PPPs as required by Article 37 (1) of Regulation (EU) 2017/625. Planned deadline for this action is 30 of December 2023. Explanation: At the moment analyses according to Lithuania needs are carried out in several accredited laboratories outside country. With regard to fulfil the recommendation it is planned to communicate those most suitable laboratories and under agreement designate them as an official laboratories to carry out the analysis of PPPs as required by Article 37 (1) of Regulation (EU) 2017/625. Page: 1

The recommendation states as its basis

While the sampling procedures were generally in line with applicable EU requirements, the audit team noted that this was not the case for aquaculture (finfish farming products), for which it was indicated that all samples should be taken from fish ready to be placed on the market. This is not in line with pertinent EU legal requirements (15), which requires that, for Group A substances, samples must be taken on fish at all stages of farming. In two of the SFVS territorial services with active fish farms, the audit team saw that sampling was indeed only on fish ready to be placed on the market for consumption.

Whilst the residue monitoring plan is generally implemented in accordance with planned arrangements and in line with EU rules, not sampling farmed fish at all stages of production for Group A substances and repeated sampling of the same producer, have the potential to compromise the effectiveness of the plan.

Member state response

for To ensure that the Quality System instructions of the competent f authority are compliant with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC with directions in Annex III, the procedure for taking aquaculture samples will be changed: instead of "samples are taken of each fish species in the pond that are being prepared for supply to the market " will be changed to "all the samples must be taken at farm level, on fish at all stages of farming, including fish which is ready to be placed on the market for consumption". As well as, training will be held for inspectors of territorial departments, during which they will be introduced to the changes in the instructions and new legal acts related to the new format of RMP plan for 2023 Deadline: December 31, 2022

The recommendation states as its basis

The staff interviewed by the audit team were familiar with the instructions for sampling. However, the audit team observed three cases where repeated sampling of the same producer had occurred within a short period of time (16).

Whilst the residue monitoring plan is generally implemented in accordance with planned arrangements and in line with EU rules, not sampling farmed fish at all stages of production for Group A substances and repeated sampling of the same producer, have the potential to compromise the effectiveness of the plan.

Member state response

ns to The Competent Authority would like to emphasize, that cases, where several samples are taken from the same producer at the laughterhouse for testing several different groups of substances are single cases. It is specified in the quality management work instructions. Instructions, procedures and guidelines to this effect will be updated, recirculated and recommunicated on an annual basis, territorial departments will be introduced to new material instructed how to apply it during sampling. Training will be provided on the new procedures. Inspectors, that take official samples, will be reminded by Circular of official instructions in relation to the avoidance of multiple sampling from a single supplier. Page: 1 ns of report ref. DG(SANTE) 2022-7485 of the audit carried out from 03 May 2022 nants in live animals and animal products including controls on veterinary medicinal Proposed by the competent authority ne: December 31, 2022.

The recommendation states as its basis

In the SVFS territorial services visited, the audit team scrutinised 14 non-compliant results identified in 2019-2021 and observed the following: a. sample submission to the laboratory, completion of analyses and reporting of test results were generally timely; b. follow-up investigations were carried out in all but one case (due to COVID-19- related restrictions) within the deadline specified in national instructions (14 days); c. restrictions were placed on goods and animals pending the outcome of the investigation; d. contrary to EU requirements (26), in six cases, the investigation did not result in any conclusion on the origin of the non-compliances, only a description of the actions taken had been presented (the audit team did acknowledge that the determination of the origin of the non-compliances had not been always possible ­ which should have been resulted in an appropriate conclusion); e. when natural occurrence of certain substances (e.g., thiouracil, hormones and steroids) was assumed, no justification for this assumption (e.g., reference to available scientific data/publications) had been made; f. effective, proportionate and dissuasive penalties were applied when the operator's responsibilities had been established.

Prompt investigations of non-compliant residue results, and the imposition of appropriate sanctions contribute to identifying and reducing the causes of unacceptable residues in live animals and food of animal origin. Nevertheless, the effectiveness of the system is weakened by the policy of informing operators in advance of an investigation and by the sometimes incomplete investigations of the origin of non-compliances.

Member state response

results The Competent Authority has developed quality system igin instructions that ensure reliable follow-up procedures and an ) are assessment of the risk of non - compliant results. As well as there e stricter control of cases of non ­ compliant samples. ­ it e ensured that the territorial departments of the Competent ity adhere to deadlines during the investigation, fills out nts properly: Competent Authority will perform cation of documents, counselling will be provided during the igation, assistance in analysing data and scientific literature port the final conclusion. ne: December 31, 2022.

The recommendation states as its basis

No validation/verification data were presented for the screening method for chloramphenicol in milk and milk products, only results of ongoing method performance verification, covering six years, were demonstrated. This is not in line with pertinent EU requirements (33).

In all of the validation files scrutinised, no information was available on the species from which urine, plasma/serum and muscle included in the validations had originated. This significantly inhibits verification that the methods were properly validated for all of the matrix/species combinations included in the residue monitoring plan.

In all of the validation files scrutinised, stability was not addressed either in solution or in matrix. This is not in line with the EU legislation (34). The audit team pointed out that, if stability data are available from scientific literature or from another laboratory, these data do not need to be determined again by the concerned laboratory, provided that identical conditions apply (34).

The audit team noted that during routine use of the thyrostat method, there was no consideration of the instability of the analytes during freezing/thawing cycles and during storage in a freezer (35) which may affect the analytical validity of such samples and thus undermine the analytical validity of the results (i.e. truly non-compliant samples may not be detected).

Notwithstanding the fact that all of the laboratories are duly designated for the purposes of official control, accredited, operate methods included in their respective scopes of accreditation, apply adequate internal quality control procedures and perform well in proficiency tests, deficiencies in the validation of analytical methods and in the interpretation of the analytical results undermine the reliability of said results and the consequent decisions taken.

Member state response

ds used by the Institute have been validated in ated accordance with the requirements of Commission Decision 02/657/EC. The validation followed the EURL guidelines, the EURL evaluation methodology, and the calculations were made the EURL recommended software based on an alternative ission validation methodology. quirements defined in Commission Decision 2002/657/EC t when repeatability results are lower than reproducibility s. The criterion for assessing reproducibility was not ied for low concentrations, the requirement sets down that sult should be as low as possible. With the new Commission enting Regulation (EU) 2021/808 entering into force, the ability and reproducibility requirements have changed. boratory has performed method validations based on an ative validation model, in which repeatability is not directly ined as in the conventional validation model, and the CV% ariation for a given assay. The reproducibility results are used culate the CC and CC values. Repeatability results are not Page: 2 ns of report ref. DG(SANTE) 2022-7485 of the audit carried out from 03 May 2022 nants in live animals and animal products including controls on veterinary medicinal t authority d a

The recommendation states as its basis

The audit team noted that the interpretation of the analytical results was made by the NFVRAI laboratory without any verification of this by the SFVS. The audit team observed 14 laboratory reports related to the non-compliant samples scrutinised during the audit and observed that in none of these cases had a comparison/reference been made with the relevant CC (which was consistently absent on the analytical reports) which is not in line with EU requirements (38). Such an approach can question the legal validity of the decisions made by the SVFS on the basis of the NFVRAI laboratory reports.

Notwithstanding the fact that all of the laboratories are duly designated for the purposes of official control, accredited, operate methods included in their respective scopes of accreditation, apply adequate internal quality control procedures and perform well in proficiency tests, deficiencies in the validation of analytical methods and in the interpretation of the analytical results undermine the reliability of said results and the consequent decisions taken.

Member state response

ees legal In order to ensure that the interpretation of laboratory test results lts. guarantees the legal validity of the decisions taken and complies ith the requirements of Article 5 of Commission Implementing he following shall be foreseen by oducts and prohibited substances (e.g., under the Harmful Residues Plan, the y assessment report shall additionally ision limit (numerical value of the CC) r the analyte under investigation. em procedure KSP 7.8.2 Evaluation ts shall be supplemented by providing e Harmful Residues Plan, for veterinary ibited substances (e.g., Group A ls of the test reports for the evaluation results, an additional reference to the Page: 4 ns of report ref. DG(SANTE) 2022-7485 of the audit carried out from 03 May 2022 nants in live animals and animal products including controls on veterinary medicinal t authority rical value of the CC) shall be est results, together with the result

The recommendation states as its basis

The audit team noted that there is a clause in the national rules on organic agriculture on response to positive laboratory results that is not in line with EU legislation. See paragraph 62 below. There were also a limited number of other discrepancies with EU legislation in the implementation of the Lithuanian control system, caused either by incorrect or absence of guidance in the relevant Orders or by incorrect interpretation. These discrepancies are detailed in the relevant sections of the report. Conclusions on relevant national legislation and provisions

As stipulated in the national Rules on Organic Agriculture, Ekoagros applies a threshold for detected unauthorised substances below which, no contamination is recorded or investigation or other follow-up carried out. The threshold is formally 0.01 mg/kg, but since the measurement of uncertainty, which the laboratory is obliged to indicate (generally 50%), must also be added the threshold is in practice most often 0.02 mg/kg. Furthermore, this still applies if several substances are found, as long as the level of each substance is below the threshold. In 2019-2020, some 40% of the positive samples found in the risk-based surveys were below the threshold and in practice regarded as negative. Paragraph 88 below gives an example of similar effects of the threshold on the follow- up of suspected cases. The application of a threshold is not in line with Article 91 of Commission Regulation (EC) No 889/2008. Any presence of unauthorised substance is a potential non-compliance with the organic rules and should be investigated. In this context, the uncertainty factor is irrelevant as it applies to the level of contamination and not to whether there is presence or not.

The Rules on Organic Agriculture lay down the overall procedure and rights and obligations regarding particular types of irregularities, such as presence of an unauthorised substance. In cases of the latter, if the level of (each) unauthorised substance is above the threshold (see 62 above), the lot in question is blocked and the operator is given 5 days to request an investigation, for which he has to pay the additional analyses of samples. If the operator does not make such a request the lot is downgraded to conventional and if on a farm, the field is furthermore downgraded to conversion and the farmer loses the subsidy on the field for that year.

Order No 3D-370 of 22 May 2009 describes the procedure for the exchange of information of non-compliances with other Member States and the Commission in the OFIS system. The audit team examined examples of the follow-up done in response to notifications made by other Member States. One of them involved the finding of Glyphosate in oats exported by a grain trader in 2019. The lot was originally composed from 140 truckloads of oats from over 50 farmers. By analysing the samples referred to in paragraph 45 above, Glyphosate was confirmed in 121 of the 140 truckloads. However, after applying the threshold described in paragraph 62 above, only seven samples, involving four farms were considered positive with a need for follow-up. Inspections and sampling, either of remaining grain or of soil from the fields where the oats had been grown, verified Glyphosate contamination in three of the farms. The remaining farms with Glyphosate levels below the threshold in the original sample were not included in risk category I (see paragraph 35 above) for controls in the following 20 year. Ekoagros explained that this principle was not yet in place when this case occurred, but that it would be considered if a similar case happened again.

Apart from the application of the threshold, the team noted that appropriate investigations and reporting were done in the examined OFIS cases.

The recommendation states as its basis

As stipulated in Order No 3D-630, Ekoagros produces an annual activity report, which is also published. Furthermore, the national Rules on Organic Agriculture require that Ekoagros shall submit to the Ministry of Agriculture, by 1 March each year, a summary of the primary production by the certified operators in the previous year. The audit team noted that none of these reports fully give the summary of the control activities envisaged in Article 27(14) of Regulation (EC) No 834/2007 to enable the competent authority to timely monitor the control activities. This is mitigated by the fact that the control activities are subject to annual audits by the AEOFD, as mentioned above.

Order No 3D-397 lays down the obligations and deadlines for communication about identified infringements between the bodies involved with inspections and control, i.e. SFVS, the State Plant Service and Ekoagros. The audit team noted that information to AEOFD is not covered in this order. Ekoagros and AEOFD stated that Ekoagros 7 nevertheless immediately notifies each case when an unauthorised substance is found as well as cases of fraud. However, other cases of non-compliance affecting the organic status of the product are only transmitted to AEOFD in summarised form once a month. This is not fully in line with Article 30(2) of Regulation (EC) No 834/2007 and Article 92(4) of Regulation (EC) No 889/2008, which require that such cases are notified to the competent authority without delay. The authorities stated that cases not immediately notified typically concern parallel production or unauthorised use of non-organic seed, both of which do not require urgent coordinated action, e.g. to prevent marketing of non- compliant products.

The recommendation states as its basis

The audit team noted that the management of the operator list is in line with EU requirements apart from the absence of a certificate for operators in their first year of 8 conversion, which in principle is not in line with Article 29(1) of Regulation (EC) No 834/2007.

