A supplier says an MBS or ACR impact modifier, or a modified PC/ABS compound, is ‘REACH and RoHS compliant.’ What evidence should the buyer check before approving the exact material for an EU application?
Treat the claim as a dated, product-specific conclusion—not a permanent certificate. First identify the exact grade, color, formulation revision, producer, manufacturing site and intended EU use. For REACH, distinguish Candidate List communication duties, Annex XVII restrictions and any other obligation that actually applies; record the Candidate List date used. For RoHS, confirm that the end product is in scope, review the ten restricted substances and any applicable exemption, and assess each homogeneous material rather than averaging the whole assembly. Build technical documentation from supplier declarations, material knowledge and risk-based test reports. If testing is needed, specify the relevant IEC 62321 method and use a laboratory whose ISO/IEC 17025 accreditation scope covers that method and matrix. The EU importer or finished-product manufacturer must make the final legal determination for the exact product and market.
Information that changes the recommendation
- Exact product name, complete grade and color code, formulation or document revision, lot, producer legal entity and manufacturing-site address
- Material role: neat MBS or acrylic impact modifier, masterbatch, modified PC/ABS compound, molded homogeneous plastic or finished electrical/electronic equipment
- Destination country, intended use, date placed on the market, customer specification and whether the finished product is within RoHS scope
- Signed declaration identifying the applicable law, substance list or amendment, Candidate List cut-off date, exclusions, exemptions and authorized signatory
- Full formulation risk map covering resin, impact modifier, flame retardant, pigment, stabilizer, lubricant, filler, recycled content and packaging or assembly materials where relevant
- Evidence route for each risk: controlled supplier information, substance or material declaration, safety data, analytical report or finished-product technical documentation
- Test report sample identity, sampling location, preparation, method edition, analytes, reporting limits, units, uncertainty or decision rule and pass/fail basis
- Laboratory identity and current ISO/IEC 17025 accreditation scope for the named IEC 62321 method and polymer matrix
- China manufacturer or source-factory identity, sample-to-order traceability, change notification and quotation tied to the exact compliant grade, quantity, Incoterm and validity date
Separate REACH questions before collecting documents. ECHA explains that Candidate List inclusion can trigger immediate duties for substances on their own, in mixtures and in articles. For an article containing a Candidate List substance above 0.1% weight by weight, Article 33 communication duties can apply; other notification conditions and the SCIP duty must be assessed by the responsible EU or EEA actor. Annex XVII is a separate set of restrictions on substances on their own, in mixtures or in articles. A supplier statement should therefore name the exact product, covered legal provisions and authentic Candidate List date. The phrase ‘REACH certified’ does not by itself show which duty was evaluated.
Keep RoHS at the finished-product and homogeneous-material level. The European Commission describes RoHS as restricting ten substances in electrical and electronic equipment. Directive 2011/65/EU and Delegated Directive (EU) 2015/863 set maximum concentration values by weight in homogeneous materials: 0.1% for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP, and 0.01% for cadmium, subject to scope and applicable exemptions. A plastic housing or compound may be one homogeneous material, but a declaration for its base resin does not automatically cover its pigment, flame retardant, modifier, coating, label, fastener or the finished equipment.
Build evidence by risk rather than ordering the same test for every grade. IEC 63000 specifies technical documentation that an electrical or electronic product manufacturer compiles to declare compliance with applicable substance restrictions. Start with bill-of-material and formulation knowledge, supplier controls and declarations; identify substances or ingredients with plausible risk, document why evidence is sufficient, and test where information is incomplete, inconsistent, high-risk or required by the customer. A laboratory report is one input to the technical file, not a substitute for product identity, scope, supplier change control or the manufacturer's conformity assessment.
Choose the analytical method for the analyte and decision. IEC 62321-3-1:2026 describes XRF screening for elements including lead, mercury, cadmium, total chromium and total bromine in uniform materials. Screening total chromium cannot by itself identify hexavalent chromium, and total bromine cannot identify PBB or PBDE, so an inconclusive or elevated screen may need the appropriate confirmatory method. For polymeric materials, IEC 62321-12:2023 provides a reference GC-MS method for simultaneous determination of PBB, PBDE and the four RoHS phthalates. State the method edition, sample preparation and decision rule instead of requesting a generic ‘RoHS test.’
