Slovakia

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The audit team examined the contingency plans for X. fastidiosa, B. xylophilus and A. planipennis. In general, the selected contingency plans contain the information required by Article 25(2) of Regulation (EU) 2016/2031, however the plans lack some relevant details. Specifically, the plans lack sufficient detail on CA's access to specific resources when required such as access to machinery needed for felling of trees, access to extra personnel required to undertake additional surveys when demarcated areas are established and any other services needed under extraordinary circumstances for the rapid and effective eradication or, where appropriate, containment of the priority pest concerned as required by Article 25(2)(c) of Regulation (EU) 2016/2031.

Slovakia has developed procedures to eradicate outbreaks of priority pests with contingency plans prepared and simulation exercises being undertaken. However, the published contingency plans do not include all the necessary detail to help the authorities rapidly and effectively eradicate any established priority pests, which may delay the implementation of eradication measures and containment of the outbreaks.

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The audit team noted that, according to the CHEDs evaluated and data in TRACES-NT for the period January 2023 to November 2024, only eight of 31 consignments of goods of animal origin authorised for direct transit at a BCP of introduction in Slovakia had their arrival at the exit BCP in another Member State confirmed in Part III of the CHED. The SVFA stated that it does not follow-up on these consignments, which is not in line with Article 20 of Delegated Regulation (EU) 2019/2124 and its own documented procedures. 9 5.2.4 Documentary, identity and physical checks of consignments 5.2.4.1 Checks on consignments of animals

However, some shortcomings were noted in the performance of official controls on 12 goods of animal origin and the decision-making and follow-up of consignments of goods of non-animal origin transferred to control points. The competent authorities took corrective actions to address the majority of these shortcomings, thereby minimising the risk of non-compliant animals and goods entering the EU through BCPs in Slovakia.

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In all of the five 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 four establishments. In general, the hazard identification section of the operators' HACCP plans was incorrect (certain relevant hazards were not mentioned such as pesticides, mycotoxins, dioxins, although these were relevant for different feed materials or heavy metals relevant for additives/premixtures) or very generic without the level of detail necessary for a proper hazard identification (as required by Article 6(2)(a) of Regulation (EC) No 183/2005) and consequent risk assessment. This issue was not reflected in the inspection reports seen by the auditors and operators were thus unaware that there was a deficiency. The audit team noted that, when interviewed during the audit, some inspectors correctly identified these deficiencies.

In one feed material producer the company used direct drying during its production process. In the hazard analyses this processing step was not assessed at all. The company did not include dioxin tests in its own sampling plan. This potential risk was overlooked during previous official controls.

While the planning of inspections is largely based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency, the effectiveness of controls is weakened by shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their HACCP systems, (ii) operators' tests on cross-contamination, and (iii) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis Planning of official sampling

Medlemsstatens svar

ÚKSÚP ÚKSÚP zabezpecí preskolenie inspektorov odboru kontroly ­ oddelenia kontroly krmív a výzivy zvierat (alej len "OKKVZ") na platné zdokumentované pracovné postupy. Súcasou skolení budú prípadové stúdie. Skolenia budú vykonané vzdy v mensích skupinách, aby bola zabezpecená lepsia interakcia medzi inspektormi OKKVZ. Zabezpecí sa aj lepsia komunikácia medzi odborom krmív a výzivy zvierat (alej len "OKVZ") zodpovedným za implementáciu legislatívnych poziadaviek a za metodické riadenie výkonu kontroly a OKKVZ zodpovedným za výkon úradných kontrol. V nadväznosti na vykonané skolenia bude vykonaná séria supervízií zamestnancami OKVZ, ako aj vo forme svedeckých auditov vykonaných audítormi Útvaru interného auditu, kontroly a kvality. Plnenie: séria skolení do 30.6.2024; supervízia ­ do 31.12.2023 nasledujúcich 6 mesiacov

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Verification of establishments' tests on minimisation of cross-contamination, required by part 2(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. At the three compound feed manufacturers visited (all using coccidiostats in production lines where feed for non-target species was also produced), the audit team scrutinised operators' documentation on the related testing and interviewed inspectors who usually control those establishments. In two establishments, the operators carried out cross-contamination tests at least once per year by collecting samples from the first batch produced after the use of coccidiostats and testing the concentration of the coccidiostats in the subsequent batches. The audit team noted that both of these operators` testing approaches were not effective in preventing potential cross-contamination (e.g.: samples were not collected from the first mixing of the first batch produced after the use of 6 coccidiostats). In the third establishment, cross-contamination testing was not carried out in the last five years and this fact was overlooked during official controls.

CCTIA prepared a guidance document to help inspectors in the assessment of operator`s cross-contamination tests. However, this guidance does not give comprehensive information on how to carry out an adequate assessment of such tests (e.g.: place of sampling, mixing of samples, first mixing to be sampled). The audit team noted that most feed inspectors met experienced difficulties in assessing the operators' procedures and the results of cross- contamination tests.

While the planning of inspections is largely based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with appropriate frequency, the effectiveness of controls is weakened by shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their HACCP systems, (ii) operators' tests on cross-contamination, and (iii) operators' compliance with labelling requirements. 5.2.2 Sampling and analysis Planning of official sampling

Medlemsstatens svar

ÚKSÚP ÚKSÚP prepracuje metodický pokyn c. 3/2013 pre prevádzkovateov ,,Overovanie krízovej kontaminácie pri výrobe kmnych zmesí preplachovaním dopravných ciest výrobnej linky" a standardný pracovný pokyn c. 03/19 ,,Inspekcná cinnos" pre výkon úradnej kontroly v termíne. Metodický pokyn pre prevádzkovateov bude zverejnený na webovom sídle ÚKSÚP a na vsetkých informacných platformách ÚKSÚP. V prípade dodatocných otázok a poziadaviek od krmivárskych podnikov, ÚKSÚP zorganizuje pre krmivárske podniky online skolenie. Plnenie: Page: 1 eport ref. DG(SANTE) 2023-7699 of the audit carried out from 09 October ontrols on feed hygiene tion Proposed by the competent authority epracovanie metodického pokynu a standardného pracovného stupu: do 30.4.2024. eskolenie inspektorov OKKVZ + supervízia v priebehu sledujúcich 6 mesiacov

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Verification that operators meet legislative labelling requirements forms part of routine inspections. At all FeBOs visited, the audit team scrutinised operators' labels and other relevant documents and interviewed inspectors normally controlling those establishments and made the following observations: · In two establishments, labels of complete feed containing coccidiostats did not contain the identification number of the coccidiostats used, which is not in line with the requirements laid down in Article 15(f) of Regulation (EC) No 767/2009. · In one establishment, the label contained an additive which was not used in the compound feed. This is not in line with the requirements laid down in Article 15(f) of Regulation (EC) No 767/2009. · In two establishments, several 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. 7 · The feeding instruction on the labels of a complementary feed for dairy cows and fattening pigs would result in Vitamin A concentration (in complete feed) higher than the maximum limit established by Commission Implementing Regulation (EU) No 2015/724. · On a label of complete feed, the Vitamin A concentration was higher than the maximum limit established by Commission Implementing Regulation (EU) No 2015/724.

ISCVBM inspectors routinely control operator`s specific regular own tests on stability required by point 2 of Section 4 "Quality control" of Annex I to Regulation (EU) 2019/4. Conclusion on the planning and implementation of inspections

Medlemsstatens svar

SÚP SÚP pripraví sériu skolení formou prípadových stúdií ­ spektori OKKVZ budú rozdelení do mensích (dvojice-trojice) upiniek po regionálnej príslusnosti (západoslovenský kraj ­ 5 spektori; stredoslovenský kraj ­ 4 inspektori; východoslovenský aj ­ 3 inspektori). Z dôvodu zabezpecenia zastupitenosti, sa olení zúcastnia aj zamestnanci OKVZ, zodpovední za gislatívu, registráciu a hodnotenie. Skolenie bude zamerané na hodnocovanie etikiet. Výstupom zo skolenia bude písomné hodnotenie etikiet spolu so zdôvodnením a urcením z ktorého ávneho predpisu daná povinnos pri oznacovaní vyplýva. zdý inspektor OKKVZ a zamestnanec OKVZ vyhodnotí iketu doplnkového a kompletného krmiva pre hospodárske ieratá; dietetického krmiva; náhradky mlieka; premixu; tamíno­minerálnej zmesi, kompletného krmiva a doplnkového miva pre spolocenské zvieratá. Skolenie musí kazdý inspektor KVZ absolvova do konca roka 2024. uhy etikiet pouzité pre prípadové stúdie: Kompletné krmivo pre kurcatá s kokcidiostatikom Doplnkové minerálne krmivo pre teatá Kompletné krmivo pre nosnice Kompletné krmivo na kmenie rastúcich osípaných vo veku od 5 do 12 týzdov Dietetické krmivo Doplnkové krmivo pre dojnice Premix Page: 2 eport re

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CCTIA has prepared guidance on official sampling, including a sampling report template, based on the requirements laid down in Annex I to Regulation (EC) No 152/2009. However, the instruction on the preparation of the final sample does not distinguish between contamination distributed uniformly and non-uniformly. 8

SVFA has also prepared an instruction on official sampling. However, the calculation of the incremental samples in the case of non-uniform distribution of contamination (for example cross-contamination of medicated feed) is not in line with the requirements of point 5.2 of Annex I to Regulation (EC) No 152/2009.

The audit team observed official sampling in two compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In both establishments, the feed inspector sampled a case of contamination with non-uniform distribution. During the preparation of the final samples, inspectors did not use dividers, contrary to part 9.4 of Annex I to Regulation (EC) No 152/2009. In one case, the inspector implemented the official sampling procedure on the whole batch, however some parts of the batch were inaccessible and could not be sampled. The inspector did not use the official sampling procedure based on the sampled portion, which is not in line with the requirements of part 8.3 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 mostly are appropriately designated, shortcomings in the implementation of official sampling, a lack of verification of sample homogenisation procedures in the laboratories, and deficiencies in the assessment of laboratory test`s results collectively undermine the legal and technical validity of the official samples and the reliability of decisions made on the basis of such results. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

KSÚP n. ÚKSÚP prepracuje metodický pokyn c. 20/2023 "Vzorkovanie". xaktné metodické usmernenie k odberu omerne rozlozených surovín budú upravené a doplnené kapitoly venované: ch vzoriek j vzorky delicom vzoriek vzoriek do clánku 4 - Príprava vzorkovacích up trojkomorového delica vzoriek pre OKKVZ, vrátane na kazdú jednu hranicnú Bola zahájená príprava na spustenie verejného lom nákupu delicov vzoriek1. Výroba delicov , ktorých dodanie sa ocakáva do 3-4 mesiacov ávky. Page: 3 eport ref. DG(SANTE) 2023-7699 of the audit carried out from 09 October ontrols on feed hygiene lení anie", ráci. e" elicov dopted truction food - in 2024 - 260 it mission thods of d controls, 9") nal training y and food les in eport ref. DG(SANTE) 2023-7699 of the audit carried out from 09 October ontrols on feed hygiene roposed by the competent authority : 024 t training has been organized at the end of January 2024. SR will issue a guideline for the relevant district ry and food administrations for the purchase of sample for feed for the purpose of using the division of samples cording to the methodological instruction - collection of feed samples in 2024 (VPO). Sampling and their division control of undesir

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The interpretation of the analytical results of official feed samples is the responsibility of the officials of the Department of Feed and Animal Nutrition, based on laboratory reports provided by the testing laboratories. The audit team identified several assessments which were erroneous (e.g.: non-compliances were not identified), incomplete, or not in line with the requirements of Annex IV, Part B of Regulation (EC) No 767/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited and mostly are appropriately designated, shortcomings in the implementation of official sampling, a lack of verification of sample homogenisation procedures in the laboratories, and deficiencies in the assessment of laboratory test`s results collectively undermine the legal and technical validity of the official samples and the reliability of decisions made on the basis of such results. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

ficial ÚKSÚP zabezpeci, aby referenti zodpovední za hodnotenie lytických výsledkov úradných vzoriek krmív brali pri í do úvahy vsetky nevyhnutné kritériá pre hodnotenie s nariadením (ES) c. 797/2009, zaviedla riaditeka ncíp dvojstupovej kontroly, t. j. nadriadený, resp. zamestnanec kontroluje vsetky výstupy hodnotiteov, ci boli v posudku zohadnené vsetky výsledky kých rozborov a ci na oznacení sú uvedené a posúdené ovinné údaje. Bez súhlasného stanoviska riaditeky sp. povereného zamestnanca nie je vydaný posudok. opatrenie je v okamzitej platnosti od skoncenia auditu ) 2023-7699, od 25.10.2023. Page: 5 eport ref. DG(SANTE) 2023-7699 of the audit carried out from 09 October ontrols on feed hygiene tion Proposed by the competent authority

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In the visited laboratories, the audit team examined the system of preparation of the final samples submitted for testing. One of the laboratories homogenised the samples received with a mechanical separator before milling the entire sample, from which test samples were prepared. The second laboratory milled the entire sample without any prior homogenisation (the auditors noted that this laboratory no longer tests official samples for mycotoxins). However, neither laboratory had produced documentary evidence verifying that the amounts weighed out, as provided for in the methods of analysis, were homogeneous and representative of the final samples as laid down in part A.1. of Annex II 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 mostly are appropriately designated, shortcomings in the implementation of official sampling, a lack of verification of sample homogenisation procedures in the laboratories, and deficiencies in the assessment of laboratory test`s results collectively undermine the legal and technical validity of the official samples and the reliability of decisions made on the basis of such results. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

e ÚKSÚP ed Úradná vzorka krmiva napriek tomu, ze je odvázená priamo pri jej bere inspektorom OKVZ, bude kontrolne prevázená aj pri evzatí vzorky, pricom váhy budú podlieha metrologickej ntrole. Zavedená zmena v postupe si bude vyzadova tualizáciu Interného pokynu c. 10/2023 ,,Zberná linka úradne obratých vzoriek" Zárove bude aktualizovaná prírucka kvality danie c. 3 zo da 10.08.2020, do ktorej sa doplnia podmienky e neprijatie vzorky laboratóriom na analýzu v prípade splnenia legislatívnej poziadavky na minimálnu hmotnos orky. kcia laboratórnych cinností ÚKSÚP v rámci skúsobného boratória pre rezíduá pesticídov (SLAPe) vykoná interné erenie homogenity (internú stúdiu) za vyuzitia homogenizácie nuálnej a prístrojovej, s cieom získania potvrdenia, ze mogenizácia vykonaná inspektorom OKKVZ v teréne pri bere vzorky je ekvivalentná s prístrojovou homogenizáciou v boratórnych podmienkach (do 6 mesiacov) nenie: rava interného pokynu a prírucky kvality do 29.2.2024; konanie internej stúdie do 30.6.2024 úsobné laboratórium VPÚ BA adná vzorka krmiva odobraná v zmysle platného Metodického kynu Odber úradných vzoriek krmív v roku 2024 (VPO) daného 15.12.2023 Státnou veterinárnou a potravinovou

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The competent authority has made significant improvements to increase the registration of non-commercial pig establishments in the national register system. It also made improvements in the system to facilitate the use of information to plan certain official controls for ASF. However, the fact that the system does not always keep records of the number of pigs present in certain establishments (i.e., one pig farms) prevents the accurate 5 and risk-based planning of official controls, both during peace time and during disease outbreaks.

The national plan to reduce the wild porcine population seems to have been effective in recent years. The strategy is based on reliable data. However, the population is still high and even increasing in certain areas of the country. The competent authority acknowledges the need to develop a national action plan to continuously manage the wild porcine animals' population to avoid the spread of ASF, in line with Annex IV of the Commission Implementing Regulation (EU) 2023/594 by 17 September 2023.

The competent authorities implement both passive and active surveillance of hunted and dead wild boar. There is no evidence that the authorities systematically verify the implementation of these official control and thus, confirm that all wild porcine meat intended for human consumption originates from carcases with negative results.

The laboratory network provides reliable and consistent support for the implementation of ASF control programme.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

SVPS SR zavedie úradné kontroly na identifikáciu a registráciu osípaných vo vsetkých aktívnych registrovaných chovoch osípaných. SVPS SR zabezpecí implementáciu postupov od zaciatku roka . Zmení systém dohlasovania zmien do CEHZ v "D chovoch", tak, aby bolo zrejmé, ci v danom chove sa zviera nachádza alebo nie.

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Home slaughter is not always reported to the authorities in order to supervise it, not allowing the competent authority to comply with their approved eradication programme.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

The competent authority informed the audit team that the target to inspect 100% of home slaughters is not feasible for the capacity of the SVFA and that this issue will be discussed with policy makers colleagues in the European Commission. 14 System is in place Surveillance in wild porcine animals to test all wild porcine animals 35. There are financial incentives to hunt, report and dispose of dead wild hunted that are porcine animals. intended for human 36. According to the SVFA, in free, buffer and restricted zones I, all dead and consumption in sick wild porcine suspected of infection with ASF virus, should be tested Restriction zones with Polymerase Chain Reaction (PCR) test and serological tested. In II and II. restriction zone I, all hunted wild porcine should be PCR tested. All wild porcine animals hunted intended for human consumption in restricted zones II and III must be tested and have a negative PCR (and serological) test before being released to the hunter.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

the Expertná skupina pre AMO do konca roka 2023 navrhne postup a zabezpecenie nahlasovania kazdej domácej zabíjacky na príslusný orgán, postup vykonávania plánovaných frekvencií veterinárneho dohadu nad domácim zabíjaním osípaných a zverejní informáciu o týchto plánovaných kontrolách na svojom vom sídle a cieom, zvýsenia povedomia drziteov osípaných o legislatívnych poziadavkách na vcasné ohlasovanie domácich zabíjaciek." SVPS SR zabezpecí implementáciu postupov od zaciatku roka 2024.

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The epidemiological enquiries do not always include the required information. This prevents the competent authority from taking informed decisions to implement adequate prevention and control measures to avoid the spreading and ensure the eradication of the disease.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

d Expertná skupina pre AMO do konca roka 2023 este arly podrobnejsie rozpracuje a doplní existujúci vzor epidemiologického setrenia. Po úprave vzoru budú vsetky vykonávané epidemiologické setrenia v co najkratsom case zasielané na SVPS SR na overenie súladu s legislatívou EÚ. d Upravený pohotovostný plán bude implementovaný od zaciatku roka 2024.

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There are unnecessary delays in confirming ASF in domestic pigs, resulting in the setting of restriction areas five days after the suspicion of the disease was reported. This creates an unnecessary time window during which the infection can be spread to both domestic pigs and wild porcine animals.

The confirmation of disease in suspect cases was delayed. The audit team assessed two epidemiological linked outbreaks. The officials visited the first reported suspect and took samples on the same day of the epidemiological investigation report. However, the competent authority did not give any urgency to the samples. And the laboratory did not process them until four days later. The direct linked establishment was neither investigated nor sampled until four days after the initial suspicion. By SVFA's decision, the NRL was not (and still is not) operational during weekends. This resulted in the confirmation of these outbreaks four and five days after the initial suspicion was reported. In the interim, the authorities did not set a temporary restriction zone around the establishments, and the protection and surveillance zones were not set until five days after the initial suspicion. This is not in line with Article 9(1)(c) of Commission Delegated Regulation (EU) 2020/687.

Medlemsstatens svar

Expertná skupina pre AMO do konca roka 2023 navrhne úpravu pohotovostného plánu na eradikáciu AMO tak, aby sa ible. minimalizovalo riziko sírenia AMO po nahlásení prípadov Page: 1 ober 2023 of report ref. DG(SANTE) 2023-7722 of the audit carried out from 20 June to 4 ls in relation to African swine fever Action Proposed by the competent authority zrenia v súlade s odporúcaním auditu. Upravený pohotovostný plán bude implementovaný od zaciatku roka 2024.

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The veterinary authorities have suitable contingency plans, equipment, and the capacity to deal with confirmed ASF outbreaks.

The system implemented by the competent authorities to verify that official controls are planned on a risk basis (e.g., identification and registration; biosecurity measures, surveillance), and are implemented with appropriate frequency to ensure that the objectives of the legislations are effectively achieve is weak.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

ties Okrem opatrení uvedených v bodoch 1-4 SVPS SR zabezpecí overovanie úradných postupov nasledovne: ficial SVPS SR upraví a doplní Metodický pokyn na kontrolu biologickej bezpecnosti v chovoch osípaných tak aby zohadoval vsetky poziadavky Nariadenia 2023/594 a doplní o kontrolu plnenia monitoringu na centrálnej úrovni. nd SVPS SR bude vykonáva kontrolu monitoringu AMO u domácich osípaných pravidelne najmenej 1x rocne. SVPS SR zabezpecí aby údaje zasielané z regionálnych úradov te umozovali vyhodnoti plnenie cieov a tieto bude kontrolova vyhodnocova a prijíma nápravné opatrenia. SVPS SR zavedie postup vykonávania kontrol sluzieb poskytovaných oprávnenými súkromnými veterinárnymi lekármi. S SR zabezpecí implementáciu postupov od zaciatku roka 2024.

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The last internal audit report issued in March 2023 included nine recommendations and a deadline of 10 working days for the creation of an action plan to address those recommendations. Up until the closing meeting of this audit (4 July), no action plan had been created and no reminder had been issued. The competent authority did not provide evidence that they have officially addressed those important shortcomings and weakens the prevention and control system for ASF in the country.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

a SVPS SR má vypracovanú Smernicu na vykonávanie interného auditu, kde sú urcené lehoty na jednotlivé kroky interného auditu, vrátane vypracovania návrhu správy z interného auditu, jeho pripomienkovanie auditovanou organizáciou, schválenia recnej správy, predkladania opatrení, ich vyhodnocovania a vo svelte týchto výsledkov, interný audit SVPS SR vypracováva program interného auditu na nasledujúce programovacie obdobie. V roku 2022, vsak SVPS SR zacala s implementáciou rozsiahleho informacného systému, v ktorom interný audit zohráva významnú úlohu. Vedúci odboru auditu a kontroly podcenil casovú nárocnos projektu a bez zmien procesu interného auditu sa dostal do výrazného meskania lehôt, najmä Page: 2 ober 2023 of report ref. DG(SANTE) 2023-7722 of the audit carried out from 20 June to 4 ls in relation to African swine fever vanej rných covania záciami. ných v tak, Page: 3

Medlemsstatens svar

nej porade/skolení od 19.4. 2023 do 21.04. 2023 na IVVL boli RVPS upozornené na dodrziavanie postupov pri zoriek a testovaní na mikrobiologické kritériá týkajúce sa potravinách a pri odbere vzoriek z prostredia poda enia (ES) c.2073/2005 a usmernenia EURL. Súcasne bola na to tému na skolení prezentovaná prezentácia od Národného ného laboratória pre Listeria monocytogenes v SR. R vypracuje metodický pokyn na uplatovanie cl.5 ods.3 riadenia (ES) c.2073/2005. Termín: do 31.12. 2023 Pozvanka_HP3-HP4_ 19.-21. april 2023 IVVL KE.pdf

Medlemsstatens svar

SVPS SR vypracuje metodický pokyn týkajúci sa zberu údajov o bicných látkach v surovom mlieku iných druhov ako je hovädzí dobytok a pre zber výsledkov o rezíduách inhibicných látok od PPP v rámci vlastného testovania surového mlieka na príjme. Termín: 31.12.2023 Page: 1

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The fact that, contrary to the CCA's instructions, one out the three DVFAs audited performs official controls outside of the harvest period in conjunction with the fact that the CCA has no effective mechanisms in place to identify and rectify such shortcomings, could affect negatively the reliability of the official controls in the field of FNAO.

