The European Food Safety Authority
As it can be seen from its title, one of the most important objectives of regulation (EC) N° 178/2002 of the European Parliament and the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety1 (the regulation) was the establishment of a new authority which following the propositions of the European Parliament was to be named European Food Safety Authority (EFSA). The establishment of the EFSA is a consequence of the BSE food-crisis and the following loss of consumer confidence in the capability of the administrative institutions of the Community to apply a successful risk management to the satisfaction of consumers. The recitals of the regulation clearly state the wishes of the Community to have access to high-quality, independent and efficient scientific and technical support (recital 32), to have a leading independent reference point in risk management (recital 34) and to have an independent scientific source of advice, information and risk communication (recital 35).
The field of tasks the EFSA is charged ranges from independent scientific views on food safety, to support on human nutrition and to the contribution to the Communitys role in the development of international food safety standards.
In the following the mission of EFSA and its main tasks will be described with a focus on the Scientific Panels and a short overview of its structure.
Mission of EFSA
The mission of EFSA is laid down in Art. 22 of Regulation (EC) 178/2002. The first objective of EFSA is the provision of scientific advice and scientific and technical support to the Communitys legislation and policies in all fields, which have an impact on food and feed safety. As it is said in recital 32 of the regulation the scientific and technical basis of Community legislation relating to the safety of food and feed should contribute to the achievement of a high level of health protection within the Community. There is little doubt in the strong belief of the Community legislator that there is a tight connection between science based food or feed safety legislation and the assurance of consumer confidence in the decision-making process underpinning food law. A second objective of the mission of EFSA is that the Authority shall provide independent information in all fields related to food or feed safety and communicate on risks.
The Authority shall further contribute to a high level of protection of human life and health taking into account of animal health and welfare, plant health and the environment.
To perform the objective to communicate on risk the Authority has the mission to collect and analyse data to allow the characterisation and monitoring of risks, which have an impact of food and feed safety.
Early this year, the World Health Organization (WHO) has published the Report of a Joint WHO/FAO Expert Consultation2 on "Diet, Nutrition and the Prevention of Chronic Diseases" which demonstrates that nutrition, i.e. food stuffs play an important role in the origin and prevention of diseases such as obesity, diabetes, cardiovascular diseases, cancer and osteoporosis and bone fractures. Food law regarding the labelling and advertising of food or in other words said "food information law" may play an important role in the prevention of such diseases. To promulgate good food information law legislators must have sufficient knowledge of the nutrition sciences. It is therefore only consistent that a further mission of the Authority is the provision of scientific advice and scientific and technical support in human nutrition in relation to community legislation as well as assistance concerning communication on nutritional issues within the framework of the community health programme. This is in line with Art. 3 (p) of the Consolidated Version of the Treaty Establishing the European Community3 which states that the activities of the Community shall include a contribution to the attainment of a high level of health protection.
In order to enable the Community to base its measures on science the Authority shall provide scientific opinions, which will serve as the scientific basis needed. Such measures can be regulatory provisions for example directives or regulations regarding the fortification of foods with vitamins, minerals or other substances or measures to be taken by the Commission with a view to the precautionary principle.
Independence of the EFSA is one of the major concerns of Regulation (EC) 178/2002. The Authority shall therefore carry out its tasks in conditions, which enable it to serve as a point of reference by virtue of its independence, the scientific quality of the opinions, the transparency of its procedures and the diligence in performing its tasks.
To accomplish the mission of the Authority a high degree of cooperation between the Authority, the Commission and the Member States and their competent bodies especially with regard to risk assessment, risk management and risk communication is required.
Tasks and Operating of EFSA
The manifold tasks of the Authority are enumerated in article 23 of Regulation 178/2002. Primarily it is the task of the Authority to provide Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any question within its mission and especially to provide scientific and technical support to the Commission. Technical support or assistance shall be provided, for example, when requested by the Commission to take crisis management measures with regard to safety of food or feed under art. 55 of the Regulation.
Opinions of the Authority may not only be requested by the Commission but also by the European Parliament and the Member States. However, the Authority may refuse the request for an opinion if the background information explaining the scientific issue is not given or the Community interest is lacking. Details shall be regulated in implementing rules yet to be established by the Commission. In order to deliver acceptable opinions the Authority has to establish a monitoring system to identify diverging opinions and to cooperate with the relevant Community institutions with a view to clarify the divergences.
When the Commission requests scientific or technical assistance the Authority is not obliged to carry out scientific evaluation through the Scientific Committee or a Scientific Panel. Assistance consists of scientific or technical work involving the application of well-established scientific or technical working principles.
Data collection by EFSA relates to food consumption and the exposure to risks related to food consumption, incidence and prevalence of biological risks, contaminants in food and feed and residues. The data collected shall be made available to the European Parliament, the Commission and Member States.
Pursuant to art. 6 of Regulation (EC) 178/2002 food law shall be based on risk analysis and risk assessment shall be based on the available scientific evidence. The carrying out of risk analysis and risk assessment needs specific methodologies. To promote and to coordinate the development of uniform risk assessment methodologies is a further task of the EFSA.
EFSA, however, is not restricted to being of assistance to community institutions or Member States when measures have to be taken. The Authority has the task to commission scientific studies for the accomplishment of its mission, with other words said, to initiate scientific research when necessary. This includes the search and collection of data and the identification emerging risks thus operating as some kind of pre-warning system. With regard to identify emerging risks a special monitoring system yet to be established by the Authority shall ensure the collection of the relevant data in order to discover the emerging of serious risks the information about them hall be forwarded to the European Parliament, the Commission and the Member States. If studies are to be commissioned by the Authority the best available independent scientific sources shall be used.
