Novel foods authorisation guidance
Novel foods authorisation requirements and what you need to submit as part of a novel food application.
Novel foods are any food that was not used for human consumption to a significant degree within the United Kingdom (UK) or the European Union (EU) before 15 May 1997. This means that the foods don’t have a ‘history of consumption’. Examples of novel foods include:
- new foods, for example, phytosterols and phytostanols used in cholesterol reducing spreads
- traditional foods eaten elsewhere in the world, for example, chia seeds, baobab
- foods produced from new processes, for example, bread treated with ultraviolet light to increase the level of vitamin D present
Novel foods need to be authorised before they can be placed on the market in Great Britain (GB). The placing of novel foods on the market in GB must be in accordance with the retained EU regulation 2015/2283 There are two authorisation routes:
- traditional food notification
- full application
EU Food Law continues to apply in Northern Ireland, under the current terms of the Protocol on Ireland/ Northern Ireland (Annex II). The novel status of a product in Northern Ireland is based on the European Commission determination and before being placed on the Northern Ireland market, novel foods must go through the EU authorisation processes. Only novel foods authorised by the European Commission may be placed on the Northern Ireland market. Under the provisional Common Framework for Food and Feed Safety and Hygiene, Northern Ireland continues to fully participate in the risk analysis processes concerning food and feed safety
The register of novel foods sets out a list of novel foods permitted for use in Great Britain. The register does not replace retained EU regulations 2015/2283 which are the legal basis for the placing on the market and use of novel foods. Unless data protection measures are triggered, you can sell an authorised novel food in accordance with the conditions set out in the register. The register shows where data protection is in place.
To apply for an authorisation of a novel food in GB use our regulated products application service. After completing an application form, you’ll be sent a link where you can upload your application documents which will form your dossier. There is no fee for the application.
Traditional food notification
This is a simplified route to authorise products that have 25 years’ continuous use by a significant number of people in a country outside the UK or EU.
This route has reduced data requirements reflecting their wide use in other parts of the world. There is a four-month period within which the review is conducted. If there are no objections the product is authorised and placed on the authorised list.
Detailed guidance for traditional food notifications
The retained EU law, Regulation (EU) 2017/2468, and guidance previously developed by EFSA set out what the is needed in the application. The EFSA guidance remains relevant as our approach is based on EU processes. You should follow the parts that relate to the development of dossiers only and not the application process:
- EFSA guidance on the preparation and presentation of an application for authorisation of traditional foods from third countries
For novel foods other than those under the traditional food notification route, you need to submit a full set of information.
It should contain the administrative data, such as information relating to the applicant.
It should contain information specific to the novel food such as:
- identity of the novel food
- production process
- compositional data
- the history of use of the novel food and/or of its source
- proposed uses and use levels and anticipated intake
- absorption, distribution, metabolism and excretion
- nutritional information
- toxicological information and allergenicity
It should also include a list of all references.
It should include:
- the glossary or abbreviations of terms quoted throughout the dossier
- the certificates (on the accreditation of laboratories, certificates of analyses)
- full copies / reprints of all pertinent scientific data (published and unpublished)
- full study reports
- scientific opinions of national/international regulatory bodies
Detailed guidance for full applications
Detailed guidance and application requirements are set out in retained EU law Regulation (EC) 2017/2469 and guidance previously developed by EFSA. The EFSA guidance remains relevant as our approach is based on EU processes. You should follow the parts that relate to the development of dossiers only and not the application process:
- EFSA guidance on the preparation and presentation of an application for authorisation of a novel food
If you submitted a novel food application to the EU before 1 January 2021 and the assessment process for this application has not been completed, you will need to submit your application to us, using our regulated products application service. When completing the application form, you will be asked to provide your EFSA question number.
If your novel food has been authorised by the European Commission before 1 January 2021 and the necessary legislation is in place, that authorisation will remain valid in Great Britain and you don’t need to apply for a new authorisation.
How long will my application take?
The law includes deadlines for key steps in the process. In a full novel food application made under Article 10, one month is allowed for the validation process, then up to nine months (on a start stop the clock basis if further information is needed) for the risk assessment element, with up to a further seven months for any subsequent risk management considerations and authorisation decision. These add up to a total of seventeen months as the overall legislative timeline for authorisation, noting this can be extended if the clock is stopped and re-started.
The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. We encourage applicants to follow the guidance and provide as much information as possible to ensure we can process your request as efficiently as possible.
If you have any questions about the authorisation procedure or process, you can contact us at email@example.com
Apply for authorisation
Consultation process (Article 4)
A consultation process (also known as an Article 4 request) is available if you:
- are unsure of the status of your product
- have evidence that it has a history of consumption in the UK or EU prior to May 1997
Retained EU Regulation 2018/456 details the information we will require to make the decision on whether the product is novel.
If the conclusion of the process is that your product is novel, then you will need to apply for authorisation to legally market the product in GB.
To submit your Article 4 request and supporting evidence, use our regulated products application service. In the ‘Product type’ section select ‘Other’.
We will list the outcomes of Article 4 consultations once a determination has been made.
Published: 30 May 2018
Last updated: 2 February 2023