REACH and RoHS: EU Chemical Compliance for China Imports

If you import goods from China into the EU, two separate chemical regulations will follow your products across the border: REACH and RoHS. RoHS is the narrower one. It bans ten specific hazardous substances in electrical and electronic equipment above set concentration limits, and compliance sits inside the CE marking process through a self-declaration. REACH is the broad one. It covers practically every consumer product, and instead of a single ban list it creates layered duties: restrictions in Annex XVII that apply to specific substances and uses, a communication duty for Substances of Very High Concern above 0.1 percent, an ECHA notification duty above that plus one tonne a year, and since 2021 a notification to the SCIP database.

And in both cases the legal responsibility rests on the EU importer, not the Chinese factory. CN Ally works through exactly this gap for buyers: supplier verification, specification discipline, and inspection services that make sure the documents arriving with your shipment describe the product actually in the cartons. Where a sourcing agent genuinely earns its fee in chemical compliance is not in collecting certificates but in knowing which ones are real and which are decoration.

The core difference: REACH and RoHS in one table

Most articles treat these as two names for one thing. They are not. One regulates chemistry across all articles; the other regulates a fixed list of substances in electronics.

RoHS · REACH

• Full name: Directive 2011/65/EU (amended by 2015/863) · Regulation (EC) 1907/2006
• Scope: Electrical and electronic equipment (EEE) only · All articles placed on the EU market
• What it controls: 10 fixed restricted substances · Substances of Very High Concern + Annex XVII restrictions + substance registration
• Style: Hard concentration limits per homogeneous material · Layered duties: communicate, notify, restrict
• Proof of compliance: Technical documentation, EU Declaration of Conformity, CE mark · Supplier declarations, test reports, SCIP dossier where triggered
• Assessment: Self-certification, no notified body · Supplier data review plus importer responsibility
• Who carries the duty: The EU importer (manufacturer obligations apply to the importer of record) · The EU importer for articles

The overlap matters too. Lead appears in both regimes, and a substance can sit on the REACH Candidate List while also being restricted under RoHS. The classic example is DEHP: a Candidate List SVHC, restricted under REACH Annex XVII entry 51 in children's articles, and one of the four phthalates RoHS restricts in electronics. Satisfying one regime never automatically satisfies the other.

RoHS: the ten-substance rule for electronics

RoHS applies only to electrical and electronic equipment, across eleven defined product categories from large household appliances to automatic dispensers. The regulation names ten substances and sets maximum concentration values measured per homogeneous material, meaning each uniform component (a wire, a solder joint, a plastic housing) is tested individually rather than averaging across the whole device.

Substance · Maximum concentration (homogeneous material)

• Lead (Pb): 0.1% (1,000 ppm)
• Mercury (Hg): 0.1%
• Cadmium (Cd): 0.01% (100 ppm)
• Hexavalent chromium (Cr VI): 0.1%
• Polybrominated biphenyls (PBB): 0.1%
• Polybrominated diphenyl ethers (PBDE): 0.1%
• Bis(2-ethylhexyl) phthalate (DEHP): 0.1%
• Butyl benzyl phthalate (BBP): 0.1%
• Dibutyl phthalate (DBP): 0.1%
• Diisobutyl phthalate (DIBP): 0.1%

The first six date to the original RoHS framework; the four phthalates were added by Delegated Directive 2015/863, applicable from 2019. Cadmium is the strict one at a tenth of the others' limit, and solder, the most common failure point in China-sourced electronics, is where lead overruns typically show up.

Several categories of equipment are excluded outright: equipment for essential security interests, equipment designed to be sent into space, large-scale stationary industrial tools and fixed installations, means of transport, non-road mobile machinery for professional use, active implantable medical devices, photovoltaic panels installed permanently by professionals, and equipment made solely for research and development. Batteries and accumulators inside equipment are not RoHS territory at all; they sit under the EU Batteries Regulation, which carries its own mercury, cadmium, and lead limits.

RoHS compliance runs through self-certification. There is no notified body, no mandatory third-party lab. The manufacturer (or the EU importer acting in that role) carries out internal production control, compiles technical documentation, draws up an EU Declaration of Conformity, affixes the CE mark, and keeps the documentation for ten years after the last unit is placed on the market. Every product needs a type, batch, or serial number plus the importer's name and address. Our CE marking guide covers the mechanics of that declaration process; the point here is that RoHS is one of the CE directives, and a CE mark on electronics without an RoHS assessment behind it is a broken promise.

