Latvia

The recommendation states as its basis

Although the process to designate establishments in accordance with Article 44 of Regulation 2023/594 began in April 2023 for new applications, the process to revise the designation of establishments designated under Regulation 2021/605 is still ongoing.

The recommendation states as its basis

The FVS is incorrectly allowing a significant proportion of pigs to move from pig establishments located in restricted zone II because they consider these movements compliant with all of the relevant requirements in Regulation 2023/594 without this being the case. For example, the authorities approve biosecurity plans that do not meet all compliance standards, there is , inadequate verification of the implementation of continuous surveillance in farms in restricted zones and pigs are allowed to move without pre- movement clinical examinations from establishments that do not qualify for this derogation. Many of these pigs move to an abattoir for immediate slaughter and their meat obtains the EU/oval health mark for which it is not eligible. 8

The recommendation states as its basis

The absence of effective verification of the implementation of the official controls related to the biosecurity inspections and the correct implementation of continuous surveillance on pig establishments in restricted zone II, led to many pig establishments being incorrectly assessed as compliant with all requirements of Regulation 2023/594.

The recommendation states as its basis

Inspections of PPP end users are organised in a way that allows each one to be eligible for selection based on risk every three to four years. Risk criteria are defined annually in internal guidelines and include: · Previous PPP use violations · Lack of inspection in the past three years (e.g., new users) · Crop types (e.g., pollinator-attractive crops like oilseed rape, beans, peas) · Use of high-risk PPPs (e.g., first registration class products for fumigation) The audit team noted that data from the pesticide residue monitoring programme or the water monitoring programme are not taken into account in the prioritisation of controls, which is not in line with Article 24(2)(a) of Regulation (EU) 2017/62.

Risk criteria are in place for planning controls, but they do not include data from the pesticide residue monitoring programme or the water monitoring programme, which reduces the targeting and efficiency of the controls. 5.2.3. Delegation of certain tasks Findings

The recommendation states as its basis

In general, the findings in the inspection reports reflected the situation regarding the HACCP-based procedures. Nevertheless, in some of the establishments visited, the audit team detected deficiencies in relation to these plans (including the prerequisite pro- grammes) which were not mentioned in the inspection reports. For example: in some es- tablishments HACCP plans were not updated by the FBO (e.g. alkaline phosphatase test used for heat-treatment verification but the HACCP plan contained peroxidase test; flowchart was not updated regarding re-work); discrepancy between the time/temperature values of pasteurisation in the HACCP plan and the actual values used; no mention in the plan that certain processes require time separation; layout plan of the establishment did not include all the cold storage facilities; pest control plans were in- complete (lack of evidence of bait maps and monitoring of rodent activity).

In most of the establishments visited by the audit team that were manufacturing ready- to-eat (RTE) dairy products, environmental sampling carried out by the FBOs to detect the possible presence of Listeria monocytogenes (L. monocytogenes) did not follow the European Union Reference Laboratory (EURL) guidelines on sampling the food pro- cessing area and equipment for detection of this pathogen (in particular, sampling of en- vironment should also take place during processing). In the establishments visited this sampling was carried out after cleaning and disinfection (before processing) only. In one of the establishments visited manufacturing RTE products, the FBO's own-check sam- pling plan did not include any environmental (i.e. processing areas and equipment) sam- pling for the detection of L. monocytogenes. This is not in line with Article 5(2) of Reg- ulation (EC) No 2073/2005.

The above-mentioned shortcomings had not been detected by the CAs during official controls and audits. A CCA representative confirmed to the audit team that this specific issue with environmental sampling for Listeria has not been checked during official con- trols.

In one of the establishments visited, cottage cheese was not tested for all the microbio- logical parameters required by Regulation (EC) No 2073/2005 (i.e. it was not tested for coagulase-positive staphylococci and Escherichia coli). This non-compliance was not detected during official controls. The audit team noted that, in general, the own-control sampling frequency for food pathogens was low in the smaller capacity establishments (one sample annually per product) and often consisted of only one sample unit instead of the five required in Annex I to Regulation (EC) No 2073/2005; in this regard, no dero- gation (based on Article 5 of this Regulation) had been granted by FVS to the FBOs.

The official controls did not cover FBOs' compliance with procedures, based on HACCP principles in sufficient depth, in particular, regarding microbiological criteria, and therefore did not identify all relevant shortcomings.

Member state response

emot vr rekomendcij minto, plnots veikt sekojosus korektvos paskumus: 1. 2024.gada III.ceturksn organizt piena savksanas un prstrdes uzmumu uzraudzbai pilnvaroto prtikas inspektoru atkrtotas apmcbas par oficils kontroles pamatprincipiem uzmumu HACCP sistmu izvrtsanai, pasi attiecb uz mikrobiololoisko kritriju kontroli, saska ar Regul (EK) Nr. 2073/2005 noteikto. 2. Veicot plnoto TSV prtikas inspektoru profesionls darbbas uzraudzbu, pasu uzmanbu veltt tam, k tiek novrttas uzmumu pasontroles procedras, jo pasi attiecb uz mikrobioloisko kritriju kontroli, saska ar Regul (EK) Nr. 2073/2005 noteikto. 3. 2024.gada IV ceturksn atkrtoti informt prtikas aprit iesaisttos uzmjus (PAIU), kuri razo lietosanai prtik gatavus piena produktus, par Regulas (EK) Nr. 2073/2005 5. panta 2.punkt noteikto prasbu, ka paraugu emsanas pln jiekauj ar razosanas platbu un iekrtu prbaude L.monocytogenes iespjams kltbtnes noteiksanai, un, saska ar Eiropas Savienbas references laboratoriju (ESRL) vadlnijm, paraugu emsanai jnotiek prstrdes laik. Page: 1

The recommendation states as its basis

The FVS maintains its own list of primary production fishing vessels despite the existence of a list of commercial fishing vessels maintained by the Ministry of Agriculture. Registration with the latter is a pre-requisite to obtain a fishing licence, but not the registration with the FVS. The audit team noted that the FVS procedure in place for registration of fishing vessels does not require the verification of the information available (i.e., by cross-checking with information held on the list of the Ministry of Agriculture or the EU fleet register). The system relies on the operators' application for registration, which, in some cases, may never come. Therefore, the procedure does not allow the CA to obtain readily available information to ensure the completeness of the lists in line with the requirement in point 1(b) of Article 4 of Regulation (EC) No 853/2004 and thus reliably identify all fishing vessels that should be included in the scope of official controls.

In this respect, the audit team noted some discrepancies between the FVS's lists and the list of the Latvian fishing vessels included in the EU fishing fleet register. The audit team also noted that a fishing vessel, which was included only in the EU fishing fleet register, but not in the CA's list, engaged in commercial fishing activities recorded in the Latvian Fisheries Integrated Control and Information System (LZIKIS) of the Ministry of Agriculture, primarily used by the State Environmental Service.

The audit team noted that the form used by operators for applying for approval of their vessels does not require details about the vessel's characteristics (e.g., gross tonnage, length etc.). The application form used is the same, both for approvals and registrations. Furthermore, the approval procedure does not require, either the direct consultation of the EU fishing fleet register, or the Ministry of Agriculture to obtain information, that would allow the CA to assess the veracity or correctness of an application in accordance to point 2 of Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council.

The audit team noted that, based on the information available in the EU fishing fleet register, one vessel on the FVS's list for primary production fishing vessels, was one of the biggest vessels of the Latvian fleet and had the same characteristics (length and gross tonnage, engine power, fishing gear etc.) as one of the approved freezer vessels (a sister vessel). Based on further information collected, the vessel produces without an approval, 5 frozen fishery products, which are then landed in a third country in packages without bearing an identification mark.

With regard to vessels (fishing, freezer and factory vessels), weaknesses were noted in the registration and approval procedures as these can start operation without having been registered or approved with the CA and remain out of the scope of official controls (contrary to the requirements in national legislation).

Member state response

Lai nodrosintu atbilstosu kuu reistrciju vai atzsanas procesu, 2023.gada 02.maij tika veiktas izmaias PVD procedr KR.10.P.001 "PVD uzraudzbai pakauta uzmuma reistrcija" nosakot sekojoso "Saemot pieteikumu par kua reistrciju / atzsanu, informciju nodod Dzvnieku izcelsmes produktu razosanas uzraudzbas daas attiecgajiem specilistiem izvrtsanai un atzinuma sniegsanai par pieteikum nordts darbbas atbilstbu kua veidam un t darbbai". Papildus tam ir uzskti Ministru kabineta noteikumu Nr.1015 "Krtba, kd izsniedz specilo atauju (licenci) komercdarbbai zvejniecb, k ar maks valsts nodevu par specils ataujas (licences) izsniegsanu" grozjumi, kas paredzs komerczvejas licencu izsniegsanu tikai pc kua darbbas reistrcijas / atzsanas PVD.

The recommendation states as its basis

In all of the establishments visited, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on their assessment of the operators' HACCP plans. The audit team noted that the inspectors' assessment of the hazard identification part of the HACCP plan was deficient in three of the six establishments. In these cases, the hazard identification part of the operators' HACCP plans was inadequate or very generic without the level of detail necessary for appropriate hazard identification and consequent risk assessment. In one establishment, the FeBO identified some critical control points in its own hazard analyses. However, the audit team noted that the established 4 critical limits and operator`s monitoring producers were not adequate for these critical control points, and therefore were not in line with the requirements laid down in Article 6(2) of Regulation (EC) No 183/2005. While the inspectors did identify some of these deficiencies during the interviews with the audit team, these issues were not reflected in any of the inspection reports seen and operators were thus unaware of these problems.

Planning of inspections is based on appropriate risk-related factors and allows official controls to be carried out on all operators on a risk basis and with appropriate frequency. However, the effectiveness of the system of official controls is weakened by a number of shortcomings in the inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on homogeneity of mixing, (iii) operators' fulfilment of requirements on retained samples, and (iv) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

1) PVD kvalittes sistmas procedra KR.10.P.206 "Metodiskie nordjumi un prbaudes protokola aizpildsana dzvnieku barbas aprit iesaistto uzmumu prbaudei " tiks aktualizta ar nordjumiem prbaudes protokola B daas (prasbu prbaude) attiecg prbaudes posma ail "konstatjumi" preczi aprakstt uzmuma noteiktos apdraudjumus un identifictos kritiskos kontroles punktus. Konkrts izmaias procedr plnots veikt ldz 01.11.2022. 2) Veikt valsts veterinro inspektoru, kas pilnvaroti veikt barbas aprites uzmumu prbaudes, virsuzraudzbu uzmumu prbaud. Praktiski vrtjot. k inspektors novrt uzmuma HACCP sistmas dokumentciju un darbbas, t. sk. apdraudjuma apzinsanu un sekojosu kritisko kontroles punktu identificsanu. Virsuzraudzbu veikt ldz 30.06.2023. 3) Organizt un stenot apmcbas "HACCP sistma dzvnieku barbas aprites uzmumos un ts novrtsana." Mcbas veikt ldz 01.12.2022.

The recommendation states as its basis

Verification of establishments' tests on homogeneity of mixing required by part 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005 forms part of the inspections, when applicable. At the three compound feed manufacturers visited, the audit team scrutinised operators' documentation on the related testing, and interviewed inspectors who usually control those establishments. In all of the three establishments, testing of mixing homogeneity had been carried out annually and reports of the tests were available. In two cases, the inspectors experienced difficulties to interpret the testing procedures and related results, and as a consequence their assessment of the operator's tests on homogeneity of mixing was inappropriate.

