EU
The Union list on novel foods has been published in The Official Journal of the European Union on 20 December 2017. On 1 January 2018, this novel food regulation has come into effect.
This novel food regulation introduces a centralized authorization procedure for novel foods. All applications will be submitted directly to the EU Commission instead of to individual Member States and the European Food and Safety Authority (EFSA) will conduct a scientific risk assessment if needed. Application can be done via two different procedures:
- The authorization procedure for novel foods
- The notification procedure for a traditional food from a third country
All approved novel foods will be transformed into a generic authorization with this Union list. In addition, novel food approvals will no longer be holder-specific. All Food Business Operators complying with the conditions and specifications laid down in the Union list will be able to market a novel food which is identical to one that has already been approved, without having to apply for a substantial equivalence.
Additional legislation can be found here:
- 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.