(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

In addition to this common basis, specific hygiene rules are necessary for certain foodstuffs. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (6) lays down these rules.

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

(15)

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

(16)

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

(17)

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

(18)

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

(19)

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

(20)

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

(21)

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

(22)

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

(23)

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

(24)

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

(25)

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

(26)

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

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

(g)

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

(a)

primary production for private domestic use;

(b)

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

(c)

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

(d)

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

(a)

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

(b)

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

(c)

‘establishment’ means any unit of a food business;

(d)

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

(e)

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

(f)

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

(g)

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

(h)

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

(i)

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

(j)

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

(k)

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

(l)

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

(m)

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

(n)

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

(o)

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

(a)

compliance with microbiological criteria for foodstuffs;

(b)

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

(c)

compliance with temperature control requirements for foodstuffs;

(d)

maintenance of the cold chain;

(e)

sampling and analysis.

(a)

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

(b)

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

(c)

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

(d)

establishing and implementing effective monitoring procedures at critical control points;

(e)

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

(f)

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

and

(g)

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

(a)

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

(b)

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

(c)

retain any other documents and records for an appropriate period.

(a)

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

(b)

under Regulation (EC) No 853/2004;

or

(c)

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

(a)

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

(b)

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

and

(c)

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

(a)

they have been developed in accordance with paragraph 1;

(b)

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

and

(c)

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

(a)

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

(b)

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

(c)

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

and

(d)

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

(a)

they have been developed in accordance with paragraph 2;

(b)

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

and

(c)

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

(a)

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

(b)

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

(c)

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

(d)

scientific advice, particularly new risk assessments;

(e)

microbiological and temperature criteria for foodstuffs.

4.

(a)

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

(b)

describe the foodstuffs and establishments concerned;

(c)

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

and

(d)

give any other relevant information.

(a)

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

or

(b)

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

(a)

Regulation (EC) No 853/2004;

(b)

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (11);

and

(c)

Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (12).

1.

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

2.

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

3.

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

4.

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

5.

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

6.

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

7.

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

8.

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

9.

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

10.

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

1.

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

2.

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

—

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

—

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

—

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

—

Chapter IV applies to all transportation.

1.

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

2.

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

3.

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

4.

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

5.

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

6.

Sanitary conveniences are to have adequate natural or mechanical ventilation.

7.

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

8.

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

9.

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

10.

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

1.

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

2.

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

3.

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

1.

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

2.

In particular, where necessary:

1.

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

2.

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

3.

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

4.

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

5.

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

6.

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

7.

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

1.

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

2.

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

3.

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

1.

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

2.

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

3.

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

4.

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

1.

2.

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

3.

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

4.

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

5.

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

6.

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

1.

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

2.

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

1.

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

2.

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

3.

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

4.

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

5.

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

6.

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

7.

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

8.

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

1.

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

2.

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

3.

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

4.

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

1.

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

2.

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

3.

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

1.

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

2.

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

and

3.

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

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

(15)

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

(16)

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

(17)

The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC (6), 95/50/EC (7), 95/160/EC (8), 95/161/E (9) and 95/168/EC (10), and Council Decisions 95/409/EC (11), 95/410/EC (12) and 95/411/EC (13). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (14) provides for a similar procedure in respect of live animals and hatching eggs.

(18)

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

(19)

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

(20)

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

(21)

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

(22)

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

(23)

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

(24)

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

(25)

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

(26)

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

(27)

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

(28)

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

(29)

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

(30)

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

(a)

primary production for private domestic use;

(b)

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

(c)

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

(d)

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

(e)

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

5.

(a)

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

(b)

animal welfare requirements;

and

(c)

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

1.

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

2.

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

3.

the definitions laid down in Annex I;

and

4.

any technical definitions contained in Annexes II and III.

(a)

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

and

(b)

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

(a)

primary production;

(b)

transport operations;

(c)

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

or

(d)

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

(a)

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

or

(b)

provided the establishment with conditional approval.

(a)

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

or

(b)

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

(a)

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

or

(b)

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

(a)

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

(b)

(c)

the product satisfies:

and

(d)

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

(a)

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

(b)

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

and

(c)

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

(a)

model documents may be established;

and

(b)

provision may be made for the use of electronic documents.

(a)

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

(b)

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

and

(c)

eggs.

2.

(a)

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

and

(b)

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

(a)

the development of guides to good practice;

(b)

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

(c)

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

(d)

scientific advice, particularly new risk assessments;

(e)

microbiological and temperature criteria for foodstuffs;

(f)

changes in patterns of consumption.

4.

(a)

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

(b)

describe the foodstuffs and establishments concerned;

(c)

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

and

(d)

give any other relevant information.

(a)

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

(b)

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

or

(c)

in accordance with paragraph 8.

(a)

prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption;

or

(b)

permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

1.

to lay down rules for the transport of meat while it is warm;

2.

to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

3.

to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

4.

to specify recognised testing methods for marine biotoxins;

5.

to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

6.

to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

7.

to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

8.

to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

9.

to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

10.

to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

11.

without prejudice to Directive 96/23/EC (22), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk;

and

12.

to approve equivalent processes for the production of gelatine or collagen.

(a)

Regulation (EC) No 852/2004;

(b)

Regulation (EC) No 854/2004;

and

(c)

Directive 2004/41/EC.

—

wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game;

and

—

wild birds that are hunted for human consumption.

