Croatia

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However, registered businesses are allowed to trade their products in the whole territory of Croatia, which is not in line with the requirements of Article 1.5.(b).(ii) of Regulation (EC) No 853/2004.

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The central office of SI ­ Independent Internal Audit Service (staffed with 3 auditors) also carries out the supervision of the work of the DBs entrusted with official controls: supervision is carried out by documentary checks at the DB headquarters, with a limited component performed by witness audit in the field. No internal audit in the dairy sector had been performed in the recent years (the last audit in the veterinary field was carried out in 2024 on official sampling of poultry caecum, involving 10 DBs and 1 witness au- dit in the field).

Staff of DBs had not been provided with specific training since a long time: some years ago an online training on HACCP in dairy had been provided but not sufficiently de- tailed on the verification/validation of the milk heat-treatment process. Moreover, AVs of DBs have to deal with a large number of FBOs involved in the processing of different commodities (meat, milk, fish, retail, etc.), making it hard to be specialised in any of them. Due to this lack of training and of some specific knowledge required in the dairy processing sector, the effectiveness of the official controls carried out by DBs is also sometimes questionable.

The SI organises at least twice a year a co-ordination meeting between Veterinary and Sanitary Inspection. Coordination activities between VFSI and VFSD had not been doc- umented.

The VFSD have a formal computerised reporting system in place for the outcome of official controls (approval/registration processes, animal health controls) called VetIs, to which also the VFSI has access. This latter uses its own database e-Inspector for reporting of official controls, for its exclusive use (the VFSD has no access to this database). Conclusions on competent authorities

Limited and insufficient training impact the technical knowledge of the control staff and, ultimately, on the effectiveness of official controls.

The lack of adequate supervision (internal audit) and the limited coordination between CAs do not provide sufficient guarantees that consistent enforcement and actions are always carried out.

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All visited establishments had a valid approval at the time of the audit team visit. How- ever, also discrepancies were noted: a. some FBOs had not informed the CAs about relevant changes that had occurred in the structure/equipment/activities, as required by Article 6.2 of Reg. 852/2004, and by Article 9 of Rules on the registration and approval of establishments and registration of operators in food businesses (OG 123/19). No specific sanctions had been applied by the VFSI staff in such cases; b. in one of the holdings visited, the operator had not informed the CA on the ceased operation of sale of raw milk through 3 vending machines: the operator has been sanctioned by VFSI Decision on 18 March 2025; c. in one establishment one storage building and two new reception silos for raw milk had been added later (in 2024) to the original layout; however, the approval was not amended because the new premises lacked the approval/license of the SI ­ Sector of Building Inspection (to note that the entire site was not fenced). The VFSD requested in writing specific information on the case to the SI­ Sector of Building Inspection, but no response was received. As a results, the VFSI inspec- tor requested the unapproved parts not to be used until their full approval: howev- er, both the storage building (with packaging material for the use by the sister company stored inside) and the two silos for the raw milk (clean, but with smell of fresh milk) were already occasionally used by the FBO without the inspector be- ing aware of this; d. some activities performed in another establishment visited (butter, fresh cheese, cottage cheese) were not included in the approval; 8 e. approval of establishments, to which flexibility options had been granted, had been done without adequate verification of the actual conditions (including sepa- ration in time of specific operations) and FBO's self-control system (simplified HACCP/GHP). No specific prescriptions concerning separation in time/in space had been included in the approval conditions, in order to ensure hygienic pro- cessing conditions.

The provisions and procedures in place for the registration and/or approval of dairy businesses are adequate to maintain oversight over the approval conditions. However, the current approvals granted to FBOs do not always ensure that all activities and struc- tures are covered by a valid approval.

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Official controls over raw milk criteria ensure that these latter are generally correctly and timely enforced by the FBOs. However, the obligation of FBO to notify the CAs about non-compliances is not always consistently enforced.

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The NRL is EN ISO/IEC 17025 accredited for the determination of the following organisms; A. chinensis, Citrus tristeza virus, Clavibacter sepedonicus, Globodera rostochiensis and G. pallida, Phyllosticta citricarpa, Phytophthora ramorum, Plum pox virus, Ralstonia solanacearum and Thrips palmi. It has participated in interlaboratory testing for PWN in 2020 and 2023, P. japonica in 2023, and for Spodoptera frugiperda, T. palmi and Agrilus planipennis in 2024. For the multi-annual survey programme which includes more than 400 species (see Chapter 5.2), the limited number of pests included in the accreditation is not fully in line with the requirements of Article 37(5)(a) of Regulation (EU) 2017/625. This Article requires that the scope of the accreditation of an official laboratory, shall include those methods of laboratory analysis, test or diagnosis required to be used by the laboratory for analyses, tests or diagnoses, when it operates as an official laboratory.

The NRL has a quality assurance system in place. This laboratory is accredited and has participated in interlaboratory testing for the determination of some priority and EU quarantine pests. Nevertheless, the incomplete accreditation for the remaining methods required for the multi-annual survey programme, reduces the level of assurance in their respective survey results.

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The CAAF informed the audit team that several counties of Croatia which have X. fastidiosa host plants, but environmental conditions with a low risk, are not taken into account in the survey for this pest. The design of the survey system practically assigns a zero risk to these areas, rather than a low risk. This is not in line with the environmental suitability factors, as described in the EFSA Guidelines and therefore, not fully in line with Article 2(3) and (4) of Regulation (EU) 2020/1201 which, requires that surveys shall be performed on the basis of the level of risk. Additionally, islands which have difficult access are not part of the survey programme for the presence of X. fastidiosa. This is not in line with Article 2(3) of the same Regulation.

The SI also surveys in Croatia for the presence of X. fastidiosa. Planning of these surveys is done by assigning the staff available to maximise the number of inspections. The responsible staff from the SI informed the audit team that these surveys are not statistically based, contrary to the requirements of Article 2(4) of Implementing Regulation (EU) 2020/1201. The SI surveys garden centres and nurseries in four inland counties. Urban areas and crops are surveyed in another five counties. For the 2024 survey season, the SI planned to survey 36 nurseries and garden centres, 28 urban areas and 17 fields, taking a total of 105 samples. For the current 2025 season, the SI is planning to survey a total of 90 sites and take 115 samples.

For the implementation of the 2024 annual survey plan for X. fastidiosa, the PHD reported that CAAF and SI have implemented 408 visual inspections, 35 of which were implemented in nurseries. The same CAs took 297 samples during the 2024 season, of these 115 were taken in garden centres. Although the sampling target was fully achieved, concerning the number of sites visited and samples taken (see paragraph 22 and 23), it is not possible to determine the confidence level achieved by this survey at national level (see paragraph 21 and 23).

The multi-annual survey programme for the relevant Union quarantine pests (including relevant priority pests) provides a basis for the early detection of any outbreaks of these pests. The small number of shortcomings identified do not have a critical impact on the outcome of the survey programmes.

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The CAAF has 20 pheromone traps to capture beetles of the genus Monochamus sp. while the CFRI has 28. The beetles captured are tested at the CFRI (see paragraph 3) to determine whether they belong to any non-European species, which are EU quarantine pests. However, they are not examined for the presence of PWN, contrary to the requirements of Article 2(1) of Implementing Decision 2012/535/EU which requires that, MS shall annually conduct surveys for Bursaphelenchus xylophilus on the vector.

For the 2024 annual survey for PWN, the CFRI visited seven counties, and performed 2 610 visual examinations of individual trees. Field inspectors visited 32 forest units and took 28 samples of wood, exceeding the annual plan. The CFRI reported that surveys focussed on symptomatic trees of Pinus halepensis by the coastal counties and Pinus sylvestris in the non-coastal ones. CFRI captured 130 Monochamus sp. beetles in the 29 pheromone traps placed. These beetles were analysed at the CFRI laboratory to determine whether they belonged to non-European species. However, they were not tested for the presence of PWN (see paragraph 30).

In 2024, the CAAF visited 5 counties and took 25 samples of wood from forest stands and public areas near ports. This CA reported captured 10 Monochamus sp. beetles which were examined with the same objective as the beetles captured by the CFRI.

The multi-annual survey programme for the relevant Union quarantine pests (including relevant priority pests) provides a basis for the early detection of any outbreaks of these pests. The small number of shortcomings identified do not have a critical impact on the outcome of the survey programmes.

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The contingency plans are overall in line with the requirements of Article 25(2) of Regulations (EU) 2016/2031. All CAs participated in the drafting of the plans (see paragraph 2 and 3) however, they have not consulted the relevant stakeholders in the process of drawing up and keeping up to date the contingency plans. This is contrary to the requirements of Article 25(1) of Regulations (EU) 2016/2031.

The CAs informed the audit team that they are considering how to amend the national legislation to address these issues. Once they are addressed, the CAs can review these plans, which is a requirement under Article 25(4) of Regulation (EU) 2016/2031. Conclusions on contingency plans

By developing all required contingency plans, Croatia has laid down a solid basis to eradicate any outbreak of relevant EU priority pests. Once the shortcomings identified in the simulation exercises are addressed, the CAs will be able to rapidly implement eradication measures in the case of an outbreak of a priority pest.

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In four establishments visited, tests to assess the homogeneity of mixing were carried out at least every five years. The contracted laboratory used the statistical program provided by the manufacturer of the tracer particles, however, wrongly performed the statistical analysis - a chi-squared goodness-of-fit test for homogeneity - based on the raw values of the optical density measurements (in general < 5) and not as required by the software by analysing the calculated amount of tracer particles per sample (in general > 200). When conducting a chi-squared goodness-of-fit test, low expected counts (e.g. <5) not only violate the chi-squared approximation assumptions but also directly reduce the test's power to detect inhomogeneous mixing. In one example the auditors noted that a coefficient of variation of 58.6% resulted wrongly in the conclusion that the mixing was effective regarding the homogeneity. Accordingly, the scrutinised tests for homogeneity of mixing were not in line with the requirements laid down by part 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005 and this was overlooked during previous official inspections.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. While feed inspectors regularly use checklists and guidance documents and official inspections are documented, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's assessment of the adequacy of operators' tests on homogeneity of mixing. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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The auditor team noted in several sampling-related non-compliances in compound feed for broiler chicken identified between 2022 and 2024 that the non-compliance decisions were wrongly based on unavoidable carry-over of coccidiostats in non-target feed exceeding maximum allowed levels (Section VII of Directive 2022/32/EC). However, the respective coccidiostats were listed on the product labels of the compound feeds as authorised feed additives. The audit team established as well that in these sampling-related non-compliances the measured concentration of coccidiostats was significantly smaller than (i) declared on the label, and (ii) the respective allowed concentration range as defined in the authorisation. However, these non-compliances were overlooked by the SI's inspectors and the Croatian Veterinary Institute's laboratory. These findings are not in line with the legal requirements of Article 15(e) and (f) of Regulation (EC) 767/2009. Conclusion on the planning and implementation of official sampling

Many aspects of the planning and implementation of sampling and testing of official feed samples are positive. The risk-based approach adopted for the planning of official sampling, its implementation, and availability of suitable sampling equipment ensure official samples' legal and technical validity. However, the test results interpretation approach for determining sampling-related non-compliances does not take into account all the relevant factors set out in the legislation affecting the legal validity of these decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 5.2.3 Actions taken on non-compliances

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Despite initial challenges which provoked the quick spread of ASF, authorities controlled affectively outbreaks on pig establishments using all required measures. The epidemics highlighted resource challenges for the authorities, who did not perform complete epidemiological investigations for all outbreaks and could not carry out quick final disinfections of all affected premises.

The clear rules for biosecurity measures and surveillance for domestic pigs contribute to prevent the entry and spread of AFS. However, the fact that many outbreaks were detected by continuous passive surveillance without notification of suspicions indicates important gaps in awareness or notification.

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Medlemsstatens svar

In line with national Law on official controls and other official activities, competent authorities will make an nt on mutual cooperation to enable effective and efficient cooperation on organization and implementation of March 31, 2025 official controls.

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Despite initial challenges which provoked the quick spread of ASF, authorities controlled affectively outbreaks on pig establishments using all required measures. The epidemics highlighted resource challenges for the authorities, who did not perform complete epidemiological investigations for all outbreaks and could not carry out quick final disinfections of all affected premises.

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Medlemsstatens svar

Ministry of Agriculture, Forestry and Fisheries (MAFF) response sued instructions and specific questionnaire to be during epidemiological investigation of ASF suspicion or confirmation. State Inspectorate (SI) response 1. Veterinarska inspekcija Drzavnog inspektorata u January 31, 2025 postupku je izrade Upute i predlozaka zapisnika za epidemiolosko istrazivanje koju e koristiti veterinarski inspektori kod svake postavljene sumnje i/ili pozitivnog slucaja, kako bi se utvrdilo podrijetlo, nacin sirenja Page: 1 port ref. DG(SANTE) 2024-8112 of the audit carried out from 04 June 2024 to s in relation to African swine fever Action Proposed by the competent authority Proposed action plan deadline bolesti te izracunalo vjerojatno vrijeme tijekom kojeg je March 31, 2025 bolest prisutna u zarazenim objektima kako to odreuje cl. 57. Uredbe 2016/429 2. Epidemiolosko istrazivanje na predlosku zapisnika biti e u skladu s preporukama iz Vodica o sluzbenim kontrolama u podrucju zdravlja zivotinja, Verzija III, od 08. sijecnja 2024.godine izdanog od strane Ministarstva poljoprivrede. Nakon prikupljenih podataka na terenu za svaku sumnju i/ili pozitivan nalaz sastavljat e se ,,Epidemiolosko izvjes

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Medlemsstatens svar

MAFF response For better clarity and to ensure full implementation of the ovisions laid down by the IR (EU) 2023/594, MAFF amended the Order on ASF (O.G. 88/24) in Article 1.14 ements for all establishments in restricted zones from which pigs have to be moved to have approved biosecurity plan. Page: 2 port ref. DG(SANTE) 2024-8112 of the audit carried out from 04 June 2024 to s in relation to African swine fever Action Proposed by the competent authority Proposed action plan deadline SI response 1. Nakon sto je Ministarstvo poljoprivrede izdalo novu In place Naredbu o mjerama kontrole za suzbijanje africke svinjske kuge u RH (Narodne novine, broj: 88/24) od 25. srpnja 2024.godine, te dopunilo odredbe u clanku 1. tocka 14. koje sada glase: na objektima na kojima se drzi 5 i vise rasplodnih svinja ili vise od 50 svinja ukupno te na svim objektima s kojih se svinje premjestaju, te uz mjere propisane naredbom donesenom u skladu s clankom 7. stavak 4. Zakon o zdravlju zivotinja i ovom Naredbom, mora biti izraen i u primjeni plan biosigurnosti. Prema istoj Naredbi u clanku 3. stavak 2. radi odobravanja izuzea od zabrane premjestanja, veterinarska inspekcija Drzavnog inspektorata za objek

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Medlemsstatens svar

SI response ola) 1. U drugoj polovici 2024.godine, a na nakon provedene revizije DG (SANTE) 2024-8112, provedene su Page: 3 port ref. DG(SANTE) 2024-8112 of the audit carried out from 04 June 2024 to s in relation to African swine fever ion Proposed by the competent authority Proposed action plan deadline edukacije za ovlastene veterinare ovlastenih veterinarskih organizacija i delegiranih tijela tijekom odrzanog 7. Hrvatskog veterinarskog kongresa, od strane visih veterinarskih inspektora Sektora za veterinarski nadzor i nadzor sigurnosti hrane sa naslovima tema: Uvjeti kojima moraju udovoljiti subjekti u poslovanju s hranom radi umanjenja rizika od africke svinjske kuge - prilagodba poslovanja subjekata u poslovanju s hranom Novosti u koristenju TRACES sustava u meunarodnom prometu i certificiranje unutar drzave Edukacija za veterinarske inspektore u podrucnim dima sa istim naslovima tema biti e odrzana on line December 31, sve veterinarske inspektore. 2024 U tijeku je edukacija i u samim objektima odobrenim za njenje rizika od africke svinjske kuge, koja se vodi od strane viseg veterinarskog inspektora December 31, cijaliste - za meso papkara, kopitara, peradi, kunia, 2025 ljaci

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Medlemsstatens svar

MAFF response la) MAFF updated the ASF surveillance programme with the je instructions for delivery of laboratory test results report to the hunting associations. SI response 1. Nakon azuriranja Programa nadziranja ASK od 07. December 31, Page: 5 port ref. DG(SANTE) 2024-8112 of the audit carried out from 04 June 2024 to s in relation to African swine fever tent authority Proposed action plan deadline a 6 u dijelu 10. 2024 pretrazivanje i dostava je dostavu obavijesti od e organizacije ima pretrazivanja, te tocke opije izvjesa o u bilo putem e-poste ili na nim inspekcijskim e isto provodi. a veterinarski nadzor i postupku izrade Plana rada a 2025.godinu kojim e biti nja sluzbenih kontrola jerava dokumentacija vinja ili pronalazak lesina izvjesima o rezultatima inarski inspektori djelatnici March 31, 2025 z navedenog razloga nije je u preporuci navodi. U dnicke Upute za lovne i kojom e biti jasno odreena iljevi provjere postivanje svih urnosti u lovistima i m nesukladnostima. or za zdravlje zivotinja; farmski December 31, otinja, promet i oznacavanje 2025 terinarski nadzor i nadzor og inspektorata tijekom 2025. fikacije sluzbenih kontrola koje port ref. DG(SANTE) 2024-8112 of the au

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Notwithstanding the fact that some risk factors are not considered in deciding what analytes are to be tested for and the planning process for the NRCP is not finalised before the beginning of calendar year, the annual plans are largely in line with applicable legal requirements, contributing to the effectiveness of controls on residues.

Whilst the NRCP is generally implemented in accordance with planned arrangements the lack of sampling during the first four months of the year, use of inconsistent (15) Part 3 of Annex II to Regulation (EU) 2021/808. (16) Part 4 of Annex II to Regulation (EU) 2021/808. (17) Article 34(5) of Regulation (EU) 2017/625. (18) Parts 5 and 6 of Annex II to Regulation (EU) 2021/808. (19) Article 35(2) of Regulation (EU) 2017/625. (20) Article 2(2) and Annex III to Regulation (EU) 2022/1644. (21) Part 3(c) in Section III of Annex II to Regulation (EC) No 853/2004. 5 instructions for sampling and problems with implementation of sample targeting have the potential to compromise the effectiveness of the plan.

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Whilst the NRCP is generally implemented in accordance with planned arrangements the lack of sampling during the first four months of the year, use of inconsistent (15) Part 3 of Annex II to Regulation (EU) 2021/808. (16) Part 4 of Annex II to Regulation (EU) 2021/808. (17) Article 34(5) of Regulation (EU) 2017/625. (18) Parts 5 and 6 of Annex II to Regulation (EU) 2021/808. (19) Article 35(2) of Regulation (EU) 2017/625. (20) Article 2(2) and Annex III to Regulation (EU) 2022/1644. (21) Part 3(c) in Section III of Annex II to Regulation (EC) No 853/2004. 5 instructions for sampling and problems with implementation of sample targeting have the potential to compromise the effectiveness of the plan.

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While the national laboratories involved in the NRCP are officially designated by the Minister of Agriculture, this was not the case with regard to laboratories located in other Member States. This is not in line with the requirements of EU legislation (30), which stipulates that each laboratory shall be designated by the competent authority. The audit team also noted that no arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities were included in the designation letters.

Notwithstanding the fact that the national laboratories are accredited to EN ISO/IEC 17025, operate methods included in their respective scopes of accreditation and take part in proficiency tests with largely satisfactory results, there were nevertheless some shortcomings in validation and internal quality controls, which weaken an otherwise well-functioning national laboratory network. The fact that four subcontracted laboratories in other Member States had not yet been designated as official laboratories could compromise the ability of the competent authority to take effective enforcement action in the event of non-compliant results being reported by these laboratories. (35) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808, Section 7.7 of EN ISO/IEC 17025. (36) Article 5 of Regulation (EU) 2021/808. (37) Section 4.1 of EN ISO/IEC 17025. 9

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With regard to method validation the audit team noted: a) Nearly all methods were validated according to relevant EU legal act (32) which was in force at the time of the validation but matrices of minor species were often not included and the number of samples used for validation was unrepresentative of the species concerned. Examples include: · The method for nitrofurans in muscle for which 10 samples representing bovine, porcine, broiler, fresh and sea water fish (two of each) were used for method validation. Furthermore, there were frequently not enough replicates at each spiking level (four instead of six); · The method for ivermectins which was validated in bovine milk (ovine and caprine milk was excluded) and in bovine and porcine liver. Poultry, ovine and caprine livers were also tested but there was no validation in these matrices. b) No method verification or re-validation had been performed when MRLs or RPAs had been amended. c) In validation files scrutinised, stability in solution was checked for nitrofuran metabolites but in case of other methods, it was not addressed either in solution or in matrix. This is not in line with EU legislation (33). The audit team pointed out that, if stability data are available from scientific literature or from another laboratory, these data do not need to be determined experimentally again by the concerned laboratory, provided that identical conditions apply. d) The screening method for steroids was under the process of verification due to the change of the kit provider.

Notwithstanding the fact that the national laboratories are accredited to EN ISO/IEC 17025, operate methods included in their respective scopes of accreditation and take part in proficiency tests with largely satisfactory results, there were nevertheless some shortcomings in validation and internal quality controls, which weaken an otherwise well-functioning national laboratory network. The fact that four subcontracted laboratories in other Member States had not yet been designated as official laboratories could compromise the ability of the competent authority to take effective enforcement action in the event of non-compliant results being reported by these laboratories. (35) Article 4 and Chapter 3 of Annex I to Regulation (EU) 2021/808, Section 7.7 of EN ISO/IEC 17025. (36) Article 5 of Regulation (EU) 2021/808. (37) Section 4.1 of EN ISO/IEC 17025. 9

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The audit team noted however, that in line with BSIS documented procedures, health certificates based on the model provided for in Annex III to Regulation (EU) 2020/1158, accompanying wild collected mushrooms and wild fruits of the genus Vaccinium, were systematically accepted following the documentary check, although the entire required official attestation in Part II 1.1 of the certificate was deleted by the certifying officer in the third country that issued the certificate. The audit team noted that in such cases, the documentary check had not ascertained that the conditions for entry into the EU for such goods, including the official certificate, specified in Articles 3 and 4 of that Regulation, were fulfilled, which is not in line with Article 2(2)(b) of Regulation (EU) 2019/2130.

