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Document 52000PC0438(03)

Proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption

/* COM/2000/0438 final - COD 2000/0180 */

OJ C 365E , 19.12.2000, p. 102–122 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

52000PC0438(03)

Proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption /* COM/2000/0438 final - COD 2000/0180 */

Official Journal C 365 E , 19/12/2000 P. 0102 - 0122


Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption

EXPLANATORY MEMORANDUM

I. SUMMARY

The present proposals result from a recast of Community legislation on

- food hygiene as contained in Council Directive 93/43/EEC on the hygiene of foodstuffs and in a number of Council Directives on public health problems and governing the production and placing on the market of products of animal origin,

- animal health aspects related to the placing on the market of products of animal origin, as contained in a number of Council Directives that partially overlap with the food hygiene Directives,

- official controls on products of animal origin contained in the above product-specific Directives.

These Directives (17 in total) have been gradually developed since 1964 in response to the needs of the internal market, taking into account however a high level of protection. The multiplicity of these Directives, the intermingling of different disciplines (hygiene, animal health, official controls) and the existence of different hygiene regimes for products of animal origin and other food have led to a complex situation. This situation can be improved by recasting the legal requirements and separating aspects of food hygiene from animal health and official control issues.

The recast is primarily motivated by the need to ensure a high level of health protection for the different disciplines concerned.

The leitmotif throughout the recast of the hygiene rules is that food operators bear full responsibility for the safety of the food they produce. The implementation of hazard analysis and control principles and the observance of hygiene rules must ensure this safety. This is in line with the internationally accepted approach advocated by the Codex Alimentarius. In addition, provision is made for the hygiene rules to be applied at all levels of the food chain, from primary production to delivery to the final consumer.

Where the recast of the hygiene rules sets out the obligations for food operators throughout the food chain, this has resulted in a separate text defining the duties of the competent authorities with regard to controls on products of animal origin. These controls are specific to the type of product. They will apply in addition to the rules to be proposed under point 4 (proposal for a Regulation on official food and feed safety controls) of the Action Plan in the Annex to the Commission's White Paper on food safety.

Finally, products of animal origin may carry pathogens (swine fever, foot-and-mouth disease, etc.) which can seriously affect the health of animals coming into contact with such products. Although not harmful to humans, such products may cause serious losses and restrictions on the farms affected by such problems. The recast of the veterinary rules has helped to better identify these problems and define the measures that need to be taken in order to prevent the spread of animal diseases through products of animal origin. These measures are the subject of a separate proposal.

The recasting exercise has thus resulted in proposals for Regulations relating to food hygiene, official controls and animal health problems.

A Directive to repeal the existing legislation with respect to the above subjects is attached.

With this package of proposals, a number of important activities referred to in the Commission's White Paper on Food Safety is submitted.

II. FOOD HYGIENE

1. Hygiene rules applicable to all food

Directive 93/43/EEC on the hygiene of foodstuffs is based on the following principles:

- the paramount concern to protect human health,

- the use of hazard analysis, risk assessment and other management techniques to identify, control and monitor critical points in food businesses,

- the adoption of microbiological criteria and temperature control measures in accordance with scientifically accepted principles,

- the development of codes of good hygiene practice,

- the monitoring of food hygiene by the competent authorities of the Member States,

- the obligation on food business operators to ensure that only foodstuffs not harmful to human health are placed on the market.

The implementation of this Directive has shown that these principles remain valid and that their application can be extended to all foodstuffs. It is therefore a logical consequence of the recasting exercise to apply the rules of Directive 93/43/EEC to products of animal origin as well, which at present fall outside its scope.

At the same time, the rules contained in Directive 93/43/EEC have been revised in order to take account of recent developments in food hygiene:

a) The HACCP system

In order to bring Community legislation into line with the principles of food hygiene laid down by the Codex Alimentarius, it is proposed that the Hazard Analysis Critical Control Point (HACCP) principles prescribed by that organisation be introduced. The implementation of these principles would, if adopted, be mandatory for all operators of food establishments. It prescribes a number of logical steps to be followed by operators throughout the production cycle in order to allow - through hazard analysis - the identification of points where control is critical with regard to food safety.

The principles contain an obligation for manufacturers to keep records of the checks they carry out. This obligation is new and it is felt to be essential so that surveillance testing can be carried out effectively and efficiently by the competent authorities.

In implementing HACCP, operators will have to live up to their responsibilities. They will need to design a specific monitoring programme. All possible hazards must be identified and proper control procedures for every food establishment individually established. Corrective action must be taken when controls show that problems may occur. Regular updates of the system must be made. The correct application of the system will increase consumer protection.

Own-check programmes are already applied in some parts of the food industry. For other sectors of the food industry, the principles of own-checks are new. The own-checking system has to be made sufficiently flexible to take account of the different circumstances possibly present in practice, in particular with regard to small enterprises. For that purpose, codes can be developed to serve as a support tool for implementing the HACCP system.

b) Food Safety Objectives (FSOs)

At present, hygiene legislation for certain sectors, and in particular for products of animal origin, give a detailed description of the measures to be taken in order to ensure food safety.

Discussions on food safety nowadays are focussing on the objective that must be achieved in order to ensure food safety, rather than concentrating on a detailed description of the measures to be taken in order to ensure food safety. This implies that food operators must define their own procedures for achieving a defined objective. The advantages of such a system are simpler legislation (which can be limited to the setting of objectives, thus avoiding detailed descriptions of the means for reaching the objective), and more flexibility for food operators (who have the obligation to establish documented systems on the means developed by them to meet the objective set by law).

In such a system, food safety is the result of the respect of general hygiene rules imposed by food safety legislation, the obligation for food operators to develop procedures for ensuring the respect of the food safety objective fixed by legislation and the implementation of the HACCP system.

The Commission acknowledges the advantage of such a system which is based on the overriding principle that the food operator is responsible for the placing on the market of safe food. However, since FSOs have to be based on sound scientific advice, their setting requires time and careful risk management reflection. It is for that reason that the present proposal does not fix FSOs, but lays down a procedure that will allow the Commission to fix FSOs in the future. In the meanwhile, the detailed legislation is maintained albeit in a format that is adapted to the obligation for food operators to apply the HACCP system. These detailed rules could be reviewed in parallel with the setting of FSOs where feasible, without lowering the level of consumer protection.

c) The tracing of food and food ingredients

Recent food emergencies have demonstrated that the identification of the origin of food and food ingredients is of prime importance for consumer protection. The hygiene proposal introduces certain principles that must allow to improve tracing, and in particular:

- The registration of food businesses by the competent authority and the allocation of a registration number to each of them. This registration number must follow the product to its destination. In certain cases, where the competent authority wishes to have assurances about compliance of food businesses with the hygiene rules prior to starting-up such business, the approval of the food business concerned is required. In that event, the approval number will follow the product.

- The obligation for food businesses to ensure that adequate procedures are in place to withdraw food from the market where such food presents a risk to the health of the consumer, and to keep adequate records which must enable them to identify the supplier of ingredients and foods used in their operation.

The complexity of the food chain and the often complicated multi-ingredient composition of foodstuffs may require more detailed rules to ensure appropriate tracing up and down the place of manufacture. A procedure is for laying such detailed rules, where necessary, is proposed.

d) Imports of products into the Community

Provision is made for foodstuffs imported into the Community to comply with the Community hygiene standards or with equivalent standards.

e) Exports of Community products to non-member countries

Food exported to non-member countries cannot be permitted to present a risk to human health. Such products must therefore meet at least the same standards as apply for marketing within the Community, in addition to standards possibly imposed by the non-member country concerned.

f) The farm to table approach and primary production

Biological and chemical hazards in food may find their origin at the farm. Although certain product specific Directives address this problem, the matter has never been approached in a global way. It is proposed that the general hygiene rules be extended so as to cover hygiene at farm level. In doing so, Community legislation on food hygiene will be provided with an instrument that covers the entire food chain, from farm to table. To achieve the required level of hygiene at farm level, it is suggested that possible hazards occurring in primary production and methods to control such hazards shall be addressed in guides to good practice.

Although the food safety system proposed at the level of primary production is risk based, a formal implementation of the HACCP system is not foreseen. Such system could possibly be introduced at a later stage when experience with the new hygiene rules demonstrates that it can be practically applied at primary production.

