Ref. Ares(2020)1304822 - 02/03/2020

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6669

FINAL REPORT OF AN AUDIT CARRIED OUT IN IRELAND FROM 07 MAY 2019 TO 16 MAY 2019 IN ORDER TO EVALUATE THE CONTROL SYSTEM IN PLACE GOVERNING THE PRODUCTION OF HORSE INCLUDING TRACEABILITY

In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote. Executive Summary

The report describes the outcome of an audit carried out by the Directorate-General for Health and in Ireland from 7 to 16 May 2019. The objective of this audit was to evaluate the control system in place governing the production of , including traceability of live animals and products derived thereof.

The audit found that since the 2013 "horse meat scandal" the competent authority has introduced several changes in the control system and the applicable legislation aimed at improved compliance with and enforcement of the relevant EU requirements, and to ensure that only horses with the correct identification and clearance for slaughter enter the food chain. The control system also includes official sampling for species identification and specific residues analyses, with overall satisfactory results. In addition, it has put in place several measures to investigate suspected irregularities and to enhance awareness, and has made efforts to strengthen cooperation between the various actors. The procedures in place for the registration of keepers of horses are properly implemented, but the system does not allow the identification of - and, therefore controls over - horse dealers whose main activity is to buy and keep horses for a limited period of time. The passport models and the lay-out for the information they should contain comply with EU rules, and different mechanisms have been put in place in order to ensure their authenticity and to avoid tampering. The identity checks by the passport issuing bodies prior to their issue are accurate. Nonetheless, both the fact that a number of horses are not yet identified and instances of delayed identification of horses, highlight that owners/keepers do not consistently meet their obligations. Having said so, the automatic exclusion from the food chain of horses which were registered late or for which duplicate or replacement passports were issued, mitigates potential risks in the production of horse meat. The central database for the registration and identification of horses is updated with information from the passport issuing bodies and the . Even if the design of the database contains all the information required under EU rules, the data itself is not sufficiently accurate/reliable, due in particular to the absence of (or delayed) notifications and/or recording of the animals' status, thus jeopardising the controls on the horse identification and movements. As regards the processing establishments, the procedures for their approval were implemented correctly. The official controls over the production of horse meat and the associated compliance by operators with the relevant EU requirements, are organised on a risk basis and implemented using comprehensive documented procedures and guidance; overall, these controls ensure that the relevant requirements are enforced. Controls in respect of Trichinella were equally satisfactory. The competent authorities' controls in slaughterhouses over the eligibility of horses for slaughter for human consumption are comprehensive, allowing the detection of non-compliances and irregularities. As such, the system ensures that only horses with correct identification and clearance for slaughter enter the food chain. However, the audit team observed a large-scale absence of recording of medicinal treatments in the passports, which casts doubts on the reliability of this information. At the same time, verification of compliance with these recording

I requirements is very limited. This, together with the fact that the official controls pay limited attention to the subsequent fate of the substantial number of horses which are excluded from the food chain, diminishes the effect of the otherwise robust controls in the slaughterhouses. The question remains what is happening with these ineligible horses, as an accurate reconciliation of the number of horses and their ultimate destiny is not possible. Exclusion from the food chain in accordance with the rules in place has a significant economic impact for the owners of the animals which, in turn, may provide an incentive to introduce them into the food chain anyhow, and moreover generates animal welfare concerns (e.g. abandoned animals or killing of animals).

The report contains recommendations to the competent authorities of Ireland to address the shortcomings identified.

II Table of Contents

1 Introduction...... 1 2 Objectives and scope...... 1 3 Legal Basis...... 2 4 Background ...... 2 5 Findings and Conclusions ...... 3 5.1 National legislation and provisions...... 3 5.2 Competent authorities ...... 4 5.3 Holdings/keepers registration and food business establishments approval ...... 9 5.3.1 Holdings/keepers registration...... 9 5.3.2 Food business establishments approval...... 10 5.4 Organisation and implementation of official controls ...... 11 5.4.1 Official controls on horse identification and movements of animals...... 11 5.4.1.1 Identification document ...... 11 5.4.1.2 Identification verification (transponder) ...... 14 5.4.1.3 Databases...... 15 5.4.1.4 Movement controls...... 16 5.4.2 Official tasks at establishment level...... 19 5.4.2.1 Organisation of official controls...... 19 5.4.2.2 Ante-mortem inspection (AMI) ...... 20 5.4.2.3 Post-mortem inspection (PMI)...... 20 5.4.2.4 Official sampling and analyses...... 22 5.4.2.5 Official laboratories ...... 23 5.4.3 Official controls on Food business operators obligations...... 24 5.4.3.1 Food chain information and verification of identification ...... 24 5.4.3.2 Animal welfare...... 24 5.4.3.3 General and specific hygiene requirements of establishments...... 25 5.4.3.4 HACCP-based programmes ...... 25 5.4.3.5 Microbiological criteria ...... 25 5.4.3.6 Traceability, health and identification marking ...... 26 5.4.4 Official controls on import and trade of live horses, horse meat and products derived thereof ...... 26 5.4.4.1 Live horses ...... 26

III 5.4.4.2 Horse meat/horse products derived thereof...... 27 5.4.5 Official controls on production, import and trade of animal by-products consisting of/containing horse materials ...... 27 5.4.6 Official controls on distribution and use of veterinary medicinal products ...... 27 5.5 Rapid Alert System for Food and Feed (RASFF)...... 30 5.6 Lessons learned from the "Horse meat scandal" in 2013...... 30 6 Overall Conclusions ...... 32 7 Closing Meeting...... 33 8 Recommendations ...... 33

IV ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation AIM Animal Identification and Movement System AMI Ante-mortem inspection CA Competent authority CCA Central competent authority CED Central Equine Database CVO Chief Veterinary Officer DAFM Department for Agriculture, Food and the Marine DG Health and Food Directorate-General for Health and Food Safety of the European Safety Commission EU European Union FBO Food Business Operator FCI Food Chain Information declaration FSAI Food Safety Authority of Ireland HACCP Hazard Analysis and Critical Control Points MS Member States OV Official Veterinarian PIO Passport Issuing Organisation PMI Post-mortem inspection PVP Private veterinary practitioner(s) SIU Department's Special Investigation Unit SOP(s) Standard Operating Procedure(s) TAO Technical Agricultural Officer TN(s) Trader Notice(s) TVI Temporary Veterinary Inspector VMP(s) Veterinary medicinal product(s) VPHIS Veterinary Public Health Inspection Service VPHRL Veterinary Public Health Regulatory Laboratory VPN(s) Veterinary Procedural Notice(s)

V 1 INTRODUCTION

The audit took place in the Ireland from 07 to 16 May 2019. The audit team comprised three auditors from Directorate-General for Health and Food Safety of the European Commission, (DG Health and Food Safety) and was accompanied during the whole audit by representatives of the central competent authority (CCA), the Department for Agriculture, Food and the Marine (DAFM). In addition, representatives of local and Regional authorities involved in the control systems accompanied the audit team during the relevant part of the audit.

An opening meeting was held on 7 May 2019 with the CCA in Co Dublin. At this meeting, the audit team confirmed the objectives of, and itinerary for, the audit, and additional information required for the satisfactory completion of the audit was requested.

2 OBJECTIVES AND SCOPE

The objective of the audit was to assess whether the official control system governing the production of fresh horse meat1, including traceability, and products derived therefrom is compliant with the requirements laid down in Union legislation.

In terms of scope, the audit covered the implementation of the official control system covering the production, processing and distribution chain of fresh horse meat, including traceability.

The table below lists the sites visited and the meetings held during the audit:

COMPETENT AUTHORITIES (CAS) Central 1 Opening and closing meetings. Regional Met in all establishments visited Local Met in all establishments visited

FOOD BUSINESS ESTABLISHMENTS Slaughterhouses 2 1 with annexed cutting plant Standalone cutting plant 1 Passports Issuing Bodies 2 Horse holdings 1 Horse trainer. Race course 1 Racing controlling body

1 In the context of this series of audits the term "horse meat" means meat from domestic solipeds (i.e. Equus caballus, Equus asinus and their cross-breeds).

1 3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

A full list of the EU legal instruments referred to in this report is mentioned in the Annex to this report. Legal acts quoted refer, where applicable, to the last amended version.

4 BACKGROUND This was the first audit of a series of audits planned by DG Health and Food Safety in 2019 in four Member States (MS), i.e. Ireland, Belgium, Poland and Romania.

In the past, audits on horse identification for the purpose of control of animal diseases were carried out between 2011 and 2016 in three MS (Bulgaria, Romania and the United Kingdom), whilst between 2011 and 2012 five other audits have been carried out to evaluate the official controls related to slaughter and processing of fresh equine meat in the selected MS (Spain, Belgium, Italy, Poland and France). The outcomes of these latter were summarised in the overview report (ref. DG(SANCO)/2013-6950) published at:

http://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=52.

In 2013, FSAI discovered a widespread fraud of beef adulterated with horse meat. Tests on some products labelled as beef found they were up to 100% horse meat. The discovery led to the recall of beef products in supermarkets across Europe and to further investigations leading to prosecutions in several MS. Production of horse meat in Ireland

The table below indicates the number of horses slaughtered in previous years:

YEAR HORSES SLAUGHTERED 2012* 24,362 2013* 10,711 2014 7,602 2015 6,033 2016 7,618 2017 7,748 2018 6,573 * Due to the financial crisis, many owners were no longer in a position to keep their horses and a significantly higher number of horses were slaughtered in 2012 and 2013.

2 The CCA explained that there are not specific farms rearing horses for slaughtering. The origin of horses slaughtered could be very different (e.g. animals injured, breeders sending horses at the end of their life, sport horses not good enough for competing, etc.) They also added that on farm equine emergency slaughter is not available in the country.

Ireland has a very significant industry of sport and race horses: it is the third largest producer of sport horses in the world and exports 65% of their production of live horses. More than 9,000 foals of thoroughbred horses are produced annually and are exported to more than 30 different countries.

The consumption of horse meat in Ireland is marginal to nil and the production is exported mainly to France, Switzerland, Belgium, The Netherlands and Sweden.

5 FINDINGS AND CONCLUSIONS

5.1 NATIONAL LEGISLATION AND PROVISIONS

Legal requirements

Article 291 of the Treaty on the Functioning of the EU. Article 10 of Regulation (EC) No 853/2004. Findings

1. The Statutory Instrument (S.I.) No. 62 of 2016 gives effect to the provisions of Commission Implementing Regulation (EU) No 2015/262 on methods for the identification of horses.

2. The "Control on Places where Horses are Kept Regulations 2014" (S.I. No 113 of 2014) lays down provisions for registration of premises keeping horses.

3. The "Control of Horses Act, 1996" lays down provisions for licensing of horses kept or brought into urban and other areas where they can cause a danger to persons/properties or nuisance. The same Act provides the legal basis for the control of stray horses.

4. The "Equidae (Change of Ownership) Regulations 2016" (S.I. No. 201 of 2016) lays down procedures for recording changes in ownership of equidae: The person transferring and acquiring the ownership of the animal is responsible of notifying the changes in ownership to the passport issuing body.

5. The European Communities (Animal Remedies)(No.2) Regulations 2007 (S.I. No. 786 of 2007) gives effect to Directive 2001/82/EC and to Regulation (EC) No 2377/90 (now repealed by Regulation (EU) No 470/2009: it regulates the use of veterinary medicinal products, including the "in cascade use" in food-producing animals.

6. The "European Communities (Control of Animal Remedies and Their residues) Regulations 2009" (S.I. No. 183 of 2009) gives effect to Council Directives 96/22/EC and 96/23/EC. It regulates the use of specific drugs suitable for zootechnical and

3 therapeutic treatments and requires records of use of any veterinary medicinal products in food-producing animals. Moreover, it requires Food Business Operators (FBOs) running slaughterhouses to implement a plan for the detection of substances, veterinary drugs and contaminants specified in Annex I to Directive 96/23/EC.

7. Some Articles of the above mentioned national acts are penal provisions to which the relevant sections of the Diseases of Animal Act 1966 (Registration of Horse Premises) Order 2012 and the Animal Health and Welfare Act 2013 apply (sanctions).

8. A series of Veterinary Procedural Notices (VPN) and Standard Operating procedures (SOPs) contain specific provisions for the delivery of the inspection program. They may be integrated by Trader Notices to directly inform operators and/or official staff about changes in legislation or in procedures in place.

9. The CCA informed the audit team that there is no specific legislation implementing Article 10 of Regulation (EC) No 853/2004. Therefore, the food business establishments in the horse meat sector cannot avail of the adaptations provided in EU legislation.

10. A Tripartite Agreement (TPA) between Ireland, France and UK, which came into force on 18 May 2014, regulates the free movement of registered horses.

Conclusions on national legislation and provisions

11. National legislation has been issued in order to transpose/implement and allows enforcement of the Union Directives and Regulations relevant to the areas covered by this audit.

12. A tripartite agreement has been signed with two Member States in order to facilitate the movement of horses between the three MS.

5.2 COMPETENT AUTHORITIES

Legal requirements

Articles 4, 5 and 6 of Regulation (EC) No 882/2004.

Findings

Competent authorities 13. Several different authorities are involved in the control and supervision of the different areas covered by the audit (e.g. animal identification and movements, administration of veterinarian medicines, horse meat production, animal-by-products):  The Food Safety Authority of Ireland (FSAI) maintains overarching authority over the nation’s food supply and has overall responsibility for the enforcement of food safety legislation, apart from at the level of primary production. FSAI

4 manages its responsibility through contractual arrangements with official agencies, including DAFM. Section 48 of the FSAI Act, 1998 gives the legislative basis for this. The FSAI provides, through its audit activities, an independent evaluation on the effectiveness of the official food control system and/or FBOs' compliance with respect to a specific aspect of food law. A summary of FSAI audits can be found via the following link: https://www.fsai.ie/enforcement_audit/audit/reports.html FSAI has established a cross agency working group to prepare for and coordinate implementation of the requirements of Regulation (EU) 2017/625 of the European Parliament and of the Council. These new requirements will be integrated into the service contracts with all official agencies when the legislation is fully in force. FSAI has also provided advice to the Government Departments (Department of Health and DAFM) on the national legislation to give effect to this Regulation, including on the need to ensure sanctions for violations perpetrated through fraudulent or deceptive practices. FSAI also commenced training with official agencies in 2018 and 2019 to prepare to implement the requirements the Regulation. DAFM, which operates both centrally and regionally, is the CA responsible for ensuring the safety of animal-based food products and has the authority to promulgate food inspection regulations, and enforce food safety laws and regulations. All equine establishments and activities related to horse meat (i.e. slaughterhouses, cutting plants, storage and despatch) are, since the horse meat scandal in 2013, under their control and no longer under the control of the local authorities, in order to ensure consistency in the control system. Within the DAFM, the Veterinary Public Health Inspection Service (VPHIS), headed by the Deputy Chief veterinary Officer, has the ultimate control over the slaughtering of livestock and production of food products derived from animals. The inspection personnel assigned to the approved establishments fall into three categories: a) salaried, permanent VPHIS inspectors (Official veterinarians – OVs), b) Temporary Veterinary Inspectors (VI) serving as contractors to the CCA, and c) salaried, permanent Technical Agricultural Officers (TAO). 14. DAFM is in charge of the Animal Identification and Movement System (AIM) which contains the Central Equine Database (CED). Passport issuing bodies 15. DAFM has delegated the issuance of equine passports to Passports Issuing Organisations (PIOs) which must be approved by the Department. At the time of the audit, seven PIOs have been approved for maintaining studbooks and issuing identity documents (passports) for registered horses (those with a pedigree and thus eligible for entry in a studbook). Two of them are also approved to issue passports in respect of horses for breeding and production, having no pedigree and thus ineligible for entry in a

5 studbook. The first approval granted to a PIO is valid for one year; the following ones have a validity of three years. The updated list of approved PIOs is available on the DAFM website at: http://www.agriculture.gov.ie/farmingsectors/animalbreeding/approvedestablishmentsintheveteri naryandzootechnicalfieldapprovedlaboratories/. 16. DAFM carries-out inspections on PIOs, with a minimum frequency of once every three years, in order to ensure they comply with their obligations (e.g. follow the procedures, completing records and transmission of data to central database, etc.) A comprehensive and extensive checklist is used during the inspections. The audit team was given access to inspection reports drafted by DAFM. Sport associations 17. In addition to the CAs and passport issuing bodies described above, the sport associations also play a role in the sector audited. DAFM has the oversight role in relation to corporate governance of the State body responsible for horse racing in Ireland. 18. The associations mentioned below must verify that any horse participating in any event in the country is properly identified (i.e. microchipped and valid passport) and meet the requirements concerning the vaccination status of the animal:  Horse Racing Ireland is the national authority for thoroughbred racing with the responsibility for the governance, development and promotion of the industry under the Horse and Greyhound Racing Act 2001. It operates under the aegis of DAFM as a Commercial State Body.  The Irish Horseracing Regulatory Body is the sole body that is independently responsible for making and enforcing the rules of racing and provides adequate integrity services for the purpose of enforcing discipline and ensuring that the horses are run fairly and properly. It includes amongst other duties, the anti- doping controls and the check of horses' identity before racing.  Horse sport Ireland is the national governing body for equestrian sports in Ireland, and for international show jumping, eventing and dressage. In addition it operates several studbooks. It assumes a role in bringing sport and breeding together. Coordination and collaboration between CAs, passport issuing bodies and sport associations 19. The service contract FSAI has concluded with DAFM specifies that: ‘Where, during the course of official controls, the Official Agency identifies violations which may indicate fraudulent/deceptive practices in so far as they relate to food legislation, these will be investigated by the official agency and reported to the Authority.’ 20. A FSAI Food Fraud Task Force was established as a follow up measure in relation to tackling food fraud. Its role is to act as a communications, coordination and networking group where intelligence and research can be shared at national and international level. Issues that are considered include raising awareness, improving mechanisms for

6 monitoring and surveillance and training of enforcement officers. The Task Force advises on a multi-agency basis across different enforcement arms of the State. It comprises representatives from a number of enforcement agencies including (e.g. An Garda Síochána, Customs and Excises Service, DAFM, Food Standard Agency in Northern Ireland, local Authorities, State Laboratory, etc.). 21. DAFM informed the audit team that they are in contact with the PIOs on an ongoing basis. In this regard, evidence was provided that exchanges of information between them take place when necessary (e.g. PIOs had informed DAFM about indications of non- compliances and of significant irregularities detected.) 22. Some good examples of the collaboration and flow of information between the services involved are: a. Collaboration between the audit and investigation Division of two investigation Units of the FSAI (Food Fraud Task Force) (see paragraph 156 and 157) and DAFM. Joint investigations and actions are on-going. b. The information from the PIOs is sent automatically on a daily basis to the AIMS data base where the information is checked and, in case of problems, these are notified automatically. c. PIOs informed AIMs and the central office of DAFM when serious issues were identified (e.g. related to performance of veterinarians, alteration of passports). In situations like these, DAFM informed the local office(s) in order to investigate the situation. d. An Equine Liaison Group meets regularly (generally once a year) to discuss issues regarding the sector; it comprises the CCAs of the Republic of Ireland and of Northern Ireland, representative of the equine industry, and of the private veterinary practitioners. e. FSAI, Food Standard Scotland and the National Food Crime Unit of the in Northern Ireland have concluded a data sharing agreement. 23. However, the audit team also noted the following: a. AIMs is not forwarding the up-dated information to the PIOs, who as a consequence, have to up-date their own databases manually. b. When the sport associations identify problems related to the identification of horses and/or their passport during events and competitions it is not required to transmit this information to DAFM, AIMs or PIOs. The consequences are limited to prohibition of racing or participating at the events, and they advise the owner to contact the PIO for fixing the identification records noted in the passport. c. FBOs running the slaughterhouses can during the pre-clearance (see paragraph 33) come across identification issues. In these cases, the horse is not sent to the and it is not required to pass this information to the CAs. It can be considered as a missed opportunity to identify possible wrongdoing, and to

7 inform the relevant CA and other slaughterhouses to draw attention to the potential identification issues and to prevent non-eligible horses being presented for slaughter a second time or somewhere else. d. Staff from PIOs stated that private veterinary practitioners (PVP) rarely inform them about inaccuracies or identification issues. At the first identification visit microchipping of the animal is delayed until discrepancies (e.g. missing registration of the holding, wrong ownership, etc.) are solved. In some cases, it was stated that changes in identification marks, due to the age, have been communicated to the PIO. Enforcement 24. DAFM Regional Office personnel is responsible for the enforcement of equine identification legislation. They work closely with the local authorities in addressing any issue that can arise. DAFM further co-operates with multi-agency initiatives enforcing legislation at fairs etc. 25. SOP 02/2015 (Enforcement Procedures at Approved Meat and Milk Pasteurising Premises) describes all of the enforcement procedures to be followed by DAFM staff at Slaughter Plants. 26. The CCA and CAs met explained that even if there are legal basis and procedures for applying sanctions, it is sometimes challenging to enforce the requirements of the legislation in the sector audited, mainly due to difficulties in carrying out official controls for detecting some non-compliances and gathering the proof to support them. Moreover, in cases of alleged fraud it is difficult to prove intent, responsibility and risk for public health. For instance, in their view the following obligations are difficult to enforce:  The registration of medical treatments in the passports (see also paragraphs 34, 110 and 136.a);  The change of ownership must be communicated by the new owners to the PIO and registered (see also paragraph 45);  The passport accompanying the body of dead animals, e.g. to knackeries, often animals are received without passports (see also paragraphs 46.b and 47.b)  The notification of the movement of horses leaving the territory or when dead (see also paragraph 60).

8 Conclusions on competent authorities 27. CAs are designated for the performance of official controls for the different sectors covered by the audit and they have the necessary powers to carry out their duties and enforce the legal requirements. 28. DAFM has the overall responsibility of identification of horses, which is largely delegated to private organisations (PIOs), in particular, the issuance of passports. These bodies, which are under the supervision of the authorities, must inform the CCA about registered animals as well as any issue related to the performance of the delegated tasks. 29. The system in place requires the different CAs involved in the sector audited to coordinate and exchange information in order to ensure that accurate information is available, in particular when horses enter the food chain. Many efforts have been made to ensure and enhance co-operation; however, some relevant information available at specific levels is not shared among the different actors involved, in particular when horses are intended for slaughter. 30. Measures for enforcing the legislation are in place and could be used when necessary. However, in the competent authorities' views some of the requirements laid down in the EU/national rules are difficult to enforce mainly because controls for detecting non-compliances in these areas are not easy to implement.

5.3 HOLDINGS/KEEPERS REGISTRATION AND FOOD BUSINESS ESTABLISHMENTS APPROVAL Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 4 of Regulation (EC) No 853/2004, Article 3 of Regulation (EC) No 854/2004 and Article 31 of Regulation (EC) No 882/2004. Article 3 of Directive 1990/425/EEC and Article 9 of Directive 96/23/EC/EU Findings

5.3.1 Holdings/keepers registration

31. According to national legislation enacted in 2014, all premises where horses are kept, including the ones where horses are kept on a temporary basis (e.g. sporting/cultural events, horse trainers), must be registered with the DAFM. Upon registration, a premise's number is assigned. Holdings that are already registered to keep cattle and/or sheep/goats have their registration file amended to include horses. There are currently approximately 23,500 premises registered by DAFM to keep horses. The vast majority of these are farm holdings. The CA stated that some owner/keepers are not registered, mainly when not having a permanent residence2. 32. The CCA stated that premises of horse dealers supplying horses to slaughterhouses have

2 The Travelling Community: a small indigenous population with a distinct horse culture

9 to be registered as any other premise were horses are kept. Considering the limited trade, the CA had not considered necessary the specific identification in the premises registration of this activity. 33. Both horse slaughterhouses visited have a register on the premises where the keeper verifies the identification of the horse(s), by cross-checking the transponder, the passport and querying the central DAFM database, prior to the formal introduction in the slaughterhouse. Horses that are found not compliant during this pre-screening must wait until their documents are corrected by the last owner, or are rejected and may leave the holding. In some cases the horses can remain in this holding for several days. In practice it operates as a marshalling centre; however, the CAs do not consider them as such and not posing a higher risk.3 The operators of the holding had neither a holding register nor records of medical treatments (see also chapter 5.4.3.1). 34. According to one holding owner, no inspections by the DAFM took place in the past. The VPHIS, in charge of controls in the horse slaughterhouse has no responsibility in these holdings.

5.3.2 Food business establishments approval

35. Any FBO wishing to produce horse meat and derived products must have their premises approved by DAFM. The approval procedure starts with a "Notification of Intention", submitted by the FBO to the DAFM Meat Hygiene Division. Upon receipt, a documentary check is carried out and if the outcome is positive, the formal application is made. Then, an on-the-spot inspection of the premises must take place and, if the outcome is satisfactory, the Meat Hygiene Division grants a first conditional approval valid for three months. A second conditional approval (valid for a further three months) can be granted in case an additional inspection is satisfactory but there are some issues to be fixed. Once the plant is operating to the satisfaction of VPHIS, at the expiry of the first or second conditional approval granted, the Meat Hygiene Division issues a full approval certificate to the FBO. 36. In the cutting plant visited, the audit team confirmed that the approval procedure was followed as described above. 37. (4)

3 Art 7.1 Council Directive 2009/156/EC making reference to marshalling centres, defined as assembly centres in Art.2.2.o of Council Directive of 64/432/EEC). 4 In their response, the CA in their letter of 13 December 2019 with Ref Ares(2019)7873393-20/12/2019) clarified the situation concerning the temporally conditional approval in another slaughterhouse after a fire. Due to this clarification, the finding is no longer relevant.

10 Conclusions on holdings/keepers registration and food business establishments approval 38. Procedures are in place for registration of keepers of horses and they are properly implemented. However, the registration system of horse keeping premises does not allow the CAs to identify horse dealers whose main activity is to buy and keep horses for a limited period of time in order to be sold later to slaughterhouses. The CA does not consider holdings where these animals are kept are marshalling centres and not as posing a higher risk by the CA, although in practice they are. 39. Adequate procedures are in place for the approval of food business establishments and where checked by the audit team, they had been correctly implemented.

5.4 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS Legal requirements Articles 3, 8, 9, 54 and 55 of Regulation (EC) No 882/2004, Article 17 and 18 of Regulation (EC) No 178/2002, Articles 4 and 5 of Regulation (EC) No 854/2004 and Article 1 of Regulation (EC) No 2073/2005. Articles 11 and 12 of Regulation (EC) No 882/2004 and Chapter II of Commission Implementing Regulation (EU) 2015/1375. Articles 3, 4, 7-9, 11 and 17 of Directive 2009/156/EC and Article 3 of Regulation (EU) No 2015/262. Articles 10-13, 15-18 and Chapter V of Directive 96/23/EC, Title VI of Directive 2011/82 and Articles 8-10 of Directive 1996/22/EC. Article 4, Chapter III of Title II and Chapter I of Title III of Regulation (EC) No 1069/2009. Findings 40. Regional personnel from DAFM is responsible for enforcing equine identification legislation. SOP 01/2018 details the official controls to be carried out over the FBOs' responsibilities in relation to passport checks, including verification of their authenticity by checking their security features.

5.4.1 Official controls on horse identification and movements of animals Art 3.4 of Regulation (EC) No 2015-262 gives the overall responsibility to the CA to ensure that the keepers of equine animals and issuing bodies fulfil their obligations under this Regulation.

Horses identification

5.4.1.1 Identification document 41. According to national legislation, equine keepers must submit a completed application for the passport within six months of the recorded date of birth of the animal. Non- compliance with this obligation is not an offence. However, where this condition is not met and sufficient time is not provided to the PIO to carry out all the required checks

11 and a passport cannot be issued within 12 months, a duplicate or replacement document must be issued and the equine is automatically and irrevocably excluded from the food chain. Identification documents are issued directly and to the applicant keeper only. It is an offence for a person to keep an equine that is not properly identified. Similarly, it is an offence for a person other than the keeper to be in possession of a passport. It is further prohibited for a person to hold more than one passport in respect of an equine. 42. Concerning the model of the horse passports, it is up to the PIOs to decide the layout and information of the passports. However, since 1/1/2016, they are obliged to have the same minimum up-dated content in the passports issued. The audit team observed that different lay-outs and security features were used by the PIOs (e.g. some included security features such as holograms, special paper and riveting, PIOs' name embossed on the paper, numbered pages, etc.). In addition, the lay-out of passports issued in foreign countries show also different formats. The different passport models checked during the audit provided for recording of all the data required under Union law. 43. The passports issued in the past vary in format and content and e.g. before 1/7/2000 no page for the medicinal treatments was included, and before 1/7/2009 it was not mandatory to have electronic identification. It is not required to replace old passports with new models if they comply with the transitional provisions laid down in Art.43 of Regulation (EU) No 2015/262. 44. As required by Article 38 of Regulation (EC) No 2015/262, the PIO records the required identification data in its database and subsequently, within 15 days, notifies that data to the central database. Similarly, all passport updates notified to the PIO must be notified to the central database. 45. In case of change of ownership national legislation requires the purchaser to notify the issuing PIO of the new owner's details. In this regard the CAs and PIOs visited stated that the change of ownership is very seldom transmitted to the PIOs for endorsement and therefore updated in the passports. One of the PIOs visited stated that cases occurred where up to ten different owners have been keeping horses before ownership was finally updated in the passport and in the PIO's database. As a consequence of this omission, the PIO database and the AIM are not recording updated data. 46. The procedure for the handling of the passports is as follows: a. Passports of dead or slaughtered horses have to be returned to the issuing PIO or to the AIMs offices respectively. In case of dead animals, it is the keepers' responsibility to inform and send the passport to the issuing PIO. b. For slaughtered animals: passports have to be made invalid by stamping or cut by VI and then returned to the AIM (which in turn may destroy or return them to the issuing PIO, in accordance with specific procedures agreed with each PIO). c. For animals dead or euthanized in other locations (e.g. farms, race courses, veterinary clinics, etc.): if the passport is available it should accompany the dead animal to the knackery, however the Irish Horse racing Regulatory board might send it directly to the PIOs.

