How the EU classifies a peptide: medicine, novel food, or neither

The EU runs two separate authorisation systems that can each apply to a peptide — a harmonised medicinal-product test enforced country by country, and a single, EU-wide novel-food approval list for anything sold as a food or supplement that wasn't eaten in the bloc before 1997. A peptide that fails both isn't in a legal grey zone; it's simply not authorised for sale, under either system.

The medicine test: EU-wide definition, national enforcement

Article 1(2) of Directive 2001/83/EC defines a "medicinal product" for the whole EU in two ways that will look familiar from this site's own UK MHRA classification page: by presentation (anything presented as treating or preventing disease) or by function (anything that may be used to restore, correct or modify a physiological function through a pharmacological, immunological or metabolic action, or to make a medical diagnosis). That's not a coincidence — the UK's own Human Medicines Regulations 2012 were built to implement this same EU directive, and kept the same two-part test after Brexit. What isn't harmonised is enforcement: each EU member state's own national medicines regulator (France's ANSM, Germany's BfArM, Italy's AIFA, and so on) applies this shared definition to a specific product on its own territory, which is why the same peptide can, in practice, draw a faster or slower enforcement response depending which EU country it's sold into — the underlying legal test is identical either way.

The other gate: Novel Food authorisation

A peptide marketed as a food ingredient or supplement rather than a medicine still has to clear a second, genuinely EU-wide system: Regulation (EU) 2015/2283 on novel foods. Under this regulation, any food or food ingredient that wasn't consumed "to a significant degree" within the EU before 15 May 1997 is a "novel food," and it's illegal to place it on the EU market as a food until it clears a formal European Commission safety authorisation, informed by a risk assessment from the European Food Safety Authority (EFSA), and is added to the EU's Union list of authorised novel foods. Unlike medicines regulation, this part genuinely is decided once for the whole bloc — a product either makes it onto the Union list, or it hasn't, EU-wide.

A real 2025 example: Serrapeptase's novel food application failed

This isn't a hypothetical gate. Serrapeptase — a bacterially-derived proteolytic enzyme sold in oral supplement form and often marketed alongside other "peptide" and enzyme products — went through exactly this process and didn't clear it: the European Commission issued a formal decision on 30 January 2025 terminating the procedure for authorising a serrapeptase-based product ("Serrapeptase Rx," application reference NF/2020/1588) as a novel food, without adding it to the EU's Union list. The practical effect is straightforward: placing that product on the market as a food or supplement in the EU remains unauthorised, regardless of how it's labelled or marketed, until (unless) a future application succeeds. It's a useful, dated, real-world illustration of what "failing the novel food gate" actually looks like as an official EU record, not an abstract regulatory possibility.

Why a peptide can fail both tests at once

The medicine test and the novel food test are independent of each other, which means a peptide can fail — or simply never attempt — both at the same time. An injectable peptide marketed for a physiological effect (weight loss, tissue repair, growth-hormone stimulation) almost certainly meets the function test for a "medicinal product" under Directive 2001/83/EC in the first place, which would normally take it out of food/supplement regulation entirely and place it under national medicines law instead — meaning it needs a marketing authorisation from an EU member state's regulator, not a novel food approval, and almost certainly doesn't have one either. A product marketed more cautiously as an oral "supplement" to avoid that medicinal classification still has to clear the novel food gate covered in section 2 — and, as the Serrapeptase decision shows, an EU-adjacent enzyme or peptide product can fail that gate too. Either route a seller picks, "sold across the EU" describes where a product is being offered, not that either EU-wide system has cleared it.

Why this is genuinely EU-wide, not one country's rule

Both frameworks on this page — the Directive 2001/83/EC medicinal-product definition and the Regulation (EU) 2015/2283 novel food regime — are EU regulations and directives that bind every member state, unlike this site's existing GLP-1 reimbursement comparison page, which tracks each country's own separate national insurance decision for the same approved drugs. This page is about whether a product can lawfully be sold at all, EU-wide; that one is about whether an already-approved drug gets subsidised, country by country. They're different questions about the same regulatory bloc, and worth keeping separate.

The practical takeaway

A peptide sold into the EU has to clear one of two entirely separate approval systems before it's lawfully on the market at all — a national medicines authorisation if it's functioning as a medicine, or an EU-wide novel food authorisation if it's functioning as a food or supplement — and most grey-market "research" or "bioactive" peptides sold online haven't gone through either one. "Sold across the EU" or "compliant with EU regulations" on a seller's page isn't itself evidence that either gate has been cleared; check for an actual EU marketing authorisation number or a listing on the EU's Union list of novel foods before treating either claim as settled.