Regulation (EU) 2015/2283 on novel foods
What this means for your business
- Enforced by
- The Crown Estate, Crown Estate Scotland, OPSS, ECJU, FSA, Food Standards Scotland, APHA, Forestry Commission, Natural England
- Applies to
- United Kingdom
- On this page
- 10 compliance obligations, 1 practical guide
What you must do
10 compliance obligations under this legislation.
Risk assessment 1
Check if your food is a novel food and seek authority advice if unsure
If you run a food business and want to sell a product in Great Britain, you must first find out whether it is covered by the novel foods rules. If you cannot be sure, you have to contact the Food Safety Authority and give them the information they need to make a decision before the product goes on the market.
Management duties 2
Ensure labelling and monitoring for authorised novel foods
If you want to market a new food product, you need to meet the regulator’s authorisation conditions. This means your product must carry clear labelling that tells consumers about any health, nutrition or special properties, and any limits on use. You also have to carry out agreed post‑market monitoring and report the results to the authority.
Request confidentiality for novel‑food application data
When you apply for authorisation of a novel food, you can ask that any part of the information you submit be kept confidential if publishing it would hurt your competitive position. You must clearly identify the sections you want kept secret, explain why, and submit this request with your application. If the authority disagrees, you have three weeks to withdraw the application while the information remains confidential; otherwise you must accept the authority’s decision on what can stay confidential.
Other requirements 1
Only place authorised novel foods on the market
If your business sells or uses a novel food in Great Britain, you must make sure it has been authorised by the relevant authority and that you follow any conditions of use and labelling set out in that authorisation. You cannot market a novel food that hasn’t got the proper approval.
Offences and prohibitions 1
Fail to comply with novel foods authorisation requirements
Unlimited fineIf you place a novel food on the market, import it, or make a health claim about it without the required EU authorisation or without following the procedures set out in the novel foods Regulation, you commit a criminal offence. Conviction can lead to a fine (which may be unlimited) and/or imprisonment, depending on the seriousness of the breach.
Registration and licensing 1
Obtain authorisation before selling a traditional food from a third country
If you want to sell a traditional food that comes from a country outside the EU in Great Britain, you must get formal approval from the food safety authority before you put it on the market. The authority has 3 months to decide once they’ve received your application. If they refuse, you may not sell that product.
Reporting and filing 4
Ensure novel food meets safety, truth‑in‑claim and nutrition criteria
If you want to market a novel food in the UK, you must prove it is safe, that any marketing claims are honest, and that it does not give consumers a nutritional disadvantage compared with the food it replaces. In practice this means gathering scientific safety evidence, checking your product labels and marketing materials, and preparing a detailed dossier for the regulator before you launch the product.
Provide requested information to the Food Safety Authority
If you are applying for novel‑food authorisation and the Food Safety Authority asks you for more data, you must send that information within the deadline they set. Failing to do so means the Authority will issue its opinion based only on the material it already has.
Provide required information to the Food Safety Authority
If you apply to place a traditional food from a third country on the GB market, you must give the Food Safety Authority the data it asks for, and you must do so within the time it sets (normally within six months). If you send extra information on your own initiative, you still have to meet the six‑month deadline for the Authority’s opinion.
Report new safety information on novel foods to the Food Safety Authority
If your business has placed a novel food on the market, you must tell the Food Safety Authority as soon as you learn of any new scientific or technical data that could affect its safety assessment, or any ban or restriction on the product in another country. This keeps the safety evaluation up‑to‑date and helps protect consumers.
Penalties for non-compliance
1 penalty under this legislation. 1 carry an unlimited fine.
Fail to comply with novel foods authorisation requirements
Unlimited fine
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
39 classified provisions from this legislation.
Duties 12
- s.4 Procedure for determination of novel food status
- s.6 Requirement for authorisation
- s.7 General conditions for authorisation of novel foods
- s.9 Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation requirements necessary
- s.11 Opinion of the Food Safety Authority
- s.12 Authorisation of a novel food ... other legitimate factors relevant
- s.15 Procedure for notifying the placing on the market of a traditional food from a third country the appropriate authority
- s.17 Opinion of the Food Safety Authority on a traditional food from a third country
- s.18 Authorisation of a traditional food from a third country ... other legitimate factors relevant
- s.23 Confidentiality of applications for authorisation
- s.25 Additional information requirements
- Domestic list of authorised novel foods Domestic list of authorised novel foods
Powers 3
Definitions 3
- s.3 Definitions novel food' means any food that was not used for human consumption to a significant degree within the EU or the United Kingdom before 15 May 1997, irrespective of the dates of accession of member States, and that falls under at least one of the following categories— food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the EU or the United Kingdom before 15 May 1997;food consisting of, isolated from or produced from microorganisms, fungi or algae;food consisting of, isolated from or produced from material of mineral origin;food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the EU or the United Kingdom and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:traditional propagating practices which have been used for food production within the EU or the United Kingdom before 15 May 1997; ornon-traditional propagating practices which have not been used for food production within the EU or the United Kingdom before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the EU or the United Kingdom before 15 May 1997 and the food from those animals has a history of safe food use within the EU or the United Kingdom;food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;food resulting from a production process not used for food production within the EU or the United Kingdom before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;food consisting of engineered nanomaterials as defined in point (f) of this paragraph;vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:a production process not used for food production within the EU or the United Kingdom before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; orthey contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;food used exclusively in food supplements within the EU or the United Kingdom before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC; b) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country, prior to a notification referred to in Article 14; c) ‘traditional food from a third country’ means novel food as defined in point (a) of this paragraph, other than novel food as referred to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from primary production as defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a history of safe food use in a third country; d) “the applicant third country prescribe
- Determination of authorisation status Determination of authorisation status
- Regulations and devolved powers Regulations and devolved powers