01 Sep 2020
  • Adopted
  • Very high importance
  • Europe
  • Binding legal instruments (regulations, directives and decisions)
  • Food


The purpose of the regulation is to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers' interests. The regulation replaces Regulation (EC) No 258/97 and improves conditions so that food businesses can easily bring new and innovative foods, including food consisting of engineered nanomaterials, to the EU market, while maintaining a high level of food safety for European consumers.

Key definitions

  • Novel food: Any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories: (i) food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997; (ii) food consisting of, isolated from or produced from microorganisms, fungi or algae; [...] (viii) food consisting of engineered nanomaterials as defined in point (f) of this paragraph; (ix) vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where: 1) a production process not used for food production within the Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or 2) they contain or consist of engineered nanomaterials. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material. For the full list of categories in the definition, see Article 3, paragraph 2.
  • Engineered nanomaterial: Any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. (The definition is different to that of European Commisions, EC 2011).

Data and information requirements

  • In order to apply for authorisation of a novel food, an application must be sent to the European Commission. The application must include a list of information, which include, among others, the name and address of the applicant, detailed composition of the novel food, scientific evidence demonstrating that the novel food does not pose a safety risk to human health and, where appropriate, analysis method(s). For the full list of information requirements for an authorisation application, see Article 10, paragraph 2.
  • When test methods are applied to engineered nanomaterials, as part of demonstrating safety in an authorization application, the applicant shall provide an explanation of their scientific appropriateness for nanomaterials. Where applicable, the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of nanomaterials, must be provided as well.

Decision procedure

1) The procedure for authorising a novel food shall start either on the European Commission's initiative or following an application to the European Commission by an applicant.
2) The European Commission can consult the European Food Safety Authority (EFSA), to give its opinion on whether a novel food may pose a safety risk to human health. EFSA shall adopt its opinion within nine months.
3) The Commission shall, assisted by the Standing Committee on Plants, Animals, Food and Feed, adopt implementing acts authorising the placing on the market of a novel food and updating the Union list.

Decision-support tools

  • Risk assessment
  • Safety assessment

Risk management procedures

  • The European Commission or the European Food Safety Authority can request from an applicant, that additional information on matters concerning risk management are provided.

Monitoring requirements

  • The EuropeanCommission may, for food safety reasons and taking into account the opinion of EFSA, impose post-market monitoring requirements. Such requirements may include, on a case-by-case basis, the identification of the relevant food business operators.

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Legislative History

  1. Final act signed

    November 25 th, 2015

    Final act signed

  2. Final act published

    December 11 th, 2015

    Final act published

  3. Entry of act into force

    January 01 th, 2018

    Entry of act into force