Explanatory Memorandum to COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

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dossier COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant ...
source COM(2007)672 EN
date 24-10-2007
1. PROCEDURE

1. On 28th July 2006, the Commission adopted the proposal for a European Parliament and Council Regulation establishing a common authorisation procedure for food additives, food enzymes and food flavourings [Document (COM (2006)0423 final)] as part of a package of four proposals on food improvement agents. The proposal was submitted to the Council and the European Parliament on 28th July 2006.

2. The Economic and Social Committee adopted its opinion on 25th April 2007.

3. The Council has agreed a ‘general approach’ on the proposal at the EPSCO meeting on 31st May 2007.

4. The European Parliament has given in first reading a favourable opinion on the proposal on 10th July 2007.

5. The present proposal amends the original proposal [COM (2006)0423 – 2006/0143(COD)] so as to take into account the amendments of the European Parliament that were accepted by the Commission.

With regard to the original proposal, the European Parliament adopted 31 amendments. Commissioner Kyprianou had indicated to the plenary meeting on 9th July 2007 that the Commission could accept most of the amendments, wholly or in part, and subject to rewording. From the adopted amendments the Commission cannot accept the following amendments: 14, 20, 31, and 33.

The amendments in the revised proposal are in bold and underlined . A number of amendments have been reformulated so as to ensure consistency of the terminology used throughout the proposal.

Within certain Articles, the numbering of the paragraphs has been adapted in order to take into account the addition or deletion of elements in the Commission proposal.

II. OBJECTIVES OF THE PROPOSAL

6. As part of the efforts undertaken to improve Community legislation on the basis of the “farm to table” concept, in the White Paper on Food Safety, the Commission announced its intention to update and complete existing legislation with regard to food additives and flavourings and to lay down specific provisions in respect of enzymes. (Actions 11 and 13 of the White Paper).

This proposal aims to ensure the proper functioning of the internal market, while also ensuring a high level of protection of human health as regards food additives, food enzymes and food flavourings.

In order to do this, it aims to establish a common authorisation procedure that is centralised, effective, expedient and transparent and that is based on risk assessment carried out by the European Food Safety Authority (EFSA) and a risk management system in which the Commission takes action within the framework of a regulatory committee procedure (comitology). It assigns to the Commission, on the basis of the EFSA’s scientific assessments, the task of creating, maintaining and updating a general positive list for each category of substances concerned. The inclusion of a substance on one of these lists means that its use is authorised in general for all operators in the Community.

7. The proposed Regulation on the common authorisation procedure is part of the package of proposals on 'food improvement agents’ which refers to the proposals on food additives, food enzymes and flavourings. It contributes to the Commission’s simplification programme and also provides for harmonisation and promotes consistency between the three related areas.

III. OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT

8. Technical/editorial amendments

The majority of the proposed amendments aim to improve the proposal from a technical and editorial point of view. These amendments have largely been taken over by the Commission in some cases subject to editorial changes (Amendments concerned: 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 15, 19, 21, 23, 24, 25, 27, 28, 30, 32).

Amendment 23 is acceptable in substance. However, it is already stated in Article 11 that the Authority shall make its opinions public without delay; therefore repetition of the same provision in Article 5 i is not appropriate for reasons of legal drafting.

Amendment 31, although editorial, cannot be accepted for reasons of legal drafting.

9. Transparency

Amendments 9, 10, 19, 21, 27, 28 and 32 strengthen the transparency and information provisions which were already underlying principles of the Commission proposal.

However, amendment 20 requires all application files to become available to stakeholders. The Commission intends to make public a list of all requests for authorisation and information on progress, but routine publication of the full application files is not acceptable. Access to documents held by the Commission can be granted under the provisions of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents.

10. 5 year data protection with individual authorisations (Article 2 and Article 12)

The proposal provides for a system of positive lists of food additives, food enzymes and flavourings. The inclusion of a substance on one of these lists means that its use is authorised in general for all operators in the Community. This is the situation today with regard to food additives.

Amendments 14 and 33 provide for a 5-year period of data protection and as a result preferential authorisation of the substance during this time for the company that provided the data. Such provision would change radically the present system for food additives which has been in place for a long time and is generally adopted internationally. It would also result in a duplication of regulatory approaches (individual authorization for 5 years followed by a general authorisation), a complication of systems of control and increased administrative procedures. This approach is thus not in line with the objective of the simplification of the regulatory framework. Finally a system that grants exclusive rights to individual operators could hinder the free movement of products that are safe and comply with the criteria of the specific legislation, which goes against the objectives of a measure made under Article 95 of the EC Treaty. Therefore, these amendments have not been taken over in the amended proposal.

11. Deadlines (Article 5  i and Article 7(1))

Amendment 22 increases the time for the European Food Safety Authority (Authority) to give its opinion from six to nine months. This is accepted in the amended proposal.

On the other hand amendment 37 reduces the time for the Commission to present a draft measure to the Standing Committee from nine to six months. There are cases, notably for food additives, where six months will not be enough for the Commission to present a measure after having consulted the Member States and relevant stakeholders on the technological need, benefit to the consumer, the potential to mislead the consumer and other relevant factors. This form of consultation taking into account the views of stakeholders when drafting proposals can only be achieved if adequate time is available. Therefore this part of amendment 37 is not integrated in the amended proposal.

12. Comitology (Article 7 and Article 14)

The Commission proposal referred to the normal regulatory procedure since it was adopted around the time that Council Decision 2006/512/EC, amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission, was adopted. Therefore the proposal should be amended to take the new regulatory procedure with scrutiny into account.

Amendments 34, 35, 36 and 37 support comitology for updating the lists of food additives, food enzymes and flavourings whilst they align the text of the proposal to the provisions of the new regulatory procedure with scrutiny. These amendments are welcomed and accepted in principle, subject to some editorial changes. Amendment 36 in particular, although accepted in principle, is not taken on board in the text of Article 2 i as it is already covered by the amendment introduced in Article 7. In addition the possibility to use the urgency procedure is introduced for the removal of substances from the Community list and for adding, removing or changing specifications or restrictions of use, in case of a particular risk to human health.

13. Pursuant to Article 250 i of the EC-Treaty, the Commission amends it proposals in accordance with the lines set out above.