Medlemsstatens svar

V novembri 2023 sa uskutocnilo skolenie Národného programu vzdelávacích aktivít, ktorého sa okrem inspektorov, zúcastnili aj vedúci oddelení kontroly potravín rastlinného pôvodu zo vsetkých RVPS na Slovensku. Vsetci prítomní boli oboznámení s výsledkami auditu a vyzvaní na väcsiu dôslednos pri plánovaní kontrol. SVPS SR vyzvala vedúcich pracovníkov RVPS zodpovedných za plánovanie kontrol, aby navrhnuté plány kontrol konzultovali aj s inspektormi, ktorí tieto kontroly vykonávajú a respektovali ich praktické pripomienky, s cieom zabezpeci, aby sa úradné kontroly potravín vykonávali na vsetkých stupoch produkcie potravín, vrátane zberu prvovýrobkov. SVPS SR v snahe zlepsi kontrolu plánovaného odberu vzoriek zo strany centrálnej autority, zaviedla do rocného plánu odberu vzoriek novú struktúrovanú tabuku pre plánovanie odberu vzoriek na mikrobiologické parametre poda jednotlivých potravinárskych komodít. Táto tabuka bude súcasou kazdorocne vydávaného pokynu na plánovanie odberu vzoriek potravín rastlinného pôvodu. Okrem toho SVPS SR sa pripravuje na prechod na nový komplexný informacný systém ­ software "KVEPIS", ktorého súcasou bude aj automatické plánovanie úradných kontrol na základ

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The inspectors overlooked the fact that to avail import certificates for seeds for sprouting from third countries, like mung beans and lentils, is a legal requirement, and that such certificates were not available at the premises. The inspectors also overlooked that the establishment used alfalfa seeds certified for sowing and not intended for sprouting. 7

During the audit, the FBO requested the missing import certificates from the supplier of mung beans and immediately after the audit they were evaluated as satisfactory by the inspectors. However, no such certificate was provided for lentil seeds imported from Türkiye. Processors (cut fruits and vegetables, freezing and frozen plants)

Although sprout-producing establishments are identified by the CAs as representing higher risk FBOs, the fact that verification of compliance with Regulation (EC) No 208/2013 on certification requirements of imported seeds for sprouting and Regulation (EC) No 2073/2005 on preliminary tests for seeds and analyses of sprouts have been systematically overlooked during official controls, undermines the effectiveness of such controls.

Medlemsstatens svar

Inspektori RVPS, ktorí vykonávajú úradné kontroly u pestovatea klíckov, boli zo strany SVPS SR vyzvaní na nevyhnutnos vyzadovania dokladov sprevádzajúcich zásielku semien na klícenie (importných certifikátov), a neumoznenie výroby klíckov z iných semien. Page: 1 report ref. DG(SANTE) 2023-7741 of the audit carried out from 18 September ls relating to microbial safety of food of non-animal origin Action Proposed by the competent authority SVPS SR v snahe zamedzi prehliadaniu nevyhnutných legislatívnych poziadaviek zo strany RVPS, zabezpecí pre inspektorov RVPS checklist, ktorý bude tvori obsahovú cas úradného záznamu. Pouzívanie checklistu bude záväzné pre vsetkých inspektorov vykonávajúcich úradné kontroly u pestovateov klíckov. Checklist bude tvori prílohu novelizovaného písomného pokynu SVPS SR - Manuálu na plánovanú úradnú kontrolu potravín v prevádzkach rastlinnej prvovýroby. Termín od 1.1. 2024.

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Although sprout-producing establishments are identified by the CAs as representing higher risk FBOs, the fact that verification of compliance with Regulation (EC) No 208/2013 on certification requirements of imported seeds for sprouting and Regulation (EC) No 2073/2005 on preliminary tests for seeds and analyses of sprouts have been systematically overlooked during official controls, undermines the effectiveness of such controls.

Medlemsstatens svar

Inspektori RVPS, ktorí vykonávajú úradné kontroly u pestovatea líckov boli zo strany SVPS SR vyzvaní na kontrolu výsledkov ults. predbezného testovania semien urcených na klícenie. SVPS SR, v snahe zamedzi prehliadaniu nevyhnutných legislatívnych poziadaviek zo strany RVPS, zabezpecí pre inspektorov RVPS checklist, ktorý bude tvori obsahovú cas úradného záznamu. Pouzívanie checklistu bude záväzné pre vsetkých inspektorov vykonávajúcich úradné kontroly u pestovateov klíckov. Checklist bude tvori prílohu novelizovaného písomného pokynu SVPS SR - Manuálu na plánovanú úradnú kontrolu potravín v prevádzkach rastlinnej prvovýroby. Termín od 1.1. 2024.

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There have been no specific training activities at SVFA and DVFAs focussing only on microbiological risks of FNAO. Training activities regarding FNAO have mainly targeted food safety in general, according to food commodities. The manual regarding official controls of FNAO is included in the training programme. The manual contains topics such as sprouts and seeds for sprouting, fruit and vegetables microbiology and hygiene, and Listeria monocytogenes (L. monocytogenes). However, the audit team identified that such training activities did not ensure that the controls were implemented effectively (see paragraphs 25-27, 29-31, 34 and 39-41). Audit / Supervision

The training system is not able to deliver appropriate competency of staff, which has an impact on the reliability of official controls. 4

In one district, at the primary producers visited, regular inspections took place during and after harvest, at the level of premises (packing area, buildings and facilities). The inspection frequency was largely respected. Evidence of one follow-up activity was provided regarding structural deficiencies and an official penalty had been issued. The inspectors informed the audit team that analytical reports regarding the microbiological quality of water are always examined during official controls, as reported in the official inspection reports. However, these analytical reports were not available, as the FBOs have not carried out the analyses.

In another district visited, harvest operations were never inspected. The CCA informed the audit team that they were not aware of this fact and that inspectors received training that official controls must be performed during harvest and on how to perform such controls during harvest. In 2020, a non-compliance was identified and recorded in the reports, which was related to the lack of registration. In this case an official penalty was issued. Sprout-producing establishment

The inspectors overlooked the fact that to avail import certificates for seeds for sprouting from third countries, like mung beans and lentils, is a legal requirement, and that such certificates were not available at the premises. The inspectors also overlooked that the establishment used alfalfa seeds certified for sowing and not intended for sprouting. 7

Additionally, inspectors did not realise that the analytical results, related to the own- controls in terms of frequency, were not in line with the Regulation (EC) No 2073/2005. In particular, the analytical requirement regarding preliminary tests of seeds for sprouting was never implemented by the FBO.

During the audit, the FBO requested the missing import certificates from the supplier of mung beans and immediately after the audit they were evaluated as satisfactory by the inspectors. However, no such certificate was provided for lentil seeds imported from Türkiye. Processors (cut fruits and vegetables, freezing and frozen plants)

Not all inspectors were aware of the environmental control measures for L. monocytogenes that FBOs must implement. The inspectors informed the audit team that they verify the sampling plans and analyses carried out by the FBOs.

Regarding sampling of L. monocytogenes at surfaces level, not all inspectors have expertise in controlling the FBOs' monitoring plan (why, when, where and how to sample surfaces), nor knowledge of which measures have to be taken in the case of positive results. Processor (cut fruits and vegetables)

During this visit, the inspector of DVFA performed an inspection of the blanching area, detecting for the first time a non-compliance related to wet floor.

The fact that, contrary to the CCA's instructions, one out the three DVFAs audited performs official controls outside of the harvest period in conjunction with the fact that the CCA has no effective mechanisms in place to identify and rectify such shortcomings, could affect negatively the reliability of the official controls in the field of FNAO.

Medlemsstatens svar

V novembri 2023 sa uskutocnilo skolenie Národného programu vzdelávacích aktivít pre inspektorov vykonávajúcich kontroly ntrols, potravín rastlinného pôvodu. Jedna z tém skolení bola aj 5. mikrobiologická bezpecnos potravín, s osobitým zameraním na potraviny na priamu spotrebu. V súlade s Nariadením Komisie 2073/2005 boli zrekapitulované poziadavky na analýzy patogénov, speciálne Salmonella a Listeria monocytogenes. Page: 2 report ref. DG(SANTE) 2023-7741 of the audit carried out from 18 September ls relating to microbial safety of food of non-animal origin tent authority j na potrebu analýz vírusov v , Norovírus), ktorých výskyt v potravín, hoci nie sú súcasou u potravín.

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The CAs (SVFA and DVFAs) do not verify and enforce that FBOs manufacturing ready- to-eat foods, which may pose a L. monocytogenes risk for public health, take samples, in accordance with Article 5(2) of Regulation 2073/2005, of the processing areas and equipment for the presence of L. monocytogenes (2).

Not all inspectors were aware of the environmental control measures for L. monocytogenes that FBOs must implement. The inspectors informed the audit team that they verify the sampling plans and analyses carried out by the FBOs.

Regarding sampling of L. monocytogenes at surfaces level, not all inspectors have expertise in controlling the FBOs' monitoring plan (why, when, where and how to sample surfaces), nor knowledge of which measures have to be taken in the case of positive results. Processor (cut fruits and vegetables)

Several inspectors' knowledge and expertise on how to verify FBOs' management of L. monocytogenes risk was limited, and this could lead to an underestimation of this risk.

Medlemsstatens svar

Na skolení v novembri 2023 odznela samostatná prednáska na of tému Listeria monocytogenes, jej výskyt a nebezpecenstvá v k potravinách na priamu spotrebu. Prezentáciu pripravila f zástupkya mikrobiologického laboratória. V prezentácii nariadenia 2073/2005 ohadom orov na Listeria monocytogenes zo ov informovala o moznosti vyuzi lný Kubín ohadom vytvorenia e s cl. 3 ods. 2 nariadenia 2073/2005. príruckou hygienické pokyny pre nes pri výrobe hlbokozmrazenej ciou PROFEL, ktorá bola validovaná ená na vyuzívanie potravinárskym pektorom kontrolujúcim prevádzky odporucené vyuzíva informácie prevádzky. Inspektori boli vyzvaní, aby bajúcich potraviny na priamu a kontrolu cistoty povrchov sterové prednásky preskolení. ta vyzvala vsetky RVPS v SR na dodrziavanie legislatívnych potravinárskym výrobám. Page: 3 report ref. DG(SANTE) 2023-7741 of the audit carried out from 18 September ls relating to microbial safety of food of non-animal origin Action Proposed by the competent authority

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In one district, at the primary producers visited, regular inspections took place during and after harvest, at the level of premises (packing area, buildings and facilities). The inspection frequency was largely respected. Evidence of one follow-up activity was provided regarding structural deficiencies and an official penalty had been issued. The inspectors informed the audit team that analytical reports regarding the microbiological quality of water are always examined during official controls, as reported in the official inspection reports. However, these analytical reports were not available, as the FBOs have not carried out the analyses.

In another district visited, harvest operations were never inspected. The CCA informed the audit team that they were not aware of this fact and that inspectors received training that official controls must be performed during harvest and on how to perform such controls during harvest. In 2020, a non-compliance was identified and recorded in the reports, which was related to the lack of registration. In this case an official penalty was issued. Sprout-producing establishment

The inspectors overlooked the fact that to avail import certificates for seeds for sprouting from third countries, like mung beans and lentils, is a legal requirement, and that such certificates were not available at the premises. The inspectors also overlooked that the establishment used alfalfa seeds certified for sowing and not intended for sprouting. 7

Additionally, inspectors did not realise that the analytical results, related to the own- controls in terms of frequency, were not in line with the Regulation (EC) No 2073/2005. In particular, the analytical requirement regarding preliminary tests of seeds for sprouting was never implemented by the FBO.

During the audit, the FBO requested the missing import certificates from the supplier of mung beans and immediately after the audit they were evaluated as satisfactory by the inspectors. However, no such certificate was provided for lentil seeds imported from Türkiye. Processors (cut fruits and vegetables, freezing and frozen plants)

Neither the inspector, nor the CCA representative, identified very serious non- conformities noted by the audit team, such as widespread and evident condensation water on all the ceilings, right above the exposed product ready to be packaged, as well as dust and rust on equipment situated directly above the conveyor-belts transporting the blanched product ready for packing.

The fact that, contrary to the CCA's instructions, one out the three DVFAs audited performs official controls outside of the harvest period in conjunction with the fact that the CCA has no effective mechanisms in place to identify and rectify such shortcomings, could affect negatively the reliability of the official controls in the field of FNAO.

Medlemsstatens svar

SVPS SR sa pripravuje na prechod na nový komplexný s informacný systém ­ software "KVEPIS", ktorého súcasou bude aj online tvorba úradných záznamov prostredníctvom checklistov, specifických pre jednotlivé skupiny potravinárskych cinností (napr. výroba, distribúcia, maloobchod, at). V roku 2024 má software "KVEPIS" vstúpi do skúsobnej prevádzky, jeho plná prevádzka sa ocakáva od roku 2025. SVPS SR v snahe zamedzi prehliadaniu nevyhnutných legislatívnych poziadaviek zo strany RVPS, a do doby kedy bude mozné vyuzíva online checklisty systému KVEPIS, zabezpecí pre inspektorov RVPS checklist, ktorý bude tvori obsahovú cas úradného záznamu. Pouzívanie checklistu bude záväzné pre vsetkých inspektorov vykonávajúcich úradné kontroly v prvovýrobe. Checklist bude tvori prílohu novelizovaného písomného pokynu SVPS SR - Manuálu na plánovanú úradnú kontrolu potravín v prevádzkach rastlinnej prvovýroby. Termín: checklist - od 1.1. 2024, software KVEPIS predpoklad od januára 2025. liky Page: 4 report ref. DG(SANTE) 2023-7741 of the audit carried out from 18 September ls relating to microbial safety of food of non-animal origin Page: 5

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Several of the OVs interviewed did not have a clear understanding of what actions to take in the small number of cases where farmers present cattle for AMI with only one ear tag, instead of the compulsory two. Some OVs considered that those bovine animals did not have suitable identification and therefore could not enter the human food chain.

The available guidance, in the form of methodological instructions issued by the 3 CCA, for OVs on AMI tasks and animal identification, is silent on how to handle animals with only one ear tag.

The knowledge and currently available guidance does not allow the OVs to be aware or identify the correct course of action they should take in case of unfrequently presented situations related to cattle identification, in particular the presence of animals with only one ear tag.

Medlemsstatens svar

ot SVPS SR doplní metodický pokyn o usmernenie prípadov, kedy cal inspektor v case kontroly ante mortem zistí, ze zviera prislo na ect. bitúnok iba s jednou usnou znackou. Veterinárny inspektor pozastaví zabitie konkrétneho zvieraa a nariadi opatrenie na dolozenie vysvetlenia dôvodov preco zviera nie je oznacené v súlade s platnou legislatívou. Pokia sú podané informácie relevantné, Veterinárny inspektor povolí zabitie zvieraa na bitúnku. V opacnom prípade nariadi neskodné odstránenie tela zvieraa kafilériou. Termín: 31.10.2022

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None of the slaughterhouse FBOs visited had clearly displayed the maximum number of animals that could be kept in each pen in the lairage, as required by Regulation (EC) 1099/2009 on the protection of animals at the time of killing.

The CA has not enforced the requirement that pens in the lairages of approved slaughterhouses clearly display information on the the maximum number of animals that could be kept in them, as required by Regulation (EC) 1099/2009.

Medlemsstatens svar

V checkliste kontrolných otázok oznacených ako ,,Príloha c. 7 A ­ kontrola prevádzkových pravidiel urcená pre VI na bitúnku pre HD, ovce, kozy, kone, osípané" (Appendix to recommendation 2) pre kontrolu dodrziavania prevádzkových pravidiel na bitúnkoch, je v bode 4.1 napísané ,,Uvete císlo koterca/ohrady a k tomu pocet reálne ustajnených zvierat a plochu ustajovacieho priestoru". Je tam tiez moznos ,,Doplte v poznámke". SVPS SR osobitným listom upozorní na povinnos ustanovenú v prílohe III, bod 2.3 a dôsledné venovanie pozornosti /kontroly aj na tento bod. Termín: 31.10.2022

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In two of the establishments, the hygiene facilities inside the slaughterhouse (wash hand basin and sterilisers) were not easily accessible for the OV during PMI. In one of the establishments, the OV did not have suitable facilities to properly reach and inspect the hindquarters of the carcases before applying the health mark. Emergency slaughter at the holding of provenance

At the five establishments visited, the OV carried out health marking after PMI and specified risk material removal. In one of the slaughterhouses, the OV applied the health mark to carcases with visual contamination on them. See paragraph 23.

PMI is in general carried out in line with EU requirements but the practical inspection arrangements and facilities are, in some of the establishments, not fully suitable and can lead to contaminated carcases being passed as fit for human consumption.

Medlemsstatens svar

re 1.) SVPS SR vykonala v rámci Národného plánu vzdelávacích h all aktivít na rok 2022 v doch 13. - 15.6.2022 skolenie v sektore n, produktov zivocísneho pôvodu a pracovnú poradu, ktorej sa 12 of zúcastnili hlavne vedúci odborov a oddelení hygieny potravín zivocísneho pôvodu RVPS, kde prezentovala predbezné zistenia z AUDITU DG (SANTE) 2022 ­ 7463. Page: 1 of report ref. DG(SANTE) 2022-7463 of the audit carried out from 28 April 2022 ace governing the production and placing on the market of bovine meat, including ction Proposed by the competent authority .) Príslusná RVPS na základe zistení z auditu ulozila opatrenia a znízenie rizika kontaminácie povrchu jatocných tiel ovädzieho dobytka pri ich jatocnom opracovaní (Úradný záznam veterinárnej kontrole c. TT/2022/Kr/05 zo da 03.05.2022, torý bol v ten de poslaný mailom audítorom). .) SVPS SR v rámci Národného plánu vzdelávacích aktivít na ok 2022 vykoná v poslednom kvartáli roku 2022 skolenie pre radných veterinárnych lekárov a úradných veterinárnych sistentov, ktorí vykonávajú úradné kontroly v sektore cerstvého äsa domácich kopytníkov zamerané (okrem iného) na správu z uditu DG (SANTE) 2022 ­ 7463 a na poziadavky a osobitné echnic

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In two of the slaughterhouses, the slaughtermen did not remove the hides in a hygienic manner that prevented the contact between the outside of the hide and the carcase in order to avoid contaminating the meat. In one of these establishments, further steps on the line did not remove the visible contamination that had occurred because of these practices. The OV/ OA did not identify this either and as a result, carcases with visible contamination were health marked and placed in the chillers.

Neither the regular checks carried out by the OVs on FBO's practices and hygiene of meat production, nor the supervisory mechanisms in place, are effective in identifying certain issues. As a result, correction of these issues is not enforced and they continue to persist. 7

Medlemsstatens svar

.) SVPS SR vykonala v rámci Národného plánu vzdelávacích legal aktivít na rok 2022 v doch 13. - 15.6.2022 skolenie v sektore roduktov zivocísneho pôvodu a pracovnú poradu ktorej sa úcastnili hlavne vedúci odborov a oddelení hygieny potravín ivocísneho pôvodu RVPS, kde prezentovala predbezné zistenia AUDITU DG (SANTE) 2022 ­ 7463. .) SVPS SR v rámci Národného plánu vzdelávacích aktivít na ok 2022 vykoná v poslednom kvartáli roku 2022 skolenie pre radných veterinárnych lekárov a úradných veterinárnych sistentov, ktorí vykonávajú úradné kontroly v sektore cerstvého äsa domácich kopytníkov zamerané (okrem iného) na správu z uditu DG (SANTE) 2022 ­ 7463 a na vseobecné a osobitné oziadavky týkajúce sa postupov a hygieny operácií vyplývajúce o zistení auditu v súlade s nariadeniami (ES) c. 852/2004 a c. 53/2004. Page: 2 of report ref. DG(SANTE) 2022-7463 of the audit carried out from 28 April 2022 ace governing the production and placing on the market of bovine meat, including nt authority o konca septembra 2022 nariadi oddelení hygieny potravín ri vykonávaní vnútornej cov sa vedúci zamestnanci y týkajúce sa postupov a hygieny ú ustanovené v nariadení (ES) a osobitne na tie poziadavky, kt

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FINDINGS AND CONCLUSIONS

The planning of the residue monitoring is timely and largely follows the principles of EU legislation. Nevertheless, shortcomings in the sampling strategy for poultry have the potential to undermine the effectiveness of the plan. 5.1.3. Implementation of the residue monitoring plan Findings

Staff interviewed from two DVFAs were familiar with sampling procedures and explained that farms were selected based on local knowledge (e.g., animal health situation, size, type of production, previously known non-compliances). The remaining samples were taken at slaughterhouses for bovine animals and, in the case of poultry, also at cutting plants. This latter approach (see finding 5) resulted in samples being collected from frozen products and from imported products some of (8) Article 12 of Regulation (EU) 2017/625. (9) Article 9(4) of Regulation (EU) 2017/625 and Point 1 of Annex III to Directive 96/23/EC. 4 which originated from foreign cutting plants and thus undermined the necessary traceability back to the farm of origin, as required under EU law (10).

In relation to the sampling strategy, the staff interviewed stated that on-farm and slaughterhouse sampling was in general targeted. This was not the case for samples taken at cutting plants. In these cases, regardless of the purpose of the tests (i.e. to be tested for group A or for group B substances) sampling was either random or targeted based on criteria that were not relevant for the detection of illegal treatments (e.g., shelf life and the country of origin) which is not in line with the requirements of EU law (11).

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For the testosterone (in serum) case the competent authority failed to ensure compliance with EU requirements (17). In this case the audit team noted considerable delays in conducting follow-up activities. The investigation was initiated with an on-the spot visit eight months after the non-compliant result was detected and following several requests for information from the central level. The suspect samples, taken during the on-the-spot visit, were rejected by the laboratory as they had deteriorated and the sampling was not repeated. One year after the identification of the non-compliant result, and without any further action to complete the investigation, all of the animals from the affected farm were moved out of the farm (with the authorisation of the DVFA) and traded to another Member State.

