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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 consumption (1), and in particular points 9 and 10 of Article 18 thereof,
Whereas:
(1)
Commission Regulation (EC) No 2075/2005 (2) has been substantially amended several times (3). 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 Council (4), Regulation (EC) No 854/2004 and Regulation (EC) No 882/2004 of the European Parliament and of the Council (5) 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 Council (7) and with Annex VIII to Commission Regulation (EU) No 142/2011 (8).
(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/EC (9).
(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/EEC (10) as regards intra-Union trade in swine and in Commission Regulation (EU) No 206/2010 (11) 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/EC (12) and meat products in accordance with Commission Decision 2007/777/EC (13).
(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_001/2011 (14).
(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 Council (15).
(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:
CHAPTER I
GENERAL PROVISION
Article 1
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)
Trichinella means any nematode belonging to the species of the genus Trichinella;
(2)
controlled housing conditions means a type of animal husbandry where swine are kept at all times under conditions controlled by the food business operator with regard to feeding and housing;
(3)
compartment means a group of holdings which apply controlled housing conditions. All holdings applying controlled housing conditions in a Member States, may be considered as one compartment.
CHAPTER II
OBLIGATIONS OF COMPETENT AUTHORITIES AND OF FOOD BUSINESS OPERATORS
Article 2
Sampling of carcasses
1. Carcasses of domestic swine shall be sampled in slaughterhouses as part of the post-mortem examination as follows:
(a)
all carcasses of breeding sows and boars or at least 10 % of carcasses of animals sent in for slaughter each year from each holding that is officially recognised as applying controlled housing conditions, shall be examined for Trichinella;
(b)
all carcasses from holdings that are not officially recognised as applying controlled housing conditions shall be systematically examined for Trichinella.
A sample shall be collected from each carcass and the sample shall be examined for Trichinella, in a laboratory designated by the competent authority, using one of the following methods of detection:
(a)
the reference method of detection set out in Chapter I of Annex I; or
(b)
an equivalent method of detection set out in Chapter II of Annex I.
2. Carcasses of horses, wild boar and other farmed and wild animal species susceptible to Trichinella infestation shall be systematically sampled in slaughterhouses or game-handling establishments as part of the post-mortem examination.
A sample shall be collected from each carcass and the sample shall be examined in accordance with Annexes I and III in a laboratory designated by the competent authority.
3. Pending the results of the Trichinella examination and provided full traceability is guaranteed by the food business operator, carcasses of domestic swine and of horses may be cut up into a maximum of six parts in a slaughterhouse or in a cutting plant on the same premises.
By way of derogation from the first subparagraph and following approval by the competent authority, such carcasses may be cut up at a cutting plant attached to or separate from the slaughterhouse provided that:
(a)
the procedure is under supervision by the competent authority;
(b)
a carcass or the parts thereof have not more than one cutting plant as its destination;
(c)
the cutting plant is situated within the territory of the Member State; and
(d)
in the case of a positive result all the parts are declared unfit for human consumption.
Article 3
Derogations
1. By way of derogation from Article 2(1), meat of domestic swine that has undergone a freezing treatment in accordance with Annex II under the supervision of the competent authority shall be exempt from Trichinella examination.
2. By way of derogation from Article 2(1), carcasses and meat of not weaned domestic swine less than five weeks of age shall be exempt from Trichinella examination.
3. By way of derogation from Article 2(1), carcasses and meat of domestic swine may be exempt from Trichinella examination where the animals come from a holding or a compartment officially recognised as applying controlled housing conditions in accordance with Annex IV, if:
(a)
no autochthonous Trichinella infestations in domestic swine kept in holdings officially recognised as applying controlled housing conditions have been detected in the Member State in the past three years, during which time continuous testing has been conducted in accordance with Article 2; or
(b)
historical data on continuous testing carried out on slaughtered swine population provide at least 95 % confidence that the prevalence of Trichinella does not exceed one per million in that population; or
(c)
the holdings applying controlled housing conditions are located in Belgium or Denmark.
4. Where a Member State implements the derogation provided for in paragraph 3, the Member State concerned shall inform the Commission and the other Member States at the Standing Committee on Plants, Animals, Food and Feed and submit an annual report to the Commission containing the information referred to in Chapter II of Annex IV. The Commission shall publish the list of Member States implementing the derogation on its website.
