COUNCIL DIRECTIVE 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community and in particular Article 100a thereof,
Having regard to the proposal from the Commission,
In cooperation with the European Parliament (1),
Having regard to the opinion of the Economic and Social Committee (2)
Whereas the free movement of foodstuffs is an essential pre-condition for the completion of the internal market; whereas this principle implies confidence in the standard of safety of foodstuffs for human consumption in free circulation, and in particular their standard of hygiene, throughout all stages of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer;
Whereas the protection of human health is of paramount concern;
Whereas this protection has already been the subject of Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (3) as well as of more specific rules in this field; whereas an important objective of such controls is food hygiene; whereas Directive 89/397/EEC concentrates on inspection, sampling and analysis and should be supplemented by provisions aimed at improving the level of food hygiene and increasing confidence in the standard of hygiene of foodstuffs in free circulation;
Whereas the general rules of hygiene for foodstuffs to be observed at the time of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer must be harmonized in order to protect human health;
Whereas the use of hazard analysis, risk assessment and other management techniques to identify, control and monitor critical points is recognized;
Whereas microbiological criteria and temperature control criteria may be adopted for certain classes of foodstuffs; whereas, if adopted, they should be in accordance with scientifically accepted general principles;
Whereas Member States shall encourage and participate in the development of guides to good hygiene practice to which food businesses may refer, based, where appropriate, on the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius (4);
Whereas the Commission, assisted by Member States and other interested parties, is to encourage the development of guides to good hygiene practice to which food businesses may refer where necessary throughout the Community;
Whereas, however, a food business operator is responsible for the hygiene conditions in his food business; whereas this Directive does not therefore impose observance of guides to good hygiene practice, which have no legal force;
Whereas, in order to have the general rules of hygiene for foodstuffs and the guides to good hygiene practices implemented, the application of standards of the EN 29000 series should be recommended;
Whereas observance of the general rules of hygiene for foodstuffs should be controlled in accordance with Directive 89/397/EEC by the competent authorities of the Member States, with the aim of preventing the consumer from being harmed by foodstuffs unfit for human consumption or potentially dangerous to human health;
Whereas food business operators must ensure that only foodstuffs not harmful to health are placed on the market and appropriate powers should be granted to the competent authorities to protect public health; whereas, however, the legitimate rights of food businesses should be guaranteed;
Whereas the Commission should be made aware of the identity of the competent authorities in the Member States responsible for the official control of food hygiene,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive lays down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with these rules.
2. This Directive shall apply without prejudice to the provisions adopted in the context of more specific Community food hygiene rules. Within three years of the adoption of this Directive, the Commission shall examine the relationship between the specific Community food hygiene rules and those of this Directive and, if necessary, make proposals.
Article 2
For the purposes of this Directive:
- food hygiene, hereinafter called 'hygiene' shall mean all measures necessary to ensure the safety and wholesomeness of foodstuffs. The measures shall cover all stages after primary production (the latter including, for example, harvesting, slaughter and milking), during preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer,
- food business shall mean any undertaking, whether for profit or not and whether public or private, carrying out any or all of the following: preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling or offering for sale or supply of foodstuffs,
- wholesome food shall mean food which is fit for human consumption as far as hygiene is concerned.
Article 3
1. The preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply of foodstuffs shall be carried out in a hygienic way.
2. Food business operators shall identify any step in their activities which is critical to ensuring food safety and ensure that adequate safety procedures are identified, implemented, maintained and reviewed on the basis of the following principles, used to develop the system of HACCP (Hazard analysis and critical control points):
- analysing the potential food hazards in a food business operation,
- identifying the points in those operations where food hazards may occur,
- deciding which of the points identified are critical to food safety - the 'critical points',
- identifying and implementing effective control and monitoring procedures at those critical points, and
- reviewing the analysis of food hazards, the critical control points and the control and monitoring procedures periodically and whenever the food business operations change.
3. Food business operators shall comply with the rules of hygiene as listed in the Annex. Derogations from certain provisions of the Annex may be granted according to the procedure laid down in Article 14.
Article 4
Without prejudice to more specific Community rules, microbiological criteria and temperature control criteria for certain classes of foodstuffs may be adopted in accordance with the procedure laid down in Article 14 and after consulting the Scientific Committee for Food set up by Decision 74/234/EEC (5).
