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On June 20, 20231, the Food Standards Agency (FSA) and Food Standards Scotland (FSS) launched a new system2 for enterprises to submit applications for products required for premarket authorizations. As revealed by the authorities, the new system can help enterprises follow correct procedures and provide enterprises a checklist of required materials, making it easier to submit good-quality dossiers. Moreover, applicants can check the application progress in the system.
Who should now use this new system
In UK, the following regulated products need to obtain the authorization for product or process before being sold on the market. They are:
Extraction solvents
Feed additives
Feed for particular nutritional uses (dietetic feed)
Feed detoxification processes
Flavorings
Food contact materials
Food additives
Food enzymes
Genetically modified organisms (GMOs) as food and feed
Irradiated foods
Novel foods
Smoke flavorings
Therefore, it is necessary for relevant stakeholders to use this new system when
Stakeholders want to apply for a new authorization. Please refer to Guidance for Regulated Product Applicants3 for more authorization details about each type.
Stakeholders submitted the application to EU before January 1, 2021 but the assessment process has not been finished.
Please note:
New authorization for regulated products in Northern Ireland continues to follow EU rules.
The authorization of regulated products granted by EU before January 1, 2021, with corresponding legislation in place, is still valid in Great Britain.
What will come next
After receiving the application, the FSA with FSS will carry out a risk analysis process for the product. The risk assessment will be carried out as per the requirements of retained EU laws4 and guidance previously developed by the European Food Safety Authority (EFSA). Unless otherwise specified by the law, the risk analysis process is likely to last at least one year.
If the risk analysis passes, FSA gives the advice when a Ministerial decision or a change to legislation is required. Then ministers will take decision or consider changes to legislation. For most regulated product types, their authorizations will be added accordingly in relevant legislation, except for food enzymes, as well as the recycled processes and active & intelligent materials of FCM5. After this step, such products can be placed on the market. Read more at Risk Analysis Process Flowchart6.
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