12 47. The audit team noted the following concerning the procedure for handling the passports: a. The passport of slaughtered animals were made invalid and returned to AIMs offices. b. In the knackeries, different situations can occur: i. Dead animals or abandoned horses collected are often not identified and not accompanied with a passport. In this case the collector completes a "special form". ii. When horses are identified and the passport accompanies the body, it must be invalidated, a stamp placed on it and the name of the knackery and the day they received the animal must be recorded. Passports must be transferred to AIM through the local veterinarian of the DAFM office in order to update the central database. c. At the knackery visited the audit team noted that in most cases either the passports were absent or not handed over to the AIM (i.e. passports accompanying the dead horses had been stored for several years). Many horses are not identified. As a consequence the AIM database was not updated and therefore dead animals were still present and registered as "alive". The transmission of passports has only started recently. An instruction from 2013 requires sending the passports back monthly. The Regional CA stated that the instruction about the time limits for sending back the passport to the central office was not very clear and therefore they have amended it recently to clarify this requirement. The "special form" must also be transmitted to the local veterinarian of DAFM office. Some of the horse keepers and PVP met during the audit stated that the knackeries have started to request them to send the passports of horses sent to them. This was not the case in the past. d. Dead horses are registered with the passport number or the reference to the commercial docket at the knackeries only since January 2018, on instruction of the CA. e. The CCA noted the deficiencies and drafted in the course of this audit, new "Intake procedures for fallen horses into Knackeries". They stated that after consultation and evaluation the procedure will be implemented. 48. The CCA stated that when a horse is slaughtered/dead in a different MS there is no uniformity in the way the feed-back information is transmitted: sometimes the CA of the other MS informs DAFM (who informs the relevant PIO); sometimes they inform the PIO directly (who informs DAFM) and sometimes no information is received. The CAs have no means to evaluate if MS transmit the information in all cases required. When a foreign horse is slaughtered in Ireland DAFM informs the CA of the country of origin. Usually the passport is kept for 28 days and later destroyed or rendered invalid. If the foreign animal is sent to a knackery, then the PIO of the country of origin is informed by DAFM. 49. The CCA informed the audit team that a sharp increase of unwanted horses (defined as

13 those no longer wanted by their current owner because they are old, injured, sick, unmanageable, or fail to meet their owner's expectations) and stray horses had coincided with the economic downturn. These horses were usually not identified and were involved in several road accidents; in this case, collection of the bodies is done mainly by the knackeries and paid from the local authorities/council budgets. Specific national legislation was enacted in response to this problem. 50. Only horses that are fully eligible at the pre-clearance are allowed to enter the slaughterhouse and be presented for ante-mortem inspection by the VI. 51. Exclusion of horses as food producing animals occurs in the following situations: a. According to the CAs, the FBOs and the racing authorities met, more than half of the horses in Ireland are in the passport declared irreversibly excluded from the food chain by the owner, the keeper or the PVP in case veterinary medicines not permitted in horses for human consumption have been administered to the animal. In this regard a trainer stated that he systematically excludes the horses when accepting an animal for training as this reduces the administrative burden for recording medical treatments, and that this is becoming quite a common practice. At the trainer premises and the knackery visited, the audit team could confirm this. b. The PIO must exclude the horse from the food chain when late registration (> 12 months old) occurs and in case a passport is duplicated. The PIO registers the exclusion in the passport and in the Central Equine Database (CED).

5.4.1.2 Identification verification (transponder) 52. Since 2009, all horses must be identified with a transponder. Microchips required as a link between the equine and its passport must be sourced directly by an approved PIO to PVP who must implant them. Each party must retain a record of the person to whom the microchips were supplied. The CCA checks that companies delivering microchips comply with EU and international standards and issues them a certificate of compliance. 53. The PVP is allowed to implant the transponder in any horse to be identified, even if the animal will not be registered at the PIO who provided it. In these situations, the PIOs noted that they cannot reconcile the number of microchips delivered to the PVP and horses identified as they have no access to the database of the other PIO which registered the equine. No official controls in this regard are carried out; however, the authorities and staff from PIOs met explained that some desk verifications can be done and that it is an offence if microchips are misused by the PVP. One PIO visited has a financial rebate system to encourage the PVP to correctly use and communicate the stock of transponders at the time of the next order. 54. The CAs met are aware that there is still a significant number of horses with no or late identification and registration. In fact, there are many owners that are still applying for the first identification of their horses older than twelve months (up to five years old as seen by the audit team).

14 55. Accurate official controls on horse identification are carried out at the slaughterhouses (see chapter 5.4.2.2. concerning ante-mortem inspection). 56. The fact that animals were found at the slaughterhouses with more than one active transponder implanted together with the information received from the operators and authorities show that the identification system in not as reliable as was initially thought, but also demonstrates good controls by the OVs (see also paragraph 86).

5.4.1.3 Databases 57. DAFM established in early 2013 a central equine database (CED) that was populated with PIO registration data dating back to Jan 1990. Later, VPN 05/2016 sets out the obligation to have all horses registered in the database. Some security features and automatic plausibility checks are carried out. The Animal Identification and Movement System (AIM), managed by the DAFM, contains the CED. 58. The CCA explained that the CED is an identification and not a movement database. It primarily records identification information on equidae that are kept in the country. As referenced to in Recital 18 of Regulation (EU) No 2015/262, ‘having regard to the frequency at which equidae are moved, it is not appropriate to establish a system where equidae should be traceable in real time’. This is however not a justification not to register that animals are leaving the country permanently. The registration of the "keeper" is required and if the animal has left the country, the information is no longer correct. 59. The design of the private databases used by PIOs is not specified, however, a protocol for sending updates to the AIM database is used for daily transmission of data and appears to function satisfactory. 60. The central database is insufficiently up-to-date, mainly because: a. contrary to the provisions of Article 27 of Regulation (EU) No 2015/262, there is a lack of notification by the keepers of equine animals of transfers of ownership, absence of records on horses leaving the territory, delayed or absent notification of change of status by keepers, veterinarians and/or PIOs (horses excluded from the food chain at a later stage after registration, appear as eligible horses for food chain) or deaths not notified by keepers. b. In addition, no checks are carried out to verify if the passports of dead animals are returned to the PIOs and if this information is included in the database. The CCA also noted an instance where the slaughterhouses' officials had not communicated to AIMs that, when checking the passport, it appeared that the horse should have been excluded from the food chain and that in the database the status of the horse had not been updated to record this exclusion. 61. Therefore, and although the lay-out of the CED foresees the collection of the information as prescribed by the EU legislation, its content cannot reliably guarantee the eligibility of horses for slaughter for human consumption, or for reconciliation and the

15 verification tasks. The CED contains 540.000 horses but the CA estimates that only 250.000 are still alive and present on the territory.

62. The CCA stated that CAs from other MS do not have access to its database, as required by Art. 40(2) of Regulation (EC) No 2015/262. They also noted that they have to date not received requests from other MS concerning data registered in the database.

63. The CA stated that it is difficult to organise a system of control to verify and enhance the reliability of the data in the CED.

5.4.1.4 Movement controls 64. Under national legislation (See paragraph 2) the movements of animals must be traced via registers maintained on each registered premises. No equine can be moved without being accompanied by its passport. 65. Premises where there is permanent residency are required to maintain records of movements off/onto the premises, to include premises identification to/from which the equine has moved. Also operators keeping horses on a temporary basis (e.g. sporting/cultural events, veterinary clinics, trainers) must maintain records of the identity of each horse and of the details of the owners/keepers who present the equine to the event/premises, including their premises registration number. 66. Horses entering into the country on a permanent basis must be registered by the PIOs. The registration of these horses is based mainly on the information contained in the passports presented (no physical check is carried out). In this regard, the PIOs visited noted that the organisations registering horses around the world (e.g. stud-books, federations, etc.) have their own independent system of identification and the exchange of data with the different associations/organisations is quite cumbersome. Moreover, considering the different passport models, the different features used to ensure their authenticity etc. in the different countries, it is very difficult and challenging to establish whether the documentation presented is authentic and, consequently, to ascertain the reliability of the information accompanying the horses (e.g. if the information in the passport declaring that the horse is eligible for meat production, is reliable or not). The PIOs visited stated that to date, they had not detected foreign passports that had been tampered with. 67. The CA has not granted general or limited exemption in respect of movement of horses from other MS, in accordance with Article 3 of Directive 2009/156/EC, which refers to an exemption for movement of horses that are located in an area close to the border of a neighbouring country. 68. Under the provisions of the Tripartite Agreement with the UK and France (see paragraph 10) registered horses may travel between these countries without veterinary health certification; however, the commercial document which will contain the identification details of the horse has to be notified through the TRACES system5 for the

5 TRACES (TRAde Control and Expert System) is the European Commission's multilingual online management tool for all

16 movements with France. As a consequence of this flexible rule, DAFM is not able to determine which horses have left the country, temporarily or permanently. It is up to the owner to inform the DAFM and PIOs if the horses remain in these countries or when they return. Movements are allowed if horses are microchipped, are accompanied by the passport and are fit and healthy to travel. The CCA provided information which showed that not all the movements between Ireland and France are covered by the TPA and are registered in TRACES. In the case other movements, not covered by the TPA, health certificates are issued and the information is integrated in TRACES. 69. It is the owner's responsibility to inform DAFM and PIOs if the horses remain outside the territory or when they return. If permanently resident in the new country, they must be registered at the PIO in the country of residence. The up-dating of AIMs is not done until the PIOs have been informed of the registration of these horses in other countries by the relevant CAs. The information from owners and transmission of this new registration to the country of origin is seldom done. As a consequence, DAFM is not able to determine which horses have left the country, temporarily or permanently. 70. Movements to slaughter plants are recorded on the AIM, by DAFM personnel supervising the slaughter. Each equine presented at a slaughterhouse must be accompanied by the Food Chain Information (FCI) declaration signed by the presenting keeper, and recording the premises registration number of the holding from which the equine was moved.

Conclusions on official controls on horse identification and movement controls 71. The PIOs carry out an accurate check prior to issuing the horse passports. The passport models as well as the information they contain, comply with EU rules and different mechanisms have been put in place in order to ensure their authenticity and avoid tampering. 72. The fact that a number of horses are not yet identified, together with the late identification of horses after the compulsory period of time (12 months) highlight that the owners/keepers do not consistently meet their obligations on horse identification and recording of changes in ownership. Nonetheless, the automatic exclusion from the food chain of horses which were registered late of for which duplicate or replacement passports were issued, mitigates potential risks in the production of horse meat. 73. Accurate official controls on horse identification are carried out at the slaughterhouses to ensure that only properly identified horses are eligible for slaughter for human consumption. 74. A database for containing data about the registration and identification of horses is kept at central level and is updated with information from the PIOs and the slaughterhouses. Even if the database provides for the recording of all the information required under EU rules. The information contained is not sufficiently sanitary requirements on intra-EU trade and importation of animals, semen and embryo, food, feed and plants. https://ec.europa.eu/food/animals/traces_en

17 accurate/reliable as relevant provisions (notably Artt. 12, 27 and 35) of Regulation (EU) No 2015/262 are not consistently adhered to, thus jeopardising the controls on horse identification and movements.

Conclusions on official controls on horse identification and movement controls cont. 75. Rules are in place for keeping track of movements of horses; however, due to the unreported changes of ownership(s), to the frequent movements within the country, the free movements for different reasons and under certain rules (TPA) and, in some cases, for a temporary period of time, the CA is not in a position to ascertain reliably their movements. 76. CAs from other MS, and vice-versa, have no access to the central national database as required by Art. 40(2) of Regulation (EC) No 2015/262. 77. Additional hurdles to provide for a reliable system are the lack of uniformity in passport's models at national and international level, the associated difficulties to ascertain their authenticity and the reliability of the information contained therein, and the absence of an obligation (with the exception in slaughterhouses) to notify the relevant CAs when problems in the identification of animals are detected.

5.4.2 Official tasks at establishment level

5.4.2.1 Organisation of official controls 78. The permanent presence of OV is required in slaughter plants. DAFM staff is assigned to carry out inspections in cutting plants with a frequency based on a risk basis. 79. Different SOPs and VPNs concerning the performance of the official controls operated by DAFM staff have been issued. For instance: a. SOP 01/2018 describes the official controls at slaughterhouses, which include: Verification of HACCP based procedures, Ante-Mortem Inspection (AMI), Post- Mortem Inspection (PMI) and labelling and traceability of horse meat. b. VPN 03/2016 describes the verification procedures to be carried out on FBO operations on daily, weekly or monthly and risk assed basis. c. SOP 06/2008 describes the verification procedures in relation to FBO Food Safety Management System, including HACCP. d. SOP 03/2018 describes the verification procedures carried out in relation to control of Animal By-Products (ABP) at slaughterhouses. 80. Since 2017, all horses must be registered in the central database prior to being presented for slaughter, and must be pre-cleared on the Central Equine Database to determine whether they have already been excluded from food chain: No equine can be presented for slaughter unless the AIM records have first been checked and verified that, according to the information recorded at that point in time, the equine is eligible for human consumption.

18 81. The check can be undertaken by either the FBO or by specific DAFM administrative personnel. Where this is not the case or where the information on the database differs from the passport, the equine is excluded from the food chain and cannot be presented for slaughter.

82. Once a record is checked, the result, time, date and login details of the premises from which this check is undertaken are recorded on the database.

83. FBOs of the slaughterhouses have specific limited access to AIM for this purpose and must undertake this documentary check in respect of all horses prior to accepting them onto the slaughter premises and subsequent presentation for AMI and slaughter.

5.4.2.2 Ante-mortem inspection (AMI) 84. All horses presented at slaughter plants must undergo AMI which is carried out either by the OV or TVIs. TAOs may assist the TVIs with documentary checks and includes the verification of the identity of the horses presented for slaughter 85. In particular, AMI consists of the following actions: a. During the physical examination, all horses are scanned for a microchip and the details of any microchip(s) detected are compared against the data on the passport and are recorded by DAFM personnel. b. The equine is compared with the information recorded on the passport, including the marking chart completed by the PVP at the time of initial identification. c. Verification of the transponder with the passport and the database is carried out in the lairage using a scanner/mobile phone to record transponder numbers electronically and allowing electronic data transfer to the central database. Any discrepancy between the transponder details on the passport and the transponder in the animal renders the horse ineligible for the food chain, unless the issuing PIO or the AIM Division can clarify the discrepancies to the satisfaction of the OV. Where additional transponders, not recorded on the passport, are detected the equine is also excluded from the food chain.

d. Passports are examined by DAFM officials for evidence of tampering. 86. The audit team saw evidence of cases where the official staff detected irregularities in identification of horses (in passports, transponders, correspondence and marking) during the AMI and prescribed actions were taken (e.g. exclusion from the food chain, and the information passed on to the regional and central authorities for further investigations).

87. In the passports of horses which remain eligible for slaughter, medical treatments are hardly ever recorded, and controls of PVP in this regard are rarely carried out.

88. An Equine Seminar was held in June 2017 bringing together all parties involved in official controls to discuss equine slaughter and the industry in general.

19 5.4.2.3 Post-mortem inspection (PMI) 89. All slaughtered horses must undergo PMI, to be carried out either by the OVIs or TVIs. TAOs may assist the OV with documentary procedures and sampling. 90. In the two slaughterhouses visited, the audit team noted the following: a. In one slaughterhouse, the intestines, livers and spleen were not inspected by the OV: The FBO collected them immediately, without consent of the OV, as they were not used for human consumption. This deficiency was corrected during the visit. b. In both slaughterhouses, evidence was seen that grey horses were identified and an accurate inspection to detect melanosis (i.e. specific cuts) was carried out. In case of generalised presence, the carcases were disposed of as ABP Category 3 material. c. In both slaughterhouses the PMI registers indicated that, in case of significant non-compliances, the carcases were discarded. 91. In addition to the verification of identity carried out at time of AMI, the presence of transponder is verified also twice on the slaughter-line and cross-checked by TAOs against the information provided. At the PMI post, the anatomical part containing the transponder is removed and disposed of as Cat1 material. Since 2019 the removal of microchips is supervised by DAFM personnel to ensure that only the microchip(s) recorded on the passport are present and that the transponder is removed. In the case that the transponder is not found in the carcase or the hide, a mention is made on the commercial document (CMR) "foreign body not found". Although this procedure is place is intended to ensure a high level of food safety, it is not in line with Art.34 (3) of Regulation (EC) No 2015/262(6). 92. Where additional microchips are discovered, the carcases are automatically excluded from the food chain. The CA informed the audit that the OV had identified horses with two or more active microchips in the carcase and which were excluded from the food chain. Evidence was provided. These irregularities were brought to the attention of the Department's Special Investigation Unit (SIU), for further investigation. 93. The OVs and/or official technical staff control the presence and numbers of the transponders three times during slaughter (at AMI, after bleeding and prior to the final PMI) and, according to the CA, this system has proved to be effective to identify wrongdoings which otherwise might not have been identified. 94. A full, in-depth verification of the passports finalises the process of verification after PMI.

6 Where, as required by paragraph 1(a) of this Article, the transponder cannot be recovered from the body of an equine animal slaughtered for human consumption, the official veterinarian shall declare the meat or the part of the meat containing the transponder unfit for human consumption in accordance with Chapter V(1)(n) of Section II of Annex I to Regulation (EC) No 854/2004.

20 95. VPN 18/2011 describes the official controls and the verification procedures carried out by DAFM staff. Verification of the FBOs' results is part of PMI. This VPN is further integrated in TN MH 02/2009, which prescribes that each slaughterhouse must have in place a contingency plan outlining what steps will be taken in the event of a positive Trichinella result. Carcases are health marked but not released until written evidence of the negative result on Trichinella testing is available.

5.4.2.4 Official sampling and analyses 96. VPN 18/2011 (Official Controls on Trichinella Sampling by FBOs at Porcine &Equine Slaughterhouses &Game Handling Establishments) describes the verification procedures to be carried out by DAFM staff in relation to Trichinella of Equine. 97. Official samples for Trichinella are taken following instructions from the headquarters. 98. Official samples of water are taken annually when water is not an ingredient of the food produced and four times per year when water is used as an ingredient. 99. VPN 03/2018 (Sampling of Animals recorded on AME1 for Inhibitory Substances and verification of additional sampling in accordance with the FBOs Self-Monitoring Plan) describes control and sampling procedures to be carried out by DAFM Staff in relation to sampling of equine which are deemed to have a risk of residues of inhibitory substances. 100. Official samples for the presence of residues are taken in accordance with the sampling plan received from the headquarters. Guidelines have been issued in order to assist the official staff in the process for the selection criteria to follow for horses to be tested, and the procedures to follow. There is currently no obligation to detain any carcass or offal from an animal sampled under NRP. Equine FBOs are advised to detain carcasses/meat/offal for equines tested for NSAIDs as a positive result (results are received within one week of sampling) would most likely result in a withdrawal/recall. DAFM staff and FBOs do not receive the results of other NRP samples taken unless the result is positive. DAFM staff routinely receive the results of NRP samples when there are positive results, enabling them to take appropriate enforcement action, up to and including a recall/withdrawal, as appropriate. An example was shown of testing of a horse suspected of having been treated with , the carcase having been detained and released once the negative result was sent back to the OVI. 101. DAFM noted that after the 2013 horse meat scandal it continues to carry out intensive phenylbutazone testing of equine carcases, and incorporated additional sampling into the National Residues Control Plan. Results from the implementation of the 2016 National Residues Control Plan showed five non-compliant samples (three for antimicrobials and two for anthelmintics), whilst in 2017 one non-compliant sample for NSAIDs was detected. 102. Concerning sampling and analysis carried out to identify the animal species used in the production of a particular food, the CCA provided the audit team the following information:

21  A random sampling programme was put in place in 2013 to detect the presence of horse meat in beef products, followed by a DNA Verification Programme in 2014, to randomly test finished beef products for presence of horsemeat.  The current sampling program for 2019 is described in VPN 02/2019. The samples are chosen at random from DAFM approved meat processing facilities and are taken by DAFM officers. Beef trimmings, beef mince and beef preparations (e.g. beef burgers, meat balls, beef mince steaks) can be included on a risk basis. No non- compliances have been detected to date.  FSAI Sampling, Speciation Analysis and Next Generation Sequencing (NGS) In tandem with official agencies, horse meat speciation and similar genetic studies have been carried out by FSAI as part of targeted surveillance of the authenticity of foodstuffs (plant and animal) on the market before, during and after 2013. In the wake of the horsemeat incident and as part of an ongoing EU-wide programme on food fraud, the FSAI’s study of beef products in 2014 found no traces of horse DNA in the 52 beef products analysed, which included burgers, meat-based meals, corned beef, meat balls and pasta dishes. This suggests compliance by the industry in follow-up to the horsemeat incident.  The FSAI monitors on the Irish market to ensure that they are complying with the requirements of food law and are safe. This surveillance can include sampling and analysis to identify the different animal (or plant) species which have been used in the production of a particular food, to confirm that no mislabelling for consumers is taking place, and to verify that the actual content of ingredients matches their declared content.  A list of relevant FSAI surveys carried out from 2014 to date can be found on the FSAI website: https://www.fsai.ie/enforcement_audit/monitoring/food_monitoring_surveillance/labelling.html

 In 2017 and 2018 FSAI adapted a new DNA sequencing technique to allow its use in indiscriminate checks of food for the DNA content which, in turn, reveals the biological content. It is a method that allows untargeted analysis, i.e. there is no need to rely on any prior information to check the integrity of a food’s content in relation to what is declared on the label.

5.4.2.5 Official laboratories 103. The Veterinary Public Health Regulatory Laboratory (VPHRL) is the National Reference Laboratory for parasites. The CCA stated that the VPHRL fulfil its obligations under the new EU Regulation No 625/2017, e.g.: a. Recommendation for approval of official laboratories; b. Organisation and oversight of participation of official laboratories in proficiency tests (PT): the last one took place on June 2018; reports of the PTs are circulated including following-up of the underperformance, training of official laboratories,

22 etc.; c. Regular audits: The most recent audit of the laboratory carrying out Trichinella spiralis testing was conducted in November 2018. The report of the audit was circulated and corrective actions were followed up. 104. In addition, VPHRL acts as an official laboratory carrying out testing for the presence of Trichinella spp. in horse meat samples using the magnetic stirrer method for pooled sample digestion (the reference methods laid down by Regulation (EC) No. 2015/1375). The method is listed in the scope of accreditation, INAB Reg. No. 171T. 105. In 2018 VPHRL tested 240 horsemeat samples for detection of Trichinella spp., 120 from each slaughterhouse visited and one sample from each slaughterhouse for water microbiological analysis. 106. The laboratory that routinely tests horse meat samples for Trichinella spp. is using the magnetic stirrer method for pooled sample digestion, the reference method in Regulation (EC) No 2015/1375, which is listed in their scope of accreditation, INAB Reg. No. 151T. The laboratory participated in proficiency tests (PT) organised by VPHRL, with satisfactory results. 107. The CCA stated that there have been no positive samples identified in horses, in decades. Between 2003 and 2013 wildlife surveys were organised, and the testing for Trichinella was conducted at the VPHRL. Each year a small number of Trichinella- positive foxes were identified. Larvae were submitted to the EURL for species identification and were all found to be T. spiralis.

5.4.3 Official controls on Food business operators obligations

5.4.3.1 Food chain information and verification of identification 108. All horses presented for slaughter must be accompanied by a completed FCI declaration, provided and signed by the presenting keeper (e.g. the trader, the transporter) who is responsible for the correctness of the data its contains. FBOs must have documented procedures including the checks on the FCI. 109. Both horse slaughterhouses visited have a holding adjacent to the premises where the keeper verifies the identification of the horse(s), by cross-checking the transponder, the passport and querying the central DAFM database, prior to the formal introduction in the slaughterhouse. The horses that during this pre-screening are not compliant have to wait until their documents are corrected by the last owner, or are rejected and may leave the holding. The FBO does not pass information concerning these horses to the VI or the PIOs. The verification is not repeated in the slaughterhouse prior to introduction (see also paragraph 33). 110. In one of the slaughterhouses visited, Part 1 of the FCI is completed and signed by the keeper of the equine animal, Part 2 is completed and signed by the haulier and Part 3 is completed and signed by the FBO. In the other slaughterhouses visited, the FCI was always completed and signed by the FBO responsible for the holding adjacent to the

23 slaughterhouse. It was noted that the FCI never indicates the use of medicines and there was no indication that this information had been requested from the previous owner of the animal. The keeper met at one slaughterhouse explained that he relies on the oral statement and the information reported in the passports. None of the passports checked by the audit team contained a record of any medical treatment. Possible treatments at holdings of traders are not recorded. As a consequence, the reliability of the FCI cannot be properly verified.

5.4.3.2 Animal welfare 111. FBOs must assess the welfare of each equine and must immediately notify the OV about any concern. 112. In the slaughterhouses visited verification of the effectiveness of the stunning was carried out by the FBOs on each horse. During the visits, the audit team noted that the animal welfare requirements were respected in the lairage and during the stunning.

5.4.3.3 General and specific hygiene requirements of establishments 113. The official controls cover verification of the general and specific hygiene requirements of establishments. The audit team checked the reports drafted after the inspections and they reflected, in general, the situation seen in the establishments. The latter were mostly in line with the requirements but some deficiencies noted by the audit team had not been identified or registered by the OV or during supervisory visits: a. In one slaughterhouse the cutting room was congested with indications of recurrent condensation; carved cutting boards difficult to clean and disinfect were present; Insufficient height at the overhanging of legs, with de-hided nozzle touching the floor. b. In general the hygienic dressing and slaughter were satisfactory in both slaughterhouses; however, some individual human errors in respecting hygiene routines, mainly in one slaughterhouse (correct sequence of rinsing/washing hands, knives and steels, followed by use of sterilisers) were noted. c. Some maintenance and cleaning issues were noted in one slaughterhouse visited. d. The unloading procedure of carcases in the independent cutting plant visited was not hygienic, as the staff was kicking the carcases to assist their movement along the rail.

5.4.3.4 HACCP-based programmes 114. S.I. No. 183/2009 requires FBOs to establish and implement a plan for the detection of residues and contaminants in the food they produce. 115. FBOs are obliged to draft a self-monitoring plan for residues of antimicrobial substances and phenylbutazone. Results of the self-monitoring plans implemented by the two slaughterhouses visited by the audit team were provided by the CCA and evidence was seen of its implementation.

24 116. At the establishments visited HACCP programmes were in place and evidence was provided that the official controls covered their proper implementation. 117. The audit team did not verify the HACCP in detail but own-checks were in place, and implemented.

5.4.3.5 Microbiological criteria 118. VPN 04/2011 describes the verification procedures by OVs of compliance of FBOs with the requirements of Regulation (EC) No. 2073/2005 in DAFM approved plants. 119. At the slaughterhouses visited, evidence was provided that own-checks were carried out by FBOs. In one slaughterhouse it was noted that the microbiological testing of carcases was carried out at a reduced frequency. No official guidance permitting this reduction, nor proof of its authorisation was provided. The CAs explained that this situation was allowed in the past, with no documentary evidence, and they have not considered revising it. Regulation (EC) No 2005/2073 foresees indeed the possibility that small slaughterhouses in small quantities may be exempted from these sampling frequencies, however, when justified on the basis of a risk analysis and consequently authorised by the competent authority, 120. It was also noted that the results presented by this FBO were what must be considered unrealistically low (Total Viable Count always zero or less than one). In this regard the OV explained that he had also noted this fact and was of the opinion that parallel samples could be taken for a double check to verify the results. However, due to personnel constraints and limited laboratory facilities this was not considered possible. The CCA stated that it is their responsibility to decide on verification and to take additional samples.

5.4.3.6 Traceability, health and identification marking 121. SOP 01/2018 describes the official controls in relation to labelling and traceability of all ; this involves twice yearly audits of FBO's compliance with labelling and traceability requirements. 122. DAFM introduced Trader Notices stating obligations of FBOs in relation to traceability issues. 123. During a visit to one establishment evidence was provided that the CA had identified some discrepancies between commercial documents (CMRs) from the slaughterhouse and cutting plant. This issue was not yet corrected and similar discrepancies were not identified by the following routine official controls by the technical assistant. 124. In general, the health and identification marking were satisfactorily applied to carcases and on labels respectively.

25 5.4.4Official controls on import and trade of live horses, horse meat and products derived thereof

5.4.4.1 Live horses 125. The CCA stated that during the last three years there were neither imports nor trade of live horses destined to slaughter, either directly or via a collection centre. Horses are introduced into the country for other reasons and have to be registered by the PIOs. The CCA provided data from TRACES confirming that no horses destined for slaughter have been introduced into Ireland or exported to other MS or outside the EU (see also paragraph 48 and 66 concerning the obligation to register imported horses by the PIOs). 126. The CA demonstrated, based on TRACES documents (CIVETs) and health certificates requested that significant trade in horses to the continent takes place, however, little attention was given to the control thereof.

5.4.4.2 Horse meat/horse products derived thereof 127. The CCA stated that there were neither imports nor trade of horsemeat and products thereof into Ireland. The horse meat produced in the country is mainly distributed to a number of MS, and to one third country.

