Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down specific hygiene rules for food of animal origin

(presented by the Commission)

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.

2000/0179 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down specific hygiene rules for food of animal origin

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission [1],

[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) European Parliament and Council Regulation ......(on the hygiene of foodstuffs) lays down the basic hygiene rules to be respected by food operators in order to ensure food safety.

(2) Certain food may present specific hazards to human health requiring the setting of specific hygiene rules in order to ensure food safety.

(3) This is in particular the case for food of animal origin in which microbiological and chemical hazards have frequently been reported.

(4) In the context of the common agricultural policy, specific health rules affecting the production and placing on the market of products included in the list contained in Annex I to the Treaty have already been established.

(5) These health rules have ensured that barriers to trade for the products concerned were removed, thus contributing to the creation of the internal market, whilst ensuring a high level of protection of public health.

(6) These specific rules are contained in a large number of Directives and in particular in:

- Council Directive 64/433/EEC of 26 June 1964, on health conditions for the production and marketing of fresh meat [5], as last amended by Directive 95/23/EC [6],

[5] OJ 121, 29.7.1964, p. 2101/64.

[6] OJ L 243, 11.10.1995, p. 7.

- Council Directive 71/118/EEC of 15 February 1971, on health problems affecting the production and placing on the market of fresh poultry meat [7], as last amended by Directive 97/79/EC [8],

[7] OJ L 55, 8.3.1971, p. 23.

[8] OJ L 24, 30.1.1998, p. 31.

- Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (Trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine [9], as last amended by Directive 94/59 [10],

[9] OJ L 26, 31.1.1977, p. 8.

[10] OJ L 315, 8.12.1994, p. 18.

- Council Directive 77/99/EEC of 21 December 1976, on health problems affecting the production and marketing of meat products and certain other products of animal origin [11], as last amended by Directive 97/76/EC [12],

[11] OJ L 26, 31.1.1977, p. 85.

[12] OJ L 10, 16.1.1998, p. 25.

- Council Directive 89/437/EEC of 20 June 1989, on hygiene and health problems affecting the production and the placing on the market of egg products [13], as last amended by Directive 96/23/EC,

[13] OJ L 212, 22.7.1989, p. 87.

- Council Directive 91/492/EEC of 15 July 1991, laying down the health conditions for the production and the placing on the market of live bivalve molluscs [14], as last amended by Directive 97/79/EC,

[14] OJ L 168, 24.9.1991, p. 1.

- Council Directive 91/493/EEC of 22 July 1991, laying down the health conditions for the production and the placing on the market of fishery products [15], as last amended by Directive 97/79/EC;

[15] OJ L 268, 24.9.1991, p. 15.

- Council Directive 91/495/EEC of 27 November 1990, concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat [16], as last amended by the act of accession of Austria, Finland and Sweden,

[16] OJ L 268, 24.9.1991, p. 41.

- Council Directive 92/45/EEC of 16 June 1992, on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat [17], as last amended by Directive 97/79/EC,

[17] OJ L 268, 14.9.1992, p. 35.

- Council Directive 92/46/EEC of 16 June 1992, laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products [18], as last amended by Directive 96/23/EC,

[18] OJ L 268, 14.9.1992, p. 1.

- Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(1)(a)(i) of Directive 91/493/EEC [19],

[19] OJ L 187, 7.7.1992, p. 41.

- Council Directive 92/118/EEC laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC [20], as last amended by Directive 97/79/EC,

[20] OJ L 62, 15.3.1993, p. 49.

- Council Directive 94/65/EC of 14 December 1994, laying down the requirements for the production and placing on the market of minced meat and meat preparations [21].

[21] OJ L 368, 31.12.1994, p. 10.

(7) With regard to public health, these Directives contain common principles such as those related to the responsibilities of manufacturers of products of animal origin, the obligations of the competent authorities, the technical requirements for the structure and operation of establishments handling products of animal origin, the hygiene requirements which must be complied with in these establishments, the procedures for the approval of establishments, the conditions for storage and transport, the health marking of the products, etc...

(8) Many of these principles are the same as the principles laid down in Regulation......(on the hygiene of foodstuffs) which serve as a common basis for all food.

(9) This common basis allows simplifying the Directives referred to above.

(10) These specific rules can be further simplified by eliminating possible inconsistencies which have arisen at the time of their adoption.

(11) With the introduction of the HACCP procedure, food operators must develop methods to control and reduce or eliminate biological, chemical or physical hazards.

(12) The above elements lead to a complete recasting of the specific hygiene rules and to more transparency.

(13) The principle objective of the recasting of the general and specific hygiene rules is to ensure a high level of consumer protection with regard to food safety.

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

(15) The primary production, the transport of animals, the slaughter and processing facilities up to the point of sale at the retailers level must be considered as interacting entities where animal health, animal welfare and public health are intertwined.

(16) This requires adequate communication between the different stakeholders along the food chain.

(17) Microbiological criteria, targets and/or performance standards may be laid down in accordance with the appropriate procedures foreseen for the purpose in Regulation ... (on the hygiene of foodstuffs); awaiting the setting of new microbiological criteria, the criteria fixed in the Directives referred to above shall continue to apply.

(18) In the case of establishments with a limited production capacity for handling food of animal origin and which are the subject of particular constraints or serving the local market only, Member States must be given the tools necessary to define specific hygiene rules for such establishments provided that the objectives of food safety are not compromised and taking into account that in certain cases the local market may exceed national borders.

(19) Imported food of animal origin must be of at least the same or an equivalent health standard as that produced within the Community, and uniform procedures to ensure that this objective is attained must be introduced.

