# L_2008277EN.01001501.xml

| 18.10.2008 | EN | Official Journal of the European Union | L 277/15 |
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18.10.2008

EN

Official Journal of the European Union

L 277/15

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COMMISSION REGULATION (EC) No 1021/2008

of 17 October 2008

amending Annexes I, II and III to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption and Regulation (EC) No 2076/2005 as regards live bivalve molluscs, certain fishery products and staff assisting with official controls in slaughterhouses

(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 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (1), and in particular Article 16 and Article 17(1) thereof,

Whereas:

| (1) | Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 sets out requirements for the health marking of carcases when there are no grounds for declaring the meat unfit for human consumption. Some of those requirements have created confusion in the identification of products produced within the Community and products produced outside the Community. It is therefore appropriate to clarify those provisions in order to ensure their smooth implementation. |
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(1)

Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 sets out requirements for the health marking of carcases when there are no grounds for declaring the meat unfit for human consumption. Some of those requirements have created confusion in the identification of products produced within the Community and products produced outside the Community. It is therefore appropriate to clarify those provisions in order to ensure their smooth implementation.

| (2) | However, in order not to disrupt the trade in the products concerned, it should be provided that products for which a health mark has been applied in accordance with Regulation (EC) No 854/2004 before 1 November 2009 may be imported into the Community until 31 December 2009. |
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(2)

However, in order not to disrupt the trade in the products concerned, it should be provided that products for which a health mark has been applied in accordance with Regulation (EC) No 854/2004 before 1 November 2009 may be imported into the Community until 31 December 2009.

| (3) | Article 5(6) of Regulation (EC) No 854/2004 allows Member States to authorise slaughterhouse staff to assist with official controls by carrying out certain specific tasks of official auxiliaries in relation to the production of meat from poultry and lagomorphs. Part A of Chapter III of Section III of Annex I to that Regulation provides that that authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as official auxiliaries for the tasks of such auxiliaries. |
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(3)

Article 5(6) of Regulation (EC) No 854/2004 allows Member States to authorise slaughterhouse staff to assist with official controls by carrying out certain specific tasks of official auxiliaries in relation to the production of meat from poultry and lagomorphs. Part A of Chapter III of Section III of Annex I to that Regulation provides that that authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as official auxiliaries for the tasks of such auxiliaries.

| (4) | Article 14 of Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (2), provides that, until 31 December 2009, that training may be limited to ensuring that slaughterhouse staff are trained for the specific tasks they are authorised to perform. |
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(4)

Article 14 of Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (2), provides that, until 31 December 2009, that training may be limited to ensuring that slaughterhouse staff are trained for the specific tasks they are authorised to perform.

| (5) | That limitation has not affected negatively the requirements for the official controls with regard to fresh meat, as provided for in Regulation (EC) No 854/2004. It is therefore appropriate to make the transitional arrangement provided for in Regulation (EC) No 2076/2005 permanent and allow the Member States to implement either a complete or a limited training system and to decide upon its practical arrangements, including the examination procedure. It is therefore appropriate to delete Article 14 of Regulation (EC) No 2076/2005 and to amend Part A of Chapter III of Section III of Annex I to Regulation (EC) No 854/2004 accordingly. |
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(5)

That limitation has not affected negatively the requirements for the official controls with regard to fresh meat, as provided for in Regulation (EC) No 854/2004. It is therefore appropriate to make the transitional arrangement provided for in Regulation (EC) No 2076/2005 permanent and allow the Member States to implement either a complete or a limited training system and to decide upon its practical arrangements, including the examination procedure. It is therefore appropriate to delete Article 14 of Regulation (EC) No 2076/2005 and to amend Part A of Chapter III of Section III of Annex I to Regulation (EC) No 854/2004 accordingly.

| (6) | Point 4 of Part A of Chapter II of Annex II to Regulation (EC) No 854/2004 provides that live bivalve molluscs from Class B areas are not to exceed 4 600E. coli per 100 g of flesh and intravalvular liquid. Article 17a of Regulation (EC) No 2076/2005 introduces, until 31 December 2009, a tolerance in 10 % of samples for live bivalve molluscs originating from those areas. |
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(6)

Point 4 of Part A of Chapter II of Annex II to Regulation (EC) No 854/2004 provides that live bivalve molluscs from Class B areas are not to exceed 4 600E. coli per 100 g of flesh and intravalvular liquid. Article 17a of Regulation (EC) No 2076/2005 introduces, until 31 December 2009, a tolerance in 10 % of samples for live bivalve molluscs originating from those areas.

| (7) | That tolerance does not represent a risk for public health provided that in the 10 % of samples, live bivalve molluscs do not exceed an upper limit of 46 000E. coli per 100 g of flesh and intravalvular liquid. It is therefore appropriate to retain this tolerance on a permanent basis. It is therefore appropriate to delete Article 17a of Regulation (EC) No 2076/2005 and to amend point 4 of Part A of Chapter II of Annex II to Regulation (EC) No 854/2004 accordingly. |
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(7)

That tolerance does not represent a risk for public health provided that in the 10 % of samples, live bivalve molluscs do not exceed an upper limit of 46 000E. coli per 100 g of flesh and intravalvular liquid. It is therefore appropriate to retain this tolerance on a permanent basis. It is therefore appropriate to delete Article 17a of Regulation (EC) No 2076/2005 and to amend point 4 of Part A of Chapter II of Annex II to Regulation (EC) No 854/2004 accordingly.

| (8) | An opinion of the European Food Safety Authority adopted on 30 August 2004 on contaminants in the food chain related to the toxicity of fishery products belonging to the family of Gempylidae has demonstrated that fishery products belonging to that family, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may have adverse gastrointestinal effects if not consumed under certain conditions. Regulation (EC) No 854/2004 requires competent authorities in the Member States to carry out checks regarding the marketing conditions that food business operators must comply with in relation to fishery products belonging to the family of Gempylidae. |
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(8)

An opinion of the European Food Safety Authority adopted on 30 August 2004 on contaminants in the food chain related to the toxicity of fishery products belonging to the family of Gempylidae has demonstrated that fishery products belonging to that family, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may have adverse gastrointestinal effects if not consumed under certain conditions. Regulation (EC) No 854/2004 requires competent authorities in the Member States to carry out checks regarding the marketing conditions that food business operators must comply with in relation to fishery products belonging to the family of Gempylidae.

| (9) | Those conditions apply to fresh, prepared and processed fishery products derived from those species. However, similar risks for the consumer may be encountered with frozen fishery products derived from that family. It is therefore appropriate to require competent authorities to carry out checks also for frozen fishery products belonging to that family. |
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(9)

Those conditions apply to fresh, prepared and processed fishery products derived from those species. However, similar risks for the consumer may be encountered with frozen fishery products derived from that family. It is therefore appropriate to require competent authorities to carry out checks also for frozen fishery products belonging to that family.

| (10) | Regulations (EC) No 854/2004 and (EC) No 2076/2005 should therefore be amended accordingly. |
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(10)

Regulations (EC) No 854/2004 and (EC) No 2076/2005 should therefore be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I, II and III to Regulation (EC) No 854/2004 are amended in accordance with the Annex to this Regulation.

Article 2

In Regulation (EC) No 2076/2005, Articles 14 and 17a are deleted.

Article 3

Products of animal origin for which a health mark has been applied in accordance with point (c) of paragraph 3 of Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 before 1 November 2009 may be imported into the Community until 31 December 2009.

Article 4

This Regulation shall enter into force on the 10th day following its publication in the Official Journal of the European Union.

However, point 1(a) of the Annex to this Regulation shall apply from 1 November 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 October 2008.

For the Commission

Androulla VASSILIOU

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.

1

(2)  
  OJ L 338, 22.12.2005, p. 83.

