The UK and the European Union are currently negotiating a Sanitary and Phytosanitary (SPS) Agreement, which could affect how regulated products are authorised and placed on the market in Great Britain (GB). The proposed agreement aims to simplify the movement of agri-food goods between the UK and the EU while reducing administrative burdens for businesses. This would mean that it will be no longer necessary to apply for registration of regulated products, such as novel foods, food enzymes, food and feed additives, in the UK.
Although negotiations are still ongoing, the UK authorities have already published information on the potential implications for businesses and market authorisation procedures. Companies working with regulated food and feed products should start assessing how the proposed changes could affect their regulatory strategies. This is particularly important for those companies who do not have authorisation or have not submitted application for authorisation on the EU side.
Possible move towards EU-aligned market authorisations
One of the most significant proposed changes relates to dynamic alignment with EU legislation within the scope of the SPS Agreement. Under this approach, Great Britain would align its rules with relevant EU legislation and update them as EU rules evolve over time.
If implemented without major exceptions, this could mean that:
- EU market authorisation would be required to place a regulated product on the GB market
- EU conditions of use and post-authorisation obligations would also apply in GB
- EU authorisations already applicable in Northern Ireland could extend to the whole UK
- Existing GB authorisations would no longer apply in the long term
In practice, this would represent a significant shift from the current system where Great Britain and the EU operate separate regulatory authorisation frameworks following Brexit.
Regulatory alignment across food and agri-food legislation
The scope of the proposed SPS Agreement is broad and may affect several areas of food and feed legislation.
These include, for example:
- food and feed safety rules
- hygiene requirements and food law
- nutrition and health claims
- food labelling and compositional standards
- pesticide and veterinary medicine residue limits
- authorisation of regulated food and feed products
Although divergence between UK and EU rules has so far been relatively limited, regulatory alignment could require operational and compliance adjustments for some businesses.
Impact on ongoing GB authorisation applications
The proposed agreement could also affect applications currently being processed in the GB Market Authorisation Service.
According to the Food Standards Agency (FSA), a substantial number of applications currently in the system may not reach a ministerial decision before the agreement enters into force.
While existing GB rules remain in place for now, businesses with applications in progress should monitor developments closely and consider whether EU authorisation may become necessary for future market access.
Expected timeline for the SPS Agreement
The UK government is aiming for the agreement to enter into force around mid-2027, but they aim at coming to an agreement already this spring.
Until mid-2027:
- existing GB regulatory rules continue to apply
- negotiations between the UK and the EU are ongoing
- details on transitional arrangements are still being developed
Authorities have indicated that further guidance for businesses will be published as negotiations progress.
What businesses should consider now
Even though the final scope of the SPS Agreement has not yet been confirmed, companies working with regulated food and feed products should begin preparing for possible changes.
Key considerations may include:
- reviewing regulatory strategies for products marketed in Great Britain
- assessing whether EU authorisation may be required in the future
- monitoring changes to legislation within the scope of the agreement
- evaluating the potential impact on product development timelines and market access strategies
Businesses are encouraged to familiarise themselves with the proposed changes and consider how regulatory alignment with the EU could affect their operations. Companies should closely follow developments and assess how potential EU alignment may affect their regulatory and market access strategies.
Our teams closely monitor legislative developments in the UK, EU and USA, and our experienced food and feed specialists are well positioned to support clients on questions related to regulatory changes. We support clients across the full lifecycle of food and feed regulatory activities, including strategic planning, dossier preparation, submissions and post-authorisation support.
Whether you are developing innovative foods or feeds or adapting to new regulatory expectations in your applications, Medfiles provides tailored support to help you achieve compliant and timely market access. We will keep you informed on the recent and upcoming regulatory developments between the EU and UK.
Mari Eskola, Ph.D. | Team leader, Regulatory Science and Reports // Senior Regulatory Affairs Expert, Food and Feed
Mari Eskola joined Medfiles in 2021 and leads the Regulatory Science and Reports Team. Since starting at Medfiles, she has been involved in a wide range of projects relating to food, feed, and cosmetics safety.
Mari has nearly 30 years of broad international expertise in the chemical and regulatory safety of food and feed, acquired across the European Union, national authorities, and industry. At Medfiles, she brings over 15 years’ experience as a regulatory food and feed risk assessor. Mari developed her risk assessment expertise working for 10 years at the European Food Safety Authority (EFSA), where she conducted regulatory risk assessments of contaminants in food and feed. She also served as Acting and Deputy Head of the EFSA Contaminants Unit. She is a food chemist specialising in analytical chemistry and obtained her PhD in food science in 2002.
In addition, Mari has extensive food and feed research and regulatory experience from several European institutes, including the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the University of Natural Resources and Life Sciences in Austria, and the former Finnish Food Safety Authority. She has international experience in project and people management and has authored numerous scientific publications, including many EFSA scientific opinions and risk assessments.
Ingrid Hagberg, M.Sc. | Regulatory Affairs Expert & Toxicologist, Food and Feed
Ingrid joined Medfiles in autumn 2023 as a Toxicologist and Regulatory Affairs Expert. Since then, she has been involved in projects related to food, feed, and cosmetics. Before joining Medfiles, Ingrid worked at Health Canada, where she evaluated and managed risks associated with chemical substances in food.
During this time, she developed strong expertise in the regulatory risk assessment of food-related substances such as contaminants and food flavourings. This has given Ingrid deep knowledge in using toxicology in risk assessment which she expertly uses in her food, feed, and cosmetics projects at Medfiles. She also has several years of experience as a food inspector for the Government of Canada, where she carried out regulatory tasks in food safety and labelling.
As a native English speaker, Ingrid excels in communicating with international agencies and preparing high-quality reports. She holds a B.Sc. in Food Science from Carleton University (Canada) and an M.Sc. in Toxicology from the University of Eastern Finland. Her combined background in food science and toxicology offers a rare and valuable skillset that directly benefits our clients.