(20) The present recast means that the existing hygiene rules can be repealed; this is achieved through Council Directive .../.../EC repealing certain Directives on the hygiene of foodstuffs and on the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC [22].

[22] OJ L ...

(21) The products covered by this Regulation are included in Annex I to the Treaty.

(22) Scientific advice underpins Community legislation on food hygiene; to this end, the scientific committees in the field of consumer protection and food safety set up by Commission Decision 97/579/EC of 23 July 1997 [23] and the Scientific Steering Committee set up by Commission Decision 97/404/EC of 10 June 1997 [24] should be consulted wherever necessary.

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

[24] OJ L 169, 27.6.1997, p. 85.

(23) In order to take account of technical and scientific progress, a procedure should be available to adopt certain requirements called for in the present Regulation; equally, a procedure should be available enabling, where necessary, a smooth transition to the required health level.

(24) 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/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [25], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

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

HAVE ADOPTED THIS REGULATION:

Article 1 Scope

This Regulation lays down the specific hygiene rules to ensure the hygiene of food of animal origin.

Article 2 Definitions

For the purpose of this Regulation, the definitions laid down in Regulation ....(on the hygiene of foodstuffs) shall apply. In addition, the definitions laid down in Annex I to the present Regulation shall apply.

Article 3 General obligation

In addition to the requirements laid down in Regulation ....(on the hygiene of foodstuffs) , food business operators shall ensure that food of animal origin is obtained and marketed in accordance with Annex II to the present Regulation.

Article 4 Imports from third countries

Food of animal origin imported from third countries shall comply with the requirements laid down in Annex III to the present Regulation.

Article 5 Amending of Annexes and implementing measures

In accordance with the procedure referred to in Article 6,

1. Provisions in the Annexes to this Regulation may be repealed, amended, adapted or supplemented in order to take account of the development of codes to good practice, the implementation of food safety programmes by food operators, new risk assessments and the possible setting of food safety targets and/or performance standards.

2. Implementing measures to ensure the uniform implementation of the Annexes may be taken.

Article 6 Standing Committee procedure

1. The Commission shall be assisted by the Standing Veterinary Committee , instituted by Council Decision 68/361/EEC [26].

[26] 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 7

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 DEFINITIONS

1. MEAT

1.1 meat: all parts of animals which are fit for human consumption;

1.1.1 meat of domestic ungulates: meat of domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds;

1.1.2 poultry meat: meat of farmed birds including birds which are not considered as domestic but which are farmed as domestic animals (farmed game birds);

1.1.3 meat of lagomorphs: meat of rabbits, hares and rodents farmed for human 1consumption

1.1.4 wild game meat: meat of:

- wild land mammals which are hunted, including mammals living in enclosed territory under conditions of freedom similar to those of wild game;

- wild birds which are hunted;

1.1.5 farmed game meat: meat of farmed even-toed ungulate game mammals (including Cervidae and Suidae) and of farmed ratites;

1.2 large wild game: wild mammals of the Orders Artiodactyla, Perissodactyla and Marsupialia, as well as other mammal species classified under national hunting legislation as large game;

1.3 small wild game: wild game birds and wild game mammals not classified as large game;

1.4 carcase (domestic ungulates): the whole body of a slaughtered domestic ungulate after bleeding, evisceration and removal of the limbs at the carpus and the tarsus, removal of the head, tail and where appropriate the udder, and in addition, in the case of bovine animals, sheep, goats and solipeds, after flaying;

1.5 carcase (poultry): the whole body of a bird after bleeding, plucking and evisceration; however, removal of the heart, liver, lungs, gizzard, crop and kidneys, sectioning of the legs at the tarsus and removal of the head, oesophagus or trachea are optional;

1.6 New-York dressed poultry: poultry carcases for which the evisceration has been deferred;

1.7 fresh meat: meat, including meat which is vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any preserving process other than chilling, freezing or quick-freezing to ensure preservation;

1.8 offals: meat other than that of the carcase even if it remains naturally connected to the carcase;

1.9 viscera: offal from the thoracic, abdominal and pelvic cavities, including the trachea and oesophagus, and in birds the crop;

1.10 slaughterhouse: an establishment for slaughtering animals, the meat of which is intended for sale for human consumption, including any place available in connection therewith for the confinement of animals while awaiting slaughter there;

1.11 cutting plant: an establishment used for boning and/or cutting up carcases, parts of carcases and other edible parts of animals including premises adjacent to sale points where these operations are carried out for supplying the consumer or other sale points;

1.12 game collection centre: an establishment where killed wild game is kept prior to being transported to a game handling establishment;

1.13 game handling establishment: an establishment for the skinning of game and the further handling of game meat obtained after hunting;

1.14 minced meat: boned meat which has been reduced into fragments or passed through a spiral screw mincer;

1.15 mechanically separated meat: product resulting from the mechanical separation of meat left on the bones after boning, so that the cellular structure of the meat is broken;

1.16 meat preparations: fresh meat including minced meat which has had foodstuffs, seasonings or additives added to it or which has undergone a treatment insufficient to modify the internal cellular structure of the meat and thus to eliminate the characteristics of the fresh meat;

2. LIVE BIVALVE MOLLUSCS

2.1 bivalve molluscs: filter-feeding lamellibranch molluscs, and by exten sion, echinoderms, tunicates and marine gastropods;

2.2 marine biotoxins: poisonous substances accumulated by bivalve molluscs feeding on plankton containing toxins;

2.3 conditioning: the storage of live bivalve molluscs coming from class A areas in tanks or any other installation containing clean sea water or in natural sites to remove sand, mud or slime and to improve organoleptic qualities;

2.4 gatherer: any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market;

