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Luxembourg, 27 June 2002

Hygiene rules: Byrne welcomes Council agreement on more flexibility particularly for traditional products

The Council has reached today a political agreement on the Commission's proposal on the hygiene of foodstuffs presented by the European Commission on 14 July 2000. Under this proposal food operators right through the food chain will bear primary responsibility for food safety. The focus is on setting objectives while leaving business flexibility to decide the safety measures to take, rather than prescribing them in great detail. The Council followed the Commission's proposal in providing for flexibility to accommodate the needs of food businesses that are situated in regions suffering from special geographical constraints and to take account of traditional methods of food production.

The Council largely endorses the basic principles underlying the new hygiene rules. These aim to introduce a uniform and all embracing hygiene regime covering all food in all sectors. It replaces Directive 93/43/EEC and fills the gaps that were left in that Directive. It now applies to the entire food chain including primary production and products of animal origin.

"Sound effective hygiene rules are the bottom line to ensure safe food. I welcome the excellent work undertaken by the Council", said David Byrne, Commissioner for Health and Consumer Protection. "I am particularly grateful that the need for flexibility has been generally endorsed. Throughout the Union, there are longstanding cultural traditions with regard to food and food preparation that I am keen to protect and encourage. Producers of such traditional food make an enormous contribution to our cultural diversity, through enabling us to enjoy a wide variety of foods and flavours. The rules on food hygiene as agreed today are flexible enough to ensure that these traditions are preserved. The new rules can also be shaped so as to take account of the situation of food businesses that are situated in regions suffering from geographical constraints such as those located on remote islands and in mountainous areas."


The implementation of harmonised hygiene rules has in the past proved difficult in traditional food production and in food businesses in remote islands, mountain areas and other geographically isolated regions. "The responsibility for adapting the rules to such local situations is to be left to Member States since they are better placed to judge and find appropriate solutions, provided the basic principle of food safety is not compromised", David Byrne said.

The political agreement of today confirms the Commission view that flexibility is necessary to safeguard traditional methods of food production and also for regions suffering from geographical constraints. The leading principles for implementing flexibility are subsidiarity and transparency.

This will allow adaptation of the rules openly without compromising the basic objectives of food hygiene and will allow the continued use of for example traditional maturation techniques that are applied for the manufacture or traditional meat and dairy products.

Implementation of a HACCP system implies the involvement of staff with specialised skills, which small and medium enterprises (SMEs) may not have. Therefore special arrangements to facilitate HACCP implementation are foreseen, in particular by providing for the use of procedures set out in guides for the application of HACCP principles. Such sectoral codes can give for example small cheese producers more detailed indications on hazards and controls.

These special arrangements may also specify the period during which food business operators shall retain documents that must demonstrate the effective application of the HACCP measures, where such documents are required.

The Council also accepted the amendment of the European Parliament, supported by the Commission, that introduces some limitation to the scope of the Regulation. This amendment aims to exclude 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. The Commission believes that that such activities have an exclusively local character. As a matter of subsidiarity, such activities should be dealt with by the Member States. The Commission therefore welcomes the Council's addition that Member States shall establish, under national law, rules governing these activities. The exclusion of the direct supply of natural products, such as wild berries, fish, wild game, home grown fruit etc. from the scope of the Regulation is in line with the need to apply a certain degree of flexibility.

Basic principles

A basic principle is the primary responsibility of food producers for the safety of food through the use of programmes for self-checking and modern hazard control techniques. The implementation of a harmonised Hazard Analysis Critical Control Point (HACCP) system will become obligatory for all non-primary food operators. This type of self-checking programme is already in place in parts of the food industry, but not yet in others, for example in egg processing factories. HACCP prescribes a logical series of steps to identify, throughout the production chain, points where control is critical to food safety and to focus on the specific hazards particular to the business concerned.

In most food businesses checking the quality of raw materials, avoiding bacterial contamination (for example salmonella), maintaining the cold chain during storage and transport and appropriate anti-bacterial heat treatment are critical in ensuring safety. Companies will be obliged to keep records of safety checks carried out under HACCP for surveillance purposes. On farms, Codes of Good Practice are to be used as the safety management instrument. The Council has accepted the Commission's point of view that the introduction of HACCP at farm level is over-ambitious and disproportionate.

Another key principle is the compulsory registration of all food businesses. Such registration will allow competent authorities to better organise their controls.

These principles together with the key principles of traceability and the withdrawal from the market of food presenting a serious risk to consumer health (as already laid down in the General Food Law) will constitute a coherent set of rules that will lead to enhanced consumer protection.

The basic hygiene rules which are part of standard operating procedures of food businesses, cleanliness of premises, washing hands before handling food, etc, remain as before.

Legislative process

The proposal takes the form of Council and Parliament Regulation rather than a Directive to ensure uniform application, better transparency and to facilitate rapid updating in the light of new technical and scientific developments. The Commission is particularly pleased that the Council acknowledges the need for Regulations in matters of food hygiene as opposed to a looser framework of Directives. Given that in the past food hygiene rules were not always uniformly implemented across the Member States, it is hoped that this approach will achieve the objective of more uniform implementation. The proposal on food hygiene must be seen as a reference text for the other proposals of the food hygiene package. The political agreement offers therefore a solid basis for the further development of the other proposals in the food hygiene package.

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