The recommendation states as its basis

Within these parameters and as relevant for the different types of operators, consideration is given to the specific crops grown, type of animal husbandry, not having the same inspection time each year, seasonality of organic processors etc. for determining the best inspection time. However, the audit team noticed that with the abovementioned time schedule for annual inspections of farms, the majority of livestock farms will only ever be visited in the summer. There are around 1 000 livestock farms in Lithuania and therefore only a few of them can be subject to additional inspections in the period where winter housing of animals can be checked. Even for crop production, occasional inspections outside the May-October period could be useful, e.g. to detect autumn or early spring use of unauthorised fertiliser.

The recommendation states as its basis

The audit team noted that the figures indicated in Lithuania's annual report submitted under Article 92f of Regulation (EC) No 889/2008 for risk based additional inspections and unannounced inspections was higher than the figures, mentioned above, collected during the audit. Ekoagros explained that for the annual report, the broadest interpretation of additional inspections was used, not limited to those that were planned based on risk. This is however not what is intended to be indicated in the tables for the annual report, given in Annex XIII C to Regulation (EC) No 889/2008. (See also paragraph 60 below). SFVS market inspections

The audit team noticed discrepancies, similar to those noted for additional inspections (see paragraph 39 above), between the figures for risk based samples indicated in Lithuania's annual report submitted under Article 92f of Regulation (EC) No 889/2008 and those collected during the audit.

The recommendation states as its basis

The National Food and Veterinary Risk Assessment Institute has been officially designated by a competent authority in Lithuania for the work that it carries out for the SFVS. This is, however, not the case for the two private laboratories used by Ekoagros, which is not in line with Article 37(1) of Regulation (EU) 2017/625. The laboratory used for the routine samples is officially designated in the Member State for analysis in respect of organic controls as required by Article 37(2)(b) of the same regulation, but this has not been verified for the other laboratory.

The recommendation states as its basis

The audit team noted that the accredited scope of the laboratories included screening methods for an extensive range of substances and single substance methods e.g. for Glyphosate, Chlormequat, Mepiquat, and Fosetyl-Al. The audit team noted that the latter substances, in particular Glyphosate (and its metabolites), are regularly included in the analyses requested by Ekoagros. This is however not the case for the samples taken by SFVS, which are generally only subject to multi-residue screening.

The recommendation states as its basis

The audit team also noted however, that disbudding of young bovine animals is generally allowed for all and is not subject to the case-by-case approval required in Article 18(1) of Regulation (EC) No 889/2008. The proper implementation of this derogation is monitored during the inspections. 17

The recommendation states as its basis

The audit team reviewed documents for movements of pigs from Part II to a slaughterhouse. Two holdings had supplied pigs for slaughter. These holdings received multiple consignments of pigs from an area listed in Part II within the previous 30 days. This is not in accordance with Article 3(1) of decision 2014/709/EU, as pigs should not be certified for slaughter until the standstill period of 30 days has elapsed. 5.1.2 Control of fresh meat, meat preparations and meat products from domestic pig Legal requirements Article 18 of Regulation (EC) 178/2002; Directive 2002/60/EC; Directive 2002/99/EC; Commission implementing Decision 2014/709/EU; Annex II, sections I and III of Regulation (EC) No 853/2004; Articles 4(6) and 5 Regulation (EC) No 854/2004; Annex III, section I, Chapter IV, Points 3 and 13 of Regulation (EC) No 853/2004. Findings

The controls over live pigs moving within Lithuania allows pig meat from Part II to be 9 dispatched to other Member States and third countries, and for pig meat from Part III to be limited to the Lithuanian market with very low risk of spreading the disease. However, these guarantees are weakened by the inconsistent application of standstill requirements and the absence of verification on channelling for pig meat coming from Part III.

All holdings in the protection zone were visited within 2 days (including a door-to-door visit to houses in villages to establish if they kept pigs.). An additional 8 holdings were found to have pigs i.e. pigs were present but their movements had not been notified to central database. The authorities confirmed that this was a problem throughout the country with up to ten percent of non-commercial holdings not declaring movement of pigs. All holdings visited got a restriction notice for animals and a census performed. The audit team saw records confirming the number of holdings visited the expected number of pigs (extracted from central database) and the actual number of pigs present. These actions are in accordance with Article 10 of Directive 2002/60/EC.

The recommendation states as its basis

All of the FeBOs visited had implemented HACCP-based systems. Detailed assessment criteria for HACCP-based procedures are described in the guidance/checklists (see finding 17). However, the local inspectors met could not demonstrate sufficient knowledge to assess the adequacy of the HACCP-based procedures, in particular hazard analysis of feed additives. This is not in line with the requirements of Article 6 and 7 of Regulation (EC) No 183/2005.

All of the FeBOs visited, where tests on homogeneity of mixing and on carry-over of coccidiostats were relevant, included relevant tests their HACCP plans and carried out such tests regularly. The audit team noted that these tests, as described in the FeBOs' procedures, were not fit for purpose in a number of operators visited. However the local inspectors met were not able to adequately evaluate the methods and the results of testing and assess compliance with the requirements laid down in Point 3 of Annex II section "PRODUCTION" of Regulation (EC) No 183/2005.

Planning of inspections is based on appropriate risk-related factors and ensures that the official controls are carried out regularly, on a risk-basis and with an appropriate frequency. With regard to implementation, whilst the verification of hygiene and maintenance of facilities and equipment, and FeBO`s traceability systems, were carried out adequately, the effectiveness of the inspections was weakened by several factors, most notably inadequate assessment of FeBOs HACCP systems including tests on homogeneity of mixing and carry-over of coccidiostats, and shortcomings in officials' verification of the correctness of feed labelling. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Member state response

1. Priorities for strengthening of official feed control are set for 020, which inter alia include assessment of FeBOs hazard analysis procedures, tests on homogeneity of mixing and carry- over. Priorities are stated in Official Veterinary Feed Monitoring and Control Plan for 2020 (approved by the Order No. B1-52 of Director of State Food and Veterinary Service of 23 January 2020) Completed on 23 January 2020 2. Seminars ­ discussions with FeBOs (all FeBOs, which use coccidiostats will be invited) will be organized. Deficiencies of FeBOs procedures for hazard analysis, mixing homogeneity and carry-over testing will be discussed. Best EU practices will be presented and the need for national guidance document will be discussed. Deadline: 30 June 2020 3. Group of advanced inspectors will be created and approved. Special trainings will be organised for them. Trainings will include labelling of feed, feed hazard analysis, evaluation of mixing homogeneity and carry-over tests applied by FeBOs. Training materials will be disseminated to all feed inspectors and associations of FeBOs. Group of advanced inspectors will be responsible for the auditing of HACCP system of all approved feed manu

The recommendation states as its basis

The audit team checked the documentation/labelling of imported feed additives and noted that generally these products fulfilled the relevant authorisation requirements laid down in Article 3 of Regulation (EC) No 1831/2003. Some shortcomings were identified relating to amino acids (no safety information on the label or on the bag, inadequate identification number was put on the label). The competent authority had overlooked these non-compliances during previous official inspections.

At the remaining (non-importer) FeBOs visited, official inspections included the labelling control of feed additives and premixtures during preceding inspections. There were instances of inadequate labels which were spotted and reported; the FeBOs remedied the issues. At the time of the audit, in the majority of the establishments visited the audit team identified some shortcomings relating to labelling of feed additives/premixtures used as ingredients for production and to the labelling of premixtures and complementary feeds. Examples of non-compliances included: Safety recommendations regarding the use and/or specific requirements mentioned in the authorisation of the feed additive were not labelled on the product, contrary to Article 16(1)(e) of Regulation (EC) No 1831/2003. Identification numbers of feed additives were missing on the labels of premixtures, contrary to the legal requirement in Article 16(1)(7) of Regulation (EC) No 1831/2003. The use of certain complementary feed containing vitamin A in accordance with the label instruction would lead to the established maximum levels of vitamin A in complete feed for fattening pigs and dairy cattle being exceeded, which is contrary to the requirements laid down in Commission Implementing Regulation (EU) No 2015/724. Labelling of complementary feed containing feed additives with maximum levels did not contain adequate instructions for proper use required by point 4 Annex II Regulation (EC) 767/2009. 11 Complete feed contained a higher concentration of an antioxidant than the established maximum limit, contrary to the requirements of Commission Regulation (EC) No 2316/98. Complementary feed was labelled as compound feed which is not in line with the requirements of Article 15(a) of Regulation (EC) No 767/2009. Instructions on the labelling of feed additives allowed using this feed additive in combination with another feed additive for which the authorisation was suspended. This is not in line with the requirements of point 1 Article 3 of Regulation (EC) No 1831/2003. The competent authority had overlooked these non-compliances during previous official inspections. Conclusion on the planning and implementation of inspections

Planning of inspections is based on appropriate risk-related factors and ensures that the official controls are carried out regularly, on a risk-basis and with an appropriate frequency. With regard to implementation, whilst the verification of hygiene and maintenance of facilities and equipment, and FeBO`s traceability systems, were carried out adequately, the effectiveness of the inspections was weakened by several factors, most notably inadequate assessment of FeBOs HACCP systems including tests on homogeneity of mixing and carry-over of coccidiostats, and shortcomings in officials' verification of the correctness of feed labelling. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Member state response

s 1. Priorities for strengthening of official feed control are set out in of Official Veterinary Feed Monitoring and Control Plan for 2020, which inter alia include assessment of feed labelling. Completed on 23 January 2020 2. Seminars for FeBOs will be organized. Requirements for Page: 1 report ref. DG(SANTE) 2019-6631 of the audit carried out from 22 October ives, their ingredients and traceability tion Proposed by the competent authority belling of feed will be presented, with the special emphasis on belling non-compliances established during official feed control. adline: 30 June 2020 Training for official inspectors will be organized. Theoretical d practical parts of assessment of feed labels will be included. adline: 31 October 2020

The recommendation states as its basis

Several local inspectors met were not knowledgeable on, and subsequently could not follow, the official sampling requirements laid down by Regulation (EC) No 152/2009, 13 including the concept of 'sampled portion' and calculation the number of incremental samples.

Local inspectors use a common sampling protocol for official sampling of feed and food. This protocol contains information on, inter alia, the type of product, total quantity of the product, type of the laboratory analysis, quantity of the sample and the address of the laboratory. In the protocol, there is no requirement to note the size of the sampled portion. The audit team reviewed some sampling protocols and could conclude that the protocols did not contain the information required by point 10 of Annex 1 to Regulation (EC) No 152/2009. Conclusion on the planning and implementation of sampling

Planning of official sampling is effective and risk-based. Notwithstanding strong laboratory performance, several factors (such as flawed sampling protocols, and a lack of understanding of sampling requirements) weaken the implementation of sampling and thus the effectiveness of the whole official sampling system. 5.2.3 Actions taken on non-compliances

Member state response

Training for official inspectors on feed sampling will be ganized. Training will include theoretical part and practical feed mpling exercises at FeBOs' premises. adline: 31 October 2020 Sampling Report form will be amended and special section for e indication of sampling portion size will be included. adline: 30 June 2020 Page: 2

The recommendation states as its basis

The CAs informed the audit team that the verification of the registration of primary producers in operation is done by cross-checking data with controls on retail level, especially on local markets. However, in one RO visited the number of primary FBOs registered in the scope of this audit moved from 3 in 2017 to 46 in 2019 indicating that there may still be a significant number of unregistered primary producers in the country.

The ROs and the CCA informed the audit team that during controls at retail level, non- registered primary producers of FNAO are still being identified. The CCA concluded that at the time of the audit not all primary producers of FNAO were registered. FBOs involved in the "sprout chain"

Procedures are in place for the registration of primary producers in a national electronic database. However, to date not all FBOs within the scope of this audit have met their obligation to be registered. Thus, not all FBOs are under official control.

In the first RO visited, there were 46 primary producers of soft berries of which 33 registered in 2019; at the time of the audit, none has been inspected. The CA informed the audit team that based on its interpretation of the national law, all primary producers have to be classified as "Very Low Risk" which implies inspection within 6 years after registration. As a consequence, no inspection reports were available.

In the second RO visited there were 26 primary producers, 19 of which having been registered in 2019. Seven inspection reports for 2018 were available, none indicating non-compliances related to the scope of this audit. The head of service and the inspectors informed the audit team that those primary producers have to be inspected at earliest after 6 months but within in one year from the registration, in line with the national law. Cultivation

The audit team informed the inspectors that producers of seeds for sprouting have to be under official control, but no actions have been taken by the CAs in this regard as they were not aware of this requirement. Sprout-Producing Establishments First sprout-producing establishment

Member state response

distribute them. Deadline: by the end of the 2nd quarter of 2020. 3. The CAs have to organise meetings with farmers with the provision of information on the requirements of the registration. Deadline: during 2020. 4. The Chamber of Agriculture of the Republic of Lithuania has to be approached regarding the dissemination of information on the registration to farmers engaged in primary production. Deadline: 31/12/2019. taken 1. In accordance with the Quality Management Programme KT-2- garding 1-D3 "Categorisation of food business operators into risk groups", e the CCA has to set the coefficient for the assessment of official he control results (coefficient 2) for 2020 as 1.5 for primary duction business operators engaged in the production of leafy l risks. vegetables and berries. Non-animal origin food production establishments engaged in the production of frozen fruit, vegetables, lettuces, berries, mushrooms or their mixtures have to be categorised as high risk establishments and in 2020 they have Page: 1 ons of report ref. DG(SANTE)/2019-6674-MR of the audit carried out from 03 official controls relating to microbial safety of food of non-animal origin Action Proposed by the compe

The recommendation states as its basis

Important factors such as size of the plant and production volume are not taken into account for the risk categorisation. The CCA agreed that adding this relevant information would improve the risk based plan.