2.5 production area: any sea, estuarine or lagoon area containing natural beds of bivalve molluscs or sites used for cultivation of bivalve molluscs from which live bivalve molluscs are taken;

2.6 relaying area: any sea, estuarine or lagoon area approved by the competent authority, with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs;

2.7 dispatch centre: any approved on-shore or off-shore installation for the reception, conditioning, washing, cleaning, grading and wrapping of live bivalve molluscs fit for human consumption;

2.8 purification centre: an approved establishment with tanks fed by clean sea water in which live bivalve molluscs are placed for the time necessary to remove microbiological contamination, so making them fit for human consumption;

2.9 relaying: an operation whereby live bivalve molluscs are transferred to approved sea, lagoon or estuarine areas under the supervision of the competent authority for the time necessary to remove contamination. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening;

2.10 faecal coliform: facultative aerobic, gram-negative, non-sporeforming, cytochrome oxidase negative, rod-shaped bacteria that are able to ferment lactose with gas production in the presence of bile salts, or other surface active agents with similar growth-inhibiting properties, at 44°C + 0.2°C within 24 hours;

2.11 E. coli: faecal coliform which also forms indole from tryptophan at 44°C + 0.2°C within 24 hours;

2.12 clean seawater: sea water, brackish water or seawater preparations made from fresh water, free from microbiological contamination, objectionable substances and/or toxic marine plankton in such quantities likely to adversely affect the health quality of bivalve molluscs and fishery products.

3. FISHERY PRODUCTS

3.1 fishery products: all seawater or freshwater animals, wild or farmed, other than live bivalve molluscs, aquatic mammals and frogs, or parts of these animalsincluding their roes and livers, ;

3.2 aquaculture products: all fishery products born and raised in controlled conditions until placed on the market as a foodstuff as well as seawater or freshwater fish or crustaceans caught in their natural environment when juvenile and kept until they reach the desired commercial size for human consumption. Fish and crustaceans of commercial size caught in their natural environment and kept alive to be sold at a later date are not considered to be aquaculture products if they are merely kept alive without any attempt being made to increase their size or weight;

3.3 factory vessel: any vessel, fishing or not, on which fishery products undergo one or more of the following operations followed by wrapping: filleting, slicing, skinning, mincing, or processing; fishing vessels in which only crustaceans and molluscs are cooked on board are not deemed to be factory-vessels;

3.4 freezer vessel: any vessel, fishing or not, on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins. Where necessary, these operations are followed by wrapping and/or packaging;

3.5 mechanically recovered fish flesh: flesh obtained by mechanical means from gutted whole fish or bones after filleting;

3.6 clean seawater: see definition at point 2.12;

3.7 clean river or lake water: river or lake water free from microbiological contamination or any objectionable substances in quantities likely to adversely affect the health quality of fishery products.

4. EGGS

4.1 eggs: eggs of birds in shell, fit for direct consumption or for the preparation of egg products, other than broken, incubated or cooked eggs;

4.2 liquid egg: untreated egg contents after removal of the shell;

4.3 egg production farm: farm for the production of eggs intended to human consumption;

4.4 cracked eggs: eggs with a damaged but unbroken shell, with intact membranes.

5. MILK

5.1 milk: the lactic secretion of the mammary gland free of colostrum;

5.2 raw milk: milk which has not been heated beyond 40°C; treatments such as homogenisation and standardisation which have an effect on the quality of the milk may be carried out;

5.3 milk production holding: a holding in which one or more cows, ewes, goats, buffaloes or females of other species are kept to supply milk;

5.4 dairy establishment: an establishment for the processing of milk, or for the further processing of already processed milk.

6. FROGS' LEGS AND SNAILS

6.1 frogs' legs: posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species Rana (family Ranidae);

6.2 snails: terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and species of the family Achatinidae.

7. PROCESSED PRODUCTS

7.1 processed product: foodstuff resulting from the application to unprocessed products of a treatment such as heating, smoking, curing, maturing, drying, marinating etc or a combination of these processes and/or products; substances necessary for their manufacture or for giving specific characteristics to the products may be added;

7.2 meat products: products resulting from the application of a treatment to meat;

7.3 processed fish products: fishery products to which a treatment has been applied;

7.4 egg products: products resulting from the application of a treatment to eggs or to the various components or mixtures thereof after removal of the shell and membranes. They may be partially supplemented by other foodstuffs or additives. They may be liquid, concentrated, dried, crystallised, frozen, quick-frozen or coagulated.

7.5 milk products: products resulting from the application to raw milk of a treatment, such as heat-treated drinking milk, milk powder, whey, butter, cheese, yoghurt (whether or not with acid, salt, spices or fruits added) and re-constituted drinking milk;

7.6 rendered animal fat: fat derived from rendering meat, including bones, and intended for human consumption;

7.7 greaves: the protein-containing residue of rendering, after partial separation of fat and water;

7.8 gelatine: natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals (including fish and poultry);

7.9 treated stomachs, bladders and intestines: stomachs, bladders and intestines which have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning.

8. OTHER DEFINITIONS

8.1 composite product: a foodstuff containing products, whether unprocessed or processed, of animal and plant origin;

8.2 re-wrapping: the removal of the original wrapping from the product for replacing it by a new wrapping, possibly after having applied to the unwrapped product physical operations such as cutting or slicing;

8.3 wholesale market: means a food business which includes several separate units which share common installations and sections where foodstuffs are sold to food businesses and not to the final consumer.

ANNEX II SPECIFIC REQUIREMENTS

Preface

1. This Annex applies to unprocessed and processed products of animal origin. Composite products are not subject to the requirements of the present Annex. However, it must be ensured that possible hazards resulting from the use of ingredients of animal origin are identified and controlled, and where necessary eliminated or reduced to acceptable levels.

