REACH, RoHS and Chemical Compliance for EU Products

REACH, RoHS and Chemical Compliance for EU Products: A Practical Guide for Chinese Brands

Your Bluetooth headphones passed CE testing. Your EU Responsible Person signed the mandate. Your container is on a ship to Hamburg. Then your compliance consultant sends a message: "Do you have a REACH SVHC declaration for the plastic housing? And does the solder on your PCB meet RoHS 3?"

You ask your factory in Dongguan what REACH means. They send a test report from 2019 that says "lead content within limits." You ask whether the report covers the new SVHC list. Silence. You search "REACH compliance China" and find 1,200 pages of EU legal text, 235 substances on the SVHC candidate list, and a RoHS directive updated in 2015 to include four new phthalates nobody mentioned.

REACH and RoHS are the chemical compliance layer that sits underneath CE marking. CE testing verifies electrical safety and performance. REACH and RoHS verify that the materials inside your product — plastic, paint, solder, battery chemistry, textile dyes — do not contain substances the EU has restricted, banned, or placed under reporting obligations. Get this wrong and your product is non-compliant even with a valid CE certificate. Marketplaces know this. Customs knows this. And market surveillance authorities are getting better at catching it.

Here is what REACH and RoHS require, which substances matter most for Chinese manufacturers, what documentation you need, and how to avoid the most common — and expensive — chemical compliance failures.

What REACH Is and Why It Exists

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is the EU's chemical regulation framework, adopted in 2007 and managed by the European Chemicals Agency (ECHA) in Helsinki. REACH applies to virtually every product placed on the EU market — electronics, textiles, toys, furniture, jewellery, cosmetics, kitchenware, sports equipment. If your product contains any chemical substance (and every physical product does), REACH applies.

The core idea: the manufacturer or importer is responsible for demonstrating that the chemicals in their product are safe for human health and the environment. The burden of proof sits with the company placing the product on the market.

For Chinese brands selling in the EU, REACH matters because it creates three layers of obligation:

• Restrictions (Annex XVII): Certain substances are banned or limited above specific concentration thresholds in products. If your product contains a restricted substance above the limit, it cannot be sold in the EU. Period.
• SVHC Candidate List: Substances of Very High Concern are published on a list that ECHA updates approximately every six months. As of late 2025, the list contains 235+ substances. If your product contains an SVHC above 0.1% by weight, you must provide sufficient information to your customers — and in many cases to consumers — to allow safe use.
• Authorisation (Annex XIV): Some SVHCs are moved to the authorisation list, meaning they can only be used if the company obtains specific authorisation from the European Commission. This is rare for consumer products but relevant for industrial applications.

The SVHC list grows. Every six months, ECHA evaluates new substances and adds them. A product that was compliant in January may need a new declaration in July. This is why REACH compliance is not a one-time test — it is an ongoing monitoring obligation.

What RoHS Is and How It Differs from REACH

RoHS stands for Restriction of Hazardous Substances. It is a specific EU directive (2011/65/EU, amended by 2015/863 — "RoHS 3") that restricts ten hazardous substances in electrical and electronic equipment (EEE). Where REACH covers all products, RoHS applies specifically to electronics.

If your product needs a power source — battery, plug, solar panel, USB cable — or contains any electronic component, RoHS applies. That includes Bluetooth speakers, smart watches, LED lamps, electric toothbrushes, drone motors, USB cables, wireless chargers, and anything with a circuit board.

The ten restricted substances under RoHS 3 and their maximum concentration limits:

• Lead (Pb) — 0.1% (1000 ppm)
• Cadmium (Cd) — 0.01% (100 ppm)
• Mercury (Hg) — 0.1% (1000 ppm)
• Hexavalent chromium (Cr6+) — 0.1% (1000 ppm)
• Polybrominated biphenyls (PBB) — 0.1% (1000 ppm)
• Polybrominated diphenyl ethers (PBDE) — 0.1% (1000 ppm)
• Bis(2-ethylhexyl) phthalate (DEHP) — 0.1% (1000 ppm)
• Butyl benzyl phthalate (BBP) — 0.1% (1000 ppm)
• Dibutyl phthalate (DBP) — 0.1% (1000 ppm)
• Diisobutyl phthalate (DIBP) — 0.1% (1000 ppm)

The first six were in the original RoHS directive. The last four phthalates were added in 2015 and became mandatory in 2019. Many Chinese factories still reference "RoHS 2" test reports that predate the phthalate additions. Those reports are no longer sufficient for EU compliance.

