Marketing authorisation procedures for genetically modified food and feed
The food and feed covered by the scope of Regulation (EC) No. 1829/2003 may not be placed on the market without marketing authorisation. The simplified notification procedure envisaged in the Novel Foods Regulation has been withdrawn.
The Commission issued implementing provisions (Regulation (EC) No. 641/2004) for the submission of the application and the notification of existing products (cf. List of marketable genetically modified food and feed) as well as transitional measures for products which have not yet been granted marketing authorisation (cf. List of applications for marketing authorisation for genetically modified food and feed pursuant to the Novel Foods Regulation. Marketing authorisation can only be granted for products which do not have a negative impact on the health of humans, animals or the environment and which do not mislead the consumer or user. Furthermore, the products may not differ from comparable products they are to replace to such an extent that their normal consumption could lead to nutritional deficiencies in humans or animals. Genetically modified feed may not impair the specific traits of products obtained from the animals fed on it to such an extent that it could harm or mislead the consumer.
In the case of genetically modified organisms (GMOs) that can be used - for instance, as maize or soya beans – both as food or feed, marketing authorisation must be sought for both purposes
The applicant and marketing authorisation holder or their representatives must be resident in the European Union (EU).
Marketing authorisation applications are to be sent to the competent authority in a Member State – in Germany the Federal Institute for Consumer Protection and Food Safety (BVL). The national authority passes on the application to the European Food Safety Authority (EFSA). It, in turn, sends a copy to the other Member States. The summary, to be enclosed with the application, is published by EFSA.
It is the task of EFSA to examine, on the basis of the documents enclosed with the application, whether the product corresponds to the requirements in terms of placing on the market and labelling.
Regulation (EC) No. 1829/2003 obliges EFSA to publish, by 18 April 2004, comprehensive instructions as an aid for applicants for the preparation and submission of their application.
EFSA is called on to pass on the results of the application examination, if possible, within six months in the form of an opinion to the European Commission, the Member States and the applicant. This opinion is – with the exception of confidential information – published and there is an opportunity to submit comments within 30 days.
Taking into account the opinion of EFSA, the European Commission prepares a draft decision; for it to be approved it requires a qualified majority in the Standing Committee on the Food Chain and Animal Health which consists of representatives of the Member States.
In contrast to the approvals envisaged in the Novel Foods Regulation which are unlimited in time, marketing authorisations are granted pursuant to Regulation (EU) No. 1829/2003 for a period of 10 years. On application they can be renewed for a further 10 years.
Food and feed which have received marketing authorisation are entered in a Community register along with the date of marketing authorisation and, where appropriate, a specific detection marker for the respective GMO.
Food or feed (cf. List of marketable food and feed), that is legally on the market, continues to be marketable if the Commission is informed of the date when it was first placed on the market by 18 October 2004 and is given the documentation required for the applications pursuant to Regulation (EC) No 1829/2003.
Any genetically modified food and feed currently going through the application procedure pursuant to Regulation (EC) No 258/1997 (cf. List of applications for marketing authorisation for genetically modified food and feed pursuant to the Novel Foods Regulation) are now treated as applications pursuant to Regulation (EC) No 1829/2003.
