# Official Journal L 226/25 J

| | ISSN 1725-2555 |
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| Official Journal
  of the European Union | L 226 |
| | |
| English edition | Legislation | Volume 4725 June 2004 |

ISSN 1725-2555

Official Journal

of the European Union

L 226

English edition

Legislation

Volume 4725 June 2004

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| Contents | | | page |
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| | * | Notice to readers | 1 |

Contents

page

*

Notice to readers

1

| | | Corrigenda |
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| | * | Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004 ) | 3 |
| | * | Corrigendum 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 ( OJ L 139, 30.4.2004 ) | 22 |
| | * | Corrigendum 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 ( OJ L 139, 30.4.2004 ) | 83 |
| | * | Corrigendum to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC ( OJ L 139, 30.4.2004 ) (
  1
  ) | 128 |

Corrigenda

*

Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004 )

3

*

Corrigendum 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 ( OJ L 139, 30.4.2004 )

22

*

Corrigendum 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 ( OJ L 139, 30.4.2004 )

83

*

Corrigendum to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC ( OJ L 139, 30.4.2004 ) (
  1
  )

1

128

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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25.6.2004

| 25.6.2004 | EN | Official Journal of the European Union | L 226/1 |
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EN

Official Journal of the European Union

L 226/1

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NOTICE TO READERS

| ES: | El presente Diario Oficial se publica en español, danés, alemán, griego, inglés, francés, italiano, neerlandés, portugués, finés y sueco.
  Las correcciones de errores que contiene se refieren a los actos publicados con anterioridad a la ampliación de la Unión Europea del 1 de mayo de 2004. |
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ES:

El presente Diario Oficial se publica en español, danés, alemán, griego, inglés, francés, italiano, neerlandés, portugués, finés y sueco.

Las correcciones de errores que contiene se refieren a los actos publicados con anterioridad a la ampliación de la Unión Europea del 1 de mayo de 2004.

| CS: | Tento Úřední věstník se vydává ve španělštině, dánštině, němčině, řečtině, angličtině, francouzštině, italštině, holandštině, portugalštině, finštině a švédštině.
  Tisková oprava zde uvedená se vztahuje na akty uveřejněné před rozšířením Evropské unie dne 1. května 2004. |
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CS:

Tento Úřední věstník se vydává ve španělštině, dánštině, němčině, řečtině, angličtině, francouzštině, italštině, holandštině, portugalštině, finštině a švédštině.

Tisková oprava zde uvedená se vztahuje na akty uveřejněné před rozšířením Evropské unie dne 1. května 2004.

| DA: | Denne EU-Tidende offentliggøres på dansk, engelsk, finsk, fransk, græsk, italiensk, nederlandsk, portugisisk, spansk, svensk og tysk.
  Berigtigelserne heri henviser til retsakter, som blev offentliggjort før udvidelsen af Den Europæiske Union den 1. maj 2004. |
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DA:

Denne EU-Tidende offentliggøres på dansk, engelsk, finsk, fransk, græsk, italiensk, nederlandsk, portugisisk, spansk, svensk og tysk.

Berigtigelserne heri henviser til retsakter, som blev offentliggjort før udvidelsen af Den Europæiske Union den 1. maj 2004.

| DE: | Dieses Amtsblatt wird in Spanisch, Dänisch, Deutsch, Griechisch, Englisch, Französisch, Italienisch, Niederländisch, Portugiesisch, Finnisch und Schwedisch veröffentlicht.
  Die darin enthaltenen Berichtigungen beziehen sich auf Rechtsakte, die vor der Erweiterung der Europäischen Union am 1. Mai 2004 veröffentlicht wurden. |
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DE:

Dieses Amtsblatt wird in Spanisch, Dänisch, Deutsch, Griechisch, Englisch, Französisch, Italienisch, Niederländisch, Portugiesisch, Finnisch und Schwedisch veröffentlicht.

Die darin enthaltenen Berichtigungen beziehen sich auf Rechtsakte, die vor der Erweiterung der Europäischen Union am 1. Mai 2004 veröffentlicht wurden.

| ET: | Käesolev Euroopa Liidu Teataja ilmub hispaania, taani, saksa, kreeka, inglise, prantsuse, itaalia, hollandi, portugali, soome ja rootsi keeles.
  Selle parandused viitavad aktidele, mis on avaldatud enne Euroopa Liidu laienemist 1. mail 2004. |
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ET:

Käesolev Euroopa Liidu Teataja ilmub hispaania, taani, saksa, kreeka, inglise, prantsuse, itaalia, hollandi, portugali, soome ja rootsi keeles.

Selle parandused viitavad aktidele, mis on avaldatud enne Euroopa Liidu laienemist 1. mail 2004.

| EL: | Η παρούσα Επίσημη Εφημερίδα δημοσιεύεται στην ισπανική, δανική, γερμανική, ελληνική, αγγλική, γαλλική, ιταλική, ολλανδική, πορτογαλική, φινλανδική και σουηδική γλώσσα.
  Τα διορθωτικά που περιλαμβάνει αναφέρονται σε πράξεις που δημοσιεύθηκαν πριν από τη διεύρυνση της Ευρωπαϊκής Ένωσης την 1η Μαΐου 2004. |
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EL:

Η παρούσα Επίσημη Εφημερίδα δημοσιεύεται στην ισπανική, δανική, γερμανική, ελληνική, αγγλική, γαλλική, ιταλική, ολλανδική, πορτογαλική, φινλανδική και σουηδική γλώσσα.

Τα διορθωτικά που περιλαμβάνει αναφέρονται σε πράξεις που δημοσιεύθηκαν πριν από τη διεύρυνση της Ευρωπαϊκής Ένωσης την 1η Μαΐου 2004.

| EN: | This Official Journal is published in Spanish, Danish, German, Greek, English, French, Italian, Dutch, Portuguese, Finnish and Swedish.
  The corrigenda contained herein refer to acts published prior to enlargement of the European Union on 1 May 2004. |
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EN:

This Official Journal is published in Spanish, Danish, German, Greek, English, French, Italian, Dutch, Portuguese, Finnish and Swedish.

The corrigenda contained herein refer to acts published prior to enlargement of the European Union on 1 May 2004.

| FR: | Le présent Journal officiel est publié dans les langues espagnole, danoise, allemande, grecque, anglaise, française, italienne, néerlandaise, portugaise, finnoise et suédoise.
  Les rectificatifs qu'il contient se rapportent à des actes publiés antérieurement à l'élargissement de l'Union européenne du 1er mai 2004. |
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FR:

Le présent Journal officiel est publié dans les langues espagnole, danoise, allemande, grecque, anglaise, française, italienne, néerlandaise, portugaise, finnoise et suédoise.

Les rectificatifs qu'il contient se rapportent à des actes publiés antérieurement à l'élargissement de l'Union européenne du 1er mai 2004.

| IT: | La presente Gazzetta ufficiale è pubblicata nelle lingue spagnola, danese, tedesca, greca, inglese, francese, italiana, olandese, portoghese, finlandese e svedese.
  Le rettifiche che essa contiene si riferiscono ad atti pubblicati anteriormente all'allargamento dell'Unione europea del 1o maggio 2004. |
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IT:

La presente Gazzetta ufficiale è pubblicata nelle lingue spagnola, danese, tedesca, greca, inglese, francese, italiana, olandese, portoghese, finlandese e svedese.

Le rettifiche che essa contiene si riferiscono ad atti pubblicati anteriormente all'allargamento dell'Unione europea del 1o maggio 2004.

| LV: | Šis Oficiālais Vēstnesis publicēts spāņu, dāņu, vācu, grieķu, angļu, franču, itāļu, holandiešu, portugāļu, somu un zviedru valodā.
  Šeit minētie labojumi attiecas uz tiesību aktiem, kas publicēti pirms Eiropas Savienības paplašināšanās 2004. gada 1. maijā. |
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LV:

Šis Oficiālais Vēstnesis publicēts spāņu, dāņu, vācu, grieķu, angļu, franču, itāļu, holandiešu, portugāļu, somu un zviedru valodā.

Šeit minētie labojumi attiecas uz tiesību aktiem, kas publicēti pirms Eiropas Savienības paplašināšanās 2004. gada 1. maijā.

| LT: | Šis Oficialusis leidinys išleistas ispanų, danų, vokiečių, graikų, anglų, prancūzų, italų, olandų, portugalų, suomių ir švedų kalbomis.
  Čia išspausdintas teisės aktų, paskelbtų iki Europos Sąjungos plėtros gegužės 1 d., klaidų ištaisymas. |
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LT:

Šis Oficialusis leidinys išleistas ispanų, danų, vokiečių, graikų, anglų, prancūzų, italų, olandų, portugalų, suomių ir švedų kalbomis.

Čia išspausdintas teisės aktų, paskelbtų iki Europos Sąjungos plėtros gegužės 1 d., klaidų ištaisymas.

| HU: | Ez a Hivatalos Lap spanyol, dán, német, görög, angol, francia, olasz, holland, portugál, finn és svéd nyelven jelenik meg.
  Az itt megjelent helyesbítések elsősorban a 2004. május 1-jei európai uniós bővítéssel kapcsolatos jogszabályokra vonatkoznak. |
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HU:

Ez a Hivatalos Lap spanyol, dán, német, görög, angol, francia, olasz, holland, portugál, finn és svéd nyelven jelenik meg.

Az itt megjelent helyesbítések elsősorban a 2004. május 1-jei európai uniós bővítéssel kapcsolatos jogszabályokra vonatkoznak.

| MT: | Dan il-Ġurnal Uffiċjali hu ppubblikat fil-ligwa Spanjola, Daniża, Ġermaniża, Griega, Ingliża, Franċiża, Taljana, Olandiża, Portugiża, Finlandiża u Svediża.
  Il-corrigenda li tinstab hawnhekk tirreferi għal atti ppubblikati qabel it-tkabbir ta’ l-Unjoni Ewropea fl-1 ta' Mejju 2004. |
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MT:

Dan il-Ġurnal Uffiċjali hu ppubblikat fil-ligwa Spanjola, Daniża, Ġermaniża, Griega, Ingliża, Franċiża, Taljana, Olandiża, Portugiża, Finlandiża u Svediża.

Il-corrigenda li tinstab hawnhekk tirreferi għal atti ppubblikati qabel it-tkabbir ta’ l-Unjoni Ewropea fl-1 ta' Mejju 2004.

| NL: | Dit Publicatieblad wordt uitgegeven in de Spaanse, de Deens, de Duitse, de Griekse, de Engelse, de Franse, de Italiaanse, de Nederlandse, de Portugese, de Finse en de Zweedse taal.
  De rectificaties in dit Publicatieblad hebben betrekking op besluiten die vóór de uitbreiding van de Europese Unie op 1 mei 2004 zijn gepubliceerd. |
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NL:

Dit Publicatieblad wordt uitgegeven in de Spaanse, de Deens, de Duitse, de Griekse, de Engelse, de Franse, de Italiaanse, de Nederlandse, de Portugese, de Finse en de Zweedse taal.

De rectificaties in dit Publicatieblad hebben betrekking op besluiten die vóór de uitbreiding van de Europese Unie op 1 mei 2004 zijn gepubliceerd.

| PL: | Ten Dziennik Urzędowy jest wydawany w językach: hiszpańskim, duńskim, niemieckim, greckim, angielskim, francuskim, włoskim, niderlandzkim, portugalskim, fińskim i szwedzkim.
  Sprostowania zawierają odniesienia do aktów opublikowanych przed rozszerzeniem Unii Europejskiej dnia 1 maja 2004 r. |
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PL:

Ten Dziennik Urzędowy jest wydawany w językach: hiszpańskim, duńskim, niemieckim, greckim, angielskim, francuskim, włoskim, niderlandzkim, portugalskim, fińskim i szwedzkim.

Sprostowania zawierają odniesienia do aktów opublikowanych przed rozszerzeniem Unii Europejskiej dnia 1 maja 2004 r.

| PT: | O presente Jornal Oficial é publicado nas línguas espanhola, dinamarquesa, alemã, grega, inglesa, francesa, italiana, neerlandesa, portuguesa, finlandesa e sueca.
  As rectificações publicadas neste Jornal Oficial referem-se a actos publicados antes do alargamento da União Europeia de 1 de Maio de 2004. |
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PT:

O presente Jornal Oficial é publicado nas línguas espanhola, dinamarquesa, alemã, grega, inglesa, francesa, italiana, neerlandesa, portuguesa, finlandesa e sueca.

As rectificações publicadas neste Jornal Oficial referem-se a actos publicados antes do alargamento da União Europeia de 1 de Maio de 2004.

| SK: | Tento úradný vestník vychádza v španielskom, dánskom, nemeckom, gréckom, anglickom, francúzskom, talianskom, holandskom, portugalskom, fínskom a švédskom jazyku.
  Korigendá, ktoré obsahuje, odkazujú na akty uverejnené pred rozšírením Európskej únie 1. mája 2004. |
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SK:

Tento úradný vestník vychádza v španielskom, dánskom, nemeckom, gréckom, anglickom, francúzskom, talianskom, holandskom, portugalskom, fínskom a švédskom jazyku.

Korigendá, ktoré obsahuje, odkazujú na akty uverejnené pred rozšírením Európskej únie 1. mája 2004.

| SL: | Ta Uradni list je objavljen v španskem, danskem, nemškem, grškem, angleškem, francoskem, italijanskem, nizozemskem, portugalskem, finskem in švedskem jeziku.
  Vsebovani popravki se nanašajo na akte objavljene pred širitvijo Evropske unije 1. maja 2004. |
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SL:

Ta Uradni list je objavljen v španskem, danskem, nemškem, grškem, angleškem, francoskem, italijanskem, nizozemskem, portugalskem, finskem in švedskem jeziku.

Vsebovani popravki se nanašajo na akte objavljene pred širitvijo Evropske unije 1. maja 2004.

| FI: | Tämä virallinen lehti on julkaistu espanjan, tanskan, saksan, kreikan, englannin, ranskan, italian, hollannin, portugalin, suomen ja ruotsin kielellä. Lehden sisältämät oikaisut liittyvät ennen Euroopan unionin laajentumista 1. toukokuuta 2004 julkaistuihin säädöksiin. |
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FI:

Tämä virallinen lehti on julkaistu espanjan, tanskan, saksan, kreikan, englannin, ranskan, italian, hollannin, portugalin, suomen ja ruotsin kielellä. Lehden sisältämät oikaisut liittyvät ennen Euroopan unionin laajentumista 1. toukokuuta 2004 julkaistuihin säädöksiin.

| SV: | Denna utgåva av Europeiska unionens officiella tidning publiceras på spanska, danska, tyska, grekiska, engelska, franska, italienska, nederländska, portugisiska, finska och svenska.
  Rättelserna som den innehåller avser rättsakter som publicerades före utvidgningen av Europeiska unionen den 1 maj 2004. |
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SV:

Denna utgåva av Europeiska unionens officiella tidning publiceras på spanska, danska, tyska, grekiska, engelska, franska, italienska, nederländska, portugisiska, finska och svenska.

Rättelserna som den innehåller avser rättsakter som publicerades före utvidgningen av Europeiska unionen den 1 maj 2004.

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Corrigenda

| 25.6.2004 | EN | Official Journal of the European Union | L 226/3 |
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25.6.2004

EN

Official Journal of the European Union

L 226/3

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Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

(
  Official Journal of the European Union L 139 of 30 April 2004
  )

Regulation (EC) No 852/2004 should read as follows:

REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 29 April 2004

on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

| (1) | The pursuit of a high level of protection of human life and health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 (4). That Regulation also lays down other common principles and definitions for national and Community food law, including the aim of achieving free movement of food within the Community. |
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(1)

The pursuit of a high level of protection of human life and health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 (4). That Regulation also lays down other common principles and definitions for national and Community food law, including the aim of achieving free movement of food within the Community.

| (2) | Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (5) laid down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with these rules. |
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(2)

Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (5) laid down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with these rules.

| (3) | Experience has shown that these rules and procedures constitute a sound basis for ensuring food safety. In the context of the common agricultural policy, many directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health. |
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(3)

Experience has shown that these rules and procedures constitute a sound basis for ensuring food safety. In the context of the common agricultural policy, many directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

| (4) | With regard to public health, these rules and procedures contain common principles, in particular in relation to the manufacturers ‘and competent authorities’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks. |
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(4)

With regard to public health, these rules and procedures contain common principles, in particular in relation to the manufacturers ‘and competent authorities’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

| (5) | These principles constitute a common basis for the hygienic production of all food, including products of animal origin listed in Annex I to the Treaty. |
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(5)

These principles constitute a common basis for the hygienic production of all food, including products of animal origin listed in Annex I to the Treaty.

| (6) | In addition to this common basis, specific hygiene rules are necessary for certain foodstuffs. 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 (6) lays down these rules. |
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(6)

In addition to this common basis, specific hygiene rules are necessary for certain foodstuffs. 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 (6) lays down these rules.

| (7) | The principal objective of the new general and specific hygiene rules is to ensure a high level of consumer protection with regard to food safety. |
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(7)

The principal objective of the new general and specific hygiene rules is to ensure a high level of consumer protection with regard to food safety.

| (8) | An integrated approach is necessary to ensure food safety from the place of primary production up to and including placing on the market or export. Every food business operator along the food chain should ensure that food safety is not compromised. |
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(8)

An integrated approach is necessary to ensure food safety from the place of primary production up to and including placing on the market or export. Every food business operator along the food chain should ensure that food safety is not compromised.

| (9) | Community rules should not apply either to primary production for private domestic use, or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, they should apply only to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation. |
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(9)

Community rules should not apply either to primary production for private domestic use, or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, they should apply only to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation.

| (10) | Food hazards present at the level of primary production should be identified and adequately controlled to ensure the achievement of the objectives of this Regulation. However, in the case of the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer. |
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(10)

Food hazards present at the level of primary production should be identified and adequately controlled to ensure the achievement of the objectives of this Regulation. However, in the case of the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

| (11) | The application of hazard analysis and critical control point (HACCP) principles to primary production is not yet generally feasible. However, guides to good practice should encourage the use of appropriate hygiene practices at farm level. Where necessary, specific hygiene rules for primary production should supplement these guides. It is appropriate for the hygiene requirements applicable to primary production and associated operations to differ from those for other operations. |
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(11)

The application of hazard analysis and critical control point (HACCP) principles to primary production is not yet generally feasible. However, guides to good practice should encourage the use of appropriate hygiene practices at farm level. Where necessary, specific hygiene rules for primary production should supplement these guides. It is appropriate for the hygiene requirements applicable to primary production and associated operations to differ from those for other operations.

| (12) | Food safety is a result of several factors: legislation should lay down minimum hygiene requirements; official controls should be in place to check food business operators' compliance and food business operators should establish and operate food safety programmes and procedures based on the HACCP principles. |
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(12)

Food safety is a result of several factors: legislation should lay down minimum hygiene requirements; official controls should be in place to check food business operators' compliance and food business operators should establish and operate food safety programmes and procedures based on the HACCP principles.

| (13) | Successful implementation of the procedures based on the HACCP principles will require the full cooperation and commitment of food business employees. To this end, employees should undergo training. The HACCP system is an instrument to help food business operators attain a higher standard of food safety. The HACCP system should not be regarded as a method of self-regulation and should not replace official controls. |
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(13)

Successful implementation of the procedures based on the HACCP principles will require the full cooperation and commitment of food business employees. To this end, employees should undergo training. The HACCP system is an instrument to help food business operators attain a higher standard of food safety. The HACCP system should not be regarded as a method of self-regulation and should not replace official controls.

| (14) | While the requirement of establishing procedures based on the HACCP principles should not initially apply to primary production, the feasibility of its extension will be one element of the review that the Commission will carry out following implementation of this Regulation. It is, however, appropriate for Member States to encourage operators at the level of primary production to apply such principles as far as possible. |
| --- | --- |

(14)

While the requirement of establishing procedures based on the HACCP principles should not initially apply to primary production, the feasibility of its extension will be one element of the review that the Commission will carry out following implementation of this Regulation. It is, however, appropriate for Member States to encourage operators at the level of primary production to apply such principles as far as possible.

| (15) | The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing ‘critical limits’ does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses. |
| --- | --- |

(15)

The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing ‘critical limits’ does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses.

| (16) | Flexibility is also appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002. |
| --- | --- |

(16)

Flexibility is also appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002.

| (17) | The setting of objectives such as pathogen reduction targets or performance standards may guide the implementation of hygiene rules. It is therefore necessary to provide procedures for that purpose. Such objectives would supplement existing food law, such as Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (7), which provides for the establishment of maximum tolerances for specific contaminants, and Regulation (EC) No 178/2002, which prohibits the placing on the market of unsafe food and provides a uniform basis for the use of the precautionary principle. |
| --- | --- |

(17)

The setting of objectives such as pathogen reduction targets or performance standards may guide the implementation of hygiene rules. It is therefore necessary to provide procedures for that purpose. Such objectives would supplement existing food law, such as Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (7), which provides for the establishment of maximum tolerances for specific contaminants, and Regulation (EC) No 178/2002, which prohibits the placing on the market of unsafe food and provides a uniform basis for the use of the precautionary principle.

| (18) | To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. This Regulation takes account of international obligations laid down in the WTO Sanitary and Phytosanitary Agreement and the international food safety standards contained in the Codex Alimentarius. |
| --- | --- |

(18)

To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. This Regulation takes account of international obligations laid down in the WTO Sanitary and Phytosanitary Agreement and the international food safety standards contained in the Codex Alimentarius.

| (19) | The registration of establishments and the cooperation of food business operators are necessary to allow the competent authorities to perform official controls efficiently. |
| --- | --- |

(19)

The registration of establishments and the cooperation of food business operators are necessary to allow the competent authorities to perform official controls efficiently.

| (20) | The traceability of food and food ingredients along the food chain is an essential element in ensuring food safety. Regulation (EC) No 178/2002 contains rules to ensure the traceability of food and food ingredients and provides a procedure for the adoption of implementing rules to apply these principles in respect of specific sectors. |
| --- | --- |

(20)

The traceability of food and food ingredients along the food chain is an essential element in ensuring food safety. Regulation (EC) No 178/2002 contains rules to ensure the traceability of food and food ingredients and provides a procedure for the adoption of implementing rules to apply these principles in respect of specific sectors.

| (21) | Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to Community rules. The present Regulation defines certain specific hygiene requirements for food imported into the Community. |
| --- | --- |

(21)

Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to Community rules. The present Regulation defines certain specific hygiene requirements for food imported into the Community.

| (22) | Food exported to third countries from the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002. The present Regulation defines certain specific hygiene requirements for food exported from the Community. |
| --- | --- |

(22)

Food exported to third countries from the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002. The present Regulation defines certain specific hygiene requirements for food exported from the Community.

| (23) | Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary. |
| --- | --- |

(23)

Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

| (24) | Since this Regulation replaces Directive 93/43/EEC, the latter should be repealed. |
| --- | --- |

(24)

Since this Regulation replaces Directive 93/43/EEC, the latter should be repealed.

| (25) | The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the affected industries time to adapt. |
| --- | --- |

(25)

The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the affected industries time to adapt.

| (26) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8), |
| --- | --- |

(26)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.   This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

| (a) | primary responsibility for food safety rests with the food business operator; |
| --- | --- |

(a)

primary responsibility for food safety rests with the food business operator;

| (b) | it is necessary to ensure food safety throughout the food chain, starting with primary production; |
| --- | --- |

(b)

it is necessary to ensure food safety throughout the food chain, starting with primary production;

| (c) | it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain; |
| --- | --- |

(c)

it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;

| (d) | general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility; |
| --- | --- |

(d)

general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility;

| (e) | guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles; |
| --- | --- |

(e)

guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles;

| (f) | it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment; |
| --- | --- |

(f)

it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment;

| (g) | it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard. |
| --- | --- |

(g)

it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard.

This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.

2.   This Regulation shall not apply to:

| (a) | primary production for private domestic use; |
| --- | --- |

(a)

primary production for private domestic use;

| (b) | the domestic preparation, handling or storage of food for private domestic consumption; |
| --- | --- |

(b)

the domestic preparation, handling or storage of food for private domestic consumption;

| (c) | the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; |
| --- | --- |

(c)

the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

| (d) | collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen. |
| --- | --- |

(d)

collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.

3.   Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation.

Article 2

Definitions

1.   For the purposes of this Regulation:

| (a) | ‘food hygiene’, hereinafter called ‘hygiene’, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use; |
| --- | --- |

(a)

‘food hygiene’, hereinafter called ‘hygiene’, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use;

| (b) | ‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing; |
| --- | --- |

(b)

‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing;

| (c) | ‘establishment’ means any unit of a food business; |
| --- | --- |

(c)

‘establishment’ means any unit of a food business;

| (d) | ‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country; |
| --- | --- |

(d)

‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country;

| (e) | ‘equivalent’ means, in respect of different systems, capable of meeting the same objectives; |
| --- | --- |

(e)

‘equivalent’ means, in respect of different systems, capable of meeting the same objectives;

| (f) | ‘contamination’ means the presence or introduction of a hazard; |
| --- | --- |

(f)

‘contamination’ means the presence or introduction of a hazard;

| (g) | ‘potable water’ means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (9); |
| --- | --- |

(g)

‘potable water’ means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (9);

| (h) | ‘clean seawater’ means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food; |
| --- | --- |

(h)

‘clean seawater’ means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food;

| (i) | ‘clean water’ means clean seawater and fresh water of a similar quality; |
| --- | --- |

(i)

‘clean water’ means clean seawater and fresh water of a similar quality;

| (j) | ‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself; |
| --- | --- |

(j)

‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself;

| (k) | ‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself; |
| --- | --- |

(k)

‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;

| (l) | ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards; |
| --- | --- |

(l)

‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards;

| (m) | ‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes; |
| --- | --- |

(m)

‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes;

| (n) | ‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed; |
| --- | --- |

(n)

‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed;

| (o) | ‘processed products’ means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics. |
| --- | --- |

(o)

‘processed products’ means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.

2.   The definitions laid down in Regulation (EC) No 178/2002 shall also apply.

3.   In the Annexes to this Regulation the terms ‘where necessary’, ‘where appropriate’, ‘adequate’ and ‘sufficient’ shall mean respectively where necessary, where appropriate, adequate or sufficient to achieve the objectives of this Regulation.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligation

Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

Article 4

General and specific hygiene requirements

1.   Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in part A of Annex I and any specific requirements provided for in Regulation (EC) No 853/2004.

2.   Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No 853/2004.

3.   Food business operators shall, as appropriate, adopt the following specific hygiene measures:

| (a) | compliance with microbiological criteria for foodstuffs; |
| --- | --- |

(a)

compliance with microbiological criteria for foodstuffs;

| (b) | procedures necessary to meet targets set to achieve the objectives of this Regulation; |
| --- | --- |

(b)

procedures necessary to meet targets set to achieve the objectives of this Regulation;

| (c) | compliance with temperature control requirements for foodstuffs; |
| --- | --- |

(c)

compliance with temperature control requirements for foodstuffs;

| (d) | maintenance of the cold chain; |
| --- | --- |

(d)

maintenance of the cold chain;

| (e) | sampling and analysis. |
| --- | --- |

(e)

sampling and analysis.

4.   The criteria, requirements and targets referred to in paragraph 3 shall be adopted in accordance with the procedure referred to in Article 14(2).

Associated sampling and analysis methods shall be laid down in accordance with the same procedure.

5.   When this Regulation, Regulation (EC) No 853/2004 and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other Community or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.

6.   Food business operators may use the guides provided for in Articles 7, 8 and 9 as an aid to compliance with their obligations under this Regulation.

Article 5

Hazard analysis and critical control points

1.   Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.

2.   The HACCP principles referred to in paragraph 1 consist of the following:

| (a) | identifying any hazards that must be prevented, eliminated or reduced to acceptable levels; |
| --- | --- |

(a)

identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;

| (b) | identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; |
| --- | --- |

(b)

identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

| (c) | establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; |
| --- | --- |

(c)

establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;

| (d) | establishing and implementing effective monitoring procedures at critical control points; |
| --- | --- |

(d)

establishing and implementing effective monitoring procedures at critical control points;

| (e) | establishing corrective actions when monitoring indicates that a critical control point is not under control; |
| --- | --- |

(e)

establishing corrective actions when monitoring indicates that a critical control point is not under control;

| (f) | establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively;
  and |
| --- | --- |

(f)

establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively;

and

| (g) | establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f). |
| --- | --- |

(g)

establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f).

When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.

3.   Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.

4.   Food business operators shall:

| (a) | provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business; |
| --- | --- |

(a)

provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business;

| (b) | ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times; |
| --- | --- |

(b)

ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times;

| (c) | retain any other documents and records for an appropriate period. |
| --- | --- |

(c)

retain any other documents and records for an appropriate period.

5.   Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2). Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1. Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c).

Article 6

Official controls, registration and approval

1.   Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.

2.   In particular, every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.

Food business operators shall also ensure that the competent authority always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment.

3.   However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required:

| (a) | under the national law of the Member State in which the establishment is located; |
| --- | --- |

(a)

under the national law of the Member State in which the establishment is located;

| (b) | under Regulation (EC) No 853/2004;
  or |
| --- | --- |

(b)

under Regulation (EC) No 853/2004;

or

| (c) | by a decision adopted in accordance with the procedure referred to in Article 14(2). |
| --- | --- |

(c)

by a decision adopted in accordance with the procedure referred to in Article 14(2).

Any Member State requiring the approval of certain establishments located on its territory under national law, as provided for in subparagraph (a), shall inform the Commission and other Member States of the relevant national rules.

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 7

Development, dissemination and use of guides

Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles in accordance with Article 8. Community guides shall be developed in accordance with Article 9.

The dissemination and use of both national and Community guides shall be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis.

Article 8

National guides

1.   When national guides to good practice are developed, they shall be developed and disseminated by food business sectors:

| (a) | in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and consumer groups; |
| --- | --- |

(a)

in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and consumer groups;

| (b) | having regard to relevant codes of practice of the Codex Alimentarius;
  and |
| --- | --- |

(b)

having regard to relevant codes of practice of the Codex Alimentarius;

and

| (c) | when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I. |
| --- | --- |

(c)

when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.

2.   National guides may be developed under the aegis of a national standards institute referred to in Annex II to Directive 98/34/EC (10).

3.   Member States shall assess national guides in order to ensure that:

| (a) | they have been developed in accordance with paragraph 1; |
| --- | --- |

(a)

they have been developed in accordance with paragraph 1;

| (b) | their contents are practicable for the sectors to which they refer;
  and |
| --- | --- |

(b)

their contents are practicable for the sectors to which they refer;

and

| (c) | they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered. |
| --- | --- |

(c)

they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.

4.   Member States shall forward to the Commission national guides complying with the requirements of paragraph 3. The Commission shall set up and run a registration system for such guides and make it available to Member States.

5.   Guides to good practice drawn up pursuant to Directive 93/43/EEC shall continue to apply after the entry into force of this Regulation, provided that they are compatible with its objectives.

Article 9

Community guides

1.   Before Community guides to good practice for hygiene or for the application of the HACCP principles are developed, the Commission shall consult the Committee referred to in Article 14. The objective of this consultation shall be to consider the case for such guides, their scope and subject matter.

2.   When Community guides are prepared, the Commission shall ensure that they are developed and disseminated:

| (a) | by or in consultation with appropriate representatives of European food business sectors, including SMEs, and other interested parties, such as consumer groups; |
| --- | --- |

(a)

by or in consultation with appropriate representatives of European food business sectors, including SMEs, and other interested parties, such as consumer groups;

| (b) | in collaboration with parties whose interests may be substantially affected, including competent authorities; |
| --- | --- |

(b)

in collaboration with parties whose interests may be substantially affected, including competent authorities;

| (c) | having regard to relevant codes of practice of the Codex Alimentarius;
  and |
| --- | --- |

(c)

having regard to relevant codes of practice of the Codex Alimentarius;

and

| (d) | when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I. |
| --- | --- |

(d)

when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.

3.   The Committee referred to in Article 14 shall assess draft Community guides in order to ensure that:

| (a) | they have been developed in accordance with paragraph 2; |
| --- | --- |

(a)

they have been developed in accordance with paragraph 2;

| (b) | their contents are practicable for the sectors to which they refer throughout the Community;
  and |
| --- | --- |

(b)

their contents are practicable for the sectors to which they refer throughout the Community;

and

| (c) | they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered. |
| --- | --- |

(c)

they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.

4.   The Commission shall invite the Committee referred to in Article 14 periodically to review any Community guides prepared in accordance with this Article, in cooperation with the bodies mentioned in paragraph 2.

The aim of this review shall be to ensure that the guides remain practicable and to take account of technological and scientific developments.

5.   The titles and references of Community guides prepared in accordance with this Article shall be published in the C series of the Official Journal of the European Union.

CHAPTER IV

IMPORTS AND EXPORTS

Article 10

Imports

As regards the hygiene of imported food, the relevant requirements of food law referred to in Article 11 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

Article 11

Exports

As regards the hygiene of exported or re-exported food, the relevant requirements of food law referred to in Article 12 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

CHAPTER V

FINAL PROVISIONS

Article 12

Implementing measures and transitional arrangements

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 14(2).

Article 13

Amendment and adaptation of Annexes I and II

1.   Annexes I and II may be adapted or updated in accordance with the procedure referred to in Article 14(2), taking into account:

| (a) | the need to revise the recommendations set out in Annex I, Part B, paragraph 2; |
| --- | --- |

(a)

the need to revise the recommendations set out in Annex I, Part B, paragraph 2;

| (b) | the experience gained from the implementation of HACCP-based systems pursuant to Article 5; |
| --- | --- |

(b)

the experience gained from the implementation of HACCP-based systems pursuant to Article 5;

| (c) | technological developments and their practical consequences and consumer expectations with regard to food composition; |
| --- | --- |

(c)

technological developments and their practical consequences and consumer expectations with regard to food composition;

| (d) | scientific advice, particularly new risk assessments; |
| --- | --- |

(d)

scientific advice, particularly new risk assessments;

| (e) | microbiological and temperature criteria for foodstuffs. |
| --- | --- |

(e)

microbiological and temperature criteria for foodstuffs.

2.   Derogations from Annexes I and II may be granted, in particular in order to facilitate the implementation of Article 5 for small businesses, in accordance with the procedure referred to in Article 14(2), taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation.

3.   Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7 of this Article, national measures adapting the requirements laid down in Annex II.

| 4. | (a) | The national measures referred to in paragraph 3 shall have the aim of:






  (i) | enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food;
  or |
| --- | --- | --- | --- |

4.

(a)

The national measures referred to in paragraph 3 shall have the aim of:

(i)

enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food;

or

| (ii) | accommodating the needs of food businesses situated in regions that are subject to special geographical constraints. |
| --- | --- |

(ii)

accommodating the needs of food businesses situated in regions that are subject to special geographical constraints.

(b)

In other cases, they shall apply only to the construction, layout and equipment of establishments.

5.   Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. The notification shall:

| (a) | provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought; |
| --- | --- |

(a)

provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

| (b) | describe the foodstuffs and establishments concerned; |
| --- | --- |

(b)

describe the foodstuffs and establishments concerned;

| (c) | explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;
  and |
| --- | --- |

(c)

explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;

and

| (d) | give any other relevant information. |
| --- | --- |

(d)

give any other relevant information.

6.   The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of the adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 14(1). The Commission may decide, in accordance with the procedure referred to in Article 14(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2.

7.   A Member State may adopt national measures adapting the requirements of Annex II only:

| (a) | in compliance with a decision adopted in accordance with paragraph 6;
  or |
| --- | --- |

(a)

in compliance with a decision adopted in accordance with paragraph 6;

or

| (b) | if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6. |
| --- | --- |

(b)

if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6.

Article 14

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its Rules of Procedure.

Article 15

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing criteria, requirements or targets in accordance with Article 4(4).

Article 16

Report to the European Parliament and the Council

1.   The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council.

2.   The report shall, in particular, review the experience gained from the application of this Regulation and consider whether it would be desirable and practicable to provide for the extension of the requirements of Article 5 to food business operators carrying out primary production and those associated operations listed in Annex I.

3.   The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 17

Repeal

1.   Directive 93/43/EEC shall be repealed with effect from the date of application of this Regulation.

2.   References to the repealed Directive shall be construed as being made to this Regulation.

3.   However, decisions adopted pursuant to Articles 3(3) and 10 of Directive 93/43/EEC shall remain in force pending their replacement by decisions adopted in accordance with this Regulation or Regulation (EC) No 178/2002. Pending the setting of the criteria or requirements referred to in Article 4(3)(a) to (e) of this Regulation, Member States may maintain any national rules establishing such criteria or requirements that they had adopted in accordance with Directive 93/43/EEC.

4.   Pending the application of new Community legislation laying down rules for official controls on food, Member States shall take all appropriate measures to ensure the fulfilment of the obligations laid down in or under this Regulation.

Article 18

Entry into force

This Regulation shall enter into force on the 20th day after that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

It shall apply 18 months after the date on which all of the following acts have entered into force:

| (a) | Regulation (EC) No 853/2004; |
| --- | --- |

(a)

Regulation (EC) No 853/2004;

| (b) | 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 (11);
  and |
| --- | --- |

(b)

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 (11);

11

and

| (c) | 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 (12). |
| --- | --- |

(c)

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 (12).

12

However, it shall apply no earlier than 1 January 2006.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament

The President

P. COX

For the Council

The President

P. M. McDOWELL

ANNEX I

PRIMARY PRODUCTION

PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS

I.   Scope

| 1. | This Annex applies to primary production and the following associated operations:






  (a) | the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature; |
| --- | --- | --- |

1.

This Annex applies to primary production and the following associated operations:

(a)

the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;

| (c) | the transport of live animals, where this is necessary to achieve the objectives of this Regulation;
  and |
| --- | --- |

(c)

the transport of live animals, where this is necessary to achieve the objectives of this Regulation;

and

| (c) | in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment. |
| --- | --- |

(c)

in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.

II.   Hygiene provisions

| 2. | As far as possible, food business operators are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo. |
| --- | --- |

2.

As far as possible, food business operators are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.

| 3. | Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including:






  (a) | measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste;
  and |
| --- | --- | --- |

3.

Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including:

(a)

measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste;

and

| (b) | measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents. |
| --- | --- |

(b)

measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents.

| 4. | Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:






  (a) | to keep any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner; |
| --- | --- | --- |

4.

Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:

(a)

to keep any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner;

| (b) | to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels; |
| --- | --- |

(b)

to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels;

| (c) | as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals; |
| --- | --- |

(c)

as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals;

| (d) | to use potable water, or clean water, whenever necessary to prevent contamination; |
| --- | --- |

(d)

to use potable water, or clean water, whenever necessary to prevent contamination;

| (e) | to ensure that staff handling foodstuffs are in good health and undergo training on health risks; |
| --- | --- |

(e)

to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

| (f) | as far as possible to prevent animals and pests from causing contamination; |
| --- | --- |

(f)

as far as possible to prevent animals and pests from causing contamination;

| (g) | to store and handle waste and hazardous substances so as to prevent contamination; |
| --- | --- |

(g)

to store and handle waste and hazardous substances so as to prevent contamination;

| (h) | to prevent the introduction and spread of contagious diseases transmissible to humans through food, including by taking precautionary measures when introducing new animals and reporting suspected outbreaks of such diseases to the competent authority; |
| --- | --- |

(h)

to prevent the introduction and spread of contagious diseases transmissible to humans through food, including by taking precautionary measures when introducing new animals and reporting suspected outbreaks of such diseases to the competent authority;

| (i) | to take account of the results of any relevant analyses carried out on samples taken from animals or other samples that have importance to human health;
  and |
| --- | --- |

(i)

to take account of the results of any relevant analyses carried out on samples taken from animals or other samples that have importance to human health;

and

| (j) | to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation. |
| --- | --- |

(j)

to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation.

| 5. | Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:






  (a) | to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels; |
| --- | --- | --- |

5.

Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:

(a)

to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels;

| (b) | to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, plant products; |
| --- | --- |

(b)

to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, plant products;

| (c) | to use potable water, or clean water, whenever necessary to prevent contamination; |
| --- | --- |

(c)

to use potable water, or clean water, whenever necessary to prevent contamination;

| (d) | to ensure that staff handling foodstuffs are in good health and undergo training on health risks; |
| --- | --- |

(d)

to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

| (e) | as far as possible to prevent animals and pests from causing contamination; |
| --- | --- |

(e)

as far as possible to prevent animals and pests from causing contamination;

| (f) | to store and handle wastes and hazardous substances so as to prevent contamination; |
| --- | --- |

(f)

to store and handle wastes and hazardous substances so as to prevent contamination;

| (g) | to take account of the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health;
  and |
| --- | --- |

(g)

to take account of the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health;

and

| (h) | to use plant protection products and biocides correctly, as required by the relevant legislation. |
| --- | --- |

(h)

to use plant protection products and biocides correctly, as required by the relevant legislation.

| 6. | Food business operators are to take appropriate remedial action when informed of problems identified during official controls. |
| --- | --- |

6.

Food business operators are to take appropriate remedial action when informed of problems identified during official controls.

III.   Record-keeping

| 7. | Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request. |
| --- | --- |

7.

Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request.

| 8. | Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:






  (a) | the nature and origin of feed fed to the animals; |
| --- | --- | --- |

8.

Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:

(a)

the nature and origin of feed fed to the animals;

| (b) | veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods; |
| --- | --- |

(b)

veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods;

| (c) | the occurrence of diseases that may affect the safety of products of animal origin; |
| --- | --- |

(c)

the occurrence of diseases that may affect the safety of products of animal origin;

| (d) | the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health;
  and |
| --- | --- |

(d)

the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health;

and

| (e) | any relevant reports on checks carried out on animals or products of animal origin. |
| --- | --- |

(e)

any relevant reports on checks carried out on animals or products of animal origin.

| 9. | Food business operators producing or harvesting plant products are, in particular, to keep records on:






  (a) | any use of plant protection products and biocides; |
| --- | --- | --- |

9.

Food business operators producing or harvesting plant products are, in particular, to keep records on:

(a)

any use of plant protection products and biocides;

| (b) | any occurrence of pests or diseases that may affect the safety of products of plant origin;
  and |
| --- | --- |

(b)

any occurrence of pests or diseases that may affect the safety of products of plant origin;

and

| (c) | the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health. |
| --- | --- |

(c)

the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.

| 10. | The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm technicians, with the keeping of records. |
| --- | --- |

10.

The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm technicians, with the keeping of records.

PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE

| 1. | National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations. |
| --- | --- |

1.

National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations.

| 2. | Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:






  (a) | the control of contamination such as mycotoxins, heavy metals and radioactive material; |
| --- | --- | --- |

2.

Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:

(a)

the control of contamination such as mycotoxins, heavy metals and radioactive material;

| (b) | the use of water, organic waste and fertilisers; |
| --- | --- |

(b)

the use of water, organic waste and fertilisers;

| (c) | the correct and appropriate use of plant protection products and biocides and their traceability; |
| --- | --- |

(c)

the correct and appropriate use of plant protection products and biocides and their traceability;

| (d) | the correct and appropriate use of veterinary medicinal products and feed additives and their traceability; |
| --- | --- |

(d)

the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;

| (e) | the preparation, storage, use and traceability of feed; |
| --- | --- |

(e)

the preparation, storage, use and traceability of feed;

| (f) | the proper disposal of dead animals, waste and litter; |
| --- | --- |

(f)

the proper disposal of dead animals, waste and litter;

| (g) | protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority; |
| --- | --- |

(g)

protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;

| (h) | procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control; |
| --- | --- |

(h)

procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;

| (i) | measures relating to the cleanliness of slaughter and production animals; |
| --- | --- |

(i)

measures relating to the cleanliness of slaughter and production animals;

| (j) | measures relating to record-keeping. |
| --- | --- |

(j)

measures relating to record-keeping.

ANNEX II

GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS (EXCEPT WHEN ANNEX I APPLIES)

INTRODUCTION

Chapters V to XII apply to all stages of production, processing and distribution of food and the remaining Chapters apply as follows:

| — | Chapter I applies to all food premises, except premises to which Chapter III applies |
| --- | --- |

—

Chapter I applies to all food premises, except premises to which Chapter III applies

| — | Chapter II applies to all rooms where food is prepared, treated or processed, except dining areas and premises to which Chapter III applies |
| --- | --- |

—

Chapter II applies to all rooms where food is prepared, treated or processed, except dining areas and premises to which Chapter III applies

| — | Chapter III applies to those premises listed in the heading to the Chapter |
| --- | --- |

—

Chapter III applies to those premises listed in the heading to the Chapter

| — | Chapter IV applies to all transportation. |
| --- | --- |

—

Chapter IV applies to all transportation.

CHAPTER I

General requirements for food premises (other than those specified in chapter iii)

| 1. | Food premises are to be kept clean and maintained in good repair and condition. |
| --- | --- |

1.

Food premises are to be kept clean and maintained in good repair and condition.

| 2. | The layout, design, construction, siting and size of food premises are to:






  (a) | permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and provide adequate working space to allow for the hygienic performance of all operations; |
| --- | --- | --- |

2.

The layout, design, construction, siting and size of food premises are to:

(a)

permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and provide adequate working space to allow for the hygienic performance of all operations;

| (b) | be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces; |
| --- | --- |

(b)

be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces;

| (c) | permit good food hygiene practices, including protection against contamination and, in particular, pest control;
  and |
| --- | --- |

(c)

permit good food hygiene practices, including protection against contamination and, in particular, pest control;

and

| (d) | where necessary, provide suitable temperature-controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and, where necessary, recorded. |
| --- | --- |

(d)

where necessary, provide suitable temperature-controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and, where necessary, recorded.

| 3. | An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled. |
| --- | --- |

3.

An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled.

| 4. | An adequate number of washbasins is to be available, suitably located and designated for cleaning hands. Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the hand-washing facility. |
| --- | --- |

4.

An adequate number of washbasins is to be available, suitably located and designated for cleaning hands. Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the hand-washing facility.

| 5. | There is to be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area is to be avoided. Ventilation systems are to be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible. |
| --- | --- |

5.

There is to be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area is to be avoided. Ventilation systems are to be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible.

| 6. | Sanitary conveniences are to have adequate natural or mechanical ventilation. |
| --- | --- |

6.

Sanitary conveniences are to have adequate natural or mechanical ventilation.

| 7. | Food premises are to have adequate natural and/or artificial lighting. |
| --- | --- |

7.

Food premises are to have adequate natural and/or artificial lighting.

| 8. | Drainage facilities are to be adequate for the purpose intended. They are to be designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they are to be so designed as to ensure that waste does not flow from a contaminated area towards or into a clean area, in particular an area where foods likely to present a high risk to the final consumer are handled. |
| --- | --- |

8.

Drainage facilities are to be adequate for the purpose intended. They are to be designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they are to be so designed as to ensure that waste does not flow from a contaminated area towards or into a clean area, in particular an area where foods likely to present a high risk to the final consumer are handled.

| 9. | Where necessary, adequate changing facilities for personnel are to be provided. |
| --- | --- |

9.

Where necessary, adequate changing facilities for personnel are to be provided.

| 10. | Cleaning agents and disinfectants are not to be stored in areas where food is handled. |
| --- | --- |

10.

Cleaning agents and disinfectants are not to be stored in areas where food is handled.

CHAPTER II

Specific requirements in rooms where foodstuffs are prepared, treated or processed (excluding dining areas and those premises specified in chapter III)

| 1. | In rooms where food is prepared, treated or processed (excluding dining areas and those premises specified in Chapter III, but including rooms contained in means of transport) the design and layout are to permit good food hygiene practices, including protection against contamination between and during operations. In particular:






  (a) | floor surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate. Where appropriate, floors are to allow adequate surface drainage; |
| --- | --- | --- |

1.

In rooms where food is prepared, treated or processed (excluding dining areas and those premises specified in Chapter III, but including rooms contained in means of transport) the design and layout are to permit good food hygiene practices, including protection against contamination between and during operations. In particular:

(a)

floor surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate. Where appropriate, floors are to allow adequate surface drainage;

| (b) | wall surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the competent authority that other materials used are appropriate; |
| --- | --- |

(b)

wall surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the competent authority that other materials used are appropriate;

| (c) | ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures are to be constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable mould and the shedding of particles; |
| --- | --- |

(c)

ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures are to be constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable mould and the shedding of particles;

| (d) | windows and other openings are to be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment are, where necessary, to be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination, windows are to remain closed and fixed during production; |
| --- | --- |

(d)

windows and other openings are to be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment are, where necessary, to be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination, windows are to remain closed and fixed during production;

| (e) | doors are to be easy to clean and, where necessary, to disinfect. This will require the use of smooth and non-absorbent surfaces unless food business operators can satisfy the competent authority that other materials used are appropriate;
  and |
| --- | --- |

(e)

doors are to be easy to clean and, where necessary, to disinfect. This will require the use of smooth and non-absorbent surfaces unless food business operators can satisfy the competent authority that other materials used are appropriate;

and

| (f) | surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate. |
| --- | --- |

(f)

surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate.

| 2. | Adequate facilities are to be provided, where necessary, for the cleaning, disinfecting and storage of working utensils and equipment. These facilities are to be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water. |
| --- | --- |

2.