The system in place ensures that consignments of animals and goods entering the EU are presented for official controls, and that those controls are ensures that such consignments are presented for official controls and that those controls are, with the limited exception of certain specific documentary checks, generally carried out in line with documented procedures and EU requirements.

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The following legislation and guidelines are relevant in the context of the audit: 4 · The Croatian Plant Health Act (Official Gazette of the Republic of Croatia (OG, No. 127/19) implements Regulation (EU) 2016/2031 and lays down the division of competences for the performance of official controls in the field of plant health, and the rights and powers of phytosanitary and forestry inspectors responsible for official controls in this area. According to Article 5 of this act, the MA is responsible for the coordination of these matters, and under its Article 7 the MA is responsible for establishing a DA when a positive finding of the pest is confirmed. The MA and the SI explained to the audit team that they disagree on whether or not this act provides the necessary legal basis for the SI to take immediate actions when a positive finding of the pest is confirmed. In the view of the SI, they do not have the legal basis to implement eradication measures until the MA has established a DA, while the MA considers that the SI can take measures when a priority pest is confirmed, even before a DA has been established. This disagreement contributed to the delay in implementing eradication measures in 2019, further described under section 5.4. The inability to find a solution to a fundamental issue indicates a lack of coordination between the CAs involved, contrary to Article 4(2)(a) of Regulation (EU) 2017/625, according to which Member States shall ensure the efficient and effective coordination between all CAs involved and the consistency of the official activities. · Decision on the designation of demarcated areas where measures are implemented to prevent the spread of A. chinensis (OG, No. 13/20). The decision is adopted by the MA and is updated when necessary. · The National plan for the annual surveys for A. chinensis and eight other pests, drawn up by the MA, forms the basis for surveys carried out in pest-free areas and in DAs. · The Action Plan to control and prevent the spread of A. chinensis for the period 2022-2025, adopted in 2022. The Action Plan describes the measures to be taken in DAs to eradicate the pest, the division of competencies between the CAs, the training of operators and information to the public. It does however not include a time schedule for the application of the eradication measures, contrary to the requirements of Article 27(1) of Regulation (EU) 2016/2031. The plan further lays down that the felling of specified plants in the infested zone (IZ) may be exempted if it is possible to carry out individual recording and mapping of these plants every month from May to September. While this is in line with the applicable EU legislation, EU law also requires that the exemption is for exceptional cases where a responsible official body concludes that such felling is inappropriate, and that measures to prevent any possible spread of the pest from those plants must be applied. These elements are not included in the Action Plan, hence it does not correspond to the requirements as laid down in Annex II, section 3(1)(b) of Decision (EU) 2012/138. 5 5.1.3 Documented control procedures and audits

The plant health controls are carried out by designated authorities, mainly in line with EU and national legislation, but the disagreement concerning the interpretation of the legislation indicates poor coordination between the MA and the SI and has contributed to delays in the implementation of the applicable EU legislation.

During the on-site visit in the DA of Jankolovica, the audit team noted that specified plants remained also in this IZ. The SI explained to the audit team that in this case the reason was the Croatian legislation concerning felling of trees, according to which the owner is responsible for the felling and must at least be informed before any tree is felled. According to the SI, the task of identifying and getting in contact with the owner was time consuming and not possible in some cases. To leave specified trees in the IZ for an undefined time is not in accordance with Annex II, section 3(1)(b) of Decision (EU) 2012/138, and the inability to take immediate eradication measures when the pest is present on private premises is contrary to the requirements of Article 17(4) of Regulation (EC) 2016/2031. 5.5.3 Destruction of plants

The requirement to contact owners before felling trees in combination with the inability of the CA to swiftly identify these owners, leads to delays in the felling of specified plants in the IZs increasing the risks for the continued spread of the pest.

Medlemsstatens svar

Croatian response of September 2022: he Plant Health Act (OG 127/19, 83/22) ensures the implementation of Regulation 2016/2031. Point (5) of the Article 21 of the above mentioned Regulation empowers the phytosanitary or forestry inspector to order and monitor the implementation of phytosanitary measures to eradicate the relevant Union quarantine pest present on the territory of the Republic of Croatia, as regards Article 17(1) and (2) Regulation (EU) 2016/2031. Also, General contingency plan in case of an exceptional occurrence of harmful organisms on plants and plant product is in force and its revision will be considered in order to improve the coordination between the implementers. It is planned to be revised by the beginning of April 2023 Page: 1 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis tion Proposed by the competent authority rthermore, in October we plan to issue an der that will be prescribing additional asures and its entry into force will enable sier and faster implementation of the asures. oatian response of

The Plant Health Act (OG 127/19, 83/22) *An Order prescribing additional measures ensures the implementation of Regulation to enable easier and faster implementation of 2016/2031. Point (5) of the Article 21 of the the measures has been published at above mentioned Regulation empowers the https://narodne- phytosanitary or forestry inspector to order novine.nn.hr/clanci/sluzbeni/2022_11_139_2 and monitor the implementation of 093.html phytosanitary measures to eradicate the vant Union quarantine pest present on the territory of the Republic of Croatia, as regards Article 17(1) and (2) Regulation (EU) 2016/2031. Also, General contingency plan in case of an exceptional occurrence of harmful organisms on plants and plant product is in force and its revision will be considered in order to improve the coordination between the implementers. It is planned to be revised by the beginning of April 2023 Page: 1 ations (updated), received 13 March 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority Updated Action proposed by the com

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The following legislation and guidelines are relevant in the context of the audit: 4 · The Croatian Plant Health Act (Official Gazette of the Republic of Croatia (OG, No. 127/19) implements Regulation (EU) 2016/2031 and lays down the division of competences for the performance of official controls in the field of plant health, and the rights and powers of phytosanitary and forestry inspectors responsible for official controls in this area. According to Article 5 of this act, the MA is responsible for the coordination of these matters, and under its Article 7 the MA is responsible for establishing a DA when a positive finding of the pest is confirmed. The MA and the SI explained to the audit team that they disagree on whether or not this act provides the necessary legal basis for the SI to take immediate actions when a positive finding of the pest is confirmed. In the view of the SI, they do not have the legal basis to implement eradication measures until the MA has established a DA, while the MA considers that the SI can take measures when a priority pest is confirmed, even before a DA has been established. This disagreement contributed to the delay in implementing eradication measures in 2019, further described under section 5.4. The inability to find a solution to a fundamental issue indicates a lack of coordination between the CAs involved, contrary to Article 4(2)(a) of Regulation (EU) 2017/625, according to which Member States shall ensure the efficient and effective coordination between all CAs involved and the consistency of the official activities. · Decision on the designation of demarcated areas where measures are implemented to prevent the spread of A. chinensis (OG, No. 13/20). The decision is adopted by the MA and is updated when necessary. · The National plan for the annual surveys for A. chinensis and eight other pests, drawn up by the MA, forms the basis for surveys carried out in pest-free areas and in DAs. · The Action Plan to control and prevent the spread of A. chinensis for the period 2022-2025, adopted in 2022. The Action Plan describes the measures to be taken in DAs to eradicate the pest, the division of competencies between the CAs, the training of operators and information to the public. It does however not include a time schedule for the application of the eradication measures, contrary to the requirements of Article 27(1) of Regulation (EU) 2016/2031. The plan further lays down that the felling of specified plants in the infested zone (IZ) may be exempted if it is possible to carry out individual recording and mapping of these plants every month from May to September. While this is in line with the applicable EU legislation, EU law also requires that the exemption is for exceptional cases where a responsible official body concludes that such felling is inappropriate, and that measures to prevent any possible spread of the pest from those plants must be applied. These elements are not included in the Action Plan, hence it does not correspond to the requirements as laid down in Annex II, section 3(1)(b) of Decision (EU) 2012/138. 5 5.1.3 Documented control procedures and audits

The Action Plan referred to under section 5.1.2 sets out the measures to be applied in DAs and refers to the relevant EU legislation concerning measures to be taken to eradicate the pest. As explained under section 5.1.2, the plan does not fully correspond to the requirements as laid down in EU legislation.

Inspectors receive training and have good knowledge of the pest and use the available documented procedures as support when implementing the EU requirements. However, the Action Plan does not define any timelines for implementing eradication measures and does not restrict exemptions for felling of specified plants to exceptional cases, in line with EU requirements, risking that eradication measures are implemented with a delay, and the continued spread of the pest.

As described under section 5.1.2, the exemption from the felling of specified plants in the IZ, as laid down in the Action Plan, is not confined to exceptional cases, nor does it require any further measures to prevent the possible spread of the pest to be applied, contrary to the applicable EU legislation. The practical application was demonstrated during an on- site visit in a DA where the audit team noted that specified plants still remained in the IZ. The CAs stated that in this case they had allowed for the exemption from felling and that they carry out regular surveys in the IZ, as laid down in the Action Plan.

The implementation of the Action Plan leads to specified plants being exempted from felling, even when the EU requirements for such exemption are not fulfilled, risking the continued spread of the pest. 11

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oatian response of September 2022: Page: 2 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority The current Action Plan will be revised to define the time schedule for actions. It will specify how much time should elapse from the appearance of a positive finding to the listing of plants for which measures need to be taken, as well as the time period for selecting a contractor, and also the time period in which all felling measures must be carried out. After the update, we will submit the AP for inspection. Re. the positive findings in Jankolovica The time period for the implementation of the measures has been determined. An intensive monitoring was conducted in September in an area of 4.58 ha and 191 trees (148 poplar, 36 plane and 7 figs) designated for felling were marked. A response/permission/solution from the Ministry of Economy and Sustainable Development for felling these trees on the area is in progress (September 2022). Replacement nesting houses for golden crows will be installe

The current Action Plan will be revised to *Revised Action Plan including a time define the time schedule for actions. It will schedule for eradication measures provided specify how much time should elapse from to the Commission. the appearance of a positive finding to the listing of plants for which measures need to be taken, as well as the time period for selecting a contractor, and also the time period in which all felling measures must be carried out. After the update, we will submit the AP for inspection. Re. the positive findings in Jankolovica The time period for the implementation of the measures has been determined. An intensive monitoring was conducted in September in an area of 4.58 ha and 191 trees (148 poplar, 36 Page: 2 ations (updated), received 13 March 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis authority Updated Action proposed by the competent authority felling were ution from inable es on the 22). lden crows s of the ized up for the he eradication ementation he final and as soon osanitary ling and s of be removed to 28 Page: 3 ations

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The accreditation of the NRL for their diagnostic methods for A. chinensis will ensure that their results are sound and reliable.

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are The Centre for Plant Protection laboratory is the NRL in Plant Health and expects to have completed the accreditation process for A chinensis by the end of 2023. The CFRI will collaborate with Centre for Plant Protection of Croatian Agency for Agriculture and Food for accreditation of morphological identification via intra laboratory comparisons

are The Centre for Plant Protection laboratory is *No updated Action the NRL in Plant Health and expects to have completed the accreditation process for A chinensis by the end of 2023. The CFRI will collaborate with Centre for Plant Protection of Croatian Agency for Agriculture and Food for accreditation of morphological identification via intra laboratory comparisons

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The following legislation and guidelines are relevant in the context of the audit: 4 · The Croatian Plant Health Act (Official Gazette of the Republic of Croatia (OG, No. 127/19) implements Regulation (EU) 2016/2031 and lays down the division of competences for the performance of official controls in the field of plant health, and the rights and powers of phytosanitary and forestry inspectors responsible for official controls in this area. According to Article 5 of this act, the MA is responsible for the coordination of these matters, and under its Article 7 the MA is responsible for establishing a DA when a positive finding of the pest is confirmed. The MA and the SI explained to the audit team that they disagree on whether or not this act provides the necessary legal basis for the SI to take immediate actions when a positive finding of the pest is confirmed. In the view of the SI, they do not have the legal basis to implement eradication measures until the MA has established a DA, while the MA considers that the SI can take measures when a priority pest is confirmed, even before a DA has been established. This disagreement contributed to the delay in implementing eradication measures in 2019, further described under section 5.4. The inability to find a solution to a fundamental issue indicates a lack of coordination between the CAs involved, contrary to Article 4(2)(a) of Regulation (EU) 2017/625, according to which Member States shall ensure the efficient and effective coordination between all CAs involved and the consistency of the official activities. · Decision on the designation of demarcated areas where measures are implemented to prevent the spread of A. chinensis (OG, No. 13/20). The decision is adopted by the MA and is updated when necessary. · The National plan for the annual surveys for A. chinensis and eight other pests, drawn up by the MA, forms the basis for surveys carried out in pest-free areas and in DAs. · The Action Plan to control and prevent the spread of A. chinensis for the period 2022-2025, adopted in 2022. The Action Plan describes the measures to be taken in DAs to eradicate the pest, the division of competencies between the CAs, the training of operators and information to the public. It does however not include a time schedule for the application of the eradication measures, contrary to the requirements of Article 27(1) of Regulation (EU) 2016/2031. The plan further lays down that the felling of specified plants in the infested zone (IZ) may be exempted if it is possible to carry out individual recording and mapping of these plants every month from May to September. While this is in line with the applicable EU legislation, EU law also requires that the exemption is for exceptional cases where a responsible official body concludes that such felling is inappropriate, and that measures to prevent any possible spread of the pest from those plants must be applied. These elements are not included in the Action Plan, hence it does not correspond to the requirements as laid down in Annex II, section 3(1)(b) of Decision (EU) 2012/138. 5 5.1.3 Documented control procedures and audits

The CAs informed the audit team that in the case of the outbreak in Jankolovica, the most recent case that required the establishment of a new DA, the finding was confirmed in June 2019, but the decision to establish the DA was only adopted in September 2019. This is contrary to the requirements laid down in Article 18 of Regulation (EU) 2016/2031 and in Article 6 of Decision (EU) 2012/138, according to which a DA should be established immediately when a positive finding of the pest is confirmed. It is also contrary to the requirements of the Action Plan, which sets out that measures shall be implemented in accordance with Article 6 of Decision (EU) 2012/138. Conclusions on DAs

There are procedures in place to establish DAs in line with EU legislation, which provides a basis for the proper implementation of eradication measures. However, delays in establishing a DA, such as for the outbreak in Jankolovica, increases the risk of the continued spread of the pest. 9

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oatian response of September 2022: According to Article 7, paragraph 1, point 5 of Plant Health Act, MA as the competent authority, establishes, amends, and abolishes demarcated areas (DAs). Following the above, MA has developed an application that will allow it to make maps of DAs after receiving positive laboratory findings and to publish them in the Official Gazette of the Republic of Croatia. Page: 7 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority In accordance with the new findings in Jankolovica in June, new maps of the demarcated areas were made and are currently in the process of being published in the National Official Gazette. When they are published, we will deliver you the updated version. Croatian response of March 2023: The DA to reflect the new findings in Jankolovica in June has been established via Decision 110/2022 of 23/09/2022 and the relevant maps published in the National Official Gazette at https://narodne- novine.nn.hr/clanci/sluzbeni/2022_09_110_1 627.html

cording to Article 7, paragraph 1, point 5 *Maps to reflect the updated demarcated of Plant Health Act, MA as the competent areas have been published in the National authority, establishes, amends, and abolishes Official Gazette https://narodne- demarcated areas (DAs). novine.nn.hr/clanci/sluzbeni/2022_09_110_1 627.html Following the above, MA has developed an application that will allow it to make maps of DAs after receiving positive laboratory findings and to publish them in the Official Gazette of the Republic of Croatia. Page: 5 ations (updated), received 13 March 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority Updated Action proposed by the competent authority In accordance with the new findings in Jankolovica in June, new maps of the demarcated areas were made and are currently in the process of being published in the National Official Gazette. When they are published, we will deliver you the updated version.

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The audit team visited an area just next to the outbreak site of Jankolovica, in the DA established in 2019, where the SI informed the audit team that they had carried out one survey in June 2020, three surveys in 2021 (July/July/August), and one survey in the beginning of June 2022, all with negative results. HAPIH also conducted eight surveys in this DA in 2020, all of which had negative results. During the visit, the audit team quickly noted a large number of flying beetles, and at least 18 adult specimens of A. chinensis were caught in a 30-minute period during the visit. Based on the large number of A. chinensis and other observations made by the audit team, such as feeding marks on trees and the placing of exit holes fairly high in the trees which is a sign of heavy infestation, the audit team considered that the pest had been active in the area since at least 2020.

The audit team could not establish the reasons for the failure of both the SI inspectors and HAPIH experts to detect the infestation in the course of the surveys carried out during the previous two years. The SI did not provide any information about actions taken to ensure the effectiveness and appropriateness of official controls and other official activities, contrary to the requirements of Article 5(1)(a) of Regulation (EU) 2017/625, or that it had carried out control verification procedures required under Article 12(2) of the same Regulation, on this aspect. 5.5.2 Removal of plants

The presence of the pest in previously and regularly surveyed areas show that SI monitoring is incapable of detecting even heavy infestations of A. chinensis. This significantly undermines efforts to stop the further spread of the pest.

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Croatian response of September 2022: Page: 8 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority SI will establish and implement procedures for the verification of controls in accordance with the requirements of the Article 5, paragraph 1, point (a) and Article 12, paragraph 2 of Regulation (EU) 2017/625. CAAF - Centre for Plant Protection has in place operating and control procedures for both laboratory and field activities. These written and officially approved procedures include general procedure for Plant Health Surveys, specific procedure for A. chinensis visual inspections and sampling, and many procedures regarding laboratory work and identification. CAAF - CPP is accredited according to ISO 9001 and ISO 17 025 Standards. The procedures are continuously being improved, upgraded and revised when necessary. The system of documenting non- compliances is in place. Page: 9 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(S

SI will establish and implement procedures SI will have control verification procedures for the verification of controls in accordance established. with the requirements of the Article 5, paragraph 1, point (a) and Article 12, CAAF considers that it has in place paragraph 2 of Regulation (EU) 2017/625. procedures and arrangements ensuring the effectiveness and appropriateness of official activities in plant health. Control verification is an integrated part of the respective CAAF - Centre for Plant Protection has in procedures. Corrective actions are taken place operating and control procedures for when shortcomings are identified, and both laboratory and field activities. These documented procedures are regularly written and officially approved procedures updated, as appropriate. In attachment, please find: include general procedure for Plant Health - an updated documents on visual inspections Surveys, specific procedure for A. chinensis and sampling of Anoplophora chinensis, visual inspections and sampling, and many - a document on organization of a respective procedures regarding laboratory work and survey, identification. CAAF - CPP is accredited Page: 6 ations (updated), recei

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The requirement to contact owners before felling trees in combination with the inability of the CA to swiftly identify these owners, leads to delays in the felling of specified plants in the IZs increasing the risks for the continued spread of the pest.

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Croatian response of September 2022: In accordance with Annex II, section 3(1)(a) of the Implementing Decision 2012/138/EU, Page: 11 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority SI inspectors will order immediate felling of infected plants and plants with symptoms of infection with the harmful organism Anoplophora chinensis and the complete removal of their roots Croatian response of March 2023: The Croatian CAs have marked 220 trees for felling and added that administrative procedures to engage a felling contractor company are in progress.

In accordance with Annex II, section 3(1)(a) 220 trees have been marked for felling and of the Implementing Decision 2012/138/EU, administrative procedures to engage a felling SI inspectors will order immediate felling of contractor company are in progress. Page: 7 ations (updated), received 13 March 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis Action Proposed by the competent authority Updated Action proposed by the competent authority infected plants and plants with symptoms of infection with the harmful organism Anoplophora chinensis and the complete removal of their roots

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As described under section 5.1.2, the exemption from the felling of specified plants in the IZ, as laid down in the Action Plan, is not confined to exceptional cases, nor does it require any further measures to prevent the possible spread of the pest to be applied, contrary to the applicable EU legislation. The practical application was demonstrated during an on- site visit in a DA where the audit team noted that specified plants still remained in the IZ. The CAs stated that in this case they had allowed for the exemption from felling and that they carry out regular surveys in the IZ, as laid down in the Action Plan.

During the on-site visit in the DA of Jankolovica, the audit team noted that specified plants remained also in this IZ. The SI explained to the audit team that in this case the reason was the Croatian legislation concerning felling of trees, according to which the owner is responsible for the felling and must at least be informed before any tree is felled. According to the SI, the task of identifying and getting in contact with the owner was time consuming and not possible in some cases. To leave specified trees in the IZ for an undefined time is not in accordance with Annex II, section 3(1)(b) of Decision (EU) 2012/138, and the inability to take immediate eradication measures when the pest is present on private premises is contrary to the requirements of Article 17(4) of Regulation (EC) 2016/2031. 5.5.3 Destruction of plants

The implementation of the Action Plan leads to specified plants being exempted from felling, even when the EU requirements for such exemption are not fulfilled, risking the continued spread of the pest. 11

The requirement to contact owners before felling trees in combination with the inability of the CA to swiftly identify these owners, leads to delays in the felling of specified plants in the IZs increasing the risks for the continued spread of the pest.

During the on-site visit to one garden centre in a DA, the audit team noted that it was located in the near vicinity of the IZ referred to in section 5.5.2, where the specified plants had not been removed. In spite of this, the CAs had not taken any measures specifically aimed at preventing the spread of the pest to the garden centre. 5.6.3 Issuance and controls on plant passports

The system of movement control of specified plants from DAs is in line with the EU requirements. However, the improper implementation of eradication measures in the IZs increases the risk for spread of the pest to nearby garden centres, risking the further spread of the pest through sales of specified plants from these places.

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zone Croatian response of September 2022: ) SI inspectors will, in accordance with Annex I section 3(1)(b) of the Implementing Decision 2012/138/EU and the Action Plan, order felling of all specified plants within a diameter of 100 m, and the complete removal of their roots. Page: 12 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis authority trees for tive ntractor response of s 5., 6. ica are d for felling . ry nt authority mentation fer zones. destroyed all In total 148 9 Morus spp. ). round plants infested e felled, lants chipped Page: 13 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis ction Proposed by the competent authority ll activities were carried out under the upervision of the SI inspectors on the site. n a buffer zones CAAF will carry out ntensive survey (in total 50 visual nspections). As additional measure we lanted sentinel trees (Acer palmatum and cer neg

zone SI inspectors will, in accordance with Annex 220 trees have been marked for felling and ) II section 3(1)(b) of the Implementing administrative procedures to engage a Decision 2012/138/EU and the Action Plan, felling contractor company are in progress. order felling of all specified plants within a diameter of 100 m, and the complete removal of their roots.

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The destruction of infested plants and of specified plants in the IZ has been delayed due to the ban on burning during summers, the shortage of machinery for mechanical destruction and lengthy tendering procedures. The involvement of local governments in this procedure is foreseen to abolish the need for a tendering procedure, addressing one of the reasons for the current delays.

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to Croatian response of September 2022: o avoid the spread of harmful organisms, he disposal of felled plants will be carried ut in accordance with Annex II, section (1)(c) of the Implemented Decision 012/138/EU, and in accordance with the ction Plan by implementing the ordered hytosanitary measures. Ordered measures ill be implemented in the presence of the ompetent SI inspector. Page: 14 ations (updated) received 5 June 2023 tted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2022-7403 of in order to evaluate the situation and controls for Anoplophora chinensis authority ss of pany, which trees are s have been 2023. ots were ctor company n of plants ate nder the on the site. Page: 15

to To avoid the spread of harmful organisms, The felling contractor company will the disposal of felled plants will be carried complete this task once the trees are felled. out in accordance with Annex II, section 3(1)(c) of the Implemented Decision 2012/138/EU, and in accordance with the Action Plan by implementing the ordered phytosanitary measures. Ordered measures will be implemented in the presence of the competent SI inspector. Page: 8

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The audit team examined a number of approval files and associated records, noting that, in several cases, only part of the abovementioned procedure had applied. In several of the files, the conditional approval had expired well before the competent authority could perform the on-site visit necessary to either prolong the conditional approval or grant a full approval. This resulted in plants continuing their activities for several months without a valid approval, contrary to the requirements of Article 44(3) of Regulation (EC) No 1069/2009. According to the competent authority, such situations are due to insufficient resources to perform all of the on-site visits required by the approval process in a timely fashion.

The registration of establishments and regular updating of the lists of establishments is effective and facilitates the planning of official controls. The national rules for approval of establishments are in line with EU requirements, however, the implementation of the rules is deficient resulting in a situation where an ABP plant whose conditional approval has expired, can continue to operate. This undermines an otherwise well-functioning approval process with resulting risks to public and animal health. 5.2.2 Planning of official controls

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consumption has been prepared for publication in the Official Gazette. This provided the legal basis for a slightly modified procedure for approving of ABP establishments. Now, the second inspection of the establishment that has been granted conditional approval will be carried out by two, even only one member of the expert committee if it is the competent (regional) veterinary inspector, instead of all three members of the expert committee being present. It turned out that the most common problem in the past was the organization of the simultaneous presence of 3 members of the committee who come from different institutions within the 3 months that the conditional decision is valid. The date until the conditional decision is valid will be indicated in the note of published List of ABP plants. New Ordinance should be published not later than the end of October 2022. VFSD will develop a Procedure for the authorization of farms that use milk or

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In the dairy sector, official controls covering food hygiene requirements include checks on the disposal of ABP from the processing of milk. However, such controls do not cover the use of milk-derived products for the feeding of farmed animals contrary to the requirements of Article 4.3 of Regulation (EC) No 1069/2009. In particular, the audit team noted that there were no controls on sweet whey (a by-product of the manufacture of semi- hard cheeses) dispatched to farms for the feeding of pigs. As a result, such whey, which originates from the clotting of pasteurised milk but whose pH is not necessarily below six, was sent to farms that were not authorised to receive it on the basis of the risks linked to the possible spread of epizootic diseases (e.g. foot and mouth disease), contrary to the requirements of point 3 of Part II of section 4 of Chapter II of Annex X to Regulation (EU) No 142/2011.

The audit team noted that, while there is a process for the authorisation of such farms, it is incomplete as it does not require the abovementioned assessment. The process is based solely on a declaration by the farmer, which results in the registration of the farm. At the time of the audit, there were no farms registered for the use of milk-derived products for the feeding of animals (such as pigs) susceptible to foot and mouth disease.

Official controls do not verify compliance with the requirements for milk-derived products used for feeding of farmed animals. This, combined with procedures for the authorisation of farms (using milk-derived products for feeding pigs) that do not include an assessment of the risks of feeding such ABP in the context of possible outbreak of epizootic diseases, could present a risk in case of an outbreak of such diseases, in particular foot-and-mouth disease. 10

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- milk derived products as stated in point 3 of Part II of section 4. of Chapter II. of Annex X Regulation (EU) No 142/2011. According to that Procedure farms will need to apply for permit to use products in question for feeding of farmed animals. II of Risk assessment of each individual farm that submits an application for the use of concerned products will be carried out considering how it is categorized with regard to biosecurity in the case of pig farms (system has been already established within national farm register, with data entered since 2019) and based on the records of the veterinary inspector. However, as some proper legal base is required for authorization decisions, we decided (as for some other practical reasons as well) to prepare new ABP legislation ­ national Animal By Products Act. This new Act should be published by the end of 2023, taking out ABP part from present Veterinary Act, and covering in better and more practical way legislative procedures prescribed now by Ordinance (the same Ordinance which will be changed by October 2022), Page: 1 commendations of report ref. DG(SANTE) 2022-7419 of the audit carried out from 13 to 27 May ontrols on animal by-product

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sis for the adoption of a new `Ordinance on registration and approval of establishments in the nimal origin business, which will replace the existing Ordinance (Official Gazette 123/2019, The new Ordinance will not contain a provision on the possibility of registering facilities for slaughter of small ungulates on the holding of origin. ments registered under the current Ordinance for the slaughter of small ungulates on the f origin shall, ex officio, if they comply with the relevant provisions of Regulation (EC) and the Ordinance on measures to adapt to the requirements of food regulations. 51/15, 1/19), to be entered in the Register of approved establishments in the food business of animal small-capacity establishments for the slaughter of ungulates. In another case, if the registered s for slaughtering small ungulates do not comply with the provisions of the above regulations not possible to approve them, they will be deleted from the Register of registered ments in the food business of animal origin (currently there are 2 existing establishments of s the derogation provided for in Article 1 (3) (d) of Regulation 853/2004 on the direct supply of ntities of poultry and bivalve me

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P prinicples, senior veterinary inspectors (VVI) from the DIRH Central Office will conduct or veterinary inspectors and authorized veterinarians of delegated bodies performing official slaughterhouses in all regional offices (Zagreb, Osijek, Rijeka, Varazdin and Split) with special o the procedures for accepting animals for slaughter (slaughter of pure animals). ings will be organised and conducted by the end of 2022. nd of 2022, the Veterinary Inspection of the State Inspectorate will update the procedure ON OF THE IMPLEMENTATION OF OFFICIAL CONTROLS" by introducing changes with the out of the total number of planned verifications for the calendar year, 25% of inspections exclusive on HACCP system audits, and the remaining 75% of supervision will continue to be ve. ion, the veterinary inspection of the State Inspectorate will send a letter to the Croatian ber to organize trainings for authorized veterinarians of delegated bodies by the end of er to comply with the provisions of Art. 5 (1) (b) increase the level of knowledge of veterinarians of delegated bodies in relation to the control of food business operators and shment of procedures based on the principles of the HACCP system

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certain tasks of official controls was entrusted to the SI, and under the previous Law on Veterinary Medicine, these tasks were entrusted to the Ministry of Agriculture. Accordingly, in the coming period until the end of 2021 and during 2022, measures will be taken to better coordinate, communicate and educate DB by SI, in order to meet the provisions of Art. 5. Regulation (EU) 2017/625. 2.) Sector for Veterinary Supervision and Food Safety Supervision, the Veterinary Inspection Service will conduct trainings in 5 Regional Offices of (regional) veterinary inspectors working in the field of conducting official controls of fishery products by the end of 2021 and in the first quarter of 2022, making a risk assessment after the performed supervision in order to establish a positive finding on the food safety criteria in order to change the risk to higher and to forward the information to the authorized veterinarians DB and enter the data on the change of risk in the `VETI' application. The training program will also include supervision over the control and keeping of records on temperature regimes in facilities for storage and processing of fishery products. The trainings will also ref

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trol of the approval of facilities approved under the flexibility es of Regulation (EC) 853/2004, as follows: tor for Veterinary Supervision and Food Safety Supervision, erinary Inspection Service from the Central Office will duct trainings as already stated in point 1 of the Action Plan in (five) Regional Offices, with clear instructions on mandatory trol of registered quantities of products in the `VETI' system. incoming traceability documents (invoices, receipts ...) are cked and compared with the quantities entered in the `VETI' lication. s will also be given as an Instruction for the work of veterinary pectors in the Plan for 2022 to check the performance of (all) ivities for which they are approved and that for those activities t are not performed in the facility when conducting official trols in facilities for processing fishery products officially uest for deletion from the Register will be sent to CA (MA). h an obligation will be determined by a letter to authorised erinarians of DB, to inform the competent SVI by official letter er the determination of the termination of the approved activity FBO, so that it has information about it and requests official etion from the Re

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ervision, Veterinary Inspection Service from the Central ce, will conduct trainings as stated in the action plan in items e: 3 ref. DG(SANTE) 2021-7161 of the audit carried out from 19 April 2021 to ing the production and placing on the market of fishery products on Proposed by the competent authority d 2 for inspectors conducting official controls in facilities for essing fishery products and placing on the market GH and ted to determining the shelf life of the product in relation to liance with the requirements of Art. 7 Regulation (EC) /2005, ie food safety criteria and taking measures to prevent recurrence of unacceptable microbiological contamination, ng on RASFF notifications, and changing the risk of the FBO lity to a higher category. Page: 4

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For the establishments listed in section 2 of this report, the auditor analysed the most recent inspection reports and interviewed the inspectors on the assessment of operators' HACCP plans. The auditor noted that the assessment of the hazard identification part of the HACCP-plan by the inspectors was not always comprehensive: 1) For feed additives in general, it was not always verified that only authorised substances are used in the manufacture of feed. 2) For feed additives produced by fermentation, the necessity to verify that only authorised strains of the microorganisms were used, was missed by all of the inspectors interviewed. 3) For feed additives of mineral origin and produced by chemical synthesis, the occurrence of certain chemical hazards (e.g. dioxins/polychlorinated biphenyls (PCBs), heavy metals) was omitted in some cases. 4) The carrier of vegetable origin in a premixture was not a subject to hazard identification and this was not spotted by the inspectors. 5) In some cases, hazards which were not justified were included in the HACCP-plan (e.g. melamine in domestically produced cereals). 6) In one case, the auditor noted that the operator's hazard identification was generic without the level of detail necessary for a proper hazard identification, while the inspector made a largely comprehensive assessment of the hazard identification. However, the failure of the operator to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was not reflected in the most recent inspection report seen. Consequently, the operator was not notified about those deficiencies and was thus not incentivised to rectify them.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's (a) assessment of operators' HACCP plans, (b) assessment of the adequacy of operators' tests on homogeneity of mixing and cross-contamination, and (c) verification of operators' compliance with labelling requirements. 6 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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The verification of establishments' tests on homogeneity of mixing and minimisation of cross- contamination, required by part 2(b) and 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. The SI explained that relevant operators carry out those tests at least once every five years. The auditor noted that certain substances which are likely to naturally occur in many feed materials (e.g. sodium ions) were erroneously used by operators for the test on the homogeneity of mixing. In some tests on cross-contamination, operators used tracers (e.g. iron and zinc particles) even though those tracers were not representative of the physical properties of the substances of concern (e.g. coccidiostats). The auditor noted that the inspectors were not provided with assessment criteria to enable them to effectively evaluate the operators' checks on homogeneity of mixing and the measures to avoid 5 cross-contamination. This is not in line with the requirements laid down by Article 5(1)(a)(b) of Regulation (EU) 2017/625.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's (a) assessment of operators' HACCP plans, (b) assessment of the adequacy of operators' tests on homogeneity of mixing and cross-contamination, and (c) verification of operators' compliance with labelling requirements. 6 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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The official check of whether operators meet the legislative labelling requirements always forms part of the inspections. The auditor interviewed several inspectors on assessment of operators' labels and noted the following: 1) In general, the inspectors interviewed referred to Article 16 of Regulation (EC) No 1831/2003, Chapter IV of Regulation (EC) No 767/2009 and the Annex to Regulation (EU) No 68/2013 as a source of pertinent legal requirements. However, none of the inspectors mentioned legal acts authorising individual feed additives, which often contain additional labelling requirements. This led to several cases where some specific labelling information was missing on the labels seen and this was not spotted by the inspectors. 2) In two labels of premixtures, the stability conditions should have been mentioned in the directions for use for certain feed additives, as required by the respective authorisation acts. This deficiency was not spotted by the inspector interviewed and had not been noted in the most recent inspection report. 3) A product containing the feed additive clinoptilolite was claimed to be effective against mycotoxins and the inspector interviewed erroneously endorsed that claim. However, at the time of the audit, the additive was authorised only for the category "technological additives", functional groups "binders" and "anti-caking agents". 4) A trade name only was given for one feed additive without further itemisation. This was not spotted by the inspector during the interview and had not been noted in the most recent inspection report. 5) In several cases, certain mandatory labelling information required by Articles 15 and 17 of Regulation (EC) No 767/2009 (e.g. batch or lot reference number, net quantity, moisture content, instruction for proper use) was missing which was not spotted by the inspectors interviewed and had not been noted in the most recent inspection reports. Conclusion on the planning and implementation of inspections

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's (a) assessment of operators' HACCP plans, (b) assessment of the adequacy of operators' tests on homogeneity of mixing and cross-contamination, and (c) verification of operators' compliance with labelling requirements. 6 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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The VFSD showed that it had written designations for all four laboratories. The auditor noted that while most of the requirements laid down in Article 37 of Regulation (EU) 2017/625 were met, methods of laboratory analysis used for the purposes of official controls by two of the laboratories were not in the scope of their respective accreditation to EN ISO/IEC 17025, thus not fulfilling the requirements of Article 37(5)(a) of said Regulation.

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in the legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 5.2.3 Actions taken on non-compliances

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The auditor noted that, contrary to the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009, none of the three regional offices included in the scope of this audit possessed a mechanical or automatic divider necessary for preparing the final samples in case of the control of constituents, including genetically modified material, or substances likely to be distributed in a non-uniform way in feed materials. In two of the three regional offices, there was no adequate equipment available for sampling of large bulk consignments (e.g. a long sampling spear). This is not in line with the requirements laid down in Article 5(1)(f) of Regulation (EU) 2017/625.

The auditor interviewed several inspectors on the implementation of sampling provisions laid down in Article 1 of, and Annex I to, Regulation (EC) No 152/2009. In addition, a number of sampling reports from previous years were scrutinised. Based on these, the auditor observed the following: 1) The concept of "sampled portion" was in many cases misunderstood and thus not implemented properly by the inspectors. 2) In many cases, the inspectors experienced difficulties with the determination of the analyte's distribution pattern in the matrix. As a result, the calculation of the number of incremental samples was erroneous. 3) In many cases, the legal requirements on the size of the aggregate sample and size/number of final samples were not properly implemented. 4) Due to the absence of mechanical or automatic dividers (within the respective service), all of the final samples were prepared by quartering, which cannot ensure representative division in case of the control of constituents, including genetically modified material, or substances likely to be distributed non-uniformly in feed materials. This is not in line with the requirements laid down in part 1 of Annex I to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in the legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 5.2.3 Actions taken on non-compliances

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The auditor interviewed several inspectors on the implementation of sampling provisions laid down in Article 1 of, and Annex I to, Regulation (EC) No 152/2009. In addition, a number of sampling reports from previous years were scrutinised. Based on these, the auditor observed the following: 1) The concept of "sampled portion" was in many cases misunderstood and thus not implemented properly by the inspectors. 2) In many cases, the inspectors experienced difficulties with the determination of the analyte's distribution pattern in the matrix. As a result, the calculation of the number of incremental samples was erroneous. 3) In many cases, the legal requirements on the size of the aggregate sample and size/number of final samples were not properly implemented. 4) Due to the absence of mechanical or automatic dividers (within the respective service), all of the final samples were prepared by quartering, which cannot ensure representative division in case of the control of constituents, including genetically modified material, or substances likely to be distributed non-uniformly in feed materials. This is not in line with the requirements laid down in part 1 of Annex I to Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in the legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 5.2.3 Actions taken on non-compliances

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The auditor interviewed the representatives of the Croatian Veterinary Institute's laboratory responsible for the evaluation and interpretation of the analytical results, and scrutinised a number of analytical reports from previous years. It was noted that when interpreting the analytical results and establishing non-compliance as regards undesirable substances within the meaning of Article 1 of, and Annex I to, Directive 2002/32/EC, the laboratory took account of moisture content and measurement uncertainty but not correction for analytical recovery, which is required in part C(6) of Annex II to Regulation (EC) No 152/2009. Furthermore, the level of recovery was not indicated in the laboratory reports seen, which is not in line with pertinent requirements of said Regulation. (3) (3) In their response to the draft report, the laboratory noted that, for chemical elements, the recovery range was 95,6 to 102,3% thus the correction for recovery had not been necessary in line with the provisions of part C(6) of Annex II to Regulation (EC) No 152/2009. 8 Conclusion on the planning and implementation of official sampling

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in the legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 5.2.3 Actions taken on non-compliances

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The audit team noted that some of the production areas contained several "production zones", which may have different classifications; other production areas did not have this division. The audit team noted that this could be a wrong use of terminology as all "production zones" had fixed location and boundaries, had at least one sampling point for microbiological quality monitoring and were individually monitored for E. coli. and therefore individually classified, which are requirements of Regulation (EU) 2019/627 for production areas. 10 In their response to the draft report, it was confirmed that the CVI cannot carry out checks on phytoplankton, and a certain number of samples are processed for biotoxins by the NRL. 11 In their response to the draft report, it was clarified that there is no need to include the requirement for official controls by the competent authority on the operation of official and reference laboratories in the contract signed between the CVI and the IOF, because it is already prescribed by other MoA regulations. 5

In order to classify production areas (or "production zones" in those production areas that are further divided), the competent authorities did not fix a review period for sampling data in order to determine compliance with the requirements for class A, B and C areas, contrary to Article 52(3) of Regulation (EU) 2019/627. National legislation established the conditions for reviewing the classification of the areas: in general, a result over the expected limits for a given class triggered a new sampling on the seventh and tenth day. The downgrade of classification only took place if one of these results, or if one result of the following months' regular monitoring samples, resulted over the expected limits. The downgrade was reverted if results were within the expected limit during three consecutive months. These conditions of Croatian national legislation do not allow an adequate classification of production areas, therefore production areas may be classified as A, B and C without meeting the corresponding standards of Articles 53- 55 of Regulation (EU) 2019/627.

The MoA has not started carrying out sanitary surveys in production areas (or "production zones" in those production areas that are further divided), contrary to Article 56(2) of Regulation (EU) 2019/627.

The monitoring plan established the requirements for the sampling to check the microbiological quality of live bivalve molluscs, as required in Article 59(b) of Regulation (EU) 2019/627. In particular, the monitoring plan established: The sampling frequency, which was monthly in all production areas (or "production zones" in those production areas that are further divided). The periodicity is in line with the above-mentioned EURL guidance document. 12 The guidance document of the EU Reference Laboratory for monitoring bacteriological and viral contamination of bivalve molluscs ("Good Practice Guide; issue 7", December 2018). 6 The location of the sampling points. The competent authority designated these points years ago but there was no robust basis to support their locations. It could not be ensured that they were representative of the production areas, contrary to Article 61(1) of Regulation (EU) 2019/627 and, therefore, they were of limited value. In addition, until sanitary surveys are completed, the monitoring plan is not in line with Articles 57 and 58 of Regulation (EU) 2019/627. The sampling method, including sampling at different depths when molluscs are farmed in ropes. The audit team found the method adequate for samples intended for microbiological analysis. The bivalve mollusc species, which was aquaculture mussel when this species was available. The plan did not consider sampling other mollusc species available in the same geographical location, either aquaculture oysters in the same area or natural beds in overlapping production areas. Therefore, and partly due to the lack of sanitary surveys, the competent authority did not take into account the likely variation in faecal contamination between different molluscs species, contrary to Article 61(2)(a) of Regulation (EU) 2019/627. b) For the presence of toxin-producing plankton in water

As explained in point 10 of this report, in general, a result over the expected limits for a given class triggered a new sampling on the seventh and tenth day. The downgrade of classification only took place if one of these results or if one result of the following months' regular monitoring samples, had a result over the expected limits. The downgrade was reverted if results were within the expected limit during three consecutive months. This is contrary to Article 52(3) of Regulation (EU) 2019/627, based on which this reversion should only take place if the evaluation of the results available for the review period determine compliance with the corresponding standards. b) For the presence of toxin-producing plankton in water

The competent authority has established the location and boundaries of "production zones", monitors them individually for microbiological quality and classifies them. They conform to the EU concept of production areas, but the use of the term "production zones" is misleading.

The current classification of production areas (or "production zones" in those production areas that are further divided) is not in line with the EU requirements. This poses certain doubts that the level of contamination of molluscs harvested corresponds to the value expected according to their classification. In addition, as the plan does not consider sampling other mollusc species available in the same geographical location, this generates a risk of misclassification of the corresponding areas.

The lack of sanitary surveys questions the validity of the designated sampling points for microbiological monitoring and their representativeness for production areas, which has direct implications in the adequate classification of production areas.

The fact that the competent authority: does not close or reclassify the production area when certain regulatory limits for microbiological quality are exceeded for the first time, has not established review periods, and reverts the downgrade of classification with a few good results, may result in the placing on the market of bivalve molluscs with amounts of E. coli higher than the permitted ones, therefore being a potential risk for consumers.