Animal feed may condition food hygiene. Detailed specific Community legislation on this aspect already exists or has been proposed. There is therefore no need to extend the measures on food hygiene with rules on the safety of animal feed.

g) Flexibility

Experience in the Community has shown that a certain flexibility is needed in particular for small businesses, especially those situated in regions suffering from special geographical constraints (mountains, remote islands), and for the manufacture of traditional products. The proposals joined herewith aim to ensure such flexibility by requiring Member States, as a matter of subsidiarity, to ensure the appropriate level of hygiene in these businesses, without however compromising the objectives of food safety. The competent authorities in the Member States are the most appropriate bodies to judge about the needs at that level, and they must take their responsibilities in this matter.

Together with the already existing principles for ensuring the hygiene of foodstuffs, these amendments constitute a sound basis for ensuring a high level of hygiene in food businesses.

2. Hygiene rules applicable to food of animal origin

a) Introduction

As early as 1964, it was recognised that public health protection with regard to hazards in products of animal origin was regulated in a different way in the different Member States. With regard to meat in particular, health issues were used, justifiably or not, to create and maintain barriers to intra-Community trade and with a view to protecting national markets. The matter was of such a complicated nature and possible health hazards so paramount that it was felt that the only solution to this problem was a full harmonisation of the sector, with the objective to remove barriers to trade whilst ensuring a high level of consumer protection. This resulted in Directive 64/433/EEC on health problems related to the intra-Community trade in fresh meat. The attempt was successful, although it took several years to arrive at the high health level and free circulation we know today.

Similar problems to those related to meat existed in other sectors, and there was a need to make the same efforts for products of animal origin in general. All these products present potential hazards to human health that justify the harmonisation of national rules and setting a high level of health protection. The creation of the single market has boosted this process, and today a complete harmonisation of health rules related to the placing on the market of products of animal origin has been achieved.

The detailed hygiene rules are contained in the following texts:

Directive 64/433/EEC (fresh meat) Directive 71/118/EEC (poultrymeat) Directive 77/96/EEC (trichina examination) Directive 77/99/EEC (meat products) Directive 89/362/EEC (milking hygiene) Directive 89/437EEC (egg products) Directive 91/492/EEC (live bivalve molluscs) Directive 91/493/EEC (fishery products) Directive 91/495/EEC (rabbit meat and farmed game meat) Directive 92/45/EEC (game meat) Directive 92/46/EEC (milk and milk products) Directive 92/48/EEC (fishing vessels) Directive 92/118/EEC (gelatine, frogs' legs and snails) Directive 94/65/EC (minced meat).

Although these specific rules have helped to maintain a high level of health protection, ensure free circulation within the Community and establish uniform procedures for the importation of products of animal origin from non-member countries, it must be recognised that they are sometimes unnecessarily complicated and contain repetitions of similar or identical requirements, thus overlapping each other. Sometimes the rules contained in the different Directives have even been found to be contradictory. All these deficiencies contribute to difficulties of interpretation and implementation.

The method of simplifying the present hygiene rules for products of animal origin is by recasting the different Directives. This approach is suggested by the observation that a number of procedures and requirements in them are identical, almost identical or similar in nature. By condensing these, a set of rules common to all food can be identified, thus avoiding the repetition, overlap and inconsistencies occurring in the Directives in force. The remaining rules are specific to a particular product, and are kept in product-specific annexes.

b) Scope

There was an urgent need to clarify and better define the scope of the future detailed health rules on food of animal origin.

Retail sale

The rules of the specific food legislation are felt to be too detailed for implementation at retail level. Hygiene at that level can continue to be ensured through the implementation of the general hygiene rules, which contain all elements needed to ensure food safety. This includes procedures for fixing storage and transport temperatures and, where necessary, fixing microbiological criteria. This ensures continuity throughout, for example maintaining the cold chain up to purchase by the consumer.

Product definition

The definitions of products of animal origin contained in the present specific rules are not laid out or interpreted in a uniform way. An area of major confusion is that of composite products, which contain, together with products of animal origin, other foods of plant origin.

It is proposed that products of animal origin in future be categorised as follows:

- unprocessed (raw) products, such as meat, raw milk, eggs, fish and molluscs,

- processed products such as meat products, egg products, processed fish,

These categories would constitute the basis for defining the scope of the specific hygiene legislation for products of animal origin.

It is believed that the hygiene of composite products can satisfactorily be assured through the implementation of general hygiene rules, it being understood that in such products the ingredient of animal origin is obtained in accordance with the specific hygiene rules.

c) Approval of establishments

The approval of food-manufacturing and processing establishments is a traditional element of the specific hygiene legislation. It allows the monitoring authorities to ensure that all establishments involved in the manufacture of food of animal origin are operating in accordance with the required hygiene standards. Only establishments which are approved and listed by the competent authorities are allowed to place their products on the market. Such establishments will receive an approval number which must follow the products during marketing.

d) Health marking

The health mark was first introduced with the adoption of the fresh meat Directive (Directive 64/433/EEC). The presence of the health mark on meat is an official recognition that the meat has been produced and inspected in accordance with the prescribed health rules. It may also constitute an element which allows the origin of the meat to be traced back to the establishment of origin (slaughterhouse, cutting plant) through the establishment's approval number, this number being a part of the health mark. This is an important tool for the monitoring authorities for taking action in case health problems occur during the marketing of meat.

With the adoption of other specific health Directives for other products of animal origin, the use of the health mark has been extended for control purposes to these products. However, with the introduction of the systematic registration of food businesses and the fact that each food business must be given a registration number which must follow the product, the need for a health mark for tracing purposes becomes less obvious. In addition, bearing in mind that the primary responsibility for food safety rests with the food business operators, the need for an official recognition of food safety aspects through the approval of establishments and the application of a health mark is less prominent. Further debate is therefore required on the need to maintain the approval and health marking systems as applied at present. In the meanwhile, it is proposed to maintain the principles of health marking for products of animal origin. The situation can be reviewed when other systems for tracing the origin of foodstuffs show more efficient.

e) Detailed requirements

One of the main criticisms of the specific food hygiene legislation in force is that it is too prescriptive, which leads to an over-rigid system not leaving enough flexibility for the manufacturer to develop new techniques. However, during the consultation process it was found that deletion of detail was not a general demand. It seemed a well-accepted principle that specific rules also contain a certain level of detail necessary to ensure the safety of a product and a high level of consumer protection, although existing rules could be simplified.

Where deletion of detail has been implemented to simplify legislation, this has been done with the aim of avoiding repetition, and in certain cases which are justified through the introduction of HACCP procedures. The implementation of HACCP procedures should show whether there is further room for reducing the detailed requirements in future.

Deletion of detail has also been implemented where existing requirements can easily be replaced by codes to good hygiene practices. The further elaboration of such codes must show whether details contained at present in a legally binding context, can be replaced by guidelines contained in the said codes.

It is felt that, in the absence of codes to good hygiene practices and lacking experience on the application of the HACCP principles, an abrupt deletion of detail would create a vacuum leaving a number of food operators in doubt about the correct procedures to be implemented for ensuring a correct level of hygiene.

In some cases, and in order to address the problems linked with recent outbreaks of food-borne diseases, the existing rules have actually been tightened. New measures to reduce carcase contamination have been introduced, such as the need to present clean animals for slaughter, and the obligation to apply evisceration techniques that avoid the spilling of gut contents on the carcase. Recent experience in some Member States and the scientific literature show that such measures help to reduce risks associated with product contamination substantially.

f) Microbiological criteria

With the review of the existing specific legislation, an examination has been undertaken to see to what extent the existing microbiological criteria must be updated. For this reason it has been decided to submit them for re-examination to the scientific committee(s). Pending decisions in this matter, it is proposed that the existing microbiological criteria remain applicable.

g) Temperatures for storage and transport

The specific legislation in force contains different storage and transport temperatures for the different products covered by the specific hygiene legislation.

