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Document 32014R0216
Commission Regulation (EU) No 216/2014 of 7 March 2014 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat Text with EEA relevance
Commission Regulation (EU) No 216/2014 of 7 March 2014 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat Text with EEA relevance
Commission Regulation (EU) No 216/2014 of 7 March 2014 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat Text with EEA relevance
IO L 69, 8.3.2014, p. 85–92
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
No longer in force, Date of end of validity: 30/08/2015; Arna aisghairm le 32015R1375
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8.3.2014 |
EN |
Official Journal of the European Union |
L 69/85 |
COMMISSION REGULATION (EU) No 216/2014
of 7 March 2014
amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat
(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 6, 8, 10 and 12 of Article 18 thereof,
Whereas:
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(1) |
Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for Trichinella in meat (2) lays down rules for the sampling of carcases of species susceptible to Trichinella infection, for the determination of the status holdings and regions and conditions for import of meat into the Union. It also provides for reference methods and equivalent methods of detection of Trichinella in samples of carcases. |
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(2) |
The European Food Safety Authority (EFSA) adopted on 3 October 2011 a Scientific Opinion on the public health hazards to be covered by inspection of meat (swine) (3). 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. |
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(3) |
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. |
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(4) |
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. |
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(5) |
A negligible risk status for a country or region is no longer recognised in an international context by the World Animal Health Organisation (OIE). Instead, such recognition is linked to compartments of one or more holdings applying specific controlled housing conditions. |
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(6) |
For reasons of consistency with international standards, and in order to enhance a 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 adapted, rationalised and simplified. |
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(7) |
Belgium and Denmark notified in 2011 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 which comply with the conditions for controlled housing at the date of entry into force of this Regulation 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. |
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(8) |
The EU Reference Laboratory for parasites has recommended clarifying the text of the Regulation in relation to the procedure of certain equivalent methods for Trichinella testing. |
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(9) |
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 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) (4) and with Annex VIII to Commission Regulation (EU) No 142/2011 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 (5). |
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(10) |
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 of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (6). |
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(11) |
Regulation (EC) No 2075/2005 should therefore be amended accordingly. |
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(12) |
The requirements provided for in this Regulation involve an adaptation of current practices both for food business operators and competent authorities. It is therefore appropriate to allow a delayed application of some of the provisions of this Regulation. |
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(13) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 2075/2005 is amended as follows:
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(1) |
Article 1 is replaced by the following: ‘Article 1 Definitions For the purposes of this Regulation, the following definitions shall apply:
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(2) |
Articles 2 and 3 are replaced by the following: ‘Article 2 Sampling of carcases 1. Carcases of domestic swine shall be sampled in slaughterhouses as part of the post-mortem examination as follows:
A sample shall be collected from each carcase and the sample shall be examined for Trichinella, in a laboratory designated by the competent authority, using one of the following methods of detection:
2. Pending the results of the Trichinella examination and provided full traceability is guaranteed by the food business operator, such carcases may be cut up into a maximum of six parts in a slaughterhouse or in a cutting plant on the same premises as the slaughterhouse (the premises). By way of derogation from the first subparagraph and following approval by the competent authority, such carcases may be cut up at a cutting plant attached to or separate from the slaughterhouse provided that:
3. Carcases 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 carcase and the sample shall be examined in accordance with Annexes I and III in a laboratory designated by the competent authority. 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), carcases 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), carcases 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:
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 of the Food Chain and Animal Health and submit an annual report to the Commission containing the information referred to in Chapter II of Annex IV. The Commission shall publish on its website the list of Member States implementing the derogation. Where a Member State fails to submit that annual report or the annual report is unsatisfactory for the purposes of this Article, then the derogation shall cease to apply to that Member State.’; |
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(3) |
Articles 8 to 12 are replaced by the following: ‘Article 8 Official recognition of holdings applying controlled housing conditions 1. For the purpose 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 Denmark or Belgium in accordance with Article 3, paragraph 3(c) at the date of application of this Regulation are considered to be officially recognised applying controlled housing conditions as listed in Annex IV to this Regulation. 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 holdings’ Trichinella status. 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 audits shall be risk-based, taking account of disease history and 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 effectively 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 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 holdings 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:
3. Following withdrawal of 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 should be removed from the compartment until compliance is re-established.’; |
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(4) |
Article 13 is replaced by the following: ‘Article 13 Import health requirements Meat of animal species that may be carriers of Trichinella, containing striated muscles and coming from a third country may only be imported into the Union if examination for Trichinella has been performed in accordance with Articles 2 and 3 in that third country before export.’; |
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(5) |
Article 14 is deleted; |
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(6) |
Article 15 is replaced by the following: ‘Article 15 Documents The health certificate accompanying imports of meat as referred to in Article 13 shall be endorsed with a statement by the official veterinarian to the effect that the examination for Trichinella in the third country of origin has been performed in accordance with Article 13. That document shall accompany the meat in the original unless an exemption has been granted in accordance with Article 14(4) of Regulation (EC) No 854/2004.’; |
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(7) |
Annex I is amended in accordance with Annex I to this Regulation; |
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(8) |
Annex IV is replaced by the text in Annex II to this Regulation. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 June 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2014.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 139, 30.4.2004, p. 206.
