In August we described the UK–EU sanitary and phytosanitary agreement as the wildcard nobody had priced, and we said so on the strength of one trade report about a letter we had not read. That caveat no longer applies. The government’s own business guidance, published in May 2026 and revised on 30 July, states the outcome in plain terms: “Great British novel food authorisations will cease to apply, and any data protection periods and associated market exclusivity connected with that authorisation will no longer apply.” The Food Standards Agency’s own board paper, written for a closed session in December 2025 and published in June, goes further: under dynamic alignment “there will no longer be a need for the FSA’s market authorisation service, unless any exceptions are agreed.”
That paper also puts a number on what is sitting in the service the FSA expects to close: 415 applications as of 30 October 2025, against 101 authorisations granted in the whole period since the UK took the function over from the EU. The average application takes two years and two months to get through. The agreement is meant to take effect in mid-2027.
This piece sets out what the primary documents actually say, where the carve-out arguments stand, and what the FSA has told applicants to do about it. It is a follow-up to our August analysis of the cell-cultivated products sandbox, and it changes that analysis: the risk we flagged as unpriced is now the government’s stated base case, not a reported possibility.
What the government’s guidance says, and to whom
Defra published a list of EU legislation “in scope” of the agreement on 9 March 2026. Regulation (EU) 2015/2283 on novel foods is on it, alongside the additives, enzymes, flavourings and food-for-specific-groups regulations. The same page says: “The EU has accepted there will need to be areas where the UK will retain its own rules … We have been clear about the importance of being able to set high animal welfare standards, support public health, and support the use of new and innovative technologies.”
The sector guidance that followed in May is where the treatment diverges. Defra wrote separate “preparing your business” pages for different parts of the agri-food economy. Read side by side, they do not describe novel foods and precision breeding in the same tense.
| Regulated area | What Defra’s guidance says (updated 30 July 2026) | Status of a carve-out |
|---|---|---|
| Novel foods (Reg. 2015/2283) | “Great British novel food authorisations will cease to apply, and any data protection periods and associated market exclusivity connected with that authorisation will no longer apply.” | Not mentioned as an exception. Generic line only: exceptions “subject to the ongoing negotiation”. |
| Regulated products generally (additives, enzymes, flavourings, GMOs, smoke flavourings, extraction solvents, feed additives) | “Great British food and feed authorisations will cease to apply, and EU authorisations will apply in Great Britain in their place.” | Not mentioned as an exception. |
| Edible insects (a novel-food sub-category) | “Some products will need to be reformulated or withdrawn from the Great British market when Great British authorisations are withdrawn under the SPS agreement from mid-2027.” | None. Withdrawal is described as the outcome. |
| GMOs (Reg. 1829/2003 etc.) | “Authorisations for GMOs will revert to EU single market processes.” | None. Described as minimal change. |
| Precision breeding (Genetic Technology (Precision Breeding) Act 2023, England) | “Precision breeding is subject to ongoing negotiations between the UK and the EU as part of the SPS agreement. The EU have accepted there will need to be a number of areas where we need to retain our own rules.” | Live negotiating position. Government told the EFRA Committee in April that the UK “should continue to have its own rules” here. |
| Animal welfare | Not in the food-manufacturing guidance. | Government agreed with EFRA’s recommendation to seek a carve-out (response published 17 April 2026). |
The pattern is hard to miss. Where the government intends to fight for an exception, its guidance says so and declines to give businesses detailed instructions until the negotiation concludes. Where it does not, the guidance tells businesses what to check on the European Commission’s portal and which products to reformulate or withdraw. Novel foods are in the second group.
The Defra page is careful to add that “there may be further changes between now and when the agreement is in place” and that exceptions are “subject to the ongoing negotiation.” It also promised that “further details on upcoming changes” including “any exceptions and transition periods” would be announced in summer 2026. As of our reading on 14 September 2026, the page carries a 30 July revision date and the exceptions section still reads as it did in May.
