European Food Authority – Amended Proposal

Amended proposal for an EU Regulation laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety - COM(2001) 475 final

The proposal outlines the general objectives and problems that are encountered in the EU in relation to food regulation. The primary hurdle is the huge diversity of concepts, principles and definitions of food in the Member States. The outcome of these differences is that the free movement of food is impeded and there is no uniform safety standard, the proposal aims to address these issues and harmonise standards across the EU.

General Food Law

1. The definition of "Food" in the proposals is broad, and is stated as: "any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. It includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment." (Article 2 definition of "food".)

2. "Food law" itself is defined as: "the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at community or national level; it covers any stage of production, processing and distribution of food, and also feed for food-producing animals." (Article 3 Other definitions.)

3. The general objectives of European Food Law are set out as the protection of not only human life and health but also free movement in the Community of food and feed and the protection of consumers' interests, including the promotion of fair practices in food trade. International standards shall be taken into consideration in this, except where they are deemed ineffective, inappropriate or would result in a different level of protection and/or there is a scientific justification for them to be disapplied (see below Scientific Committee.)

4. To this end the proposed regulation states that proper risk analysis be carried out in an independent, objective and transparent manner. The "Precautionary Principle" (Article 7) means that, in the event of scientific uncertainty, provisional risk management measures which are proportionate and no more restrictive of trade than is required to achieve a high level of health protection, will be adopted and regularly reviewed according to a comprehensive risk assessment. There are also measures for harmonisation of Community legislation over the import and export of food and feed, and a requirement that the presentation of food, including shape, appearance or packaging of it, does not mislead the consumer.

5. The basic safety threshold stated is that food shall be deemed unsafe if it is considered to be injurious to health and/or unfit for human consumption. However, other matters of fact will be taken into account in determining safety; namely, the normal conditions of use of the food, the information provided to the consumer, the effects of the food on the health of the person consuming it and subsequent generations (i.e. cumulative toxic effects of the food) and the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumer. It is proposed that there will be public consultation during the preparation of food law "except where the urgency of the matter does not allow it." (Article 9.)

6. The test for who is responsible for ensuring food safety at any stage of the production process is one of "control" and Member states shall monitor and verify that all relevant requirements of food law are fulfilled and will lay down the rules on measures and penalties applicable to infringements, as long as these are "effective, proportionate and dissuasive." (Article 17(1) Responsibilities)

Positive obligations on food and feed business operators are imposed in the form of:

• Traceability requirements; i.e. that at all stages of the production and sale of the food or feed, those with control over it know where it came from and where it is going;
• Notification requirements; where the food/feed business operator "considers or suspects" unsafe food is on the market they must notify the competent authorities;
• Collaboration requirements; with competent authorities on action to avoid risks posed by a food they supply or have supplied; and
• Withdrawal requirements; where the food/feed business operator "considers or suspects" food or feed over which it has had control was not in compliance with safety requirements.

Food which complies with specific Community provisions of food law shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is in circulation.

However, if there are indications that, despite conformity with the provisions, the food is unsafe, the competent authorities are not barred from taking appropriate measures to impose restrictions on it. Where any unsafe food had formed part of a batch, lot or consignment, it shall be presumed that all of the food in that batch, lot or consignment is also unsafe, unless there is no evidence of this following a detailed assessment.

European Food Authority

It is proposed that the main enforcer of the regulations and requirements of European food law should be a newly formed European Food Authority (the 'Authority'.) The Authority therefore has a broad remit proposed for it. All features of the food production chain as defined under food law and safety would be dealt with by the new Authority which will commence operations on 1 January 2002.

The Authority shall comprise of 4 management layers:

1. Management Board: This will monitor the organisation and devise its programme of work;

2. Executive Director and his staff: This layer will deal with the administrative side and the implementation of the programme of work;

3. Advisory Forum: This layer will advise the Executive Director and help to pool data;

4. Scientific Committee & Scientific Panels: This layer will ensure consistency of scientific opinion, collect data and identify emerging risks.

It is proposed that the Authority would be totally independent, objective and carry out its business in a wholly transparent manner. It is possible to analyse the more general proposals put forward as to how the Authority should run its affairs using these three headings:

"Independent"

1. The Management Board will consist of a mix of delegates from the European Parliament, Council, Commission and representatives of consumers and industry.

2. The Executive Director will be appointed by the Management Board after an open competition.

3. The Advisory Forum will consist of one representative designated by each Member State.

4. Members of Scientific Committee and Panels will be independent scientists recruited on the basis of an open application procedure.

The Authority will be able to communicate autonomously in the fields falling within its competence, its purpose being to provide objective, reliable and easily understandable information. However, the Commission will remain fully responsible for communicating risk management measures; the appropriate information will therefore be exchanged between the Authority and the Commission.

