Most US manufacturers I talk to think REACH and RoHS are a European problem that their EU distributor handles quietly in the background. That assumption holds right up until a shipment gets flagged at a port of entry, or a long-standing EU customer asks for a REACH registration number the US company doesn't have and has no legal way to obtain directly. By then the fix isn't a compliance fix. It's a lost contract.
REACH (Regulation (EC) No 1907/2006) and RoHS (Directive 2011/65/EU) are two different legal instruments with two different purposes: REACH governs the chemical substances themselves, RoHS restricts specific hazardous substances in electrical and electronic equipment. But they overlap constantly for anyone exporting components, finished electronics, coatings, plastics, or chemical formulations into the EU, and both frameworks are moving right now in ways that change what US exporters need to have on file before goods clear customs.
Why These Two Frameworks Keep Colliding for US Exporters
REACH is substance-based: it doesn't care what your product is, it cares what's in it and at what concentration. RoHS is product-based: it applies to electrical and electronic equipment (EEE) across eleven defined categories and restricts a specific list of substances regardless of overall chemical safety. A single connector or cable assembly can trigger obligations under both at the same time: REACH because of a plasticizer or flame retardant present above a notification threshold, RoHS because the part goes into a category of EEE covered by Annex II.
The mechanics that trip up US exporters aren't the chemistry. They're the legal architecture. REACH registration is a duty that attaches to EU-based manufacturers and importers, not to the non-EU factory that made the product. A US company has no standing to register a substance under REACH on its own. Article 8 solves this through the Only Representative mechanism: a non-EU manufacturer appoints an EU-established legal or natural person who then carries the same registration, reporting, and liability obligations an EU manufacturer would carry. If no Only Representative is appointed, that legal burden falls on whichever EU-based company imports the product, and most EU distributors will not accept that risk quietly forever.
RoHS obligations follow a similar pattern. The Declaration of Conformity and CE marking under Article 7 and Article 13(2) of 2011/65/EU are the legal responsibility of whoever places the product on the EU market first, but the technical documentation supporting that declaration has to originate somewhere, and increasingly EU customers are pushing that burden back up the supply chain to the US manufacturer as a condition of doing business.
The PFAS Restriction Moving Through REACH Right Now
The single biggest REACH development for US exporters isn't a new chemical ban that already took effect. It's a restriction proposal still working through the process, and it's enormous in scope. In January 2023, five national authorities, Germany, the Netherlands, Denmark, Sweden, and Norway, submitted a REACH Annex XV restriction dossier to the European Chemicals Agency (ECHA). The dossier proposed restricting per- and polyfluoroalkyl substances, PFAS, as a single class covering an estimated 10,000 individual substances. That makes it one of the broadest restriction proposals ECHA has ever received, and it covers uses ranging from fluoropolymer coatings and textiles to semiconductors, medical devices, and firefighting foam.
That review process has now largely played out. RAC adopted its final opinion on 2 March 2026, backing a near-universal restriction and rejecting sector-specific derogations across the board with the single exception of personal protective equipment. SEAC's draft opinion followed on 26 March 2026, with its public consultation closing 25 May 2026, and likewise supports a broad ban with only a handful of narrow, time-limited carve-outs rather than the wide derogation structure manufacturers had been hoping for. A US exporter that makes fluoropolymer seals for industrial equipment should no longer plan around open-ended sector relief; the working assumption now has to be a near-universal ban with a short list of time-limited exceptions, PPE chief among them.
In my view, the mistake I see US manufacturers make with PFAS is waiting for the final rule before doing anything. In my experience, once a restriction like this is adopted and published in the Official Journal, the transition period tends to run something like the two years RoHS gave manufacturers between the 2015/863 amendment and its 22 July 2019 compliance date — rarely enough time to requalify an entire product line's chemistry from a standing start. The exporters in the best position right now are the ones already mapping which of their formulations contain PFAS above trace levels and pricing out substitute chemistries, given where RAC and SEAC have now landed.