Planning of inspections is based on appropriate risk-related factors and allows official controls to be carried out on all operators on a risk basis and with appropriate frequency. However, the effectiveness of the system of official controls is weakened by a number of shortcomings in the inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on homogeneity of mixing, (iii) operators' fulfilment of requirements on retained samples, and (iv) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

1) PVD papildins kvalittes sistmas procedru KR.10.P.206 "Metodiskie nordjumi un prbaude protokola aizpildsana dzvnieku barbas aprit iesaistto uzmumu prbaudei": - ar informatvu aprakstu par homogintes testiem un to novrtsanu; - nordjumu inspektoriem parbaudes protokola B daas (prasbu prbaude) attiecgaj prbaudes posma ail "konstatjumi" preczi aprakstt konkrt uzmuma Page: 1 ort ref. DG(SANTE) 2022-7430 of the audit carried out from 10 May 2022 to eed hygiene Action Proposed by the competent authority humogenittes testu veiksanas krtbu, aprinsanu un rezulttus. Izmaias plnots veikt ldz 01.11.2022. 2) Organizt un stenot inspektoru apmcbas par barbas homogenitti un ts novrtsanu. Mcbas veikt ldz 01.12.2022. 3) veikt inspektoru profesionls darbbas praktisko virsuzraudzbu novrtjot k inspektori veic uzmuma homogenittes atbilstbas prbaudi. Virsuzraudzbu veikt ldz 30.06.2023.

The recommendation states as its basis

Routine inspections include a verification of the operators' obligation to take samples of ingredients and from each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities, using a procedure pre- established by the manufacturer (hereinafter retained samples), as required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised the operators' documentation on collection, storage, packaging and labelling of retained samples, interviewed inspectors who usually control those establishments and made the following observations: · in two compound feed producers, the retained samples were not sealed; · in one establishment, the FeBO did not collect retained samples from some types of ingredients (vitamins and microelements). 5 The above is not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and was not identified in any of the recent inspection reports seen.

Planning of inspections is based on appropriate risk-related factors and allows official controls to be carried out on all operators on a risk basis and with appropriate frequency. However, the effectiveness of the system of official controls is weakened by a number of shortcomings in the inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on homogeneity of mixing, (iii) operators' fulfilment of requirements on retained samples, and (iv) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

1) PVD kvalittes sistmas procedr KR.10.P.206 "Metodiskie ordjumi un prbaude protokola aizpildsana dzvnieku barbas aprit iesaistto uzmumu prbaudei" tiks papildinta ar nordjumiem inspektoriem prbaudes protokola B daas (prasbu prbaude) attiecgaj prbaudes posma ail "konstatjumi" preczi aprakstt uzmuma visu izejvielu un sarazots barbas paraugu bankas paraugu noemsanu izsekojambu, uzglabsanas nosacjumus, iepakosanu, marsanu, identifikciju un aizzmogosanu. Konkrts izmaias procedr plnots veikt ldz 01.11.2022. 2) Inspektoru profesionls darbbas virsuzraudzb, novrtt k inspektori uzmum novrt uzmuma paraugu bankas paraugu noemsanu, kas paredzti uzglabsanai uzmum, iepakosanu, uzglabsanu marsanu, aizzmogosanu un uzskaiti. Virsuzraudzbu veikt ldz 30.06.2023. 3) Ietvert inspektoru apmcbs tmu par uzmumu pienkumiem paraugu noemsan vism izejvielm un sarazotai Page: 2 ort ref. DG(SANTE) 2022-7430 of the audit carried out from 10 May 2022 to eed hygiene ion Proposed by the competent authority bai, k ar paraugu uzglabsanas nosacjumu atbilstbas rosinsanu. as veikt ldz 01.12.2022.

The recommendation states as its basis

Verification that operators comply with labelling requirements forms part of routine inspections. At all of the FeBOs visited, the audit team scrutinised operators' labels and other relevant documents, interviewed inspectors who usually control those establishments and made the following observations: · The feeding instruction on the label of a complementary feed for dairy cows would result in an enzyme concentration (in complete feed) lower than the minimum established by Commission Implementing Regulation (EU) No 2020/1096. · Three labels of complementary feed containing feed additives with established maximum limits did not contain clear dosage instructions, which is not in line with the requirements laid down in Article 17(1)(b) of Regulation (EC) No 767/2009. · On a label of a complete feed, a feed additive was listed under an incorrect functional group. This is not in line with the requirements laid down in Article 15(f) of Regulation (EC) No 767/2009. Conclusion on the planning and implementation of inspections

Planning of inspections is based on appropriate risk-related factors and allows official controls to be carried out on all operators on a risk basis and with appropriate frequency. However, the effectiveness of the system of official controls is weakened by a number of shortcomings in the inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, (ii) operators' testing on homogeneity of mixing, (iii) operators' fulfilment of requirements on retained samples, and (iv) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Member state response

) PVD prbauzu pln veterinrs uzraudzbas jom 2023. am, barbas razosanas uzmumos paredzt prbaudt jumus visai razotajai barbai. 01.01.2023. Organizt atkrtotas apmcbas 2023.gada 1.pusgad par nieku barbas marsanas prasbm ar marjumu lzi. 01.07.2023.

The recommendation states as its basis

The feed inspectors interviewed stated that, based on SOP 79, they had routinely collected at least two final samples during official sampling (one defence sample kept by the operator, and a control sample for testing). The SOP does not contain any instruction that three final samples should be routinely collected. Consequently, feed inspectors usually collect two final samples (see finding 28). This is not in line with the requirements of part 9.4 of Annex I to Regulation (EC) No 152/2009. 5.2.2.2 Implementation of official sampling

The audit team observed official sampling at two compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). Based on these, the audit team made the following observations: · In one establishment, the feed inspector sampled a feed material for mycotoxin analyses. During the preparation of the final samples, the inspector did not use a divider, as required by part 9.4 of Annex I to Regulation (EC) No 152/2009. The local feed inspectors stated that a divider was not available for them. · In both establishments, two final samples were prepared (see finding 26) which contradicts the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited, and operate effective quality control, significant shortcomings in the implementation of sampling and testing undermine the legal and technical validity of the samples and reliability of decisions made on the basis of results. Furthermore, not all of the laboratories conducting official testing are designated, and audited, as required. Cumulatively these shortcomings weaken the overall effectiveness of the official control system. 5.2.3 Actions taken on non-compliances

Member state response

Paraugu daltju 11 PVD TSV un Robezkontroles punktiem, id kuros tiek emti barbas paraugi, tiks iegdi saskaa ar Publisko irkumu likumu. Tiks aktualizta PVD kvalittes sistmas procedra 10.P.079 "Visprgie metodiskie nordjumi dzvnieku bas paraugu noemsanai" , lai nodrosintu trs gala paraugu atavosanu : laboratorijai (kontrolei), parallo paraugu saucei), uzmumam (aizstvbai). cedra tiks papildinta ar prasbu nostt ar parallo paraugu R laboratorijai uzglabsanai ldz noemts barbas derguma mia beigm. ualizt ldz 01.11.2022. PVD kvalittes sistmas procedru KR.10.P.197 "Paraugu aiosanas un idetifikcijas krtba " papildint ar prasbu bas paraugu marjum papildus nordt barbas derguma Page: 3 ort ref. DG(SANTE) 2022-7430 of the audit carried out from 10 May 2022 to eed hygiene ion Proposed by the competent authority miu un katra gala parauga mri (kontrolei, parallais augs ,uzmumam) ualizt ldz 01.11.2022.

The recommendation states as its basis

The audit team scrutinised a number of non-compliant laboratory results and observed that, in general, the laboratory test reports did not contain any information on the analytical recovery or moisture content and the related correction, which is essential for a legally valid assessment of the laboratory results, as required in part C.6 of Annex II to Regulation (EC) No 152/2009. The audit team identified cases where, after correction for recovery and moisture content, the results might have been interpreted as compliant, contrary to what was observed in the interpretation by the feed inspectors. 5.2.2.3 Testing of official feed samples

The audit team scrutinised raw data for a number of analytical tests and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that the expanded 8 measurement uncertainty was properly reported. However, results were not recalculated for feed with a moisture content equivalent to 12%, and in the reports seen, the analytical recovery was not indicated, and it was unclear whether the result(s) had been corrected for recovery. This is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. The audit team noted that there is a laboratory procedure (Section 2.5 of DC-RI-M-611/1), which describes the steps to be taken where undesirable substances are detected and this is in line with the said legal requirements. However, some of the laboratory staff interviewed were unaware of the relevant level at which additional testing is required (i.e. 50% of the target specification level) and the associated requirements of part C.6. of Annex II to Regulation (EC) No 152/2009 as described in this procedure. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited, and operate effective quality control, significant shortcomings in the implementation of sampling and testing undermine the legal and technical validity of the samples and reliability of decisions made on the basis of results. Furthermore, not all of the laboratories conducting official testing are designated, and audited, as required. Cumulatively these shortcomings weaken the overall effectiveness of the official control system. 5.2.3 Actions taken on non-compliances

Member state response

Veikt izmaias kvalittes sistmas procedr KR.10.P.198 ziojuma par testsanas rezulttu atbilstbu sagatavosana un tsana", ka saemot izmekljumu testsanas rezulttus, iecinties, ka laboratorijas testu ziojumos ir informcija par ltisko atgstambu un mitruma saturu un ar to saistto ltisko rezulttu korekciju. Analtisko rezulttu novrtjumu kt tikai tad, ja rezultt ir ietvertas atgstambas un mitruma ura korekcijas. ualizt ldz 01.11.2022. Lai nodrosintu laboratorijai informciju par maksimli aujamjiem lmeiem nevlamm vielm un barbas devm, kas nepieciesami, lai konrtos gadjumos noteiktu ni, kad ir nepieciesama papildus testsana, aktualizt littes sistmas procedru KR.10.P.206. prasbas Parauga msanas akta/ekspertzes pieteikuma (E daas) aizpildsan ar sbu nordt sada "Nosakmie rdtji" pie noteikta rdtja ula (numuru) un maksimli pieaujamo lmeni konrtam jam. ualizt ldz 01.11.2022. iecb uz nevlamo vielu testsanu barb, kuras tiek kaittas Direktv 2002/32/EK, BIOR nodrosins, ka tsanas prskatos tiks neprprotami nordta informcija par bas mitruma saturu un atgstambas korekciju, kur stambas koeficienta iegsanu auj noteikt pielietot metode. ildes termis: 01.09.2022. Page: 4 ort ref. DG(SANTE) 2022-7430 of the audit ca

The recommendation states as its basis

The competent authority indicated that four external laboratories in other Member States are contracted by the BIOR to conduct a small number of analyses of official samples. While the BIOR has criteria in place with regard to the evaluation of contracted laboratories providing analytical services, these do not take into account the requirements of Article 37 of Regulation (EU) 2017/625 in respect of the designation of laboratories in other Member States. 7

In respect of audits of the BIOR, in line with Article 39 of Regulation (EU) 2017/625, the competent authority has scheduled a laboratory audit for 2023 as part of its internal audit programme (the last audit was in 2012). In addition, regular audits of the EN ISO/IEC 17025 quality system are conducted by the Latvian National Accreditation Bureau every 12 to 18 months, with the latest audit performed in October 2021. The competent authority does not conduct audits of any of the four external laboratories providing analytical services and does not have a procedure in place to verify the outcomes of accreditation assessment audits, which is not in line with Article 39 of Regulation (EU) 2017/625.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited, and operate effective quality control, significant shortcomings in the implementation of sampling and testing undermine the legal and technical validity of the samples and reliability of decisions made on the basis of results. Furthermore, not all of the laboratories conducting official testing are designated, and audited, as required. Cumulatively these shortcomings weaken the overall effectiveness of the official control system. 5.2.3 Actions taken on non-compliances

Member state response

Lai nodrosintu, ka cits dalbvalsts esoss barbas testsanas atorijas, ar kurm noslgts lgums, tiek izraudztas k oficilas laboratorijas un atbilst sdas izraudzsanas prasbm un, mpetent iestde steno atbilstosus paskumus, lai kontroltu ls laboratorijas, ar kurm noslgts lgums, kas nodrosins stbu Regulas 2017/625 37. panta 2. punktam un 39. pantam, pbas ministrija veiks grozjumus: 18. gada 9. mart starp Zemkopbas ministriju un zintnisko ttu BIOR noslgtaj lgum Nr. 2018/42 "Par normatvajos noteikto funkciju un valsts prvaldes uzdevumu izpildes ssanu". noteikts pienkums instittam BIOR (attiecgi papildinot 3. sadau "Institta ,,BIOR" pienkumi un tiesbas") par to ls kontroles laik noemto paraugu analzi, testsanu un ostiku, kuru nav iespjams nodrosint institta BIOR atorijs, slgt lgumu ar tdu Eiropas Savienbas dalbvalsts atoriju, kuru PVD bs nozmjis k oficilo kontroles atoriju, k ar informt PVD par noslgtajiem lgumiem. mkopbas ministrijas 2020. gada 19. jnija krtb Nr.12 a par valsts uzraudzbas un kontroles programmu miem prtikas un dzvnieku barbas aprites, inrmedicnas un robezkontroles jom". noteikts pienkums PVD rakstiski nozmt k oficils oles laboratorijas citu ES dalbvalstu kompetento iestzu as o

The recommendation states as its basis

The internal procedure (DC-RI-M-611/1) sets the approach to ensure that feed samples are homogeneous and representative of the final sample and that cross-contamination is minimised. The laboratory provided documentary evidence of satisfactory homogeneity checks conducted for dioxins and dioxin-like PCBs in fishmeal. However, homogeneity checks as above were not documented for the test methods reviewed, i.e. heavy metals (BIOR-T-012-148-2013/4) and mycotoxins in feed materials and compound feed (BIOR-T-012-185-2016/3). The audit team pointed out that complete homogeneity is essential to ensure technical and legal validity of the results in case of testing for analytes heterogeneously distributed in the matrix (e.g., mycotoxins and botanical impurities in feed materials).

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited, and operate effective quality control, significant shortcomings in the implementation of sampling and testing undermine the legal and technical validity of the samples and reliability of decisions made on the basis of results. Furthermore, not all of the laboratories conducting official testing are designated, and audited, as required. Cumulatively these shortcomings weaken the overall effectiveness of the official control system. 5.2.3 Actions taken on non-compliances

Member state response

lgo paraugu viendabguma nodrosinsanai tiks veikta vismaz rs parallo paraugu testsana gadjumos, kad tiks konstattas vlams vielas, kuras tiek uzskaittas Direktv 2002/32/EK. iks papildinta BIOR rcbas instrukcija DC-RI-M-611/1 Dzvnieku barba. Vadlnijas paraugu sagatavosanai un rezulttu iosanai.), kur tiks noteikta vismaz 3 parallo paraugu estsana parauga viendabguma pierdsanai un parallo paraugu estsanas rezulttu izkliedes kritriji. zpildes termis: 01.09.2022.

The recommendation states as its basis

The audit team scrutinised raw data for a number of analytical tests and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that the expanded 8 measurement uncertainty was properly reported. However, results were not recalculated for feed with a moisture content equivalent to 12%, and in the reports seen, the analytical recovery was not indicated, and it was unclear whether the result(s) had been corrected for recovery. This is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. The audit team noted that there is a laboratory procedure (Section 2.5 of DC-RI-M-611/1), which describes the steps to be taken where undesirable substances are detected and this is in line with the said legal requirements. However, some of the laboratory staff interviewed were unaware of the relevant level at which additional testing is required (i.e. 50% of the target specification level) and the associated requirements of part C.6. of Annex II to Regulation (EC) No 152/2009 as described in this procedure. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited, and operate effective quality control, significant shortcomings in the implementation of sampling and testing undermine the legal and technical validity of the samples and reliability of decisions made on the basis of results. Furthermore, not all of the laboratories conducting official testing are designated, and audited, as required. Cumulatively these shortcomings weaken the overall effectiveness of the official control system. 5.2.3 Actions taken on non-compliances

Member state response

ttiecb uz nevlamo vielu testsanu barb, kuras tiek uzskaittas Direktv 2002/32/EK, BIOR nodrosins, ka estsanas prskatos, tiks nordts atgstambas koeficients un itruma saturs barbas paraug. zpildes termis: 01.09.2022. Page: 6

Member state response

l 1. Ministru kabineta noteikumi Grozjumi Ministru kabineta gada 18. jnija noteikumos Nr. 328 "Prasbas kautuvm, kurs nokauto dzvnieku gau maz daudzum realiz vietj tirg" sobrd tiek saskaoti ar Eiropas Komisiju, aptursanas periods noteikts ldz 2022. gada 14. novembrim. emot vr to, ka augsmintajos noteikumos sobrd tiek veikti grozjumi, ir paredzts svtrot ar punktu par saimniecb nokautu dzvnieku gaas piegdi tikai vietj tirg. Audita ziojum ir atsauce uz Regulas (EK) Nr. 853/20041. panta 4. punktu un norde uz to, ka valsts tiesbu aktos nav skaidri noteikts, kas tiek uzskatts par "vietjo mazumtirdzniecbas uzmumu" saska valsts noteikumiem attiecb uz normatvo aktu par mjputnu un zaveidgo gaas piegdi mazos daudzumos, galapatrtjam vai vietjiem mazumtirdzniecbas uzmumiem, kas tiesi piegd sdu gau galapatrtjam. Regul 178/2002 ir defincija "Mazumtirdzniecba", ttad secgi vietjais mazumtirdzniecbas uzmums ir uzmums, kas vietj tirg nodarbojas ar mazumtirdzniecbu. Defincija "vietjais tirgus" ir skaidrota Prtikas aprites uzraudzbas likum (Latvij razotu produktu prdosana patrsanai Latvij). Td uzskatm, ka papildus skaidrojums nav nepieciesams. Tomr, ja, saj gadjum, ir runa par Ministru kabineta 2009. ga

The recommendation states as its basis

FINDINGS AND CONCLUSIONS

Whilst the RCPs for 2019 to 2022 that were submitted to the European Commission indicated that non-compliant results from previous years were taken into account to increase the sample numbers (especially for eggs), this was not the case in practice. For certain substance groups with a relatively high number of non-compliant results (e.g. for salinomycin and toltrazuril in eggs), neither the sample numbers for coccidiostats nor the frequency of testing for these particular substances had been changed. Furthermore, egg production increased year by year.

While in line with EU requirements (13), the national legal requirements (14) and the related procedure (15) both indicate that Latvian and other Member States products of animal origin shall be sampled. This was not enforced. Planned sample numbers for bovine, ovine and porcine animals and poultry were based solely on the number of animals of Latvian origin slaughtered, without considering the number of animals traded/moved into Latvia for slaughter. In 2021, 20 % of all pigs slaughtered in Latvia came from neighbouring Member States, as well as approximately 7 % of the slaughtered (6) Cabinet Regulation No 644 of 27 August 2013 on the control of certain substances and their residues in animals and their products and their financing. (7) KR.10.P.281 `Procedure for determining the number of samples/tests for laboratory examination' (8) Article 9(1) of Regulation (EU) 2017/625. (9) Point II 7.4.3. of Cabinet Regulation No 644 of 27 August 2013 on the control of certain substances and their residues in animals and their products and their financing. (10) In its response to the draft report, the competent authority noted that information on the sales of veterinary medicinal products in Latvia is now available, is collected regularly, and is posted on the FVS website www.pvd.gov.lv (11) https://www.zm.gov.lv/lauksaimnieciba/statiskas-lapas/lauksaimniecibas-gada-zinojumi?nid=531#jump (12) http://pub.ldc.gov.lv/pub_stat.php?lang=lv (13) Annex IV to Directive 96/23/EC applicable at the time of the audit and from 15 December 2022 replaced by Article 4(c) and Annex I to Regulation (EU) 2022/1646. (14) Point II 7.4.1. of Cabinet Regulation No. 644 of 27 August 2013 on the control of certain substances and their residues in animals and their products and their financing. (15) Point 2. of Annex 2 to Procedure KR.10.P.281 of 27.11.2018. 5 bovine animals and a smaller percentage of sheep and poultry. Consequently, for pigs, approximately 30 fewer samples were taken than should have been.

The selection of holdings to be sampled is within the competence of each TSU office, which decides on the farms and establishments to be sampled. Sampling was assigned well in advance to farms and establishments randomly chosen from those planned for various routine inspections during the month. Production volumes, previous non- compliant test results, the outcome of previous routine inspections on farms, quality parameters of raw milk, change of activity type of the operators/farms, etc., are factors which are not considered in the planning, however. This is not in line with applicable EU requirements (21). Conclusions on planning of residue monitoring

Whilst the planning process for the RCP is timely and the plan is sufficiently broad (16) FVS register at https://registri.pvd.gov.lv/ur (17) For the 2022 RCP: Order No 5 of 14/01/2022 For the Residue Control Programme 2022, code:1.19. (18) Annex IV to Directive 96/23/EC and the Annex to Decision 97/747/EC. (19) Chapter 1 and 2 of the Annex to Decision 97/747/EC. (20) Article 9(2) of Regulation (EU) 2017/625. (21) Article 9(1) and (2) of Regulation (EU) 2017/625, Annex III to Directive 96/23/EC applicable at the time of the audit and from 15 December 2022 replaced by Article 2(2) and Points 6. and 7. of Annex III to Regulation (EU) 2022/1644. 6 in the scope of testing, some risk factors are not taken into account, thus weakening the effectiveness of the plan.

Member state response

e Pamatojoties uz ieprieksjo gadu testsanas rezulttiem un konstattajm neatbilstbm mazajs saimniecbs, olu paraugu skaits uz kokcidiostatiem palielints par 10 paraugiem Atliekvielu kontroles pln 2023.gadam. Atliekvielu kontroles plns 2023.gadam papildints ar Latvij kausanai ievesto dzvnieku skaitu. Kritriji novietu izvlei paraugu emsanai ir aprakstti procedr KR.10.P.108 "Vadlnijas paraugu izvlei Atliekvielu kontroles programmas dzvniekiem un dzvnieku izcelsmes produktiem novietns, primrs razosanas uzmumos, olu sirosanas un iepakosanas uzmumos, kautuvs stenosanai". 2023.gad plnotas apmcbas inspektoriem par vadlnijs iekauto kritriju piemrosanu. Sastdot Atliekvielu kontroles plnu 2023.gadam, tika emta vr informcija par Latvij produktvajiem dzvniekiem izplattkajm veterinrajm zlm no 2022. gada 1. ceturksa ldz 2022. gada 3. ceturksnim. Procedr KR.10.P.108 "Vadlnijas paraugu izvlei Atliekvielu kontroles programmas dzvniekiem un dzvnieku izcelsmes produktiem novietns, primrs razosanas uzmumos, olu sirosanas un iepakosanas uzmumos, kautuvs stenosanai" tiks papildints esoso kritriju saraksts novietu izvlei atliekvielu kontrolei. Deadline for the implementation: 1.09.2023.

The recommendation states as its basis

The selection of holdings to be sampled is within the competence of each TSU office, which decides on the farms and establishments to be sampled. Sampling was assigned well in advance to farms and establishments randomly chosen from those planned for various routine inspections during the month. Production volumes, previous non- compliant test results, the outcome of previous routine inspections on farms, quality parameters of raw milk, change of activity type of the operators/farms, etc., are factors which are not considered in the planning, however. This is not in line with applicable EU requirements (21). Conclusions on planning of residue monitoring

In the three TSUs visited, sampling was in most of the cases examined neither targeted nor performed without prior notice being given to the operator. Most of the samples were taken randomly by food inspectors (at slaughterhouses and from honey) and by veterinary inspectors (for eggs, milk, fish). This is not in line with EU requirements (25).

