What a REACH Certificate of Conformance Should Actually Say (Most Don't)

Every few months, a client forwards us a document titled something like “REACH Certificate of Conformance” from their Chinese or Indian supplier. It’s usually a single page. It states — in very confident terms — that the product “complies with REACH Regulation (EC) No 1907/2006.” Sometimes there’s a company stamp. Occasionally, a signature.

And almost universally, it proves very little.

This isn’t entirely the supplier’s fault. REACH itself doesn’t define a standard certificate format. There’s no ECHA-approved template, no mandatory fields, no registration number to cross-check. The “REACH CoC” is a market artifact — something supply chains started demanding because it made procurement feel more controlled. The problem is that a document can confidently state full compliance while leaving every real obligation completely unaddressed.

Here’s what the regulation actually requires, what a valid REACH declaration should contain, and how to tell whether the one sitting in your supplier file is worth the paper it’s printed on.

REACH Doesn’t Define a Standard Certificate — And That’s the Core Problem

Regulation (EC) No 1907/2006 covers 141 articles and 17 technical annexes. Nowhere in those pages does it describe a “certificate of conformance.” The obligations it creates are specific — registration numbers for substances above one tonne per year, substance notifications, Safety Data Sheet requirements, SVHC communication — but it never mandates a single consolidated certificate to prove them.

What the regulation does specify are communication obligations. Under Article 31, suppliers of substances or mixtures that meet certain hazard criteria must provide a Safety Data Sheet. Under Article 33, any supplier of an article containing a Substance of Very High Concern (SVHC) above 0.1% (w/w) must communicate sufficient information to allow safe use — and must respond to consumer requests within 45 days. These are the real obligations. A CoC may reference them, but it is not the same as fulfilling them.

The practical consequence? A supplier can generate a REACH CoC overnight — in good faith or otherwise — and it will look exactly like one from a supplier who completed registration, ran substance identification testing, and maintains a live Safety Data Sheet aligned to Annex II of the regulation. Unless you know what to look for, you can’t tell them apart.

ECHA’s Candidate List — the live register of SVHCs — currently contains more than 240 substances and is updated twice per year, in June and December. Every update creates a potential gap between what your supplier certified 18 months ago and what the current List covers. A CoC with no issue date and no substance-specific reference isn’t a compliance document. It’s a statement of intent.

The Four REACH Obligations a Valid Declaration Should Address

Not every product triggers every REACH obligation. Whether you’re dealing with a substance, a mixture, or an article changes the picture considerably. But a meaningful REACH declaration — one you can actually use in a compliance file — should address the following four areas explicitly, with substance-specific information where applicable.

1. Substance registration status

If your supplier is an EU manufacturer or importer of a substance at or above 1 tonne per year, that substance must be registered with ECHA and assigned a registration number. A valid CoC should include the REACH registration number, or explicitly state why the substance is exempt (polymer exemption, R&D quantity, below tonnage threshold). “Registered under REACH” without a number is unverifiable — and in a compliance audit, essentially meaningless.

2. SVHC status referenced to a dated version of the Candidate List

This is where most certificates fall short. A compliant declaration should confirm whether any SVHC on the Candidate List is present above 0.1% (w/w) — and it must reference the specific List version used for the assessment. A declaration that doesn’t date its SVHC assessment may already be incomplete before it reaches your inbox.

3. Restrictions compliance under Annex XVII

Annex XVII restricts the manufacture, placing on market, or use of certain hazardous substances. It currently covers over 70 restriction entries, including lead, cadmium, certain phthalates, and azo dyes used in textile products. Your supplier’s CoC should either confirm these restrictions don’t apply to the substance in question, or explicitly address the ones that do. A blanket “complies with REACH” statement provides no audit trail for restrictions compliance.

4. Article 33 communication for finished articles

If you’re importing finished goods — not raw chemicals — Article 33 is typically your primary obligation. If an article contains an SVHC above the 0.1% threshold, you must communicate at minimum the substance name and safe-use information to B2B customers. For consumer-facing products, you have 45 days to respond to any buyer inquiry. A CoC covering an article should state whether any Candidate List SVHC is present and at what concentration — not just that “the product complies with REACH.”

