Chemical Testing for EU Compliance: REACH, RoHS, and POPs Explained
EU chemical compliance sits on three pillars: REACH Regulation (EC) No 1907/2006, RoHS Directive 2011/65/EU, and POPs Regulation (EU) 2019/1021. They overlap, but they serve different purposes. This guide explains what each law requires, when testing is needed, how to scope a risk-based plan, and which documents authorities and marketplaces expect before you ship. For practical scoping or a quick gap review, you can always contact us.
1. Know Your Legal Scope: REACH, RoHS, POPs
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REACH governs chemicals across the board. For finished goods, two areas matter most: the SVHC Candidate List duties at or above 0.1 percent weight by weight per article and the Annex XVII restrictions that ban or limit specific substances in defined uses. If an SVHC is present at or above 0.1 percent in any component article, Article 33 communication applies and you may also need a SCIP notification under EU waste rules.
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RoHS applies to electrical and electronic equipment (EEE). It sets homogeneous-material limits for lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, and four phthalates. Technical documentation should follow a due-diligence approach per EN IEC 63000, combining supplier evidence, screening, and targeted testing.
- POPs bans or restricts persistent organic pollutants in substances, mixtures, and articles. Always check the annexes of the regulation for listed substances and their concentration thresholds before entering the EU market.
Placing a product on the EU market requires more than just testing. A structured approach helps ensure legal compliance, from traceability and technical documentation to labeling and marketplace readiness. To help with this, we’ve created a practical overview of the full process. View the guide here: Launching a New Product in the EU (2025 Edition).
2. Decide When Testing Is Needed
Testing is one of the most valuable tools in compliance because it provides independent, third-party confirmation that your product meets legal safety requirements. Commission laboratory tests when risk or uncertainty remains after supplier review, or when new or amended EU limits affect your materials. Typical triggers include soft PVC or elastomers where phthalates or PAHs are plausible, recycled black plastics where brominated flame retardants are plausible, skin-contact textiles with coated prints, or EEE where RoHS metals and restricted phthalates must be verified. The higher the risk category of the product, the more testing is recommended (for example, toys, food contact materials, and electrical equipment are subject to stricter expectations due to their potential safety impacts).
3. Build a Risk-Based Test Plan
Map the bill of materials, finishes, and contact types. Select worst-case variants by material, thickness, colorant, and surface treatment so one report set can justify coverage for a family of SKUs. Align analyses with legal duties: SVHC screening and Annex XVII targets for REACH, Annex II limits for RoHS, listed POPs where relevant. Learn more in our risk analysis guide.
4. Choose Methods That Match the Risk
Use screening first, confirmation second. XRF is efficient for RoHS metals and halogen flags at the homogeneous-material level. Confirm with ICP-MS or ICP-OES for metals, GC-MS or LC-MS for organics such as phthalates, PAHs, or flame retardants. For coated textiles, adhesives, and inks, ensure extraction conditions fit the matrix and the legal limit.
5. Sampling, Identification, and Chain of Custody
Record the sampling plan, who selected samples, and the lot or production date. Tie photos and part IDs to the tested pieces so results match what you sell. Keep a clean trail in the technical file, including supplier declarations, version control, and any deviations or retests.
6. REACH Essentials: SVHC, Annex XVII, SCIP
Check the Candidate List on each update, then refresh supplier declarations and screening as needed. If any component article in a complex product contains an SVHC at or above 0.1 percent weight by weight, inform professional recipients, provide consumers with information on request within 45 days, and evaluate SCIP duties. For restrictions, verify scope and limits in Annex XVII. Consider newer measures such as the microplastics restriction in Regulation (EU) 2023/2055 where relevant.
7. RoHS Due Diligence and EN IEC 63000
For EEE, build a documentation file that reflects EN IEC 63000: supplier material data, risk screening, targeted confirmations, and rationale for what you did not test. Limits apply in homogeneous materials, not whole products. When ready, prepare your EU Declaration of Conformity referencing Directive 2011/65/EU and any applicable exemptions.
8. POPs Checks
Review the POPs annexes for listed substances such as certain PBDEs and SCCPs. If a listed POP is present above its concentration limit in a substance, mixture, or article, the product cannot be placed on the market unless a specific derogation applies. Test recycled streams and black plastics carefully.
9. Keep Compliance Alive After Launch
Update the file when suppliers or formulations change, track ECHA updates, and monitor incident reports. If a safety risk emerges, products may need to be withdrawn or notified through the EU Safety Gate. For electrical products, maintain up-to-date registrations under the WEEE system. For products sold in Germany, make sure to register with the LUCID Packaging Register (for all consumer packaging) and keep your registration up to date as required under the German Packaging Act (VerpackG). Product labelling must also remain compliant with EU rules at all times (see our full guide to labelling requirements for GPSR compliance). These are legal obligations separate from product safety, but they are enforced with equal scrutiny and should be part of your ongoing compliance routine.
Frequently Asked Questions
What chemical safety laws apply in the EU?
For most non-food consumer products, the key chemical regulations are REACH, RoHS (for electrical goods), and POPs. These laws limit or prohibit certain hazardous substances in products placed on the EU market.
Do I need to test every product for chemicals?
No. Testing should be based on material risk. If you use soft plastics, recycled materials, coatings, adhesives, or electronic components, you may need testing to confirm compliance with REACH, RoHS, or POPs. We offer risk-based test planning tailored to your product and materials.
What are REACH SVHC and Annex XVII requirements?
Under REACH, you must track Substances of Very High Concern (SVHCs) if any component contains one at ≥0.1% w/w. You must also check Annex XVII for restricted substances and uses. If an SVHC is present above the threshold, a SCIP notification may be required.
When does RoHS apply and what are the limits?
RoHS applies to electrical and electronic equipment sold in the EU. It restricts substances such as lead, mercury, cadmium, chromium VI, and certain flame retardants and phthalates. RoHS testing must be done on homogeneous materials. The full limits are listed in Directive 2011/65/EU.
How do I document RoHS compliance properly?
Use the EN IEC 63000 standard. This means collecting supplier declarations, screening data, and test results. The file should link directly to your product identity and be supported by a signed Declaration of Conformity. We can help you structure the file for audit readiness.
What should a chemical test report include?
Request ISO/IEC 17025 reports. These must show methods, limits, results with units, dates, authorisation, model identification, and measurement uncertainty if applicable. Clear photos and label references help tie the report to your Declaration of Conformity.
Do I need Safety Data Sheets (SDS)?
Yes, if your product includes substances or mixtures such as coatings, inks, adhesives, batteries, or textile finishes. SDS (previously MSDS) must follow the 16-section EU format and support your risk analysis. These are part of the technical file.
What happens if I don't meet chemical safety rules?
Products may be blocked at customs, removed from online platforms, or subject to recalls. Fines or bans may apply for violations. To avoid these issues, ensure your documentation is complete and up to date. We can help you identify and close compliance gaps.