The SVFA explained that human resource-related constraints were the origin of the significant shortfalls noted in this case. Changes had been recently introduced in the respective DVFA team and that additional sampling at this farm is planned for 2021. However, no action has been taken to update the documented procedures in order to ensure that, should a similar situation reoccur in future, adequate corrective actions and coordination measures would be put in place in a timely manner to guarantee the effectiveness of the official controls, i.e. proper investigation of the non-compliant results, as required under the EU legislation (18). Conclusions on follow-up of non-compliant results

The planned arrangements for investigating non-compliant residues results are well established and could provide for an effective investigation of non-compliant results. However, deficiencies were noted in the competent authority's ability to ensure its consistent implementation.

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Based on national legislation (20) the designation of official laboratories for the area of residue and contaminants is within the responsibility of the MARD on the request of the SVFA SK. The most recent designation of laboratories involved in the (17) Article 4(4) of Regulation (EU) 2019/2090. (Similar requirements existed in Directive 96/23/EC). (18) Articles 4.2(a) and 12(3) of Regulation (EU) 2017/625. (Similar requirements existed in Article 4 of Directive 96/23/EC). (19) Article 37(4e) and 37(5) of Regulation (EU) 2017/625. (20) Zákon o potravinách 152/1995 Z. z. 7 residue testing in the context of legal requirements (21) dated 10 December of 2019 refers to one workplace of Dolný Kubin and limits the validity of designation up to the period of validity of the accreditation certificate. Out of four accreditation certificates attached to the designation, only one (for Kosice) at time of audit was still valid (until 5 September 2021). The competent authority stated that the administrative ambiguities in designation would be amended.

The SVFI ­ VFI Bratislava which is an NRL for substance group A3 (Steroids) has no confirmatory methods in place for stanozolol and boldenone in bovine/porcine urine. Screened positive samples are sent for confirmation to an NRL in another Member State on the case-by-case basis. The SVFI ­ VFI Bratislava neither has a contract with this laboratory, nor has it been designated by the competent authorities of Slovakia as required by EU legislation (23).

Whilst sensitive and accredited methods were available, the shortcomings in laboratories designation, method validation and internal quality controls cumulatively weakened the laboratory performance and the reliability of the results generated. (40) Point 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (41) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808. (42) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. (43) In their response to the draft report, the competent authorities noted that quality controls would be modified to improve their effectiveness by using spiking concentrations at MRL level for each analyte/matrix combination tested. At the same time, the recovery values would be checked against the requirements and records (charts) maintained for each calendar year separately. 11

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With regard to the method validation the audit team noted that: a) both laboratories validated their relevant methods in mixed urine and/or mixed muscle of various animal species. Whilst this approach is acceptable for checking whether the method is in general suitable for the intended use, further validations in relevant matrix/species combinations is required to check the matrix effects (26); For SVFI ­ VFI Bratislava b) both screening methods (for ethynylestradiol and trenbolone) were most recently validated in 2010 and 2020, respectively, in six samples of urine and muscle each. The design of analytical experiments and method to establish CC values were not in line with legal requirements (27) or EURL guidelines (28). Not all method performance parameters as defined in EU legislation (29) had been evaluated during validation and only three spiked samples were measured for robustness calculation. The CC values for ethinylestradiol in muscle and for both trenbolone isomers in urine and in muscle were lower than respective limits of detection (LODs) established in the laboratory; c) confirmatory methods for various steroids (A3) in urine were validated up to the end of 2012. In order to combine all six steroid analytes in a single method, measurements were carried out in 2018 for the new method validation (17 - trenbolone) or revalidation (17-trenbolone and 17- and 17-nortestosterone). The evaluation of these data was only completed during the audit. The validation protocol for the 17-ethynylestradiol includes experimental data at three concentration levels and method validation results for repeatability, accuracy, CC and uncertainty. Selectivity/specificity, ruggedness and stability were not evaluated although required (29); d) the method for nitroimidazoles was validated at three concentration levels and in all relevant matrices. All method performance parameters except stability had been evaluated. Irrespective of experimental results, the lowest calibrated level of 0.5 µg/kg was assigned as the CC value for all analyte/matrix combinations except for HMMNI (30) for which 2.0 µg/kg was assigned. This approach differs from that described in the relevant EU legislation (31); For SVFI ­ VFI Kosice: e) the old software in use for processing of technical data generated during the thyrostats (A2) analysis does not allow to automatically register the real time measurements and quality control records. Both methods (for thyrostats (A2) in urine and muscle and for coccidiostats (B2b) in poultry muscle) were most recently validated in 2012; (26) Point 2.10. of Annex I to Regulation (EU) 2021/808. (27) Point 2.7 of Annex I to Regulation (EU) 2021/808. (28) Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer) available here: EU Food Safety Regulations for VMP Residues in Food from Animal Origin | EURL (anses.fr) (29) Table 5 in Point 2.1 of Annex I to Regulation (EU) 2021/808. (30) 2-hydroxymethyl-1-methyl-5-nitroimidazole. (31) Point 2.6.1. of Annex I to Regulation (EU) 2021/808. 9 f) different to what is expected (32) both methods were validated at single concentration levels and in case of thyrostats (A2) varying from the level recommended by the EURL (33); g) selectivity/specificity, relative matrix effect (recovery), ruggedness and stability were not evaluated in the method validation process although required (34). For thyrostats (A2), the method validation protocol covers only the LOD, limit of quantification (LOQ), range of testing and uncertainty. The internal instruction for method validation (35) lists basic method performance parameters as: LOD, LOQ, accuracy, precision, range, linearity, sensitivity, selectivity and uncertainty. It was not followed in either of the two methods checked by the audit team (36); h) the method for coccidiostats (B2b) was validated at the level of interest in the EU for lasalocid, diclazuril and toltrazuril. For nine other anal

Whilst sensitive and accredited methods were available, the shortcomings in laboratories designation, method validation and internal quality controls cumulatively weakened the laboratory performance and the reliability of the results generated. (40) Point 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (41) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808. (42) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. (43) In their response to the draft report, the competent authorities noted that quality controls would be modified to improve their effectiveness by using spiking concentrations at MRL level for each analyte/matrix combination tested. At the same time, the recovery values would be checked against the requirements and records (charts) maintained for each calendar year separately. 11

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With regard to the quality control records and charts examined the audit team noted: a) for ELISA methods, negative and positive control samples are included in each analytical run. However, no control checks at CC level are carried out but control samples spiked at various levels including the EURL recommended concentrations (33) are added in each analytical run. While the laboratory stated that in general, no control charts/tables are maintained for screening methods, copies of those operated for confirmatory analysis of 19-nortestorerone and trenbolone in urine showed that such controls were recorded without indicating the animal species for the matrices tested. b) monitoring of method performance for nitroimidazoles in various matrices is carried out by including in each analytical batch samples fortified with (32) Point 2.2. of Annex I to Regulation (EU) 2021/808. (33) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. (34) Articles 3, 7 and point 2.1 of Annex I to Regulation (EU) 2021/808. (35) IP 50 Validácia skúsobných metód. (36) In their response to the draft report, the competent authorities noted that the consistency of the validation protocols and internal instructions will be checked and revised according to the requirements laid down in Regulation (EU) 2021/808. Furthermore, the LC-MS/MS method for thyrostats will be validated against the criteria defined in this Regulation after the purchasing a new instrument as recommended by the EURL. (37) Annex to Commission Regulation (EC) No 124/2009. (38) Commission Regulation (EC) No 2430/1999, Annex to Commission Regulation (EC) No 1800/2004, Annex to Commission Regulation (EC) No 1289/2004, Annex to Commission Regulation (EC) No 1464/2004, Annex II to Commission Regulation (EC) No 1443/2006, Annex to Commission Regulation (EC) No 109/2007, Annex to Commission Regulation (EU) No 875/2010, Annex to Commission Implementing Regulation (EU) No 388/2011, Annex to Commission Implementing Regulation (EU) 2017/1914. (39) Point 2.8 of Annex I to Regulation (EU) 2021/808. 10 concentrations from 0.5 to 2 µg/kg (assigned CC values) and plotting the obtained absolute recovery values on control charts. There are in general clear criteria on the assessment of those data. However, the audit team noted numerous cases where analytical recoveries were outside the acceptable ranges described in EU legislation (40) which had not been spotted/assessed on the control charts. c) in line with EU requirements (41) long term trends in method performance have been demonstrated for dimetridazole and ipronidazole in 2017 -2020 and also for Hydroxy Metronidazole. d) in case of thyrostats (A2) a spiking concentration of 50 µg/kg is used to monitor recovery both in urine and in muscle samples. This concentration is far above the Minimum Method Performance Requirements (MMPRs) recommended by the EURLs (42). Whilst the control lines have been established based on the 2012 method validation data, only the ten most recent quality control results were inserted on the control chart. No long-term trends in the method performance are monitored. e) for coccidiostats (B2b) in muscle the quality control data and charts for narasin, monensin, semduramycin, diclazuril, nicarbazin and toltrazuril in 2020 were available. Except for narasin, the spiking concentration of 50 µg/kg for each of these substances does not provide any information on the method performance at the MRL or CC level. The acceptable recovery range of 60 % to120 % differs from the one required (39)(43).

Whilst sensitive and accredited methods were available, the shortcomings in laboratories designation, method validation and internal quality controls cumulatively weakened the laboratory performance and the reliability of the results generated. (40) Point 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (41) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808. (42) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. (43) In their response to the draft report, the competent authorities noted that quality controls would be modified to improve their effectiveness by using spiking concentrations at MRL level for each analyte/matrix combination tested. At the same time, the recovery values would be checked against the requirements and records (charts) maintained for each calendar year separately. 11

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There are clear biosecurity rules for pig holdings and the competent authorities have set an annual frequency of official inspections to verify compliance with them. However, the frequency of inspections set for commercial holdings in 2020 is insufficient to guarantee that adequate safeguard measures and compliance with animal health requirements have been in place in those holdings, notably in those situated in restricted areas, to ensure that the possible risk of spread of ASF via movements of pigs is properly mitigated.

The fact that the central competent authority applies a very limited level of supervision and verification to confirm implementation by the district authorities of the planned arrangements does not allow them to detect and / or correct the shortcomings identified with 5 regard to prevention, surveillance and control of ASF.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

In the guidance mentioned above, the central competent authority has also 9 included specific instructions for the DVFAs to carry out the inspections provided by Article 3(3)(a) of Decision 2014/709/EU; i.e. at least twice a year, with an interval of at least four months, for commercial holdings that may be involved in derogated movements in accordance with Articles 3, 3a, 3b, 4 and 5 of the said Decision. None of the DVFAs audited provided documented evidence to confirm that they had carried out more inspections on commercial holdings than those indicated by the numbers included in the table above and in the one presented in Annex 3, in accordance with the target of just one inspection per year in commercial holdings. That frequency of inspections would be insufficient to comply with the requirements laid down in those Articles for such derogated movements.

As evidenced by the data of both tables, most of the DVFAs inspect very few non-commercial holdings compared to the set targets. The competent authority expressed the opinion that annual biosecurity inspections of all non-commercial holding was unrealistic despite this target being included in their 2020 approved control programme for co-financing. Wild boar population management

Medlemsstatens svar

The central veterinary authority expressed to the EC auditors the current state of play and feasibility of this exercise from the personal and timing point of view (by taking into account the deficiencies / abilities of veterinary inspectors during COVID crisis and measures adapted by the Slovak government in order to stop spreading COVID-19 infection among citizens) Slovak central veterinary authority is recognised of the situation and the obligation of performing the¬biological safety controls. The aim is to consider all possibilities how to reach and achieve the set of controls/inspections, as expected. Updated CA response 17/09/2021 : 1. SVFA has organised the meeting with responsible experts from the ministry level and Central database of farm animals 2. The improvements of the system regarding database od pig farms envisaged in due course 3. Following the actual data from the central database the checks of biosecurity of pig farms ( incl. non-commercial ) are ongoing 4. The guidelines for DVFAs sent in order to perform the checks in 2021 as much as possible in order to reach the goals prescribed 5. The state of play of checks performed will be summarised by central veterinary

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The competent authorities are allowing movements of live pigs from areas situated in Part III without ensuring that they meet the necessary conditions. This could facilitate the spread of ASF and jeopardise its control.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

central veterinary authority has adapted the monitoring of ASF in pig holdings in dance-with CIR (EC) 2021//605 Page: 1 pdated 17 September 2021 ted by the competent authorities of Slovakia in response to Report ref. DG(SANTE) 2021-7241 of 021 in order to evaluate the implementation of animal health controls in relation to African swine Action Proposed by the competent authority

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Slovakia has established a very good framework for the control system of ASF at national level with appropriate legislation, control plans and staff instructions. The veterinary authorities have suitable contingency plans, equipment and the capacity to deal with confirmed ASF outbreaks and to control cases in wild boar. This has been confirmed by the fact that the authorities have successfully controlled 28 outbreaks of ASF in pig holdings since July 2019. Epidemiological inquiries of outbreaks provided limited added value to understand the origin and potential further transmission of the disease in the affected holdings and geographical areas where they happened.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

The central veterinary authority added to the model epidemiological report for introduction/deletion of the part concerning the length of time the ASF virus may have 8 existed on¬the farm as well as the indication of the possible origin of the ASF that occurred on the farm.

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Laboratory testing for ASF meets, with some exceptions, the standards to provide sound and technically valid results. There has been a sub-optimal collaboration with the EU reference laboratory for ASF (EURL) in relation to validation of the new molecular test used for confirmation of the disease and the NRL could not yet confirm the reliability of that test participating in the annual inter-laboratory test organised by the EURL.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

The Veterinary institute Zvolen introduced Bai et al. (Yin WANS, Lizhe Xu. Lance Noll. Colin Stov, Elizabeth Porter, Jinping Fu, Yuan Fens, La lit li and Peddireddi, Xmin Liu, Kimberly Dodd, Wei Jia, Jian fa Bai) multiplex ASFV/IC PCR assay. This multiplex¬PCR assay is upgraded Zsak PCR assay that has been widely accepted and used worldwide. The effect of this introduction is a reduction of false-negative results of ASFV using of porcine housekeeping beta actin gene as an internal control. Before start of routine usage of multiplex ASFV/1C PCR assay, Veterinary institute Zvolen¬ processed western validation and verification study on reference and field samples based with Principles and methods of validation of diagnostic assays for infectious diseases, OIE, Section 2.2, OIE Guidelines International Reference Standards for polymerase Chain Reaction assays¬, Guidelines for validation of qualitative real-time PCR methods, 2014. As a confirmation of performance of this method, there is a Feedback on XVIII ASF interlaboratory¬Comparison Test (ILCT) 2021 where the European Union Reference Laboratory (EURL) for ASF, INIA-CISA, Valdelmos, Spain, confirmed the participation of Page: 2 pdate

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The implementation of measures to enhance surveillance has been satisfactory in commercial holdings but sub-optimal in non-commercial ones, notably on the thousands of pigs slaughtered on-farm. Therefore, surveillance for ASF in commercial holdings is probably sensitive enough, but there is considerable uncertainty with the capacity of surveillance to detect promptly the disease in the non-commercial sub-population.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

The central veterinary authority shall adjust the monitoring of domestic slaughterers in cordance with the programme approved in Decision (EU) 2020/368. Page: 3 pdated 17 September 2021 ted by the competent authorities of Slovakia in response to Report ref. DG(SANTE) 2021-7241 of 021 in order to evaluate the implementation of animal health controls in relation to African swine Proposed by the competent authority Page: 4

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The 2018-2020 MANCP includes as its national strategic objective for animal welfare to ensure a high level of protection of animals. This MANCP does not contain information on how the prioritisation of official controls and allocation of resources reflect this objective. The MANCP includes information on planning of animal welfare checks in its section 7.8.8. The MANCP progress report of 2019 includes contributions from the districts to the controls on the protection of animals at the time of slaughter. It includes a detailed description and analysis of the controls carried out.

For the scope of this audit, the 2018-2020 MANCP has complete information. This can make possible for the authorities to analyse whether they are directing their efforts effectively. However, as this MANCP does not contain information on how the prioritisation of official controls and allocation of resources reflect the national strategic objective for animal welfare to ensure a high level of protection of animals, this is a missed opportunity for the authorities to demonstrate how they ensure this objective.

Medlemsstatens svar

acrocného národného plánu budú zahrnuté kontroly ochrany zvierat pocas usmrcovania vykonávané vo frekvencii urcenej na základe analýzy rizika, v rámci ktorej je k jednotlivým ukazovateom welfare priradená váha. Na základe toho sa vypracoval operacný cie na jeden rok v SR vykonáva minimálne 1 zaznamenanú kontrolu ochrany zvierat na bitúnku rocne alebo maximálne 4 zaznamenané kontroly rocne na kazdom schválenom bitúnku v SR. Tento cie bude mozné kazdorocne vyhodnoti na základe poctov schválených , fungujúcich bitúnkov v danom roku. Prioritou sú nastavené váhy závaznosti k jednotlivým prvkom analýzy rizika. Najsilnejsou prioritou je spôsob omrácenia, frekvencia zabíjania a druhy zabíjaných zvierat, cím sa zabezpecí výkon kvalitnej kontroly ochrany zvierat pocas usmrcovania na kazdom bitúnku poda ich závaznosti. Tento operatívny plán sa uvedie do MANCP az v roku 2022, nakoko strategický plán na rok 2021 je uz schválený a sú na neho vyclenené zdroje. V roku 2022 bude operacný cie zaclenený do MANCP, cím by sa mali zabezpeci udské a financné zdroje, ktorými sa naplní tento cie, aby sme zabezpecili usmrcovanie zvierat bez pocitu strachu, bolesti a utrpenia.

n Letter from competent authority dated 6 July 2021 The multi-annual national plan will include animal welfare checks at the time of killing, carried out at a frequency determined on the basis of a risk analysis in which the various welfare indicators will be given a particular weighting. This has been used to create a one- year operational target in Slovakia to carry out at least one recorded animal welfare inspection annually at the slaughterhouse or a maximum of four recorded inspections annually in every approved slaughterhouse in Slovakia. It will be possible to evaluate this target annually on the basis of the number of approved and operational slaughterhouses in that year. Priority will be given to severity weightings for the different elements of the risk analysis. The greatest priority is given to the stunning method, the frequency of slaughter and the species of animals slaughtered, which will ensure high-quality animal welfare checks at the time of killing in each slaughterhouse according to their severity. This operational plan will only be introduced into the MANCP in 2022, as the strategic plan for 2021 has already been approved and resources allocated to it. In 2022

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In only one District, one of the chosen for the audit, the daily mortality rates of each flock are sent to the slaughterhouses, in an excel table. The central competent authority clarified that they will evaluate this initiative to explore its use in all Districts, to be in line with point 1(1.1) of the Annex III Directive to 2007/43/EC. The audit team noted that the excel table developed in one District is complete and worked well in the District audited.

Although in only one District the daily mortality rates of each flock are sent to the slaughterhouses, the excel table developed in this District to help/facilitate the owners/keepers to communicate the daily mortality rates to the slaughterhouses, is a valuable tool for the veterinarians in the slaughterhouses to evaluate at what stage of the birds' life the animal welfare problems have occurred.

Medlemsstatens svar

VPS SR- vypracuje usmernenie pre prevádzkovateov fariem , v ktorých sa vtáky chovajú pri hustote zástavu vyssej ako 33 kg/m². Prevádzkovate bude v zmysle Page: 1 t ref. DG(SANTE) 2021-7251 of the audit carried out from 02 February hter and during related operations ion Proposed by the competent authority viek smernice 2007/43/ES povinný vies záznamy ennej miere úmrtnosti a súhrnnej miere úmrtnosti. Tieto namy budú podpísané pred prevozom zvierat na bitúnok romným veterinárnym lekárom vykonávajúcim erinárny dozor na farme. Záznamy o dennej úmrtnosti úhrnnej miere úmrtnosti budú vypracované formou excel uky, do ktorej sa zapísu vsetky zákonné poziadavky. vádzkovatelia fariem budú povinní záznamy dorucova bitúnok spolu so zvysnou povinnou sprievodnou umentáciou ako sprievodná dokumentácia kda súvaného na bitúnok. SVPS SR vypracuje usmernenie pre prevádzkovateov únkov, v ktorom sa usmerní príjem na bitúnok hydiny- jlerov chovaných pri hustote zástavu vyssej ako 33 m² iba so sprievodnou dokumentáciou o dennej miere tnosti od narodenia po odsun na bitúnok. Záznam bude inne podpísaný veterinárnym lekárom vykonávajúcim or na farme.

Letter from competent authority dated 6 July 2021 1. The SVFA will develop guidance for farm operators where birds are reared at a stocking density greater than 33 kg/m². In accordance with Directive 2007/43/EC the operator will be required to keep records of daily mortality rates and cumulative mortality rates. These records will be signed by the private veterinarian carrying out veterinary supervision on the farm before the animals are transported to the slaughterhouse. Records of daily mortality Page: 1 received 3 September 2021 itted by the competent authorities of Slovakia in response to Report ref. DG(SANTE) 2021-7251 of ary 2021 in order to evaluate controls of animal welfare at slaughter and during related operations ction Proposed by the competent authority ates and cumulative mortality rates will be entered in an Excel table in which all statutory equirements are entered. Farm operators will be required to submit the records to the laughterhouse, together with the remaining mandatory accompanying documentation as ocumentation accompanying the flock moved to the slaughterhouse. . The SVFA will draw up guidance for slaughterhouse operators in which it will set out that roil

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The audit team noted that there is no instruction available to the official veterinarian of the slaughterhouse on how to check the plausibility of the data and of the cumulative daily mortality rate taking into account the number of broilers slaughtered and the number of broilers dead on arrival at the slaughterhouse. Currently, the official veterinarian assesses the plausibility of this data based on his/her experience. This is not in line with Articles 4(2)(a) and 5(1)(b) of Regulation (EU) 2017/625 requiring the Member State to ensure consistency and effectiveness of official controls across its territory and competent authorities to have procedures/arrangements in place to ensure the impartiality, quality and consistency of official controls.

The absence of instruction for slaughterhouse officials on how to check the plausibility of the data and of the cumulative daily mortality rate prevents the authorities from having consistent and high quality assessments carry out from different officials.