SFVS has the legal power to perform inspections at all stages of production. SFVS is the CCA in charge for official controls pre-, during and after harvest. However, all the inspectors met informed the audit team that inspections are performed at the level of the premises (storing and/or packing area). Primary production before and during harvest is not subject to official controls. 9

There is an official control system in place covering FNAO. However, contrary to the requirements of Article 3(3) of Regulation (EU) No 882/2004, primary production before and during harvest is not under official control and this weakens the effectiveness of official controls related to FNAO.

The audit team visited two ROs. Both heads of the service informed the audit team that official controls take place at the premises, after harvest. Inspections at field level before and during harvest are not carried out, as confirmed by the inspectors met.

Requirements such as workers' hygiene, use of fertilisers, irrigation waters, and facilities were addressed by the inspectors without going into the field. Inspectors confirmed that official controls take place exclusively at the premises. 11

The leafy green vegetables primary producer visited was classified as "medium risk", but when asked about this classification, inspectors informed the audit team that it was related to premises (trading of imported leafy green vegetables, packaging and labelling). The inspectors informed the audit team that the right risk categorisation, including only the primary production on the field and greenhouse, will be assessed as "very low risk", contrary to the national law.

This last FBO was already inspected but inspections never took place in the field. This was the first inspection performed by inspectors on the field regarding microbiological risks.

For another three processing establishments, documents related to the risk categorisation were asked. This information established that for one of them, the risk categorisation was not done yet, and that these establishments had not been assessed in respect of all their activities (processors, wholesalers) contrary to national law. 12

Due to the fact that in practice all primary producers are classified in the "very low risk category", the risk based categorisation cannot prioritise primary producers of FNAO with higher microbiological risks for official controls. This weakens targeting, and thus the effectiveness of the official control system.

Member state response

or Atsizvelgiant Europos Komisijos audito ataskaitos projekto rekomendacij Nr. 1, Lietuvos Respublikos zems kio ministerija C. atliks Augal apsaugos plano tikslinim, traukiant j rodikl susijus su itin pavojing veiklij medziag naudojimo stebsena, kaip to reikalauja Europos Parlamento ir Tarybos direktyvos 2009/128/EB 4 straipsnio 1 dalis. Sios rekomendacijos vykdymo terminas ­ 2020 m. I ketvirtis.

Member state response

ly Atsizvelgiant Europos Komisijos atlikto audito ataskaitos projekte nurodyt rekomendacij Nr. 2, Lietuvos Respublikos kio ministerija patikslins Apdorojimo augal apsaugos produktais rangos technins apziros taisykli, patvirtint ive. Lietuvos Respublikos zems kio ministro 2001 m. birzelio 19 d. sakymu Nr. 199, nuostatas pagal Europos Parlamento ir Tarybos irektyvos 2009/128/EB reikalavimus. Sio veiksmo vykdymo terminas ­ 2020 m. I ketvirtis.

Member state response

Atsizvelgiant Europos Komisijos audito ataskaitos projekto rekomendacij Nr. 3, Valstybin augalininkysts tarnyba prie Zems kio ministerijos perzirs ir atitinkamai papildys kio subjekt, naudojanci augal apsaugos produktus, tikrinimo (kontrolin) klausimyn, j traukiant papildomus klausimus, susijusius su vandens ir vandens aplinkos patikrinimo reikalavimu. Sio veiksmo vykdymo terminas ­ 2019 m. IV ketvirtis.

Member state response

t Atsizvelgiant Europos Komisijos audito ataskaitos projekto per rekomendacij Nr. 4, Lietuvos institucijos perzirs nacionalinius teiss aktus ir papildys juos nuostatomis dl Integruotosios kenksmingj organizm kontrols (IKOK) princip oficialiosios Page: 1 ugust 2019 report ref. DG(SANTE)/2019-6722-MR of the audit carried out from 26 March achieve the sustainable use of pesticides by the competent authority profesionalij augal apsaugos produkt audotoj veikloje, pagal Europos Parlamento ir Tarybos 128/EB 14 straipsnio 4 dal, siejant j su Nr. 1107/2009 55 straipsniu. imo ir tikslinimo terminas ­ 2020 m. I ketvirtis. Page: 2

The recommendation states as its basis

SFVS is aware that for the assessment of complex supporting documentation specific knowledge (i.e. chemistry education) is essential to verify the statements given in the DoC. At the time of the audit, such expertise is available at the NRL and at the CCA.

CAs recognise that a lack of food inspectors with relevant background and training for FCM, e.g. chemistry, as well as the limited role of the NRL is a limiting factor in the implementation of official controls in the FCM area. 5.2.2 Registration/Approval of FCM Business Operators Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004 and Article 31 of Regulation (EC) No 882/2004. Findings

In addition, at central level, CAs in 2017 assessed a number of DoC and supporting documentation and only in 10% of cases, were DoC and supporting documentation in compliance with legislation.

At the second plastic manufacturer (also distributor), the inspectors moved one-step further assessing the contents of the DoC. The inspectors succeeded to a certain extent but deficiencies including information on dual use substances, a missing statement about Non-Intentionally Added Substances (NIAS) and incompleteness in the evaluation of migration from the printed surface were not identified. Inspectors also had difficulties in assessing EU requirements relating to GMP on inks.

Moreover, the audit team observed that the DoC provided by this manufacturer had some inconsistencies compared to the DoC prepared by its supplier. For example regarding specific migration limits (SML ­ i.e. for monomers and others starting substances) the manufacturer gave information not consistent with the information provided by the supplier. The point had not been identified by the inspectors during official control.

At the third plastic manufacturer, the inspectors asked for DoC and, as supporting documentation, they asked for starting materials (pellets) and migration test for suitable use for food. The inspectors assessed the DoC as in compliance without asking for evidence regarding GMP, specific migration test (verification of the compliance with SMLs), information about the process (re-use of cut off materials) and the risk analysis done by the BO to evaluate NIAS, theoretical calculation for migration limits and organoleptic tests.

The audit team noted that official controls on plastics, in most cases, do not include sufficient checks on the supporting documentation for statements in the DoC (final product). In particular, the following were missing: An assessment of the supporting documentation relating to the completeness of laboratory results in matters of SML or organoleptic tests; An assessment of NIAS ­ e.g. impurities, reaction products and decomposition that can be formed during the processing of a granulate into the final product; A verification of the BOs' risk assessment required under Article 19 of Regulation (EU) No 10/2011.

Concerning DoCs, the audit team observed that the inspectors relied on the information provided by the BOs. The inspectors have limited expertise for evaluating the formula of a product and for assessing the documents provided by the BOs.

The audit team observed that the inspectors, after requesting the help of a more experienced staff member of the CCA, were able to carry out an in-depth evaluation of the DoC documents provided and furthermore, completed the evaluation in a shorter time. The outcome of their inspection was also communicated to the FBO more accurately and clearly. However, deficiencies in the DoC regarding NIAS information were not identified by the inspectors.

The specific checklists provided for plastic do not include all the legal requirements of the DoC as listed in Annex IV of Regulation (EU) No 10/2011 to the point that most of these DoCs examined by the inspectors would not meet all the criteria set out in the legislation.

The effectiveness of the controls in place is hampered by the fact that inspectors are not suitably trained or experienced to evaluate compliance of FCM legislation, including a detailed analysis of the DoC and supporting documentation. Such expertise is not always sought or cannot be provided by the CA. However, when sought or provided, the performance of the inspectors is largely enhanced. 5.2.5 Official Sampling Procedures and Laboratory Performances Legal Requirements Article 4(2)(c), Article 11, Article 12(1), (2) and (3) and Article 33 of Regulation (EC) No 882/2004. Findings

Member state response

A will revise and update checklists. dline: 21 December 2018 In order to increase knowledge, skills and competences of CAs ctors, CCA will conduct at least 5 internal training sessions RO. Deadline: 1 May 2019 3. CCA provides technical assistance (desk officer at CCA is available for the consultations for RO inspectors) regarding DoC and Supporting documents. This information was announced to RO at the Meeting with RO (17 April 2018) as well as by e-mail (8 June 2018).

The recommendation states as its basis

Moreover, those non-compliances have to be placed in the context where DoCs are not checked for their completeness but only for their presence or absence. This means that, regarding DoC, no non-compliances have been identified because the official control, so far, focused on the DoC presence and whether it was suitable for the intended purpose of use. At the time of this audit there was no evidence that supporting documentation has been systematically required.

GMP is controlled based on a checklist prepared by SFVS, which reflects the basic requirements of Regulation (EC) No 2023/2006. Inspectors rely mainly on what the BOs provide to them during the inspections concerning manufacturing procedures and risk analysis. Moreover, the risk analysis documents were never asked for nor verified by the inspectors.

One of the official work instructions contains a checklist, which prompts inspectors to examine the requirements of the DoC e.g. "does the declaration meet the established requirements?" However, at the first plastic manufacturer (also distributor) the representative of the RO and the inspectors informed the audit team that regarding DoC the inspection is limited and focuses on its presence or absence. An assessment of DoC and supporting documentation was not carried out at the time of the audit.

The inspectors informed the audit team that during inspection the assessment of DoC is not done. Regarding DoC, they limit the verification to its presence or absence. However, the CCA informed the audit team that the inspectors may, to some extend but not systematically, verify the statement regarding the intended use reported in the DoC.

The CCA informed the audit team that the risk assessments done by FCM manufacturers for substances referred to in Article 19 of Regulation (EU) No 10/2011 had to date not been requested and therefore not evaluated by the SFVS. Inspectors accept the DoC and supporting documentation without verification of completeness of the information given, which does not help identify cases where risk assessments should have been carried out. FBOs

Concerning plastic packaging, the fact that some elements of the DoC were missing (producer, dual use substances, overall migration and surface/volume ratio) was not identified by the inspectors, which stated that, at the time of the audit, they only seek for presence of the DoC without assessing such document.

The reports of the previous three years were available, checklists had been completed and annexes to trace the controls were available. From the previous reports, it was clear that up to now, regarding official controls on FCM, the inspectors focus on traceability, labelling and hygiene conditions (storage and use). Concerning DoC, inspectors limit themselves only to register its presence or absence. Moreover, in the reports reviewed by the audit team, there was no evidence that manufacturing and processing equipment had been controlled.

Concerning non-compliances, the SFVS provide figures (see paragraph 43 and 44) on their number, type and severity. During the visits to the two FBOs, the audit team reviewed four official reports and confirmed that non-compliances regarding DoC relate to its absence and that no verification had been made regarding its content. Importers/Retailers

The audit team observed an inspection to a retailer classified as low risk. The inspectors informed the audit team that, regarding DoC, they limit their inspection to verifying its presence without verification of the content. However, during this inspection they moved one-step further and attempted to assess the DoC. The inspectors succeeded to a certain extent but deficiencies such as dual use of substances, missing statement about NIAS and incompleteness regarding the intended use were not identified by the inspectors.

The three previous inspection reports, completed checklists and annexes to trace the controls were available. The reports indicated that, up to now, regarding official controls on FCM, the inspectors focused on traceability, labelling and hygiene condition (storage and use). Concerning DoC, inspectors limit themselves only to record its presence or absence. Moreover, in the reports reviewed by the audit team, there was no evidence that manufacturing and processing equipment had been controlled. The audit team was informed that at retailer level, manufacturing and processing equipment is checked only if there is a consumer complaint or suspicion.

The audit team observed one inspection at an importer classified as high risk. The high risk ranking was due to a RASFF notification. Compared to the previous controls, the inspectors moved one-step further and they performed an in-depth verification of the DoC. The inspectors informed the audit team that generally they limit the verification to the presence or absence of the DoC. However, the fact that reference to GMP was not mentioned in the DoC, was not identified by the inspectors. Moreover, the inspectors accepted the statement in the DoC regarding the intended use even if they did not properly verify the test provided. Conclusions on Implementation of Official Controls over BOs and FBOs

Official controls largely focus on the presence of a DoC presented by the BOs and did not sufficiently verify the completeness of the DoC. Limited controls were made on the completeness of supporting documentation for the DoC, which would lead to inadequate or incomplete risk assessments/DoCs being overlooked. Thus, non-compliant products might go undetected and correct application of the relevant legislation would not be enforced.

