REACH Compliance for Non-EU Manufacturers: SVHC, SCIP, and ECHA Registration Explained

REACH controls the chemical substances inside almost everything sold in the EU, from the coating on a metal bracket to the flame retardant in a cable sleeve. In April 2026, the European Commission confirmed it will not move forward with the long-planned overhaul of the regulation. Commissioner Jessika Roswall told the Parliament’s environment committee, “We have come to the conclusion to not open REACH at this point.” For manufacturers exporting into the EU, that means the current rules are stable for the foreseeable future, not a moving target.

REACH is dense on two fronts at once.

The technical side covers toxicology, chemical classification, and hazard assessment. The bureaucratic side adds a running list of registrations, declarations, and database notifications that don’t stop once you’ve filed them. The original regulation, published in the Official Journal in December 2006, ran to 849 pages, and the consolidated version in force today, updated through dozens of amendments since then, is longer still.

What matters to most manufacturers is simpler than the politics in Brussels: does REACH apply to what you make, and if so, what do you actually have to do? Start with your role in the supply chain, since that determines almost everything else.

What Is REACH and Does It Apply to My Product?

REACH is Regulation (EC) No 1907/2006, in force since June 1, 2007. It runs on a simple principle: the industry, not the authorities, has to prove a substance is safe before it goes on the EU market. No data, no market.

The regulation assigns different obligations depending on your role:

• A manufacturer produces chemical substances inside the EU.
• An importer brings substances, mixtures, or articles into the EU from outside.
• A downstream user takes an already-registered substance or mixture and uses it in production, without being the one who manufactured or imported it.
• A distributor stores and resells without changing the product.

Most non-EU manufacturers who buy their raw materials and components from EU suppliers fall into the downstream user category, and that carries the lightest set of obligations of the four. If you manufacture a finished product outside the EU and sell it through EU distributors or importers, REACH generally doesn’t ask you to register anything yourself. It asks you to know what’s inside your product and be ready to answer specific questions about it.

Substance, Mixture, or Article: Which One Is My Product?

REACH treats these three categories very differently, and getting the classification wrong is one of the most common sources of confusion.

A substance is a chemical element and its compounds. A mixture, previously called a preparation, combines two or more substances, like a paint or an adhesive. An article is an object given a specific shape, surface, or design during manufacturing that determines its function more than its chemical composition, like a connector, a housing, or a length of cable.

A plastic enclosure for an electronic device is an article. The resin it was molded from is a substance. Which one you’re actually supplying, or manufacturing, determines which set of rules applies to you, and most finished manufactured goods qualify as articles rather than substances or mixtures.

Do I Need to Register My Product with ECHA?

Registration is tied to producing or importing a substance or mixture at 1 tonne per year or more. The data requirements scale up in bands as the tonnage increases.

Articles only trigger a registration duty if they contain a substance intended to be released during normal use, and that released substance exceeds 1 tonne per year across the producer or importer’s total volume. For a screw, a connector, a sensor, or a machined housing, this almost never applies, because there’s no intentional release of a substance in normal use.

If you buy your components from EU-based suppliers, you act as a downstream user of those materials, and a downstream user never has a registration duty, regardless of volume. The obligation, if it exists at all, sits further up the chain with whoever manufactures or imports the underlying substance.

Registration becomes relevant if you import substances or mixtures yourself directly from outside the EU, such as lubricants, adhesives, or surface treatments used in your own production process. If you bring in more than 1 tonne per year of a specific substance that way, the registration duty can land on you as the importer.

What Is an SVHC and Why Does the 0.1% Threshold Matter for My Product?

A Substance of Very High Concern (SVHC) is a substance identified as carcinogenic, mutagenic, or toxic for reproduction, persistent and bioaccumulative, or of an equivalent level of concern, a category that covers endocrine disruptors, sensitizers, and neurotoxic substances.

ECHA maintains these on the Candidate List, which reached 253 entries in February 2026 and typically grows twice a year. The most recent addition, n-Hexano, was the first substance ever added to the list based on neurotoxicity under the equivalent level of concern criterion, rather than the traditional carcinogenicity, mutagenicity, or reproductive toxicity tests.

If an article contains an SVHC above 0.1% by weight, two obligations kick in. You have to communicate that presence down the supply chain and to any consumer who asks, free of charge, within 45 days under Article 33. You may also need to notify ECHA directly if the substance also exceeds 1 tonne per year for your company.

Following a 2015 ruling from the EU’s top court, the 0.1% threshold gets calculated on each individual component article, not on the finished assembled product. A cable assembly with one SVHC-containing connector calculates the threshold against the connector’s own weight, not the weight of the entire cable. Many companies get this wrong by calculating against the total product weight, which understates how much SVHC is actually present.

Do I Need to Notify SCIP for My Product?

SCIP is ECHA’s database for substances of concern in articles, running since January 2021. Unlike registration, it has no minimum tonnage. It applies as soon as an article placed on the EU market contains an SVHC above 0.1% by weight.

Retail distributors selling directly to consumers, waste operators, and companies with no EU establishment aren’t directly targeted by the SCIP obligation. Whoever does place your article on the EU market, whether that’s your importer or your EU distributor, needs accurate SVHC data from you to notify correctly on your behalf.

This is why component-level SVHC declarations from your own suppliers matter, even if you never file anything with ECHA yourself. Your EU importer’s ability to notify SCIP correctly depends entirely on the information you pass along.

REACH vs. CLP vs. RoHS: How Are They Different?

These three get confused constantly, and they cover genuinely different things.

RoHS covers a fixed, short list of restricted substances and applies exclusively to electrical and electronic products. REACH’s Candidate List is far larger and applies across every category of manufactured goods, not just electronics. If your product includes electrical or electronic components, RoHS adds its own separate restricted-substance list on top of REACH.

What Happens If I Get REACH Wrong?

ECHA’s REF-12 enforcement project, covering imports and published in December 2025, found that 32% of substances inside imported mixtures lacked proper registration, compared to 7% for substances imported on their own. Jewelry came out worst among product categories, with an 18% noncompliance rate driven mainly by nickel, cadmium, and lead.

There’s no single EU-wide REACH fine. Each member state sets its own penalties under national law, and across the REF-12 inspections, the most common enforcement action was a written warning, not a monetary fine.

For most manufacturers, the real risk is an EU distributor or importer declining to bring in your product because you can’t answer a substance declaration request inside the deadline, not a penalty from an EU authority.

Is My Sector a Common REACH Enforcement Target?

ECHA’s REF-10 inspection project checked more than 2,400 products across 26 countries and found an overall noncompliance rate of 18%. That number jumped to 52% for electric toys, chargers, cables, and headphones, the highest of any category checked. Certain sectors keep showing up for the same handful of substances across REF inspections and Safety Gate alerts.

If your product sits in one of these categories, treating supplier substance declarations as a routine part of onboarding a new component, rather than a one-time check, keeps you ahead of the pattern these enforcement numbers describe.

Do I Need REACH Documentation in My CE Marking Technical File?

Neither the Machinery Directive’s Annex VII nor the new Machinery Regulation’s Annex IV lists a formal REACH declaration among the required technical file documents.

Nonetheless, finished machine still counts as an article, or a complex object made of articles, under REACH. As the manufacturer placing it on the market, you have your own REACH obligations toward your customers, including responding to SVHC requests under Article 33 and notifying SCIP where relevant, especially if the machine gets resold further down the chain.

Keeping supplier SVHC or material declarations on file, even though no regulation formally requires it as a named technical file document, gives you the information you need to answer those requests accurately. This matters most for higher-risk components: wiring, plastics with flame retardants, coated metals, rubber, and PVC parts. If the machine includes electrical or electronic equipment, RoHS applies as a separate, parallel obligation with its own restricted substance list.

Where Does This Leave My Product?

If you buy your components and raw materials from EU suppliers, you’re almost certainly a downstream user with no registration duty of your own. The practical work that matters is making sure your supplier SVHC declarations stay current and that you can respond to an Article 33 request inside 45 days.

REACH rarely fits into a fixed-scope package the way a single CE marking assessment does. Send us the specific questions you have about your product, and we’ll build the engagement, and the hours, around exactly what you need answered.

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