Check whether the report can be traced to the purchased material. The report should identify the sample by full grade, color, lot or other unique code and show who sampled it and from where. Confirm the laboratory's current accreditation scope rather than accepting an ISO/IEC 17025 logo alone; ISO describes the standard as requirements for laboratory competence, impartiality and consistent operation, but the scope must cover the relevant method and activity. Compare the reporting limit with the legal or contractual limit and review measurement uncertainty and the agreed decision rule when results approach a threshold.
Control changes after approval. Require advance notice for changes to raw materials, recycled-content source, pigment, flame-retardant package, stabilizer, manufacturing site, process or compliance status. Set a review trigger when ECHA updates the Candidate List, REACH Annex XVII changes, a RoHS exemption changes, the formulation changes or a report expires under the buyer's policy. Retain declarations, test reports, bills of material, supplier confirmations, approved samples and review records under one exact-grade revision. Reconfirm obligations for the destination and date rather than copying an old declaration to a new market.
For a Chinese manufacturer or source factory, verify the legal producer and the site covered by the declaration and report. Tie the approved sample, TDS, SDS, compliance declaration, test sample, COA, bag label and purchase order to the same controlled grade and revision. A China factory-gate price does not prove compliance and should be quoted only with exact grade, quantity, package, Incoterm, named place and validity. Compliance documents, price, capacity and lead time must be reconfirmed for the actual batch and transaction; this article is a verification framework, not legal advice or approval of any grade.
Step-by-step evaluation
- 01Define the EU destination, finished-product category, customer requirements and responsible importer or manufacturer before asking the material supplier for evidence.
- 02Freeze the exact grade, color, formulation revision, production site and lot identity; map every ingredient or homogeneous material that the claim must cover.
- 03Issue a compliance questionnaire that separately asks about the current REACH Candidate List, Annex XVII restrictions, RoHS Annex II substances, exemptions and document dates.
- 04Review supplier declarations and technical documentation against the exact product identity; reject unsigned, undated, family-level or scope-free statements.
- 05Perform a documented risk assessment and select IEC 62321 screening or confirmatory methods only for unresolved or contractually required risks.
- 06Verify the laboratory's current ISO/IEC 17025 scope, sample traceability, method edition, reporting limits, uncertainty and decision rule before accepting the report.
- 07Approve with change-notification and periodic legal-list review triggers, then repeat the assessment whenever the formula, site, source, destination or applicable requirements change.
What to record before approval
- Record the Candidate List publication date or version in every REACH declaration; ‘latest list’ becomes ambiguous after the next update.
- Do not average a restricted substance across a finished assembly: RoHS concentration limits apply at homogeneous-material level, subject to scope and exemptions.
- Do not treat an XRF screen for total bromine or total chromium as automatic proof for PBB/PBDE or hexavalent chromium; use the method chain appropriate to the result.
- Check that the tested sample matches the purchased grade, color, formulation revision and production source; a report for a natural resin or another color may not cover the order.
- Have qualified EU regulatory counsel or the responsible economic operator confirm borderline scope, exemptions, article definitions, notification duties and market-specific obligations.
Primary sources and official test methods
- European CommissionRoHS Directive — scope and ten restricted substances
- EUR-LexDirective 2011/65/EU on restriction of hazardous substances in EEE
- EUR-LexDelegated Directive (EU) 2015/863 — four RoHS phthalates and concentration limits
- European Chemicals AgencyCandidate List obligations under REACH
- European Chemicals AgencySubstances restricted under REACH — Annex XVII table
- IECIEC 63000:2016 — technical documentation for hazardous-substance restrictions
- IECIEC 62321-3-1:2026 — XRF screening of uniform materials
- IECIEC 62321-12:2023 — PBB, PBDE and phthalates in polymers by GC-MS
- ISOISO/IEC 17025:2017 — competence of testing and calibration laboratories