Article 5
1. Member States shall encourage the development of guides to good hygiene practice which may be used voluntarily by food businesses as a guide to compliance with the provisions of Article 3.
2. Where the guides to good hygiene practice referred to in paragraph 1 are developed, they shall be developed as follows:
- by food business sectors and representatives of other interested parties, such as appropriate authorities and consumer groups,
- in consultation with interests substantially affected, including the competent authorities,
- where appropriate, having regard to the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius.
3. The guides referred to in paragraphs 1 and 2 may be developed under the aegis of a national standards institute referred to in list 2 of the Annex to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (6).
4. Member States shall assess the guides to good hygiene practice referred to in paragraphs 1 and 2 with a view to determining the extent to which they may be presumed to comply with Article 3.
5. Member States shall forward to the Commission those guides to good hygiene practice which they presume to comply with Article 3.
The Commission shall make these guides available to the Member States.
6. Where one or more Member States, or the Commission, consider that, for the purposes of harmonization, there may be a need for guides to good hygiene practice to be developed on a European basis (hereafter referred to as 'European guides to good hygiene practice'), the Commission shall consult Member States in the framework of the Standing Committee on Foodstuffs in accordance with Article 14. The object of this consultation shall be to consider the case for such voluntary guides in the sectors or activities concerned, and, where such guides are considered necessary:
- to indicate the intended scope, subject matter and timetable for development of such voluntary guides, taking into account the time needed for consultation with interests substantially affected by them, and
- to refer such voluntary guides for development and/or assessment under the aegis of a European standards institute.
7. In developing the European guides to good hygiene practice referred to in paragraph 6, all necessary measures shall be taken in order to:
- ensure that such guides are developed by representatives of food business sectors and representatives of other interests substantially affected, such as, for example, the competent authorities and consumer groups,
- ensure that the contents of such guides comply with the provisions of Article 3 and, where appropriate, have regard to the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius,
- ensure that the contents of such guides are practicable for the food industry sectors to which they refer throughout the Community,
- ensure that the relevant guides to good hygiene practice drawn up in accordance with paragraphs 1 to 3 are taken into account,
- ensure that all interests substantially affected by such guides, including Member States, are consulted and their comments taken into account.
8. The titles and references of European guides to good hygiene practice developed in accordance with the procedure in paragraphs 6 and 7 shall be published in the C series of the Official Journal of the European Communities. Member States shall ensure that such published guides are drawn to the attention of the relevant food business sectors and the appropriate authorities in their territories.
Article 6
Member States shall, if they consider it appropriate, recommend food business operators to apply the European Standards of the EN 29000 series in order to implement the general rules of hygiene and the guides to good hygiene practice.
Article 7
1. Subject to the Treaty, Member States may maintain, amend or introduce national hygiene provisions that are more specific than those laid down by this Directive, provided that such provisions:
- are not less stringent than those given in the Annex,
- do not constitute a restriction, hindrance or barrier to trade in foodstuffs produced in accordance with this Directive.
2. Until detailed provisions have been laid down in accordance with Article 4, Member States may maintain, amend or introduce the relevant national provisions, subject to the Treaty.
3. Should a Member State deem it necessary, in the cases provided for in paragraphs 1 and 2, to adopt new legislation or amend existing legislation, it shall communicate to the Commission and the other Member States the measures envisaged and give the reasons justifying them. The Commission shall consult the Member States within the Standing Committee on Foodstuffs set up by Decision 69/414/EEC (7) if it considers such consultation to be useful or if a Member State so requests.
The Member State may take the envisaged measures only three months after such communication and provided that it has not received an opinion to the contrary from the Commission.
In the latter event, before the expiry of the period referred to in the second subparagraph, the Commission shall initiate the procedure provided for in Article 14 in order to determine whether the envisaged measures may be implemented subject, if necessary, to the appropriate amendments.
Article 8
1. The competent authorities shall carry out controls in accordance with Directive 89/397/EEC in order to ensure that the provisions of Article 3 of this Directive and, where appropriate, any provisions laid down pursuant to Article 4 of this Directive are being complied with by food businesses. In doing so, due consideration shall be given to the guides to good hygiene practice referred to in Article 5 of this Directive, where they exist.
2. Inspections by competent authorities shall include a general assessment of the potential food safety hazards associated with the business. Competent authorities shall pay particular attention to critical control points identified by food businesses to assess whether the necessary monitoring and verification controls are being operated.
Member States shall provide that all food premises are inspected at a frequency which has regard to the risk associated with the premises.
3. The competent authorities shall ensure that controls on foodstuffs imported into the Community are carried out in accordance with Directive 89/397/EEC for the purpose of ensuring that the relevant provisions of Article 3 and, where appropriate, any provisions laid down pursuant to Article 4, are being observed.
Article 9
1. If while carrying out the controls referred to in Article 8, the competent authorities ascertain that failure to comply with the provisions of Article 3 or, where appropriate, any provisions laid down pursuant to Article 4 might result in risks to the safety or wholesomeness of foodstuffs they shall take appropriate measures, which may extend to the withdrawal and/or the destruction of the foodstuff or to the closure of all or part of the undertaking for an appropriate period of time.
In determining the risk to food safety or wholesomeness regard shall be had to the nature of the food, the manner in which it is handled and packed and any process to which the food is subjected before supply to the consumer and the conditions under which it is displayed and/or stored.
2. Member States shall take the necessary measures to ensure that any natural or legal person affected by the control has a right of appeal against the measures taken by the competent authority following the control.
Article 10
1. If a hygiene problem likely to pose a serious risk to human health arises or spreads in the territory of a third country, the Commission, either on its own initiative or at the request of a Member State, shall take the following measures without delay, depending on the seriousness of the situation:
- suspend imports from all or part of the third country concerned and, where necessary, from the transit third country, and/or
- lay down special conditions for foodstuffs from all or part of the third country concerned.
2. The Commission may, in the case provided for in paragraph 1, take interim protective measures regarding the foodstuffs concerned.
3. Except in an emergency, the Commission shall consult the Member States before taking the measures referred to in paragraphs 1 and 2.
4. The Commission shall notify the Council and the Member States without delay of any decision taken pursuant to paragraphs 1 and 2.
Any Member State may refer the Commission's decision to the Council within 30 days of the notification referred to in the first subparagraph. The Council, acting by a qualified majority, may confirm, amend or revoke the decision adopted by the Commission. If the Council has not taken a decision within 30 days, the decision of the Commission is deemed to be revoked.
5. Where a Member State officially informs the Commission of the need to take safeguard measures and the Commission has not had recourse to the provisions of paragraphs 1 and 2, that Member State may take interim protective measures with regard to imports of the foodstuffs in question.
When a Member State takes interim protective measures, it shall inform the other Member States and the Commission.
Within 10 working days, the Commission shall put the matter before the Standing Committee on Foodstuffs in accordance with the procedure laid down in Article 14 with a view to the extension, amendment or abrogation of the national interim protective measures.
Article 11
1. Where a Member State, as a result of new information or of a reassessment of existing information, has good reason to suspect that application of the detailed provisions laid down pursuant to Article 4 constitutes a health risk, it may temporarily suspend or restrict application of the provisions in question in its territory. It shall inform the other Member States and the Commission thereof without delay and give reasons for its decision.
2. The Commission shall examine the reasons given by the Member State referred to in paragraph 1 as soon as possible in the Standing Committee on Foodstuffs and shall deliver its opinion and take any necessary measures in accordance with the procedure laid down in Article 14.
Article 12
Member States shall designate the competent authorities responsible for the control of hygiene and shall notify the Commission of them.
Article 13
Amendments to references to international standards, such as those of the Codex Alimentarius, contained in this Directive, may be adopted in accordance with the procedure laid down in Article 14.
Article 14
The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as 'the Committee').
The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission.
The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 15
The Commission shall submit a report to the European Parliament and the Council, by 31 December 1998, together with any appropriate proposals, on the experience gleaned from the implementation of this Directive.
Article 16
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 months after adoption. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Member States shall communicate to the Commission the provisions of national law which they adopted in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 17
This Directive is addressed to the Member States.
Done at Luxembourg, 14 June 1993.