—

food of animal origin, including honey and blood;

—

live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption;

and

—

other animals destined to be prepared with a view to being supplied live to the final consumer.

1.

The identification mark must be applied before the product leaves the establishment.

2.

However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place.

3.

An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (23) lays down requirements concerning labelling or marking.

4.

Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin.

5.

The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities.

6.

The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK.

Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement.

7.

The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.

8.

When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY.

9.

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

10.

In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping.

11.

For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.

12.

In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in points 6, 7 and, where appropriate, 8.

13.

When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only.

14.

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

1.

Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2.

2.

The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:

3.

In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures.

1.

Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004.

2.

Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7.

3.

The relevant food safety information referred to in point 1 is to cover, in particular:

4.

5.

Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned.

6.

If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits.

7.

If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of:

Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the animals may not take place until the official veterinarian so permits.

8.

Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian.

1.

During collection and transport, animals must be handled carefully without causing unnecessary distress.

2.

Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits.

1.

2.

To avoid contaminating meat, they must:

3.

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

4.

The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

5.

There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

6.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby.

7.

They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.

8.

If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose.

9.

They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

1.

are constructed so as to avoid contamination of meat, in particular by:

2.

have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

3.

have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

4.

have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and

5.

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

1.

After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter.

2.

3.

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

4.

Animals must be clean.

5.

Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No 854/2004 to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions.

6.

Animals brought into the slaughter hall must be slaughtered without undue delay.

7.

Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular:

8.

Complete skinning of the carcase and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat.

9.

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

10.

The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect.

11.

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

12.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No 854/2004.

13.

Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:

However, provided that it shows no pathological lesion, the penis may be discarded immediately.

14.

Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed.

15.

If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption.

16.

After post-mortem inspection:

17.

After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII.

18.

When destined for further handling:

19.

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

20.

If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed.

1.

Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

2.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

3.

However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3.

4.

Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b).

1.

An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons.

2.

A veterinarian must carry out an ante-mortem inspection of the animal.

3.

The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.

4.

If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary.

5.

A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse.

6.

A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse.

7.

The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No 854/2004, including any additional tests required in the case of emergency slaughter.

8.

Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat.

9.

Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears a special health mark which cannot be confused either with the health mark provided for in Regulation (EC) No 854/2004 or with the identification mark provided for in Annex II, Section I to this Regulation. Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance with national law.

1.

2.

Meat must attain the temperature specified in point 1 and remain at that temperature during storage.

3.

Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that:

4.

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

5.

Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

1.

During collection and transport, animals must be handled carefully without causing unnecessary distress.

2.

Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority.

3.

Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected.

1.

They must have a room or covered space for the reception of the animals and for their inspection before slaughter.

2.

To avoid contaminating meat, they must:

3.

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

4.

The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

5.

There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

6.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:

These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

7.

They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

1.

Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:

2.

If the following operations are undertaken in a cutting plant:

food business operators must ensure that separate rooms are available for that purpose.

1.

2.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem inspection is carried out under suitable conditions.

3.

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

4.

Animals brought into the slaughter room must be slaughtered without undue delay.

5.

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

6.

Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly.

7.

After post-mortem inspection:

8.

After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm.

9.

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

10.

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

1.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

2.

However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:

3.

As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 1(b).

4.

Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

1.

The farm must undergo regular veterinary inspection.

2.

The food business operator must inform the competent authority in advance of the date and time of slaughter.

3.

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

4.

The holding must have premises suitable for the hygienic slaughter and further handling of the birds.

5.

Animal welfare requirements must be complied with.

6.

The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter.

7.

The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No 854/2004.

8.

In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority.

9.

Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production.

1.

The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals (Cervidae and Suidae), unless the competent authority considers them inappropriate.

2.

The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals.

3.

Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:

4.

Food business operators may also slaughter bison on the farm in accordance with point 3 in exceptional circumstances.

1.

Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot.

2.

It is however enough if at least one person of a hunting team has the knowledge referred to in point 1. References in this Section to a ‘trained person’ are references to that person.

3.

The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing.

4.

Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:

5.

The competent authority should encourage hunters' organisations to provide such training.

1.

After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled.

2.

The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

3.

Meat of large wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal.

4.

5.

Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary.

6.

During transport to the game-handling establishment, heaping must be avoided.

7.

Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

8.

In addition, unskinned large wild game may be skinned and placed on the market only if:

9.

The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game.

1.

The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

2.

If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority.

3.

Meat of small wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 1.

4.

Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary.

5.

Evisceration must be carried out, or completed, without undue delay upon arrival at the game -handling establishment, unless the competent authority permits otherwise.

6.

Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

7.

The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game.

1.

are constructed so as to avoid contamination of meat and products, in particular by:

2.

have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products;

3.

have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III;

4.

have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination;

and

5.

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

1.

The raw material used to prepare minced meat must meet the following requirements.

2.

The following raw material may be used to prepare meat preparations:

3.

The raw material used to produce MSM must meet the following requirements.

1.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is:

2.

The following requirements apply to the production of minced meat and meat preparations.

3.

The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat.

4.

The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.

5.

Minced meat, meat preparations and MSM must not be re-frozen after thawing.

1.

In addition to the requirements of Directive 2000/13/EC (24), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require.

2.

Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption.

1.

Food business operators must ensure that the following items are not used in the preparation of meat products: