Novel food regulation

Regulation (EC) No 258/97 on novel foods was first adopted in 1997. The Novel Food Regulation was reformed in 2015, with the entry into force of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, which has been fully applied since 1 January 2018.

What was reformed?

• Centralisation of approval procedure

• All applications are reviewed and authorisations granted by the European Commission.
• Safety assessments are carried out by the European Food Safety Authority (EFSA).
• Time limits were specified for the safety assessment and the approval procedure, which reduced 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 are included in the union list of approved novel foods in the European Union.
  • The authorisation for novel foods are no longer operator-specific, but are general. This means that authorised novel foods can be placed on the market by all food business operators in accordance with the conditions of use provided. The exception to this are novel foods which have been applied for and granted data protection for a period of five years.

• 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 remained 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, was clarified by dividing products into categories and expanded by the addition of new product 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