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            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:

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:

2.   Pending the results of the Trichinella examination and provided full traceability is guaranteed by the food business operator.

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:

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

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:

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:

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:

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:

2.   The competent authority shall withdraw official recognition of holdings or categories of holdings as free from Trichinella where:

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:

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:

2.   Where the trichinoscopic method is used, the competent authority shall ensure that:

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.

For the Commission

Markos KYPRIANOU            

Member of the Commission

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(1)OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226, 25.6.2004, p. 83.

(2)OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004, p. 22.

(3)OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.

(4)OJ L 26, 31.1.1977, p. 67.

(5)OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004, p. 12.

(6)OJ L 325, 12.12.2003, p. 31.

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ANNEX I

Detection methods

CHAPTER I

REFERENCE 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

Where needed, up to 15 g can be added to a total pool of 100 g and examined together with these samples in accordance with 3(I). More than 15 g must be examined as a complete pool. For pools of up to 50 g, the digestion fluid and the ingredients may be reduced to 1 litre of water, 8 ml of hydrochloric acid and 5 g of pepsin.

III.   Positive or doubtful results

Where examination of a collective sample produces a positive or uncertain result, a further 20 g sample is taken from each pig in accordance with 2(a). The 20 g samples from five pigs are pooled and examined using the method described above. In this way samples from 20 groups of five pigs will be examined.

When Trichinella is detected in a pooled sample from five pigs, further 20 g samples are collected from the individual pigs in the group and each is examined separately using the method described above.

Parasite samples are to be kept in 90 % ethyl alcohol for conservation and identification at species level at the Community or national reference laboratory.

After parasite collection, positive fluids (digestive juice, supernatant fluid, washings, etc.) are to be decontaminated by heating to at least 60 oC.

CHAPTER II

EQUIVALENT METHODS

A.   Mechanically assisted pooled sample digestion method/sedimentation technique

1.   Apparatus and reagents

2.   Collecting of specimens and quantity to be digested

As stipulated in Chapter I(2).

3.   Procedure

I.   Grinding

Grinding the meat samples in a meat mincer beforehand will improve the digestion quality. If an electrical blender is used, the blender must be operated three to four times for approximately one second each time.

II.   Digestion procedure

This procedure may involve complete pools (100 g of samples at a time) or pools of less than 100 g.

III.   Recovery of larvae by sedimentation

Where the digests are unclear or they are not examined within 30 minutes of their preparation, they must be clarified as follows:

IV.   Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

B.   Mechanically assisted pooled sample digestion method/‘on filter isolation’ technique

1.   Apparatus and reagents

As stipulated in Chapter II(A)(1).

Additional equipment:

2.   Collecting of specimens

As stipulated in Chapter I(2).

3.   Procedure

I.   Grinding

Grinding the meat samples in a meat mincer beforehand will improve the digestion quality. If an electrical blender is used, the blender must be operated three to four times for approximately one second each time.

II.   Digestion procedure

This procedure may involve complete pools (100 g of samples at a time) or pools of less than 100 g.

III.   Recovery of larvae by filtration

IV.   Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

C.   Automatic digestion method for pooled samples of up to 35 g

1.   Apparatus and reagents

2.   Collecting of specimens

As stipulated in Chapter I(2).

3.   Procedure

I.   Digestion procedure

II.   Recovery of larvae

III.   Cleaning equipment

IV.   Use of membrane filters

Each polycarbonate membrane filter may be used no more than five times. The filter is to be turned between each use. In addition, the filter must be checked after each use for any damage which would make it unsuitable for further use.

V.   Method to be applied when digestion is incomplete and filtration cannot be carried out

Once the blender has been put through an automatic cycle in accordance with C(3)(I), open the lid of the reaction chamber and check whether there is foam or any liquid remaining in the chamber. If this is the case, proceed as follows:

VI.   Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

CHAPTER III

TRICHINOSCOPIC EXAMINATION

1.   Apparatus

2.   Collecting of specimens

In the case of whole carcases, several hazelnut-size samples are taken from each animal:

3.   Procedure

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ANNEX II

Freezing treatments

A.   Freezing method 1

B.   Freezing method 2

C.   Freezing method 3

Treatment consists of commercial freeze-drying or freezing of meat for specified time-temperature combinations with temperature monitored at the centre of each cut.

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ANNEX III

Examination of animals other than swine

Horse meat, wild game meat and other meat that could contain Trichinella parasites must be examined in accordance with one of the digestion methods specified in Chapter I or II of Annex I, with the following changes:

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ANNEX IV

Detailed conditions for Trichinella-free holdings and regions with a negligible Trichinella risk

For the purpose of this Annex,

         ‘controlled housing conditions in integrated production systems’ 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.

CHAPTER I

OBLIGATIONS ON FOOD BUSINESS OPERATORS

CHAPTER II

OBLIGATIONS ON THE COMPETENT AUTHORITIES

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(1)OJ L 35, 8.2.2005, p. 1.

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