FSA guidance on regulated product applications and the proposed UK-EU SPS Agreement
The FSA sets out what a regulated product application must contain and how a proposed UK-EU SPS Agreement could change market authorisation in Great Britain.
What the FSA has published
The Food Standards Agency (FSA) has published application guidance for regulated food and feed products. These are products that must go through risk analysis and obtain market authorisation before sale in Great Britain. They include novel foods, food additives, flavourings and food enzymes.
The guidance also carries a notice about the UK-EU Sanitary and Phytosanitary (SPS) Agreement, which the UK Government is negotiating. Negotiations are continuing, and the notice states that existing GB rules continue to apply for now.
What the proposed SPS Agreement could mean
The FSA says that an agreement built on dynamic alignment would, subject to any exceptions that are negotiated, change how regulated products are authorised. A product would need EU market authorisation before it could be placed on the GB market. EU conditions of use, along with any post-authorisation requirements, would apply in GB too.
EU authorisations already apply in Northern Ireland, and under the proposed arrangement they would extend to the whole UK. Authorisations granted in GB would stop applying.
The FSA adds that exceptions to dynamic alignment may be negotiated in a limited number of areas. These remain subject to negotiation, and further updates will follow.
Applications already in progress or planned
Because of the expected timeframe, the FSA says a substantial number of applications in the GB Market Authorisation Service are unlikely to reach the point of ministerial decision before the Agreement is in place. It will keep updating businesses with applications in the service, and relevant trade associations, and will provide transition information as soon as it is available.
For businesses thinking of applying, the FSA says they should read the current list of regulations in scope on GOV.UK and understand their product-specific requirements. They should also consider whether they may need to apply to the EU as well, and assess possible effects on their preparation timeline. More broadly, the FSA encourages businesses to consider how potential changes could affect their products and to consider reviewing their regulatory strategy.
What a complete application needs
Applications are made through the FSA online portal. Each has two parts: administrative information, and technical and safety information. Dossier requirements and structure differ by product type, so applicants must follow the guidance for their own regime, such as novel foods or food additives.
The FSA says incomplete applications are likely to be delayed, deemed invalid or refused. The portal includes a checklist to help applicants confirm that a dossier is complete. The guidance makes several further points:
- An authorisation is generally issued for a particular substance rather than a composite product. For example, the requirement relates to the novel food 2'-fucosyllactose, not to a flavoured drink that contains it.
- Applicants must submit all relevant data, whether or not the results support the product.
- The FSA's working language is English, and it accepts dossiers in English and Welsh. Anything in another language, including annexes and references, must come with a translation.
- Only certain file types can be uploaded. Zip files, which are barred for security reasons, and images are not saved. A single upload can hold up to 100 files and 200 MB in total, and several uploads are allowed.
- When the FSA requests further information, each request specifies a deadline. The FSA says it will not ask the same question twice, so it will not send follow-up requests to chase information that is still missing.
Contacts
Questions about a specific application should go to [email protected]. General questions about the impact of the SPS Agreement on market authorisations should go to [email protected]. The FSA also runs a market authorisations newsletter that people can sign up to.
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