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[X1THE 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.
(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.
(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.
(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.
(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.
(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.
(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) ,
HAVE ADOPTED THIS REGULATION:
Editorial Information
X1 Substituted by 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).
1. This Regulation lays down specific rules for the organisation of official controls on products of animal origin.
[F11a. This Regulation shall apply in addition to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (7) .]
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 (8) , and any civil or criminal liability arising from the breach of their obligations.
Textual Amendments
1. For the purposes of this Regulation, the following definitions shall apply:
[F2(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;]
(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;
[F2(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;]
(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;
(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.
2. The definitions laid down in the following Regulations shall also apply as appropriate:
(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 (9) ;
[F1(b)(a) Regulation (EC) No 882/2004;]
(c) Regulation (EC) No 852/2004, except for the definition of ‘ competent authority ’ ;
and
(d) Regulation (EC) No 853/2004.
Textual Amendments
[F31. The competent authorities shall approve establishments when, and in the manner, specified in Article 31(2) of Regulation (EC) No 882/2004.]
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. [F2(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
(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.
F26.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
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;
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;
(b) Regulation (EC) No 853/2004;
and
(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;
(b) the official controls specified in Articles 5 to 8;
and
(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;
(b) the design and maintenance of premises and equipment;
(c) pre-operational, operational and post-operational hygiene;
(d) personal hygiene;
(e) training in hygiene and in work procedures;
(f) pest control;
(g) water quality;
(h) temperature control;
and
(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;
(b) comply with Community legislation on residues, contaminants and prohibited substances;
and
(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;
(b) to verify the food business operator's relevant records;
(c) to take samples for laboratory analysis whenever necessary;
and
(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;
(b) in the case of slaughterhouses, animal welfare aspects;
(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.
Member States shall ensure that official controls with respect to fresh meat take place in accordance with Annex I.
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:
food chain information;
ante-mortem inspection;
animal welfare;
post-mortem inspection;
specified risk material and other animal by-products;
and
laboratory testing.
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.
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:
the communication of inspection results;
decisions concerning food chain information;
decisions concerning live animals;
decisions concerning animal welfare;
and
decisions concerning meat.
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.
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.
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.
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:
are qualified and undergo training in accordance with those provisions;
act independently from production staff;
and
report any deficiency to the official veterinarian.
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.
Member States shall ensure that official veterinarians and official auxiliaries are qualified and undergo training in accordance with Annex I, Section III, Chapter IV.
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.
Member States shall ensure that official controls with respect to fishery products take place in accordance with Annex III.
Member States shall ensure that official controls with respect to raw milk and dairy products take place in accordance with Annex IV.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
To ensure the uniform application of the principles and conditions laid down in Article 11 of Regulation (EC) No 178/2002 and Title VI, Chapter II, of Regulation (EC) No 882/2004 the procedures laid down in this Chapter shall apply.]
Textual Amendments
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).
[F32 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 Article 48(3) of Regulation (EC) No 882/2004. However, a third country may appear on such lists without a Community control having taken place if:
(a) the risk determined in accordance with Article 46(3)(a) of Regulation (EC) No 882/2004 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.]
3. Lists drawn up in accordance with this Article may be combined with other lists drawn up for public and animal health purposes.
[F34. When drawing up or updating lists, particular account shall be taken of the criteria listed in Articles 46 and 48(3) of Regulation (EC) No 882/2004. Regard shall also be had to:]
(a) the legislation of the third country on:
products of animal origin,
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
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;
[F2(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;
(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;
(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;
(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;
(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;
(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.
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.
Textual Amendments
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
(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;
(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).
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).
5. The Commission shall arrange for up-to-date versions of all lists to be available to the public.
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:
the risk determined in accordance with Article 18(18) does not warrant it;
and
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.
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
[F3(b) any specific import conditions established in accordance with Article 48 of Regulation (EC) No 882/2004.]
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.
Textual Amendments
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:
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,
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;
or
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 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).
Transitional measures of general scope designed to amend non-essential elements of this Regulation, inter alia , by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 19(2).]
Textual Amendments
F4 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
[F41. Annexes I, II, III, IV, V and VI may be amended or supplemented by the Commission to take account of scientific and technical progress. Those measures, designed to amend non-essential elements of this Regulation, inter alia , by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).
2. Exemptions from Annexes I, II, III, IV, V and VI may be granted by the Commission, provided that they do not affect the achievement of the objectives of this Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).]
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:
enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food;
accommodating the needs of food businesses with a low throughput or that are situated in regions that are subject to special geographic constraints;
or
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:
food chain information;
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;
(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
(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;
(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.