(2) OJ L 338, 22.12.2005, p. 60.
(3) EFSA Journal 2011; 9(10):2351[198 pp.], published 3 October 2011.
ANNEX I
Annex I to Regulation (EC) No 2075/2005 is amended as follows:
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(1) |
in Chapter I, point 3. Procedure, the following paragraph is added: ‘IV. Cleaning and decontamination procedure after a positive or doubtful result When the examination of a collective or individual sample produces a positive or doubtful latex agglutination result, all material in contact with meat (blender bowl, beaker, stirring rod, temperature sensor, conical filtration funnel, sieve and forceps) must be carefully decontaminated by soaking for few seconds in warm water (65 to 90 °C). Meat residues or inactivated larvae that could remain on their surface may be removed with a clean sponge and tap water. If required, a few drops of detergent can be added for degreasing equipment. It is then recommended to rinse each piece thoroughly to remove all traces of detergent.’; |
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(2) |
Part D, of Chapter II, point 3 is replaced by the following: ‘3. Procedure I. For complete pools (100 g of samples at a time)
II. Pools of less than 100 g as set out in Chapter I(3)(II) For pools of less than 100 g, the procedure set out in Chapter I(3)(II) must be followed. III. Positive or doubtful results Where examination of a collective sample produces a positive or uncertain latex agglutination result, a further 20 g sample is taken from each swine in accordance with Chapter I(2)(a). The 20 g samples from five swine are pooled and examined using the method described in Section I. In this way samples from 20 groups of five swine must be examined. When a positive latex agglutination is obtained from a group of five swine, further 20 g samples are collected from the individuals in the group and each is examined separately using the method described in Section I. When a positive or uncertain latex agglutination result is obtained, at least 20 g of swine muscle must be sent to the national reference laboratory for confirmation using one of the methods described in Chapter I. Parasite samples must be kept in 90 % ethyl alcohol for conservation and identification at species level at the EU or national reference laboratory. After parasite collection, positive fluids must be decontaminated by heating to at least 60 °C. IV. Cleaning and decontamination procedure after a positive or doubtful result. When the examination of a collective or individual sample produces a positive or doubtful latex agglutination result, all material in contact with meat (blender bowl, beaker, stirring rod, temperature sensor, conical filtration funnel, sieve and forceps) must be carefully decontaminated by soaking for few seconds in warm water (65 to 90 °C). Meat residues or inactivated larvae that could remain on their surface may be removed with a clean sponge and tap water. If required, a few drops of detergent can be added for degreasing equipment. It is then recommended to rinse each piece thoroughly to remove all traces of detergent.’ |
ANNEX II
‘ANNEX IV
CHAPTER I
OFFICIAL RECOGNITION OF A HOLDINGS OR A COMPARTMENT AS APPLYING CONTROLLED HOUSING CONDITIONS
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A. |
The following requirements must be met by food business operators to obtain official recognition of holdings:
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B. |
Food business operators of holdings officially recognised as applying controlled housing conditions shall inform the competent authority where any of the requirements laid down in point A is no longer fulfilled or where any other change has occurred that might affect the status of the holding. |
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C. |
The competent authorities in Member States may only recognise a holding or a category of holdings provided that they have verified that the requirements laid down in point A are met. |
CHAPTER II
REPORTING ON TRICHINELLA SITUATION
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(a) |
The number of cases (imported and autochthonous) of Trichinella in humans, including epidemiological data shall be reported in accordance with Commission Decision 2000/96/EC (*4). |
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(b) |
The number of tests and the results of testing for Trichinella in domestic swine, wild boar, horses, game and any other susceptible animals shall be submitted in accordance with Annex IV to Directive 2003/99/EC. Data on domestic swine shall, at least, provide specific information related to:
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(*2) OJ L 300, 14.11.2009, p. 1.