Medlemsstatens svar

Ministarstvo poljoprivrede izradit e u cetvrtom kvartalu nd 2021. godine novi Pravilnik o mikrobioloskom razvrstavanju are i postupku u slucaju onecisenja zivih skoljkasa te posebnim ) and 62 pravilima organizacije i provedbe sluzbenih kontrola koja se provode na proizvodnim podrucjima i podrucjima za onovno polaganje zivih skoljkasa. Tim Pravilnikom e se, u skladu s clancima 52 (2) i (3) te clankom 62 Uredbe (EU) 627/2019 detaljno propisati obveze Uprave za veterinarstvo i sigurnost hrane i veterinarskih inspektora Drzavnog inspektorata, vezane uz klasifikaciju proizvodnih podrucja i donosenje odluka, ovisno o razini fekalnog onecisenja. Istim Pravilnikom biti e odreeno vrijeme preispitivanja podataka dobivenih s proizvodnih podrucja i podrucja za ponovno polaganje, kako bi se utvrdila usklaenost s normama navedenim u clancima 53, 54 i 55 Uredbe (EU) 627/2019. Nakon stupanja na snagu spomenutog pravilnika nadlezno tijelo obaviti e novu klasifikaciju, odnosno reklasifikaciju trenutacnih proizvodnih podrucja na osnovu postojeih podataka, a u skladu s propisanim periodom preispitivanja. Ministarstvo poljoprivrede planira tijekom 2022. godine dovrsiti izradu sveobuhvatnog sanitarnog p

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The monitoring plan established the requirements for the sampling of water to check for the presence of toxin-producing plankton in production areas, as required in Article 59(c) of Regulation (EU) 2019/627. In particular, the monitoring plan established: The sampling frequency for water, which was weekly except from December to March, when it was fortnightly (due to the absence of biotoxins episodes, according to the explanation provided). The weekly periodicity was adequate but the evidence presented to support fortnightly sampling did not provide a robust basis for this decision: the audit team noted at least two results over the limit for biotoxins (one of PSP and one of lipophilic toxin) during these winter months. Peaks of plankton preceding biotoxin episodes can go unnoticed in between two samplings. The location of the sampling points. These points were located inside production areas, coinciding with sampling points for biotoxins. Therefore, they were of limited value as early warnings suggesting an accumulation of biotoxins, and are not representative, contrary to Article 61(1) of Regulation (EU) 2019/627. The sampling method, which consisted of a 20 microns mesh diameter net, pulled vertically from the bottom to the surface. This method was adequate for qualitative purposes as it filtered larger amounts of water and, therefore, concentrated the number of phytoplankton cells (the IOF provided data collected in 2007 that show higher accumulation of cells using this net) and it could complement a quantitative method. However, the vertical pulling of the net does not allow the collection of a representative sample of the water column, contrary to Article 61(7) of Regulation (EU) 2019/627. 7 The persons that could collect samples. According to the information provided, in general, staff from the IOF took water samples, using the method described in the previous point (i.e. net). In remoter areas, authorized veterinarians took water samples. The audit team assessed a PSP episode that occurred in one of these remoter areas, and noted a very low number of the corresponding plankton species. Following the request of the audit team for an explanation on that, the IOF found that authorized veterinarians did not use the prescribed sampling method and they collected only surface water.

The IOF established the list of toxin-producing plankton species that had to be monitored, but did not determine thresholds for some of them. According to the information provided, these species were rare in the Croatian waters, but the audit team noted that laboratory results regularly reported a few of them (e.g. Alexandrium spp.). In addition, the laboratory did not consider the different toxicity of different species within the same genus (e.g. Dinophysis spp). c) For the presence of biotoxins in live bivalve molluscs

The official control system did not foresee any decisions following monitoring for the presence of toxin-producing plankton in water. In particular, it did not foresee an intensive sampling following results suggesting an accumulation of toxins in live bivalve mollusc flesh, contrary to Article 61(3)(a) of Regulation (EU) 2019/627.

According to the information provided, the laboratory did not have to highlight results exceeding the limits when transmitting the test results to competent authorities. The laboratory did not have to transmit the results to other laboratories in charge of analyses for biotoxins either, although this could help the analyst to focus on potentially positive samples. c) For the presence of biotoxins in live bivalve molluscs

The current monitoring programme for toxin-producing plankton is not adequate as an 11 early warning system for the appearance of biotoxins in molluscs. In addition, the fact that the official control system does not foresee any decisions following this monitoring, makes it of no value.

Medlemsstatens svar

ce of U Pravilniku o mikrobioloskom razvrstavanju i postupku u s 61(1), slucaju onecisenja zivih skoljkasa te posebnim pravilima rovedbe sluzbenih kontrola koja se provode odrucjima i podrucjima za ponovno skoljkasa, koji e Ministarstvo raditi u cetvrtom kvartalu 2021. godine, bit ce/pragovi za plankton koji proizvodi Pravilniku biti e detaljno propisane ne uz postupanja nadleznih tijela u slucaju 61 (7) Uredbe (EU) 627/2019 javanje odredbi clanka 61 (7) Uredbe zorkovanje morske vode radi kontrole ktona koji proizvodi toksine obavljat e se nja koja osigurava da je predmetni ativan za vodeni stupac. joprivrede e, prilikom izrade Plana za eispitati potrebu revidiranja dosadasnjih ja morske vode - planktona koji proizvodi skoljkasa koji se pretrazuju na prisutnost odine Institut za oceanografiju i ribarstvo aciju osoba / ovlastenih veterinara iz la koji uzorkuju morsku vodu. Page: 2 received 15 May 2021 dations of report ref. DG(SANTE) 2021-7255 of the audit carried out from 01 February in place for live bivalve molluscs Action Proposed by the competent authority

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The monitoring plan established the requirements for the sampling to check for the presence of biotoxins in live bivalve molluscs. In particular, the monitoring plan established: The sampling frequency, which was weekly in production areas. Although this frequency met the requirement of Article 61(4) of Regulation (EU) 2019/627, the plan did not include the sampling of all "production zones", therefore is does not comply with Article 59(c) of Regulation (EU) 2019/627. The location of the sampling points. The competent authority designated these points years ago, and in smaller production areas they coincided with the sampling points for microbiological quality. There was no robust basis to support these locations as representative of the production areas, which Article 61(1) of Regulation (EU) 2019/627 requires. The sampling method. The audit team found it adequate for samples intended for biotoxin analysis. The bivalve mollusc species, which was aquaculture mussel when this species was available in a production area; and the most abundant species available in the rest of the cases. Aquaculture mussel was also the indicator species when a production area with natural beds coincided geographically with a production area with farmed molluscs. The use of mussels as indicator species is common due to their toxin accumulation rates; however, the use of the most abundant species as indicator species does not meet the requirements of Article 61(6) of Regulation (EU) 2019/627. d) For the presence of chemical contaminants 8

There are several factors that diminish the value of the monitoring programme for biotoxins for detecting biotoxins above the established limits in production areas: the plan does not include all "production zones"13, the sampling points may not be representative of the area monitored, and the most abundant specie, and not the most representative one, is sometimes used as indicator. Although biotoxin episodes can be therefore overlooked or underestimated during monitoring, the risk of presence of biotoxins in Croatian molluscs does not seems high as data from previous years show very few episodes of biotoxins in Croatian waters.

Medlemsstatens svar

esence U svrhu kontrole prisutnosti morskih biotoksina u skladu s c), 61(1) clankom 59 ( c ) i clankom 61 (1 i 6) Uredbe 2019/627 Ministarstvo poljoprivrede e prilikom izrade Plana za 2022. godinu prema potrebi preispitati potrebu revidiranja dosadasnjih tocaka uzorkovanja na prisutnost planktona koji proizvodi toksine u vodama na proizvodnim podrucjima i na podrucjima za ponovno polaganje te tocaka uzorkovanja na prisutnost biotoksina u zivim skoljkasima. Na osnovu raspolozivih rezultata iz dosadasnjih Programa praenja i relevantne znanstvene literature, a u skladu s dostupnim vrstama koje se na nekom podrucju izlovljavaju, odredit e se vrsta skoljaka kod koje je brzina nakupljanja toksina najvea.

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Regarding the ASP laboratory reviewed: The laboratory validated and accredited this method in 2009 and it has not renewed the validation since then (according to the information provided, it was due to the considerable amount of certified reference material that it implied and the corresponding costs, and because there was no ASP in Croatian waters). The laboratory carried out the validation in mussels, although some of the samples tested in this laboratory were from other molluscs' species. This may have an impact on the testing results due to the potential matrix effect. The laboratory carried out the testing according to a SOP, using reference material tissue as internal quality control. However, the SOP did not reflect the actual identification and performance criteria used during the analysis. The participation in the last inter-comparison tests showed satisfactory results.

Regarding the PSP laboratory visited: The laboratory recently revalidated this method in December 2020. The accreditation of this method did not have within its scope all the compounds that this laboratory tested. The laboratory carried out the testing according to a SOP, and used only certified reference material. There were internal quality controls established for the method, tested in each sequence of analysis. The laboratory tested all the relevant PSP compounds, however the SOP did not reflect it (i.e. GTX 6 and C3, 4). The participation results of the last inter-comparison tests showed good results for total toxicity, but unsatisfactory results for STX in one of the three samples. The laboratory suspected a problem with the equipment but did not find a conclusive explanation for the result; therefore, it did not implement any corrective action. As the STX is the most toxic compound of this group, this could pose a risk of underestimation of PSP if an episode would occur.

Regarding the two lipophilic toxin laboratories reviewed: The laboratories validated and accredited this method in 2014 for all the compounds of the lipophilic toxin group. 15 The laboratories carried out the validation in mussels, although some of the samples tested in this laboratory were from other mollusc species. One of the laboratories recently started the revalidation of the method and the other laboratory scheduled a revalidation in 2021. In both cases, the revalidation was going to include other mollusc species, which is imperative in order to take into account the potential matrix effect in the testing results. The laboratories carried out the testing according to the corresponding laboratory SOP, using in both cases the certified reference materials commercially available for this toxin group to prepare calibration standards and internal quality controls. However, the SOPs did not include the performance criteria for internal quality controls. In one of the laboratories, the SOP did not reflect the formula for calculation of individual toxin concentrations, and in the other, it did not include the identification criteria for certain compounds. The results of participation in the last inter-comparison tests showed unsatisfactory and questionable results for some of the compounds/individual toxins of this group. Both laboratories suspected a problem with the sample matrix but did not find a conclusive explanation for this result. This could pose a risk of underestimation of the lipophilic toxin group when an episode occurs (the lipophilic toxin group is the most common biotoxin in Croatian waters).

Although laboratories have validated the analytical methods, a validation carried out more than a decade ago or the use of a method validated for one species when analysing a different one may diminish its significance.

The fact that not all the PSP compounds that laboratories test are included in the scope of accreditation of the method diminishes the reliability of those tests results.

Laboratories provide, in principle, reliable results but there is certain risk of underestimation of biotoxins as laboratories did not find conclusive explanations for unsatisfactory and questionable results in proficiency tests.

Medlemsstatens svar

Laboratoriji su akreditirali sve metode koje primjenjuju pri ke analizama. Za neke od metoda, za koje je postupak , validacije obavljen prije vise godina, tijekom 2022. godine 4. bit e provedena revalidacija. U podrucju akreditacije navest e se toksini koji su bili u postupku validacije i postupku provedbe PT - i prosiriti akreditaciju na toksine koje je potrebno validirati. 2022. godine e se u postupak akreditacije PSP metode ukljuciti spojevi koji su ve validirani i ukljuceni u postupak ispitivanja PSP toksina u uzorcima skoljkasa Page: 3 received 15 May 2021 dations of report ref. DG(SANTE) 2021-7255 of the audit carried out from 01 February in place for live bivalve molluscs Action Proposed by the competent authority

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According to national legislation, and in line to Article 101(1)(e) of Regulation (EU) 2017/625, National Reference Laboratories (NRLs) had to provide scientific and technical assistance to the competent authority. However, currently they provided scarce assistance to the MoA (e.g. regarding the designation of sampling points or the species to be sampled) and of limited value for developing the monitoring plan for the production areas. 8 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. 9 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. 4

Since 20019, the MoA has not carried out audits of official laboratories, contrary to the requirement of Article 39 of Regulation (EU) 2017/625. Every year, the MoA signs a contract with the CVI, which designates two of its laboratories as official controls laboratories for the implementation of the monitoring plan of production areas. Traditionally, the CVI subcontracts part of the biotoxin analyses to the IOF. Although the original contract foresees the possibility of subcontracting, this may only occur where the CVI itself is not able to ensure the implementation of the plan. The audit team had doubts about the need for subcontracting biotoxin analyses as the two CVIs designated are fully equipped and receive a limited number of samples per week (nine on average, see points 55-58), but the CVI explained that subcontracting to the IOF is in line with the internal organisation of the activities of the CVI and MoA10. The subcontracting contract does not contain certain legal requirements that are included in the original contract signed between MoA and CVI (e.g. the official controls by the competent authority on the operation of official and reference laboratories)11.

The national legislation that incorporates the EU requirements is obsolete and does not correctly interpret some of these requirements, which is of particular relevance in relation to the decisions that the competent authority takes subsequent to the monitoring of production areas for microbiological quality. The MoA, which designs the monitoring plan that is the basis for the official control of production areas, has a reduced oversight of the sector. This is partly due to the currently significant lack of input from NRLs into the monitoring plan. All this has a negative impact in the effectiveness of the control of production areas.

Regarding the NRL: This laboratory did not prepare inter-comparison tests but it requested to the EURL the participation of the two other official control laboratories in the EURL annual proficiency testing. There was no established frequency; their participation depended on the availability of samples at the EURL. According to the information provided for one of the biotoxins as an example, one of the laboratories participated every year since 2014. Due to the pandemic in 2020, the laboratories did not participate in a proficiency testing in 2020. The result of the 2019 proficiency testing indicated that the two official control laboratories could not always detect all the compounds of the PSP group. It also showed questionable or unsatisfactory results for a few of the PSP compounds and for some of the compounds of the lipophilic toxin group. This may lead to a potential underestimation of these toxins if an episode would occur. The NRL asked laboratories to carry out a follow-up of these results, but only closer support would ensure the appropriate follow-up that Article 101(1)(c) of Regulation (EU) 2017/625 requires. Apart from requesting follow-up of questionable or unsatisfactory proficiency testing results, the audit team did not find evidence of implementation of Article 101(1)(b) of Regulation (EU) 2017/625, regarding the responsibilities of NRLs to coordinate the activities of official laboratories with a view of improving the methods of laboratory analysis. 16 Conclusions on laboratories

The NRL for biotoxins is not entirely fulfilling all its responsibilities and tasks, which can affect negatively the harmonisation and improvement in the performance of testing methods by other official laboratories and the competence of staff when using these complex analytical methods.

Medlemsstatens svar

U cetvrtom kvartalu 2021. godine Ministarstvo ticle poljoprivrede provest e u skladu s clankom 39 stavkom 1 the Uredbe (EU) 2017/625 reviziju sva tri sluzbena ories laboratorija, ukljucujui i NRL. NRL za biotoksine e kontinuirano nastaviti: - Suradnju s EURLMB i sudjelovanje u meulaboratorijskim usporednim ispitivanjima koje organizira taj laboratorij - Organizirati meulaboratorijska usporedna ispitivanja s sluzbenim laboratorijima (u Hrvatskoj) kad dobije uzorke od EURLMB obzirom da u hrvatskim vodama nema pozitivnih rezultata za sve grupe biotoksina u skoljkasima koji bi se mogli koristiti za meulaboratorijska usporedna ispitivanja. - Prosljeivati informacije nadleznim tijelima i sluzbenim laboratorijima (zakljucke s godisnjih sastanaka europskih NRLs i drugu relevantnu dokumentaciju) - davati sugestije i primjedbe pri izradi Plana praenja na zahtjev nadleznog tijela Nacionalni referentni laboratoriji e nastaviti pruzati potporu i biti na raspolaganju Ministarstvu poljoprivrede te sudjelovati na sastancima pri izradi plana praenja. NRL za mikrobiologiju e nastaviti s kontinuiranom dostavom izvjesa sa sastanka EURL kao i godisnjih izvjesa. Page: 4 received 15 May 2021 dations of r

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However, the audit team noted that Article 10(7) of the Ordinance No 19/16 does not allow CBs to carry out inspection visits to plant/animal production operators from 15 November to 1 March, which may limit the effectiveness of the controls for the reasons indicated in paragraph 47. Conclusions on Relevant National Legislation and Provisions

The two CBs informed the audit team that in accordance with national legislation and instruction from the CA, inspection visits to plant/animal production operators can only take place from 1 March to 15 November. The CBs and the audit team consider that this constraint could cause CBs difficulties to visit some operators at the time when the occurrence of non-compliances is more likely (i.e conditions of animals kept indoor during winter, olive producers, use of fertilisers in plant production, additional visits). In addition, operators know that inspection will not take place during this period. 11

Medlemsstatens svar

Preporuka se odnosi na odredbu Pravilnika o ekoloskoj poljoprivrednoj proizvodnji (Narodne novine, br. 19/16), clanak 10. stavak 7. kojom je propisano da kontrolna tijela provode strucnu kontrolu proizvodnje (subjekti kategorije A iz Upisnika) u razdoblju od 1. ozujka do 15. studenoga. Ova odredba je ocijenjena kao ogranicavajua za kontrolna tijela koja nisu u mogunosti tijekom zime provjeriti sukladnost subjekata s odredbama Uredbe 834/2007, pogotovo kada se radi o drzanju zivotinja na otvorenome, koje se u zimskom razdoblju smjestaju u nastambe. U Pravilniku o kontrolnom sustavu ekoloske poljoprivrede (Narodne novine, br. 11/20) vremensko, odnosno terminsko ogranicenje za provoenje kontrola je ukinuto. Clankom 32. stavkom 1. propisano je da se planiranje kontrola kod subjekata kategorije A (proizvoaci) provode u pravilu u razdoblju vegetacije, a da planiranje termina kontrola ovisi o vrsti proizvodnje, kriticnim fazama, period vegetacije i podneblju. Hrvatska smatra da je ova preporuka usvojena.

The recommendation refers to Article 10(7) or of the Rules on organic agricultural production (Narodne novine (NN; Official Gazette of the Republic of Croatia) No 19/16), which requires control bodies (CBs) to carry out controls on production (category- A operators in the Register) from 1 March to 15 November. This provision is considered restrictive for CBs that are unable to verify in winter whether operators comply with Regulation (EC) No 834/2007, especially with regard to the keeping outdoors of animals that are housed indoors in winter. The Rules on the control system for organic agriculture (NN No 11/20) have abolished the time limit for carrying out controls. Article 32(1) requires controls of category-A operators (producers) to be planned as a rule during the vegetation period, and the time limits for controls to be planned according to Page: 1 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic Action Proposed by the competent authority the type of production, critical phase, vegetation per

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The CCA provided evidence to the audit team that results of controls are communicated by the CAs to the PA and from the CBs to the PA. However, the audit team also noted that in some cases the CBs did not notify irregularities either to the CCA or to the PA, which is not in line with Articles 92(4) and 92(6) of Regulation (EC) No 889/2008.

The audit team reviewed examples of the exchange of information between the CBs, the CAs, the PA and SI. The audit team noted that overall there is a good communication between the CAs and the PA. However, it was noted that communication between the MA and the SI was not adequate. Similarly the audit team identified cases where the communication between CBs and other interested parties (like other CBs, CAs or PA) was not adequate or did not happen due to a lack of documented procedures to enable exchange of information, which is not in line with Article 31 of Regulation (EC) No 834/2007 and Article 92 of Regulation (EC) No 889/2008 (see also findings 9, 19, 35 and 95). Conclusions on Competent Authorities and Control Bodies

However, the audit team noted that there was no adequate official communication between the MA and the SI on supervision activities of CBs. The SI did not receive the monthly inspection reports and documentary evidence issued by CBs and submitted to the MA and the result of the documentary supervision. The CAs stated that there is not yet a procedure in place to exchange information between the two parties as from April 2019 the SI is not anymore under the MA.

The majority of OFIS cases notified of Croatian products are related to few operators. Four operators were involved in several OFIS notifications. The audit team noted that the MA, when irregularities are detected, notifies the case to other MSs in the OFIS system. However, the audit team noted that on several occasions the CCA was not able to reply in OFIS within the required 30 days. The CCA stated that they do not have a formal procedure in place to deal with OFIS notifications. The MA is working on an updated organic Ordinance which would include procedures for dealing with OFIS notifications. The audit team also noted that even if the MA starts investigations, it is the SI who is responsible for carrying out the inspections and the follow-up to the operators involved. The lack of an efficient and fluid communication between the two services may be the reason for several cases of delays in finalising investigations.

