Now the UK has left the EU, pre-market approval is required for the following regulated products:
- Extraction solvents
- Feed additives
- Feed for particular nutritional uses
- Feed detoxification processes
- Food contact materials
- Food additives
- Food enzymes
- Genetically modified organisms as feed and food
- Irradiated food
- Novel food
- Smoke flavourings
For now, the UK has decided to continue to follow the EU Regulations and the EFSA guidance documents.
However, applicants must submit a separate dossier to the UK Food Standards Agency (FSA). The following steps should be followed:
- Applicants must register their intention to submit a dossier via the online application service. After completing the application form the applicant will be issued an application number & a link where the documents that support your dossier can be filed.
- Once you have filed your dossier, it will take the FSA 8 calendar days to perform an administrative check & 30 working days to validate the dossier.
- Once the dossier has passed validation, a scientific risk assessment will be performed by the FSA.
- The timelines for this assessment will depend on the complexity of the product, but it is estimated that this risk assessment will take approximately 1 year.
- Once the risk assessment has been performed, the evidence is presented to ministers who will decide whether the product should be authorized for use in Great Britain.
Pen & Tec´s regulatory experts can help you to obtain authorisation in the UK in a cost effective and time effective way.
If you need guidance or have any questions, feel free to contact us and we will be happy to help.