The RoHS exemptions list, and why it expires

Some restricted-substance uses have no workable substitute yet, so the directive grants time-limited exemptions. Annex III lists general exemptions: lead in high melting temperature type solders, lead in certain glass and ceramic components, lead as an alloying element in steel, aluminium, and copper, and mercury in specific lamp applications. Annex IV covers exemptions specific to medical devices and monitoring and control instruments.

Two things about exemptions trip up importers. First, they are temporary. General exemptions run for a maximum of five years, medical and monitoring equipment get up to seven, and they have to be renewed by application. Several lead exemptions were renewed with revised wording in 2025, and the Commission continues reviewing the list. Second, an exemption is never a blanket permission. If your product relies on one, your technical documentation should name the specific exemption and its expiry, and your supplier's declaration should say the same. When an exemption lapses and the supply chain keeps shipping as before, the product quietly goes out of compliance while every document in the folder still looks fine.

REACH: the four duties that actually hit importers

REACH is enormous as a regulation. For an importer of articles (finished goods, as opposed to chemicals or mixtures), it distills to four practical obligations.

1. Check Annex XVII restrictions first. Annex XVII is a long table of substance-and-use combinations that are banned or restricted outright. The entries most commonly relevant to China-sourced consumer goods include entry 27 (nickel release from items with prolonged skin contact, 0.5 µg/cm² per week, 0.2 for piercing posts), entry 63 (lead in jewelry and hair accessories at 0.05 percent), entries 51 and 52 (phthalates in children's articles), entry 23 (cadmium in various uses), and entry 50 (polycyclic aromatic hydrocarbons in consumer articles). Unlike the SVHC list, these are hard restrictions: if your product falls in the entry, the limit applies, no notification workaround.

2. Communicate SVHCs under Article 33. If an article contains a Candidate List substance above 0.1 percent weight by weight, the supplier must give the recipient of the article enough information for safe use, including at minimum the substance name. This applies to every business customer down the chain with no tonnage threshold, and consumers get the same information on request, free of charge, within 45 days. This is not a ban: your product can contain an SVHC and be legal as long as the duty is fulfilled.

3. Notify ECHA under Article 7(2). A step up from communication: if the SVHC is above 0.1 percent w/w and the total amount in the articles you import exceeds one tonne per year, you must notify ECHA within six months of the substance's inclusion on the Candidate List.

4. Notify the SCIP database. Since 5 January 2021, suppliers of articles containing Candidate List substances above 0.1 percent w/w must submit information to ECHA's Substances of Concern in Products database, established under the Waste Framework Directive. The duty covers EU producers, importers, assemblers, and distributors; retailers who sell exclusively and directly to consumers are excluded. The responsibility belongs to the EU importer, though a contractual arrangement can let a supplier's foreign user submit the data on the importer's behalf.

Duty · Trigger · Timing

• Annex XVII restriction: Product matches a listed entry · Before placing on the market
• Article 33 communication: SVHC above 0.1% w/w in an article · At supply; 45 days for consumer requests
• Article 7(2) notification: SVHC above 0.1% + over 1 tonne/year · Within 6 months of list inclusion
• SCIP notification: SVHC above 0.1% w/w in an article · Since 5 January 2021, before market placement

The Candidate List is a moving target

The Candidate List is updated roughly twice a year, and it grows. As of the 4 February 2026 update, it contains 253 entries, with the most recent additions including n-hexane and a fluorinated bisphenol used as a process regulator. Some entries are groups of chemicals, so the actual number of affected substances is higher than the entry count.

For importers this creates a compliance rhythm that a one-time test report cannot satisfy. A REACH screening report dated last year was performed against last year's list. Products with long life cycles need periodic re-screening, and supplier declarations should always reference the Candidate List version or date they were checked against. A declaration that says "REACH compliant" with no date is not a working document. Inclusion on the list is also a warning of direction: Candidate List substances can be moved to the Authorisation List, after which continued use requires an authorisation that the importer of an article cannot realistically obtain. When a substance in your product appears on the Candidate List, the right question is not only whether you meet the 0.1 percent threshold today but whether you have a substitution plan.

Two upcoming developments are worth watching without overreacting. The EU's PFAS restriction proposal has been in the pipeline since early 2023 and, if adopted, would reshape fluorinated coatings, water repellents, and non-stick treatments across textiles and consumer goods. It is not in force. The microplastics restriction is in force since October 2023 and already affects intentionally added microplastics in products like rinse-off cosmetics and, on a longer phase-in, items such as synthetic sports turf infill. Neither should drive panic orders, but both should appear in your supplier questionnaire for affected categories.

Reading test reports and supplier declarations

This is where compliance usually fails in practice. The documents look right and say nothing.

