Determination of novel food status: Commission Implementing Regulation 2018/456

Regulation (EU) 2018/456 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


Over the last years, the EU food sector has experienced a vast number of new foods: from third countries, from new agricultural practices and, mostly, from new technological processes. Consumers demand genuine and differentiate products has pushed the sector to do more. Trends changes and the market must respond to that change. The insect has finally reached our tables and confirmed to be safe by the European Food Safety Agency (EFSA).

Those defined as “novel food” (new foods) falls- in the EU food regulation framework- under the Regulation 2015/2283 on Novel Food. A novel food, by definition, is a food or a food ingredient that has not been consumed before the 15th of May 1997 in the EU. A new production process, which is called “not traditional” is also a factor that affects the evaluation of new food. The year 1997 makes the watershed for the Novel Food because of the very first regulation, Regulation (EC) No 258/97, released in that year. A new version in 2015 update and refined the previous one, changing, eliminating and introducing new concept as well. Today, every new food must be evaluated and concluded to be safe for consumption before being introduced in the EU market. A submission to the European Commission and an evaluation of EFSA are required for entering the market.

Although it seems easy to determine whether a food is “novel”, sometimes it is not. Producers or manufacturers are not always sure about the status of their product but, fortunately, Article 4 introduce a procedure that helps those before committing to formal submission. The Commission Implementing Regulation (EU) 2018/456 refers as “Determination of novel food status” or “Consultation process on novel food status” guides the Food Business Operators through a consultation process in accordance with Art. 4 which foreseen a consultation with the Member States (where the food wants to be introduced firstly on the market) and asks for a public opinion on that.

The essential point of the procedure is to demonstrate a solid history of consumption of the potential novel food and that there are no changes in the structure of the food, nutritional value, metabolism and or level of undesirable substances.

The content of a consultation request consists in:

  1. A cover letter;
  2. A technical dossier;
  3. Supporting documentation;
  4. An explanatory note clarifying the purpose and relevance of the submitted documentation


Commission Implementing Regulation 2018/456 provides in the Annex templates and instruct the FBO to send them electronically to the Member State. The consultation process foresees the evolution from the Member States which can ask the EFSA to give its opinion as well. Additional information can be asked from authorities to the FBO. The novel food status shall be concluded within 4 months from the received of all the relevant and comprehensive information, an extension can be applied whether other information is asked, and the applicant needs more time to retrieve them.

Confidentiality is a guarantee when there are justifying reasons behind it, However, confidentiality shall not apply to (a)the name and address of the applicant; (b)the name and description of the food; (c)a summary of the studies submitted by the applicant; (d)where appropriate, the analysis method(s).

FBOs should be sure when their products are novel or not and the regulation gives them the tool to do so. It has to be pointed out, however, that most of the time, retrieving the right consumption data is even harder than going straight to the formal submission. The success rate seems to be low, at the moment. Robust and reliable data of consumption are difficult to find. The high rate of rejection by the EFSA can be seen also on their website.