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The European
Parliament and the Council adopted on 10
November 2003
Regulation (EC) 2065/2003
on smoke flavourings used or intended for use in or on foods. The Regulation establishes a Community
procedure 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.
Important information to producers and users of smoke flavour primary product and derived products.
Article 20, concerning transitional measures, of Regulation 2065/2003/EC, lays down that only primary products for which a valid
application has been submitted before 16 June 2005, can continued to be placed on the market thereafter.
Applications shall be accompanied by the information listed in annex II of the Regulation. In addition, the European Food Safety Authority (EFSA) has
prepared a document that gives guidance to the
petitioners. It is strongly advised to follow this guidance.
List of valid applications 
Regulation 2065/2003 on smoke flavourings lays down the procedure how primary products for smoke flavourings are to be regulated in the
Community. In the first phase, EFSA received applications for primary products that were already on the market. Of the 16 notified products, 14 were considered as
valid applications and subject to evaluation. The other two applications were not considered to be valid and therefore were withdrawn from the market. After the start
of the evaluation, applications for three more notified products were withdrawn and products were withdrawn from the market, thus EFSA having to finally evaluate only
11 notified products.
After EFSA has finished all the evaluations, the Commission will prepare a Community list of permitted primary products for smoke flavourings.
EFSA evaluations
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