Medlemsstatens svar

S SR usmerní veterinárnych inspektorov ajúcich kontroly ochrany zvierat pocas rcovania na bitúnkoch v zmysle: 1. Fyzická kontrola dokladov a úhynov : UVL je povinný skontrolova vsetky sprievodné doklady dolozené k presunutým zvieratám na únok . Následne sa vykonáva kontrola poda odického pokynu, ante mortem prehliadka a post tem prehliadka. UVL bude povinný si vsíma Page: 2 t ref. DG(SANTE) 2021-7251 of the audit carried out from 02 February hter and during related operations ion Proposed by the competent authority aj mnozstvo uhynutých zvierat pri preprave , pocas toho UVL posudzuje, ci prípadné vyssie úhyny pri preprave mohli by spôsobené napr. klimatickými podmienkami pocas prepravy, alebo musí analyzova, ci chovate, aby znízil dennú mieru úmrtnosti v posledných doch a tým aj súhrnnú mieru úmrtnosti nevykazoval úhyny, ale uz uhynuté kusy nechal nalozi do auta­ tu si zase UVL musí vsíma v akom stave sú kadávery zvierat, ktoré boli privezené na bitúnok - vyhodnotí, ci sú cerstvé, "teplé" ­ úhyn pocas prepravy, alebo uz v rozklade ..pre overenie nejasností a prícin, sa urobí pitva.. ) 2. UVL si vsíma priebeh úhynov na farme ­ ci boli vyssie denné miery úmrtnosti v zaciatkoch ( tiet

etter from competent authority dated 6 July 2021 he SVFA will set out the following guidance for veterinary inspectors carrying out animal elfare inspections at the time of killing in slaughterhouses: . Physical inspection of documents and deaths: The official veterinarian must check all ocuments accompanying animals transferred to the slaughterhouse. Then a check is carried ut in accordance with the practical guidelines, as well as an ante-mortem inspection and a ost-mortem inspection. The official veterinarian will also have to take note of the number of nimals that died during transport and assess whether any higher mortality in transit is due to, or instance, meteorological conditions during transport, or she or he must judge whether the Page: 2 received 3 September 2021 itted by the competent authorities of Slovakia in response to Report ref. DG(SANTE) 2021-7251 of ary 2021 in order to evaluate controls of animal welfare at slaughter and during related operations thority the daily mortality rate over the preceding few days, and failed to report mortalities and allowed dead animals to be urpose the official veterinarian must note the condition of use and assess whether they are

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While Slovakia takes targeted actions regarding some active substances, e.g. in water protection areas (paragraph 51), the current NAP does not specifically identify indicators to monitor the use of PPPs containing active substances of particular concern as required by Article 4 (1) of SUD.

The draft new NAP does not specifically identify indicators to monitor the use of PPPs containing active substances of particular concern as required by Article 4 (1) of SUD2.

Neither the first nor the draft revised NAP contains indicators to monitor the use of PPPs containing active substances of particular concern.

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The review was conducted more than five years after the adoption of the NAP, meaning that Slovakia is not in line with Article 4(2) of SUD, which requires NAPs to be reviewed at least every five years.

The overall objective of the first, and current NAP, is to minimise the hazards and risks arising from pesticides, but it does not establish quantitative objectives and targets, and the mandatory review was not concluded within the five-year period required under the Directive.

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However, one of the sections of the instruction entitled "Guidelines for Veterinary Inspectors-Fresh Meat of Domestic Ungulates- Part 1, Ante-Mortem Inspection" describes the following: "Where the official veterinarian is not present at the slaughterhouse on receipt of an animal which has suffered an injury and suffers from pain or an animal which is excessively exhausted after transport and, therefore, delaying slaughter by carrying out ante-mortem inspection could cause further unnecessary suffering, the slaughterhouse operator may in exceptional cases slaughter/kill it without delay without ante mortem inspection, but must immediately inform the official veterinarian and submit to him the body and all parts necessary for the inspection.

This instruction is in contravention of Article 45(a) of Regulation (EU) 2019/627 and in contradiction with another SVFA guidance "Guidelines for Veterinary Inspectors-Fresh Meat of Domestic Ungulates- Part 3, Post-Mortem Inspection" which, in the section on decisions concerning meat, clearly states as the first reason for considering meat as unfit for human consumption when it `comes from animals which have not undergone ante- mortem inspection'.

The SVFA issues instructions in the form of guidelines to OVs and other staff. One of such guidelines allows, in some cases and on welfare grounds, the use of meat for 16 human consumption from animals slaughtered in the lairage without AMI. This is not in line with Article 45(a) of Regulation (EU) 2019/627.

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Whilst the SVFA has developed a website with the lists of registered and approved ABP establishments which was in line the technical specifications for the format of such lists (available on the web page: https://ec.europa.eu/food/sites/food/files/safety/docs/fs- animal-products-app-est-technical_spec_04032012_en.pdf), the audit team noted that the details of some of the ABP establishments were not up-to-date, contrary to the requirements of Article 47(1) of Regulation (EC) No 1069/2009 and Article 20a of Regulation (EU) No 142/2011. For example: Some ABP establishments appeared on the list with the remark `temporary approval' until a date in 2018, although such an approval can be granted only for a maximum period of six months, The storage plant visited is included in the list of approved plants carrying out intermediate activities and plants/establishments storing ABP (Section I of the above technical specifications) for storage of Category 1 and 2 materials, and is listed with the prefix "COLC" reserved for collection centres in the technical specifications. The use of the prefix is not correct as the activities of the storage plant visited do not fall under the definition of a collection centre as specified in point 53 of Annex I to Regulation (EU) No 142/2011, One of the operators visited was still registered for transporting Category 1 and 2 ABP but stated that his company had ceased this activity two years ago, and The national legislation allows granting derogations to use some ABP for specific feeding purposes for a 3­year period only. The SVFA grants such derogations for feeding of zoo animals, circus animals, reptiles and birds of prey other than zoo and circus animals, fur animals, wild animals, dogs in recognised dog kennels, or pack of hounds. Contrary to the national provisions, some operators appeared still on the list of these registered ABP operators with derogations, although the derogations had expired in 2018 or 2019. Conclusions on the registration, approval and listing of ABP plants, establishments and operators

Inaccurate statuses recorded in the lists of approved ABP operators, plants and establishments indicate that despite changes in the activities of individual operators the information contained in the lists remain unchanged. Delayed or absent notification of changes related to operators' activities result in lists not being up-to- date and as a consequence can affect the planning of official controls and result in official controls being scheduled for operators which are no longer active and exclude operators which has only recently received their registration/approval.

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The SVFA has established a procedure for approval of ABP plants which meets the requirements of Article 44 of Regulation (EU) No 1069/2009. Despite applying the procedure during the approval process, in two out of five ABP plants visited the available approval-related documentation did not demonstrate that the competent authority had checked if the plant operators had carried out validation of processing in accordance with all of the procedures and indicators required by Section 2 of Chapter 1 of Annex XVI to Regulation (EU) No 142/2011. For example: An ABP plant processing Category 3 material had received an approval even though the operator's documentation did not clearly demonstrate that the validation of the processing method used (method 7) met all of the specific process requirements laid down in point G of Chapter III of Annex IV to Regulation (EU) No 142/2011(2). The operator's records presented during the audit indicated that the operator had validated a processing method which was relevant for the production of a product for human consumption ­ an earlier step of the processing chain, from which some remaining material was used for the production of PAP and fat - rather than a processing method relevant for the production of DP (PAP and fats); In another ABP processing plant using Category 3 material, the competent authority granted the approval even though the validation file for the processing method 7 was incomplete. The heating process identified as a CCP, required heating of the raw material to a minimum core temperature of 100°C for 60 minutes. The validation charts did not indicate the time when the process started and ended, thus did not allow to assess when and where to measure the exposure time for the required temperature parameter. The audit team noted that neither of the above mentioned operators had reported issues regarding the microbiological quality of the final product and that the results of the (2) In its response to the draft report the competent authority noted that supporting documentation relating to the official inspection for approval purposes is held by the SVFA and not the DVFA. 7 microbiological tests performed by both the operator and the competent authority were compliant.

Most of the inspectors interviewed by the audit team were not aware about the sampling requirements for validation of the processing method 7 provided for in point G of Chapter III of Annex IV to Regulation (EC) No 142/2011 and thus were unable to carry out the checks required by Section 2 of Chapter 1 of Annex XVI to Regulation (EU) No 142/2011 prior to granting the approval.

While adequate procedures exist for registration and approval of ABP operators, plants and establishments, inaccuracies in their implementation, identified in processing plants in relation to the assessment of the processing method 7 validation, 8 weaken their effectiveness.

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The SVFA decides on the inspection frequencies based on risk factors such as the intended use of the commodity (e.g. feed or for technical use), seasonality (or not) of production and size of the establishment. The inspectors at district level can increase the inspection frequency if they consider it justified based on their local risk assessment. The methodological instructions contain guidance on the risk factors to be taken into account for this purpose. Contrary to Article 9(1)(c) of Regulation (EU) 2017/625, the 9 compliance history of the establishment is not included in the risk factors. The audit team noted that in none of the establishments visited had the shortcomings detected during the previous inspection led to an increase in the inspection frequency. The SVFA representative stated that the DVFA staff rarely increase the inspection frequency.

While the inspection frequencies are established without taking into account the past performance of the operator, this deficiency is largely mitigated by the effective follow-up actions, including additional inspections and sampling where relevant, taken when cases of non-compliance are identified during routine inspections.

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Regarding the general hygiene checks, the installations and equipment seen in the plants visited were in adequate condition and the general hygiene requirements were complied with, with the exception of an ABP plant processing Category 3 material where the audit team noted certain shortcomings that had not been recorded in earlier inspection reports. In particular, some of the plastic containers used were very dirty and broken and the clean area was insufficiently protected against rodents and pests (the doors were not properly fitted and as a consequence there were gaps allowing entering of insects and mice), contrary to Article 25(1)(c) and (d) of Regulation (EC) No 1069/2009.

Concerning the official controls on the effective implementation of the permanent written procedure based on the HACCP principles, including operator's own checks and the standards of the products after processing, the audit team noted that all plants 11 visited established such procedures and carried out own controls and these were checked by the inspectors.

The audit team examined several inspection reports and noted that these had not identified a number of shortcomings in relation to the permanent written procedure based on the HACCP principles in the two plants processing Category 3 material visited. The procedures were not in line with the requirements of Article 29 of Regulation (EU) No 1069/2009 regarding the following points: In line with point 1(a) of Section 4 of Chapter II of Annex IV to Regulation (EU) No 142/2011, in one of the processing plants, the size of the raw material particles before feeding into the cooker was identified as a CCP. However, the CCP was checked by the operator (`monitored') only once a year. This is contrary to Article 29(1)(d) of Regulation (EU) No 1069/2009 which requires to establish and implement effective monitoring at CCPs. Evidence of annual calibration of measuring devices was available. However, in the other processing plant visited, the range of calibration of the thermometers covered only the range of the CCP point limit upwards which does not ensure correct monitoring of the processing conditions required by point 1 of Section 2 of Chapter II of Annex IV to Regulation (EU) No 142/2011.

The sampling and testing regimes and the procedure followed for ABP sampling of the final products as part of the operators' own checks were largely satisfactory in the plants visited. The laboratory results of the examinations assessed by the audit team were also satisfactory. However, the audit team noted that the procedures for microbiological sampling as part of own checks were not compliant with the requirements of Chapter I of Annex X to Regulation (EU) No 142/2011 and this was not noted during previous official controls: Only one sample of the end product destined as feed material for analysis of Salmonella was taken instead of the five required. In one of the Category 3 ABP processing plants, some of the own check samples for Salmonella were taken from the product at 90°C (at which temperature Salmonella will not survive) instead of taking it in the final product in the storage area or before dispatch.

In one of the plants processing Category 3 material, the PAP destined for production of petfood contained small but clearly visible plastic particles originating from plastic 12 wrapping or otherwise packaging materials. The audit team noted that the operator had in place a sieve which allowed for capturing particles of a bigger size. The presence of packaging materials in feedstuffs is contrary to the requirements of Article 6 and Point 7 of Chapter I of Annex III to Regulation (EC) No 767/2009 of the European Parliament and of the Council and was not detected by the inspectors during previous controls.

Concerning the checks on storage conditions, the audit team noted that in one of the plants processing Category 3 material, the raw ABP comprising raw meat and fats from slaughterhouses (including ABP from other Member States) destined for production of processed petfood was stored in rooms without temperature control. The operator stated that the raw material would be processed within 24 hours and considered that no cooling was necessary. However, the fact that the ABP was undergoing fermentation suggests that the products were stored at ambient temperature for longer than 24 hours from their delivery to the plant. The lack of suitable temperature-controlled storage facilities for incoming material was not noted during previous official inspections. This is contrary to point 1(f) of Section 1, and point 3 of Section 2, of Chapter II of Annex IX to Regulation (EU) No 142/2011. 5.3.3.2 Official controls in other ABP establishments

Although relatively frequent, the official controls on certain topics are superficial and ineffective in identifying non-compliances in relation to the general hygiene requirements, the permanent written procedures based on the HACCP principles, some areas of own checks and traceability and record keeping.

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In the DVFAs visited, the official controls on ABP covered identification of ABP. Nonetheless, the audit team noted the following shortcomings in relation to identification of ABP: In the OF/SI plant, the operator kept some big bags and plastic containers not bearing any identification descriptions and filled with raw ABP and some other products; the plant representative explained that these were raw material and final products for and from production of OF/SI, and In the multispecies slaughterhouse with a cutting plant, some ABP had been collected in containers which did not bear identification of the category and the required warning sentence. 13 All the above is not in line with Point 2 of Chapter II of Annex VIII to Regulation (EU) No 142/2011, requiring proper identification of stored ABP.

Regarding traceability, evidence was available that during inspections the competent authorities check the availability of documentation that is required in the national and EU legislation (for example, in slaughterhouses; ante and post-mortem inspection logbooks, information on quantities of SRM removed and ABP generated, commercial documents and health certificates, if applicable). However, the audit team noted that the official controls in some of the establishments visited have not included the checks on records or, when they covered the record keeping, did not detect a number of non- compliances with Article 22 of Regulation (EC) No 1069/2009 and the relevant requirements of Chapter III and Chapter IV of Annex VIII to Regulation (EU) No 142/2011.

The records of previous inspections in the OF/SI plant visited did not contain any remarks on record keeping, even though in line with Section 7 of Chapter III of Annex XVI to Regulation (EU) No 142/2011, official controls of OF/SI plants must always include a check on the records kept by the operator. The audit team noted that the operator does not keep any register of incoming and outgoing materials or commercial documents for consignments of raw ABP received from another Member State, contrary to the requirements of Article 22 of Regulation (EC) No 1069/2009 and point 2 of Chapter III of Annex VIII to Regulation (EU) No 142/2011. These non-compliances were not noted during previous inspections.

In the ABP storage plant visited, a register of incoming ABP was available. However, the number of copies of commercial documents issued at the place of ABP origin kept in the register was lower than the number of ABP consignments handled by the storage plant. The inspector responsible for the controls explained that, in most cases, commercial documents were forwarded directly to the head office of the storage plant. The inspector did not however verify if the commercial documents are indeed available at the head office, contrary to Article 32(2) of Regulation (EU) No 142/2011, which requires that official controls must include checks on the keeping of records, including other documents.

The audit team examined several inspection reports and noted that these had not identified a number of shortcomings in relation to the permanent written procedure based on the HACCP principles. These were not fully in line with the requirements of Article 29 of Regulation (EU) No 1069/2009 regarding the following points: In the Category 1 and 2 storage plant visited, the procedures seen belonged to the mother company and were not adjusted for this site. There was no documented evidence of carrying out some of the own checks described in the procedures (e.g. pest control), 14 In the plant producing OF/SI, the procedures had not been updated and there were shortcomings in their implementation as there were no records of CCP monitoring. The HACCP team had not been nominated and no HACCP review had been carried out.

Concerning the general hygiene, the audit team noted in the storage plant visited that in the previous last inspection report the competent authority had only recorded one shortcoming whereas during the on-the-spot visit the audit team noted several others which concerned the collection of the ABP and the maintenance and cleaning of the site and equipment: The containers on-the-spot for collection and transport of ABP had no lids or other kinds of cover and were dirty with deposits of rotten materials from previous loads. A register was available for cleaning of trucks. However, there was no instruction for the drivers on how to clean and if needed, disinfect the containers. The official veterinarian responsible for the controls stated that he had instructed the drivers to use the disinfection product undiluted; the audit team noted that this was against the instruction on the disinfectant label. The above is not in line with the requirements laid down in Section 1 of Chapter I of Annex VIII to Regulation (EU) No 142/2011. In addition, the waste water trap was filthy and blocked up and not allowing for effective drainage of the waste water, contrary to Article 25(1)(d) of Regulation (EC) No 1069/2009.

Although relatively frequent, the official controls on certain topics are superficial and ineffective in identifying non-compliances in relation to the general hygiene requirements, the permanent written procedures based on the HACCP principles, some areas of own checks and traceability and record keeping.

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The PHA and SVFA are aware that for the assessment of complex supporting documentation specific knowledge (i.e. chemistry education) is essential to verify the statements given in the DoC. At the time of the audit, such expertise is available at the NRL and inspectors on the spot could ask for technical support. However, the NRL stated that, caused by a shortage of staff (one person in charge), they are able to address a limited number of requests.

Furthermore, based on the national legislation, in order to be employed as an inspector at the PHA, an education in the field of public health, including food safety, is required. A Degree in Chemistry, on its one, is not enough as a requirement. 4

Although the CA acknowledge the relevance of staff with a chemistry background for in-depth FCM controls, current rules of engagement prevent their recruitment into the RPHA, thus limiting in-depth knowledge to a limited number of NRL personnel. 5.2.2 Registration / Approval of FCM Business Operators Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004 and Article 31 of Regulation (EC) No 882/2004. Findings

Although DVFA inspectors have stated that they have not received adequate training on FCM legislation, they performed the appropriate checks. However, unlike PHA, SVFA has provided generic checklists that do not fully cover the legal requirements of the DoC to the point that most of these DoCs examined by the inspectors would not meet the criteria set out in the legislation.

Official controls rely on BOs' risk assessment, instead of verifying if these risk assessments are fit for purpose. This result in limited controls being made on the completeness of supporting documentation in the DoC, which implies that inadequate or incomplete risk assessments/DoCs are being overlooked. Thus, products which present a potential health risk could be placed on the market.

The effectiveness of the controls in place is hampered by the fact that inspectors are not suitably qualified to evaluate specific details of DoCs as required by legislation, for which they rely on expertise to be provided by others, but such expertise may not always be sought.

Medlemsstatens svar

allocate capital expenditures for NRL instrument equipment to be able to provide more comprehensive and expanded FCM analyzes 2. Continue to provide regular training on the basis of annual plans specifically targeting practical aspects of the exercise of official controls 3. Continue the activities to ensure the increase of stuff of each RPHA in SR and PHA in the field of FCM 4. Increase the number of NRL staff to provide in-depth professional assistance in carrying out official controls and audits at manufacturers Deadline: 31.12.2018 SVFA

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However, concerning non-compliances the CAs could not provide figures on their number, type and severity. Indeed, in four cases out of the five reviewed on the spot 3 In their response to the draft report the CAs noted that in light of the audit findings, measures will be taken for more consistent requirements for the DoC and supporting documentation. 9 which were under RPHA responsibility, no measures were taken after deadlines had expired and enforcement procedures were not initiated.

At one producer visited, the audit team noted that, based on the last reports for 2017 and 2016, the DoCs were not in compliance and in none of the cases were measures taken by the CAs to ensure compliance (i.e. correction of the deficiencies noted).

At the second manufacturer the last report available was for 2017 and no non- compliances had been detected. For this manufacturer no audit or other inspection regarding FCM was carried out. An audit covering GMP was planned for 2015 but never carried out, according to the RPHA, due to limited staff resources.

At the same RPHA the audit team also checked official documentation regarding a plastic bottle manufacturer. This manufacturer was audited for GMP in 2017 and no non-compliances were identified. This was the only official control carried out in the last six years to this FCM producer.

Concerning non-compliances the DVFA are not able to provide figures on their number, type and severity. During the visits at the two FBOs, the audit team reviewed six official reports and none of them contained non-compliance.

Centrally, CAs do not keep data regarding non-compliances. Inspectors did not systematically record and did not systematically address the detected non-compliances. This leads to the loss of an element of risk-based planning (i.e. the history of compliance). 5.2.5 Official Sampling Procedures and Laboratory Performances Legal Requirements Article 4(2)(c), Article 11, Article 12(1), (2) and (3) and Article 33 of Regulation (EC) No 882/2004. Findings

Medlemsstatens svar

1. SVFA will adopt the system of administration of records on shortcomings referred for resolution to the competent RPHA. Page: 1 port ref. DG(SANTE)/2018-6375-MR of the audit carried out from r official controls related to food contact materials in EU Member States osed by the competent authority : 31.7.2018 l adopt a system for recording records with non- ces 31.12.2018 A RPHA will ensure that the application of ment measures in the event of non-compliance is y applied

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However, concerning non-compliances the CAs could not provide figures on their number, type and severity. Indeed, in four cases out of the five reviewed on the spot 3 In their response to the draft report the CAs noted that in light of the audit findings, measures will be taken for more consistent requirements for the DoC and supporting documentation. 9 which were under RPHA responsibility, no measures were taken after deadlines had expired and enforcement procedures were not initiated.

At one producer visited, the audit team noted that, based on the last reports for 2017 and 2016, the DoCs were not in compliance and in none of the cases were measures taken by the CAs to ensure compliance (i.e. correction of the deficiencies noted).

In one RPHA visited, the audit team saw evidence of official control carried out at retail level regarding FCM. The same checklists were used in all cases. Although the inspectors identified a number of non-compliances in the DoC checked, nothing was mentioned in the report (measures, deadlines, corrective actions). Conclusions on Implementation of Official Controls over BOs 13

At the RPHAs visited, the audit team investigated cases of non-compliant DoCs and the RPHAs follow-up of the cases and the measures (sanctions such as penalties and in two cases withdrawals of FCM related products from use before 2010). However, the follow-up at the BOs, in the majority of the cases was not in line with the procedures in place.

However, the audit team noted a number of shortcomings, where recommendations from the CAs were not followed up and no further action was taken regarding non-compliant BOs. Conclusion on National Enforcement Measures

There is a system of national enforcement measures in place. However, no evidence was provided that these measures are consistently implemented or applied following inspections. In this way official controls lose they effectiveness in raising/maintaining levels of compliance and, in addition, it could result in products which present a potential health risk being placed on the market.

Medlemsstatens svar

1. 12. 2018 Page: 2

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The CB met described in detail how it had now changed its approach to handling risk assessment in order to address Recommendations No 1 and No 4 of audit report 2014- 7098. Previous non-compliances detected by the CB are now taken into account. However, the audit team still has concerns on the appropriateness of the overall risk categorisation of operators. The current approach is complex, utilising 20 criteria to calculate the risk score to categorise an operator. More significant is the realisation during this audit that the criteria and the scoring applied is contradictory in some instances and potentially leads to the CB targeting the incorrect operators for additional controls and sampling (see section 5.2.3 Planning and Prioritisation).

CBs are approved by the CA and subject to annual supervision in line with EU rules. However, the supervision carried out by the CA, did not fully consider all aspects of risk assessment and its overall impact on selection of operators for sampling and additional controls. 5.2.2 Registration of operators Legal Requirements Articles 28(1) 28(2), 28(5) of Council Regulation (EC) No 834/2007 Article 92b of Commission Regulation (EC) No 889/2008 Findings

The planning of the allocation of CB inspectors commences in mid-December and is finalised in April. At the time of the audit, the CB confirmed that the planning for 2018 in terms of inspection dates was not yet available. The CB explained that they inform the CA on a weekly basis of their inspection plans.

