Supplier declarations: TSE/BSE, animal-origin-free, nitrosamine and REACH statements

Why declarations sit in a quality file

Declarations are signed supplier statements about how a product was made or what it contains, and they may cover a product rather than a single lot, so check which. They do not replace a certificate of analysis. They answer questions a certificate cannot: what went into the process, and which regulations the supplier says it has considered. A research lab rarely needs all of them; this glossary helps you decide which to ask for.

Definitions below come from EMA, FDA, the European Commission and the UK Health and Safety Executive, read on 30 October 2026. [1] [2] [3] [4] [5] [6]

TSE/BSE statement

What it covers. The EU note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products (EMA/410/01 rev.3) concerns materials derived from TSE-relevant animal species, defined as cattle, sheep, goats and other species naturally susceptible to TSE agents. It applies to materials used to prepare active substances, excipients, and raw materials and reagents used in production, with bovine serum albumin, enzymes and culture media given as examples. It also covers materials that contact manufacturing equipment or the product. [1]

What is outside it. The note says pigs and birds are not TSE-relevant species, nor are dogs, rabbits or fish. [1] A European Pharmacopoeia monograph identical to the note is the basis for EDQM certificates of suitability, the formal way a material maker demonstrates TSE compliance. [1] EMA's guideline page says the note should be read together with explanatory notes on its scope for human medicines and on gelatin used in pharmaceuticals. [2]

Relevance to synthetic peptides. Chemical synthesis does not use animal tissue as a starting material, so the useful question is about everything else: reagents, enzymes, resins, filters or excipients that might be animal-derived. A statement that says only "synthetic" does not answer that.

Animal-origin-free statement

What it covers. A supplier claim that no animal-derived material was used. We found no regulatory definition in the sources we read, so the scope is whatever the supplier writes: starting materials only, or also reagents, process aids and equipment contact surfaces. Read the scope line before relying on it, and prefer a statement that names the categories it covers, mirroring the TSE note's list. [1]

Nitrosamine risk statement

What it covers. EMA describes nitrosamines as probable human carcinogens based on animal studies and says marketing authorisation holders should consider their manufacturing processes for nitrosamine risk across human medicines. [3] FDA's guidance, revised September 2024, is addressed to manufacturers of active ingredients and drug products and covers root causes, risk assessment, testing and controls, and nitrosamine drug substance-related impurities, which share structural similarity to the active ingredient; FDA keeps updated acceptable intake limits on a separate page. [4]

Relevance to research peptides. These frameworks are written for authorised medicines and their ingredients. A research lab buying non-pharmaceutical material rarely needs one, unless the work supports a regulated product. If you ask, ask what the supplier assessed, not whether a nitrosamine was detected.

REACH and SVHC statements

What they cover. The European Commission describes REACH as the main EU law protecting health and the environment from chemical risks; substances above 1 tonne per year per company must be registered with ECHA, and substances of very high concern are to be replaced progressively where alternatives exist. [5] UK REACH applies the same structure in Great Britain, with some aspects applying only at 1 tonne per year or more and tailored provisions for research and development. [6]

Relevance to research peptides. Milligram research purchases sit far below the registration tonnage, so a registration number is rarely meaningful. The question that can matter is whether the product contains a listed substance of very high concern; ask that, and record the answer with its date because the list changes.

Which declarations matter for synthetic peptides

On 30 October 2026, OMNI Peptides' terms and Peptides EU's FAQ described certificates of analysis but neither mentioned TSE, animal-origin, nitrosamine or REACH statements. [7] [8] Expect to ask for them, and expect some small suppliers to decline.

Request wording

Send one message per product and ask for signed, dated statements on letterhead.

• TSE/BSE: Please confirm whether any material derived from cattle, sheep, goats or other TSE-relevant species was used in manufacturing [product], including reagents, enzymes, culture media, excipients and materials contacting equipment or product.
• Animal origin: Please state whether [product] is free of animal-derived materials, and list which categories the statement covers.
• Nitrosamines: Please state whether a nitrosamine risk assessment has been performed for [product] and its conclusion.
• REACH: Please state whether [product] contains any substance on the current Candidate List of substances of very high concern, with the list date you checked.