As part of a package of legislative measures to update the food laws at EU level, the European Commission presented its Proposal to revise the current Novel Foods Regulation (EC) No 258/97 on 14 January 2008 . The Novel Foods Regulation concerns novel foods and novel food ingredients which do not have a significant history of human consumption within the EU before 15 May 1997. These novel foods are subject to a pre-market safety assessment and authorisation procedure. The Proposal is aimed at ensuring food safety, protecting human health, securing the functioning of the internal market for food and achieving legal clarity.
The Proposal covers foods that have been produced using technologies which have not been used previously, such as emerging technologies in breeding and food production processes. Food additives, flavourings, extraction solvents, food enzymes, vitamins and minerals are not covered by the Proposal. Originally, the assessment of genetically modified food was included in the Novel Foods Regulation, however since 2003, genetically modified food is regulated by its own Regulation (EC) No 1829/2003. This change is now also reflected in the Proposal. The definition of novel foods also includes foods which have a history of safe use in a third country. For these ‘third country’ foods, the Proposal introduces a notification procedure with the Commission Novel foods authorised under Regulation (EC) No 258/97 shall maintain their novel foods status. Authorisations for any new uses of such foods will however require an authorisation under the Proposal. Applications submitted under Regulation (EC) No 258/97, for which a final decision has not taken place before the effective date of the new Regulation, shall be considered as an application under the new Regulation.
Instead of submitting an application to both the competent authority in the Member State and to the Commission, the Proposal introduces one centralised procedure. An application will be submitted to the Commission after which the European Food Safety Authority will assess the product.
In addition, the Proposal covers rules for data protection, the possibility of additional labelling information and penalties to be laid down by the Member States. A socalled ‘Community list’ is introduced. Only novel foods included in this list may be placed on the market.
Although the Proposal intends to simplify the assessment and authorisation process of novel foods, separate applications still need to be made for a substance with different food uses. Furthermore, the Proposal refers to several other regulations for further substantiation which arguably makes the Proposal less transparent than it would otherwise be.
The adoption of the Proposal by the Council and the European Parliament jointly may take some time as there are still some issues surrounding the Proposal to be resolved.