5.4.5 Official controls on production, import and trade of animal by-products consisting of/containing horse materials 128. SOP 03/2018 describes the verification procedures to be carried out by DAFM staff in relation to control of ABPs at slaughter plants. 129. The CAs have approved 36 establishments dealing with fallen stock ("knackeries") as intermediate Category 2 plants7, according to Article 24 of Regulation (EC) No 1069/2009 and are considering the derogations as laid down by Article 18 of the same Regulation. 130. Fallen animals are usually sent to or collected by knackeries where hides and some carcases are harvested for meat for feeding dogs and zoo animals, after which the remaining parts are sent to rendering plants. However, not all knackeries harvest the meat. In fact, at the knackery visited, the audit team was informed that horse meat is seldom collected as it is not considered suitable for racing dogs. 131. The CCA provided the following data concerning knackeries: a. the number of horses sent to knackeries: in 2016 (3,360), 2017 (2,920) and 2018 (3,035). b. The amount of horsemeat harvested in the knackeries for feeding of dogs: 5,000 Kg in 2016, 4,000 Kg in 2017 and 5,000 Kg in 2018.

7 Under the repealed Regulation (EC) No 1774-2002 the establishments were categorised as “intermediate Category 2 plants”

26 132. The CA stated that, all equines excluded from human consumption due to identification issues in both slaughterhouses are euthanized on site and disposed of as Category 1 Animal By-Products 133. Irish legislation prohibits trade with/imports from other MS and third countries of ABP.

5.4.6Official controls on distribution and use of veterinary medicinal products 134. S.I. No. 786/2007 and S.I. No. 183/2009 require official controls to be carried out in relation to the detention and use of veterinary medicinal products (VMPs) in food- producing animals. The "off label" use ("cascade") by PVP is regulated and records of medications must be maintained pursuant to a veterinary prescription issued for any VMP. Offences are sanctioned in accordance with provisions of Regulation 34 of S.I. No. 183/2009. 135. All PVP registered by the Veterinary Council are allowed to use veterinary medicines, including in cascade use, and they are the solely authorised persons to perform the identification by inserting the transponder and the verification of the markings. The CAs stated that it is PVPs' responsibility to prescribe the medical treatment and record it in the horse passport. 136. From the minutes of the meetings of the Equine Liaison Group of 2016 and 2017 it emerges that there are some concerns around the use of medication in the horse industry. Key areas needing particular attention were: a. Record keeping/recording of medicines administered in the passport and the non- availability of passports when animals are being treated, leading to the passport not being endorsed with medical treatments, as required; b. Accurate administration of medicines, particularly relating to the use of medicines (such as phenylbutazone) which can be mixed in with feed, leading to some of the treatments accidentally transferred to other horses for which it was not intended; c. Scarcity of approved medicines for horses, leading to the use of unauthorised/exceptional medicines, usually (but not necessarily) used via cascade rules and prescribed by PVPs. 137. At the horse training facilities visited, no medicines were kept and the prescriptions from the PVP were available. 138. The CCA stated that random controls on use of veterinary medicines are carried out at veterinarians' practices as well as on their clients' holdings. These controls are decided at central level and different areas are covered each year. However, verification of compliance with the requirements on prescription and correct recording of the applied treatments in the horse passports is rarely performed. 139. The audit team checked more than 100 passports at the different locations visited (slaughterhouses, race course, PIOs.) With very few exceptions, no medical treatments were recorded, even when horses were more than 10 years old. In the audit team's view, this near-absence of records appears very unrealistic, even if the EU legislation requires

27 that only certain veterinary medications must be recorded in the passport. The CA acknowledged the finding. 140. The CAs carries out controls in this respect occasionally, in case of complaints. 141. The PIOs met stated that in case a keeper/owner administrates a prohibited substance to a horse which has not been excluded from the food chain, this information should be transmitted to them in order to update their database. However, such information had not been notified, to date. 142. At the final meeting the CCA acknowledged that there is a gap in the system to control the use of veterinary medication and the inclusion of certain information in the passports, and indicated that a draft document to address this, was being prepared. (see also paragraph 138)

28 Conclusions on organisation and implementation of official controls 143. The official controls over production of horse meat are organised on a risk basis, and implemented using comprehensive documented procedures and guidance, and covering relevant aspects of the Irish and EU legislation. The controls are overall in line with EU rules, with the exception of an issue concerning post-mortem inspection of the offals. The procedure for sampling, testing and the release of horse carcases with regard to Trichinella requirements, is satisfactory and adequately followed. 144. The CA in the slaughterhouses carries out the verification of the eligibility of horses for slaughter for human consumption in a meticulous way, allowing the detection non- compliances and irregularities. The system ensures that only horses with correct identification and clearance for slaughter enter the food chain. However, the virtually complete absence of records of the medical treatments in the passports, together with the scarce verification of compliance with the requirements on prescription and correct recording of the applied treatments in the horse passports, reduces the confidence that only horses which are eligible for human consumption are presented for slaughter. 145. The official control system in place includes also taking official samples for species identification and specific residues analyses in order to verify how the FBOs can guarantee the safety of horse meat. The results are overall satisfactory. 146. Official controls for verification of FBOs' compliance with the relevant EU requirements (including: FCI, hygiene, HACCP, own-check sampling, animal welfare, traceability, labelling, identification marking, etc.) in horse meat establishments are in place and in general ensure that the requirements applicable to establishments are enforced, despite certain occasions where limited non-compliances were overlooked during the CA controls. In contrast, the reliability of the FCI cannot be properly verified, and its veracity is not challenged. 147. The microbiological carcase testing in the framework of FBO own-checks was not in line with the requirements of Regulation (EC) No 2073/2005 because the reduced sampling frequencies applied by FBO were not formally notified and/or authorised. In addition, there was no verification of the reliability of the results despite the latter being questionable. 148. The CA does not perform official controls on import/export of live horses destined for slaughter, horse meat, and ABPs, as this trade is nil or marginal. However, evidence is available that the export of horses is certainly not marginal. 149. The official controls pay limited attention to the fate of the quite large amount of horses which are not eligible for slaughter for human consumption, and of the veracity of the information in passports concerning medical treatments. This diminishes the effect of the otherwise robust controls in the slaughterhouses.

29 5.5 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) Legal requirements Article 50 of Regulation (EC) No 178/2002 and Regulation (EU) No 16/2011. Findings 150. FSAI is the contact point for RASFF and is the lead agency in the case of a food crisis. An inter-Agency Protocol for the management of food crises has been established. 151. Since 2011, one alert was notified through the RASFF system on horse meat originating from Ireland. It concerned residues of phenylbutazone found in one sample taken within the framework of the national residues monitoring plan for 2014. 152. Investigation concerning a more recent RASFF notification from March 2019 had not started at the time of the audit as the CCA were awaiting for more detailed information it had requested from the CA which had launched the RASFF notification. In the meantime, the implicated products were withdrawn from the market.

Conclusions on RASFF 153. The system for follow-up of RASFF notifications and for food incidents can ensure that adequate actions are taken by the CAs in case these notifications/incidents are linked to horse meat, particularly concerning their follow-up and the measures taken regarding the products involved.

5.6 LESSONS LEARNED FROM THE "HORSE MEAT SCANDAL" IN 2013 Findings 154. In addition to the specific measures taken in the horse meat sector and already reported in the relevant parts of this report (DNA verification programme, mandatory registration and pre-clearance on the EDB prior to slaughter, the Equine Seminar in 2017, the purchase of scanner/mobile phones to record transponder numbers, the enhanced procedure to supervise the removal of transponders), the CCA provided the audit team with additional actions put in place after the horse scandal which cover a broader context. In particular, FSAI noted that many of the lessons learned and actions taken have occurred at EU, MS and national level. 155. FSAI has developed strategies with the official agencies and controls on fraudulent and deceptive practices now form part of the service contracts 156. A FSAI Food Fraud Task Force has been established as a follow up measure in relation to tackling food fraud. Its role is to act as a communications, coordination and networking group where intelligence and research can be shared at national and international level. Issues that are considered include raising awareness, improving mechanisms for monitoring and surveillance and training of enforcement officers. The Task Force advises on a multi-agency basis across different enforcement arms of the State. It comprises representatives from a number of enforcement agencies including (e.g. An Garda Síochána, Customs and Excises Service, DAFM, Food Standard Agency

30 in Northern Ireland, local Authorities, State Laboratory, etc.) 157. Evidence of the awareness and action of the Food Fraud Task Force and SUI was seen as a response to articles in the national press which had reported that horses unfit for human consumption had entered the food chain with falsified documents; at least 30 horses were alleged to have been sold into abattoirs using bogus paperwork. The CCA stated that an investigation was launched in March 2019 by SIU. 158. A memorandum of understanding, data sharing agreements between FSAI, and the National Food Crime Unit of the Food Standards Agency in Northern Ireland are in place and meetings, communication and cooperation occurs on an ongoing basis. A Memorandum of Understanding between FSAI and the FSA NI may be found at the site below: https://www.fsai.ie/uploadedFiles/About_Us/service_contracts/MoU_FSA_NI.pdf 159. A Food Fraud section is now available on the FSAI website: https://www.fsai.ie/enforcement_audit/food_fraud.html 160. The FSAI Food Fraud Conference: Safeguarding the Food Chain - Protecting Authenticity and Integrity took place in 2017, to share national and international practices on how regulators, inspectors, , food scientists and academia can work in collaboration to protect the authenticity and integrity of the food supply chain. The conference presented an opportunity to bring together all stakeholders to examine current issues around the authenticity and integrity of our food, the public health implications and effective prevention control strategies. 161. Several sources (CAs, FBO's, race horse association and OVs) met expressed the main issues related with the sector audited. They stated that, given a. that a very large number of horses is excluded from the food chain (e.g. for late registration, administration of some medicines, personal choice by the first owner), b. that euthanizing or disposing of animals in accordance with the rules implies significant costs, and c. that selling of horses, excluded from the food chain, at the end of their career is seldom sufficient to recuperate some costs, there was an increased incentive to search for options to reduce or avoid cost. The lack of alternatives to the life-long keeping of redundant and unwanted horses, which have been excluded from slaughter for human consumption, has led to neglect and abandonment with serious animal health and welfare consequences. They also indicated that the risk that some of these horses would re-enter the food-chain, cannot be excluded. In their view it would be preferable and would be welcome a legal framework similar to the one the EU accepts for imports of horse meat from third countries (i.e. any horse becomes eligible for the food chain after a waiting period of 6 months, under controlled conditions,

31 like in a feed-lot.

