The European Commission today adopted a proposal for a Regulation of the Parliament and Council, to be adopted by co-decision, laying down fundamental principles and requirements of food law and establishing a European Food Authority (EFA). The proposal presented by Health and Consumer Commissioner David Byrne together with the Enterprise Commissioner Erkki Liikanen is the centrepiece of the Commission's strategy for a proactive food policy covering the entire food chain, from the farm to the fork. Its primary objective is to provide the basis for the assurance of a high level of protection of human life whilst ensuring the effective functioning of the internal market. The package will not only contribute to a high level of consumer health protection in the area of food safety, but also to the restoration and maintenance of consumer confidence in food. The Commission decided that the necessary staffing and resources would have to be devoted to the EFA to ensure its success. Within 3 years it is expected to have about 250 staff and a budget of some €40 million. A review of ultimate staffing and budgetary requirements will be made at this time so as to ensure that the Authority has the resources necessary for its full operation. Preliminary figures would indicate a staff size of around 330. The Commission will subsequently come forward with its proposal for the location of the EFA.
"Safety is the most important ingredient in our food. Europe must have the capacity to ensure that we can deliver this to our consumers. This legislative package is designed to overcome the weaknesses of the past and put food safety firmly on top of our agenda. The substantive food law and the creation of the European Food Authority are the building blocks, the very foundations upon which our new food safety policy will rest," Health and Consumer Commissioner David Byrne said when presenting the proposal.
Byrne went on to emphasise, "We have to re-gain public confidence in the capacity of the food industry and in public authorities to ensure that food is safe. The new food law provides the basic principles and requirements for the marketing of food and for the assurance of a safe food supply to consumers. It will also address the safety of animal feeds particularly where these may have a direct or indirect effect on food safety. A well-resourced Food Authority underpins this approach with top class, up-to-date scientific advice to consumers, industry, Member States, the Commission and the European Parliament. A key element of the Authority is the closest involvement of the food safety authorities of the Member States to facilitate the early identification of emerging risks and to avoid confusing and conflicting messages to consumers."
Launching the legislation, Commissioner Liikanen said, "It is vital that the highest standards are applied in the food industry in the common interests of consumers and industry. Our food industry employs over 2.6 million people in Europe with annual production exceeding €600 billion. A food industry that applies the very best standards of food safety will continue to grow, be competitive and increase employment."
Today's proposal for a regulation lays out the basic principles and requirements for the marketing of food and feed, to assure a safe food supply, and sets up the Food Authority as the key instrument in achieving the new food law objectives. The regulation establishes crisis management procedures, expands the rapid alert system, puts in place procedures to prevent the marketing of unsafe foods and places responsibility on businesses to put only safe food and feed on the market. This integrated and comprehensive approach initiates a new way of dealing with food safety.
General food law principles and requirements
The proposal lays down common overarching principles and requirements for EU food law, harmonising divergent approaches both at European and national level. The guiding principles as presented today will form the basis for any future revision of existing and for any new proposals for food legislation.
The main provisions of the law are the following:
Setting up a European Food Authority
The European Food Authority will give effect to the general principles and requirements of food law and will have a key role in improving human health protection and consumer confidence. The Authority will be a separate legal entity from the Community institutions. Its mandate is broad, so that it can take a comprehensive view of the food chain and provide a coherent scientific basis for policy and legislation. Therefore the EFA will cover all issues having a direct or indirect impact on the safety of food, as well as animal health and welfare and plant health and nutrition. It will also provide scientific opinions on any issue related to genetically modified organisms.
The EFA will have six main functions:
The main focus of the EFA will be to provide excellent, independent scientific advice and establish a network of close co-operation with similar bodies in Member States. It will have a key function in assessing risks related to all food and feed operations.
Management board: The Authority will be fully independent, transparent in its workings and accountable to democratic institutions. Its Management Board will be composed of four representatives appointed by the Council of Ministers, four representatives appointed by the Commission, four representatives appointed by the European Parliament, and four representatives of consumers and industry designated by the Commission. The Board, on the basis of a proposal by the Commission, will appoint the Executive Director for a period of 5 years.
Advisory Forum: The EFA will be assisted by an Advisory Forum, composed of fifteen representatives from competent bodies in the Member States, e.g. national food agencies.
Scientific Panels: The Scientific Panels will be composed of independent scientific experts following a call for expressions of interest and appointed by the Management Board. . The following panels will be established (replacing the current Scientific Steering Committee and five sectoral Scientific Committees): the panel on food additives, flavourings, processing aids and materials in contact with food; the panel on additives and products or substances used in animal feed; the panel on plant protection products and their residues; the panel on genetically modified organisms; the panel on dietetic products, nutrition and allergies; the panel on biological hazards; the panel on contaminants in the food chain; the panel on animal health and welfare. A Scientific Committee will be responsible for the general co-ordination necessary to ensure the consistency of the scientific opinion procedure. This Committee will be composed of the Chairpersons of the Scientific Panels and six independent experts who do not belong to any the panels.