While national procedures clearly state that, in line with applicable EU legal requirements (26), RCP samples can only be taken by trained and authorised sampling officers, this was not always the case. In one TSU, samples were regularly taken by official veterinarians engaged in ante- and post-mortem inspection at slaughter. Whilst these veterinarians were likely capable of carrying out the sampling correctly, they had not been trained for the task. This is not in line with pertinent EU requirements (27).

Contrary to applicable EU requirements (21), the choice of animals to be sampled was not risk-based but random with no justification given. For aquaculture finfish, sampling was carried out exclusively at processing plants on fish ready to be placed on the market and not at all stages of production, as required by EU legislation, which stipulates that, for Group A (illegal) substances, samples must be taken from fish at all stages of farming (28).

The audit team noted that, in two visited TSUs, sometimes it happened that a single sample taken was registered in the records as several individual samples that were originally planned. Therefore, the number of samples actually collected was lower than the number indicated in the plan.

In general, the RCP is implemented as planned. The majority of samples however, are taken with prior notice being given to the operators and in many cases are selected randomly, rather than being targeted as required by EU legislation and national legal requirements. Collectively these shortcomings in implementation weaken the effectiveness of residues controls.

Member state response

Uz audita norises laiku mums bija uzsktas krtjs regulrs apmcbas, kuru laik ATKRTOTI tika pievrsta uzmanba tiesi paraugu noemsanas krtbai. Plnots turpint regulras apmcbas inspektoriem un veterinrrstiem, kuri iesaistti atliekvielu kontroles plna izpild, lai nodrosintu mrtiecgu Page: 1 rt ref. DG(SANTE) 2022-7487 of the audit carried out from 15 November aminants in live animals and animal products tion Proposed by the competent authority raugu emsanu. Mcbs plnots ar skaidrot Oficilo kontrou gulas prasbas attiecb uz oficilo kontrou veiksanu bez prieksja paziojuma, izemot gadjumus, kad sds paziojums vajadzgs un piencgi pamatots oficils kontroles veiksanai. ocedra KR.10.P.108 "Vadlnijas paraugu izvlei Atliekvielu ntroles programmas dzvniekiem un dzvnieku izcelsmes oduktiem novietns, primrs razosanas uzmumos, olu rosanas un iepakosanas uzmumos, kautuvs stenosanai", tiks pildinta, ka akvakultras paraugi, aizliegto vielu un vides esrojuma konstatsanai, ir jnoem visos razosanas posmos. adline for the implementation: 31.12.2023.

The recommendation states as its basis

In the three TSUs visited, there were delays in the identification of non-compliances. In one case (up to one year after having received the result), the non-compliance (chloramphenicol) was overlooked by the inspector in charge. It was discovered by the central competent authority in the framework of result collection and transmission to the European Food Safety Authority. In the other cases, the delays occurred when the inspector in charge was absent. In none of the TSUs visited was the evaluation of test results regularly supervised.

Out of the non-compliant results detected between 2019 and 2022 (to date), the auditors evaluated 12 files from five different TSUs. The following observations were made: a. sample submission to the laboratory, completion of analyses and transmission of test results were timely; b. the assessment of the results was, in some cases, performed with delays ranging from four days to four weeks, while the instructions indicate that this task should be performed within a maximum of three days from receipt of the result; c. in the chloramphenicol case mentioned above, no follow-up measure was deemed to be necessary given that a year had elapsed before it was identified; d. the operators were in nearly all cases immediately informed of the non-compliant result and for the follow-up inspections, in some cases, prior notice was given to the animal holding/food business operator. This is not in line with applicable EU requirements (39); e. follow-up investigations were undertaken in most of the cases very promptly. However, in many cases these did not satisfy EU legal requirements (40) or national (36) Cabinet Regulation No 597 available here: https://likumi.lv/ta/en/en/id/284603-veterinary-hygiene-and- harmlessness-requirements-for-the-handling-of-raw-milk (37) Regulation (EU) 2019/2090. (38) Procedure KR.10.P.253 `Action in cases where residues are detected or suspected in samples of live animals and foodstuffs of animal origin' of 07/09/2022. (39) Article 9(4) of Commission Regulation (EU) 2017/625. (40) Articles 137 and 138 of Commission Regulation (EU) 2017/625. 9 procedures as they did not include actions (by the competent authority) to identify the cause and ensure that the operator prevented recurrence; f. proportionate and dissuasive penalties were applied when the operator's responsibilities had been established. Conclusions on follow-up of non-compliant results

In general, whilst follow-up investigations were initiated promptly, the effectiveness of these in identifying the cause of the result was undermined by giving operators prior notice of the investigation and by the absence of measures to ensure that operators remedied the problem.

Member state response

V lmen tiks ieviesta virsuzraudzba par laboratorisko mekljumu rezulttu izvrtsanu, plnotas ar apmcbas TSV he vadtjiem un veckajiem prtikas inspektoriem par konkrts V atliekvielu kontroles programmas datu iegsanu no boratorisko izmekljumu uzkrsanas un analzes programmas UNDA" ks papildinta procedra KR.10.P.210 "Prbauzu veiksanas tba Prtikas un veterinr dienesta uzraudzbas objektos", ka djumos, kad prbaudi novietn nav iespjams veikt bez prieksja brdinjuma, netiks paziots par paraugu noemsanu atliekvielm. ocedra KR.10.P.253 "Rcba gadjumos, kad ir konstattas vai aizdomas par atliekvielu kltbtni dzvu dzvnieku un dzvnieku celsmes prtikas produktu paraugos" tiks papildinta ar punktu, r tiks ierakstts, ka gadjumos, kad tiek konstatta atliekvielu tbtne, iespju robezs, ir jnosaka atliekvielu avots. adline for the implementation: 31.12.2023.

The recommendation states as its basis

The BIOR laboratory is mentioned in national legal acts as official laboratory and NRL and performs its activities based on contract with the Ministry of Agriculture. Neither the BIOR nor its subcontracted laboratory are designated as official laboratories in line with current legal requirements (41). The audit team was informed that there are plans to modify the national legal acts and the contract by the end of December 2022. There is also an intention to amend (by the end of 2022) the relevant national legal acts to enable the FVS to undertake and execute the competent authority duties related to the designation and supervision of performance of official control laboratories.

The FVS has a formal agreement (42) with BIOR describing the arrangements for, inter alia, carrying out laboratory testing for the official controls on the food chain which includes controls on residues. Whilst the agreement does not cover requirements regarding the accreditation status of analytical methods as required by EU law (43), both laboratories are accredited to EN ISO/IEC 17025. BIOR is accredited to this standard by the the Latvian National Accreditation Bureau with a flexible scope for the majority of testing covered by the RCP.

The BIOR laboratory is well-equipped and in many respects functions well. Nevertheless, shortcomings in the validation of some analytical methods, the implementation of quality controls and the reporting of analytical results, undermine confidence in the reliability of certain results. This combined with the absence of its designation as an official control laboratory (and that of its subcontracted partner) weakens the effectiveness of the residue control system.

Member state response

es of The response of the Ministry of Agriculture: Page: 2 rt ref. DG(SANTE) 2022-7487 of the audit carried out from 15 November aminants in live animals and animal products ction Proposed by the competent authority he competence of the BIOR Institute as an official laboratory is efined in the first part of Article 21.2 of the Food Circulation upervision Law: "(1) The duties of the official laboratory defined n Article 38 of the Regulation (EU) 2017/625 of the European arliament and of the Council on official controls are performed y the Food Safety, Animal Health and Environmental scientific nstitute "BIOR"." see https://likumi.lv/ta/en/en/id/47184-law-on-the- upervision-of-the-handling-of-food ) aboratory sampling during official control is regulated by the greement No. 2018/42 On the Financing of the Performance of he Functions and Tasks of the State Administration Defined in the egulatory Acts (Amanedments on 29.12.2022) and the procedure f the Ministry of Agriculture of December 30, 2022 "Procedure or measures of the state monitoring and control program in the ield of food and animal feed circulation, veterinary medicine and order control". here have been made amendments (30.1

The recommendation states as its basis

In screening mode, a single point matrix calibration spike at the reporting level / target concentration is used to identify samples requiring confirmatory analysis. The laboratory explained that in general, the presence of a peak at the specific retention time triggers a confirmatory analysis and no detection capability for screening (CC) (which should be established during method validation) is used for this purpose. Also, the laboratory uses the concentration value of the first calibration point (the lowest level of calibration) from the method validation as a `simplified' CC value for reporting compliant results. This approach is not fully in line with EU rules which require a screening target concentration and a CC value to be clearly defined (47) and used to categorise the sample as potentially non-compliant.

Regarding method validation the audit team noted that: a) method validations were performed largely in line with EU rules (48), though no verification of methods for screening purposes (for which they are mainly used) had been carried out. As a consequence, CC values for screening (and cut-off levels) had not been established. Also, the stability of analytes in matrix, with the exception of chloramphenicol (A6), was not a part of the method validation plan; b) for same analytical methods used for testing residues of prohibited substances the CC values were established with the use of commercial software but had not always been verified by analysing blank samples spiked at the calculated CC as (45) Article 37(4)(a) of Regulation (EU) 2017/625. (46) Maximum Residue Limits listed in Table 1 of the Annex to Regulation (EU) No 37/2010, Minimum Required Performance Limits laid down according to Article 7 of Regulation (EU) 2021/808 or, for unauthorised substances, concentrations recommended by the EURLs, Regulation (EU) 1881/2006, Regulation (EC) 396/2005. (47) Article 2(15), (39), Article 3(3) and Points 1.1.2, 2.1 and 2.7 of Annex I to Regulation (EU) 2021/808. (48) Article 3 of Decision 2002/657/EC which was in force at the time of method validations, Article 3 of Regulation (EU) 2021/808. 11 required by legislation (49). The audit team noted that another approach to calculate the CC values was based on the lower calibration point, which means these values were obtained experimentally. In more recent validations, CC values were calculated using Method 3 as described in EU legislation (50). c) the laboratory stated that method for coccidiostats in eggs was originally validated in 2017 and the validation results updated in 2022 were based on internal quality control records. In an appendix to the method dated 9 January 2020, CC had been verified for seven compounds. For two of these (decoquinate and maduramicin) CC differed from the figures quoted in the RCP submitted to the Commission services. The method performance was also not verified in rabbit muscle while used for testing in this matrix. d) the method for quinolones in muscle was validated in matrices from major animal species. The methods for nitrofuran metabolites and chloramphenicol were recently revalidated to ensure that the lower reference points for action (51) are met.

The BIOR laboratory is well-equipped and in many respects functions well. Nevertheless, shortcomings in the validation of some analytical methods, the implementation of quality controls and the reporting of analytical results, undermine confidence in the reliability of certain results. This combined with the absence of its designation as an official control laboratory (and that of its subcontracted partner) weakens the effectiveness of the residue control system.

Member state response

gal Institute "BIOR will ensure validation of all new analytical ethods and methods with non-compliances revealed during the udit: Decision limits for confirmation (CC) will be assessed according to Method 3 as proposed by Regulation 808/2021; Detection capability for screening (CC) will be assessed according to Method 2 as proposed by Regulation 808/2021; The stability of analytes in the matrix will be determined according to Regulation 808/2021. eadline for the implementation: 31.12.2023.

The recommendation states as its basis

With regard to internal quality control routines in place, the audit team noted that: a) the laboratory had procedures in place for monitoring ongoing method performance. Quality control charts were used; b) quality control samples spiked at the concentration level of interest are included in the screening analytical runs. This is in line with legal requirements (52). c) in order to quantify a non-compliant result, two sample aliquots are spiked with known concentrations of the analyte and the result is calculated as the average of the two determinations on the condition that they do not differ by more than 30%. No independent quality control sample in a relevant matrix is included in the confirmatory analytical run. This practice is not in line with EU legislation (53). d) for the multi-residue method for antibacterial substances the laboratory operated quality control samples spiked at 10% of the Maximum Residue Limit/target concentration (all substances in all relevant matrices) in the attempt to collect data for the ongoing method validation at this concentration level as required in the legislation (54). This is considered a good practice. e) the audit team noted that results which are not in line with the minimum trueness of quantitative methods as laid down in EU legislation (55) are generally accepted.

