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The border is part of your supply chain: what changes when a product is regulated on the way in

A new ingredient crossing the border isn't one decision, it's three. What UK novel food and customs rules actually change for a supplement founder.

The border is part of your supply chain: what changes when a product is regulated on the way in

Picture the way most founders plan a supply chain: find the ingredient, find the manufacturer, get the product made, sell it. A straight line. For an ingestible product, there's a fourth party in that chain who never signs a contract and doesn't care about your launch date: the regulator, at the point the ingredient crosses the border.

A supplement brand importing a new ingredient is dealing with three separate questions: can the ingredient legally be sold in Great Britain, can it clear the border, and can you verify that every batch is what you actually ordered? Settling one does not settle the others.

That changes what "sourcing a new ingredient" actually means. It's not one decision, it's three, and they sit with three different questions.

Three separate questions, not one

For most physical products, sourcing is primarily a commercial and logistical question. For ingestible products, there is another layer: the ingredient itself may be subject to a separate regulatory regime before it can be sold. Three questions come before the commercial one:

1. Is this ingredient legal to sell in Great Britain at all? Not "is it sold elsewhere," not "is it natural," but has it been specifically authorised, or does it have a recognised history of consumption here. 2. Can it physically get through the border? Customs treatment, documentation, and duty are a distinct process from the food-safety question, and clearing one does not clear the other. 3. Can you prove, batch by batch, that what arrives matches what you were sold? Whether this is a formal regulatory requirement varies by ingredient and product category, so it's worth checking with a regulatory consultant or your manufacturing partner. Regulatory or not, it's the question that protects you if either of the first two goes wrong later.

The mistake is treating these as one process called "getting it approved". They are not. A supplier can be legitimate, a shipment can clear customs, and the ingredient can still be unsuitable for sale in Great Britain. The legality question therefore needs to be resolved first. The brands that get caught out are usually the ones who solve the customs question first, get a supplier, agree a price, get it shipped, and only discover the legality question was still open after the product has already landed.

The first threshold: novel food authorisation

For food and supplement ingredients specifically, the UK's Food Standards Agency runs a novel foods regime that exists for exactly this situation. Its own guidance defines a novel food as "any food that was not used for human consumption to a significant degree within the United Kingdom (UK) or the European Union (EU) before 15 May 1997," and states plainly that "novel foods need to be authorised before they can be placed on the market in Great Britain" (FSA, Novel foods authorisation guidance). The cutoff date is central to the assessment. An ingredient being established in another market, described as "natural", or supported by strong scientific evidence does not, by itself, establish that it can be sold in Great Britain. If it does not have the required history of consumption, authorisation may be needed before it can be placed on the market, and that authorisation runs through a dossier and a safety assessment, not a self-declaration.

This is a founder decision, not a compliance afterthought, because it sits upstream of everything else. The practical rule is simple: check novel food status before the ingredient reaches the formulation stage, and document the conclusion against current FSA guidance. Not "we think it's fine because it's sold as a supplement in the US." The US market answering that question tells you nothing about the UK one.

Novel food status is also separate from product claims. Health claims have their own regulatory requirements, while claims to prevent, treat or cure disease can raise a separate medicines classification question involving the MHRA (GOV.UK, Importing food supplements and health foods). These should be assessed independently rather than treated as part of the novel food check.

The second threshold: getting it through customs

Novel food authorisation and customs clearance are two separate systems, run by two separate bodies, and clearing one tells you nothing about the other. GOV.UK's own step-by-step guidance to importing goods lays out what the customs side actually requires: an EORI number that starts with GB, a commodity code on the import declaration that "will determine the rate of duty you need to pay and if you need an import licence," and a declaration that establishes the value of the goods so duty and VAT can be calculated (GOV.UK, Import goods into the UK: step by step).

Customs is often treated as someone else's problem: the freight forwarder's, the courier's or the supplier's. That can work until something is wrong. The commodity code affects duty and whether an import licence is required, so it is worth confirming the classification and licensing position before the first shipment rather than discovering an issue at the border. That matters more, not less, when the product in the container has a shelf life.

The third threshold: proving the batch that arrives is the batch you were sold

Novel food status and customs clearance tell you whether the ingredient can be sold and imported. They do not tell you whether the specific batch arriving at your warehouse matches the specification you agreed with your supplier. That is a quality-control function, and it is the one nobody outside the business is checking on your behalf.

The exact testing regime will depend on the ingredient and product category, so this should be confirmed with your regulatory consultant or manufacturing partner. Operationally, however, the question is straightforward: what is tested on every batch, who performs the testing, and what happens if a batch fails? If you cannot answer that in one sentence, the gap is not with your supplier, it is with the question you have not asked them yet.

Building this into how you evaluate a new ingredient

The practical fix isn't a bigger compliance function. It's moving these three questions earlier in the process, so they sit next to the commercial decision rather than after it.

  • Before agreeing commercial terms: check the ingredient's novel food status against current FSA guidance and document the conclusion.
  • Before placing the first order: confirm the commodity code, licensing position and duty treatment, and understand who is responsible if the shipment is queried at the border.
  • Before locking the product specification: confirm what is tested on each batch, who is responsible for testing, and what happens if a batch fails.

Asking these questions early costs a conversation. Discovering the answers after the ingredient is committed, packaging is designed and a launch date is public can cost weeks, additional testing, or a reformulation. Novel food authorisation can itself take time, which is why the question belongs at the beginning of the sourcing process and not after the product is already built. The border isn't a shipping detail at the end of your supply chain. It's a decision point inside it, and it belongs in the same conversation as your operational planning, not bolted on after the fact. That's the kind of gap our operational excellence work is usually called in to close: not because the founder missed something obvious, but because nobody had built the question into the process at the point it needed to be asked.

FAQ

What regulatory obligations apply when a supplement brand imports a new ingredient? Two separate obligations, run by different bodies. First, the ingredient's novel food status has to be checked against current FSA guidance: if it lacks a recognised history of consumption in the UK or EU before 15 May 1997, it needs formal authorisation before sale. Second, the shipment itself has to clear customs, which requires an EORI number, a correct commodity code, and a customs declaration, regardless of whether the novel food question is settled.

Does having a supplement sold legally in another country mean it's cleared for the UK? No. A history of sale in another market, even a large one, says nothing about whether the ingredient has a recognised history of consumption in the UK or EU before the 15 May 1997 cutoff that UK novel food guidance uses. The two questions are unrelated, and treating overseas sale as UK clearance is one of the more common gaps we see.

Who checks whether an ingredient needs novel food authorisation? It should be a founder-level check before commercial terms are agreed with a supplier, done against the FSA's current guidance, in writing. It isn't automatically covered by a manufacturer, a formulator, or a freight forwarder, and assuming one of them has already checked it is exactly the assumption that causes the delay.

Is batch testing a regulatory requirement or a quality-control choice? That's a specific question for a regulatory consultant or your manufacturing partner, since it depends on the ingredient and the product category. What's within scope here is the operational habit: a founder should be able to say, in one sentence, what's tested on every batch and who's accountable if a batch fails, before that ingredient is locked into a product spec.

Gaia Gabiati is Consulting Lead at The Boutique Consultancy. Over a decade of leadership across health clubs, private members' clubs, hospitality, wellness and multi-site aesthetics clinics, from Milan through Harvey Nichols, Virgin Active, Third Space and Soho House, to running the operational side of multi-site luxury aesthetics clinics. She works alongside founder Kirsty Newman on the operational and delivery side of client engagements.

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