Novel Foods

UK Novel Foods manufacturer with dossiers held

Novel Foods is the biggest regulatory blocker for UK brand founders working with botanicals, peptides, nootropics, and other next-generation actives. We hold multiple Novel Foods dossiers so brands can develop products under our authorisation instead of starting from zero.

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What is a Novel Food, and why does it apply to your product?

Novel Foods is a piece of UK and EU regulation covering any food or supplement ingredient that wasn't 'consumed to a significant degree' before 15 May 1997. Before such an ingredient can be legally sold as a food or supplement in-market, it needs Novel Foods authorisation: a formal regulatory process involving a scientific dossier on safety, composition, and proposed use levels.

For supplement brand founders, Novel Foods applies more often than people realise. If your product uses:

Peptide supplements: certain collagen peptides, creatine peptides, specialised peptide actives
Non-native adaptogens or botanicals: certain Asian and South American herbal actives
Novel protein sources: insect protein, microbial protein, lab-grown actives

Then Novel Foods is likely part of your regulatory path. Without authorisation, the ingredient can't be sold as a food/supplement in the UK or EU, meaning your product is non-compliant and can be pulled from retail.

The cost of starting from zero

A new Novel Foods dossier typically costs low six-to-seven figures in regulatory work (scientific literature review, safety studies, toxicology data, composition analysis) and takes 2 to 4 years to work through the FSA or EFSA approval process. For most supplement brand founders, that's not an option.

Working under an existing dossier

Authorisation can, in many cases, be shared with other brands working on the same or related ingredients. If we hold the dossier and your formulation is in-scope, you can manufacture under our authorisation: cutting months to years off your regulatory timeline and saving the dossier-generation cost entirely.

Our dossiers

Novel Foods authorisations available to clients in scope

We hold multiple Novel Foods dossiers. If your product involves ingredients that fall within the scope of these authorisations, you can manufacture with us under our dossier: no separate application, no years-long wait, no six-figure regulatory spend.

This puts us in a rare position in UK supplement contract manufacturing. Most of our competitors route Novel Foods regulatory work to third-party consultants or simply refuse projects where it's required.

We check Novel Foods status for every formulation at NPD feasibility. If your product is in scope of our dossiers, we scope a route to production under our authorisation. If it isn't, we flag the regulatory path upfront, so there are no surprises mid-launch.

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Outside the scope

New ingredients, new dossiers, new options

If your formulation uses an ingredient outside our existing dossiers, and Novel Foods authorisation doesn't already exist for that ingredient generally, you have three options:

Substitute with an authorised alternative. Often there's a related ingredient already authorised that delivers the same functional benefit. We'll flag this during NPD.
Generate a new Novel Foods dossier. Full-scale regulatory project, long timeline, high cost. We can work with regulatory consultants to scope it but we don't generate third-party dossiers ourselves.
Formulate for a non-Novel-Foods market. Some target markets (certain Middle East, Asia, North America markets) don't have Novel Foods equivalents, the ingredient may be legal there without UK/EU authorisation.

We check Novel Foods status for every formulation during NPD feasibility. If your product has a regulatory blocker, we'll tell you upfront, not mid-launch.

What ingredients require Novel Foods authorisation in the UK?

Any food or supplement ingredient not consumed to a significant degree in the UK/EU before 15 May 1997. Common examples for supplement brands: certain peptide actives, non-native adaptogens, novel protein sources, and other next-generation ingredients.

How much does Novel Foods authorisation cost?

Generating a new dossier typically costs low six-to-seven figures in regulatory work, including scientific literature review, safety studies, toxicology data, and composition analysis. The approval process takes 2 to 4 years. Manufacturing under an existing dossier (ours or another holder's) avoids this entirely.

How long does Novel Foods approval take?

2 to 4 years from dossier submission to authorisation. Complex ingredients (novel proteins, specialised peptides) often longer.

Do you hold Novel Foods dossiers?

Yes. We hold multiple Novel Foods dossiers. Whether your specific formulation is in scope depends on the ingredient and concentration; we check at NPD feasibility stage.

What's the difference between Novel Foods authorisation and BRCGS certification?

BRCGS is a manufacturing-site food safety audit, it certifies HOW we make things. Novel Foods is an ingredient-level regulatory approval, it certifies WHAT ingredients are legally sellable. You need both.

Who regulates Novel Foods in the UK?

The Food Standards Agency (FSA) in the UK; the European Food Safety Authority (EFSA) for EU markets. Post-Brexit the UK operates its own authorisation regime in parallel with the EU.

Is your ingredient Novel Foods-authorised?

Send us your formulation and target markets. We'll come back with a Novel Foods status check, authorisation options, and, if we hold a dossier in scope, a costed path to production under it.

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