Commission Press Release (IP/08/37), 14 January 2008
The European Commission has today adopted a proposal to revise the Novel Foods Regulation with a view to improving the access of new and innovative foods to the EU market, while still maintaining a high level of consumer protection. Under the draft Regulation, novel foods would be subject to a simpler and more efficient authorisation procedure, which should enable safe, innovative foods to reach the EU market faster. Moreover, special provisions are made for foods which have not been traditionally sold in the EU but which have a safe history of use in third countries, in order to create a more proportionate system and positive environment for trade. The proposal also sets out certain data protection rules, which aim to protect newly developed foodstuffs once authorised, and encourage companies to invest in developing new types of foods and food production techniques.
Commissioner for Health, Markos Kyprianou said "This proposal aims to create a more efficient and practical system for regulating novel foods, which will offer EU consumers the benefit of the most up-to-date choice of foodstuffs possible and provide a favourable environment for the food industry in Europe .."
Novel foods are defined as those which were not consumed to any significant degree before May 1997 (when the Regulation entered into force). They may be foods produced using new techniques and technologies, or food which has been consumed elsewhere in the world but has no tradition of consumption in the EU. Following an extensive stakeholder consultation, the Commission decided to review the legislation for novel foods, taking into account technological developments, scientific advice and the experience gained through the application of the legislation. An impact assessment on the major changes was carried out by the Commission in 2006.The proposal adopted today addresses short-comings identified in the current Regulation, and seeks to create a regulatory framework which will better stimulate innovation in the food sector.
Centralised authorisation procedure
Under the revised legislation, the assessment and authorisation procedure for novel foods will be centralised. This means that, instead of the initial assessment being carried out by a single Member State and then sent to other Member States for comment, the Commission will receive the application for authorisation and the European Food Safety Authority will carry out the scientific assessment on the product. If the product is found to be safe, the Commission will present Member States with a proposal to authorise it in the Standing Committee on the Food Chain and Animal Health. This will make the authorisation procedure faster, more uniform and clearer for applicants.
Protection of innovative foods
The proposed Regulation includes data protection provisions for newly developed innovative food. Under the new system, the initial applicant would be given authorisation to market the food for 5 years before it becomes a generic foodstuff that can be produced and marketed by others.
The Commission's proposal makes provisions for food which has not been consumed before in Europe , but which has a history of safe use elsewhere. For such foodstuffs, the authorisation procedure is simplified. The third country will need to send a notification to the Commission, accompanied by proof of the history of safe use of the food in its territory, instead of a full dossier of data on the foodstuff, as required for newly developed foods. This notification is then submitted to EFSA and Member States , and if no objections are raised, the operator can place the traditional food on the market after five months of the notification.
For more information, see: http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm