30.4.2004   

EN

Official Journal of the European Communities

L 139/1

(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 /2004 of the European Parliament and of the Council of ... 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 fanning, 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;

(1)

"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 /2004 (12); 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 1, 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.../2004 (15);

(b)

Regulation (EC) No.../2004 of the European Parliament and of the Council of laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (16); and

(c)

Directive 2004/41/EC of the European Parliament and of the Council of 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 (17).