One of the very important tasks of EFSA is the operation of the rapid alert system established under art. 50 passim. The Authority is the addressee of all informations and messages forwarded via the rapid alert system which will be analyzed by it with a view to provide the Commission and the Member States with any information required for the purposes of risk analysis.
Transparency is a must for EFSA. All its activities have to be carried out with a high level of transparency meaning that not only the agendas and minutes of the meetings of its scientific bodies shall be made public but also the opinions with minority opinions included. Nevertheless, confidential informations received with request for confidentiality shall not be divulged by EFSA with the exception that conclusions of the scientific opinions relating to foreseeable health effects shall on no account be kept confidential. This ensures the necessary information of the general public. Any other non-confidential information concerning the mission of the Authority shall be made public rapidly. However, EFSA must seek close cooperation with the Commission and the Member States to promote the necessary coherence in the risk communication process. Wide access to the documents in possession of EFSA shall be ensured.
Scientific Committee and Scientific Panels
Of the bodies of the Authority Management Board, Executive Director, Advisory Forum and Scientific Committee and Scientific Panels only the latter ones shall be treated in this short relation as the scientific bodies are the most important ones for consumers and food business operators in the European Union.
Both of the bodies are responsible for providing the scientific opinions of the Authority. Where necessary public hearings may be organised.
The Scientific Committee composed of the Chairs of the Scientific Panels and six independent scientific experts is responsible for general coordination of the work of the Panels to ensure the consistency of the scientific opinion procedure.
For the time being the following eight Panels are set up:
- Panel on food additives, flavourings, processing aids and materials in contact with food,
- Panel on additives and products or substances used in animal feed,
- Panel on plant health, plant protection products and their residues,
- Panel on genetically modified organisms,
- Panel on dietetic products, nutrition and allergies,
- Panel on biological hazards,
- Panel on contaminants in the food chain,
- Panel on animal health and welfare.
The titles of the panels are a mirror of the problems and risks emerged in the European Union during the last decade.
The members of the Scientific Panels shall be appointed by the Management Board upon proposition of the Executive Director after a call for expression of interests has been published. The procedure laid out for the choice of the experts will ensure independence and international reputation of the Scientific Committee and the Scientific Panels.
The importance of EFSA for the work of the legal profession
The importance of EFSA for the work of the lawyer may be highlighted by some examples of Community law in the making. Reference is made to the Preliminary Draft Proposal for a Regulation on the Addition of Vitamins and Minerals and of certain Substances to Foods4 and the Draft Proposal for a Regulation on Nutrition and Health Claims Made on Foods5 supposing that both drafts will be made law in or the other manner.
The Draft Proposal on the Addition of Vitamins and Minerals and other substances to Foods provides a procedure for certain substances under Community scrutiny: substances contained in a food and ingested in amounts exceeding those ingested under normal conditions thus giving rise to concern about risks to public health might be placed under Community scrutiny. Food business operators may submit to EFSA at any time scientific data demonstrating the safety of a substance under community scrutiny. If within a period of three years a decision has not been taken to allow its use the substance concerned will be prohibited indefinitely. The decision mentioned shall be taken in accordance with the regulatory procedure laid down in Decision 1999/468/EC6 by the Standing Committee on the Food Chain and Animal Health. In cases where the substance in question is used only by one food business operator the decision might be of direct and individual concern to him thus giving the food business operator the right to attack the decision even though it was not specifically addressed to him. Grounds for an attack of the decision could be that neither the Authority nor the Standing Committee have carried out a proper risk analysis with a risk assessment including hazard identification, hazard characterisation exposure assessment and risk characterisation as provided in art.6 of the Regulation. In other words said, the procedure to put a substance under Community scrutiny is a legal procedure where certain rules of law laid down in the Regulation have to be respected by EFSA and where food business operators need legal advice.
The Draft Proposal for a Regulation on Nutrition and Health Claims provides that "health claims i.e. claims that state, suggest or imply that a relationship exists between a food category, a food or one of it constituents and health and "reduction of disease risk claims i.e. claims that state that the consumption of a food significantly reduces a major risk factor in the development of s human disease can only be made when approved by the Community. To obtain an approval an application shall be submitted to the Authority. The application shall be accompanied not only by the studies carried out or by other material but also inter alia a proposal for the wording of the health claim for which approval is sought. The Authority has to inform the Member States and the Commission. A summary of the dossier shall be made public. The Authority will give an opinion, which will be the basis for the decision of the Commission. Under art. 230 para. 4 of the Consolidated versions of the Treaty on European Union and of establishing the European Community (200)7 such decisions are attackable by the applicant. Here too, legal advice should be sought by food business operators and can be given by the legal profession in order to ensure that the rules of law governing the application procedure are applied correctly.
This short overview shall suffice to demonstrate that EFSA and the performance of its mission and tasks within the frame of Regulation (EC) 178/2002 and the relevant Community food law might be an important field of activities for European lawyers.
The establishment of EFSA is certainly an import step for the development of an efficient EU Food Safety Policy. When food law and risk management measures are based on the scientific opinions of an independent authority lost consumer confidence can be regained. Efficient performance of the missions and tasks will help to ensure the achievement of a high level of consumer protection. However, it cannot be denied that EFSA can be used to create a huge and sluggish administration as experience demonstrates that scientist do not tend to be decisive but tend to avoid taking risks. Though EFSA itself will not act as risk manager its opinions will be the fundamentals of the measures taken by risk managers. Science can have the effect of creating obstacles to innovation in the food business as being innovative means taking risks.
1O.J. L 31/ of 3.2.2002
2WHO Technical Report Series 916, Geneva 2003
3O.J. C 325 of 24 December 2002
6O.J. of 28.06.1999 L 184/23
7O.J. of 24.12.2002 C 325
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