As is the case for microbiological standards, the justification for differences in storage and transport temperatures for the different commodities needs to be scientifically confirmed. The Scientific Committee has been informed and a working group has been established to examine this question.

h) Small production units

It is felt that small establishments serving the local market or those situated in regions with particular supply constraints do not always need to fulfil all of the structural requirements prescribed and that they can produce safe products under specific rules adapted to this type of production. The present proposals contain, therefore, where necessary, special rules for the infrastructure of such establishments. These special rules must not compromise food safety.

i) Imports from non-member countries

The proposal contains a uniform procedure for organising imports from non-member countries of products of animal origin destined for human consumption. These procedures consist essentially of the following steps:

- audits and/or assessment of the competent authority performance and on-the-spot inspections to verify compliance/equivalence with EU requirements,

- establishment of a list of non-member countries matching EU standards,

- establishment of import conditions and certification requirements for each non-member country,

- establishment of a list of establishments in non-member countries meeting EU standards.

j) Quality and labelling

The present specific hygiene rules contain a number of quality requirements for the products concerned, such as the fat and collagen content of minced meat, the freezing point of milk, etc. At the same time, labelling requirements for these quality aspects exist. Although the importance of these requirements for consumer protection is recognised, it is considered that they have no direct hygiene impact. It must therefore be examined how these elements can be integrated elsewhere in Community legislation. Quality requirements are maintained pending the establishment of more specific rules.

k) Hygiene rules and BSE

The hygiene rules do not specifically address BSE. Safeguard measures for that purpose have been provided for in Commission legislation, and proposals have been made to combat that particular problem. However, with the recast, some rules have been tightened. Some materials have been excluded from the manufacture of products such as mechanically recovered meat. These new measures will bring better guarantees for protection against possible health risks including those posed by BSE. In general however, the proposed rules apply without prejudice to more specific rules for the prevention and control of certain transmissible spongiform encephalopathies.

III. Animal health requirements

The animal health rules are designed to prevent the spread of animal diseases such as swine fever and foot-and-mouth disease through products of animal origin. These rules are contained in the following Council Directives:

Directive 72/461/EEC (fresh meat) Directive 80/215/EEC (meat products) Directive 91/67/EEC (aquatic animal products) Directive 91/494/EEC (poultrymeat) Directive 91/495/EEC (rabbit meat and farmed game meat) Directive 92/45/EEC (game meat) Directive 92/46/EEC (milk and milk products)

As for the hygiene rules, similar observations can be made with regard to the need to recast the animal health rules. Since these rules have no direct impact on consumer health, it has been judged useful to separate the two aspects. A separate proposal for animal health purposes is therefore being presented.

A high level of protection has been maintained in this field, too. The attached proposal elucidates the animal hazards that can occur in products of animal origin and how to eliminate such hazards. The same principles with regard to official controls, Community inspections and imports from non-member countries as for hygiene purposes are proposed.

IV. Official controls

1. Control requirements applicable to all food and feed

Requirements for official controls are already laid down for different sectors such as veterinary public health, animal health, foodstuffs and animal feed. This sectorial approach has lead to a situation whereby requirements of a similar nature are covered in a different way for the different sectors concerned, or that certain aspects are not covered for a particular sector, thus leaving loopholes in legislation. By way of response to this situation and in accordance with the Commission's intentions announced in the White Paper (Action 4 of the Annex to the White Paper), a proposal will be established that lays down the general control principles that must be observed in ensuring that food and feed legislation is complied with. This proposal will cover all aspects related to the official controls for the safety of both feed and foodstuffs and in particular the responsibilities of the official services in the Member States, the action to be taken in the case of risk to the consumer, the training of control officials, the application of contingency plans, controls on imported products, inspections by the Commission, safeguard measures etc.

2. Specific control requirements

Although a number of general control requirements can be laid down for all food, it must not be lost of sight that the specificity of certain products requires the setting of specific control requirements. This is in particular the case for products of animal origin, which present hazards that are very specific to the type of commodity.

Existing detailed inspection procedures such as ante- and post-mortem inspections on meat are of a very technical nature. Some of these procedures have been implemented for over 30 years without major changes. Although they have proven their effectiveness for controlling certain diseases such as tuberculosis and glanders, intensive discussions are taking place to review these traditional inspection procedures so as to address hazards that are linked to modern methods of food production. These discussions are concentrating in particular on the prevention by modern inspection procedures of food-borne infections such as the ones caused by Salmonella sp., E. coli, Listeria, Campylobacter etc, and on the development of a risk based system for controlling other hazards.

In order to enable the Commission to react promptly when these discussions arrive at appropriate results, a separate proposal has been drawn up under which all the detailed inspection procedures are described. While awaiting the result of the scientific assessment, it is proposed that the present rules continue to apply.

V. Future steps

When the present proposals are adopted, the Union will have specific food hygiene legislation which ensures a very high standard with regard to public health protection. It will contain a number of important general requirements, some of which will be new for operators and for the monitoring authorities. A follow-up of the implementation of these requirements should be ensured. Also the development of codes to good hygiene practises constitutes an important element in the evolution of food safety.

It is therefore proposed that the Commission should closely follow this evolution and make a report on the implementation of the self-checking regimes run by operators, on the establishment of codes to good hygiene practises and on the experience in the Member States with inspections and audits for monitoring the correct implementation of these regimes.

The Commission will furthermore be vigilant in following closely all new technical and scientific developments.

It is likely that in the coming years there will be a need to adapt legislation again in function of the elements described above. A revision clause to formalise this intention is inserted.

VI. The external dimension and general considerations

During the last few decades the market for food has changed dramatically. Food and trade have become increasingly international in character, the Community trades in food products with almost every corner of the earth, and our traders are constantly seeking new markets and products in newly emerging economies. With the changing marketplace, there are growing concerns about food safety: potential hazards such as microbiological food contamination and residues of medicinal products or other chemical contaminants may travel with foodstuffs and present new challenges to policymakers to develop adequate systems to safeguard human health. This is reflected in international agreements and obligations, and in an enhanced role for international organisations such as the Codex Alimentarius and the International Office of Epizootics, which have established sanitary standards, recommendations and guidelines for international trade in food.

The Commission's proposals respond to this challenge by introducing requirements with regard to the hygienic quality of imported food taking account of the existing international standards and guidelines.

VII. Food hygiene and the commission's green paper on food law

In the Commission's Green Paper on Food Law of 30.04.1997 (COM(97)176), a number of principles that are of importance in relation to food hygiene have been identified, and interested groups were invited to give their views on these matters. A summary of these comments is given hereunder. These comments show the need to improve Community food hygiene legislation with regard to important questions.

a) Consistency of hygiene rules

The Member States support the steps taken to consolidate and simplify the vertical hygiene Directives and to assess the relationship between these and the general hygiene of foodstuffs covered in Directive 93/43/EEC. Member States agree that the general hygiene Directive should form the basis for hygiene measures for all foodstuffs, regardless of origin, including a requirement for Hazard Analysis and Critical Control Point (HACCP) systems. However, the need for additional detailed requirements where the risk to health from a product necessitates this is also supported.

Most commentators are of the opinion that the Codex Alimentarius Commission's full seven principles of HACCP should be taken as the basis for Community measures, with flexibility for low-risk businesses. Guides to good hygiene practice are seen as a useful tool, particularly for small businesses.

In principle, the non-governmental organisations are in agreement with these comments, advocating a farm-to-table, risk related approach. They agree that the general hygiene Directive and HACCP should form the basis for Community measures, with additional measures where necessary contained in annexes to a single hygiene text.

b) Retail sale

Commentators are in agreement that the provisions of the food hygiene Directive 93/43/EEC are appropriate for the retail sale of food. However, several recommend that the Commission should focus on developing suitable, simple temperature-control provisions for this part of the supply chain.

c) Quality provisions

Most commentators have said that quality aspects should not form part of hygiene legislation, as quality provisions and hygiene have a different aim and should not be addressed in the same instrument. However, several Member States are of the opinion that the quality of foodstuffs is a matter for concern with regard to consumer protection.

Comments from non-governmental organisations agree that quality issues should be removed from the hygiene rules. Quality rules currently contained in hygiene legislation should be reviewed and if necessary put into separate legislation.

d) Safeguard clause

There have been few governmental comments on this subject but all are in favour of an extension. The scope should also apply to products traded within the Community.

e) Controls and enforcement

Member States have sent substantial but differing comments on this subject to the Commission. One country would like the reduction of the current control systems and, in the future, more focus on the suitability and reliability of companies' own control systems. Another wants to see no substitution of the official supervisory control systems on foodstuffs in favour of internal company procedures. One comment especially welcomes the continuing separation of responsibilities between the official controls of national authorities and the Commission. The drawing-up of requirements for quality controls, including a follow-up of controls and the qualifications of staff in charge of controls is requested.