2. Unless specified otherwise, the requirements laid down in this Annex shall not apply to the point of retail trade.

3. Where approval of establishments is required under the present Annex, the following shall apply:

a) Approved establishments shall be given an approval number to which codes shall be added to indicate the types of products of animal origin manufactured. For wholesale markets, the approval number may be completed with a secondary number indicating units or groups of units selling or manufacturing products of animal origin.

b) Member States shall maintain up-to-date lists of approved establishments with their respective approval numbers.

In addition to the above, the approval is also required for wholesale markets where unprocessed or processed products of animal origin are handled.

4. Where required under the present Annex, products of animal origin shall carry an oval health mark in accordance with the following rules:

a) The health mark shall be applied during or immediately after manufacture in the establishment in such a way that it cannot be re-used.

b) The health mark must be legible, indelible and the characters must be easily decipherable; it must be clearly displayed for the controlling authorities.

c) The health mark shall carry the following information:

- the name of the country of dispatch, which may be written out in full or shown as an abbreviation as follows:

A, B, DK, D, EL, E, F, FIN, IRL, I, L, NL, P, S, UK,

- the approval number of the establishment,

d) The health mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The health mark may also be an irremovable tag made of a resistant material.

For products of animal origin which are placed in transport containers or large packages and intended for further handling, processing or wrapping in another establishment, the health mark may be applied to the external surface of the container or packaging. In this event, the recipient food operator must maintain a record of the quantities, type, origin and the destination of the products of animal origin;

e) The health marking of individual products of animal origin contained in a retail sale unit is not necessary if the health mark is applied to the external surface of that retail sales unit.

f) When the health mark is applied directly to products of animal origin, the colours used shall be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

g) If products of animal origin are unwrapped and subsequently re-wrapped, handled or further processed in another establishment, the latter establishment must be approved and apply its own health mark to the product.

Products to which the above health mark must not be applied shall carry a mark that allows the origin of the products to be traced and that is distinctly different from the oval health mark.

5. Any substance other than potable water applied to products for hazard reduction, as well as their conditions for use, must be approved in accordance with the procedure referred to in Article 6, after the opinion of the Scientific Committee. The implementation of this paragraph shall be without prejudice to the correct implementation of the requirements of the present Regulation

6. Where necessary, special conditions may be granted by the competent authority in particular in order to take account of traditional production methods.

7. The present Annex shall apply without prejudice to the relevant animal health rules and without prejudice to more stringent rules laid down for the prevention and control of certain transmissible spongiform encephalopathies.

SECTION I: MEAT OF DOMESTIC UNGULATES

The animals, or where appropriate each batch of animals sent for slaughter must be identified so that its origin can be traced.

Animals may not come from a holding or an area subject to a movement prohibition for reasons of animal health unless permitted by the competent authority.

CHAPTER I: CONDITIONS FOR SLAUGHTERHOUSES

Slaughterhouses must be constructed and equipped in accordance with the following conditions:

1. They must have adequate and hygienic lairage facilities or, climate permitting, waiting pens which are easy to clean and disinfect. These facilities must be equipped for watering the animals and feeding them if necessary. The drainage of the wastewater must not compromise food safety.

Where considered necessary by the competent authority, they must also have separate lockable premises or climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals.

The size of the lairage facilities must enable to ensure the respect of the welfare of the animals. Their lay-out must facilitate ante-mortem inspections including the identification of the animals or groups of animals.

2. Have a slaughter room and where appropriate a sufficient number of rooms appropriate to the operations being carried out and be constructed in such a way as to avoid contamination of the meat by ensuring that:

(a) there is a distinctly separated area for stunning and bleeding;

(b) in the case of pig slaughtering, there is a separation of scalding, depilation, scraping and singeing operations of pigs from other operations;

(c) there are installations ensuring that there is no contact between the meat and the floors, walls or equipment;

(d) where slaughter lines are operated, these are designed to allow a constant progress of the slaughter process and avoid cross-contamination between the different parts of the slaughter line;

where different slaughter lines are operated in the same premises, adequate separation of these lines is ensured in order to prevent cross- contamination;

(e) the following operations are carried out separately from the operations during which meat is obtained:

- emptying stomachs and intestines; in slaughterhouses with a limited throughput, the competent authority may allow the cleaning of stomachs and intestines in the slaughter room at times when no slaughtering is taking place;

- further handling of guts and tripe, if this is carried out in the slaughterhouse;

- preparation and cleaning of other offal; skinned heads must be handled at a sufficient distance from meat and other offal, if these operations are carried out in the slaughterhouse and do not take place at the slaughter line;

(f) there is a separate place for packaging offal if this is done in the slaughterhouse;

(g) there is an appropriate area, sufficiently protected, for dispatching meat.

3. They must have facilities for disinfecting tools with hot water supplied at not less than 82°, or an alternative system having an equivalent effect.

4. The equipment for washing hands used by the staff engaged in handling exposed meat shall be provided with taps that are non-hand operable.

5. Lockable premises must be provided for the refrigerated storage of detained meat and for the storage of meat declared unfit for human consumption.

6. There must be a separate place with appropriate facilities for the cleaning and disinfection of means of transport of livestock. These places and facilities are not compulsory if officially authorised places and facilities exist nearby.

7. They must have lockable premises reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period. The premises must be cleaned and disinfected under official supervision before slaughter is resumed.

8. If manure and stomach or gut content is stored in the slaughterhouse precincts, they must have a special area or place for that purpose.

CHAPTER II: CONDITIONS FOR CUTTING PLANTS

Cutting plants must:

1. Be constructed so as to allow constant progress of the operations or ensure separation between the different production batches.

2. Have rooms for the separate storage of packed and exposed meat, unless stored at different times.

3. Have cutting rooms equipped to ensure that the cold chain is not interrupted during cutting operations.

4. Have equipment for washing hands provided with taps that are non-hand operable to be used by the staff engaged in handling exposed meat.

5. They must have facilities for disinfecting tools with hot water supplied at not less than 82°, or an alternative system having an equivalent effect.

CHAPTER III: SLAUGHTER HYGIENE

1. After arrival in the slaughterhouse, the slaughter of the animals shall not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter. Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of animals that have undergone emergency slaughter outside the slaughterhouse, farmed game slaughtered at the place of production and wild game.

Animals which have died during transport or in the lairages shall not be used for human consumption.

2. The state of cleanliness of the animals must be such as not to present an unnecessary risk of contaminating the meat during slaughter operations.

3. Before slaughter, animals must be presented to the competent authority in order to be submitted to an ante-mortem inspection. Slaughterhouse operators shall follow the instructions of the competent authority in order to ensure that the ante-mortem inspection is carried out under suitable conditions.

4. Slaughter animals brought into the slaughter hall must be slaughtered without undue delay.

5. Stunning, bleeding, skinning, dressing and evisceration must be carried out without undue delay in such a way that contamination of the meat is avoided. It must in particular be ensured that,

- the trachea and oesophagus remain intact during bleeding, except in the case of ritual slaughter.

- during the removal of hides and fleece, contact between the outside of the skin and the carcase is prevented, and that operators and equipment coming into contact with the outer surface of hides and fleece do not touch the meat.

- measures are taken to prevent the spillage of digestive tract contents during evisceration and that evisceration is completed as soon as possible after stunning.

- removal of the udder does not result in contamination of the carcase with milk.

6. Skinning must be complete; however, the skinning of the head is not required

- in the case of heads of calves and ovines, provided that such heads are handled so as to avoid contamination of meat

- if such heads, including tongues and brains, are not intended for human consumption.

When not skinned, pigs must have their bristles removed immediately. The risk of contamination of the meat with scalding water must minimised. Only approved additives may be used for this operation provided that pigs are thoroughly rinsed afterwards with potable water.

7. The carcases must not contain visible faecal contamination. Any visible contamination must be removed by trimming.

8. Carcases and offal shall not come into contact with floors, walls or work stands.

9. Slaughtered animals must be presented to the competent authority in order to be submitted to a post-mortem inspection. Slaughterhouse operators shall follow the instructions of the competent authority in order to ensure that the post-mortem inspection is carried out under suitable conditions. Parts of the slaughtered animals that have been removed before the post mortem inspection is performed, must remain identifiable as belonging to a given carcase. However, provided it shows no pathological symptom or lesion, the penis may be discarded immediately.

Both kidneys must be removed from their fatty covering and peri-renal capsule.

If the blood or offals of several animals are collected in the same container before completion of the post mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption. Carcases and offal shall not come into contact with each other before post-mortem inspection is finalised.

10.After post mortem inspection,

- the tonsils of bovine animals under six weeks and pigs must be removed hygienically,

- the parts unfit for human consumption must be removed at once from the clean sector of the establishment,

- meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption.

- viscera or parts of viscera which have not been removed from the carcase before post-mortem inspection, except for the kidneys or unless specified elsewhere, must be removed entirely if possible and as quickly as possible.

11.After completion of slaughter and post-mortem inspection procedures, the meat must be stored in accordance with the requirements laid down in Chapter IX of the present Section.

12.Where establishments are approved for the slaughter of different animal species or for the handling of carcases of farmed game and wild game, precautions must be taken to prevent cross-contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed game slaughtered at the farm and for wild game must be available.

CHAPTER IV: HYGIENE DURING CUTTING AND BONING

1. Carcases of domestic ungulates may be cut into half-carcases, and half-carcases into quarters or a maximum of three pieces in approved slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

2. The work on meat must be organised in such a way as to prevent the growth of pathogenic micro-organisms or the formation of toxins or other pathogenic substances, and in particular:

(a) Meat intended for cutting must be brought into the work rooms progressively as needed.

(b) During cutting, boning, slicing, dicing, wrapping and packaging, the cooling of the meat must not be interrupted.

Where meat is boned and cut prior to reaching the temperatures for storage and transport provided for in Chapter IX of the present Section, such meat must be transferred directly from the slaughter premises to the cutting room, or after a waiting period in the cold store.. As soon as it is cut and where appropriate packaged, the meat must be chilled to 7°C for carcase meat and 3°C offals

(c) Where the premises are approved for the cutting of meat of different species, precautions must be taken to avoid cross-contamination, where necessary by separation of the operations of the different species in either space or time.

CHAPTER V: SPECIAL CONDITIONS

Member States may adapt the requirements laid down in Chapters I and II with a view to accommodate the needs of establishments situated in regions suffering from special geographical constraints or affected by supply difficulties, or those serving the local market. Hygiene shall not be compromised. The Member States shall inform the Commission of the details of such special conditions.

Establishments serving the local market shall mean slaughterhouses and cutting plants marketing their meat in the vicinity of the place where such slaughterhouses and cutting plants are situated.

CHAPTER VI: CASUALTY AND EMERGENCY SLAUGHTER

1. Meat from animals that have undergone emergency slaughter following serious physiological or functional problems is not authorised for human consumption.