Appropriate co-operation will take place between the member states, competent bodies in the member states in the form of advisory forums, and consumer and other interested groups. The Authority may use national organisations to carry out certain tasks but will at all times maintain overall consistency and control.

It is proposed the Authority will be financed by the Community budget and its accounts will be examined by the Court of Auditors each year. However, the possibility of fees will be examined again after the legislation enacting the Authority has been in force for 3 years.

"Objective"

The Authority will not only undertake scientific risk assessment but will also take into account societal, economic, ethical and environmental factors and the feasibility of controls. The Authority shall be open to the participation of 3rd countries which have concluded agreements with the EU by which they have adopted and apply EU legislation in food law, the scope of their participation will be outlined in those agreements. (Article 49.)

One of the main roles proposed for the Authority is that it would give the casting opinion on contentious scientific issues; by having the "last word" it will clarify the European Union's position in relation to inconsistent and conflicting theories. This would also be in connection with the adoption of a comprehensive approach to emergency food safety measures which would allow effective action plans to be undertaken in a uniform and consistent manner. Where there is a substantive divergence over scientific issues the two sides to the debate will co-operate in producing a joint document to the Commission which shall be made public.

"Transparent"

(i) Risk Assessment: The risk analysis which the Authority would undertake would have three inter-connected principles: risk assessment, risk management and risk communication. One of the main aspects of the Authority would therefore be to provide a uniform and objective mouthpiece to consumers and member states on all aspects of food safety.

The opinions of the Scientific Committee and Scientific Panels, the information on which these opinions were based, their study results and annual reports, and the annual declarations of interest made by members of the Management Board, Advisory Forum, Scientific Committee and Scientific Panels shall all be made public.

(ii) Traceability: As part of the drive for transparency, a comprehensive system of traceability within food and food business is proposed, so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, therefore avoiding the potential for unnecessary wider disruption in the event of food safety problems. However, as part of this proposal it is emphasised that a food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe and thus is it proposed that food business operators should have primary legal responsibility for ensuring food safety.

(iii) Review: Within 3 years of the Authority commencing operations and every 6 months thereafter, the Authority, in collaboration with the Commission, shall commission an independent external evaluation of its achievements. The evaluation will take into account the views of the stakeholders both at EU and national levels. (Article 61)

Emergency Provisions

There is provision for information to be kept confidential if this is specifically requested and deemed to be justified but professional secrets will come secondary to the needs of market surveillance and enforcement activities and in particular there will be a 'rapid alert information system' which will immediately disseminate information to members of any direct or indirect risk to human health.

The emergency powers of the Authority, acting on its own initiative or at the request of a Member State where it is 'evident' that there is a serious risk to human or animal health and/or the environment that cannot be adequately contained by measures of the Member States concerned, depending on the gravity of the situation, are as follows:

• Suspension of placing on the market;
• Suspension of placing on the market or use;
• Special conditions;
• Any other appropriate interim measure; and
• Where imported from a 3rd country outside the community, suspension of importation.

These provisions are extremely vague and potentially very wide ranging, one safeguard is that within 10 days the measures implemented must be put before a Standing Committee on the Food Chain and Animal Health composed of representative of the Member States and the measures must be reviewed and confirmed, amended, revoked or extended. However, if there is any delay in adopting community measures the individual Member State concerned may adopt national interim protective measures until they are put in place.

Article 55 proposes that the Community shall draw up a 'General Plan' with the cooperation of the Authority and Member States which will specify the types of situation and risks which would involve the setting up of a 'Crisis Unit' to evaluate the risks, identify which emergency option is to be used and keep the public informed.

Comment:

The proposals are comprehensive and appear largely similar to the UK's own Food Safety Act 1990 and Food Standards Act 1999 in their aims and objectives. Possible drawbacks with these proposals would be the increased regulatory burden, in particular from the proposal that food business operators should have primary legal responsibility for ensuring food safety as they are "best placed" to do so, and positive obligations to fulfil in connection with this. One only needs to look at the UK headlines recently relating to condemned meat finding its way into supermarkets to realise that, in the context of the often complex webs of sale of produce contracts, this may be a rather simplistic view to take.

The interim protective measures' option - coupled with an 'anything goes' approach to emergency powers - means that unless Member States press for more checks and balances to be written into the General Plan or a producer element secures strong representation in the Crisis Unit, there is a very real danger that the Authority would have draconian legal powers without any effective means of challenge or appeal against its decisions.

The amended final proposal is available by copying and pasting or clicking on the following link: http://europa.eu.int/comm/food/fs/intro/efa_prop2_en.pdf

For further information please contact Jessica Burt on +44 (0)20 7367 3589 or by e-mail at [email protected].