What's on this page:
Certain food and feed products, called regulated products, require authorisation before they can be sold in the UK. Food Standards Scotland (FSS) and the Food Standards Agency (FSA) carry out a risk analysis process for regulated products and provide advice to ministers, who decide whether the product can be placed on the market in Scotland, England and Wales.
What you need to submit as part of your regulated product application
Important: market authorisation process reform
On 1st April 2025 the legislation covering the market authorisation process in Great Britain (GB) for regulated products was amended which:
- removes requirements for the periodic renewal of authorisations for feed additives, smoke flavourings and food or feed containing, consisting of or produced from genetically modified organisms.
- allows authorisations to come into effect following ministerial decision and then be published in an official register or list, rather than being prescribed by statutory instrument (SI).
Our guidance was amended to take these changes into account. You may wish to refer to further information on the reforms and how they relate to specific product types.
Before you start
Before you begin the application process, please consider if you need to apply for a regulated product market authorisation. This page explains the application requirements and will help you to work out if you need to make an application.
You will need to apply for a regulated product authorisation if you wish to place one of the following product types on the market in GB. Follow the links for specific FSS guidance according to each product type (‘regime’). These pages also link to the relevant guidance and regulations applicable to each regime:
- Extraction Solvents
- Feed additives
- Feed for particular nutritional uses (PARNUTS)
- Feed Detoxification processes
- Flavourings
- Food additives
- Food contact materials
- Food enzymes
- Genetically modified organisms (GMOs) as food and feed
- Irradiated food
- Novel foods
- Smoke flavourings
- Precision bred organisms (PBOs)
In addition, if you wish to apply for an authorisation of a cannabidiol (CBD) product you can find more information in our CBD guidance.
If you wish to apply for an authorisation of a cell-cultivated product (CCP) you can find more information in our CCP guidance.
Existing authorisations
If your product or process was authorised by the European Commission (EC) before 1st January 2021 and the necessary legislation applies, that authorisation remains valid in GB.
Placing your product on the Northern Ireland market
Applicants wishing to place regulated products (excluding feed additives) on the Northern Ireland market continue to follow the EU authorisation process. However, regulated products authorised in GB may also be placed on the Northern Ireland market, provided they are eligible for, and are moved through, the Northern Ireland Retail Movement Scheme (NIRMS). Feed additives are ineligible to be moved through NIRMS. Feed additives placed on the Northern Ireland market are assessed by EFSA. If there is any difference in approach, this is managed through the relevant provisional Common Frameworks.
The application process
Once you’ve established that the product you wish to market is a regulated product that is not already authorised in GB, you must review the information on this page and the guidance specific to your regime before you submit your application to ensure you have all the required information.
This information is needed so that our risk assessors can assess whether the product or process is safe and to inform the decision on whether the application will be authorised.
The registers of regulated products lists the regulated products permitted for use in GB and provides references to their terms of authorisation.
Important:
The quality of the dossier, and the information provided, will significantly affect the time needed for analysis and authorisation. We encourage applicants to follow the guidance and provide all the required information to ensure we can process your application as efficiently as possible. Incomplete applications are likely to be delayed and/or deemed invalid or refused.
For an overview of the authorisation process, please refer to our [ link to regulated product process flowchart] regulated product process flowchart and [ link to risk analysis process flowchart] risk analysis process flowchart.
For most regulated product types, once products or processes are authorised, they are listed in online registers which also set out how they can be used.
The registers for the following products or processes have not yet been established:
- food enzymes
- food contact materials - recycled processes
- food contact materials - active and intelligent materials
Until the registers are in place, these products may be placed on the market if they meet requirements of:
- the General Food Law
- the relevant general criteria in the food enzyme and food contact material legislation.
Please note: Authorisations are not generally issued for composite foods. The authorisation requirement relates to a particular substance (for example, 2’-fucosyllactose as a novel food) rather than to a composite product containing a regulated product as an ingredient (for example, a flavoured drink containing the novel food 2’-fucosyllactose). Applications for authorisations must be prepared accordingly.
The authorisation process
In assessing your application, we will take into account assimilated law and the guidance previously developed by the European Food Safety Authority (EFSA), as outlined in the regime-specific guidance pages.