Personnel and budget: The EFA will be funded from the Community budget and, when fully operational could in the light of the review employ about 330 staff, including a substantial in-house scientific expertise. Its resource needs will be reviewed within three to four years to establish more precisely its needs in the light of operational experience. It is envisaged that some 250 people will be employed by the Authority within three years, with a budget of some €40 million. The EFA will initially be funded from the Community budget, but the feasibility of partial funding by fees for services provided will be examined.
Conflicting scientific opinions
The Authority will be mandated to exercise vigilance in order to ensure early identification of a potential source of conflict between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks. A main contribution to solve upcoming potential conflicts will be the effective running and setting up of scientific networks. If the EFA identifies a potential source of conflict, it shall ensure that all relevant scientific information is shared. Where the conflict involves a national scientific body, the EFA and this body shall be obliged to co-operate, in consultation with the Advisory Forum, with a view to either resolving the conflict or presenting a joint document clarifying the contentious scientific issues.
Members of the Management Board, the Advisory Forum and scientists on the panels shall act independently. For this purpose they will make a declaration of commitment and a declaration of interests annually in writing. At each meeting they will declare any special interest which might be considered prejudicial to their independence in relation to the items on the agenda.
Proactive analysis and networking
Central to the restoration of consumer confidence, the Authority will have a clear pro-active role in collection and analysis of scientific and other relevant types of data, allowing for identification and early warning of emerging risks in the food chain. The EFA will co-ordinate the collection of exposure data from a variety of monitoring programmes. The EFA will collaborate with scientific and institutions in the Member States and the Joint Research Centre of the Commission to make the best possible use of available expertise. The Authority will be expected to set up fully integrated networks with authorities, universities and research institutes in the Member States. It will be able to commission short-term scientific activities when required to complete the scientific basis for its advice, and to outsource certain of its tasks.
A special role in communication and transparency
The Authority will communicate actively with the public about its work and results. The information will be objective, reliable and easily understandable for the general public.
The EFA will make public the opinions of the Scientific Committee and the scientific panels, minority opinions always being included, as well as the annual declarations of interest and the declarations of interest made in relation to items on the agendas of meetings and the results of scientific work. The Management Board is enabled to hold some of its meetings in public and may invite consumer representatives to observe some of the EFA´s activities. It shall also ensure wide access to documents it posesses.
Crisis management: rapid alert and planning for crisis management
The Commission remains responsible for risk management measures, and for emergency measures such as marketing bans or imposing specific conditions for marketing. In fact, this proposal extend to all foods, whatever the type and origin, the emergency procedures existing at present in the veterinary sector, on the basis of which the Commission can adopt a ban, on its own initiative or at the request of a Member State, in case of serious risk to human health. Within less than 10 working days such measures are to be reviewed by a newly created Committee on Food safety and Animal Health, in which will be merged four existing standing Committees.
It is proposed that the EFA will be charged with the day-to-day operation of a broadened rapid alert system for food and feedstuffs involving the Member States, the Commission and the EFA. The new rapid alert system will cover the entire food chain, notably adding feed to its scope. The system is based on the obligation for the members of a network to notify to the EFA any information relating to the existence of a serious direct or indirect risk to human health deriving from food or feed. Food and feed businesses shall also immediately inform their national competent authorities if they establish that a product poses a serious direct or indirect risk to health. Member States must forward any such information to the EFA and also notify all measures taken to restrict the marketing of a product, whether of EU origin or imported. The EFA will evaluate if the product in question poses a serious risk to health and, if so, immediately transmit such information to other authorities in the rapid alert network. The expertise of the Authority will bring the necessary scientific and technical expertise to assess the notifications received through this system on their health impact and urgency. The Authority will also assist as necessary in crisis management. The Commission will, together with the EFA and the Member States draw up a plan for food and feed crisis management. In case of a crisis, the Commission would set up immediately a crisis unit, involving the Authority for necessary scientific and technical advice. The crisis unit would collect and evaluate all relevant information and identify options to prevent, reduce or eliminate the risk effectively and rapidly. The crisis unit would equally be in charge of measures to inform the public in times of crises.
The White Paper on Food Safety of January this year set out to modernise legislation and produce a coherent and transparent set of rules, reinforcing controls from the farm to the table and increasing the capability of our scientific advice system. Public consultations on the White paper and reactions of the European Parliament and the Council of Ministers confirmed that the creation of a Food Authority with scientific and technical competence is generally regarded as the most effective way to address to growing need for a solidly science-based policy and to increase consumer confidence.
History of scientific advice in the EU
Fundamental changes in the organisation of scientific advice on which Community legislation is based were first introduced in 1997, in response to the BSE crisis. The basic principle of separation of risk assessment and risk management was developed in the Commission Communication of April 1997 and implemented with a Decision of October 1997 setting up a scientific Steering Committee and 8 specialised scientific committees. At the same occasion, the principles of independence, excellence and transparency were set out as the basic operating rules for the functioning of these committees.
Practical experience acquired in the work of the committees over the past years has demonstrated a lack of capacity in the current system which has led to serious delays in both the delivery of advice required for decisions to manage risks to consumer health and for the authorisation of products, processes and -substances under EU legislation. Notably the lack of in-house scientific expertise to undertake preparatory work for the actual risk assessment task of the committee's members was identified in the White Paper on Food Safety (link) as a hindrance to the delivery of rapid and effective advice.