Explanatory Memorandum to COM(2002)400 - Smoke flavourings used or intended for use in or on foods - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)400 - Smoke flavourings used or intended for use in or on foods. |
|---|---|
| source | COM(2002)400  |
| date | 15-07-2002 |
The current situation in the Member States concerning the authorisation of smoke flavourings is diverse. Some Member States have a very strict authorisation procedure, others have none at all. Thus, there is a need for harmonisation at Community level.
The objective of the present proposal is to establish Community procedures for the safety assessment and the authorisation of smoke flavourings intended for use in or on foods in order to ensure a high level of protection of human health and protection of consumers' interests, as well as to ensure fair trade practices.
Smoke flavourings are produced from condensed smoke. The chemical composition of smoke is complex depending among other things on the species of wood used, the method used for developing smoke, the water content of the wood and the temperature and oxygen concentration during smoke generation. Smoked foods in general give rise to health concern. The condensed smoke is however 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.
A wide range of different smoke flavourings is produced from the purified primary smoke condensates. The Scientific Committee on Food (SCF) concluded in its report of 25 June 1993 that the existing multitude of smoke flavourings is based on only a limited number of commercially available smoke condensates and that, therefore, the toxicological evaluation should focus on the limited number of individual smoke condensates rather than on the multitude of derived smoke flavourings.
The present draft proposes to establish a safety assessment and authorisation procedure for primary smoke condensates and primary tar fractions which can be used as such in and on foods and/or for the production of derived smoke flavourings. The primary products for which no health concern is revealed during evaluation and their conditions of use will be included in a positive list of products authorised to the exclusion of all others in the Community.
Smoke flavourings for the Community market are produced by few companies inside and outside of the EU. Each of these companies has a very limited number of primary products. It is estimated that not more than 20 products need to be evaluated.
It is proposed to restrict the authorisations to a period of 10 years after which the authorisations will need to be renewed. This provision ensures that products are regularly re-evaluated according to the latest scientific and technical knowledge and ensures also that authorised products which are no longer used will disappear from the Community positive list.
For an application for authorisation of a primary product, detailed information on the production method of this product as well as on the further steps in the production of derived smoke flavourings, the intended uses in or on specific food or food categories, chemical specifications, toxicological studies and validated methods for sampling and detection of the primary product and derived smoke flavourings have to be provided by the applicant. The evaluation will be done by the European Food Safety Authority according to a defined time limited and transparent procedure. The Authority has to inform the Commission and the Member States about the receipt of an application and has to provide a summary thereof or the whole dossier. Confidentiality for sensitive data is provided if requested by the applicant, except for information of direct relevance to the assessment of the safety of the product.
After the European Food Safety Authority has completed its scientific evaluation, the Commission will propose a risk management decision to be adopted by the regulatory procedure laid down by Council Decision 1999/468/EC.
Since many smoke flavourings are already on the market in the Community, the transition to a Community positive list should be smooth and should not lead to unfair conditions for smoke flavouring producers. Therefore, the proposal foresees an initial period of 18 months during which applications for existing and new products can be submitted to the European Food Safety Authority. The establishment of the Community list will take place in a single step procedure after the European Food Safety Authority has expressed opinions on all products for which applications have been submitted during the 18-month period. This procedure will ensure that all companies are subject to the same conditions. After the initial establishment new products may be added following evaluation by the European Food Safety Authority.
The Scientific Committee on Food in its report on smoke flavourings of 25 June 1993, provided a non-exhaustive list of types of wood which may be used for the production of smoke flavourings. This list is annexed to the present Regulation. Additional species of wood, not present in the list, may be included after primary products produced from those species have received a favourable opinion from the European Food Safety Authority.
This Proposal intends to ensure a high level of protection of human health and the protection of consumers' interests with respect to smoke flavourings intended for use in or on foods and to ensure market unity while abiding by the principle of proportionality.
This Proposal has no financial implications for the budget of the European Community.