COMMISSION REGULATION (EC) No 2075/2005
of 5 December 2005
laying down specific rules on official controls for Trichinella in meat
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 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)
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2), Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on the official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (3) lay down the health rules and requirements regarding food of animal origin and the official controls required.
(2)
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.
(3)
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 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.
(4)
Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (4) was repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (5).
(5)
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 for standard use. The trichinoscopic method should only be used under exceptional circumstances for the examination of a small number of animals slaughtered per week, provided that measures are taken by the food business operator to process the meat in such a way that it is completely safe for consumption. However, the method should be replaced by a more reliable detection method within a transitional period. Other methods, such as serological tests, can be useful for monitoring purposes once the tests have been validated by a Community reference laboratory as soon as such a laboratory has been appointed by the Commission. Serological tests are not suitable for detecting Trichinella infestation in individual animals intended for human consumption.
(6)
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.
(7)
Holdings should be officially recognised by the competent authority as Trichinella-free, provided specific conditions are met. Fattening pigs coming from such holdings should be exempted from inspection for Trichinella. Categories of holdings should be officially recognised by the competent authority as Trichinella-free, provided specific conditions are met. Such recognition should reduce the number of on-site inspections to be carried out by the competent authority, but is only feasible in Member States with a history of very low disease prevalence.
(8)
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 of 17 November 2003 on the monitoring of zoonoses and zoonotic agents (6).
(9)
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.
(10)
The measures provided in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISION
Article 1
Definition
For the purposes of this Regulation ‘Trichinella’ means any nematode belonging to species of the genus Trichinella.
CHAPTER II
OBLIGATIONS OF COMPETENT AUTHORITIES AND OF FOOD BUSINESS OPERATORS
Article 2
Sampling of carcases
1. Carcases of domestic swine shall be systematically sampled in slaughterhouses as part of the post-mortem examination.
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:
(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. Pending the results of the Trichinella examination and provided full traceability is guaranteed by the food business operator.
(a)
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).
(b)
By way of derogation from subparagraph (a) 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:
(i)
the procedure is under supervision by the competent authority;
(ii)
a carcase or the parts thereof will not have more than one cutting plant as its destination;
(iii)
the cutting plant is situated within the territory of the Member State; and
(iv)
in case of a positive result all the parts will be declared unfit for human consumption.
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.
Such sampling must not be carried out where the competent authority has ascertained by risk assessment that the risk of Trichinella infestation of a particular farmed or wild species is negligible.
A sample shall be collected from each carcase and the sample shall be examined in accordance with Annex 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 domestic swine kept solely for fattening and slaughter shall be exempt from Trichinella examination where the animals come from:
(a)
a holding or category of holdings that has been officially recognised by the competent authority as free from Trichinella in accordance with the procedure set out in Chapter II of Annex IV;
(b)
a region where the risk of Trichinella in domestic swine is officially recognised as negligible following:
(i)
forwarding of a notification to that effect by the Member State concerned, together with an initial report containing the information set out in Chapter II(D) of Annex IV, to the Commission and the other Member States; and
(ii)
approval of the region as a region presenting a negligible Trichinella risk in accordance with the following procedure:
the other Member States shall have three months from receipt of the notification referred to in (i) to send written comments to the Commission. If the Commission or a Member State raises no objections, the region is recognised as a region presenting a negligible Trichinella risk and domestic swine coming from that region shall be exempted from examination for Trichinella at the time of slaughter;
the Commission shall publish the list of regions recognised as such on its website.
3. Where a competent authority implements the derogation provided for in paragraph 2, the Member State concerned shall submit an annual report to the Commission containing the information referred to in Chapter II(D) of Annex IV in accordance with Article 9(1) of Directive 2003/99/EC.
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.
Article 4
Trichinella examination and application of health mark
1. Carcases as referred to in Article 2 or parts thereof, except for those referred to in Article 2(2)(b), 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 carcases 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, 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 shall be properly trained and participate in:
Trichinella
(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:
(a)
where they provide grounds for suspecting Trichinella infestation; or
(b)
when samples coming from the same holding were previously found to be positive using the trichinoscopic method referred to in Article 16(1).
2. All positive samples shall be forwarded to the national reference laboratory or the Community reference laboratory for determination of the Trichinella species involved.
Article 7
Contingency plans
The competent authorities of the Member States shall prepare a contingency plan by 31 December 2006 outlining all action to be taken where samples as referred to in Articles 2 and 16 test positive to Trichinella. That plan shall include details covering:
(a)
traceability of infested carcase(s) and parts thereof containing muscle tissue;
(b)
measures for dealing with infested carcase(s) and parts thereof;
(c)
investigation of the source of infestation and any spreading among wildlife;
(d)
any measures to be taken at the retail or consumer level;
(e)
measures to be taken where the infested carcase cannot be identified at the slaughterhouse;
(f)
determination of the Trichinella species involved.
