After much debate over its remit, functions and even its name, the European Food Safety Authority (EFSA) was finally born on 28 January 2002. The authority is, however, only one part of the EU's vision for food safety in the 21st century. Alongside its creation comes a whole new set of principles and mechanisms for ensuring that the food enjoyed throughout Europe is safe to eat.

The EU regulation which creates the EFSA also lays down the general principles of food law and sets out agreed principles governing food and feed in general, with particular reference to safety. It sets out general obligations on food and feed businesses, on the Commission and on the member states and lays down rules and procedures on issues such as traceability, use of the precautionary principle, the operation of rapid alert systems and crisis management.

The overall stated aim of the regulation is to provide the basis for guaranteeing a high level of human health and consumer protection, taking account of diversity in the food supply, including traditional products, and the need for effective functioning of the internal market.

Principles of food law

The regulation requires that food law "shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers' interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment." It must aim to achieve the free movement of goods and must, as a rule, take into account international standards.

Food law must be based on risk analysis where appropriate and any risk assessment must be based on the available scientific evidence available and undertaken in an independent, objective and transparent manner. Risk management must take account of risk assessment results, the opinion of the EFSA, other legitimate factors and the precautionary principle where relevant. The precautionary principle approach is permitted where there may be harmful effects on health and where scientific uncertainty persists. However, any measures taken must be proportionate and must take account of technical and economic feasibility and other legitimate factors in the case at hand.

Food law must also protect consumer interests by preventing fraudulent or deceptive practices, the adulteration of food and other misleading practices. The regulation requires open and transparent public consultation during the preparation, evaluation and revision of food law, except where urgency prohibits this.

Principles of food/feed safety

No food or feed may be placed on the market if it is unsafe - meaning if it is injurious to health or unfit for human consumption. Certain aspects must be considered when making this determination, eg normal conditions of use, labelling, long-term effects of consumption, and probable cumulative toxic effects etc. Feed is unsafe if it has an adverse effect on human or animal health or it makes the food derived from food-producing animals unsafe.

Any food or feed imported into the EU must comply with the relevant requirements of food law or equivalent conditions/requirements recognised by the Community. Likewise, any food or feed exported must comply with food law unless otherwise requested by the authorities of the importing country. Where food/feed which cannot be marketed in the EU is exported or re-exported, the receiving country must be informed of the reasons and circumstances for the non-marketing. In a further bid to protect third countries, the regulation says that when contributing to the development of international food standards the EU and member states must not create unnecessary obstacles to developing countries' exports.

Obligations

Food and feed business operators are required to comply with food law and member states are obliged to monitor that compliance and to enforce food law. The latter must maintain a system of official controls, including public communication on safety and risks, food/feed safety surveillance and other monitoring activities at all stages of production, processing and distribution. They must also determine measures and penalties applicable to infringements. These must be effective, proportionate and dissuasive.

In addition to the existing EU requirement that the labelling, advertising and presentation of food must not mislead consumers, all food and feed must now be labelled or identified in such a way as to permit traceability. Business operators must be able to identify those supplying them with any food, feed, food-producing animal or any substance for incorporation into food/feed, as well as those whom they supply. This information must be available to the competent authorities upon demand.

Where a food business operator considers that a food which it has imported, produced, processed, manufactured or distributed does not comply with food safety requirements, it must immediately initiate procedures to withdraw that food from the market and must inform the competent authorities. Where the product may have reached the consumer, the operator must effectively and accurately inform the consumers of the reason for withdrawal, and if necessary, recall from consumers products already supplied to them.

Where the food may be injurious to health, the business must immediately inform the competent authorities of this and of the action taken to prevent risks. They must not prevent or discourage any person from co-operating with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food. Similar rules apply to feed business operators.

Crisis management

The regulation formally establishes a rapid alert system for the notification of food and feed safety risks. The system, managed by the Commission, comprises a network of contact points in each member state, the Commission and the EFSA. Serious risks to human health, both direct and indirect, must be notified to the Commission who will then notify the other members of the network. Member states must notify any measures taken which impose restrictions on food, including agreements with professional operators, and details of any health risk-based rejections of food or feed at border posts.

Border post rejections must be immediately notified by the Commission to all other EU border posts and to the originating country. Information given to the network will, in general, be open to the public. However, information governed by professional secrecy will not be released except where required to protect human health.

Where the risks to human health cannot be contained satisfactorily by national measures the Commission has the power to suspend the marketing or use of, or lay down other measures governing, the food or feed in question. Where a member state informs the Commission of a need to take emergency measures and the Commission fails to follow the above rule, that member state may adopt interim protective measures.

In the longer term, the regulation requires the Commission to draw up, in close co-operation with the EFSA and the member states, a general plan for crisis management in the field of food and feed safety. This will specify the types of situation involving health risks which are unlikely to be controlled using existing provisions. It will specify the practical procedures necessary to manage a crisis, including the principles of transparency to be applied and a communication strategy.

The Commission is empowered to set up a crisis unit immediately, in which the EFSA will participate, and provide scientific and technical assistance if necessary. This unit would collect and evaluate all relevant information and identify the options available to control the risk as effectively and rapidly as possible. The unit would be able to call upon any public or private person whose expertise it deemed necessary to manage the crisis effectively and would have to inform the public of the risks involved and the measures taken.

Regulation (EC) no 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31. 01.02.02 pp 1-24