Medlemsstatens svar

I prije provedbe revizije DG(SANTE) 2019-6710 bila je uspostavljena procedura razmjene podataka o provedenim kontrolama. Prema navedenoj proceduru, kontrolna tijela su obvezna jednom godisnje, za proizvoace koji su ukljuceni u Mjeru 11 (potpora za ekolosku proizvodnju), potvrditi provoenje ekoloskih praksi za povrsine koje su ukljucene ukljucene u Mjeru 11. Ova razmjena podataka provodi se kroz AGRONET sustav AP na temelju sporazuma koji je sklopljen izmeu AP i KT-ova. nikom o kontrolnom sustavu ekoloske poljoprivrede uspostavljen je dodatni protokol za nu informacija o subjektima ukljucenim u kontrolni sustav i o rezultatima kontrola izmeu KT-ova i NT-ova. Ugovaranje sa subjektima Page: 1 ommendations received 10 March 2020 o the recommendations of report ref. DG(SANTE) 2019-6710 of the audit carried out from 24 September ontrol systems for organic production and labelling of organic products Action Proposed by the competent authority nkom 18. stavkom 3. propisano je da KT-ovi dostavljaju MP i AP na mjesecnoj razini obavijest o svim ugovorima o kontroli koje su sklopili sa subjektima. Na ovaj nacin osigurava se da AP ima informaciju o subjektima koji se namjeravaju ukljuciti u kon

Even before audit DG(SANTE) 2019-6710, here was a procedure in place for the exchange of data on controls carried out. The procedure requires CBs to confirm, once a year, in respect of producers included in Measure 11 (support for organic production), that organic practices have been implemented in the areas included in Measure 11. The data are exchanged via the PA's AGRONET system further to an agreement between the paying agency (PA) and CBs. The Rules on the control system for organic agriculture establish an additional procedure for the exchange of information on operators included in the control system and on the results of controls between CBs and competent authorities (CAs). Contracts with operators Page: 2 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic t authority ubmit Agriculture asis, on all with operators. formation on ed in the on any red in the r operators ucers. it information to the MA, without delay. d of the ct with a not been entered into with accordance the PA will f the SI s

Medlemsstatens svar

Pravilnikom o kontrolnom sustavu ekoloske Poljoprivrede propisani su oblici nadzora e kontrolnih tijela koje provodi DI. Clankom 40. propisani su oblici nadzora kao redovni i Page: 2 ommendations received 10 March 2020 o the recommendations of report ref. DG(SANTE) 2019-6710 of the audit carried out from 24 September ontrol systems for organic production and labelling of organic products Action Proposed by the competent authority izvanredni nadzor. Redovni nadzor provodi se najmanje jednom godisnje kod svih kontrolnih tijela i obuhvaa: d -pregled dokumentacije u uredu kontrolnog tijela (office audit), -nadzor kontrole koju provodi kontrolno tijelo kod subjekta (witness audit) -revizija kontrole koju je provelo kontrolno tijelo kod subjekta (revision audit) Izvanredni nadzor provodi se po potrebi, obavezno a u slucaju utvrenih nepravilnosti u radu kontrolnog tijela kako bi se potvrdila provedba nalozenih korektivnih mjera. Clankom 41. Pravilnika propisana je ucestalost i obuhvat redovitog nadzora, a clankom 42. opisuje se sadrzaj izvjesa o provedenom nadzoru koje se dostavlja Ministarstvu poljoprivrede u roku od 60 dana ukoliko nema nepravilnosti ili u roku od 15 dana ukoliko je utv

The Rules on the control system for organic ut agriculture lay down the forms of supervision of CBs to be carried out by the SI. Article 40 ness defines the forms of supervision as regular and extraordinary supervision. Regular supervision is carried out at least once a year on all CBs and comprises: - document checks on the CB's premises (`office audit'); - supervision of the controls carried out by the CB on an operator (`witness audit'); - a review of the controls already carried out by the CB on an operator (`revision audit'). Extraordinary supervision is carried out as the need arises, and is mandatory if irregularities are detected in the CB's work, so as to confirm that the corrective measures imposed have been enforced. Article 41 of the Rules lays down the frequency and scope of regular supervision, while Article 42 lays down the content of the supervision report to be submitted to the MA within 60 days where Page: 5 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic t authority hin 15 days

Medlemsstatens svar

Pravilnikom o kontrolnom sustavu ekoloske poljoprivrede, clankom 9. stavkom 1. kontrolnim tijelima propisuje se obaveza uspostave procedure procjene rizika i kriteriji za procjenu rizika. Navedenu proceduru kontrolna tijela su obvezna dostaviti MP u svrhu izdavanja ovlastenja. Ve ovlastena kontrolna tijela obvezna su dostaviti navedeno u roku od godine dana od dana stupanja na snagu Pravilnika. Ovom odredbom osigurava se da MP moze ocijeniti usklaenost procedure KT-a s propisanim zahtjevima te po potrebi zatraziti izmjene i/ili dopune procedure. Ovom odredbom osigurava se da DI moze ocijeniti usklaenost postupanja KT-a s uspostavljenom procedurom prilikom provoenja nadzora rada KT-a. oer, u Prilogu 14. propisuje se obrazac izvijesa o provedenom nadzoru rada kontrolnog tijela koji provodi DI. Ovim obrascem se osigurava uzimanje u obzir svih relevantnih Page: 3 ommendations received 10 March 2020 o the recommendations of report ref. DG(SANTE) 2019-6710 of the audit carried out from 24 September ontrol systems for organic production and labelling of organic products Action Proposed by the competent authority elemenata kontrole (navedeni su na obrascu), odnosno posljednja akreditacijsk

Article 9(1) of the Rules on the control system for organic agriculture requires CBs to establish a risk assessment procedure and risk assessment criteria. CBs are required to he submit their procedure to the MA in order to as obtain authorisation. CBs already authorised n are required to submit their procedure within ne year of entry into force of the Rules. This provision allows the MA to assess whether the CB's procedure is in line with the requirements and to request a change to the procedure where appropriate. The provision also allows the SI to assess, when supervising the CB's work, whether the Page: 8 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic t authority the procedure ard form for sion of the CB's ant elements the form) to be bsequent report to be the number t, the number ol elements ommission mpliance dure, risk initial and of measures, ). sment nnual report, e previous ed the risk n their annual Page: 9 ndations (updated) received 29 June 2020 mitted by the competent authorities o

Medlemsstatens svar

Popis subjekata p- ravilnikom o kontrolnom sustavu ekoloske poljoprivrede osigurava se osnova za kreiranje Popisa subjekata u ekoloskoj poljoprivredi (koji objavljuje MP) direktno iz popisa subjekata oji objavljuju kontrolna tijela, sto je osigurano clankom 7. stavkom 2.(e) Pravilnika, koji 2b propisuje obvezne podatke koje kontrolna tijela objavljuju na svojim web stranicama (popis subjekata s vazeim dokazima o sukladnosti). SNT je utvrdilo da popis subjekata koji se trenutno kreira na temelju Upisnika subjekata nije adekvatan niti moze biti dovoljno azuran, obzirom da se upis, ispis i promjena u Upisniku provodi kao upravni postupak s rokovima propisanim Zakonom o opem upravnom postupku (Narodne novine, br. 47/09). Obzirom da su popisi subjekata koje vode kontrolna tijela podlozni promjenama iskljucivo na temelju sklapanja ili raskidanja ugovora o kontroli, smatramo da su fleksibilniji i prihvatljiviji za kreiranje popisa subjekata na nacionalnoj razini. d Hrvatska smatra da je ova preporuka djelomicno usvojena. MP e objaviti popis subjekata s pripadajuim pisanim dokazima na web stranici najkasnije do 3. travnja 8. svibnja 2020. godine. Usklaenost pisanog dokaza modelom iz Prilog

The Rules on the control system for organic date to agriculture provide the basis for the creation of a list of operators in organic agriculture ct (published by the MA) directly from the list of operators published by the CBs, as ensured by Article 7(2)(e) of the Rules, which specifies the data to be published by CBs on their websites (a list of operators with valid evidence of compliance). r r The CCA found that the list of operators ation, currently being created on the basis of the Register of operators is not appropriate and Page: 11 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic ction Proposed by the competent authority cannot be kept sufficiently up-to-date, since ntries to, deletions from and changes to the egister are carried out as an administrative rocedure with the deadlines laid down in the eneral Administrative Procedures Act (NN o 47/09). Since the lists of operators anaged by CBs are subject to changes olely on the basis of the conclusion or ermination of control contracts, we co

Medlemsstatens svar

Pravilnikom o kontrolnom sustavu ekoloske poljoprivrede, clankom 31. osigurava se pravna osnova za kreiranje Popisa trgovaca koji su izuzeti od primjene clanka 28. Uredbe (EZ) br. 834/2007. Trgovci koji udovoljavaju uvjetima iz clanka 28. stavka 2. Uredbe 834/2007 obavijest o prodaji ekoloskih proizvoda dostavljaju MP. Ukoliko trgovac koji je podnio h zahtjev ispunjava uvjete MP ga evidentira u Popisa trgovaca koji su izuzeti od primjene clanka 28. Uredbe (EZ) br. 834/2007. atska smatra da je ova preporuka usvojena.

ctly Article 31 of the Rules on the control system not for organic agriculture provides the legal n basis for the creation of a list of traders who e with are exempted from Article 28 of Regulation (EC) No 834/2007. Traders that satisfy the conditions under Article 28(2) of Regulation (EC) No 834/2007 must notify the MA of their sales of organic products. If a trader that has submitted a request fulfils the conditions, the MA will record the trader in the list of traders exempted from Article 28 of Regulation (EC) No 834/2007. ADDITIONAL CLARIFICATION Page: 17 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic t authority erators comply on comprises legal or application. n-line check if they erators with be exempt from list of ailable to the xempted . have to be ption was period, SI will t 5% of lable at this the Page: 18 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control

Medlemsstatens svar

Pravilnikom o kontrolnom sustavu ekoloske poljoprivrede, clankom 11. stavkom 1. kontrolnim tijelima propisuje se obaveza uspostave procedure razmjene informacija. Navedenu proceduru KT je obvezno dostaviti MP u svrhu izdavanja ovlastenja. Ve ovlasteni s KT-ovi obvezni su dostaviti navedeno u roku od godine dana od dana stupanja na snagu Pravilnika. Ministarstvo poljoprivrede e ocijeniti usklaenost procedure s propisanim zahtjevima te po potrebi zatraziti izmjene i/ili dopune procedure. odredbom osigurava se da MP moze ocijeniti usklaenost procedure KT-a s propisanim zahtjevima te po potrebi zatraziti izmjene i/ili dopune procedure, kao i da DI moze ocijeniti Page: 6 ommendations received 10 March 2020 o the recommendations of report ref. DG(SANTE) 2019-6710 of the audit carried out from 24 September ontrol systems for organic production and labelling of organic products Action Proposed by the competent authority usklaenost postupanja KT-a s uspostavljenom procedurom prilikom provoenja nadzora rada KT-a. Nadalje, clankom 11. stavkom 2. propisano je postupanje KT-ova u slucaju kada subjekt mijenja KT (razmjena dokumentacije o subjektu), a stavkom 3. istoga clanka propisana je obveza

Article 11(1) of the Rules on the control system for organic agriculture requires CBs to establish an information exchange procedure. le CBs are required to submit their procedure to o the the MA in order to obtain authorisation. CBs already authorised are required to submit by their procedure within one year of entry into of force of the Rules. The MA will assess whether the procedure is in line with the equirements and request a change to the procedure where appropriate. This provision allows the MA to assess whether the CB's procedure is in line with the requirements and to request a change to the procedure where appropriate. It also allows the SI to assess, when supervising the CB's work, whether the CB's procedure is in line with the procedure in place. Moreover, Article 11(2) lays down a procedure for CBs where an operator changes Page: 19 ndations (updated) received 29 June 2020 mitted by the competent authorities of Croatia in response to Report ref. DG(SANTE) 2019-6710 of ober 2019 in order to evaluate the control systems for organic production and labelling of organic t authority n the requires the the s CB. to submit s entered into information to the MA, s have ange CB a

Medlemsstatens svar

In order to ensure that only consignments of beeswax compliant with the requirements of Annex XIV Chapter II Section 1 Table 2(10) in the Regulation (EU) No 142/2011 are accepted for transit through Croatian territory the Veterinary and Food Safety Directorate has drafted and sent to all BIPs in the Republic of Croatia official letter (CLASS: 322-01/18-01/373, REF. NO: Ref. No: 525-10/1113-18-2 of 29th J u n e 2 0 1 8 ) . I n t h e o f f i c i a l l e t t e r there are clearly stated all requirements which have to be met for consignments of beeswax, originating from third countries, in transit across the territory of the European Union such as prescribed in the Regulation (EU) No 142/2011 and described procedures to be carried out at the BIPs by border veterinary inspectors during performing documentary check of consignments of beeswax in transit, such as described in Article 11(1) (a) of the Directive (EC) No 97/78. The effectiveness of implementation of these measures will be assessed within the supervision of the BIPs, performed twice a year by the Head of Border Veterinary Inspection Service. Page 1

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DAFI stated, that the information in the farm registry is not sufficient to differentiate farms in regards of the microbiological risks of their crop.

Agricultural inspectors are informed by letter about the planned controls to be conducted in a given year. In 2017 and 2018 the number of FNAO controls was set at ten per Agricultural Inspector in charge of food safety. Inspectors stated that they would need to do an effortful individual research to identify farms with the riskiest crops. Therefore, the inspectors met by the audit team choose to add the controls on microbiological risk to the controls of FBOs which were selected for plant protection controls.

The only selection criterion provided by DAFI to the inspectors was the size of farm to be taken into account.

However, regarding primary production, the official control system is not risk based regarding microbiological contamination. Moreover, the selection of farms is based on criteria for controls on plant protection and not specific for microbiological risks. This is not in line with Article 3(1) of Regulation (EC) No 882/2004. 5.2.4 Implementation of Official Controls over FBO's Obligations Legal requirements Article 10(2)(b)(i), 10(2)(c) and 10(2)(d), and Article 15(1) of Regulation (EC) No 882/2004, Articles 4, Article 5, Article 6, Article 7, Article 8, Annex I and Annex II of Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Regulation (EU) No 208/2013, Regulation (EU) No 211/2013, Article 1 and Annex I of Regulation (EC) No 2073/2005. Findings Farm inspections

Medlemsstatens svar

l The Agricultural Inspection will introduce in the Control Plan the risk criteria for primary producers to their official control system in line with Article 3 (1) of Regulation (EC) No. 882/2004. Deadline: end of October 2019

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There are 17 staff on central level and around 70 inspectors in charge of official controls for primary production. Around 30 are dedicated to food safety controls. They have at least a bachelor degree with additional training for food safety issues. Inspectors had received training on microbiological risks at primary production stage in 2017. However, some staff showed a lack of knowledge regarding basic food hygiene requirements in FNAO and legal obligations for sprouting businesses (see chapter 5.2.4).

The staff performing official controls for primary production are trained regarding the reduction of microbiological risks at primary production and in sprout production. However, the training of some inspectors did not enable them to undertake their duties with full competence which is not in line with Articles 4 (2)(a) and 6 of Regulation (EC) No 882/2004. 5.2.2 Registration / Approval of Food Establishments Legal requirements Article 6 of Regulation (EC) No 852/204, Article 2 of Regulation (EU) No 210/2013 and Article 31 of Regulation (EC) No 882/2004 5 Findings Registration of primary producers

The audit team verified the approval files of both sprout-producing establishments and noticed that for one sprouting establishment a sampling plan was required and delivered after the inspection. The analytical results provided, however, did not cover the bacteria required by the sampling plane, in particular no analyses for STEC. The approval, however has been granted. In addition, during the on-site visit several non-compliances have been observed (see chapter 5.2.4). Conclusions on Registration / Approval of Food Establishments

There is a system in place for approval of sprouting establishments aimed at ensuring that applicant FBOs meet the relevant requirements, but this system does not ensure that non-compliances have been rectified before the approval is granted. 5.2.3 Organisation and Scope of Official Controls Legal requirements Article 17 of Regulation (EC) No 178/2002 and Articles 3 of Regulation (EC) No 882/2004 Findings Primary producers and sprouting business

The checklist covers all necessary items, however the audit team noted, that during the inspection several non-compliances were not noted by the inspectors: Field and farm toilets without soap, disinfection, towels; Dysfunctional toilets, carton boards on toilet floors; Missing staff instructions and warning signs for hand washing and disinfection in staff toilets; Wooden boxes stored in open air for the harvest of leafy vegetables; Potential risky use of standing water and sponges to treat the cutting surface of lettuce; Presence of bird nests and excrements in packaging and food storage area; Dirty packing / sorting machines said to be unused, but not labelled or identified as such, dirty packaging material (cartoon boxes). Sprout-producing establishments

There are two sprout producers serving the national market. They are approved by DAFI and inspected once a year using a checklist with no non-compliances. Both were visited by the audit team, witnessing the CA inspections. The inspector carrying out the inspection did not note, however, that the facilities showed notable hygiene shortcomings (e.g. non-washable surfaces, dirty hand-shower, not easy to clean and disinfect surfaces in the production area).

Regarding seeds for sprouting, both FBO and CA were not aware of the certification requirements for seeds imported from third countries. The seeds were purchased in other Member States and considered as EU produce. The analytical testing of seeds as 10 required by Regulation (EC) 2073/2005 was not done. The audit team was informed by the CCA that a derogation for pre-testing was in place, but there was no written evidence available. DAFI stated that the derogations were given formless and without further conditions because of the small size of the seed consignments received by the FBOs.

Regarding the final produce, the FBOs did analyse their final produce systematically, but one of them did not check for Listeria, and the other one not for STEC as required. Freezing/Packing Establishments

There is an official control system in place along the FNAO production chain. The implementation at primary production, however, shows a number of gaps, notably related to provision of training and specific instructions (i.e. what are relevant non- compliances regarding the hygiene of staff, safe handling of food and suitable facilities). Therefore, significant non-compliances were not detected. Thus, non- compliant products might be undetected and the correct application of the relevant legislation might not be enforced.

Regarding the sprouting businesses the inspectors did not verify effectively compliance of import certificates because they were not familiar with the certification and traceability requirements established in Regulations (EU) Nos 208/2013 and 211/2013. Furthermore, inspectors did not verify that the own checks contained the analyses of sprouts for Listeria monocytogenes and STEC. Thus, the implementation of official controls on sprout producers is not sufficiently effective in verifying and, as appropriate, enforcing applicable hygiene rules.

The CA did grant informally derogations for the pre-testing of seeds of sprouting without any conditions which is not in line with the rules and criteria laid down in Regulation (EC) No 2073/2005 for seeds for sprouting. Thus, non-compliant products might be placed on the market and could pose a health risk for the consumers. 5.2.5 Official Sampling Procedures Legal requirements Article 11 of Regulation (EC) No 882/2004 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005 Findings

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The Agricultural Inspection will increase the qualification of the inspectors involved in official controls by adequate training in order to ensure effective and appropriate official controls as required by Articles 4 (2)(a) and 6 of Regulation (EC) No 882/2004. Deadline: end of March 2019

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Regarding seeds for sprouting, both FBO and CA were not aware of the certification requirements for seeds imported from third countries. The seeds were purchased in other Member States and considered as EU produce. The analytical testing of seeds as 10 required by Regulation (EC) 2073/2005 was not done. The audit team was informed by the CCA that a derogation for pre-testing was in place, but there was no written evidence available. DAFI stated that the derogations were given formless and without further conditions because of the small size of the seed consignments received by the FBOs.

Regarding the final produce, the FBOs did analyse their final produce systematically, but one of them did not check for Listeria, and the other one not for STEC as required. Freezing/Packing Establishments

Regarding the sprouting businesses the inspectors did not verify effectively compliance of import certificates because they were not familiar with the certification and traceability requirements established in Regulations (EU) Nos 208/2013 and 211/2013. Furthermore, inspectors did not verify that the own checks contained the analyses of sprouts for Listeria monocytogenes and STEC. Thus, the implementation of official controls on sprout producers is not sufficiently effective in verifying and, as appropriate, enforcing applicable hygiene rules.

The CA did grant informally derogations for the pre-testing of seeds of sprouting without any conditions which is not in line with the rules and criteria laid down in Regulation (EC) No 2073/2005 for seeds for sprouting. Thus, non-compliant products might be placed on the market and could pose a health risk for the consumers. 5.2.5 Official Sampling Procedures Legal requirements Article 11 of Regulation (EC) No 882/2004 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005 Findings

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he Agricultural Inspection will verified compliance at sprouting establishments with the rules and criteria laid down in Regulation (EC) Nos 2073/2005, Annex 1, Chapter 1 and Chapter 3.3 in accordance with Regulation (EC) No 882/2004 regarding testing of seeds for sprouting and sprouts. Deadline: end of October 2019

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Regarding seeds for sprouting, both FBO and CA were not aware of the certification requirements for seeds imported from third countries. The seeds were purchased in other Member States and considered as EU produce. The analytical testing of seeds as 10 required by Regulation (EC) 2073/2005 was not done. The audit team was informed by the CCA that a derogation for pre-testing was in place, but there was no written evidence available. DAFI stated that the derogations were given formless and without further conditions because of the small size of the seed consignments received by the FBOs.

Regarding the sprouting businesses the inspectors did not verify effectively compliance of import certificates because they were not familiar with the certification and traceability requirements established in Regulations (EU) Nos 208/2013 and 211/2013. Furthermore, inspectors did not verify that the own checks contained the analyses of sprouts for Listeria monocytogenes and STEC. Thus, the implementation of official controls on sprout producers is not sufficiently effective in verifying and, as appropriate, enforcing applicable hygiene rules.

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he Agricultural Inspection will verified compliance at sprouting establishments with the rules and criteria laid down in Regulation U) No 208/2013 regarding traceability of seeds for sprouting and in Regulation (EU) No 211/2013 regarding importation of seeds for sprouting. Deadline: end of March 2019

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The laboratories role as NRLs is limited so far in organizing workshops every two years to pass on information to regional laboratories in Croatia (26 veterinarian and 40 public health regional laboratories). PTs for these laboratories were carried out 2016 for Salmonella, Listeria monocytogenes and coagulase-positive staphylococci, by subcontract through a private PT provider. Technical equipment and staffing situation

Regarding their role as NRLs, the laboratories distribute information on a very limited scale and frequency in Croatia. Proficiency tests for Croatian official laboratories are carried out but do not include Escherichia coli and Campylobacter. 5.2.7 Procedures for Performance and Reporting of Control Activities Legal requirements Article 8 and Article 9 of Regulation (EC) No 882/2004 Findings

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The Veterinary and Food Safety Directorate for 2019 provided funds for co-financing the work of reference laboratories in the amount of 700,825.00 HRK (budget item MP: K821055). From the aforementioned funds for the work of reference laboratories (CVI and CIPH), it is possible to pay the costs for the detection and characterisation of pathogenic VTEC as well as other food related pathogens. Page: 1 port ref. DG(SANTE)/2018-6384-MR of the audit carried out from 16 October relating to microbial safety of primary production of food of non-animal origin Page: 2

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ral CA will evaluate every already approved control plan with the aim to verify that every element necessary to verify compliance with the product specification is contained in the checklists. At least 12 equired control plans will be revised by the end of 2019 and priority will be given to PDO products of animal origin where the origin of feed should be verified. By the end of June 2020 all approved control plans for 20 PDO and PGIs registered at the time of the audit will be revised. In the following administrative supervisions of CBs which will be carried out by the Directorate for Food and Phytosanitary Policy the implementation of revised control plans will be checked.

CA will evaluate every already approved Control Plans for PGI *Please note control plan with the aim to verify that that it has been necessary to delete every element necessary to verify this text in order to protect the compliance with the product specification provisionos of Article 339 of the is contained in the checklists. At least 12 Lisbon Treaty as regards trol plans will be revised by the end of confidentiality and PDO * are being e 2019 and priority will be given to PDO in the process of revision and red products of animal origin where the amended versions will be approved rigin of feed should be verified. By the by the end of June. CA will submit end of June 2020 all approved control the amended versions in July 2019. plans for 20 PDO and PGIs registered at the time of the audit will be revised. In By the end of May CA did not the following administrative supervisions conduct witness audits at operators of CBs which will be carried out by the for PGI * and PDO *. According to rectorate for Food and Phytosanitary the Plan of administrative Policy the implementation of revised supervisons, witness audit for PGI * control plans will be checked. is planned for June 2019 and w

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The audit team noted that not all the elements necessary to verify compliance with the product specifications were contained in the checklists, and therefore were inadequately checked, even if records were available at the operators´ premises. For example, the control plans for PDOs of animal origin did not cover verification that the feed came from within the same geographical area (which is also a requirement established in Article 1 of Regulation (EU) No 664/2014). The CA stated that so far it has been satisfied with the statements made by operators that such feed is sourced from the geographical area specified in the product specification.