The BIOR laboratory is well-equipped and in many respects functions well. Nevertheless, shortcomings in the validation of some analytical methods, the implementation of quality controls and the reporting of analytical results, undermine confidence in the reliability of certain results. This combined with the absence of its designation as an official control laboratory (and that of its subcontracted partner) weakens the effectiveness of the residue control system.

Member state response

uality control samples will be included in each analytical run ollowing EU requirements: or the screening step: (a) control samples for system suitability f the instrument; (b) quality control samples which are fortified t a concentration close to the STC for authorised harmacologically active substances as well as for prohibited or nauthorised substances; (c) compliant control samples (blank amples), and when relevant, reagent blanks. or the confirmation step: (a) control sample to determine uitability of the instrument; (b) quality control samples which are ortified at a concentration close to the MRL or ML for authorised Page: 4 rt ref. DG(SANTE) 2022-7487 of the audit carried out from 15 November aminants in live animals and animal products the competent authority active substances or close to the RPA or LCL unauthorised substances (non-compliant control liant control samples, and when relevant, ion regarding conformation step was applied substances when a standard additional method e undoubted conformation. Therefore, non- were spiked at a level of at least 50% of the ent in the samples (estimated during screening w on, the approach will be changed according quality control sa

The recommendation states as its basis

The reporting routines did not facilitate the interpretation of test results in line with applicable EU requirements (57). Results were reported without indicating the applicable CC value or measurement uncertainty. Compliant results are reported as below the concentration of the lowest calibration point, but the meaning of reported figures is not explained in the report. Conclusions on laboratories

The BIOR laboratory is well-equipped and in many respects functions well. Nevertheless, shortcomings in the validation of some analytical methods, the implementation of quality controls and the reporting of analytical results, undermine confidence in the reliability of certain results. This combined with the absence of its designation as an official control laboratory (and that of its subcontracted partner) weakens the effectiveness of the residue control system.

Member state response

heir CC value or measurement uncertainty will be stated with the ed the screening target concentration (STC). umerical values below the screening target be reported as "< STC", meaning that the tected above the indicated concentration. mplementation: 01.04.2023. Page: 5

The recommendation states as its basis

Approval is granted once FVS has verified that all applicable requirements are met. However, the verification that operators of Category 3 material processing plants have carried out an adequate validation of their process is not effective as several operators implement processing methods that are not in line with the specific process requirements of the methods for which they are approved by FVS. Since the derived products from these processing plants meet the relevant microbiological criteria, the risks to feed safety arising from these incorrect process parameters are limited. 5.2.2 Planning of official controls

The recommendation states as its basis

Since February 2019, the FVS has been responsible for the control of wild boar carcases in processing rooms and storage facilities of hunting grounds (chillers, freezers or other equipment), where wild boar carcases are stored while ASF test results are awaited. To date, the FVS does not have an overview of the facilities available for each hunting ground. When the FVS started to carry out official controls on hunting grounds, they set, mainly due to staff constraints, an objective for 2019 of inspecting 10% of the hunting grounds (the same objective of 10% for 2020), and a minimum number of carcases based on a statistical approach. From March to December 2019, 190 hunting grounds were inspected. The visits targeted either the bigger hunting grounds or the ones with a higher number of hunted animals, although the competent authorities expected a higher percentage of non-compliances linked to the lack of adequate storage facilities for carcases in the smaller hunting grounds. Following this approach, it would take the FVS at least ten years to verify the implementation of the biosecurity requirements in all the hunting grounds, which limits the effectiveness of these official controls. The audit team verified a sample of official controls carried out on hunting grounds, which all had storage rooms and where hunters kept the carcases in them until the laboratory results were available. The FVS confirmed that all hunting grounds inspected so far had been in compliance with these requirements.

The official control on the handling and storage of wild boar carcases in general and on the destruction of carcases resulted positive to ASF in particular has improved since the FVS became responsible for this control in 2019. However, its efficiency is limited until official controls are more representative.

Member state response

in Due to the COVID-19 crisis we do not plan any changes in the (1)(a) number / percentage of hunting premises to be inspected this year as the inspection regime, in general, is already impacted. We plan to increase the proportion of hunting premises to be inspected (per year) up to 15-20% starting from January 2021 if the impact of COVID-19 will decrease.

The recommendation states as its basis

The objective of the State Forest Service for the current hunting season is to inspect 1,200 hunting grounds (they had inspected around 1,000 so far this season). Inspections are unannounced and, contrary to a legal requirement in force a few years ago, hunters do not have to inform the State Forest Service offices in advance of when they plan to hunt. For this reason, and according to the information provided to the audit team, inspectors have not been able to perform their tasks in half of the visits, as no hunting activities were taking place. In addition, inspections do not target any specific species so only in approximately 300 out of the 1,000 inspections wild boar was being hunted.

According to the State Forest Service, when wild boar is being hunted, inspectors must focus on biosecurity aspects. These are, for example, checking the presence of disinfectant at the point of hunting, the burial of offal if wild boars are gutted on the spot or the transport of offal to a watertight container or that carcases do not get in contact. However, inspectors have not received any specific training on biosecurity and there are no instructions or guidelines available to them.

The State Forest Service has prepared a checklist for the inspections, but it does not contain any detail on the biosecurity aspects checked (only yes/no). There is an online application to report the inspection results, but it does not contain details on the species that were hunted during the inspection therefore there is no overview of the wild boar hunting grounds visited. The State Forest Service assumed that there was hunting of wild boar if biosecurity was reported.

According to the data contained in the online application, inspectors have never found any non-compliance on biosecurity. An inspector clarified that although not reported, in cases of shortcomings, they normally prefer to instruct hunters to improve their awareness regarding biosecurity. 8 5.1.4 Control of ABPs of domestic and feral pigs Legal requirements Articles 2, 7 and 10 of Decision 2014/709/EU. Findings

The official controls at the point of hunting, including for biosecurity, which remain under the competence of the State Forest Service, are still a very weak point in the control of ASF in Latvia and they increase the potential risk of spread of ASF 9 infection not only within the country but also in other Member States.

Member state response

n Following the recommendations, the State Forest Service will (1)(a) supplement the hunting section of the "Control report" by adding: 1. Note on wild boar hunting; 2. The results of the biosecurity inspection, particularly in areas of: a. disinfection; b. animal by-products; c. dressing areas. The deadline for the implementation of these measures is set by the 1st April 2021 (beginning of the next hunting season). Theoretical and practical training for the State Forest Service officials on the inspection of biosecurity requirements during the wild boar hunting will be organized at the regional level in collaboration with Food and Veterinary Service. Series of these trainings are planned to be completed by the end of 2020. Page: 1

The recommendation states as its basis

The audit team noted that the five BCPs evaluated have shared facilities for different categories of goods, but in all cases, the risk assessments required by Article 3(9) of Regulation (EU) 2019/1014 for the shared use of facilities had not been completed. It also noted that the storage facilities at the selected BCPs were not suitable for simultaneously storing at the appropriate temperatures chilled and frozen goods for which the BCPs were designated, as required by Article 3(1)(c) of the same Regulation.

Border Inspection Posts have been re-designated following the introduction of the OCR. However, there were shortcomings in the required risk assessment for the sharing of facilities and the facilities for storing at appropriate temperatures the different categories of goods for which the BCPs were designated. 15

Although the volume of imports through the BCPs concerned is low, the non- compliances identified may have an impact on the hygienic handling and storage of goods for which those BCP have been designated. The competent authorities have initiated corrective actions to ensure that those risks are minimised or eliminated.

The recommendation states as its basis

The audit team noted that the five BCPs evaluated have shared facilities for different categories of goods, but in all cases, the risk assessments required by Article 3(9) of Regulation (EU) 2019/1014 for the shared use of facilities had not been completed. It also noted that the storage facilities at the selected BCPs were not suitable for simultaneously storing at the appropriate temperatures chilled and frozen goods for which the BCPs were designated, as required by Article 3(1)(c) of the same Regulation.

Border Inspection Posts have been re-designated following the introduction of the OCR. However, there were shortcomings in the required risk assessment for the sharing of facilities and the facilities for storing at appropriate temperatures the different categories of goods for which the BCPs were designated. 15

Although the volume of imports through the BCPs concerned is low, the non- compliances identified may have an impact on the hygienic handling and storage of goods for which those BCP have been designated. The competent authorities have initiated corrective actions to ensure that those risks are minimised or eliminated.

The recommendation states as its basis

The authorities confirmed there is no routine post-mortem inspection for home slaughtered pigs on non-commercial holdings. On the non-commercial holding visited by audit team, the herd owner indicated they would inform the authorities of any 6 abnormalities observed during slaughter. On this non-commercial holding, located in Part II, the audit team noted two pigs slaughtered in 2017/18 with no input from the official veterinarian which is contrary to Article 16, of Directive 2002/60/EC (the eradication plan) and to the ASF strategy for Eastern Part of the EU (SANTE/7113/2015 - Rev 7) which requires home slaughtering only under veterinary supervision in Part II. 5.1.3 Control of carcases, fresh meat, meat preparations and meat products from feral pigs Legal requirements Article 18 of Regulation (EC) 178/2002; Articles 15 and 16 of Directive 2002/60/EC; Directive 2002/99/EC; Commission Implementing Decision 2014/709/EU; Annex III, section IV of Regulation (EC) No 853/2004; Articles 4(6) and 5 Regulation (EC) No 854/2004. Findings

Home slaughter of pigs, on non-commercial farms, is not carried out under veterinary supervision which weakens the surveillance for ASF on these farms.

The recommendation states as its basis

The authorities estimate that seventy percent of hunting grounds have primary processing facilities (including access to chills) with the remainder of hunting grounds using home storage for carcases awaiting ASF test results. In hunting ground visited by audit team, facilities for dressing wild boar, chill storage and a dedicated pit for disposal of animal by-products were available.

Storage of wild boar carcases and biosecurity in hunting grounds is poorly controlled and not all restrictions applicable to wild boar meat are respected. This increases the potential risk of spread of ASF infection.

The recommendation states as its basis

The authorities estimate that seventy percent of hunting grounds have primary processing facilities (including access to chills) with the remainder of hunting grounds using home storage for carcases awaiting ASF test results. In hunting ground visited by audit team, facilities for dressing wild boar, chill storage and a dedicated pit for disposal of animal by-products were available.

Storage of wild boar carcases and biosecurity in hunting grounds is poorly controlled and not all restrictions applicable to wild boar meat are respected. This increases the potential risk of spread of ASF infection.

The ASF expert group has not received results related to compliance with biosecurity in hunting grounds. The checklist used by State Forest Service does not allow for any detailed assessment of the effectiveness of the measures. Not all hunting grounds comply with biosecurity advice (see point 21) as many considered to have sub- standard facilities. The central authority estimate it will be October 2018 when official controls, related to the new rules for hunting ground biosecurity, will commence. At the time of audit, no plan for these official controls had been established4. Conclusions on verification and supervision

The recommendation states as its basis

The audit team visited a holding using Article 3b derogation and noted: The permit to move pigs from this holding to slaughterhouses was issued quarterly (five separate movement permits were available as the holding supplied five different abattoirs and each movement permit requires a route plan). The holding is inspected at least four times per annum by the territorial structural unit who, inter alia, review biosecurity plans. The common biosecurity plan (breeding holding and fattening unit) is not approved in advance by competent authority, which is not in line with Article 3b of Decision 2014/709/EU. There is official sampling for ASF, as required by Article 3b(b). The official veterinarian confirmed they select pigs to be sampled to ensure sick pigs and samples from all age groups and stables within holding are included. In addition, the business operator carries out regular surveillance for ASF. Records of post mortem examinations and sampling / test results for ASF were available with samples taken throughout the month e.g. 19 samples tested in January, 14 in February and 14 in March (2018). The audit team noted delays of up to 10 days between sampling and test results being available. The authorities confirmed this was due to the business operator collecting samples over a number of days before submitting them for laboratory testing. The audit team reviewed movements of pigs into this herd for the period January to March 2018 and confirmed all pigs originated from a single, separate breeding holding. For holdings using the derogation provided by Article 3b of Decision 2014/709/EU, the authorities confirmed they did not carry out a complete risk assessment related to the risk mitigation measures in place in both the breeding holding and the holding of dispatch. This is not in compliance with Article 3b(d) of Decision 2014/709/EU.

