Regulation (EU) 2025/40Applies from 12 Aug 2026Independent publication - not legal advice
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Supplier Declarations for Substances: Asking So the Answer Is Evidence

The declaration letter that actually works: named thresholds, intentional-use statements, basis of knowledge, change notification. Plus how to grade the answers that come back.

Published 24 October 2026Checked against the regulation text on 24 October 2026European Union

The short answer

A substance declaration is evidence only if it is specific. The working form names: the material or component it covers, by specification; the substance families addressed (PFAS by the Article 5 thresholds; the four metals against the 100 mg/kg sum; substances of concern as a screened position); whether any are intentionally used; the basis of the declarant's knowledge (formulation knowledge, testing, upstream declarations - and which); and the change-notification commitment, with a named contact and lead time. Signed, dated, and tied to a specification version.

Anything vaguer ('our products comply with EU regulations') transfers no knowledge and will be read by an auditor as the absence of a declaration wearing a signature. The roles station made the same point about supplier information generally; this guide is its chemistry-specific instrument.

Asking well: the request letter's content

The request should make answering easy and evasion visible. Attach the specification the declaration must cover, the thresholds in numbers (25 ppb / 250 ppb / 50 ppm; 100 mg/kg sum), and the form of words that would satisfy you - suppliers answer the question they are asked, and most vagueness in replies is authored by the request. State the purpose plainly: the declaration enters a legal technical file and may be produced to authorities. State the renewal rhythm: on specification change, on the declarant's formulation change, and at a maximum interval. Suppliers with mature compliance systems recognise the shape and answer in days; suppliers who have never been asked properly need the template doing half their work - provide it.

Grading the answers that come back

Replies sort into three grades. A-grade: specific, threshold-referenced, basis stated, change clause accepted - file and move on. B-grade: specific on intentional use but silent on basis or thresholds - one follow-up round, naming the missing elements, usually converts it. C-grade: boilerplate compliance language, refusal without structure, or a declaration covering a different specification than the one supplied - treat as no declaration, and escalate commercially: the supplier is telling you, in the only language available to them, that this evidence does not exist in their house. For food-contact PFAS lines and metals-bearing decorations, a C-grade answer on a high-volume line is a sourcing decision, not a correspondence thread: qualify the alternative while the thread continues.

The declaration chain and its weakest link

Declarations chain: your supplier declares on the basis of their supplier's declaration, and the chain is as strong as its least specific link. For high-risk inputs - greaseproof agents, pigments, recycled streams - the file benefits from seeing one level deeper: the upstream declaration or the test report the immediate declaration rests on, held directly or warranted available. Confidentiality is handled by structure, as the roles station prescribed: sealed declarations, third-party-held dossiers, NDA-covered composition data. What cannot be handled is absence. A chain with a missing link should be recorded as such, with the compensating control (your own testing, from this station's testing guide) named in its place - the honest architecture an auditor respects.

When a supplier refuses or cannot declare

Refusals come in two kinds and must not be confused. The structured kind protects composition confidentiality while offering evidence another way - third-party dossier, sealed declaration, test reports under NDA. That is a negotiation about form, and it usually closes. The empty kind declines specificity itself: no thresholds, no basis, no change commitment. That is information about the supplier's own house, and the professional response is to price it as risk - your own testing at their cost in the short term, re-qualification of the input in the medium term. What never works is accepting the empty declaration into the file and proceeding: the file now contains a document that proves you asked and were refused, filed as if it were the answer.

Primary sources on the record

Legal status: Evidence practice supporting Articles 5 and 15-18 of Regulation (EU) 2025/40. Application position for this topic: From 12 August 2026.

Follow the line

Station 07 - Substances and PFAS Substances of Concern and PFAS Under the PPWR: Article 5 Explained Minimise substances of concern, hold PFAS in food-contact packaging under the ppb thresholds, keep the heavy-metals sum under 100 mg/kg. The pillar guide to the regulation's chemistry bench. Station 07 - Substances and PFAS Testing Packaging for PFAS and Heavy Metals: A Practical Programme Total fluorine screening, targeted PFAS analysis, XRF for metals and the laboratory methods behind them. Designing a testing programme by risk - what to test, how often, and how to file results. Station 07 - Substances and PFAS Substances of Concern: What the Term Covers and What Minimisation Requires The PPWR borrows its concern list from the chemicals framework - CMRs, endocrine disruptors, persistent substances and more. How the category is built, and what a defensible minimisation file looks like.