Practical consequence: anyone modelling a UK launch on the basis of a GB novel food authorisation should read Defra’s own words as the base case, not the downside case. The downside case is that no transitional arrangement is agreed either.
The FSA’s arithmetic
The FSA’s paper CLO 25/12/01, considered in closed session at the 10 December 2025 board meeting and published on 25 June 2026, is the most candid document in this story. Its purpose was to get board agreement to re-prioritise the queue, and to do that it had to describe the queue.
| Phase | Average time taken (completed cases) | Applications in the service, 30 October 2025 |
|---|---|---|
| Pre-validation (administrative checks and suitability) | 6 months | 157 |
| Risk assessment | 8 months | 146 |
| Risk management, consultation and authorisation | 12 months | 112 |
| Total | 2 years 2 months | 415 |
Ten applications were authorised in 2025/26 to the date of the paper. The cumulative total since EU exit is 101. The averages exclude time spent waiting for applicants to answer information requests, so the elapsed time from filing to decision is longer than the 26 months shown.
The paper’s reasoning is explicit. “It is likely that only those applications well advanced in the final stages of the process would be able to be authorised before the introduction of legislation to align with the EU.” Continuing to run a full service “will require significant nugatory work for applicants … and for the FSA/FSS.” And the sentence the sector should have read in December: applicants “are likely to gain greater benefit from focussing on gaining approval in the EU, particularly if they have only applied in GB.”
The board was asked to agree three prioritisation principles. The second is the one that matters here: “We will prioritise work on applications which are within government priority sectors for innovation and growth. We assume these three areas are Cell Cultivated Products (CCP), precision fermentation and precision breeding.” Paragraph 3.12 draws the consequence for everyone else: “applications which do not fall within these priorities are unlikely to progress through the queue.”
Note what this list shares with the Defra guidance. Precision breeding is prioritised by the FSA and has a stated carve-out to negotiate. Cell-cultivated products and precision fermentation are prioritised by the FSA and sit inside a regulation whose GB authorisations, on the government’s own account, cease to apply in mid-2027. The FSA is accelerating precisely the dossiers whose output has the shortest stated shelf life.
There is a partial answer to that in the paper itself. Paragraph 3.8 says “any authorisations made in 2026 could give some time on the market, depending on any transitional arrangements,” and that “a positive risk assessment from the FSA may also have some value in signalling to other regulators that a product is safe.” That is a real argument, and we return to it below. But it is an argument for the value of an FSA opinion, not an FSA authorisation.
Practical consequence: the FSA’s own paper tells applicants outside the three priority areas that their applications are unlikely to progress. If you filed a GB-only dossier for a fermentation-derived ingredient that is not a “precision fermentation” product in the FSA’s sense, or for a botanical, an extract or an insect, the paper is telling you where you stand.
What the FSA has told applicants directly
The FSA answered public questions at its March 2026 board meeting, and the answers, published in June, are more direct than the paper. Asked what reliance businesses could place on the UK process delivering “a meaningful regulatory outcome,” the agency replied that “a substantial number of applications in the FSA/FSS Market Authorisation Service are unlikely to reach the point of ministerial decision before the Agreement is in place,” that it had “written to applicants to inform them as to what this means for their application and actions they may wish to consider,” and that “it is for businesses to decide whether they wish to continue to engage with the FSA’s market authorisation process, or if they wish to focus on gaining approval in the EU.”
Asked separately whether regulatory sandboxes had been agreed in principle as outside the agreement’s scope, given that the EU’s own Biotech Act excludes novel foods from its sandbox provisions, the FSA said the agreement “would follow a model of dynamic alignment with EU law, including the authorisation of regulated products,” that the EU had accepted “a limited number of areas where the UK would need to retain its own rules,” and that “exceptions will only be agreed if they meet strict conditions set by the EU. Which exceptions are included in the Agreement, their scope and operation, depends on the outcomes of negotiations.”