When You’re the EU Importer: The Obligation Doesn’t Stay With the Supplier

One of the most persistent misunderstandings we encounter in EU market entry work is treating a supplier’s REACH CoC as a compliance transfer. It isn’t. If you are importing a substance, mixture, or article into the EU — and your supplier is based outside the EU — you are the responsible party under REACH. The CoC from your Taiwanese or Turkish supplier is a starting point for your due diligence, not a finished compliance document.

The Only Representative (OR) mechanism exists for exactly this scenario. A non-EU manufacturer can appoint an EU-established OR to handle REACH registration obligations, which shifts the importer’s registration burden to that representative. But even with an OR in place, Article 33 obligations for articles containing SVHCs remain with the importer. The OR doesn’t absorb everything.

In practical terms, this means your internal REACH compliance file should contain: the supplier’s CoC with issue date and Candidate List version, your own SVHC assessment if the supplier’s coverage is insufficient, the current Safety Data Sheet where applicable, and a record confirming you verified the file against the most recent Candidate List update. If the DGCCRF or another national competent authority asks to see your REACH compliance documentation during a market surveillance inspection, “we have a certificate from the supplier” won’t be sufficient on its own.

Market surveillance activity under REACH has been increasing across EU Member States, particularly for cosmetic ingredients, children’s articles, and consumer electronics components. Having a structured compliance file — not just a folder of supplier-issued certificates — is what determines whether an inspection ends in a day or generates a formal corrective action.

How to Audit a REACH CoC Before It Costs You

Here’s a practical checklist our team uses when reviewing supplier documentation for clients entering the EU market. It takes roughly 20 minutes per product and has surfaced real gaps in certificates that initially looked fine.

Step 1: Check the issue date and Candidate List version referenced. If the CoC doesn’t specify which version of the Candidate List was used, or was issued more than 12 months ago, request an updated version. Cross-reference the current List at echa.europa.eu before accepting the document.

Step 2: Verify registration numbers independently. ECHA’s public registered substance database allows lookup by EC number or substance name. If a CoC claims REACH registration, confirm it. Unregistered substances carrying registration claims are more common than most importers expect.

Step 3: Confirm how the 0.1% SVHC threshold was calculated. The threshold applies per article, not per component. A supplier calculating per component may be systematically underreporting SVHC presence. Ask for the methodology explicitly, not just the conclusion.

Step 4: Check Annex XVII applicability to your specific product category. Identify which restriction entries could apply to your use case. Cosmetic preservatives, toy coatings, textile dyes, and plastic components each have distinct restrictions. Don’t assume a general-use CoC covers your specific application.

Step 5: Request substance-level data for complex products. For mixtures or multi-component articles, ask for a substance-by-substance SVHC assessment rather than a blanket product-level declaration. A supplier who won’t or can’t provide this is itself a compliance signal worth taking seriously.

A well-structured REACH certificate doesn’t need to be long. Two or three pages covering these five points is more defensible in an audit than a ten-page document padded with disclaimers and missing actual substance data. The value of a CoC lies entirely in its specificity.

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The EU’s Chemicals Strategy for Sustainability is driving continuous expansion of the Candidate List through 2027 and beyond — SVHC designations are accelerating, particularly for endocrine disruptors, PBT substances, and chemicals of concern in everyday consumer articles. A compliance process that relies on a single CoC issued at supplier onboarding and never reviewed again is a process that accumulates hidden risk with every biannual ECHA update.

Get the dates right, get the substance names right, and verify against the current Candidate List every time ECHA publishes. That’s the actual baseline — everything else is just paperwork.

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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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• SVHC Identification Testing and Supplier Documentation Review — Qalitex Laboratories provides ISO 17025-accredited analytical testing for SVHC identification and substance characterisation to support EU importers’ REACH compliance files.
• Canadian Chemical Compliance and Regulatory Filing Support — Androxa supports Canadian manufacturers with chemical compliance assessments and regulatory submissions ahead of EU or US market entry.