RoHS: What Already Changed and What's Still Under Review
RoHS's restricted substance list is not static, and the last expansion is a useful marker for what "compliant" actually means today. Directive (EU) 2015/863 amended 2011/65/EU to add four phthalates, DEHP, BBP, DBP, and DIBP, to the original six restricted substances (lead, mercury, cadmium, hexavalent chromium, PBB, and PBDE), bringing the total to ten. The new limits took effect 22 July 2019 for most categories of electrical and electronic equipment, and 22 July 2021 for medical devices, including in vitro diagnostic medical devices, and monitoring and control instruments. Any US exporter whose RoHS documentation still only tests against the original six substances is shipping against an outdated standard.
The thresholds themselves are worth stating plainly because they get misquoted constantly: Annex II sets a maximum concentration value of 0.1% by weight in homogeneous materials for lead, mercury, hexavalent chromium, PBB, PBDE, and all four phthalates, and a stricter 0.01% by weight for cadmium. "Homogeneous material" is the term that catches people, because it means the threshold applies to each individually separable material in a part, not the part as a whole, which is why a coating or solder joint can fail RoHS even when the bulk assembly would pass.
Beyond the substance list, the European Commission has had RoHS under a formal evaluation since 2022, examining in particular the exemption renewal process under Article 5, which manufacturers of specialized equipment rely on to keep using restricted substances where no viable substitute exists. That evaluation has not yet produced a confirmed recast proposal or a set date, but the direction of travel, tighter exemption renewal criteria and closer alignment with the broader EU circular economy agenda, is consistent enough that US exporters holding RoHS exemptions should not assume renewal is automatic.
REACH vs. RoHS: How the Two Frameworks Actually Differ
| REACH (EC 1907/2006) | RoHS (2011/65/EU) | |
|---|---|---|
| What it regulates | Chemical substances, on their own, in mixtures, or in articles | Ten restricted substances in electrical and electronic equipment |
| Scope trigger | Any substance manufactured or imported into the EU at 1 tonne/year or more; SVHC communication duty at >0.1% w/w in an article | Products falling into one of 11 EEE categories defined in Annex I |
| Key threshold | 0.1% w/w for Article 33 SVHC communication duty | 0.1% w/w for most substances; 0.01% w/w for cadmium |
| Who holds the legal duty | EU manufacturer, EU importer, or an appointed Only Representative (Article 8) | Whoever places the product on the EU market (manufacturer, importer, or authorized representative) |
| Compliance proof | Registration dossier, safety data sheet, SVHC notification | CE marking plus Declaration of Conformity under Article 7 |
| Current pressure point | PFAS restriction dossier under ECHA committee review since 2023 | Exemption renewal process under Article 5 evaluation since 2022 |
The Compliance Mechanics US Exporters Actually Need in Place
Two mechanisms do most of the work, and both are frequently missing or out of date in the files I review for US manufacturers.
The Only Representative appointment. If your company manufactures a substance, mixture, or article outside the EU and an EU-based distributor or customer is currently listed as the "importer" for REACH purposes, that distributor is carrying legal registration and reporting liability for your chemistry without necessarily having full visibility into your formulation. That arrangement tends to work until it doesn't: the moment the distributor changes, exits the relationship, or gets acquired, the registration can lapse with the product still moving. An Only Representative appointed directly by the US manufacturer under Article 8 keeps that continuity under the exporter's own control rather than a downstream customer's.
SVHC notification and communication. ECHA does not update the Substance of Very High Concern candidate list on a fixed calendar. It has, however, added new entries multiple times a year in recent cycles, and each addition creates an immediate Article 33 communication duty with no phase-in grace period. If a substance already present in your product crosses onto the candidate list, you are legally required to tell your EU customers as soon as that product ships above 0.1% w/w. That duty applies whether or not your existing technical file has been updated to reflect it. Exporters who treat their SVHC list as a document they check once, at initial product launch, are the ones who get caught flat when ECHA's next update lands.
RoHS technical documentation carries the same "keep it current" problem. A Declaration of Conformity that was accurate when a product first entered the EU market doesn't stay accurate if a supplier changes a solder alloy, a wire insulation compound, or a connector housing material without the exporter re-testing against the current ten-substance list.
Practical Steps for US Exporters Right Now
- Build a substance inventory, not a paperwork audit. Most compliance gaps I see trace back to a US manufacturer not actually knowing, at the formulation level, what's in a purchased component, because that information sat with a tier-two or tier-three supplier who never disclosed it. Full material declarations from every supplier, refreshed on a defined cycle rather than once at qualification, are the foundation everything else sits on.
