The EU’s legislation governing the general principles of food law and harmonised controls also underpins the European Food Safety Authority, a European agency which provides the scientific reference point for food-related control and evaluation.
Advertisement
ACT
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.
SUMMARY
The White Paper on food safety emphasises the need for a policy underpinned by a sound scientific basis and up-to-date legislation. The general overhaul of EU legislation is designed to restore consumer confidence in the wake of recent food-related crises, with all the interested parties having a part to play: the general public, non-governmental organisations, professional associations, trading partners and international trade organisations.
The free movement of safe and wholesome food is a key principle in the smooth functioning of the internal market. Since differences between the food laws of the Member States may hamper the free movement of foodstuffs, it is necessary to define at EU level a common basis for measures governing human food and animal feed.
With a view to adopting a comprehensive, integrated “farm to table” approach, legislation must cover all aspects of the food production chain: primary production, processing, transport, distribution through to the sale or supply of food and feed. At all stages of this chain, the legal responsibility for ensuring the safety of foodstuffs rests with the operator. A similar system should apply to feed business operators.
The European Food Safety Authority (EFSA) enhances the current scientific and technical support system. Its main task is to provide assistance and independent scientific advice, and to create a network geared to close cooperation with similar bodies in the Member States. It assesses risks relating to the food chain and informs the general public accordingly.
Lastly, the recent food crises have shown that it is necessary to improve the procedures relating to food safety. For this reason,the scope of the rapid alert system was extended to cover animal feed and to identify measures to be taken in emergencies and for crisis management. A Standing Committee on the Food Chain and Animal Health is also being set up to replace the existing committees.
GENERAL FOOD LAW
General food law covers all stages of the food production chain. The related principles and procedures in force must be adapted as soon as possible.
General principles
The objectives pursued by means of food law are:
- protection of human life and health, and protection of consumers’ interests, with due regard for the protection of animal health and welfare, plant health and the environment;
- EU-wide free movement of human food and animal feed;
- consideration of existing or planned international standards.
Food law is based mainly on risk analysis drawing on the available scientific evidence. Under the precautionary principle, the Member States and the Commission may take appropriate provisional risk-management measures when an assessment points to the likelihood of harmful health effects and there is a lack of scientific certainty.
There is a requirement for transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law. When a food or feed product is deemed to constitute a risk, the authorities must inform the general public of the nature of the risk to human or animal health.
General obligations in the food trade
Food and feed imported with a view to being placed on the market or exported to a third country must comply with the relevant requirements of EU food law.
The European Union and its Member States must contribute to the development of international technical standards for food and feed, as well as for animal health and plant protection.
General requirements of food law
Food must not be placed on the market if it is unsafe, i.e. if it is harmful to health and/or unfit for consumption. In determining whether any food is unsafe, account is taken of the normal conditions of use, the information provided to the consumer, the likely immediate or delayed effect on health, the cumulative toxic effects and, where appropriate, the particular health sensitivities of a specific category of consumers. If food which is unsafe forms part of a batch, lot or consignment, the entire quantity is presumed to be unsafe.
Feed must not be placed on the market or given to any food-producing animal if it is unsafe. Feed is deemed to be unsafe if it has an adverse effect on human or animal health. The entire quantity of a batch, lot or consignment is considered unsafe if any part of it fails to satisfy the requirements.
At all stages of the food production chain, business operators must ensure that food and feed satisfies the requirements of food law and that those requirements are being adhered to. The Member States enforce the law, ensuring that operators comply with it and laying down appropriate measures and penalties for infringements.
The traceability of food, feed, food-producing animals and all substances incorporated into foodstuffs must be established at all stages of production, processing and distribution. To this end, business operators are required to apply appropriate systems and procedures.
If an operator considers that a food or feed product which has been imported, produced, processed, manufactured or distributed is harmful to human or animal health, steps must be taken immediately to withdraw the product from the market and to inform the competent authorities accordingly. In cases where a product may have reached consumers, the operator must inform them and recall the products already supplied.
EUROPEAN FOOD SAFETY AUTHORITY (EFSA)
A European Food Safety Authority (“the Authority”) will provide scientific advice and scientific and technical support in all areas impacting on food safety. It constitutes an independent source of information on all matters in this field and ensures that the general public is kept informed.