Where a Member State fails to submit that annual report or the annual report is unsatisfactory for the purposes of this Article, the derogation shall cease to apply to that Member State.
Article 4
Trichinella examination and application of health mark
1. Carcasses as referred to in Article 2 or parts thereof, except for those referred to in the second subparagraph of Article 2(3), may not leave the premises, before the result of the Trichinella examination is found to be negative.
Similarly, other parts of an animal intended for human or animal consumption which contain striated muscle tissue may not leave the premises before the result of the Trichinella examination is found to be negative.
2. Animal waste and animal by-products not intended for human consumption and not containing striated muscle may leave the premises before the results of the Trichinella examination are available.
However, the competent authority may require a Trichinella examination or prior treatment of animal by-products to be carried out before permitting them to leave the premises.
3. Where a procedure is in place in the slaughterhouse to ensure that no part of carcasses examined leaves the premises until the result of the Trichinella examination is found to be negative and the procedure is formally approved by the competent authority or where the derogation provided for in the second subparagraph of Article 2(3) applies, the health mark provided for in Article 5(2) of Regulation (EC) No 854/2004 may be applied before the results of the Trichinella examination are available.
Article 5
Training
The competent authority shall ensure that all personnel involved in the examination of samples to detect Trichinella shall be properly trained and participate in:
(a)
a quality control programme of the tests used to detect Trichinella; and
(b)
a regular assessment of the testing, recording and analysis procedures used in the laboratory.
Article 6
Methods of detection
1. The methods of detection set out in Chapters I and II of Annex I shall be used for examining samples as referred to in Article 2 where they provide grounds for suspecting Trichinella infestation.
2. All positive samples shall be forwarded to the national reference laboratory or the EU reference laboratory for determination of the Trichinella species involved.
Article 7
Contingency plans
The competent authorities of the Member States shall provide for a contingency plan outlining all action to be taken where samples as referred to in Article 2 test positive for Trichinella. That plan shall include details covering:
(a)
traceability of infested carcasses and parts thereof containing muscle tissue;
(b)
measures for dealing with infested carcasses and parts thereof;
(c)
investigation of the source of infestation and any spread among wildlife;
(d)
any measures to be taken at the retail or consumer level;
(e)
measures to be taken where infested carcasses cannot be identified at the slaughterhouse;
(f)
determination of the Trichinella species involved.
Article 8
Official recognition of holdings applying controlled housing conditions
1. For the purposes of this Regulation, the competent authority may officially recognise a holding or a compartment applying controlled housing conditions where the requirements laid down in Annex IV are complied with.
2. Holdings or a compartment applying controlled housing conditions in Belgium or Denmark, in accordance with Article 3(3)(c), on 1 June 2014 shall be considered to be officially recognised as applying controlled housing conditions as listed in Annex IV.
Article 9
Obligation on food business operators to inform
Food business operators of holdings officially recognised as applying controlled housing conditions shall inform the competent authority of any requirement as laid down in Annex IV that is no longer fulfilled or of any other change that might affect the Trichinella status of those holdings.
Article 10
Audits of holdings officially recognised as applying controlled housing conditions
The competent authority shall ensure that audits are carried out periodically of holdings officially recognised as applying controlled housing conditions.
The frequency of the audits shall be risk-based, taking account of the disease history and the prevalence, previous findings, the geographical area, local susceptible wildlife, animal husbandry practices, veterinary supervision and farmers' compliance.
The competent authority shall verify that domestic swine coming from those holdings are examined in accordance with Article 2(1).
Article 11
Monitoring programmes
The competent authority may implement a monitoring programme covering the population of domestic swine coming from a holding or a compartment officially recognised as applying controlled housing conditions, in order to verify that Trichinella is actually absent in that population.
The frequency of testing, the number of animals to be tested and the sampling plan shall be laid down in the monitoring programme. To that end, meat samples shall be collected and examined for the presence of Trichinella parasites in accordance with Chapter I or II of Annex I.
The monitoring programme may include serological methods as an additional tool once a suitable test is validated by the EU reference laboratory.
Article 12
Withdrawal of official recognition of holdings as applying controlled housing conditions
1. Where the results of the audits carried out in accordance with Article 10 show that the requirements of Annex IV are no longer fulfilled, the competent authority shall withdraw the holding's official recognition without delay.
