CHAPTER I GENERAL PROVISION CHAPTER II OBLIGATIONS OF COMPETENT AUTHORITIES AND OF FOOD BUSINESS OPERATORS CHAPTER III IMPORTS CHAPTER IV REPEAL AND FINAL PROVISIONS
CHAPTER IREFERENCE METHOD OF DETECTION Magnetic stirrer method for pooled sample digestion 1.Apparatus and reagents 2.Collecting of specimens and quantity to be digested 3.Procedure I.Complete pools (100 g of samples at a time) II.Pools of less than 100 g III.Positive or doubtful results IV.Cleaning and decontamination procedure after a positive or doubtful result...CHAPTER IIEQUIVALENT METHODS A.Mechanically assisted pooled sample digestion method/sedimentation technique 1.Apparatus and reagents 2.Collecting of specimens and quantity to be digested 3.Procedure I.Grinding II.Digestion procedure III.Recovery of larvae by sedimentation IV.Positive or doubtful results B.Mechanically assisted pooled sample digestion method/'on filter isolation' technique 1.Apparatus and reagents 2.Collecting of specimens 3.Procedure I.Grinding II.Digestion procedure III.Recovery of larvae by filtration IV.Positive or doubtful results C.Automatic digestion method for pooled samples of up to 35...1.Apparatus and reagents 2.Collecting of specimens 3.Procedure I.Digestion procedure II.Recovery of larvae III.Cleaning equipment IV.Use of membrane filters V.Method to be applied when digestion is incomplete and filtration...VI.Positive or doubtful results D.Magnetic stirrer method for pooled sample digestion/'on filter isolation' and...1.Apparatus and reagents 2.Collecting of specimens 3.Procedure I.For complete pools (100 g of samples at a time)...II.Pools of less than 100 g as set out in...III.Positive or doubtful results IV.Cleaning and decontamination procedure after a positive or doubtful result...E.Artificial digestion test for in vitro detection of Trichinella spp....A.Freezing method 1 B.Freezing method 2 C.Freezing method 3 CHAPTER IOFFICIAL RECOGNITION OF HOLDINGS OR A COMPARTMENT AS APPLYING CONTROLLED HOUSING CONDITIONSA.The following requirements must be met by food business operators...B.Food business operators of holdings officially recognised as applying controlled...C.The competent authority may only recognise a holding or a...CHAPTER IIREPORTING ON TRICHINELLA SITUATION(a)The number of cases (imported and autochthonous) of Trichinella in...(b)The number of tests and the results of testing for...

Commission Implementing Regulation (EU) 2015/1375

of 10 August 2015

laying down specific rules on official controls for Trichinella in meat

(Codification)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption1, and in particular points 9 and 10 of Article 18 thereof,

Whereas:

(1)

Commission Regulation (EC) No 2075/20052 has been substantially amended several times3. In the interests of clarity and rationality that Regulation should be codified.

(2)

Regulation (EC) No 853/2004 of the European Parliament and of the Council4, Regulation (EC) No 854/2004 and Regulation (EC) No 882/2004 of the European Parliament and of the Council5 lay down the health rules and requirements regarding food of animal origin and the official controls required.

(3)

In addition to those rules, more specific requirements should be laid down for Trichinella. Meat of domestic swine, wild boar, horses and other animal species may be infested with nematodes of the genus Trichinella. Consumption of meat infested with Trichinella can cause serious disease in humans. Measures should be put in place to prevent human disease caused by the consumption of meat infested with Trichinella.

(4)

This Regulation should lay down rules for the sampling of carcasses of species susceptible to Trichinella infection, for the determination of the status of holdings and compartments and conditions for the import of meat into the Union. It should also provide for reference methods and equivalent methods for the detection of Trichinella in samples of carcasses.

(5)

In order to facilitate the operation of cutting premises, the provision that allows the cutting of carcasses of domestic swine under certain conditions pending the results of the Trichinella examination, should also apply to horses under the same conditions.

(6)

On 22 November 2001, the Scientific Committee on Veterinary Measures relating to Public Health adopted an opinion on trichinellosis, epidemiology, methods of detection and Trichinella-free pig production. On 1 December 2004, the Scientific Panel on Biological Hazards (Biohaz) of the European Food Safety Authority (EFSA) adopted an opinion on the suitability and details of freezing methods to allow human consumption of meat infected with Trichinella or Cysticercus. On 9 and 10 March 2005, Biohaz adopted an opinion on risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella.

(7)

On 3 October 2011, EFSA adopted a Scientific Opinion on the public health hazards to be covered by inspection of meat (swine)6. In that opinion, EFSA identified Trichinella as a medium risk for public health related to the consumption of pig meat and concludes that with respect to inspection methods for biological hazards, a pork carcass safety assurance, with a range of preventive measures and controls applied both on-farm and at slaughterhouse in an integrated way is the only way to ensure an effective control of the main hazards.

