REACH and RoHS Compliance for EU Imports: A Practical Guide

A buyer orders 6,000 cotton tote bags with a screen-printed logo and a metal zip. No electronics anywhere in the product, so nobody thinks about chemical compliance. The bags reach Hamburg, a German retailer runs its own screening, and the printed ink comes back carrying a phthalate above the limit. Two pallets are quarantined and the whole print run has to be repeated.

RoHS is the regulation buyers remember, because it is the one that comes up on electronics. REACH is the one that catches everything else, and it applies to textiles, toys, packaging and printed decoration with no electronics in sight.

RoHS: ten substances, one threshold

The Restriction of Hazardous Substances Directive restricts ten substances in electrical and electronic equipment. Six have been in force since the original directive: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers. Four phthalates were added by amendment and apply from July 2019: DEHP, BBP, DBP and DIBP.

Substance group Limit Measured against
Lead, mercury, hexavalent chromium, PBB, PBDE 0.1 percent by weight Each homogeneous material
Cadmium 0.01 percent by weight Each homogeneous material
Four phthalates 0.1 percent each Each homogeneous material

Homogeneous material is the phrase that decides whether a test passes. It means a material that cannot be mechanically separated into different materials: a cable jacket, a solder joint, a painted surface, a gold plating. Testing a whole assembled product gives a blended figure that can hide a failing component, and blending is what a rushed supplier will propose.

The scope now reaches most categories of electrical equipment, with cables, spare parts and components included. Medical devices and monitoring instruments were brought in on their own timetables between 2014 and 2017.

REACH: the part with no size limit

REACH regulates chemicals in the European Union, and for articles the operative rule is simple to state. If a substance on the candidate list of substances of very high concern is present above 0.1 percent by weight in an article, the supplier must pass information down the supply chain and give a consumer the information within 45 days of a request.

That threshold applies per article, not per shipment weight. A metal zip, a printed panel, a handle and a plastic shell are separate articles for this purpose. A 0.09 percent concentration in one small component can still be above the limit if a heavier component dilutes the average.

Since January 2021, importers of articles containing a candidate list substance above the threshold must also submit a notification to the European Chemicals Agency database. Where the annual quantity of the substance in imported articles exceeds one tonne, a separate notification duty applies.

Alongside the candidate list, the restrictions annex bans or limits specific substances in specific consumer articles. The ones that come up most in Chinese supply chains are polycyclic aromatic hydrocarbons in rubber and plastic consumer goods, phthalates in articles for children, lead in jewellery and in jewellery components, and certain azo dyes, nickel release and dimethyl fumarate in textiles and leather.

What testing actually involves

RoHS screening on one homogeneous material runs about $150 to $400. A laptop charger with a plug, a cable jacket, two solder alloys, a painted case and three connector platings can easily become nine samples. Buyers who budget for one test discover the real number when the laboratory asks for a bill of materials.

REACH screening for a defined group of candidate list substances runs $500 to $1,500 depending on how many are included. Polycyclic aromatic hydrocarbon testing adds $150 to $300, and azo dye testing for textiles sits in a similar range.

The efficient sequence is a bill of materials review before any sample is sent. Mapping each homogeneous material to the tests it needs costs an afternoon and avoids paying for screening on materials that are known compliant, such as unpainted stainless steel.

What to demand from the factory, in writing

Ask for test reports on the specific materials used in your order, not a generic report for the product family. Ask for the list of materials covered against the actual bill of materials, so a substitution is visible. Ask for a signed declaration covering the four phthalates and the candidate list, dated after the most recent update to it.

Then build the change control that makes the file hold. A factory that swaps an ink supplier, a plasticiser or a plating process without telling anyone has invalidated the report while leaving the document in place. Our guide to CE marking covers the rest of the European file, because RoHS sits inside the CE marking system while REACH sits outside it.

The materials that actually fail

Failures cluster in a small number of materials. Soft PVC is the first, because phthalates are plasticisers and soft PVC is where they get used. Recycled plastic is the second, because the feedstock is unknown and can carry restricted substances from a previous life. Printed decoration is the third, and in textiles it fails more than any other component.

Solders and platings account for a large share of RoHS failures: lead in a solder joint, cadmium in a stabiliser or a plating, hexavalent chromium in a passivation layer. Each sits in a small, heavy component that is easy to leave off a sampling plan.

Natural materials are not automatically clean. Cotton can carry azo dyes, leather can carry chromium from tanning, and a natural fibre fabric can carry a finish that introduces a restricted substance. The fibre being natural says nothing about the chemistry applied to it.

Small components are where the failures hide.

Where testing quietly gets skipped

Two scenarios account for most non-compliant shipments that arrive with documents attached. The first is testing at product level instead of material level, which produces a blended figure that passes while one component fails.

The second is a supplier who tested a similar product for another buyer and reuses that report. The materials differ, the line differs, and the report describes a product that was never shipped to you. Report reuse is common, and the only reliable defence is comparing the material list on the report against your own bill of materials line by line.

Screen the bill of materials before any sample leaves the factory. It is the cheapest step in the process and the one most commonly skipped.

A third, smaller category is the report that is genuine but old. Candidate list additions and restriction changes mean a two-year-old declaration covers a narrower set of substances than the regulation now does. Date the evidence, not only the product.

Frequently asked questions

Does REACH apply to products with no electronics?

Yes. REACH is a chemicals regulation and it applies to articles across categories, including textiles, toys, furniture, packaging and printed matter. Buyers whose only compliance experience is with electronics are the ones most frequently caught by it.

What is the difference between RoHS and REACH?

RoHS is product legislation aimed at electrical and electronic equipment, with a fixed list of ten substances and hard concentration limits. REACH is a general chemicals framework that applies to far more products and works through a candidate list, information duties and specific restrictions.

Does the candidate list change over time?

It is updated by the European Chemicals Agency, historically about twice a year. A declaration signed two years ago covers the list as it stood then. That is why the date on a declaration is worth reading before the signature.

Is a supplier declaration enough, or do I need testing?

A declaration from a supplier with a documented materials control system can be acceptable for low-risk materials. For plastics, printed decoration, soft PVC and recycled material, testing is the only reliable evidence, because those are precisely the materials where contamination appears.

Where does RoHS fit in the CE marking process?

RoHS is one of the directives covered by the CE marking regime. The Declaration of Conformity should cite it alongside the safety, EMC and radio directives that apply, and the technical file should hold the supporting evidence.

Send us the product and the bill of materials. We will map which homogeneous materials need testing, which substances actually apply to your category, and what the programme costs before samples are sent. The assessment is free. You can see how we handle factory documentation on our services page, or send the specification through the contact form.