2. Where domestic swine from a holding officially recognised as applying controlled housing conditions test positive to Trichinella, the competent authority shall without delay:
(a)
withdraw the holding's official recognition;
(b)
examine all domestic swine of that holding at the time of slaughter;
(c)
trace and test all breeding animals that arrived on the holding and, as far as possible, all those that left the holding in at least the six months preceding the positive finding; to that end, meat samples shall be collected and examined for presence of Trichinella parasites using the detection methods laid down in Chapters I and II of Annex I;
(d)
when relevant, as far as is feasible, investigate the spread of parasite infestation due to the distribution of meat from domestic swine slaughtered in the period preceding the positive finding;
(e)
inform the Commission and the other Member States;
(f)
when relevant, initiate an epidemiological investigation to elucidate the cause of infestation;
(g)
take appropriate measures where any infested carcass cannot be identified at the slaughterhouse, including:
(i)
increasing the size of each meat sample collected for testing of the suspect carcasses; or
(ii)
declaring the carcasses unfit for human consumption;
(iii)
taking appropriate measures for the disposal of suspect carcasses or parts thereof and those testing positive.
3. Following withdrawal of the recognition, holdings may be officially recognised again once the problems identified have been solved and the requirements laid down in Annex IV are fulfilled to the satisfaction of the competent authority.
4. If the inspection identified a lack of compliance with Article 9 or positive testing in a holding of a compartment, the holding concerned shall be removed from the compartment until compliance is re-established.
CHAPTER III
IMPORTS
Article 13
Import health requirements
1. Meat containing striated muscles of animal species that may be carriers of Trichinella may only be imported into the Union if prior to export the examination for Trichinella has been performed in accordance with conditions equivalent to those laid down in Article 2 or 3 in the third country where the animals were slaughtered.
2. A third country may only apply the derogations provided for in Article 3(2) and (3) if it has informed the Commission of the application of those derogations and if it has been listed for that purpose:
(i)
in Part 1 of Annex I to Regulation (EU) No 206/2010 for imports of live domestic swine;
(ii)
in Part 1 of Annex II to Regulation (EU) No 206/2010 for imports of fresh meat of domestic swine; or
(iii)
in Part 2 of Annex II to Decision 2007/777/EC for imports of meat products produced exclusively from meat or meat products of domestic swine.
Article 14
Documents
1. In the model health certificate for intra-Union trade in live domestic swine set out in Model 2 in Annex F to Directive 64/432/EEC the official veterinarian shall include the information on the official recognition of the holding of origin as applying controlled housing conditions as provided for in Article 8 of this Regulation.
2. In the model health certificate for imports into the Union of domestic swine set out in the Models POR-X and POR-Y in Part 2 of Annex I to Regulation (EU) No 206/2010, the official veterinarian shall include the information on the official recognition by the competent authority of a third country of the holding of origin as applying controlled housing conditions equivalent to those provided for in Annex IV to this Regulation.
3. In the veterinary certificate, in accordance with Model POR set out in Part 2 of Annex II to Regulation (EU) No 206/2010, accompanying consignments of meat intended for imports into the Union from third countries, the official veterinarian shall include the public health attestation of the examination for Trichinella carried out in accordance with Article 13 of this Regulation in the third country of origin of the meat.
4. In the animal and public health certificate, the model of which is set out in Annex II to Decision 2000/572/EC, accompanying consignments of meat preparations intended for imports into the Union from third countries, the official veterinarian shall include the public health attestation of the examination for Trichinella carried out in accordance with Article 13 of this Regulation in the third country of origin of the meat.
5. In the animal and public health certificate, the model of which is set out in Annex III to Decision 2007/777/EC, accompanying consignments of certain meat products and treated stomachs, bladders and intestines intended for imports into the Union from third countries, the official veterinarian shall include the public health attestation of the examination for Trichinella carried out in accordance with Article 13 of this Regulation in the third country of origin of the meat.
CHAPTER IV
REPEAL AND FINAL PROVISIONS
Article 15
Repeal
Regulation (EC) No 2075/2005 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI.
Article 16
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 August 2015.
For the Commission
The President
Jean-Claude JUNCKER
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