Participation in the Authority is open to the Member States of the European Union and to other countries applying EU food safety law.
The Authority is endowed with legal personality. The Court of Justice of the European Communities has jurisdiction in any dispute relating to contractual liability.
The Authority’s tasks
In the areas within its sphere of competence, the tasks of the European Food Safety Authority are as follows:
- To provide the European institutions and the Member States with the best possible scientific advice on its own initiative or at the request of the Commission, the European Parliament or a Member State. The Authority’s independent scientific opinions have to do with matters of food safety and other related issues (animal and plant health, GMOs, nutrition, etc.). They serve as a basis for policy decisions in respect of risk management. As regards the scientific evaluation of substances, products or processes which are subject to a system of prior authorisation or registration on a positive list under EU law, sectoral Regulations or Directives of the European Parliament and of the Council lay down the procedures whereby the Authority’s scientific opinions are delivered.
- To promote and coordinate the development of uniform risk assessment methods.
- To provide scientific and technical support to the Commission.
Scientific and technical assistance involves scientific work for which the expertise of the Authority’s Scientific Committee and Panels is not needed (e.g. evaluation of technical criteria).
The Authority will also provide scientific support in connection with crisis management. - To commission scientific studies necessary for the accomplishment of its mission, whilst avoiding any duplication with European or national research programmes.
- To search for, collect, collate, analyse and summarise scientific and technical data in areas relating to food safety (exposure of individuals to risks arising from consumption of foodstuffs, biological risks, contaminants and residues).
The Commission is required to publish a report on the existing data collection systems at European level. - To take action to identify and characterise emerging risks.
The Authority will establish monitoring procedures geared to searching for, collecting, collating and analysing information and data with a view to the identification of emerging risks. - To build up European networks of organisations operating in the field of food safety.
The Authority will participate in the rapid alert system linking the Commission and the Member States. It will encourage the exchange of information, knowledge and good practice, the coordination of action and the implementation of joint projects. - The Commission is to compile an inventory of European-level data collection systems.
- To provide, at the request of the Commission, scientific and technical support aimed at improving cooperation between the Commission, the candidate countries, international organisations and third countries.
- To ensure that the general public and other interested parties receive reliable, objective and comprehensible information.
- To express its own conclusions and ideas on matters within its remit.
Organisation
The main components of the Authority are:
- Management Board
The 14 members of the Management Board are appointed by the Council, in consultation with the European Parliament, from a list drawn up by the Commission. Four of the members are required to have a background in consumer organisations and other interests in the food production chain. The Commission is represented on the Management Board. Although the members’ term of office is four years, which may be renewed once for a maximum of five years, the initial term of office for half of the members is six years. The Management Board elects its Chairperson for a two-year period, which is renewable. It adopts the rules of procedure, the work programme, the preliminary draft budget and the final budget (following the Budgetary Authority’s vote on the general budget), and the general activity report. The Management Board must ensure that the Authority performs the tasks assigned to it under the conditions laid down in the founding Regulation. - Executive Director
The Executive Director is appointed by the Management Board, on the basis of a list proposed by the Commission, for a period of five years which may be renewed for a period not exceeding five years, and is the legal representative of the Authority. Prior to being appointed, the nominee is invited to make a statement before the European Parliament and to reply to questions put by its Members. The Executive Director is responsible mainly for the day-to-day administration of the Authority and for implementation of the budget. He or she draws up a proposal for the work programme, in consultation with the Commission, and implements it, maintains contact with the European Parliament and forwards the general report on the Authority’s activities to the European institutions and bodies by 15 June of each year at the latest. - Advisory Forum
Comprising one representative per Member State (representing national bodies responsible for risk assessment), the Forum advises the Executive Director in the performance of the latter’s duties, particularly in connection with drawing up the work programme and prioritising requests for scientific opinions. Chaired by the Executive Director, the Forum meets at least four times a year. It encourages the European networking of national bodies operating within the Authority’s fields of activity: exchanging information, pooling knowledge and making the most of the available resources. - Scientific Committee and Scientific Panels
These are composed of independent scientific experts appointed for three years by the Management Board on a proposal from the Executive Director. They are responsible for adopting the Authority’s scientific opinions within their respective spheres of competence. - Scientific Committee
Composed of the chairpersons of the scientific panels and six independent experts. Responsible for general coordination with the scientific panels, it may also organise public debates and set up working groups on matters which do not fall within the competence of the scientific panels. - Scientific Panels
The ten Scientific Panels are: 1) Panel on additives, flavourings, processing aids and materials in contact with food; 2) Panel on additives and products or substances used in animal feed; 3) Panel on plant protection products and their residues; 4) Panel on genetically modified organisms; 5) Panel on dietetic products, nutrition and allergies; 6) Panel on biological hazards; 7) Panel on contaminants in the food chain; 8) Panel on animal health and welfare; 9) Panel on plant health.