The requirements of Article 3b of Decision 2014/709/EU, which derogates from the need for a 30 day standstill, are not fully implemented and may increase the risk of spread of ASF infection.

The recommendation states as its basis

The audit team visited a holding using Article 3b derogation and noted: The permit to move pigs from this holding to slaughterhouses was issued quarterly (five separate movement permits were available as the holding supplied five different abattoirs and each movement permit requires a route plan). The holding is inspected at least four times per annum by the territorial structural unit who, inter alia, review biosecurity plans. The common biosecurity plan (breeding holding and fattening unit) is not approved in advance by competent authority, which is not in line with Article 3b of Decision 2014/709/EU. There is official sampling for ASF, as required by Article 3b(b). The official veterinarian confirmed they select pigs to be sampled to ensure sick pigs and samples from all age groups and stables within holding are included. In addition, the business operator carries out regular surveillance for ASF. Records of post mortem examinations and sampling / test results for ASF were available with samples taken throughout the month e.g. 19 samples tested in January, 14 in February and 14 in March (2018). The audit team noted delays of up to 10 days between sampling and test results being available. The authorities confirmed this was due to the business operator collecting samples over a number of days before submitting them for laboratory testing. The audit team reviewed movements of pigs into this herd for the period January to March 2018 and confirmed all pigs originated from a single, separate breeding holding. For holdings using the derogation provided by Article 3b of Decision 2014/709/EU, the authorities confirmed they did not carry out a complete risk assessment related to the risk mitigation measures in place in both the breeding holding and the holding of dispatch. This is not in compliance with Article 3b(d) of Decision 2014/709/EU.

The requirements of Article 3b of Decision 2014/709/EU, which derogates from the need for a 30 day standstill, are not fully implemented and may increase the risk of spread of ASF infection.

The recommendation states as its basis

MA representative stated that the Ministry carries out audits on subordinated services. These audits, however, focus on compliance with national provisions and do not take into account requirements of Article 4(6) of Regulation (EC) No 882/2004. Conclusions:

SPPS has not put in place audit of official controls on the marketing and use of plant protection products, contrary to the requirements of Article 4(6) of Regulation (EC) No 882/2004.

Member state response

CA State Plant Protection Service (SPPS) does not agree with ng findings and conclusions in the "Draft report o fan audit carried out in Latvia from 09 october to 13 october 2017 in order to evaluate the system put in place to implement article 4(6) of Regulation (EC) No.882/2004 (National audit system)" (hereafter ­ DG SANTE Audit) The findings of DG SANTE Audit concentrate on official controls on the marketing and use of plant protection products. Regulation (EC) No.882/2004 is not applicable to the marketing and use of plant protection products. Legislative basis for these fields are included in Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides. Official controls on the marketing and use of plant protection products have never been subject to Regulation (EC) No.882/2004. These controls are not included within MANCP. There are no references to official controls on the marketing and use of plant protection products in Regulation (EC) No.882/2004. Article 4(6) of

SPPS will put in place internal audit system which an individual auditor provides audit services on official controls. The auditor will based on the contract signed with SPPS and based on the audit plan.

The recommendation states as its basis

The FVS representatives stated that each audit programme may be modified in the course of operational management on the basis of emerging needs. The FVS Director General approves a modified version and it becomes valid. FVS presented a number of programmes that received modifications and varied from initial versions. Modifications usually concerned moving an audit series to the following year when it was subsequently launched or dropped from the programme. The DG SANTE audit team noted that none of the audit reference documents contain provisions on documenting reasons for changes in audit programme. 16

The DG SANTE audit team examined multi-annual and annual audit programmes and related records and noted that: a) Multi-annual programmes covered a five-year period: 2012 ­ 2016 and 2017 ­ 2021, and each of them was further broken down to individual annual programmes. b) For the period 2012 ­ 2016, apart from the final results, the five-year programme and annual programmes, no records were available that could demonstrate how the development process was completed. c) For the period 2017 ­ 2021 the five-year programme and some additional documents were available, these were: the audit universe and the risk universe. Nonetheless, an explanation on the importance of the areas, a reasoning behind risk factors and methodology how the risk criteria applies, thus determine the final selection of relevant (risky) areas, topics and scopes for audits were not in place.

The audit planning process is not adequately documented which results in a lack of transparency of prioritisation of areas covered by the programme. As a consequence FVS cannot demonstrate that its audit programme is risk-based thus achieves an appropriate coverage of relevant official control activities. 17 5.2.5 Implementation of the audit process 5.2.5.1 Legal requirements Article 2(6) of Regulation (EC) No 882/2004 states that "Audit" "means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives." In section 5.1 of the Annex of Decision 2006/677/EC further guidance is provided to Member States on the `Systematic Approach', including: "A systematic approach should be applied to the planning, conduct, follow-up and management of audits. To that end, the audit process should: ....... -- be supported by documented audit procedures and records to ensure consistency between auditors and to demonstrate that a systematic approach is followed, -- include procedures for generating audit findings, including the identification of evidence of compliance and noncompliance, as appropriate, and for preparing, approving and distributing audit reports, -- include procedures to review audit conclusions, in order to identify system-wide strengths and weaknesses in the control system, disseminate best practice and ensure the monitoring of corrective and preventive actions, -- be monitored and reviewed to ensure the audit programme's objectives have been met and to identify opportunities for improvement." Section 6.1 of the Annex of Commission Decision 2006/677/EC provides guidance on implementation of the Audit Process: "To comply with the requirements of Article 4(6) of Regulation (EC) No 882/2004, the audit system should cover the following three points set out in Article 2(6): (a) Verification of compliance with planned arrangements in order to provide assurances that official controls are carried out as intended and that any instructions or guidelines given to staff carrying out the controls are followed. This may largely be addressed by document review, but will also require on-site verification. The audit team will require good generic audit knowledge and skills to address this audit objective. (b) Verification of the effective implementation of planned arrangements. In order to assess effectiveness, that is the extent to which planned results are achieved, on-site operational implementation must be included. This should include an assessment of the quality and consistency of the controls and should involve on-site audit activities. The audit team will require the relevant technical expertise in order to address this audit objective. (c) The audit system should also seek to assess whether the planned arrangements are suitable to achieve the objectives of Regulation (EC) No 882/2004, and in particular the single integrated multi-annual national control plan. This should include assessing the suitability of official controls, with regard, for example, to their frequency and the methods applied, having regard to the structure of the production chain(s) and to production practices and volume. The audit team should have substantial knowledge 18 and understanding of system auditing, together with relevant technical input to address this audit objective. In order to determine whether the planned arrangements are suitable to achieve the objectives set out in (c) above, the following should be considered: Audit criteria should include strategic objectives stemming from Regulations (EC) No 178/2002 and (EC) No 882/2004 (including the single integrated multi-annual national control plan) and national legislation. The primary focus of audits should be the control arrangements relating to the critical points for control in the production chain(s). The emphasis should be on assessing w

Member state response

f According to the Action Plan of CA Food and Veterinary Service is planned to develop the guidelines for risk-based planning of an audit program until October 31, 2018. The Action Plan is ilable on CA web site p://www.pvd.gov.lv/public/ck/files/PVD/Darba%20plans%202 %20_parakstits.pdf Page: 3

According to the Action Plan of CA Food and Veterinary Service it is planned to develop the guidelines for risk-based planning of an audit program until October 31, 2018. The Action Plan is available on CA web site: http://www.pvd.gov.lv/public/ck/files/PVD/D arba%20plans%202018%20_parakstits.pdf. Page: 1

The recommendation states as its basis

The CBs have subcontracted the sampling activity to the National Reference Laboratory (NRL). The contract covers the main requirements for the testing of organic samples. 5 The CA stated that, so far, the sampling activity carried out by the NRL has not been subject to supervision. The NRL has also been designated for the testing of organic products by the CA (see also chapter 5.2.6).

CBs are accredited and approved in accordance with national and EU rules. CBs are subject to effective annual supervision by the CA which includes office and witness audits as well as direct inspections at operators selected based on relevant risks. The sampling activity outsourced to the NRL has however so far not been subject to supervision by the CA. 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Article 92(2) and 92b of Commission Regulation (EC) No 889/2008. Findings

Member state response

1. Lai nodrosintu pietiekamas laboratorijas ekspertu zinsanas bioloisks lauksaimniecbas produkcijas paraugu emsan, kontroles institcijas ir vienojuss ar laboratorijas vadbu par laboratorijas ekspertu apmcbm. Mcbu programm tiks ietverta risku izvrtsana, kas var rasties saistb ar bioloisku produktu razosanu un prstrdi. Apmcbas plnotas 2017. gada februra - marta mnes. 2. Lai prliecintos, ka laboratorijas izstrdts paraugu emsanas procedras tiek izpildtas un ir pietiekamas, un, lai nodrosintu paraugu prstvniecbu un ticambu, kontroles institcijas 2017.gada bioloisks lauksaimniecbas kontroles un uzraudzbas programm ir ieplnojusas auditu laboratorij. 2017.gad no maija ­ septembrim. kontroles institcijas plno 7 paraugu emsanas uzraudzbas viztes. 3. kompetent institcija (CA) kontroles institciju ikgadjs uzraudzbas laik prbauds, k kontroles institcijas veikusas plnotos paraugu emsanas uzraudzbas paskumus 2017.gad, k ar izvrts laboratorijas ekspertu apmcbas procesu.

The recommendation states as its basis

The two CBs have procedures in place requiring the operators to submit a full description of their activities, including a description of precautionary measures put in place to avoid potential contamination of organic products. CBs' inspectors have to verify the implementation of these precautionary measures when visiting the operators. However, the audit team noted that CB1 does not require farmers to maintain a description of precautionary measures contrary to Article 63(1) and (2) of Regulation (EC) No 889/2008. Nevertheless, inspectors observed during inspections verified the precautionary measures put in place by the operators.

Both CBs have well developed and comprehensive documented procedures in place providing good guidance to inspectors to achieve a high level of consistency and effectiveness of controls at operators. Comprehensive information is generally available to the inspectors in advance of the controls allowing them to prepare well and to acquire a good understanding of the situation on the spot. One CB does not require farmers to provide all compulsory information in advance of the controls (such as precautionary measures), but nevertheless verifies it on the spot. 10 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 of Regulation (EC) No 834/2007. Article 23(1) of Regulation (EC) No 834/2007 Regulation. Title III of Commission Regulation (EC) No 889/2008. Article 27(13) of Council Regulation (EC) No 834/2007. Article 18 of Regulation (EC) No 178/2002. Findings

Member state response

ontroles institcija KS1 veikusi sdas darbbas: 1. Sertificjamo jomu izvrtsanas protokolos papildus ietverta Regulas (EK) Nr.889/2008 63.panta 1.punkta c) apakspunkta prasba par piesardzbas paskumiem, Page: 1 r 2016 rt ref. DG(SANTE)/2016-8744-MR of the audit carried out from 14 June organic production and labelling of organic products azintu neatautu ista piesrojuma risku, miem uzglabsanas es (skat procedras: 2; ANN-F-BL-011- 18-11.11.2016.-R6; ; ANN-F-BL-020- 6-11.11.2016.-R9). rasbas kontroles s krtjs plnots eratoram uzrdt ardzbas paskumu plnu, mus. a februr plno rojuma riska un nu. anta 2.punkt deklarcij, ko paraksta ldzot lgumu ar deklarciju operators uls un nacionlaj , k ar apemas uzturt rakstu, ievrot azintu neatautu vielu (skat deklarciju: .) Page: 2

The recommendation states as its basis

There is currently no formalised system in place to ensure that consignments of EU origin which move between two points in the EU via a third country and re-enter the EU via Latvia are controlled as required under EU legislation. However, due to a combination of factors the probable level of trade is low and the competent authority has begun the process of establishing a system.