The Grocer, whose report we relied on at one remove in our sandbox piece, quoted the FSA’s head of market authorisation policy, Rebecca Sudworth, on the letter itself: “Given the proposed timescales for an agreement, a substantial number of applications in the GB Market Authorisation Service are unlikely to progress to the point of ministerial decision before the agreement is in place. We have agreed with the board and with relevant ministers a set of prioritisation principles which we have applied to the current caseload, and we have communicated to applicants what this means for their applications.” The same report put the number of recipients at around 600 market authorisation holders and businesses with applications in the system, and quoted a regulatory lawyer at Mills & Reeve, Katrina Anderson, reading the communications as a signal that government and FSA “are moving forward on the basis that there will not be exemptions.”
We still have not read the letter. But we no longer need it: the board paper it was based on, and the FSA’s own summary of it, are public.
What a carve-out would have to satisfy
The May 2025 Common Understanding is the only text both sides have published, and paragraph 28 is the relevant one. The agreement “should include a short list of limited exceptions to dynamic alignment,” and an exception “could only be agreed if: (i) it does not lead to lower standards as compared to European Union rules, (ii) it does not negatively affect European Union animals and goods being placed on the market in the United Kingdom in respect of Great Britain, and (iii) it respects the principle that only animals and goods compliant with European Union rules move into the European Union.”
The Alternative Proteins Association’s evidence to the House of Lords European Affairs Committee, received on 16 April 2026, is the fullest public case that novel foods can pass that test. Its argument is that the UK sandbox does not lower standards, does not restrict EU goods entering Great Britain, and does not affect what moves into the EU. It asks for a permanent carve-out and, failing that, “a time-limited exemption of at least five years.” It also states the timing problem more bluntly than any official document: the FSA sandbox “is targeting completion of safety evaluations for cultivated meat by February 2027,” the government’s target for the agreement “is mid-2027,” and “if alignment takes effect at that point and novel foods are within scope, the sandbox programme would lose its potential for major impact just as it reaches key milestones.”
Two things count against the APA’s position in the documents we have read. First, the EFRA Committee’s recommendation for a 24-month transition period, which would have covered exactly this gap, was rejected in the government’s response of 17 April 2026: “We know that some businesses require longer to adjust to the new arrangements and will continue to work with them to ensure a smooth transition.” Second, the government has publicly named the exceptions it intends to seek — animal welfare and precision breeding — and has not named novel foods.
The counter-evidence is that the Defra list-in-scope page does say the government has “been clear about the importance of … support[ing] the use of new and innovative technologies,” and the Common Understanding does not say the list of exceptions is closed. The honest reading is that a novel foods exception is possible, has been asked for by industry and by at least one company directly, and has not been claimed by the government as a negotiating objective in any document we can find.
Where the negotiation actually is
The Council of the EU authorised the Commission to open negotiations on 13 November 2025. The FSA told its board in March that “the UK and the EU are aiming to reach an agreement by the next UK-EU Summit, which is likely to be this Summer.” That summit was called for 22 July, then postponed after Keir Starmer resigned as Prime Minister on 22 June; The Grocer reported the Cabinet Office saying the summit would now be held “later this year,” and industry sources telling it that “the technical side of SPS negotiations are largely complete.”
The new Prime Minister, Andy Burnham, is the addressee of the open letter that prompted this piece. Green Queen reported on 14 September that BeneMeat, the Czech company that has filed a UK dossier for cultivated meat for human consumption and already sells a cultivated pet-food ingredient in the EU, has written asking that any agreement preserve “the UK’s ability to assess and approve novel food products based on its own scientific evidence and timeline.” Its CEO, Roman Kříž, is quoted: “The agreement has not yet been concluded, but the uncertainty surrounding Britain’s future regulatory approach is already affecting business decisions.” The letter says the company’s investment, partnership and manufacturing conversations in the UK are “on hold.”