Member state response

CCA will update internal quality assurance documentation ng checklists) for plastic FCMs to cover specific quirements for DoC. Deadline: 21 December 2018 2. Enforcement of the implementation of the requirements for the DoC for plastics by providing regular relevant information to RO (e.g. trainings, e-mail, meetings). Page: 1

The recommendation states as its basis

At the time of the audit, the FBOs producing GI spirit drinks were not subject to specific official controls relating to the details of the Technical Files. This is not in line with Article 24 of Regulation (EC) No 110/2008.

There is no prioritisation system in place for the implementation of official controls at producers/processors of GI spirit drinks. 5.2.3 Procedures and Performance of Official Control Activities Legal Requirements Articles 12, 13(1), 23, 24(1), 36(3), 44 and 46(1) of Regulation (EU) No 1151/2012. Commission Delegated Regulation (EU) No 664/2014, in particular Article 1. Commission Implementing Regulation (EU) No 668/2014, in particular Article 4. Article 18 of Regulation (EC) No 178/2002. Articles 8(1), 9 and 10(2)(b)(vi) of Regulation (EC) No 882/2004. Regulation (EU) No 1169/2011 Articles 22(1) of Regulation (EC) No 110/2008. 7 Findings Controls at Visited Premises

Member state response

inks 1. CA will update control procedure for alcohol manufacturing. ency Separate checklists will be developed for every GI spirit drink following its GI specification. Deadline: 1 March 2019

The recommendation states as its basis

The audit team observed three different inspections at producers/processors of PDO/PGI/TSG agricultural products and foodstuffs. In each case the inspectors reviewed the key elements of the relevant Product Specifications. Official samples are taken according to the VMVT sampling plan and analysed by NMVRVI. The inspectors met were generally competent and satisfactorily performed a traceability check. However, they did not always check every element of the Product Specifications. In addition, some elements of the controls were superficial. Examples include restricting the documentary checks to very recent production batches rather than reviewing documents from a range of batches since the last official control. This was particularly important where official controls were undertaken once in every two years. According to KT-2-2-19 maximum time between official controls is 2 years. Official controls at producers of GI spirit drinks

Although official controls are undertaken at an agreed frequency at producer/processors of agricultural products and foodstuffs, inspectors do not always check each element of the Product Specification.

Member state response

ucts 1. CA will revise control procedure checklists for producers / processors of GI agriproducts and foodstuffs and update the checklists in accordance with their specifications in order to ensure verification during control procedures. Deadline: 1 July 2019 Page: 1

The recommendation states as its basis

During interviews carried out with the SPS, the regional plant health services and producers of seed and ware potatoes in different places of production, the audit team noted that: The particularities of the ware potato production system in Lithuania (very high proportion of non-registered production) have only recently started to be taken into consideration in earnest during the elaboration of the annual surveillance plans; When samples are taken, the potato lots in question are not allowed to be moved until the sample has been tested negative. Seed potatoes are also not allowed to be certified until all samples taken from the seed farm have been tested negative; In practice, the samples of ware potatoes from seed farms are taken and analysed before those of seed. In all cases examined there were no significant delays in the time elapsed between sampling, dispatch of samples and initial screening for either seed or ware potatoes; Although it is the policy to systematically include the ware/other potatoes grown on seed farms in the annual sampling, at one of the seed farms visited, this was not implemented. 13

Although it has been reduced over the last 10 years, Lithuania is still amongst the Member States with the highest incidence of ring rot. The strategy to ensure that places of production of seed potatoes are free, by testing both seed and ware of such farms is therefore commendable, although it was not implemented in all cases. 5.2.2 Handling of suspected and confirmed Cms outbreaks Legal requirements Articles 3, 4, 5, 6 and 7 and Annex V of Directive 93/85/EEC. Articles 16.1 and 16.2 of Council Directive 2000/29/EC. Findings

Member state response

Having in mind fact that such requirements is already listed in the Order of the Ministry of Agriculture No 3D-97 Section 4.2 providing that samples from seed and ware potatoes from the same place of production should be collected, SPSMoA will strengthen implementation of such requirement in practice.

Member state response

SMoA will implement recommendation of the Audit team on necessary measures for eradicating Cms are implemented on the contaminated place of production. In particular: a) Order of the Director of the State Plant Service under the Ministry of Agriculture No. A1-122 "On the approval of the description of destruction of potato ring rot" will be amended by the 15th of March. Statement, that certified seed potatoes cannot be ntroduced to the same place of production until all potatoes which designated as probably contaminated or contaminated have been h disposed. b) This requirement is already clarified by the Order No. A1-122 (listed requirements for the next 4 years for contaminated fields, probably contaminated fields and other fields). As this provision is mentioned in the current legislation, Lithuania suggests to delete his point from the recommendations. c) SPSMoA will amend the Order No. A1-122 stating that voluntary potatoes should be monitored on all fields of contaminated place of production. d) SPSMoA will provide suggestions for the Ministry Agriculture with a request to initiate a changes (increase) in the amount of fines, in the case of infringements.

The recommendation states as its basis

Chill storage was available in both hunting grounds visited by audit team for carcase storage pending laboratory results. They were domestic upright / chest freezers which required the carcase to be cut up pre-storage. In one hunting ground, chills were spread across three separate locations within the hunting ground. Hunters confirmed no identification was applied to carcase parts during storage and that each freezer contained only one carcase. In case of a positive result, the authorities stated all carcases / carcase parts present in the freezer would be destroyed. However, in case of a negative result, the system does not provide reliable guarantees that only carcase parts related to the negative result would be released. This is not in compliance with ASF strategy for Eastern Part of the EU (point 3.1.2.).

There is limited traceability of wild boar carcase meat pending laboratory testing as no means of identification is applied making it difficult to correlate test results to individual carcases / carcase parts.

The recommendation states as its basis

The competent authority confirmed that the expert group membership was changed in May 2016 and currently includes veterinarians, wildlife biologists and epidemiologists but no hunters which is contrary to Article 15(2) of Directive 2002/60/EC. The authorities indicated they have plans to expand group to include hunters and representation from the Ministry of the Environment.

The re-established expert group has not met formally and there were no records to confirm the informal meetings /contacts between group members which had taken place. The competent authority confirmed that the expert group has been invited to prepare a report on wild boar management covering improvements in hunting ground biosecurity, wild boar census and hunting quotas. To date, the expert group has not verified the effectiveness of the measures adopted to eradicate ASF from the infected area, which is not in line with Article 15(2)(a) of Directive 2002/60/EC.

The competent authority has not fully engaged the ASF expert group is to provide assistance with the control of ASF and to verify the effectiveness of eradication measures.

The recommendation states as its basis

The audit team reviewed one epidemiological investigation on a non-commercial holding. The authorities could not establish the origin of the two pigs on the outbreak holding as they were not identified as required by article 5(2) of Council Directive 2008/71/EC. The authorities confirmed that census performed in this District, following six further outbreaks of ASF in 2017, disclosed a further two non-commercial holdings where origin of pigs was unknown and two pig keepers who had not declared pigs. 5.1.3 Movement restrictions

The identification and registration deficiencies in some non-commercial farms significantly weaken the tracing of pigs and makes the containment of disease difficult in an outbreak.

The recommendation states as its basis

Where authorised veterinarians are used for biosecurity checks, there is no direct supervision of their work (see point 26 and 27).

The inter-District cross checks on biosecurity and internal audit on ASF controls contribute to the verification and harmonisation of disease control measures performed by officials in this area. No such verification and harmonisation currently exists for tasks performed by authorised veterinarians, who have a less severe interpretation of biosecurity requirements. This makes their contribution to ensure implementation of biosecurity measures less valuable.

The recommendation states as its basis

The private veterinarian of the consigning holding confirmed that he, rather than the official veterinarian, randomly selected healthy pigs for ASF sampling when required for intra-Union trade. The audit team confirmed that sick pigs were present on the holding at time of sampling and were not sampled. This was accepted practice by one certifying OV in the District authority visited and did not follow the requirements of a staff instruction. This is not in accordance with Part A of Chapter IV of the Annex to Decision 2003/422/EC.

Within Lithuania, movement controls are in place and reduce the risk of virus spread from infected area to non-infected area. Inadequate targeting of pre-movement testing weakens an otherwise satisfactory system for movement of live pigs from infected areas. This produces less guarantees than it could in reducing the spread of disease due to the movement of live animals from the infected area.

The recommendation states as its basis

With regard to the fulfilment of the minimum number of samples and isolates to be tested, the situation was as follows: Salmonella ­ not all available isolates gathered under the SNCP were reported, as required by Decision 2013/652/EU. This was also the case for the isolates gathered in the context of Regulation (EC) No 2073/2005, for 2014 and 2016 (see point 11). E. coli ­The required 85 isolates were gathered from caecal samples each year and a few more were reported in 2015 and 2016. C. jejuni­ The minimum 85 isolates to be tested was not reached in 2014 but was exceeded in 2016. ESBL- or AmpC-producing E. coli ­ The required number of samples (150) to be tested was achieved for 2015 and for 2016. Isolates from samples collected at poultry primary production

The number of Salmonella isolates gathered from samples taken per animal population is lower than the number of isolates required by the EU legislation. Point 2.2 of part A of the Annex to Decision 2013/652/EU requires that when this happens, all the Salmonella isolates available must be subject to AST and reported. This was not done, despite additional isolates being available. This is because no steps have been taken to ensure that isolates obtained from samples taken under farmers' own checks schemes are kept and made available to the NRL (as required by Article 6 of Directive 2003/99/EC, 4 see point 6). No steps have been taken either to ensure that if brought to this laboratory, these isolates are subject to susceptibility testing and reported. The following table provides an overview of the samples taken for Salmonella testing under the SNCP. The number of isolates obtained and the number of isolates subjected to AST for the years 2014 to 2016 are also included: Official Own control samples No No of No of isolates No of Samples No of isolates No of isolates Samples isolates tested for AMR tested for obtained taken obtained AMR and taken and reported reported Laying hens 2014 51 15 0 667 2 0 Broilers 2014 226 Turkeys 2014 9 0 0 1465 0 0 Laying hens 2016 26 Broilers 2016 208 0 0 35 2 0 Turkeys 2016 17 0 0 534 3 0 1 1 1631 4 0 6 6 25 0 0

The audit team noted that there were isolates from slaughterhouses own checks available at the NRL which were not subject to AST and reported, 6 in 2014 and 63 in 2016. In addition, 5 such isolates obtained by 1 of the slaughterhouse visited, (4 in 2014 and 1 in 2016) were not sent to the NRL and therefore did not undergo AST and were not reported. Isolates gathered from caecal samples collected at slaughter

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that reduce the representativeness of data obtained, in particular the lack of an even distribution of sampling over all months of the year, the lack of randomisation to select samples and sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operators' own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 12 and 33 of Regulation (EC) No 882/2004. Findings

Member state response

he minimum number of isolates is subject to antimicrobial susceptibility testing as required by point 2.2 of Part A of the Annex to Decision 2013/652/EU, the State Food and Veterinary Service (hereinafter ­ SFVS) has issued a letter to the territorial State Food and Veterinary Services, which informs that, as from 1 January 2018, food business operators and primary production farm holdings located in the areas under their control, upon detection of Salmonella during self-control analysis, have to arrange for the transfer of the isolate of this bacteria to the National Food and Veterinary Risk Assessment Institute for the analysis of serotype and antimicrobial resistance.

The recommendation states as its basis

Since 2014, SFVS annually drafts working instructions detailing the requirements concerning the sampling framework and analysis as set out in Decision 2013/652/EU. Whilst continuous improvements have been made since the inception of the programme in 2014, some issues still need to be brought fully in line with EU requirements, as follows: The number of samples to be taken annually was not based on the minimum number of isolates or samples (as applicable) laid down in point 2.2 of Part A of the Annex to Decision 2013/652/EU. Instead, it is based on the number of samples or isolates co-financed by the European Commission. As a consequence, the number of samples taken is not adjusted to make up for a low number of isolates being obtained over a year. As a result, the number of isolates obtained for Campylobacter jejuni in broilers in 2014 did not reach the minimum required. In addition, the collection of samples started in April in 2015, 2016 and 2017 (after the publication of the Grant Decision that details the co-financing), which affected the representativeness of the samples taken (see point 15). 3 The standard forms used to accompany the samples to the laboratory contain all the necessary information to fully identify and trace the samples, including the epidemiological unit of origin. 5.2.1.2 Sampling design Legal requirements Articles 1 to 3 of Decision 2013/652/EU; Article 4 to 7 of Directive 2003/99/EC. Findings 5.2.1.2.1 Sampling framework

Except for 2014, and contrary to the requirements set out in point 2.3.1 of part A of the Annex to Decision 2013/652/EU, the caecal samples gathered under the AMR monitoring programme were not evenly distributed over each month of the year, affecting the representativeness of these samples. Instead, monthly sampling took place only from April to December in 2015 and in 2016. Likewise, it started in April in 2017.

