Corrigendum to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

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

Regulation (EC) No 854/2004 should read as follows:

REGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 29 April 2004

laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

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

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

Having consulted the Committee of the Regions,

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

Whereas:

(1) Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) lays down general hygiene rules applying to all foodstuffs and Regulation (EC) No 853/2004 of the European Parliament and of the Council (5) lays down specific hygiene rules for products of animal origin.

(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:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down specific rules for the organisation of official controls on products of animal origin.

2. It shall apply only in respect of activities and persons to which Regulation (EC) No 853/2004 applies.

3. The performance of official controls pursuant to this Regulation shall be without prejudice to food business operators' primary legal responsibility for ensuring food safety, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (7), and any civil or criminal liability arising from the breach of their obligations.

Article 2

Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

(a) ‘official control’ means any form of control that the competent authority performs for the verification of compliance with food law, including animal health and animal welfare rules;

(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;

(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 (8);

(c) Regulation (EC) No 852/2004, except for the definition of ‘competent authority’; and

(d) Regulation (EC) No 853/2004.

CHAPTER II

OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

Article 3

Approval of establishments

1. (a) When Community legislation requires the approval of establishments, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it meets the relevant requirements of Regulations (EC) No 852/2004 and (EC) No 853/2004 and other relevant requirements of food law. (b) The competent authority may grant conditional approval if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new on-site visit carried out within three months of the granting of conditional approval that the establishment meets the other requirements referred to in (a). If clear progress has been made but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months.

2. In the case of factory and freezer vessels flying the flag of Member States, the maximum periods of three and six months applying to the conditional approval of other establishments may be extended, if necessary. However, conditional approval shall not exceed a total of 12 months. Inspections of such vessels shall take place as specified in Annex III.

3. The competent authority shall give each approved establishment, including those with conditional approval, an approval number, to which codes may be added to indicate the types of products of animal origin manufactured. For wholesale markets, secondary numbers indicating units or groups of units selling or manufacturing products of animal origin may be added to the approval number.

4. (a) The competent authority shall keep the approval of establishments under review when carrying out official controls in accordance with Articles 4 to 8. (b) If the competent authority identifies serious deficiencies or has to stop production at an establishment repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's approval. However, the competent authority may suspend an establishment's approval if the food business operator can guarantee that it will resolve deficiencies within a reasonable time. (c) In the case of wholesale markets, the competent authority may withdraw or suspend approval in respect of certain units or groups of units.

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.

6. Member States shall maintain up-to-date lists of approved establishments, with their respective approval numbers and other relevant information, and make them available to other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 19(2).

Article 4

General principles for official controls in respect of all products of animal origin falling within the scope of this Regulation

1. Member States shall ensure that food business operators offer all assistance needed to ensure that official controls carried out by the competent authority can be performed effectively

They shall in particular:

— give access to all buildings, premises, installations or other infrastructures;

— 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.

Article 5

Fresh meat

Member States shall ensure that official controls with respect to fresh meat take place in accordance with Annex I.

1. The official veterinarian shall carry out inspection tasks in slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market in accordance with the general requirements of Section I, Chapter II, of Annex I, and with the specific requirements of Section IV, in particular as regards: (a) food chain information; (b) ante-mortem inspection; (c) animal welfare; (d) post-mortem inspection; (e) specified risk material and other animal by-products; and (f) laboratory testing.

2. The health marking of carcases of domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, as well as half-carcases, quarters and cuts produced by cutting half-carcases into three wholesale cuts, shall be carried out in slaughterhouses and game-handling establishments in accordance with Section I, Chapter III, of Annex I. Health marks shall be applied by, or under the responsibility of, the official veterinarian when official controls have not identified any deficiencies that would make the meat unfit for human consumption.

3. After carrying out the controls mentioned in points 1 and 2, the official veterinarian shall take appropriate measures as set out in Annex I, Section II, in particular as regards: (a) the communication of inspection results; (b) decisions concerning food chain information; (c) decisions concerning live animals; (d) decisions concerning animal welfare; and (e) decisions concerning meat.

