FAQs

It is expected that the process yields batches representative of the Novel Food that will reach the consumers. It is also necessary that the production is governed by a food safety management system based upon Hazard Analysis and Critical Control Points (HACCP) principles in line with assimilated Regulation (EC) No 852/2004. Food Business Operators should ensure that quality and safety assurance (e.g. HACCP, GMP, ISO) are also implemented and part of the dossier. Provided the production process complies with the above, a Novel Food can be approved at smaller production scales, as long as this is justified in the dossier.

Following authorisation, if the scaled-up production process deviates significantly from the process described in the original dossier and/or the Novel Food produced deviates from the approved compositional specification, a new submission will likely be necessary. This would allow for evaluation of the impact of the altered process and, if appropriate, extension of its authorisation for use. Consultation through an Article 4 request can be utilised to confirm this.

Specific tests may be required depending on the nature of the Novel Food and available safety data. A comprehensive literature review should be the first step in the safety evaluation. To evaluate genotoxicity, an in-vitro reverse mutation assay (OECD TG 471) and a micronucleus assay (OECD TG 487) are likely to be required for most applications. In-vivo testing might be required if concerns over potential toxicological risks are highlighted by the in-vitro testing, the nature of the Novel Food, or a general lack of data in the scientific literature.

The most common issue in dossiers that are not approved is not providing the data to support the safety of the novel food. If a safety issue emerges this would also have an impact on the potential for authorisation if effective risk management measures could not be identified to manage the risk.

We find that the factors that cause delays are when there isn’t a narrative that pulls the evidence generated together and explains how safety for each area has been considered and is addressed by the evidence. Where applicants haven’t read the guidance for putting together applications this can also have a significant impact on the likelihood of being successful.

A Novel Food application requires the disclosure of confidential information, such as details about the production process and composition of the Novel Food, to enable authorities to evaluate the food’s safety. Applicants can request that confidential proprietary information be removed from documents intended for public access. This includes dossier versions used in public consultations and scientific opinions released by authorities, ensuring that sensitive details are not disclosed.

A Novel Food may be granted a five-year period of exclusive marketing rights if its authorisation was granted on the basis of proprietary data. During this exclusivity period, only the original applicant can market the Novel Food. This is not applicable to traditional foods.

Data must be provided on at least five representative non-consecutive batches of each form of the Novel Food (e.g., dried, frozen, powder). These should be produced independently (preferably with independent batches of raw materials) and their composition should cover characteristics expected due to process and raw material variability (including seasonal). Food Business Operators should justify the selection of their batches both in terms of sampling strategy and representativeness.