The Substances That Catch Chinese Brands

Most chemical compliance failures for Chinese brands come from a short list of materials common in Chinese manufacturing but restricted under EU rules. Here are the ones that cause the most problems:

Lead in solder and metal alloys

Lead-based solder is still widely used in Chinese electronics manufacturing — cheaper and easier to work with than lead-free alternatives. But lead is restricted under both RoHS (0.1%) and REACH Annex XVII (0.05% in jewellery, in toys, in food-contact materials). A factory that switches to leaded solder to save €0.03 per unit can make an entire production batch non-compliant.

Phthalates in plastics

Phthalates are plasticisers used to make PVC and other plastics soft and flexible — found in cable insulation, vinyl pouches, phone cases, toy parts, and flexible packaging. Four phthalates (DEHP, BBP, DBP, DIBP) are restricted under RoHS for electronics and under REACH Annex XVII in toys and childcare articles at 0.1%. Chinese factories routinely use phthalate-based plasticisers because they are inexpensive and perform well. The alternatives cost more and have different processing characteristics.

Cadmium in pigments and batteries

Cadmium is used in red and yellow pigments for plastics and ceramics, in nickel-cadmium batteries, and in metal plating. REACH Annex XVII restricts cadmium in jewellery, plastics, and paints at 0.01%. RoHS restricts it at 0.01% in electronics. Cadmium pigments are still common in Chinese plastics manufacturing, particularly for low-cost consumer goods.

Nickel in metal trim

Nickel is restricted under REACH Annex XVII in products intended for prolonged skin contact — jewellery, watch cases, belt buckles, eyewear frames, clothing fasteners. The restriction limits nickel release rates, not just nickel content. Many Chinese metal suppliers use nickel-containing alloys that release nickel above the permitted rate, particularly in low-cost jewellery and watch accessories.

Formaldehyde and azo dyes in textiles

Formaldehyde is used in textile finishes, adhesives in composite wood products, and leather tanning. REACH restricts formaldehyde in textiles at specific limits (30 ppm for baby products, 300 ppm for direct skin contact, 75 ppm for interior textiles). Chinese textile factories routinely use formaldehyde-based resins for wrinkle-free finishes — a cost-effective solution that can exceed EU limits.

Certain azo dyes — used extensively in Chinese textile manufacturing — can break down into carcinogenic aromatic amines. REACH Annex XVII bans 24 specific azo dyes in textiles and leather articles that contact human skin. Testing for azo dyes is mandatory for textile products in the EU, and failures are one of the most common reasons for RAPEX notifications.

The Compliance Documentation You Need

REACH and RoHS compliance is documented through test reports and declarations. Here is what you need before your products enter the EU market:

RoHS test report

A RoHS test report is issued by an accredited laboratory that analyses your product's components for the ten restricted substances. The report must cover RoHS 3 — including the four phthalates added in 2015. The lab disassembles the product, identifies homogeneous materials, and tests each material using XRF screening followed by chemical confirmation. A valid RoHS test report includes: product description and photos, bill of materials with component breakdown, test method references (IEC 62321 series), per-material results for all ten substances, pass/fail determination, lab accreditation (ISO 17025), and issue date.

RoHS test reports do not expire officially, but marketplaces and surveillance authorities typically expect reports no older than 2-3 years, particularly if the SVHC list has been updated since the report was issued.

REACH SVHC declaration

A REACH SVHC declaration is a statement from the manufacturer (or importer) confirming whether the product contains any SVHC above 0.1% by weight. It can be a declaration based on material information from suppliers and testing. But if you claim "no SVHC above 0.1%," you need evidence to back it up.

The SVHC list is updated approximately every six months. Each update can add new substances. A declaration made in January may be outdated by July. You need a process for reviewing the updated list against your product's material composition.

