Novel Foods - the Different Ways to Get Approval - Role of Commission, EFSA and Member States

Novel Food is defined as food that has not been consumed to a significant degree by humans in the EU prior to 1997, when the first Regulation on novel food came into force. 'Novel Food' can be newly developed, innovative food or food ingredients or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU.

Novel Food must be safe for consumers and properly labelled to not mislead the consumers.

Before placing a novel food on the European Union market, the applicant must first submit to the Commission an online application for authorisation („e-submission“) in line with the requirements of Article 10 of the new Regulation. In most cases the Commission will request the European Food Safety Authority (EFSA) to carry out a risk assessment. EFSA will adopt its opinion in 9 months from the date of receipt of a valid application from the Commission. Within the seven months from the date of the publication of the EFSA's opinion, the Commission shall submit to the Standing Committee on Plants, Animals, Food and Feed a draft implementing act authorising the placing on the market of a novel food and updating the Union list. Once the act receives a favourable vote from the Standing Committee and is adopted and published by the Commission, the novel food can be lawfully placed on the European Union market.

To facilitate trade of traditional food from non-EU countries, which are considered novel foods in the EU, the new Novel Food Regulation introduces a more appropriate assessment procedure for traditional food new to the EU. Before placing a traditional food on the European Union market, an applicant must first submit to the Commission an online notification for authorisation in line with the requirements of Article 14 of the new Regulation. If the traditional food in question can historically be demonstrated as being safe and there are no safety concerns raised by EU Member States or EFSA, that traditional food will be allowed to be placed on the market on the basis of a notification from the food business operator.

If one or more EU countries or EFSA submit duly reasoned safety objections, the Commission cannot authorise the placing on the market of the traditional food concerned or update the Union list. In that case, the applicant may submit an application to the Commission following the requirements of Article 16 of the new novel food regulation.

In Austria AGES is responsible for the safety assessment and classification of novel foods and works close with colleagues from DG SANTE- EU CAFAB (Competent Authorities together with Food Assessment Bodies) "Novel Food Working Group", a group comprised of Novel Food experts from the EU Member States together with officials from the European Commission and experts from EFSA. AGES is also a member of the EFSA Network on Novel Foods (EFSA meetings in Parma).