Non-governmental organisations have also commented extensively on controls and enforcement of EU legislation. The separation of responsibilities for control and enforcement between inspections conducted by companies, national authorities and the Commission is welcomed, provided that the respective responsibilities are clearly defined and that the results of controls are made public.

Consumer organisations have asked for more transparency in order to establish mutual confidence.

f) External dimension

All governmental comments are in agreement on the increasing importance of the external dimension in the foodstuffs sector. The Community should play an active role in Codex Alimentarius negotiations.

Non-governmental organisations point out the increasing importance of international developments in the food sector and ask for an effective involvement of the Community.

VIII. Food hygiene and the Commission's White Paper on Food Safety

The proposals joined herewith respond to a number of actions announced in the Annex to the Commission's White Paper on Food Safety (and in particular actions 8 and 28). The recast of existing legislation results in a comprehensive and integrated approach, covering all food from the farm to the point of sale to the consumer. This leads to a better coherence and transparency of food legislation. In addition, the role of the stakeholders in the food chain is better defined. The basic principles of food safety are herewith respected. The Commission believes that, together with the other proposals announced in the White Paper on Food Safety or already tabled, a high level of human health and consumer protection is achieved.

It is also the Commission's intention to ensure that the proposed policies remain dynamic. For that purpose, a number of activities have already been launched to ensure that further risk assessments are undertaken and that the results of these assessments will be introduced in future Community legislation.

IX. The form of the acts

As explained in the Commission's Green Paper on the general principles of food law in the Union, the Commission believes that Community law in the form of regulations presents a number of advantages, such as the guarantee of a uniform application throughout the single market, a better transparency of Community law and the possibility for rapid updating of Community legislation to take account of technical and scientific developments. It is for these reasons that the present proposals are submitted in the form of Regulations.

2000/0180 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down detailed 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],

[1] OJ C ...

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C ...

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C ...

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] OJ C ...

Whereas:

(1) Community legislation lays down the general rules for performing official controls of foodstuffs.

(2) In addition to the general rules, detailed rules must be laid down for official controls on products of animal origin in order to take account of specific animal and public health hazards that may be associated with such products.

(3) Such detailed rules for official controls on products of animal origin must include all aspects which may affect the safety of such products with regard to animal and public health, in particular requirements during the primary production and subsequent handling, manufacture, processing, storage and transport of animals and products, ante-mortem inspections of slaughter animals, animal welfare, post-mortem inspections of slaughtered animals, compliance with hygiene conditions in establishments, the treatment to be applied to products of animal origin in order to eliminate animal health risks and other measures to protect animal and public health.

(4) Official controls must cover those aspects which are most important for protecting animal and public health and be based on the most recent information available on problems which might constitute a hazard to human health.

(5) Official controls should be carried out with the aim of analysing and identifying potential risks to the health of those handling or consuming products of animal origin.

(6) The detailed rules for the organisation of official controls must be based on a proper risk analysis and on the opinion of the Scientific Committee. For that purpose, it is necessary to proceed to a risk assessment of the current ante- and post-mortem inspection procedures; Awaiting the results thereof, the present inspection procedures must remain in place.

(7) It must be ensured that the animal welfare rules are complied with, in particular with regard to humane slaughter of animals.

(8) Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market [5], as last amended by the Act of Accession of Austria, Finland and Sweden, provides that, in order to ensure the free movement of goods within the Community, official checks on products of animal origin must be carried out at the place of dispatch and that spot checks in the Member State of destination can be carried out at the place of destination; In the event of a serious presumption of irregularity however, checks can be carried out while the goods are in transit.

[5] OJ L 395, 30.12.1989, p. 13.

(9) Community legislation on food safety must have a sound scientific basis.To that end, the scientific committees in the field of consumer protection and food safety set up by Commission Decision 97/579/EC [6] must be consulted wherever necessary.

[6] OJ L 237, 28.8.1997, p. 18.

(10) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of council Decision 1999/468/EEC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [7], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision,

[7] OJ L 184, 17.7.1999, p. 23.

HAVE ADOPTED THIS REGULATION:

Article 1

This Regulation lays down the detailed rules for the organisation of official controls with regard to animal health and public health on products of animal origin intended for human consumption.

Article 2

For the purposes of this Regulation, the definitions laid down in

- Council Directive 89/662/EEC concerning veterinary checks in intra-Community trade with a view to the completion of the internal market,

- Council Regulation .../... laying down the animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption,

- European Parliament and Council Regulation .../...on the hygiene of foodstuffs,

shall apply as appropriate.

Article 3

In addition to more general requirements on the official control of foodstuffs laid down in Community legislation, Member States shall ensure that products of animal origin are subject to official controls under this Regulation.

Article 4

In accordance with the procedure referred to in Article 5 and where necessary after having obtained the opinion of the appropriate Scientific Committee, the Commission shall:

(a) amend or supplement the Annexes to this Regulation in order to take account of scientific and technical progress, in particular with regard to the ante- and post-mortem inspection procedures for meat;

(b) adopt any implementing rules needed to ensure uniform implementation of this Regulation;

Article 5

1. The Commission shall be assisted by the Standing Veterinary Committee , instituted by Council Decision 68/361/EEC [8].

[8] OJ L 225, 18.10.1968, p. 23.

2. Where reference is made to this paragraph, the Regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof.

3. The period provided for in Article 5(6) of decision 1999/468/EC shall be 3 months.

Article 6

This Regulation shall enter into force on the date of its publication in the Official Journal of the European Communities.

It shall apply from 1 January 2004

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

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

CONTROL REQUIREMENTS APPLICABLE TO ALL PRODUCTS

1. Official controls shall be carried out on products of animal origin at all stages from primary production up to and including the marketing and in particular:

(a) Controls on farms shall aim to verify compliance with hygiene rules and animal health rules. These controls shall be combined with controls concerning animal welfare, residues and feedstuffs required under Community legislation.

Where hygiene, animal welfare or residue rules are not complied with, or diseases communicable to humans and animals are diagnosed, appropriate action shall be taken.

In the case of slaughter animals, the official service responsible for carrying out ante- and post-mortem inspection at the slaughterhouse shall be informed about any problem occurring at the farm that may have an impact on food safety.

(b) Controls on establishments, to verify or examine compliance with the specific hygiene rules laid down in Regulation ... (laying down specific hygiene rules for food of animal origin) and in particular:

- where appropriate, compliance with the approval conditions,

- the correct use of the health marks or registration numbers,

- the health status of the products,

- compliance with temperature requirements and, where applicable, microbiological requirements,

(c) Without prejudice to the requirements of Council Directive 89/662/EEC, controls during the marketing of products, to verify or examine in particular:

- compliance with the rules on health marking,

- compliance with maintaining of the cold chain,

- where appropriate, the documents accompanying the consignment

(d) Any other control necessary to verify compliance with Community legislation.

2. During official controls,

(a) the operators of establishments, the owner or his representative, as well as persons responsible for the products during marketing must facilitate the controls, ensure suitable conditions and make available any space and facilities needed to ensure a proper control;

(b) the competent authority shall be given free access to establishments and any other infrastructures such as farms, vessels, means of transport, auction halls, etc.

ANNEX II

MEAT INSPECTION

CHAPTER I: REQUIREMENTS APPLICABLE TO ALL MEAT

The official controls shall include ante-mortem and post-mortem inspections of food animals. Ante- and post-mortem inspections shall be carried out in accordance with the procedures described in this Annex pending an opinion of the appropriate Scientific Committee on their review.

I. RESPONSIBILITIES AND FREQUENCY OF CONTROLS

1. Official controls shall be carried out under the supervision and responsibility of the official veterinarian. He may be assisted by auxiliaries placed under his authority and responsibility for carrying out the following activities:

(a) where ante-mortem inspection on the holding is foreseen, collecting information needed by the official veterinarian to assess the health status of the herd or flock of origin and to make a diagnosis;

(b) ante-mortem inspection in the slaughterhouse, provided that the official veterinarian is actually able to supervise the work of the auxiliaries directly on the spot. In this case the auxiliary's role is to make an initial check on the animals and to help with purely practical tasks;

(c) post-mortem inspection, provided that the official veterinarian is actually able to supervise the work of the auxiliaries directly on the spot;

(d) health control of cut and stored meat;

(e) inspection and supervision of approved establishments, means of transport, etc.

2. In order to provide the assistance referred to above, the auxiliaries shall form part of an inspection team under the authority and responsibility of the official veterinarian and must be independent of the establishment being inspected. The competent authority of the Member State concerned shall determine the composition of the inspection team for each establishment in such a way that the official veterinarian is able to supervise the above operations.

3. The frequency of official controls shall be determined on the basis of an assessment of the health risks. Care shall be taken in particular to ensure that:

(a) in slaughterhouses, at least one official veterinarian is present throughout both the ante-mortem and post-mortem inspection; Member States may request a derogation from this requirement to accommodate the needs of small and medium sized slaughterhouses. For that purpose, they shall submit to the Commission a fully documented dossier to justify their request. This dossier shall contain information on the qualifications of the inspectors replacing the official veterinarian, the type of slaughterhouses where they will operate and the conditions under which they will perform inspections. The Commission shall examine the dossier and where appropriate approve the request in accordance with the procedure laid down in Article 5. This approval may include the conditions under which this derogation may be applied.

(b) in cutting plants, a member of the inspection team is present at least once a day when meat is being worked on;

(c) in approved cold stores and re-packaging centers, a member of the inspection team is regularly present.

4. Detailed rules governing the assistance referred to above shall be adopted if necessary, in accordance with the procedure referred to in Article 5.

II. ANTE-MORTEM HEALTH INSPECTION

1. Before slaughter, animals must undergo an ante-mortem inspection. Sufficient lighting must be available.

2. Where provided for in this Regulation, the ante-mortem inspection shall be carried out at the holding of provenance of the animals.

3. The inspection must determine, in particular, whether:

(a) the animals are properly identified and do come from a holding or an area subject to a movement prohibition for reasons of animal health, unless permitted under Community law.,

(b) the animals are suffering from a disease transmissible to humans or animals, show symptoms of such a disease or are in a general condition indicating that such a disease may occur,

(c) the animals show symptoms of a disease or a disorder affecting their general condition which may make their meat unfit for human consumption,

(d) animal welfare rules have been complied with,

(e) animals presented for slaughter are clean; if they are not clean, the official veterinarian shall give appropriate instructions to ensure that the animals are made clean or to prevent otherwise the meat being contaminated during the slaughter operations,

(f) the animals come from a holding or area subject to a animal or public health restriction,

(g) other conditions which might adversely affect human or animal health are present,

(h) rules on the use of veterinary medicinal products have been complied with.

4. Animals

- suffering from a notifiable animal disease or a disease transmissible to animals or humans,

- showing signs that they have had substances administered to them or have consumed substances which may make their meat harmful to human health,

may not be slaughtered for human consumption. Such animals must be killed separately and their meat hygienically disposed of.

5. The slaughter of animals suspected of suffering from a disease or showing signs of conditions which may adversely affect human or animal health, must be deferred. These animals must undergo, where necessary, detailed examination in order to make a diagnosis. Where post-mortem inspection is necessary in order to make a diagnosis the veterinarian may decide that the animals are to be slaughtered separately or after the normal slaughtering process. Those animals must undergo a post-mortem inspection supplemented, if necessary, by sampling and laboratory examinations.

6. The slaughter of animals under a specific scheme for the eradication or control of a specific disease such as brucellosis or tuberculosis or other zoonotic agents such as salmonellosis must be carried out under the conditions imposed by and the direct supervision of the official veterinarian.

III. POST-MORTEM HEALTH INSPECTION

1. Slaughtered animals must be submitted without delay to a post-mortem health inspection in accordance with scientific rules. This inspection shall include, in particular:

(a) a visual inspection of the slaughtered animal and its organs with a view to detecting visible contamination or other defects;

(b) palpation and, where judged necessary by the official veterinarian, incision of those parts of the animal which have undergone any change or are suspect for any other reason;

(c) organoleptic examination;

(d) where necessary, laboratory tests, in particular to reveal the presence of agents of zoonotic diseases;

(e) any measure deemed necessary to check compliance with Community rules on the use of veterinary medicinal products and other chemical substances used during farming and on residues.

2. Where necessary in order to make a diagnosis or further investigations, the official veterinarian may request that the slaughter process be slowed down or halted.

3. Where the ante-mortem or post-mortem inspection reveals a condition likely to affect human or animal health the official veterinarian may ask for the requisite laboratory tests to be carried out if he considers them necessary to substantiate his diagnosis or to detect substances with pharmacological action likely to be present given the pathological condition observed.

Where any doubt remains, further cuts and inspections must be made until a definitive diagnosis can be reached.

4. Lymphnodes requiring incision must be systematically subjected to multiple incisions and a visual inspection.

5. During the inspection precautions must be taken to ensure that meat is not contaminated by actions such as palpation, cutting or incision.

IV. EMERGENCY SLAUGHTER

The meat of animals that have undergone emergency slaughter must, in addition to the normal post-mortem inspection, undergo sampling for further examination or any other examination considered necessary.

V. DECISION FOLLOWING HEALTH INSPECTIONS

1. Following ante-mortem and post-mortem inspection, the following shall be declared unfit for human consumption:

(a) meat from

- animals affected by one of the diseases subject to animal-health restrictions, unless procedures have been introduced under the Community rules to eliminate any animal-health risk;

- cachectic animals;

- animals slaughtered too young;

(b) meat found to exhibit:

- cachexia;

- generalised infectious disease;

- septicaemia, pyaemia, toxaemia or viraemia;

- the presence of residues of prohibited substances or residues in excess of permitted Community levels;

- malignant or multiple tumours;

- multiple abscesses;

- serious injuries in different areas of the carcase or in different viscera;

- insufficient bleeding;

- extensive blood or serum infiltration;

- widespread subcutaneous or muscular parasitic infestation;

- ecchymosis;

- where appropriate, organoleptic anomalies;

- anomalies in consistency, particularly oedema or severe emaciation;

- widespread lesions, soiling or contamination;

(c) parts of a slaughtered animal which show localised lesions, contamination or inflammation not affecting the health of the rest of the meat;

(d) the blood of an animal whose meat has been declared unfit for human consumption in accordance with the preceding points, and blood contaminated by stomach contents or any other substance;

(e) carcases the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this Regulation;

(f) the carcases of animals suffering from any other condition which may constitute a public health danger according to the professional opinion of the official veterinarian.

The official veterinarian can give instruction that the meat can only be used for a particular purpose such as processing.

VI. COMMUNICATION OF INSPECTION RESULTS

The official veterinarian shall record the results of the ante-and post-mortem inspections. If inspection reveals the presence of a disease or condition which might affect public or animal health, or of residues, this information shall be communicated to the competent authority responsible for supervising the holding of provenance of the animals, and to the person responsible for the animals concerned. Following such communication, immediate action must be taken to remedy the situation.

VII. PROFESSIONAL QUALIFICATIONS OF AUXILIARIES

1. Only persons who have passed a test organised by the competent authority of the Member States may be appointed as auxiliaries.

2. Only candidates who prove that they have:

(a) followed at least 400 hours of theoretical training, including laboratory demonstrations, and

(b) received at least 200 hours of practical training

shall be eligible for the above test. The practical training shall take place in slaughterhouses, cutting plants, cold stores and at inspection posts for meat or, in the case of ante-mortem inspection, on a holding.

3. The tests for auxiliaries shall consist of a theoretical part and a practical part and shall cover the following subjects:

(a) for the inspection of holdings:

(i) theoretical part:

- familiarity with the farming industry - organisation, economic significance, production methods, international trade, etc.,

- anatomy and pathology,

- basic knowledge of diseases - viruses, bacteria, parasites, etc.,

- monitoring for disease, use of medicines and vaccines, residue testing,

- hygiene and health inspection,

- animal welfare on the farm, during transport and at the slaughterhouse,

- environmental requirements - in buildings, on farms and in general,

- national and international rules,

- consumer concerns and quality control;

(ii) practical part:

- visits to farms of different types and using different rearing methods,

- visits to production establishments,

- loading and unloading of means of transport,

- visits to laboratories,

- veterinary checks,

- documentation,

- practical experience;

(b) for inspection at slaughterhouses:

(i) theoretical part:

- 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,

- basic knowledge of hygiene, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work and the control of the HACCP system,

- knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat,

- knowledge of the laws, regulations and administrative provisions relating to their work,

- sampling procedures;

(ii) practical part:

- identification of animals,

- inspection and assessment of slaughtered animals,

- identification of animal species by examination of typical parts of the animal,

- identification of a number of parts of slaughtered animals in which changes have occurred, and comments thereon,

- post-mortem inspection in a slaughterhouse,

- hygiene control, including the control of the HACCP system,

- sampling,

- identification of meat.

