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 comp