The days when sampling took place were not chosen randomly. This is due to pre- determined criteria (for instance, targeting specific farms of origin that were slaughtered on particular days or the availability of vehicles to transport the samples to the laboratory) were used instead. This is not in line with point 2.3 of Part A of the Annex to Decision 2013/652/EU.

In the poultry slaughterhouses visited the vast majority of samples taken came from different epidemiological units (flocks) but this was not the case in the pig slaughterhouse, where the number of epidemiological units (pig farms) was much smaller than the number of samples to be taken. This does not meet the requirements of point 2.3.1 of Part A of the Annex to Decision 2013/652/EU. Personnel from SFVS met declared that for 2019 they have already planned to sample from a higher number of pig slaughterhouses to increase the number of epidemiological units.

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that reduce the representativeness of data obtained, in particular the lack of an even distribution of sampling over all months of the year, the lack of randomisation to select samples and sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operators' own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 12 and 33 of Regulation (EC) No 882/2004. Findings

Member state response

ensure that sampling is representative, as from 1 January 2018, ing will be distributed evenly over each month, as required by point 2.3.1 of Part A of the Annex to Decision 2013/652/EU. A procedure for the analysis of prevalence of zoonotic and commensal bacteria in broiler chicken, laying hens, meat turkeys and fresh broiler chicken meat and for the analysis of antimicrobial resistance for 2018 has been approved by Order of Director of the SFVS, which will come into force as from 1 January 2018. Training has been planned to be conducted for responsible inspectors of the territorial SFVSs in January 2018 on sampling under this monitoring programme, including discussion of random sampling, as required by point 2.3 of Part A of the Annex to Page: 1 ref. DG(SANTE)/2017-6197-MR of the audit carried out from 12 ng of antimicrobial resistance in zoonotic and commensal bacteria in Action Proposed by the competent authority Decision 2013/652/EU. During the training, the inspectors will be explained that samples have to be selected in different seasons and from different epidemiological units. In order to ensure clear understanding of the sampling, the concept of "random samples" has been

The recommendation states as its basis

For the reasons detailed in point 7, significant delays were also noted in the implementation of the sampling plan at retail outlets. These delays can hamper the representativeness of the data collected, which is contrary to point 1d of Part A of the Annex to Decision 2013/652/EU. In addition, it does not take account of EFSA's technical specifications 2.

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the legislation. However, shortcomings were noted that reduce the representativeness of data obtained, in particular the lack of an even distribution of sampling over all months of the year, the lack of randomisation to select samples and sampling of repeated epidemiological units. The measures in place to gather Salmonella isolates from food business operators' own checks were also insufficient to achieve the objectives of Decision 2013/652/EU. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 12 and 33 of Regulation (EC) No 882/2004. Findings

Member state response

To ensure that sampling at retail is representative, the sampling plan for 2018 will be carried out from 1 January to 31 December, as required by Article 2(1) and point 1 of Part A of the Annex to Decision 2013/652/EU. In view of the EFSA technical specifications, the sampling plan will be designed to cover 80 per cent of the entire population of the country in different regions.

The recommendation states as its basis

The NRL holds an International Organisation for Standardisation (ISO) 17025 accreditation (issued by the National Accreditation Bureau). However, contrary to the requirements set out in Articles 12 and 33.3 of Regulation (EC) No 882/2004, not all methods applied for the official analysis of samples relevant to this audit are included in the scope of accreditation (just 2 out of 11). Consequently, they have never been checked by the accreditation body in the last 3 years. According to the representatives from the NRL met, it is planned to incorporate progressively the remaining methods in the coming 2 to 3 years.

The laboratory for the official monitoring of AMR is involved in proficiency tests with satisfactory results. However, the reliability of the data obtained and reported is affected by a) the limited extent to which methods relevant for AMR monitoring are included in the scope of accreditation and b) weaknesses in the internal quality control system. These weaknesses refer notably to the lack of consistent use of reference strain, the absence of viable counts on the test suspension when performing MIC determination and the validation of the MacConkey agar plates.

Member state response

The methods that are applied to the official analysis of samples have been validated and in May 2018 they will be submitted to the National Accreditation Bureau under the Ministry of Economy for accreditation. Page: 2 ref. DG(SANTE)/2017-6197-MR of the audit carried out from 12 ng of antimicrobial resistance in zoonotic and commensal bacteria in Proposed by the competent authority .4.4.B.36 Determination of antimicrobial resistance microdilution method 4.4.B.59 Determination of indicative commensal ichia coli in pathological material 4.4.B.61 Isolation of ESBL- and AmpC-producing ichia coli in clinical, pathological material and foodstuffs 4.4.B.64 Isolation of carbapenemases-producing ichia coli in clinical, pathological material and foodstuffs 6579-3:2014 Microbiology of the food chain ­ general for Salmonella detection, counting and serotyping. Part 3. ination of the serologic type for Salmonella.

The recommendation states as its basis

The AST performed for the latest reporting period included all the antimicrobials foreseen in Decision 2013/652/EU and results were interpreted using the epidemiological cut-off values and the concentration ranges foreseen in the legislation. Laboratory procedures were available on-the-spot and generally followed the relevant international standards. However, some shortcomings were noted by the audit team: MIC determination Quality controls with reference strains were not run every day that the tests were performed in order to monitor the quality of test results, as detailed in the ISO and Clinical and Laboratory Standards Institute (CLSI) relevant standards, and this alternative frequency had not been validated. In addition, viable counts on the test suspension were not carried out, as required by ISO 20776-1:2006 standard. This is not in line with point 3 of part A of the Annex to Decision 2013/652/EU. It was not possible to ascertain whether all the steps described in the laboratory standard procedures were actually followed because of gaps in the corresponding internal records. For instance, although manual records were kept of the working temperature for each incubator, they were not kept on the duration of the incubation phase. As a consequence, it is not possible to know if the incubation times described in the ISO or CLSI standards are respected. This insufficient record keeping is not in line with point 4.13.2 of ISO 17025 and therefore this does not fulfill the requirements of point 3 of part A of the Annex to Decision 2013/652/EU. Protocols for detection of presumptive E. coli producing ESBL and AmpC enzymes The procedure used for validating the plates of the MacConkey agar with cefotaxime does not correspond to the one published by the EURL. It is not used every time that any of the protocols for selective enrichment of ESBL or Carbapenemases are performed. This is not in line with point 4.1 of part A of the Annex to Decision 2013/652/EU. 8 5.2.2.4 Storage of the isolates

The laboratory for the official monitoring of AMR is involved in proficiency tests with satisfactory results. However, the reliability of the data obtained and reported is affected by a) the limited extent to which methods relevant for AMR monitoring are included in the scope of accreditation and b) weaknesses in the internal quality control system. These weaknesses refer notably to the lack of consistent use of reference strain, the absence of viable counts on the test suspension when performing MIC determination and the validation of the MacConkey agar plates.

Member state response

ments have been made to the method quality control plans inhibitory concentration determination tests and or AmpC- or carbapenemases-producing Escherichia coli) rdance with the recommendations of points 3, 4 and 5 of the Annex to Decision 2013/652/EU. 9.3-1 Quality Control Plan No 44 (SDP 5.4.4.B.36 ­ ination of antimicrobial resistance by the microdilution ) revision 2, 13-11-2017. 9.3-1 Quality Control Plan No 43 (SDP 5.4.4.B.61 ­ ion of ESBL- and AmpC-producing Escherichia coli in al, pathological material and foodstuffs); SDP 5.4.4.B.64 ­ ion of carbapenemases-producing Escherichia coli in al, pathological material and foodstuffs) revision 2, 02-11- Page: 3

Member state response

Recommendation accepted In response to draft audit conclusions the State Plant Service under the Ministry of Agriculture (SPS) will review and amend internal procedures for new plant protection products applications assessment and decision making when Lithuania is concern Member State. Deadline: June 2017.

Member state response

Recommendation accepted SPS will review and amend internal procedures for assessment and decision making of plant protection products applications submitted according mutual recognition procedure. Deadline: June 2017.

Member state response

s Recommendation accepted. SPS will review internal procedures for processing applications for renewal of authorisation. Deadline June 2017.

Member state response

mendation accepted will communicate with Commission and Member States decisions are taken concerning Article 36(3), and also the ther Member States and the European Food Safety Authority for decisions concerning Article 44(4) of Regulation (EC) No 1107/2009 Page: 1 y 2017 ANNEX II report ref. DG(SANTE)/2016-8782-MR of the audit carried out from 10 tion of plant protection products

The recommendation states as its basis

A high number of additional visits are carried out but these are not primarily unannounced although this is a requirement of Article 65(4) of Regulation (EC) No 889/2008. Furthermore, the risk assessment carried out to select additional visits to organic processors is not in line with Article 65(4) of Regulation (EC) No 889/2008 as it does not take into consideration the production quantities resulting in a reduced number of additional checks at processors handling large quantities of products. 5.2.4 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

The recommendation states as its basis

A high number of additional visits are carried out but these are not primarily unannounced although this is a requirement of Article 65(4) of Regulation (EC) No 889/2008. Furthermore, the risk assessment carried out to select additional visits to organic processors is not in line with Article 65(4) of Regulation (EC) No 889/2008 as it does not take into consideration the production quantities resulting in a reduced number of additional checks at processors handling large quantities of products. 5.2.4 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

The recommendation states as its basis

Derogations granted by the CCA comply with specific EU requirements with the exception of tethering of animals in small holdings. 12 5.2.8 Imports of Products from Organic Production Legal Requirements Articles 32 and 33 of Regulation (EC) No 834/2007. Regulation (EC) No 1235/2008. In particular, Article 7, Chapter 3 of Title III, Article 19 and Annexes II, III, V and VI. Findings

The recommendation states as its basis

Order No 3D-352 of 17 May 2012 describes the procedure for official controls on imports of organic products. The CtrlA, SFVS and Customs are involved in these controls: Importers have to inform the CtrlA of the intention to import products five days before the arrival of the consignment and to provide all the relevant information of the product including a copy of the certificate of inspection; The CtrlA has five working days to verify this information, in particular that the certifying body in the non EU country, or the category of the organic product, are included in Annexes III or IV of Regulation (EC) No 1235/2008. When compliance of this information with organic requirements is confirmed the CtrlA stamps the certificate of inspection indicating that it has to be checked by the SFVS ("prohibited to market without the authorisation of the SFVS"). The CCA immediately updates the CtrlA of any amendments that are made to Regulation (EC) No 1235/2008, in particular Annexes III and IV; The SFVS authorises the organic product for marketing after carrying out a physical and identity check. This check is carried out on all imported organic products, as required by Order No B1-255 of 2 March 2013 (see also paragraphs 1 and 44). The CCA also indicated that organic products of animal origin are not imported into the European Union through Lithuanian borders; The CCA and CtrlA indicated that Customs is responsible for completing Box 17 of the certificate of inspection after the SFVS carries out the physical and identity check. Article 20 of Order No 3D-352 of 17 May 2012 however indicates that the SFVS is the relevant authority responsible for completing Box 17 under the provisions of Article 13(8) of Regulation (EC) No 1235/2008. The audit team noted that the CCA was aware of this difference between the written procedure and the controls although it had not modified the procedure to be in compliance with the requirements of Article 8(1) of Regulation (EC) No 882/2004.

Samples of certificates of inspections were seen by the audit team. Box 17 had been completed by Customs officials and Box 18 had been completed by the first consignee, which is in line with Article 13 of Regulation (EC) No 1235/2008. 13 Conclusions

Although the import controls that are being implemented do not fully adhere to the written procedure put in place by the CCA, they adequately ensure compliance with the requirements of Article 33 of Regulation (EC) No 834/2007 and Article 13 of Regulation (EC) No 1235/2008. 5.2.9 Measures in cases of irregularities and infringements Legal Requirements Articles 54 and 55(1) of Regulation (EC) No 882/2004. Article 30 of Regulation (EC) No 834/2007. Articles 91, 92, 92a and 92d of Regulation (EC) No 889/2008. Findings

The recommendation states as its basis

There is a well-developed catalogue of sanctions for non-compliances but in some cases the cumulative nature of the non-compliances detected is not taken into account resulting in an incorrect perception of the severity of the non-compliance and, consequently, enforcement measures that are neither proportionate nor dissuasive.