Since the previous audit, and in order to address recommendations Nos 1 and 4 from audit report 2014-7098, previous non-compliances are now factored into the risk assessment calculation. The audit team thoroughly reviewed the approach to risk assessment and noted a number of contradictions. The CB met has a highly complex approach to calculate the score to allocate an operator to a specific risk category which requires 20 criteria to be addressed. Article 65(4) of Regulation (EC) No 889/2008 specifies three criteria which have to be taken into account for the risk assessment. These are (i) results of previous controls, (ii) the quantity of products concerned and (iii) the risk for exchange of products. The audit team noted two out of these three criteria were not included in the approach used by the CB visited. 6

Each of the 20 criteria is reviewed separately by the CB when it performs the risk assessment of each operator. In relation to the first of these criteria, previous non- compliances, the following approach is used. The number of points attributed to an operator when a non-compliant result is confirmed with regard to unauthorised substances is 25 points. These 25 points remain on the record of the operator for the purpose of calculating the risk categorisation of the operator for the subsequent five years. A similar approach for carrying over risk points is applied when complaints from other CBs are received relating to a specific operator. If this occurs, an additional 10-30 risk points could be added to the risk categorisation score regardless of whether or not the complaint is upheld.

The second criterion, the quantity of products produced by the operator is only indirectly considered. One of the 20 criteria refers to the size of the operator's holding which only applies to primary producers. As an example, a holding the size of 1000 ha receives one risk point. This approach does not factor in the type of production, whether it is vineyard, tillage, or pasture and how such different production activities give rise to different quantities. The risk assessment criteria make no reference to the quantity of product produced for any other activity.

Regarding the third risk criteria, that associated with exchange of products (organic and non-organic), at mixed operators, a risk score of two points is allocated.

The CB stated that there were five other criteria which indirectly assessed the issue of quantity. However, the audit team noted that all of these criteria would only add one or two points per criteria. This would not ensure that such significant risks are taken into account in a proportionate manner.

The handling of other risk criteria also raised concerns for the audit team. Examples include the situation where more points are allocated to operators who have a greater number of species of animals on their land than those with a single species. This leads to a situation where an operator with 1000 cattle gets one point however an operator with two goats and two sheep got more points. The audit team also noted that when an operator complied with the requirement to obtain a derogation for the use of non-organic seed, an additional risk point was added.

Medlemsstatens svar

- CA aktualizuje interný pokyn IP 13/2018 ,,Výkon rocnej ie oprávnenej inspekcnej organizácie príslusným orgánom ekologickej ponohospodárskej výrobe" v zmysle odporúcania tak, aby dohad nad súkromnými inspekcnými organizáciami zahal hodnotenie výsledkov postupov analýzy rizika a aby bolo v priebehu dohadu overené, ci je výsledné zaradenie do kategórie rizika úcelne vykonané, - CA aktualizuje tlacivo - Kancelársky audit - kontrolný list, - CA vykoná skolenie inspektorov CA zamerané na kontrolu analýzy riziká pri dohade CB. Termín: XII/2018

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Although considerable effort goes into the calculation of the score to categorise an operator as high, medium or low risk, such efforts are undermined due to the flawed approach to risk assessment used by the CB met. This adversely affects the planning and prioritisation of controls. 5.2.4 Controls of operators Legal Requirements Titles II and III of Regulation (EC) No 834/2007 Titles II and IV of Commission Regulation (EC) No 889/2008 . Article 27 of Regulation (EC) No 834/2007 Articles 65 and 65(3) of Commission Regulation (EC) No 889/2008 Articles 8, 9 of Regulation (EC) No 882/2004 Findings

Medlemsstatens svar

- CA aktualizuje metodický pokyn MP 3/2017 ,, Analýza rizika ená inspekcnou organizáciou v ekologickej ponohospodárskej obe v SR" tak, aby oprávnené IO pri analýze rizika ednoznacne zohadovali tri kritériá v súlade s cl. 65 ods. 4 nariadenia c. 889/2008, a aby analýza rizika zabezpecila, ze na úcel dodatocných kontrol a odberu vzoriek budú vybraní relevantní prevádzkovatelia, - CA vykoná skolenie v nadväznosti na aktualizovaný metodický pokyn MP 3/2017, - CB aktualizuje metodický postup ,,Hodnotenie rizika prevádzkovateov v rámci ekologickej ponohospodárskej výroby" tak, aby boli pri analýze rizika jednoznacne zohadnené tri kritériá v súlade s cl. 65 ods. 4 nariadenia c. 889/2008, Page: 1 2018 eport ref. DG(SANTE)/2018-6402-MR of the audit carried out from 14 March duction and labelling of organic products Action Proposed by the competent authority Termín: IV/2019

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The audit team noted that, although the operator had an in house quality system in place, the inspector did not refer to this resource (and as referred to in Article 67(1)(c) of Regulation (EC) No 889/2008) or take this into account for the assessment of the effectiveness of precautionary measures implemented by the operator. The operator undertook laboratory testing of every batch of product in an accredited laboratory and this information was not factored into the calculation of the risk assessment and risk categorisation of this establishment.

The inspector checked cleaning records which consisted of computer print outs of a cleaning system. These records did not provide any evidence that the cleaning system was confirmed as being fit for purpose or that it was effectively implemented. This is not in line with Article 26(2)(b) and (3)(e) of Regulation (EC) No 889/2008). The CB inspector did not report this as a non-compliance in his report.

The control commenced with a physical inspection of the pasta production area from reception of raw materials to packaging of final product. The inspector noted the details of the raw materials stored at the time of the control. This was a time consuming task which was undertaken manually as the inspector did not use a camera. The inspector referred to the operator's Hazard analysis and critical control points (HACCP) plan and checked a number of food safety criteria. The HACCP plan did not contain any critical processing steps relating to organic production as stipulated in Article 26(2)) of Regulation (EC) No 889/2008.

CB inspectors met were generally well qualified and knowledgeable. However, the verification of the effectiveness of precautionary measures is superficial. There is a risk that potential non-compliances are overlooked as procedures are not based on critical processing steps relating to organic production and results from in house quality systems are not necessarily taken into account. 5.2.5 Controls on Labelling and Traceability Legal Requirements Articles 5, 23, 23(1), 24, 27 of Regulation (EC) No 834/2007 11 Title III of Commission Regulation (EC) No 889/2008. Article 18 of Regulation (EC) No 178/2002. Findings

Medlemsstatens svar

- CA vydá usmernenie CB, aby inspektori súkromných inspekcných organizácií dôsledne overovali úcinnos of preventívnych opatrení s cieom overi, ci prevádzkovatelia vykonávali postupy zalozené na vhodných kritických krokoch pri spracovaní, - CB aktualizuje metodický postup ,,Proces kontroly" za úcelom zabezpecenia overenia inspektormi CB preventívnych opatrení a vykonávania postupov prevádzkovatemi zalozených na vhodných kritických krokoch pri spracovaní, - CB vykoná skolenie inspektorov zamerané na výkon kontroly s dôrazom na overenie úcinnosti preventívnych opatrení a kontrolu, ci prevádzkovatelia vykonávajú postupy zalozené na vhodných kritických krokoch pri spracovaní, - CA pri dohadových a svedeckých auditoch inspektorov CB preverí efektivitu prijatých opatrení v súvislosti s odporúcaním c. 3 Termín: XII/2018, rok 2019

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Although the CB stated that sampling on suspicion can be carried out if required, the audit team later confirmed that inspectors are not provided with any sampling equipment and in reality no sampling on suspicion is carried out which is not in line with Article 65(2) if Regulation (EC) No 889/2008. One inspector clarified that if planned sampling controls were being undertaken, in those circumstances sampling equipment would be available and used by the inspectors.

The CB inspectors are not equipped to undertake sampling on suspicion should the need arise during controls at operators. 5.2.7 Measures in cases of irregularities and infringements Legal Requirements Articles 55(1), 54 of Regulation (EC) No 882/2004 Articles 27(5)(d), 30 of Regulation (EC) No 834/2007 Articles 91, 92, 92(a) 92(d) of Commission Regulation (EC) No 889/2008 Findings

The audit team reviewed a number of files and noted that the CB had undertaken an in depth investigation relating to the detection of an unauthorised substance in a sample of leaves from an organic orchard (0.013 mg/kg of Thiacloprid which is a commonly used insecticide in fruit production). The sample had been taken by a third party who notified the CB of this suspected irregularity. The CB launched an investigation during which the neighbouring farmer confirmed that he was at fault. The CB decided the affected land had to undergo a new conversion period of three years in line with the above mentioned catalogue of measures. The CB's decision on this occasion was based on the fact that the operator did not take adequate precautionary measures such as agreeing with the neighbouring conventional farmer on the conditions for spraying. However, the CB had not taken any sample to confirm the result of the third party sample and to substantiate or rule out the irregularity. This is not in line with the SK catalogue of measures referred to above which requires sampling in such circumstances "to prove the breaking of organic production rules". Moreover, it is not in line with Article 65(2) of Regulation (EC) No 889/2008 which stipulates that the CB shall take and analyse samples in each case where the use of products or techniques not authorised for organic production is suspected. Moreover, the CB stated that the decertified area was defined based on inspector's experience.

Medlemsstatens svar

CA upraví metodický pokyn MP 06/2018 ,,Pravidlá pre odber cle vzoriek v ekologickej ponohospodárskej výrobe v SR" v zmysle ­ doplní poziadavku týkajúcu sa vybavenia inspektorov CB na vykonávanie odberu vzoriek v prípade podozrenia, ak by vznikla takáto potreba pocas kontrol u prevádzkovateov, - CB zabezpecia vybavenie inspektorov na odbery vzoriek v prípade podozrenia, Page: 2 2018 eport ref. DG(SANTE)/2018-6402-MR of the audit carried out from 14 March duction and labelling of organic products tent authority deckých auditov zameria na to, ci odberovým zariadením, inspektorov CB preverí efektivitu losti s odporúcaním c. 4

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The audit team reviewed a number of files and noted that the CB had undertaken an in depth investigation relating to the detection of an unauthorised substance in a sample of leaves from an organic orchard (0.013 mg/kg of Thiacloprid which is a commonly used insecticide in fruit production). The sample had been taken by a third party who notified the CB of this suspected irregularity. The CB launched an investigation during which the neighbouring farmer confirmed that he was at fault. The CB decided the affected land had to undergo a new conversion period of three years in line with the above mentioned catalogue of measures. The CB's decision on this occasion was based on the fact that the operator did not take adequate precautionary measures such as agreeing with the neighbouring conventional farmer on the conditions for spraying. However, the CB had not taken any sample to confirm the result of the third party sample and to substantiate or rule out the irregularity. This is not in line with the SK catalogue of measures referred to above which requires sampling in such circumstances "to prove the breaking of organic production rules". Moreover, it is not in line with Article 65(2) of Regulation (EC) No 889/2008 which stipulates that the CB shall take and analyse samples in each case where the use of products or techniques not authorised for organic production is suspected. Moreover, the CB stated that the decertified area was defined based on inspector's experience.

Overall, the CA and CB invest considerable effort into the follow-up of reported irregularities. However, enforcement measures are not always taken in line with the catalogue of measures. In addition, the investigations carried out to establish the existence of an irregularity are not always sufficiently robust.

Medlemsstatens svar

CA aktualizuje katalóg opatrení, - CA vykoná skolenie pre CB týkajúce sa katalógu opatrení, aných v CB za úcelom dohadu ziavanie katalógu opatrení CB Page: 3

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The NRL failed to meet its obligations as laid down in Article 33(2)(b), (c) and (d) of Regulation (EC) No 882/2004 (before 29 April 2018), and currently fails to meet its obligations under Article 101(1)(b), (c) and (g) of Regulation (EC) 2017/625. Despite being aware of this since 2007, the SVFA has not managed to correct this non- compliance. The NRL has not organised any comparative tests for rabies diagnosis for the four other official laboratories that are carrying out such tests. As described in the action plan in response to the recommendation in the 2007 audit report, a specific instruction was issued to the NRL for rabies in 2007 to address this non-compliance (Instruction No 3081/07-223-1). The SVFA had established through two inspections of the NRL (in 2008 and 2015) that the laboratory had not followed this instruction. In February 2018 the SVFA issued a general instruction for reference laboratories (Methodological instruction No. 3/2018-370) which is based on Articles 100 and 101 of Regulation (EC) 2017/625. The NRL does not coordinate the activities of official laboratories responsible for diagnostic tests for rabies and does not organise training for staff of those laboratories. They would however offer assistance if requested by a control laboratory. The NRL has regular contacts with the EU reference laboratory but has not disseminated to the official national laboratories information that the EU reference laboratory for rabies has supplied.

The NRL stated that the confirmatory tests, using molecular methods, on certain samples that have been tested for rabies using FAT in the other four laboratories provides adequate information about the quality of the test results obtained from the other laboratory. However, in recent years confirmatory tests have only been carried out on (certain) rabies-negative samples and all rabies-positive samples in 2013 and 2015 originated from one other laboratory. The rabies-positive test results from other laboratories have always given positive results also in the NRL, where they have been confirmed by PCR. No confirmatory tests for rabies-positive results have been needed since 2015, and all positive cases in 2013 and 2015 were diagnosed in one of the four official laboratories. The NRL confirms negative results obtained in official control laboratories in suspect cases with human exposure. In 2016-2017, 110 such samples from wild and domestic animals were tested. All tests carried out in the NRL confirmed the negative results obtained in the control laboratory. 17

However, the national reference laboratory has never met all of its obligations under EU legislation to coordinate and verify the quality of tests carried out in the laboratory network. These obligations cannot be replaced by the confirmation of certain test results from the other laboratories. This hampers the ability of the competent authority to assess the reliability of the important rabies screening tests carried out in the four other laboratories in the laboratory network. The competent authority has not addressed this non-compliance despite promising to do so following the audit by Commission services in 2007.

Medlemsstatens svar

Since of 1 March 2019 only the nominated national reference laboratory (NRL) for rabies (Veterinary Institute in Zvolen) will carry out all laboratory activities in accordance with national rabies eradication programme. NRL has all the appropriate methods and provides the competent authority with timely and reliable results that are regularly verified through the successful participation in international comparative tests. Other official laboratories will not be involved in laboratory diagnostic. Page: 1

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Until recently (the end of 2017) SSCIA carried out audits completed by two auditors of which one was a permanent employee of SSCIA and another worked on a contractual basis. From 2018 these auditors are no longer available and audit activities are suspended.

CCTIA covers four fields of official controls falling under Regulating (EC) No 882/2004. The SSCIA representative stated that audit planning requires regular audits in 20 each of the areas once a year, therefore for selection of audit areas a risk-based approach does not apply. Until the end of 2017 SSCIA managed to meet the target of four audits per year. At the time of this audit the 2018 audit programme was not in place as SSCIA has lost two auditors (see finding 23).

All competent authorities have audit services in place to implement the audit programmes and these significantly vary in terms of planning process and availability of auditors. While DAC (SVFA) provides, in principle, assurance that audits will be continued as planned, this cannot be ensured by ODKAS (PHA) which is struggling with a decrease in the number of auditors and increase of audits and, in 2018, SSCIA (CCTIA) that has neither the audit programme in place nor the resources to execute it.

According to the SSCIA representative prior to 2016 no arrangements for monitoring and review of the audit process were in place. The Methodological instruction No 1/2017 put in place some provisions for these activities but they have not been implemented. Moreover, in 2017 the audit team was so small (two auditors only) that all improvements/changes could be implemented immediately therefore, there were not recorded. SSCIA has not initiated further work on monitoring and review procedures since the future format of the audit process has not been decided yet.

Medlemsstatens svar

ÚKSÚP ÚKSÚP zabezpecí v roku 2018 vykonanie interných auditov, ako to vyzaduje cl. 4 ods. 6 nariadenia (ES) c. 882/2004 (alej len ,,nariadenia") tým, ze zabezpecí dostatocné personálne obsadenie organizacného útvaru zabezpecujúceho výkon interných auditov. ÚKSÚP da 04.05.2018 vypracoval program interných auditov výkonu úradnej kontroly zahajúci vsetky oblasti výkonu úradnej kontroly v zmysle nariadenia.

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The DG SANTE audit team examined the records from the Commission meetings and noted that none of them contained evidence that: a) the Commission checked whether the audit processes achieved their objectives, and/or b) how and to what extent the Commission contributed to the continuous improvement of the SVFA and/or the CCTIA audit process. SVFA and CCTIA were unable to present such evidence. Moreover, the summary information presented by the SVFA and the CCTIA representatives to the Commission reflected on the outcome of audits and performance statistics (number of 12 audits carried out vs. audits planned) but did not present an insight into other steps of the audit process, for instance planning of the audit programme.

The DG SANTE audit team noted that the Commission members have sufficient authority but insufficient expertise to assess the audit process and contribute to its improvement.

The DG SANTE assessed the records and noted that: Evaluation of the implementation of the audits on official controls was limited to checks on performance statistics (number of audits carried out vs. audits planned). The review focused on the outcome of the audits (audit findings and conclusions) rather than the audit process itself. As a result the Forum suggested adjustments for issues identified during audits on official controls and did not propose any improvements to the audit process. The Forum did not conclude if, or to what extent, audits achieved their objectives. The Forum concluded that audits were carried out in accordance with the audit procedure. However, during the period covered by the review (2015 ­ 2017) the procedure was not formally in place as it was only adopted in November 2017.

The DG SANTE audit team noted that of twelve members of the Forum: at least one person was involved in development of the audit procedures, nine persons represented RPHAs ­ from an audit point of view they were auditees, and except the one person involved in development of audit procedures, the other Forum members had no expertise in audit. 13 Conclusions

All competent authorities have put in place arrangements for independent scrutiny as required by Article 4(6) of Regulation (EC) No 882/2004. However, both the Committee and the Forum lack a fully-independent person (or body) with audit expertise. This limits the abilities of the existing arrangements to assess the suitability of the audit process and to ensure that it can contribute to improving the performance of the audit activities. As a consequence, in their current format, the arrangements in place cannot assess whether internal audit systems are achieving their objectives. 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: - generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, - specific technical knowledge and skills, - personal attributes, - education, - work experience, - auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

Medlemsstatens svar

Da 19.06.2018 ÚKSÚP rozsíril samostatné oddelenie kontroly a interného auditu o alsieho zamestnanca, ktorý po absolvovaní potrebných vzdelávacích aktivít bude zabezpecova výkon interných auditov. ÚKSÚP ku du 31.06.2018 organizacnou zmenou zrusil samostatné oddelenie kontroly a interného auditu a da 01.07.2018 zriadil oddelenie kontroly a interného auditu s plánovaným poctom 4 zamestnancov. Termín: do 31.12.2018 MPRV SR Komisia pre nezávislé preskúmanie procesu auditu bude pravidelne prizýva na svoje stretnutia nezávislú osobu ­ s odbornými znalosami v oblasti auditu. Táto moznos uz bola prediskutovaná na zasadnutí komisie, ktoré sa uskutocnilo 10.5.2018, kde boli prediskutované závery auditu (na základe návrhu správy z auditu). Pricom zo zasadnutia komisie boli prijaté odporúcania, na ich plnení sa pracuje. Bude vykonaná aktualizácia statútu komisie (budú doplnené poziadavky na nezávislú osobu a jej povinnosti.). Termín do 12.2018 ÚVZ SR Úloha c. 1 a) Prehodnoti a upravi metodiku nezávislého preskúmania auditov, tak aby spal ciele poziadaviek poda cl. 4(6) nariadenia (ES) c. 882/2004. b) Vykona opravu a doplnenie metodiky tak, aby boli dané jasné pravidlá na posúdenie, ci systém au

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The DAC representative stated that, although it is planned, there is currently no methodology in place demonstrating how the risk criteria are applied through the risk universe to result in the audit programme. For establish the coverage DAC uses a combination of geographical distribution and topics audited in each of the DVFA. Within three years, each of the DVFAs must be audited at least once. Within one series of audits in selected area, individual audits must be carried out at least in two and preferably in three DVFAs. The Head of DAC selects areas and topics for the audits on the basis of a history of non-compliance in official controls, results of DG SANTE audits and available human resources. When developing the three-year programme DAC discusses areas and topics for audits with the SVFA sector-specific Departments. The DG SANTE audit team noted that newly emerging risks are integrated into the programme on an ad-hoc basis (e.g. animal origin commodities).

CCTIA covers four fields of official controls falling under Regulating (EC) No 882/2004. The SSCIA representative stated that audit planning requires regular audits in 20 each of the areas once a year, therefore for selection of audit areas a risk-based approach does not apply. Until the end of 2017 SSCIA managed to meet the target of four audits per year. At the time of this audit the 2018 audit programme was not in place as SSCIA has lost two auditors (see finding 23).

The PHA audit programme reflects the Slovak MANCP and covers all areas of official controls by RPHAs. ODKAS develops the programme on a yearly basis and presents it to the Advisory Forum for modifications and approval. The ODKAS representative stated that the audit programme is based on a geographical distribution of RPHAs and it does not cover the central level of PHA.

The PHA audit programme does not focus on specific areas or risks but rather follows the number and type of claims registered by ODKAS from a given region or a topic. Following the decision of the Advisory Forum (February 2018), beginning from 2018 the programme will cover all 36 RPHAs within a period of five years and focus on more specific areas; e.g. claims on deteriorating food quality triggered more targeted audits on food and food traceability.

The ODKAS representative stated that currently no methodology for risk-based selection of areas for audit is in place and the Head of ODKAS follows the procedure requiring him to propose areas and topics for audits. These are selected following the occurrence of claims notified to PHA, the number of notification of infectious diseases, e.g. hepatitis, or particular interest in some specific areas, e.g. production of baby food. Moreover, the Advisory Forum has the right to add areas and topics for audits which deems necessary.

All competent authorities have arrangements in place for developing audit programmes and these reflect responsibilities and areas of official controls laid down in the Slovak MANCP. Nevertheless, competent authorities have a variety of approaches for risk- based prioritisation of areas for audit, and these are neither supported by clear methodologies nor systematically documented. As a consequence, currently, none of the authorities could demonstrate that their programmes were risk-based or achieved an appropriate coverage of relevant official control activities.

The DG SANTE audit team interviewed the DAC representatives and examined some audit files and noted the following: Procedures for preparing, approving and distributing audit reports, and arrangements to review audit conclusions and ensure the monitoring of corrective and preventive actions are in place. The consistency between auditors at the level of generating audit findings (including identification of evidence of compliance and noncompliance) and their proper recording in audit reports in accordance to the newly introduced procedures following the 2017 Directive is ensured by the Head of DAC who participates in at least the first audit of the series and conducts regular consultations with auditors discussing the current internal audit issues. DAC is continuing to work on the methodology for the audit programme (to demonstrate that is risk-based and covers relevant areas).

