FAQs

Allergenicity considerations should be always addressed in a dossier, although the extent of allergenicity data required for a Novel Food dossier submission depends on the nature of the food and its production process. Allergenicity data is particularly critical for novel proteins, traditional proteins generated by novel production methods or from novel sources.

At a minimum, literature searches should be provided to supply information about the potential risks and the protein should be clearly identified and compared to determine homology with known allergens. This comparison involves analysing the amino acid sequence against those of known allergens in established databases. In cases of high cross-allergenicity risks, in-vitro and even clinical data might have to be provided.

A scientific dossier should detail the applicant, Novel Food identity, composition, production process, stability data and its intended use, target population and dietary intake assessment. It should also include nutritional, toxicological and allergenicity data to ensure that if introduced into the market it is safe and not disadvantageous nutritionally.

For authorisation in Great Britain, scientific dossiers are submitted electronically to the Food Standards Agency via the dedicated FSA portal.

In the EU and Northern Ireland, pre-application documents (notification of studies and tests included in the dossier) should be submitted on Connect EFSA. The dossier should be submitted via the dedicated EU Commission e-submission portal (EFSA ESFC portal).

Yes, the process and scientific requirements in GB and EU are similar and Food Business Operators can refer to the EFSA’s Novel Food scientific guidance for authorisations in both regions. However, because the review processes are independent and involve different scientific committees, Food Business Operators may receive specific requests for clarifications / additional information when submitting their dossier to the Food Standards Agency and Food Standards Scotland in GB.

A minimum of five independent batches are required, and they should be sampled in a manner adequate to address potential compositional variations (e.g. seasonal) of the raw materials. If several production processes are proposed and/or different forms of the Novel Food (e.g. powder, liquid), five batches are required for each proposed format variation. Similarly, shelf-life studies should be provided for each primary packaging material and format intended to be used. The batches should be within proposed specifications and be representative of the product as intended for consumption.

The need of in-vivo studies is highly dependent on the nature of the Novel Food and the other data provided. There is a general effort to minimise the number of animal studies and use model systems wherever possible. However, in some cases, there are no alternatives.

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.

Considerations on Absorption Distribution Metabolism and Excretion (ADME) are required as a part of a Novel Food dossier submission. These requirements take a tiered approach. The extent of data required, including the need of human clinical studies, is on a case-by-case scenario. When the Novel Food is composed of substances commonly found in the body / diet or consists of polymers (with evidence provided that they do not degrade in the gastrointestinal tract), ADME studies may not be needed.