# L_2007280EN.01000501.xml

| 24.10.2007 | EN | Official Journal of the European Union | L 280/5 |
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24.10.2007

EN

Official Journal of the European Union

L 280/5

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COMMISSION REGULATION (EC) No 1237/2007

of 23 October 2007

amending Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Decision 2006/696/EC as regards the placing on the market of eggs from Salmonella infected flocks of laying hens

(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 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of Salmonella and other specified food-borne zoonotic agents (1) and, in particular Article 5(6) thereof,

Having regard to 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), and in particular Article 9 thereof,

Whereas:

| (1) | Regulation (EC) No 2160/2003 lays down rules to ensure that proper and effective measures are taken to detect and control Salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health. |
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(1)

Regulation (EC) No 2160/2003 lays down rules to ensure that proper and effective measures are taken to detect and control Salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health.

| (2) | Pursuant to Annex II to Regulation (EC) No 2160/2003, with effect from 72 months after the date of entry into force of that Regulation, eggs may only be used for direct human consumption as table eggs if they originate from a commercial flock of laying hens subject to a national control programme and not under official restriction. |
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(2)

Pursuant to Annex II to Regulation (EC) No 2160/2003, with effect from 72 months after the date of entry into force of that Regulation, eggs may only be used for direct human consumption as table eggs if they originate from a commercial flock of laying hens subject to a national control programme and not under official restriction.

| (3) | Commission Decision 2006/696/EC of 28 August 2006 laying down a list of third countries from which poultry, hatching eggs, day-old chicks, meat of poultry, ratites and wild game-birds, eggs and egg products and specified pathogen-free eggs may be imported into and transit through the Community and the applicable veterinary certification conditions, and amending Decisions 93/342/EEC, 2000/585/EC and 2003/812/EC (3) lays down veterinary certification conditions for imports and transit through the Community of eggs and egg products. |
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(3)

Commission Decision 2006/696/EC of 28 August 2006 laying down a list of third countries from which poultry, hatching eggs, day-old chicks, meat of poultry, ratites and wild game-birds, eggs and egg products and specified pathogen-free eggs may be imported into and transit through the Community and the applicable veterinary certification conditions, and amending Decisions 93/342/EEC, 2000/585/EC and 2003/812/EC (3) lays down veterinary certification conditions for imports and transit through the Community of eggs and egg products.

| (4) | A high prevalence of Salmonella Enteritidis and Salmonella Typhimurium was detected in flocks of laying hens in Member States during a study carried out in accordance with Commission Decision 2004/665/EC of 22 September 2004 concerning a baseline study on the prevalence of Salmonella in laying flocks of Gallus gallus (4). |
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(4)

A high prevalence of Salmonella Enteritidis and Salmonella Typhimurium was detected in flocks of laying hens in Member States during a study carried out in accordance with Commission Decision 2004/665/EC of 22 September 2004 concerning a baseline study on the prevalence of Salmonella in laying flocks of Gallus gallus (4).

| (5) | According to the Report of the European Food Safety Authority on Trends and Sources of Zoonoses, Zoonotic agents and Antimicrobial Resistance and Foodborne Outbreaks in the European Union in 2005 (5) eggs and egg products are the most important source of known foodborne outbreaks of salmonellosis in humans. In addition, according to that report, Salmonella Enteritidis and Salmonella Typhimurium were responsible for 88 % of the outbreaks where the serovar was demonstrated. |
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(5)

According to the Report of the European Food Safety Authority on Trends and Sources of Zoonoses, Zoonotic agents and Antimicrobial Resistance and Foodborne Outbreaks in the European Union in 2005 (5) eggs and egg products are the most important source of known foodborne outbreaks of salmonellosis in humans. In addition, according to that report, Salmonella Enteritidis and Salmonella Typhimurium were responsible for 88 % of the outbreaks where the serovar was demonstrated.

| (6) | In view of the high prevalence of Salmonella Enteritidis and Salmonella Typhimurium in certain Member States, its public health impact and the reluctance of food business operators to trade table eggs from infected flocks, the date on which restrictions on the consumption of table eggs are to apply, should be brought forward but should still allow food business operators sufficient time to comply with the new requirements without causing any disturbance to markets. |
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(6)