Medlemsstatens svar

ci stáleho zlepsovania systému interného auditu, zhromazuje výsledky ajúcich auditov. Tieto výsledky sa od zavedenia novej Smernice na výkon interného 2017 systematicky zhromazujú a vyhodnocujú. V súcasnej dobe je okument upravujúci postupy pri vyhodnocovaní rizík na základe výsledkov itu, ale i výsledkov úradných kontrol a supervízie ako aj podnetov obcanov. ijatia uvedeného dokumentu je jese 2018. Posledné kritérium bude systematicky z spustením databázy podnetov oklad prvý polrok 2019 a roka 2018 vypracuje analýzu rizika pre výkon auditov výkonu úradnej eom zabezpeci výkon interných auditov výkonu úradnej kontroly a pokry i výkonu úradnej kontroly. nie kontroly a interného auditu vypracuje aktualizáciu metodiky na výkon itov výkonu úradnej kontroly s cieom zabezpeci prijímanie a následné plnenie trení na odstránenie zistených nedostatkov. .12.2018 a upravi metodiku výkonu auditov, so zaclenením jasne definovaných dosiahnutie cieov auditu, vrátane organizacného a personálneho systému auditu nariadenia (ES) c. 882/2004. hodnoti a upravi systém zostavovania programu auditov zalozeného na riziku sa na konkrétne oblasti a riziká v rozsahu kompetencií ÚVZ SR (RÚVZ) poda ákona c. 152/1

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The competent authority provided numbers of domestic pigs sampled under passive surveillance, in the entire territory of Slovakia and in the 3 DVFAs which form the buffer zone (from 2017 onwards) and which were previously in the high risk area (2015 & 2016): Whole country ASF ASF Buffer Zone High Risk Area 2017 2016 2015 (to 23/06/17) 2017 2016 2015 Samples tested 6 11 3 6 0 2 for ASF (PCR)

Should the disease enter the domestic pig population, the extremely low level of passive surveillance in this sector, across the territory of Slovakia and in the buffer zone in particular, does not provide confidence that ASF would be detected at an early stage following introduction. This will delay the implementation of control measures, increasing the risk for further spread. 14

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In hunting ground visited, laboratory reports for active surveillance in 2 of the 3 wild boar hunted in the 2016 ­ 2017 season confirmed it took 10 and 17 days for ASF test results to be available after sampling with delays of 4 and 13 days respectively to get samples to laboratory.

In one DVFA visited, a selection of laboratory reports were reviewed for passive surveillance in wild boar (found dead) up to the end of May 2017. The time interval between reporting the carcase in the field and a test result being available for was around 13 - 14 days - this included, in one instance, a delay of 6 days to get samples to the laboratory from the field.

In NRL a selection of ASF test results were reviewed for passive surveillance in wild boar carried out in June 2017. The time interval between reporting the carcase in the field and a test result being available ranged from 5 - 7 days and NRL confirmed they now send test results to DVFA by e-mail. Notwithstanding, this still does not meet the objectives of the approved programme for early detection of ASF. Conclusions on early detection

To avoid delay in early detection, CA have recently focussed on reducing the time between sampling and reporting of ASF results from wild boar found dead. Despite this, the reporting time remains relatively long which may delay implementation of control measures.

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Commercial farms visited maintained holding registers albeit, one register was not kept on the holding as required by Article 4(2)(c) of Directive 2008/71/EC. The register was kept on an associated holding under the same ownership. Movements to single pig holdings are recorded in the registers with the code "63" and this type of movement was observed by auditors to be a common occurrence. In the registers reviewed, no record of destination was recorded in holding register when pigs moved to single pig holdings. This is not in accordance with Article 4(1) of Directive 2008/71/EC.

CA should have the ability to deal with outbreaks of ASF on all sizes of holdings with minimal delay in depopulation. However, in the event of confirmation of ASF, performing a census and tracing of pigs will be time consuming and will demand increased resources when dealing with non-registered pig holdings. This may delay containment of disease in an outbreak scenario. 16

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The current ASF strategy for the eastern part of the EU considers a non-disruptive and gradual reduction of wild boar densities as optimal to reduce the spread of ASF. CA confirmed there was currently no such strategy in place. However, CA advised drafting was on-going to set national densities for cloven hoofed animals, including wild boar, which will require amendment of The Act on Hunting. 1 SANTE/7113/2015 ­ Rev 7 ASF Strategy for Eastern Part of the EU 3

CA confirmed that supplementary feeding of wild boar in the buffer zone is prohibited. However, District Forestry Offices recommend that hunting ground users can allocate up to one percent of total hunting ground area for growing crops to sustain wildlife (including wild boar) - crops include oats and maize.

In hunting ground visited by audit team (located in the buffer zone) this practice was observed with 3.5 hectares dedicated to growing crop specifically to sustain wildlife. This practice does not take into account the ASF Strategy which recommends a ban on feeding wild boar in order to decrease wild boar density.

The current ASF Strategy for Eastern Part of the EU considers limitation of wild boar populations as a priority. There is currently no such strategy for non-disruptive and gradual reduction of wild boar densities in Slovakia

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There are few chill facilities for wild boar carcases in the buffer zone. CA confirmed that hunted wild boar carcases are allowed to move within the buffer zone (including to hunters homes), before test results are available. 5

Biosecurity requirements in hunting grounds are well defined but not always followed and few official controls of hunting grounds have been performed to date. There are few chill facilities for wild boar carcases in the buffer zone. Consequently, hunted wild boar carcases are allowed to move within the buffer zone (including to hunters homes), before test results are available. This will increase the risk of further spread of disease in the event of a positive case in wild boar.

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Various events such as births, deaths and movements must be notified by the keeper to database within specific deadlines, e.g. movements between holdings of bovines, ovines/caprines and porcines have to be notified within 7 days according to national legislation which implements the requirements of Article 7(1) of Regulation (EC) No 1760/2000 of the European Parliament and of the Council. All national deadlines for notifications either comply or go beyond EU requirements.

Data provided by the competent authority shows that average notification times have improved during the past five years for all types of notifications in bovines as follows: Bovines - Percentage notifications of: Birth within 7 days of tagging 2010 2011 2012 2013 2014 2015 within 14 days of tagging 49.49 52.94 54.77 63.32 77.56 85.52 within 21 days of tagging 70.15 72.76 73.27 80.71 87.00 88.84 78.28 80.22 80.16 86.74 90.10 90.04 Death on farm within 7 days 94.38 96.68 94.98 96.48 96.65 97.15 within 14 days 95.66 98.44 96.92 98.48 98.52 98.94 within 21 days 96.22 98.91 97.50 99.02 99.03 99.33 Slaughter within 7 days 64.69 66.59 67.65 69.01 75.07 84.12 within 14 days 76.32 77.55 77.75 78.34 82.68 89.50 within 21 days 81.22 82.29 81.48 82.27 86.66 91.74 Off-Movement * within 7 days 90.44 90.74 90.25 92.42 96.29 98.05 within 14 days 94.52 94.90 94.12 95.46 98.16 98.97 within 21 days 95.73 96.10 95.57 96.54 98.68 99.19 On-Movement* within 7 days 90.44 90.74 90.25 92.42 96.29 98.05 within 14 days 94.52 94.90 94.12 95.46 98.16 98.97 within 21 days 95.73 96.10 95.57 96.54 98.68 99.19 * figures for off-movements and on-movements are the same due to system explained in finding 9. 5

The competent authority stated that both the buyer and seller each have a legal responsibility to notify the FACR within 7 days of bovine movements under national legislation. Notifications between holdings can be notified in two ways, i.e.: a) in hard copy: where the seller (holding of origin) completes a section on a paper form and gives the form to the buyer (holding of destination). According to the competent authority the form usually accompanies the animal. The buyer completes their section and forwards it to the FACR, or b) electronic: where the seller notifies the database and a message is forwarded to the buyer to confirm receipt of the animal on-line. This option is only possible when both the seller and the buyer have electronic access.

In both of the above options, the database will only accept movement when both the seller and the buyer complete the notification. The competent authority stated that the decision to link the notification from the seller and the buyer in one common notification to the database had improved overall compliance, and in particular data coherence. However, the current notification system has potentially negative impact on data completeness in FACR as described in findings 6 and 7.

For paper notifications, if a buyer fails to notify the database then the seller, through no fault of their own, has also failed to meet their legal obligation to notify. As indicated in finding 55, over 50% of movements are notified via paper. The only way to detect if the buyer fails to report the movement is through official controls on site, by matching movement documents with the database entries or when the seller becomes aware that the database has not been updated and they contact the competent authority. For electronic notifications, the buyer is prevented from making the notification for the on- movement if the seller fails to notify the off-movement.

In 2015, there were 845 movements of bovines where the destination holding did not notify the arrival (floating animals). This figure is based only on electronic notifications because there is no systematic way to know if a buyer does not notify a movement and no figure is available for the number of movements for which the buyer did not notify via hard copy.

The database does not flag "floating" animals if the buyer does not confirm receipt by a certain period or trigger any follow-up action by the competent authority.

The template paper notification form includes the date of movement, a date of signature for the seller and a date of signature for the buyer. The date of signature is accepted as the date of notification and is used to calculate compliance with legal deadlines. According to the competent authority, buyers and sellers always insert the same date of signature on the paper notification form. Therefore, the same date of notification for on and off-movements is always recorded in the database. For electronic notifications, the date when the buyer notifies the on-movement is used as the date of notification for both the on and the off-movement. 6

Based on the figures in finding 3 for 2015, the vast majority (98%) of notifications are received within the 7 day legal deadline which relates to 300,722 notifications. About 50% of these (or about 150,000) were via hard copy and according to the competent authority, all were signed by both the buyer and the seller on the same day. 2% of notifications were over the 7 day legal deadline (i.e. 3,493), which means that both the seller and the buyer signed the same non-compliant date for about 1,700 notifications. The buyer's signature (responsible for notifying on-movement) cannot pre-date the seller's (responsible for notifying the off-movement). Therefore, if the seller signs late then the buyer also has to sign late which means that their notification will be recorded as late in the database. For electronic notifications, the buyer is equally prevented from making the notification for the on-movement within the legal deadline if the seller notifies the off-movement outside the 7 day deadline.

The current system of directly linking each on/off notification prevents keepers from making notifications in certain situations where the connected buyer or seller has not completed their part in the notification process. It is very difficult for the competent authority to detect if the buyer fails to submit a notification on behalf of the buyer and the seller.

The fact that 100% of on/off paper notifications (over 150,000 in 2015) include the same date of signature for both the buyer and the seller may indicate that in some instances keepers insert an incorrect date on the notification which affects perceived compliance levels and merits further investigation by the competent authority. For electronic notifications, the date of notification by the buyer is also recorded by the database as the date of notification of the seller.

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Article(2)(3) of Regulation (EC) No 1082/2003 and Article 3 of Regulation (EC) No 1505/2006 require that the selection of holdings to be inspected by the competent authority shall be made on the basis of risk analysis. The two articles go on to specify the criteria that the risk analysis shall take into account. The competent authority stated 8 that although there had been a risk analysis in the database for several years to select holding for inspection that it could not be used by DVFA's because it did not provide appropriate data/results. Therefore, a new one was being developed which should be available in the near future.

The audit team visited two DVFAs and discussed how holdings were selected for on- the-spot inspections. Discussions focused on 2015 as an example year because the new risk analysis was discussed at national training in April 2016 and was subsequently implemented which meant that two systems were applied during 2016. In DVFA 1, staff were aware of the new methodological instruction but the annual plan for IRS inspections was based on the annual plan for Cross Compliance (CC) controls, i.e. in May 2015, the 12 holdings selected to be visited for CC checks were also selected for IRS controls. Subsequently, another 15 holdings were inspected for IRS controls during 2015 based on a number of criteria according to DVFA staff such as newly registered holdings, time since last inspection or requests from keepers. In DVFA 2, there was an annual plan in January 2015 which staff said used the previous version of the methodological instructions. The plan included over 20 bovine holdings for on-the-spot inspections. The plan was considerably revised in May when the plan for CC controls was received with several holdings on the original IRS plan being deleted and some holdings on the CC plan being added. 12 holdings were checked for IRS during 2015, 4 of which also had CC controls at the same time. In both DVFAs, there was no written evidence of how the selection process operated for the additional 15 holdings in DVFA 1 or the January plan in DVFA 2. There was no evidence demonstrating that the holdings planned to be visited presented a greater risk that holdings not on the plan. Both DVFA's mentioned a lack of resources as a factor in doubling up visits to holdings and carrying out CC and IRS inspections at the same time.

Although some criteria used for the selection of holding to be visited for CC controls may be the same as those for selecting holdings for IRS controls, they are not all the same, e.g. disease history and therefore the 3% holding selected may not represent the highest risk based on purely IRS criteria. Also CC controls are only carried out on holdings which receive subsidies and therefore not all holdings are included. The CA stated that CC controls are generally notified in advance (up to 48 hours) to the keeper. This presents difficulties for complying with Article 4 of Regulation (EC) No 1082/2003 which states that in general on-the-spot checks shall be unannounced.

Target figures for on-the-spot controls comply with EU requirements but the selection process for holdings is not based on the criteria in relevant EU legislation. A new risk analysis currently being developed will form an important part of rectifying this situation and better target holdings with higher risks of being non-compliant.

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The SVFA confirmed they had not considered increasing the minimum rate of checks in subsequent years where a significant degree of non-compliance existed (see finding 16) as required by Article 2(2) of Regulation (EC) No 1082/2003 and Article 2 of Regulation (EC) No 1505/2006.

The competent authority has not increased the minimum rate of checks in subsequent years where a significant degree of non-compliance existed as required by relevant EU legislation which could lead to an improvement in accuracy of the database.

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National legislation allows sheep less than 12 months of age to move to "temporary holdings" where they should be slaughtered within 7 days of the move. A generic code in the database captures all off-movements to "temporary holdings", of which there were 4,044 in 2015. However, the "temporary holdings" are not registered on the national database as required by Article 7 of Council Regulation (EC) No 21/2004 and do not have to comply with the normal legal obligations of a holding. EU legislation does not include the concept of "temporary holdings". All slaughters associated with these movements should be notified to the DVFA's but DVFA staff confirmed that this does not always happen and therefore the system does not confirm that all sheep moved to the "temporary holdings" are actually killed within 7 day deadline on this farm.

The movement of live sheep to "temporary holdings" which are not registered on the central database and which are not subject to the normal legal requirements or official controls results in significant numbers of sheep moving outside the official control system and lost traceability.

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The audit team visited three farms (bovine, ovine and porcine) and examined the IRS on each, including reports from the last on-the-spot official controls. In general, the level of compliance was high and the reports from the last official controls on each holding indicated that a comparative examination between individual identifications on animals, holding registers and the national database was carried out during the visit. No non- compliances were detected on any of the three holdings during those controls. But the audit team noted that the national template for the sheep holding register does not 11 include the following information required in point B of the Annex of Regulation 21/2004 and this information was not recorded anywhere else: the date of tagging, information concerning replacement tags, and transporter details, e.g. licence plate number.

There were non-compliances related to information recorded in the holding registers for sheep which can affect identification/traceability of animals.

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The requirement set out in point 2.3.1 of Part A of the Annex to Decision 2013/652/EU that caecal samples collected at slaughterhouses shall be distributed evenly over each month of the year was not adhered to in 2014 or 2015 and will most likely not be achieved for 2016 for the following reasons: 5 The SVFA annual instructions (see point 10) were not introduced timely enough. Notably the 2015 instruction was introduced in June and therefore sampling did not cover the previous months of the year. The officials interviewed stated that sample delivery to the laboratory during the summer months and December was problematic. As a consequence, in the two slaughterhouses visited December was not included in the sampling plans for 2015 and 2016. In addition, in the poultry slaughterhouse visited, July and August were also not included in the 2016 sampling plan. During 2014, the isolation E.coli from caecal samples ceased at the end of September since the 85 isolates gathered by that date had already been tested for antimicrobial susceptibility. Therefore, no isolates from the last quarter of the year were gathered from the caecal samples. Isolates from samples collected at poultry primary production

SFVA made the initial allocation on the basis of the total annual throughput of the slaughterhouse and not to the throughput of animals of domestic origin as required by point 2.3.1 of part A of the Annex to Decision 2013/652/EU (for example, in the pig slaughterhouse visited 30-35% of pigs slaughtered originated from other Member States). This inadequate allocation design, and the lack of oversight of sampling by SVFA, prevented achieving the samples outlined in the sampling plan and resulted in only 131 of the 150 required pig caecal samples taken in 2015.

The documented procedures and instructions in place could ensure adequate implementation of most of the provisions laid down in the legislation. However, the delays in the implementation of the sampling plan, the exclusion of some months of the year and, notably, shortcomings in the allocation of samples to slaughterhouses calls into question the representativeness of sampling.

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sentative, as set out by On the basis of SVFA SR Instruction No.: 1032/16-370 of to Decision 23.3.2016, each DVFA involved in sampling, worked out the Plan evel on the basis of for sampling, which was sent to the SVFA SR. All months, from les evenly over each the beginning of monitoring till the end of the year 2016, are included into the Plan. Identification of epidemiological unit must be stated as obligatory data. In order to ensure representativeness of the samples, sampling is performed preferentially from the epidemiologic units that have not been tested yet. SVFA SR will ensure that the instruction for sampling of AMR monitoring is issued in time, in order to distribute sampling evenly over each month of the year. In 2016, sampling is carried out at the slaughterhouses slaughtering more than 60% of domestic population of animals. Since 2017, the slaughterhouses will be selected for monitoring AMR according to the number of slaughtered domestic animals. The numbers of slaughtered animals, based on the SVFA SR Instruction, will always be acquired at the end of the year.

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In 2014, contrary to point 2.2 of Part A of the Annex to Decision 2013/652/EU, only 100 Salmonella isolates (including the 12 non-mandatory isolates obtained from poultry meat) were subject to AST and reported to EFSA; this was despite the fact that additional isolates were available. For laying hens only 4 isolates were tested and reported despite another 2 isolates being available for testing. In the case of broilers at farm and slaughter levels, only 19 and 58 isolates, respectively, were subject to AST and reported, whereas another 44 isolates obtained at farm level and enough isolates to complete the minimum 85 at slaughterhouse level were available. SVFA stated that only 100 Salmonella isolates were tested because this is the number of tests co-financed under Decision 2013/653/EU. According to SVFA the same issue could arise for 2016.

In relation to the above point, the audit team noted that Salmonella isolates originating from samples collected by food business operators in the context of Regulation (EC) No 2073/2005 were available in the corresponding private laboratories. Despite the minimum required number of isolates not being achieved, the competent authority did not make use of the possibility of using these isolates for AST, as set out by Article 3 of Decision 2013/652/EU (see point 27). According to the competent authority this was because there are no national provisions requiring these private laboratories to submit the isolates for this purpose (see section on Closing Meeting). 5.2.2.2 Representativeness of sampling

Regarding the selection of Salmonella isolates for AST, in 2014 not all isolates available from different epidemiological units were tested (see point 16). The selection of isolates for AST made by the Veterinary and Food Institute (VFI) in Bratislava, which is the national reference laboratory (NRL) for Salmonella, was aimed at covering different serotypes, ensuring an even distribution throughout the year and representativeness in the geographical origin.

Due to the low prevalence of Salmonella in Slovakia, the minimum 85 isolates were not available for each population of laying hens, broilers and fattening turkeys. Nevertheless not all eligible isolates available from different epidemiological units were subjected to AST (see point 16). Isolates from carcase samples collected at slaughter

For the year 2015, the competent authority gathered 13 Salmonella pig carcase isolates. The minimum 85 isolates were not achieved due to the low Salmonella prevalence in pig carcasses. Nevertheless, in the pig slaughterhouse visited the audit team noted that despite 1 positive result from a food business operator being communicated to the competent authority at local level, the collection of this isolate from the private laboratory did not take place. The competent authority confirmed that similar situations occur in other slaughterhouses (see point 17).

For 2014, not all of the Salmonella isolates available were tested for antimicrobial susceptibility even though the minimum number required for each combination of bacterial species and type of sample had not been achieved.

In 2015, the competent authority did not gather (for the purpose of antimicrobial susceptibility testing) isolates from samples taken by food business operators in the context of Regulation (EC) No 2073/2005, even though the minimum 85 Salmonella isolates from pig carcasses had not been achieved. 5.2.3 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU; Article 33 of Regulation (EC) No 882/2004. Findings

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la isolates from It was directed by the Instruction No.: 2052/16-370 of 14.6.2016 .2 of Part A of the that from each animal population of different epidemiologic units microbial 85 isolates of Salmonella will be tested. In case of insufficient ble Salmonella isolates number of isolates from the official controls, the isolates from , in order to comply with FBO own control samples, tested and achieved in official laboratories, will be included in testing. SVFA SR will elaborate an Instruction for DVFA, for proceeding in acquiring strains from FBO, isolated in other than official laboratories. In case of insufficient number of isolates from different epidemiologic units, all available Salmonella isolates will be tested. This process will be implemented also in other years in which AMR monitoring will be performed. Page: 1 t authority on 1 July 2016 ecommendations of Report ref. DG(SANTE)/2016-8917-MR of the audit carried out from 08 March and reporting of antimicrobial resistance in zoonotic and commensal bacteria in certain food- a in Slovakia, the for each population of rkeys. Particularly in laying la incidence very low, greater prevalence is in ary, the large prevalence is in iso

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During the annual meetings of Slovakian microbiological NRLs, technical issues related to the official laboratory activities are presented and discussed. Nevertheless, SVFA during the last control visit to the NRL for Salmonella in January 2016 identified that the NRL for AMR did not fulfil its obligations in relation to coordination of activities in the AST area. In particular the NRL for AMR did not disseminate information supplied by the EURL and did not coordinate, for the AST area, the activities of the NRL for Salmonella. Some corrective actions had been implemented already with a successful inter-laboratory proficiency test on Salmonella AST organised by the NRL for AMR at the NRL for Salmonella.

The audit team noted that there was still room for improvement in the cooperation between these two laboratories and in the coordination role of the NRL for AMR. In particular, there was still a lack of dissemination of information provided by the EURL on AST. Similarly, there was no feedback from the NRL for Salmonella to the NRL for AMR on the results of participation in the relevant proficiency tests.

