REACH and Regulated Substances: The Importer's Checks

REACH is Regulation (EC) No 1907/2006, which governs the registration, evaluation, authorisation and restriction of chemical substances in the European Union. Its scope goes beyond chemistry in the everyday sense: pure substances, mixtures and articles, meaning most manufactured products. A product imported from outside the Union has no registration to make as an article. The exception: a substance intended to be released by the product, a fragrance for instance, may need to be registered in certain cases.

The concrete obligations rest on three lists. The candidate list identifies substances of very high concern, the SVHCs, and triggers information duties. The authorisation list, Annex XIV, subjects certain substances to authorisation to keep being used in Europe. The restriction list, Annex XVII, bans or limits substances in specific uses. Also worth remembering: REACH imposes no CE marking, and no standardised certificate exists. Compliance is proven through documents and tests, not through a logo.

ECHA, the European Chemicals Agency, expands the candidate list about twice a year; it now numbers over two hundred entries. Listed substances include carcinogenic, mutagenic or reprotoxic substances, persistent and bioaccumulative substances, and endocrine disruptors. Phthalates, lead salts and bisphenol compounds are among them. A product compliant on the previous order can become non-compliant after a simple update to the list.

The threshold to know: 0.1% by weight. Above it, Article 33 of the regulation requires informing your professional customers without them having to ask, and consumers on simple request, free of charge, within forty-five days. The information provided must allow safe use of the article, substance by substance.

Since 5 January 2021, an article containing more than 0.1% of an SVHC must also be entered in the SCIP database, maintained by ECHA under the Waste Framework Directive. This declaration falls to European suppliers of articles, and therefore to the importer placing the product on the market. Require from each factory the version of the list used and the date of its declaration: a letter citing a list three years old is worthless.

Annex XVII bans or caps substances in articles placed on the market. Certain families come up regularly in checks: phthalates in plasticised materials, azo dyes liable to release carcinogenic aromatic amines, nickel in articles in contact with skin, cadmium, lead in jewellery and accessories.

Other texts overlap depending on the product. The RoHS Directive 2011/65/EU governs hazardous substances in electrical and electronic equipment, backed by CE marking. The Toy Safety Directive 2009/48/EC and Regulation (EC) No 1935/2004 on materials in contact with food add their own limits. Before any order, list the material families in your product: plastics, coatings, inks, glues, textiles, metal finishes. Each family calls for its own restrictions, and this list is what a reasonable test plan is built on.

Factories readily send REACH compliance letters. Many are generic templates signed without analysis, sometimes in the name of a company other than the one actually manufacturing. Others cite an old version of the candidate list or omit entire materials, inks and adhesives being the most common.

A declaration retains its usefulness: it commits the supplier in writing. But it must be verified. Require the material breakdown of the product, named test reports and the exact details of the manufacturing factory. If the supplier refuses any document on its materials, treat the risk as high and let the actual product speak: an independent test, by an accredited laboratory, on samples drawn from series production, establishes what no letter can prove.

A verification plan comes down to three steps. First, identify the at-risk materials: soft plastics, paints, prints, glues, dyed textiles, metal coatings. Then, fix the timing: tests on the pre-production sample, then checks on the first series production run. Finally, document: test reports, signed declarations, the candidate list version and the date of each item.

Retest whenever the material, subcontractor or process changes: a plastic pellet quietly swapped can push a compliant product outside the limits. Keep everything for several years, alongside your commercial file. These records will help you respond to a professional customer, to a consumer request within the forty-five-day deadline, or to a customs check.

Sorva is a brokerage and sourcing house. Our Chinese-speaking team in Guangzhou runs these exchanges with factories in their own language, starting from supplier selection: material breakdown required, dated declarations made in the name of the correct entity, laboratory tests framed on representative samples. If your product needs more depth, our regulatory compliance study and our pre-shipment inspection complete the process, with a documented file you can present as is.

In most cases, you pay no fees: you open a file with us, we negotiate the goods for you, and we take a commission on their ex-factory value.