The CB records also demonstrated that the planning was followed. All users of the registered names were inspected at least once a year and other stages of the production, including producers supplying the products, were also subject to inspection in the period of three years foreseen in the control plans. However, as described in the previous paragraph, as the origin of feed is not verified, no separate inspections are planned to feed mills supplying to the producer to cross-check the invoices and delivery notes provided. Official controls of GI spirits

Official controls at producers/processors of PDO/PGI/TSG agricultural products and foodstuffs are undertaken on a regular basis by following documented procedures and they are overall effective. However it cannot be ensured that all of the relevant elements of the product specification are checked by the CBs for all products

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According to the Plan of administrative supervisions of CBs in ) of 2019 made by the Directorate for Food and Phytosanitary Policy, 12 witness audits are planned (11 on one CB and 1 on other CB) with 12 registered names covered and one office audit at the headquarters of both CBs. In 2020 registered names not covered by the supervision in 2018 and 2019 will be covered. As regards the finding No 13, availability of the checklists and records evaluated by the CBs will be ensured by the enforcement of the new national Ordinance on PDO, PGI and TSG for agricultural products and foodstuffs and optional quality term "mountain product", where obligation for submitting all the documents following the summary of inspections to the CA is prescribed for the CB. Entering into force of the new Ordinance is Page: 1 ch 2019 report ref. DG(SANTE)/2018-6405-MR of the audit carried out from 13 related to Protected Designation of Origin (PDO), Protected Geographical tural Products and Foodstuffs Action Proposed by the competent authority planned for April 2019.

According to the Plan of administrative Ordinance on PDO/PGI/TSG for supervisions of CBs in 2019 made by the agricultural products and foodstuffs Directorate for Food and Phytosanitary (relevant sections highlighted in of Policy, 12 witness audits are planned (11 yellow): on one CB and 1 on other CB) with 12 registered names covered and one office audit at the headquarters of both CBs. In Page: 1 eport recommendations (updated) received 07/06/2019 f Croatia to the recommendations of report ref. DG(SANTE)/2018-6405-MR of the audit carried out from 13 der to evaluate the control systems related to Protected Designation of Origin (PDO), Protected Geographical lities Guaranteed (TSG) for Agricultural Products and Foodstuffs Action Proposed by the competent Update on the action proposed by authority the competent authority 2020 registered names not covered by the PRAVILNIK ZOI supervision in 2018 and 2019 will be ZOZP ZTS.docx covered. As regards the finding No 13, availability Published document is available on of the checklists and records evaluated by the link of Official Gazette: the CBs will be ensured by the https://narodne- enforcement of the new national novine.nn.hr/clanci/sluz

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Training of official staff has not been sufficient for keeping them up-to-date in their area, which does not meet the requirement laid down in Article 6(a) and (b) of Regulation (EC) No 882/2004. In addition, there are no documented procedures (containing information and instructions for staff performing official controls in the area of rabies eradication), that meet the requirements laid down in Article 8 of Regulation (EC) No 882/2004. Training on the implementation of the rabies eradication programme was last organised by the CCA in 2012, before the start of the nationwide ORV programme. Since then, no additional training has been organised and the only available instructions are the national legal acts. There were no instructions or guidelines for staff of the AVOs on how to determine which of the wild animals delivered dead to the veterinary station should be submitted for rabies testing under the passive surveillance programme (see also finding 50). 5 The official staff interviewed did not all apply the same definitions for animals submitted for testing under the passive surveillance and were not aware that foxes and jackals found dead should be seen as indicator animals and tested for rabies. There were no instructions or guidelines for official staff in charge of controls on the storage conditions for oral vaccine baits, the aerial distribution of vaccine, or the implementation of the monitoring and surveillance programmes by AVOs. Conclusions on competent authorities

National legislation provides a sound legal basis for all relevant aspects of the rabies eradication programme, and the division of tasks among the Departments in the VFSD provides a good basis for effective implementation of the rabies eradication. However, due to the lack of up-to-date training, information and instructions for official staff and authorised veterinary organisations, and the omission of important tasks in the annual inspection plan for veterinary inspectors, important components of the rabies eradication programme have not been adequately implemented and controlled.

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ing In period of 22-24 May 2018 educations were carried out regarding animal health measures with specific part on OVF and es eradication program. Education covered all 21 Croatian counties with participation of 236 authorised veterinarians and veterinary inspectors. Specific subjects were covered during educations as follows: - general information on rabies and OVF programme, - preliminary conclusions and rabies audit outcome - passive and active surveillance of rabies - detail instructions on all relevant tasks related to sampling were given in order to improve the registration and management of surveillance data (official sampling form has to be filled properly by authorised veterinarian containing information on sample origin, suspicion-passive surveillance, active surveillance, OVF monitoring, animals found dead and road kill, etc.). All information are publicly available and published on the official VFSD web site: http://www.veterinarstvo.hr/default.aspx?id=1114. Annual plan for official controls is amended with special attention to rabies and OVF and related controls. In accordance with instructions on sampling and OVF programme, veterinary inspectors should include in thei

n period of 22-24 May 2018 educations were carried out regarding animal health measures specific part on OVF and rabies eradication program. Education covered all 21 oatian counties with participation of 236 authorised veterinarians and veterinary inspectors. Specific subjects were covered during educations as follows: - general information on rabies and OVF programme, - preliminary conclusions and rabies audit outcome - passive and active surveillance of rabies - detail instructions on all relevant tasks related to sampling were given in order to improve the registration and management of surveillance data (official sampling form has to be filled properly by authorised veterinarian containing information on sample origin, suspicion-passive surveillance, active surveillance, OVF monitoring, animals found dead and road kill, etc.). All information are publicly available and published on the official VFSD web site: http://www.veterinarstvo.hr/default.aspx?id=1114. Annual plan for official controls is amended with special attention to rabies and OVF and related controls. In accordance with instructions on sampling and OVF programme, veterinary inspectors should include in their person

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The procedures did not indicate that there needs to be a transporter for the sea journey who is established, or in the case that the applicant is established in a non-EU country, represented in the Member State (Article 10(1) of the Regulation). As a result port inspectors did not detect the absence of an authorised transporter responsible for the journey by sea (which should be in box 6.4 of section 1 of the journey logs). In practice, the port veterinarians make all requests regarding fulfilling the legal requirements for the export of animals to a forwarding agent, or the captain of the livestock vessel, although the competent authority has not defined if either of these actors have any legal responsibilities in relation to the welfare of animals during transport.

The written procedures did not include instructions to take into account the judgement of the European Court of Justice in case C-424/13: Zuchtvieh3 (hereafter "the Zuchtvieh ruling") when checking journey logs; i.e. the organiser of the journey has to submit a journey log which is realistic and compliant with the Regulation up to the destination, including the stages of the journey which take place outside the EU.

The officials did not receive sufficient information in advance of the arrival of a livestock vessel, thus they had to assess everything (e.g. stocking density plan and feed plan for the sea journey) once the vessel was in the port.

The official controls at the port are insufficient to minimise the risk of welfare problems for the animals involved in the journey. These are the result of under resourcing, insufficient planning (e.g. no sufficient time for vessel inspection), absence of detailed instructions and verification to trigger improvement.

The authorities have procedures for approval of the livestock vessels. Although these procedures include the network document translated to Croatian language, this has not been adapted to create suitable procedures and instructions to officials at the port. The instructions for staff to perform the vessel approval are not sufficient, which is not in line with Article 8(1) of Regulation (EC) No 882/2004.

The audit team noted that on 31 July 2018 the port veterinarians completed in one hour the preloading inspection of a large vessel used to carry over 3000 bovine animals (see also paragraph 23). For that vessel, it was unrealistic to complete a preloading inspection in just one hour.

The port veterinarians checked 78 loadings in 2017 and 40 loadings in the first semester of 2018. The reports of inspections did not indicate any deficiencies for vessels in the port in the last three years.

The veterinary inspector did not check the water production records or the working order of the drainage pump, alarms of the ventilation, fresh water and lighting systems5. This is not in line with Article 20(1)(c) of the Regulation. The procedures indicated the legal requirements for ventilation and alarms but did not indicate how to check these. The inspectors admitted that they were not competent to assess some of the "non-veterinary" requirements of the Regulation, such as the number of air exchanges required to provide sufficient ventilation.

The procedure indicates also the need for assessing the amount of feed, but not how to do it, conclude, record and report. The veterinarians generally relied on the agent's statement 5 In their response to the draft report the Competent Authority noted that " Inspection of the ventilation, alarm system, fresh water system and lighting system is carried out by the engineer of Ministry of Transport and infrastructure, Port authority-Pula at least 2 times a year, and when approving the ship jointly in cooperation with veterinary inspectors. After these checks, the veterinary inspector checks the functionality of all systems before loading, but does not perform detailed technical checks" 8 for this check. During the audit, the port veterinarian did some calculations on the spot during the loading. The audit team noted that procedures such as feeding plan could have been verified by the authorities in advance of the arrival of the vessel.

The inspectors confirmed to the audit team that they assess ventilation subjectively, based on their experience, and did not verify the air changes per hour required by Annex I Chapter IV, Section 1 point 2(a) of the Regulation.

The port veterinarians do not have the sufficient technical knowledge to perform a proper inspection of the livestock vessel and thus they do not assess effectively all the necessary elements. This, together with the short time allocated for the inspections, the absence of an approved classification society to verify the strength calculations of pen rails and decks indicates that the Croatian system to approve livestock vessels for transport in the EU and for inspecting them subsequently before each loading is insufficient to guarantee that animal welfare requirements are respected.

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The competent authority did not provide evidence that it has a procedure to verify the effectiveness and appropriateness of the official controls at the exit point, which is not in line with Article 4(2)(a) of Regulation (EC) No 882/2004. The majority of shortcomings detected during this audit were unknown to the authorities, e.g. that port veterinarians did not detect systematic deficiencies in journey logs (see paragraph 18) and procedures with insufficient detail for carrying out a practical assessment of requirements (see paragraph 34).

There were no reports on checks performed before November 2017. From November 2017 to May 2018 10 consignments were the subject of reports to the Member States of origin: one without one hour rest in the journey log, four that did not provide temperature records, three animals unfit for transport (two mastitis and one sick animal euthanised), one dead animal with no water in the vehicle and one with unsuitable dividers in the vehicle.

The audit team reviewed documentation of consignments arriving from five other Member States. None of them indicated who the sea transporter was. The audit team noted that: 5 In all journey logs seen, only organisers from one Member State had indicated the transfer of animals to a livestock vessel in box 6.1 of section 1. The logs from all other countries indicated the journeys ended at the port. However, in some journey logs the organisers indicated the name of the livestock vessel ­ so they had considered the journey out of the EU. But they failed to indicate the name and number of the authorised transporter responsible for this stage of the journey in box 6.4 of section 1 of the journey log. Only one Member State included the length of the sea journey in the total expected duration of the journey.

During four days, 101 trucks from five Member States arrived at the port during a heatwave to load cattle in a vessel that departed in August 2018. For those 101 trucks, veterinary inspectors detected that: in 26% of the trucks, animals had been exposed during the journeys to temperatures above 35oC; 6 16% of the truck drivers did not provided temperature records of the vehicles and 7% did not provided the journey logs; the journey planning, which is responsibility of the organisers, did not avoid the arrival of vehicles at the same time; daytime temperatures were well over 30oC, and thus the loading of vehicles at departure should not have been carried out if authorities there had checked the weather forecast for the port.

In that incident, the port veterinarians and representatives from the central authority did not have a clear course of action to follow to deal with the animals already in the port and those on their way4. After this incident the Croatian authorities notified three Member States by e-mail and for the other two Member States issued section V of the journey logs. Only one Member State replied to the Croatian contact point.

After this incident the Croatian authorities requested better coordination, scheduling and communication to all interested parties (shipping agent, port operator and main road transporter). During the closing meeting of this audit, the central authority stated that they will improve the related procedures.

The central authority indicated that they did not impose sanctions in relation to this incident. In their opinion, the detected infringements were caused by the lack of proper planning in the countries of departure of the consignments. They indicated they have a procedure that allows any vehicle to be detained until the fine is paid.

The authorities provided a document with the financial penalties for infringements to the Regulation. These range from HRK 10,000 (EUR 1,347) to HRK 100,000 (EUR 13,476). The average daily rental of a livestock vessel is EUR 25,000. The central authority indicated during the closing meeting that they plan to have new rules for sanctions next year. Conclusions on welfare of the animals arriving at the port

The official controls at the port are insufficient to minimise the risk of welfare problems for the animals involved in the journey. These are the result of under resourcing, insufficient planning (e.g. no sufficient time for vessel inspection), absence of detailed instructions and verification to trigger improvement.

As the authorities have not established a verification procedure over the official controls at the port, they are unable to detect and correct the existing weaknesses in their checks; 4 In their response to the draft report the Competent Authority noted that "During the incident a decision was made to load the animals on the ship, as the competent authority considered that returning the animals by road transport to the place of origin would cause additional animal suffering due to the weather conditions". 7 non-conformities persist undetected and thus are not communicated to the authorities of the Member States of departure. All this hinders continuous improvement to ensure the welfare of animals during transport.

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At the port, there was a single veterinary official in charge of many tasks, some of which occurred simultaneously, e.g inspection of the ship, control of documents from arriving trucks, assessment of fitness of animals. As result, not all tasks were completed properly and with the necessary attention.

The capacity of the assembly centre is not sufficient to accommodate all the animals loaded onto certain livestock vessels. In most cases, this is not a problem as the authorities co-ordinate the arrival of the trucks to the port and there are no major delays in transferring animals from road vehicles to the vessels. However, this can constitute a major problem in a case where the authorities refuse the loading of a big vessel. The authorities did not have arrangements to unload, accommodate, feed and water the animals in such cases and safeguard their welfare. This is not in line with Article 22(2) and Article 23 of the Regulation.

Procedures do not indicate that it is responsibility of the organisers to ensure that the time of arrival at the port should not coincide with the arrival of other vehicles in order to minimise the waiting time inside the port. This issue had to be raised with the organisers concerned, as required by Article 5(3)(a) of the Regulation, are legally responsible for coordinating the different parts of the journey.

In that incident, the port veterinarians and representatives from the central authority did not have a clear course of action to follow to deal with the animals already in the port and those on their way4. After this incident the Croatian authorities notified three Member States by e-mail and for the other two Member States issued section V of the journey logs. Only one Member State replied to the Croatian contact point.

After this incident the Croatian authorities requested better coordination, scheduling and communication to all interested parties (shipping agent, port operator and main road transporter). During the closing meeting of this audit, the central authority stated that they will improve the related procedures.

The current arrangements do not guarantee the welfare of the animals if there is a delay in loading a vessel. Neither the organisers, nor transporters, nor the authorities had contingency plans for this eventuality.

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The veterinary inspector did not check the water production records or the working order of the drainage pump, alarms of the ventilation, fresh water and lighting systems5. This is not in line with Article 20(1)(c) of the Regulation. The procedures indicated the legal requirements for ventilation and alarms but did not indicate how to check these. The inspectors admitted that they were not competent to assess some of the "non-veterinary" requirements of the Regulation, such as the number of air exchanges required to provide sufficient ventilation.

The procedure indicates also the need for assessing the amount of feed, but not how to do it, conclude, record and report. The veterinarians generally relied on the agent's statement 5 In their response to the draft report the Competent Authority noted that " Inspection of the ventilation, alarm system, fresh water system and lighting system is carried out by the engineer of Ministry of Transport and infrastructure, Port authority-Pula at least 2 times a year, and when approving the ship jointly in cooperation with veterinary inspectors. After these checks, the veterinary inspector checks the functionality of all systems before loading, but does not perform detailed technical checks" 8 for this check. During the audit, the port veterinarian did some calculations on the spot during the loading. The audit team noted that procedures such as feeding plan could have been verified by the authorities in advance of the arrival of the vessel.

The competent authorities indicated they only get information on completion of sea journeys if vessels return to the port and if they request information on incidences in the last five journeys.

The inspectors confirmed to the audit team that they assess ventilation subjectively, based on their experience, and did not verify the air changes per hour required by Annex I Chapter IV, Section 1 point 2(a) of the Regulation.

The port veterinarians do not have the sufficient technical knowledge to perform a proper inspection of the livestock vessel and thus they do not assess effectively all the necessary elements. This, together with the short time allocated for the inspections, the absence of an approved classification society to verify the strength calculations of pen rails and decks indicates that the Croatian system to approve livestock vessels for transport in the EU and for inspecting them subsequently before each loading is insufficient to guarantee that animal welfare requirements are respected.

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The competent authority has not approved a classification society to verify the strength calculations of pen rails and decks on livestock vessels, which is not in line with Annex I Chapter IV Section I point 1 of the Regulation and this aspect was also not verified. Conclusion on welfare of animals during sea transport

The port veterinarians do not have the sufficient technical knowledge to perform a proper inspection of the livestock vessel and thus they do not assess effectively all the necessary elements. This, together with the short time allocated for the inspections, the absence of an approved classification society to verify the strength calculations of pen rails and decks indicates that the Croatian system to approve livestock vessels for transport in the EU and for inspecting them subsequently before each loading is insufficient to guarantee that animal welfare requirements are respected.

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The procedures did not indicate that there needs to be a transporter for the sea journey who is established, or in the case that the applicant is established in a non-EU country, represented in the Member State (Article 10(1) of the Regulation). As a result port inspectors did not detect the absence of an authorised transporter responsible for the journey by sea (which should be in box 6.4 of section 1 of the journey logs). In practice, the port veterinarians make all requests regarding fulfilling the legal requirements for the export of animals to a forwarding agent, or the captain of the livestock vessel, although the competent authority has not defined if either of these actors have any legal responsibilities in relation to the welfare of animals during transport.

The failure to identify any natural or legal person as the authorised transporter for the journey by sea is further risk for animal welfare. However, this is also the failure of the authorities of the other Member States who approved journey logs which did not indicate an authorised transporter for the sea journey.

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Examination of the reports of these assessments showed that they did give useful input regarding compliance with MF requirements and international internal auditing standards. While the assessment does not explicitly consider the objectives of Article 4(6) of Regulation (EC) No 882/2004 or the guidance laid down in Commission Decision 2006/677/EC, the template used addresses many points of relevance for the implementation of audits required by Article 4(6) of Regulation (EC) No 882/2004, including issues such as: Purpose, powers and responsibility of the audit service; Independence and objectivity; Competence/professional expertise and continuing training; Quality assurance of internal audit activity; Management and performance of internal audits; Planning; Reporting and follow-up.

The DG SANTE audit team consider that MF cannot give an independent assessment of the suitability or effectiveness of the common audit procedures which IIAS are required to implement, since these procedures are developed and defined by MF itself.

It was noted that the external quality check reports contain a disclaimer stating that they cannot be considered to constitute an external assessment as envisaged under the International Standards for the Professional Practice of Internal Auditing 1312. 12

While current arrangements give some assurance about the performance of the IIAS and can add value, they do not fully address the requirement for independent scrutiny in that the MF assessment does not consider objectives of Article 4(6) of Regulation (EC) No 882/2004 and the MF cannot give an independent assessment of the suitability of its own audit procedures. 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 13 official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

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Samostalna sluzba za unutarnju reviziju Ministarstva poljoprivrede prihvaa danu preporuku te e osigurati provedbu preporuke. S obzirom da je za provedbu preporuke potrebno osigurati odreena financijska sredstva zatrazit emo da se ova aktivnost uvrsti u Plan proracuna za 2019. godinu te e se nakon osiguranja financijskih sredstava provesti natjecaj za odabir vanjskog procjenitelja s adekvatnim kompetencijama kako bi se ispunili ciljevi zahtjeva iz clanka 4 stavka 6 Uredbe (EZ) br. 882/2004. S obzirom na potrebu planiranja financijskih sredstava te provedbu javnog natjecaja za odabir vanjskog procjenitelja preporuka e biti provedena u 2019. godini. Page: 1

Samostalna sluzba za unutarnju reviziju Ministarstva zdravstva prihvaa preporuku uz napomenu da je Odjel za reviziju provoenja sluzbene kontrole zdravstvene ispravnosti, higijene i sigurnosti hrane osnovan 2014. godine te da sukladno Meunarodnom standardu 1312 jos nije proteklo razdoblje od pet godina u kojem se treba provesti vanjska procjena kvalitete. Za provedbu vanjske procjene kvalitete potrebno je u Drzavnom proracunu osigurati znacajna financijska sredstva, odraditi pripremne radnje i provesti javni natjecaj, kako bi se odabrao kvalificirani neovisni vanjski procjenitelj. Planirani rok provedbe preporuke je kraj 2020. godine do kada se ocekuje uz prethodno navedene aktivnosti da e biti popunjeno i radno mjesto voditelja SSUR-a. Page: 1

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While interviewing both the AVs and VIs, the audit team noted that in general they were aware of the tasks to be performed, the requirements contained in SNCPs and the procedures to be followed. However some difficulties concerning the implementation of official sampling, in particular as regards the sampling frequency and/or protocol in the breeding and laying hen populations, was observed by the audit team (for more details see paragraphs Nos 68 and 69). Supervision and Audit

A training system is in place in order to ensure that relevant staff carries out their duties competently and consistently and the VIs and AVs are familiar with the tasks to be performed in the context of the SNCPs. However, there are some difficulties for staff to implement adequately the official sampling, particularly the sampling frequency and/or protocol in breeders and in laying hen population.

The audit team was informed by the VFSD that in the 2015 annual plan for official controls they forgot to include Salmonella official sampling for all the various poultry populations. However they detected the problem in the course of the year and to remedy the situation a complementary document was prepared. The document indicated the poultry holdings where Salmonella sampling had to be performed in the second half of 2015 and was sent by the VFSD to the regional offices and from there to the branch offices in order to be implemented. The CA informed the audit team that this document could partially cover the official sampling required by the SNCPs in 2015. However, due to limited time available for the branch offices to organise the sampling, an insufficient number of official samples were taken, in particular in breeding and laying hen populations where a higher number of official samples had to be collected.