Textual Amendments
F4 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
[F4Without prejudice to the general application of Article 16 and Article 17(1), implementing measures may be laid down in accordance with the regulatory procedure referred to in Article 19(2), and amendments to Annexes I, II, III, IV, V or VI, as measures designed to amend non-essential elements of this Regulation, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), to specify:]
tests to assess the performance of food business operators and their staff;
the method of communicating inspection results;
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;
rules concerning the content of tests for official veterinarians and official auxiliaries;
microbiological criteria for process control in relation to hygiene in establishments;
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;
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,
rules for laboratory testing;
the cold treatment to be applied to meat in relation to cysticercosis and trichinosis;
conditions under which holdings and regions can be certified as officially free of cysticercus or trichinae;
methods to be applied when examining for the conditions referred to in Annex I, Section IV, Chapter IX;
for fattening pigs, criteria for controlled housing conditions and integrated production systems;
criteria for the classification of production and relaying areas for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:
limit values and analysis methods for marine biotoxins,
virus testing procedures and virological standards,
and
sampling plans and the methods and analytical tolerances to be applied to check compliance with the criteria;
organoleptic criteria for the evaluation of the freshness of fishery products;
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;
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 [F3.]
[F2. . . . .
. . . . .
. . . . .
. . . . .]
Textual Amendments
F2 Deleted by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
F3 Substituted by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
F4 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
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.
[F43. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.]
Textual Amendments
F4 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
The Commission shall consult the European Food Safety Authority on matters falling within the scope of this Regulation whenever necessary and, in particular:
before proposing to modify the specific requirements concerning post-mortem inspection procedures laid down in Section IV of Annex I;
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
before proposing implementing measures on the matters referred to in Article 18(5) to (15).
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.
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:
Regulation (EC) No 852/2004;
Regulation (EC) No 853/2004
and
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 (10) .
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.
does not contain patho-physiological abnormalities or changes;
does not bear faecal or other contamination;
and
does not contain specified risk material, except as provided for under Community legislation, and has been produced in accordance with Community legislation on TSEs.
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.
the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter;
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.
that welfare has been compromised;
or
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).
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.
to reach a definitive diagnosis;
or
to detect the presence of:
an animal disease,
residues or contaminants in excess of the levels laid down under Community legislation,
non-compliance with microbiological criteria,
or
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.
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.
the monitoring and control of zoonoses and zoonotic agents;
specific laboratory testing for the diagnosis of TSEs in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (11) ;
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 (12) ;
and
the detection of OIE List A and, where appropriate, OIE List B diseases.
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
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.
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 [F5BE, [F6BG,] CZ, DK, DE, EE, GR, ES, FR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, [F6RO,] SI, SK, FI, SE and UK;]
the mark must indicate the approval number of the slaughterhouse;
and
[F7when applied in a slaughterhouse located within the Community, the mark must include the abbreviation CE, EB, EC, EF, EG, EK, EO, EY, ES, EÜ, EK or WE.
Those abbreviations must not be included in marks applied on meat imported into the Community from slaughterhouses located outside the Community.]
Textual Amendments
F5 Substituted by Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (Text with EEA relevance).
F6 Inserted by Council Regulation (EC) No 1791/2006 of 20 November 2006 adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania.
F7 Substituted by Commission Regulation (EC) No 1021/2008 of 17 October 2008 amending Annexes I, II and III to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption and Regulation (EC) No 2076/2005 as regards live bivalve molluscs, certain fishery products and staff assisting with official controls in slaughterhouses (Text with EEA relevance).
Textual Amendments
F8 Deleted by Commission regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (Text with EEA relevance).
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.
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.
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.
animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health;
rules on the use of veterinary medicinal products have not been complied with;
or
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.
an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV;
and
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.
derives from animals that have not undergone ante-mortem inspection, except for hunted wild game;
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;
derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days;
results from the trimming of sticking points;
derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise provided for in Section IV;
derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;
is not in conformity with microbiological criteria laid down under Community legislation to determine whether food may be placed on the market;
exhibits parasitic infestation, unless otherwise provided for in Section IV;
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;
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;
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;
has been treated illegally with decontaminating substances;
has been treated illegally with ionising or UV-rays;
contains foreign bodies (except, in the case of wild game, material used to hunt the animal);
exceeds the maximum permitted radioactivity levels laid down under Community legislation;
indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or organoleptic anomalies, in particular a pronounced sexual odour;
derives from emaciated animals;
contains specified risk material, except as provided for under Community legislation;
shows soiling, faecal or other contamination;
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;
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.
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:
in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and HACCP-based procedures;
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
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.
in slaughterhouses, throughout both ante-mortem and post-mortem inspection;
and
in game handling establishments, throughout post-mortem inspection.
the official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:
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,
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
the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks properly;
the official veterinarian need not be present at all times during post-mortem inspection if:
an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other meat from the same animal,
the official veterinarian subsequently inspects all such meat,
and
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.
to animals that have undergone emergency slaughter;
to animals suspected of having a disease or condition that may adversely affect human health;
to bovine animals from herds that have not been declared officially free of tuberculosis;
to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis;
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 (13) ;
when stricter controls are necessary to take account of emerging diseases or particular OIE List B diseases.