VIII. OTHER RESPONSIBILITIES DURING INSPECTIONS

Owners or persons responsible for the animals must co-operate with the officials carrying out ante- and post-mortem inspections. They must provide access to the animals, meat and relevant documentation, in a condition suitable for inspection. They must provide additional assistance at the request of the official veterinarian or auxiliary. Where they fail to cooperate as requested, the inspection shall be suspended until they consent to do so to the extent required for the inspection.

CHAPTER II: MEAT OF DOMESTIC UNGULATES

In addition to the common requirements, the following requirements shall apply:

I. ANTE-MORTEM HEALTH INSPECTION

Where the ante-mortem inspection is carried out at the slaughterhouse, the animals must undergo such inspection 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

II. POST- MORTEM HEALTH INSPECTION

1. Post-mortem inspections shall include, where necessary:

- incision of certain organs and lymph nodes and, depending on the conclusions reached during the inspection, the uterus;

- a visual inspection or palpation. Where such inspection indicates that the animal has lesions which could contaminate the carcases, equipment, staff or premises, such organs may not be incised in the slaughter-room or any other part of the establishment where meat could be contaminated;

2. Inspections must proceed as follows:

A. Bovine animals over six weeks old

(a) 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.

(b) inspection of the trachea; visual examination and palpation of the lungs and oesophagus; 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;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

(e) 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;

(f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and the peritoneum;

(j) visual inspection of the genital organs;

(k) 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.

B. Bovine animals under six weeks old

(a) visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn retropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal of the tonsils;

(b) 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;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

(e) 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;

(f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) 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.

C. Swine

(a) visual inspection of the head and throat; incision and examination of the submaxillary lymph nodes (Lnn mandibulares); visual inspection of the mouth, fauces and tongue;

(b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

(e) visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes;

(f) visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) visual inspection of the genital organs;

(k) visual inspection of the udder and its lymph nodes (Lnn. supramammarii); incision of the supramammary lymph nodes in sows;

(l) visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened.

D. Sheep and goats

(a) 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;

(b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales); in the event of doubt, these organs and lymph nodes must be incised and examined;

(c) visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;

(d) visual inspection of the diaphragm;

(e) visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;

(f) visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(k) visual inspection of the udder and its lymph nodes;

(l) visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened.

E. Domestic solipeds

(a) visual inspection of the head and, after freeing the tongue, the throat; palpation and, if necessary, incision of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei). The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined and palpated. The tonsils must be removed;

(b) 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;

(c) 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;

(d) visual inspection of the diaphragm;

(e) visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales);

(f) 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;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) visual inspection of the genital organs of stallions and mares;

(k) visual inspection of the udder and its lymph nodes (Lnn. supramammarii) and, if necessary, incision of the supramammary lymph nodes;

(l) visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened;

(m) 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.

III. SPECIAL CONTROLS

A. TRICHINOSIS

Meat from porcine animals (domestic, farmed game and wild game) and solipeds shall either be submitted to an examination to detect the possible presence of trichinae (Trichinella spp) or undergo a cold treatment.

B. CYSTICERCOSIS IN SWINE AND CATTLE

Examination for Cysticercus bovis and Cysticercus cellulosae shall include an examination of the parts of the animal likely to be infested.

After removal of parts unfit for human consumption, meat from animals with non-generalised infestation must undergo a cold treatment.

C. GLANDERS IN SOLIPEDS

Examination for glanders in solipeds shall include a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum.

The following shall be established in accordance with the Standing Veterinary Committee procedure, and after the Scientific Committee has given its opinion:

(a) the methods to be applied when examining for the conditions referred to in this heading;

(b) the cold treatment to be applied to meat in the case of trichinosis and cysticercosis;

(c) the conditions under which derogations can be granted to the regions of the Community shown by epidemiological studies to be free of trichinosis or glanders.

IV. DECISION TO DECLARE MEAT UNFIT FOR HUMAN CONSUMPTION FOLLOWING ANTE-MORTEM AND POST-MORTEM INSPECTION

1. In addition to the cases provided for in Chapter I(V), the following shall be declared unfit for human consumption:

(a) meat from animals:

(i) in which one of the following conditions has been diagnosed:

- generalised actinobacillosis or actinomycosis,

- blackleg and anthrax,

- generalised tuberculosis,

- generalised lymphadenitis,

- glanders,

- rabies,

- tetanus,

- acute salmonellosis,

- acute brucellosis,

- swine erysipelas,

- botulism;

(ii) showing acute lesions of broncho-pneumonia, pleurisy, peritonitis, metritis, mastitis, arthritis, pericarditis, enteritis or meningo-encephalomyelitis confirmed by a detailed inspection, possibly supplemented by a bacteriological examination and an investigation for residues of substances with a pharmacological effect. However, when the results of these special examinations are favourable, the carcases shall be declared fit for human consumption after the parts unfit for human consumption have been removed;

(iii) affected by the following parasitic diseases: generalised sarcocystosis, generalised cysticerosis, trichinosis;

(iv) which are dead, stillborn or unborn;

(v) which have been slaughtered too young, and the meat of which is oedematous;

(vi) showing clinical signs of emaciation or advanced anaemia;

(vii) which have produced a positive or inconclusive reaction to tuberculin and in which the post-mortem inspection has revealed localised tuberculous lesions located in a number of organs or areas of the carcase. However, when a tuberculous lesion has been found in the lymph nodes of the same organ or part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes shall be declared unfit for human consumption;

(viii) which have reacted positively or inconclusively to brucellosis confirmed by lesions indicating acute infection. Even where no such lesion has been found, the udder, genital tract and blood must nevertheless be declared unfit for human consumption;

(b) parts of carcases showing signs of major serous or haemorrhagic infiltrations, localised abscesses or localised contamination;

(c) offal and viscera with pathological lesions of infectious, parasitic or traumatic origin;

(d) where a carcase or offal is affected with caseous lymphadenitis or any other suppurative condition but that condition is not generalised or associated with emaciation:

(i) any organ and its associated lymph node, if the condition concerned exists on the surface or in the substance of that organ or lymph node;

(ii) in any cases where (i) does not apply, the lesion and such of the surrounding parts as appropriate having regard to the age and degree of activity of the lesion, on the understanding that an old, firmly encapsulated lesion may be regarded as inactive;

(e) meat resulting from trimming of the sticking point;

(f) the liver and kidneys of animals more than two years old from regions where plans implemented under Article 5 of Directive 96/23/EC have revealed the generalised presence of heavy metals in the environment;

(g) meat which gives off a pronounced sexual odour.

2. The following must bear a special mark and be processed:

(i) meat from male pigs used for breeding;

(ii) meat from uncastrated male pigs, cryptorchid and hermaphrodite pigs with a carcase weight of more than 80 kg, except where the establishment is able to guarantee that carcases giving off a pronounced boar taint may be detected, using a method recognised in accordance with the Standing Veterinary Committee procedure or, in the absence of such a method, one recognised by the competent authority concerned.

V. SPECIAL CONDITIONS FOR LOW CAPACITY SLAUGHTERHOUSES

(a) Slaughterhouse situated in regions suffering from special geographical constraits or affected by supply difficulties and slaughterhouses supplying meat locally must notify the veterinary service of the time of slaughter and the number and provenance of the animals, so that the ante-mortem inspection can be carried out either on the farm or immediately prior to slaughter at the slaughterhouse;

(b) The official veterinarian or an auxiliary must carry out the post mortem inspection of the meat. Where the meat has lesions or appears to have deteriorated, the post-mortem inspection must be carried out by the official veterinarian. The official veterinarian or the auxiliary under his responsibility must regularly verify compliance with the hygiene rules laid down in this Regulation.