4. Official auxiliaries may assist the official veterinarian with official controls carried out in accordance with Sections I and II of Annex I as specified in Section III, Chapter I. In that case, they shall work as part of an independent team.

5. (a) Member States shall ensure that they have sufficient official staff to carry out the official controls required under Annex I with the frequency specified in Section III, Chapter II. (b) A risk-based approach shall be followed to assess the number of official staff that need to be present on the slaughter line in any given slaughterhouse. The number of official staff involved shall be decided by the competent authority and shall be such that all the requirements of this Regulation can be met.

6. (a) Member States may allow slaughterhouse staff to assist with official controls by carrying out certain specific tasks, under the supervision of the official veterinarian, in relation to the production of meat from poultry and lagomorphs in accordance with Annex I, Section III, Chapter III, part A. If they do so, they shall ensure that staff carrying out such tasks: (i) are qualified and undergo training in accordance with those provisions; (ii) act independently from production staff; and (iii) report any deficiency to the official veterinarian. (b) Member States may also allow slaughterhouse staff to carry out specific sampling and testing tasks in accordance with Annex I, Section III, Chapter III, Part B.

7. Member States shall ensure that official veterinarians and official auxiliaries are qualified and undergo training in accordance with Annex I, Section III, Chapter IV.

Article 6

Live bivalve molluscs

Member States shall ensure that the production and placing on the market of live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods undergo official controls as described in Annex II.

Article 7

Fishery products

Member States shall ensure that official controls with respect to fishery products take place in accordance with Annex III.

Article 8

Raw milk and dairy products

Member States shall ensure that official controls with respect to raw milk and dairy products take place in accordance with Annex IV.

Article 9

Action in the case of non-compliance

1. When the competent authority identifies non-compliance with the Regulations referred to in Article 4(2)(a) and (b), it shall take action to ensure that the food business operator remedies the situation. When deciding which action to take, the competent authority shall take account of the nature of the non-compliance and the food business operator's past record with regard to non-compliance.

2. Such action shall include, where appropriate, the following measures:

(a) the imposition of sanitation procedures or any other corrective action deemed necessary to ensure the safety of products of animal origin or compliance with the relevant legal requirements;

(b) the restriction or prohibition of the placing on the market, import or export of products of animal origin;

(c) monitoring or, if necessary, ordering the recall, withdrawal and/or destruction of products of animal origin;

(d) authorisation to use products of animal origin for purposes other than those for which they were originally intended;

(e) the suspension of operations or closure of all or part of the food business concerned for an appropriate period of time;

(f) the suspension or withdrawal of the establishment's approval;

(g) in the case of consignments from third countries, seizure followed by destruction or re-dispatch;

(h) any other measure that the competent authority deems appropriate.

3. The competent authority shall provide the food business operator concerned, or a representative, with:

(a) written notification of its decision concerning the action to be taken in accordance with paragraph 1, together with the reasons for the decision; and

(b) information on rights of appeal against such decisions and of the applicable procedure and time limits.

Where appropriate, the competent authority shall also notify the competent authority of the Member State of dispatch of its decision.

CHAPTER III

PROCEDURES CONCERNING IMPORTS

Article 10

General principles and conditions

To ensure the uniform application of the principles and conditions laid down in Article 11 of Regulation (EC) No 178/2002 the procedures laid down in this c+hapter shall apply.

Article 11

Lists of third countries and parts of third countries from which imports of specified products of animal origin are permitted

1. Products of animal origin shall be imported only from a third country or a part of third country that appears on a list drawn up and updated in accordance with the procedure referred to in Article 19(2).

2. A third country shall appear on such lists only if a Community control in that country has taken place and demonstrates that the competent authority provides appropriate guarantees as specified in paragraph 4. However, a third country may appear on such lists without a Community control having taken place there if:

(a) the risk determined in accordance with Article 18(18) does not warrant it; and

(b) it is determined, when deciding to add a particular third country to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

3. Lists drawn up in accordance with this Article may be combined with other lists drawn up for public and animal health purposes.