Adequate facilities are to be provided, where necessary, for the cleaning, disinfecting and storage of working utensils and equipment. These facilities are to be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water.

| 3. | Adequate provision is to be made, where necessary, for washing food. Every sink or other such facility provided for the washing of food is to have an adequate supply of hot and/or cold potable water consistent with the requirements of Chapter VII and be kept clean and, where necessary, disinfected. |
| --- | --- |

3.

Adequate provision is to be made, where necessary, for washing food. Every sink or other such facility provided for the washing of food is to have an adequate supply of hot and/or cold potable water consistent with the requirements of Chapter VII and be kept clean and, where necessary, disinfected.

CHAPTER III

Requirements for movable and/or temporary premises (such as marquees, market stalls, mobile sales vehicles), premises used primarily as a private dwelling-house but where foods are regularly prepared for placing on the market and vending machines

| 1. | Premises and vending machines are, so far as is reasonably practicable, to be so sited, designed, constructed and kept clean and maintained in good repair and condition as to avoid the risk of contamination, in particular by animals and pests. |
| --- | --- |

1.

Premises and vending machines are, so far as is reasonably practicable, to be so sited, designed, constructed and kept clean and maintained in good repair and condition as to avoid the risk of contamination, in particular by animals and pests.

| 2. | In particular, where necessary:






  (a) | appropriate facilities are to be available to maintain adequate personal hygiene (including facilities for the hygienic washing and drying of hands, hygienic sanitary arrangements and changing facilities); |
| --- | --- | --- |

2.

In particular, where necessary:

(a)

appropriate facilities are to be available to maintain adequate personal hygiene (including facilities for the hygienic washing and drying of hands, hygienic sanitary arrangements and changing facilities);

| (b) | surfaces in contact with food are to be in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable, corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate; |
| --- | --- |

(b)

surfaces in contact with food are to be in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable, corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate;

| (c) | adequate provision is to be made for the cleaning and, where necessary, disinfecting of working utensils and equipment; |
| --- | --- |

(c)

adequate provision is to be made for the cleaning and, where necessary, disinfecting of working utensils and equipment;

| (d) | where foodstuffs are cleaned as part of the food business' operations, adequate provision is to be made for this to be undertaken hygienically; |
| --- | --- |

(d)

where foodstuffs are cleaned as part of the food business' operations, adequate provision is to be made for this to be undertaken hygienically;

| (e) | an adequate supply of hot and/or cold potable water is to be available; |
| --- | --- |

(e)

an adequate supply of hot and/or cold potable water is to be available;

| (f) | adequate arrangements and/or facilities for the hygienic storage and disposal of hazardous and/or inedible substances and waste (whether liquid or solid) are to be available; |
| --- | --- |

(f)

adequate arrangements and/or facilities for the hygienic storage and disposal of hazardous and/or inedible substances and waste (whether liquid or solid) are to be available;

| (g) | adequate facilities and/or arrangements for maintaining and monitoring suitable food temperature conditions are to be available; |
| --- | --- |

(g)

adequate facilities and/or arrangements for maintaining and monitoring suitable food temperature conditions are to be available;

| (h) | foodstuffs are to be so placed as to avoid the risk of contamination so far as is reasonably practicable. |
| --- | --- |

(h)

foodstuffs are to be so placed as to avoid the risk of contamination so far as is reasonably practicable.

CHAPTER IV

Transport

| 1. | Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained in good repair and condition to protect foodstuffs from contamination and are, where necessary, to be designed and constructed to permit adequate cleaning and/or disinfection. |
| --- | --- |

1.

Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained in good repair and condition to protect foodstuffs from contamination and are, where necessary, to be designed and constructed to permit adequate cleaning and/or disinfection.

| 2. | Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination. |
| --- | --- |

2.

Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination.

| 3. | Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there is, where necessary, to be effective separation of products. |
| --- | --- |

3.

Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there is, where necessary, to be effective separation of products.

| 4. | Bulk foodstuffs in liquid, granulate or powder form are to be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such containers are to be marked in a clearly visible and indelible fashion, in one or more Community languages, to show that they are used for the transport of foodstuffs, or are to be marked ‘for foodstuffs only’. |
| --- | --- |

4.

Bulk foodstuffs in liquid, granulate or powder form are to be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such containers are to be marked in a clearly visible and indelible fashion, in one or more Community languages, to show that they are used for the transport of foodstuffs, or are to be marked ‘for foodstuffs only’.

| 5. | Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the risk of contamination. |
| --- | --- |

5.

Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the risk of contamination.

| 6. | Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contamination. |
| --- | --- |

6.

Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contamination.

| 7. | Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored. |
| --- | --- |

7.

Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored.

CHAPTER V

Equipment requirements

| 1. | All articles, fittings and equipment with which food comes into contact are to:






  (a) | be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination; |
| --- | --- | --- |

1.

All articles, fittings and equipment with which food comes into contact are to:

(a)

be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination;

| (b) | be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination; |
| --- | --- |

(b)

be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination;

| (c) | with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected;
  and |
| --- | --- |

(c)

with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected;

and

| (d) | be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area. |
| --- | --- |

(d)

be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.

| 2. | Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation's objectives. |
| --- | --- |

2.

Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation's objectives.

| 3. | Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice. |
| --- | --- |

3.

Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice.

CHAPTER VI

Food waste

| 1. | Food waste, non-edible by-products and other refuse are to be removed from rooms where food is present as quickly as possible, so as to avoid their accumulation. |
| --- | --- |

1.

Food waste, non-edible by-products and other refuse are to be removed from rooms where food is present as quickly as possible, so as to avoid their accumulation.

| 2. | Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect. |
| --- | --- |

2.

Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect.

| 3. | Adequate provision is to be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores are to be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests. |
| --- | --- |

3.

Adequate provision is to be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores are to be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests.

| 4. | All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination. |
| --- | --- |

4.

All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination.

CHAPTER VII

Water supply

| 1. | (a) | There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated; |
| --- | --- | --- |

1.

(a)

There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated;

| (b) | Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When such water is used, adequate facilities are to be available for its supply. |
| --- | --- |

(b)

Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When such water is used, adequate facilities are to be available for its supply.

| 2. | Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it is to circulate in a separate duly identified system. Non-potable water is not to connect with, or allow reflux into, potable water systems. |
| --- | --- |

2.

Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it is to circulate in a separate duly identified system. Non-potable water is not to connect with, or allow reflux into, potable water systems.

| 3. | Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form. |
| --- | --- |

3.

Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form.

| 4. | Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it from contamination. |
| --- | --- |

4.

Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it from contamination.

| 5. | Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food. |
| --- | --- |

5.

Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food.

| 6. | Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to cool the containers after heat treatment is not a source of contamination for the foodstuff. |
| --- | --- |

6.

Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to cool the containers after heat treatment is not a source of contamination for the foodstuff.

CHAPTER VIII

Personal hygiene

| 1. | Every person working in a food-handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing. |
| --- | --- |

1.

Every person working in a food-handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing.

| 2. | No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator. |
| --- | --- |

2.

No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator.

CHAPTER IX

Provisions applicable to foodstuffs

| 1. | A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption. |
| --- | --- |

1.

A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption.

| 2. | Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination. |
| --- | --- |

2.

Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination.

| 3. | At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state. |
| --- | --- |

3.

At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.

| 4. | Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access from resulting in contamination). |
| --- | --- |

4.

Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access from resulting in contamination).

| 5. | Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage. |
| --- | --- |

5.

Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage.

| 6. | Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health. |
| --- | --- |

6.

Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health.

| 7. | The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins. |
| --- | --- |

7.

The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins.

| 8. | Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers. |
| --- | --- |

8.

Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers.

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

| 1. | Material used for wrapping and packaging are not to be a source of contamination. |
| --- | --- |

1.

Material used for wrapping and packaging are not to be a source of contamination.

| 2. | Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination. |
| --- | --- |

2.

Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination.

| 3. | Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its cleanliness is to be assured. |
| --- | --- |

3.

Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its cleanliness is to be assured.

| 4. | Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect. |
| --- | --- |

4.

Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect.

CHAPTER XI

Heat treatment

The following requirements apply only to food placed on the market in hermetically sealed containers:

| 1. | any heat treatment process used to process an unprocessed product or to process further a processed product is:






  (a) | to raise every party of the product treated to a given temperature for a given period of time;
  and |
| --- | --- | --- |

1.

any heat treatment process used to process an unprocessed product or to process further a processed product is:

(a)

to raise every party of the product treated to a given temperature for a given period of time;

and

| (b) | to prevent the product from becoming contaminated during the process; |
| --- | --- |

(b)

to prevent the product from becoming contaminated during the process;

| 2. | to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices; |
| --- | --- |

2.

to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices;

| 3. | the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation). |
| --- | --- |

3.

the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation).

CHAPTER XII

Training

Food business operators are to ensure:

| 1. | that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity; |
| --- | --- |

1.

that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity;

| 2. | that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP principles;
  and |
| --- | --- |

2.

that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP principles;

and

| 3. | compliance with any requirements of national law concerning training programmes for persons working in certain food sectors. |
| --- | --- |

3.

compliance with any requirements of national law concerning training programmes for persons working in certain food sectors.

---

(1)  
  OJ C 365 E, 19.12.2000, p. 43.

1

(2)  
  OJ C 155, 29.5.2001, p. 39.

2

(3)  Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 267), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 1), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.

3

(4)  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 (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

4

(5)  
  OJ L 175, 19.7.1993, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

5

(6)  See page 22 of this Official Journal.

6

(7)  
  OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.

7

(8)  
  OJ L 184, 17.7.1999, p. 23.

8

(9)  
  OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC) No 1882/2003.

9

(10)  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the 2003 Act of Accession.

10

(11)  See page 83 of this Official Journal.

11

(12)  
  OJ L 157, 30.4.2004, p. 33.

12

---

| 25.6.2004 | EN | Official Journal of the European Union | L 226/22 |
| --- | --- | --- | --- |

25.6.2004

EN

Official Journal of the European Union

L 226/22

---

Corrigendum 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

(
  Official Journal of the European Union L 139 of 30 April 2004
  )

Regulation (EC) No 853/2004 should read as follows:

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

| (1) | Pursuant to Regulation (EC) No 852/2004 (4), the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs. |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 852/2004 (4), the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs.

| (2) | Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported. |
| --- | --- |

(2)

Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported.

| (3) | In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health. |
| --- | --- |

(3)

In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

| (4) | With regard to public health, these rules contain common principles, in particular in relation to the manufacturers ‘and competent authorities’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks. |
| --- | --- |

(4)

With regard to public health, these rules contain common principles, in particular in relation to the manufacturers ‘and competent authorities’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

| (5) | These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing directives. |
| --- | --- |

(5)

These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing directives.

| (6) | It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin. |
| --- | --- |

(6)

It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin.

| (7) | The requirement in Regulation (EC) No 852/2004 whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification. |
| --- | --- |

(7)

The requirement in Regulation (EC) No 852/2004 whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification.

| (8) | Taken together, these elements justify a recasting of the specific hygiene rules contained in existing directives. |
| --- | --- |

(8)

Taken together, these elements justify a recasting of the specific hygiene rules contained in existing directives.

| (9) | The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy. |
| --- | --- |

(9)

The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy.

| (10) | It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin. |
| --- | --- |

(10)

It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin.

| (11) | Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer. |
| --- | --- |

(11)

Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

| (12) | The requirements of Regulation (EC) No 852/2004 are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No 852/2004 should suffice for wholesale activities consisting only of storage or transport. |
| --- | --- |

(12)

The requirements of Regulation (EC) No 852/2004 are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No 852/2004 should suffice for wholesale activities consisting only of storage or transport.

| (13) | Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No 852/2004 are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments. |
| --- | --- |

(13)

Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No 852/2004 are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments.

| (14) | In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation. |
| --- | --- |

(14)

In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation.

| (15) | The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 (5), food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark. |
| --- | --- |

(15)

The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 (5), food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark.

| (16) | Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community. |
| --- | --- |

(16)

Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community.

| (17) | The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC (6), 95/50/EC (7), 95/160/EC (8), 95/161/E (9) and 95/168/EC (10), and Council Decisions 95/409/EC (11), 95/410/EC (12) and 95/411/EC (13). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. 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 (14) provides for a similar procedure in respect of live animals and hatching eggs. |
| --- | --- |

(17)

The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC (6), 95/50/EC (7), 95/160/EC (8), 95/161/E (9) and 95/168/EC (10), and Council Decisions 95/409/EC (11), 95/410/EC (12) and 95/411/EC (13). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. 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 (14) provides for a similar procedure in respect of live animals and hatching eggs.

| (18) | It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses. |
| --- | --- |

(18)

It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses.

| (19) | Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures. |
| --- | --- |

(19)

Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures.

| (20) | The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods. |
| --- | --- |

(20)

The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods.

| (21) | There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail. |
| --- | --- |

(21)

There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail.

| (22) | In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks. |
| --- | --- |

(22)

In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks.

| (23) | This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory. |
| --- | --- |

(23)

This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory.

| (24) | It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage. |
| --- | --- |

(24)

It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage.

| (25) | The present recasting means that the existing hygiene rules can be repealed. Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (15) achieves this. |
| --- | --- |

(25)

The present recasting means that the existing hygiene rules can be repealed. Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (15) achieves this.

| (26) | In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs (16), which the repeal of Annex II to Council Directive 92/118/EEC (17) renders void. |
| --- | --- |

(26)

In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs (16), which the repeal of Annex II to Council Directive 92/118/EEC (17) renders void.

| (27) | Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary. |
| --- | --- |

(27)

Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

| (28) | To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. |
| --- | --- |

(28)

To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health.

| (29) | The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the industries affected time to adapt. |
| --- | --- |

(29)

The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the industries affected time to adapt.

| (30) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (18), |
| --- | --- |

(30)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (18),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.   This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They shall apply to unprocessed and processed products of animal origin.

2.   Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation.

3.   This Regulation shall not apply in relation to:

| (a) | primary production for private domestic use; |
| --- | --- |

(a)

primary production for private domestic use;

| (b) | the domestic preparation, handling or storage of food for private domestic consumption; |
| --- | --- |

(b)

the domestic preparation, handling or storage of food for private domestic consumption;

| (c) | the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; |
| --- | --- |

(c)

the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

| (d) | the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat; |
| --- | --- |

(d)

the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;

| (e) | hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer. |
| --- | --- |

(e)

hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

4.   Member States shall establish, according to national law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such national rules shall ensure the achievement of the objectives of this Regulation.

| 5. | (a) | Unless expressly indicated to the contrary, this Regulation shall not apply to retail. |
| --- | --- | --- |
| (b) | However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:






  (i) | the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply;
  or |

5.

(a)

Unless expressly indicated to the contrary, this Regulation shall not apply to retail.

(b)

However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:

(i)

the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply;

or

| (ii) | the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity. |
| --- | --- |

(ii)

the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity.

(c)

Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b).

6.   This Regulation shall apply without prejudice to:

| (a) | relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies; |
| --- | --- |

(a)

relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies;

| (b) | animal welfare requirements;
  and |
| --- | --- |

(b)

animal welfare requirements;

and

| (c) | requirements concerning the identification of animals and the traceability of products of animal origin. |
| --- | --- |

(c)

requirements concerning the identification of animals and the traceability of products of animal origin.

Article 2

Definitions

The following definitions shall apply for the purposes of this Regulation:

| 1. | the definitions laid down in Regulation (EC) No 178/2002; |
| --- | --- |

1.

the definitions laid down in Regulation (EC) No 178/2002;

| 2. | the definitions laid down in Regulation (EC) No 852/2004; |
| --- | --- |

2.

the definitions laid down in Regulation (EC) No 852/2004;

| 3. | the definitions laid down in Annex I;
  and |
| --- | --- |

3.

the definitions laid down in Annex I;

and

| 4. | any technical definitions contained in Annexes II and III. |
| --- | --- |

4.

any technical definitions contained in Annexes II and III.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligations

1.   Food business operators shall comply with the relevant provisions of Annexes II and III.

2.   Food business operators shall not use any substance other than potable water — or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water — to remove surface contamination from products of animal origin, unless use of the substance has been approved in accordance with the procedure referred to in Article 12(2). Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator's duty to comply with the requirements of this Regulation.

Article 4

Registration and approval of establishments

1.   Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments:

| (a) | that meet the relevant requirements of Regulation (EC) No 852/2004, those of Annexes II and III of this Regulation and other relevant requirements of food law;
  and |
| --- | --- |

(a)

that meet the relevant requirements of Regulation (EC) No 852/2004, those of Annexes II and III of this Regulation and other relevant requirements of food law;

and

| (b) | that the competent authority has registered or, where required in accordance with paragraph 2, approved. |
| --- | --- |

(b)

that the competent authority has registered or, where required in accordance with paragraph 2, approved.

2.   Without prejudice to Article 6(3) of Regulation (EC) No 852/2004, establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only:

| (a) | primary production; |
| --- | --- |

(a)

primary production;

| (b) | transport operations; |
| --- | --- |

(b)

transport operations;

| (c) | the storage of products not requiring temperature-controlled storage conditions;
  or |
| --- | --- |

(c)

the storage of products not requiring temperature-controlled storage conditions;

or

| (d) | retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b). |
| --- | --- |

(d)

retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b).

3.   An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with 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 (19):

| (a) | granted the establishment approval to operate following an on-site visit;
  or |
| --- | --- |

(a)

granted the establishment approval to operate following an on-site visit;

or

| (b) | provided the establishment with conditional approval. |
| --- | --- |

(b)

provided the establishment with conditional approval.

4.   Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No 854/2004. In particular, food business operators shall ensure that an establishment ceases to operate if the competent authority withdraws its approval or, in the case of conditional approval, fails to prolong it or to grant full approval.

5.   This Article shall not prevent an establishment from placing food on the market between the date of application of this Regulation and the first subsequent inspection by the competent authority, if the establishment:

| (a) | is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation;
  or |
| --- | --- |

(a)

is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation;

or

| (b) | is of a type in respect of which there was no requirement for approval before the application of this Regulation. |
| --- | --- |

(b)

is of a type in respect of which there was no requirement for approval before the application of this Regulation.

Article 5

Health and identification marking

1.   Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either:

| (a) | a health mark applied in accordance with Regulation (EC) No 854/2004;
  or |
| --- | --- |

(a)

a health mark applied in accordance with Regulation (EC) No 854/2004;

or

| (b) | when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation. |
| --- | --- |

(b)

when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.

2.   Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4.

3.   Food business operators may not remove a health mark applied in accordance with Regulation (EC) No 854/2004 from meat unless they cut or process it or work upon it in another manner.

Article 6

Products of animal origin from outside the Community

1.   Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if:

| (a) | the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted; |
| --- | --- |

(a)

the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted;

| (b) | (i) | the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, of establishments from which imports of that product are permitted, when applicable, |
| --- | --- | --- |

(b)

(i)

the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, of establishments from which imports of that product are permitted, when applicable,

| (ii) | in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No 854/2004 or in approved Community establishments,
  and |
| --- | --- |

(ii)

in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No 854/2004 or in approved Community establishments,

and

| (iii) | in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable; |
| --- | --- |

(iii)

in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable;

| (c) | the product satisfies:






  (i) | the requirements of this Regulation, including the requirements of Article 5 on health and identification marking; |
| --- | --- | --- |

(c)

the product satisfies:

(i)

the requirements of this Regulation, including the requirements of Article 5 on health and identification marking;

| (ii) | the requirements of Regulation (EC) No 852/2004;
  and |
| --- | --- |

(ii)

the requirements of Regulation (EC) No 852/2004;

and

| (iii) | any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin, |
| --- | --- |

(iii)

any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin,

and

| (d) | the requirements of Article 14 of Regulation (EC) No 854/2004 concerning certificates and documents are satisfied, when applicable. |
| --- | --- |

(d)

the requirements of Article 14 of Regulation (EC) No 854/2004 concerning certificates and documents are satisfied, when applicable.

2.   By way of derogation from paragraph 1, the importation of fishery products may also take place in accordance with the special provisions laid down in Article 15 of Regulation (EC) No 854/2004.

3.   Food business operators importing products of animal origin shall ensure that:

| (a) | products are made available for control upon importation in accordance with Directive 97/78/EC (20); |
| --- | --- |

(a)

products are made available for control upon importation in accordance with Directive 97/78/EC (20);

| (b) | importation complies with the requirements of Directive 2002/99/EC (21);
  and |
| --- | --- |

(b)

importation complies with the requirements of Directive 2002/99/EC (21);

and

| (c) | operations under their control that take place after importation are carried out in accordance with the requirements of Annex III. |
| --- | --- |

(c)

operations under their control that take place after importation are carried out in accordance with the requirements of Annex III.

4.   Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification, which need not be in the format specified in paragraph 1(d)).

CHAPTER III

TRADE

Article 7

Documents

1.   When required in accordance with Annex II or III, food business operators shall ensure that certificates or other documents accompany consignments of products of animal origin.

2.   In accordance with the procedure referred to in Article 12(2):

| (a) | model documents may be established;
  and |
| --- | --- |

(a)

model documents may be established;

and

| (b) | provision may be made for the use of electronic documents. |
| --- | --- |

(b)

provision may be made for the use of electronic documents.

Article 8

Special guarantees

1.   Food business operators intending to place the following food of animal origin on the market in Sweden or Finland shall comply with the rules set out in paragraph 2 in respect of salmonella:

| (a) | meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM; |
| --- | --- |

(a)

meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM;

| (b) | meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM;
  and |
| --- | --- |

(b)

meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM;

and

| (c) | eggs. |
| --- | --- |

(c)

eggs.

| 2. | (a) | In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation. |
| --- | --- | --- |
| (b) | In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation. |
| (c) | In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella. |
| (d) | The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland. |
| (e) | In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that:






  (i) | the checks referred to in subparagraph (a) have been carried out with negative results;
  or |

2.

(a)

In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation.

(b)

In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation.

(c)

In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella.

(d)

The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland.

(e)

In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that:

(i)

the checks referred to in subparagraph (a) have been carried out with negative results;

or

| (ii) | the meat is intended for one of the purposes referred to in subparagraph (c);
  or |
| --- | --- |

(ii)

the meat is intended for one of the purposes referred to in subparagraph (c);

or

| (iii) | the meat comes from an establishment covered by subparagraph (d). |
| --- | --- |

(iii)

the meat comes from an establishment covered by subparagraph (d).

(f)

In the case of eggs, a certificate stating that the tests referred to in subparagraph (b) have been carried out with negative results, or that the eggs are destined to be used in the manner referred to in subparagraph (c), must accompany consignments.

3.   In accordance with the procedure referred to in Article 12(2):

| (a) | the requirements of paragraphs 1 and 2 may be updated to take account in particular of changes to Member States' control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004;
  and |
| --- | --- |

(a)

the requirements of paragraphs 1 and 2 may be updated to take account in particular of changes to Member States' control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004;

and

| (b) | the rules laid down in paragraph 2 in respect of any of the foodstuffs referred to in paragraph 1 may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned. |
| --- | --- |

(b)

the rules laid down in paragraph 2 in respect of any of the foodstuffs referred to in paragraph 1 may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.

4.   For the purposes of this Article, ‘control programme’ means a control programme approved in accordance with Regulation (EC) No 2160/2003.

CHAPTER IV

FINAL PROVISIONS

Article 9

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 12(2).

Article 10

Amendment and adaptation of Annexes II and III

1.   Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account:

| (a) | the development of guides to good practice; |
| --- | --- |

(a)

the development of guides to good practice;

| (b) | the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004; |
| --- | --- |

(b)

the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004;

| (c) | the technological developments and their practical consequences and consumer expectations with regard to food composition; |
| --- | --- |

(c)

the technological developments and their practical consequences and consumer expectations with regard to food composition;

| (d) | scientific advice, particularly new risk assessments; |
| --- | --- |

(d)

scientific advice, particularly new risk assessments;

| (e) | microbiological and temperature criteria for foodstuffs; |
| --- | --- |

(e)

microbiological and temperature criteria for foodstuffs;

| (f) | changes in patterns of consumption. |
| --- | --- |

(f)

changes in patterns of consumption.

2.   Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they do not affect the achievement of the objectives of this Regulation.

3.   Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 8, national measures adapting the requirements laid down in Annex III.

| 4. | (a) | The national measures referred to in paragraph 3 shall have the aim of:






  (i) | enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food;
  or |
| --- | --- | --- | --- |

4.

(a)

The national measures referred to in paragraph 3 shall have the aim of:

(i)

enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food;

or

| (ii) | accommodating the needs of food businesses situated in regions that are subject to special geographic constraints. |
| --- | --- |

(ii)

accommodating the needs of food businesses situated in regions that are subject to special geographic constraints.

(b)

In other cases, they shall apply only to the construction, layout and equipment of establishments.

5.   Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall:

| (a) | provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought; |
| --- | --- |

(a)

provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

| (b) | describe the foodstuffs and establishments concerned; |
| --- | --- |

(b)

describe the foodstuffs and establishments concerned;

| (c) | explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;
  and |
| --- | --- |

(c)

explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;

and

| (d) | give any other relevant information. |
| --- | --- |

(d)

give any other relevant information.

6.   The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 12(1). The Commission may decide, in accordance with the procedure referred to in Article 12(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2 of this Article.

7.   A Member State may adopt national measures adapting the requirements of Annex III only:

| (a) | in compliance with a decision adopted in accordance with paragraph 6; |
| --- | --- |

(a)

in compliance with a decision adopted in accordance with paragraph 6;

| (b) | if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6;
  or |
| --- | --- |

(b)

if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6;

or

| (c) | in accordance with paragraph 8. |
| --- | --- |

(c)

in accordance with paragraph 8.

8.   A Member State may, of its own initiative and subject to the general provisions of the Treaty, maintain or establish national rules:

| (a) | prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption;
  or |
| --- | --- |

(a)

prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption;

or

| (b) | permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation. |
| --- | --- |

(b)

permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

Article 11

Specific decisions

Without prejudice to the generality of Article 9 and Article 10(1), implementing measures may be laid down, or amendments to Annex II or III adopted, in accordance with the procedure referred to in Article 12(2):

| 1. | to lay down rules for the transport of meat while it is warm; |
| --- | --- |

1.

to lay down rules for the transport of meat while it is warm;

| 2. | to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat; |
| --- | --- |

2.

to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

| 3. | to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying; |
| --- | --- |

3.

to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

| 4. | to specify recognised testing methods for marine biotoxins; |
| --- | --- |

4.

to specify recognised testing methods for marine biotoxins;

| 5. | to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:






  (a) | limit values and analysis methods for other marine biotoxins; |
| --- | --- | --- |

5.

to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

(a)

limit values and analysis methods for other marine biotoxins;

| (b) | virus testing procedures and virological standards;
  and |
| --- | --- |

(b)

virus testing procedures and virological standards;

and

| (c) | sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards; |
| --- | --- |

(c)

sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards;

| 6. | to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health; |
| --- | --- |

6.

to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

| 7. | to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae; |
| --- | --- |

7.

to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

| 8. | to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D; |
| --- | --- |

8.

to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

| 9. | to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products; |
| --- | --- |

9.

to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

| 10. | to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count; |
| --- | --- |

10.

to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

| 11. | without prejudice to Directive 96/23/EC (22), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk;
  and |
| --- | --- |

11.

without prejudice to Directive 96/23/EC (22), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk;

22

and

| 12. | to approve equivalent processes for the production of gelatine or collagen. |
| --- | --- |

12.

to approve equivalent processes for the production of gelatine or collagen.

Article 12

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its Rules of Procedure.

Article 13

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex III, Section III, to other animal species.

Article 14

Report to the European Parliament and to the Council

1.   The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council reviewing the experience gained from the implementation of this Regulation.

2.   The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 15

This Regulation shall enter into force on the 20th day after that of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the following acts have entered into force:

| (a) | Regulation (EC) No 852/2004; |
| --- | --- |

(a)

Regulation (EC) No 852/2004;

| (b) | Regulation (EC) No 854/2004;
  and |
| --- | --- |

(b)

Regulation (EC) No 854/2004;

and

| (c) | Directive 2004/41/EC. |
| --- | --- |

(c)

Directive 2004/41/EC.

However, it shall apply no earlier than 1 January 2006.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament

The President

P. COX

For the Council

The President

M. McDOWELL

ANNEX I

DEFINITIONS

For the purpose of this Regulation:

1.   MEAT

1.1.   
  ‘Meat’ means edible parts of the animals referred to in points 1.2 to 1.8, including blood.

1.2.   
  ‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds.

1.3.   
  ‘Poultry’ means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites.

1.4.   
  ‘Lagomorphs’ means rabbits, hares and rodents.

1.5.   
  ‘Wild game’ means:

| — | wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game;
  and |
| --- | --- |

—

wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game;

and

| — | wild birds that are hunted for human consumption. |
| --- | --- |

—

wild birds that are hunted for human consumption.

1.6.   
  ‘Farmed game’ means farmed ratites and farmed land mammals other than those referred to in point 1.2.

1.7.   
  ‘Small wild game’ means wild game birds and lagomorphs living freely in the wild.

1.8.   
  ‘Large wild game’ means wild land mammals living freely in the wild that do not fall within the definition of small wild game.

1.9.   
  ‘Carcase’ means the body of an animal after slaughter and dressing.

1.10.   
  ‘Fresh meat’ means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere.

1.11.   
  ‘Offal’ means fresh meat other than that of the carcase, including viscera and blood.

1.12.   
  ‘Viscera’ means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop.

1.13.   
  ‘Minced meat’ means boned meat that has been minced into fragments and contains less than 1 % salt.

1.14.   
  ‘Mechanically separated meat’ or ‘MSM’ means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure.

1.15.   
  ‘Meat preparations’ means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat.

1.16.   
  ‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption.

1.17.   
  ‘Cutting plant’ means an establishment used for boning and/or cutting up meat.

1.18.   
  ‘Game-handling establishment’ means any establishment in which game and game meat obtained after hunting are prepared for placing on the market.

2.   LIVE BIVALVE MOLLUSCS

2.1.   
  ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs.

2.2.   
  ‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins.

2.3.   
  ‘Conditioning’ means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging.

2.4.   
  ‘Gatherer’ means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market.

2.5.   
  ‘Production area’ means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.

2.6.   
  ‘Relaying area’ means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs.

2.7.   
  ‘Dispatch centre’ means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

2.8.   
  ‘Purification centre’ means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption.

2.9.   
  ‘Relaying’ means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening.

3.   FISHERY PRODUCTS

3.1.   
  ‘Fishery products’ means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals.

3.2.   
  ‘Factory vessel’ means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing.

3.3.   
  ‘Freezer vessel’ means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging.

3.4.   
  ‘Mechanically separated fishery product’ means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure.

3.5.   
  ‘Fresh fishery products’ means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling.

3.6.   
  ‘Prepared fishery products’ means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

4.   MILK

4.1.   
  ‘Raw milk’ means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect.

4.2.   
  ‘Milk production holding’ means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food.

5.   EGGS

5.1.   
  ‘Eggs’ means eggs in shell — other than broken, incubated or cooked eggs — that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products.

5.2.   
  ‘Liquid egg’ means unprocessed egg contents after removal of the shell.

5.3.   
  ‘Cracked eggs’ means eggs with damaged shell and intact membranes.

5.4.   
  ‘Packing centre’ means an establishment where eggs are graded by quality and weight.

6.   FROGS' LEGS AND SNAILS

6.1.   
  ‘Frogs' legs’ means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae).

6.2.   
  ‘Snails’ means terrestrial gastropods of the species Helix pomatiaLinné, Helix aspersaMuller, Helix lucorum and species of the family Achatinidae.

7.   PROCESSED PRODUCTS

7.1.   
  ‘Meat products’ means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat.

7.2.   
  ‘Dairy products’ means processed products resulting from the processing of raw milk or from the further processing of such processed products.

7.3.   
  ‘Egg products’ means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products.

7.4.   
  ‘Processed fishery products’ means processed products resulting from the processing of fishery products or from the further processing of such processed products.

7.5.   
  ‘Rendered animal fat’ means fat derived from rendering meat, including bones, and intended for human consumption.

7.6.   
  ‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water.

7.7.   
  ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

7.8.   
  ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation.

7.9.   
  ‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning.

8.   OTHER DEFINITIONS

8.1.   
  ‘Products of animal origin’ means:

| — | food of animal origin, including honey and blood; |
| --- | --- |

—

food of animal origin, including honey and blood;

| — | live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption;
  and |
| --- | --- |

—

live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption;

and

| — | other animals destined to be prepared with a view to being supplied live to the final consumer. |
| --- | --- |

—

other animals destined to be prepared with a view to being supplied live to the final consumer.

8.2.   
  ‘Wholesale market’ means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators.

ANNEX II

REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN

SECTION I: IDENTIFICATION MARKING

When required in accordance with Article 5 or 6, and subject to the provisions of Annex III, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions.

A.   APPLICATION OF THE IDENTIFICATION MARK

| 1. | The identification mark must be applied before the product leaves the establishment. |
| --- | --- |

1.

The identification mark must be applied before the product leaves the establishment.

| 2. | However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place. |
| --- | --- |

2.

However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place.

| 3. | An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (23) lays down requirements concerning labelling or marking. |
| --- | --- |

3.

An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (23) lays down requirements concerning labelling or marking.

| 4. | Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin. |
| --- | --- |

4.

Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin.

B.   FORM OF THE IDENTIFICATION MARK

| 5. | The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. |
| --- | --- |

5.

The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities.

| 6. | The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.
  In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK.
  Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement. |
| --- | --- |

6.

The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK.

Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement.

| 7. | The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. |
| --- | --- |

7.

The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.

| 8. | When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY. |
| --- | --- |

8.

When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY.

C.   METHOD OF MARKING

| 9. | The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material. |
| --- | --- |

9.

The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material.

| 10. | In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping. |
| --- | --- |

10.

In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping.

| 11. | For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging. |
| --- | --- |

11.

For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.

| 12. | In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in points 6, 7 and, where appropriate, 8. |
| --- | --- |

12.

In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in points 6, 7 and, where appropriate, 8.

| 13. | When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only. |
| --- | --- |

13.

When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only.

| 14. | When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs. |
| --- | --- |

14.

When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

SECTION II: OBJECTIVES OF HACCP-BASED PROCEDURES

| 1. | Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2. |
| --- | --- |

1.

Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2.

| 2. | The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:






  (a) | is properly identified; |
| --- | --- | --- |

2.

The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:

(a)

is properly identified;

| (b) | is accompanied by the relevant information from the holding of provenance referred to in Section III; |
| --- | --- |

(b)

is accompanied by the relevant information from the holding of provenance referred to in Section III;

| (c) | does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits; |
| --- | --- |

(c)

does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits;

| (d) | is clean; |
| --- | --- |

(d)

is clean;

| (e) | is healthy, as far as the food business operator can judge;
  and |
| --- | --- |

(e)

is healthy, as far as the food business operator can judge;

and

| (f) | is in a satisfactory state as regards welfare on arrival at the slaughterhouse. |
| --- | --- |

(f)

is in a satisfactory state as regards welfare on arrival at the slaughterhouse.

| 3. | In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures. |
| --- | --- |

3.

In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures.

SECTION III: FOOD CHAIN INFORMATION

Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse.

| 1. | Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004. |
| --- | --- |

1.

Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004.

| 2. | Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7. |
| --- | --- |

2.

Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7.

| 3. | The relevant food safety information referred to in point 1 is to cover, in particular:






  (a) | the status of the holding of provenance or the regional animal health status; |
| --- | --- | --- |

3.

The relevant food safety information referred to in point 1 is to cover, in particular:

(a)

the status of the holding of provenance or the regional animal health status;

| (b) | the animals' health status; |
| --- | --- |

(b)

the animals' health status;

| (c) | veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods; |
| --- | --- |

(c)

veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods;

| (d) | the occurrence of diseases that may affect the safety of meat; |
| --- | --- |

(d)

the occurrence of diseases that may affect the safety of meat;

| (e) | the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonoses and residues; |
| --- | --- |

(e)

the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonoses and residues;

| (f) | relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian; |
| --- | --- |

(f)

relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian;

| (g) | production data, when this might indicate the presence of disease;
  and |
| --- | --- |

(g)

production data, when this might indicate the presence of disease;

and

| (h) | the name and address of the private veterinarian normally attending the holding of provenance. |
| --- | --- |

(h)

the name and address of the private veterinarian normally attending the holding of provenance.

| 4. | (a) | However, it is not necessary for the slaughterhouse operator to be provided with:






  (i) | the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme);
  or |
| --- | --- | --- | --- |

4.

(a)

However, it is not necessary for the slaughterhouse operator to be provided with:

(i)

the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme);

or

| (ii) | the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report. |
| --- | --- |

(ii)

the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report.

| (b) | The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer. |
| --- | --- |

(b)

The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer.

| 5. | Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned. |
| --- | --- |

5.

Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned.

| 6. | If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits. |
| --- | --- |

6.

If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits.

| 7. | If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of:






  (a) | porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of provenance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding and found them to be healthy accompanies them; |
| --- | --- | --- |

7.

If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of:

(a)

porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of provenance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding and found them to be healthy accompanies them;

| (b) | domestic solipeds; |
| --- | --- |

(b)

domestic solipeds;

| (c) | animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the favourable outcome of the ante-mortem inspection accompanies them;
  and |
| --- | --- |

(c)

animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the favourable outcome of the ante-mortem inspection accompanies them;

and

| (d) | animals that are not delivered directly from the holding of provenance to the slaughterhouse. |
| --- | --- |

(d)

animals that are not delivered directly from the holding of provenance to the slaughterhouse.

Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the animals may not take place until the official veterinarian so permits.

| 8. | Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian. |
| --- | --- |

8.

Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian.

ANNEX III

SPECIFIC REQUIREMENTS

SECTION I: MEAT OF DOMESTIC UNGULATES

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements.

| 1. | During collection and transport, animals must be handled carefully without causing unnecessary distress. |
| --- | --- |

1.

During collection and transport, animals must be handled carefully without causing unnecessary distress.

| 2. | Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits. |
| --- | --- |

2.

Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which domestic ungulates are slaughtered meet the following requirements.

| 1. | (a) | Slaughterhouses must have adequate and hygienic lairage facilities or, climate permitting, waiting pens that are easy to clean and disinfect. These facilities must be equipped for watering the animals and, if necessary, feeding them. The drainage of the wastewater must not compromise food safety. |
| --- | --- | --- |

1.

(a)

Slaughterhouses must have adequate and hygienic lairage facilities or, climate permitting, waiting pens that are easy to clean and disinfect. These facilities must be equipped for watering the animals and, if necessary, feeding them. The drainage of the wastewater must not compromise food safety.

| (b) | They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the competent authority considers that such facilities are unnecessary. |
| --- | --- |

(b)

They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the competent authority considers that such facilities are unnecessary.

| (c) | The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must facilitate ante-mortem inspections, including the identification of the animals or groups of animals. |
| --- | --- |

(c)

The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must facilitate ante-mortem inspections, including the identification of the animals or groups of animals.

| 2. | To avoid contaminating meat, they must:






  (a) | have a sufficient number of rooms, appropriate to the operations being carried out; |
| --- | --- | --- |

2.

To avoid contaminating meat, they must:

(a)

have a sufficient number of rooms, appropriate to the operations being carried out;

| (b) | have a separate room for the emptying and cleaning of stomachs and intestines, unless the competent authority authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis; |
| --- | --- |

(b)

have a separate room for the emptying and cleaning of stomachs and intestines, unless the competent authority authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis;

| (c) | ensure separation in space or time of the following operations:






  (i) | stunning and bleeding; |
| --- | --- | --- |

(c)

ensure separation in space or time of the following operations:

(i)

stunning and bleeding;

| (ii) | in the case of porcine animals, scalding, depilation, scraping and singeing; |
| --- | --- |

(ii)

in the case of porcine animals, scalding, depilation, scraping and singeing;

| (iii) | evisceration and further dressing; |
| --- | --- |

(iii)

evisceration and further dressing;

| (iv) | handling clean guts and tripe; |
| --- | --- |

(iv)

handling clean guts and tripe;

| (v) | preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at the slaughter line; |
| --- | --- |

(v)

preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at the slaughter line;

| (vi) | packaging offal;
  and |
| --- | --- |

(vi)

packaging offal;

and

| (vii) | dispatching meat; |
| --- | --- |

(vii)

dispatching meat;

| (d) | have installations that prevent contact between the meat and the floors, walls and fixtures;
  and |
| --- | --- |

(d)

have installations that prevent contact between the meat and the floors, walls and fixtures;

and

| (e) | have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. |
| --- | --- |

(e)

have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

| 3. | They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. |
| --- | --- |

3.

They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

| 4. | The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. |
| --- | --- |

4.

The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

| 5. | There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. |
| --- | --- |

5.

There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

| 6. | There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby. |
| --- | --- |

6.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby.

| 7. | They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period. |
| --- | --- |

7.

They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.

| 8. | If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose. |
| --- | --- |

8.

If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose.

| 9. | They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service. |
| --- | --- |

9.

They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

Food business operators must ensure that cutting plants handling meat of domestic ungulates:

| 1. | are constructed so as to avoid contamination of meat, in particular by:






  (a) | allowing constant progress of the operations;
  or |
| --- | --- | --- |

1.

are constructed so as to avoid contamination of meat, in particular by:

(a)

allowing constant progress of the operations;

or

| (b) | ensuring separation between the different production batches; |
| --- | --- |

(b)

ensuring separation between the different production batches;

| 2. | have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; |
| --- | --- |

2.

have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

| 3. | have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; |
| --- | --- |

3.

have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

| 4. | have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and |
| --- | --- |

4.

have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and

| 5. | have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. |
| --- | --- |

5.

have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which domestic ungulates are slaughtered must ensure compliance with the following requirements.

| 1. | After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter. |
| --- | --- |

1.

After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter.

| 2. | (a) | Meat from animals other than those referred to in subparagraphs (b) and (c) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. |
| --- | --- | --- |

2.

(a)

Meat from animals other than those referred to in subparagraphs (b) and (c) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse.

| (b) | Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:






  (i) | animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter VI; |
| --- | --- | --- |

(b)

Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i)

animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter VI;

| (ii) | animals slaughtered at the place of production in accordance with Section III;
  and |
| --- | --- |

(ii)

animals slaughtered at the place of production in accordance with Section III;

and

| (iii) | wild game, in compliance with Section IV, Chapter II. |
| --- | --- |

(iii)

wild game, in compliance with Section IV, Chapter II.

| (c) | Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human consumption if, on inspection, no serious lesions other than those due to the accident are found. |
| --- | --- |

(c)

Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human consumption if, on inspection, no serious lesions other than those due to the accident are found.

| 3. | The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced. |
| --- | --- |

3.

The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced.

| 4. | Animals must be clean. |
| --- | --- |

4.

Animals must be clean.

| 5. | Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No 854/2004 to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions. |
| --- | --- |

5.

Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No 854/2004 to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions.

| 6. | Animals brought into the slaughter hall must be slaughtered without undue delay. |
| --- | --- |

6.

Animals brought into the slaughter hall must be slaughtered without undue delay.

| 7. | Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular:






  (a) | the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a religious custom; |
| --- | --- | --- |

7.

Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular:

(a)

the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a religious custom;

| (b) | during the removal of hides and fleece:






  (i) | contact between the outside of the skin and the carcase must be prevented;
  and |
| --- | --- | --- |

(b)

during the removal of hides and fleece:

(i)

contact between the outside of the skin and the carcase must be prevented;

and

| (ii) | operators and equipment coming into contact with the outer surface of hides and fleece must not touch the meat; |
| --- | --- |

(ii)

operators and equipment coming into contact with the outer surface of hides and fleece must not touch the meat;

| (c) | measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to ensure that evisceration is completed as soon as possible after stunning;
  and |
| --- | --- |

(c)

measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to ensure that evisceration is completed as soon as possible after stunning;

and

| (d) | removal of the udder must not result in contamination of the carcase with milk or colostrum. |
| --- | --- |

(d)

removal of the udder must not result in contamination of the carcase with milk or colostrum.

| 8. | Complete skinning of the carcase and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat. |
| --- | --- |

8.

Complete skinning of the carcase and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat.

| 9. | When not skinned, porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water. |
| --- | --- |

9.

When not skinned, porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water.

| 10. | The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect. |
| --- | --- |

10.

The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect.

| 11. | Carcases and offal must not come into contact with floors, walls or work stands. |
| --- | --- |

11.

Carcases and offal must not come into contact with floors, walls or work stands.

| 12. | Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No 854/2004. |
| --- | --- |

12.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No 854/2004.

| 13. | Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:






  (a) | remain identifiable as belonging to a given carcase;
  and |
| --- | --- | --- |

13.

Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:

(a)

remain identifiable as belonging to a given carcase;

and

| (b) | come into contact with no other carcase, offal or viscera, including those that have already undergone post-mortem inspection. |
| --- | --- |

(b)

come into contact with no other carcase, offal or viscera, including those that have already undergone post-mortem inspection.

However, provided that it shows no pathological lesion, the penis may be discarded immediately.

| 14. | Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed. |
| --- | --- |

14.

Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed.

| 15. | If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption. |
| --- | --- |

15.

If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption.

| 16. | After post-mortem inspection:






  (a) | the tonsils of bovine animals and solipeds must be removed hygienically; |
| --- | --- | --- |

16.

After post-mortem inspection:

(a)

the tonsils of bovine animals and solipeds must be removed hygienically;

| (b) | parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; |
| --- | --- |

(b)

parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment;

| (c) | meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption;
  and |
| --- | --- |

(c)

meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption;

and

| (d) | viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely and as soon as possible, unless the competent authority authorises otherwise. |
| --- | --- |

(d)

viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely and as soon as possible, unless the competent authority authorises otherwise.

| 17. | After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII. |
| --- | --- |

17.

After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII.

| 18. | When destined for further handling:






  (a) | stomachs must be scalded or cleaned; |
| --- | --- | --- |

18.

When destined for further handling:

(a)

stomachs must be scalded or cleaned;

| (b) | intestines must be emptied and cleaned;
  and |
| --- | --- |

(b)

intestines must be emptied and cleaned;

and

| (c) | heads and feet must be skinned or scalded and depilated. |
| --- | --- |

(c)

heads and feet must be skinned or scalded and depilated.

| 19. | Where establishments are approved for the slaughter of different animal species or for the handling of carcases of farmed game and wild game, precautions must be taken to prevent cross-contamination by separation either in time or in space of operations carried out on the different species. Separate facilities for the reception and storage of unskinned carcases of farmed game slaughtered at the farm and for wild game must be available. |
| --- | --- |

19.

Where establishments are approved for the slaughter of different animal species or for the handling of carcases of farmed game and wild game, precautions must be taken to prevent cross-contamination by separation either in time or in space of operations carried out on the different species. Separate facilities for the reception and storage of unskinned carcases of farmed game slaughtered at the farm and for wild game must be available.

| 20. | If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed. |
| --- | --- |

20.

If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed.

CHAPTER V: HYGIENE DURING CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of domestic ungulates takes place in accordance with the following requirements.

| 1. | Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant. |
| --- | --- |

1.

Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

| 2. | The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:






  (a) | meat intended for cutting is brought into the workrooms progressively as needed; |
| --- | --- | --- |

2.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

(a)

meat intended for cutting is brought into the workrooms progressively as needed;

| (b) | during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more than 3 °C for offal and 7 °C for other meat, by means of an ambient temperature of not more than 12 °C or an alternative system having an equivalent effect;
  and |
| --- | --- |

(b)

during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more than 3 °C for offal and 7 °C for other meat, by means of an ambient temperature of not more than 12 °C or an alternative system having an equivalent effect;

and

| (c) | where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time. |
| --- | --- |

(c)

where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time.

| 3. | However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3. |
| --- | --- |

3.

However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3.

| 4. | Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b). |
| --- | --- |

4.

Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b).

CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE

Food business operators must ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if it complies with all the following requirements.

| 1. | An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons. |
| --- | --- |

1.

An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons.

| 2. | A veterinarian must carry out an ante-mortem inspection of the animal. |
| --- | --- |

2.

A veterinarian must carry out an ante-mortem inspection of the animal.

| 3. | The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal. |
| --- | --- |

3.