A useful RoHS test report tests homogeneous materials individually. It should list each tested component, the method used (IEC 62321 is the standard series), the measured value or a result of "not detected" with the detection limit stated, and the limit applied. A single page declaring a finished product "RoHS compliant" with no material breakdown is a statement of opinion, not evidence. Common red flags: no lab name or accreditation mark on the report, a report issued to a different company than your supplier, a report that covers one model number while the shipment contains five variants, or a report older than your supplier's current bill of materials.

A REACH SVHC declaration should name the Candidate List date or version screened against and state, for each relevant substance group, either that none of the listed substances was detected above 0.1 percent or that specific substances were found and are communicated. "Passed REACH" without a list version is meaningless. The factory or OEM typically provides the RoHS declaration at component level and the REACH screening at finished-product level, and these should arrive as two separate documents. A single vague "compliance certificate" that lumps both together tends to collapse the first time a customs officer or a retailer's compliance team asks for the underlying test data.

Independent verification matters because China-side documentation varies. A test report is only as good as the sample that was tested, and pre-shipment inspection plus targeted lab testing on production samples closes the loop between the paperwork and the goods.

Whose job is compliance: the importer, the factory, or both

The legal answer is clear, and it surprises many first-time buyers. Under both RoHS and REACH, the obligations for products imported into the EU rest on the EU importer. The Chinese manufacturer has no REACH registration duty, no SCIP notification duty, and no CE declaration duty. A factory can help enormously by providing material declarations, full bills of materials, and genuine test reports, but it cannot do your compliance for you.

There is one formal exception worth knowing. REACH allows a non-EU manufacturer to appoint an Only Representative based in the EU, who takes over the importer's registration obligations for substances and mixtures. This matters if you import chemical substances or mixtures themselves. For articles, the finished-goods category nearly all sourcing buyers operate in, the Only Representative route does not change the picture: the importer remains responsible for SVHC duties, restrictions, and SCIP.

Practically, this means your supplier relationship has to be structured for compliance from the start. Ask for the full BOM with materials per component, require declarations dated against a specific Candidate List version, reserve the right to test production samples at an accredited lab of your choosing, and write the restricted-substance requirements into the purchase contract rather than leaving them as a verbal assurance. Our product certifications master list covers how these documents fit into the wider certification landscape across markets.

Your REACH and RoHS rulebook

Run every China-sourced product bound for the EU through this logic and most chemical compliance problems disappear.

If it has electronics, RoHS applies. Screen the ten substances at homogeneous-material level, check whether any used exemption is still in force, and fold the assessment into your CE declaration. No electronics means no RoHS.

Check Annex XVII before anything else. It is the only part of REACH that bans your product outright. Match your product category and materials against the relevant entries.

Treat 0.1 percent as your working line. Above it in an article, the SVHC communication duty triggers, the consumer 45-day clock starts, and SCIP notification follows. Build your BOM review so you know where you stand before the first shipment.

Date every declaration. A REACH declaration without a Candidate List version and a RoHS declaration without a material breakdown are filing cabinet filler. Require both, and re-screen when the list grows or the design changes.

Keep the importer in the picture. Certificates issued in the factory's name do not transfer obligations to you. The name on the declaration of conformity and the SCIP dossier is yours, which is exactly why the verification step has to be yours too.

For a first product in a regulated category, the sequence that works: define the restricted-substance requirements in the RFQ, verify supplier documents before tooling, test production samples, and file your SCIP notification before the goods reach the market. If you want that chain handled by people who do it every week, write to hi@cnally.com.

Frequently asked questions

Do my non-electronic products need RoHS?

No. RoHS covers electrical and electronic equipment only. A wooden toy, a cotton bag, or a ceramic vase with no electrical function has no RoHS obligation, though REACH still applies to all of them.

Does a REACH test report also prove RoHS compliance?

No, and this is one of the most common document traps. A REACH SVHC screening tests for a different substance set at different thresholds than RoHS, and RoHS requires per-homogeneous-material testing against its own ten-substance list. Ask for both documents separately.

What does "SVHC-free to the latest Candidate List" mean?

It should mean the product was screened against the most recent Candidate List version published by ECHA (253 entries as of February 2026) and no listed substance was found above 0.1 percent. The phrase is only trustworthy if the declaration states the list date it refers to.

How often do I need to retest?

At minimum when something changes: a new supplier, a reformulated material, a design revision, or a new Candidate List entry relevant to your product. For long-running products, periodic re-screening against the current list is the standard practice.

Can my Chinese supplier file the SCIP notification for me?

Not on their own authority. The SCIP duty belongs to the EU importer. A contractual arrangement can let the supplier submit the dossier as a foreign user in ECHA's tools, but the responsibility for the notification and its content stays with you.