REACH Annex XVII compliance statement

Separate from the SVHC declaration, you need to verify that your product does not contain any Annex XVII restricted substances above their limits. This covers lead in jewellery, cadmium in pigments, nickel release in metal trim, azo dyes in textiles, phthalates in toys, formaldehyde in textiles, and dozens of other restrictions.

The compliance statement is typically a self-declaration supported by test reports for the relevant restricted substances. For textiles, this means azo dye testing, formaldehyde testing, and any applicable flame retardant testing. For electronics, it means RoHS testing plus any additional REACH-restricted substances not covered by RoHS.

DoC — Declaration of Conformity

For products with CE marking, the EU Declaration of Conformity must list all applicable directives and regulations. For electronics, this includes the RoHS Directive alongside the EMC Directive, Low Voltage Directive, and RED (Radio Equipment Directive). REACH is a regulation, not a directive, so it does not appear on the DoC — but compliance is still legally required, and non-compliance can invalidate the CE marking.

How to Get Testing Done

Testing should be done by an ISO 17025-accredited laboratory. For Chinese brands manufacturing in China, testing in China before export is the best option — cheaper, faster, and catches problems before the product leaves the factory. International labs like SGS, TÜV, Intertek, and Bureau Veritas have accredited labs in Shenzhen, Shanghai, Guangzhou, and Ningbo. A full RoHS 3 test costs €300-€800 depending on component count, with 5-10 working day turnaround.

If your product has already shipped, European labs can test it — but costs are higher (€500-€1,500) and turnaround is 10-15 working days. The risk is that your product is already in a warehouse and listed on marketplaces while you wait.

The best practice is to test at the pre-production stage — when you can still change materials — and again at the production stage. Factories sometimes substitute materials between sampling and mass production. A production-batch test catches that.

Common Compliance Failures and How to Avoid Them

Using outdated RoHS reports

A factory sends a RoHS 2 test report from 2018. It tests for six substances, not ten. The four phthalates added in RoHS 3 are missing. When Amazon or a surveillance authority asks for current compliance documentation, the report is invalid. Request a RoHS 3 (2011/65/EU + 2015/863) test report from an ISO 17025-accredited lab. If the factory pushes back, explain that the phthalate requirement has been mandatory since July 2019.

Confusing REACH SVHC with REACH Annex XVII

A brand obtains a REACH SVHC declaration but not an Annex XVII compliance statement. They believe they are "REACH compliant." Then a surveillance authority tests the product and finds cadmium in a plastic component at 0.03% — above the Annex XVII limit of 0.01%. The product is recalled. The SVHC declaration was never going to catch this because cadmium in plastics is restricted under Annex XVII, not the SVHC list. You need both: an SVHC declaration for the candidate list and an Annex XVII compliance statement for the restrictions.

Not re-checking after SVHC list updates

A brand does REACH SVHC testing in January. ECHA adds three new substances to the SVHC list in June. The brand does not review the update. One of the new substances is a plasticiser used in the product's cable insulation. When a marketplace requests an updated declaration, the brand cannot provide one. The listing is suspended. Subscribe to ECHA's SVHC update notifications (free) and review each update against your product's bill of materials. If a new substance is relevant, update your declaration — and if needed, re-test.

Trusting supplier declarations without verification

A factory provides a "REACH compliance certificate" that turns out to be a self-declaration with no test data. The brand accepts it and lists the product. A surveillance authority tests the product and finds restricted phthalates. The brand is liable — not the factory. Under EU law, the company placing the product on the market is responsible. Always verify with an independent test report from an accredited lab, particularly for the first production batch.

Missing nickel release testing for metal products

A Chinese brand sells stainless steel watch bands on Amazon Europe. The steel alloy contains nickel. The product passes a material composition test, but nobody tests for nickel release rate — which is what REACH Annex XVII actually restricts. A consumer develops a skin reaction, reports it, and the product is flagged for recall. Nickel release testing (EN 1811 for prolonged skin contact, EN 12472 for coated items) is specific and must be requested explicitly from the lab.