Once you have submitted your application, we will carry out initial checks to make sure it contains all the necessary information. FSS, and the FSA, will then carry out an analysis to decide if the product or process is safe to be placed on the market in GB. This may involve risk analysis by one of our Joint Expert Groups and/or Scientific Advisory Committees and a consideration of other legitimate factors (for example, risks to the environment). These will be combined to form an evidence package.
Based on this evidence, we will consider possible risk management options and make a recommendation to ministers. There will be an opportunity to comment on the application by taking part in a consultation during the risk management process. The decision on authorisation is made by the respective Minister in Scotland, England and Wales, with the Minister in Northern Ireland kept informed.
If a decision is taken to support an authorisation the relevant register will be updated to reflect the change.
The timing of the full risk analysis process will depend on how complex the application is and on the type of product. For some products, the deadlines are set in legislation.
Ongoing applications to the European Union (EU)
If you submitted your application to the EU before 1st January 2021 and the analysis process has not been completed, you will need to submit your application to us using our application portal. Please include your EFSA question number in your submission.
We may take into account the published EFSA opinion and the outcome of any risk management discussions at the end of the transition period (31st December 2020), but in some cases we may still need to carry out a full risk analysis and consider risk management options.
How to apply
Applications are made via our [add link to Regulated products to regime-specific pages]online application portal, where you can upload all the required information. Once your application has been submitted you will receive an email with your case reference number and a secure link where you can view your application and case history.
General advice on submitting an application
When applying for a regulated product authorisation you will have to supply administrative, technical and safety information. This information will form your application dossier.
The dossier requirements and structure are specific to each product type. You must read and follow the detailed guidance for the regime your product falls under and submit the required data and information specified in the relevant guidance.
Some new products, particularly those produced by genetic modification, may require applications under more than one regime. If this might be relevant to your product, you are strongly advised to contact the FSA at regulatedproducts@food.gov.uk before starting an application.
FSS’ regime specific guidance links to parts of the technical guidance produced by EFSA where it remains relevant.
As detailed in FSS’ regime specific guidance, you should follow the parts of the EFSA guidance that relate to the development of dossiers only (not the application process).
What is needed for an application
An application consists of two parts:
1. Administrative information
We will need to know:
- who is applying for the authorisation.
- who is responsible for the product or process.
- who we should contact if we have any questions.
It is also helpful to know the application’s status in the EU, if it has been submitted there.
Applicants must provide up-to-date details to FSS for correspondence. Failure to do so may result in the application(s) being deemed invalid.
2. Technical and safety information
The dossier needs to contain all the information requested within the applicable regime regulations and guidance. Failure to submit all the necessary information may result in the application being delayed and/or deemed invalid or refused.
The application portal includes a checklist to ensure your dossier is complete when you submit it.
You should not submit your application until you have uploaded all supporting information to the online application portal.
We need this information to understand more about the product or process and how it is intended to be used. This will allow us to carry out a thorough risk analysis, where appropriate, to verify whether the product or process can be used safely to inform the decision on whether the application will be authorised.
You should include all relevant data, whether the results are supportive of the product or not, to demonstrate that you understand the risks and have identified how these can be managed. You should clearly list all the data provided and explain how it supports the application.
You should also tell us what information in the application you would like to be kept confidential, in line with the criteria set out in FSS’ regime-specific guidance. Copies of all references and a table of references should be provided, which should clearly indicate which files or parts of files are regarded as confidential and for which a data protection request has been made.
Please note, our working language is English. Dossiers can be accepted in English and Welsh. Any documents, including supporting documents such as annexes or references that are in other languages must be translated and the translation provided with the submission.
File names, File types
Files within the dossier should be named logically. Further details are given within the checklists in the portal. This minimises the chance that key data is lost. Dossiers which do not clearly state each file’s role will take longer to assess. It is also important to cross reference files within the dossier where applicable and make supporting information clear. More information on File names can be found [add link to Regulated products Applications Required Files names and File types] Here
Only certain types of files can be uploaded more information can be found [add link to Regulated products Applications Required Files names and File types ] Here.