4. When lists are drawn up or updated, particular account shall be taken of the following criteria:

(a) the legislation of the third country on: (i) products of animal origin, (ii) the use of veterinary medicinal products, including rules on their prohibition or authorisation, their distribution, their placing on the market and the rules covering administration and inspection; and (iii) the preparation and use of feedingstuffs, including the procedures for using additives and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of the raw materials used for preparing feedingstuffs and of the final product;

(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.

Article 12

List of establishments from which imports of specified products of animal origin are permitted

1. Products of animal origin may be imported into the Community only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up and updated in accordance with this Article, except:

(a) when, on a case-by-case basis, it is decided, in accordance with the procedure referred to in Article 19(2), that the guarantees that a specified third country provides in respect of imports of specified products of animal origin are such that the procedure provided for in this Article is unnecessary to ensure compliance with the requirements of paragraph 2; and

(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.

Article 13

Live bivalve molluscs, echinoderms, tunicates and marine gastropods

1. Notwithstanding Article 12(1)(b), live bivalve molluscs, echinoderms, tunicates and marine gastropods shall come from production areas in third countries that appear on lists drawn up and updated in accordance with Article 12.

2. The requirement of paragraph 1 shall not apply to pectinidae harvested outside classified production areas. However, official controls with respect to pectinidae shall take place in accordance with Annex II, Chapter III.

3. (a) Before the lists referred to in paragraph 1 are drawn up, particular account shall be taken of the guarantees that the competent authority of the third country can give concerning compliance with the requirements of this Regulation on the classification and control of production zones. (b) An on-the-spot Community inspection visit shall take place before such lists are drawn up unless: (i) the risk determined in accordance with Article 18(18) does not warrant it; and (ii) it is determined, when deciding to add a particular production area to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

4. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

Article 14

Documents

1. A document meeting the requirements set out in Annex VI shall accompany consignments of products of animal origin when they are imported into the Community.

2. The document shall certify that the products satisfy:

(a) the requirements laid down for such products according to Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 or provisions that are equivalent to those requirements; and

(b) any special import conditions established in accordance with Article 18(19).

3. Documents may include details required in accordance with other Community legislation on public and animal health matters.

4. Exemptions from paragraph 1 may be granted in accordance with the procedure referred to in Article 19(2) when it is possible to obtain the guarantees referred to in paragraph 2 of this Article in another manner.

Article 15

Special provisions for fishery products

1. The procedures laid down in this Chapter do not apply to fresh fishery products landed in the Community directly from a fishing vessel flying the flag of a third country.

Official controls with respect to such fishery products shall take place in accordance with Annex III.

2. (a) Fishery products imported from a factory or freezer vessel flying the flag of a third country shall come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4). (b) However, by way of exemption from Article 12(2)(b), a vessel may also be included on such lists: (i) on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of another third country to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that: — that third country appears on the list of third countries, drawn up in accordance with Article 11, from which imports of fisheries products are permitted, — 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 (ii) on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of a Member State, to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that: — all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that Member State, — the competent authority of that Member State has inspected the vessel and has declared that it complies with Community requirements, and — the competent authority of that Member State has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements. (c) The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

3. When fishery products are imported directly from a fishing or freezer vessel, a document signed by the captain may replace the document required under Article 14.

4. Detailed rules for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 19(2).

CHAPTER IV

FINAL PROVISIONS

Article 16

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 19(2).

Article 17

Amendment and adaptation of the Annexes

1. Annexes I, II, III, IV, V and VI may be amended or supplemented to take account of scientific and technical progress in accordance with the procedure referred to in Article 19(2).

2. Exemptions from Annexes I, II, III, IV, V and VI may be granted in accordance with the procedure referred to in Article 19(2), provided that they do not affect the achievement of the objectives of this Regulation.