CHAPTER III: POULTRYMEAT

In addition to the common requirements, the following requirements shall apply:

I. ANTE-MORTEM INSPECTION

1. Slaughter of a flock of poultry from a holding may be authorised only when:

(a) either the birds intended for slaughter have been submitted to an ante-mortem inspection at the holding and are accompanied by the health certificate provided for in point V,

(b) or, 24 to 72 hours before the arrival of the birds at the slaughterhouse, the official veterinarian is in possession of a document to be established by the competent authority containing:

- relevant up-to-date information regarding the flock of provenance, in particular details taken from the holding's records covering the type of poultry slaughtered,

- proof that the holding of origin is under the supervision of a veterinarian responsible for the health at the farm.

This information must be assessed before deciding what measures are to be taken with respect to birds coming from the holding concerned, particularly the type of ante-mortem inspection required.

Where the conditions laid down in (a) or (b) above are not met, it may be decided:

- either to postpone slaughter until the holding of origin has been inspected with a view to obtaining the required information,

- orto authorise slaughter after carrying out the tests provided for in (2)(b) below.

Any costs incurred as a result of the application of this paragraph shall be charged to the farmer in accordance with rules to be adopted by the competent authority.

However, in the case of farmers with an annual production of not more than 20 000 domestic fowl, 15 000 ducks, 10 000 turkeys, 10 000 geese, or an equivalent number of another species of poultry, the ante-mortem inspection may be carried out at the slaughterhouse. In that case, the farmer must provide a statement to the effect that his annual production does not exceed the said numbers.

2. The ante-mortem inspection on the farm of provenance shall comprise:

(a) checking the farmer's records or documentation;

(b) additional examination to determine whether the birds:

(i) are suffering from a disease transmissible to humans or animals or are behaving, individually or collectively, in a manner indicating that such a disease may occur;

(ii) show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption;

(c) regular sampling of water and feed to check compliance with withdrawal periods;

(d) tests for zoonotic agents.

3. Where there is doubt as to the identity of a consignment of poultry and the birds are to undergo ante-mortem health inspection at the slaughterhouse, the official veterinarian must examine each crate where the birds show symptoms as referred to in point 2(b) of this Chapter.

4. Where the birds are not slaughtered within three days of the issue of the health certificate provided for in point 1(a):

- where the birds have not left the holding of origin, a new health certificate must be issued,

- where the birds are already at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided a new health certificate is issued, or the birds are re-examined.

5. In the case of clinically healthy poultry from a flock which must be slaughtered under a programme for the control of infectious disease or a zoonotic disease, the birds must be slaughtered at the end of the day or under conditions such that other poultry are not contaminated.

If the animals of such a flock show clinical symptoms of the following diseases:

(a) ornithosis;

(b) salmonellosis,

their slaughter for human consumption shall be prohibited.

Slaughter is authorised at the end of the normal slaughter process provided precautions are taken to keep to a minimum the risk of spreading bacteria and to clean and disinfect the facilities after slaughter. The meat of such birds must be handled in the same way as meat declared unfit for human consumption.

6. In slaughterhouses situated in regions suffering from special geographical constraints or affected by supply difficulties, or in those serving the local market, the following rules must be complied with.

(a) Slaughterhouses must notify the veterinary service of the time of slaughter and the number and origin of the birds.

(b) The official veterinarian or an auxiliary must be present at the time of slaughter. Where this is not possible the meat may not leave the establishment until the post-mortem inspection has been carried out. The official veterinarian or the auxiliary under his responsibility must regularly monitor compliance with the hygiene rules.

(c) The competent authority must monitor the distribution chain of meat from the establishment and ensure that products declared unfit for consumption are appropriately marked, used and disposed of.

II. POST-MORTEM INSPECTION

1. As part of the post-mortem inspection, the official veterinarian must:

(a) inspect the viscera and body cavities of a representative number of birds from each batch of birds from the same origin;

(b) subject to a detailed inspection a random sample of birds the meat of which was declared unfit for human consumption following the post-mortem health inspection;

(c) carry out any further investigations deemed necessary where there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.

2. In the case of partly-eviscerated birds the intestines of which are removed immediately (effilé), the viscera and the body cavities of a representative number of birds from each batch shall be inspected after evisceration. Where such inspection reveals anomalies in a number of birds, all the birds in the consignment shall be inspected in accordance with point 1.

3. In the case of deferred evisceration:

(a) the post-mortem health inspection referred to in point 1 shall take place at the latest fifteen days after slaughter, during which period the poultry must be stored at a temperature below 4°C;

(b) not later than the end of this period, evisceration must take place at an establishment approved for that purpose. In such cases, the carcases must be accompanied by the health certificate under point VI;

(c) the poultry meat must not bear the health mark before the evisceration referred to in point (b) has been performed.

III. DECISION TO DECLARE MEAT UNFIT FOR HUMAN CONSUMPTION FOLLOWING THE POST-MORTEM INSPECTION

In addition to the cases provided for in Chapter I(V), poultrymeat must be declared unfit for human consumption where the post-mortem inspection reveals any of the following:

- systematic mycosis and local lesions in organs suspected of having been caused by pathogenic agents transmissible to humans or their toxins,

- cachexia,

- extensive mechanical lesions, including those due to extensive scalding,

- ascites,

- extensive subcutaneous or muscular parasitic infestation and systematic parasitism.

IV. TECHNICAL ASSISTANCE

The competent authority may permit the members of staff of the undertaking to carry out technical operations related to inspection under the direct supervision of the official veterinarian provided they have received special training from the official veterinarian. The general criteria for such training shall be laid down in accordance with the procedure referred to in Article 5.

V. SPECIMEN HEALTH CERTIFICATE

HEALTH CERTIFICATE*

for poultry transported from the holding to the slaughterhouse

Competent service: No** :

1. Identification of birds

Species:

Number of birds:

2. Provenance of birds

Address of holding of origin:

Identification of poultry house:

3. Destination of birds

The birds will be transported to the following slaughterhouse:

by the following means of transport:

4. Declaration

I, the undersigneddeclare that the birds described above were examined before slaughter at the above-mentioned holding at (time) ....... on (date) ....... and were found to be healthy.

Done at ....................................., on ...............................................

(Place) (Date)

Stamp

.................................................. (Signature of veterinarian)

VI. SPECIMEN HEALTH CERTIFICATE

HEALTH CERTIFICATE

for poultry intended for the production of foie gras, stunned, bled and plucked at the fattening holding and transported to a cutting plant equipped with a separate room for evisceration

Competent service: No*:

1. Identification of uneviscerated carcases

Species:

Number:

2. Provenance of uneviscerated carcases

Address of fattening holding:

3. Destination of uneviscerated carcases

The uneviscerated carcases will be transported to the following cutting plant:

4. Declaration

I, the undersigned declare that the uneviscerated carcases described above are of birds which were examined before slaughter on the above-mentioned fattening holding at (time) ....... on ....... (date) and found to be healthy.

Done at ....................................., on ...............................................

(Place) (Date)

Stamp

.................................................. (Signature of veterinarian)

CHAPTER IV: MEAT FROM FARMED LAGOMORPHS

As a general rule, the requirements applicable to poultrymeat shall apply mutatis mutandis. However, where the ante-mortem inspection is not carried out at the holding of origin, the animals must undergo such inspection within 24 hours of arrival at the slaughterhouse. Where more than 24 hours elapse between the ante-mortem inspection and slaughter, the animals must be re-inspected immediately before slaughter.

CHAPTER V: FARMED GAME MEAT

In addition to the common requirements, the following requirements shall apply:

I. ANTE-MORTEM HEALTH INSPECTIONS

1. Ante-mortem inspection must be carried out either at the slaughterhouse or at the holding of provenance before slaughter at the holding or transportation to the slaughterhouse. In the latter case, the ante-mortem inspection at the slaughterhouse may be restricted to detecting injuries sustained during transport. In addition, the identification of the animals must be checked.

Live animals inspected at the holding must be accompanied by a certificate drawn up in accordance with the specimen in point III stating that the animals were inspected at the holding and found healthy.

2. Where the ante-mortem inspection is not carried out at the holding of provenance, the animals must undergo such inspection within 24 hours of arrival at the slaughterhouse. The animals must be re-inspected immediately before slaughter where more than 24 hours elapse between the ante-mortem inspection and slaughter.

Each animal or batch of animals sent for slaughter must be identified to enable the competent authority to determine its provenance.

II. POST-MORTEM HEALTH INSPECTION

Meat from species susceptible to trichinosis must be examined for the presence of trichinae.

III. SPECIMEN HEALTH CERTIFICATE

HEALTH CERTIFICATE

for live farmed game transported from the holding to the slaughterhouse

Competent service: No*:

I. Identification

Species of animal:

Number of animals:

Identification marking:

II. Provenance of animals

Address of holding of origin:

III. Destination of animals

These animals are being transported to the following slaughterhouse:

by the following means of transport:

IV. Declaration

I, the undersigned hereby declare that the animals described above underwent an ante-mortem inspection at the above holding on ....... (date) at ....... (time) and were found to be healthy.

Done at ....................................., on ...............................................

(Place) (Date)

Stamp

.................................................. (Signature of veterinarian)

CHAPTER VI: WILD GAME MEAT

In addition to the common requirements, the following requirements shall apply:

I. POST MORTEM HEALTH INSPECTION

1. Wild game must be inspected as soon as possible after admission to the game processing house.

2. During post-mortem inspection, the official veterinarian must carry out:

(a) a visual examination of the carcase, its cavities and where appropriate organs with a view to:

- detecting any abnormalities. For this purpose, the diagnosis may be based on any information provided by the hunter 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;

(b) an investigation of organoleptic abnormalities,

(c) palpation of organs, where necessary;

(d) an analysis of residues including environmental contaminants by sampling, where there are serious grounds for suspecting the presence of residues or contaminants. Where 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 which are suspected of showing the same abnormalities;

(e) examination for characteristics indicating that the meat presents a health risk, including:

(i) abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter;

(ii) the generalised presence of tumours or abscesses affecting different internal organs or muscles;

(iii) arthritis, orchitis, changes in the liver or the spleen, inflammation of the intestines or the umbilical region;

(iv) the presence of foreign bodies in the body cavities, stomach or intestines or in the urine, where the pleura or peritoneum are discoloured;

(v) formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs;

(vi) significant abnormalities of colour, consistency or odour of muscle tissue or organs;

(vii) aged open fractures;

(viii) emaciation and/or general or localised oedema;

(ix) recent pleural or peritoneal adhesions;

(x) other obvious extensive changes, such as putrefaction.

3. Where the official veterinarian so requires, the spinal column and the head must be split lengthwise.

4. In the case of small wild game not eviscerated immediately after killing, the official veterinarian must carry out a post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a disease transmissible to man or defects as referred to in point 2, the veterinarian must carry out more checks on the entire batch to determine whether it must be declared unfit for human consumption or whether each carcase must be inspected individually.

5. In the event of doubt, the official veterinarian may perform any further cuts and inspections of the relevant parts of the animals necessary to reach a final diagnosis.

6. In the case of wild boar or other species susceptible to trichinosis, several samples of meat from each animal must be analysed. Samples must be taken at least from the jaw and diaphragmatic muscles, the muscles of the lower front leg, the intercostal muscles and the tongue muscles. The samples must be analysed using methods approved in accordance with the procedure referred to in Article 5 and on the basis of an opinion from the Scientific Veterinary Committee.

II. DECISION TO DECLARE MEAT UNFIT FOR HUMAN CONSUMPTION FOLLOWING INSPECTION

In addition to the cases provided for in Chapter I(V), the following wild game meat shall be declared unfit for human consumption:

- meat presenting lesions, except for recent lesions due to killing, and localised malformations or abnormalities, insofar as these render the meat unfit for human consumption or dangerous to human health,

- meat presenting characteristics as listed in point I(2)(e) of this Chapter during post-mortem inspection,

- meat in which trichinosis is detected,

- meat showing anomalies which may render it unfit for human consumption.

ANNEX III

LIVE BIVALVE MOLLUSCS

1. The competent authority must fix the location and the boundaries of production areas for bivalve molluscs. The areas from which harvesting of bivalve molluscs is authorised must be classified by the competent authority in three categories according to the level of the faecal contamination as follows:

(a) Class A areas: areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the requirements of point IV of this Section.

(b) Class B areas: areas from which live bivalve molluscs may be collected, but only placed on the market for human consumption after treatment in a purification centre or after relaying.

(c) Class C areas: areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period (at least two months).

2. In order to determine the faecal contamination level of an area, the competent authority must:

- make an inventory of the sources of pollution from 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,

- 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.

3. The public-health control arrangements must include the periodic monitoring of live bivalve mollusc relaying and production areas in order to:

(a) prevent any malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b) check the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;

(c) check for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;

(d) check for the presence of chemical contaminants, maximum permitted levels of which shall be fixed in accordance with the procedure referred to in Article 5.

For the purposes of (b), (c) and (d) above, sampling plans must be drawn up for carrying out such checks at regular intervals or on a case-by-case basis where harvesting periods are irregular.

4. Sampling plans for production and relaying areas must take particular account of:

(a) likely variations in faecal contamination;

(b) possible variations in the presence of plankton containing marine biotoxins. Sampling must be carried out as follows:

(i) monitoring plankton: periodic sampling to detect changes in the composition of the plankton containing toxins and the geographical distribution thereof. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling, by increasing the number of sampling points and number of samples taken in growing and fishing waters, and

(ii) periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.

Molluscs from the area concerned may not be placed on the market until further sampling has yielded satisfactory toxicity test results;

(c) possible contamination of the molluscs;

If sampling shows that placing live bivalve molluscs on the market may constitute a hazard to human health, the competent authority must close the production area from which the contaminated molluscs originated until the situation has been remedied.

5. The competent authority shall monitor production areas where the harvesting of bivalve molluscs is forbidden or subject to special conditions, to ensure that products harmful to human health are not placed on the market.

6. A control system must be set up comprising laboratory tests to verify compliance with the requirements for the end product, in particular to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.

7. The competent authority must:

(a) establish and keep up-to-date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Section.

This list must be communicated to interested parties affected by this Section, such as producers, gatherers and operators of purification centres and dispatch centres.

(b) immediately inform the interested parties affected by the present Section, and in particular the producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of the production area, or its closure, be it temporary or final.

ANNEX IV

FISHERY PRODUCTS

In addition to the common control requirements, the following shall apply:

1. Official controls on fishery products shall be carried out at the time of landing or before first sale at an auction or wholesale market.

2. Official controls shall include:

(a) Organoleptic surveillance testing.

Random checks must be carried out to check compliance with the freshness criteria laid down in Community legislation. Where there is doubt as to the freshness of the products, the organoleptic examination must be repeated.

(b) Chemical analysis.

Where 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 TVB-N (Total Volatile Basic Nitrogen).

The TVB-N levels shall be specified for each category of species in accordance with the procedure referred to in Article 5;

Where the organoleptic examination gives cause to suspect the presence of other conditions which may affect human health, samples may be taken for verification purposes.

(c) Surveillance testing for histamine to verify compliance with the permitted levels laid down in Community legislation.

(d) Surveillance testing for contaminants.

Monitoring arrangements shall be set up to control the levels in fishery products of contaminants such as heavy metals and organochlorinated substances present in the aquatic environment.

(e) Microbiological checks, where necessary.

(f) Surveillance testing to verify compliance with Community legislation on endo-parasites.

Where necessary, the following shall be established in accordance with the procedure referred to in Article 5, after an opinion has been given by the Scientific Committee:

- freshness criteria for the organoleptic evaluation of fishery products, in particular where such criteria have not been established under existing Community legislation,

- the analytical limits, methods of analysis and sampling plans to be used for performing the official checks referred to above.

3. The following shall be declared unfit for human consumption:

(a) fishery products which the organoleptic, chemical, physical or microbiological checks show are not fit for human consumption;

(b) fish or parts of fish which have not been properly examined to detect endo-parasites in accordance with Community legislation;

(c) fishery products which contain in their edible parts contaminants present in the aquatic environment, such as heavy metals and organochlorinated substances, at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans;

(d) poisonous fish and fishery products containing biotoxins;

(e) fishery products or parts thereof considered dangerous to human health.

ANNEX V

MILK AND MILK PRODUCTS

In addition to the common control requirements, the following shall apply:

Inspection of holdings.

Raw milk must come from holdings which are checked by the competent authorities of the Member State to verify compliance with the animal and public health conditions for milk production. The frequency of such checks must be proportionate to the risk. These inspections may be combined with checks carried out under other Community provisions.

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