Food Law News - EU - 2001

FSA Letter, 28 March 2001

EUROPEAN FOOD AUTHORITY - Proposed Council/EP Regulation Laying Down General Principles of Food Law and Establishing the European Food Authority (EFA)

Since the previous FSA letter, there have been two further 'Friends of the Presidency' meetings in Brussels, on 1 and 14 March. Both meetings were concerned with Articles 1-20 of the proposal and saw the first detailed consideration of Chapters I and II since preliminary discussions in December of last year. In summary, these two meetings saw long and detailed discussion of these rather complex articles with Member States (MS) posing many questions and requests for clarification to the Commission. Many issues remain unclear and much redrafting will be required. The following is an attempt to give you a flavour of the detail of the meetings.

Not surprisingly, there was a long discussion on the definition of 'food' in Article 1 and other definitions in Articles 2 and 3. The Commission clarified that veterinary medicines and pesticide residues are not included within the definition of 'food', but appeared to wish to retain tap water within that definition. It is clear that many of the definitions in Article 3 will need clarification through redrafting. The Commission confirmed that Articles 5-8 were intended to provide a general framework for legislators establishing new measures and were not intended to be imposed retrospectively. It became clear that the legal problems of the date of applicability and timing would need further consideration.

In discussion on general issues, the Commission said that it was aware of problems of inconsistencies between this Regulation and other texts. The Commission noted that, while the intention is to transfer certain articles (including those on registration of food businesses and traceability) from the Hygiene texts into this proposal, the timing of this was unclear due to the different negotiating stages of the two texts.

An extensive discussion on traceability (Article 9) was carried over from the end of the 1 March meeting to the beginning of the meeting on March 14. The Commission emphasised that this provision was intended to aid efficient withdrawal and recall of food and was deliberately very general, allowing scope for more detailed rules, either stricter or more lax, to be established for some sectors (e.g. for primary producers or with regard to GMOs) as appropriate. Such rules would be worked out, as they are now, by expert committees.

In response to detailed questioning from Member States, the Commission clarified that the intention was to ensure that the two elements of compliance and demonstration of compliance were encompassed within Article 10 (Responsibilities). When questioned over the need for new national legislation, the Commission stated that providing MS had in place legislation that was effective, proportionate and dissuasive this was likely to be sufficient.

There followed a long discussion on Articles 12 -15. Article 12 (Food Safety Requirements) is likely to undergo substantial redrafting which may include making it a requirement not to place unsafe food on the market rather than the zero risk requirement to only place safe food on the market, a revisiting, by the Commission of the definition of 'unsafe' and reconsideration of the term 'potentially' in the phrase 'potentially injurious to health' (Article 12 (4)). Similarly, MS queried amongst other things, the meaning of 'detrimental effect' in Article 13 (Feed Safety Requirements).

In relation to Article 14 (Responsibility for food safety: food businesses), questions were raised on how this article relates to imported food, obligations for withdrawal and recall and the extent to which it is compatible with requirements of the General Product Safety Directive. The Commission noted that there was a distinction between the intended obligation on food business operators to inform of risks associated with products they themselves had placed on the market (first part of article 14(2)) and an intended general obligation upon any business operator to notify the authorities if they became aware of a risk from a food whether they themselves had placed that food on the market or not (second part of Article 14(2)). It is likely that Article 15 (Responsibility for food safety: feed businesses) will be redrafted to bring it into line with Article 14.

MS raised a number of points on Articles 16, 17 and 18 (food imported and exported from the Community and International Food Standards) - most fundamentally, it was pointed out that these articles should apply to feed as well as to food. In response to questions, the Commission undertook to check compatibility of Article 16 with current customs regimes and provisions. It was also made clear that other specific measures e.g. on animal health would remain unaffected by Article 16(2). With regard to Article 17, several MS queried the difference between article 17(3) which prohibits export of unsafe food and 17(4) which prohibits export of food injurious to health or incorrectly labelled unless the importing country agrees. The Commission explained that 17(3) was intended to be a general priniciple and 17(4) a statement that food of lesser quality than required by EU legislation would not be exported to third countries unless specifically agreed. The Commission also acknowledged that this was a new requirement that would affect importers especially if they had already paid for goods and where then required to destroy them if the exporting country did not agree to their return - a concern already expressed by some respondents to consultation on this proposal. This issue will need to be revisited. Finally, the Commission agreed to improve the text of Article 20 (Public Consultation).

At the meeting on 14 March, the Swedish Presidency distributed a document including a redrafted text of Articles 21-48. Article 21 has been substantially redrafted and is given below; other articles have undergone smaller changes. This text should be regarded as a working document that may undergo further amendment as negotiations continue. We would welcome any comments you might have on redrafted Article 21.

The next 'Friends' meeting is scheduled for 28-29 March and will continue earlier discussions on the EFA. Further meetings are currently set for 5 and 20 April, 3 May and 17-18 May. The Swedes are still aiming to reach common position in June of this year.

Article 21

Mission of the Authority

1. A European Food Authority is hereby established, hereinafter referred to as the "Authority".

2. The Authority shall provide scientific advice and scientific and technical support for the Community's legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information [and communication] on all matters within these fields.

The Authority shall contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare, plant health and the environment, whilst at the same time facilitating the functioning of the internal market.

The Authority shall collect and analyse data to allow the characterisation and monitoring of risks which have a direct or indirect impact on food and feed safety.

The mission of the Authority shall also include the provision of:

3. The Authority shall provide scientific opinions which will serve as the scientific basis for the drafting and adoption of Community measures in the fields falling within its mission.

4. The Authority shall carry out its tasks in conditions which enable it to serve as a point of reference by virtue of its independence, the scientific and technical quality of the opinions it issues and the information it disseminates, the transparency of its procedures and methods of operation, and its diligence in performing the tasks assigned to it. It shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority.

5 The Authority shall act in close collaboration with the Commission and the Member States to promote the necessary coherence in the [risk communication] [risk analysis] process.

6. The Member States shall cooperate with the Authority to ensure the accomplishment of its mission.

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