We have not seen the BeneMeat letter itself and are relying on Green Queen’s quotation of it. The claim that matters — that a company with a filed UK dossier has paused UK plans — is consistent with what the FSA itself told applicants to consider.
The counter-argument
The case for accepting alignment on novel foods is not weak, and the FSA’s paper makes part of it.
First, the queue was not moving anyway. Ten authorisations in the 2025/26 year to date against 415 applications is not a functioning fast track, and we said as much in August before most of these documents were published. A regime that authorised 101 products in roughly five years is not obviously worth a carve-out fight that could cost concessions elsewhere.
Second, a single EU dossier would cover both markets. The FSA’s paper notes that applicants “are likely to gain greater benefit from focussing on gaining approval in the EU,” and that “where a product is already authorised in the EU, an identical GB authorisation brings forward the opportunity to align across markets.” Companies that sequenced the UK ahead of the EU on the strength of a faster GB route would, under alignment, be filing once instead of twice.
Third, an FSA risk assessment retains value even if the authorisation does not. Paragraph 3.8 of the paper says a positive FSA assessment “may also have some value in signalling to other regulators that a product is safe.” For the two cell-cultivated dossiers the sandbox is targeting, a completed UK risk assessment is a document an EFSA applicant would rather have than not.
The weakness in all three is the same. The EU route is the one we have documented as producing zero precision-fermented protein approvals, with dossiers stalling in validation and the clock not starting until an opinion is published. Alignment does not give a UK applicant a faster EU process; it removes the alternative to the EU process. And the data-protection point is not a detail: Defra’s guidance says GB exclusivity periods “will no longer apply,” which means an applicant who won GB market exclusivity on proprietary data would lose it on the day the agreement takes effect unless a transition is agreed — and the government has declined to seek one.
What we could not establish
- The text of the FSA’s letter to approximately 600 authorisation holders and applicants. We have the board paper it implemented and the FSA’s own description of it. We have not seen the letter.
- Any negotiating text. Neither side has published draft agreement text. Everything above rests on the Common Understanding, Defra’s guidance, the FSA’s papers and parliamentary documents.
- Whether a novel foods exception has been tabled by either side. The FSA says it “cannot give a running commentary on negotiations.” The government has named animal welfare and precision breeding as areas where it wants its own rules; we found no equivalent statement for novel foods.
- The publication date of The Grocer’s July report on the FSA letter. The article page does not display a date; Green Queen cited it in July 2026.
- Whether the 415 figure includes Article 4 consultation requests (requests for a determination of novel-food status) as well as authorisation applications. The FSA’s table does not say.
- The full text of BeneMeat’s letter to the Prime Minister. We have Green Queen’s quotations.
- What “some time on the market” would mean in practice for a product authorised in late 2026 or early 2027. The paper makes it conditional on “any transitional arrangements,” none of which have been announced.
- How the FSA’s 415 caseload reconciles with the 450-application figure we cited in August from the FSA’s regulated-products reform pages. The two are almost certainly different dates and possibly different definitions; we have not found a published reconciliation.
What to watch
- The rescheduled UK–EU summit. If an agreement is announced, the first thing to read is the list of exceptions. Novel foods either appear on it or they do not.
- Defra’s promised summer 2026 update on “any exceptions and transition periods.” It had not appeared on the relevant guidance pages by 14 September 2026.
- The February 2027 sandbox deadline against the mid-2027 agreement date. If Gourmey’s and Vital Meat’s risk assessments complete on schedule, the question is whether a ministerial decision follows before alignment, and whether a GB authorisation granted in spring 2027 has any legal life after the summer.
- Whether any transitional arrangement is agreed for products authorised in GB before entry into force. Defra’s guidance currently implies withdrawal for products such as insects that the EU has not authorised. The government rejected a general 24-month transition in April.
- Applicant behaviour. The FSA has told businesses it is their decision whether to keep engaging. The number of GB-only novel food applications withdrawn between now and mid-2027 will be the most honest measure of how the sector read that sentence.