The establishment of the new European Union food safety control system has moved forward a step with the publication of a draft regulation which lays down the general principles and requirements of food law. Tina Garrity reports

The regulation, as drafted, seeks to define the overall purpose of food law. It states that food law shall have as its main objectives the protection of human life, health or safety and the protection of consumers' interests. It shall have other objectives as appropriate, including the protection of the environment, animal health, life and welfare, and plant health and life. Food law must also seek to achieve the free movement of food and feed produced in accordance with the regulation. The proposal envisages that when food laws are drafted or adapted, account will have to be taken of international standards; but not where they would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law, or where there is scientific justification, or where they would result in a different level of protection than the one deemed appropriate in the EC.

The proposal goes on to say that food law must be based on risk analysis, except where inappropriate to the circumstances or the nature of the measure. Risk assessment must be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. Risk management must take into account the results of risk assessment and the opinion of the European Food Authority (EFA).

The role of the precautionary principle in food safety matters is spelt out as follows:
"In those specific circumstances where, following an assessment of available pertinent information, a risk to health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, while awaiting further scientific information for a more comprehensive risk assessment."
Any measures taken must be proportionate and no more trade-restrictive than required to achieve a high level of health protection. They must be reviewed within a reasonable time period depending on the nature of the risk and the type of scientific information required to resolve the issue.

The proposal lays down some general principles on consumer protection and on traceability. It places a general obligation on businesses to satisfy the relevant requirements of food law and to institute systems and procedures to verify and monitor that such requirements are met. Business operators must inform the competent authorities where a problem has arisen with food which has been placed on the market. They must collaborate with the authorities on the necessary action, including initiating product withdrawal procedures.

Member states, for their part, are required to enforce food law and to maintain a system of official controls. These include measures and penalties which are effective, proportionate and dissuasive. When determining if food is injurious to health, regard must be paid not only to short-term effects, but also to potential cumulative toxic effects and to the particular sensitivities of certain categories of consumers where the food is intended for that category. The regulation would require effective public consultation on the elaboration of food law wherever circumstances allow, and the provision of information to the public where food may present a risk to health.

european food authority
The mission of the long-awaited EFA, as stated in the proposal, will be to contribute to a high level of health and environmental protection while facilitating the functioning of the internal market. It would do this by creating an integrated coherent system of scientific and technical support for legislation and policy and by providing independent information and risk communication. The EFA would also operate the rapid alert system for food and feedstuffs.

Fourteen key tasks are envisaged for the EFA, mostly concerning the collation, analysis and provision of scientific data and opinion and the identification of risks. For example, the collection of data on food consumption and exposure to risk, the incidence and prevalence of biological risk and contaminants in food, including residues. In particular, it would seek to identify and notifying emerging risks. Under the proposal, the EFA is charged with ensuring that the public receive rapid, reliable, objective and comprehensible information in fields within its mission. It would be able to publish information on its own initiative.

Organisationally, it would consist of a management board, an executive director and staff, an advisory forum and a scientific committee with scientific panels - which would replace the six existing scientific committees. Details of how all these would operate are set out in the draft regulation. The advisory forum would consist of representatives from the national competent bodies. It would advise the executive director in the performance of his/her duties and ensure close co-operation between the EFA and the national bodies. The EFA would be required to commission scientific studies to assist it in its work but must avoid duplication with existing national or Community research programmes. In all things it must be independent and transparent.

Funding would be by Community contribution and, in due course, by any fees received for services provided, for example, fees paid by undertakings seeking Community authorisations for their products. The EFA would have legal personality and would be able to institute legal proceedings. Additionally, there would be a Committee on Food Safety and Animal Health. It is unclear from the regulation what its precise role would be, or how it would relate to the EFA, but the accompanying explanatory memorandum suggests that it would foster greater harmony of approach and provide flexibility to manage problems which affect several sectors, for example dioxin contamination of feed.

The full text of the draft regulation and the accompanying explanatory memorandum have been published as a 67-page document on the Commission's website at
http://europa.eu.int/comm/ food/fs/intro/efa_prop_en.pdf