Novel foods are governed by Regulation (EC) No 258/97. A food or food ingredient is considered a novel food if it has no history of “significant” human consumption in the European Union prior to 15th May 1997.
From 1st January 2018, Regulation (EC) N° 258/97 will be repealed in favour of the new Regulation (EU) N° 2015/2283. A number of changes are to be expected, including:
- A single centralised procedure for the assessment and authorization of novel foods (article 10)
- Facilitated access to market for mrimary products consumed in at least one third country for at least 25 years (article 14)
- Possibility of data protection provisions for 5 years (article 26)
- Engineered nanomaterials require a Novel Food authorization
- Insects are covered bu the new Regulation
Pharmanager Development assists you with:
- Assessing regulatory status.
- Finding information to prove significant human consumption within the European Union prior to 15th May 1997.
- Preparing Novel Food applications:
- – According to the full procedure (if necessary, we can help you choose or carry out the toxicology studies required for the application).
- – According to the substantial equivalence procedure.