2. Meat from animals that have undergone emergency slaughter outside the slaughterhouse following an accident is authorised for human consumption on the local market if the following requirements are fulfilled:

- the animal is examined by a veterinarian before slaughter; however, the animal may be slaughtered before examination by a veterinarian when required for welfare reasons,

- the animal is slaughtered after stunning, bled and possibly eviscerated on the spot; the veterinarian may authorise shooting in special cases,

- the slaughtered and bled animal is transported as quickly as possible after slaughter under satisfactory hygiene conditions to a slaughterhouse approved for that purpose. Where the slaughtered animal cannot be brought to such a slaughterhouse within an hour, it must be transported in a container or means of transport in which the ambient temperature is maintained between 0°C and 4°C. Evisceration must be carried out as soon as possible. If an excessively long period elapses between slaughter and evisceration, the official veterinarian may require that special checks are carried out at post-mortem inspection. If evisceration is carried out on the spot, the viscera must accompany the carcase to the slaughterhouse.

- during transport to the slaughterhouse, the slaughtered animal and where appropriate the viscera are transported hygienically and are accompanied by a certificate issued by the veterinary surgeon who has ordered slaughter attesting to the outcome of the ante-mortem inspection, the time of slaughter and the nature of any treatment administered to the animal and, if appropriate, the result of the inspection of the viscera.

- the slaughtered animal is declared wholly or partly fit for human consumption after having been submitted to a detailed post mortem examination, where necessary supplemented by a bacteriological and residue examination.

- The meat is not provided with the health mark but with an identification mark approved by the competent authority.

3. Meat from animals that have undergone emergency slaughter following an accident in a slaughterhouse may be marketed if the animals have been submitted to an examination before slaughter, if no other serious lesions than those which occurred immediately before slaughter have been found and if it has been declared wholly or partly fit for human consumption after having been submitted to a detailed post mortem examination.

CHAPTER VII: APPROVAL AND REGISTRATION OF ESTABLISHMENTS

Slaughterhouses, cutting plants and cold stores must be approved by the competent authority and be given an approval number. However, low capacity establishments distributing their products on the local market only may be registered. Such establishments shall not apply the health mark referred to in Chapter VIII.

CHAPTER VIII: HEALTH MARKING

1. Marking of meat must be carried out under the responsibility of an official veterinarian, who for this purpose, must supervise the marking and keep under his control the health stamp to be applied to the meat which must be handed over to auxiliaries or designated plant employees at the time of marking and for the length of time required for this purpose.

Health marks may not be removed unless the meat is further worked upon in another separate approved establishment where the original mark must be replaced by that establishment's own number.

2. After completion of the post mortem inspection, carcases, half carcases, quarters and carcases cut into three pieces must be stamped in ink or hot-branded on their external surface so as to ensure that the slaughterhouse of origin is easily identifiable.

3. Livers must be hot-branded, unless wrapped or packaged.

4. In the case of cut meat and packaged cut offal obtained in a cutting plant the mark must be applied to a label fixed to the packaging, or printed on the packaging. However, when cut meat or offal is wrapped, the label may be affixed to the wrapping in such a way that the label is destroyed when the wrapping is opened.

5. The health mark may include an indication of the official veterinarian who carried out the health inspection of the meat.

CHAPTER IX: STORAGE, TRANSPORT AND MATURATION

1. Except where warm cutting and boning is practised, meat must be chilled after post-mortem inspection to an internal temperature of not more than 7°C for carcase meat and 3°C for offals allong a chilling curve which ensures a constant decrease of the temperature. During the chilling operations, there must be adequate ventilation in order to prevent condensation on the surface of the meat. For technical reasons relating to maturation of the meat, a derogation may be granted on a case-by-case basis for the transportation of meat to cutting plants or butcher shops located in the immediate vicinity of a slaughterhouse, provided that such transport takes not more than one hour.

2. Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing.

3. Exposed meat must be stored in a separate room from packaged meat, unless stored at different times.

4. Carcases, half-carcases, half-carcases cut into no more than three wholesale cuts, and quarters may be transported at temperatures higher than those referred to in point 1, under conditions to be set in accordance with the procedure referred to in Article 6 after consultation of the Scientific Committee.

5. Meat must not come into contact with the floor. Containers must not be placed directly on the floor.

6. Packaged meat must not be transported with unpacked meat unless adequate physical separation is provided. Stomachs may not be transported unless scalded or cleaned, nor may heads and feet unless they are skinned or scalded and depilated.

CHAPTER X: ADDITIONAL GUARANTEES

In respect of salmonella, the following rules shall apply to beef and veal meat and meat of porcine animals intended for Sweden and Finland:

(a) The consignments must have been subjected to a microbiological test by sampling in the establishment of origin.

(b) With regard to meat of bovine and porcine animals, the test provided for in (a) must not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect.

(c) The test provided for in (a) must not be carried out for meat originating in an establishment which is subject to an operational programme recognised by the Commission, in accordance with the procedure referred to in Article 6, as equivalent to that approved for Sweden and Finland.

The operational programmes of the Member States may be amended and updated by the Commission in accordance with the procedure referred to in Article 6.

SECTION II: POULTRYMEAT

The requirements of this section apply, by analogy, to meat from lagomorphs.

Ratites must be handled in accordance with the requirements set out below but with appropriate accommodation adapted to the size of the animals to ensure the respect of hygiene.

CHAPTER I: TRANSPORT OF BIRDS TO THE SLAUGHTERHOUSE

1. During the collection of birds at the farm and during transport, birds must be handled carefully without causing unnecessary distress. Only birds which do not show symptoms of disease or other deficiencies may be transported. Where appropriate, birds showing symptoms of disease or originating in flocks that are known to be contaminated with agents of public health importance must be transported under the control of the competent authority.

