REACH Declarations of Conformity: What They Must Contain and When You Actually Need One

Every few weeks, a client sends us a supplier’s “REACH Declaration of Conformity” and asks whether it holds up. The document looks official — company letterhead, a signature, a confident statement that the product “complies with REACH Regulation (EC) No 1907/2006.” But on closer inspection, there’s no ECHA registration number, no SVHC statement, and no reference to restriction entries. What the supplier has produced is a piece of paper that says nothing verifiable.

This is more common than you’d expect. And it creates real compliance exposure.

REACH Declarations Don’t Have a Legal Template — And That’s the Problem

Unlike a CE Declaration of Conformity, which follows a standardised format defined in EU harmonised legislation, a “REACH Declaration of Conformity” has no mandatory structure prescribed in the regulation itself. Regulation (EC) No 1907/2006 does not define this document. ECHA hasn’t published a required template. The European Commission has not specified minimum content fields.

What exists instead is a market-driven expectation baked into every B2B supply chain that touches the EU: downstream users — formulators, brand owners, contract manufacturers — require written confirmation from their suppliers that incoming substances, mixtures, or articles comply with REACH. That expectation is entirely legitimate. But without a legal definition, declaration quality varies enormously. A supplier in Taiwan producing a statement for a French cosmetics customer will default to language that sounds comprehensive but commits to nothing specific.

A declaration that simply states “this product complies with REACH” is commercially useless and legally indefensible. It doesn’t tell you whether the substance is registered (a legal prerequisite for most substances placed on the EU market above 1 tonne per year), whether any Substances of Very High Concern are present above the 0.1% w/w threshold, or whether the substance is subject to an Annex XVII restriction. All three of those are separate questions — and a compliant REACH declaration needs to address all of them distinctly.

The Three Compliance Pillars Every Valid REACH Declaration Must Cover

A well-drafted REACH declaration addresses registration status, SVHC content, and restriction compliance as three separate elements. Conflating them — or addressing only one — is where declarations break down.

Registration status. Substances manufactured in or imported into the EU above one tonne per year require registration with ECHA under Title II of REACH. A compliant declaration should include the ECHA registration number or explicitly confirm exemption status — for substances such as polymers, on-site isolated intermediates, or those covered by Article 2 exemptions. Without a registration number, you have no way to verify the substance was legally placed on the EU market. For complex mixtures, the declaration should reference which component substances carry registrations, and under which dossier numbers.

SVHC content. The ECHA Candidate List currently contains over 240 substances carrying SVHC designation — covering CMR properties (carcinogenic, mutagenic, or reprotoxic), PBT/vPvB characteristics (persistent, bioaccumulative, toxic), and substances identified as having endocrine-disrupting properties. Under Article 33 of REACH, any article containing an SVHC above 0.1% by weight must come with a formal disclosure at the point of supply. A credible declaration must either confirm the article is free of Candidate List substances above this threshold, or explicitly declare which SVHCs are present and in what concentration range.

Restriction compliance. Annex XVII of REACH lists restricted substances and the conditions under which they may — or may not — be used. As of early 2026, the Annex contains more than 70 restriction entries covering substances including polycyclic aromatic hydrocarbons (PAHs) in rubber and plastic articles, lead in certain surface coatings, and specific azo dyes in textile and leather contact articles. A declaration that ignores restriction compliance is addressing only a fraction of the regulatory picture.

Article 33 and the SVHC Obligation You Cannot Contractually Waive

This is the part of REACH declarations that created problems for several of our clients last year, particularly those sourcing components from manufacturers outside the EU. Article 33(1) of REACH places a mandatory obligation on any supplier of an article to communicate SVHC presence to the recipient when that substance exceeds 0.1% by weight of the article. This obligation applies automatically. It cannot be contracted away, waived in a purchase order, or retroactively satisfied by a generic declaration that doesn’t name specific substances.

