The pathway to market governing the assessment of novel food authorizations in the United Kingdom has recently changed and this could affect your regulatory responsibilities. Prior to Brexit, the European Commission (EC) with advisement from the European Food Safety Authority (EFSA) handled the process of reviewing and approving food ingredients that could not be shown to have a history of significant human consumption in the UK or European Union (EU) prior to 15 May 1997. Foods and food ingredients, in this case, are considered novel foods and must undergo review and approval to be used in European and UK foods.
As part of the agreement to withdraw from the EU, the UK transitioned the novel food regulatory framework from EC/EFSA to the Food Standards Authority (FSA). As of 1 January 2021, novel food authorizations for England, Scotland and Wales are now coordinated and assessed by the FSA. However, it is important to note that products intended for sale in Northern Ireland must still be submitted through the EU/EFSA regulatory pathway as per Appendix 2 of the Northern Ireland Protocol.
To make for a seamless transition, the FSA has maintained the same application criteria and evaluation standards as the EC & EFSA as per EU law Regulation 2017/2469 which has been retained. This way dossiers completed as part of novel food applications submitted to the EU prior to 1 January 2021 can be resubmitted to FSA as part of the UK authorisation process.
FSA also offers a consultation process to determine whether a novel food authorisation is required for your ingredient. This process utilizes the same Article 4 request (retained EU law Regulation 2018/456) to offer guidance on whether the food is novel and when a novel food authorisation is required. This process is valuable if you cannot confirm whether your ingredient demonstrates a history of human consumption in Europe or the UK prior to 15 May 1997; for example, a change in manufacturing which affects the nature of the food could render your ingredient to be novel if it is not comparable to its commonly consumed counterpart. In this case, you may wish to consider verifying the need for a novel food authorisation prior to preparing and submitting the application.
In summary, if you are looking at bringing a food product to the UK market, you need to ensure all ingredients are acceptable for use in foods in either the EU or UK. Moving forward, any novel ingredient which was not already approved for use in the EU prior to 1 January 2021 must be submitted to FSA for review and authorisation before it can be introduced in the UK market. Dicentra has a team of scientists and regulatory specialists who can assist you in navigating the new novel foods regulatory environment in the UK. Feel free to contact us with any inquiries pertaining to the marketing of foods in the EU or UK.
FSA Novel Foods Authorisation Guidance – https://www.food.gov.uk/business-guidance/regulated-products/novel-foods-guidance#new-authorisations
PROTOCOL ON IRELAND/NORTHERN IRELAND – https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840230/Revised_Protocol_to_the_Withdrawal_Agreement.pdf