Laboratory procedures were available on the spot and generally followed the relevant international standards. However, the following was noted by the audit team: NRL for AMR The new procedures introduced for sample acceptance after the problems identified in 2014 were not documented and samples rejected were not adequately recorded. 11 The laboratory procedures for Campylobacter MIC determination were not based on the M45 standard from the Clinical and Laboratory Standards Institute (CLSI) as required by point 3 of Part A of the Annex to Decision 2013/652/EU. In particular, the time/temperature defined for incubation was not in line with the relevant standard and included deviations by up to 2ºC and 4 hours. The laboratory staff explained that despite the written procedure they followed the right temperature/time combination during the performance of the test. In 2014, the data initially reported to EFSA included some E. coli isolates resistant to ceftazidime and cefotaxime. These isolates had been subject to testing with the second panel required by the Decision, but only after EFSA requested it. For 2015, the procedure was brought in line with the Decision and E. coli isolates resistant to ceftazidime or cefotaxime should be tested with the second panel. A full evaluation of the implementation of this measure could not be done by the audit team as testing and reporting of these isolates is not due until 31 May 2016. Some inconsistencies in the results reported in 2014 (resistance to cephalosporins and susceptibility to ampicillin for three isolates) had not been detected by the staff at the laboratory. The 2014 isolates were preserved at -20ºC while point 5 of Part A of the Annex to Decision 2013/652/EU foresees -80ºC. During 2015, corrective actions were introduced with the purchase of cryotubes and adequate refrigeration equipment that were used to storage the isolates (see point 56). In 2014, the reported results included some isolates resistant to carbapenems. These isolates were later sent to the EURL and tested as susceptible to carbapenems. The laboratory considered finally that this was most probably related to a contamination of these plates. In this regard, the audit team was informed that improvements were made in the laboratory procedures in order to minimise the handling of samples to avoid contamination. These samples were later re-tested at the laboratory for training purposes and results were consistent with those provided by the EURL. With regard to the detection of ESBL- or AmpC-producing E. coli, the audit team noted that reference strains are regularly used to validate the preparation of the McConkey agar. These plates are used for up to four days after preparation. Nevertheless, this shelf life had not been defined in the internal procedures nor had validation of the medium stability for this period been performed. NRL for Salmonella Adequate quality controls with reference strains were run for each batch of plates tested and adequate records were kept. However, the documented procedures available did not detail the frequency at which the reference strains should be run. 12 The working procedure used for reading microdilution plates (holding them against a strong light) could, in accordance with the views expressed, lead to mistakes in the determination of MIC. The records available were insufficient to provide the traceability of materials such as the broth used for the performance of the test. 5.2.3.4 Storage of the isolates

Both laboratories have the necessary equipment to freeze isolates at temperatures below -80°C and to store them for at least 5 years. Nevertheless, the audit team noted that in the NRL for AMR the procedures in place required isolates to be stored at -70ºC. Back- up equipment and an emergency plan in case of equipment malfunction are available. Conclusions on official laboratories

An appropriate laboratory network for official monitoring of AMR is in place. Laboratories are properly designated and operate in accordance with the EU requirements. The NRL for AMR has been proactive in identifying and correcting shortcomings affecting the reliability of results. Nevertheless, further weaknesses identified during this audit could negatively affect the reliability of AMR results. These concern a number of inadequate documented procedures and, notably, weaknesses in the coordination role of the NRL for AMR.

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l Reference Statement of NRL for antimicrobial resistance to particular oratory documented points: rt A of the Annex to Point 45, 46 ­ coordinating activities: e 4 of Decision - NRL ­ AR had organized an interlaboratory proficiency test for 2/2004. determination of antimicrobial profile of Salmonella spp. and sent it to the NRL for Salmonella. Preparation and distribution of the interlaboratory proficiency tests will be regularly continued also in the following period. Term: from 25.1.2016 and permanently further on - NRL ­ AR participated in the meeting of NRL-AR with EURL- AR in Denmark held on 14.4.-15.4.2016, conclusions of the meeting were included in the Report from the border-crossing travel forwarded to the competent authorities including the NRL for Salmonella. Term: from 25.1.2016 and permanently further on - NRL ­ AR distributes information on antimicrobial resistance testing, submitting them to the EURL-AR Term: from 14.3.2016 and continuously as needed - NRL ­ AR will participate in workshops, training activities organised by EURL and subsequently in case of need, e.g. a new method, will train the staff of particular official laboratories by means of working meeting or

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The collection form used for reporting the "generic description of the implementation of the AMR monitoring" was also submitted to EFSA as required in Part B (2) of the Annex to Decision 2013/652/EU. The description of the sampling designs, stratification and randomisation per animal population and food was not complete for some categories such as Campylobater which according to the description provided "was carried out in accordance with Decision 2013/652/EU". Some inaccuracies were noted in the description of the sampling distribution over the year, the number of broiler slaughterhouses selected for sampling and storage temperature of isolates which were kept at -20ºC and not at -80°C as described.

The annual report includes all the mandatory information for each individual isolate reported under harmonised monitoring, and some information reported on a voluntary basis exceeds the current mandatory monitoring under EU legislation. There are though some weaknesses in the overall description of the implementation of AMR monitoring that, to some extent, undermine the reliability of the data submitted.

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all description of the All isolate-based data were included in the 2015 Report submitted ng provided to the to European Food Safety Authority, in compliance with the rate, as required by requirements of Decision 2013/652/EU and EFSA. General 2013/652/EU, in description of sampling design for particular animal and food . categories was included in the text part of the Report. The process of stratification and randomisation procedures for particular categories was also described. Furthermore, the information on sampling strategy, laboratory diagnostics and used laboratory methods, process of selection of isolates and evaluation of results and trends was described. Page: 5

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The CCA has set the minimum frequency of controls per type of approved establishment. At district level (the DVFA), the plan has to be adjusted. The minimum frequency may be reduced for small capacity establishments only. The minimum frequency established at central level for the type of establishments covered by the scope of this audit is as follows: Regular monthly controls; An annual control in order to review the maintaining of the requirements of approval according to Article 31 of Regulation (EC) No 882/2004. For poultry slaughterhouses and cutting plants the frequency is set to once every three months to control all relevant requirements for approval within a given year; A biannual control on beef labelling; and An annual control related to the use of nitrites in meat products. 7

A system of official controls is in place as described in the Country Profile for the Slovak Republic. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. The controls on the use of additives other than nitrites and traceability thereof were insufficient due to a lack of adequate guidelines. 5.2.2. Implementation of official controls

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vypracuje do 31.12. 2016 návrh dokumentovaného u na vykonávanie úradných kontrol oznacovania a ívania aditív iných ako dusitany do mäsových výrobkov o do systému svojich usmernení a pokynov pre úradné kontroly.

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The CCA has set the minimum frequency of controls per type of approved establishment. At district level (the DVFA), the plan has to be adjusted. The minimum frequency may be reduced for small capacity establishments only. The minimum frequency established at central level for the type of establishments covered by the scope of this audit is as follows: Regular monthly controls; An annual control in order to review the maintaining of the requirements of approval according to Article 31 of Regulation (EC) No 882/2004. For poultry slaughterhouses and cutting plants the frequency is set to once every three months to control all relevant requirements for approval within a given year; A biannual control on beef labelling; and An annual control related to the use of nitrites in meat products. 7

A system of official controls is in place as described in the Country Profile for the Slovak Republic. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. The controls on the use of additives other than nitrites and traceability thereof were insufficient due to a lack of adequate guidelines. 5.2.2. Implementation of official controls

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SVPS SR zvazuje tento bod v súvislosti s vyssie uvedeným . Do úradných kontrol prevádzkarní, ktoré vyrábajú mäsové výrobky a mäsové prípravky, budú poziadavky týkajúce sa pouzívania prídavných látok stanovené v nariadení (ES) c. 1333/2008 a dokumentované postupy navrhované v bode 1 zaclenené v prvom stvrroku 2017. Zistenie c. 35, týkajúce sa zmesí prídavných látok bolo prerokované aj s príslusným Odborom kontroly potravín rastlinného pôvodu SVPS SR, ktorý prehodnotí a doplní spôsob úradných kontrol oznacovania prídavných látok v týchto zmesiach poda clánku 21 a 22 Nariadenia (ES) c. 1333/2008 v platnom znení v prevádzkarach na miesanie koreniacich zmesí.

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Regarding the labelling, the DVFA identified seven products containing inaccurate information for the final consumer for various reasons, for example incorrect name of the product, the printed identification mark contained the approval number of the distributor rather than the producer (this was earlier detected by the FBO and the recent production batches are already in retail outlets with the correct approval number), incorrect number of, or an incorrect indication of the functional group of additives, used.

The CA identified some minor non-compliances in the traceability that had no impact on food safety. The CA identified inaccuracies in relation to labelling, significantly higher than during routine controls. Identified non-compliances in relation to the use of additives and traceability thereof by the FVO audit team were mainly due to a lack of adequate guidelines and training. 5.2.2.2.Official controls on FBOs' obligations Findings 11

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V doch 21.-22.októbra 2015 sa uskutocnila pracovná porada spojená so skolením organizovaná zo SVPS SR, na sa zúcastnili hlavne vedúci odborov a oddelení produktov zivocísneho pôvodu z regionálnych veterinárnych a potravinových správ, kde bola vykonaná podrobná analýza Page: 1 of Report ref. DG(SANTE)/2015-7375-MR of the audit carried out from 29 June ols over the post-slaughter traceability of meat, meat products and preparations, pocas tohto auditu vrátane oznacovania potravín, li jeho predmetom. tejto porady pre RVPS je vykonáva v rámci kontrol aj kontroly príslusných poziadaviek na nie poda nariadenia (EÚ) c. 1169/2011.

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The SVFA provided information on training activities during the last two years related to the scope of this audit. Training provided in 2015 so far, contained topics such as traceability, labelling on country of origin, information to the final consumer and official controls on MSM. During the training sessions, information obtained from internal SVFA audits, FVO audit reports as well as experience during official controls by the DVFA is being discussed. No information has been received on training specifically organised in relation to official controls on the use of additives other than nitrites in recent years2. 2 In their comments to the draft report the Competent Authorities noted that in 2013 training has been provided on the use of food additives in meat products and fishery products, in relation to Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives. 9 Conclusion on the organisation of official controls:

The CA identified some minor non-compliances in the traceability that had no impact on food safety. The CA identified inaccuracies in relation to labelling, significantly higher than during routine controls. Identified non-compliances in relation to the use of additives and traceability thereof by the FVO audit team were mainly due to a lack of adequate guidelines and training. 5.2.2.2.Official controls on FBOs' obligations Findings 11

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1.-22.októbra 2015 sa uskutocnila pracovná spojená so skolením organizovaná zo SVPS SR, na a zúcastnili hlavne vedúci odborov a oddelení v zivocísneho pôvodu z regionálnych veterinárnych inových správ, kde bola vykonaná podrobná analýza pocas tohto auditu vrátane oznacovania a pouzívania ch látok v mäsových výrobkoch a mäsových och tejto porady pre RVPS je vykonáva v rámci kontrol aj kontroly príslusných poziadaviek na nie a pouzívanie prídavných látok v mäsových h a mäsových prípravkoch poda nariadenia (ES) c. 8 2016 budú úradné kontroly oznacovania ania prídavných látok v mäsových výrobkoch vkoch súcasou Národného programu vzdelávania rnych inspektorov v sektore mäsových výrobkov.

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In one establishment the official controls were inadequate. Despite the DVFA previously identifying that traceability was not guaranteed for the production of kebab and considering that the corrective measures taken by the FBO had been assessed as satisfactory, the FVO audit team identified several significant deficiencies related to traceability, use of additives and labelling of this meat preparation: there was no clear link established between the incoming products, the production and the meat preparation produced; production records did not match the computerised records; discrepancies were noted in the volumes produced versus the amount of available intermediate products (the amount of intermediate products prepared 12 for a given production day was lower than the amount of final products produced); product labelling and advertisement on the FBOs' website were misleading (use of additives and certain other ingredients were not mentioned; instead the labelling and advertisement indicated the use of natural spices, water and salt only); there was unauthorised use of the additives diphosphates and triphosphates (E450 and E451); and some of the trade documents for consignments of raw chicken used for the production of kebab were not in line with the specifications required by Regulation (EU) No 931/2011.

In one district visited, the official controls relating to traceability, labelling and the use of additives of meat and products thereof were inadequate.

Medlemsstatens svar

á RVPS ihne po zistení nedostatkov nariadila PPP opatrenia na ich odstránenie. sa nový systém evidovania pohybu vsetkých ín a prídavných látok. PPP aktualizoval pôvodnú Page: 2 of Report ref. DG(SANTE)/2015-7375-MR of the audit carried out from 29 June ols over the post-slaughter traceability of meat, meat products and preparations, vok a pripravil novú le overil plnenie nariadených nosti výroby mäsových eceptúru na výrobu MP.

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The audit team noted that some discrepancies exist between the SNCP for breeding and laying hen flocks and relevant EU legislation, in particular sampling at the initiative of the FBO is not mandatory in the rearing phase. This is not in line with Annex II, Part B, Point 1 of Regulation (EC) No 2160/2003. The CA explained that since 2014 this sampling is no longer a FBO's obligation for financial reason. For more details see paragraph 75 and 91.

National control programmes for implementing the requirements laid down in relevant EU legislation have been established. However, discrepancies exist between Slovakian SNCPs and EU requirements as regards sampling at the initiative of the FBO in the rearing phase in breeding and laying hen populations.

Medlemsstatens svar

This inconsistency has been already corrected in our actual SNCPs for the year 2016 (SNCPs for breeding and laying hens l from 01.01.2016 now on) and the sampling at the initiative of the FBO in the rearing phase in breeding and laying hen populations complies with Annex II, Part B, point 1 of the Regulation (EC) No 2160/2003 (compulsory sampling in the flocks of day-old chicks and pullets two weeks before moving to laying phase as regards laying hens and in the flocks of day-old chicks, four-week-old birds and two weeks before moving to laying phase as regards breeding flocks of Gallus gallus). As stated in the point 75. of the Report, although FBOs were not required under national rules to performed own-check sampling in the rearing phase in 2015 they had voluntarily performed it.

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Figures from the TRACES database indicate that 49 consignments were channelled from EU BIPs to destinations in Slovakia during the 18 months prior to this audit and that receipt at destination was confirmed via box 41 of the CVED in 47 cases. In some cases, box 41 was completed well outside the 15 day limit ­ some more than a year after the consignment left the BIP of entry. The competent authority explained that this was related to LVUs reviewing records in TRACES and updating the system as required.

There were three re-imported consignments during the same period of 18 months, none had been confirmed as being received at destination in box 41. One of these was discussed at one of the LVUs visited and it was explained that the consignment had been controlled at destination 5 but that the relevant official was not aware of the requirement to enter the control in TRACES and did not have access to TRACES. That official has subsequently applied for access.

There is no specific national instruction that official controls related to ante-mortem inspection for animals arriving from other Member States should be recorded in TRACES (59% of such consignments had those controls recorded during 2013 in TRACES). The competent authority did say however, that there is a general instruction which requires that all relevant official controls should be recorded in TRACES which would apply for animals arriving for slaughter from other Member States.

There is a specific national instruction on the implementation of the requirements of Article 48.3 of Regulation (EC) No 1069/2009 (i.e. that categories 1, 2 and processed animal proteins (PAP) from category 3 animal by-products arriving from other Member States should be controlled and confirmed in TRACES as having been received at destination). According to the TRACES database, 36% of arriving consignments of PAP and categories 1 and 2 in the DOCOM module were recorded in TRACES as being controlled during 2013. 5.2.9 DOCOM module

Most CVEDs, INTRA-certificates and DOCOMs are issued correctly in Slovakia. However, for many consignments which require confirmation of receipt at destination, TRACES is not used in compliance with the legal requirements for ensuring traceability, e.g. consignments arriving from other Member States (slaughter animals, animal by-products) and imports (re- imports and channelled consignments). The best practice approach covered during training for dealing with feedback received from other Member States in Part III of INTRA-CERTS is not being implemented at LVUs. 7

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Consignments from third countries which require confirmation of receipt at destination is implemented in the Slovak Republic by the direction of the SVFA SR No 2477/2010-240. This direction will be updated and a part in respect of controls of monitored consignments will be supplemented by a part establishing a notification from the place of destination upon re-import. The direction will specify in more detail the individual steps starting with feedback notification up to the control of the consignment in TRACES system. Date: February 2015 The SVFA SR will prepare the direction in pursuance of Commission Decision 2004/292/EC, by which it will be ensured that for each consignment from other Member State intended to a slaughterhouse the performed control is entered into TRACES system. By the direction not only the obligation of entering the control into TRACES system but also the procedure of entering in it will be introduced. Date: February 2015 The SVFA SR will prepare the direction in respect of solving of feedback from other Member States via Part III of INTRA- CERTs and taking the corrective actions in case of not satisfactory results. Date: February 2015 Direction No 2015/2004-2

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Documented procedures exist related to "internal controls" (central supervisions) being carried out by the SVFA at BIPs and LVUs. The use of TRACES was covered in: · 2012 ­ 1 LVU · 2013 ­ 3 BIPs and 4 LVUs · 2014 ­ 1 BIP (twice) Neither of the LVUs visited during this audit were subject to an internal control which included TRACES within its scope. The most recent of the above reports from a BIP and an LVU were examined by the audit team and both included the use of TRACES, especially for the BIP. · The use of TRACES at LVUs related to the outward movement of consignments (controls on ABPs moving to other Member States). · The repeated incorrect use of TRACES was identified during the visit to a BIP in April, 2014 (e.g. a range of errors in part 1 of the CVEDs such as CN codes on CVEDs not matching those on health certificates, incorrect means of transport to BIP, incorrect veterinary approval numbers for establishment of origin and late pre-notification.) This led to a second visit shortly afterwards and the implementation of corrective actions.

There is a system of local supervision at LVUs. This is based on a national procedure being adapted at each LVU to fit the local situation/activities. Both LVUs visited had adapted the national procedure. One LVU had implemented supervision on a planned basis (supervision every six months) and supervision reports were created which assessed one or two individual export consignments per certifying officer and no deficiencies were detected. The other LVU stated that they carried out local supervision, however this was not in accordance with their own procedure and no reports were created during the process. Supervision at both LVUs focused on official controls and the use of TRACES related to outward movements.

The correct use of TRACES is covered by the verification activities of some sectors/official controls. In the BIPs, repeated deficiencies are detected and corrective actions are implemented as required which is not the case at LVUs. As a consequence, (i) information in the TRACES database does not always reflect accurately the controls implemented and (ii) the system is not used to detect shortcomings in the implementation of controls (e.g. no relevant controls at destination) and those remain inadequate.

Medlemsstatens svar

erification and control of the use of TRACES system at the was supplemented in a broader and more extensive scope o in pursuance of indicated findings from the FVO audit) into ogramme of internal audits of the SVFA SR for the years ­ 2017, where it is a part of sector audits, e.g. ghterhouses, ABP etc... ng the trainings prepared by the individual departments of the Page: 2 anuary 2015 rt ref. DG(SANCO)/2014-7021 -MR of a/an audit carried out from 08 ystem. wn by he controls itors t LVU l of Page: 3

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ary The periodical veterinary inspections required in a surveillance zone will be included in the contingency plan for FMD in 37(1) accordance with procedure established in the Slovak Republic for updating of the national CPs (update during November and December 2014, signature by CVO and minister and publication during January 2015). Deadline is 31.1.2015.

Medlemsstatens svar

wn SVFA will ensure preparation of CP for missing diseases in order ases to be in line with Council Directive 92/119/EEC and especially with Annex I in accordance with the procedure established in the Slovak Republic for preparation and updating of the national CPs (preparation during November and December 2014, signature by CVO and minister and publication during January 2015). Deadline is 31.1.2015.

Medlemsstatens svar

phone 10.4.2014 SVFA had a meeting with mobile phone operator. We ade a proposal for agreement with operator, according which in case of need the operator will immediately rent us mobile phones ne with at disposal for LDCC and NDCC. The matter is still open and /EC. discussions are still ongoing. Deadline is 31.12.2014.

Medlemsstatens svar

ups SVFA will ensure amendment of nominated expert groups in CPs to include persons with the specialised competences required ASF under EU legislation in accordance with the procedure established in the Slovak Republic for preparation and updating of the national CPs (preparation and update during November and December 2014, signature by CVO and minister and publication during January 2015). Deadline is 31.1.2015. Page: 1 s of Report ref. DG(SANCO)/2014-7046 -MR of a/an audit carried out from 19 on of contingency plans in relation to animal health, including provisions on the

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Official checks of identification and registration of animals in cle 8 assembly centres are performed once a year by veterinary inspectors from DVFAs according to methodological instruction f of SVFA No. 11/2007. This finding of FVO audit as regards identification and registration of animals in visited assembly centre (WH[WGHOHWHGLQ RUGHUWRUHVSHFWWKHSURYLVLRQVRI$UWLFOHRIWKH/LVERQ7UHDW\DVUHJDUGV FRQILGHQWLDOLW\ control after he has revealed shortcomings during process of certification. In order to prevent such a shortcomings, this issue has been discussed during training of veterinary inspectors of DVFAs and SVFA under National training program 2014, which was held in Kosice on 19-20.3.2014 and especially during training of veterinary inspectors responsible for identification and registration of DVFAs and SVFA under National training program 2014, which was held in Kosice on 14.5.2014. In future this issue will be incorporated into the trainings of veterinary inspectors responsible for identification and registration of DVFAs and SVFA under National training program for each year.