The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.

| 4. | If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary. |
| --- | --- |

4.

If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary.

| 5. | A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse. |
| --- | --- |

5.

A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse.

| 6. | A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse. |
| --- | --- |

6.

A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse.

| 7. | The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No 854/2004, including any additional tests required in the case of emergency slaughter. |
| --- | --- |

7.

The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No 854/2004, including any additional tests required in the case of emergency slaughter.

| 8. | Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat. |
| --- | --- |

8.

Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat.

| 9. | Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears a special health mark which cannot be confused either with the health mark provided for in Regulation (EC) No 854/2004 or with the identification mark provided for in Annex II, Section I to this Regulation. Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance with national law. |
| --- | --- |

9.

Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears a special health mark which cannot be confused either with the health mark provided for in Regulation (EC) No 854/2004 or with the identification mark provided for in Annex II, Section I to this Regulation. Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance with national law.

CHAPTER VII: STORAGE AND TRANSPORT

Food business operators must ensure that the storage and transport of meat of domestic ungulates takes place in accordance with the following requirements.

| 1. | (a) | Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3 °C for offal and 7 °C for other meat along a chilling curve that ensures a continuous decrease of the temperature. However, meat may be cut and boned during chilling in accordance with Chapter V, point 4. |
| --- | --- | --- |

1.

(a)

Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3 °C for offal and 7 °C for other meat along a chilling curve that ensures a continuous decrease of the temperature. However, meat may be cut and boned during chilling in accordance with Chapter V, point 4.

| (b) | During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the meat. |
| --- | --- |

(b)

During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the meat.

| 2. | Meat must attain the temperature specified in point 1 and remain at that temperature during storage. |
| --- | --- |

2.

Meat must attain the temperature specified in point 1 and remain at that temperature during storage.

| 3. | Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that:






  (a) | such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another;
  and |
| --- | --- | --- |

3.

Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that:

(a)

such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another;

and

| (b) | the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than two hours. |
| --- | --- |

(b)

the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than two hours.

| 4. | Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing. |
| --- | --- |

4.

Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing.

| 5. | Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. |
| --- | --- |

5.

Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

SECTION II: MEAT FROM POULTRY AND LAGOMORPHS

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements.

| 1. | During collection and transport, animals must be handled carefully without causing unnecessary distress. |
| --- | --- |

1.

During collection and transport, animals must be handled carefully without causing unnecessary distress.

| 2. | Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority. |
| --- | --- |

2.

Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority.

| 3. | Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected. |
| --- | --- |

3.

Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry or lagomorphs are slaughtered meet the following requirements.

| 1. | They must have a room or covered space for the reception of the animals and for their inspection before slaughter. |
| --- | --- |

1.

They must have a room or covered space for the reception of the animals and for their inspection before slaughter.

| 2. | To avoid contaminating meat, they must:






  (a) | have a sufficient number of rooms, appropriate to the operations being carried out; |
| --- | --- | --- |

2.

To avoid contaminating meat, they must:

(a)

have a sufficient number of rooms, appropriate to the operations being carried out;

| (b) | have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the competent authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis; |
| --- | --- |

(b)

have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the competent authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis;

| (c) | ensure separation in space or time of the following operations:






  (i) | stunning and bleeding; |
| --- | --- | --- |

(c)

ensure separation in space or time of the following operations:

(i)

stunning and bleeding;

| (ii) | plucking or skinning, and any scalding;
  and |
| --- | --- |

(ii)

plucking or skinning, and any scalding;

and

| (iii) | dispatching meat; |
| --- | --- |

(iii)

dispatching meat;

| (d) | have installations that prevent contact between the meat and the floors, walls and fixtures;
  and |
| --- | --- |

(d)

have installations that prevent contact between the meat and the floors, walls and fixtures;

and

| (e) | have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. |
| --- | --- |

(e)

have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

| 3. | They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. |
| --- | --- |

3.

They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

| 4. | The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. |
| --- | --- |

4.

The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

| 5. | There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. |
| --- | --- |

5.

There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

| 6. | There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:






  (a) | transport equipment such as crates;
  and |
| --- | --- | --- |

6.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:

(a)

transport equipment such as crates;

and

| (b) | means of transport. |
| --- | --- |

(b)

means of transport.

These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

| 7. | They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service. |
| --- | --- |

7.

They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

| 1. | Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:






  (a) | are constructed so as to avoid contamination of meat, in particular by:






  (i) | allowing constant progress of the operations;
  or |
| --- | --- | --- | --- |

1.

Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:

(a)

are constructed so as to avoid contamination of meat, in particular by:

(i)

allowing constant progress of the operations;

or

| (ii) | ensuring separation between the different production batches; |
| --- | --- |

(ii)

ensuring separation between the different production batches;

| (b) | have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; |
| --- | --- |

(b)

have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

| (c) | have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; |
| --- | --- |

(c)

have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

| (d) | have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination;
  and |
| --- | --- |

(d)

have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination;

and

| (e) | have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. |
| --- | --- |

(e)

have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

| 2. | If the following operations are undertaken in a cutting plant:






  (a) | the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and plucked on the fattening farm;
  or |
| --- | --- | --- |

2.

If the following operations are undertaken in a cutting plant:

(a)

the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and plucked on the fattening farm;

or

| (b) | the evisceration of delayed eviscerated poultry, |
| --- | --- |

(b)

the evisceration of delayed eviscerated poultry,

food business operators must ensure that separate rooms are available for that purpose.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure compliance with the following requirements.

| 1. | (a) | Meat from animals other than those referred to in (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. |
| --- | --- | --- |

1.

(a)

Meat from animals other than those referred to in (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse.

| (b) | Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:






  (i) | delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI; |
| --- | --- | --- |

(b)

Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i)

delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI;

| (ii) | farmed game slaughtered at the place of production in accordance with Section III;
  and |
| --- | --- |

(ii)

farmed game slaughtered at the place of production in accordance with Section III;

and

| (iii) | small wild game in accordance with Section IV, Chapter III. |
| --- | --- |

(iii)

small wild game in accordance with Section IV, Chapter III.

| 2. | Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem inspection is carried out under suitable conditions. |
| --- | --- |

2.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem inspection is carried out under suitable conditions.

| 3. | Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available. |
| --- | --- |

3.

Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available.

| 4. | Animals brought into the slaughter room must be slaughtered without undue delay. |
| --- | --- |

4.

Animals brought into the slaughter room must be slaughtered without undue delay.

| 5. | Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration. |
| --- | --- |

5.

Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration.

| 6. | Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly. |
| --- | --- |

6.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly.

| 7. | After post-mortem inspection:






  (a) | parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; |
| --- | --- | --- |

7.

After post-mortem inspection:

(a)

parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment;

| (b) | meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption;
  and |
| --- | --- |

(b)

meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption;

and

| (c) | viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority. |
| --- | --- |

(c)

viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority.

| 8. | After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm. |
| --- | --- |

8.

After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm.

| 9. | When carcases are subjected to an immersion chilling process, account must be taken of the following.






  (a) | Every precaution must be taken to avoid contamination of carcases, taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time. |
| --- | --- | --- |

9.

When carcases are subjected to an immersion chilling process, account must be taken of the following.

(a)

Every precaution must be taken to avoid contamination of carcases, taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time.

| (b) | Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day. |
| --- | --- |

(b)

Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day.

| 10. | Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again. |
| --- | --- |

10.

Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again.

CHAPTER V: HYGIENE DURING AND AFTER CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of poultry and lagomorphs takes place in accordance with the following requirements.

| 1. | The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:






  (a) | meat intended for cutting is brought into the workrooms progressively as needed; |
| --- | --- | --- |

1.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

(a)

meat intended for cutting is brought into the workrooms progressively as needed;

| (b) | during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system having an equivalent effect;
  and |
| --- | --- |

(b)

during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system having an equivalent effect;

and

| (c) | where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time. |
| --- | --- |

(c)

where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time.

| 2. | However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:






  (a) | directly from the slaughter premises;
  or |
| --- | --- | --- |

2.

However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:

(a)

directly from the slaughter premises;

or

| (b) | after a waiting period in a chilling or refrigerating room. |
| --- | --- |

(b)

after a waiting period in a chilling or refrigerating room.

| 3. | As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 1(b). |
| --- | --- |

3.

As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 1(b).

| 4. | Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. |
| --- | --- |

4.

Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

CHAPTER VI: SLAUGHTER ON THE FARM

Food business operators may slaughter poultry referred to in Chapter IV, point 1(b)(i), on the farm only with the authorisation of the competent authority and in compliance with the following requirements.

| 1. | The farm must undergo regular veterinary inspection. |
| --- | --- |

1.

The farm must undergo regular veterinary inspection.

| 2. | The food business operator must inform the competent authority in advance of the date and time of slaughter. |
| --- | --- |

2.

The food business operator must inform the competent authority in advance of the date and time of slaughter.

| 3. | The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made. |
| --- | --- |

3.

The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made.

| 4. | The holding must have premises suitable for the hygienic slaughter and further handling of the birds. |
| --- | --- |

4.

The holding must have premises suitable for the hygienic slaughter and further handling of the birds.

| 5. | Animal welfare requirements must be complied with. |
| --- | --- |

5.

Animal welfare requirements must be complied with.

| 6. | The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter. |
| --- | --- |

6.

The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter.

| 7. | The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No 854/2004. |
| --- | --- |

7.

The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No 854/2004.

| 8. | In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority. |
| --- | --- |

8.

In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority.

| 9. | Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production. |
| --- | --- |

9.

Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production.

SECTION III: MEAT OF FARMED GAME

| 1. | The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals (Cervidae and Suidae), unless the competent authority considers them inappropriate. |
| --- | --- |

1.

The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals (Cervidae and Suidae), unless the competent authority considers them inappropriate.

| 2. | The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals. |
| --- | --- |

2.

The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals.

| 3. | Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:






  (a) | the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals; |
| --- | --- | --- |

3.

Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:

(a)

the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals;

| (b) | the herd undergoes regular veterinary inspection; |
| --- | --- |

(b)

the herd undergoes regular veterinary inspection;

| (c) | the owner of the animals submits a request; |
| --- | --- |

(c)

the owner of the animals submits a request;

| (d) | the competent authority is informed in advance of the date and time of slaughter of the animals; |
| --- | --- |

(d)

the competent authority is informed in advance of the date and time of slaughter of the animals;

| (e) | the holding has procedures for concentrating the animals to allow an ante-mortem inspection of the group to be made; |
| --- | --- |

(e)

the holding has procedures for concentrating the animals to allow an ante-mortem inspection of the group to be made;

| (f) | the holding has facilities suitable for the slaughter, bleeding and, where ratites are to be plucked, plucking of the animals; |
| --- | --- |

(f)

the holding has facilities suitable for the slaughter, bleeding and, where ratites are to be plucked, plucking of the animals;

| (g) | animal welfare requirements are complied with; |
| --- | --- |

(g)

animal welfare requirements are complied with;

| (h) | slaughtered and bled animals are transported to the slaughterhouse hygienically and without undue delay. If transport takes more than two hours, the animals are, if necessary, refrigerated. Evisceration may take place on the spot, under the supervision of the veterinarian; |
| --- | --- |

(h)

slaughtered and bled animals are transported to the slaughterhouse hygienically and without undue delay. If transport takes more than two hours, the animals are, if necessary, refrigerated. Evisceration may take place on the spot, under the supervision of the veterinarian;

| (i) | a declaration by the food business operator who reared the animals, stating their identity and indicating any veterinary products or other treatments administered, dates of administration and withdrawal periods, accompanies the slaughtered animals to the slaughterhouse;
  and |
| --- | --- |

(i)

a declaration by the food business operator who reared the animals, stating their identity and indicating any veterinary products or other treatments administered, dates of administration and withdrawal periods, accompanies the slaughtered animals to the slaughterhouse;

and

| (j) | during transport to the approved establishment, a certificate issued and signed by the official veterinarian or approved veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the date and time of slaughter, accompanies the slaughtered animals. |
| --- | --- |

(j)

during transport to the approved establishment, a certificate issued and signed by the official veterinarian or approved veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the date and time of slaughter, accompanies the slaughtered animals.

| 4. | Food business operators may also slaughter bison on the farm in accordance with point 3 in exceptional circumstances. |
| --- | --- |

4.

Food business operators may also slaughter bison on the farm in accordance with point 3 in exceptional circumstances.

SECTION IV: WILD GAME MEAT

CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

| 1. | Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot. |
| --- | --- |

1.

Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot.

| 2. | It is however enough if at least one person of a hunting team has the knowledge referred to in point 1. References in this Section to a ‘trained person’ are references to that person. |
| --- | --- |

2.

It is however enough if at least one person of a hunting team has the knowledge referred to in point 1. References in this Section to a ‘trained person’ are references to that person.

| 3. | The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing. |
| --- | --- |

3.

The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing.

| 4. | Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:






  (a) | the normal anatomy, physiology and behaviour of wild game; |
| --- | --- | --- |

4.

Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:

(a)

the normal anatomy, physiology and behaviour of wild game;

| (b) | abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or other factors which may affect human health after consumption; |
| --- | --- |

(b)

abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or other factors which may affect human health after consumption;

| (c) | the hygiene rules and proper techniques for the handling, transportation, evisceration, etc. of wild game animals after killing;
  and |
| --- | --- |

(c)

the hygiene rules and proper techniques for the handling, transportation, evisceration, etc. of wild game animals after killing;

and

| (d) | legislation and administrative provisions on the animal and public health and hygiene conditions governing the placing on the market of wild game. |
| --- | --- |

(d)

legislation and administrative provisions on the animal and public health and hygiene conditions governing the placing on the market of wild game.

| 5. | The competent authority should encourage hunters' organisations to provide such training. |
| --- | --- |

5.

The competent authority should encourage hunters' organisations to provide such training.

CHAPTER II: HANDLING OF LARGE WILD GAME

| 1. | After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled. |
| --- | --- |

1.

After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled.

| 2. | The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing. |
| --- | --- |

2.

The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

| 3. | Meat of large wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal. |
| --- | --- |

3.

Meat of large wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal.

| 4. | (a) | If no abnormal characteristics are found during the examination referred to in point 2, no abnormal behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained person must attach to the animal body a numbered declaration stating this. This declaration must also indicate the date, time and place of killing. In this case, the head and the viscera need not accompany the body, except in the case of species susceptible to Trichinosis (porcine animals, solipeds and others), whose head (except for tusks) and diaphragm must accompany the body. However, hunters must comply with any additional requirements imposed in the Member State where hunting takes place, in particular to permit the monitoring of certain residues and substances in accordance with Directive 96/23/EC; |
| --- | --- | --- |

4.

(a)

If no abnormal characteristics are found during the examination referred to in point 2, no abnormal behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained person must attach to the animal body a numbered declaration stating this. This declaration must also indicate the date, time and place of killing. In this case, the head and the viscera need not accompany the body, except in the case of species susceptible to Trichinosis (porcine animals, solipeds and others), whose head (except for tusks) and diaphragm must accompany the body. However, hunters must comply with any additional requirements imposed in the Member State where hunting takes place, in particular to permit the monitoring of certain residues and substances in accordance with Directive 96/23/EC;

| (b) | In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and intestines must accompany the body. The trained person who carried out the examination must inform the competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contamination that prevented him or her from making a declaration in accordance with (a); |
| --- | --- |

(b)

In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and intestines must accompany the body. The trained person who carried out the examination must inform the competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contamination that prevented him or her from making a declaration in accordance with (a);

| (c) | If no trained person is available to carry out the examination referred to in point 2 in a particular case, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and the intestines must accompany the body. |
| --- | --- |

(c)

If no trained person is available to carry out the examination referred to in point 2 in a particular case, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and the intestines must accompany the body.

| 5. | Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary. |
| --- | --- |

5.

Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary.

| 6. | During transport to the game-handling establishment, heaping must be avoided. |
| --- | --- |

6.

During transport to the game-handling establishment, heaping must be avoided.

| 7. | Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection. |
| --- | --- |

7.

Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

| 8. | In addition, unskinned large wild game may be skinned and placed on the market only if:






  (a) | before skinning, it is stored and handled separately from other food and not frozen;
  and |
| --- | --- | --- |

8.

In addition, unskinned large wild game may be skinned and placed on the market only if:

(a)

before skinning, it is stored and handled separately from other food and not frozen;

and

| (b) | after skinning, it undergoes a final inspection in accordance with Regulation (EC) No 854/2004. |
| --- | --- |

(b)

after skinning, it undergoes a final inspection in accordance with Regulation (EC) No 854/2004.

| 9. | The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game. |
| --- | --- |

9.

The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game.

CHAPTER III: HANDLING OF SMALL WILD GAME

| 1. | The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing. |
| --- | --- |

1.

The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

| 2. | If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority. |
| --- | --- |

2.

If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority.

| 3. | Meat of small wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 1. |
| --- | --- |

3.

Meat of small wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 1.

| 4. | Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary. |
| --- | --- |

4.

Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary.

| 5. | Evisceration must be carried out, or completed, without undue delay upon arrival at the game -handling establishment, unless the competent authority permits otherwise. |
| --- | --- |

5.

Evisceration must be carried out, or completed, without undue delay upon arrival at the game -handling establishment, unless the competent authority permits otherwise.

| 6. | Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection. |
| --- | --- |

6.

Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

| 7. | The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game. |
| --- | --- |

7.

The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game.

SECTION V: MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM)

CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS

Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that they:

| 1. | are constructed so as to avoid contamination of meat and products, in particular by:






  (a) | allowing constant progress of the operations;
  or |
| --- | --- | --- |

1.

are constructed so as to avoid contamination of meat and products, in particular by:

(a)

allowing constant progress of the operations;

or

| (b) | ensuring separation between the different production batches; |
| --- | --- |

(b)

ensuring separation between the different production batches;

| 2. | have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products; |
| --- | --- |

2.

have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products;

| 3. | have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III; |
| --- | --- |

3.

have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III;

| 4. | have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination;
  and |
| --- | --- |

4.

have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination;

and

| 5. | have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. |
| --- | --- |

5.

have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

CHAPTER II: REQUIREMENTS FOR RAW MATERIAL

Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used satisfy the following requirements.

| 1. | The raw material used to prepare minced meat must meet the following requirements.






  (a) | It must comply with the requirements for fresh meat; |
| --- | --- | --- |

1.

The raw material used to prepare minced meat must meet the following requirements.

(a)

It must comply with the requirements for fresh meat;

| (b) | It must derive from skeletal muscle, including adherent fatty tissues; |
| --- | --- |

(b)

It must derive from skeletal muscle, including adherent fatty tissues;

| (c) | It must not derive from:






  (i) | scrap cuttings and scrap trimmings (other than whole muscle cuttings); |
| --- | --- | --- |

(c)

It must not derive from:

(i)

scrap cuttings and scrap trimmings (other than whole muscle cuttings);

| (ii) | MSM; |
| --- | --- |

(ii)

MSM;

| (iii) | meat containing bone fragments or skin;
  or |
| --- | --- |

(iii)

meat containing bone fragments or skin;

or

| (iv) | meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed). |
| --- | --- |

(iv)

meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed).

| 2. | The following raw material may be used to prepare meat preparations:






  (a) | fresh meat; |
| --- | --- | --- |

2.

The following raw material may be used to prepare meat preparations:

(a)

fresh meat;

| (b) | meat meeting the requirements of point 1;
  and |
| --- | --- |

(b)

meat meeting the requirements of point 1;

and

| (c) | if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment:






  (i) | meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i);
  and |
| --- | --- | --- |

(c)

if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment:

(i)

meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i);

and

| (ii) | MSM meeting the requirements of Chapter III, point 3(d). |
| --- | --- |

(ii)

MSM meeting the requirements of Chapter III, point 3(d).

| 3. | The raw material used to produce MSM must meet the following requirements.






  (a) | It must comply with the requirements for fresh meat; |
| --- | --- | --- |

3.

The raw material used to produce MSM must meet the following requirements.

(a)

It must comply with the requirements for fresh meat;

| (b) | The following material must not be used to produce MSM:






  (i) | for poultry, the feet, neckskin and head;
  and |
| --- | --- | --- |

(b)

The following material must not be used to produce MSM:

(i)

for poultry, the feet, neckskin and head;

and

| (ii) | for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna. |
| --- | --- |

(ii)

for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna.

CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION

Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following requirements.

| 1. | The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is:






  (a) | at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat;
  and |
| --- | --- | --- |

1.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is:

(a)

at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat;

and

| (b) | brought into the preparation room progressively as needed. |
| --- | --- |

(b)

brought into the preparation room progressively as needed.

| 2. | The following requirements apply to the production of minced meat and meat preparations.






  (a) | Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period. |
| --- | --- | --- |

2.

The following requirements apply to the production of minced meat and meat preparations.

(a)

Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period.

| (b) | When prepared from chilled meat, minced meat must be prepared:






  (i) | in the case of poultry, within no more than three days of their slaughter; |
| --- | --- | --- |

(b)

When prepared from chilled meat, minced meat must be prepared:

(i)

in the case of poultry, within no more than three days of their slaughter;

| (ii) | in the case of animal other than poultry, within no more than six days of their slaughter;
  or |
| --- | --- |

(ii)

in the case of animal other than poultry, within no more than six days of their slaughter;

or

| (iii) | within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal. |
| --- | --- |

(iii)

within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal.

| (c) | Immediately after production, minced meat and meat preparations must be wrapped or packaged and be:






  (i) | chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations;
  or |
| --- | --- | --- |

(c)

Immediately after production, minced meat and meat preparations must be wrapped or packaged and be:

(i)

chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations;

or

| (ii) | frozen to an internal temperature of not more than -18 °C. |
| --- | --- |

(ii)

frozen to an internal temperature of not more than -18 °C.

These temperature conditions must be maintained during storage and transport.

| 3. | The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat.






  (a) | Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old. |
| --- | --- | --- |

3.

The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat.

(a)

Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old.

| (b) | Mechanical separation must take place immediately after deboning. |
| --- | --- |

(b)

Mechanical separation must take place immediately after deboning.

| (c) | If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of not more than 2 °C or frozen to an internal temperature of not more than –18 °C. These temperature requirements must be maintained during storage and transport. |
| --- | --- |

(c)

If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of not more than 2 °C or frozen to an internal temperature of not more than –18 °C. These temperature requirements must be maintained during storage and transport.

| (d) | If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological criteria for minced meat adopted in accordance with Regulation (EC) No 852/2004 it may be used in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat products. |
| --- | --- |

(d)

If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological criteria for minced meat adopted in accordance with Regulation (EC) No 852/2004 it may be used in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat products.

| (e) | MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation. |
| --- | --- |

(e)

MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

| 4. | The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.






  (a) | Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old. |
| --- | --- | --- |

4.

The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.

(a)

Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old.

| (b) | If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than -18 °C. |
| --- | --- |

(b)

If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than -18 °C.

| (c) | Flesh-bearing bones obtained from frozen carcases must not be refrozen. |
| --- | --- |

(c)

Flesh-bearing bones obtained from frozen carcases must not be refrozen.

| (d) | If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2 °C. |
| --- | --- |

(d)

If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2 °C.

| (e) | If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of not more than –18 °C within six hours. |
| --- | --- |

(e)

If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of not more than –18 °C within six hours.

| (f) | Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than –18 °C during storage and transport. |
| --- | --- |

(f)

Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than –18 °C during storage and transport.

| (g) | MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation. |
| --- | --- |

(g)

MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

| 5. | Minced meat, meat preparations and MSM must not be re-frozen after thawing. |
| --- | --- |

5.

Minced meat, meat preparations and MSM must not be re-frozen after thawing.

CHAPTER IV: LABELLING

| 1. | In addition to the requirements of Directive 2000/13/EC (24), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require. |
| --- | --- |

1.

In addition to the requirements of Directive 2000/13/EC (24), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require.

| 2. | Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption. |
| --- | --- |

2.

Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption.

SECTION VI: MEAT PRODUCTS

| 1. | Food business operators must ensure that the following items are not used in the preparation of meat products:






  (a) | genital organs of either female or male animals, except testicles; |
| --- | --- | --- |

1.

Food business operators must ensure that the following items are not used in the preparation of meat products:

(a)

genital organs of either female or male animals, except testicles;

| (b) | urinary organs, except the kidneys and the bladder; |
| --- | --- |

(b)

urinary organs, except the kidneys and the bladder;

| (c) | the cartilage of the larynx, the trachea and the extra-lobular bronchi; |
| --- | --- |

(c)

the cartilage of the larynx, the trachea and the extra-lobular bronchi;

| (d) | eyes and eyelids; |
| --- | --- |

(d)

eyes and eyelids;

| (e) | the external auditory meatus; |
| --- | --- |

(e)

the external auditory meatus;

| (f) | horn tissue;
  and |
| --- | --- |

(f)

horn tissue;

and

| (g) | in poultry, the head — except the comb and the ears, the wattles and caruncles — the oesophagus, the crop, the intestines and the genital organs. |
| --- | --- |

(g)

in poultry, the head — except the comb and the ears, the wattles and caruncles — the oesophagus, the crop, the intestines and the genital organs.

| 2. | All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other specific requirements of Section V. |
| --- | --- |

2.

All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other specific requirements of Section V.

SECTION VII: LIVE BIVALVE MOLLUSCS

| 1. | This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods. |
| --- | --- |

1.

This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods.

| 2. | Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) No 854/2004. Chapter IX applies to pectinidae harvested outside those areas. |
| --- | --- |

2.

Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) No 854/2004. Chapter IX applies to pectinidae harvested outside those areas.

| 3. | Chapters V, VI, VIII and IX, and point 3 of Chapter VII, apply to retail. |
| --- | --- |

3.

Chapters V, VI, VIII and IX, and point 3 of Chapter VII, apply to retail.

| 4. | The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:






  (a) | In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation. |
| --- | --- | --- |

4.

The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:

(a)

In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.

| (b) | In the case of other operations, they supplement the requirements of Annex II to that Regulation. |
| --- | --- |

(b)

In the case of other operations, they supplement the requirements of Annex II to that Regulation.

CHAPTER I: GENERAL REQUIREMENTS FOR THE PLACING ON THE MARKET OF LIVE BIVALVE MOLLUSCS

| 1. | Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII. |
| --- | --- |

1.

Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII.

| 2. | Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been complied with. |
| --- | --- |

2.

Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been complied with.

| 3. | Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch. |
| --- | --- |

3.

Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch.

| 4. | The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.






  (a) | In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:






  (i) | the gatherer's identity and address; |
| --- | --- | --- | --- |

4.

The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.

(a)

In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:

(i)

the gatherer's identity and address;

| (ii) | the date of harvesting; |
| --- | --- |

(ii)

the date of harvesting;

| (iii) | the location of the production area described in as precise detail as is practicable or by a code number; |
| --- | --- |

(iii)

the location of the production area described in as precise detail as is practicable or by a code number;

| (iv) | the health status of the production area; |
| --- | --- |

(iv)

the health status of the production area;

| (v) | the shellfish species and quantity;
  and |
| --- | --- |

(v)

the shellfish species and quantity;

and

| (vi) | the destination of the batch. |
| --- | --- |

(vi)

the destination of the batch.

| (b) | In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:






  (i) | the location of the relaying area;
  and |
| --- | --- | --- |

(b)

In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:

(i)

the location of the relaying area;

and

| (ii) | the duration of relaying. |
| --- | --- |

(ii)

the duration of relaying.

| (c) | In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information:






  (i) | the address of the purification centre; |
| --- | --- | --- |

(c)

In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information:

(i)

the address of the purification centre;

| (ii) | the duration of purification;
  and |
| --- | --- |

(ii)

the duration of purification;

and

| (iii) | the dates on which the batch entered and left the purification centre. |
| --- | --- |

(iii)

the dates on which the batch entered and left the purification centre.

| 5. | Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so that they are easy to read and cannot be altered. Food business operators receiving batches must date-stamp the document on receipt of the batch or record the date of receipt in another manner. |
| --- | --- |

5.

Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so that they are easy to read and cannot be altered. Food business operators receiving batches must date-stamp the document on receipt of the batch or record the date of receipt in another manner.

| 6. | Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify). |
| --- | --- |

6.

Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

| 7. | However, if:






  (a) | the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs;
  and |
| --- | --- | --- |

7.

However, if:

(a)

the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs;

and

| (b) | a single competent authority supervises all the establishments concerned, |
| --- | --- |

(b)

a single competent authority supervises all the establishments concerned,

registration documents are not necessary if that competent authority so permits.

CHAPTER II: HYGIENE REQUIREMENTS FOR THE PRODUCTION AND HARVESTING OF LIVE BIVALVE MOLLUSCS

A.   REQUIREMENTS FOR PRODUCTION AREAS

| 1. | Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the competent authority has classified — where appropriate, in cooperation with food business operators — as being of class A, B or C in accordance with Regulation (EC) No 854/2004. |
| --- | --- |

1.

Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the competent authority has classified — where appropriate, in cooperation with food business operators — as being of class A, B or C in accordance with Regulation (EC) No 854/2004.

| 2. | Food business operators may place live bivalve molluscs collected from class A production areas on the market for direct human consumption only if they meet the requirements of Chapter V. |
| --- | --- |

2.

Food business operators may place live bivalve molluscs collected from class A production areas on the market for direct human consumption only if they meet the requirements of Chapter V.

| 3. | Food business operators may place live bivalve molluscs collected from class B production areas on the market for human consumption only after treatment in a purification centre or after relaying. |
| --- | --- |

3.

Food business operators may place live bivalve molluscs collected from class B production areas on the market for human consumption only after treatment in a purification centre or after relaying.

| 4. | Food business operators may place live bivalve molluscs collected from class C production areas on the market for human consumption only after relaying over a long period in accordance with Part C of this Chapter. |
| --- | --- |

4.

Food business operators may place live bivalve molluscs collected from class C production areas on the market for human consumption only after relaying over a long period in accordance with Part C of this Chapter.

| 5. | After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate, after removal of sand, mud or slime in the same or another establishment). The permitted treatment methods are:






  (a) | sterilisation in hermetically sealed containers;
  and |
| --- | --- | --- |

5.

After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate, after removal of sand, mud or slime in the same or another establishment). The permitted treatment methods are:

(a)

sterilisation in hermetically sealed containers;

and

| (b) | heat treatments involving:






  (i) | immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90 °C and maintenance of this minimum temperature for a period of not less than 90 seconds; |
| --- | --- | --- |

(b)

heat treatments involving:

(i)

immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90 °C and maintenance of this minimum temperature for a period of not less than 90 seconds;

| (ii) | cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160 °C and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of – 20 °C;
  and |
| --- | --- |

(ii)

cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160 °C and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of – 20 °C;

and

| (iii) | steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat. |
| --- | --- |

(iii)

steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.

| 6. | Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of any relevant information concerning areas' suitability for production and harvesting, including information obtained from own-checks and the competent authority. They must use this information, particularly information on environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches. |
| --- | --- |

6.

Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of any relevant information concerning areas' suitability for production and harvesting, including information obtained from own-checks and the competent authority. They must use this information, particularly information on environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

B.   REQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING

Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure compliance with the following requirements.

| 1. | Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. Food business operators must in particular:






  (a) | adequately protect live bivalve molluscs from crushing, abrasion or vibration; |
| --- | --- | --- |

1.

Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. Food business operators must in particular:

(a)

adequately protect live bivalve molluscs from crushing, abrasion or vibration;

| (b) | not expose live bivalve molluscs to extreme temperatures; |
| --- | --- |

(b)

not expose live bivalve molluscs to extreme temperatures;

| (c) | not re-immerse live bivalve molluscs in water that could cause additional contamination;
  and |
| --- | --- |

(c)

not re-immerse live bivalve molluscs in water that could cause additional contamination;

and

| (d) | if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A. |
| --- | --- |

(d)

if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A.

| 2. | Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination. |
| --- | --- |

2.

Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination.

C.   REQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS

Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.

| 1. | Food business operators may use only those areas that the competent authority has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise any risk of the spread of contamination. |
| --- | --- |

1.

Food business operators may use only those areas that the competent authority has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise any risk of the spread of contamination.

| 2. | Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:






  (a) | use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters; |
| --- | --- | --- |

2.

Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:

(a)

use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters;

| (b) | not relay live bivalve molluscs at a density that prevents purification; |
| --- | --- |

(b)

not relay live bivalve molluscs at a density that prevents purification;

| (c) | immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be of at least two months' duration unless the competent authority agrees to a shorter period on the basis of the food business operator's risk analysis;
  and |
| --- | --- |

(c)

immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be of at least two months' duration unless the competent authority agrees to a shorter period on the basis of the food business operator's risk analysis;

and

| (d) | ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the ‘all in, all out’ system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed. |
| --- | --- |

(d)

ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the ‘all in, all out’ system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed.

| 3. | Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the competent authority. |
| --- | --- |

3.

Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the competent authority.

CHAPTER III: STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES

| 1. | The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas. |
| --- | --- |

1.

The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

| 2. | Tanks and water storage containers must meet the following requirements:






  (a) | Internal surfaces must be smooth, durable, impermeable and easy to clean. |
| --- | --- | --- |

2.

Tanks and water storage containers must meet the following requirements:

(a)

Internal surfaces must be smooth, durable, impermeable and easy to clean.

| (b) | They must be constructed so as to allow complete draining of water. |
| --- | --- |

(b)

They must be constructed so as to allow complete draining of water.

| (c) | Any water intake must be situated in a position that avoids contamination of the water supply. |
| --- | --- |

(c)

Any water intake must be situated in a position that avoids contamination of the water supply.

| 3. | In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified. |
| --- | --- |

3.

In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified.

CHAPTER IV: HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES

A.   REQUIREMENTS FOR PURIFICATION CENTRES

Food business operators purifying live bivalve molluscs must ensure compliance with the following requirements.

| 1. | Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris using clean water. |
| --- | --- |

1.

Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris using clean water.

| 2. | Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market. |
| --- | --- |

2.

Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market.

| 3. | The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. The live bivalve molluscs must be continuously purified for a period sufficient to achieve compliance with allow the health standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) No 852/2004. |
| --- | --- |

3.

The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. The live bivalve molluscs must be continuously purified for a period sufficient to achieve compliance with allow the health standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) No 852/2004.

| 4. | Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification. |
| --- | --- |

4.

Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification.

| 5. | Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification. |
| --- | --- |

5.

Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification.

| 6. | No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification. |
| --- | --- |

6.

No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification.

| 7. | Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified. |
| --- | --- |

7.

Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified.

B.   REQUIREMENTS FOR DISPATCH CENTRES

Food business operators operating dispatch centres must ensure compliance with the following requirements.

| 1. | Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause contamination of the product or affect the viability of the molluscs. |
| --- | --- |

1.

Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause contamination of the product or affect the viability of the molluscs.

| 2. | Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water. |
| --- | --- |

2.

Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

| 3. | Live bivalve molluscs must come from:






  (a) | a class A production area; |
| --- | --- | --- |

3.

Live bivalve molluscs must come from:

(a)

a class A production area;

| (b) | a relaying area; |
| --- | --- |

(b)

a relaying area;

| (c) | a purification centre;
  or |
| --- | --- |

(c)

a purification centre;

or

| (d) | another dispatch centre. |
| --- | --- |

(d)

another dispatch centre.

| 4. | The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs handled in such centres must come from a class A production area or a relaying area. |
| --- | --- |

4.

The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs handled in such centres must come from a class A production area or a relaying area.

CHAPTER V: HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No 852/2004, food business operators must ensure that live bivalve molluscs placed on the market for human consumption meet the standards laid down in this Chapter.

| 1. | They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intravalvular liquid. |
| --- | --- |

1.

They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intravalvular liquid.

| 2. | They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:






  (a) | for paralytic shellfish poison (PSP), 800 micrograms per kilogram; |
| --- | --- | --- |

2.

They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:

(a)

for paralytic shellfish poison (PSP), 800 micrograms per kilogram;

| (b) | for amnesic shellfish poison (ASP), 20 milligrams of domoic acid per kilogram; |
| --- | --- |

(b)

for amnesic shellfish poison (ASP), 20 milligrams of domoic acid per kilogram;

| (c) | for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per kilogram; |
| --- | --- |

(c)

for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per kilogram;

| (d) | for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram;
  and |
| --- | --- |

(d)

for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram;

and

| (e) | for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram. |
| --- | --- |

(e)

for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.

CHAPTER VI: WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS

| 1. | Oysters must be wrapped or packaged with the concave shell downwards. |
| --- | --- |

1.

Oysters must be wrapped or packaged with the concave shell downwards.

| 2. | Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the dispatch centre and until presented for sale to the final consumer. |
| --- | --- |

2.

Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the dispatch centre and until presented for sale to the final consumer.

CHAPTER VII: IDENTIFICATION MARKING AND LABELLING

| 1. | The label, including the identification mark, must be waterproof. |
| --- | --- |

1.

The label, including the identification mark, must be waterproof.

| 2. | In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be present on the label:






  (a) | the species of bivalve mollusc (common name and scientific name);
  and |
| --- | --- | --- |

2.

In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be present on the label:

(a)

the species of bivalve mollusc (common name and scientific name);

and

| (b) | the date of packaging, comprising at least the day and the month. |
| --- | --- |

(b)

the date of packaging, comprising at least the day and the month.

By way of derogation from Directive 2000/13/EC, the date of minimum durability may be replaced by the entry ‘these animals must be alive when sold’.

| 3. | The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual consumer-size packages for at least 60 days after splitting up the contents. |
| --- | --- |

3.

The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual consumer-size packages for at least 60 days after splitting up the contents.

CHAPTER VIII: OTHER REQUIREMENTS

| 1. | Food business operators storing and transporting live bivalve molluscs must ensure that they are kept at a temperature that does not adversely affect food safety or their viability. |
| --- | --- |

1.

Food business operators storing and transporting live bivalve molluscs must ensure that they are kept at a temperature that does not adversely affect food safety or their viability.

| 2. | Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail sale and left the dispatch centre. |
| --- | --- |

2.

Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail sale and left the dispatch centre.

CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

Food business operators harvesting pectinidae outside classified production areas or handling such pectinidae must comply with the following requirements.

| 1. | Pectinidae may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks. |
| --- | --- |

1.

Pectinidae may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks.

| 2. | In addition, where data from official monitoring programmes enable the competent authority to classify fishing grounds — where appropriate, in cooperation with food business operators — the provisions of Chapter II, Part A, apply by analogy to pectinidae. |
| --- | --- |

2.

In addition, where data from official monitoring programmes enable the competent authority to classify fishing grounds — where appropriate, in cooperation with food business operators — the provisions of Chapter II, Part A, apply by analogy to pectinidae.

| 3. | Pectinidae may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae, food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV. |
| --- | --- |

3.

Pectinidae may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae, food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV.

| 4. | Food business operators handling pectinidae must comply:






  (a) | with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the pectinidae were harvested;
  or |
| --- | --- | --- |

4.

Food business operators handling pectinidae must comply:

(a)

with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the pectinidae were harvested;

or

| (b) | as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of packaging, with the requirements of Chapter VII concerning identification marking and labelling. |
| --- | --- |

(b)

as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of packaging, with the requirements of Chapter VII concerning identification marking and labelling.

SECTION VIII: FISHERY PRODUCTS

| 1. | This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when placed on the market live. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII. |
| --- | --- |

1.

This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when placed on the market live. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII.

| 2. | Chapter III, Parts A, C and D, Chapter IV and Chapter V apply to retail. |
| --- | --- |

2.

Chapter III, Parts A, C and D, Chapter IV and Chapter V apply to retail.

| 3. | The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:






  (a) | In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation. |
| --- | --- | --- |

3.

The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:

(a)

In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation.

| (b) | In the case of other establishments, including vessels, they supplement the requirements of Annex II to that Regulation. |
| --- | --- |

(b)

In the case of other establishments, including vessels, they supplement the requirements of Annex II to that Regulation.

| 4. | In relation to fishery products:






  (a) | primary production covers the farming, fishing and collection of live fishery products with a view to their being placed on the market;
  and |
| --- | --- | --- |

4.

In relation to fishery products:

(a)

primary production covers the farming, fishing and collection of live fishery products with a view to their being placed on the market;

and

| (b) | associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:






  1. | the transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within fish farms on land;
  and |
| --- | --- | --- |

(b)

associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:

1.

the transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within fish farms on land;

and

| 2. | the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment of destination. |
| --- | --- |

2.

the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment of destination.

CHAPTER I: REQUIREMENTS FOR VESSELS

Food business operators must ensure that:

| 1. | vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I;
  and |
| --- | --- |

1.

vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I;

and

| 2. | operations carried out on board vessels take place in accordance with the rules laid down in Part II. |
| --- | --- |

2.

operations carried out on board vessels take place in accordance with the rules laid down in Part II.

I.   STRUCTURAL AND EQUIPMENT REQUIREMENTS

A.   Requirements for all vessels

| 1. | Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances. |
| --- | --- |

1.

Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

| 2. | Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic. |
| --- | --- |

2.

Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic.

| 3. | Equipment and material used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect. |
| --- | --- |

3.

Equipment and material used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect.

| 4. | When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply. |
| --- | --- |

4.

When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply.

B.   Requirements for vessels designed and equipped to preserve fresh fishery products for more than 24 hours

| 1. | Vessels designed and equipped to preserve fishery products for more than 24 hours must be equipped with holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII. |
| --- | --- |

1.

Vessels designed and equipped to preserve fishery products for more than 24 hours must be equipped with holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII.

| 2. | Holds must be separated from the engine compartments and from the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Holds and containers used for the storage of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary, ensure that melt water does not remain in contact with the products. |
| --- | --- |

2.

Holds must be separated from the engine compartments and from the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Holds and containers used for the storage of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary, ensure that melt water does not remain in contact with the products.

| 3. | In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3 °C six hours after loading and not more than 0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures. |
| --- | --- |

3.

In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3 °C six hours after loading and not more than 0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures.

C.   Requirements for freezer vessels

Freezer vessels must:

| 1. | have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not more than -18 °C; |
| --- | --- |

1.

have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not more than -18 °C;

| 2. | have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than -18 °C. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
  and |
| --- | --- |

2.

have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than -18 °C. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;

and

| 3. | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in part B, point 2. |
| --- | --- |

3.

meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in part B, point 2.

D.   Requirements for factory vessels

| 1. | Factory vessels must have at least:






  (a) | a receiving area reserved for taking fishery products on board, designed to allow each successive catch to be separated. This area must be easy to clean and designed so as to protect the products from the sun or the elements and from any source of contamination; |
| --- | --- | --- |

1.

Factory vessels must have at least:

(a)

a receiving area reserved for taking fishery products on board, designed to allow each successive catch to be separated. This area must be easy to clean and designed so as to protect the products from the sun or the elements and from any source of contamination;

| (b) | a hygienic system for conveying fishery products from the receiving area to the work area; |
| --- | --- |

(b)

a hygienic system for conveying fishery products from the receiving area to the work area;

| (c) | work areas that are large enough for the hygienic preparation and processing of fishery products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products; |
| --- | --- |

(c)

work areas that are large enough for the hygienic preparation and processing of fishery products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products;

| (d) | storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste; |
| --- | --- |

(d)

storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste;

| (e) | a place for storing packaging materials that is separate from the product preparation and processing areas; |
| --- | --- |

(e)

a place for storing packaging materials that is separate from the product preparation and processing areas;

| (f) | special equipment for disposing waste or fishery products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose; |
| --- | --- |

(f)

special equipment for disposing waste or fishery products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose;

| (g) | a water intake situated in a position that avoids contamination of the water supply;
  and |
| --- | --- |

(g)

a water intake situated in a position that avoids contamination of the water supply;

and

| (h) | hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to prevent the spread of contamination. |
| --- | --- |

(h)

hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to prevent the spread of contamination.

| 2. | However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of point 1 if no other form of handling or processing takes place on board such vessels. |
| --- | --- |

2.

However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of point 1 if no other form of handling or processing takes place on board such vessels.

| 3. | Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in part C, points 1 and 2. |
| --- | --- |

3.

Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in part C, points 1 and 2.

II.   HYGIENE REQUIREMENTS

| 1. | When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water. |
| --- | --- |

1.

When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

| 2. | As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either potable water or, where appropriate, clean water. |
| --- | --- |

2.

As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either potable water or, where appropriate, clean water.

| 3. | Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage. |
| --- | --- |

3.

Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.

| 4. | Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible. |
| --- | --- |

4.

Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible.

| 5. | Ice used to chill fishery products must be made from potable water or clean water. |
| --- | --- |

5.

Ice used to chill fishery products must be made from potable water or clean water.

| 6. | Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the products must be washed immediately and thoroughly with potable water or clean water. In that event, the viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from products intended for human consumption. Livers and roes intended for human consumption must be preserved under ice, at a temperature approaching that of melting ice, or be frozen. |
| --- | --- |

6.

Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the products must be washed immediately and thoroughly with potable water or clean water. In that event, the viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from products intended for human consumption. Livers and roes intended for human consumption must be preserved under ice, at a temperature approaching that of melting ice, or be frozen.

| 7. | Where freezing in brine of whole fish intended for canning is practised, a temperature of not more than – 9 °C must be achieved for the product. The brine must not be a source of contamination for the fish. |
| --- | --- |

7.

Where freezing in brine of whole fish intended for canning is practised, a temperature of not more than – 9 °C must be achieved for the product. The brine must not be a source of contamination for the fish.

CHAPTER II: REQUIREMENTS DURING AND AFTER LANDING

| 1. | Food business operators responsible for the unloading and landing of fishery products must:






  (a) | ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness;
  and |
| --- | --- | --- |

1.

Food business operators responsible for the unloading and landing of fishery products must:

(a)

ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness;

and

| (b) | avoid contamination of fishery products during unloading and landing, in particular by:






  (i) | carrying out unloading and landing operations rapidly; |
| --- | --- | --- |

(b)

avoid contamination of fishery products during unloading and landing, in particular by:

(i)

carrying out unloading and landing operations rapidly;

| (ii) | placing fishery products without delay in a protected environment at the temperature specified in Chapter VII;
  and |
| --- | --- |

(ii)

placing fishery products without delay in a protected environment at the temperature specified in Chapter VII;

and

| (iii) | not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products. |
| --- | --- |

(iii)

not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

| 2. | Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.






  (a) | (i) | There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption. |
| --- | --- | --- | --- |

2.

Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.

(a)

(i)

There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.

| (ii) | If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority. |
| --- | --- |

(ii)

If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority.

| (b) | At the time of display or storage of fishery products:






  (i) | the premises must not be used for other purposes; |
| --- | --- | --- |

(b)

At the time of display or storage of fishery products:

(i)

the premises must not be used for other purposes;

| (ii) | vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises; |
| --- | --- |

(ii)

vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;

| (iii) | persons having access to the premises must not introduce other animals;
  and |
| --- | --- |

(iii)

persons having access to the premises must not introduce other animals;

and

| (iv) | the premises must be well lit to facilitate official controls. |
| --- | --- |

(iv)

the premises must be well lit to facilitate official controls.

| 3. | When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice. |
| --- | --- |

3.

When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

| 4. | Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No 854/2004, in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary. |
| --- | --- |

4.

Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No 854/2004, in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary.

CHAPTER III: REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements, where relevant, in establishments handling fishery products.

A.   REQUIREMENTS FOR FRESH FISHERY PRODUCTS

| 1. | Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice. |
| --- | --- |

1.

Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice.

| 2. | Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly with potable water or, on board vessels, clean water immediately after these operations. |
| --- | --- |

2.

Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly with potable water or, on board vessels, clean water immediately after these operations.

| 3. | Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. Fillets and slices must not remain on the worktables beyond the time necessary for their preparation. Fillets and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their preparation. |
| --- | --- |

3.

Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. Fillets and slices must not remain on the worktables beyond the time necessary for their preparation. Fillets and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their preparation.

| 4. | Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products. |
| --- | --- |

4.

Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products.

| 5. | Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the first establishment on land carrying out any activity other than transport or sorting. |
| --- | --- |

5.

Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

B.   REQUIREMENTS FOR FROZEN PRODUCTS

Establishments on land that freeze fishery products must have equipment that satisfies the requirements laid down for freezer vessels in Section VIII, Chapter I, part I. C, points 1 and 2.

C.   REQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS

Food business operators manufacturing mechanically separated fishery products must ensure compliance with the following requirements.

| 1. | The raw materials used must satisfy the following requirements.






  (a) | Only whole fish and bones after filleting may be used to produce mechanically separated fishery products; |
| --- | --- | --- |

1.

The raw materials used must satisfy the following requirements.

(a)

Only whole fish and bones after filleting may be used to produce mechanically separated fishery products;

| (b) | All raw materials must be free from guts. |
| --- | --- |

(b)

All raw materials must be free from guts.

| 2. | The manufacturing process must satisfy the following requirements:






  (a) | Mechanical separation must take place without undue delay after filleting. |
| --- | --- | --- |

2.