(8)

EFSA identified certain epidemiological indicators in relation to Trichinella. Depending on the purpose and the epidemiological situation of the country, the indicators may be applied at national, regional, slaughterhouse or holding level.

(9)

EFSA recognises the sporadic presence of Trichinella in the Union, mainly in free-ranging and backyard pigs. EFSA also identified that the type of production system is the single main risk factor for Trichinella infections. In addition, available data demonstrate that the risk of Trichinella infection in pigs from officially recognised controlled housing conditions is negligible.

(10)

A negligible risk status for a country or region is no longer recognised in an international context by the World Organisation for Animal Health (OIE). Instead, such recognition is linked to compartments of one or more holdings applying specific controlled housing conditions.

(11)

In order to enhance the control system in accordance with the actual public health risks, the Trichinella risk mitigation measures, including import conditions, at slaughterhouses and the conditions for determination of the Trichinella infection status of countries, regions or holdings should be laid down taking into account, inter alia, international standards.

(12)

In 2011, Belgium and Denmark notified a Trichinella negligible risk for their territory in accordance with Regulation (EC) No 2075/2005. Such negligible risk status for a country or region is, however, no longer recognised. Nevertheless, holdings and compartments in Belgium and Denmark complying with the conditions for controlled housing on 1 June 2014 should be allowed to apply the derogation for such holdings and compartments without additional prerequisites such as further requirements of post-official recognition by the competent authority.

(13)

It should be provided that the operators must ensure that dead animals are collected, identified and transported without undue delay in accordance with Articles 21 and 22 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council7 and with Annex VIII to Commission Regulation (EU) No 142/20118.

(14)

The number of cases (imported and autochthonous) of Trichinella in humans, including epidemiological data, should be reported in accordance with Commission Decision 2000/96/EC9.

(15)

Information on the official recognition of the holding of origin as applying controlled housing conditions should be included by an official veterinarian in the animal health certificates provided for in Council Directive 64/432/EEC10 as regards intra-Union trade in swine and in Commission Regulation (EU) No 206/201011 as regards imports into the Union of domestic swine from third countries in order to enable Member States to apply the appropriate Trichinella testing regime at slaughter and not to jeopardise the status of the holding of destination of swine for breeding or production.

(16)

In order to ensure the correct application of this Regulation, third countries exporting domestic swine or meat thereof, should be listed in the relevant acts on import conditions if they apply the derogations on Trichinella sampling of domestic swine and if holdings or compartments are officially recognised as applying controlled housing conditions.

(17)

The public health attestation of the Trichinella examination should be included in the veterinary certificates accompanying fresh meat in accordance with Regulation (EU) No 206/2010, meat preparations in accordance with Commission Decision 2000/572/EC12 and meat products in accordance with Commission Decision 2007/777/EC13.

(18)

Various laboratory methods have been approved for the detection of Trichinella in fresh meat. The magnetic stirrer method for pooled-sample digestion is recommended as a reliable method for routine use. Sample size for parasitic analysis should be increased if the sample cannot be collected at the predilection site and if the type or species of animal is at higher risk of being infected. Trichinoscopic examination fails to detect non-encapsulated Trichinella species infecting domestic and sylvatic animals and humans and is no longer suitable as a detection method. Other methods, such as serological tests, can be useful for monitoring purposes once the tests have been validated by an EU reference laboratory appointed by the Commission. Serological tests are not suitable for detecting Trichinella infestation in individual animals intended for human consumption.

(19)

New apparatus for Trichinella testing using the digestion method equivalent to the reference method started being produced by private companies. In line with these developments, guidelines for the validation of new apparatus for testing of Trichinella by the digestion method were endorsed unanimously during the meeting of the Standing Committee on the Food Chain and Animal Health on 16 December 2008.

(20)

In accordance with those guidelines, in 2010 the EU reference laboratory for parasites validated a new apparatus method for testing of Trichinella in domestic swine under the code No EURLP_D_001/201114.

(21)

Freezing meat under specified conditions can kill any parasites present but certain Trichinella species occurring in game and horses are resistant when freezing is carried out using the recommended temperature and time combinations.

(22)

Regular monitoring of domestic swine, wild boar, horses and foxes or other indicator animals is an important tool for assessing changes in disease prevalence. The results of such monitoring should be communicated in an annual report in accordance with Directive 2003/99/EC of the European Parliament and of the Council15.

(23)

This Regulation generally does not allow meat of domestic swine to leave slaughterhouses before the results of examination for Trichinella infestation have been communicated to the official veterinarian. However, it is appropriate to allow, under certain strict conditions, to apply the health mark and release the meat for transport before the results are known. Under such circumstances it is essential that the competent authority verifies that full traceability of the released meat is in place at all times.

(24)

Regulation (EC) No 853/2004 does not apply to wild game or wild game meat directly supplied to the final consumer or to local retail establishments directly supplying the final consumer. It should therefore be the responsibility of the Member States to adopt national measures to mitigate the risk of Trichinella-infested wild boar meat reaching the final consumer.

(25)

The measures provided in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION: