Reform of novel food regulation

The regulation on novel foods has been reformed. The new revision, Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods was adopted at the end of 2015, and will become applicable in full from 1 January 2018.

What has been reformed?

  • Centralisation of approval procedure

    • All applications will be reviewed and authorisations granted by the European Commission

    • Authorisation will be general in nature, not granted to a specific operator

    • Safety assessments will be carried out by the European Food Safety Authority (EFSA)

    • Time limits are specified for the safety assessment and the approval procedure, which will reduce the total duration of the authorisation process

  • Simplified approval route for traditional food from non-EU countries

    • The following shall be demonstrated for a traditional food:

      • history of safe use in the country of origin

      • has been consumed for at least 25 years as a customary food by a significant part of the population

    • Foods only used in food supplements cannot be traditional foods.

  • Union list of approved novel foods

    • All new and previously approved novel foods will be included in the list of approved novel foods in the European Union

  • Possibility of data protection

    • Pertains only to the application procedure

    • The applicant can be granted exclusive marketing rights to the product for a period of at most five years

    • Criteria for eligibility include newly developed scientific evidence or proprietary scientific data of the applicant

What will remain unchanged?

  • The date by which significant history of use as food is assessed is still 15 May 1997

  • Scope of Regulation

    • The scope of the Regulation, however, has been clarified by dividing products into categories

    • New product categories include:

      • material of mineral origin

      • food derived from plants or plant parts (incl. plants resulting from new propagation processes which give rise to significant changes in the composition of the food affecting its nutritional value, metabolism or level of undesirable substances)

      • food derived from animals or animal parts (incl. animals resulting from new propagation processes)

      • cell and tissue cultures (animals, plants, microorganisms, fungi, algae)

      • nanomaterials 

      • substances used exclusively in food supplements, if they are to be used in other foods

 

MORE ON THE TOPIC IN OUR SERVICE

  • Novel Foods, (European Commission, publication), (pdf)


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