The recommendation states as its basis

The audit team noted that the competent authority made available to the staff of the BIPs visited the procedures related to transit movements (i.e. controls of transits at entry and exit BIPs and at Customs warehouses). The available procedures were up-to-date in the BIPs visited and staff also has access to the internal IT network of the competent authority which includes the entire documented system for the official import controls. 3 This is used by staff in order to be kept up-to-date in the area of their competence as required by Article 6(b) of Regulation (EC) No 882/2004. The audit team noted the following exceptions: a. previous FVO audit report (2013-6962) recommended that the competent authority develop the procedure in order to ensure that BIP staff is up-to-date on the specific provisions applicable to transits of live animals. The competent authority stated that this was under review and provided the draft version to the audit team. b. there was no procedure for the controls of external transits. BFVCD is the competent authority responsible but has not planned the controls of external transits, which are required by Article 6(1) of Directive 89/662/EEC. Those controls would aim at preventing that EU goods transiting via third countries with specific animal health risks re-enter the Union. However, due to geographical position and the trade patterns of Lithuania, those movements are limited. The audit team did not find evidence of such movements in TRACES and the competent authority confirmed this during the audit.

The competent authority has implemented the requirements for communication, cooperation and training to support the overall functioning of the controls on transits, except in regard of transits of live animals (which was a recommendation of the 2013 FVO audit) and controls on external transits (which are not included in the planning of controls).

The competent authority stated that the port and rail BIPs visited conduct manifest checks (with a view to identifying possible cases of consignments not presented at the BIPs) on an ad hoc basis and there is no recording of these controls. The road BIP visited does not monitor incoming consignments in order to identify cases that should be subject to veterinary controls, contrary to the requirements of Article 7 of Regulation (EC) 136/2004 and Article 6 of Regulation (EC) 282/2004. The audit team noted that the procedure for controls of transits does not refer to the above-mentioned requirements. 5.2.1.2 Veterinary checks

The audit team noted that the instruction for the controls of transits at entry BIPs is not sufficiently clear on the different cases faced by officials. In particular it is not clear when the BIP staff need to perform a full identity check and whether consignments that have been rejected should leave the BIP sealed (a case was noted in which the rail BIP performed a full identity check on a consignment and rejected it unsealed). The above may lead to a lack of consistency in the related controls among the different BIPs.

Member state response

Standard operating procedure of the quality system KT-6-10 "On veterinary checks of live animals in transit", work instruction KT-6-10-D1 "Veterinary checks at a border inspection post (hereinafter ­ BIP) of entry of live animals in transit" and work instruction KT-6-10-D2 "Veterinary checks at a BIP of exit of live animals in transit" were approved by Order No. B1-406 of SFVS Director of 7 May 2015. The border veterinary control procedure for EU consignments that have transited via third countries and re- entered the EU territory via a BIP will be drawn up and is envisaged to be approved by the 2nd quarter of 2016.

The recommendation states as its basis

The specific conditions for transit via the EU territory between Kaliningrad and mainland Russia are implemented following the requirements of EU legislation, with some weakness in the identity checks ­ which are limited to tail checks ­ that may lead to the non-detection of consignments that do not tally exactly with the description in the accompanying document.

Member state response

re Order No B1-312 of SFVS Director of 03-04-2015 "On other veterinary checks of consignments of animal origin products he coming in transit from the Russian Federation to the Russian 78/EC. Federation via the territory of the Republic of Lithuania" was approved to improve the veterinary control of consignments shipped in transit via the territory of the Republic of Lithuania between the Kaliningrad Region and the Russian Federation. Oder No B1-312 establishes that a veterinary inspector after risk assessment of animal origin consignments, which are transported in transit from the Russian Federation to the Russian Federation, can only carry out the seal check, a partial identity check in case the means of transport are Page: 1 etent authority on 14 August 2015 ons of Report ref. DG(SANTE)/2015-7433-MR of the Audit carried out from 23 ntrols on consignments in transit sealed by the seal of a veterinary inspector of the Russian competent veterinary authority. After the veterinary control only "seal checks" is marked in box 27 of CVED. The training course for veterinary inspectors of BIPs will be organized in the 4th quarter of 2015, where the shortcomings detected during the inspecti

The recommendation states as its basis

The official control system of transit consignments at the entry BIPs ensures that only consignments eligible for transits are accepted as required by EU legislation with the exception of specific shortcomings on (i) the enforcement of pre-notification requirements in one BIP and (ii) the screening of available information on arriving consignments in another BIP that reduce the ability to detect consignments that should undergo border controls. 5.2.2 Controls at warehouses

Member state response

To ensure that Part I of a Common Veterinary Entrance t Document (hereinafter ­ CVED) is presented to the BIP before arrival of the consignment and the information in it is fully in conformity with the arriving consignment, letter of SFVS No. B6-(1.9)-1816 of 21 July 2015 was sent to Lithuanian Customs Brokerage Association. The letter informed that the customs broker (operator) should deliver Part I of the CVED before the consignment is presented to the BIP for veterinary control and explained how Part I of the CVED should be filled in. A training course for customs brokers is planned to be organized in the 4th quarter of 2015 by specialists of the State Food and Veterinary Service, where information concerning the delivery of Part I of the CVED to a BIP and data entry in the Traces information system will be presented.

The recommendation states as its basis

The official control system of transit consignments at the entry BIPs ensures that only consignments eligible for transits are accepted as required by EU legislation with the exception of specific shortcomings on (i) the enforcement of pre-notification requirements in one BIP and (ii) the screening of available information on arriving consignments in another BIP that reduce the ability to detect consignments that should undergo border controls. 5.2.2 Controls at warehouses

Member state response

ble In the 4th quarter of 2015 the new information system red "Electronic service of electronic submission of customs 5 declarations on a single window basis" (hereinafter ­ single Page: 2 rity on 14 August 2015 ons of Report ref. DG(SANTE)/2015-7433-MR of the Audit carried out from 23 ntrols on consignments in transit em), which is based on a single start operating. When it starts cers will be able to complete a case the veterinary control procedure nsignment and the number of CVED the customs declaration. The local eive all pre-notifications of t the border control post through this on system and in case the ubjected to veterinary control, the ally get a feedback notification that VED part I) should be sent via the em to the BIP. A list of animals and with Customs Nomenclature Codes ry control should be performed is window information system. Page: 3

The recommendation states as its basis

As regards transporters, the audit team noted that in some cases the transporters indicated on the commercial documents were not identical to the ones indicated on the CMR way bill. Some of the transporters mentioned on the CMR way bills seen by the audit team during the visits to operators were not registered as ABP transporters.

In the pet food plant visited, an inspector had identified during a previous official control that a transporter used by a supplier was not a registered ABP operator. The pet food plant was requested to stop using this transporter. The audit team noted that this approach does not prevent the transporter from continuing to transport ABP for other operators without being registered. The inspector confirmed that this transporter was never used again to deliver products to the pet food plant, however, he could not say whether the transporter is now registered as an ABP operator or not.

In one of the paper traders visited, the audit team noted that the operator engaged in the trade of ABP/DP before being registered by the competent authorities; three consignments 5 were traded prior to becoming registered. According to the trader, the trading partners were the ones to highlight the obligation to be registered (see paragraph 17). 5.1.3 Organisation, planning and execution of official controls

The competent authorities have the necessary elements to maintain and implement a system of official controls as required by Regulation (EC) No 1069/2009 which is enhanced by the implementation of the quality management system in place for official controls and the good co-operation and co-ordination between SFVS and territorial SFVS; however, the effectiveness of the system is negatively affected by a number of transporters or traders not being registered as ABP operators before engaging into activities in the ABP/DP chain and consequently not being controlled. Official controls are well documented, planned on the basis of a risk assessment and executed as planned. Weaknesses arising from the use of the hygiene focused check-lists are expected to be addressed by the newly introduced traceability-specific check-list, which will enhance the effectiveness of official controls for the traceability of ABP/DP.

Member state response

g the chain On 29 September 2014, following Order No B4-629, a meeting was organised where the chiefs stered of the territorial SFVSs were presented the irregularities identified during audit. by The Quality Management Programme KT-2-4-11 "Official Veterinary Control of Animal By- Handling Establishments" will be amended by the end of the 1st quarter of 2015 by sion adding a new chapter, which would ensure the actions to be performed by inspectors to ensure that all the transporters engaged in the activity were registered with the application of the new traceability checklist approved by Order No B1-506 of 09/06/2014. Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015.

The recommendation states as its basis

In most plants and operators visited, the audit team identified a number of non-compliances, in particular in relation to commercial documents. In the traders visited for instance, it was noted that in order not to disclose their suppliers of materials, traders were generating a pair of fictitious commercial documents in which they appeared as either the destination or origin of a consignment, although the product neither ever arrived to their premises nor to Lithuania (in cases where the producer was located in another Member State). Information that would allow the origin of the product to be identified (e.g. Producer approval numbers, 8 batch numbers or container seal numbers) was omitted on dispatch commercial documents. The link between the two documents was the quantity and the date of purchase and dispatch (which corresponded). Products traded by paper traders are not accompanied to the destination by original commercial documents as required in Annex VIII, Chapter III to Regulation (EU) 142/2011 if the producers are based in another Member State, because the commercial document for dispatch is filled in and faxed to the transporter to accompany the products.

The audit team noted that several commercial documents were not properly filled in and information given was not valid. In one case for instance, the trader included his Lithuanian registration code in the field foreseen for the approval code of the producer. In other cases, commercial documents indicated a different country of destination than the actual plant of destination. In others, a competent authority from a different Member State than the one responsible for the consignor of the product was indicated. Official controls overlooked these shortcomings because the check-lists used during official controls were not adequate to cover in depth traceability issues.

Significant progress was made in 2014 as regards confirmation of arrivals in TRACES of certain consignments of ABP/DP dispatched to Lithuania which covered all consignments since the beginning of the year. Official controls in ABP establishments tended to overlook certain shortcomings in relation to the traceability of ABP/DP and commercial documents as a result of the check-lists used; this issue is expected to be addressed by a recently introduced check-list on traceability. The channelling procedure in place for imported raw ABP for the production of pet food is not fully in line with the requirements of the legislation because channelling is not extended until this reaches the pet food plant where the processing of this material takes place.

Member state response

ring On 29 September 2014, following Order No B4-629, a meeting was organised where the chiefs quired of the territorial SFVSs were presented the irregularities identified during audit. /2009, The Quality Management Programme KT-2-4-11 "Official Veterinary Control of Animal By- in Annex Product Handling Establishments" will be amended by the end of the 1st quarter of 2015 by adding a new chapter with the procedure for checking the commercial document through ion checking all paper traders with the application of the new traceability checklist approved by Order No B1-506 of 09/06/2014. Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015.

The recommendation states as its basis

The audit team noted that the channelling procedure followed for the imported raw ABP for the production of pet food is not fully in line with the requirements of Article 8(4) of Council Directive 97/78/EC. This is because: imported raw ABP are dispatched from the BIP to an intermediate storage plant, which, according to the publicly accessible lists of ABP operators, is not authorised for channelling procedures in accordance with Article 8 of the said Directive (only the pet food plant supposed to finally receive the products is authorised for that purpose). Imported consignments are split into several sub-consignments and are gradually dispatched over a period sometimes exceeding 12 months to the pet food plant accompanied by a commercial document which also lists ABP from intra-EU trade or national production, as if the channelling of the imported raw ABP ended at the intermediate storage plant and the ABP are already in free circulation. In addition, the audit team noted that the veterinary officer responsible for the storage plant is not verifying whether dispatched quantities of the channelled imported raw ABP arrive at the pet food plant concerned; the only verification carried out concerns checking in some cases (not systematically) the weekly reports of the storage plant where the remaining stocks of the ABP are listed, and signing some documents when a zero balance appears. 7 The audit team also noted that the veterinary inspector responsible for official controls in the pet food plant does not provide any feedback to the officer responsible for the storage plant about the arrival of quantities of channelled imported raw ABP.

Significant progress was made in 2014 as regards confirmation of arrivals in TRACES of certain consignments of ABP/DP dispatched to Lithuania which covered all consignments since the beginning of the year. Official controls in ABP establishments tended to overlook certain shortcomings in relation to the traceability of ABP/DP and commercial documents as a result of the check-lists used; this issue is expected to be addressed by a recently introduced check-list on traceability. The channelling procedure in place for imported raw ABP for the production of pet food is not fully in line with the requirements of the legislation because channelling is not extended until this reaches the pet food plant where the processing of this material takes place.

Member state response

followed On 29 September 2014, following Order No B4-629, a meeting was organised where the chiefs n of pet of the territorial SFVSs were presented the irregularities identified during audit. nts of The Quality Management Programme KT-2-4-11 "Official Veterinary Control of Animal By- EC, Product Handling Establishments" will be amended by the end of the 1st quarter of 2015 by he adding a new chapter concerning the strengthening of controls at the place of destination. At the plant where moment, a storage where ABPs as well as products (raw materials) subject to controls carried out ased on by an appointed veterinarian until they reach the place of destination arrive has been approved. Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015. The work instruction KT-6-1-D4 on procedure after veterinary checks of products of animal origin imported from third countries will be amended by the 1st quarter of 2015 with the reference that imported channelled consignments could be sent from the BIP to an intermediate storage plant, which, is authorised for channelling procedures in accordance with Article 8 of Council Directive 97/78/EC and

Member state response

As FBOs carry out their activities in a cold store approved by CCA and as they are registered and checked together with the approved cold store and having regard to the provision provided in point 4.4 of the Guidance document on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin on the approval of cold stores we consider that, in accordance with Article 4(2) of Regulation (EC) No 853/2004, registration could be sufficient for the FBOs renting individual cameras in the cold store without requiring any separate approval for them.

Member state response

On 02/12/2014, training was conducted for inspectors of A, territorial SFVSs during which they were presented the labelling infringements detected during the FVO audit, requirements for the application of identification marks were explained with the special emphasis on the requirement that the marking of products intended for the final consumer with the identification mark has to be endured before they leave the establishment. The territorial SFVSs where the infringement had been detected in establishments under their control have delivered evidence on actions taken in the establishments to rectify the infringement.

Member state response

On 02/12/2014, training was conducted for inspectors of territorial SFVSs. Inspectors were presented the infringement related to insufficient information in case of moving a product from one establishment to another Page: 1 ns of Report ref. DG(SANCO)/2014-7106-MR of an Audit carried out from 09 al controls over the post-slaughter traceability of meat, meat products and oof. establishment; requirements for the transfer of information on products set out in Article 3 of Regulation (EU) No 931/2011 were explained. The territorial SFVSs where the infringement had been detected in establishments under their control have delivered evidence on actions taken in the establishments to rectify the infringement and on the implementation of the procedure for the delivery of information on products when they are moved from one establishment to another. Page: 2

Member state response

All hunting clubs should be repeatedly instructed by the State Food and Veterinary Service (SFVS) territorial branches till 15 September 2014 (Order of the Director of 19 August 2014 No B1- 727 attached).

Member state response

All measures for passive surveillance in domestic pigs are set up m by the Order of the Director of SFVS of 17 February 2014 "On e in African swine fever monitoring and control measures" with the last amendments on 6 August 2014 (https://www.e- tar.lt/portal/legalAct.html?documentId=eda46460987b11e3bdd0a 9c9ad8ce1bf).

Member state response

All measures for inspection of each wild boar carcass are set up by the Order of the Director of SFVS of 17 February 2014 "On frican swine fever monitoring and control measures" with the last amendments on 6 August 2014 (https://www.e- tar.lt/portal/legalAct.html?documentId=eda46460987b11e3bdd0a 9c9ad8ce1bf).

Member state response

ich By the Decision of the SFSV Director ­ State Level Emergency anager on 21 August 2014 No B1-746 all pig keepers should till 15 September 2014 renew data about pigs kept and to register all places without any sanctions which are not registered yet and to notify about any movement of pigs kept or introduced to the holding (attached).

Member state response

the Under progress

Member state response

d The expert group meeting was held on 19 May 2014. During the meeting current situation on ASF was presented together with the s, as last draft of ASF eradication plan, which was intended to be sent Page: 1 eport ref. DG(SANCO)/2014-7295 -MR of a/an audit carried out from 14 ealth controls in relation to African swine fever on after expert group mber and all the remarks he submission. Presentation

Member state response

rder to strengthen the official control of consignments at the place estination in the Republic of Lithuania, an amendment to the Quality Standard Operating Procedure KT-2-4-2 "Official Veterinary on Health of Farm Animals" with the addition of specific tions on entering data in TRACES about arrival of animal ments from other Member States as well as to the Quality System d Operating Procedure KT-2-4-11 "Official Veterinary Control al By-Product Handling Establishments" with the addition of c instructions on entering data in TRACES concerning the control from other Member States has to be in place by 1 November program and instructions KT-6-1 "Procedure for veterinary on products of animal origin imported from third countries" and "Procedure for veterinary control on life animals imported from ountries" will be amended by adding specific instructions on g data in TRACES and completion/printing of CVED from in order to eliminate the risk of typing mistakes. The nts will also cover the requirement to receive the confirmation e place of destination about the arrival of the consignment of live or products of animal origin as required by EU legislation led, re-imported and live animals

Member state response

ress this recommendation NRMP for 2013 has been der No B1-380 of SFVS Director of 23 May 2013 idelines on sampling for implementation of NRMP for en approved by the Order No B1-376 of SFVS Director

CA response 28 May 2013: r 1 In order to address this recommendation NRMP for 2013 has been amended by the Order No B1-380 of SFVS Director of 23 May 2013 along with the guidelines on sampling for implementation of NRMP for 2013 that have been approved by the Order No B1-376 of SFVS Director of 22 May 2013.

Member state response

ddress this recommendation NRMP for 2013 has been der No B1-380 of SFVS Director of 23 May 2013 nes on sampling for implementation of NRMP for en approved by the Order No B1-376 of SFVS Director

of the CA response 28 May 2013: line In order to address this recommendation NRMP ve for 2013 has been amended by the Order No B1-380 of SFVS Director of 23 May 2013 along with the guidelines on sampling for implementation of NRMP for 2013 that have been approved by the Order No B1-376 of SFVS Director of 22 May 2013.

Member state response

of laws and basic principles related to food chain ved for all cattle, pigs and horses at the slaughterhouse, als received from other Member States will be prepared 3rd quarter of 2013. Page: 1

CA response 28 May 2013: ses at the The new set of laws and basic principles related eived to food chain information received for all cattle, e pigs and horses at the slaughterhouse, including animals received from other Member States ction will be prepared by the end of 3rd quarter of to 2013. Page: 1 Updated Action Plan received from CA on 26 September 2013 (Rec.N°3) d by the Competent Authorities of Lithuania on 28 May in response to Report ref. out from 18 to 22 March 2013 in order to evaluate the control of residues and contaminants on Proposed by the Competent Authority ted response received from CA 26 ember 2013 esponse 26 September 2013: Order of SFVS director will be issued in beginning of October 2013. Order will ude obligation for official veterinarians erify that all cattle, pigs and horses that from Member States are accompanied declaration on the use of veterinary cinal products as required by lation 853/2004 Section III (point 3.(c) .(b)) of Annex I. If declaration is not vered to official veterinarian, animals ot be slaughtered. Internal Audit rtment of SFVS during audits must fy if territorial SFVS is in compliance Section III (point 3.(c) or 4.(b)) of x I to Regul

Member state response

ruction No. KT-6-3-D5 "Procedures in case of on import and transit consignments of live instructions to deal with exceptional circumstances mortality of animals during transit) is drafted and it July 2013. nary Service organized the discussion with deral Service for Veterinary and Phytosanitary ussian Federation (central and Kaliningrad region) s decided to create international working group d agree the rules on specific situations during nd production cattle from Kaliningrad region to the he working group will include representatives of of Lithuania, Poland, Russian Federation and Page: 1

Member state response

Pursuant to point 5 of the trilateral order No B1-196/ 1B-244/ 4-314 of the Director of the State Food and Veterinary Service, Director General of the Customs Department under the Ministry of Finance of the Republic of Lithuania and Commander of the State Border Protection Service under the Ministry of Interior of the Republic of Lithuania of 29 April 2009 on the approval of procedure for the official control of animal products imported from third countries for personal use (Official Gazette, 2009-05-05, No 50-2026), the official control of consignments of animal products brought from third countries, which are not accompanied by veterinary documents, shall be performed by the Customs Department under the Ministry of Finance of the Republic of Lithuania and the State Border Protection Service under the Ministry of Interior of the Republic of Lithuania (https://www.e-tar.lt/portal/forms/legalAct.html?documentId=TAR.0450F2A88EF9) The Customs Department under the Ministry of Finance of the Republic of Lithuania has informed that they had studied the European Commission Audit Report and had no comments on it. In view of Article 6(b) of the Commission Regulation (EC) No 206/2009 of 5 Ma

Member state response

eterinary Sanitary Department of SFVS is holding n small groups) with the inspectors of territorial SFVS who inspections of animal food handling businesses. At the hasis is placed on the shortcomings of the official ed. In conducting audits on the operation of the , attention will be paid to the adequateness of e compliance with the hygiene requirements at the nd to the registration of the detected shortcomings.

Member state response

2 a training seminar on the topic "Parasites in meat that risk for human health" is held for veterinarians working in with the following presentations: thod of detection of trichina larvae and its on quality assurance of the reference method for china larvae"; irements for official quality control of Trichinella in meat that present risk for human health. Differential 012 a proficiency testing with control samples of the ch perform Trichinella examination is envisaged. with the inspectors of territorial SFVS emphasis is sity to check during the inspection of slaughterhouses, ith the requirements of the facilities, equipment, Page: 1 y 2012 t ref. DG(SANCO)/2012-6357-MR of an audit carried taken by the competent authorities with regard to official and their products Action Proposed by the Competent Authority thods used for trichina examination.

Member state response

2012 a seminar was held by the SFVS for the specialists al SFVS on the topic "New requirements for labelling of Topical issues of official control on food labelling". The made included compliance with the compulsory beef quirements of Regulation (EC) No 1760/2000 with an common labelling mistakes and presentation of specimen e labelling. eef labelling requirements will be stressed during the h inspectors of territorial SFVS.

Member state response

s of territorial SFVS responsible for official control on the nimals have been informed about the shortcomings of the ements at the time of killing identified during the audit. uarter 2012 a training course is planned for the officials of SFVS responsible for official control on the welfare of he implementation of the welfare requirements at the time quarter 2012 is planned development of the procedure on of the persons involved in killing of animals and related laughterhouses and issue of competence certificates as in Articles 7 and 21 of Council Regulation (EC) No. Page: 2

Member state response

and Before end of 2nd quarter of 2012, the contingency plans for CSF and EC, the ASF (hereafter ­ CP) will be supplemented with a specific provision that ers, in a case of suspicion about contagious diseases or uncertain epizootic ility of situation on the farm the SFVS must be notified immediately. From 20-03-2012 to 19-04-2012 trainings were conducted during which the officials of territorial SFVS were familiarised with the comments of the mission and were obliged to conduct similar trainings for private vets and animal keepers of their area with an emphasis on importance of notification about suspected contagious disease. Before end of 2nd quarter of 2012, the standard operating procedure of the quality system KT-2-4-13 "Preparation of contingency plans for contagious animal diseases" will be supplemented, with a provision that all the private vets must be familiarised (subject to signature) with all the CP worked out by the territorial SFVS and e-mail versions of the plans will be transmitted to them.

and Before end of 2nd quarter of 2012, the contingency plans for CSF and EC, the ASF (hereafter ­ CP) will be supplemented with a specific provision that ers, in a case of suspicion about contagious diseases or uncertain epizootic ility of situation on the farm the SFVS must be notified immediately. From 20-03-2012 to 19-04-2012 trainings were conducted during which the officials of territorial SFVS were familiarised with the comments of the mission and were obliged to conduct similar trainings for private vets and animal keepers of their area with an emphasis on importance of notification about suspected contagious disease. Before end of 2nd quarter of 2012, the standard operating procedure of the quality system KT-2-4-13 "Preparation of contingency plans for contagious animal diseases" will be supplemented, with a provision that all the private vets must be familiarised (subject to signature) with all the CP worked out by the territorial SFVS and e-mail versions of the plans will be transmitted to them. The attached Contingency Plan for CSF and ASF was amended on 25 September 2012. The attached standard operating procedure of the quality system KT-2- 4-13 "Preparation of continge

Member state response

in A letter of National Food and Veterinary Risk Assessment Institute t as (NFVRAI) has been sent (16-04-2012, No. 3A-248) to the Pathology Centre of the Veterinary Academy under the Lithuanian University of re that Health Science (hereafter ­ Centre) in which the Centre is obliged, in o the cases of suspicion of contagious disease to deliver samples for extra nfirmatory laboratory tests to the NFVRAI.

in A letter of National Food and Veterinary Risk Assessment Institute t as (NFVRAI) has been sent (16-04-2012, No. 3A-248) to the Pathology Centre of the Veterinary Academy under the Lithuanian University of Page: 1 ndations of Report ref. DG(SANCO)/2012-6386-MR of an audit carried tions taken during recent outbreaks of classical swine fever and to assess y the Competent Authority re that Health Science (hereafter ­ Centre) in which the Centre is obliged, in o the cases of suspicion of contagious disease to deliver samples for extra nfirmatory laboratory tests to the NFVRAI.