Conclusions on lessons learned from previous "Horse meat scandals" in 2013 162. The CA has put in place several measures to investigate fraud, to enhance the awareness, and to strengthen the legislation and the implementation thereof.

6 OVERALL CONCLUSIONS

Since the 2013 "horse meat scandal", the competent authority has introduced several changes in the control system and the applicable legislation aimed at improved compliance with and enforcement of the relevant EU requirements, and to ensure that only horses with the correct identification and clearance for slaughter, enter the food chain. The control system also includes official sampling for species identification and specific residues analyses, with overall satisfactory results. In addition, it has put in place several measures to investigate fraud and to enhance awareness, and has made efforts to strengthen cooperation between the various actors. The procedures in place for the registration of keepers of horses are properly implemented, but the system does not allow the identification of horse dealers whose main activity is to buy and keep horses for a limited period of time. The passport models and the lay-out for the information they should contain, comply with EU rules, and different mechanisms have been put in place in order to ensure their authenticity and to avoid tampering. The identity checks by the passport issuing bodies prior to their issue, are accurate. Nonetheless, both the fact that a number of horses are not yet identified, and instances of overdue identification of horses highlight that owners/keepers do not consistently meet their obligations. Having said so, the automatic exclusion from the food chain of horses which were registered late or for which duplicate or replacement passports were issued, mitigates potential risks in the production of horse meat. The central database for the registration and identification of horses is updated with information from the passport issuing bodies, and the slaughterhouses. Even if the design of the database contains all the information required under EU rules, the data itself is not sufficiently accurate/reliable due to in particular to the absence of (or delayed) notifications and/or recording of the animals' status, thus jeopardising the controls on the horse identification and movements. As regards the processing establishments, the procedures for their approval were implemented correctly. The official controls over the production of horse meat and the associated compliance by operators with the relevant EU requirements, are organised on a risk basis and implemented using comprehensive documented procedures and guidance; overall, these controls ensure that the relevant requirements are enforced. Controls in respect of Trichinella were equally satisfactory. The competent authorities' controls in slaughterhouses over the eligibility of horses for

32 slaughter for human consumption are comprehensive, allowing the detection of non- compliances and irregularities. As such, the system ensures that only horses with correct identification and clearance for slaughter, enter the food chain. However, the audit team observed a large scale absence of recording of medicinal treatments in the passports, which casts doubts on the reliability of this information. At the same time, verification of compliance with these recording requirements by owners/keepers, is very limited. This, together with the fact that the official controls pay limited attention to the subsequent fate of the substantial number of horses which are excluded from the food chain, diminishes the effect of the otherwise robust controls in the slaughterhouses. The question remains what is happening with these ineligible horses, as an accurate reconciliation of the number of horses and their ultimate destiny is not possible. Exclusion from the food chain in accordance with the rules in place has a significant economic impact for the owners of the animals which, in turn, may provide an incentive to introduce them into the food chain anyhow, and moreover generates animal welfare concerns (e.g. abandoned animals or killing of animals).

7 CLOSING MEETING

A closing meeting was held in Dublin on 16 May 2019 with the CCA. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit and advised the CCA of the relevant time limits for the production of the report and their response.

The CA provided a draft of the "Intake procedures for fallen horses into Knackeries" and preliminary information on certain corrective actions taken to address the deficiencies identified during the audit.

8 RECOMMENDATIONS

An action plan describing the actions taken or planned in response to the recommendations of this report and setting out a timetable to correct the deficiencies found should be presented to the Commission within one month of receipt of the report.

No. Recommendation

1. To take further measures aimed at verifying that owners/keepers' of horses meet the obligations of Articles 12, 27 and 35 of Regulation (EC) No 2015/262 and, mainly, concerning timely identification, the notification of any change of ownership and usual residence of the animals in Ireland, the change in their status (from food producing animals to animals which are excluded from slaughter for human consumption) and/or the death of the animals, in order to provide reasonable assurance that the information contained in the central database is up-to-date and reflects the status of the horses kept in the country.

33 No. Recommendation Recommendation based on conclusions No.72, 74 and 75. Associated findings Nos 45, 46.b, 47.b, 47.c,, 48, 54, 60, 66, 68 and 69. 2. To take measures aimed at verifying that, when horses eligible for slaughter for human consumption are treated with medicinal products, the obligations laid down in Article 37 of Regulation (EC) No 2015/262 concerning the medication records in the passport and the transmission of relevant information to the issuing body and/or to the central database are met; in particular: - in case of non-permitted treatments, the exclusion of the animal from the food chain should be recorded and the information transmitted to the relevant authorities and/or issuing body; - when permitted treatments are given, they are properly registered in the relevant part of the passport. Recommendation based on conclusions No 74, 144 and 149. Associated findings Nos 26, 33, 51,110, 135, 136.a, and 139. 3. To ensure that the offal of slaughtered horses has undergone post-mortem inspection carried out in line with the requirements of Annex I, Section IV, Chapter III of Regulation (EC) No 854/2004. Recommendation based on conclusion No 143. Associated findings No 90.

4. To verify that, in the context of the verification of FBO's compliance with microbiological criteria laid down in Regulation (EC) No 2073/2005:

- allowing FBOs to reduce the sampling frequencies is subject to the conditions laid down in Article 5 of that Regulation being met;

- appropriate actions are taken when it is identified that the results of the operator's microbiological analysis do not appear to be realistic.

Recommendation based on conclusion No 147. Associated findings Nos 119 and 120.

5. To include in the control system a verification and, where necessary, enforcement of the rules applicable to horses which are not eligible for slaughter for human consumption, to prevent their re-entry into the food chain. Recommendation based on conclusion 149 Associated findings Nos 61, 63, 69, 109, 125, 126, 138, 139 and 142. ______

34 The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6669

35 ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, 30.4.2004, Regulation (EC) No 882/2004 of the p. 1, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 on official controls performed 191, 28.5.2004, p. 1 to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 178/2002 OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the 1-24 European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 852/2004 OJ L 139, 30.4.2004, Regulation (EC) No 852/2004 of the p. 1, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 on the hygiene of foodstuffs 226, 25.6.2004, p. 3 Reg. 853/2004 OJ L 139, 30.4.2004, Regulation (EC) No 853/2004 of the p. 55, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 laying down specific hygiene 226, 25.6.2004, p. 22 rules for food of animal origin

Reg. 854/2004 OJ L 139, 30.4.2004, Regulation (EC) No 854/2004 of the p. 206, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 laying down specific rules for 226, 25.6.2004, p. 83 the organisation of official controls on products of animal origin intended for human consumption

Reg. 882/2004 - OJ L 165, 30.4.2004, Regulation (EC) No 882/2004 of the Article 45 (MS) p. 1, Corrected and European Parliament and of the Council of re-published in OJ L 29 April 2004 on official controls performed 191, 28.5.2004, p. 1 to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 2073/2005 OJ L 338, Commission Regulation (EC) No 2073/2005 22.12.2005, p. 1-26 of 15 November 2005 on microbiological criteria for foodstuffs Reg. 2074/2005 OJ L 338, Commission Regulation (EC) No 2074/2005 22.12.2005, p. 27-59 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

Reg. 2015/1375 OJ L 212, 11.8.2015, Commission Implementing Regulation (EU) p. 7–34 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat

Reg. 1099/2009 OJ L 303, Council Regulation (EC) No 1099/2009 of 24 18.11.2009, p. 1-30 September 2009 on the protection of animals at the time of killing

Dir. 98/83/EC OJ L 330, 5.12.1998, Council Directive 98/83/EC of 3 November p. 32-54 1998 on the quality of water intended for human consumption

Reg. 1169/2011 OJ L 304, Regulation (EU) No 1169/2011 of the 22.11.2011, p. 18-63 European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004

Reg. 1333/2008 OJ L 354, Regulation (EC) No 1333/2008 of the 31.12.2008, p. 16-33 European Parliament and of the Council of 16 December 2008 on food additives Dir. 2001/82/EC OJ L 311, Directive 2001/82/EC of the European 28.11.2001, p. 1-66 Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

Reg. 1950/2006 OJ L 367, Commission Regulation (EC) No 1950/2006 22.12.2006, p. 33-45 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae

Dir. 96/22/EC OJ L 125, 23.5.1996, Council Directive 96/22/EC of 29 April 1996 p. 3-9 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta- agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Dir. 96/23/EC OJ L 125, 23.5.1996, Council Directive 96/23/EC of 29 April 1996 p. 10-32 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

Dir. 96/93/EC OJ L 13, 16.1.1997, Council Directive 96/93/EC of 17 December p. 28-30 1996 on the certification of animals and animal products

Reg. 1069/2009 OJ L 300, Regulation (EC) No 1069/2009 of the 14.11.2009, p. 1-33 European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) Reg. 142/2011 OJ L 54, 26.2.2011, Commission Regulation (EU) No 142/2011 p. 1-254 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

Reg. 2015/262 OJ L 59, 3.3.2015, p. Commission Implementing Regulation (EU) 1–53 2015/262 of 17 February 2015 laying down rules pursuant to Council Directives 90/427/EEC and 2009/156/EC as regards the methods for the identification of equidae (Equine Passport Regulation)

Dir. 90/425/EEC OJ L 224, 18.8.1990, Council Directive 90/425/EEC of 26 June p. 29-41 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market

Dir. 2009/156/EC OJ L 192, 23.7.2010, Council Directive 2009/156/EC of 30 p. 1-24 November 2009 on animal health conditions governing the movement and importation from third countries of equidae