REGULATORY ADVICE ON NOVEL FOODS

Regulatory advice on Novel Foods

Regulatory advice on Novel Foods includes several options: placing a Novel Food on the market, requesting clarification from member states on whether a product is a Novel Food or not, use of a Novel Food within a food and more.

What are Novel Foods?

Novel foods are defined as foods that did not experience significant consumption by European citizens before 15 May 1997, when the first novel food regulation came into force.
Novel Foods can be innovative and newly developed foods, or foods produced with new technologies and production processes.
Foods normally eaten outside the European Union but not within it are also considered Novel Food.

Examples of novel foods:

• insects and their meals;
• new sources of vitamin K (menaquinone);
• extracts from existing foods (Antarctic krill oil rich in phospholipids from Euphausia superba);
• agricultural products from third countries (chia seeds, noni fruit juice);
• oods derived from new production processes such as UV-treated foods (milk, bread, mushrooms and yeast).

What are the European rules for Novel Foods

Novel Foods must be:

• safe for consumers;
• labelled correctly, so as not to mislead consumers;
• if the Novel Food is intended to replace another food, it must not differ in such a way as to make consumption of the Novel Food nutritionally disadvantageous for the consumer;
• prior authorization for the placing on the market of novel foods is required on the basis of an assessment in line with the above principles.

Going back to the last point, i.e. authorizations for marketing in Europe, it is important to emphasize that this is a very complex process. This complexity puts a spoke in the wheels for many pioneers in the field.

Obtaining authorization is subject to evaluation by EFSA, which explains very well how the product dossier must be drawn up and what information it must contain.
The authorization application procedure for novel foods is set out in Article 10 of EU Regulation 2015/2283. Applicants wishing to place a novel food on the EU market must submit an application to the European Commission (EC), following the requirements set out in the legislation and EFSA guidance documents.

What must the application for authorization of a Novel Food contain?

The application for the authorization of a Novel Food must contain:

1. the name and address of the applicant;
2. the name and description of the novel food;
3. the description of the production process(es);
4. the detailed composition of the novel food;
5. scientific evidence that the novel food poses no safety concern to human health;
6. where appropriate, the method(s) of analysis;
7. a proposal for intended conditions of use and specific labelling requirements not to mislead the consumer or a verifiable justification as to why these elements are not necessary.

At the request of the Commission, the European Food Safety Authority (EFSA) gives its opinion on whether the update is liable to have an effect on human health.

Novel Food advisory service

If you wish to use my advisory service for Novel Food issues, such as their identification through direct consultations or through European institutional procedures, applications for authorizations and specific regulations, please contact me through the form on this page, or write to me at info(@)angilericonsulting.com.