In the branch offices visited the audit team had the opportunity to confirm that, for the reasons explained above, the official sampling was not carried out with the required frequency in particular in breeders and in laying hen population (see also paragraphs Nos 90 and 103).

During the on-the-spot visits the audit team noted there were some problems concerning the implementation of the official sampling, particularly in the breeding hen population as regards the sampling frequency and in the laying hen population as regards the sampling frequency and the protocol. The audit team also noted that the difference between own-check and official sampling was not very clear to the staff responsible for implementing the SNCPs.

In this regard the VFSD informed the audit team that prior to 2015 all samples taken in the framework of the SNCPs were considered as official samples. However, since 2015 a distinction has been made by the CA between own-check and official sampling in national rules and the SNCPs because the relevant EU legislation stipulates that poultry populations should be sampled at the initiative of the FBO and as part of official controls. The CA explained to the audit team that due to the fact that these changes have taken place recently, the staff is still encountering difficulties in differentiating between the sampling for own-checks and the sampling for official controls and it therefore may happen that some staff does not apply the right sampling scheme.

The audit team noted that although the CA is aware of the issue concerning official sampling i.e. through the supervision of VIs carried out by the CA from central level and heads of regional offices and the monthly reports of Salmonella analysis results sent by the NRL to the CA at central level (see paragraph No 79), and that some corrective actions have been put in place to remedy the situation detected, problems were still present at the time of the current audit.

The CA did not meet the requirements contained in the SNCPs as regards official sampling frequency in breeding and laying hen populations and protocol to be used in official sampling in laying hen population. These issues are mainly due to the recent changes that have been introduced in the SNCPs, particularly concerning the different schemes to be followed for own-checks and official sampling, and therefore the staff encounter difficulties for changing the previous approach and become familiar with the new requirements. Moreover, the implementation of the SNCPs is currently compromised because of the lack of information, available to the CAs responsible for implementing the programmes, concerning the number of flocks per holding.

The audit team noted in all the farms visited that official sampling had not been carried out in 2015 and that one official sample taken in 2016 was analysed in a designated laboratory instead of being tested in the NRL as required by the SNCP.

The implementation of the SNCP for the breeding hen population is not fully satisfactory as regards own-check and official sampling frequency while the related protocols in both rearing and adult phases are applied in accordance with EU requirements and the relevant SNCP.

The audit team was provided by the CA with the data of official sampling performed in 2015. According to this data the frequency for official sampling was not in line with EU requirements (six official samples were tested while there were 64 holdings with more than 1,000 birds). The audit team noted in one of the laying hen farms visited that no 17 official samples had been taken in 2015. The CA explained that this fact was due to the mistake made in the 2015 annual planning (see paragraph No 65).

In the majority of cases reviewed by the audit team, the protocol used in official sampling was not in line with point 2.2.2 of Annex to Regulation (EU) No 517/2011 (e.g. in a caged laying hen farm two faecal samples were taken instead of the required three faecal samples and in a free range farm two faeces samples were taken instead of three pairs of boot swaps). In practical terms, the protocol for own-checks was used instead of the official one in both type of production due to the confusion between own- check and official sampling (see paragraphs Nos 68 and 69).

The implementation of the SNCP for laying hens is satisfactory as regards routine own-check sampling; in particular the frequency of own-checks applied goes beyond EU requirements. Concerning routine official sampling, this is not fully in compliance with EU requirements as regards both sampling frequency and protocol applied.

Medlemsstatens svar

egarding implementation of official sampling (sampling frequency and/or protocol) CA will organise training for veterinary inspectors and authorised the veterinarians. In addition to the training specific f instructions and procedure will be distributed to the veterinary inspectors regarding actions which should be taken en protocol and/or frequency of own- checks are not satisfactory, by the end of 0, November 2016. By the end of 2016, the check list for the poultry farm control will be updated with all information regards own-check testing and other conditions according to the SNCPs. The Annual working plan for official controls in 2017 will be updated with detail procedure for the official sampling regarding frequency and/or protocol based on the results of the official controls conducted in 2016 and on latest information about flocks satisfying criteria for official sampling. The detail procedure and explanation will be given in the Annual working plan for official controls in 2017 according to relevant Regulations concerning salmonellosis control. Regular follow up of the performance of official controls and official sampling will be performed during 2017 and subsequent measur

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The audit team noted that at the moment there is not an appropriate tool to adequately evaluate and review the progress of the implementation of the SNCPs. In particular the audit team noted that key information concerning the flocks (e.g. number of flocks for holding) is not gathered and therefore is not available to the VFSD responsible for performing these activities. In practical terms, the CA at central level knows the number of poultry holdings in the country and not the number of flocks/holding. The VFSD informed the audit team that they are aware of this problem and the Farm Register is being adapted in order to remedy this situation, in particular the flock information will be recorded in this database. The VFSD also informed the audit team that this enhanced electronic tool is expected to be ready for next year. Nevertheless no guarantees could be provided by the VFSD that the set timeframe for completion will be respected as this depends on the resources available. Conclusions on General Issues on SNCPs

Moreover, even if there are tools in place aimed at monitoring the implementation of the programmes and at reviewing and evaluating their progress, the absence of information concerning the number of flocks per holding compromises the capability of the CA to carry out these tasks properly. The CA is aware of this issue and some actions are already planned in order to remedy the situation. This lack of data calls into question the reliability of Salmonella prevalence rates in the various poultry populations.

Medlemsstatens svar

The Croatian Agriculture Agency (CAA) is the authority responsible for manages the database and the register of animals. o The CAA maintains the Central Register of Domestic Animals, which includes Farms Register. This task has been egated to the CAA by the Veterinary and Food Directorate, the competent authority for the identification and registration of animals and farms. These farm register in addition to basic data about the economy contains information on the type of production that is performed on each farm. According to Ordinance on farm registration all poultry farms must be registered, if we talk about the holdings with poultry, given the mber and types of poultry production aying hens, breeding poultry, broilers, eeding turkeys, fattening turkeys). rrently in data base it is not possible to ter data on number of flocks on the farm t only total number of poultry on the rm. Data on number of flocks on farm st be entered into sampling submission rm that is filled during routine sampling d that must be sent with the sample to e laboratory. Samples are taken by thorised veterinarians and data are llected and processed by official boratories involved in SNCP. addition to the CA

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Some discrepancies exist between the SNCPs for breeders and laying hen population and the relevant EU legislation: in these poultry populations the SNCPs provide for routine confirmatory sampling and the protocol to be used in these cases is not in line with EU requirements. Enforcement and sanctions

While interviewing both the AVs and VIs, the audit team noted that in general they were aware of the tasks to be performed, the requirements contained in SNCPs and the procedures to be followed. However some difficulties concerning the implementation of official sampling, in particular as regards the sampling frequency and/or protocol in the breeding and laying hen populations, was observed by the audit team (for more details see paragraphs Nos 68 and 69). Supervision and Audit

National rules and the SNCPs have been established for the implementation of the requirements laid down in the relevant EU legislation. In some cases national requirements go beyond the EU ones. Some discrepancies exist between the SNCPs and the relevant EU legislation, in particular as regards the Croatian practice of confirmatory sampling in breeding and laying hen populations.

A training system is in place in order to ensure that relevant staff carries out their duties competently and consistently and the VIs and AVs are familiar with the tasks to be performed in the context of the SNCPs. However, there are some difficulties for staff to implement adequately the official sampling, particularly the sampling frequency and/or protocol in breeders and in laying hen population.

The audit team was informed by the VFSD that in the 2015 annual plan for official controls they forgot to include Salmonella official sampling for all the various poultry populations. However they detected the problem in the course of the year and to remedy the situation a complementary document was prepared. The document indicated the poultry holdings where Salmonella sampling had to be performed in the second half of 2015 and was sent by the VFSD to the regional offices and from there to the branch offices in order to be implemented. The CA informed the audit team that this document could partially cover the official sampling required by the SNCPs in 2015. However, due to limited time available for the branch offices to organise the sampling, an insufficient number of official samples were taken, in particular in breeding and laying hen populations where a higher number of official samples had to be collected.

In the branch offices visited the audit team had the opportunity to confirm that, for the reasons explained above, the official sampling was not carried out with the required frequency in particular in breeders and in laying hen population (see also paragraphs Nos 90 and 103).

During the on-the-spot visits the audit team noted there were some problems concerning the implementation of the official sampling, particularly in the breeding hen population as regards the sampling frequency and in the laying hen population as regards the sampling frequency and the protocol. The audit team also noted that the difference between own-check and official sampling was not very clear to the staff responsible for implementing the SNCPs.

In this regard the VFSD informed the audit team that prior to 2015 all samples taken in the framework of the SNCPs were considered as official samples. However, since 2015 a distinction has been made by the CA between own-check and official sampling in national rules and the SNCPs because the relevant EU legislation stipulates that poultry populations should be sampled at the initiative of the FBO and as part of official controls. The CA explained to the audit team that due to the fact that these changes have taken place recently, the staff is still encountering difficulties in differentiating between the sampling for own-checks and the sampling for official controls and it therefore may happen that some staff does not apply the right sampling scheme.

The audit team noted that although the CA is aware of the issue concerning official sampling i.e. through the supervision of VIs carried out by the CA from central level and heads of regional offices and the monthly reports of Salmonella analysis results sent by the NRL to the CA at central level (see paragraph No 79), and that some corrective actions have been put in place to remedy the situation detected, problems were still present at the time of the current audit.

The CA did not meet the requirements contained in the SNCPs as regards official sampling frequency in breeding and laying hen populations and protocol to be used in official sampling in laying hen population. These issues are mainly due to the recent changes that have been introduced in the SNCPs, particularly concerning the different schemes to be followed for own-checks and official sampling, and therefore the staff encounter difficulties for changing the previous approach and become familiar with the new requirements. Moreover, the implementation of the SNCPs is currently compromised because of the lack of information, available to the CAs responsible for implementing the programmes, concerning the number of flocks per holding.

At the rearing farm visited own-check sampling frequency was not respected as in the majority of cases the own-check samples were not taken at the age of four weeks. In one case the sampling was carried out with a delay of eight weeks. The sampling protocol used was in line with the relevant SNCP.

The audit team visited two adult breeding farms. The audit team noted in one of these farms that own-check sampling was carried out in compliance with EU requirements regarding sampling frequency and the sampling protocol. At the other breeding farm visited the own-check sampling frequency varied from every three to every five weeks instead of the required two weeks and it was not possible for the CA, the AV and the audit team to link some analysis results with certain flocks. The protocol used was the one required by EU legislation.

The audit team noted in all the farms visited that official sampling had not been carried out in 2015 and that one official sample taken in 2016 was analysed in a designated laboratory instead of being tested in the NRL as required by the SNCP.

The audit team noted that, according to the SNCP, after any positive result for targeted Salmonella serotypes samples taken at the holding, the flock is considered as suspect and confirmatory sampling has to be carried out. This practice is not in line with point 2.2.2.2 (c) of Annex to Regulation (EU) No 200/2010 which permits re-sampling only in exceptional cases when the CA has reason to question the results of the testing (such as false positive or false negative results). Furthermore, the audit team noted that in the SNCP the protocol to be used in this case is not in line with the point 2.2.2.2 (b) of Annex to Regulation (EU) No 200/2010 because it does not take into account the measures to be implemented if the source of infection is not confirmed (i.e. according to the EU legislation antimicrobial testing shall be carried out or new bacteriological testing for the presence of the relevant Salmonella serotypes should be performed before trade restrictions are lifted).

The implementation of the SNCP for the breeding hen population is not fully satisfactory as regards own-check and official sampling frequency while the related protocols in both rearing and adult phases are applied in accordance with EU requirements and the relevant SNCP.

The routine confirmatory sampling policy for breeders, applied after positive result for targeted Salmonella serotypes of samples taken at the holding, is not in line with point 2.2.2.2 (c) of Annex to Regulation (EU) No 200/2010. In addition, the sampling protocol used in this case is not in line with point 2.2.2.2 (b) of Annex to Regulation (EU) No 200/2010, particularly concerning the lack of further testing when the source of Salmonella infection is not confirmed.

Medlemsstatens svar

garding the frequency of official mpling in relation to breeding hen ocks the answer is in response to recommendation No. 1. egarding the confirmatory sampling licy, this recommendation is accepted. Provides harmonization of the SNCP for eding hen flocks at Point 2.2.2.2, nex to Regulation (EU) No 200/2010 and the sampling protocol used is in line s with point 2.2.2.2 (b) of Annex to this gulation and the harmonized version of e SNCP will be fully applied in 2017. ing to Confirmatory samples will taken in following occasions: , a) In case of suspicion on relevant lmonellas - a flock suspicious of being fected with S. Enteritidis, S. phimurium, S. Hadar, S.Virchow or S. fantis is any flock in which, by boratory examination of routinely bmitted samples taken in the hatchery or mples taken from transport liners of day d chicks on the holding during delivery, e presence of the afore mentioned lmonella serotypes is confirmed, When on the basis of the conducted idemiological examination, a relation ith the cases of infection in humans is onfirmed, and ) in case veterinary inspector has uspicion on the results of testing.

Medlemsstatens svar

Regarding the frequency of official ampling in relation to laying hen flocks he answer is in response to ecommendation No. 1. Regarding the confirmatory sampling licy, this recommendation is accepted. rovides harmonization of the SNCP for aying hen flocks and confirmatory ampling will be used in accordance with oint 4, Part D of Annex II to Regulation EC) No 2160/2003. So this changed SNCP will be in full implementation in 2017 and in connection erewith, confirmatory sampling can be pplied according to procedure prescribed ses in Annex of the Regulation 517/2011 , 4, point 2., 2.1. (c). n accordance with the above, in the case f the samples originating from poultry locks suspected of being infected nella spp., the NRL along with esting on presence of Salmonella samples , must be tested so to exclude possible use f antimicrobials or bacterial growth nhibitors.

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Ordinance on special conditions for approval of certain establishments dealing with food of animal origin (OJ 100/15) sets out the requirements for FBOs processing their own milk on the holding and selling their dairy products on farm, markets, exhibitions, restaurants and retailers in the country. The Ordinance establishes that the products must be marked with a round identification mark bearing the same approval number (see paragraph 39): this is not in line with the requirements of Annex II, Section I of Regulation (EC) No 853/2004, prescribing an identification marking of foodstuffs of animal origin, when manufactured in the EU by an approved establishment, of oval shape. Conclusions on legislation and implementing measures

National legislation and guidelines necessary to implement EU requirements relevant for the sector audited have been issued and, from a preliminary analysis, they are in line with EU legislation with the exception of the national measures applied to FBOs who 4 process their own milk at farm level. These latter measures are not in line with Article 5 of Regulation (EC) No 853/2004 as they provide for placing products on the national market with the application of an identification mark which does not comply with the requirements of Annex II, Section I of Regulation (EC) No 853/2004.

The Ordinance on special conditions for approval of certain establishments dealing with food of animal origin covers specific requirements to be complied with by facilities processing milk at the farm of origin for direct supply of dairy products, marked with a special identification mark, to final consumers at the place of production and at markets and exhibitions in the whole country. These requirements are related to layout, equipment, operation and hygiene and provide that dedicated spaces must be arranged for equipment destined for collection/storage of raw milk and for by-products not intended for human consumption, rooms must also be dedicated for milk processing and for maturing of dairy products. Furthermore, changing facilities/space for storage of cleaning and disinfection agents must be located outside processing areas. At the time of this audit 104 such FBOs, manufacturing dairy products, out of a total number of 472 approved food operators, had been approved and listed by the CCA. They receive unique approval numbers (starting with letter P followed by number). The list of such approved establishments can be found at the following link: http://www.veterinarstvo.hr/default.aspx?id=109.

Medlemsstatens svar

r Croatia foresees through national legislation for FBOs processing own milk, approval under special conditions and placing products n only at the Croatian market. There are also some meat establishments subject to approval under special conditions ­ e.g. is producing meat products, meat preparations and minced meat intended to be sold at the retail shops belonging to the same FBO. Croatian CA wants to check the compliance of such establishments before granting them the permission to operate. To avoid the possibility of placing on the market of other MSs or third countries such products it was decided to apply different (national) identification mark in relation to the IM prescribed by Annex II, Section I of Regulation (EU) 853/2004. Updated action plan received on 30/11/2017 In order to ensure that the national measures applicable to FBOs processing their own milk at farms and that supply/sell their products to other retail establishments at country level are in line with Article 5 of Regulation (EC) No 853/2004 in particular concerning the use of an identification mark that meets the requirements laid down in Annex II, Section I of this Regulation, CA will take following actions:

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There is a system in place for the registration and approval of establishments that allows the CAs to keep them under official controls. However, the system in place does not require the approval of all MCCs, contrary to the requirements of Article 4 of Regulation (EC) No 853/2004.

Medlemsstatens svar

le During the audit CA explained to the auditors situation in Croatia: milk in Croatia are approved as required by 04 f raw milk from few producers in one Page: 2 01/12/2017 report ref. DG(SANTE)/2016-8845-MR of the audit carried out from 10 October al controls related to the safety of food of animal origin, in particular milk and milk s keeping and cooling the milk for few orted to the dairy revious Action plan, there are several of mentioned type of : n period on the meeting held on 4th of (Report Class: 018-04/07-01/01, No: entatives of Croatian CA asked ther the milk collecting points are gistration. EC clearly stated that are not part of activity of one dairy approved and that collecting the milk to be delivered only to one d be considered as integral part of that registration. nt to explain that: gistered collecting points in Croatia are which is collecting the milk from these such registered establishment as well as contracted by the dairy establishment paying costs for electric power for nts tre can independently sell the milk ing performing export activities, which is llecting points as a part of cold chain of stered according to the clear instruction d before the accessio

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The control system in place includes official controls for verification of FBO compliance with HACCP-based procedures. However its effectiveness is compromised as controllers are not able to identify some non-compliances in the design and implementation of the HACCP-based procedures and therefore cannot verify that FBOs identify the risks associated to their production, via CCPs, have them 19 under control and take appropriate corrective actions when necessary. 5.4.6 Microbiological criteria for foodstuffs Legal requirements Article 4 of Regulation (EC) No 854/2004 and Regulation (EC) No 2073/2005. Findings

Medlemsstatens svar

he senior veterinary inspector for milk from the central level (Department for Veterinary Inspection, Service for Planning and Veterinary Inspection, Veterinary Inspection Sector), will carry out within the framework of her work plan, official controls with the aim to increase of quality and consistency of official controls at all levels thus ensuring uniform performance of veterinary inspectors, i.e. the training of veterinary inspectors in all the veterinary offices / departments until the end of October 2017 in Page: 5 01/12/2017 report ref. DG(SANTE)/2016-8845-MR of the audit carried out from 10 October al controls related to the safety of food of animal origin, in particular milk and milk ation of official controls in milk . The purpose of this training/official e local veterinary inspectors are d enhance the work of veterinary ntation of official controls on self- ACCP principles in the milk processing nces in the implementation of of pasteurization as CCP by the food some cases due to the fact that these en noticed during the official controls, edures for validation of CCP siness operators", as educational material 8 November 2016 published on the rinary and food safety dire

Medlemsstatens svar

The Veterinary and Food Safety Directorate will amend and update existing procedure for approval of establishments dealing (EC) with food of animal origin. The procedure will be amended and updated by the end of April 2017. Furthermore, whenever there is a request for approval of larger establishments and those who carry out complex, higher risk operations as part of their business which is being approved, the approval committee, besides local competent inspectors, consists of senior veterinary inspector from the central level in charge of food controls (Veterinary Inspection Department). The Veterinary and Food Safety Directorate will draft new procedure for official controls performed by senior veterinary inspectors from the central level. The procedure will facilitate the increase of quality and consistency of official controls at all levels thus ensuring uniform performance of veterinary inspectors, including official controls during approval process. The procedure will be drafted by the end of April 2017.

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ents of Although routine analysis results of potable water in establishments related to production and storage of food of animal origin does not cover all parameters specified in Annex I part B and C of Council Directive 98/83/EC, those could be provided by external water suppliers at the FBO's request, what is prescribed by existing Law on the quality of water intended for human consumption provisions (O.J. 56/13, 64/15). Frequency of sampling and analysis and parameters to be Page: 1 of report ref. DG(SANTE)/2016-8853-MR of the audit carried out from 16 ce for official controls related to the safety of food of animal origin, in particular analyzed are set out by FBOs on risk based approach in the framework of their HACCP plans. Law on the quality of water intended for human consumption is in the procedure of being amended and it shall enter into force by 27 October 2017 at the latest. It is foreseen that water suppliers will have the obligation to provide and make it available to the FBOs, in an appropriate manner, information on all chemical and indicator parameters specified in Annex I part B and C of Council Directive 98/83/EC, what does not exclude the FBO's requirements to m

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In April 2014, the central competent authority in cooperation with Customs approved an instruction for exit checks made by Customs officials outside the working hours of BIPs. Following the newly approved instruction, the BIP staff perform the exit checks of transit consignments during the working hours of the BIPs. Customs are responsible for 9 the exit checks of transit consignments outside the working hours of the BIPs. The instruction is prepared following the requirements of Directive 97/78/EC and Decision 2000/208/EC.

In those cases where the transit checks are done by the BIP staff the seal check is done at the BIP facilities. Outside of working hours, the seal check is done by Customs officials at the Customs control post. In both cases these controls are done following the requirements of Decision 2001/812/EC. The port BIPs visited keep track of exiting transit consignments until they are unloaded into ships for dispatch outside the EU.

The audit team noted that none of the BIPs visited follow the above-mentioned work instruction: a. In the Ploce port, Customs authorities always send the exit transit consignments to the BIP for checks even if the BIP is not working. The consignment then waits until the BIP is open. b. In the Rijeka port, the exit transit checks are always performed by Customs even when the BIP is open. The local agreement to divert from the national instruction (finding 44) is not documented. Central Customs officials confirmed that Customs are obliged to check veterinary seals only in cases defined in the national instruction. This means there is no legal obligation for Customs to check the veterinary seals following the requirements of Article 3 of Decision 2000/208/EC when the BIP is open.