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:
[F7Where the establishment has used good hygiene practice in accordance with Article 4(4) of this Regulation and the HACCP procedure for at least 12 months, the competent authority may authorise staff of the establishment to carry out tasks of official auxiliaries. This authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as the official auxiliaries for the tasks of official auxiliaries or for the specific tasks they are authorised to perform. This staff must be placed under the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veterinarian shall be present at ante-mortem and post-mortem examinations, shall supervise these activities and carry out regular performance tests to ensure that the performance of the slaughterhouse staff meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Where the level of hygiene of the establishment is affected by the work of this staff, where this staff does not carry out the tasks properly or where in general this staff carries out its work in a manner that the competent authority considers unsatisfactory, this staff shall be replaced by official auxiliaries.]
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.
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.
national and Community legislation on veterinary public health, food safety, animal health, animal welfare and pharmaceutical substances;
principles of the common agricultural policy, market measures, export refunds and fraud detection (including the global context: WTO, SPS, Codex Alimentarius, OIE);
essentials of food processing and food technology;
principles, concepts and methods of good manufacturing practice and quality management;
pre-harvest quality management (good farming practices);
promotion and use of food hygiene, food related safety (good hygiene practices);
principles, concepts and methods of risk-analysis;
principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain;
prevention and control of food-borne hazards related to human health;
population dynamics of infection and intoxication;
diagnostic epidemiology;
monitoring and surveillance systems;
auditing and regulatory assessment of food safety management systems;
principles and diagnostic applications of modern testing methods;
information and communication technology as related to veterinary public health;
data-handling and applications of biostatistics;
investigations of outbreaks of food-borne diseases in humans;
relevant aspects concerning TSEs;
animal welfare at the level of production, transport and slaughter;
environmental issues related to food production (including waste management);
precautionary principle and consumer concerns;
and
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.
at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5;
and
such additional training as is required to enable official auxiliaries to undertake their duties competently.
in relation to holdings:
theoretical part:
familiarity with the farming industry organisation, production methods, international trade etc.,
good livestock husbandry practices,
basic knowledge of diseases, in particular zoonoses — viruses, bacteria, parasites etc.,
monitoring for disease, use of medicines and vaccines, residue testing,
hygiene and health inspection,
animal welfare on the farm and during transport,
environmental requirements — in buildings, on farms and in general,
relevant laws, regulations and administrative provisions,
consumer concerns and quality control;
practical part:
visits to holdings of different types and using different rearing methods,
visits to production establishments,
observation of the loading and unloading of animals,
laboratory demonstrations,
veterinary checks,
documentation;
in relation to slaughterhouses and cutting plants:
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,
HACCP and the audit of HACCP-based procedures,
animal welfare on unloading after transport and at the slaughterhouse,
basic knowledge of the anatomy and physiology of slaughtered animals,
basic knowledge of the pathology of slaughtered animals,
basic knowledge of the pathological anatomy of slaughtered animals,
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,
basic knowledge of microbiology,
ante-mortem inspection,
examination for trichinosis,
post-mortem inspection,
administrative tasks,
knowledge of the relevant laws, regulations and administrative provisions,
sampling procedure,
fraud aspects;
practical part:
animal identification,
age checks,
inspection and assessment of slaughtered animals,
post-mortem inspection in a slaughterhouse,
examination for trichinosis,
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,
hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures,
recording the results of ante-mortem inspection,
sampling,
traceability of meat,
documentation.
Carcases and offal of bovine animals under six weeks old are to undergo the following post-mortem inspection procedures:
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; [F9removal of the tonsils;]
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;
visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
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;
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;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
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.
Textual Amendments
F9 Deleted by Commission Regulation (EC) No 1663/2006 of 6 November 2006 amending Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (Text with EEA relevance).
Carcases and offal of bovine animals over six weeks old are to undergo the following post-mortem inspection procedures:
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 [F10;] [F9The tonsils must be removed;]
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;
visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
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;
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;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and the peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
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.
Textual Amendments
F10 Substituted by Commission Regulation (EC) No 1663/2006 of 6 November 2006 amending Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (Text with EEA relevance).
Carcases and offal of sheep and goats are to undergo the following post-mortem inspection procedures:
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;
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;
visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;
visual inspection of the diaphragm;
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;
visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales );
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
visual inspection of the udder and its lymph nodes;
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.