Member state response

Situcijas raksturojums un plnotie paskumi: 1. Situcijas raksturojums - Ja mcbs piedals kvjs, no kautuvm, kuras ir atztas kausanai saska ar reliisko kopienu tradicionlajm gaas ieguves metodm, mcbu materilos ir iekauta ar informcija par labturbas prasbm savaldsanai, kausanai un atasiosanai pie reliisks kausanas (skatt iesniegts prezentcijas 205, 295, 297 un 298 slaidu). Sertifikt sis apliecinjums ldz sim netika iekauts. 2. PVD k KI rakstiski informs kvju apmcbu organiztjus LLKC par to, ka: 2.1. skot ar 01.01.2015. ir nepieciesams apmct personas, kuras veic nonvsanu un ar to saistts darbbas saimniecb audztiem medjamo sugu dzvniekiem, atbilstosi regulas 1099/2009 prasbm, 2.2. turpmk nodrosint, ka tiem dzvnieku kvjiem, kuri so apmcbu ietvaros Skatt 1 punktu) ir apmcti labturbas prasbm dzvnieku kausanai saska ar reliisko kopienu tradicionlajm kausanas metodm, sertifikt veikt apliecinjumu par veikto apmcbu.

Member state response

The Food and Veterinary Service (FVS) on 25.03.2014 by letter tion informed the Association of Road Carriers "Latvijas Auto" about ation, conditions applicable to personal consignments, required by Regulation (EC) No 206/2009 and asked to explain additionally for all members of Association about the rules which must be followed. Taking account of the new FVS order No 75 from 22.05.2014. in connection with the prevention measures: a) from 22.05.2014.FVS inspectors participating in control process to help customs officers and border guards in the luggage control at the more holidays and holiday at a time of growing flow of persons travelling, b) not less frequently than once a month to organize supervision audit in all border crossing points, c) and developed the act, which is the surveillance document during supervision audit FVS update the information according the rules of personal luggage and issuing new posters and leaflets on public alerting Page: 1

Member state response

for additional financing from Ministry of Agriculture in ecure official sampling and testing program for histamine from follow the requirements laid down in Regulation (EC) No Page: 1

Member state response

ional financing from the Ministry of Agriculture order to perform the testing of suspecting samples.

equested additional financing from the of Agriculture in January 2013 in order to esting of suspecting samples. ceived from CA 19 September 2013 2013. ecure the testing of suspecting samples nuary 2014 within the allocated state

Member state response

agreed turnaround times for residue samples are g the database JUNDA.

13. the agreed turnaround times for es are checked weekly using the JUNDA. ived from CA 19 September 2013 2013. uthority will follow the execution turn ­ around times and in case of of target values the director of BIOR will ed with applying of following possibilities ne a payment for delayed analysis. bility of shortening of targeted turn-around Page: 1 Updated Action Plan received from CA on 19 September 2013 mmendations of Report ref. DG(SANCO)/2013-6761-MR of an audit carried out l of residues and contaminants in live animals and animal products including the from the Baltic region oposed by the Competent Authority l be evaluated at BIOR in September 1st n information of 9 months will be d and new GC/MS/MS system will be .

Member state response

rnal procedure DC-RI-M90 for the validation will be d instructions about calculation of critical creening and confirmatory analyses. Deadline for cedure is 01.07.2013. lines are set for validation of methods with extended 01.10.2013. ntil 01.09.2013. 01.12.2013.

y internal procedure DC-RI-M90 for will be extended with detailed about calculation of critical r screening and confirmatory line for implementation of new .07.2013. g dead-lines are set for validation of h extended list of matrices: ns ­ until 01.10.2013. ol ­ until 01.09.2013. cs ­ until 01.12.2013.

Member state response

additional financing from the Ministry of Agriculture der to perform the monitoring of the levels for e the effective control in all steps of Page: 1 Action Plan received from CA on 31 May 2013 O)/2013-6761-MR of an audit carried out live animals and animal products including the Action Proposed by the Competent Authority sh processing enterprises (a letter from high risk level of dioxins in fat fish cached in iga Bay as well as has suggested the action how g on the market contaminated production. f the FVS from 03.03.2013. the control of the r should be reinforced. med the inspectors of necessity to perform the fish products that could contain too high level of be sure that these products are not placed on the Page: 2

equested additional financing from the griculture in January 2013 in order to itoring of the levels for dioxins and ure the effective control in all steps of elivery. all fish processing enterprises (a Page: 2 Updated Action Plan received from CA on 19 September 2013 mmendations of Report ref. DG(SANCO)/2013-6761-MR of an audit carried out l of residues and contaminants in live animals and animal products including the from the Baltic region oposed by the Competent Authority om 08.03.2013.) and TSUs on high risk level s in fat fish cached in the Baltic sea and the as well as has suggested the action how to m the placing on the market contaminated n. to the Order of the FVS from 03.03.2013. ol of the production from cod liver should rced. epeatedly informed the inspectors of to perform the traceability control of fish that could contain too high level of nd PCBs and to be sure that these products laced on the market. ceived from CA 19 September 2013 2013. the order of FVS (3.03.2013.) to verify the ness of the control of dioxins the inspectors te a special attention to how the BO follow uction. And additionally the field managers ral level will check the food inspectors hey act acco

Member state response

erinr dienesta (PVD) centrlais aparts ir noteicis ktrvienbm ldz 01.09.2013. apzint potencils natvs izncinsanas vietas un attiecgi papildint visi bstamu infekcijas slimbu apkarosanas mciju. vides dienesta (VVD) starpinstitciju komunikcijas k saskaotas sadarbbas jomas un formas, kuras D un VVD starpinstitciju lgum par operatvu itucijs. Lguma noslgsana plnota ldz

Member state response

izveidota uz riska izvrtjumu balstta inspekcijas sistma, kas tta ar prtikas uzmumu reistrcijas datu bzi un prtikas ciju datu bzi, kas patlaban ir savienotas vienot Bez tam 2013. gada jnij datu bz tika veiktas uzlabojumi. Oficils kontroles laik tiek zmuma prbaud konstatts neatbilstbas Regulas 882/2004 3.panta b punkta prasbas tiek riska kritrija ­ biznesa operatoru apemsans ekausana riska novrtsanas matric patlaban nav slu d: uma kritriji; biznesa operatoru; itas sankciju piemrosanas metodes. jumu ,,PVD inspekciju plns" (Nr. 393, nordtais prbauzu biezums ir bzes kritrijs un izmantojot informciju no pdjs plnveida um. Ja pdj plnveida prbaud t protokol vrtto prtikas apriti reglamentjoso ( A grupa), tad bzes kritrijs tiek reizints ar ma samazinsana), t protokol vrtto prtikas apriti reglamentjoso tacu ir konstatti novrojumi, kas btiski itgumu un drosumu" (B grupa), tad bzes Page: 1 er 2013 ref. DG(SANCO)/2013-6876-MR of an audit carried out mpetent authorities with regard to official controls related to Action Proposed by the Competent Authority aliek nemaings, mums neatbilst protokol vrtto prtikas apriti oso normatvo aktu prasbm" (C grupa), tad bzes kritrijs nts ar koeficientu 2

controls the 1. An inspection system based on risk assessment has been set up within rmation the FVS [Food and Veterinary Service] which is closely linked to the le 3, b database for the registration of food establishments and the database of food establishment inspections, which are currently merged into a single electronic database. Furthermore, in June 2013 major changes and improvements were made to the database. During the official control, the irregularities identified during the previous check on the establishment are assessed. We therefore take the view that the requirements of Article 3(b) of Regulation 882/2004 are being complied with and an additional risk criterion, namely the inclusion in the risk assessment matrix of an undertaking by business operators to remedy irregularities, does not now need to be introduced for various reasons: - there are no objective assessment criteria; - the small number of such business operators: - the possibility of using other methods to apply penalties. 1.1. In accordance with the FVS Order 'FVS inspections plan' (No 393 of 23 September 2011), the frequency of checks stipulated in this plan is the basic criterion and changes are made us

Member state response

4.jlij PVD TSV (teritorils struktrvienbas) ir ,Par maksas iekassanu par papildu oficilo kontroli" ants ecas uz R 882/2004 55. pantu ,,Sankcijas", PVD piemro tikai ijas, kas ir noteiktas normatvajos aktos. Tieslietu ministrija umus Administratvo prkpumu kodeks (APK). ZM ministrija) ir iesniegusi Ministru kabinet grozjumus par palielinsanu par prkpumiem, kas attiecs uz prtikas izsekojambu. zstrdti kritriji samaksas piemrosanai par papildus oficilo Prtikas inspektoriem 2013. gada 8.august tika organiztas uru laik prtikas inspektori tika informti par samaksas s krtbu.

comply 1. On 4 July 2013 the Territorial Structural Units of the FVS were C) N° informed of the levying of a charge for an additional official control siness (Article 28 of Order 882/2004). ed to its 2. As regards Article 55 of Order 882/2004, the FVS only applies the penalties set out in regulatory acts. The Ministry of Justice makes amendments to the Code of Administrative Infringements (CAI). The Ministry of Agriculture has sent the Cabinet amendments increasing penalties for infringements relating to the labelling and traceability of food. 3. The FVS has drawn up criteria for the application of a fee for an additional official control. On 8 August 2013, training was organized for food inspectors during which they were informed of the arrangements for charging a fee.

Member state response

jos uzmumu atzsanas procesos nodrosint procedru tiecb uz uzmumu atzsanu divos posmos. Atzsanas gait manbu produktu izsekojambas nodrosinjumam. stdes uzmumu atzsanas laik skot ar 01.10.2013. tiks nformcija par dzvnieku sugm, no kurm iegt gaa tiks k izejvielu. S informcija tiks atrunta uzmumu atzsanas Page: 2 er 2013 ref. DG(SANCO)/2013-6876-MR of an audit carried out mpetent authorities with regard to official controls related to Action Proposed by the Competent Authority CA lap un tiks izmantota sekojosaj uzmuma prbaud. 013. prtikas inspektoru kvalifikcijas celsanas kursos izcelsmes prtikas oficil kontrole un aktualittes" veikta D procedru vienotai piemrosanai dzvnieku izcelsmes mumu atzsanas proces.

s and their 1.In subsequent establishment approval procedures, ensure procedural blishments compliance in respect of two-stage establishment approval. In the course 4. of approval, pay attention to ensuring the traceability of products. 2. During the approval of meat processing establishments, as from 1 Page: 2 mendations of Report ref. DG(SANCO)/2013-6876-MR of an audit carried out ction taken by the competent authorities with regard to official controls related to k and their products Action Proposed by the Competent Authority October 2013 information will be made available on animal species from which meat is obtained for use as a raw material. This information will be given on the CA page of the establishment approval report and will be used in the next check on the establishment. 3. In the food inspector training course held on 8 August 2013 ('Food of animal origin - official control and recent developments'), training was given in the uniform application of FVS procedures in the process of approving establishments working with food of animal origin.

