52002AE1355

Opinion of the European Economic and Social Committee on the "Proposal for a European Parliament and Council Regulation on smoke flavourings used or intended for use in or on foods"

(COM(2002) 400 final - 2002/0163 (COD))

(2003/C 85/08)

On 24 July 2002 the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 29 October 2002. The rapporteur was Mrs Davison.

At its 395th plenary session on 11 and 12 December 2002 (meeting of 11 December 2002), the European Economic and Social Committee adopted the following opinion by 95 votes in favour, 1 against and 6 abstentions.

1. Gist of the Commission proposal

1.1. On 15 July 2002, the European Commission adopted a proposal laying down new procedures for the safety assessment and authorisation of "smoke flavourings". Smoke flavourings are often used instead of fresh smoke to impart a smoky flavour to foods such as meat, fish or snacks.

1.2. The chemical composition of smoke is complex, depending among other things on the species of woods used, the method used for developing smoke, etc. Smoked foods in general give rise to health concerns.

1.3. Smoke flavourings are produced by condensing fresh smoke in water. The condensed smoke is then fractionated and purified during the production of smoke flavourings. Because of this purification process, the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process.

1.4. The Commission proposes to establish a procedure for the safety assessment and authorisation of smoke condensates (the existing multitude of smoke flavourings are based on only a limited number of commercially available smoke condensates). Smoke flavourings for the Community market are produced by few companies inside and outside the EU. Each of these companies has a very limited number of primary products. It is estimated that no more than 20 products need to be evaluated.

1.5. For an application for authorisation of a smoke condensate, the producer will need to provide detailed information on the production method as well as on the further steps in the production of derived smoke flavourings, the intended toxicological studies and validated methods for sampling and detection. The evaluation will be carried out by the European Food Safety Authority (EFSA).

1.6. The Commission will make a decision on each application based on the outcome of the evaluation. The Commission proposes to restrict the authorisations to a period of ten years after which the authorisations will need to be reviewed.

2. General comments

2.1. The Committee welcomes the Commission proposal which will ensure that a uniform and harmonised procedure for authorisation of smoke flavourings is in place in the EU. Currently, the situation is very diverse among Member States, from no legislation, to very strict requirements. Consumers, industry, and all parties involved will benefit from a transparent procedure, based on a high level of protection of public health and the protection of consumers' interests.

2.2. The Committee supports the procedure that is proposed, and in particular the designation of the EFSA as the central body for the assessment of smoke flavourings.

3. Specific comments

3.1. The Committee welcomes the establishment of a positive list of authorised products. The list will contain information such as a clear description and characterisation of the primary product, the conditions of its use in or on specific foods or food categories and the date from which the product is authorised. The Committee notes that this list, and any further updated version, will be made available to the public.

3.2. Applications for authorisation shall be accompanied by, inter alia, information necessary for the scientific evaluation of primary smoke condensates and primary tar fractions. It is the responsibility of the person who places the product on the market to provide such information. The requested information includes toxicological studies on the primary product.

3.3. The Committee is concerned that the existence of various analytical methods, and variations in the quality of these methods in detecting potential problems may undermine the stated objectives of the proposal of ensuring a harmonisation of the situation at EU level, and ensuring a high level of public health and consumer protection. It is therefore important to adopt strict criteria on sampling and testing and validate methods that will ensure the comparability and high quality of the results provided by the applicants. Such possibility is only considered in the Commission's proposal (Art. 16.2 and 16.3). The Committee believes that only applications for products assessed by using these methods should be valid.

3.4. An authorisation may be modified, suspended or revoked. This can be done at the initiative of the authorisation holder, the EFSA or a Member State. The Committee welcomes this provision and underlines its importance. Once a product is on the market, it is important to allow for some post-marketing assessment. If it appears that the use of a product is associated with adverse effects on humans or on the environment for example, and that the reasons for concern are serious and well documented, there must be a possibility to restrict or ban its use after the authorisation has been granted.

3.5. The Committee considered the opportunity to recommend that all interested parties should have the possibility to ask the Authority for a review of authorisations. The Committee recognises that this may add to the workload of the Authority, which would have to consider any request lodged by the public. Such amendment to the Commission's proposal may not be advisable, nevertheless, the Committee calls on Member States, the Commission, the Authority and authorisation holder to be open and transparent and consider with due attention any well supported request for a review of authorisations.

3.6. Authorisations granted under the proposed regulation shall be renewed every ten years. The Committee fully supports this provision. The time limit set to the authorisations ensures that a regular assessment and review of the products on the market is made.

4. Conclusions

4.1. While welcoming and supporting the proposal, the EESC invites the Commission to take into consideration its recommendations for the adoption of strict criteria on sampling and testing and validated analytical methods, so as to ensure the objective of harmonisation of the situation at European level.

Brussels, 11 December 2002.

The President

of the European Economic and Social Committee

Roger Briesch