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

4. The national measures referred to in paragraph 3 shall:

(a) have the aim of: (i) enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; (ii) accommodating the needs of food businesses with a low throughput or that are situated in regions that are subject to special geographic constraints; or (iii) permitting pilot projects to take place in order to try out new approaches to hygiene controls on meat;

(b) concern in particular the following elements of Annex I: (i) food chain information; (ii) the presence of the competent authority in establishments.

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

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

(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.

Article 18

Specific decisions

Without prejudice to the generality of Article 16 and Article 17(1), implementing measures may be laid down, or amendments to Annexes I, II, III, IV, V or VI adopted, in accordance with the procedure referred to in Article 19(2), to specify:

1. tests to assess the performance of food business operators and their staff;

2. the method of communicating inspection results;

3. criteria to determine when, on the basis of a risk analysis, the official veterinarian need not be present in slaughterhouses and game handling establishments throughout ante-mortem and post-mortem inspection;

4. rules concerning the content of tests for official veterinarians and official auxiliaries;

5. microbiological criteria for process control in relation to hygiene in establishments;

6. alternative procedures, serological or other laboratory tests that provide guarantees at least equivalent to specific post-mortem inspection procedures described in Annex I, Section IV, and may therefore replace them, if the competent authority so decides;

7. circumstances in which certain of the specific post-mortem inspection procedures described in Annex I, Section IV, are not necessary, having regard to the holding, region or country of origin and to the principles of risk analysis,

8. rules for laboratory testing;

9. the cold treatment to be applied to meat in relation to cysticercosis and trichinosis;

10. conditions under which holdings and regions can be certified as officially free of cysticercus or trichinae;

11. methods to be applied when examining for the conditions referred to in Annex I, Section IV, Chapter IX;

12. for fattening pigs, criteria for controlled housing conditions and integrated production systems;

13. criteria for the classification of production and relaying areas for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including: (a) limit values and analysis methods for marine biotoxins, (b) virus testing procedures and virological standards, and (c) sampling plans and the methods and analytical tolerances to be applied to check compliance with the criteria;

14. organoleptic criteria for the evaluation of the freshness of fishery products;

15. analytical limits, methods of analysis and sampling plans for the official controls on fishery products required under Annex III, including with regard to parasites and environmental contaminants;

16. the method by which the Commission will make lists of third countries and establishments in third countries available to the public pursuant to Articles 11, 12, 13 and 15;

17. models for documents and criteria for the use of electronic documents;

18. criteria for determining the risk that particular products of animal origin imported into the Community present;

19. special import conditions for particular products of animal origin, taking account of the associated risks, information that relevant third countries have provided and, where necessary, the results of Community controls carried out in such third countries. These special import conditions may be established for a single product of animal origin or for group of products. They may apply to a single third country, to regions of a third country, or to a group of third countries; and

20. the conditions governing imports of products of animal origin from a third country or a region of a third country pursuant to the implementation of an equivalence agreement, or to a satisfactory audit, recognising that measures applied in that third country or region offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect.

Article 19

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002.

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

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

3. The Committee shall adopt its Rules of Procedure.

Article 20

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on matters falling within the scope of this Regulation whenever necessary and, in particular:

1. before proposing to modify the specific requirements concerning post-mortem inspection procedures laid down in Section IV of Annex I;

2. before proposing to modify the rules of Annex I, Section IV, Chapter IX, on meat from animals in which post-mortem inspection has revealed lesions indicating infection with brucellosis or tuberculosis; and

3. before proposing implementing measures on the matters referred to in Article 18(5) to (15).

Article 21

Report to the European Parliament and to the Council

1. The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council reviewing the experience gained from the application of this Regulation.

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

Article 22

Entry into force

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

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

(a) Regulation (EC) No 852/2004;

(b) Regulation (EC) No 853/2004 and

(c) Directive 2004/41/EC of the European Parliament and of the Council of 29 April 2004 repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (9).

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