Member state response

13. prtikas inspektoru kvalifikcijas celsanas kursu izcelsmes prtikas oficil kontrole un aktualittes" laik ir ori par FVO audita rezulttiem un novrojumiem un spektoriem sniegtas rekomendcijas higinas prasbu ai. gada mcbu pln ir ietvertas prtikas inspektoru praktisks uvju uzraudzbas jom. , kuros tika konstatti prkpumi, noteikti neatbilstbu termii. Neatbilstbas daji jau novrstas vai sastdti rkojumi ar termiiem neatbilstbu novrsanai. piena jomu uzraudzbas jomu vadtji pievrss pastiprintu aktisks inspekcijas efektivittei jomas prtikas inspektoru zbas veiksanas laik.

eneral and 1. In the food inspector training course held on 8 August 2013 ('Food of red by animal origin - official control and recent developments'), inspectors I to were informed of the FVS audit results and observations and food inspectors were issued with recommendations on the application of r improving hygiene requirements. ficiencies in 2. The 2013 training plan includes practical training for food inspectors gulation in the field of slaughterhouse surveillance. 3. In undertakings where infringements were identified, deadlines for remedying shortcomings were set. Shortcomings have already been remedied in part, or warning notices drawn up with deadlines for remedying the shortcomings. 4. Field managers in the meat and milk sectors will pay increased attention to the effectiveness of practical inspection during the carrying out of lead supervision of field food inspectors.

Member state response

to National Action Plan will be sent to Commission and Member States by beginning of February 2013.

National Action Plan will be sent to mission and Member States by beginning ebruary 2013.

Member state response

Current requirements for the storage of PPPs at the warehouse: ed in According to Article 9 of Plant Protection Law PPPs should be stored in the original packaging and in the conditions indicated on labelling thereof and, in addition, separately from other products and substances that may affect the properties of the relevant PPPs. All PPPs are stored in warehouses in original packaging, thus minimizing the risk of cross- contamination between products. Current requirements for the storage of PPPs at the user: According to Cabinet Regulation No. 950 Regulations Regarding the Use of Plant Protection Products, at the user PPPs shall be stored in original packaging, complying with the storage conditions specified on the labelling, as well as with the requirements of Section 9, Paragraph three of the Plant Protection Law (persons who have acquired PPPs shall be liable for the storage thereof in lockable places, inaccessible to children and animals, separate from food products and fodder). PPPs registered as Class One shall be stored in a locked, ventilated room separately from other PPPs. Page: 1 s of Report ref. DG(SANCO)/2012-6294-MR of an audit carried out des Action Proposed by the

Current requirements for the storage of PPPs at the warehouse: According to Article 9 of Plant Latvian CAs: ed Protection Law PPPs should be stored in the To ensure that PPPs are stored in ventilated iginal packaging and in the conditions rooms and are separated during storage, by 1 ed on labeling thereof and, in addition, October 2013 the State Plant Protection separately from other products and substances Service will review existing legislation and that may affect the properties of the relevant make changes in the legislation governing PPPs. All PPPs are stored in warehouses in the distribution and use of plant protection original packaging, thus minimizing the risk of products. cross-contamination between products. Current requirements for the storage of PPPs at the user: According to Cabinet Regulation No. 950 Regulations Regarding the Use of Plant Protection Products, at the user PPPs shall be stored in original packaging, complying with the storage conditions specified on the labeling, as well as with the requirements of Section 9, Page: 1 Authority, 22/2/2013 the Competent Authorities of Latvia on 03 January in response to Report ref. from 10 to 14 September 2012 in order t

Member state response

ions Procedures for preparing pesticide application equipment for work, s including regular calibrations and technical checks of the pesticide application equipment, are included into training program for professional users, operators and advisors. These training programs anticipate Cabinet Regulation on training of professional users, operators, distributors of PPPs and advisors on plant protection.

ct Procedures for preparing pesticide application of equipment for work, including regular librations and technical checks of the sticide application equipment, are included to training program for professional users, erators and advisors. These training programs ticipate Cabinet Regulation on training of ofessional users, operators, distributors of Ps and advisors on plant protection.

Member state response

utors Directive 2009/128/EC required that all professional users, distributers ted and advisors have access to appropriate training. Cabinet Regulation on EC. training of professional users, operators, distributors of PPPs and advisors on plant protection establish such system. For auxiliary staff of professional users and distributers no specific training is foreseen neither by Directive nor by the Cabinet Regulation. Labour safety instruction by employer for these persons are required before the work with PPPs.

l Directive 2009/128/EC required that all Latvian CAs: professional users, distributers and advisors Special training programs for professional ed have access to appropriate training. Cabinet users, operators (auxiliary staff), advisors Page: 2 Authority, 22/2/2013 the Competent Authorities of Latvia on 03 January in response to Report ref. from 10 to 14 September 2012 in order to evaluate controls of pesticides Action Proposed by the Competent Authority Updated action proposed by the Competent Authority Regulation on training of professional users, and sale persons are anticipated by Cabinet operators, distributors of PPPs and advisors on Regulation on training of professional users, plant protection establish such system. For operators, distributors of PPPs and advisors auxiliary staff of professional users and on plant protection. It is expected that distributers no specific training is foreseen Cabinet Regulation comes into force by 28 neither by Directive nor by the Cabinet February 2013. Regulation. Labour safety instruction by employer for these persons are required before the work with PPPs.

Member state response

The Institute "BIOR" will implement the testing of new standard ) solutions against old standard solutions in accordance with document SANCO 12495/2011 and the results of these checks will be documented.

The Institute "BIOR" will implement the testing Latvian CAs: of new standard solutions against old standard By 15.04.2013 the Institute "BIOR" will olutions in accordance with document SANCO implement the testing procedure of new 12495/2011 and the results of these checks will standard solutions against old standard be documented. solutions in accordance with document SANCO 12495/2011 and documenting of results of these checks.

Member state response

It is planned to conclude during year 2013 trilateral agreement between ) of Customs Administration, Food Veterinary Service and State Plant Protection Service on cooperation and information exchange concerning Page: 2 s of Report ref. DG(SANCO)/2012-6294-MR of an audit carried out des Action Proposed by the Competent Authority import and transit of PPP. Page: 3

It is planned to conclude during year 2013 trilateral agreement between Customs 3) Administration, Food Veterinary Service and State Plant Protection Service on cooperation and information exchange concerning import and transit of PPP. Page: 3

Member state response

p to Prtikas un veterinrais dienests, sakrtojot ieksjs procedras, veiks visu nepieciesamo, lai reistrtu galgos lietotjus atbilstosi Regulas (EK) Nr.1069/2009 23.panta prasbm.

Member state response

s 2013.gadam tiks veidots: riska faktorus, kuri idedtificti trs m 2011. gad un konstatti 2012. .2013;

Member state response

risku izklstu (dioksni un metli ) barbas piedevm, barbas tvij, impotrtas no tresajm valstm m. .2013. inspekciju (plnveida prbaudes) s emta vr barbas aprites oles sistmas uzticamba 1.2013. r. 730 Dzvnieku barbas aprit as un atzsanas krtba. sana, kuru darbba reistrjama s prbaudi), tiks deleta PVD; idlapa uzmumu darbbm, kuras 012 noteiktos uzmumus). istrcijas prbaude, kas pasreiz ir Action Plan received from CA on 14/12/2012 2-MR of an audit carried out d management of risks along the feed Authority .; atbildgais ZM u darbbu klasifiktor, odus: food) izplatsana produktviem alstm; n tehniskiem produktiem. mnes pc grozjumu MK k; atbildgais Vererinrs kas uzraudzbas departaments orta pakalpojumu sniedzjs" umu inspekciju laik prbaudot, s, kas sadarbojas ar konkrto eistrts kompnijas, kas lpojumu sniegsanu, tiks reistrtas . s, kas sniedz transporta a reistrtas tikai 16 kompnijas). 2013.;

Member state response

rojuma atlieku noteiksanai tiks tda pc maistja trsanas. kumentcij tiks ieviestas ldz

Member state response

arojuma inspektoriem 25.10.2012."FVO Page: 2 Action Plan received from CA on 14/12/2012 2-MR of an audit carried out d management of risks along the feed by the Competent Authority eptembr ­ nordes uzraudzbas un barbas razotju un tirgotju asocicijas Aktualittes barbas aprites uzmumu 10.P.206 "Metodiskie nordjumi un rbas aprit iesaistto uzmumu . pielikumu: Dioksnu prraudzba s. . novembr.

Member state response

ar: a veidiem: ntroli barbas razosanas un spjgi novrst konstatts da 1. ceturksn. Page: 3

Member state response

train veterinary staff, Customs officers, including Border beginning of September/October 2012.The training themes: ggage, non-commercial pet checks, including birds. ards already received trainings on the 27th of March and on 2 on personal luggage. The Veterinary Medicine Law tipulates that at entry points staffed by Border guards ble for personal luggage checks. Since the 15th April s performing personal luggage checks.

Member state response

n the Food and Veterinary Service webpage regarding pets, including birds was updated since 6th February officers will be delivered starting from September instruction for birds and pets will be amended together list of clinics for housing of animals. It is expected to urrently started by the beginning of August 2012.

Member state response

for cleaning and disinfection for disposal of seized POAO idges are under development, will be in place after agreement with customs amendment by the end of

Member state response

th Post authority as regards new actions for animal origin as held on 4th April 2012. The cooperation agreement Page: 1 pril 2012 . DG(SANCO)/2012-6495-MR of an audit carried out order inspection posts and specific issues at selected t Authority vice and Latvia`s Post will be amended and destroying, deadline for . Page: 2

Member state response

t iespju apvienot 1. un 6. rekomendciju, jo abas ir par labturbas prkpumu gadjumiem divos uzmumos un visprjo prkpuma tendenci. ns inspektori prbaudes veic saska ar rinr dienesta procedru KR.10.P.186 "Metodiskie ku un novietnes prbaudei, k ar prbaudes protokola tvijas uzmjdarbbas ekonomisko situciju kpumu loklo izpausmi divos konkrtos uzmusos, pamatoti paaugstint soda sankciju apmru vai sodu gradcijas sistmu vis valst. stbu lielumu, ir intensificts prbauzu gi paredzot adekvtas soda sankcijas atbilstosi asbm. Veicot nkamo krtjo kontroli, uzmumiem rcbas plns neatbilstbas novrsanai. rinrais dienests ir informjis Lauku atbalsta t lielku uzmanbu dzvnieku novietu bvniecbas s to apstiprinsanas, lai novrstu labturbas prasbm vietu un iekrtu bvniecbu

t iespju apvienot 1. un 6. rekomendciju, jo abas ir par labturbas prkpumu gadjumiem divos uzmumos un visprjo prkpuma tendenci. ns inspektori prbaudes veic saska ar rinr dienesta procedru KR.10.P.186 "Metodiskie ku un novietnes prbaudei, k ar prbaudes protokola tvijas uzmjdarbbas ekonomisko situciju kpumu loklo izpausmi divos konkrtos uzmumos, pamatoti paaugstint soda sankciju apmru vai sodu gradcijas sistmu vis valst. stbu lielumu, ir intensificts prbauzu gi paredzot adekvtas soda sankcijas atbilstosi asbm. Veicot nkamo krtjo kontroli, uzmumiem rcbas plns neatbilstbas novrsanai. rinrais dienests ir informjis Lauku atbalsta t lielku uzmanbu dzvnieku novietu bvniecbas s to apstiprinsanas, lai novrstu labturbas prasbm vietu un iekrtu bvniecbu. 5.2013. un veterinr dienesta pieemto sankciju rezultt prsldzis lgumu par diennakti vecu cu piegdi, es daudzumus, atbilstosi uzmuma kapacittei. Kops Page: 1 f. DG(SANCO)/2012-6525-MR of an audit carried out animal welfare on farms and during transport posed by the Competent Authority apra, uzskot jaunus razosanas ciklus, mtns ievietoto kaits ir atbilstoss mtu maksimlajai kapacittei.