How Marketplaces Enforce Chemical Compliance

Amazon, bol.com, Otto, and other EU marketplaces enforce chemical compliance in two stages. First, document requests at listing time — when you create an electronic product listing, Amazon may request a RoHS declaration or test report. For higher-risk categories (toys, jewellery, cosmetics, textiles), REACH compliance documentation may also be required. If you cannot provide it, the listing is not approved.

Second, market surveillance alerts. EU authorities conduct product checks at customs and online. When they find a non-compliant product, they issue a RAPEX notification. Marketplaces monitor RAPEX and will suspend or remove flagged listings. A RAPEX notification is public — it appears on the EU's Safety Gate website, visible to regulators, competitors, and consumers. In 2024, approximately 60% of all RAPEX alerts involved products manufactured in China, with chemical risks (lead, cadmium, phthalates, nickel) being one of the top three violation categories alongside electrical safety and choking hazards.

The Cost of Non-Compliance

Chemical compliance failures are expensive in ways that go beyond the immediate product recall:

• Product recall: You must withdraw the product from the market — across all EU countries, not just the one where the violation was found. For a product sold across five Amazon marketplaces, that means removing five listings, recalling inventory from five FBA warehouses, and potentially destroying non-compliant stock.
• Customs holds: If customs authorities identify a chemical compliance risk during import inspection, they can hold the entire container. Each day of delay costs warehousing and demurrage fees. If the product is non-compliant, the shipment is refused entry and must be re-exported or destroyed — at the importer's cost.
• Marketplace account risk: Repeated compliance violations can lead to marketplace account suspension. Amazon's product compliance policy links violations to account health metrics. Multiple violations can trigger a full account review, blocking all your listings.
• Reputational damage: A RAPEX notification is public and permanent. It appears in search results for your brand name. Distributors and retail partners check RAPEX. A single notification can make a European distributor refuse to stock your products.

Compare this to the cost of compliance: a full RoHS 3 test report (€300-€800), a REACH SVHC declaration (€200-€500 for testing or €0 for a self-declaration backed by supplier data), and a REACH Annex XVII test for relevant substances (€200-€600). Total chemical compliance testing for a typical consumer product: €700-€1,900 — less than the cost of a single customs hold.

REACH and RoHS Compliance Checklist

Before your product enters the EU market, confirm the following:

• ✅ RoHS 3 test report from an ISO 17025-accredited lab covering all ten restricted substances
• ✅ REACH SVHC declaration based on the current candidate list (check the latest update date)
• ✅ REACH Annex XVII compliance statement covering product-specific restricted substances
• ✅ Nickel release testing if the product has metal components in skin contact (EN 1811 / EN 12472)
• ✅ Azo dye testing if the product contains textiles or leather (EN 14362-1)
• ✅ Formaldehyde testing if the product contains textiles or composite wood (EN ISO 14184-1)
• ✅ Lead and cadmium testing if the product is jewellery, a toy, or food-contact material
• ✅ Supplier declarations backed by test reports for raw materials and components
• ✅ A process for reviewing SVHC list updates every six months
• ✅ All compliance documentation available in English for EU authorities and marketplaces

How FiveX Helps with Chemical Compliance

REACH and RoHS compliance is one of the most overlooked areas in EU market entry. Most Chinese brands focus on CE marking and assume chemical compliance is included. It is not — CE testing and chemical compliance testing are separate processes with separate documentation.

FiveX's Go-to-Market program includes chemical compliance as part of the pre-launch compliance package. We identify which REACH and RoHS requirements apply to your product, coordinate testing with accredited labs in China, review factory test reports for completeness, and build the SVHC monitoring process into your compliance calendar. We also ensure your marketplace listings carry the right compliance documentation before they go live.

Chemical compliance is not the most exciting part of entering the EU market. But it is one of the most common reasons products get pulled from shelves, flagged in RAPEX, or blocked at customs. Getting it right costs less than €2,000 in testing fees. Getting it wrong can cost your entire European launch.

If you are planning to sell in the EU and have not yet addressed REACH and RoHS compliance — or if you are already selling and want to verify your documentation is current — book a Go-to-Market meeting with our team. We will review your product, identify which tests you need, and get you compliant before your next shipment leaves China.