Navigation und Service

Authorisation procedure

The authorisation procedure laid down in Articles 4 and 6 of the Novel Foods Regulation must always be applied if the novel food or feed is not essentially similar to conventional products. The procedure is compulsory in the case of foods and ingredients whose molecular structure has been modified and for products where a novel process was used in their production if this leads to a major modification of their composition or structure (cf. Procedure for the placing on the market of novel foods).

The applicant submits an application to the competent authority of the Member State in which the product is to be placed on the market for the first time and a copy of this application along with a summary to the European Commission.

In Germany the competent authority for the receipt of such applications is the Federal Institute for Consumer Protection and Food Safety (BVL). The Federal Institute for Risk Assessment (BfR) is responsible for examining the health safety of novel foods and food ingredients.

Each application must be accompanied by all the information that is needed in order to prove that the product complies with the authorisation criteria. This includes the results of the safety assessment to be undertaken by the applicant

The European Commission published criteria for safety assessment in its recommendation of 29 July 1997 (97/618/EC) concerning the scientific aspects and the format of the information required in applications for authorisation for novel foods and food ingredients.

Furthermore, a labelling proposal for presentation and labelling is to be submitted pursuant to the labelling provisions of the Novel Foods Regulation (cf. Labelling provisions for novel foods).

Here is a chart to illustrate the authorisation procedure

(60 days)

The competent national authority submits a report on the initial assessment to the European Commission within three months of receipt of the application. The European Commission then distributes copies of this report to the other Member States. The decision on authorisation may stipulate conditions for the use and the designation of the product as well as specific labelling provisions.

The Member States and the European Commission can then submit comments on or reasoned objections to the placing of the product on the market within 60 days of the distribution of the initial assessment report. They may also concern the envisaged presentation or labelling.

If no objections are raised, the competent Member State informs the applicant that it may place the product on the market. In the case of reasoned objections a decision is required under the committee procedure (Article 13) pursuant to Article 7 of the Novel Foods Regulation. In the case of all questions which might have an impact on public health, one of the competent Scientific Bodies of the European Food Safety Authority (EFSA) (which has replaced the Scientific Committee on Food (SCF) of the European Commission) will be consulted, in accordance with Article 11 of the Novel Foods Regulation, prior to any decision being taken about authorising the placing of the product on the market.

At the end of the committee procedure in which the European Commission is supported by the Standing Committee on the Food Chain and Animal Health (which consists of delegates from the Member States and takes its decisions on the basis of a qualified majority), the European Commission informs the applicant about the decision taken. The decisions are also published in the Official Journal of the European Communities.

If a Member State has grounds for assuming that novel foods and food ingredients already on the market constitute a threat to human health or the environment, it can – in accordance with Article 12 of Regulation (EC) 258/97 - temporarily ban the trade in and use of the product concerned on its sovereign territory. After informing the other Member States and the European Commission, the latter must then examine the reasons and take a decision under the committee procedure together with the Standing Committee on the Food Chain and Animal Health.

The list of applications is available at the website of the European Commission (see bottom of the page).

Up