- Confirm who legally holds your REACH obligations today. If it's an EU distributor rather than an Only Representative you appointed, get clarity in writing on what happens if that relationship ends, and price out appointing your own Only Representative before you need one.
- Re-test against the current RoHS substance list, not the list your product was originally qualified against. If your last RoHS test report predates July 2019, it doesn't cover the four phthalates added by 2015/863, and an EU customs or market surveillance check will not grade on a curve for when the product was originally designed.
- Map your PFAS exposure now, independent of where the final ECHA decision lands. With RAC and SEAC now both backing a near-universal ban and only narrow, time-limited carve-outs, the exporters who already know which product lines contain PFAS, and what the substitute chemistry costs, are the ones who will absorb whatever transition period gets set without a scramble.
REACH and RoHS documentation review itself sits with legal counsel or a specialist REACH/RoHS consultancy, not with us. Where we do fit is upstream of that: if your company needs an environmental management system that can hold this kind of regulatory exposure systematically, rather than tracking it product-line by product-line in spreadsheets, that's exactly the gap ISO 14001 is built to close, and it's worth building out alongside whatever REACH and RoHS documentation process you already have running. For more on how we scope an EMS build-out, see our ISO 14001 service page.
A US exporter that treats REACH and RoHS as a one-time certification rather than a maintained compliance posture is the one that gets blindsided by the next SVHC list update or substance restriction. Both frameworks are built to evolve, and the companies that stay ahead of them are the ones that built the monitoring habit in from the start, not the ones scrambling to explain a gap to an EU customer after the fact.
If you want help standing up the ISO 14001 environmental management system that keeps this kind of regulatory exposure under control long-term, our team can walk through what that build-out looks like: get in touch.
Last updated: 2026-09-10
Frequently Asked Questions
Does REACH apply to a US company that only exports finished products to the EU, with no EU legal entity?
Yes, indirectly. A non-EU manufacturer cannot register a substance under REACH directly, but the obligation doesn't disappear — it attaches to whoever is legally the EU importer, or to an Only Representative the US company appoints under REACH Article 8. If your product contains a Substance of Very High Concern above 0.1% w/w, the Article 33 communication duty to downstream EU customers applies regardless of where your company is legally based.
What is an Only Representative and does my company need one?
An Only Representative (OR) is an EU-established person or company that a non-EU manufacturer appoints under REACH Article 8 to carry out registration, notification, and reporting duties on the manufacturer's behalf. You need one if you export chemicals, mixtures, or articles into the EU and don't want that legal registration burden sitting by default with an EU distributor or importer whose continuity you don't control.
What's the practical difference between REACH and RoHS compliance?
REACH regulates chemical substances themselves across virtually any product category, triggered by concentration thresholds like the 0.1% w/w SVHC communication duty under Article 33. RoHS restricts ten specific substances, at a 0.1% w/w threshold for most and 0.01% w/w for cadmium, but only within electrical and electronic equipment as defined by Annex I of Directive 2011/65/EU. A product can require both a REACH SVHC disclosure and a RoHS Declaration of Conformity at the same time.
Is PFAS currently banned under REACH?
Not yet as a blanket ban. A REACH Annex XV restriction dossier covering an estimated 10,000 PFAS substances was submitted to ECHA in January 2023 by Germany, the Netherlands, Denmark, Sweden, and Norway, and it has been under review by ECHA's risk assessment and socio-economic analysis committees since then, with sector-specific derogations under discussion rather than a single uniform cutoff date. US exporters should be mapping PFAS content in their products now rather than waiting for the final restriction text.
What happens if my product fails a RoHS check at an EU border or in market surveillance?
Market surveillance authorities in EU member states can request the technical documentation and Declaration of Conformity behind your CE marking at any time, not just at the point of import. If a product tests above the Annex II thresholds, the authority can require corrective action, withdrawal from the market, or recall, and the legal responsibility falls on whoever placed the product on the EU market — which is exactly why outdated RoHS test reports (predating the 2019 phthalate limits) are a live liability, not a paperwork formality.
Jared Clark
Principal Consultant, Certify Consulting
Jared Clark is the founder of Certify Consulting, helping organizations achieve and maintain compliance with international standards and regulatory requirements.