Large file uploads
You can only upload a maximum of 100 files at one time and uploads should not exceed 200 MB in total. You may carry out multiple uploads.
If you have information that is not available in any of these formats or sizes, please contact FSA at regulatedproducts@food.gov.uk to discuss options.
This is particularly recommended for GM applicants before uploading their files.
Advice on providing a valid application
The points below will not apply to all regimes but give some general advice:
- detailed guidance is provided in the FSS guidance documents which link, where appropriate, to the relevant EFSA guidance. Applicants should always refer to regime-specific guidance for clarification, as relevant guidance is reviewed as needed to maintain appropriate standards and support high-quality dossiers.
- you should clearly explain the product’s purpose, intended use and its composition. You must provide evidence of the product’s composition and how you know the product’s authenticity. For example, it may be necessary to give the chemical name or scientific (Latin) name, depending on regime.
- all the necessary technical information, as outlined in the [add link to Regulated products to regime-specific pages]regime specific guidance, should be included when you submit your application. For example, appropriate validation and/or accreditation documents for methods of analysis are required for all regimes and should be included in applications when they are submitted.
- we advise following the headings and subheadings given in the relevant EFSA guidance, to aid validation. All sections must be completed by the applicant to be considered a valid dossier. If a section given in the guidance is not appropriate for the product, the dossier should include a reasoned justification as to why that is the case (e.g. history of use).
- the technical dossier should explain how the product meets the criteria set out in the relevant regulation and guidance. You should clearly list all the data provided and explain how it supports the view that the product is safe. You must submit all relevant data, whether the results are supportive of the product or not.
- for most application routes, the dossier should include your analysis of the product’s risk, with enough information to verify this analysis. The focus of the analysis is that you show your understanding of the risks and identified how the risks can be managed.
- where appropriate, information on the relevance and strength of the data, as well as test methods, should be included, as should an interpretation of the data. If applicable, the variability of the product should be considered when selecting the batches for testing. Applications with fewer batches than specified in the guidance must provide a full justification for the number submitted.
- for dossiers that require completion of a production section, a Hazard Analysis Critical Control Plan (HACCP) is useful. The information in this section should identify whether there are new risks introduced by the production process and to what extent existing hazards from the starting material are managed. If the effectiveness of a step is supported by the product analytical testing, this should be clearly stated.
Further considerations
Applicants should review the request for information to ensure they thoroughly understand what is being asked. If, after consulting the relevant guidance, there are any remaining questions these should be raised as soon as possible. If there are any complex technical matters that cannot be resolved through written communication, in exceptional circumstances we may arrange a meeting, provided the issues have been clearly articulated in writing first.
As outlined above, applicants are expected to submit complete applications and requests for information will be issued at the discretion of FSS and the FSA. Decisions regarding the timeframes for responding to requests for information, and the adequacy and completeness of responses, also remain at both FSS the FSA’s discretion.
We will consider circumstances on a case-by-case basis and will strive to ensure consistency and fairness for applicants whilst facilitating a timely and efficient authorisation process.
Make a regulated product application
You can now use our online application portal to[add link to Regulated products to regime-specific pages] make a regulated product application.
Getting help
If you have any questions about authorisations of regulated products or having consulted the registers have general questions concerning whether a product is permitted in GB, please contact regulatedproducts@food.gov.uk before starting an application.
For other queries, including imports and registering a food business, please read our guidance for food businesses and if you require further assistance.
Providing information on authorised regulated products
If you need to contact us about an existing authorisation, please email regulatedproducts@food.gov.uk. You should use this route to notify us of any new or developing safety concerns about an authorised product, such as if you become aware of anything new casting doubt on a previous safety analysis.
Additionally, you must (where required) use this route to send us post-market monitoring reports, post-market environmental monitoring reports, updates, or changes to analytical or detection methods, and any other information related to an existing authorisation.
When emailing, please mention the authorisation or product you are referring to, what type of information you are providing and include the RP number if applicable.
Businesses are legally required to report to FSS or the FSA if they have reasons to believe that placing the food or feed product on the market could do harm to consumers.
In Scotland, you must report any food safety incidents to FSS. If the incident relates to a business in England, Wales or Northern Ireland then you must report these to the FSA.