2. Equipment used for collecting live birds must be cleaned and disinfected before re-use. Crates for delivering poultry to the slaughterhouse must be made of non-corrodible material and be easy to clean and disinfect.

3. Upon arrival at the slaughterhouse, birds must be rested before slaughter.

CHAPTER II: CONDITIONS FOR SLAUGHTERHOUSES

Slaughterhouses must:

1. Have a room or covered space for the reception if the animals and for their inspection before slaughter;

2. Be constructed in such a way as to avoid the contamination of the meat, ensuring in particular that:

- There is a slaughter room for stunning and bleeding on the one hand, and plucking and any scalding on the other, to be carried out in separate places.

- There is a room for evisceration and further dressing which is large enough for evisceration to be carried out in a place sufficiently far from the other work stations, or separated from them by a partition, to prevent contamination.

- Slaughter lines are designed to allow a constant progress of the slaughter process and to avoid cross contamination between different parts of the slaughter line as well as contact between carcasses and walls, equipment etc.

- There is an appropriate area, sufficiently protected, for dispatching meat.

3. Have refrigeration facilities of sufficient capacity in relation to the volume of production.

4. Have lockable premises for the refrigerated storage of detained meat.

5. Have facilities for disinfecting tools with hot water supplied at not less than 82°, or an alternative system having an equivalent effect.

6. Have equipment for washing hands used by the staff engaged in handling exposed meat provided with taps that are non-hand operable.

7. There must be a separate place with appropriate facilities for the cleaning and disinfection of means of transport and, where appropriate, transport equipment such as crates. These places and facilities are not compulsory if officially authorised places and facilities exist nearby.

CHAPTER III: CONDITIONS FOR CUTTING PLANTS

Cutting plants must:

1. Be constructed so as to allow constant progress of the operations or ensure separation between the different batches.

2. Have rooms for the separate storage of packed and exposed meat, unless stored at different times.

3. Have cutting rooms equipped to ensure that the cold chain is not interrupted during cutting operations.

4. The equipment for washing hands used by staff handling exposed meat shall be provided with taps that are non-hand operable.

5. Have facilities for disinfecting tools with hot water supplied at not less than 82°, or an alternative system having an equivalent effect.

If the following operations are undertaken in a cutting plant:

- the evisceration of geese and ducks reared for the production of "foie gras", which have been stunned, bled and plucked on the fattening farm;

- the evisceration of "New York dressed" poultry,

separate rooms must be available for that purpose unless these operations are separated in time from the cutting operations and proper cleaning and disinfection procedures are in place.

CHAPTER IV: SLAUGHTER HYGIENE

1. Crates for delivering live poultry must be cleaned and disinfected each time they are emptied.

2. Only live animals intended for slaughter may be brought into the slaughter premises with the exemption of farmed ratites slaughtered at the place of production, "New York Dressed" poultry slaughtered at the farm, small wild game and geese and ducks reared for the production of "foie gras" which have been stunned, bled and plucked on the fattening farm. Animals that have died during transport or before slaughter shall not be used for human consumption.

3. Where provided for in Community legislation, animals must before slaughter be presented to the competent authority in order to be submitted to an ante-mortem inspection. Slaughterhouse operators shall follow the instructions of the competent authority in order to ensure that the ante-mortem inspection is carried out under suitable conditions.

4. Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available.

5. Animals brought into the slaughter room must be immediately slaughtered after stunning, save in case of slaughter according to religious rite;

6. Stunning, bleeding, skinning or plucking, dressing and evisceration must be carried out without delay in such a way that contamination of the meat is avoided. It must in particular be ensured that measures are taken to prevent the spillage of digestive tract contents during evisceration

7. Slaughtered animals must be submitted to a post-mortem inspection under the supervision of the competent authority. Slaughterhouse operators shall follow the instructions of the competent authority in order to ensure that the post-mortem inspection is carried out under suitable conditions ensuring in particular that slaughtered poultry can be inspected properly.

8. Viscera or parts of viscera which have not been removed from the carcase before post-mortem inspection must, except for the kidneys, be removed entirely, if possible, and as quick as possible after inspection has been completed.

9. After inspection and evisceration, slaughtered birds must be cleaned and chilled to a temperature of not more than 4°C as soon as possible, unless the meat is cut while warm. "New York dressed poultry" obtained at the farm of production may be kept for up to 15 days at a temperature which must not exceed 4°C; they must, at the latest at the end of this period, be eviscerated in a slaughterhouse or in a cutting plant. Such poultry must be accompanied by a certificate signed by the competent authority stating that the uneviscerated carcases are of birds which were examined before slaughter on the farm of origin and were found to be healthy at the time of examination.

10.When poultry carcases are subjected to an immersion chilling process, account must be taken of the following:

(a) Every precaution must be taken to avoid cross-contamination of carcases taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time.

(b) Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary.

(c) Calibrated control equipment must continuously record the following:

- the water consumption during spray-washing before immersion,

- the temperature of the water of the tank or tanks at the points of entry and exit of the carcases,

- the water consumption during immersion,

- the total weight of the immersed carcases.

11.Sick or suspect birds or birds slaughtered in application of disease eradication or control programmes must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again.

CHAPTER V: HYGIENE DURING CUTTING AND BONING

The work on meat must be organised in such a way as to prevent the growth of pathogenic micro-organisms or the formation of toxins or other pathogenic substances, and in particular:

1. Meat intended for cutting must be brought into the work rooms progressively as needed.

2. During cutting, boning, slicing, dicing, wrapping and packaging, the cooling of the meat must not be interrupted.

Where meat is boned and cut prior to reaching 4°C, such meat must be transferred directly from the slaughter premises to the cutting room in a single operation, or after a waiting period in the cold store. Cutting must be carried out immediately after transfer.

