Novel food regulation

Novel foods regulation controls which new foods and food processes can be placed on the market. A food is novel if it was not sold to a significant degree in the European Union before 15 May 1997.

The novel foods regulation applies to:

• foods with a new or intentionally modified molecular structure
• foods consisting of, or isolated from, micro-organisms, fungi or algae
• foods consisting of, isolated from or produced from minerals
• foods consisting of, isolated from or produced from plants or their parts (except foods obtained by traditional propagating practices with a safe history of use)
• foods resulting from a new production process that significantly changes composition or structure, affecting nutritional value, metabolism or the level of undesirable substances

Engineered nanomaterials, certain animal‑derived foods (for example, cultured meat and some insect products), and some new forms of vitamins and minerals are also treated as novel foods under the same regulation.

The regulation requires that novel foods be safe for consumers and properly labelled, so as not to mislead consumers. If novel food is intended to replace another food, it must not differ in a way that the consumption of the novel food would be nutritionally disadvantageous for the consumer

Exemptions from the novel food regulation

If a food or ingredient has a proven history of safe use as food and was sold commercially in at least one EU member state before 15 May 1997, it is generally not considered a novel food.

Regulatory context for novel foods in Great Britain and Northern Ireland

In Northern Ireland, EU Regulation (EU) 2015/2283 on novel foods continues to apply. The Novel Foods Regulations (Northern Ireland) 2017 sets out how the EU rules are applied and enforced. Authorisations are granted at the EU level and listed on the Union list of authorised novel foods.

In Great Britain, novel foods are authorised under the GB regime. Businesses apply through the UK-regulated products application service. Some GB-authorised products may be supplied into NI via the Northern Ireland retail movement scheme, subject to scheme conditions.

How to check if your product falls under novel food regulation

It is your responsibility to know if the novel foods regulation applies to a product you want to sell. If you are not sure whether a food or ingredient is considered novel in Northern Ireland, you should:

• read the official EU guidance on novel food
• check the EU novel food catalogue and the Union list to see if a similar product is listed

For GB authorisation, look at the Food Standards Agency (FSA) guidance to understand how novel products are classified and assessed.

If you remain unsure regarding the novel food status of your product, you should follow the procedure for the determination of novel food status, and contact the competent authority of the Member State where you first intend to place your product on the market.

Food business operators must provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of the regulation. Before you can place novel foods on the market, they must undergo safety assessment and authorisation.