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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
  • Flavourings
  • 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.

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