EU Issues Implementing Regulation on Novel Foods

On 19 March 2018, the European Union issued a Regulation implementing article 4 of Regulation 2283/2015 on novel foods. The new regulation concerns the consultation process for the determination of novel food status. The regulation becomes effective on 8 April 2018.

Verisk 3E Analysis

Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Regulation 2018/456/EU) provides the tools to food business operators applying for a novel food classification according to the Novel Foods Regulation.

In order to determine the novel food status of a particular food, food business operators will submit a consultation request to a single member state of their choosing, even if they plan on placing the novel food on the market in several member states simultaneously. The request must be submitted with a full technical dossier justifying the reason and relevance of the food as a novel food. Required information includes the name, description, and proposed category of the novel food, intended use, and production process as well as any history of human consumption of the food since 1997. The member state will respond within four to eight months validating the consultation request with supporting justification. Where the food business operator submits insufficient information in the consultation request, the recipient member state shall request additional information or make the relevant updates to the consultation request within the time period specified by the recipient member state. The member state's decision will clarify if a food is to be considered as a novel food.

If the food is not validated as a novel food, the manufacturer may submit a full novel food application to the European Commission.  The consultation request shall be considered not valid where: 

• the food business operator does not provide the requested information or updated consultation request within the period specified by the member state;
• the submitted additional information is insufficient to conclude that the consultation request is valid.

If validated, the food business operator may place the product on the market as a novel food. Once the request is granted by the member state, a food business operator may request certain information to remain confidential. However, confidentiality will not apply to the name and address of the food business operator, name and description of the food, summary of the studies submitted, and analyses methods (if appropriate).

Annexes I and II to the regulation contain templates of the cover letter for the consultation request and the technical dossier, respectively.

Background Information

‘Novel food’ means any food that was not used for human consumption to a significant degree within the EU before 15 May 1997, and which falls under at least one of the following categories:

• 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;
• food consisting of, isolated from or produced from microorganisms, fungi or algae;
• food consisting of, isolated from or produced from material of mineral origin;
• food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
  • traditional propagating practices which have been used for food production within the EU before 15 May 1997; or
  • non-traditional propagating practices which have not been used for food production within the EU before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
• food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
• food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
• food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
• food consisting of engineered nanomaterials as defined in point (f) of this paragraph;
• 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:
  • 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
  • they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;
• food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC.

Business Impact

Food operators should carefully choose the member state to which to submit the consultation, as its decision is binding in the EU. Regulation 2018/456/EU becomes effective 8 April 2018.