3. As soon as it is cut, and where appropriate wrapped and packaged, the meat must be chilled to 4°C.

4. Where the premises are approved for the cutting of meat of different species or for handling "New York Dressed" poultry and small wild game, precautions must be taken to avoid cross-contamination, where necessary by separation of the operations of the different species in either space or time.

CHAPTER VI: SPECIAL CONDITIONS

1. Member States may adapt the requirements laid down in Chapters II and III with a view to accommodate the needs of establishments situated in regions suffering from special geographical constraints or affected by supply difficulties, or those serving the local market. Hygiene shall not be compromised. The Member States shall inform the Commission of the details of such special conditions.

Establishments serving the local market shall mean farms with an annual production of under 10.000 birds supplying fresh poultry meat coming from their holdings in small quantities:

- either directly to the final consumer at the holding or at the weekly markets in the vicinity of their holdings or,

- to retailers with a view to direct sale to the final consumer, provided that such retailers pursue their activities in the same or neighbouring locality as that of the producer.

2. Member States may

- allow the further handling in establishments approved for that purpose of farmed game birds and small farmed game animals which are slaughtered and bled at the farm;

- grant a derogation from the slaughter and evisceration provisions in the case of the production of partially eviscerated or non-eviscerated farmed game birds.

3. Slaughter, bleeding and plucking of poultry reared and slaughtered for the production of "foie gras" may be carried out at the farm, provided these operations are carried out in a separate room fully complying with hygiene rules. The uneviscerated carcases must be transported immediately, under respect of the cold chain principles, to a slaughterhouse or cutting plant with a special room where the carcases must be eviscerated within 24 hours under the supervision of the competent authority. During transport, such poultry carcases must be accompanied by a certificate signed by the official veterinarian giving information about the health status of the flock of origin and the hygiene at the farm of production.

4. Where the competent authority authorises the slaughter of animals at the farm in accordance with point 3, the following conditions shall apply:

- the farm must undergo regular veterinary inspection and not be placed under any animal- or public-health restriction;

- the competent authority must be informed in advance of the date of slaughter of birds;

- the holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made;

- the holding must have premises suitable for the hygienic slaughter and further handling of the birds;

- animal welfare requirements must be complied with.

CHAPTER VII: APPROVAL AND REGISTRATION OF ESTABMISHMENTS

Slaughterhouses, cutting plants and cold stores must be approved by the competent authority and be given an approval number. However, low capacity establishments referred to in Chapter VI distributing their products on the local market only may be registered.

CHAPTER VIII: ADDITIONAL GUARANTEES

In respect of salmonella, the following rules shall apply to meat of domestic fowl, turkey, guinea fowl, ducks and geese intended for Sweden and Finland:

(a) The consignments must have been subjected to a microbiological test by sampling in the establishment of origin.

(b) The test provided for in (a) must not be carried out for meat originating in an establishment which is subject to an operational programme recognised by the Commission, in accordance with the procedure referred to in Article 6, as equivalent to that approved for Sweden and Finland.

The operational programmes of the Member States may be amended and updated by the Commission in accordance with the procedure referred to in Article 6.

SECTION III: MEAT OF FARMED GAME

1. The provisions for meat of domestic ungulates shall apply to the production and marketing of meat of farmed even-toed game mammals (Cervidae and Suidae).

2. The provisions for poultry meat shall apply to the production and marketing of meat from ratites.

3. Notwithstanding paragraphs 1 and 2, the competent authority may authorise the slaughter of farmed game at the place of origin where it cannot be transported, in order to avoid any risk for the handler or to protect the welfare of the animals. This authorisation may be granted if:

- the herd undergoes regular veterinary inspection and is not under any animal- or public-health restriction;

- a request is submitted by the owner of the animals;

- the competent authority is informed in advance of the date of slaughter of the animals;

- the holding has facilities for concentrating the animals to allow an ante-mortem inspection of the group to be made;

- the holding has premises suitable for the slaughter, sticking and bleeding, and where ratites are to be plucked, plucking of the animals;

- slaughter by sticking and bleeding is preceded by stunning in accordance with Directive 93/119/EC; slaughter by shooting may be allowed;

- slaughtered and bled animals are transported suspended, under satisfactory conditions of hygiene, to an approved establishment as soon as possible after slaughter. Where animals slaughtered at the place of rearing cannot be brought within one hour to an approved establishment, they must be transported in a container or means of transport in which the ambient temperature is maintained at between 0°C and 4°C. Evisceration must be carried out as soon as possible after stunning and bleeding.

- during transport to the approved establishment, slaughtered animals are accompanied by a certificate issued and signed by the official veterinarian attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the time of slaughter.

4. All operations for the slaughter of reindeer destined for intra-Community trade may be carried out in mobile slaughter units in accordance with the provisions for meat of domestic ungulates. In accordance with the procedure referred to in Article 6, and after the opinion of the Scientific Committee, the conditions under which mobile slaughterhouses can be used for the slaughter of other species shall be laid down.

SECTION IV: WILD GAME MEAT

This Section does not apply to trophies or killed wild game transported by travellers, insofar as this involves a small quantity of small wild game or only one whole item of large wild game and where the circumstances indicate that the game is not intended for commercial purposes, and provided that it does not come from an area or region subject to animal health restrictions or restrictions because of the presence of residues.

CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

1. Persons responsible for hunting wild game and for placing it on the market for human consumption must have sufficient knowledge of wild game hygiene and pathology in order to undertake an init