In view of the high prevalence of Salmonella Enteritidis and Salmonella Typhimurium in certain Member States, its public health impact and the reluctance of food business operators to trade table eggs from infected flocks, the date on which restrictions on the consumption of table eggs are to apply, should be brought forward but should still allow food business operators sufficient time to comply with the new requirements without causing any disturbance to markets.

| (7) | However, where a flock of laying hens has been indicated as the source of infection in a food borne outbreak as a result of the epidemiological investigation of food-borne outbreaks in accordance with Directive 2003/99/EC of the European Parliament and the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (6), the restrictions on the use of table eggs set out in Annex II to Regulation (EC) No 2160/2003 should apply without delay. |
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(7)

However, where a flock of laying hens has been indicated as the source of infection in a food borne outbreak as a result of the epidemiological investigation of food-borne outbreaks in accordance with Directive 2003/99/EC of the European Parliament and the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (6), the restrictions on the use of table eggs set out in Annex II to Regulation (EC) No 2160/2003 should apply without delay.

| (8) | Taking account of the public health risk of eggs infected with Salmonella, rules should be laid down on the marking of eggs to guarantee that eggs from flocks which are subject to restrictions within the framework of a Salmonella control programme provided for in Regulation (EC) No 2160/2003, are marked in a way which easily distinguishes them from table eggs before being placed on the market. |
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(8)

Taking account of the public health risk of eggs infected with Salmonella, rules should be laid down on the marking of eggs to guarantee that eggs from flocks which are subject to restrictions within the framework of a Salmonella control programme provided for in Regulation (EC) No 2160/2003, are marked in a way which easily distinguishes them from table eggs before being placed on the market.

| (9) | In order to exclude false-positive initial results, the competent authority should be allowed to lift the restrictions laid down in Paragraph 2 of Part D to Annex II of that Regulation if the Salmonella infection is not confirmed in the flocks of laying hens using a strict protocol. |
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(9)

In order to exclude false-positive initial results, the competent authority should be allowed to lift the restrictions laid down in Paragraph 2 of Part D to Annex II of that Regulation if the Salmonella infection is not confirmed in the flocks of laying hens using a strict protocol.

| (10) | Third countries, from which Member States are authorised to import eggs, should provide guarantees, equivalent to the requirements within the Community and the model certificate for eggs in Decision 2006/696/EC should be amended accordingly. |
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(10)

Third countries, from which Member States are authorised to import eggs, should provide guarantees, equivalent to the requirements within the Community and the model certificate for eggs in Decision 2006/696/EC should be amended accordingly.

| (11) | Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7), in particular Article 12 thereof, lays down rules concerning food and feed exported or re-exported from the Community for placing on the market in a third country. Those provisions apply to table eggs. Accordingly, it is not necessary to lay down specific provisions with regard to the export of such eggs in this Regulation. |
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(11)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7), in particular Article 12 thereof, lays down rules concerning food and feed exported or re-exported from the Community for placing on the market in a third country. Those provisions apply to table eggs. Accordingly, it is not necessary to lay down specific provisions with regard to the export of such eggs in this Regulation.

| (12) | To avoid any disturbance of trade, the use of certificates issued in accordance with the current model certificates set out in Decision 2006/696/EC should be allowed for a period of 60 days following the date of application of this Regulation. |
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(12)

To avoid any disturbance of trade, the use of certificates issued in accordance with the current model certificates set out in Decision 2006/696/EC should be allowed for a period of 60 days following the date of application of this Regulation.

| (13) | Regulation (EC) No 2160/2003 should therefore by amended accordingly. |
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(13)

Regulation (EC) No 2160/2003 should therefore by amended accordingly.

| (14) | 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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(14)

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

Annex II to Regulation (EC) No 2160/2003 is amended in accordance with Annex I to this Regulation.

Article 2

Annex II to Decision 2006/696/EC is amended in accordance with Annex II to this Regulation.

Article 3

Consignments of eggs for which certificates have been issued in accordance with Decision 2006/696/EC in its version before 1 November 2007 may be imported into the Community for a period of 60 days following that date.