Article 33(2) goes further: consumers — not just business customers — can request SVHC information directly from the supplier, and the supplier has 45 days to respond. In practice, this means the obligation exists regardless of whether your B2B customer specifically asks. Pre-empting it with accurate disclosure documentation is the only defensible approach.

What makes this particularly relevant for companies entering the French or broader EU market is that the 0.1% threshold applies per article in a complex object — not to the finished product as a whole. A cosmetic packaging component, an electronic display module, a composite textile article — each is assessed as its own discrete article. The total weight of the finished assembly is not the relevant denominator. This is a consistent source of miscalculation, especially for importers dealing with multi-component goods assembled outside the EU before being placed on the EU market.

The SCIP Database: The Companion Obligation That Gets Overlooked

Alongside Article 33 supply chain communications sits a parallel obligation that our team now treats as standard in every REACH compliance review: SCIP database notifications.

Since January 5, 2021, suppliers of articles to the EU market are required to submit information about SVHC content to ECHA’s SCIP database (Substances of Concern in Products) under Article 9(1)(i) of the Waste Framework Directive. The purpose is circular economy support — ensuring that waste operators and recyclers have access to hazardous substance data throughout a product’s lifecycle. SCIP notifications are separate from the supply chain communication under Article 33. A supplier’s REACH declaration may tick the Article 33 box and say nothing about SCIP.

The information submitted to SCIP must include the SVHC identity and concentration range, the article category, safe use information, and product identifiers. ECHA provides a free submission tool — IUCLID — for this purpose. And yet, in our due diligence reviews for clients entering the EU market, SCIP compliance gaps remain one of the more frequent findings. It’s not that companies are unaware of REACH. It’s that they’ve focused on the supply chain documentation side and haven’t connected it to the broader waste and circular economy framework.

If you are requesting REACH declarations from suppliers, adding a SCIP confirmation field to your questionnaire template costs nothing and closes a real gap.

What to Do When a Supplier’s Declaration Falls Short

If a supplier provides a REACH declaration that doesn’t cover all three pillars — or simply restates the regulation without specific claims — you have practical options.

First, request a revised declaration using a structured template. Bodies such as FEFCO (packaging) and FEBEA (French cosmetics) have circulated guidance on minimum declaration content, and several major EU retailers now publish mandatory supplier REACH questionnaires. A template with specific fields — ECHA registration number, SVHC presence or absence with CAS numbers, Annex XVII restriction confirmation, and SCIP notification status — removes ambiguity and forces the conversation to be substantive.

Second, validate independently where the risk warrants it. For high-risk inputs — substances with PBT concern, materials intended for food-contact or leave-on cosmetic applications, or components from regions with less robust regulatory equivalents — third-party analytical testing against the Candidate List is both feasible and proportionate. A targeted SVHC screen at an ISO 17025-accredited EU laboratory can cost as little as €300–€600 per sample. That produces defensible, auditable data rather than a supplier’s assertion.

Third, escalate when a supplier cannot demonstrate registration. Placing a non-registered substance on the EU market is a direct breach of REACH Article 5 — the “no data, no market” principle. Crucially, the liability for ensuring registration compliance rests with the EU importer or manufacturer, not the upstream supplier. If the substance lacks a valid ECHA registration number and doesn’t qualify for a documented exemption, the company placing it on the EU market carries the exposure.

The DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) and its counterparts in other Member States have increased REACH enforcement activity in recent years. Enforcement actions can involve product withdrawal, significant administrative penalties, and — for systematic commercial-scale breaches involving prohibited substances — criminal liability. A supplier declaration you haven’t evaluated against specific requirements is not a defence at inspection.

Know your supply chain. Review the declarations you’re holding against these three pillars. The time to find a gap is before customs, not after.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Related from our network

• ISO 17025-Accredited SVHC and Contaminant Screening for Raw Materials — Qalitex Laboratories provides third-party analytical testing that supports REACH Candidate List verification and supplier qualification.
• Chemical Compliance and REACH Guidance for Canadian Exporters Entering the EU — Androxa helps Canadian manufacturers understand chemical registration and documentation obligations for European market access.