The Executive Director and the members of all the bodies of the Authority undertake to act independently in the public interest. They must make a declaration of commitment and a declaration of interest indicating any interests, whether direct or indirect, which might be considered prejudicial to their independence.
The Authority will carry out its activities with a high level of transparency. In this connection, it will make public the agendas and minutes of meetings of the Scientific Committee and the Scientific Panels, the opinions adopted, the results of scientific studies, its final accounts, the annual report of activities and the annual declarations of interest made by the aforementioned parties. The Authority must ensure that the public is given objective and accessible information. The decisions it takes pursuant to Regulation (EC) No 1049/2001 regarding access to documents may form the subject of a complaint to the Ombudsman or an action before the Court of Justice.
Financial provisions
The Authority’s budget, presented by 31 March each year at the latest, consists of revenue (contributions from the European Union and from any candidate country or third party involved, charges for publications, conferences, training, etc.) and expenditure (staff, administrative, infrastructure and operational expenses, contracts entered into with third parties). It must be in balance.
Acting as the budgetary authority, the European Parliament and the Council will authorise the appropriations for the subsidy to the Authority. On a recommendation of the Council, the Parliament will, before 30 April of year “N + 2”, give a discharge to the Executive Director in respect of the implementation of the budget for year “N”.
PROCEDURES RELATING TO FOOD SAFETY
Existing procedures have been beefed up.
Rapid alert system
The rapid alert system now covers all foodstuffs and animal feed. The network involves the Member States, the Commission in a management capacity and, innovatively, the Authority as a member of the network.
By means of this rapid alert system, the Member States notify the Commission, which immediately transmits the information throughout the network, of:
- any measure aimed at restricting the placing on the market or forcing the withdrawal or recall of food or feed;
- any measure involving professional operators aimed at preventing or controlling the use of food or feed;
- any rejection of a batch or consignment of food or feed by a competent authority at a border post of the European Union.
Information concerning a food-related risk which is disseminated within the rapid alert network must be made available to the general public.
Emergencies
Where food or feed originating in the EU or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and the risk cannot be controlled by measures taken by the Member State(s) concerned, the Commission is to adopt immediately, on its own initiative or at the request of a Member State, one or more of the following measures, depending on the gravity of the situation:
- for products of EU origin: suspension of the placing on the market or use of the product in question, imposition of special conditions and adoption of any other appropriate interim measure;
- for products imported from a third country: suspension of imports, imposition of special conditions and adoption of any other appropriate interim measure.
Such measures are adopted by the committee procedure (Standing Committee on the Food Chain and Animal Health).
However, in emergencies, the Commission alone may provisionally adopt the necessary measures, after consulting the Member State(s) concerned and informing the other Member States. In such a case, the provisional measures in question must, within 10 working days at most, be confirmed, amended, revoked or extended in the context of the Standing Committee on the Food Chain and Animal Health.
When a Member State officially informs the Commission of the need to take emergency measures and the Commission does not act, the Member State may take interim protective measures. It should immediately inform the other Member States and the Commission thereof. Within a period of 10 working days, the Commission must refer the matter to the Standing Committee on the Food Chain and Animal Health with a view to extending, amending or revoking the national interim protective measures.
General crisis-management plan
In close cooperation with the Authority and the Member States, the Commission is required to draw up a general plan for crisis management, specifying the situations entailing direct or indirect risks to human health not provided for by the Regulation, and setting out the practical procedures necessary for managing a resultant crisis.
When a situation involving a serious risk cannot be dealt with under the existing provisions, the Commission must immediately set up a crisis unit, in which the Authority participates by providing scientific and technical support. The crisis unit is responsible for collecting and evaluating all relevant information and identifying the options available for preventing, eliminating or reducing the risk to human health.
Standing Committee on the Food Chain and Animal Health
A Standing Committee on the Food Chain and Animal Health, composed of representatives of the Member States and chaired by the Commission representative, is organised in sections to deal with all the relevant matters.
Final provisions
The Authority publishes its annual activity report before 15 June each year.
Before 1 January 2005, the Commission will publish a report on the experience acquired from implementing the rapid alert system and dealing with emergencies.
Before 1 January 2005, and every six years thereafter, the Authority will commission an independent external evaluation of its achievements, the impact of its activities and its working practices.
In EU legislation, reference to the European Food Safety Authority will replace every reference to the Scientific Committee on Food, the Scientific Committee on Animal Nutrition, the Scientific Veterinary Committee, the Scientific Committee on Pesticides, the Scientific Committee on Plants and the Scientific Steering Committee.
In EU legislation, reference to the Standing Committee on the Food Chain and Animal Health will replace every reference to the Standing Committee on Foodstuffs, the Standing Committee for Feedingstuffs, the Standing Veterinary Committee and the Standing Committee on Plant Health relating to plant protection products and the setting of maximum residue levels.
Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are repealed.
REFERENCES
Regulation (EC) No 178/2002 – 21.02.2002-01.01.2005 – OJ L 031 of 01. 02. 2002.
Amending acts:
Regulation (EC) No 1642/2003 [adoption: codecision COD/2002/0179] – 01.10.2003 – OJ L 245 of 29. 09. 2003
Regulation (EC) No 575/2006 – 28.04.2006 – OJ L 100 of 08.04.2006
RELATED ACTS
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 178/2002 as regards the term of office of the Executive Director of the European Food Safety Authority [COM(2005) 0190 final – Not published in the Official Journal]
This proposal modifies the procedure for extending the term of office of the executive directors of all Community agencies that were making provision for this, including the EFSA. The Commission proposes that the term “renewal” be dispensed with and replaced by the word “extension” subject to limitations: the term of office may be extended only once for a maximum period of 5 years. This extension is proposed by the Commission after an evaluation of the executive director’s term of office, and according to the future needs of the EFSA.
Statement of revenue and expenditure of the European Food Safety Authority for the financial year 2007 [Official Journal L 126 of 16.05.2007].
Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission [Official Journal L 379 of 24.12.2004]
Commission Decision 2004/478/EC of 29 April 2004 concerning the adoption of a general plan for food/feed crisis management [Official Journal L 160 of 30.04.2004]
This decision provides for the adoption of a general crisis-management plan whenever a critical situation arises or where there may be a potentially serious risk.
In the event of a crisis arising, the general plan entails the setting up of a crisis unit composed of the crisis coordinators from the Member States affected and other representatives of the Commission and the Authority, with the latter providing the necessary scientific and technical assistance. The crisis unit is expected to take rapid and efficient action, after having analysed all the relevant data and identifying the options available for managing the crisis.
It is also required to inform the public about the risks in question and the measures already taken. It may utilise the technical resources of the Rapid Alert System for Food and Feed (RASFF), the Early Warning and Response System (EWRS) for human diseases, the animal disease notification system (ADNS) and the networks operating in the research field that are managed by the Commission’s Directorate-General for Research.
Commission Regulation (EC) No 1304/2003 of 11 July 2003 on the procedure applied by the European Food Safety Authority to requests for scientific opinions referred to it [Official Journal L 185 of 24.07.2003]
The Authority issues scientific opinions, pursuant to EU legislation, when requested to do so by the Commission, the European Parliament or a Member State, and it may also issue own-initiative opinions. It establishes a register of all requested opinions and own-initiative opinions. The circumstances in which requests for opinions are refused, accepted, amended or combined are specified. The requesting party may stipulate a deadline for the delivery of the required opinion. If no deadline is set, the Authority will inform the applicant of the anticipated time needed to deliver the opinion. If the Authority is unable to meet the deadline stipulated, it will inform the applicant accordingly and set a final deadline. In cases of clear urgency, the Authority will take all the necessary measures to ensure that a requested or own-initiative opinion is delivered as soon as possible. There are two scenarios indicating urgency: an emerging risk likely to constitute a serious risk to human or animal health or the environment; an urgent need on the part of the Commission for a more detailed scientific basis for managing a serious risk.