The manufacturing process must satisfy the following requirements:

(a)

Mechanical separation must take place without undue delay after filleting.

| (b) | If whole fish are used, they must be gutted and washed beforehand. |
| --- | --- |

(b)

If whole fish are used, they must be gutted and washed beforehand.

| (c) | After production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or a stabilising treatment. |
| --- | --- |

(c)

After production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or a stabilising treatment.

D.   REQUIREMENTS CONCERNING PARASITES

| 1. | The following fishery products must be frozen at a temperature of not more than – 20 °C in all parts of the product for not less than 24 hours; this treatment must be applied to the raw product or the finished product:






  (a) | fishery products to be consumed raw or almost raw; |
| --- | --- | --- |

1.

The following fishery products must be frozen at a temperature of not more than – 20 °C in all parts of the product for not less than 24 hours; this treatment must be applied to the raw product or the finished product:

(a)

fishery products to be consumed raw or almost raw;

| (b) | fishery products from the following species, if they are to undergo a cold smoking process in which the internal temperature of the fishery product is not more than 60 °C:






  (i) | herring; |
| --- | --- | --- |

(b)

fishery products from the following species, if they are to undergo a cold smoking process in which the internal temperature of the fishery product is not more than 60 °C:

(i)

herring;

| (ii) | mackerel; |
| --- | --- |

(ii)

mackerel;

| (iii) | sprat; |
| --- | --- |

(iii)

sprat;

| (iv) | (wild) Atlantic and Pacific salmon; |
| --- | --- |

(iv)

(wild) Atlantic and Pacific salmon;

and

| (c) | marinated and/or salted fishery products, if the processing is insufficient to destroy nematode larvae. |
| --- | --- |

(c)

marinated and/or salted fishery products, if the processing is insufficient to destroy nematode larvae.

| 2. | Food business operators need not carry out the treatment required under point 1 if:






  (a) | epidemiological data are available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites;
  and |
| --- | --- | --- |

2.

Food business operators need not carry out the treatment required under point 1 if:

(a)

epidemiological data are available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites;

and

| (b) | the competent authority so authorises. |
| --- | --- |

(b)

the competent authority so authorises.

| 3. | A document from the manufacturer, stating the type of process they have undergone, must accompany fishery products referred to in point 1 when placed on the market, except when supplied to the final consumer. |
| --- | --- |

3.

A document from the manufacturer, stating the type of process they have undergone, must accompany fishery products referred to in point 1 when placed on the market, except when supplied to the final consumer.

CHAPTER IV: REQUIREMENTS FOR PROCESSED FISHERY PRODUCTS

Food business operators cooking crustaceans and molluscs must ensure compliance with the following requirements.

| 1. | Rapid cooling must follow cooking. Water used for this purpose must be potable water or, on board vessels, clean water. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached. |
| --- | --- |

1.

Rapid cooling must follow cooking. Water used for this purpose must be potable water or, on board vessels, clean water. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached.

| 2. | Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands. |
| --- | --- |

2.

Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

| 3. | After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature laid down in Chapter VII. |
| --- | --- |

3.

After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature laid down in Chapter VII.

CHAPTER V: HEALTH STANDARDS FOR FISHERY PRODUCTS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No 852/2004, food business operators must ensure, depending on the nature of the product or the species, that fishery products placed on the market for human consumption meet the standards laid down in this Chapter.

A.   ORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS

Food business operators must carry out an organoleptic examination of fishery products. In particular, this examination must ensure that fishery products comply with any freshness criteria.

B.   HISTAMINE

Food business operators must ensure that the limits with regard to histamine are not exceeded.

C.   TOTAL VOLATILE NITROGEN

Unprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to TVB-N or TMA-N have been exceeded.

D.   PARASITES

Food business operators must ensure that fishery products have been subjected to a visual examination for the purpose of detecting visible parasites before being placed on the market. They must not place fishery products that are obviously contaminated with parasites on the market for human consumption.

E.   TOXINS HARMFUL TO HUMAN HEALTH

| 1. | Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. |
| --- | --- |

1.

Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.

| 2. | Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be 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 and comply with the standards laid down in Chapter V, point 2, of that section. |
| --- | --- |

2.

Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be 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 and comply with the standards laid down in Chapter V, point 2, of that section.

CHAPTER VI: WRAPPING AND PACKAGING OF FISHERY PRODUCTS

| 1. | Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt-water does not remain in contact with the products. |
| --- | --- |

1.

Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt-water does not remain in contact with the products.

| 2. | Frozen blocks prepared on board vessels must be adequately wrapped before landing. |
| --- | --- |

2.

Frozen blocks prepared on board vessels must be adequately wrapped before landing.

| 3. | When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:






  (a) | is not a source of contamination; |
| --- | --- | --- |

3.

When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:

(a)

is not a source of contamination;

| (b) | is stored in such a manner that it is not exposed to a risk of contamination; |
| --- | --- |

(b)

is stored in such a manner that it is not exposed to a risk of contamination;

| (c) | intended for re-use is easy to clean and, where necessary, to disinfect. |
| --- | --- |

(c)

intended for re-use is easy to clean and, where necessary, to disinfect.

CHAPTER VII: STORAGE OF FISHERY PRODUCTS

Food business operators storing fishery products must ensure compliance with the following requirements.

| 1. | Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice. |
| --- | --- |

1.

Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

| 2. | Frozen fishery products must be kept at a temperature of not more than –18 °C in all parts of the product; however, whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than –9 °C. |
| --- | --- |

2.

Frozen fishery products must be kept at a temperature of not more than –18 °C in all parts of the product; however, whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than –9 °C.

| 3. | Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability. |
| --- | --- |

3.

Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.

CHAPTER VIII: TRANSPORT OF FISHERY PRODUCTS

Food business operators transporting fishery products must ensure compliance with the following requirements.

| 1. | During transport, fishery products must be maintained at the required temperature. In particular:






  (a) | fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice; |
| --- | --- | --- |

1.

During transport, fishery products must be maintained at the required temperature. In particular:

(a)

fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice;

| (b) | frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned food, must be maintained during transport at an even temperature of not more than –18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C. |
| --- | --- |

(b)

frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned food, must be maintained during transport at an even temperature of not more than –18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C.

| 2. | Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits. |
| --- | --- |

2.

Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits.

| 3. | If fishery products are kept under ice, melt water must not remain in contact with the products. |
| --- | --- |

3.

If fishery products are kept under ice, melt water must not remain in contact with the products.

| 4. | Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability. |
| --- | --- |

4.

Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.

SECTION IX: RAW MILK AND DAIRY PRODUCTS

CHAPTER I: RAW MILK — PRIMARY PRODUCTION

Food business operators producing or, as appropriate, collecting raw milk must ensure compliance with the requirements laid down in this Chapter.

I.   HEALTH REQUIREMENTS FOR RAW MILK PRODUCTION

| 1. | Raw milk must come from animals:






  (a) | that do not show any symptoms of infectious diseases communicable to humans through milk; |
| --- | --- | --- |

1.

Raw milk must come from animals:

(a)

that do not show any symptoms of infectious diseases communicable to humans through milk;

| (b) | that are in a good general state of health, present no sign of disease that might result in the contamination of milk and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder; |
| --- | --- |

(b)

that are in a good general state of health, present no sign of disease that might result in the contamination of milk and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder;

| (c) | that do not have any udder wound likely to affect the milk; |
| --- | --- |

(c)

that do not have any udder wound likely to affect the milk;

| (d) | to which no unauthorised substances or products have been administered and that have not undergone illegal treatment within the meaning of Directive 96/23/EC;
  and |
| --- | --- |

(d)

to which no unauthorised substances or products have been administered and that have not undergone illegal treatment within the meaning of Directive 96/23/EC;

and

| (e) | in respect of which, where authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed. |
| --- | --- |

(e)

in respect of which, where authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed.

| 2. | (a) | In particular, as regards brucellosis, raw milk must come from:






  (i) | cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC (25), is free or officially free of brucellosis; |
| --- | --- | --- | --- |

2.

(a)

In particular, as regards brucellosis, raw milk must come from:

(i)

cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC (25), is free or officially free of brucellosis;

| (ii) | sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive 91/68/EEC (26);
  or |
| --- | --- |

(ii)

sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive 91/68/EEC (26);

or

| (iii) | females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved. |
| --- | --- |

(iii)

females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved.

| (b) | As regards tuberculosis, raw milk must come from:






  (i) | cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of tuberculosis;
  or |
| --- | --- | --- |

(b)

As regards tuberculosis, raw milk must come from:

(i)

cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of tuberculosis;

or

| (ii) | females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved. |
| --- | --- |

(ii)

females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved.

| (c) | If goats are kept together with cows, such goats must be inspected and tested for tuberculosis. |
| --- | --- |

(c)

If goats are kept together with cows, such goats must be inspected and tested for tuberculosis.

| 3. | However, raw milk from animals that do not meet the requirements of point 2 may be used with the authorisation of the competent authority:






  (a) | in the case of cows or buffaloes that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to the phosphatase test; |
| --- | --- | --- |

3.

However, raw milk from animals that do not meet the requirements of point 2 may be used with the authorisation of the competent authority:

(a)

in the case of cows or buffaloes that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to the phosphatase test;

| (b) | in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, either:






  (i) | for the manufacture of cheese with a maturation period of at least two months;
  or |
| --- | --- | --- |

(b)

in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, either:

(i)

for the manufacture of cheese with a maturation period of at least two months;

or

| (ii) | after having undergone heat treatment such as to show a negative reaction to the phosphatase test; |
| --- | --- |

(ii)

after having undergone heat treatment such as to show a negative reaction to the phosphatase test;

and

| (c) | in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure its safety. |
| --- | --- |

(c)

in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure its safety.

| 4. | Raw milk from any animal not complying with the requirements of points 1 to 3 — in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC — must not be used for human consumption. |
| --- | --- |

4.

Raw milk from any animal not complying with the requirements of points 1 to 3 — in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC — must not be used for human consumption.

| 5. | The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk. |
| --- | --- |

5.

The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk.

II.   HYGIENE ON MILK PRODUCTION HOLDINGS

A.   Requirements for premises and equipment

| 1. | Milking equipment, and premises where milk is stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk. |
| --- | --- |

1.

Milking equipment, and premises where milk is stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk.

| 2. | Premises for the storage of milk must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment. |
| --- | --- |

2.

Premises for the storage of milk must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment.

| 3. | Surfaces of equipment that are intended to come into contact with milk (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials. |
| --- | --- |

3.

Surfaces of equipment that are intended to come into contact with milk (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.

| 4. | After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of raw milk must be cleaned and disinfected in an appropriate manner before re-use. |
| --- | --- |

4.

After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of raw milk must be cleaned and disinfected in an appropriate manner before re-use.

B.   Hygiene during milking, collection and transport

| 1. | Milking must be carried out hygienically, ensuring in particular:






  (a) | that, before milking starts, the teats, udder and adjacent parts are clean; |
| --- | --- | --- |

1.

Milking must be carried out hygienically, ensuring in particular:

(a)

that, before milking starts, the teats, udder and adjacent parts are clean;

| (b) | that milk from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk presenting such abnormalities is not used for human consumption; |
| --- | --- |

(b)

that milk from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk presenting such abnormalities is not used for human consumption;

| (c) | that milk from animals showing clinical signs of udder disease is not used for human consumption otherwise than in accordance with the instructions of a veterinarian; |
| --- | --- |

(c)

that milk from animals showing clinical signs of udder disease is not used for human consumption otherwise than in accordance with the instructions of a veterinarian;

| (d) | the identification of animals undergoing medical treatment likely to transfer residues to the milk, and that milk obtained from such animals before the end of the prescribed withdrawal period is not used for human consumption;
  and |
| --- | --- |

(d)

the identification of animals undergoing medical treatment likely to transfer residues to the milk, and that milk obtained from such animals before the end of the prescribed withdrawal period is not used for human consumption;

and

| (e) | that teat dips or sprays are used only if the competent authority has approved them and in a manner that does not produce unacceptable residue levels in the milk. |
| --- | --- |

(e)

that teat dips or sprays are used only if the competent authority has approved them and in a manner that does not produce unacceptable residue levels in the milk.

| 2. | Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must be cooled immediately to not more than 8 °C in the case of daily collection, or not more than 6 °C if collection is not daily. |
| --- | --- |

2.

Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must be cooled immediately to not more than 8 °C in the case of daily collection, or not more than 6 °C if collection is not daily.

| 3. | During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk must not be more than 10 °C. |
| --- | --- |

3.

During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk must not be more than 10 °C.

| 4. | Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:






  (a) | the milk is processed within two hours of milking;
  or |
| --- | --- | --- |

4.

Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:

(a)

the milk is processed within two hours of milking;

or

| (b) | a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises. |
| --- | --- |

(b)

a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises.

C.   Staff hygiene

| 1. | Persons performing milking and/or handling raw milk must wear suitable clean clothes. |
| --- | --- |

1.

Persons performing milking and/or handling raw milk must wear suitable clean clothes.

| 2. | Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk to wash their hands and arms. |
| --- | --- |

2.

Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk to wash their hands and arms.

III.   CRITERIA FOR RAW MILK

| 1. | The following criteria for raw milk apply pending the establishment of standards in the context of more specific legislation on the quality of milk and dairy products. |
| --- | --- |

1.

The following criteria for raw milk apply pending the establishment of standards in the context of more specific legislation on the quality of milk and dairy products.

| 2. | A representative number of samples of raw milk collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4.
  The checks may be carried out by, or on behalf of:






  (a) | the food business operator producing the milk; |
| --- | --- | --- |

2.

A representative number of samples of raw milk collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4.

The checks may be carried out by, or on behalf of:

(a)

the food business operator producing the milk;

| (b) | the food business operator collecting or processing the milk; |
| --- | --- |

(b)

the food business operator collecting or processing the milk;

| (c) | a group of food business operators;
  or |
| --- | --- |

(c)

a group of food business operators;

or

| (d) | in the context of a national or regional control scheme. |
| --- | --- |

(d)

in the context of a national or regional control scheme.

| 3. | (a) | Food business operators must initiate procedures to ensure that raw milk meets the following criteria:






  (i) | for raw cows' milk:






  Plate count at 30 °C (per ml) | ≤ 100 000  (*1) |
| --- | --- | --- | --- | --- |
| Somatic cell count (per ml) | ≤ 400 000  (*2) |

3.

(a)

Food business operators must initiate procedures to ensure that raw milk meets the following criteria:

(i)

for raw cows' milk:

Plate count at 30 °C (per ml)

≤ 100 000  (*1)

Somatic cell count (per ml)

≤ 400 000  (*2)

| (ii) | for raw milk from other species:






  Plate count at 30 °C (per ml) | ≤ 1 500 000  (*3) |
| --- | --- | --- |

(ii)

for raw milk from other species:

Plate count at 30 °C (per ml)

≤ 1 500 000  (*3)

| (b) | However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion:






  Plate count at 30 °C (per ml) | ≤ 500 000  (*4) |
| --- | --- | --- |

(b)

However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion:

Plate count at 30 °C (per ml)

≤ 500 000  (*4)

| 4. | Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:






  (a) | it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90 (27), exceeds the levels authorised under that Regulation;
  or |
| --- | --- | --- |

4.

Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:

(a)

it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90 (27), exceeds the levels authorised under that Regulation;

or

| (b) | the combined total of residues of antibiotic substances exceeds any maximum permitted value. |
| --- | --- |

(b)

the combined total of residues of antibiotic substances exceeds any maximum permitted value.

| 5. | When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation. |
| --- | --- |

5.

When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER II: REQUIREMENTS CONCERNING DAIRY PRODUCTS

I.   TEMPERATURE REQUIREMENTS

| 1. | Food business operators must ensure that, upon acceptance at a processing establishment, milk is quickly cooled to not more than 6 °C and kept at that temperature until processed. |
| --- | --- |

1.

Food business operators must ensure that, upon acceptance at a processing establishment, milk is quickly cooled to not more than 6 °C and kept at that temperature until processed.

| 2. | However, food business operators may keep milk at a higher temperature if:






  (a) | processing begins immediately after milking, or within four hours of acceptance at the processing establishment;
  or |
| --- | --- | --- |

2.

However, food business operators may keep milk at a higher temperature if:

(a)

processing begins immediately after milking, or within four hours of acceptance at the processing establishment;

or

| (b) | the competent authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy products. |
| --- | --- |

(b)

the competent authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy products.

II.   REQUIREMENTS FOR HEAT TREATMENT

| 1. | When raw milk or dairy products undergo heat treatment, food business operators must ensure that this satisfies the requirements of Regulation (EC) No 852/2004, Annex II, Chapter XI. |
| --- | --- |

1.

When raw milk or dairy products undergo heat treatment, food business operators must ensure that this satisfies the requirements of Regulation (EC) No 852/2004, Annex II, Chapter XI.

| 2. | When considering whether to subject raw milk to heat treatment, food business operators must:






  (a) | have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC) No 854/2004;
  and |
| --- | --- | --- |

2.

When considering whether to subject raw milk to heat treatment, food business operators must:

(a)

have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC) No 854/2004;

and

| (b) | comply with any requirements that the competent authority may impose in this regard when approving establishments or carrying out checks in accordance with Regulation (EC) No 854/2004. |
| --- | --- |

(b)

comply with any requirements that the competent authority may impose in this regard when approving establishments or carrying out checks in accordance with Regulation (EC) No 854/2004.

III.   CRITERIA FOR RAW COWS' MILK

| 1. | Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before processing:






  (a) | raw cows' milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml;
  and |
| --- | --- | --- |

1.

Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before processing:

(a)

raw cows' milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml;

and

| (b) | processed cows' milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml. |
| --- | --- |

(b)

processed cows' milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml.

| 2. | When milk fails to meet the criteria laid down in point 1, the food business operator must inform the competent authority and take measures to correct the situation. |
| --- | --- |

2.

When milk fails to meet the criteria laid down in point 1, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER III: WRAPPING AND PACKAGING

Sealing of consumer packages must be carried out immediately after filling in the establishment where the last heat treatment of liquid dairy products takes place, by means of sealing devices that prevent contamination. The sealing system must be designed in such a way that, after opening, the evidence of its opening remains clear and easy to check.

CHAPTER IV: LABELLING

| 1. | In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:






  (a) | in the case of raw milk intended for direct human consumption, the words ‘raw milk’; |
| --- | --- | --- |

1.

In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:

(a)

in the case of raw milk intended for direct human consumption, the words ‘raw milk’;

| (b) | in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words ‘made with raw milk’. |
| --- | --- |

(b)

in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words ‘made with raw milk’.

| 2. | The requirements of point 1 apply to products destined for retail trade. The term ‘labelling’ includes any packaging, document, notice, label, ring or collar accompanying or referring to such products. |
| --- | --- |

2.

The requirements of point 1 apply to products destined for retail trade. The term ‘labelling’ includes any packaging, document, notice, label, ring or collar accompanying or referring to such products.

CHAPTER V: IDENTIFICATION MARKING

By way of derogation from the requirements of Annex II, Section I:

| 1. | rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated; |
| --- | --- |

1.

rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated;

| 2. | in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment. |
| --- | --- |

2.

in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment.

SECTION X: EGGS AND EGG PRODUCTS

CHAPTER I: EGGS

| 1. | At the producer's premises, and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, effectively protected from shocks and out of direct sunshine. |
| --- | --- |

1.

At the producer's premises, and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, effectively protected from shocks and out of direct sunshine.

| 2. | Eggs must be stored and transported at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties. |
| --- | --- |

2.

Eggs must be stored and transported at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties.

| 3. | Eggs must be delivered to the consumer within a maximum time limit of 21 days of laying. |
| --- | --- |

3.

Eggs must be delivered to the consumer within a maximum time limit of 21 days of laying.

CHAPTER II: EGG PRODUCTS

I.   REQUIREMENTS FOR ESTABLISHMENTS

Food business operators must ensure that establishments for the manufacture of egg products are constructed, laid out and equipped so as to ensure separation of the following operations:

| 1. | washing, drying and disinfecting dirty eggs, where carried out; |
| --- | --- |

1.

washing, drying and disinfecting dirty eggs, where carried out;

| 2. | breaking eggs, collecting their contents and removing parts of shells and membranes;
  and |
| --- | --- |

2.

breaking eggs, collecting their contents and removing parts of shells and membranes;

and

| 3. | operations other than those referred to in points 1 and 2. |
| --- | --- |

3.

operations other than those referred to in points 1 and 2.

II.   RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that raw materials used to manufacture egg products comply with the following requirements.

| 1. | The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre delivers them directly to a processing establishment, where they must be broken as soon as possible. |
| --- | --- |

1.

The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre delivers them directly to a processing establishment, where they must be broken as soon as possible.

| 2. | Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III. |
| --- | --- |

2.

Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III.

III.   SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that all operations are carried out in such a way as to avoid any contamination during production, handling and storage of egg products, in particular by ensuring compliance with the following requirements.

| 1. | Eggs must not be broken unless they are clean and dry. |
| --- | --- |

1.

Eggs must not be broken unless they are clean and dry.

| 2. | Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible. |
| --- | --- |

2.

Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible.

| 3. | Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed. |
| --- | --- |

3.

Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed.

| 4. | Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption. |
| --- | --- |

4.

Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption.

| 5. | After breaking, each particle of the egg product must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment, if this processing renders it fit for human consumption. When a batch is found to be unfit for human consumption, it must be denatured so as to ensure that it is not used for human consumption. |
| --- | --- |

5.

After breaking, each particle of the egg product must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment, if this processing renders it fit for human consumption. When a batch is found to be unfit for human consumption, it must be denatured so as to ensure that it is not used for human consumption.

| 6. | Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment. |
| --- | --- |

6.

Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment.

| 7. | If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as soon as possible. |
| --- | --- |

7.

If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as soon as possible.

| 8. | Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing. |
| --- | --- |

8.

Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing.

IV.   ANALYTICAL SPECIFICATIONS

| 1. | The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product. |
| --- | --- |

1.

The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product.

| 2. | The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process. |
| --- | --- |

2.

The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process.

| 3. | The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product. |
| --- | --- |

3.

The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product.

V.   LABELLING AND IDENTIFICATION MARKING

| 1. | In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured. |
| --- | --- |

1.

In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured.

| 2. | In the case of liquid eggs, the label referred to in point 1 must also bear the words: ‘non-pasteurised egg products - to be treated at place of destination’ and indicate the date and hour of breaking. |
| --- | --- |

2.

In the case of liquid eggs, the label referred to in point 1 must also bear the words: ‘non-pasteurised egg products - to be treated at place of destination’ and indicate the date and hour of breaking.

SECTION XI: FROGS' LEGS AND SNAILS

Food business operators preparing frogs' legs or snails for human consumption must ensure compliance with the following requirements.

| 1. | Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose. |
| --- | --- |

1.

Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose.

| 2. | Establishment in which frogs' legs are prepared must have a room reserved for the storage and washing of live frogs, and for their slaughter and bleeding. This room must be physically separate from the preparation room. |
| --- | --- |

2.

Establishment in which frogs' legs are prepared must have a room reserved for the storage and washing of live frogs, and for their slaughter and bleeding. This room must be physically separate from the preparation room.

| 3. | Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human consumption. |
| --- | --- |

3.

Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human consumption.

| 4. | Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination indicates that they might present a hazard, they must not be used for human consumption. |
| --- | --- |

4.

Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination indicates that they might present a hazard, they must not be used for human consumption.

| 5. | Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately chilled to a temperature approaching that of melting ice, frozen or processed. |
| --- | --- |

5.

Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately chilled to a temperature approaching that of melting ice, frozen or processed.

| 6. | After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human consumption. |
| --- | --- |

6.

After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human consumption.

SECTION XII: RENDERED ANIMAL FATS AND GREAVES

CHAPTER I: REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS

Food business operators must ensure that establishments collecting or processing raw materials for the production of rendered animal fats and greaves comply with the following requirements.

| 1. | Centres for the collection of raw materials and further transport to processing establishments must be equipped with facilities for the storage of raw materials at a temperature of not more than 7 °C. |
| --- | --- |

1.

Centres for the collection of raw materials and further transport to processing establishments must be equipped with facilities for the storage of raw materials at a temperature of not more than 7 °C.

| 2. | Each processing establishment must have:






  (a) | refrigeration facilities; |
| --- | --- | --- |

2.

Each processing establishment must have:

(a)

refrigeration facilities;

| (b) | a dispatch room, unless the establishment dispatches rendered animal fat only in tankers;
  and |
| --- | --- |

(b)

a dispatch room, unless the establishment dispatches rendered animal fat only in tankers;

and

| (c) | if appropriate, suitable equipment for the preparation of products consisting of rendered animal fats mixed with other foodstuffs and/or seasonings. |
| --- | --- |

(c)

if appropriate, suitable equipment for the preparation of products consisting of rendered animal fats mixed with other foodstuffs and/or seasonings.

| 3. | However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than as provided for in Chapter II, point 1(d). |
| --- | --- |

3.

However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than as provided for in Chapter II, point 1(d).

CHAPTER II: HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES

Food business operators preparing rendered animal fats and greaves must ensure compliance with the following requirements.

| 1. | Raw materials must:






  (a) | derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection; |
| --- | --- | --- |

1.

Raw materials must:

(a)

derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;

| (b) | consist of adipose tissues or bones, which are reasonably free from blood and impurities; |
| --- | --- |

(b)

consist of adipose tissues or bones, which are reasonably free from blood and impurities;

| (c) | come from establishments registered or approved pursuant to Regulation (EC) No 852/2003 or in accordance with this Regulation;
  and |
| --- | --- |

(c)

come from establishments registered or approved pursuant to Regulation (EC) No 852/2003 or in accordance with this Regulation;

and

| (d) | be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within 12 hours after the day on which they were obtained. |
| --- | --- |

(d)

be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within 12 hours after the day on which they were obtained.

| 2. | During rendering the use of solvents is prohibited. |
| --- | --- |

2.

During rendering the use of solvents is prohibited.

| 3. | When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality. |
| --- | --- |

3.

When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality.

| 4. | Rendered animal fat, depending on type, must meet the following standards: | Ruminants | Porcine animals | Other animal fat |
| --- | --- | --- | --- | --- |
| Edible tallow | Tallow for refining | Edible fat | Lard and other fat for refining | Edible | For refining |
| Premier jus (28) | Other | Lard (29) | Other |
| FFA (m/m % oleic acid) maximum | 0,75 | 1,25 | 3,0 | 0,75 | 1,25 | 2,0 | 1,25 | 3,0 |
| Peroxide maximum | 4 meq/kg | 4 meq/kg | 6 meq/kg | 4 meq/kg | 4 meq/kg | 6 meq/kg | 4 meq/kg | 10 meq/kg |
| Total insoluble impurities | Maximum 0,15  % | Maximum 0,5  % |
| Odour, taste, colour | Normal |

4.

Rendered animal fat, depending on type, must meet the following standards:

Ruminants

Porcine animals

Other animal fat

Edible tallow

Tallow for refining

Edible fat

Lard and other fat for refining

Edible

For refining

Premier jus (28)

Other

Lard (29)

Other

FFA (m/m % oleic acid) maximum

0,75

1,25

3,0

0,75

1,25

2,0

1,25

3,0

Peroxide maximum

4 meq/kg

4 meq/kg

6 meq/kg

4 meq/kg

4 meq/kg

6 meq/kg

4 meq/kg

10 meq/kg

Total insoluble impurities

Maximum 0,15  %

Maximum 0,5  %

Odour, taste, colour

Normal

| 5. | Greaves intended for human consumption must be stored in accordance with the following temperature requirements.






  (a) | When greaves are rendered at a temperature of not more than 70 °C, they must be stored:






  (i) | at a temperature of not more than 7 °C for a period not exceeding 24 hours;
  or |
| --- | --- | --- | --- |

5.

Greaves intended for human consumption must be stored in accordance with the following temperature requirements.

(a)

When greaves are rendered at a temperature of not more than 70 °C, they must be stored:

(i)

at a temperature of not more than 7 °C for a period not exceeding 24 hours;

or

| (ii) | at a temperature of not more than –18 °C. |
| --- | --- |

(ii)

at a temperature of not more than –18 °C.

| (b) | When greaves are rendered at a temperature of more than 70 °C and have a moisture content of 10 % (m/m) or more, they must be stored:






  (i) | at a temperature of not more than 7 °C for a period not exceeding 48 hours or a time/temperature ratio giving an equivalent guarantee;
  or |
| --- | --- | --- |

(b)

When greaves are rendered at a temperature of more than 70 °C and have a moisture content of 10 % (m/m) or more, they must be stored:

(i)

at a temperature of not more than 7 °C for a period not exceeding 48 hours or a time/temperature ratio giving an equivalent guarantee;

or

| (ii) | at a temperature of not more than –18 °C. |
| --- | --- |

(ii)

at a temperature of not more than –18 °C.

| (c) | When greaves are rendered at a temperature of more than 70 °C and have a moisture content of less than 10 % (m/m), there are no specific requirements. |
| --- | --- |

(c)

When greaves are rendered at a temperature of more than 70 °C and have a moisture content of less than 10 % (m/m), there are no specific requirements.

SECTION XIII: TREATED STOMACHS, BLADDERS AND INTESTINES

Food business operators treating stomachs, bladders and intestines must ensure compliance with the following requirements.

| 1. | Animal intestines, bladders and stomachs may be placed on the market only if:






  (a) | they derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection; |
| --- | --- | --- |

1.

Animal intestines, bladders and stomachs may be placed on the market only if:

(a)

they derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;

| (b) | they are salted, heated or dried;
  and |
| --- | --- |

(b)

they are salted, heated or dried;

and

| (c) | after the treatment referred to in (b), effective measures are taken to prevent re-contamination. |
| --- | --- |

(c)

after the treatment referred to in (b), effective measures are taken to prevent re-contamination.

| 2. | Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3 °C. |
| --- | --- |

2.

Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3 °C.

SECTION XIV: GELATINE

| 1. | Food business operators manufacturing gelatine must ensure compliance with the requirements of this section. |
| --- | --- |

1.

Food business operators manufacturing gelatine must ensure compliance with the requirements of this section.

| 2. | For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents. |
| --- | --- |

2.

For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

| 1. | For the production of gelatine intended for use in food, the following raw materials may be used:






  (a) | bones; |
| --- | --- | --- |

1.

For the production of gelatine intended for use in food, the following raw materials may be used:

(a)

bones;

| (b) | hides and skins of farmed ruminant animals; |
| --- | --- |

(b)

hides and skins of farmed ruminant animals;

| (c) | pig skins; |
| --- | --- |

(c)

pig skins;

| (d) | poultry skin; |
| --- | --- |

(d)

poultry skin;

| (e) | tendons and sinews; |
| --- | --- |

(e)

tendons and sinews;

| (f) | wild game hides and skins;
  and |
| --- | --- |

(f)

wild game hides and skins;

and

| (g) | fish skin and bones. |
| --- | --- |

(g)

fish skin and bones.

| 2. | The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed. |
| --- | --- |

2.

The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

| 3. | Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption. |
| --- | --- |

3.

Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

| 4. | Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation. |
| --- | --- |

4.

Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

| 5. | Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.






  (a) | They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities. |
| --- | --- | --- |

5.

Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

(a)

They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

| (b) | The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials. |
| --- | --- |

(b)

The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

| (c) | If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch. |
| --- | --- |

(c)

If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

| 1. | In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment. |
| --- | --- |

1.

In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment.

| 2. | Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature. |
| --- | --- |

2.

Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

| 1. | The production process for gelatine must ensure that:






  (a) | all ruminant bone material derived from animals born, reared or slaughtered in countries or regions classified as having a low incidence of BSE in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days, followed by an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a sterilisation step of 138 to 140 °C during four seconds or by any approved equivalent process;
  and |
| --- | --- | --- |

1.

The production process for gelatine must ensure that:

(a)

all ruminant bone material derived from animals born, reared or slaughtered in countries or regions classified as having a low incidence of BSE in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days, followed by an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a sterilisation step of 138 to 140 °C during four seconds or by any approved equivalent process;

and

| (b) | other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation. |
| --- | --- |

(b)

other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.

| 2. | If a food business operator manufacturing gelatine complies with the requirements applying to gelatine intended for human consumption in respect of all the gelatine that it produces, it may produce and store gelatine not intended for human consumption in the same establishment. |
| --- | --- |

2.

If a food business operator manufacturing gelatine complies with the requirements applying to gelatine intended for human consumption in respect of all the gelatine that it produces, it may produce and store gelatine not intended for human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table.

| Residue | Limit |
| --- | --- |
| As | 1 ppm |
| Pb | 5 ppm |
| Cd | 0,5  ppm |
| Hg | 0,15  ppm |
| Cr | 10 ppm |
| Cu | 30 ppm |
| Zn | 50 ppm |
| SO2 (Reith Williams) | 50 ppm |
| H2O2 (European Pharmacopoeia 1986 (V2O2)) | 10 ppm |

Residue

Limit

As

1 ppm

Pb

5 ppm

Cd

0,5  ppm

Hg

0,15  ppm

Cr

10 ppm

Cu

30 ppm

Zn

50 ppm

SO2 (Reith Williams)

50 ppm

H2O2 (European Pharmacopoeia 1986 (V2O2))

10 ppm

SECTION XV: COLLAGEN

| 1. | Food business operators manufacturing collagen must ensure compliance with the requirements of this section. |
| --- | --- |

1.

Food business operators manufacturing collagen must ensure compliance with the requirements of this section.

| 2. | For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents. |
| --- | --- |

2.

For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

| 1. | For the production of collagen intended for use in food, the following raw materials may be used:






  (a) | hides and skins of farmed ruminant animals; |
| --- | --- | --- |

1.

For the production of collagen intended for use in food, the following raw materials may be used:

(a)

hides and skins of farmed ruminant animals;

| (b) | pig skins and bones; |
| --- | --- |

(b)

pig skins and bones;

| (c) | poultry skin and bones; |
| --- | --- |

(c)

poultry skin and bones;

| (d) | tendons; |
| --- | --- |

(d)

tendons;

| (e) | wild game hides and skins;
  and |
| --- | --- |

(e)

wild game hides and skins;

and

| (f) | fish skin and bones. |
| --- | --- |

(f)

fish skin and bones.

| 2. | The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed. |
| --- | --- |

2.

The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

| 3. | Raw materials listed in point 1(a) to (d) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption. |
| --- | --- |

3.

Raw materials listed in point 1(a) to (d) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

| 4. | Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation. |
| --- | --- |

4.

Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

| 5. | Collection centres and tanneries may also supply raw material for the production of collagen intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.






  (a) | They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities. |
| --- | --- | --- |

5.

Collection centres and tanneries may also supply raw material for the production of collagen intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

(a)

They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

| (b) | The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials. |
| --- | --- |

(b)

The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

| (c) | If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch. |
| --- | --- |

(c)

If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

| 1. | In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the collagen-processing establishment. |
| --- | --- |

1.

In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the collagen-processing establishment.

| 2. | Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature. |
| --- | --- |

2.

Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN

| 1. | Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion or by an approved equivalent process. |
| --- | --- |

1.

Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion or by an approved equivalent process.

| 2. | After having been subjected to the process referred to in point 1, collagen may undergo a drying process. |
| --- | --- |

2.

After having been subjected to the process referred to in point 1, collagen may undergo a drying process.

| 3. | If a food business operator manufacturing collagen complies with the requirements applying to collagen intended for human consumption in respect of all the collagen that it produces, it may produce and store collagen not intended for human consumption in the same establishment. |
| --- | --- |

3.

If a food business operator manufacturing collagen complies with the requirements applying to collagen intended for human consumption in respect of all the collagen that it produces, it may produce and store collagen not intended for human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that collagen complies with the residue limits set out in the following table.

| Residue | Limit |
| --- | --- |
| As | 1 ppm |
| Pb | 5 ppm |
| Cd | 0,5 ppm |
| Hg | 0,15 ppm |
| Cr | 10 ppm |
| Cu | 30 ppm |
| Zn | 50 ppm |
| SO2 (Reith Williams) | 50 ppm |
| H2O2 (European Pharmacopoeia 1986 (V2O2)) | 10 ppm |

Residue

Limit

As

1 ppm

Pb

5 ppm

Cd

0,5 ppm

Hg

0,15 ppm

Cr

10 ppm

Cu

30 ppm

Zn

50 ppm

SO2 (Reith Williams)

50 ppm

H2O2 (European Pharmacopoeia 1986 (V2O2))

10 ppm

CHAPTER V: LABELLING

Wrapping and packaging containing collagen must bear the words ‘collagen fit for human consumption’ and indicate the date of preparation.

Appendix to ANNEX III

Image 1

---

(1)  
  OJ C 365 E, 19.12.2000, p. 58.

1

(2)  
  OJ C 155, 29.5.2001, p. 39.

2

(3)  Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 288), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 23), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.

3

(4)  See page 3 of this Official Journal.

4

(5)  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 (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

5

(6)  
  OJ L 371, 31.12.1994, p. 36.

6

(7)  
  OJ L 53, 9.3.1995, p. 31.

7

(8)  
  OJ L 105 9.5.1995, p. 40.

8

(9)  
  OJ L 105, 9.5.1995, p. 44.

9

(10)  
  OJ L 109, 16.5.1995, p. 44.

10

(11)  
  OJ L 243, 11.10.1995, p. 21.

11

(12)  
  OJ L 243, 11.10.1995, p. 25.

12

(13)  
  OJ L 243, 11.10.1995, p. 29.

13

(14)  
  OJ L 325, 12.12.2003, p. 1.

14

(15)  
  OJ L 157, 30.4.2004, p. 33.

15

(16)  
  OJ L 168, 2.7.1994, p. 34.

16

(17)  Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49). Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60).

17

(18)  
  OJ L 184, 17.7.1999, p. 23.

18

(19)  See page 83 of this Official Journal.

19

(20)  Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9). Directive amended by the 2003 Act of Accession.

20

(21)  Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (OJ L 18, 23.1.2003, p. 11).

21

(22)  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

22

(23)  Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs (OJ L 173, 6.7.1990, p. 5). Regulation as last amended by Regulation (EC) No 2052/2003 (OJ L 305, 22.11.2003, p. 1).

23

(24)  Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

24

(25)  Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64). Directive as last amended by the 2003 Act of Accession.

25

(26)  Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

26

(*1)  Rolling geometric average over a two-month period, with at least two samples per month.

*1

(*2)  Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels.

*2

(*3)  Rolling geometric average over a two-month period, with at least two samples per month.

*3

(*4)  Rolling geometric average over a two-month period, with at least two samples per month.

*4

(27)  Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 546/2004 (OJ L 87, 25.3.2004, p. 13).

27

(28)  Rendered animal fat obtained by low-temperature rendering of fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms.

28

(29)  Rendered animal fat obtained from the adipose tissues of porcine animals.

29

---

| 25.6.2004 | EN | Official Journal of the European Union | L 226/83 |
| --- | --- | --- | --- |

25.6.2004

EN

Official Journal of the European Union

L 226/83

---

Corrigendum 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

(
  Official Journal of the European Union L 139 of 30 April 2004
  )

Regulation (EC) No 854/2004 should read as follows:

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

| (1) | Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) lays down general hygiene rules applying to all foodstuffs and Regulation (EC) No 853/2004 of the European Parliament and of the Council (5) lays down specific hygiene rules for products of animal origin. |
| --- | --- |

(1)

Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) lays down general hygiene rules applying to all foodstuffs and Regulation (EC) No 853/2004 of the European Parliament and of the Council (5) lays down specific hygiene rules for products of animal origin.

| (2) | Specific rules for official controls on products of animal origin are necessary to take account of specific aspects associated with such products. |
| --- | --- |

(2)

Specific rules for official controls on products of animal origin are necessary to take account of specific aspects associated with such products.

| (3) | The scope of the specific control rules should mirror the scope of the specific hygiene rules for food business operators laid down in Regulation (EC) No 853/2004. However, Member States should also carry out appropriate official controls to enforce national rules established in accordance with Article 1(4) of that Regulation. They may do so by extending the principles of this Regulation to such national rules. |
| --- | --- |

(3)

The scope of the specific control rules should mirror the scope of the specific hygiene rules for food business operators laid down in Regulation (EC) No 853/2004. However, Member States should also carry out appropriate official controls to enforce national rules established in accordance with Article 1(4) of that Regulation. They may do so by extending the principles of this Regulation to such national rules.

| (4) | Official controls on products of animal origin should cover all aspects that are important for protecting public health and, where appropriate, animal health and animal welfare. They should be based on the most recent relevant information available and it should therefore be possible to adapt them as relevant new information becomes available. |
| --- | --- |

(4)

Official controls on products of animal origin should cover all aspects that are important for protecting public health and, where appropriate, animal health and animal welfare. They should be based on the most recent relevant information available and it should therefore be possible to adapt them as relevant new information becomes available.

| (5) | Community legislation on food safety should have a sound scientific basis. To that end, the European Food Safety Authority should be consulted whenever necessary. |
| --- | --- |

(5)

Community legislation on food safety should have a sound scientific basis. To that end, the European Food Safety Authority should be consulted whenever necessary.

| (6) | The nature and intensity of the official controls should be based on an assessment of public health risks, animal health and welfare, where appropriate, the type and throughput of the processes carried out and the food business operator concerned. |
| --- | --- |

(6)

The nature and intensity of the official controls should be based on an assessment of public health risks, animal health and welfare, where appropriate, the type and throughput of the processes carried out and the food business operator concerned.

| (7) | It is appropriate to provide for the adaptation of certain specific control rules, through the transparent procedure provided for in Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004, to provide flexibility in order to accommodate the specific needs of establishments which use traditional methods, have a low throughput or are located in regions that are subject to special geographical constraints. The procedure should also allow pilot projects to take place in order to try out new approaches to hygiene controls on meat. However, such flexibility should not compromise food hygiene objectives. |
| --- | --- |

(7)

It is appropriate to provide for the adaptation of certain specific control rules, through the transparent procedure provided for in Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004, to provide flexibility in order to accommodate the specific needs of establishments which use traditional methods, have a low throughput or are located in regions that are subject to special geographical constraints. The procedure should also allow pilot projects to take place in order to try out new approaches to hygiene controls on meat. However, such flexibility should not compromise food hygiene objectives.

| (8) | Official controls on the production of meat are necessary to verify that food business operators comply with hygiene rules and respect criteria and targets laid down in Community legislation. These official controls should comprise audits of food business operators ‘activities and inspections, including checks on food business operators’ own controls. |
| --- | --- |

(8)

Official controls on the production of meat are necessary to verify that food business operators comply with hygiene rules and respect criteria and targets laid down in Community legislation. These official controls should comprise audits of food business operators ‘activities and inspections, including checks on food business operators’ own controls.

| (9) | In view of their specific expertise, it is appropriate for official veterinarians to carry out audits and inspections of slaughterhouses, game handling establishments and certain cutting plants. Member States should have discretion to decide which are the most appropriate staff for audits and inspections of other types of establishments. |
| --- | --- |

(9)

In view of their specific expertise, it is appropriate for official veterinarians to carry out audits and inspections of slaughterhouses, game handling establishments and certain cutting plants. Member States should have discretion to decide which are the most appropriate staff for audits and inspections of other types of establishments.

| (10) | Official controls on the production of live bivalve molluscs and on fishery products are necessary to check for compliance with the criteria and targets laid down in Community legislation. Official controls on the production of live bivalve molluscs should in particular target relaying and production areas for bivalve molluscs and the end product. |
| --- | --- |

(10)

Official controls on the production of live bivalve molluscs and on fishery products are necessary to check for compliance with the criteria and targets laid down in Community legislation. Official controls on the production of live bivalve molluscs should in particular target relaying and production areas for bivalve molluscs and the end product.

| (11) | Official controls on the production of raw milk are necessary to check for compliance with criteria and targets laid down in Community legislation. Such official controls should in particular target milk production holdings and raw milk upon collection. |
| --- | --- |

(11)

Official controls on the production of raw milk are necessary to check for compliance with criteria and targets laid down in Community legislation. Such official controls should in particular target milk production holdings and raw milk upon collection.

| (12) | The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow competent authorities and the industries affected time to adapt. |
| --- | --- |

(12)

The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow competent authorities and the industries affected time to adapt.

| (13) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6), |
| --- | --- |

(13)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.   This Regulation lays down specific rules for the organisation of official controls on products of animal origin.

2.   It shall apply only in respect of activities and persons to which Regulation (EC) No 853/2004 applies.

3.   The performance of official controls pursuant to this Regulation shall be without prejudice to food business operators' primary legal responsibility for ensuring food safety, as laid down in 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), and any civil or criminal liability arising from the breach of their obligations.

Article 2

Definitions

1.   For the purposes of this Regulation, the following definitions shall apply:

| (a) | ‘official control’ means any form of control that the competent authority performs for the verification of compliance with food law, including animal health and animal welfare rules; |
| --- | --- |

(a)

‘official control’ means any form of control that the competent authority performs for the verification of compliance with food law, including animal health and animal welfare rules;

| (b) | ‘verification’ means checking, by examination and the provision of objective evidence, whether specified requirements have been fulfilled; |
| --- | --- |

(b)

‘verification’ means checking, by examination and the provision of objective evidence, whether specified requirements have been fulfilled;

| (c) | ‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence; |
| --- | --- |

(c)

‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;

| (d) | ‘audit’ means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives; |
| --- | --- |

(d)

‘audit’ means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives;

| (e) | ‘inspection’ means the examination of establishments, of animals and food, and the processing thereof, of food businesses, and their management and production systems, including documents, finished product testing and feeding practices, and of the origin and destination of production inputs and outputs, in order to verify compliance with the legal requirements in all cases; |
| --- | --- |

(e)

‘inspection’ means the examination of establishments, of animals and food, and the processing thereof, of food businesses, and their management and production systems, including documents, finished product testing and feeding practices, and of the origin and destination of production inputs and outputs, in order to verify compliance with the legal requirements in all cases;

| (f) | ‘official veterinarian’ means a veterinarian qualified, in accordance with this Regulation, to act in such a capacity and appointed by the competent authority; |
| --- | --- |

(f)

‘official veterinarian’ means a veterinarian qualified, in accordance with this Regulation, to act in such a capacity and appointed by the competent authority;

| (g) | ‘approved veterinarian’ means a veterinarian designated by the competent authority to carry out specific official controls on holdings on its behalf; |
| --- | --- |

(g)

‘approved veterinarian’ means a veterinarian designated by the competent authority to carry out specific official controls on holdings on its behalf;

| (h) | ‘official auxiliary’ means a person qualified, in accordance with this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian;
  and |
| --- | --- |

(h)

‘official auxiliary’ means a person qualified, in accordance with this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian;

and

| (i) | ‘health mark’ means a mark indicating that, when it was applied, official controls had been carried out in accordance with this Regulation. |
| --- | --- |

(i)

‘health mark’ means a mark indicating that, when it was applied, official controls had been carried out in accordance with this Regulation.

2.   The definitions laid down in the following Regulations shall also apply as appropriate:

| (a) | Regulation (EC) No 178/2002; |
| --- | --- |

(a)

Regulation (EC) No 178/2002;

| (b) | the definitions of ‘animal by-products’, ‘TSEs’ (transmissible spongiform encephalopathies) and ‘specified risk material’ laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (8); |
| --- | --- |

(b)

the definitions of ‘animal by-products’, ‘TSEs’ (transmissible spongiform encephalopathies) and ‘specified risk material’ laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (8);

| (c) | Regulation (EC) No 852/2004, except for the definition of ‘competent authority’;
  and |
| --- | --- |

(c)

Regulation (EC) No 852/2004, except for the definition of ‘competent authority’;

and

| (d) | Regulation (EC) No 853/2004. |
| --- | --- |

(d)

Regulation (EC) No 853/2004.

CHAPTER II

OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

Article 3

Approval of establishments

| 1. | (a) | When Community legislation requires the approval of establishments, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it meets the relevant requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 and other relevant requirements of food law. |
| --- | --- | --- |
| (b) | The competent authority may grant conditional approval if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new on-site visit carried out within three months of the granting of conditional approval that the establishment meets the other requirements referred to in (a). If clear progress has been made but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months. |

1.

(a)

When Community legislation requires the approval of establishments, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it meets the relevant requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 and other relevant requirements of food law.

(b)

The competent authority may grant conditional approval if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new on-site visit carried out within three months of the granting of conditional approval that the establishment meets the other requirements referred to in (a). If clear progress has been made but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months.

2.   In the case of factory and freezer vessels flying the flag of Member States, the maximum periods of three and six months applying to the conditional approval of other establishments may be extended, if necessary. However, conditional approval shall not exceed a total of 12 months. Inspections of such vessels shall take place as specified in Annex III.

