New Novel Foods Regulation entered into application on 1 January 2018. For the first time, the authorisation system is centralised, with applications submitted to the European Commission rather than individual Member States. The new Regulation also opens the door to insect-based products.

As from 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods applies. The Regulation modifies the existing rules dating back to 1997 for the introduction of novel foods into the EU.

The main changes include:

  • expanded categories of novel foods;
  • Union list of authorised novel foods;
  • centralised EU authorisation system with applications submitted to the European Commission and not to individual Member States as previously;
  • scientific risk assessment by the European Food Safety Agency (EFSA);
  • simplified assessment procedure for traditional food from non-EU countries opening the door for instance to insect-based products;
  • provisions on data protection to protect the newly developed scientific evidence and proprietary data of applicants and to promote innovation.

In parallel, to facilitate the implementation of the new Regulation the following implementing acts have been adopted and published on 30 December 2017:

  • Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
  • Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods;
  • Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.

These implementing regulations will enter into force on 19 January 2018.

Other implementing and delegated acts will follow in the future as the new Regulation confers upon the Commission the implementing and delegated powers.