Intertek has prepared and facilitated numerous successful novel food submissions in the European Union. Our team of experts can help your company navigate the scientific and regulatory requirements for novel foods.
The European Union’s (EU’s) Novel Foods Regulation (EC) No 258/97 applies to foods and food ingredients that have not been used for human consumption to a significant degree within the European Community before 15 May, 1997.
The EU Novel Foods Regulation states that novel foods falling within scope MUST NOT:
- Present a danger to consumers
- Mislead consumers
- Differ from foods or food ingredients for which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer
A full Novel Foods application for each company’s ingredient is required unless "Substantial Equivalence" can be demonstrated. Substantial Equivalence "notification" provides a quicker route to market based on comparison to a traditional counterpart or existing approved food ingredient. This comparison is based on composition, nutritional value, metabolism, intended use and the level of undesirable substances.
EU Novel Foods Services
Intertek has extensive experience in negotiating with the European Commission and European Food Safety Authority (EFSA), as well as Member State Novel Food Competent Authorities and their Expert Committees, resulting in successful applications on behalf of our clients. Our services include:
- Determination of Novel / Not Novel classification Feasibility assessments to determine whether sufficient data is available to support a Novel Food application or Substantial Equivalence notification
- Provide recommendations for the generation of additional data where information gaps exist
- Design and placement of pre-clinical and clinical studies where needed
- Dietary exposure assessments using recognized food consumption databases
- Preparation and submission of Novel Food dossiers and Substantial Equivalence notifications
- Stewardship of submissions at the Member State, EFSA, and Commission level to approval
Frequently Asked Questions
A novel food is defined as any food that was not used for human consumption to a significant degree within the EU before 15 May 1997. In short, approval requires compiling of a scientific dossier and submitting to the European Commission for risk assessment by EFSA and legislative procedure by the European Commission.
To help determine the novel status of a food ingredient, food business operators can engage in a consultation process with a Member State. The novel food consultation dossier is submitted to one Member State, and this Member State has 4 months (extendable by up to 4 months) to issue an opinion as to whether they consider the food ingredient to be “novel.” Decisions on the status of an ingredient reviewed by a Member State via the novel food consultation process are listed on the EC website. Alternatively, Intertek can perform novelty assessments to determine the status of a food ingredient, or compile the novel food consultation dossier.
From submission to authorization, approval typically takes 2 to 3 years. Timing is highly dependent on the types of questions raised and the need for additional technical or safety studies.
Approval is generic, unless an applicant has developed proprietary scientific data needed by EFSA to conclude on the ingredients safety. In that case, exclusivity is granted for 5-years. Thus, once exclusivity has been granted to an applicant, no other applicants can reference that study for a period of 5 years, even if it is publicly available. Once the 5-year exclusivity period expires, other applicants can refer to that publicly available data for their application but cannot claim that it is proprietary to them.
A traditional food is defined as being derived from primary production with a history of safe food use in a third country (consumption for at least 25 years in the customary diet of a significant number of people in at least one third country). The applicant must prepare a notification, which is submitted to the European Commission for authorization. If there are any safety concerns, a full application must be submitted.
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