3.   The competent authority shall give each approved establishment, including those with conditional approval, an approval number, to which codes may be added to indicate the types of products of animal origin manufactured. For wholesale markets, secondary numbers indicating units or groups of units selling or manufacturing products of animal origin may be added to the approval number.

| 4. | (a) | The competent authority shall keep the approval of establishments under review when carrying out official controls in accordance with Articles 4 to 8. |
| --- | --- | --- |
| (b) | If the competent authority identifies serious deficiencies or has to stop production at an establishment repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's approval. However, the competent authority may suspend an establishment's approval if the food business operator can guarantee that it will resolve deficiencies within a reasonable time. |
| (c) | In the case of wholesale markets, the competent authority may withdraw or suspend approval in respect of certain units or groups of units. |

4.

(a)

The competent authority shall keep the approval of establishments under review when carrying out official controls in accordance with Articles 4 to 8.

(b)

If the competent authority identifies serious deficiencies or has to stop production at an establishment repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's approval. However, the competent authority may suspend an establishment's approval if the food business operator can guarantee that it will resolve deficiencies within a reasonable time.

(c)

In the case of wholesale markets, the competent authority may withdraw or suspend approval in respect of certain units or groups of units.

5.   Paragraphs 1, 2 and 3 shall apply both:

| (a) | to establishments that begin placing products of animal origin on the market on or after the date of application of this Regulation;
  and |
| --- | --- |

(a)

to establishments that begin placing products of animal origin on the market on or after the date of application of this Regulation;

and

| (b) | to establishments already placing products of animal origin on the market but in respect of which there was previously no requirement for approval. In the latter case, the competent authority's on-site visit required under paragraph 1 shall take place as soon as possible. |
| --- | --- |

(b)

to establishments already placing products of animal origin on the market but in respect of which there was previously no requirement for approval. In the latter case, the competent authority's on-site visit required under paragraph 1 shall take place as soon as possible.

Paragraph 4 shall also apply to approved establishments that placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation.

6.   Member States shall maintain up-to-date lists of approved establishments, with their respective approval numbers and other relevant information, and make them available to other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 19(2).

Article 4

General principles for official controls in respect of all products of animal origin falling within the scope of this Regulation

1.   Member States shall ensure that food business operators offer all assistance needed to ensure that official controls carried out by the competent authority can be performed effectively

They shall in particular:

| — | give access to all buildings, premises, installations or other infrastructures; |
| --- | --- |

—

give access to all buildings, premises, installations or other infrastructures;

| — | make available any documentation and record required under the present regulation or considered necessary by the competent authority for judging the situation. |
| --- | --- |

—

make available any documentation and record required under the present regulation or considered necessary by the competent authority for judging the situation.

2.   The competent authority shall carry out official controls to verify food business operators' compliance with the requirements of:

| (a) | Regulation (EC) No 852/2004; |
| --- | --- |

(a)

Regulation (EC) No 852/2004;

| (b) | Regulation (EC) No 853/2004;
  and |
| --- | --- |

(b)

Regulation (EC) No 853/2004;

and

| (c) | Regulation (EC) No 1774/2002. |
| --- | --- |

(c)

Regulation (EC) No 1774/2002.

3.   The official controls referred to in paragraph 1 shall include:

| (a) | audits of good hygiene practices and hazard analysis and critical control point (HACCP)-based procedures; |
| --- | --- |

(a)

audits of good hygiene practices and hazard analysis and critical control point (HACCP)-based procedures;

| (b) | the official controls specified in Articles 5 to 8;
  and |
| --- | --- |

(b)

the official controls specified in Articles 5 to 8;

and

| (c) | any particular auditing tasks specified in the Annexes. |
| --- | --- |

(c)

any particular auditing tasks specified in the Annexes.

4.   Audits of good hygiene practices shall verify that food business operators apply procedures continuously and properly concerning at least:

| (a) | checks on food-chain information; |
| --- | --- |

(a)

checks on food-chain information;

| (b) | the design and maintenance of premises and equipment; |
| --- | --- |

(b)

the design and maintenance of premises and equipment;

| (c) | pre-operational, operational and post-operational hygiene; |
| --- | --- |

(c)

pre-operational, operational and post-operational hygiene;

| (d) | personal hygiene; |
| --- | --- |

(d)

personal hygiene;

| (e) | training in hygiene and in work procedures; |
| --- | --- |

(e)

training in hygiene and in work procedures;

| (f) | pest control; |
| --- | --- |

(f)

pest control;

| (g) | water quality; |
| --- | --- |

(g)

water quality;

| (h) | temperature control;
  and |
| --- | --- |

(h)

temperature control;

and

| (i) | controls on food entering and leaving the establishment and any accompanying documentation. |
| --- | --- |

(i)

controls on food entering and leaving the establishment and any accompanying documentation.

5.   Audits of HACCP-based procedures shall verify that food business operators apply such procedures continuously and properly, having particular regard to ensuring that the procedures provide the guarantees specified in Section II of Annex II to Regulation (EC) No 853/2004. They shall, in particular, determine whether the procedures guarantee, to the extent possible, that products of animal origin:

| (a) | comply with microbiological criteria laid down under Community legislation; |
| --- | --- |

(a)

comply with microbiological criteria laid down under Community legislation;

| (b) | comply with Community legislation on residues, contaminants and prohibited substances;
  and |
| --- | --- |

(b)

comply with Community legislation on residues, contaminants and prohibited substances;

and

| (c) | do not contain physical hazards, such as foreign bodies. |
| --- | --- |

(c)

do not contain physical hazards, such as foreign bodies.

When, in accordance with Article 5 of Regulation (EC) No 852/2004, a food business operator uses procedures set out in guides to the application of HACCP principles rather than establishing its own specific procedures, the audit shall cover the correct use of these guides.

6.   Verification of compliance with the requirements of Regulation (EC) No 853/2004 concerning the application of identification marks shall take place in all establishments approved in accordance with that Regulation, in addition to verification of compliance with other traceability requirements.

7.   In the case of slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market, an official veterinarian shall carry out the auditing tasks referred to in paragraphs 3 and 4.

8.   When carrying out auditing tasks, the competent authority shall take special care:

| (a) | to determine whether staff and staff activities in the establishment at all stages of the production process comply with the relevant requirements of the Regulations referred to in paragraph 1(a) and (b). To support the audit, the competent authority may carry out performance tests, in order to ascertain that staff performance meets specified parameters; |
| --- | --- |

(a)

to determine whether staff and staff activities in the establishment at all stages of the production process comply with the relevant requirements of the Regulations referred to in paragraph 1(a) and (b). To support the audit, the competent authority may carry out performance tests, in order to ascertain that staff performance meets specified parameters;

| (b) | to verify the food business operator's relevant records; |
| --- | --- |

(b)

to verify the food business operator's relevant records;

| (c) | to take samples for laboratory analysis whenever necessary;
  and |
| --- | --- |

(c)

to take samples for laboratory analysis whenever necessary;

and

| (d) | to document elements taken into account and the findings of the audit. |
| --- | --- |

(d)

to document elements taken into account and the findings of the audit.

9.   The nature and intensity of auditing tasks in respect of individual establishments shall depend upon the assessed risk. To this end, the competent authority shall regularly assess:

| (a) | public and, where appropriate, animal health risks; |
| --- | --- |

(a)

public and, where appropriate, animal health risks;

| (b) | in the case of slaughterhouses, animal welfare aspects; |
| --- | --- |

(b)

in the case of slaughterhouses, animal welfare aspects;

| (c) | the type and throughput of the processes carried out;
  and |
| --- | --- |

(c)

the type and throughput of the processes carried out;

and

| (d) | the food business operator's past record as regards compliance with food law. |
| --- | --- |

(d)

the food business operator's past record as regards compliance with food law.

Article 5

Fresh meat

Member States shall ensure that official controls with respect to fresh meat take place in accordance with Annex I.

| 1. | The official veterinarian shall carry out inspection tasks in slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market in accordance with the general requirements of Section I, Chapter II, of Annex I, and with the specific requirements of Section IV, in particular as regards:






  (a) | food chain information; |
| --- | --- | --- |

1.

The official veterinarian shall carry out inspection tasks in slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market in accordance with the general requirements of Section I, Chapter II, of Annex I, and with the specific requirements of Section IV, in particular as regards:

(a)

food chain information;

| (b) | ante-mortem inspection; |
| --- | --- |

(b)

ante-mortem inspection;

ante-mortem

| (c) | animal welfare; |
| --- | --- |

(c)

animal welfare;

| (d) | post-mortem inspection; |
| --- | --- |

(d)

post-mortem inspection;

| (e) | specified risk material and other animal by-products;
  and |
| --- | --- |

(e)

specified risk material and other animal by-products;

and

| (f) | laboratory testing. |
| --- | --- |

(f)

laboratory testing.

| 2. | The health marking of carcases of domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, as well as half-carcases, quarters and cuts produced by cutting half-carcases into three wholesale cuts, shall be carried out in slaughterhouses and game-handling establishments in accordance with Section I, Chapter III, of Annex I. Health marks shall be applied by, or under the responsibility of, the official veterinarian when official controls have not identified any deficiencies that would make the meat unfit for human consumption. |
| --- | --- |

2.

The health marking of carcases of domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, as well as half-carcases, quarters and cuts produced by cutting half-carcases into three wholesale cuts, shall be carried out in slaughterhouses and game-handling establishments in accordance with Section I, Chapter III, of Annex I. Health marks shall be applied by, or under the responsibility of, the official veterinarian when official controls have not identified any deficiencies that would make the meat unfit for human consumption.

| 3. | After carrying out the controls mentioned in points 1 and 2, the official veterinarian shall take appropriate measures as set out in Annex I, Section II, in particular as regards:






  (a) | the communication of inspection results; |
| --- | --- | --- |

3.

After carrying out the controls mentioned in points 1 and 2, the official veterinarian shall take appropriate measures as set out in Annex I, Section II, in particular as regards:

(a)

the communication of inspection results;

| (b) | decisions concerning food chain information; |
| --- | --- |

(b)

decisions concerning food chain information;

| (c) | decisions concerning live animals; |
| --- | --- |

(c)

decisions concerning live animals;

| (d) | decisions concerning animal welfare;
  and |
| --- | --- |

(d)

decisions concerning animal welfare;

and

| (e) | decisions concerning meat. |
| --- | --- |

(e)

decisions concerning meat.

| 4. | Official auxiliaries may assist the official veterinarian with official controls carried out in accordance with Sections I and II of Annex I as specified in Section III, Chapter I. In that case, they shall work as part of an independent team. |
| --- | --- |

4.

Official auxiliaries may assist the official veterinarian with official controls carried out in accordance with Sections I and II of Annex I as specified in Section III, Chapter I. In that case, they shall work as part of an independent team.

| 5. | (a) | Member States shall ensure that they have sufficient official staff to carry out the official controls required under Annex I with the frequency specified in Section III, Chapter II. |
| --- | --- | --- |

5.

(a)

Member States shall ensure that they have sufficient official staff to carry out the official controls required under Annex I with the frequency specified in Section III, Chapter II.

| (b) | A risk-based approach shall be followed to assess the number of official staff that need to be present on the slaughter line in any given slaughterhouse. The number of official staff involved shall be decided by the competent authority and shall be such that all the requirements of this Regulation can be met. |
| --- | --- |

(b)

A risk-based approach shall be followed to assess the number of official staff that need to be present on the slaughter line in any given slaughterhouse. The number of official staff involved shall be decided by the competent authority and shall be such that all the requirements of this Regulation can be met.

| 6. | (a) | Member States may allow slaughterhouse staff to assist with official controls by carrying out certain specific tasks, under the supervision of the official veterinarian, in relation to the production of meat from poultry and lagomorphs in accordance with Annex I, Section III, Chapter III, part A. If they do so, they shall ensure that staff carrying out such tasks:






  (i) | are qualified and undergo training in accordance with those provisions; |
| --- | --- | --- | --- |

6.

(a)

Member States may allow slaughterhouse staff to assist with official controls by carrying out certain specific tasks, under the supervision of the official veterinarian, in relation to the production of meat from poultry and lagomorphs in accordance with Annex I, Section III, Chapter III, part A. If they do so, they shall ensure that staff carrying out such tasks:

(i)

are qualified and undergo training in accordance with those provisions;

| (ii) | act independently from production staff;
  and |
| --- | --- |

(ii)

act independently from production staff;

and

| (iii) | report any deficiency to the official veterinarian. |
| --- | --- |

(iii)

report any deficiency to the official veterinarian.

| (b) | Member States may also allow slaughterhouse staff to carry out specific sampling and testing tasks in accordance with Annex I, Section III, Chapter III, Part B. |
| --- | --- |

(b)

Member States may also allow slaughterhouse staff to carry out specific sampling and testing tasks in accordance with Annex I, Section III, Chapter III, Part B.

| 7. | Member States shall ensure that official veterinarians and official auxiliaries are qualified and undergo training in accordance with Annex I, Section III, Chapter IV. |
| --- | --- |

7.

Member States shall ensure that official veterinarians and official auxiliaries are qualified and undergo training in accordance with Annex I, Section III, Chapter IV.

Article 6

Live bivalve molluscs

Member States shall ensure that the production and placing on the market of live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods undergo official controls as described in Annex II.

Article 7

Fishery products

Member States shall ensure that official controls with respect to fishery products take place in accordance with Annex III.

Article 8

Raw milk and dairy products

Member States shall ensure that official controls with respect to raw milk and dairy products take place in accordance with Annex IV.

Article 9

Action in the case of non-compliance

1.   When the competent authority identifies non-compliance with the Regulations referred to in Article 4(2)(a) and (b), it shall take action to ensure that the food business operator remedies the situation. When deciding which action to take, the competent authority shall take account of the nature of the non-compliance and the food business operator's past record with regard to non-compliance.

2.   Such action shall include, where appropriate, the following measures:

| (a) | the imposition of sanitation procedures or any other corrective action deemed necessary to ensure the safety of products of animal origin or compliance with the relevant legal requirements; |
| --- | --- |

(a)

the imposition of sanitation procedures or any other corrective action deemed necessary to ensure the safety of products of animal origin or compliance with the relevant legal requirements;

| (b) | the restriction or prohibition of the placing on the market, import or export of products of animal origin; |
| --- | --- |

(b)

the restriction or prohibition of the placing on the market, import or export of products of animal origin;

| (c) | monitoring or, if necessary, ordering the recall, withdrawal and/or destruction of products of animal origin; |
| --- | --- |

(c)

monitoring or, if necessary, ordering the recall, withdrawal and/or destruction of products of animal origin;

| (d) | authorisation to use products of animal origin for purposes other than those for which they were originally intended; |
| --- | --- |

(d)

authorisation to use products of animal origin for purposes other than those for which they were originally intended;

| (e) | the suspension of operations or closure of all or part of the food business concerned for an appropriate period of time; |
| --- | --- |

(e)

the suspension of operations or closure of all or part of the food business concerned for an appropriate period of time;

| (f) | the suspension or withdrawal of the establishment's approval; |
| --- | --- |

(f)

the suspension or withdrawal of the establishment's approval;

| (g) | in the case of consignments from third countries, seizure followed by destruction or re-dispatch; |
| --- | --- |

(g)

in the case of consignments from third countries, seizure followed by destruction or re-dispatch;

| (h) | any other measure that the competent authority deems appropriate. |
| --- | --- |

(h)

any other measure that the competent authority deems appropriate.

3.   The competent authority shall provide the food business operator concerned, or a representative, with:

| (a) | written notification of its decision concerning the action to be taken in accordance with paragraph 1, together with the reasons for the decision;
  and |
| --- | --- |

(a)

written notification of its decision concerning the action to be taken in accordance with paragraph 1, together with the reasons for the decision;

and

| (b) | information on rights of appeal against such decisions and of the applicable procedure and time limits. |
| --- | --- |

(b)

information on rights of appeal against such decisions and of the applicable procedure and time limits.

Where appropriate, the competent authority shall also notify the competent authority of the Member State of dispatch of its decision.

CHAPTER III

PROCEDURES CONCERNING IMPORTS

Article 10

General principles and conditions

To ensure the uniform application of the principles and conditions laid down in Article 11 of Regulation (EC) No 178/2002 the procedures laid down in this c+hapter shall apply.

Article 11

Lists of third countries and parts of third countries from which imports of specified products of animal origin are permitted

1.   Products of animal origin shall be imported only from a third country or a part of third country that appears on a list drawn up and updated in accordance with the procedure referred to in Article 19(2).

2.   A third country shall appear on such lists only if a Community control in that country has taken place and demonstrates that the competent authority provides appropriate guarantees as specified in paragraph 4. However, a third country may appear on such lists without a Community control having taken place there if:

| (a) | the risk determined in accordance with Article 18(18) does not warrant it;
  and |
| --- | --- |

(a)

the risk determined in accordance with Article 18(18) does not warrant it;

and

| (b) | it is determined, when deciding to add a particular third country to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees. |
| --- | --- |

(b)

it is determined, when deciding to add a particular third country to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

3.   Lists drawn up in accordance with this Article may be combined with other lists drawn up for public and animal health purposes.

4.   When lists are drawn up or updated, particular account shall be taken of the following criteria:

| (a) | the legislation of the third country on:






  (i) | products of animal origin, |
| --- | --- | --- |

(a)

the legislation of the third country on:

(i)

products of animal origin,

| (ii) | the use of veterinary medicinal products, including rules on their prohibition or authorisation, their distribution, their placing on the market and the rules covering administration and inspection;
  and |
| --- | --- |

(ii)

the use of veterinary medicinal products, including rules on their prohibition or authorisation, their distribution, their placing on the market and the rules covering administration and inspection;

and

| (iii) | the preparation and use of feedingstuffs, including the procedures for using additives and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of the raw materials used for preparing feedingstuffs and of the final product; |
| --- | --- |

(iii)

the preparation and use of feedingstuffs, including the procedures for using additives and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of the raw materials used for preparing feedingstuffs and of the final product;

| (b) | the organisation of the third countries' competent authorities, their powers and independence, the supervision to which they are subject and the authority that they have effectively to enforce the applicable legislation; |
| --- | --- |

(b)

the organisation of the third countries' competent authorities, their powers and independence, the supervision to which they are subject and the authority that they have effectively to enforce the applicable legislation;

| (c) | the training of staff in the performance of official controls; |
| --- | --- |

(c)

the training of staff in the performance of official controls;

| (d) | the resources, including diagnostic facilities available to competent authorities; |
| --- | --- |

(d)

the resources, including diagnostic facilities available to competent authorities;

| (e) | the existence and operation of documented control procedures and control systems based on priorities; |
| --- | --- |

(e)

the existence and operation of documented control procedures and control systems based on priorities;

| (f) | where applicable, the situation regarding animal health and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases; |
| --- | --- |

(f)

where applicable, the situation regarding animal health and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases;

| (g) | the extent and operation of official controls on imports of animals and products of animal origin; |
| --- | --- |

(g)

the extent and operation of official controls on imports of animals and products of animal origin;

| (h) | the assurances which the third country can give regarding compliance with, or equivalence to, Community requirements; |
| --- | --- |

(h)

the assurances which the third country can give regarding compliance with, or equivalence to, Community requirements;

| (i) | the hygiene conditions of production, manufacture, handling, storage and dispatch actually applied to products of animal origin destined for the Community; |
| --- | --- |

(i)

the hygiene conditions of production, manufacture, handling, storage and dispatch actually applied to products of animal origin destined for the Community;

| (j) | any experience of marketing of the product from the third country and the results of any import controls carried out; |
| --- | --- |

(j)

any experience of marketing of the product from the third country and the results of any import controls carried out;

| (k) | the results of Community controls carried out in the third country, in particular the results of the assessment of the competent authorities, and the action that competent authorities have taken in the light of any recommendations addressed to them following a Community control; |
| --- | --- |

(k)

the results of Community controls carried out in the third country, in particular the results of the assessment of the competent authorities, and the action that competent authorities have taken in the light of any recommendations addressed to them following a Community control;

| (l) | the existence, implementation and communication of an approved zoonoses control programme;
  and |
| --- | --- |

(l)

the existence, implementation and communication of an approved zoonoses control programme;

and

| (m) | the existence, implementation and communication of an approved residue control programme. |
| --- | --- |

(m)

the existence, implementation and communication of an approved residue control programme.

5.   The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

Article 12

List of establishments from which imports of specified products of animal origin are permitted

1.   Products of animal origin may be imported into the Community only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up and updated in accordance with this Article, except:

| (a) | when, on a case-by-case basis, it is decided, in accordance with the procedure referred to in Article 19(2), that the guarantees that a specified third country provides in respect of imports of specified products of animal origin are such that the procedure provided for in this Article is unnecessary to ensure compliance with the requirements of paragraph 2;
  and |
| --- | --- |

(a)

when, on a case-by-case basis, it is decided, in accordance with the procedure referred to in Article 19(2), that the guarantees that a specified third country provides in respect of imports of specified products of animal origin are such that the procedure provided for in this Article is unnecessary to ensure compliance with the requirements of paragraph 2;

and

| (b) | in the cases specified in Annex V. |
| --- | --- |

(b)

in the cases specified in Annex V.

In addition, fresh meat, minced meat, meat preparations, meat products and mechanically separated meat (MSM) may be imported into the Community only if they have been manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with this Article or in approved Community establishments.

2.   An establishment may be placed on such a list only if the competent authority of the third country of origin guarantees that:

| (a) | that establishment, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with relevant Community requirements, in particular those of Regulation (EC) No 853/2004, or with requirements that were determined to be equivalent to such requirements when deciding to add that third country to the relevant list in accordance with Article 11; |
| --- | --- |

(a)

that establishment, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with relevant Community requirements, in particular those of Regulation (EC) No 853/2004, or with requirements that were determined to be equivalent to such requirements when deciding to add that third country to the relevant list in accordance with Article 11;

| (b) | an official inspection service in that third country supervises the establishments and makes available to the Commission, where necessary, all relevant information on establishments furnishing raw materials;
  and |
| --- | --- |

(b)

an official inspection service in that third country supervises the establishments and makes available to the Commission, where necessary, all relevant information on establishments furnishing raw materials;

and

| (c) | it has real powers to stop the establishments from exporting to the Community in the event that the establishments fail to meet the requirements referred to under (a). |
| --- | --- |

(c)

it has real powers to stop the establishments from exporting to the Community in the event that the establishments fail to meet the requirements referred to under (a).

3.   The competent authorities of third countries appearing on lists drawn up and updated in accordance with Article 11 shall guarantee that lists of the establishments referred to in paragraph 1 are drawn up, kept up-to-date and communicated to the Commission.

| 4. | (a) | The Commission shall provide the contact points that Member States have designated for this purpose with regular notifications concerning new or updated lists that it has received from the competent authorities of third countries concerned in accordance with paragraph 3. |
| --- | --- | --- |
| (b) | If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public. |
| (c) | The Commission shall, whenever at least one Member State makes written comments, or whenever it considers that the modification of a list is necessary in the light of relevant information such as Community inspection reports or a notification under the rapid alert system, inform all Member States and include the point on agenda of the next meeting of the relevant section of the Standing Committee on the Food Chain and Animal Health for decision, where appropriate, in accordance with the procedure referred to in Article 19(2). |

4.

(a)

The Commission shall provide the contact points that Member States have designated for this purpose with regular notifications concerning new or updated lists that it has received from the competent authorities of third countries concerned in accordance with paragraph 3.

(b)

If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public.

(c)

The Commission shall, whenever at least one Member State makes written comments, or whenever it considers that the modification of a list is necessary in the light of relevant information such as Community inspection reports or a notification under the rapid alert system, inform all Member States and include the point on agenda of the next meeting of the relevant section of the Standing Committee on the Food Chain and Animal Health for decision, where appropriate, in accordance with the procedure referred to in Article 19(2).

5.   The Commission shall arrange for up-to-date versions of all lists to be available to the public.

Article 13

Live bivalve molluscs, echinoderms, tunicates and marine gastropods

1.   Notwithstanding Article 12(1)(b), live bivalve molluscs, echinoderms, tunicates and marine gastropods shall come from production areas in third countries that appear on lists drawn up and updated in accordance with Article 12.

2.   The requirement of paragraph 1 shall not apply to pectinidae harvested outside classified production areas. However, official controls with respect to pectinidae shall take place in accordance with Annex II, Chapter III.

| 3. | (a) | Before the lists referred to in paragraph 1 are drawn up, particular account shall be taken of the guarantees that the competent authority of the third country can give concerning compliance with the requirements of this Regulation on the classification and control of production zones. |
| --- | --- | --- |
| (b) | An on-the-spot Community inspection visit shall take place before such lists are drawn up unless:






  (i) | the risk determined in accordance with Article 18(18) does not warrant it;
  and |

3.

(a)

Before the lists referred to in paragraph 1 are drawn up, particular account shall be taken of the guarantees that the competent authority of the third country can give concerning compliance with the requirements of this Regulation on the classification and control of production zones.

(b)

An on-the-spot Community inspection visit shall take place before such lists are drawn up unless:

(i)

the risk determined in accordance with Article 18(18) does not warrant it;

and

| (ii) | it is determined, when deciding to add a particular production area to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees. |
| --- | --- |

(ii)

it is determined, when deciding to add a particular production area to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

4.   The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

Article 14

Documents

1.   A document meeting the requirements set out in Annex VI shall accompany consignments of products of animal origin when they are imported into the Community.

2.   The document shall certify that the products satisfy:

| (a) | the requirements laid down for such products according to Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 or provisions that are equivalent to those requirements;
  and |
| --- | --- |

(a)

the requirements laid down for such products according to Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 or provisions that are equivalent to those requirements;

and

| (b) | any special import conditions established in accordance with Article 18(19). |
| --- | --- |

(b)

any special import conditions established in accordance with Article 18(19).

3.   Documents may include details required in accordance with other Community legislation on public and animal health matters.

4.   Exemptions from paragraph 1 may be granted in accordance with the procedure referred to in Article 19(2) when it is possible to obtain the guarantees referred to in paragraph 2 of this Article in another manner.

Article 15

Special provisions for fishery products

1.   The procedures laid down in this Chapter do not apply to fresh fishery products landed in the Community directly from a fishing vessel flying the flag of a third country.

Official controls with respect to such fishery products shall take place in accordance with Annex III.

| 2. | (a) | Fishery products imported from a factory or freezer vessel flying the flag of a third country shall come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4). |
| --- | --- | --- |
| (b) | However, by way of exemption from Article 12(2)(b), a vessel may also be included on such lists:






  (i) | on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of another third country to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:






  — | that third country appears on the list of third countries, drawn up in accordance with Article 11, from which imports of fisheries products are permitted, |

2.

(a)

Fishery products imported from a factory or freezer vessel flying the flag of a third country shall come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4).

(b)

However, by way of exemption from Article 12(2)(b), a vessel may also be included on such lists:

(i)

on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of another third country to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:

—

that third country appears on the list of third countries, drawn up in accordance with Article 11, from which imports of fisheries products are permitted,

| — | all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that third country, |
| --- | --- |

—

all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that third country,

| — | the competent authority of that third country has inspected the vessel and has declared that it complies with Community requirements,
  and |
| --- | --- |

—

the competent authority of that third country has inspected the vessel and has declared that it complies with Community requirements,

and

| — | the competent authority of that third country has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements; |
| --- | --- |

—

the competent authority of that third country has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements;

or

| (ii) | on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of a Member State, to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:






  — | all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that Member State, |
| --- | --- | --- |

(ii)

on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of a Member State, to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:

—

all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that Member State,

| — | the competent authority of that Member State has inspected the vessel and has declared that it complies with Community requirements,
  and |
| --- | --- |

—

the competent authority of that Member State has inspected the vessel and has declared that it complies with Community requirements,

and

| — | the competent authority of that Member State has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements. |
| --- | --- |

—

the competent authority of that Member State has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements.

(c)

The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

3.   When fishery products are imported directly from a fishing or freezer vessel, a document signed by the captain may replace the document required under Article 14.

4.   Detailed rules for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 19(2).

CHAPTER IV

FINAL PROVISIONS

Article 16

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 19(2).

Article 17

Amendment and adaptation of the Annexes

1.   Annexes I, II, III, IV, V and VI may be amended or supplemented to take account of scientific and technical progress in accordance with the procedure referred to in Article 19(2).

2.   Exemptions from Annexes I, II, III, IV, V and VI may be granted in accordance with the procedure referred to in Article 19(2), provided that they do not affect the achievement of the objectives of this Regulation.

3.   Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7, national measures adapting the requirements laid down in Annex I.

4.   The national measures referred to in paragraph 3 shall:

| (a) | have the aim of:






  (i) | enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; |
| --- | --- | --- |

(a)

have the aim of:

(i)

enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food;

| (ii) | accommodating the needs of food businesses with a low throughput or that are situated in regions that are subject to special geographic constraints;
  or |
| --- | --- |

(ii)

accommodating the needs of food businesses with a low throughput or that are situated in regions that are subject to special geographic constraints;

or

| (iii) | permitting pilot projects to take place in order to try out new approaches to hygiene controls on meat; |
| --- | --- |

(iii)

permitting pilot projects to take place in order to try out new approaches to hygiene controls on meat;

| (b) | concern in particular the following elements of Annex I:






  (i) | food chain information; |
| --- | --- | --- |

(b)

concern in particular the following elements of Annex I:

(i)

food chain information;

| (ii) | the presence of the competent authority in establishments. |
| --- | --- |

(ii)

the presence of the competent authority in establishments.

5.   Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall:

| (a) | provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought; |
| --- | --- |

(a)

provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

| (b) | describe the establishments concerned; |
| --- | --- |

(b)

describe the establishments concerned;

| (c) | explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;
  and |
| --- | --- |

(c)

explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;

and

| (d) | give any other relevant information. |
| --- | --- |

(d)

give any other relevant information.

6.   The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 19(1). The Commission may decide, in accordance with the procedure referred to in Article 19(2), whether the envisaged measures may be implemented subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraphs 1 or 2 of this Article.

7.   A Member State may adopt national measures adapting the requirements of Annex I only:

| (a) | in compliance with a decision adopted in accordance with paragraph 6; |
| --- | --- |

(a)

in compliance with a decision adopted in accordance with paragraph 6;

| (b) | if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6. |
| --- | --- |

(b)

if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6.

8.   When a Member State adopts national measures implementing a pilot project to try out new approaches to hygiene controls on meat in accordance with paragraphs 3 to 7, the Member State shall communicate the results to the Commission as soon as they are available. The Commission shall then consider proposing general measures in accordance with paragraph 1.

Article 18

Specific decisions

Without prejudice to the generality of Article 16 and Article 17(1), implementing measures may be laid down, or amendments to Annexes I, II, III, IV, V or VI adopted, in accordance with the procedure referred to in Article 19(2), to specify:

| 1. | tests to assess the performance of food business operators and their staff; |
| --- | --- |

1.

tests to assess the performance of food business operators and their staff;

| 2. | the method of communicating inspection results; |
| --- | --- |

2.

the method of communicating inspection results;

| 3. | criteria to determine when, on the basis of a risk analysis, the official veterinarian need not be present in slaughterhouses and game handling establishments throughout ante-mortem and post-mortem inspection; |
| --- | --- |

3.

criteria to determine when, on the basis of a risk analysis, the official veterinarian need not be present in slaughterhouses and game handling establishments throughout ante-mortem and post-mortem inspection;

| 4. | rules concerning the content of tests for official veterinarians and official auxiliaries; |
| --- | --- |

4.

rules concerning the content of tests for official veterinarians and official auxiliaries;

| 5. | microbiological criteria for process control in relation to hygiene in establishments; |
| --- | --- |

5.

microbiological criteria for process control in relation to hygiene in establishments;

| 6. | alternative procedures, serological or other laboratory tests that provide guarantees at least equivalent to specific post-mortem inspection procedures described in Annex I, Section IV, and may therefore replace them, if the competent authority so decides; |
| --- | --- |

6.

alternative procedures, serological or other laboratory tests that provide guarantees at least equivalent to specific post-mortem inspection procedures described in Annex I, Section IV, and may therefore replace them, if the competent authority so decides;

| 7. | circumstances in which certain of the specific post-mortem inspection procedures described in Annex I, Section IV, are not necessary, having regard to the holding, region or country of origin and to the principles of risk analysis, |
| --- | --- |

7.

circumstances in which certain of the specific post-mortem inspection procedures described in Annex I, Section IV, are not necessary, having regard to the holding, region or country of origin and to the principles of risk analysis,

| 8. | rules for laboratory testing; |
| --- | --- |

8.

rules for laboratory testing;

| 9. | the cold treatment to be applied to meat in relation to cysticercosis and trichinosis; |
| --- | --- |

9.

the cold treatment to be applied to meat in relation to cysticercosis and trichinosis;

| 10. | conditions under which holdings and regions can be certified as officially free of cysticercus or trichinae; |
| --- | --- |

10.

conditions under which holdings and regions can be certified as officially free of cysticercus or trichinae;

| 11. | methods to be applied when examining for the conditions referred to in Annex I, Section IV, Chapter IX; |
| --- | --- |

11.

methods to be applied when examining for the conditions referred to in Annex I, Section IV, Chapter IX;

| 12. | for fattening pigs, criteria for controlled housing conditions and integrated production systems; |
| --- | --- |

12.

for fattening pigs, criteria for controlled housing conditions and integrated production systems;

| 13. | criteria for the classification of production and relaying areas for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:






  (a) | limit values and analysis methods for marine biotoxins, |
| --- | --- | --- |

13.

criteria for the classification of production and relaying areas for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

(a)

limit values and analysis methods for marine biotoxins,

| (b) | virus testing procedures and virological standards,
  and |
| --- | --- |

(b)

virus testing procedures and virological standards,

and

| (c) | sampling plans and the methods and analytical tolerances to be applied to check compliance with the criteria; |
| --- | --- |

(c)

sampling plans and the methods and analytical tolerances to be applied to check compliance with the criteria;

| 14. | organoleptic criteria for the evaluation of the freshness of fishery products; |
| --- | --- |

14.

organoleptic criteria for the evaluation of the freshness of fishery products;

| 15. | analytical limits, methods of analysis and sampling plans for the official controls on fishery products required under Annex III, including with regard to parasites and environmental contaminants; |
| --- | --- |

15.

analytical limits, methods of analysis and sampling plans for the official controls on fishery products required under Annex III, including with regard to parasites and environmental contaminants;

| 16. | the method by which the Commission will make lists of third countries and establishments in third countries available to the public pursuant to Articles 11, 12, 13 and 15; |
| --- | --- |

16.

the method by which the Commission will make lists of third countries and establishments in third countries available to the public pursuant to Articles 11, 12, 13 and 15;

| 17. | models for documents and criteria for the use of electronic documents; |
| --- | --- |

17.

models for documents and criteria for the use of electronic documents;

| 18. | criteria for determining the risk that particular products of animal origin imported into the Community present; |
| --- | --- |

18.

criteria for determining the risk that particular products of animal origin imported into the Community present;

| 19. | special import conditions for particular products of animal origin, taking account of the associated risks, information that relevant third countries have provided and, where necessary, the results of Community controls carried out in such third countries. These special import conditions may be established for a single product of animal origin or for group of products. They may apply to a single third country, to regions of a third country, or to a group of third countries;
  and |
| --- | --- |

19.

special import conditions for particular products of animal origin, taking account of the associated risks, information that relevant third countries have provided and, where necessary, the results of Community controls carried out in such third countries. These special import conditions may be established for a single product of animal origin or for group of products. They may apply to a single third country, to regions of a third country, or to a group of third countries;

and

| 20. | the conditions governing imports of products of animal origin from a third country or a region of a third country pursuant to the implementation of an equivalence agreement, or to a satisfactory audit, recognising that measures applied in that third country or region offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect. |
| --- | --- |

20.

the conditions governing imports of products of animal origin from a third country or a region of a third country pursuant to the implementation of an equivalence agreement, or to a satisfactory audit, recognising that measures applied in that third country or region offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect.

Article 19

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its Rules of Procedure.

Article 20

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on matters falling within the scope of this Regulation whenever necessary and, in particular:

| 1. | before proposing to modify the specific requirements concerning post-mortem inspection procedures laid down in Section IV of Annex I; |
| --- | --- |

1.

before proposing to modify the specific requirements concerning post-mortem inspection procedures laid down in Section IV of Annex I;

| 2. | before proposing to modify the rules of Annex I, Section IV, Chapter IX, on meat from animals in which post-mortem inspection has revealed lesions indicating infection with brucellosis or tuberculosis;
  and |
| --- | --- |

2.

before proposing to modify the rules of Annex I, Section IV, Chapter IX, on meat from animals in which post-mortem inspection has revealed lesions indicating infection with brucellosis or tuberculosis;

and

| 3. | before proposing implementing measures on the matters referred to in Article 18(5) to (15). |
| --- | --- |

3.

before proposing implementing measures on the matters referred to in Article 18(5) to (15).

Article 21

Report to the European Parliament and to the Council

1.   The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council reviewing the experience gained from the application of this Regulation.

2.   The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 22

Entry into force

This Regulation shall enter into force on the 20th day after that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

It shall apply 18 months after the date on which all of the following acts have entered into force:

| (a) | Regulation (EC) No 852/2004; |
| --- | --- |

(a)

Regulation (EC) No 852/2004;

| (b) | Regulation (EC) No 853/2004
  and |
| --- | --- |

(b)

Regulation (EC) No 853/2004

and

| (c) | Directive 2004/41/EC of the European Parliament and of the Council of 29 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 (9). |
| --- | --- |

(c)

Directive 2004/41/EC of the European Parliament and of the Council of 29 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 (9).

9

However, it shall apply no earlier than 1 January 2006.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament

The President

P. COX

For the Council

The President

M. McDOWELL

ANNEX I

FRESH MEAT

SECTION I: TASKS OF THE OFFICIAL VETERINARIAN

CHAPTER I: AUDITING TASKS

| 1. | In addition to the general requirements of Article 4(4) concerning audits of good hygiene practices, the official veterinarian is to verify continuous compliance with food business operators' own procedures concerning any collection, transport, storage, handling, processing and use or disposal of animal by-products, including specified risk material, for which the food business operator is responsible. |
| --- | --- |

1.

In addition to the general requirements of Article 4(4) concerning audits of good hygiene practices, the official veterinarian is to verify continuous compliance with food business operators' own procedures concerning any collection, transport, storage, handling, processing and use or disposal of animal by-products, including specified risk material, for which the food business operator is responsible.

| 2. | In addition to the general requirements of Article 4(5) concerning audits of HACCP-based principles, the official veterinarian is to check that the operators' procedures guarantee, to the extent possible, that meat:






  (a) | does not contain patho-physiological abnormalities or changes; |
| --- | --- | --- |

2.

In addition to the general requirements of Article 4(5) concerning audits of HACCP-based principles, the official veterinarian is to check that the operators' procedures guarantee, to the extent possible, that meat:

(a)

does not contain patho-physiological abnormalities or changes;

| (b) | does not bear faecal or other contamination;
  and |
| --- | --- |

(b)

does not bear faecal or other contamination;

and

| (c) | does not contain specified risk material, except as provided for under Community legislation, and has been produced in accordance with Community legislation on TSEs. |
| --- | --- |

(c)

does not contain specified risk material, except as provided for under Community legislation, and has been produced in accordance with Community legislation on TSEs.

CHAPTER II: INSPECTION TASKS

When carrying out inspection tasks in accordance with this Chapter, the official veterinarian is to take account of the results of the auditing tasks carried out in accordance with Article 4 and Chapter I of this Annex. Where appropriate he or she is to target inspection tasks accordingly.

A.   Food chain information

| 1. | The official veterinarian is to check and analyse relevant information from the records of the holding of provenance of animals intended for slaughter and to take account of the documented results of this check and analysis when carrying out ante- and post-mortem inspection. |
| --- | --- |

1.

The official veterinarian is to check and analyse relevant information from the records of the holding of provenance of animals intended for slaughter and to take account of the documented results of this check and analysis when carrying out ante- and post-mortem inspection.

| 2. | When carrying out inspection tasks, the official veterinarian is to take account of official certificates accompanying animals, and any declarations made by veterinarians carrying out controls at the level of primary production, including official veterinarians and approved veterinarians. |
| --- | --- |

2.

When carrying out inspection tasks, the official veterinarian is to take account of official certificates accompanying animals, and any declarations made by veterinarians carrying out controls at the level of primary production, including official veterinarians and approved veterinarians.

| 3. | When food business operators in the food chain take additional measures to guarantee food safety by implementing integrated systems, private control systems, independent third party certification or by other means, and when these measures are documented and animals covered by these schemes clearly identifiable, the official veterinarian may take this into account when carrying out inspection tasks and reviewing the HACCP-based procedures. |
| --- | --- |

3.

When food business operators in the food chain take additional measures to guarantee food safety by implementing integrated systems, private control systems, independent third party certification or by other means, and when these measures are documented and animals covered by these schemes clearly identifiable, the official veterinarian may take this into account when carrying out inspection tasks and reviewing the HACCP-based procedures.

B.   Ante-mortem inspection

| 1. | Subject to paragraphs 4 and 5:






  (a) | the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter; |
| --- | --- | --- |

1.

Subject to paragraphs 4 and 5:

(a)

the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter;

| (b) | that inspection must take place within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter. |
| --- | --- |

(b)

that inspection must take place within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter.

In addition, the official veterinarian may require inspection at any other time.

| 2. | Ante-mortem inspection must in particular determine whether, as regards the particular animal inspected, there is any sign:






  (a) | that welfare has been compromised;
  or |
| --- | --- | --- |

2.

Ante-mortem inspection must in particular determine whether, as regards the particular animal inspected, there is any sign:

(a)

that welfare has been compromised;

or

| (b) | of any condition which might adversely affect human or animal health, paying particular attention to the detection of zoonotic diseases and diseases on List A or, where appropriate, List B of the Office International des Epizooties (World organisation for animal health, OIE). |
| --- | --- |

(b)

of any condition which might adversely affect human or animal health, paying particular attention to the detection of zoonotic diseases and diseases on List A or, where appropriate, List B of the Office International des Epizooties (World organisation for animal health, OIE).

| 3. | In addition to routine ante-mortem inspection, the official veterinarian is to carry out a clinical inspection of all animals that the food business operator or an official auxiliary may have put aside. |
| --- | --- |

3.

In addition to routine ante-mortem inspection, the official veterinarian is to carry out a clinical inspection of all animals that the food business operator or an official auxiliary may have put aside.

| 4. | In the case of emergency slaughter outside the slaughterhouse and of hunted wild game, the official veterinarian at the slaughterhouse or game handling establishment is to examine the declaration accompanying the body of the animal issued by the veterinarian or the trained person in accordance with Regulation (EC) No 853/2004. |
| --- | --- |

4.

In the case of emergency slaughter outside the slaughterhouse and of hunted wild game, the official veterinarian at the slaughterhouse or game handling establishment is to examine the declaration accompanying the body of the animal issued by the veterinarian or the trained person in accordance with Regulation (EC) No 853/2004.

| 5. | Where provided for in Section III, Chapter II, or in Section IV, ante-mortem inspection may be carried out at the holding of provenance. In such cases, the official veterinarian at the slaughterhouse need carry out ante-mortem inspection only when and to the extent specified. |
| --- | --- |

5.

Where provided for in Section III, Chapter II, or in Section IV, ante-mortem inspection may be carried out at the holding of provenance. In such cases, the official veterinarian at the slaughterhouse need carry out ante-mortem inspection only when and to the extent specified.

C.   Animal welfare

The official veterinarian is to verify compliance with relevant Community and national rules on animal welfare, such as rules concerning the protection of animals at the time of slaughter and during transport.

D.   Post-mortem inspection

| 1. | Carcases and accompanying offal are to be subjected without delay after slaughter to post-mortem inspection. All external surfaces are to be viewed. Minimal handling of the carcase and offal or special technical facilities may be required for that purpose. Particular attention is to be paid to the detection of zoonotic diseases and diseases on OIE List A and, where appropriate, OIE List B. The speed of the slaughter line and the number of inspection staff present are to be such as to allow for proper inspection. |
| --- | --- |

1.

Carcases and accompanying offal are to be subjected without delay after slaughter to post-mortem inspection. All external surfaces are to be viewed. Minimal handling of the carcase and offal or special technical facilities may be required for that purpose. Particular attention is to be paid to the detection of zoonotic diseases and diseases on OIE List A and, where appropriate, OIE List B. The speed of the slaughter line and the number of inspection staff present are to be such as to allow for proper inspection.

| 2. | Additional examinations are to take place, such as palpation and incision of parts of the carcase and offal and laboratory tests, whenever considered necessary:






  (a) | to reach a definitive diagnosis;
  or |
| --- | --- | --- |

2.

Additional examinations are to take place, such as palpation and incision of parts of the carcase and offal and laboratory tests, whenever considered necessary:

(a)

to reach a definitive diagnosis;

or

| (b) | to detect the presence of:






  (i) | an animal disease, |
| --- | --- | --- |

(b)

to detect the presence of:

(i)

an animal disease,

| (ii) | residues or contaminants in excess of the levels laid down under Community legislation, |
| --- | --- |

(ii)

residues or contaminants in excess of the levels laid down under Community legislation,

| (iii) | non-compliance with microbiological criteria,
  or |
| --- | --- |

(iii)

non-compliance with microbiological criteria,

or

| (iv) | other factors that might require the meat to be declared unfit for human consumption or restrictions to be placed on its use, |
| --- | --- |

(iv)

other factors that might require the meat to be declared unfit for human consumption or restrictions to be placed on its use,

particularly in the case of animals having undergone emergency slaughter.

| 3. | The official veterinarian is to require carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old to be submitted for post-mortem inspection split lengthways into half carcases down the spinal column. If the inspection so necessitates, the official veterinarian may also require any head or any carcase to be split lengthways. However, to take account of particular eating habits, technological developments or specific sanitary situations, the competent authority may authorise the submission for inspection of carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old, not split in half. |
| --- | --- |

3.

The official veterinarian is to require carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old to be submitted for post-mortem inspection split lengthways into half carcases down the spinal column. If the inspection so necessitates, the official veterinarian may also require any head or any carcase to be split lengthways. However, to take account of particular eating habits, technological developments or specific sanitary situations, the competent authority may authorise the submission for inspection of carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old, not split in half.

| 4. | During the inspection, precautions must be taken to ensure that contamination of the meat by actions such as palpation, cutting or incision is kept to a minimum. |
| --- | --- |

4.

During the inspection, precautions must be taken to ensure that contamination of the meat by actions such as palpation, cutting or incision is kept to a minimum.

| 5. | In the event of an emergency slaughter, the carcase shall be subjected to post-mortem examination as soon as possible in accordance with paragraphs 1 to 4 before it is released for human consumption. |
| --- | --- |

5.

In the event of an emergency slaughter, the carcase shall be subjected to post-mortem examination as soon as possible in accordance with paragraphs 1 to 4 before it is released for human consumption.

E.   Specified risk material and other animal by-products

In accordance with specific Community rules on specified risk material and other animal by-products, the official veterinarian is to check the removal, separation and, where appropriate, marking of such products. The official veterinarian is to ensure that the food business operator takes all necessary measures to avoid contaminating meat with specified risk material during slaughter (including stunning) and removal of specified risk material.

F.   Laboratory testing

| 1. | The official veterinarian is to ensure that sampling takes place and that samples are appropriately identified and handled and sent to the appropriate laboratory within the framework of:






  (a) | the monitoring and control of zoonoses and zoonotic agents; |
| --- | --- | --- |

1.

The official veterinarian is to ensure that sampling takes place and that samples are appropriately identified and handled and sent to the appropriate laboratory within the framework of:

(a)

the monitoring and control of zoonoses and zoonotic agents;

| (b) | specific laboratory testing for the diagnosis of TSEs in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (10); |
| --- | --- |

(b)

specific laboratory testing for the diagnosis of TSEs in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (10);

| (c) | the detection of unauthorised substances or products and the control of regulated substances, in particular within the framework of the National Residue Plans referred to in Council Directive 96/23/EC (11);
  and |
| --- | --- |

(c)

the detection of unauthorised substances or products and the control of regulated substances, in particular within the framework of the National Residue Plans referred to in Council Directive 96/23/EC (11);

and

| (d) | the detection of OIE List A and, where appropriate, OIE List B diseases. |
| --- | --- |

(d)

the detection of OIE List A and, where appropriate, OIE List B diseases.

| 2. | The official veterinarian is also to ensure that any other necessary laboratory testing takes place. |
| --- | --- |

2.

The official veterinarian is also to ensure that any other necessary laboratory testing takes place.

CHAPTER III: HEALTH MARKING

| 1. | The official veterinarian is to supervise health marking and the marks used. |
| --- | --- |

1.

