REACH and SVHC for US companies selling into the EU

You are almost never the duty holder under REACH. Your EU customer is, which is why their questionnaire arrives with a deadline attached and yours does not.

The most useful thing to understand about REACH, if you are a US company, is that it probably does not apply to you directly. It applies with force to your customer, and that is why their questionnaire arrives with a deadline and a tone.

Quoted from the consolidated Regulation (EC) No 1907/2006, checked on 6 September 2026.

The duty follows EU establishment

REACH obligations attach to entities established in the EU. A US manufacturer selling to an EU distributor is not the importer — the distributor is, and the registration and notification duties are theirs.

Article 8 provides the one route by which a non-EU company takes the duty on deliberately:

A natural or legal person established outside the Community who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title.

An Only Representative is something you choose, usually to relieve your EU customers of duties they would rather not carry. It is a commercial decision with a legal form, not a default obligation.

What your customer is actually obliged to do

Article 33(1) — the one behind almost every questionnaire you receive:

Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

Article 33(2) adds the consumer-facing version, with a clock:

On request by a consumer … The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

Your customer cannot answer either question without data from you. That is the entire mechanism by which REACH reaches a US supplier: contractually, through someone else's 45-day clock.

The notification threshold is different, and has two limbs

Article 7(2) requires notification to the Agency where a Candidate List substance is present in articles and both:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Both limbs, not either. And Article 7(3) carves out cases where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal — in which case they must instead supply appropriate instructions to the recipient.

So a substance above 0.1% does not automatically trigger notification. Volume matters, and so does whether exposure can be excluded.

Two things worth getting right

0.1% is measured per article, including each article inside an assembled product. The threshold in Articles 7 and 33 is expressed against "the article", and the EU Court of Justice settled in 2015 how that applies to a product made of several components: it is for "the importer of a product made up of more than one article, to determine for each article" whether a Candidate List substance is present above 0.1%. A substance that is a trace across the whole product can still cross the threshold in one component, so answer component by component, and record which components your figures cover.

The Candidate List is a moving list. It is maintained by ECHA under Article 59 and updated periodically. Any answer you give is an answer as at a date, against a version of the list — which is why an undated declaration is close to worthless here, exactly as it is for PFAS. Check the current list at ECHA rather than working from a copy.

What to do as the US supplier

1. Ask which duty they are discharging. Article 33 communication and Article 7(2) notification need different information. The second needs tonnage.
2. Answer per article, with the basis stated. Component or assembled product — say which.
3. Give the substance name and CAS number. Article 33 sets the substance name as the minimum, and a name without a CAS number creates a second round of email.
4. Date every answer, and name the list version you checked it against.
5. Consider an Only Representative if EU sales are strategic. It moves a burden your customers feel, and they know it.
6. Reuse the work. The data behind a REACH answer is the same data behind PFAS reporting and Prop 65 — which substances, at what concentration, doing what job. Collect it once.

General information, not legal advice. The Regulation is linked above; the Candidate List is maintained by ECHA and changes — check both, and take EU advice on your specific position.