The official controls of exit transit consignments are correctly implemented in the vast majority of cases ensuring that consignments leave the EU territory as required by EU legislation, except for the Rijeka BIP. The different, undocumented implementation of instructions on exit transit controls at this BIP level cannot ensure that the exiting consignments are checked to confirm that they have not been manipulated during transit. 10

Medlemsstatens svar

exit BIPs In order to ensure that official controls on transiting consignments in at all exit BIPs comply with the requirements of Article 3 of Decision 2000/208/EC and to verify that the consignments have not been manipulated i.e. to verify that transiting consignment at exit BIP is the same one dispatched from entry BIP and in accordance with the data within the accompanying certificate, in April 2014, the Veterinary and Food Safety Directorate has prepared Guidelines on procedures which are applied during checks of transiting consignments exiting EU customs territory, i.e. persons responsible for consignments, border veterinary inspectors and customs officials at all border crossings with approved BIPs are obliged to implement these procedures. In particular, these Guidelines define the procedures which should be applied by customs officials during checks performed out of office hours of the exit BIP. As agreed between the Veterinary and Food Safety Directorate and the Central Office of Customs Administration, application of procedures as defined in Guidelines of 28th April 2014 is obligatory for all customs officials at all Croatian BIPs. As during the FVO mission it was found

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A consignment split in the warehouse visited had been rejected by the third country of destination due to a mismatch between the lot number on the boxes and the lot number on the health certificate accompanying the consignment from origin. The competent authority interpreted that there is no legal requirement to check/record the lot numbers of the consignments during the full identity check. This is contrary to the requirements of Article 4(4)(a)(ii) of Directive 97/78/EC. The operator of the warehouse stated it had taken corrective actions and strengthened controls during loading, cross-checking the lot number to match with the information on the health certificate.

The audit team conducted traceability exercises both to trace back and trace forward a randomly selected product in the warehouse. The data from TRACES matched precisely the info provided by the competent authorities' and the operator's records. However, the lot number of the consignment examined did not match that indicated in the original health certificate which accompanied the consignment. This had not been detected during the checks upon arrival at the warehouse, which is not in line with the requirements of Article 4(4)(a)(iii) of Directive 97/78/EC and Article 4 of Decision 2000/571/EC.

There are controls at the warehouses, but identity checks upon arrival at the warehouses do not ensure that mismatches with the certificates are identified. The mismatch with the original certificate means that those goods are (i) accepted for transit without adequate guarantees and (ii) are re-certified incorrectly by EU officials at the time of dispatch. The risk to animal health is mitigated since currently only canned fishery products are stored in the warehouses. Furthermore, the traceability system put in place by the operator allows for the reconciliation of the goods. 5.2.5 Controls at the exit BIP

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s In order to ensure implementation of the identity check at the warehouses intended for storing non-compliant consignments (indirect transit) as required by Article 4 of Council Directive 97/78/EC and Article 4 of Commission Decision 2000/571/EC, the Veterinary and Food Safety Directorate has issued an official letter to all BIPs in the Republic of Croatia (CLASS: 023-01/13- 01/561, REF. NO: 525-10/1113-15-24 of 6th July 2015). By this letter, border veterinary inspectors in all warehouses in the Republic of Croatia approved in accordance with Article 12 of Council Directive 97/78/EC and under their competence, when carrying out veterinary checks during storing and prior to shipping to the third countries, are requested, in addition to documentary check, to perform also a full identity check of each consignment in accordance with Article 4 of Commission Decision 2000/571/EC. In case the consignment does not fulfil the requirements of the full identity check, border veterinary inspector is obliged to proceed in accordance with article 17 of Council Directive 97/78/EC, in agreement with the person responsible for the consignment or his/her representative. In addition, as stated in t

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ntrolni popis sukladno Zakonu o provedbi uredbe (EZ) br 396/2005 o maksimalnim razinama ostataka pesticida u i na hrani hrani za zivotinje biljnog i zivotinjskog podrijetla (,,Narodne novine", broj 80/13) uvrsten je u sustav e-inpektor krajem 2015. odine. Kontrolni popis sukladno Zakonu o provedbi uredbe (EZ) br. 1107/2009 o stavljanju na trziste sredstava za zastitu bilja ("Narodne novine" br. 80/2013) uvrsten je u sustav e-inpektor u sijecnju 2016. godine. Kontrolni popis sukladno Zakonu o odrzivoj uporabi pesticida (,,Narodne novine", broj 14/2014) biti e uvrsten u sustav e- inpektor nakon donosenja novog Pravilnika o odrzivoj uporabi pesticida cija izrada je u tijeku. U izradi je Procedura o nadzorima ispravnosti sredstava za zastitu bilja koje inspektori provode kod distributera. Jednako tako u izradi je i Procedura nadzora pravilne primjene sredstava za zastitu bilja i higijene hrane na razini primarne proizvodnje koje inspektori provode kod korisnika sredstava za zastitu bilja (proizvoaca bilja). U obje procedure bit e propisano preciznije nacin provoenja inspekcijskog nadzora kao i poduzimanje mjera kod utvrenih nesukladnosti. U prilozima procedura bit e i obrasci zapisnika

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in Ministarstvo poljoprivrede e inicirati komunikaciju sa svim tijelima nadleznima za sluzbene kontrole, kako bi osigurali ucinkovitu i uspjesnu suradnju svih tijela ukljucenih u sluzbene kontrole. Prvi sastanci u smislu poboljsanja koordinacije e biti odrzani do kraja 4. kvartala 2016. godine.

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Ministarstvo poljoprivrede e dati prijedlog Ministarstvu zdravlja da u svoje procedure provoenja nadzora uvrste dodatne stavke on koje e osigurati bolju razmjenu informacija izmeu sanitarne inspekcije, koja je nadlezna za proizvodnju kemikalija, i poljoprivredne inspekcije, koja je nadlezna za stavljanje na trziste sredstava za zastiu bilja.

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Sukladno preporukama, laboratorij e poboljsati program analize formulacija. on Prema dosadasnjem iskustvu s ilegalnim i krivotvorenim sredstvima za zastitu bilja i prepakiranim sredstvima za zastitu bilja, potrebno je provoenje detaljnije analize formulacija. Laboratorij e poboljsati fizikalno-kemijske metode koristei (gdje je mogue) standardne i odobrene postupke (CIPAC, AOAC). Osim fizikalno-kemijskih metoda analize, laboratorij je svjestan da trenutna analiza udjela aktivne tvari u formulaciji nije dovoljna za utvrivanje vjerodostojnosti proizvoda na trzistu i njegove usklaenosti s uvjetima odobrenja, sukladno clanku 29 Page: 2 2016 port ref. DG(SANTE)/2015-7480-MR of the audit carried out from 13 October e of plant protection products 1) Uredbe (EZ) br. 1107/2009. otrebna je detaljnija analiza povezana s analizom ko-formulanata necistoa u formulaciji i shodno tome, laboratorij e poboljsati nalize u tom podrucju. Meutim, analize takve vrste zahtijevaju ofisticiranu opremu poput dvojne spektrometrije masa s dekvatnim analizatorom masa (qTOF, QqQ, TOF) koju aboratorij ne posjeduje. ako postupak akreditacije laboratorija koji provode analizu ormulacija nije zahtjev Uredbe (EZ) br.

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tavljanje na trziste krivotvorenih roba je kazneno djelo prema Kaznenom zakonu Republike Hrvatske, te su stoga i sankcije za aznena djela krivotvorenja SZB propisana Kaznenim zakonom epublike Hrvatske. nistarstvo pojoprivrede e kod revizije Zakona o provedbi redbe 1107/2009 uzeti u obzir preporuku te e se propisati vee ovcane kazne koje e biti odvraajue od stavljanja na trziste redstava koja nisu registrirana sukaldno clanku 28. Uredbe 107/2009. ako sudci imaju na raspolaganju kazne propisane Zakonom o rovedbi Uredbe 1107/2009, ukazujemo da prema dosadasnjoj udskoj praksi oni vrlo cesto propisuju kazne koje su manje od ropisanih tim Zakonom. Page: 3

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In 2014, RMP sampling started in the second half of March, as the planning process was not finalised earlier. In 2015, VMPRMD had forwarded the first set of sampling requests to the regional coordinators in the week preceding the FVO audit. VSFD was aware of the fact that the RMP planning process needs to be finalised as soon as possible in order to fulfil the requirement in point 2.1 of the Annex to Decision 98/179/EC regarding the distribution of sampling over the whole year.

With the exception of the absence of residue monitoring in the first two months of the year and the lack of verification on how control bodies implement suspect or targeted sampling, the residue monitoring plan is implemented effectively. 5.1.4 Other residue monitoring programmes Legal Requirements Articles 9 and 11 of Directive 96/23/EC; Articles 8 and 10 of Regulation (EC) No 882/2004. Findings

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nt authority response: The request for the sampling under the residue monitoring plan will be distributed in December to ensure the sampling in the first quarter of the next year.

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The audit team examined the SOP and the validation report of the analytical method for milk. Whilst the validation was broadly in line with the requirements of Decision 2002/657//EC, the quantification of benzimidazoles in milk was not in conformity with point 2.1.2.1 of the Annex to this Decision as recovery correction was not implemented. Conclusions on laboratories

Despite some shortcomings in the implementation of some analytical methods (e.g. the lack of application of analytical recovery for benzimidazoles and recording of the use of analytical standards), the competent authority can have confidence in the laboratory performance and the reliability of analytical results as all of the laboratories in the network are accredited to ISO 17025 and methods are adequately validated and staff are appropriately trained.

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Competent authority response: This recommendation is intended for laboratory NRL-5 (Laboratory for Analytical Chemistry and Residues in Krizevci) These are corrective actions: In order to correct calculation and expression of results method for the determination of benzimidazoles residues in milk (Rev. 1) is revised (attached to the action plan: Rev. 2 SOP 5.4/K3/SOP108). In point 5.7 of the SOP chapter Expression of the result is added which indicated that the positive compounds have to be corrected for recovery according to the values obtained using the control spiked samples on the day of analysis which is in accordance with requirements from point 2.1.2.1. of the Annex of Decision 2002/657/EC. This is applicable from the date of issuance of the new SOP revision. Annex: NRL-5 SOP 108 Rev 02 and NRL-5 SOP 108 Rev 2-first page.

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The handling of pure standards (weighing and further preparation of stock/intermediate/spiking standard solutions) was not properly separated from the handling of samples in order to avoid potential cross-contamination of standards and official samples. The records of pure standards expiry dates and vial discard dates were not sufficiently detailed to demonstrate that standards used were in date. 5.1.6.3 Laboratory for Analytical Chemistry and Residues in Krizevci (NRL-5)

Despite some shortcomings in the implementation of some analytical methods (e.g. the lack of application of analytical recovery for benzimidazoles and recording of the use of analytical standards), the competent authority can have confidence in the laboratory performance and the reliability of analytical results as all of the laboratories in the network are accredited to ISO 17025 and methods are adequately validated and staff are appropriately trained.

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t authority response: This recommendation is intended for laboratory NRL-4 (Laboratory for Analytical Chemistry and Residues in Rijeka) These are corrective actions: Precise balance for weighing of samples has been removed in other separate room and therefore is physically separate from the Page: 1 May 2015 DG(SANTE)/2015-7510-MR of an Audit carried out from 10 aminants in live animals and animal products including controls on al balance for weighing of standards. ion to the forms prescribed by the general procedure of Standards for measurement NRL-4 introduce the new n procedure RU R-3-SRM: Preparation of secondary e materials (attached to the action plan: Rev. 00, 15). Within procedure Diary for preparation of secondary e materials is introduced in order to monitor pure standard ates and vial discard dates. Annex: NRL-4 RU R-3- SRM nd NRL-4 RU R-3 SRM Rev00- first page.

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In line with Article 2 of Directive 2006/130/EC, the VPHFSS has drawn up a list of veterinary medicinal products which are exempted from the prescription requirement of Article 67 of Directive 2001/82/EC. The VPHFSS has not yet notified this list to the European Commission as required by Article 3(1) of Directive 2006/130/EC.

Notwithstanding the observations made by the audit team concerning discrepancies in 10 the information held for some veterinary medicinal products and the fact that the Commission services had not been notified about the list of products exempted from veterinary prescription, the marketing authorisation of veterinary medicinal products as well as their distribution and use are in compliance with EU legislation. 5.2.3 Official controls on veterinary medicinal products Legal Requirements Article 3, 4 and 8 of Regulation (EC) No 882/2004; Article 80 of Directive 2001/82/EC; Article 4(2) of Regulation (EC) No 854/2004. Findings

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tent authority response : fication to EC has been sent on 21st May 2015. Page: 2

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The audit team noted that although the current planning of official controls takes into account some risk criteria, not all of those required by Article 3 of Regulation (EC) No 882/2004 are included, namely, the records of compliance of operators and the reliability of operators' own checks. According to the competent authorities it is planned to develop a software application which will allow these additional factors to be taken into account. However, this is at a very early stage of development and it is not known when the system will be operational.

A comprehensive system of official controls along the ABP/DP chain has been put in place and all relevant operators are subject to official controls which are carried out using comprehensive checklists which include requirements on the traceability of ABP/DP. Official controls on ABP/DP are carried out largely as planned and their effectiveness is verified through verification activities. These arrangements enable the competent authorities to provide guarantees that the risk of diversion/misuse of ABP/DP is adequately taken into account and these will be will further strengthened by a software application to be implemented soon. However, the level of official controls would be more risk-based once the operators' past records of compliance and the reliability of operators' own checks are taken into account during the planning process.

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r Procedure defining the requirement for persons responsible for the load to provide the notifications of arrival of consignments prior to arrival on EU territory was the drafted at the beginning of May 2014, in accordance with the Article 2 of the Regulation (EC) No 136/2004, and sent to all BIPs. This procedure is also described in the Manual of procedures at BIPs. The procedure for pre-notification is published and available on the official web site of the Ministry of Agriculture (direct link: http://www.veterinarstvo.hr/default.aspx?id=1237 ) In order to ensure that the mentioned procedure for pre-notification is applied at BIPs, the following activities are carried out: - Every border veterinary inspector, who is on duty, is obliged to check if every consignment is pre-notified before its arrival at the territory of the Republic of Croatia (the time of the pre-notification and the exact time of the arrival of consignment is being checked). - The document supporting the information on the pre-notification time is being kept at BIP during the period of 3 years. - Head of the BIP is obliged to check, on daily basis, if the procedure for pre- notification is applied for every cons

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ies in Bearing in mind the recommendation given in your Draft report, regarding the deficiencies noted for storage facilities in Rijeka BIP, in the section for NHC, where the consignments of animal by-products at different temperature regime could not be stored simultaneously, if it is necessary, Veterinary and Food Safety Directorate is providing the following answer: As the BIP Port Rijeka cannot ensure storage of consignments of animal by- products on chilled regime in commercial warehouse within the Rijeka customs area (except in the way already described in procedure which was sent 14/05/2014), as well as taking into account that the BIP Port Rijeka from 01/07/2013 until this moment hasn't had any consignments of this kind and, for now, there is no need for storing the consignments of animal by-products in chilled regime (+4-+8) at the BIP concerned, we agree that the EC makes changes on the list of registered BIPs according to the Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces, in

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ocedure for verifying the effectiveness of official ls will be set up by 30 November 2014. ll comprise a checklist to be filled in by staff carrying he verification procedure. The new verification policy on the abovementioned procedure will be applied as of uary 2015 at the latest.

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dure is being developed for the approval of business ishments that handle food of animal origin. The ure will be ready by 15 October 2014. he case of larger establishments and those that carry out ex operations as part of their business which is being ved, pproval board will consist of senior veterinary ctors of the central Veterinary Inspection Department mployees of the Sector for Veterinary Public Health ood Safety. gards the registration, i.e. approval of milk collection es, Croatian authorities discussed the technical details rning compliance with the criteria at technical ngs with Commission representatives during the pre- sion negotiations. Action points were jointly adopted at meetings. Croatia complied with these action points hus successfully closed Negotiation Chapter 12. At a ical meeting in Brussels in December 2007 -- at which ical details were discussed about the categorisation of Page: 1 DG(SANCO)/2014-7218 -MR of a/an audit carried out from 24 rols related to the safety of food of animal origin, in particular milk and l origin and he d by the opted ection il it is shipped perts ships milk to onsidered as ed not acquire point shipping ng must dits of the one from 20

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set of rules containing national provisions on flexibility r in Article 10 of Regulation (EC) No 853/2004 nd Member andstill Page: 2 DG(SANCO)/2014-7218 -MR of a/an audit carried out from 24 rols related to the safety of food of animal origin, in particular milk and

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st will contain detailed instructions as to which eters are to be tested in water tests. The checklist will eviewed by 30 November 2014. , veterinary inspectors will take part in continuous n water testing through control and instructional will be carried out by senior veterinary of the Veterinary Inspection Department of the d Veterinary Inspections Service of the Sector ary Inspection.

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, as part of their control and instructional checks, rinary inspectors for milk establishments of the Inspection Department of the Planning and Inspections Service of the Sector for Veterinary will train veterinary inspectors responsible for milk processing establishments (according to the approved establishments there are 12) in all units, nary offices, that have jurisdiction over these nts. The goal is to enhance the work of inspectors as regards checks of the requirement of ishments to develop and implement a HACCP n accordance with Article 5 of Regulation (EC) of the European Parliament and of the Council 2004 on the hygiene of foodstuffs and the of Commission Regulation (EC) No 2073/2005 logical criteria for foodstuffs. Special attention d to the implementation of a validation process for teurisation equipment as a critical control point e/time) -- as laid down in Annex II, Section IX, Point II of Regulation (EC) No 853/2004 and and Page: 3 DG(SANCO)/2014-7218 -MR of a/an audit carried out from 24 rols related to the safety of food of animal origin, in particular milk and a, Chapter I of Regulation (EC) No 2074/2005 -- hecking pasteurisation in line with a reference s provided

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action plan referred to under 5, the plan of official of the Veterinary Inspection Service for 2015 will in particular on the validation of pasteurisation t in all milk processing establishments. Page: 4 DG(SANCO)/2014-7218 -MR of a/an audit carried out from 24 rols related to the safety of food of animal origin, in particular milk and

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lan referred to under 5.

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procedure for verifying the effectiveness of official trols will be set up by 30 November 2014. t will comprise a checklist to be filled in by staff carrying he verification procedure. The new verification policy on the abovementioned procedure will be applied as of uary 2015 at the latest.

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ew of the findings of the Food and Veterinary Office, he Independent Audit Unit of the Ministry of Agriculture he Veterinary Inspectorate, a risk of conflict of interest een confirmed as regards CBs carrying out official ols Given that the findings of several audits and ctions of various accredited authorised veterinary s are similar and indicate that this is not an isolated this body has taken additional measures in order to e the risk of conflict of interest to a minimum. These de: ifying the Croatian Accreditation Agency; ifying CBs of the findings and of the need for ctive measures; ifying the inspection procedure and revising the ency of inspections performed by CBs as part of entrusted tasks. ew of the foregoing, the Directorate for Veterinary and Safety sent a letter class: 322-01/14-01/1559, ref. 25-10/0249-14-2 of 19 September 2014 to all CBs, ming them of the most common inconsistencies ified, with the purpose of resolving the issue as Page: 1 ef. DG(SANCO)/2014-7275 -MR of an audit carried out from 24 ontrols related to the safety of food of animal origin, in particular meat and effectively as possible. Please find the letter enclosed. The Directorate for Veterinary and

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he Directorate for Veterinary and Food Safety of the istry of Agriculture is drawing up a programme for co- nancing national reference laboratories, under which funds uld be allocated to national reference laboratories for the rpose of covering part of their expenses incurred in rforming their legal obligations. The funds for this rpose have been earmarked in the Croatian State Budget. rsuant to Article 33 of Regulation (EC) 882/2004, national ference laboratories are required, inter alia, to organise mparative tests between official national laboratories. Page: 3 ef. DG(SANCO)/2014-7275 -MR of an audit carried out from 24 ontrols related to the safety of food of animal origin, in particular meat and Since the authorised national reference laboratory for trichinella is the Laboratory for Diagnostics of the Vinkovci Veterinary Institute (part of the Croatian Veterinary Institute), the abovementioned programme will require the Croatian Veterinary Institute to organise comparative tests with laboratories of authorised veterinary bodies which carry out trichinella testing on meat intended for public consumption. The Veterinary Inspection Department will develop a set of instructions ai

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ocedure is being developed for the approval of business establishments that handle food of animal origin. The procedure will be ready by 15 October. In the case of larger establishments and those who carry out complex operations as part of their business which is being approved, the approval board will consist of senior veterinary inspectors of the central Veterinary Inspection Department and employees of the Sector for Veterinary Public Health and Food Safety.

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The checklist will contain detailed instructions as to which parameters are to be tested in water tests. The checklist will have been reviewed by 30 November 2014. In addition, veterinary inspectors will take part in continuous education on water testing through control and instructional checks that will be carried out by senior veterinary inspectors of the Planning and Veterinary Inspections Service of the Sector for Veterinary Inspection.

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2015, as part of their control and instructional checks, senior veterinary inspectors for meat establishments of the inary Inspection Department of the Planning and Veterinary Inspections Service of the Sector for Veterinary Inspection will train veterinary inspectors responsible for individual meat establishments in all veterinary offices (units) that have jurisdiction over these establishments. The goal is to enhance the work of veterinary inspectors as regards checks of the requirement of food establishments to develop and implement a HACCP programme in accordance Page: 5 ef. DG(SANCO)/2014-7275 -MR of an audit carried out from 24 ontrols related to the safety of food of animal origin, in particular meat and Article 5 of Regulation (EC) No 852/2004 of the pean Parliament and of the Council of 29 April 2004 on hygiene of foodstuffs and the provisions of Commission lation (EC) No 2073/2005 on microbiological criteria foodstuffs. icular attention will also be paid to: - the integration of the microbiological criteria referred to in Regulation (EC) No 2073/2005 into HACCP procedures, so that these criteria could be used in programme verification and tests; - a sampling plan for micr

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set of rules containing national provisions on flexibility ided for in Article 10 of Regulation (EC) No 853/2004 been notified to the European Commission and Member : 6 ef. DG(SANCO)/2014-7275 -MR of an audit carried out from 24 ontrols related to the safety of food of animal origin, in particular meat and es under reference No 2014/0454/HR. The standstill od ends on 18 December 2014. : 7