The official veterinarian is to supervise health marking and the marks used.

| 2. | The official veterinarian is to ensure, in particular, that:






  (a) | the health mark is applied only to animals (domestic ungulates, farmed game mammals other than lagomorphs, and large wild game) having undergone ante-mortem and post-mortem inspection in accordance with this Regulation and when there are no grounds for declaring the meat unfit for human consumption. However, the health mark may be applied before the results of any examination for trichinosis is available, if the official veterinarian is satisfied that meat from the animal concerned will be placed on the market only if the results are satisfactory;
  and |
| --- | --- | --- |

2.

The official veterinarian is to ensure, in particular, that:

(a)

the health mark is applied only to animals (domestic ungulates, farmed game mammals other than lagomorphs, and large wild game) having undergone ante-mortem and post-mortem inspection in accordance with this Regulation and when there are no grounds for declaring the meat unfit for human consumption. However, the health mark may be applied before the results of any examination for trichinosis is available, if the official veterinarian is satisfied that meat from the animal concerned will be placed on the market only if the results are satisfactory;

and

| (b) | health-marking takes place on the external surface of the carcase, by stamping the mark in ink or hot branding, and in such a manner that, if carcases are cut into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark. |
| --- | --- |

(b)

health-marking takes place on the external surface of the carcase, by stamping the mark in ink or hot branding, and in such a manner that, if carcases are cut into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark.

| 3. | The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bearing the following information in perfectly legible characters:






  (a) | the mark must indicate name of the country in which the establishment is located, which may be written out in full in capitals or shown as a two-letter code in accordance with the relevant ISO standard.
  In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK; |
| --- | --- | --- |

3.

The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bearing the following information in perfectly legible characters:

(a)

the mark must indicate name of the country in which the establishment is located, which may be written out in full in capitals or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK;

| (b) | the mark must indicate the approval number of the slaughterhouse;
  and |
| --- | --- |

(b)

the mark must indicate the approval number of the slaughterhouse;

and

| (c) | when applied in a slaughterhouse within the Community, the mark must include the abbreviation CE, EC, EF, EG, EK or EY. |
| --- | --- |

(c)

when applied in a slaughterhouse within the Community, the mark must include the abbreviation CE, EC, EF, EG, EK or EY.

| 4. | Letters must be at least 0,8 cm high and figures at least 1 cm high. The dimensions and characters of the mark may be reduced for health marking of lamb, kids and piglets. |
| --- | --- |

4.

Letters must be at least 0,8 cm high and figures at least 1 cm high. The dimensions and characters of the mark may be reduced for health marking of lamb, kids and piglets.

| 5. | The colours used for health marking must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs. |
| --- | --- |

5.

The colours used for health marking must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

| 6. | The health mark may also include an indication of the official veterinarian who carried out the health inspection of the meat. Competent authorities and food business operators may continue to use equipment that they ordered before entry into force of this Regulation until it is exhausted or requires replacement. |
| --- | --- |

6.

The health mark may also include an indication of the official veterinarian who carried out the health inspection of the meat. Competent authorities and food business operators may continue to use equipment that they ordered before entry into force of this Regulation until it is exhausted or requires replacement.

| 7. | Meat from animals having undergone emergency slaughter outside the slaughterhouse must bear a special health mark, which cannot be confused either with the health mark provided for in this Chapter or with the identification mark provided for in Annex II, Section I, to Regulation (EC) No 853/2004. |
| --- | --- |

7.

Meat from animals having undergone emergency slaughter outside the slaughterhouse must bear a special health mark, which cannot be confused either with the health mark provided for in this Chapter or with the identification mark provided for in Annex II, Section I, to Regulation (EC) No 853/2004.

| 8. | Meat from unskinned wild game cannot bear a health mark unless, after skinning in a game handling establishment, it has undergone post-mortem inspection and been declared fit for human consumption. |
| --- | --- |

8.

Meat from unskinned wild game cannot bear a health mark unless, after skinning in a game handling establishment, it has undergone post-mortem inspection and been declared fit for human consumption.

| 9. | This Chapter is to apply without prejudice to animal health rules on health marking. |
| --- | --- |

9.

This Chapter is to apply without prejudice to animal health rules on health marking.

SECTION II: ACTION FOLLOWING CONTROLS

CHAPTER I: COMMUNICATION OF INSPECTION RESULTS

| 1. | The official veterinarian is to record and to evaluate the results of inspection activities. |
| --- | --- |

1.

The official veterinarian is to record and to evaluate the results of inspection activities.

| 2. | (a) | If inspections reveal the presence of any disease or condition that might affect public or animal health, or compromise animal welfare, the official veterinarian is to inform the food business operator. |
| --- | --- | --- |

2.

(a)

If inspections reveal the presence of any disease or condition that might affect public or animal health, or compromise animal welfare, the official veterinarian is to inform the food business operator.

| (b) | When the problem identified arose during primary production, the official veterinarian is to inform the veterinarian attending the holding of provenance, the food business operator responsible for the holding of provenance (provided that such information would not prejudice subsequent legal proceedings) and, where appropriate, the competent authority responsible for supervising the holding of provenance or the hunting area. |
| --- | --- |

(b)

When the problem identified arose during primary production, the official veterinarian is to inform the veterinarian attending the holding of provenance, the food business operator responsible for the holding of provenance (provided that such information would not prejudice subsequent legal proceedings) and, where appropriate, the competent authority responsible for supervising the holding of provenance or the hunting area.

| (c) | If the animals concerned were raised in another Member State or in a third country, the official veterinarian is to inform to the competent authority of the Member State where the establishment is located. That competent authority is to take appropriate measures in accordance with applicable Community legislation. |
| --- | --- |

(c)

If the animals concerned were raised in another Member State or in a third country, the official veterinarian is to inform to the competent authority of the Member State where the establishment is located. That competent authority is to take appropriate measures in accordance with applicable Community legislation.

| 3. | The results of inspections and tests are to be included in relevant databases. |
| --- | --- |

3.

The results of inspections and tests are to be included in relevant databases.

| 4. | When the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other inspection activity, suspects the presence of an infectious agent mentioned on OIE List A or, where appropriate, OIE List B, the official veterinarian must immediately notify the competent authority and both must take all necessary measures and precautions to prevent the possible spread of the infectious agent in accordance with applicable Community legislation. |
| --- | --- |

4.

When the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other inspection activity, suspects the presence of an infectious agent mentioned on OIE List A or, where appropriate, OIE List B, the official veterinarian must immediately notify the competent authority and both must take all necessary measures and precautions to prevent the possible spread of the infectious agent in accordance with applicable Community legislation.

CHAPTER II: DECISIONS CONCERNING FOOD CHAIN INFORMATION

| 1. | The official veterinarian is to verify that animals are not slaughtered unless the slaughterhouse operator has been provided with and checked relevant food chain information. |
| --- | --- |

1.

The official veterinarian is to verify that animals are not slaughtered unless the slaughterhouse operator has been provided with and checked relevant food chain information.

| 2. | However, the official veterinarian may allow animals to undergo slaughter in the slaughterhouse even if the relevant food chain information is not available. In this case, all relevant food chain information must be supplied before the carcase is approved for human consumption. Pending a final judgement, such carcases and related offal must be stored separately from other meat. |
| --- | --- |

2.

However, the official veterinarian may allow animals to undergo slaughter in the slaughterhouse even if the relevant food chain information is not available. In this case, all relevant food chain information must be supplied before the carcase is approved for human consumption. Pending a final judgement, such carcases and related offal must be stored separately from other meat.

| 3. | Notwithstanding paragraph 2, when relevant food chain information is not available within 24 hours of an animal's arrival at the slaughterhouse, all meat from the animal is to be declared unfit for human consumption. If the animal has not yet been slaughtered, it is to be killed separately from other animals. |
| --- | --- |

3.

Notwithstanding paragraph 2, when relevant food chain information is not available within 24 hours of an animal's arrival at the slaughterhouse, all meat from the animal is to be declared unfit for human consumption. If the animal has not yet been slaughtered, it is to be killed separately from other animals.

| 4. | When the accompanying records, documentation or other information shows that:






  (a) | animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health; |
| --- | --- | --- |

4.

When the accompanying records, documentation or other information shows that:

(a)

animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health;

| (b) | rules on the use of veterinary medicinal products have not been complied with;
  or |
| --- | --- |

(b)

rules on the use of veterinary medicinal products have not been complied with;

or

| (c) | any other condition which might adversely affect human or animal health is present, animals may not be accepted for slaughter other than in accordance with procedures laid down under Community legislation to eliminate human or animal health risks. |
| --- | --- |

(c)

any other condition which might adversely affect human or animal health is present, animals may not be accepted for slaughter other than in accordance with procedures laid down under Community legislation to eliminate human or animal health risks.

If the animals are already present at the slaughterhouse, they must be killed separately and declared unfit for human consumption, taking precautions to safeguard animal and public health where appropriate. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance.

| 5. | The competent authority is to take appropriate action if it discovers that the accompanying records, documentation or other information do not correspond with the true situation on the holding of provenance or the true condition of the animals or aim deliberately to mislead the official veterinarian. The competent authority is to take action against the food business operator responsible for the holding of provenance of the animals, or any other person involved. This action may consist in particular of extra controls. The food business operator responsible for the holding of provenance or any other person involved are to bear the costs of such extra controls. |
| --- | --- |

5.

The competent authority is to take appropriate action if it discovers that the accompanying records, documentation or other information do not correspond with the true situation on the holding of provenance or the true condition of the animals or aim deliberately to mislead the official veterinarian. The competent authority is to take action against the food business operator responsible for the holding of provenance of the animals, or any other person involved. This action may consist in particular of extra controls. The food business operator responsible for the holding of provenance or any other person involved are to bear the costs of such extra controls.

CHAPTER III: DECISIONS CONCERNING LIVE ANIMALS

| 1. | The official veterinarian is to verify compliance with the food business operator's duty pursuant to Regulation (EC) No 853/2004 to ensure that animals accepted for slaughter for human consumption are properly identified. The official veterinarian is to ensure that animals whose identity is not reasonably ascertainable are killed separately and declared unfit for human consumption. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance. |
| --- | --- |

1.

The official veterinarian is to verify compliance with the food business operator's duty pursuant to Regulation (EC) No 853/2004 to ensure that animals accepted for slaughter for human consumption are properly identified. The official veterinarian is to ensure that animals whose identity is not reasonably ascertainable are killed separately and declared unfit for human consumption. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance.

| 2. | When there are overriding animal welfare considerations, horses may undergo slaughter at the slaughterhouse even if the legally required information concerning their identity has not been supplied. However, this information must be supplied before the carcase may be declared fit for human consumption. These requirements also apply in the case of emergency slaughter of horses outside the slaughterhouse. |
| --- | --- |

2.

When there are overriding animal welfare considerations, horses may undergo slaughter at the slaughterhouse even if the legally required information concerning their identity has not been supplied. However, this information must be supplied before the carcase may be declared fit for human consumption. These requirements also apply in the case of emergency slaughter of horses outside the slaughterhouse.

| 3. | The official veterinarian is to verify compliance with the food business operator's duty under Regulation (EC) No 853/2004 to ensure that animals that have such hide, skin or fleece conditions that there is an unacceptable risk of contamination of the meat during slaughter are not slaughtered for human consumption unless they are cleaned beforehand. |
| --- | --- |

3.

The official veterinarian is to verify compliance with the food business operator's duty under Regulation (EC) No 853/2004 to ensure that animals that have such hide, skin or fleece conditions that there is an unacceptable risk of contamination of the meat during slaughter are not slaughtered for human consumption unless they are cleaned beforehand.

| 4. | Animals with a disease or condition that may be transmitted to animals or humans through handling or eating meat and, in general, animals showing clinical signs of systemic disease or emaciation, are not to be slaughtered for human consumption. Such animals must be killed separately, under conditions such that other animals or carcases can not be contaminated, and declared unfit for human consumption. |
| --- | --- |

4.

Animals with a disease or condition that may be transmitted to animals or humans through handling or eating meat and, in general, animals showing clinical signs of systemic disease or emaciation, are not to be slaughtered for human consumption. Such animals must be killed separately, under conditions such that other animals or carcases can not be contaminated, and declared unfit for human consumption.

| 5. | The slaughter of animals suspected of having a disease or condition that may adversely affect human or animal health is to be deferred. Such animals are to undergo detailed ante-mortem examination in order to make a diagnosis. In addition, the official veterinarian may decide that sampling and laboratory examinations are to take place to supplement post-mortem inspection. If necessary, the animals are to be slaughtered separately or at the end of normal slaughtering, taking all necessary precautions to avoid contamination of other meat. |
| --- | --- |

5.

The slaughter of animals suspected of having a disease or condition that may adversely affect human or animal health is to be deferred. Such animals are to undergo detailed ante-mortem examination in order to make a diagnosis. In addition, the official veterinarian may decide that sampling and laboratory examinations are to take place to supplement post-mortem inspection. If necessary, the animals are to be slaughtered separately or at the end of normal slaughtering, taking all necessary precautions to avoid contamination of other meat.

| 6. | Animals that might contain residues of veterinary medicinal products in excess of the levels laid down in accordance with Community legislation, or residues of forbidden substances, are to be dealt with in accordance with Directive 96/23/EC. |
| --- | --- |

6.

Animals that might contain residues of veterinary medicinal products in excess of the levels laid down in accordance with Community legislation, or residues of forbidden substances, are to be dealt with in accordance with Directive 96/23/EC.

| 7. | The official veterinarian is to impose the conditions under which animals are to be dealt with under a specific scheme for the eradication or control of a specific disease, such as brucellosis or tuberculosis, or zoonotic agents such as salmonella, under his/her direct supervision. The competent authority is to determine the conditions under which such animals may be slaughtered. These conditions must have the aim of minimising contamination of other animals and the meat of other animals. |
| --- | --- |

7.

The official veterinarian is to impose the conditions under which animals are to be dealt with under a specific scheme for the eradication or control of a specific disease, such as brucellosis or tuberculosis, or zoonotic agents such as salmonella, under his/her direct supervision. The competent authority is to determine the conditions under which such animals may be slaughtered. These conditions must have the aim of minimising contamination of other animals and the meat of other animals.

| 8. | Animals that are presented to a slaughterhouse for slaughter must as a general rule be slaughtered there. However, in exceptional circumstances, such as a serious breakdown of the slaughter facilities, the official veterinarian may allow direct movements to another slaughterhouse. |
| --- | --- |

8.

Animals that are presented to a slaughterhouse for slaughter must as a general rule be slaughtered there. However, in exceptional circumstances, such as a serious breakdown of the slaughter facilities, the official veterinarian may allow direct movements to another slaughterhouse.

CHAPTER IV: DECISIONS CONCERNING ANIMAL WELFARE

| 1. | When the rules concerning the protection of animals at the time of slaughter or killing are not respected, the official veterinarian is to verify that the food business operator immediately takes necessary corrective measures and prevents recurrence. |
| --- | --- |

1.

When the rules concerning the protection of animals at the time of slaughter or killing are not respected, the official veterinarian is to verify that the food business operator immediately takes necessary corrective measures and prevents recurrence.

| 2. | The official veterinarian is to take a proportionate and progressive approach to enforcement action, ranging from issuing directions to slowing down and stopping production, depending on the nature and gravity of the problem. |
| --- | --- |

2.

The official veterinarian is to take a proportionate and progressive approach to enforcement action, ranging from issuing directions to slowing down and stopping production, depending on the nature and gravity of the problem.

| 3. | Where appropriate, the official veterinarian is to inform other competent authorities of welfare problems. |
| --- | --- |

3.

Where appropriate, the official veterinarian is to inform other competent authorities of welfare problems.

| 4. | When the official veterinarian discovers that rules concerning the protection of animals during transport are not being respected, he or she is to take necessary measures in accordance with the relevant Community legislation. |
| --- | --- |

4.

When the official veterinarian discovers that rules concerning the protection of animals during transport are not being respected, he or she is to take necessary measures in accordance with the relevant Community legislation.

| 5. | When:






  (a) | an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV;
  and |
| --- | --- | --- |

5.

When:

(a)

an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV;

and

| (b) | those checks identify non-compliance with the rules on the protection of animals, |
| --- | --- |

(b)

those checks identify non-compliance with the rules on the protection of animals,

the official auxiliary is immediately to inform the official veterinarian and, if necessary in cases of urgency, is to take the necessary measures referred to in paragraphs 1 to 4 pending the arrival of the official veterinarian.

CHAPTER V: DECISIONS CONCERNING MEAT

| 1. | Meat is to be declared unfit for human consumption if it:






  (a) | derives from animals that have not undergone ante-mortem inspection, except for hunted wild game; |
| --- | --- | --- |

1.

Meat is to be declared unfit for human consumption if it:

(a)

derives from animals that have not undergone ante-mortem inspection, except for hunted wild game;

| (b) | derives from animals the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this Regulation or Regulation (EC) No 853/2004; |
| --- | --- |

(b)

derives from animals the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this Regulation or Regulation (EC) No 853/2004;

| (c) | derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days; |
| --- | --- |

(c)

derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days;

| (d) | results from the trimming of sticking points; |
| --- | --- |

(d)

results from the trimming of sticking points;

| (e) | derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise provided for in Section IV; |
| --- | --- |

(e)

derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise provided for in Section IV;

| (f) | derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia; |
| --- | --- |

(f)

derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;

| (g) | is not in conformity with microbiological criteria laid down under Community legislation to determine whether food may be placed on the market; |
| --- | --- |

(g)

is not in conformity with microbiological criteria laid down under Community legislation to determine whether food may be placed on the market;

| (h) | exhibits parasitic infestation, unless otherwise provided for in Section IV; |
| --- | --- |

(h)

exhibits parasitic infestation, unless otherwise provided for in Section IV;

| (i) | contains residues or contaminants in excess of the levels laid down in Community legislation. Any overshooting of the relevant level should lead to additional analyses whenever appropriate; |
| --- | --- |

(i)

contains residues or contaminants in excess of the levels laid down in Community legislation. Any overshooting of the relevant level should lead to additional analyses whenever appropriate;

| (j) | without prejudice to more specific Community legislation, derives from animals or carcases containing residues of forbidden substances or from animals that have been treated with forbidden substances; |
| --- | --- |

(j)

without prejudice to more specific Community legislation, derives from animals or carcases containing residues of forbidden substances or from animals that have been treated with forbidden substances;

| (k) | consists of the liver and kidneys of animals more than two years old from regions where implementation of plans approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals in the environment; |
| --- | --- |

(k)

consists of the liver and kidneys of animals more than two years old from regions where implementation of plans approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals in the environment;

| (l) | has been treated illegally with decontaminating substances; |
| --- | --- |

(l)

has been treated illegally with decontaminating substances;

| (m) | has been treated illegally with ionising or UV-rays; |
| --- | --- |

(m)

has been treated illegally with ionising or UV-rays;

| (n) | contains foreign bodies (except, in the case of wild game, material used to hunt the animal); |
| --- | --- |

(n)

contains foreign bodies (except, in the case of wild game, material used to hunt the animal);

| (o) | exceeds the maximum permitted radioactivity levels laid down under Community legislation; |
| --- | --- |

(o)

exceeds the maximum permitted radioactivity levels laid down under Community legislation;

| (p) | indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or organoleptic anomalies, in particular a pronounced sexual odour; |
| --- | --- |

(p)

indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or organoleptic anomalies, in particular a pronounced sexual odour;

| (q) | derives from emaciated animals; |
| --- | --- |

(q)

derives from emaciated animals;

| (r) | contains specified risk material, except as provided for under Community legislation; |
| --- | --- |

(r)

contains specified risk material, except as provided for under Community legislation;

| (s) | shows soiling, faecal or other contamination; |
| --- | --- |

(s)

shows soiling, faecal or other contamination;

| (t) | consists of blood that may constitute a risk to public or animal health owing to the health status of any animal from which it derives or contamination arising during the slaughter process; |
| --- | --- |

(t)

consists of blood that may constitute a risk to public or animal health owing to the health status of any animal from which it derives or contamination arising during the slaughter process;

| (u) | in the opinion of the official veterinarian, after examination of all the relevant information, it may constitute a risk to public or animal health or is for any other reason not suitable for human consumption. |
| --- | --- |

(u)

in the opinion of the official veterinarian, after examination of all the relevant information, it may constitute a risk to public or animal health or is for any other reason not suitable for human consumption.

| 2. | The official veterinarian may impose requirements concerning the use of meat derived from animals having undergone emergency slaughter outside the slaughterhouse. |
| --- | --- |

2.

The official veterinarian may impose requirements concerning the use of meat derived from animals having undergone emergency slaughter outside the slaughterhouse.

SECTION III: RESPONSIBILITIES AND FREQUENCY OF CONTROLS

CHAPTER I: OFFICIAL AUXILIARIES

Official auxiliaries may assist the official veterinarian with all tasks, subject to the following restrictions and to any specific rules laid down in Section IV:

| 1. | in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and HACCP-based procedures; |
| --- | --- |

1.

in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and HACCP-based procedures;

| 2. | in relation to ante-mortem inspection and checks concerning the welfare of animals, official auxiliaries may only make an initial check of animals and help with purely practical tasks;
  and |
| --- | --- |

2.

in relation to ante-mortem inspection and checks concerning the welfare of animals, official auxiliaries may only make an initial check of animals and help with purely practical tasks;

and

| 3. | in relation to post-mortem inspection, the official veterinarian must regularly check the work of official auxiliaries and, in the case of animals having undergone emergency slaughter outside the slaughterhouse, carry out the inspection personally. |
| --- | --- |

3.

in relation to post-mortem inspection, the official veterinarian must regularly check the work of official auxiliaries and, in the case of animals having undergone emergency slaughter outside the slaughterhouse, carry out the inspection personally.

CHAPTER II: FREQUENCY OF CONTROLS

| 1. | The competent authority is to ensure that at least one official veterinarian is present:






  (a) | in slaughterhouses, throughout both ante-mortem and post-mortem inspection;
  and |
| --- | --- | --- |

1.

The competent authority is to ensure that at least one official veterinarian is present:

(a)

in slaughterhouses, throughout both ante-mortem and post-mortem inspection;

and

| (b) | in game handling establishments, throughout post-mortem inspection. |
| --- | --- |

(b)

in game handling establishments, throughout post-mortem inspection.

| 2. | However, the competent authority may adapt this approach in certain slaughterhouses and game handling establishments identified on the basis of a risk analysis and in accordance with criteria laid down in accordance with Article 18, point 3, if there are any. In such cases:






  (a) | the official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:






  (i) | an official veterinarian or an approved veterinarian carried out ante-mortem inspection at the holding of provenance, checked the food chain information and communicated the results of the check to the official auxiliary at the slaughterhouse, |
| --- | --- | --- | --- |

2.

However, the competent authority may adapt this approach in certain slaughterhouses and game handling establishments identified on the basis of a risk analysis and in accordance with criteria laid down in accordance with Article 18, point 3, if there are any. In such cases:

(a)

the official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:

(i)

an official veterinarian or an approved veterinarian carried out ante-mortem inspection at the holding of provenance, checked the food chain information and communicated the results of the check to the official auxiliary at the slaughterhouse,

| (ii) | the official auxiliary at the slaughterhouse is satisfied that the food chain information does not point to any possible problem for food safety and that the animal's general state of health and welfare is satisfactory,
  and |
| --- | --- |

(ii)

the official auxiliary at the slaughterhouse is satisfied that the food chain information does not point to any possible problem for food safety and that the animal's general state of health and welfare is satisfactory,

and

| (iii) | the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks properly; |
| --- | --- |

(iii)

the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks properly;

| (b) | the official veterinarian need not be present at all times during post-mortem inspection if:






  (i) | an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other meat from the same animal, |
| --- | --- | --- |

(b)

the official veterinarian need not be present at all times during post-mortem inspection if:

(i)

an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other meat from the same animal,

| (ii) | the official veterinarian subsequently inspects all such meat,
  and |
| --- | --- |

(ii)

the official veterinarian subsequently inspects all such meat,

and

| (iii) | the official auxiliary documents his/her procedures and findings in a manner that allows the official veterinarian to be satisfied that standards are being met. |
| --- | --- |

(iii)

the official auxiliary documents his/her procedures and findings in a manner that allows the official veterinarian to be satisfied that standards are being met.

However, in the case of poultry and lagomorphs, the official auxiliary may discard meat with abnormalities and, subject to Section IV, the official veterinarian need not systematically inspect all such meat.

| 3. | The flexibility provided for in paragraph 2 does not apply:






  (a) | to animals that have undergone emergency slaughter; |
| --- | --- | --- |

3.

The flexibility provided for in paragraph 2 does not apply:

(a)

to animals that have undergone emergency slaughter;

| (b) | to animals suspected of having a disease or condition that may adversely affect human health; |
| --- | --- |

(b)

to animals suspected of having a disease or condition that may adversely affect human health;

| (c) | to bovine animals from herds that have not been declared officially free of tuberculosis; |
| --- | --- |

(c)

to bovine animals from herds that have not been declared officially free of tuberculosis;

| (d) | to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis; |
| --- | --- |

(d)

to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis;

| (e) | in the case of an outbreak of a disease listed on OIE List A or, where appropriate, OIE List B. This concerns animals susceptible to the particular disease in question that come from the particular region as defined in Article 2 of Council Directive 64/432/EEC (12); |
| --- | --- |

(e)

in the case of an outbreak of a disease listed on OIE List A or, where appropriate, OIE List B. This concerns animals susceptible to the particular disease in question that come from the particular region as defined in Article 2 of Council Directive 64/432/EEC (12);

| (f) | when stricter controls are necessary to take account of emerging diseases or particular OIE List B diseases. |
| --- | --- |

(f)

when stricter controls are necessary to take account of emerging diseases or particular OIE List B diseases.

| 4. | In cutting plants, the competent authority is to ensure that an official veterinarian or an official auxiliary is present when meat is being worked on with a frequency appropriate to achieving the objectives of this Regulation. |
| --- | --- |

4.

In cutting plants, the competent authority is to ensure that an official veterinarian or an official auxiliary is present when meat is being worked on with a frequency appropriate to achieving the objectives of this Regulation.

CHAPTER III: INVOLVEMENT OF SLAUGHTERHOUSE STAFF

A.   SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY AND LAGOMORPHS

The Member States may permit slaughterhouse staff to take over the activities of the official auxiliaries in controlling the production of poultry and rabbit meat under the following conditions:

| (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 who have been trained in the same way as the official assistants and have passed the same examination to carry out tasks of the official auxiliaries and form part of the competent authority's independent inspection team, 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 tasks meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Detailed rules for the performance tests shall be laid down in accordance with the procedure set out in Article 18. 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.
  Responsibilities for production and inspection in the establishment must be kept separate and any establishment wishing to use the establishment's own inspectors must possess internationally recognised certification. |
| --- | --- |

(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 who have been trained in the same way as the official assistants and have passed the same examination to carry out tasks of the official auxiliaries and form part of the competent authority's independent inspection team, 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 tasks meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Detailed rules for the performance tests shall be laid down in accordance with the procedure set out in Article 18. 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.

Responsibilities for production and inspection in the establishment must be kept separate and any establishment wishing to use the establishment's own inspectors must possess internationally recognised certification.

| (b) | The competent authority of the Member State shall decide, in principle and on a case-by-case basis, whether to permit the implementation of the system described above. Where the Member State decides in principle in favour of this system, it shall inform the Commission of that decision and its associated conditions. For food business operators in a Member State implementing the system, the actual use of the system is optional. Food business operators shall not be forced by the competent authority to introduce the system described here. Where the competent authority is not convinced that the food business operator satisfies the requirements, the system shall not be implemented in that establishment. In order to assess this, the competent authority shall carry out an analysis of the production and inspection records, the type of activities undertaken in the establishment, the history of compliance with rules, the expertise, professional attitude and sense of responsibility of the slaughterhouse staff in regard to food safety, together with other relevant information. |
| --- | --- |

(b)

The competent authority of the Member State shall decide, in principle and on a case-by-case basis, whether to permit the implementation of the system described above. Where the Member State decides in principle in favour of this system, it shall inform the Commission of that decision and its associated conditions. For food business operators in a Member State implementing the system, the actual use of the system is optional. Food business operators shall not be forced by the competent authority to introduce the system described here. Where the competent authority is not convinced that the food business operator satisfies the requirements, the system shall not be implemented in that establishment. In order to assess this, the competent authority shall carry out an analysis of the production and inspection records, the type of activities undertaken in the establishment, the history of compliance with rules, the expertise, professional attitude and sense of responsibility of the slaughterhouse staff in regard to food safety, together with other relevant information.

B.   SPECIFIC SAMPLING AND TESTING TASKS

Slaughterhouse staff who have received specific training, under the supervision of the official veterinarian, may, under the responsibility and the supervision of the official veterinarian, carry out specific sampling and testing tasks in respect of animals of all species.

CHAPTER IV: PROFESSIONAL QUALIFICATIONS

A.   OFFICIAL VETERINARIANS

| 1. | The competent authority may appoint only veterinarians who have passed a test meeting the requirements of paragraph 2 as official veterinarians. |
| --- | --- |

1.

The competent authority may appoint only veterinarians who have passed a test meeting the requirements of paragraph 2 as official veterinarians.

| 2. | The competent authority must make arrangements for the test. The test is to confirm knowledge of the following subjects to the extent necessary depending on the veterinarian's background and qualifications:






  (a) | national and Community legislation on veterinary public health, food safety, animal health, animal welfare and pharmaceutical substances; |
| --- | --- | --- |

2.

The competent authority must make arrangements for the test. The test is to confirm knowledge of the following subjects to the extent necessary depending on the veterinarian's background and qualifications:

(a)

national and Community legislation on veterinary public health, food safety, animal health, animal welfare and pharmaceutical substances;

| (b) | principles of the common agricultural policy, market measures, export refunds and fraud detection (including the global context: WTO, SPS, Codex Alimentarius, OIE); |
| --- | --- |

(b)

principles of the common agricultural policy, market measures, export refunds and fraud detection (including the global context: WTO, SPS, Codex Alimentarius, OIE);

| (c) | essentials of food processing and food technology; |
| --- | --- |

(c)

essentials of food processing and food technology;

| (d) | principles, concepts and methods of good manufacturing practice and quality management; |
| --- | --- |

(d)

principles, concepts and methods of good manufacturing practice and quality management;

| (e) | pre-harvest quality management (good farming practices); |
| --- | --- |

(e)

pre-harvest quality management (good farming practices);

| (f) | promotion and use of food hygiene, food related safety (good hygiene practices); |
| --- | --- |

(f)

promotion and use of food hygiene, food related safety (good hygiene practices);

| (g) | principles, concepts and methods of risk-analysis; |
| --- | --- |

(g)

principles, concepts and methods of risk-analysis;

| (h) | principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain; |
| --- | --- |

(h)

principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain;

| (i) | prevention and control of food-borne hazards related to human health; |
| --- | --- |

(i)

prevention and control of food-borne hazards related to human health;

| (j) | population dynamics of infection and intoxication; |
| --- | --- |

(j)

population dynamics of infection and intoxication;

| (k) | diagnostic epidemiology; |
| --- | --- |

(k)

diagnostic epidemiology;

| (l) | monitoring and surveillance systems; |
| --- | --- |

(l)

monitoring and surveillance systems;

| (m) | auditing and regulatory assessment of food safety management systems; |
| --- | --- |

(m)

auditing and regulatory assessment of food safety management systems;

| (n) | principles and diagnostic applications of modern testing methods; |
| --- | --- |

(n)

principles and diagnostic applications of modern testing methods;

| (o) | information and communication technology as related to veterinary public health; |
| --- | --- |

(o)

information and communication technology as related to veterinary public health;

| (p) | data-handling and applications of biostatistics; |
| --- | --- |

(p)

data-handling and applications of biostatistics;

| (q) | investigations of outbreaks of food-borne diseases in humans; |
| --- | --- |

(q)

investigations of outbreaks of food-borne diseases in humans;

| (r) | relevant aspects concerning TSEs; |
| --- | --- |

(r)

relevant aspects concerning TSEs;

| (s) | animal welfare at the level of production, transport and slaughter; |
| --- | --- |

(s)

animal welfare at the level of production, transport and slaughter;

| (t) | environmental issues related to food production (including waste management); |
| --- | --- |

(t)

environmental issues related to food production (including waste management);

| (u) | precautionary principle and consumer concerns;
  and |
| --- | --- |

(u)

precautionary principle and consumer concerns;

and

| (v) | principles of training of personnel working in the production chain. |
| --- | --- |

(v)

principles of training of personnel working in the production chain.

Candidates may acquire the required knowledge as part of their basic veterinary training, or through training undertaken, or professional experience acquired, after qualifying as veterinarians. The competent authority may arrange for different tests to take account of candidates' background. However, when the competent authority is satisfied that a candidate has acquired all the required knowledge as part of a university degree, or through continuing education resulting in a postgraduate qualification, it may waive the requirement for a test.

| 3. | The veterinarian is to have aptitude for multidisciplinary cooperation. |
| --- | --- |

3.

The veterinarian is to have aptitude for multidisciplinary cooperation.

| 4. | In addition, each official veterinarian is to undergo practical training for a probationary period of at least 200 hours before starting to work independently. During this period the probationer is to work under the supervision of existing official veterinarians in slaughterhouses, cutting plants, inspection posts for fresh meat and on holdings. The training is to concern the auditing of food safety management systems in particular. |
| --- | --- |

4.

In addition, each official veterinarian is to undergo practical training for a probationary period of at least 200 hours before starting to work independently. During this period the probationer is to work under the supervision of existing official veterinarians in slaughterhouses, cutting plants, inspection posts for fresh meat and on holdings. The training is to concern the auditing of food safety management systems in particular.

| 5. | The official veterinarian is to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official veterinarian is, wherever possible, to undertake annual continuing education activities. |
| --- | --- |

5.

The official veterinarian is to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official veterinarian is, wherever possible, to undertake annual continuing education activities.

| 6. | Veterinarians already appointed as official veterinarians must have adequate knowledge of the subjects mentioned in paragraph 2. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard. |
| --- | --- |

6.

Veterinarians already appointed as official veterinarians must have adequate knowledge of the subjects mentioned in paragraph 2. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard.

| 7. | Notwithstanding paragraphs 1 to 6, Member States may lay down specific rules for official veterinarians working on a part-time basis who are responsible for inspecting small businesses |
| --- | --- |

7.

Notwithstanding paragraphs 1 to 6, Member States may lay down specific rules for official veterinarians working on a part-time basis who are responsible for inspecting small businesses

B.   OFFICIAL AUXILIARIES

| 1. | The competent authority may appoint as official auxiliaries only persons who have undergone training and passed a test in accordance with the following requirements. |
| --- | --- |

1.

The competent authority may appoint as official auxiliaries only persons who have undergone training and passed a test in accordance with the following requirements.

| 2. | The competent authority must make arrangements for such tests. To be eligible for these tests, candidates must prove that they have received:






  (a) | at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5;
  and |
| --- | --- | --- |

2.

The competent authority must make arrangements for such tests. To be eligible for these tests, candidates must prove that they have received:

(a)

at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5;

and

| (b) | such additional training as is required to enable official auxiliaries to undertake their duties competently. |
| --- | --- |

(b)

such additional training as is required to enable official auxiliaries to undertake their duties competently.

| 3. | The practical training referred to in paragraph 2(a) is to take place in slaughterhouses and cutting plants, under the supervision of an official veterinarian, and on holdings and in other relevant establishments. |
| --- | --- |

3.

The practical training referred to in paragraph 2(a) is to take place in slaughterhouses and cutting plants, under the supervision of an official veterinarian, and on holdings and in other relevant establishments.

| 4. | Training and tests are to concern principally red meat or poultrymeat. However, persons who undergo training for one of the two categories and passed the test need only undergo abridged training to pass the test for the other category. Training and test should cover wild game, farmed game and lagomorphs, where appropriate. |
| --- | --- |

4.

Training and tests are to concern principally red meat or poultrymeat. However, persons who undergo training for one of the two categories and passed the test need only undergo abridged training to pass the test for the other category. Training and test should cover wild game, farmed game and lagomorphs, where appropriate.

| 5. | Training for official auxiliaries is to cover, and tests are to confirm knowledge of, the following subjects:






  (a) | in relation to holdings:






  (i) | theoretical part:






  — | familiarity with the farming industry organisation, production methods, international trade etc., |
| --- | --- | --- | --- | --- |

5.

Training for official auxiliaries is to cover, and tests are to confirm knowledge of, the following subjects:

(a)

in relation to holdings:

(i)

theoretical part:

—

familiarity with the farming industry organisation, production methods, international trade etc.,

| — | good livestock husbandry practices, |
| --- | --- |

—

good livestock husbandry practices,

| — | basic knowledge of diseases, in particular zoonoses — viruses, bacteria, parasites etc., |
| --- | --- |

—

basic knowledge of diseases, in particular zoonoses — viruses, bacteria, parasites etc.,

| — | monitoring for disease, use of medicines and vaccines, residue testing, |
| --- | --- |

—

monitoring for disease, use of medicines and vaccines, residue testing,

| — | hygiene and health inspection, |
| --- | --- |

—

hygiene and health inspection,

| — | animal welfare on the farm and during transport, |
| --- | --- |

—

animal welfare on the farm and during transport,

| — | environmental requirements — in buildings, on farms and in general, |
| --- | --- |

—

environmental requirements — in buildings, on farms and in general,

| — | relevant laws, regulations and administrative provisions, |
| --- | --- |

—

relevant laws, regulations and administrative provisions,

| — | consumer concerns and quality control; |
| --- | --- |

—

consumer concerns and quality control;

| (ii) | practical part:






  — | visits to holdings of different types and using different rearing methods, |
| --- | --- | --- |

(ii)

practical part:

—

visits to holdings of different types and using different rearing methods,

| — | visits to production establishments, |
| --- | --- |

—

visits to production establishments,

| — | observation of the loading and unloading of animals, |
| --- | --- |

—

observation of the loading and unloading of animals,

| — | laboratory demonstrations, |
| --- | --- |

—

laboratory demonstrations,

| — | veterinary checks, |
| --- | --- |

—

veterinary checks,

| — | documentation; |
| --- | --- |

—

documentation;

| (b) | in relation to slaughterhouses and cutting plants:






  (i) | theoretical part:






  — | familiarity with the meat industry organisation, production methods, international trade and slaughter and cutting technology, |
| --- | --- | --- | --- |

(b)

in relation to slaughterhouses and cutting plants:

(i)

theoretical part:

—

familiarity with the meat industry organisation, production methods, international trade and slaughter and cutting technology,

| — | basic knowledge of hygiene and good hygienic practices, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work, |
| --- | --- |

—

basic knowledge of hygiene and good hygienic practices, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work,

| — | HACCP and the audit of HACCP-based procedures, |
| --- | --- |

—

HACCP and the audit of HACCP-based procedures,

| — | animal welfare on unloading after transport and at the slaughterhouse, |
| --- | --- |

—

animal welfare on unloading after transport and at the slaughterhouse,

| — | basic knowledge of the anatomy and physiology of slaughtered animals, |
| --- | --- |

—

basic knowledge of the anatomy and physiology of slaughtered animals,

| — | basic knowledge of the pathology of slaughtered animals, |
| --- | --- |

—

basic knowledge of the pathology of slaughtered animals,

| — | basic knowledge of the pathological anatomy of slaughtered animals, |
| --- | --- |

—

basic knowledge of the pathological anatomy of slaughtered animals,

| — | relevant knowledge concerning TSEs and other important zoonoses and zoonotic agents, |
| --- | --- |

—

relevant knowledge concerning TSEs and other important zoonoses and zoonotic agents,

| — | knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat, |
| --- | --- |

—

knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat,

| — | basic knowledge of microbiology, |
| --- | --- |

—

basic knowledge of microbiology,

| — | ante-mortem inspection, |
| --- | --- |

—

ante-mortem inspection,

| — | examination for trichinosis, |
| --- | --- |

—

examination for trichinosis,

| — | post-mortem inspection, |
| --- | --- |

—

post-mortem inspection,

| — | administrative tasks, |
| --- | --- |

—

administrative tasks,

| — | knowledge of the relevant laws, regulations and administrative provisions, |
| --- | --- |

—

knowledge of the relevant laws, regulations and administrative provisions,

| — | sampling procedure, |
| --- | --- |

—

sampling procedure,

| — | fraud aspects; |
| --- | --- |

—

fraud aspects;

| (ii) | practical part:






  — | animal identification, |
| --- | --- | --- |

(ii)

practical part:

—

animal identification,

| — | age checks, |
| --- | --- |

—

age checks,

| — | inspection and assessment of slaughtered animals, |
| --- | --- |

—

inspection and assessment of slaughtered animals,

| — | post-mortem inspection in a slaughterhouse, |
| --- | --- |

—

post-mortem inspection in a slaughterhouse,

| — | examination for trichinosis, |
| --- | --- |

—

examination for trichinosis,

| — | identification of animal species by examination of typical parts of the animal, |
| --- | --- |

—

identification of animal species by examination of typical parts of the animal,

| — | identifying and commenting on parts of slaughtered animals in which changes have occurred, |
| --- | --- |

—

identifying and commenting on parts of slaughtered animals in which changes have occurred,

| — | hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures, |
| --- | --- |

—

hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures,

| — | recording the results of ante-mortem inspection, |
| --- | --- |

—

recording the results of ante-mortem inspection,

| — | sampling, |
| --- | --- |

—

sampling,

| — | traceability of meat, |
| --- | --- |

—

traceability of meat,

| — | documentation. |
| --- | --- |

—

documentation.

| 6. | Official auxiliaries are to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official auxiliary is, wherever possible, to undertake annual continuing education activities. |
| --- | --- |

6.

Official auxiliaries are to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official auxiliary is, wherever possible, to undertake annual continuing education activities.

| 7. | Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in paragraph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard. |
| --- | --- |

7.

Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in paragraph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard.

| 8. | However, when official auxiliaries carry out only sampling and analysis in connection with examinations for trichinosis, the competent authority need only ensure that they receive training appropriate to these tasks. |
| --- | --- |

8.

However, when official auxiliaries carry out only sampling and analysis in connection with examinations for trichinosis, the competent authority need only ensure that they receive training appropriate to these tasks.

SECTION IV: SPECIFIC REQUIREMENTS

CHAPTER I: DOMESTIC BOVINE ANIMALS

A.   BOVINE ANIMALS UNDER SIX WEEKS OLD

Carcases and offal of bovine animals under six weeks old are to undergo the following post-mortem inspection procedures:

| 1. | visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn retropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal of the tonsils; |
| --- | --- |

1.

visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn retropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal of the tonsils;

| 2. | visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption; |
| --- | --- |

2.

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

| 3. | visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum; |
| --- | --- |

3.

visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

| 4. | visual inspection of the diaphragm; |
| --- | --- |

4.

visual inspection of the diaphragm;

| 5. | visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation and, if necessary, incision of the liver and its lymph nodes; |
| --- | --- |

5.

visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation and, if necessary, incision of the liver and its lymph nodes;

| 6. | visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes; |
| --- | --- |

6.

visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

| 7. | visual inspection and, if necessary, palpation of the spleen; |
| --- | --- |

7.

visual inspection and, if necessary, palpation of the spleen;

| 8. | visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales); |
| --- | --- |

8.

visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

| 9. | visual inspection of the pleura and peritoneum; |
| --- | --- |

9.

visual inspection of the pleura and peritoneum;

| 10. | visual inspection and palpation of the umbilical region and the joints. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined. |
| --- | --- |

10.

visual inspection and palpation of the umbilical region and the joints. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.

B.   BOVINE ANIMALS OVER SIX WEEKS OLD

Carcases and offal of bovine animals over six weeks old are to undergo the following post-mortem inspection procedures:

| 1. | visual inspection of the head and throat; incision and examination of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei); examination of the external masseters, in which two incisions must be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which must be incised along one plane. The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually inspected and palpated. The tonsils must be removed; |
| --- | --- |

1.

visual inspection of the head and throat; incision and examination of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei); examination of the external masseters, in which two incisions must be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which must be incised along one plane. The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually inspected and palpated. The tonsils must be removed;

| 2. | inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthways and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption; |
| --- | --- |

2.

inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthways and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

| 3. | visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum; |
| --- | --- |

3.

visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum;

| 4. | visual inspection of the diaphragm; |
| --- | --- |

4.

visual inspection of the diaphragm;

| 5. | visual inspection and palpation of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts; |
| --- | --- |

5.

visual inspection and palpation of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts;

| 6. | visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes; |
| --- | --- |

6.

visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

| 7. | visual inspection and, if necessary, palpation of the spleen; |
| --- | --- |

7.

visual inspection and, if necessary, palpation of the spleen;

| 8. | visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales); |
| --- | --- |

8.

visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

| 9. | visual inspection of the pleura and the peritoneum; |
| --- | --- |

9.

visual inspection of the pleura and the peritoneum;

| 10. | visual inspection of the genital organs (except for the penis, if already discarded); |
| --- | --- |

10.

visual inspection of the genital organs (except for the penis, if already discarded);

| 11. | visual inspection and, if necessary, palpation and incision of the udder and its lymph nodes (Lnn. supramammarii). In cows, each half of the udder must be opened by a long, deep incision as far as the lactiferous sinuses (sinus lactiferes) and the lymph nodes of the udder must be incised, except when the udder is excluded from human consumption. |
| --- | --- |

11.

visual inspection and, if necessary, palpation and incision of the udder and its lymph nodes (Lnn. supramammarii). In cows, each half of the udder must be opened by a long, deep incision as far as the lactiferous sinuses (sinus lactiferes) and the lymph nodes of the udder must be incised, except when the udder is excluded from human consumption.

CHAPTER II: DOMESTIC SHEEP AND GOATS

Carcases and offal of sheep and goats are to undergo the following post-mortem inspection procedures:

| 1. | visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth, tongue and retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules, these examinations are not necessary if the competent authority is able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption; |
| --- | --- |

1.

visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth, tongue and retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules, these examinations are not necessary if the competent authority is able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;

| 2. | visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales); in the event of doubt, these organs and lymph nodes must be incised and examined; |
| --- | --- |

2.

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales); in the event of doubt, these organs and lymph nodes must be incised and examined;

| 3. | visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined; |
| --- | --- |

3.

visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;

| 4. | visual inspection of the diaphragm; |
| --- | --- |

4.

visual inspection of the diaphragm;

| 5. | visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts; |
| --- | --- |

5.

visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;

| 6. | visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); |
| --- | --- |

6.

visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);

| 7. | visual inspection and, if necessary, palpation of the spleen; |
| --- | --- |

7.

visual inspection and, if necessary, palpation of the spleen;

| 8. | visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales); |
| --- | --- |

8.

visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

| 9. | visual inspection of the pleura and peritoneum; |
| --- | --- |

9.

visual inspection of the pleura and peritoneum;

| 10. | visual inspection of the genital organs (except for the penis, if already discarded); |
| --- | --- |

10.

visual inspection of the genital organs (except for the penis, if already discarded);

| 11. | visual inspection of the udder and its lymph nodes; |
| --- | --- |

11.

visual inspection of the udder and its lymph nodes;

| 12. | visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined. |
| --- | --- |

12.

visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.

CHAPTER III: DOMESTIC SOLIPEDS

Carcases and offal of solipeds are to undergo the following post-mortem inspection procedures:

| 1. | visual inspection of the head and, after freeing the tongue, the throat; palpation and, if necessary, incision of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei). The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined and palpated. The tonsils must be removed; |
| --- | --- |

1.

visual inspection of the head and, after freeing the tongue, the throat; palpation and, if necessary, incision of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei). The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined and palpated. The tonsils must be removed;

| 2. | visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; palpation and, if necessary, incision of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption; |
| --- | --- |

2.

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; palpation and, if necessary, incision of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption;

| 3. | visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum; |
| --- | --- |

3.

visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

| 4. | visual inspection of the diaphragm; |
| --- | --- |

4.

visual inspection of the diaphragm;

| 5. | visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); |
| --- | --- |

5.

visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales);

| 6. | visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); incision, if necessary, of the gastric and mesenteric lymph nodes; |
| --- | --- |

6.

visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); incision, if necessary, of the gastric and mesenteric lymph nodes;

| 7. | visual inspection and, if necessary, palpation of the spleen; |
| --- | --- |

7.

visual inspection and, if necessary, palpation of the spleen;

| 8. | visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales); |
| --- | --- |

8.

visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

| 9. | visual inspection of the pleura and peritoneum; |
| --- | --- |

9.

visual inspection of the pleura and peritoneum;

| 10. | visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares; |
| --- | --- |

10.

visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;

| 11. | visual inspection of the udder and its lymph nodes (Lnn. supramammarii) and, if necessary, incision of the supramammary lymph nodes; |
| --- | --- |

11.

visual inspection of the udder and its lymph nodes (Lnn. supramammarii) and, if necessary, incision of the supramammary lymph nodes;

| 12. | visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined; |
| --- | --- |

12.

visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined;

| 13. | all grey or white horses must be inspected for melanosis and melanomata by examination of the muscles and lymph nodes (Lnn. subrhomboidei) of the shoulders beneath the scapular cartilage after loosening the attachment of one shoulder. The kidneys must be exposed and examined by incision through the entire kidney. |
| --- | --- |

13.

all grey or white horses must be inspected for melanosis and melanomata by examination of the muscles and lymph nodes (Lnn. subrhomboidei) of the shoulders beneath the scapular cartilage after loosening the attachment of one shoulder. The kidneys must be exposed and examined by incision through the entire kidney.

CHAPTER IV: DOMESTIC SWINE

A.   ANTE-MORTEM INSPECTION

| 1. | The competent authority may decide that pigs intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a lot of pigs from a holding may be authorised only if:






  (a) | the health certificate provided for in Chapter X, Part A, accompanies them;
  and |
| --- | --- | --- |

1.

The competent authority may decide that pigs intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a lot of pigs from a holding may be authorised only if:

(a)

the health certificate provided for in Chapter X, Part A, accompanies them;

and

| (b) | the requirements of paragraphs 2 to 5 are complied with. |
| --- | --- |

(b)

the requirements of paragraphs 2 to 5 are complied with.

| 2. | Ante-mortem inspection at the holding of provenance is to comprise:






  (a) | checks on records or documentation at the holding, including food chain information; |
| --- | --- | --- |

2.

Ante-mortem inspection at the holding of provenance is to comprise:

(a)

checks on records or documentation at the holding, including food chain information;

| (b) | the examination of the pigs to determine whether:






  (i) | they have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving, individually or collectively, in a manner indicating that such a disease may occur, |
| --- | --- | --- |

(b)

the examination of the pigs to determine whether:

(i)

they have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving, individually or collectively, in a manner indicating that such a disease may occur,

| (ii) | they show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
  or |
| --- | --- |

(ii)

they show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,

or

| (iii) | there is evidence or reasons to suspect that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances. |
| --- | --- |

(iii)

there is evidence or reasons to suspect that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.

| 3. | An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding. The pigs are to be sent directly to slaughter and not to be mixed with other pigs. |
| --- | --- |

3.

An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding. The pigs are to be sent directly to slaughter and not to be mixed with other pigs.

| 4. | Ante-mortem inspection at the slaughterhouse need cover only:






  (a) | a control of the animals' identification;
  and |
| --- | --- | --- |

4.

Ante-mortem inspection at the slaughterhouse need cover only:

(a)

a control of the animals' identification;

and

| (b) | a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening. |
| --- | --- |

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.

| 5. | When pigs are not slaughtered within three days of the issue of the health certificate provided for in paragraph 1(a):






  (a) | if the pigs have not left the holding of provenance for the slaughterhouse, they are to be re-examined and a new health certificate issued; |
| --- | --- | --- |

5.

When pigs are not slaughtered within three days of the issue of the health certificate provided for in paragraph 1(a):

(a)

if the pigs have not left the holding of provenance for the slaughterhouse, they are to be re-examined and a new health certificate issued;

| (b) | if the pigs are already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the pigs undergo a further veterinary ante-mortem inspection. |
| --- | --- |

(b)

if the pigs are already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the pigs undergo a further veterinary ante-mortem inspection.

B.   POST-MORTEM INSPECTION

| 1. | Carcases and offal of pigs other than those referred to in paragraph 2 are to undergo the following post-mortem inspection procedures:






  (a) | visual inspection of the head and throat; incision and examination of the submaxillary lymph nodes (Lnn mandibulares); visual inspection of the mouth, fauces and tongue; |
| --- | --- | --- |

1.

Carcases and offal of pigs other than those referred to in paragraph 2 are to undergo the following post-mortem inspection procedures:

(a)

visual inspection of the head and throat; incision and examination of the submaxillary lymph nodes (Lnn mandibulares); visual inspection of the mouth, fauces and tongue;

| (b) | visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption; |
| --- | --- |

(b)

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

| (c) | visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum; |
| --- | --- |

(c)

visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

| (d) | visual inspection of the diaphragm; |
| --- | --- |

(d)

visual inspection of the diaphragm;

| (e) | visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes; |
| --- | --- |

(e)

visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes;

| (f) | visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes; |
| --- | --- |

(f)

visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

| (g) | visual inspection and, if necessary, palpation of the spleen; |
| --- | --- |

(g)

visual inspection and, if necessary, palpation of the spleen;

| (h) | visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales); |
| --- | --- |

(h)

visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

| (i) | visual inspection of the pleura and peritoneum; |
| --- | --- |

(i)

visual inspection of the pleura and peritoneum;

| (j) | visual inspection of the genital organs (except for the penis, if already discarded); |
| --- | --- |

(j)

visual inspection of the genital organs (except for the penis, if already discarded);

| (k) | visual inspection of the udder and its lymph nodes (Lnn. supramammarii); incision of the supramammary lymph nodes in sows; |
| --- | --- |

(k)

visual inspection of the udder and its lymph nodes (Lnn. supramammarii); incision of the supramammary lymph nodes in sows;

| (l) | visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened. |
| --- | --- |

(l)

visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened.

| 2. | The competent authority may decide, on the basis of epidemiological or other data from the holding, that fattening pigs housed under controlled housing conditions in integrated production systems since weaning need, in some or all of the cases referred to in paragraph 1, only undergo visual inspection. |
| --- | --- |

2.

The competent authority may decide, on the basis of epidemiological or other data from the holding, that fattening pigs housed under controlled housing conditions in integrated production systems since weaning need, in some or all of the cases referred to in paragraph 1, only undergo visual inspection.

CHAPTER V: POULTRY

A.   ANTE-MORTEM INSPECTION

| 1. | The competent authority may decide that poultry intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a flock of birds from a holding may be authorised only if:






  (a) | the health certificate provided for in Chapter X, Part A, accompanies them;
  and |
| --- | --- | --- |

1.

The competent authority may decide that poultry intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a flock of birds from a holding may be authorised only if:

(a)

the health certificate provided for in Chapter X, Part A, accompanies them;

and

| (b) | the requirements of paragraphs 2 to 5 are complied with. |
| --- | --- |

(b)

the requirements of paragraphs 2 to 5 are complied with.

| 2. | Ante-mortem inspection on the holding of provenance is to comprise:






  (a) | checks on records or documentation at the holding, including food chain information; |
| --- | --- | --- |

2.

Ante-mortem inspection on the holding of provenance is to comprise:

(a)

checks on records or documentation at the holding, including food chain information;

| (b) | a flock inspection, to determine whether the birds:






  (i) | have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving in a manner indicating that such a disease may occur, |
| --- | --- | --- |

(b)

a flock inspection, to determine whether the birds:

(i)

have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving in a manner indicating that such a disease may occur,

| (ii) | show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
  or |
| --- | --- |

(ii)

show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,

or

| (iii) | show evidence that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances. |
| --- | --- |

(iii)

show evidence that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.

| 3. | An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding. |
| --- | --- |

3.

An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding.

| 4. | Ante-mortem inspection at the slaughterhouse need only cover:






  (a) | a control of the animals' identification;
  and |
| --- | --- | --- |

4.

Ante-mortem inspection at the slaughterhouse need only cover:

(a)

a control of the animals' identification;

and

| (b) | a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening. |
| --- | --- |

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.

| 5. | When birds are not slaughtered within three days of the issue of the health certificate referred to in paragraph 1(a):






  (a) | if the flock has not left the holding of provenance for the slaughterhouse, it is to be re-examined and a new health certificate issued; |
| --- | --- | --- |

5.

When birds are not slaughtered within three days of the issue of the health certificate referred to in paragraph 1(a):

(a)

if the flock has not left the holding of provenance for the slaughterhouse, it is to be re-examined and a new health certificate issued;

| (b) | if the flock is already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the flock is re-examined. |
| --- | --- |

(b)

if the flock is already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the flock is re-examined.

| 6. | When ante-mortem inspection is not carried out at the holding, the official veterinarian is to carry out a flock inspection at the slaughterhouse. |
| --- | --- |

6.

When ante-mortem inspection is not carried out at the holding, the official veterinarian is to carry out a flock inspection at the slaughterhouse.

| 7. | If the birds show clinical symptoms of a disease, they may not be slaughtered for human consumption. However, killing of these birds on the slaughter line may take place at the end of the normal slaughter process, if precautions are taken to avoid the risk of spreading pathogenic organisms and to clean and disinfect the facilities immediately after killing. |
| --- | --- |

7.

If the birds show clinical symptoms of a disease, they may not be slaughtered for human consumption. However, killing of these birds on the slaughter line may take place at the end of the normal slaughter process, if precautions are taken to avoid the risk of spreading pathogenic organisms and to clean and disinfect the facilities immediately after killing.

| 8. | In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry slaughtered at the holding of provenance, ante-mortem inspection is to be carried out in accordance with paragraphs 2 and 3. A certificate conforming to the model set out in Part C is to accompany the uneviscerated carcases to the slaughterhouse or cutting plant. |
| --- | --- |

8.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry slaughtered at the holding of provenance, ante-mortem inspection is to be carried out in accordance with paragraphs 2 and 3. A certificate conforming to the model set out in Part C is to accompany the uneviscerated carcases to the slaughterhouse or cutting plant.

B.   POST-MORTEM INSPECTION

| 1. | All birds are to undergo post-mortem inspection in accordance with Sections I and III. In addition, the official veterinarian is personally to carry out the following checks:






  (a) | daily inspection of the viscera and body cavities of a representative sample of birds; |
| --- | --- | --- |

1.

All birds are to undergo post-mortem inspection in accordance with Sections I and III. In addition, the official veterinarian is personally to carry out the following checks:

(a)

daily inspection of the viscera and body cavities of a representative sample of birds;

| (b) | a detailed inspection of a random sample, from each batch of birds having the same origin, of parts of birds or entire birds declared unfit for human consumption following post-mortem inspection;
  and |
| --- | --- |

(b)

a detailed inspection of a random sample, from each batch of birds having the same origin, of parts of birds or entire birds declared unfit for human consumption following post-mortem inspection;

and

| (c) | any further investigations necessary when there is reason to suspect that the meat from the birds concerned could be unfit for human consumption. |
| --- | --- |

(c)

any further investigations necessary when there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.

| 2. | In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry obtained at the holding of provenance, post-mortem inspection is to include a check on the certificate accompanying the carcases. When such carcases are transported directly from the holding to a cutting plant, post-mortem inspection is to take place at the cutting plant. |
| --- | --- |

2.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry obtained at the holding of provenance, post-mortem inspection is to include a check on the certificate accompanying the carcases. When such carcases are transported directly from the holding to a cutting plant, post-mortem inspection is to take place at the cutting plant.

C.   SPECIMEN HEALTH CERTIFICATE

Image 2

CHAPTER VI: FARMED LAGOMORPHS

The requirements for poultry are to apply to farmed lagomorphs.

CHAPTER VII: FARMED GAME

A.   Ante-mortem inspection

| 1. | Ante-mortem inspection may be carried out at the holding of provenance when the requirements of Annex III, Section III, to Regulation (EC) No 853/2004 are satisfied. In this case, an official veterinarian or an approved veterinarian is to carry out ante-mortem inspection. |
| --- | --- |

1.

Ante-mortem inspection may be carried out at the holding of provenance when the requirements of Annex III, Section III, to Regulation (EC) No 853/2004 are satisfied. In this case, an official veterinarian or an approved veterinarian is to carry out ante-mortem inspection.

| 2. | Ante-mortem inspection at the holding is to include checks on the records or documentation at the holding, including food chain information. |
| --- | --- |

2.

Ante-mortem inspection at the holding is to include checks on the records or documentation at the holding, including food chain information.

| 3. | When ante-mortem inspection takes place no more than three days before the arrival of the animals at the slaughterhouse, and animals are delivered to the slaughterhouse live, ante-mortem inspection at the slaughterhouse need only cover:






  (a) | a control of the animals' identification;
  and |
| --- | --- | --- |

3.

When ante-mortem inspection takes place no more than three days before the arrival of the animals at the slaughterhouse, and animals are delivered to the slaughterhouse live, ante-mortem inspection at the slaughterhouse need only cover:

(a)

a control of the animals' identification;

and

| (b) | a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. |
| --- | --- |

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present.

| 4. | A certificate conforming to the specimen in Chapter X, Part A, is to accompany live animals inspected at the holding. A certificate conforming to the specimen in Chapter X, Part B, is to accompany animals inspected and slaughtered at the holding. |
| --- | --- |

4.

A certificate conforming to the specimen in Chapter X, Part A, is to accompany live animals inspected at the holding. A certificate conforming to the specimen in Chapter X, Part B, is to accompany animals inspected and slaughtered at the holding.

B.   Post-mortem inspection

| 1. | This inspection is to include palpation and, where judged necessary, incision of those parts of the animal which have undergone any change or are suspect for any other reason. |
| --- | --- |

1.

This inspection is to include palpation and, where judged necessary, incision of those parts of the animal which have undergone any change or are suspect for any other reason.

| 2. | Post-mortem inspection procedures described for bovine and ovine animals, domestic swine and poultry are to be applied to the corresponding species of farmed game. |
| --- | --- |

2.

Post-mortem inspection procedures described for bovine and ovine animals, domestic swine and poultry are to be applied to the corresponding species of farmed game.

| 3. | When the animals have been slaughtered at the holding, the official veterinarian at the slaughterhouse is to check the certificate accompanying them. |
| --- | --- |

3.

When the animals have been slaughtered at the holding, the official veterinarian at the slaughterhouse is to check the certificate accompanying them.

CHAPTER VIII: WILD GAME

A.   Post-mortem inspection

| 1. | Wild game is to be inspected as soon as possible after admission to the game handling establishment. |
| --- | --- |

1.

Wild game is to be inspected as soon as possible after admission to the game handling establishment.

| 2. | The official veterinarian is to take account of the declaration or information that the trained person involved in hunting the animal has provided in accordance with Regulation (EC) No 853/2004. |
| --- | --- |

2.

The official veterinarian is to take account of the declaration or information that the trained person involved in hunting the animal has provided in accordance with Regulation (EC) No 853/2004.

| 3. | During post-mortem inspection, the official veterinarian is to carry out:






  (a) | a visual examination of the carcase, its cavities and, where appropriate, organs with a view to:






  (i) | detecting any abnormalities not resulting from the hunting process. For this purpose, the diagnosis may be based on any information that the trained person has provided concerning the behaviour of the animal before killing, |
| --- | --- | --- | --- |

3.

During post-mortem inspection, the official veterinarian is to carry out:

(a)

a visual examination of the carcase, its cavities and, where appropriate, organs with a view to:

(i)

detecting any abnormalities not resulting from the hunting process. For this purpose, the diagnosis may be based on any information that the trained person has provided concerning the behaviour of the animal before killing,

| (ii) | checking that death was not caused by reasons other than hunting. |
| --- | --- |

(ii)

checking that death was not caused by reasons other than hunting.

If an assessment cannot be made on the basis of visual examination alone, a more extensive inspection must be carried out in a laboratory;

| (b) | an investigation of organoleptic abnormalities; |
| --- | --- |

(b)

an investigation of organoleptic abnormalities;

| (c) | palpation of organs, where appropriate; |
| --- | --- |

(c)

palpation of organs, where appropriate;

| (d) | where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sampling of residues not resulting from the hunting process, including environmental contaminants. When a more extensive inspection is made on the basis of such suspicions, the veterinarian must wait until that inspection has been concluded before assessing all the game killed during a specific hunt, or those parts suspected of showing the same abnormalities; |
| --- | --- |

(d)

where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sampling of residues not resulting from the hunting process, including environmental contaminants. When a more extensive inspection is made on the basis of such suspicions, the veterinarian must wait until that inspection has been concluded before assessing all the game killed during a specific hunt, or those parts suspected of showing the same abnormalities;

| (e) | examination for characteristics indicating that the meat presents a health risk, including:






  (i) | abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter, |
| --- | --- | --- |

(e)

examination for characteristics indicating that the meat presents a health risk, including:

(i)

abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter,

| (ii) | the generalised presence of tumours or abscesses affecting different internal organs or muscles, |
| --- | --- |

(ii)

the generalised presence of tumours or abscesses affecting different internal organs or muscles,

| (iii) | arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region, |
| --- | --- |

(iii)

arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region,

| (iv) | the presence of foreign bodies not resulting from the hunting process in the body cavities, stomach or intestines or in the urine, where the pleura or peritoneum are discoloured (when relevant viscera are present), |
| --- | --- |

(iv)

the presence of foreign bodies not resulting from the hunting process in the body cavities, stomach or intestines or in the urine, where the pleura or peritoneum are discoloured (when relevant viscera are present),

| (v) | the presence of parasites, |
| --- | --- |

(v)

the presence of parasites,

| (vi) | formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present), |
| --- | --- |

(vi)

formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present),

| (vii) | significant abnormalities of colour, consistency or odour of muscle tissue or organs, |
| --- | --- |

(vii)

significant abnormalities of colour, consistency or odour of muscle tissue or organs,

| (viii) | aged open fractures, |
| --- | --- |

(viii)

aged open fractures,

| (ix) | emaciation and/or general or localised oedema, |
| --- | --- |

(ix)

emaciation and/or general or localised oedema,

| (x) | recent pleural or peritoneal adhesions,
  and |
| --- | --- |

(x)

recent pleural or peritoneal adhesions,

and

| (xi) | other obvious extensive changes, such as putrefaction. |
| --- | --- |

(xi)

other obvious extensive changes, such as putrefaction.

| 4. | Where the official veterinarian so requires, the vertebral column and the head are to be split lengthwise. |
| --- | --- |

4.

Where the official veterinarian so requires, the vertebral column and the head are to be split lengthwise.

| 5. | In the case of small wild game not eviscerated immediately after killing, the official veterinarian is to carry out a post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a disease transmissible to man or any of the characteristics listed in paragraph 3(e), the official veterinarian is to carry out more checks on the entire batch to determine whether it must be declared unfit for human consumption or whether each carcase must be inspected individually. |
| --- | --- |

5.

In the case of small wild game not eviscerated immediately after killing, the official veterinarian is to carry out a post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a disease transmissible to man or any of the characteristics listed in paragraph 3(e), the official veterinarian is to carry out more checks on the entire batch to determine whether it must be declared unfit for human consumption or whether each carcase must be inspected individually.

| 6. | In the event of doubt, the official veterinarian may perform any further cuts and inspections of the relevant parts of the animals necessary to reach a final diagnosis. |
| --- | --- |

6.

In the event of doubt, the official veterinarian may perform any further cuts and inspections of the relevant parts of the animals necessary to reach a final diagnosis.

B.   Decisions following controls

In addition to the cases provided for in Section II, Chapter V, meat presenting during post-mortem inspection any of the characteristics listed in paragraph 3(e) of Part A is to be declared unfit for human consumption.

CHAPTER IX: SPECIFIC HAZARDS

A.   Transmissible spongiform encephalopathies

Official controls carried out in relation to TSEs are to take account of the requirements of Regulation (EC) No 999/2001 and other relevant Community legislation.

B.   Cysticercosis

| 1. | The post-mortem inspection procedures described in Chapters I and IV are the minimum requirements for the examination for cysticercosis in bovine animals over six weeks old and swine. In addition, specific serological tests may be used. In the case of bovines over six weeks old, incision of the masseters at post-mortem inspection is not compulsory when a specific serological test is used. The same applies when bovine animals over six weeks old have been raised on a holding officially certified to be free of cysticercosis. |
| --- | --- |

1.

The post-mortem inspection procedures described in Chapters I and IV are the minimum requirements for the examination for cysticercosis in bovine animals over six weeks old and swine. In addition, specific serological tests may be used. In the case of bovines over six weeks old, incision of the masseters at post-mortem inspection is not compulsory when a specific serological test is used. The same applies when bovine animals over six weeks old have been raised on a holding officially certified to be free of cysticercosis.

| 2. | Meat infected with cysticercus is to be declared unfit for human consumption. However, when the animal is not generally infected with cysticercus, the parts not infected may be declared fit for human consumption after having undergone a cold treatment. |
| --- | --- |

2.

Meat infected with cysticercus is to be declared unfit for human consumption. However, when the animal is not generally infected with cysticercus, the parts not infected may be declared fit for human consumption after having undergone a cold treatment.

C.   Trichinosis

| 1. | Carcases of swine (domestic, farmed game and wild game), solipeds and other species susceptible to trichinosis are to be examined for trichinosis in accordance with applicable Community legislation, unless that legislation provides otherwise. |
| --- | --- |

1.

Carcases of swine (domestic, farmed game and wild game), solipeds and other species susceptible to trichinosis are to be examined for trichinosis in accordance with applicable Community legislation, unless that legislation provides otherwise.

| 2. | Meat from animals infected with trichinae is to be declared unfit for human consumption. |
| --- | --- |

2.

Meat from animals infected with trichinae is to be declared unfit for human consumption.

D.   Glanders

| 1. | Where appropriate, solipeds are to be examined for glanders. Examination for glanders in solipeds is to include a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum. |
| --- | --- |

1.

Where appropriate, solipeds are to be examined for glanders. Examination for glanders in solipeds is to include a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum.

| 2. | Meat from horses in which glanders has been diagnosed are to be declared unfit for human consumption. |
| --- | --- |

2.

Meat from horses in which glanders has been diagnosed are to be declared unfit for human consumption.

E.   Tuberculosis

| 1. | When animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse. |
| --- | --- |

1.

When animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

| 2. | All meat from animals in which post-mortem inspection has revealed localised tuberculous lesions in a number of organs or a number of areas of the carcase is to be declared unfit for human consumption. However, when a tuberculous lesion has been found in the lymph nodes of only one organ or part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes need be declared unfit for human consumption. |
| --- | --- |

2.

All meat from animals in which post-mortem inspection has revealed localised tuberculous lesions in a number of organs or a number of areas of the carcase is to be declared unfit for human consumption. However, when a tuberculous lesion has been found in the lymph nodes of only one organ or part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes need be declared unfit for human consumption.

F.   Brucellosis

| 1. | When animals have reacted positively or inconclusively to a brucellosis test, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse. |
| --- | --- |

1.

When animals have reacted positively or inconclusively to a brucellosis test, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

| 2. | Meat from animals in which post-mortem inspection has revealed lesions indicating acute infection with brucellosis is to be declared unfit for human consumption. In the case of animals reacting positively or inconclusively to a brucellosis test, the udder, genital tract and blood must be declared unfit for human consumption even if no such lesion is found. |
| --- | --- |

2.

Meat from animals in which post-mortem inspection has revealed lesions indicating acute infection with brucellosis is to be declared unfit for human consumption. In the case of animals reacting positively or inconclusively to a brucellosis test, the udder, genital tract and blood must be declared unfit for human consumption even if no such lesion is found.

CHAPTER X: SPECIMEN HEALTH CERTIFICATE

A.   SPECIMEN HEALTH CERTIFICATE FOR LIVE ANIMALS

Image 3

B.   SPECIMEN HEALTH CERTIFICATE FOR ANIMALS SLAUGHTERED AT THE HOLDING

Image 4

ANNEX II

LIVE BIVALVE MOLLUSCS

CHAPTER I: SCOPE

This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.

CHAPTER II: OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS

A.   CLASSIFICATION OF PRODUCTION AND RELAYING AREAS

| 1. | The competent authority must fix the location and boundaries of production and relaying areas that it classifies. It may, where appropriate, do so in cooperation with the food business operator. |
| --- | --- |

1.

The competent authority must fix the location and boundaries of production and relaying areas that it classifies. It may, where appropriate, do so in cooperation with the food business operator.

| 2. | The competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination. It may, where appropriate, do so in cooperation with the food business operator. |
| --- | --- |

2.

The competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination. It may, where appropriate, do so in cooperation with the food business operator.

| 3. | The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No 853/2004. |
| --- | --- |

3.

The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No 853/2004.

| 4. | The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected, but placed on the market for human consumption only 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 the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4 600 E.coli per 100 g of flesh and intravalvular liquid. |
| --- | --- |

4.

The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected, but placed on the market for human consumption only 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 the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4 600 E.coli per 100 g of flesh and intravalvular liquid.

| 5. | The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN test of 46 000 E.coli per 100 g of flesh and intravalvular liquid. |
| --- | --- |

5.

The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN test of 46 000 E.coli per 100 g of flesh and intravalvular liquid.

| 6. | If the competent authority decides in principle to classify a production or relaying area, it must:






  (a) | make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area; |
| --- | --- | --- |

6.

If the competent authority decides in principle to classify a production or relaying area, it must:

(a)

make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;

| (b) | examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste-water treatment, etc.; |
| --- | --- |

(b)

examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste-water treatment, etc.;

| (c) | determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area;
  and |
| --- | --- |

(c)

determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area;

and

| (d) | establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered. |
| --- | --- |

(d)

establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered.

B.   MONITORING OF CLASSIFIED RELAYING AND PRODUCTION AREAS

| 1. | Classified relaying and production areas must be periodically monitored to check:






  (a) | that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs; |
| --- | --- | --- |

1.

Classified relaying and production areas must be periodically monitored to check:

(a)

that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

| (b) | the microbiological quality of live bivalve molluscs in relation to the production and relaying areas; |
| --- | --- |

(b)

the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;

| (c) | for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;
  and |
| --- | --- |

(c)

for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;

and

| (d) | for the presence of chemical contaminants in live bivalve molluscs. |
| --- | --- |

(d)

for the presence of chemical contaminants in live bivalve molluscs.

| 2. | To implement paragraph 1(b), (c) and (d), sampling plans must be drawn up providing for such checks to take place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribution of the sampling points and the sampling frequency must ensure that the results of the analysis are as representative as possible for the area considered. |
| --- | --- |

2.

To implement paragraph 1(b), (c) and (d), sampling plans must be drawn up providing for such checks to take place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribution of the sampling points and the sampling frequency must ensure that the results of the analysis are as representative as possible for the area considered.

| 3. | Sampling plans to check the microbiological quality of live bivalve molluscs must take particular account of:






  (a) | the likely variation in faecal contamination,
  and |
| --- | --- | --- |

3.

Sampling plans to check the microbiological quality of live bivalve molluscs must take particular account of:

(a)

the likely variation in faecal contamination,

and

| (b) | the parameters referred to in paragraph 6 of Part A. |
| --- | --- |

(b)

the parameters referred to in paragraph 6 of Part A.

| 4. | Sampling plans to check for the presence of toxin-producing plankton in production and relaying waters and for biotoxins in live bivalve molluscs must take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling must comprise:






  (a) | periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling; |
| --- | --- | --- |

4.

Sampling plans to check for the presence of toxin-producing plankton in production and relaying waters and for biotoxins in live bivalve molluscs must take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling must comprise:

(a)

periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling;

| (b) | periodic toxicity tests using those molluscs from the affected area most susceptible to contamination. |
| --- | --- |

(b)

periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.

| 5. | The sampling frequency for toxin analysis in the molluscs is, as a general rule, to be weekly during the periods at which harvesting is allowed. This frequency may be reduced in specific areas, or for specific types of molluscs, if a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. It is to be increased where such an assessment suggests that weekly sampling would not be sufficient. The risk assessment is to be periodically reviewed in order to assess the risk of toxins occurring in the live bivalve molluscs from these areas. |
| --- | --- |

5.

The sampling frequency for toxin analysis in the molluscs is, as a general rule, to be weekly during the periods at which harvesting is allowed. This frequency may be reduced in specific areas, or for specific types of molluscs, if a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. It is to be increased where such an assessment suggests that weekly sampling would not be sufficient. The risk assessment is to be periodically reviewed in order to assess the risk of toxins occurring in the live bivalve molluscs from these areas.

| 6. | When knowledge of toxin accumulation rates is available for a group of species growing in the same area, a species with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits. When toxin levels in the indicator species are above the regulatory limits, harvesting of the other species is only to be allowed if further analysis on the other species shows toxin levels below the limits. |
| --- | --- |

6.

When knowledge of toxin accumulation rates is available for a group of species growing in the same area, a species with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits. When toxin levels in the indicator species are above the regulatory limits, harvesting of the other species is only to be allowed if further analysis on the other species shows toxin levels below the limits.

| 7. | With regard to the monitoring of plankton, the samples are to be representative of the water column and to provide information on the presence of toxic species as well as on population trends. If any changes in toxic populations that may lead to toxin accumulation are detected, the sampling frequency of molluscs is to be increased or precautionary closures of the areas are to be established until results of toxin analysis are obtained. |
| --- | --- |

7.

With regard to the monitoring of plankton, the samples are to be representative of the water column and to provide information on the presence of toxic species as well as on population trends. If any changes in toxic populations that may lead to toxin accumulation are detected, the sampling frequency of molluscs is to be increased or precautionary closures of the areas are to be established until results of toxin analysis are obtained.

| 8. | Sampling plans to check for the presence of chemical contaminants must enable the detection of any overshooting of the levels laid down in Commission Regulation (EC) No 466/2001 (13). |
| --- | --- |

8.

Sampling plans to check for the presence of chemical contaminants must enable the detection of any overshooting of the levels laid down in Commission Regulation (EC) No 466/2001 (13).

C.   DECISIONS AFTER MONITORING

| 1. | Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be otherwise a risk to human health, the competent authority must close the production area concerned, preventing the harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health. |
| --- | --- |

1.

Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be otherwise a risk to human health, the competent authority must close the production area concerned, preventing the harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health.

| 2. | The competent authority may re-open a closed production area only if the health standards for molluscs once again comply with Community legislation. If the competent authority closes a production because of the presence of plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory limit separated at least 48 hours are necessary to re-open it. The competent authority may take account of information on phytoplankton trends when taking this decision. When there are robust data on the dynamic of the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the competent authority may decide to re-open the area with results below the regulatory limit obtained from one single sampling. |
| --- | --- |

2.

The competent authority may re-open a closed production area only if the health standards for molluscs once again comply with Community legislation. If the competent authority closes a production because of the presence of plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory limit separated at least 48 hours are necessary to re-open it. The competent authority may take account of information on phytoplankton trends when taking this decision. When there are robust data on the dynamic of the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the competent authority may decide to re-open the area with results below the regulatory limit obtained from one single sampling.

D.   ADDITIONAL MONITORING REQUIREMENTS

| 1. | The competent authority is to monitor classified production areas from which it has forbidden the harvesting of bivalve molluscs or subjected harvesting to special conditions, to ensure that products harmful to human health are not placed on the market. |
| --- | --- |

1.

The competent authority is to monitor classified production areas from which it has forbidden the harvesting of bivalve molluscs or subjected harvesting to special conditions, to ensure that products harmful to human health are not placed on the market.

| 2. | In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control system must be set up comprising laboratory tests to verify food business operators' compliance with the requirements for the end product at all stages of production, processing and distribution. This control system is, in particular, to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health. |
| --- | --- |

2.

In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control system must be set up comprising laboratory tests to verify food business operators' compliance with the requirements for the end product at all stages of production, processing and distribution. This control system is, in particular, to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.

E.   RECORDING AND EXCHANGE OF INFORMATION

The competent authority must:

| (a) | establish and keep up to date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Annex. This list must be communicated to interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres; |
| --- | --- |

(a)

establish and keep up to date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Annex. This list must be communicated to interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres;

| (b) | immediately inform the interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of a production area, or its closure, be it temporary or final;
  and |
| --- | --- |

(b)

immediately inform the interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of a production area, or its closure, be it temporary or final;

and

| (c) | act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened. |
| --- | --- |

(c)

act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.

F.   FOOD BUSINESS OPERATORS' OWN CHECKS

To decide on the classification, opening or closure of production areas, the competent authority may take into account the results of controls that food business operators or organisations representing food business operators have carried out. In that event, the competent authority must have designated the laboratory carrying out the analysis and, if necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority and the food business operators or organisation concerned have agreed.

CHAPTER III: OFFICIAL CONTROLS CONCERNING PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

Official controls on pectinidae harvested outside classified production areas are to be carried out in fish auctions, dispatch centres and processing establishments. Such official controls are to verify compliance with the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, to Regulation (EC) No 853/2004 as well as compliance with other requirements of Annex III, Section VII, Chapter IX to that Regulation.

ANNEX III

FISHERY PRODUCTS

CHAPTER I: OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET

| 1. | Official controls on the production and placing on the market of fishery products are to include, in particular:






  (a) | a regular check on the hygiene conditions of landing and first sale; |
| --- | --- | --- |

1.

Official controls on the production and placing on the market of fishery products are to include, in particular:

(a)

a regular check on the hygiene conditions of landing and first sale;

| (b) | inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale markets, to check, in particular:






  (i) | where appropriate, whether the conditions for approval are still fulfilled, |
| --- | --- | --- |

(b)

inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale markets, to check, in particular:

(i)

where appropriate, whether the conditions for approval are still fulfilled,

| (ii) | whether the fishery products are handled correctly, |
| --- | --- |

(ii)

whether the fishery products are handled correctly,

| (iii) | for compliance with hygiene and temperature requirements,
  and |
| --- | --- |

(iii)

for compliance with hygiene and temperature requirements,

and

| (iv) | the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene; |
| --- | --- |

(iv)

the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;

and

| (c) | checks on storage and transport conditions. |
| --- | --- |

(c)

checks on storage and transport conditions.

| 2. | However, subject to paragraph 3, official controls of vessels:






  (a) | may be carried out when vessels call at a port in a Member State; |
| --- | --- | --- |

2.

However, subject to paragraph 3, official controls of vessels:

(a)

may be carried out when vessels call at a port in a Member State;

| (b) | concern all vessels landing fishery products at ports in the Community, irrespective of flag;
  and |
| --- | --- |

(b)

concern all vessels landing fishery products at ports in the Community, irrespective of flag;

and

| (c) | may, if necessary, when the competent authority of the Member State the flag of which the vessel is flying carries out the official control, be carried out while the vessel is at sea or when it is in a port in another Member State or in a third country. |
| --- | --- |

(c)

may, if necessary, when the competent authority of the Member State the flag of which the vessel is flying carries out the official control, be carried out while the vessel is at sea or when it is in a port in another Member State or in a third country.

| 3. | (a) | In the case of an inspection of a factory or freezer vessel flying the flag of a Member State carried out with a view to the approval of the vessel, the competent authority of the Member State the flag of which the vessel is flying is to carry out inspections in such a manner as to comply with the requirements of Article 3, particularly the time limits of Article 3(2). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country. |
| --- | --- | --- |

3.

(a)

In the case of an inspection of a factory or freezer vessel flying the flag of a Member State carried out with a view to the approval of the vessel, the competent authority of the Member State the flag of which the vessel is flying is to carry out inspections in such a manner as to comply with the requirements of Article 3, particularly the time limits of Article 3(2). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.

| (b) | When the competent authority of the Member State the flag of which the vessel is flying has granted the vessel conditional approval in accordance with Article 3, that competent authority may authorise a competent authority of:






  (i) | another Member State,
  or |
| --- | --- | --- |

(b)

When the competent authority of the Member State the flag of which the vessel is flying has granted the vessel conditional approval in accordance with Article 3, that competent authority may authorise a competent authority of:

(i)

another Member State,

or

| (ii) | a third country that appears on a list of third countries from which imports of fishery products are permitted drawn up in accordance with Article 11, to carry out a follow-up inspection with a view to granting full approval or prolonging conditional approval in accordance with Article 3(1)(b) or to keeping approval under review in accordance with Article 3(4). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country. |
| --- | --- |

(ii)

a third country that appears on a list of third countries from which imports of fishery products are permitted drawn up in accordance with Article 11, to carry out a follow-up inspection with a view to granting full approval or prolonging conditional approval in accordance with Article 3(1)(b) or to keeping approval under review in accordance with Article 3(4). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.

| 4. | When the competent authority of a Member State authorises the competent authority of another Member State or of a third country to carry out inspections on its behalf in accordance with paragraph 3, the two competent authorities are to agree on the conditions governing such inspections. These conditions are to ensure, in particular, that the competent authority of the Member State the flag of which the vessel is flying receives reports on the results of inspections and on any suspected non-compliance without delay, so as to enable it to take the necessary measures. |
| --- | --- |

4.

When the competent authority of a Member State authorises the competent authority of another Member State or of a third country to carry out inspections on its behalf in accordance with paragraph 3, the two competent authorities are to agree on the conditions governing such inspections. These conditions are to ensure, in particular, that the competent authority of the Member State the flag of which the vessel is flying receives reports on the results of inspections and on any suspected non-compliance without delay, so as to enable it to take the necessary measures.

chapter II: OFFICIAL CONTROLS OF FISHERY PRODUCTS

Official controls of fishery products are to include at least the following elements.

A.   ORGANOLEPTIC EXAMINATIONS

Random organoleptic checks must be carried out at all stages of production, processing and distribution. One aim of these checks is to verify compliance with the freshness criteria established in accordance with Community legislation. In particular, this includes verifying, at all stages of production, processing and distribution, that fishery products at least exceed the baselines of freshness criteria established in accordance with Community legislation.

B.   FRESHNESS INDICATORS

When the organoleptic examination reveals any doubt as to the freshness of the fishery products, samples may be taken and subjected to laboratory tests to determine the levels of total volatile basic nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N).

The competent authority is to use the criteria laid down under Community legislation.

When the organoleptic examination gives cause to suspect the presence of other conditions which may affect human health, appropriate samples are to be taken for verification purposes.

C.   HISTAMINE

Random testing for histamine is to be carried out to verify compliance with the permitted levels laid down under Community legislation.

D.   RESIDUES AND CONTAMINANTS

Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with Community legislation.

E.   MICROBIOLOGICAL CHECKS

Where necessary, microbiological checks are to be performed in accordance with the relevant rules and criteria laid down under Community legislation.

F.   PARASITES

Random testing is to take place to verify compliance with Community legislation on parasites.

G.   POISONOUS FISHERY PRODUCTS

Checks are to take place to ensure that the following fishery products are not placed on the market:

| 1. | poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae;
  and |
| --- | --- |

1.

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

and

| 2. | fishery products containing biotoxins such as Ciguatera or other toxins dangerous to human health. 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. |
| --- | --- |

2.

fishery products containing biotoxins such as Ciguatera or other toxins dangerous to human health. 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.

CHAPTER III: DECISIONS AFTER CONTROLS

Fishery products are to be declared unfit for human consumption if:

| 1. | organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation; |
| --- | --- |

1.

organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation;

| 2. | they contain in their edible parts contaminants or residues in excess of the limits laid down in Community legislation or at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans; |
| --- | --- |

2.

they contain in their edible parts contaminants or residues in excess of the limits laid down in Community legislation or at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans;

| 3. | they derive from:






  (i) | poisonous fish, |
| --- | --- | --- |

3.

they derive from:

(i)

poisonous fish,

| (ii) | fishery products not complying with the requirement of part G, point 2, of Chapter II concerning biotoxins,
  or |
| --- | --- |

(ii)

fishery products not complying with the requirement of part G, point 2, of Chapter II concerning biotoxins,

or

| (iii) | bivalve molluscs, echinoderms, tunicates or marine gastropods containing marine biotoxins in total quantities exceeding the limits referred to in Regulation (EC) No 853/2004; |
| --- | --- |

(iii)

bivalve molluscs, echinoderms, tunicates or marine gastropods containing marine biotoxins in total quantities exceeding the limits referred to in Regulation (EC) No 853/2004;

or

| 4. | the competent authority considers that they may constitute a risk to public or animal health or are for any other reason not suitable for human consumption. |
| --- | --- |

4.

the competent authority considers that they may constitute a risk to public or animal health or are for any other reason not suitable for human consumption.

ANNEX IV

RAW MILK AND DAIRY PRODUCTS

CHAPTER I: CONTROL OF MILK PRODUCTION HOLDINGS

| 1. | Animals on milk production holdings must be subject to official controls to verify that the health requirements for raw milk production, and in particular the health status of the animals and the use of veterinary medicinal products, are being complied with.
  These controls may take place at the occasion of veterinary checks carried out pursuant to Community provisions on animal or public health or animal welfare and may be carried out by an approved veterinarian. |
| --- | --- |

1.

Animals on milk production holdings must be subject to official controls to verify that the health requirements for raw milk production, and in particular the health status of the animals and the use of veterinary medicinal products, are being complied with.

These controls may take place at the occasion of veterinary checks carried out pursuant to Community provisions on animal or public health or animal welfare and may be carried out by an approved veterinarian.

| 2. | If there are grounds for suspecting that the animal health requirements are not being complied with, the general health status of the animals is to be checked. |
| --- | --- |

2.

If there are grounds for suspecting that the animal health requirements are not being complied with, the general health status of the animals is to be checked.

| 3. | Milk production holdings are to undergo official controls to verify that hygiene requirements are being complied with. These official controls may involve inspections and/or the monitoring of controls that professional organisations carry out. If it is shown that the hygiene is inadequate, the competent authority is to verify that appropriate steps are taken to correct the situation. |
| --- | --- |

3.

Milk production holdings are to undergo official controls to verify that hygiene requirements are being complied with. These official controls may involve inspections and/or the monitoring of controls that professional organisations carry out. If it is shown that the hygiene is inadequate, the competent authority is to verify that appropriate steps are taken to correct the situation.

CHAPTER II: CONTROL OF RAW MILK UPON COLLECTION

| 1. | The competent authority is to monitor the checks carried out in accordance with Annex III, Section IX, Chapter I, Part III, to Regulation (EC) No 853/2004. |
| --- | --- |

1.

The competent authority is to monitor the checks carried out in accordance with Annex III, Section IX, Chapter I, Part III, to Regulation (EC) No 853/2004.

| 2. | If the food business operator has not corrected the situation within three months of first notifying the competent authority of non-compliance with the criteria with regard to plate count and somatic cell count, delivery of raw milk from the production holding is to be suspended or — in accordance with a specific authorisation of, or general instructions from, the competent authority — subjected to requirements concerning its treatment and use necessary to protect public health. This suspension or these requirements are to remain in place until the food business operator has proved that the raw milk again complies with the criteria. |
| --- | --- |

2.

If the food business operator has not corrected the situation within three months of first notifying the competent authority of non-compliance with the criteria with regard to plate count and somatic cell count, delivery of raw milk from the production holding is to be suspended or — in accordance with a specific authorisation of, or general instructions from, the competent authority — subjected to requirements concerning its treatment and use necessary to protect public health. This suspension or these requirements are to remain in place until the food business operator has proved that the raw milk again complies with the criteria.

ANNEX V

ESTABLISHMENTS NOT SUBJECT TO THE LISTING REQUIREMENT OF ARTICLE 12(1)

The following third-country establishments need not appear on lists drawn up and updated in accordance with Article 12(4):

| 1. | establishments handling products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down requirements; |
| --- | --- |

1.

establishments handling products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down requirements;

| 2. | establishments carrying out only primary production; |
| --- | --- |

2.

establishments carrying out only primary production;

| 3. | establishments carrying out only transport operations; |
| --- | --- |

3.

establishments carrying out only transport operations;

| 4. | establishments carrying out only the storage of products of animal origin not requiring temperature-controlled storage conditions. |
| --- | --- |

4.

establishments carrying out only the storage of products of animal origin not requiring temperature-controlled storage conditions.

ANNEX VI

REQUIREMENTS FOR CERTIFICATES ACCOMPANYING IMPORTS

| 1. | The representative of the competent authority of the third country of dispatch issuing a certificate to accompany a consignment of products of animal origin destined for the Community must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. In the case of factory vessels, the competent authority may authorise the captain or another ship's officer to sign the certificate. |
| --- | --- |

1.

The representative of the competent authority of the third country of dispatch issuing a certificate to accompany a consignment of products of animal origin destined for the Community must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. In the case of factory vessels, the competent authority may authorise the captain or another ship's officer to sign the certificate.

| 2. | Certificates must be drawn up in the official language or languages of the third country of dispatch and the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or languages. If the Member State of destination so requests, certificates must also be accompanied by a certified translation into the official language or languages of that Member State. However, a Member State may consent to the use of an official Community language other than its own. |
| --- | --- |

2.

Certificates must be drawn up in the official language or languages of the third country of dispatch and the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or languages. If the Member State of destination so requests, certificates must also be accompanied by a certified translation into the official language or languages of that Member State. However, a Member State may consent to the use of an official Community language other than its own.

| 3. | The original version of the certificate must accompany consignments on entry into the Community. |
| --- | --- |

3.

The original version of the certificate must accompany consignments on entry into the Community.

| 4. | Certificates must consist of:






  (a) | a single sheet of paper;
  or |
| --- | --- | --- |

4.

Certificates must consist of:

(a)

a single sheet of paper;

or

| (b) | two or more pages that are part of an integrated and indivisible sheet of paper;
  or |
| --- | --- |

(b)

two or more pages that are part of an integrated and indivisible sheet of paper;

or

| (c) | a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘page 2 of four pages’). |
| --- | --- |

(c)

a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘page 2 of four pages’).

| 5. | Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number. |
| --- | --- |

5.

Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.

| 6. | The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the third country of dispatch. |
| --- | --- |

6.

The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the third country of dispatch.

---

(1)  
  OJ C 262 E, 29.10.2002, p. 449.

1

(2)  
  OJ C 95, 23.4.2003, p. 22.

2

(3)  Opinion of the European Parliament of 5 June 2003 (not yet published in the Official Journal), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 82), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.

3

(4)  Page 3 of this Official Journal.

4

(5)  Page 22 of this Official Journal.

5

(6)  
  OJ L 184, 17.7.1999, p. 23.

6

(7)  
  OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

7

(8)  
  OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 813/2003 (OJ L 117, 13.5.2003, p. 22).

8

(9)  
  OJ L 157, 30.4.2004, p. 33.

9

(10)  
  OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 2245/2003 (OJ L 333, 20.12.2003, p. 28).

10

(11)  
  OJ L 125, 23.5.1996, p. 10. Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

11

(12)  
  OJ L 121, 29.7.1964, p. 1977/64. Directive as last amended by Commission Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

12

(13)  
  OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 655/2004 (OJ L 104, 8.4.2004, p. 48).

13

---

| 25.6.2004 | EN | Official Journal of the European Union | L 226/128 |
| --- | --- | --- | --- |

25.6.2004

EN

Official Journal of the European Union

L 226/128

---

Corrigendum to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC

(
  Official Journal of the European Union L 139 of 30 April 2004
  )

Directive 2004/68/EC should read as follows:

COUNCIL DIRECTIVE 2004/68/EC

of 26 April 2004

laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions,

Whereas:

| (1) | Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (3) ensures a high level of animal health protection by laying down the general sanitary requirements for certain imports from third countries. |
| --- | --- |

(1)

Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (3) ensures a high level of animal health protection by laying down the general sanitary requirements for certain imports from third countries.

| (2) | It is necessary to rationalise and update the animal health provisions concerning international trade in animals provided for in Directive 72/462/EEC due to the evolution of the international standards of the Office International des Epizooties (OIE) and the adoption by this Office of new standards, together with their implications in the framework of the World Trade Organisation (WTO) and its Agreement on the Application of Sanitary and Phytosanitary Measures. |
| --- | --- |

(2)

It is necessary to rationalise and update the animal health provisions concerning international trade in animals provided for in Directive 72/462/EEC due to the evolution of the international standards of the Office International des Epizooties (OIE) and the adoption by this Office of new standards, together with their implications in the framework of the World Trade Organisation (WTO) and its Agreement on the Application of Sanitary and Phytosanitary Measures.

| (3) | In addition, Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (4) replaces the requirements for meat and meat products provided for in Directive 72/462/EEC. It is therefore necessary and appropriate to lay down similar and updated animal health provisions for imports of live ungulate animals into the Community in this Directive. |
| --- | --- |

(3)

In addition, Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (4) replaces the requirements for meat and meat products provided for in Directive 72/462/EEC. It is therefore necessary and appropriate to lay down similar and updated animal health provisions for imports of live ungulate animals into the Community in this Directive.

| (4) | In order to protect animal health, these new provisions should be extended to cover other ungulate animals that may present a similar risk of disease transmission. However, their application to such animals should be without prejudice to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (5). |
| --- | --- |

(4)

In order to protect animal health, these new provisions should be extended to cover other ungulate animals that may present a similar risk of disease transmission. However, their application to such animals should be without prejudice to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (5).

| (5) | Pursuant to Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (6), imports into the Community of equidae are allowed only from third countries appearing on a list drawn up in accordance with Directive 72/462/EEC. The provisions for establishing lists of third countries for imports of such equidae should be included in Directive 90/426/EEC. |
| --- | --- |

(5)

Pursuant to Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (6), imports into the Community of equidae are allowed only from third countries appearing on a list drawn up in accordance with Directive 72/462/EEC. The provisions for establishing lists of third countries for imports of such equidae should be included in Directive 90/426/EEC.

| (6) | Scientific knowledge concerning the susceptibility and testing of certain animals to diseases changes regularly. A procedure should therefore be established so that the scope of the list of animal species and the diseases to which they are susceptible can be rapidly updated in response to such developments. |
| --- | --- |

(6)

Scientific knowledge concerning the susceptibility and testing of certain animals to diseases changes regularly. A procedure should therefore be established so that the scope of the list of animal species and the diseases to which they are susceptible can be rapidly updated in response to such developments.

| (7) | In the interests of animal welfare and consistency of Community legislation, the general requirements of Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport (7), in particular as regards watering and feeding, should be taken into account in this Directive. |
| --- | --- |

(7)

In the interests of animal welfare and consistency of Community legislation, the general requirements of Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport (7), in particular as regards watering and feeding, should be taken into account in this Directive.

| (8) | In the interests of the protection of animal health and consistency of Community legislation, Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries (8) should also be taken into account. |
| --- | --- |

(8)

In the interests of the protection of animal health and consistency of Community legislation, Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries (8) should also be taken into account.

| (9) | The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers on the Commission (9). |
| --- | --- |

(9)

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers on the Commission (9).

| (10) | The public health and official control rules which apply to meat and meat products by virtue of Directive 72/462/EEC have been replaced by those of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (10), which should apply as from 1 January 2006. The other rules of the said Directive have been replaced by Directive 2002/99/EC, the provisions of which apply as from 1 January 2005, or will be replaced by those of this Directive. |
| --- | --- |

(10)

The public health and official control rules which apply to meat and meat products by virtue of Directive 72/462/EEC have been replaced by those of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (10), which should apply as from 1 January 2006. The other rules of the said Directive have been replaced by Directive 2002/99/EC, the provisions of which apply as from 1 January 2005, or will be replaced by those of this Directive.

| (11) | Directive 72/462/EEC should therefore be repealed when all the texts replacing the provisions thereof will be applicable. |
| --- | --- |

(11)

Directive 72/462/EEC should therefore be repealed when all the texts replacing the provisions thereof will be applicable.

| (12) | It is necessary, however, in the interest of clarity of Community legislation, to repeal certain decisions that are no longer applicable and at the same time to provide for certain implementing rules to remain in force until the necessary measures have been adopted under the new legal framework. |
| --- | --- |

(12)

It is necessary, however, in the interest of clarity of Community legislation, to repeal certain decisions that are no longer applicable and at the same time to provide for certain implementing rules to remain in force until the necessary measures have been adopted under the new legal framework.

| (13) | In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of protecting animal health to lay down rules on the conditions for the importation of live ungulate animals. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. |
| --- | --- |

(13)

In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of protecting animal health to lay down rules on the conditions for the importation of live ungulate animals. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.

| (14) | 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 (11), establishes new committee procedures and terminology. In the interests of consistency of Community legislation, those procedures and terminology should be taken into account in this Directive. |
| --- | --- |

(14)

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 (11), establishes new committee procedures and terminology. In the interests of consistency of Community legislation, those procedures and terminology should be taken into account in this Directive.

| (15) | Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (12), lays down the conditions for the importation into the Community of ungulate animals other than domestic bovine, ovine, caprine, porcine and equine animals, and provides for a list to be laid down of third countries from which Member States may import such animals as well as the health requirements to be met. This Directive should be amended in order to exclude from its scope the animal species covered by the present act. |
| --- | --- |

(15)

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (12), lays down the conditions for the importation into the Community of ungulate animals other than domestic bovine, ovine, caprine, porcine and equine animals, and provides for a list to be laid down of third countries from which Member States may import such animals as well as the health requirements to be met. This Directive should be amended in order to exclude from its scope the animal species covered by the present act.

| (16) | It is also appropriate to provide that the testing requirements upon importation of live animals covered by Directive 92/65/EEC should be updated or established by committee procedure. |
| --- | --- |

(16)

It is also appropriate to provide that the testing requirements upon importation of live animals covered by Directive 92/65/EEC should be updated or established by committee procedure.

| (17) | Directives 90/426/EEC and 92/65/EEC should therefore be amended accordingly, |
| --- | --- |

(17)

Directives 90/426/EEC and 92/65/EEC should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Directive lays down the animal health requirements for the importation into and transit through the Community of live ungulates.

Article 2

Definitions

For the purposes of this Directive, the following definitions shall apply:

| (a) | ‘third countries’ shall mean countries other than Member States, and those territories of Member States to which Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (13) and Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (14) do not apply; |
| --- | --- |

(a)

‘third countries’ shall mean countries other than Member States, and those territories of Member States to which Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (13) and Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (14) do not apply;

13

14

| (b) | ‘authorised third country’ shall mean a third country, or a part of a third country, from which the importation into the Community of live ungulate animals listed in Annex I is authorised as provided for in Article 3(1); |
| --- | --- |

(b)

‘authorised third country’ shall mean a third country, or a part of a third country, from which the importation into the Community of live ungulate animals listed in Annex I is authorised as provided for in Article 3(1);

| (c) | ‘official veterinarian’ shall mean a veterinarian authorised by the veterinary administration of a third country to perform health inspections of live animals, and to perform official certification; |
| --- | --- |

(c)

‘official veterinarian’ shall mean a veterinarian authorised by the veterinary administration of a third country to perform health inspections of live animals, and to perform official certification;

| (d) | ‘ungulates’ shall mean those animals listed in Annex 1. |
| --- | --- |

(d)

‘ungulates’ shall mean those animals listed in Annex 1.

CHAPTER II

ANIMAL HEALTH REQUIREMENTS APPLICABLE TO IMPORTS INTO THE COMMUNITY OF CERTAIN LIVE UNGULATE ANIMALS

Article 3

Authorised third countries

1.   The importation of live ungulates into and transit through the Community shall only be authorised from third countries that appear on a list or lists to be drawn up or amended in accordance with the procedure referred to in Article 14(2).

Taking into account the health situation and the guarantees provided by the third country for the animals listed in Annex I, it may be decided in accordance with the procedure referred to in Article 14(2), that the authorisation provided for in the preceding subparagraph shall apply to the whole territory of an authorised third country or to only part of its territory.

For that purpose and on the basis of the relevant international standards, account shall be taken of how the authorised third country applies and implements those standards, in particular the principle of regionalisation within its own territory and in relation to its sanitary requirements for importation from other third countries and from the Community.

2.   The authorisation for importation of live ungulates into or transiting through the Community as provided for in paragraph 1 and the specific animal health conditions provided for in Article 6(3) may be suspended or withdrawn in accordance with the procedure referred to in Article 14(2) where the animal health situation in the authorised third country justifies such suspension or withdrawal.

Article 4

Preparation of the lists of authorised third countries

When the lists of authorised third countries are drawn up or amended, particular account shall be taken of:

| (a) | the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and the environmental status of the Community; |
| --- | --- |

(a)

the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and the environmental status of the Community;

| (b) | the legislation of the third country in relation to animal health and welfare; |
| --- | --- |

(b)

the legislation of the third country in relation to animal health and welfare;

| (c) | the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively; |
| --- | --- |

(c)

the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively;

| (d) | the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community; |
| --- | --- |

(d)

the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community;

| (e) | whether the third country is a member of the OIE and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious animal diseases in its territory, in particular those diseases listed by the OIE; |
| --- | --- |

(e)

whether the third country is a member of the OIE and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious animal diseases in its territory, in particular those diseases listed by the OIE;

| (f) | the guarantees given by the third country directly to inform the Commission and the Member States:






  (i) | within 24 hours of the confirmation of the occurrence of any of the diseases listed in Annex II and of any change in the vaccination policy concerning such diseases; |
| --- | --- | --- |

(f)

the guarantees given by the third country directly to inform the Commission and the Member States:

(i)

within 24 hours of the confirmation of the occurrence of any of the diseases listed in Annex II and of any change in the vaccination policy concerning such diseases;

| (ii) | within an appropriate period, of any proposed changes in the national health rules concerning live ungulate animals, in particular regarding importation; |
| --- | --- |

(ii)

within an appropriate period, of any proposed changes in the national health rules concerning live ungulate animals, in particular regarding importation;

| (iii) | at regular intervals, of the animal health status of its territory; |
| --- | --- |

(iii)

at regular intervals, of the animal health status of its territory;

| (g) | any experience of previous imports of live animals from the third country and the results of any import controls carried out; |
| --- | --- |

(g)

any experience of previous imports of live animals from the third country and the results of any import controls carried out;

| (h) | the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out; |
| --- | --- |

(h)

the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out;

| (i) | the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on the importation from other third countries. |
| --- | --- |

(i)

the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on the importation from other third countries.

Article 5

Publication of lists of authorised third countries by the Commission

The Commission shall arrange for up-to-date versions of all lists drawn up or amended as provided for in Article 3(1) to be made available to the public. Those lists may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates.

Article 6

Specific animal health conditions for imports and transit from authorised third countries of live ungulates into the Community

1.   Specific animal health conditions for the importation and transit of live ungulates from authorised third countries into the Community shall be laid down in accordance with the procedure referred to in Article 14(2).

They may take account of the following:

| (a) | the animal species concerned; |
| --- | --- |

(a)

the animal species concerned;

| (b) | the age and sex of the animals; |
| --- | --- |

(b)

the age and sex of the animals;

| (c) | the intended destination or purpose of the animals; |
| --- | --- |

(c)

the intended destination or purpose of the animals;

| (d) | the measures to be applied after importation of the animals into the Community; |
| --- | --- |

(d)

the measures to be applied after importation of the animals into the Community;

| (e) | any special provisions applicable in the framework of intra-Community trade. |
| --- | --- |

(e)

any special provisions applicable in the framework of intra-Community trade.

2.   The specific animal health conditions provided for in paragraph 1 shall be based on the rules laid down in Community legislation for the diseases to which the animals are susceptible.

3.   However, where the equivalence of the official health guarantees provided for by the third country concerned can be formally recognised by the Community, the specific animal health conditions may be based on those guarantees.

Article 7

Guarantees from the authorised third country regarding imports of live ungulates into the Community

Imports of live ungulates into the Community shall be allowed only if the authorised third country provides the following guarantees:

| (a) | the animals must come from a disease-free territory, in accordance with the basic general criteria listed in Annex II and into which the entry of animals vaccinated against the diseases listed in that Annex must be prohibited; |
| --- | --- |

(a)

the animals must come from a disease-free territory, in accordance with the basic general criteria listed in Annex II and into which the entry of animals vaccinated against the diseases listed in that Annex must be prohibited;

| (b) | the animals must comply with the specific animal health conditions provided for in Article 6; |
| --- | --- |

(b)

the animals must comply with the specific animal health conditions provided for in Article 6;

| (c) | before the day of loading for shipment to the Community, the animals must have remained in the territory of the authorised third country for a period of time to be set out in the specific animal health conditions referred to in Article 6; |
| --- | --- |

(c)

before the day of loading for shipment to the Community, the animals must have remained in the territory of the authorised third country for a period of time to be set out in the specific animal health conditions referred to in Article 6;

| (d) | before shipment to the Community, the animals must have undergone a check by an official veterinarian to ensure that they are healthy and that the transport conditions provided for in Directive 91/628/EEC are complied with, in particular as regards watering and feeding; |
| --- | --- |

(d)

before shipment to the Community, the animals must have undergone a check by an official veterinarian to ensure that they are healthy and that the transport conditions provided for in Directive 91/628/EEC are complied with, in particular as regards watering and feeding;

| (e) | the animals must be accompanied by a veterinary certificate which complies with Article 11 and with a specimen veterinary certificate established in accordance with the procedure referred to in Article 14(2). Provision may be made for the use of electronic documents under the same procedure; |
| --- | --- |

(e)

the animals must be accompanied by a veterinary certificate which complies with Article 11 and with a specimen veterinary certificate established in accordance with the procedure referred to in Article 14(2). Provision may be made for the use of electronic documents under the same procedure;

| (f) | upon arrival in the Community, the animals must be checked at an agreed border inspection post in accordance with Article 4 of Directive 91/496/EEC. |
| --- | --- |

(f)

upon arrival in the Community, the animals must be checked at an agreed border inspection post in accordance with Article 4 of Directive 91/496/EEC.

Article 8

Derogation from guarantees to be provided by authorised third countries

By way of derogation from Articles 6 and 7, specific provisions, including model veterinary certificates, may be laid down in accordance with the procedure referred to in Article 14(2) for the importation or transit of live ungulates from third countries authorised under Article 3(1) if those animals:

| (a) | are intended exclusively for grazing or draught purposes, on a temporary basis, in the vicinity of the Community frontiers; |
| --- | --- |

(a)

are intended exclusively for grazing or draught purposes, on a temporary basis, in the vicinity of the Community frontiers;

| (b) | are related to sporting events, circuses, shows and exhibitions but not related to commercial transactions of the animals themselves; |
| --- | --- |

(b)

are related to sporting events, circuses, shows and exhibitions but not related to commercial transactions of the animals themselves;

| (c) | are intended for a zoo, an amusement park, an experimental laboratory or, as defined in Article 2(c) of Directive 92/65/EEC, an approved body, approved institute or approved centre; |
| --- | --- |

(c)

are intended for a zoo, an amusement park, an experimental laboratory or, as defined in Article 2(c) of Directive 92/65/EEC, an approved body, approved institute or approved centre;

| (d) | exclusively transit the territory of the Community through approved Community border inspection posts under customs and official veterinary approval and supervision, with no stop in the Community other than those necessary for animal welfare purposes; |
| --- | --- |

(d)

exclusively transit the territory of the Community through approved Community border inspection posts under customs and official veterinary approval and supervision, with no stop in the Community other than those necessary for animal welfare purposes;

| (e) | accompany their owners as pet animals;
  or |
| --- | --- |

(e)

accompany their owners as pet animals;

or

| (f) | are presented at an approved Community border inspection post after they have left the Community:






  — | within a period of 30 days for one of the purposes referred to in points (a), (b) and (e),
  or |
| --- | --- | --- |

(f)

are presented at an approved Community border inspection post after they have left the Community:

—

within a period of 30 days for one of the purposes referred to in points (a), (b) and (e),

or

| — | transiting a third country, |
| --- | --- |

—

transiting a third country,

or

| (g) | which belong to endangered species. |
| --- | --- |

(g)

which belong to endangered species.

Article 9

Derogation from Article 7(a) as regards imports or transit from authorised third countries where diseases listed in Annex II are present and/or vaccinations are carried out

By way of derogation from Article 7(a), and in accordance with the procedure referred to in Article 14(2), conditions may be established for the importation or transit of live ungulates into the Community from an authorised third country where certain diseases listed in Annex II are present and/or vaccinations against those diseases are carried out.

Such derogations shall be established country by country.

Article 10

Derogation from Article 7(a) as regards imports or transit from authorised third countries where imports or transit have been suspended or prohibited

By way of derogation from Article 7(a), and in accordance with the procedure referred to in Article 14(2), a specific period may be determined after which the importation or transit of live ungulates from an authorised third country may be resumed after the suspension or prohibition of importation or transit due to any change in the health situation, together with any additional conditions to be fulfilled after such resumption.

When deciding to resume the importation or transit of such animals, account shall be taken of:

| — | international standards, |
| --- | --- |

—

international standards,

| — | whether an outbreak or a number of epizootiologically interrelated outbreaks of one of the diseases listed in Annex II occurs within a geographically limited area in an authorised third country or region, |
| --- | --- |

—

whether an outbreak or a number of epizootiologically interrelated outbreaks of one of the diseases listed in Annex II occurs within a geographically limited area in an authorised third country or region,

| — | whether the outbreak or outbreaks are successfully eradicated within a limited period of time. |
| --- | --- |

—

whether the outbreak or outbreaks are successfully eradicated within a limited period of time.

Article 11

Veterinary Certificates

1.   A veterinary certificate complying with the requirements set out in Annex III shall be presented with each consignment of animals upon their import or transit into the Community.

2.   The veterinary certificate shall certify that the requirements of this Directive and other Community legislation on animal health, or where applicable in accordance with Article 6(3), provisions that are equivalent to those requirements, have been complied with.

3.   The veterinary certificate may include certification statements required under other Community legislation on public health, animal health and animal welfare.

4.   The use of the veterinary certificate provided for in paragraph 1 may be suspended or withdrawn in accordance with the procedure referred to in Article 14(2) where the animal health situation in the authorised third country justifies such suspension or withdrawal.

Article 12

Inspections and audits in third countries

1.   Inspections and/or audits may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules.

The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out such inspections and/or audits.

2.   The inspections and/or audits provided for in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred.

3.   The procedure for carrying out the inspections and/or audits in third countries as provided for in paragraph 1 may be established or amended in accordance with the procedure referred to in Article 14(2).

4.   If a serious animal health risk is identified during an inspection and/or audit as provided for in paragraph 1, even if it is not directly related to the objectives of the inspection/audit, the Commission shall immediately, take the measures necessary to safeguard animal health, as laid down in Article 18 of Directive 91/496/EEC, including the suspension or withdrawal of the authorisation provided for in Article 3(1).

Article 13

Empowering provisions

1.   The following may be established in accordance with the procedure referred to in Article 14(2):

| (a) | detailed rules for the application of this Directive; |
| --- | --- |

(a)

detailed rules for the application of this Directive;

| (b) | rules regarding the origin of animals; |
| --- | --- |

(b)

rules regarding the origin of animals;

| (c) | the criteria for classifying authorised third countries or regions thereof with regard to animal diseases; |
| --- | --- |

(c)

the criteria for classifying authorised third countries or regions thereof with regard to animal diseases;

| (d) | provisions for the use of electronic documents relating to model veterinary certificates as provided for in Article 7(e); |
| --- | --- |

(d)

provisions for the use of electronic documents relating to model veterinary certificates as provided for in Article 7(e);

| (e) | models of veterinary certificates as provided for in Article 11(1). |
| --- | --- |

(e)

models of veterinary certificates as provided for in Article 11(1).

2.   The Annexes to this Directive may be amended in accordance with the procedure referred to in Article 14(2) in order to take account, in particular of:

| (a) | scientific opinions and scientific knowledge particularly concerning new risk assessments; |
| --- | --- |

(a)

scientific opinions and scientific knowledge particularly concerning new risk assessments;

| (b) | technical developments and/or amendments to international standards; |
| --- | --- |

(b)

technical developments and/or amendments to international standards;

| (c) | the setting of safety targets for animal health. |
| --- | --- |

(c)

the setting of safety targets for animal health.

Article 14

Committee procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

3.   The Committee shall adopt its Rules of Procedure.

Article 15

Amendment to Directive 90/426/EEC

Directive 90/426/EEC is hereby amended as follows:

| 1. | Article 12 is replaced by the following:

  ‘Article 12

  1.   The importation of equidae into the Community shall only be authorised from third countries that appear on a list or lists to be drawn up or amended in accordance with the procedure referred to in Article 24(2).
  Taking into account the health situation and the guarantees provided by the third country for equidae, it may be decided in accordance with the procedure referred to in Article 24(2) that the authorisation provided for in the preceding subparagraph shall apply to the whole territory of the third country or to only part of its territory.
  For that purpose and on the basis of the relevant international standards, account shall be taken of how the third country applies and implements those standards, in particular the principle of regionalisation, within its own territory and in relation to its sanitary requirements for importation from other third countries and from the Community.


  2.   when the lists provided for in paragraph 1 are drawn up or amended, particular account shall be taken of:






  (a) | the health status of the equidae, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and environmental status of the Community; |
| --- | --- | --- |

1.

Article 12 is replaced by the following:

‘Article 12

1.   The importation of equidae into the Community shall only be authorised from third countries that appear on a list or lists to be drawn up or amended in accordance with the procedure referred to in Article 24(2).

Taking into account the health situation and the guarantees provided by the third country for equidae, it may be decided in accordance with the procedure referred to in Article 24(2) that the authorisation provided for in the preceding subparagraph shall apply to the whole territory of the third country or to only part of its territory.

For that purpose and on the basis of the relevant international standards, account shall be taken of how the third country applies and implements those standards, in particular the principle of regionalisation, within its own territory and in relation to its sanitary requirements for importation from other third countries and from the Community.

2.   when the lists provided for in paragraph 1 are drawn up or amended, particular account shall be taken of:

(a)

the health status of the equidae, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health and the environmental situation in the third country which may pose a risk to the health and environmental status of the Community;

| (b) | the legislation of the third country in relation to animal health and welfare; |
| --- | --- |

(b)

the legislation of the third country in relation to animal health and welfare;

| (c) | the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively; |
| --- | --- |

(c)

the organisation of the competent veterinary authority and its inspection services, the powers of those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply national legislation effectively;

| (d) | the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community; |
| --- | --- |

(d)

the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions applicable in the Community;

| (e) | whether the third country is a member of the Office International des Epizooties (OIE) and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious diseases of equidae in its territory, in particular those diseases listed by the OIE and in Annex A to this Directive; |
| --- | --- |

(e)

whether the third country is a member of the Office International des Epizooties (OIE) and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious diseases of equidae in its territory, in particular those diseases listed by the OIE and in Annex A to this Directive;

| (f) | the guarantees given by the third country to directly inform the Commission and the Member States:






  (i) | within 24 hours, of the confirmation of the occurrence of infectious diseases of equidae listed in Annex A and of any change in the vaccination policy concerning such diseases; |
| --- | --- | --- |

(f)

the guarantees given by the third country to directly inform the Commission and the Member States:

(i)

within 24 hours, of the confirmation of the occurrence of infectious diseases of equidae listed in Annex A and of any change in the vaccination policy concerning such diseases;

| (ii) | within an appropriate period, of any proposed changes in the national sanitary rules concerning equidae, in particular regarding the importation of equidae; |
| --- | --- |

(ii)

within an appropriate period, of any proposed changes in the national sanitary rules concerning equidae, in particular regarding the importation of equidae;

| (iii) | at regular intervals, of the animal health status of its territory concerning equidae; |
| --- | --- |

(iii)

at regular intervals, of the animal health status of its territory concerning equidae;

| (g) | any experience of previous imports of live equidae from the third country and the results of any import controls carried out; |
| --- | --- |

(g)

any experience of previous imports of live equidae from the third country and the results of any import controls carried out;

| (h) | the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out; |
| --- | --- |

(h)

the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities on the inspections which they have carried out;

| (i) | the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on importation of equidae from other third countries. |
| --- | --- |

(i)

the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on importation of equidae from other third countries.

3.   The Commission shall arrange for up-to-date versions of all lists drawn up or amended as provided for in paragraph 1 to be made available to the public.

Those lists may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates.

4.   Special import conditions for each third country or group of third countries, having regard to the animal health situation concerning equidae in the third country or countries concerned shall be established in accordance with the procedure referred to in Article 24(2).

5.   Detailed rules for the application of this Article and criteria for including third countries or parts of third countries in the lists provided for in paragraph 1 may be adopted in accordance with the procedure referred to in Article 24(2).’

| 2. | the following point is added to Article 19:






  ‘(iv) | may designate a Community reference laboratory for one or more of the diseases of equidae listed in Annex A and shall stipulate the functions, tasks and procedures regarding collaboration with laboratories responsible for diagnosing infectious diseases of equidae in the Member States.’ |
| --- | --- | --- |

2.

the following point is added to Article 19:

‘(iv)

may designate a Community reference laboratory for one or more of the diseases of equidae listed in Annex A and shall stipulate the functions, tasks and procedures regarding collaboration with laboratories responsible for diagnosing infectious diseases of equidae in the Member States.’

Article 16

Amendment to Directive 92/65/EEC

Directive 92/65/EEC is hereby amended as follows:

| 1. | the first subparagraph of Article 1 is replaced by the following:

  ‘This Directive lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to in Annex F.’ |
| --- | --- |

1.

the first subparagraph of Article 1 is replaced by the following:

‘This Directive lays down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Community acts referred to in Annex F.’

| 2. | Article 6 is amended as follows:






  (a) | in A(1), point (e) is replaced by;






  "(e) | must be accompanied by a certificate corresponding to the specimen given in Annex E part 1, bearing the following declaration: |
| --- | --- | --- | --- |

2.

Article 6 is amended as follows:

(a)

in A(1), point (e) is replaced by;

"(e)

must be accompanied by a certificate corresponding to the specimen given in Annex E part 1, bearing the following declaration:

Image 5

| (b) | in A(1), point (f) is deleted; |
| --- | --- |

(b)

in A(1), point (f) is deleted;

| (c) | in A(2), point (b) is replaced by:






  ‘(b) | where they do not come from a herd meeting the conditions laid down in (a), they must come from a holding in which no case of brucellosis or tuberculosis has been recorded in the 42 days preceding loading of the animals and in which the ruminants have in the 30 days prior to dispatch undergone with negative results a test for brucellosis and tuberculosis.’ |
| --- | --- | --- |

(c)

in A(2), point (b) is replaced by:

‘(b)

where they do not come from a herd meeting the conditions laid down in (a), they must come from a holding in which no case of brucellosis or tuberculosis has been recorded in the 42 days preceding loading of the animals and in which the ruminants have in the 30 days prior to dispatch undergone with negative results a test for brucellosis and tuberculosis.’

| (d) | in A(3), points (e), (f) and (g) are deleted; |
| --- | --- |

(d)

in A(3), points (e), (f) and (g) are deleted;

| (e) | the following point is added to (A):






  ‘4. | The testing requirements referred to in this Article and their criteria may be established in accordance with the procedure laid down in Article 26. These decisions shall take into consideration the case of ruminants reared in the arctic regions of the Community.
  Pending the decisions provided for in the preceding subparagraph, national rules shall continue to apply.’ |
| --- | --- | --- |

(e)

the following point is added to (A):

‘4.

The testing requirements referred to in this Article and their criteria may be established in accordance with the procedure laid down in Article 26. These decisions shall take into consideration the case of ruminants reared in the arctic regions of the Community.

Pending the decisions provided for in the preceding subparagraph, national rules shall continue to apply.’

| 3. | Article 17 is amended as follows:






  (a) | in paragraph 3, points (a) and (b) are replaced by the following:






  ‘(a) | a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos,
  and |
| --- | --- | --- | --- |

3.

Article 17 is amended as follows:

(a)

in paragraph 3, points (a) and (b) are replaced by the following:

‘(a)

a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos,

and

| (b) | without prejudice to Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (*1), a list of the collection centres for which these third countries are able to give the guarantees provided for in Article 11. |
| --- | --- |

(b)

without prejudice to Commission Decision 94/63/EC of 31 January 1994 drawing up a list of third countries from which Member States authorise imports of semen, ova and embryos of the ovine and caprine species and ova and embryos of the porcine species (*1), a list of the collection centres for which these third countries are able to give the guarantees provided for in Article 11.

*1

The Commission shall inform the Member States of any proposed amendments to the lists of centres and the Member States shall have 10 working days, from the date of receipt of the proposed amendments, to send written comments to the Commission.

Where no written comments are received from the Member States within that period of 10 working days, the proposed amendments shall be considered to have been accepted by the Member States and imports shall be authorised in accordance with the amended lists when the Commission notifies the competent authorities of the Member States and the third country concerned that the amendments are published on the website of the Commission.

Where written comments are received from at least one Member State within the period of 10 working days, the Commission shall inform the Member States and the Standing Committee on the Food Chain and Animal Health at its next meeting for a decision to be adopted in accordance with the procedure referred to in the second subparagraph of Article 26.

(*1)  
  OJ L 28, 2.2.1994, p. 47. Decision as last amended by Decision 2004/211/EC.’
  "

*1

| 4. | in Article 23, ‘from Article 6 (A)(1)(e) and’ is deleted; |
| --- | --- |

4.

in Article 23, ‘from Article 6 (A)(1)(e) and’ is deleted;

| 5. | Article 26 is replaced by the following:

  ‘Article 26

  1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (*2).


  2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
  The period laid down in Article 5(6) of Decision 1999/468/EC (*3) shall be set at three months.


  3.   The Committee shall adopt its Rules of Procedure.



  (*2)  
  OJ L 31, 1.2.2002, p. 1
  "


  (*3)  
  OJ L 184, 17.7.1999, p. 23.’
  " |
| --- | --- |

5.

Article 26 is replaced by the following:

‘Article 26

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (*2).

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC (*3) shall be set at three months.

3.   The Committee shall adopt its Rules of Procedure.

(*2)  
  OJ L 31, 1.2.2002, p. 1
  "

*2

(*3)  
  OJ L 184, 17.7.1999, p. 23.’
  "

*3

| 6. | The text in Annex IV to this Directive is added as Annex F. |
| --- | --- |

6.

The text in Annex IV to this Directive is added as Annex F.

CHAPTER III

FINAL PROVISIONS

Article 17

Transitional measures

Transitional measures may be laid down in accordance with the procedure referred to in Article 14(2).

Article 18

Transposal into national law

1.   Member States shall bring into force the laws, regulations, and administrative provisions necessary to comply with this Directive before 20 November 2005. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted.

Article 19

Repeal of Directive 72/462/EEC

Directive 72/462/EEC shall be repealed with effect from the date of application of Regulation (EC) No 854/2004.

Article 20

Implementing rules established in accordance with decisions adopted for the import of live animals, meat and meat products pursuant to Directive 72/462/EEC, as listed in Annex V to this Directive, shall remain in force until replaced by measures adopted under the new regulatory framework.

Article 21

Entry into force and applicability

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

Article 22

This Directive is addressed to the Member States.

Done at Luxembourg, 26 April 2004.

For the Council

The President

J. WALSH

ANNEX I

Animal species as referred to in Article 1

| Taxon |
| --- |
| Order | Family | Genera/Species |
| Artiodactyla | Antilocapridae | Antilocapra ssp. |
| Bovidae | Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammodorcas ssp., Ammotragus ssp., Antidorcas ssp., Antilope ssp., Bison ssp., Bos ssp.(including Bibos, Novibos, Poephagus), Boselaphus ssp., Bubalus ssp. (including Anoa), Budorcas ssp., Capra ssp., Cephalophus ssp., Connochaetes ssp., Damaliscus ssp.(including Beatragus), Dorcatragus ssp., Gazella ssp., Hemitragus ssp., Hippotragus ssp., Kobus ssp., Litocranius ssp., Madogua ssp., Naemorhedus ssp. (including Nemorhaedus and Capricornis), Neotragus ssp., Oreamuos ssp., Oreotragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis ssp., Patholops ssp., Pelea ssp., Procapra ssp., Pseudois ssp., Pseudoryx ssp., Raphicerus ssp., Redunca ssp., Rupicapra ssp., Saiga ssp., Sigmoceros-Alecelaphus ssp., Sylvicapra ssp., Syncerus ssp., Taurotragus ssp., Tetracerus ssp., Tragelaphus ssp.(including Boocerus). |
| Camelidae | Camelus ssp., Lama ssp., Vicugna ssp. |
| Cervidae | Alces ssp., Axis-Hyelaphus ssp., Blastocerus ssp., Capreolus ssp., Cervus-Rucervus ssp., Dama ssp., Elaphurus ssp., Hippocamelus ssp., Hydropotes ssp., Mazama ssp., Megamuntiacus ssp., Muntiacus ssp., Odocoileus ssp., Ozotoceros ssp., Pudu ssp., Rangifer ssp. |
| Giraffidae | Giraffa ssp., Okapia ssp. |
| Hippopotamidae | Hexaprotodon-Choeropsis ssp., Hippopotamus ssp. |
| Moschidae | Moschus ssp. |
| Suidae | Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Potamochoerus ssp., Sus ssp., |
| Tayassuidae | Catagonus ssp., Pecari-Tayassu ssp. |
| Tragulidae | Hyemoschus ssp., Tragulus-Moschiola ssp. |
| Perissodactyla | Rhinocerotidae | Ceratotherium ssp., Dicerorhinus ssp., Diceros ssp., Rhinoceros ssp. |
| Tapiridae | Tapirus ssp.. |
| Proboscidae | Elephantidae | Elephas ssp., Loxodonta ssp. |

Taxon

Order

Family

Genera/Species

Artiodactyla

Antilocapridae

Antilocapra ssp.

Bovidae

Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammodorcas ssp., Ammotragus ssp., Antidorcas ssp., Antilope ssp., Bison ssp., Bos ssp.(including Bibos, Novibos, Poephagus), Boselaphus ssp., Bubalus ssp. (including Anoa), Budorcas ssp., Capra ssp., Cephalophus ssp., Connochaetes ssp., Damaliscus ssp.(including Beatragus), Dorcatragus ssp., Gazella ssp., Hemitragus ssp., Hippotragus ssp., Kobus ssp., Litocranius ssp., Madogua ssp., Naemorhedus ssp. (including Nemorhaedus and Capricornis), Neotragus ssp., Oreamuos ssp., Oreotragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis ssp., Patholops ssp., Pelea ssp., Procapra ssp., Pseudois ssp., Pseudoryx ssp., Raphicerus ssp., Redunca ssp., Rupicapra ssp., Saiga ssp., Sigmoceros-Alecelaphus ssp., Sylvicapra ssp., Syncerus ssp., Taurotragus ssp., Tetracerus ssp., Tragelaphus ssp.(including Boocerus).

Camelidae

Camelus ssp., Lama ssp., Vicugna ssp.

Cervidae

Alces ssp., Axis-Hyelaphus ssp., Blastocerus ssp., Capreolus ssp., Cervus-Rucervus ssp., Dama ssp., Elaphurus ssp., Hippocamelus ssp., Hydropotes ssp., Mazama ssp., Megamuntiacus ssp., Muntiacus ssp., Odocoileus ssp., Ozotoceros ssp., Pudu ssp., Rangifer ssp.

Giraffidae

Giraffa ssp., Okapia ssp.

Hippopotamidae

Hexaprotodon-Choeropsis ssp., Hippopotamus ssp.

Moschidae

Moschus ssp.

Suidae

Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Potamochoerus ssp., Sus ssp.,

Tayassuidae

Catagonus ssp., Pecari-Tayassu ssp.

Tragulidae

Hyemoschus ssp., Tragulus-Moschiola ssp.

Perissodactyla

Rhinocerotidae

Ceratotherium ssp., Dicerorhinus ssp., Diceros ssp., Rhinoceros ssp.

Tapiridae

Tapirus ssp..

Proboscidae

Elephantidae

Elephas ssp., Loxodonta ssp.

ANNEX II

The diseases referred to in Article 4(f)(i) and the basic general criteria for a territory to be considered disease-free in accordance with Article 7(a)

| Disease | Conditions | Animals concerned |
| --- | --- | --- |
| Foot and mouth disease | no outbreak of disease, no evidence of virus infection (*4) and no vaccination carried out during the last 12 months | All species |
| Vesicular stomatitis | no case of disease during the last six months | All species |
| Swine vesicular disease | no case of disease and no vaccination carried out during the last 24 months | Species of family Suidae |
| Rinderpest | no case of disease and no vaccination carried out during the last 12 months | All species |
| Peste des petits ruminants | no case of disease and no vaccination carried out during the last 12 months | Species of the genera Ovis and Capra |
| Contagious bovine pleuropneumonia | no case of disease and no vaccination carried out during the last 12 months | Species of the genus Bos |
| Lumpy skin disease | no case of disease and no vaccination carried out during the last 36 months | Species of the genera Bos, Bison and Bubalus |
| Rift valley fever | no case of disease and no vaccination carried out during the last 12 months | All species other than those of family Suidae |
| Bluetongue | no case of disease and no vaccination carried out during the last 12 months with appropriate control of the Culicoides population | All species other than those of family Suidae |
| Sheep pox and goat pox | no case of disease and no vaccination carried out during the last 12 months | Species of the genera Ovis and Capra |
| African swine fever | no case of disease during the last 12 months | Species of family Suidae |
| Classical swine fever | no case of disease and no vaccination carried out during the last 12 months | Species of family Suidae |

Disease

Conditions

Animals concerned

Foot and mouth disease

no outbreak of disease, no evidence of virus infection (*4) and no vaccination carried out during the last 12 months

All species

Vesicular stomatitis

no case of disease during the last six months

All species

Swine vesicular disease

no case of disease and no vaccination carried out during the last 24 months

Species of family Suidae

Rinderpest

no case of disease and no vaccination carried out during the last 12 months

All species

Peste des petits ruminants

no case of disease and no vaccination carried out during the last 12 months

Species of the genera Ovis and Capra

Contagious bovine pleuropneumonia

no case of disease and no vaccination carried out during the last 12 months

Species of the genus Bos

Lumpy skin disease

no case of disease and no vaccination carried out during the last 36 months

Species of the genera Bos, Bison and Bubalus

Rift valley fever

no case of disease and no vaccination carried out during the last 12 months

All species other than those of family Suidae

Bluetongue

no case of disease and no vaccination carried out during the last 12 months with appropriate control of the Culicoides population

All species other than those of family Suidae

Sheep pox and goat pox

no case of disease and no vaccination carried out during the last 12 months

Species of the genera Ovis and Capra

African swine fever

no case of disease during the last 12 months

Species of family Suidae

Classical swine fever

no case of disease and no vaccination carried out during the last 12 months

Species of family Suidae

ANNEX III

Requirements for veterinary certificates as referred to in Article 11

| 1. | The representative of the competent authority of dispatch issuing a veterinary certificate to accompany a consignment of animals must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. |
| --- | --- |

1.

The representative of the competent authority of dispatch issuing a veterinary certificate to accompany a consignment of animals must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one.

| 2. | Veterinary certificates must be drawn up in the official language or languages of the Member State of destination and those of the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or those languages. However, a Member State may consent to the use of an official Community language other than its own. |
| --- | --- |

2.

Veterinary certificates must be drawn up in the official language or languages of the Member State of destination and those of the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or those languages. However, a Member State may consent to the use of an official Community language other than its own.

| 3. | The original version of the veterinary certificate must accompany the consignments on entry into the Community. |
| --- | --- |

3.

The original version of the veterinary certificate must accompany the consignments on entry into the Community.

| 4. | Veterinary certificates must consist of:






  (a) | a single sheet of paper;
  or |
| --- | --- | --- |

4.

Veterinary certificates must consist of:

(a)

a single sheet of paper;

or

| (b) | two or more pages that are part of a single and indivisible sheet of paper;
  or |
| --- | --- |

(b)

two or more pages that are part of a single and indivisible sheet of paper;

or

| (c) | a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘page 2 of four pages’). |
| --- | --- |

(c)

a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘page 2 of four pages’).

| 5. | Veterinary certificates must bear a unique identifying number. Where the veterinary certificate consists of a sequence of pages, each page must indicate the unique identifying number. |
| --- | --- |

5.

Veterinary certificates must bear a unique identifying number. Where the veterinary certificate consists of a sequence of pages, each page must indicate the unique identifying number.

| 6. | The veterinary certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the country of dispatch. |
| --- | --- |

6.

The veterinary certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the country of dispatch.

ANNEX IV

‘ANNEX F

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species

Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species

Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of Equidae

Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species

Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs

Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products

Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals

Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC.’

ANNEX V

List of Decisions

2003/56/EC: Commission Decision of 24 January 2003 on health certificates for the importation of live animals and animal products from New Zealand (OJ L 22, 25.1.2003, p. 38)

2002/987/EC: Commission Decision of 13 December 2002 on the list of establishments in the Falkland Islands approved for the purpose of importing fresh meat into the Community (OJ L 344, 19.12.2002, p. 39)

2002/477/EC: Commission Decision of 20 June 2002 laying down public health requirements for fresh meat and fresh poultrymeat imported from third countries, and amending Decision 94/984/EC (OJ L 164, 22.6.2002, p. 39)

2001/600/EC: Commission Decision of 17 July 2001 concerning protective measures with regard to imports of certain animals from Bulgaria due to an outbreak of bluetongue, repealing Decision 1999/542/EC, amending Decision 98/372/EC concerning the animal health conditions and veterinary certifications for import of live animals of bovine and swine species from certain European countries to take into account some aspects in relation with Bulgaria and amending Decision 97/232/EC drawing up lists of third countries from which Member States authorise imports of sheep and goats (OJ L 210, 3.8.2001, p. 51)

2000/159/EC: Commission Decision of 8 February 2000 on the provisional approval of residue plans of third countries according to Council Directive 96/23/EC (OJ L 51, 24.2.2000, p. 30)

98/8/EC: Commission Decision of 16 December 1997 on the list of establishments in the Federal Republic of Yugoslavia approved for the purpose of importing fresh meat into the Community (OJ L 2, 6.1.1998, p. 12)

97/222/EC: Commission Decision of 28 February 1997 laying down the list of third countries from which the Member States authorise the importation of meat products (OJ L 89, 4.4.1997, p. 39)

97/221/EC: Commission Decision of 28 February 1997 laying down the animal health conditions and model veterinary certificates in respect of imports of meat products from third countries and revoking Decision 91/449/EEC (OJ L 89, 4.4.1997, p. 32)

95/427/EC: Commission Decision of 16 October 1995 on the list of establishments in the Republic of Namibia approved for the purpose of importing meat products into the Community (OJ L 254, 24.10.1995, p. 28)

95/45/EC: Commission Decision of 20 February 1995 on the list of establishments in the former Yugoslav Republic of Macedonia approved for the purpose of importing fresh meat into the Community (OJ L 51, 8.3.1995, p. 13)

94/465/EC: Commission Decision of 12 July 1994 on the list of establishments in Botswana approved for the purpose of importing meat products into the Community (OJ L 190, 26.7.1994, p. 25)

94/40/EC: Commission Decision of 25 January 1994 on the list of establishments in Zimbabwe approved for the purpose of importing meat products into the Community (OJ L 22, 27.1.1994, p. 50)

93/158/EEC: Council Decision of 26 October 1992 concerning the conclusion of an Agreement in the form of an Exchange of Letters between the European Economic Community and the United States of America concerning the application of the Community third-country directive, Council Directive 72/462/EEC, and the corresponding United States of America regulatory requirements with respect to trade in fresh bovine and porcine meat (OJ L 68, 19.3.1993, p. 1)

93/26/EEC: Commission Decision of 11 December 1992 on the list of establishments in the Republic of Croatia approved for the purpose of importing fresh meat into the Community (OJ L 16, 25.1.1993, p. 24)

90/432/EEC: Commission Decision of 30 July 1990 on the list of establishments in Namibia approved for the purpose of importing fresh meat into the Community (OJ L 223, 18.8.1990, p. 19)

90/13/EEC: Commission Decision of 20 December 1989 on the procedure to be followed for amending or supplementing the lists of establishments approved in third countries for the import of fresh meat into the Community (OJ L 8, 11.1.1990, p. 70)

87/431/EEC: Commission Decision of 28 July 1987 on the list of establishments in the Kingdom of Swaziland approved for the purpose of importing fresh meat into the Community (OJ L 228, 15.8.1987, p. 53)

87/424/EEC: Commission Decision of 14 July 1987 on the list of establishments in the United Mexican States approved for the purpose of importing fresh meat into the Community (OJ L 228, 15.8.1987, p. 43)

87/258/EEC: Commission Decision of 28 April 1987 on the list of establishments in Canada approved for the purpose of importing fresh meat into the Community (OJ L 121, 9.5.1987, p. 50)

87/257/EEC: Commission Decision of 28 April 1987 on the list of establishments in the United States of America approved for the purpose of importing fresh meat into the Community (OJ L 121, 9.5.1987, p. 46)

87/124/EEC: Commission Decision of 19 January 1987 on the list of establishments in Chile approved for the purpose of importing fresh meat into the Community (OJ L 51, 20.2.1987, p. 41)

86/474/EEC: Commission Decision of 11 September 1986 on the implementation of the on-the-spot inspections to be carried out in respect of the importation of bovine animals and swine and fresh meat from non-member countries (OJ L 279, 30.9.1986, p. 55)

86/65/EEC: Commission Decision of 13 February 1986 on the list of establishments in Morocco approved for the purpose of importing fresh meat into the Community (OJ L 72, 15.3.1986, p. 40)

85/539/EEC: Commission Decision of 29 November 1985 on the list of establishments in Greenland approved for the purpose of importing fresh meat into the Community (OJ L 334, 12.12.1985, p. 25)

84/24/EEC: Commission Decision of 23 December 1983 on the list of establishments in Iceland approved for the purposes of importing fresh meat into the Community (OJ L 20, 25.1.1984, p. 21)

83/423/EEC: Commission Decision of 29 July 1983 on the list of establishments in the Republic of Paraguay approved for the purpose of importing fresh meat into the Community (OJ L 238, 27.8.1983, p. 39)

83/402/EEC: Commission Decision of 29 July 1983 on the list of establishments in New Zealand approved for the purposes of importing fresh meat into the Community (OJ L 233, 24.8.1983, p. 24)

83/384/EEC: Commission Decision of 29 July 1983 on the list of establishments in Australia approved for the purposes of importing fresh meat into the Community (OJ L 222, 13.8.1983, p. 36)

83/243/EEC: Commission Decision of 10 May 1983 on the list of establishments in the Republic of Botswana approved for the purposes of importing fresh meat into the Community (OJ L 129, 19.5.1983, p. 70)

83/218/EEC: Commission Decision of 22 April 1983 on the list of establishments in the Socialist Republic of Romania approved for the purpose of importing fresh meat into the Community (OJ L 121, 7.5.1983, p. 23)

82/923/EEC: Commission Decision of 17 December 1982 concerning the establishments in the Republic of Guatemala from which Member States may authorise the importation of fresh meat (OJ L 381, 31.12.1982, p. 40)

82/913/EEC: Commission Decision of 16 December 1982 on the list of establishments in the Republic of South Africa and Namibia approved for the purpose of importing fresh meat into the Community (OJ L 381, 31.12.1982, p. 28)

82/735/EEC: Council Decision of 18 October 1982 on the list of establishments in the People's Republic of Bulgaria approved for the purposes of exporting fresh meat to the Community (OJ L 311, 8.11.1982, p. 16)

82/734/EEC: Council Decision of 18 October 1982 on the list of establishments in the Swiss Confederation approved for the purposes of exporting fresh meat to the Community (OJ L 311, 8.11.1982, p. 13)

81/713/EEC: Commission Decision of 28 July 1981 on the list of establishments in the Federative Republic of Brazil approved for the purpose of importing fresh beef and veal and meat of domestic solipeds into the Community (OJ L 257, 10.9.1981, p. 28)

81/92/EEC: Commission Decision of 30 January 1981 on the list of establishments in the Republic of Uruguay approved for the purposes of the importation of fresh beef and veal, sheep meat and meat of domestic solipeds into the Community (OJ L 58, 5.3.1981, p. 43)

81/91/EEC: Commission Decision of 30 January 1981 on the list of establishments in the Argentine Republic approved for the purposes of the importation of fresh beef and veal, sheep meat and meat of domestic solipeds into the Community (OJ L 58, 5.3.1981, p. 39)

79/542/EEC: Council Decision of 21 December 1976 drawing up a list of third countries or parts of third countries, and laying down the animal and public health, and veterinary certification conditions, for importation into the Community of certain live animals and their fresh meat. (OJ L 146, 14.6.1979, p. 15)

78/685/EEC: Commission Decision of 26 July 1978 establishing a list of epizootic diseases in accordance with Directive 72/462/EEC (OJ L 227, 18.8.1978, p. 32).

---

(*1)  
  OJ L 28, 2.2.1994, p. 47. Decision as last amended by Decision 2004/211/EC.’

*1

(*2)  
  OJ L 31, 1.2.2002, p. 1

*2

(*3)  
  OJ L 184, 17.7.1999, p. 23.’

*3

---

(1)  Opinion of 30 March 2004 (not yet published in the Official Journal).

1

(2)  Opinion of 25 February 2004 (not yet published in the Official Journal).

2

(3)  
  OJ L 302, 31.12.1972, p. 28. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

3

(4)  
  OJ L 18, 23.1.2003, p. 11.

4

(5)  
  OJ L 61, 3.3.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

5

(6)  
  OJ L 224, 18.8.1990, p. 42. Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

6

(7)  
  OJ L 340, 11.12.1991, p. 17. Directive as amended by Regulation (EC) No 806/2003.

7

(8)  
  OJ L 268, 24.9.1991, p. 56. Directive as amended by Directive 96/43/EC

8

(9)  
  OJ L 184, 17.7.1999, p. 23.

9

(10)  See page 83 of this Official Journal.

10

(11)  
  OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

11

(12)  
  OJ L 268, 14.9.1992, p. 54. Directive as last amended by Commission Regulation (EC) No 1398/2003 (OJ L 198, 6.8.2003, p. 3).

12

(13)  
  OJ L 395, 30.12.1989, p. 13. Directive as amended by Regulation (EC) No 806/2003.

13

(14)  
  OJ L 224, 18.8.1990, p. 29. Directive as amended by Directive 2002/33/EC of the European Parliament and of the Council (OJ L 315, 19.11.2002, p. 14).

14

(*4)  In accordance with Chapter 2.1.1 of the OIE Manual.

*4

---