Article 4

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

It shall apply from:

| — | 1 November 2007 where Salmonella ssp. are identified in the flock of laying hens as the source of infection for humans by the consumption of eggs or egg products as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC, |
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—

1 November 2007 where Salmonella ssp. are identified in the flock of laying hens as the source of infection for humans by the consumption of eggs or egg products as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC,

| — | 1 January 2009 at the latest to all other flocks of laying hens. |
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—

1 January 2009 at the latest to all other flocks of laying hens.

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

Done at Brussels, 23 October 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 325, 12.12.2003, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

1

(2)  
  OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22. Regulation as last amended by Regulation (EC) No 1791/2006.

2

(3)  
  OJ L 295, 25.10.2006, p. 1.

3

(4)  
  OJ L 303, 30.9.2004, p. 30.

4

(5)  The EFSA Journal (2006), 96.

5

(6)  
  OJ L 325, 12.12.2003, p. 31. Directive as amended by Council Directive 2006/104/EC (OJ L 363, 20.12.2006, p. 352).

6

(7)  
  OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

7

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ANNEX I

In Annex II to Regulation (EC) No 2160/2003, Part D is replaced by the following:

‘D.   Specific requirements concerning flocks of laying hens

| 1. | Eggs shall not be used for direct human consumption as table eggs unless they originate from a commercial flock of laying hens subject to a national control programme established under Article 5 and not under official restriction. |
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1.

| 2. | Eggs originating from flocks with unknown health status, that are suspected of being infected or that are infected with Salmonella serotypes for which a target for reduction has been set or which were identified as the source of infection in a specific human foodborne outbreak, may be used for human consumption only if treated in a manner that guarantees the destruction of all Salmonella serotypes with public health significance in accordance with Community legislation on food hygiene.
  Eggs originating from flocks with unknown health status, that are suspected of being infected or that are infected with Salmonella serotypes for which a target for reduction has been set or which were identified as the source of infection in a specific human foodborne outbreak, shall be:






  (a) | considered as Class B eggs as defined in Article 2(4) of Commission Regulation (EC) No 557/2007 laying down detailed rules for implementing Council Regulation (EC) No 1028/2006 on marketing standards for eggs (1); |
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2.

Eggs originating from flocks with unknown health status, that are suspected of being infected or that are infected with Salmonella serotypes for which a target for reduction has been set or which were identified as the source of infection in a specific human foodborne outbreak, shall be:

(a)

considered as Class B eggs as defined in Article 2(4) of Commission Regulation (EC) No 557/2007 laying down detailed rules for implementing Council Regulation (EC) No 1028/2006 on marketing standards for eggs (1);

| (b) | marked with the indication referred to in Article 10 of Commission Regulation (EC) No 557/2007 which clearly distinguishes them from Class A eggs prior to being placed on the market; |
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(b)

marked with the indication referred to in Article 10 of Commission Regulation (EC) No 557/2007 which clearly distinguishes them from Class A eggs prior to being placed on the market;

| (c) | prohibited access to packaging centres unless the competent authority is satisfied with the measures to prevent possible cross-contamination of eggs from other flocks. |
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(c)

prohibited access to packaging centres unless the competent authority is satisfied with the measures to prevent possible cross-contamination of eggs from other flocks.

| 3. | When birds from infected flocks are slaughtered or destroyed, steps must be taken to reduce the risk of spreading zoonoses as far as possible. Slaughtering shall be carried out in accordance with Community legislation on food hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with Community legislation on food hygiene and, once applicable, part E. If not destined for human consumption, such products must be used or disposed of in accordance with Regulation (EC) No 1774/2002. |
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3.

| 4. | In order to exclude false-positive initial results, the competent authority may lift the restrictions laid down in point 2 of this Part:






  (a) | when the flock of layers is not the source of infection for humans by the consumption of eggs or egg products as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC; and |
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4.

(a)

when the flock of layers is not the source of infection for humans by the consumption of eggs or egg products as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC; and

| (b) | where the flock is subjected to a national control programme established under Article 5 and Salmonella serotypes for which a target for reduction has been set, is not confirmed by the following sampling protocol carried out by the competent authority:






  (i) | the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC (seven samples); however, a sub-sample of 25 grams must be collected of each faecal material and dust sample for analysis; all samples must be analysed separately;
  or |
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(b)

where the flock is subjected to a national control programme established under Article 5 and Salmonella serotypes for which a target for reduction has been set, is not confirmed by the following sampling protocol carried out by the competent authority:

(i)

the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC (seven samples); however, a sub-sample of 25 grams must be collected of each faecal material and dust sample for analysis; all samples must be analysed separately;

or

| (ii) | bacteriological investigation of the caeca and oviducts of 300 birds;
  or |
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(ii)

bacteriological investigation of the caeca and oviducts of 300 birds;

or

| (iii) | bacteriological investigation of the shell and the content of 4 000 eggs of each flock in pools of maximum 40 eggs. |
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(iii)

bacteriological investigation of the shell and the content of 4 000 eggs of each flock in pools of maximum 40 eggs.

In addition to the sampling in point (b), the competent authority shall verify the absence of the use of antimicrobials, potentially affecting the result of the analyses of the sampling.

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(1)  
  OJ L 132, 24.5.2007, p. 5.’
  ’

1

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ANNEX II

In Part 2 of Annex II to Decision 2006/696/EC, the model veterinary certificate for eggs (E) is replaced by the following:

‘Model veterinary certificate for eggs (E)

Image 1

Part I : Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel. No

I.2. Certificate reference number

I.2.a.

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel. No

I.6.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification:

Documentary references:

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

04.07

I.20. Quantity

I.21. Temperature of product

Ambient

Chilled

Frozen

I.22. Number of packages

I.23. Identification of container/Seal number

I.24. Type of packaging

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Approval number of establishments

Species (Scientific name)

Manufacturing plant

Cold store

Number of packages

Net weight

Image 2

Part II: Certification

E (Eggs)

II. Health information

II.a. Certificate reference number

II.b.

II.1. Health attestation

I, the undersigned official veterinarian/official inspector, declare that I am aware of the relevant provisions of Regulations (EC) Nos 178/2002, 852/2004, 853/2004 and 2160/2003 and hereby certify that the eggs described in this certificate have been obtained in accordance with those requirements, and in particular that:

II.1.1. they come from (an) establishments(s) implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004;

II.1.2. they have been kept, stored, transported and delivered in accordance with the relevant conditions laid down in Section X, Chapter I of Annex III to Regulation (EC) No 853/2004;

(1) II.1.3. they fulfil the requirements of Commission Regulation (EC) No 1688/2005 of 14 October 2005 implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning Salmonella for consignments to Finland and Sweden of certain meat and eggs;

II.1.4. the guarantees covering live animals and products thereof provided by the residue plans submitted in accordance with Directive 96/23/EC, and in particular Article 29 thereof, are fulfilled.

(2) II.1.5. they fulfil the requirements in Article 10(6) of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of Salmonella and other specified food-borne zoonotic agents. In particular:

Eggs shall not be imported from flocks of laying hens in which Salmonella ssp. has been detected a result of the epidemiological investigation of a food-borne outbreak or if no equivalent guarantees have been provided.

[From 1 January 2009 on, eggs shall also not be imported from flocks of laying hens with unknown health status, that are suspected of being infected or from flocks infected by Salmonella ssp. for which a target for reduction has been set in Community legislation (3) and on which monitoring equivalent to the monitoring laid down in the provisions in the Annex of Regulation (EC) No 1168/2006 is not applied, or if no equivalent guarantees have been provided.]

Notes

Part I:

Box I.8: provide the code for the region of origin, if necessary, as defined under code of territory in column 2, Part 1 of Annex II of Decision 2006/696/EC [as last amended].

Box I.11: Name, address and approval number of establishment of dispatch.

Box I.15: Indicate the registration number(s) of railway wagons and lorries, the names of ships and, if known, the flight numbers of aircraft. In the case of transport in containers or boxes, the total number of these and their registration and seal numbers, where applicable, should be indicated in box I.23.

Part II:

(1) Delete if the consignment is not intended for export to Sweden or Finland.

(2) Only applicable in case of import of eggs, Class A in accordance with Article 3 of Regulation (EC) No 1028/2006. Delete as appropriate.

(3) Salmonella Enteritidis and Salmonella Typhimurium

Official veterinarian or official inspector

Name (in capitals):

Qualification and title:

Local competent authority:

Date:

Stamp:

Signature:’

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