Authorisations

Authorisations

Request for a novel food authorisation

Application procedure

Food business operators can place a novel food on the European Union market only after the Commission has processed an application for the authorisation of a novel food, and has adopted an implementing act authorising the placing on the market of a novel food and updating the Union list. Thus, before placing a novel food on the European Union market, the applicant must first submit to the Commission an online application for authorisation in line with the requirements of Article 10 of the new Regulation.

If the novel food is liable to have an effect on human health, 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.

Request for the authorisation of a traditional food from a third country

Notification procedure

As with other novel foods, traditional foods from a third country can only be placed in the European Union market only after the Commission has processed a notification, has adopted an implementing act authorising the placing on the market of the traditional food and updating the Union list. Thus, 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.

Upon reception of a notification the Commission assesses the validity of the application, its completeness and the presence of the required information. The Commission then forwards the valid notification to the EU countries and to EFSA. Within four months, Member States or EFSA may submit to the Commission duly reasoned safety objections to the placing on the market of the traditional food concerned.

Where no duly reasoned safety objections have been submitted, the Commission submits to the Standing Committee on Plants, Animals, Food and Feed a draft implementing act authorising the placing on the market of the traditional 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 traditional food can be lawfully placed on the European Union market.

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.

Authorisations under the old novel food regulation

The authorisations of novel foods under the old novel food regulation were addressed specifically to the applicant and gave the applicant exclusive rights to the novel food. With the current novel food regulation, although the specific authorisations, the conditions of use, the specifications and the labelling contained in them remain valid, they are no longer applicant-specific but have become generic following their inclusion in the Union list. This enables any food business operator to place the authorised novel foods in the European Union market.

The Authorisation covers:

The authorisation and entry for a novel food in the Union list includes, where appropriate:

  • Specifications
  • Conditions of use
  • Additional specific labelling requirements
  • Post-market monitoring requirements

Labelling

Novel food is subject to the general labelling requirements laid down in (Regulation (EC) No 1169/2011). Specific additional requirements for the labelling of a novel food may also apply, if necessary, to properly inform the consumer. The label must mention the name of the food, and, where appropriate, specify the conditions of use. Any nutrition and health claim should only be made in accordance with the requirements of the Health and Nutrition Claims Regulation (EC) No 1924/2006