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of This issue has been discussed during training of veterinary inspectors of DVFAs and SVFA under National training program 2014, which was held in Kosice on 19-20.3.2014 and in the future e this issue will be incorporated into the trainings of veterinary cy inspectors of DVFAs and SVFA under National training program n this for each year. and Respective application forms for laboratory testing will be updated so as to clearly mark if the sample is taken due to a suspicion of an epizootic disease. Deadline is 31.12.2014. n .A. s regards FMD real-tIme alert exercise, SVFA in accordance ise with budgetary rules will ask MARD for allocation of financial resources for realisation of FMD real-time alert exercise in year Page: 2 s of Report ref. DG(SANCO)/2014-7046 -MR of a/an audit carried out from 19 on of contingency plans in relation to animal health, including provisions on the ills 2015. Deadline for submission of application is 31.10.2014 As regards CSF and ASF alarm drills, SVFA has included these alarm drills into trainings of veterinary inspectors of DVFAs and SVFA under National training program, which are organized twice a year. Closest training will be organized in period fr

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- CA sa v rámci dozoru v CB detailnejsie zameria na vypracované postupy týkajúce sa rocnej analýzy rizika a ich uplatovanie v praxi - CA sa v rámci dozoru v CB dôrazne zameria na analýzu rizika pri odbere vzoriek a laboratórnej analýzy a na prijatú stratégiu odberu vzoriek na základe analýzy rizika a jej uplatovanie v praxi, - CA vyskolí CB na zjednotenie postupov a formulárov na základe analýzy rizika , Termín: 4Q/2014 Zodpovedný: CA

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in 1. Personálne posilnenie vsetkých poverených odborných pracovísk a ÚKSÚP na základe reálneho mnozstva prijatých ziadostí a predpokladaného poctu predkladania nových ziadostí. 2. Návrh na zlepsenie koordinácie autorizacného systému a jeho financovania Termín: do 31. 12. 2015 Zodpovedný: MPRV SR v spolupráci s MZ SR, MZP SR a MSVVS SR

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1. Zverejovanie zoznamu autorizovaných prípravkov na ochranu rastlín a informácií o zrusených autorizáciách 1x rocne a jeho aktualizácia kazdé 3 mesiace Termín: od 1. 7. 2014 Zodpovedný: Odbor registrácie pesticídov ÚKSÚP 2. Zavedenie komplexného databázového informacného systému na úcely riadenia autorizacného procesu ako aj na úcely zverejovania informácií o prípravkoch na ochranu rastlín (on-line register prípravkov, informácie o autorizovaných pouzitiach, zrusených autorizáciách a pod.) Analýza komplexného databázového systému bola vykonaná v rokoch 2013 ­ 2014, samotná realizácia systému je plánovaná v Page: 1 r 2014 rt ref. DG(SANCO)/2014-7183 -MR of an audit carried out from 16 to 20 rokoch 2015 ­ 2016. Termín: do 31. 12. 2016 Zodpovedný: MPRV SR v spolupráci s ÚKSÚP a poverenými odbornými pracoviskami

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1. Kompletizovanie databázy distribútorov a profesionálnych er to pouzívateov prípravkov na ochranu rastlín v Slovenskej the republike a zabezpecenie výkonu samotných úradných kontrol e predmetných subjektov fytoinspekciou ÚKSÚP. Tento zoznam bude kompletizovaný na základe - hlásení o osobách, ktoré absolvujú odborné vzdelávanie na úcely získania osvedcenia o odbornej spôsobilosti pre predaj alebo pouzívanie prípravkov na ochranu rastlín, nformácií o dodávateoch a odberateoch prípravkov, zistených pri kontrole dodacích listov a fakturacných údajov pocas výkonu úradnej kontroly (informácie budú uvedené v zázname A o vykonaní úradnej kontroly), - údajov obchodného a zivnostenského registra. Termín: 30. 6. 2016 Zodpovedný: Odbor ochrany rastlín ÚKSÚP 2. Opatrenie, aby pri úradných kontrolách prípravkov na ochranu rastlín mali fytoinspektori ÚKSÚP dostupné informácie o vsetkých aktuálne schválených etiketách (súbor platných etikiet ku kazdému autorizovanému prípravku). Termín: 31. 3. 2015 Zodpovedný: Odbor ochrany rastlín ÚKSÚP, Odbor registrácie Page: 2 r 2014 rt ref. DG(SANCO)/2014-7183 -MR of an audit carried out from 16 to 20 pesticídov ÚKSÚP

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se Súcasná platná národná legislatíva v § 32 ods. 6 zákona c. 405/2011 Z. z. a § 14 ods. 1 vyhlásky MPRV SR c. 485/2011 Z. z. uvedenú poziadavku spa v zmysle cl. 6(1) smernice 2009/128/EC. Ani jeden prípravok na ochranu rastlín, autorizovaný v Slovenskej republike pre neprofesionálnych pouzívateov a uvedený v casti 1.6. Zoznamu autorizovaných prípravkov na ochranu rastlín a prípravkov na ochranu rastlín povolených na paralelný obchod nie je klasifikovaný ako toxický, vemi toxický, karcinogénny, mutagénny alebo poskodzujúci reprodukciu. 1. V metodickom postupe na výkon úradných kontrol prípravkov na ochranu rastlín bude zdôraznená poziadavka na preverenie súladu vsetkých prípravkov prítomných v maloobchodnej predajni s ich autorizáciou poda casti 1.6. uvedeného zoznamu (informácie budú uvedené v zázname A o vykonaní úradnej kontroly). Termín: 31. 12. 2014 Zodpovedný: Odbor ochrany rastlín ÚKSÚP

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retailers Zákonná povinnos výrobcov, dodávateov, distribútorov tion dovozcov a vývozcov POR vies záznamy o POR, ktoré vyrábajú, dovázajú, skladujú alebo uvádzajú na trh je v súlade s cl. 67 ods. 1 nariadenia (ES) c. 1107/2009 a je uvedená v § 35 ods. 1 zákona c. 405/2011 Z. z.. 1. Upozornenie na kontrolu uvedenej zákonnej povinnosti bude zapracované do metodického postupu na výkon úradných kontrol prípravkov na ochranu rastlín (informácie budú uvedené v zázname A o vykonaní úradnej kontroly). Page: 3 r 2014 rt ref. DG(SANCO)/2014-7183 -MR of an audit carried out from 16 to 20 2. Upozornenie na uvedenú zákonnú povinnos bude súcasou odborného vzdelávania na úcely získania osvedcenia o odbornej spôsobilosti pre predaj prípravkov. Termín: 31. 12. 2014 Zodpovedný: Odbor ochrany rastlín ÚKSÚP

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Zvýsenie poctu odobratých vzoriek POR na analytický rozbor úcinnej látky zo súcasných 60 vzoriek na 90 vzoriek v roku 2015. Tento pocet bude zapracovaný do metodického postupu v rámci úradnej kontroly POR pre rok 2015. Termín: 31. 12. 2014 Zodpovedný: Odbor ochrany rastlín ÚKSÚP 2. Rozsírenie analytického rozsahu Odbor zivotného prostredia a ekologického ponohospodárstva ÚKSÚP zvýsi rozsah analýz POR v súlade s poziadavkami danými clánkom 29, bod 1(a), (c), (d) a (f) nariadenia (EC) c. 1107/2009 so zameraním na stanovenie obsahu relevantných necistôt (v súlade s dostupnými dokumentmi poda "Manual on development and use of FAO and WHO specification for pesticides" pre registrovanú úcinnú latku v danej formulácií) a koformulantov, safenerov a synergentov v POR (v súlade s MSDS pre POR, prípadne kritériami výrobcu dodaného pri autorizácií POR). Na vyhodnocovanie vyhovujúcej/nevyhovujúcej kvality jednotlivých parametrov daných clánkom 29 (1)(f) nariadenia (EC) c. 1107/2009 navrhujeme zorganizova skolenia v rámci projektu BTSF, prípadne vypracovanie príslusného usmerujúceho dokumentu. Page: 4 r 2014 rt ref. DG(SANCO)/2014-7183 -MR of an audit carried out from 16 to 20 Termín: 31. 12. 20

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1. Opatrenia uvedené v bode 3. in 55 2. Do metodického postupu na výkon úradných kontrol bude zapracovaná poziadavka, aby sa tieto kontroly vykonávali bez predchádzajúceho upozornenia, ako sa stanovuje v clánku 3(2) nariadenia (ES) c. 882/2004. 31. 12. 2014 Zodpovedný: Odbor ochrany rastlín ÚKSÚP

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1. Plán úradných kontrol prípravkov na ochranu rastlín bude vypracovaný ústredím Odboru ochrany rastlín ÚKSÚP na základe postupne kompletizovanej databázy distribútorov a profesionálnych pouzívateov POR v Slovenskej republike. Plán úradných kontrol bude obsahova rizikovú analýzu a plánovanú frekvenciu kontrol u jednotlivých skupín kontrolovaných subjektov (skupina vekoobchodných predajcov, maloobchodných predajcov, výrobcov, vekoobchodných skladov, profesionálnych pouzívateov) samostatne pre kazdého fytoinspektora ÚKSÚP s presným urcením kontrovaných subjektov v SR v danom roku. V nasledujúcich rokoch bude obdobne vypracovaný plán (harmonogram) úradných kontrol tak, aby boli s urcenou frekvenciou kontrolované vsetky evidované subjekty. Page: 5 r 2014 rt ref. DG(SANCO)/2014-7183 -MR of an audit carried out from 16 to 20 Termín: 31. 12. 2014 Zodpovedný: Odbor ochrany rastlín ÚKSÚP

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V súlade so zákonom NR SR c. 10/1996 Z. z. o kontrole v státnej správe v znení neskorsích predpisov bude v roku 2014 vykonaný Ministerstvom pôdohospodárstva a rozvoja vidieka SR audit v kontrolných orgánoch, ktoré boli ministerstvom poverené v súlade s § 9a odsek 7 a 9 zákona NR SR c. 152/1995 Z. z. o potravinách v znení neskorsích predpisov. Page: 1

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ovaných úradných kontrol ravinárskych podnikov rastlinného ciu o kontrole kontaminantov v zázname on on the result of the official food ts ­ following this the check lists used will be updated

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rov, ktorý vykonávajú ÚKSÚP a SVPS SR) so m kontaminantov v radnej kontroly potravín rastlinného nie o postupe kontroly kontaminantov u a nasledujúce roky inspektorov o postupe pri výkone úradnej v po zbere a o pozadovaných Page: 1 of an audit carried out by the Competent Authority uffs carried out food official controls in lated to contaminants in food

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rcený SVPÚ, v ktorom stanoví a základe ktorých nebudú do mci úradnej kontroly urcené na poziadavky na denia c. 401/2006 a nariadenia c.

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torých budú na protokole o orekcii výsledku na výaznos a ú uvádza v jednotkách analytu v súlade s nariadením (EÚ) c. 333/2007.

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rte pôdohospodárstva), ktorý navrhol i laboratóriami ÚVZ SR (v je v prílohe c.1. Page: 2 of an audit carried out nt Authority ie NRL pre PAU a úradných kompetencie ÚVZ SR a RÚVZ. Zápis a tnutia je v prilozenom dokumente. Zápis c. 2 a v prílohe c. 2A je uvedená m pre ÚVZ SR je v prílohe c. 3. dnuté ako jedna moznos vytvorenie tóriu ÚVZ SR. ÚVZ SR rozhodne o e do 31.12.2013. V prípade, ze sa pre PAU, bude sa pokracova v L v rezorte pôdohospodárstva h laboratórií v kompetencii ÚVZ SR retnutí sa presne a jasne dohodnú pravidlá laboratórií ÚVZ SR, ktoré sú zodpovedné ch vzoriek. Nakoko kazdý rezort má vedené stretnutie je potrebné z dôvodu nácie laboratórií, ktoré nie sú zabezpecenie koordinácie do 31.12.2013.

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zpecí, aby vsetky riame alebo nepriame riziko né do európskeho systému rýchleho of an audit carried out nt Authority vá v zmysle clánku 50 nariadenia (ES) c.

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Actions already taken: ts The SVFA already during the FVO audit has elaborated the Instruction for listing and al delisting of approved establishments (No.4092/2012-330 from 5.12.2012) which was le 31 presented to the FVO audit team. re Training combined with working meeting took place on 20.-22. February 2013 the s, the participants of which were the representatives of the SVFA and DVFAs (heads of Departments for food hygiene and official controls and the heads of Units for food hygiene of and official controls for products of animal origin) and where the course and findings of the . FVO audit DG (SANCO)/2012-6366 were analysed. Planned actions: When carrying out the review of approval conditions of the establishments (so called ,,passport control") according to the control plan DVFAs will verify whether the maintenance of the list of establishments in the Internet is up to date. Also the verification whether the approval conditions of the establishments are accurate and the lists of establishments are up to date will be in the scope of internal audits performed by the Department for Audit and Control of the SVFA in DVFAs.

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iated The minimum frequency of official controls carried out by OV of DVFAs in establishments unt at all steps of production, processing and distribution is determined in the MANCP and ficial thereafter it is determined in individual annual control plans of individual DVFAs. Controls red by are in practice carried out more frequently (ad hoc controls, additional controls, controls at the place of destination, consumer compliances, etc.). These controls are non-announced controls. Besides these controls the approval of establishments is kept under review when Page: 1 Updated CA response received 9 September 2013 by the Competent Authorities of Slovakia on 28 May in response to Report ref. ut from 26 November to 07 December 2012 in order to evaluate the follow-up action taken official controls related to the safety of food of animal origin, in particular meat, milk and their on Proposed by the Competent Authority ying out official controls by comprehensive assessment of all relevant requirements of law once per year. Official controls are carried out in all types of establishments at a frequency; they are regular and proportionate to the risk. Frequency of controls is opriate and ful

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ons already taken:animal origin) and where the course and findings of the FVO audit rder DG (SANCO)/2012-6366 were analysed. the The working meeting of the Department of Audit and Control took place on 3.4-4.4.2013 the l participants of which were the representatives from the Departments for hygiene of animal tives origin and where the findings and deficiencies presented in the draft FVO report ANCO)/2012-6366 were analysed. ning combined with working meeting took place on 20.-22. February 2013 the icipants of which were the representatives of the SVFA and DVFAs (heads of rtments for food hygiene and official controls and the heads of Units for food hygiene official controls for products of re submitting the reworded and supplemented wording of the action plan: Page: 2 Updated CA response received 9 September 2013 by the Competent Authorities of Slovakia on 28 May in response to Report ref. ut from 26 November to 07 December 2012 in order to evaluate the follow-up action taken official controls related to the safety of food of animal origin, in particular meat, milk and their Action Proposed by the Competent Authority In the days 20-22 February 2013 the course, findings and recomme

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cal Actions already taken: ith The Ministry of Agriculture and Rural Development of the Slovak Republic (MARD) organized on 9.2.2013 the working meeting regarding the problems of potable water Page: 3 Updated CA response received 9 September 2013 by the Competent Authorities of Slovakia on 28 May in response to Report ref. ut from 26 November to 07 December 2012 in order to evaluate the follow-up action taken official controls related to the safety of food of animal origin, in particular meat, milk and their osed by the Competent Authority d chemical analyses with the aim of possibilities to access to the test results. The s were the representatives of MARD SR, Public Health Authority of the Slovak HA SR) and the SVFA SR. According to this working meeting the MARD SR inistry of Environment of the Slovak Republic (ME SR) and the Chief Medical A) for cooperation: asked the ME SR, the competent authority in the frame of public water em for the results from control of quality parameters of potable water supplied by ystem to the food producing establishments and for setting the possibilities of esults of complete analyses and minimum analyses for competent authorities - the DVFAs (lette

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Actions already taken: le 5 Training combined with working meeting took place on 20.-22. February 2013 the EC) participants of which were the representatives of the SVFA and DVFAs (heads of Departments for food hygiene and official controls and the heads of Units for food hygiene and official controls for products of animal origin) and where the course and findings of the of FVO audit DG (SANCO)/2012-6366 were analysed. Planned action: DVFAs during the performing regular official controls will focus on controls of identification markings. Page: 5

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í vyrábajú produkty a dodávajú ich do krmivárskeho áva inspektori SVPS SR a ÚVZ SR u PPP poda ých v zákone o potravinách pri úradnej kontrole vádzke. Tieto kompetencie budú uvedené v novele kytne ÚKSÚP v stanovených intervaloch gistrácie podnikov, ktoré vyrábajú a uvádzajú na y potravinárskej výroby pouzívané ako krmivá. árske podniky doplní do registra krmivárských kytne jednorazovo údaje o PPP, o ktorých domos, ze dodávajú produkty za úcelom e do 28.2.2013. y k 31.7. a 31.1. bezného roku poskytne ohto registra. latova zápis do registra v roku 2013 tým spoplatnenie nepodlieha nariadeniu (ES) c. Oddiel A, ods.2, na rok 2013, ako výhodu IA a ÚVZ SR sa zavedie vzájomný systém ohlasovanie neregistrovaných podnikov, ktoré ajú na trh krmivá v termíne do 31.7.2013. Page: 1 Action Plan received from CA on 14 January 2013 DG(SANCO)/2012-6493-MR of an audit carried out on of hazards and management of risks along the feed on Proposed by the Competent Authority

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e do systému úradných kontrol krmív zohadnenie ených v clánku 3 nariadenia (ES) c. kontrol v danom podniku so patreniami, výsledky vlastných ektor úradnej kontroly potravín (z ávrh na zaradenie daného , ktorý zabezpecí zaradenie krmív do príslusnej kategórie. ere vzoriek bude na SVPS SR né skolenie pre inspektorov 013. rcuje pri zápise do registra poda térií stanovených v MANCP. sa urcuje frekvencia kontrol. .2012, kazdý inspektor má odniku na základe zistených í tak, aby pri kazdej úradnej tória kontrol v danom podniku so Page: 2 Action Plan received from CA on 14 January 2013 DG(SANCO)/2012-6493-MR of an audit carried out on of hazards and management of risks along the feed Proposed by the Competent Authority

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etodický pokyn pre výkon úradných kontrol poda 2/2004 ohadne záznamov z kontroly a z odberu inspektorov, ktorí vykonávajú kontroly. Termín do

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overovania úcinnosti úradných kontrol, a zameria posudzovanie výsledkov a priebehu inspekcie k vrátane kontroly jednotlivých dokumentov ako aj plnenie inspekcnej správy a uvedenia nápravných nku vedenia záznamov a pouzívania tlacív na o vykonaných úradných kontrolách dohliada akreditacný orgán (SNAS) pri plánovaných orgán úradnej kontroly krmív ÚKSÚP je jednotlivých záznamov o vykonaných kontrolách riadený inspektora, ktorý kontroluje úcel a priebeh otázky a záznam ich odpovedí, celkovo posudzuje ci aná v zmysle poziadaviek stanovených poch a standardných operacných postupoch. pektorov sa vyhotoví posudok a v prípade zistených or bude preskolený. Action Plan received from CA on 14 January 2013 DG(SANCO)/2012-6493-MR of an audit carried out on of hazards and management of risks along the feed oposed by the Competent Authority overovania úcinnosti úradných kontrol, vnejsie posudzovanie výsledkov a priebehu vzoriek vcítane kontroly jednotlivých d na správne vyplnenie inspekcnej správy a atrení. cký pokyn na overovanie úcinnosti úradných 0.9.2013.

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ráciu potravinárskych podnikov dodávajúcich odukty potravinárskej výroby do krmovinového reazca a petencií zákona o potravinách v termíne do ciu susiarní krmív v rámci kompetencií termíne do 31.12.2013.

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R, CCTIA SVPS SR a ÚVZ SR sa zavedie vzájomný systém na ohlasovanie neregistrovaných podnikov, ktoré ádzajú na trh krmivá. Do národného plánu skolení pre plnené skolenie ,,Oznacovanie kmnych surovín" ako nariadenia (ES) c. 767/2009, pricom lektorov na ÚP (najvodnejsí sú lektori, ktorí sa zúcastnili s krmív). Informácia o skolení bude zaslaná aj Page: 4 Action Plan received from CA on 14 January 2013 DG(SANCO)/2012-6493-MR of an audit carried out on of hazards and management of risks along the feed Action Proposed by the Competent Authority h 2013 a 2014 bude jeden inspektor zo SVPS SR z ÚVZ SR vyskolený v rámci BTSF na krmivá. ov sa uskutocní v termíne do 30.6.2013.

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todické usmernenie s interpretáciou výsledkov pre na vykonávanie interných kontrol na krízovú aj na kontrolu neziaducich látok. ÚKSÚP novelizuje ostup na kontrolu homogenity miesacích zariadení. ÚKSÚP e podniky s vypracovanými metodickými pokynmi 2013.

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budú informova PPP vo svojej pôsobnosti o cie plánov HACCP o oblas skladovania, susenia, ia a prepravy vedajsích potravinárskych produktov ina na výrobu krmív, alebo ako krmivo. Pri ej schémy plánu HACCP bude potrebné urci CP teplota, vlhkos skladovania, zabránenie kontaminácie krobiologické, chemické a fyzikálne riziká, surovín, podmienky prepravy at. Aktualizácia ti vedajsích potravinárskych produktov urcených de ukoncená do 31.12.2013. todický pokyn k auditom systému HACCP pre Page: 5 Action Plan received from CA on 14 January 2013 DG(SANCO)/2012-6493-MR of an audit carried out on of hazards and management of risks along the feed thority y systémov HACCP v krmivárskych 30.9.2013. vak republic lture Page: 6

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as issued the Instruction to the Institute for State inary Biologicals and Medicaments (hereinafter he "ISCVBM"), No. 12/2012/01464, dated subject of sending information about veterinary ts. In line with this Instruction, the ISCVBM erly information to the SVFA SR, comprising a imported veterinary medicinal products, giving d their active substances, withdrawal period, the he medicinal product is intended for, and the total these products. Accordingly, the ISCVBM shall the SVFA SR of summary data regarding the ings (retail packs) of a veterinary medicinal pplied by wholesale distributors to public SVFA SR, veterinary surgeons providing manufacturers of medicated feed and other butors. tion shall be taken into consideration when drafting the

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of register of approved establishments of laying hens is SVFA of the SR and the register is updated after the validity on by which the relevant establishment is approved. ed to approval of establishments, identification of y approval number and registration of establishments Act. No 39/2007 Coll. on veterinary care. presented and discussed during training course A SR for official veterinarians which was held ocedures with regard to approval of establishments g of maximum capacity, identification of establishments er and registration of establishments will be part of courses organized by SVFA SR for the year 2012 is planned for January 2012).

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orated the national plan of trainings for the year 2012 veterinary inspectors performing controls of animal ll obligatory take part. One of the subjects of trainings will valuation of compliance with minimum requirements for ying hens in compliance with Directive 1999/74/EC. in January 2012)

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nized 6 training courses (119 participants) during tical visits in holdings with pig took place. ontribution to improving the quality of inspections in th pigs will be part of further training courses organized by Page: 1 ef. DG(SANCO)/2011-6053-MR of an audit carried out animal welfare on farms and during transport Action Proposed by the Competent Authority the year 2012 (Training course is planned for January

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as elaborated the national plan of trainings for the year all the veterinary inspectors performing controls of animal ll obligatory take part. One of the subjects of trainings will l evaluation of compliance with minimum requirements for broilers in compliance with Directive 2007/43/EC (First nuary 2012) 11 the SVFA SR has done survey with regard to of equipment to ensure control of environmental parameters. of the results of this survey SVFA SR will ensure of the further equipment to the relevant district veterinary nistrations. Expenditures concerning purchase of further e incorporated into the planned capital expenditure of he year 2012. Purchase will be realized up to 31. July

Medlemsstatens svar

started with revision of methodological guideline e revision is still ongoing and draft will be presented as a ng course planned for January 2012 and finalized in . instruction of SVFA SR will be issued in March 2012, ch all vehicles will be reviewed whether they possess pment for the transport of animals. Inter alia stress will be resence and functionality of the navigation system, the Page: 2 ef. DG(SANCO)/2011-6053-MR of an audit carried out animal welfare on farms and during transport Action Proposed by the Competent Authority the total weight of the animals to the size of the vehicle, y and the equipment of the ventilation and of the drinkers. te, and transport authorization of insufficiently equipped be withdrawn until the removal of deficiencies. n: up to 30. June 2012.

Medlemsstatens svar

amendment of Act No. 39/2007 coll. came into force, to rporated provisions more clearly defined responsibilities veterinarians to check fulfillment of requirements during to check navigation systems. SVFA SR has started with preparation of a new gical guideline concerning inspections of transports, in order fillment of requirements according to Regulation (EC) No. n particular regarding travel times and rest periods and to use of the records of the movement of the means of ained from the navigation system for carrying out these on of a new methodological guideline is still ongoing and hed up to 31. July 2012.