2

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ANNEX

Annexes I, II and III to Regulation (EC) No 854/2004 are amended as follows:

| 1. | Annex I is amended as follows:






  (a) | In paragraph 3 of Chapter III of Section I, point (c) is replaced by the following:






  ‘(c) | when applied in a slaughterhouse located within the Community, the mark must include the abbreviation CE, EB, EC, EF, EG, EK, EO, EY, ES, EÜ, EK or WE.
  Those abbreviations must not be included in marks applied on meat imported into the Community from slaughterhouses located outside the Community.’ |
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1.

Annex I is amended as follows:

(a)

In paragraph 3 of Chapter III of Section I, point (c) is replaced by the following:

‘(c)

when applied in a slaughterhouse located within the Community, the mark must include the abbreviation CE, EB, EC, EF, EG, EK, EO, EY, ES, EÜ, EK or WE.

Those abbreviations must not be included in marks applied on meat imported into the Community from slaughterhouses located outside the Community.’

| (b) | In Part A of Chapter III of Section III, point (a) is replaced by the following:






  ‘(a) | Where the establishment has used good hygiene practice in accordance with Article 4(4) of this Regulation and the HACCP procedure for at least 12 months, the competent authority may authorise staff of the establishment to carry out tasks of official auxiliaries. This authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as the official auxiliaries for the tasks of official auxiliaries or for the specific tasks they are authorised to perform. This staff must be placed under the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veterinarian shall be present at ante-mortem and post-mortem examinations, shall supervise these activities and carry out regular performance tests to ensure that the performance of the slaughterhouse staff meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Where the level of hygiene of the establishment is affected by the work of this staff, where this staff does not carry out the tasks properly or where in general this staff carries out its work in a manner that the competent authority considers unsatisfactory, this staff shall be replaced by official auxiliaries.’ |
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(b)

In Part A of Chapter III of Section III, point (a) is replaced by the following:

‘(a)

Where the establishment has used good hygiene practice in accordance with Article 4(4) of this Regulation and the HACCP procedure for at least 12 months, the competent authority may authorise staff of the establishment to carry out tasks of official auxiliaries. This authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as the official auxiliaries for the tasks of official auxiliaries or for the specific tasks they are authorised to perform. This staff must be placed under the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veterinarian shall be present at ante-mortem and post-mortem examinations, shall supervise these activities and carry out regular performance tests to ensure that the performance of the slaughterhouse staff meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Where the level of hygiene of the establishment is affected by the work of this staff, where this staff does not carry out the tasks properly or where in general this staff carries out its work in a manner that the competent authority considers unsatisfactory, this staff shall be replaced by official auxiliaries.’

| 2. | In Part A of Chapter II of Annex II, point 4 is replaced by the following:






  ‘4. | The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected and only placed on the market for human consumption after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed, in 90 % of the samples, 4 600E. coli per 100 g of flesh and intravalvular liquid. In the remaining 10 % of samples, live bivalve molluscs must not exceed 46 000E. coli per 100 g of flesh and intravalvular liquid.
  The reference method for this analysis is the five-tube, three dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.’ |
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2.

In Part A of Chapter II of Annex II, point 4 is replaced by the following:

‘4.

The reference method for this analysis is the five-tube, three dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.’

| 3. | In Chapter II of Annex III, Part G is replaced by the following:
  ‘G.   POISONOUS FISHERY PRODUCTS
  Checks are to take place to ensure that:






  1. | fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae; |
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3.

In Chapter II of Annex III, Part G is replaced by the following:

‘G.   POISONOUS FISHERY PRODUCTS

Checks are to take place to ensure that:

1.

fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae;

| 2. | fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects. The scientific names of the fishery products and the common names must appear on the label; |
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2.

fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects. The scientific names of the fishery products and the common names must appear on the label;

| 3. | fishery products containing biotoxins such as ciguatera or other toxins dangerous to human health are not placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No 853/2004 and comply with the standards laid down in Chapter V, point 2, of that Section.’ |
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3.

fishery products containing biotoxins such as ciguatera or other toxins dangerous to human health are not placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No 853/2004 and comply with the standards laid down in Chapter V, point 2, of that Section.’

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