Article 8
Recognition of officially Trichinella-free holdings
The competent authority may officially recognise holdings or categories of holdings as free from Trichinella where the following requirements are complied with:
(a)
in the case of holdings, the requirements laid down in Chapter I and Chapter II(A), (B) and (D) of Annex IV;
(b)
in the case of categories of holdings, the requirements laid down in Chapter II(C) and (D) of Annex IV.
Article 9
Obligation on food business operators to inform
Food business operators of holdings recognised as free from Trichinella shall inform the competent authority of any requirement as laid down in Chapter I and II(B) of Annex IV that is no longer fulfilled or of any other change that might affect holdings' Trichinella-free status.
Article 10
Inspection of Trichinella-free holdings
The competent authority shall ensure that inspections are carried out periodically of holdings recognised as free from Trichinella.
The frequency of inspections 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 ensure that all breeding sows and boars coming from Trichinella-free holdings are examined in accordance with Article 2(1).
Article 11
Monitoring programmes
The competent authority shall implement a monitoring programme covering domestic swine, horses and other animal species susceptible for Trichinella coming from holdings or categories of holdings recognised as free from Trichinella or from regions where the risk of Trichinella in domestic swine is recognised as negligible, in order to verify that the animals are effectively free from Trichinella.
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 Community reference laboratory.
Article 12
Withdrawal of official recognition of Trichinella-free holdings or regions with negligible risk
1. Where domestic swine, or other animal species susceptible to Trichinella infestation, from a holding officially recognised as free from Trichinella test positive to Trichinella, the competent authority shall without delay:
(a)
withdraw the holding's official recognition as free from Trichinella;
(b)
examine all domestic swine at the time of slaughter in accordance with Article 2(1) and conduct a serological test on all animals susceptible to Trichinella infestation on the holding once a suitable test has been validated by the Community reference laboratory;
(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 in Chapters I and II of Annex I; a serological test may be used once a suitable test is validated by the Community reference laboratory;
(d)
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)
initiate an epidemiological investigation to elucidate the cause of infestation;
(g)
increase the frequency of testing under, and the scope of the monitoring programme provided for in Article 11;
(h)
take appropriate measures where any infested carcase cannot be identified at the slaughterhouse, including:
(i)
increasing the size of each meat sample collected for testing of the suspect carcases; or
(ii)
declaring the carcases unfit for human consumption; and
(iii)
taking appropriate measures for the disposal of suspect carcases or parts thereof and those testing positive.
2. The competent authority shall withdraw official recognition of holdings or categories of holdings as free from Trichinella where:
(i)
any of the requirements laid down in Chapter I or II of Annex IV is no longer fulfilled;
(ii)
serological results or laboratory findings following sampling of slaughtered swine show that the holding or category of holdings can no longer be considered free from Trichinella.
3. When information from the monitoring programme or the wildlife monitoring programme shows that a region can no longer be considered a region where the risk of Trichinella in domestic swine is recognised as negligible, the Commission shall withdraw the region from the list and inform the other Member States.
4. Following withdrawal of recognition, holdings may be recognised as officially free from Trichinella again once the problems identified have been solved and the requirements laid down in Chapter II(A) of Annex IV are fulfilled to the satisfaction of the competent authority.
CHAPTER III
IMPORTS
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 Community if it has been examined for Trichinella in that third country before export.
Such examination shall be carried out in accordance with Article 2 on the whole carcase or, failing this, on each half-carcase, quarter, part or cut thereof.
Article 14
Derogations from Article 13
1. Meat of domestic swine may be imported without having undergone the examination referred to in Article 13, provided it comes from a holding in a third country that has been recognised by the Community as officially free from Trichinella in accordance with Article 12 of Regulation (EC) No 854/2004 on the basis of a request from the competent authority of that country, accompanied by a report to the Commission providing evidence that the requirements set out in Chapter I of Annex IV are met.
2. Meat of domestic swine may be imported without having undergone the examination referred to in Article 13, provided it has undergone a freezing treatment in accordance with Annex II carried out under the supervision of the competent authority in the third country.
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:
(a)
the meat has been examined in the third country of origin in accordance with Article 13; or
(b)
the meat satisfies the requirements set out in Article 14(1) or (2).
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.
CHAPTER IV
TRANSITIONAL AND FINAL PROVISIONS
Article 16
Transitional provisions
1. The Member State may allow the trichinoscopic method set out in Chapter III of Annex I to be used for domestic swine and wild boar in exceptional cases until 31 December 2009, where:
(a)
single carcases as referred to in Article 2 need to be examined individually in an establishment that does not slaughter more than 15 domestic swine per day or 75 domestic swine per week or prepare for placing on the market more than 10 wild boar per day; and
(b)
the detection methods set out in Chapters I and II of Annex I are not available.
2. Where the trichinoscopic method is used, the competent authority shall ensure that:
(a)
the meat is marked with a health mark that is clearly different from the health mark provided for in Article 5(1)(a) of Regulation (EC) No 853/2004, and the meat is supplied directly to the final consumer or to retail establishments directly supplying the final consumer; and
(b)
the meat is not used for the production of products where the production process does not kill Trichinella.
Article 17
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2006.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 December 2005.