Carcases and offal of solipeds are to undergo the following post-mortem inspection procedures:
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 [F10;] [F9The tonsils must be removed;]
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;
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;
visual inspection of the diaphragm;
visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales );
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;
visual inspection and, if necessary, palpation of the spleen;
visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;
visual inspection of the udder and its lymph nodes ( Lnn. supramammarii ) and, if necessary, incision of the supramammary lymph nodes;
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;
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.
the health certificate provided for in Chapter X, Part A, accompanies them;
and
the requirements of paragraphs 2 to 5 are complied with.
checks on records or documentation at the holding, including food chain information;
the examination of the pigs to determine whether:
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,
they show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
or
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.
a control of the animals' identification;
and
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.
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;
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.
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;
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;
visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
visual inspection of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales ); palpation of the liver and its lymph nodes;
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;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
visual inspection of the udder and its lymph nodes ( Lnn. supramammarii ); incision of the supramammary lymph nodes in sows;
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 health certificate provided for in Chapter X, Part A, accompanies them;
and
the requirements of paragraphs 2 to 5 are complied with.
checks on records or documentation at the holding, including food chain information;
a flock inspection, to determine whether the birds:
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,
show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
or
show evidence that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.
a control of the animals' identification;
and
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.
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;
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.
daily inspection of the viscera and body cavities of a representative sample of birds;
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
any further investigations necessary when there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.
The requirements for poultry are to apply to farmed lagomorphs.
a control of the animals' identification;
and
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.
Textual Amendments
Textual Amendments
a visual examination of the carcase, its cavities and, where appropriate, organs with a view to:
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,
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;
an investigation of organoleptic abnormalities;
palpation of organs, where appropriate;
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;
examination for characteristics indicating that the meat presents a health risk, including:
abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter,
the generalised presence of tumours or abscesses affecting different internal organs or muscles,
arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region,
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),
the presence of parasites,
formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present),
significant abnormalities of colour, consistency or odour of muscle tissue or organs,
aged open fractures,
emaciation and/or general or localised oedema,
recent pleural or peritoneal adhesions,
and
other obvious extensive changes, such as putrefaction.
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.
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.
This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.
The reference method for this analysis is the five-tube, three dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.]
make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;
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.;
determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area;
and
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.
that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;
the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;
for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;
and
for the presence of chemical contaminants in live bivalve molluscs.
the likely variation in faecal contamination,
and
the parameters referred to in paragraph 6 of Part 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;
periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.
The competent authority must:
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;
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
act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.
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.
Official controls on pectinidae and live marine gastropods, which are not filter feeders, 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.]
Textual Amendments
F13 Substituted by Commission Regulation (EU) No 505/2010 of 14 June 2010 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption (Text with EEA relevance).
a regular check on the hygiene conditions of landing and first sale;
inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale markets, to check, in particular:
where appropriate, whether the conditions for approval are still fulfilled,
whether the fishery products are handled correctly,
for compliance with hygiene and temperature requirements,
and
the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;
and
checks on storage and transport conditions.
may be carried out when vessels call at a port in a Member State;
concern all vessels landing fishery products at ports in the Community, irrespective of flag;
and
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.
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.
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:
another Member State,
or
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.
Official controls of fishery products are to include at least the following elements.
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.
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.
Random testing for histamine is to be carried out to verify compliance with the permitted levels laid down under Community legislation.
Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with Community legislation.
Where necessary, microbiological checks are to be performed in accordance with the relevant rules and criteria laid down under Community legislation.
Random testing is to take place to verify compliance with Community legislation on parasites.
Checks are to take place to ensure that:
fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae ;
fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae , in particular Ruvettus pretiosus and Lepidocybium flavobrunneum , may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects. The scientific names of the fishery products and the common names must appear on the label;
fishery products containing biotoxins such as ciguatera or other toxins dangerous to human health are not placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No 853/2004 and comply with the standards laid down in Chapter V, point 2, of that Section.]
Fishery products are to be declared unfit for human consumption if:
organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation;
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;
they derive from:
poisonous fish,
fishery products not complying with the requirement of part G, point 2, of Chapter II concerning biotoxins,
or
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
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.
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.
The following third-country establishments need not appear on lists drawn up and updated in accordance with Article 12(4):
establishments handling products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down requirements;
establishments carrying out only primary production;
establishments carrying out only transport operations;
establishments carrying out only the storage of products of animal origin not requiring temperature-controlled storage conditions.
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.
[F10Certificates must be drawn up at least 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 languages. However, a Member State may consent to the use of an official Community language other than its own.]
The original version of the certificate must accompany consignments on entry into the Community.
Certificates must consist of:
a single sheet of paper;
or
two or more pages that are part of an integrated and indivisible sheet of paper;
or
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 ’ ).
Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.
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.]
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 .
Page 3 of this Official Journal.
Page 22 of this Official Journal.
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 ).
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 ).
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 ).
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 ).
OJ 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 ).
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 ).]
Editorial Information
X1 Substituted by 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).
Textual Amendments