Member state response

sure, Before end of 2nd quarter of 2012, the standard operating procedure of Page: 1 mendations of Report ref. DG(SANCO)/2012-6386-MR of an audit carried actions taken during recent outbreaks of classical swine fever and to assess Action Proposed by the Competent Authority ct CSF the quality system KT-2-4-13 "Preparation of contingency plans for igs, contagious animal diseases" will be supplemented with a provision that place in in a case of suspicion about contagious diseases or uncertain epizootic situation on the holding, after completion of Annex 1 to the above SOP all movement into/out of the holding must be stopped immediately pending the laboratory test results rejecting the suspicion of contagious disease or following completion of a detailed epizootic examination. Such an administrative order will be handed to the owner of the holding immediately in the case of suspicion of disease.

sure, Before end of 2nd quarter of 2012, the standard operating procedure of ct CSF the quality system KT-2-4-13 "Preparation of contingency plans for igs, contagious animal diseases" will be supplemented with a provision that place in in a case of suspicion about contagious diseases or uncertain epizootic situation on the holding, after completion of Annex 1 to the above SOP /out of the holding must be stopped immediately atory test results rejecting the suspicion of contagious ing completion of a detailed epizootic examination. ative order will be handed to the owner of the holding e case of suspicion of disease. dard operating procedure of the quality system KT-2- of contingency plans for contagious animal diseases" on 25 September 2012.

Member state response

ance Before end of 2nd quarter of 2012, the CP for CSF and ASF will be 9/EC, supplemented with a specific provision that in a case of suspicion about ontagious diseases or confirmation of the disease, in the corresponding ve SFVS a responsible official shall be appointed to daily monitor the movement of animals in the central database of the Farm Animal Register (hereafter ­ CDB) and to report the detected discrepancies to the Infectious Disease Control Centre of SFVS. The holdings located in the protection and surveillance zones will be "locked" via CDB and each holding will be given instructions on the restriction of animal movement.

ance Before end of 2nd quarter of 2012, the CP for CSF and ASF will be 9/EC, supplemented with a specific provision that in a case of suspicion about ontagious diseases or confirmation of the disease, in the corresponding ve SFVS a responsible official shall be appointed to daily monitor the ls in the central database of the Farm Animal Page: 2 ndations of Report ref. DG(SANCO)/2012-6386-MR of an audit carried tions taken during recent outbreaks of classical swine fever and to assess Action Proposed by the Competent Authority Register (hereafter ­ CDB) and to report the detected discrepancies to the Infectious Disease Control Centre of SFVS. The holdings located in the protection and surveillance zones will be "locked" via CDB and each holding will be given instructions on the restriction of animal movement. The attached Contingency Plan for CSF and ASF was amended on 25 September 2012.

Member state response

ance Before end of 2nd quarter of 2012, the CP for CSF and ASF will be of supplemented with Annex 1 referred to in point 3 of this AP. gs, are Page: 2 mendations of Report ref. DG(SANCO)/2012-6386-MR of an audit carried actions taken during recent outbreaks of classical swine fever and to assess Action Proposed by the Competent Authority

ance Before end of 2nd quarter of 2012, the CP for CSF and ASF will be of supplemented with Annex 1 referred to in point 3 of this AP. The attached Contingency Plan for CSF and ASF was amended on 25 gs, September 2012. are

Member state response

the From 20-03-2012 to 19-04-2012 trainings were held for all official leted. To veterinarians of territorial SFVS responsible for health and movement ntrol of farm animals. At the trainings were discussed the provisions horses of Commission Regulation (EC) No 504/2008 on registration and identification of equidae with an emphasis on the horses intended for ent slaughter, i.e. the requirements for treatment and withdrawal periods. ines Furthermore a draft communication "On registration and identification of equidae" for territorial SFVS has been prepared and is envisaged for distribution to all territorial SFVS by the end of May 2012. Page: 3

the From 20-03-2012 to 19-04-2012 trainings were held for all official leted. To veterinarians of territorial SFVS responsible for health and movement ntrol of farm animals. At the trainings were discussed the provisions horses of Commission Regulation (EC) No 504/2008 on registration and identification of equidae with an emphasis on the horses intended for ent slaughter, i.e. the requirements for treatment and withdrawal periods. ines Furthermore a draft communication "On registration and identification of equidae" for territorial SFVS has been prepared and is envisaged for distribution to all territorial SFVS by the end of May 2012. Page: 3 ndations of Report ref. DG(SANCO)/2012-6386-MR of an audit carried tions taken during recent outbreaks of classical swine fever and to assess y the Competent Authority unication "On registration and identification of itorial State Food and Veterinary Services was signed n 17 May 2012. By this communication practice of rt for horses just before they are slaughtered was es can be slaughtered only if information about the reatment used in the passport is not less than 6 months.

Member state response

tate Food and Veterinary Service will agree until 1 October 2012 with: The Customs Department under Ministry of Finance on necessity to make internal audits on implementation of the controls on personal luggage and pet animals. The findings of those audits will be provided to r the State Food and Veterinary Service. 2. The Border Guard Service under the Ministry of the Interior on necessity to make internal audits on implementation of the controls on personal luggage. The findings of those audits will be provided to the State Food and Veterinary Service. 3. Klaipda port authority on necessity to make internal audits on implementation of the controls of galley waste from international ships arriving to Klaipda port. The results of those audits will be provided to the State Food and Veterinary Service. Page: 1

Member state response

of 2012 a seminar is envisaged for the specialists of topic "Application of the HACCP system in ng businesses": actors (including the fish from the Baltic region nitoring of CCP, corrective actions; ection procedures, sampling in accordance with islation (drawing up plans); s of the HACCP system (documents, records). Page: 1

Member state response

ions for fur animal farms are being prepared and they so the requirement for the enclosures and buildings that ed and constructed so as to minimize the entry of rats, It is expected that the project of recommendations will il January 2014.

Member state response

ressed the European Law Department under Ministry of 21 November 2012 by letter No. B6-(1.19)-2617 and asked to istake in translation of point 7 Annex I Council Directive 14 February 2013 SFVS has received a notification that icable in according to the Council Statement of 1975 on rs in one language version will be applied, so SFVS has oject of the amendment of the Order of the Director of l 2010 No. B1-173 approving welfare requirements for and this amendment is being harmonised with the act will be amended, the relevant SOP will be corrected 1 June 2013.

Member state response

D On verification of effectiveness of official controls on 16 November 2012 by order No. B1-918 and the for the controls is in place as required by Art. 8(3) of tion (EC) No 882/2004.

Member state response

D1 will be amended until 1 June 2013. And the calculation of broiler chicken density will be in line with Page: 1 ref. DG(SANCO)/2012-6526-MR of an audit carried for animal welfare on farms and during transport Action Proposed by the Competent Authority Directive 2007/43/EC.

Member state response

No 1099/2009 is applied directly and the questionnaire king of killing of animals (other than slaughtering) (annex 3 of cludes the requirements that animals must be killed in th the legal requirements. The SOP KS-2-4-6 D1 will be until 1 June 2013 and it will include the requirement for killing on farms. s planned a training of official veterinarian on welfare ments in III quarter 2013 and this issue will be covered.

Member state response

logs before being approved by the official veterinarian of the the region are revised by the specialists from the central SFVS ensure that they are realistic and in compliance with EC) No 1/2005 Article 14(1) (a) (ii).

Member state response

ritorial SFVS perform the checks of returned journey logs and SFVS carry out verification of the controls when randomly g the returned journey logs and data of the tachometers. Page: 2

Member state response

perform import control of non-animal food were given ssues of official food control. Import control of non- 6 December 2011. d include: documentary, identity, physical check; and its keeping; taking of samples: microbiologica cotoxins, pesticides, heavy metals, ionised es, 3-MCPD, dioxins), tests on genetic modification; on sample taking from food/feed; New developments . In drawing up the training plan for 2012 the fficials who perform import control of non-animal food

ls who perform import control of non-animal food were aining "Topical issues of official food control. Import non-animal food" on 6 December 2011. presented include: documentary, identity, physical check; sampling equipment and its keeping; taking of samples: logica tests, chemical (mycotoxins, pesticides, heavy d irradiation, nitrates, 3-MCPD, dioxins), tests on genetic modification; Filling in a report on sample taking from food/feed; New developments in the RASFF system. In drawing up the training plan for 2012 the trainings for the officials who perform import control of non-animal food will be included.

Member state response

d authorised CPs has been updated and put on the State Food and Veterinary Service (SFVS) as required by ulation (EC) No 1152/2009 and Article 19(2) of 669/2009. Link: ads/file/docs/Ivezimo%20punktai.doc

ist of DPIs and authorised CPs has been updated and put on ebsite of the State Food and Veterinary Service (SFVS) as red by Article 6(2) of Regulation (EC) No 1152/2009 and ticle 19(2) of Regulation (EC) No 669/2009. Link: http://vmvt.lt/uploads/file/docs/Ivezimo%20punktai.doc

Member state response

been updated and put on the website of the SFVS as 5(4) and (5) of Regulation (EU) No 258/2010. Link: ads/file/docs/Ivezimo%20punktai.doc

of CPs has been updated and put on the website of the SFVS as required by Article 5(4) and (5) of Regulation (EU) No ink: vt.lt/uploads/file/docs/Ivezimo%20punktai.doc Page: 1 e Competent Authority on 13/2/2012 bmitted by the Competent Authorities of Lithuania on 14 December in response to Report ref. arried out from 05 to 09 September 2011 in order to evaluate import controls on food of non-animal origin Action proposed by the Competent Authority Action proposed by Competent Authority

Member state response

s of 6 December 2011 "Topical issues of official food control of non-animal food" the SFVS officials were tion, about application of the provisions of Article 6 of 669/2009 and Article 5 of Regulation (EC) No Page: 1 DG(SANCO)/2011-8986-MR of an audit carried mal origin Action Proposed by the Competent Authority the required information is not notified within the riod the consignments shall be detained to ensure that rmation on all the consignments is provided as required ns.

During the trainings of 6 December 2011 "Topical issues of official Point 10.1 of SFVS director Order No. B1- rol. Import control of non-animal food" the SFVS 478 "On the approval of the Procedure of ere instructed, in addition, about application of the official food control of imported non-animal provisions of Article 6 of Regulation (EC) No 669/2009 and food" of 24 September 2008 (O.G., 2008, No. Regulation (EC) No 1152/2009. Where the required 113-4324, No. 150-6143; 2010, No. 3-144, on is not notified within the required time period the No. 12-607; 2011, No. 80-3932) establishes a all be detained to ensure that the advance requirement for importers to notify the CA at on all the consignments is provided as required by the least one working day prior to the physical regulations. arrival of the consignment as required by Article 6 of Regulation (EC) No 669/2009 and Article 5 of Regulation (EC) No 1152/2009. Information about prior notification is available on the website of the SFVS: http://vmvt.lt/lt/top/viesosios.paslaugos/isduo dami.dokumentai/bendras.ivezimo.dokument as.bid/ and http://vmvt.lt/lt/as/verslininkas/prekyba/impo rtas/negyvuniniu.produktu.importo.is.treciuju .sali

Member state response

1B-490 of the Director of the SFVS and Director oms Department under the Ministry of Finance "On of food and feed of non-animal origin" of 15 September opted (Official Gazette, 2011, No 115-5446) which lays stoms officials shall only document the procedure on circulation following the decision on suitability for nsignment and stamping the accompanying documents rmitted" made by the inspectors of the SFVS during the of the consignment.

No B1-539/1B-490 of the Director of the SFVS and Director of the Customs Department under the Ministry of Finance l control of food and feed of non-animal origin" of 15 2011 has been adopted (Official Gazette, 2011, No 115- 5446) which lays down that the customs officials shall only procedure on release for free circulation following the decision on suitability for marketing the consignment and the accompanying documents with "Release permitted" made by the inspectors of the SFVS during the official control of the consignment. Page: 2 e Competent Authority on 13/2/2012 bmitted by the Competent Authorities of Lithuania on 14 December in response to Report ref. arried out from 05 to 09 September 2011 in order to evaluate import controls on food of non-animal origin Action proposed by the Competent Authority Action proposed by Competent Authority

Member state response

ings of 6 December 2011 "Topical issues of official food ol of non-animal food" the SFVS officials were ition, on the application of the provisions of Article 7 of No 1152/2009.

trainings of 6 December 2011 "Topical issues of official food control. Import control of non-animal food" the SFVS ials were informed, in addition, on the application of the isions of Article 7 of Regulation (EC) No 1152/2009.

Member state response

hat in performing a test for aflatoxins, each must be homogenized and mixed threw wet rocedure (Silverstone mill is used). Samples are l no particles are seen.

NFVRAI ensures that in performing a test for aflatoxins, each ry sample must be homogenized and mixed threw wet ion procedure (Silverstone mill is used). Samples are until no particles are seen.

Member state response

2011 were updated the SOP of the quality system and Page: 2 DG(SANCO)/2011-8986-MR of an audit carried mal origin uthority ood imported from third countries", l food imported from third ost", l food imported from third

On 16 November 2011 were updated the SOP of the quality system nstructions: Inspection of non-animal food imported from third countries", KT-6-8-D1 "Inspection of non-animal food imported from third countries in a border inspection post", KT-6-8-D2 "Inspection of non-animal food imported from third countries in food control place". Page: 3