Guide
REACH SVHC and RoHS: Substance Compliance for EU Consumer Goods
Two EU substance regimes apply across virtually every consumer product placed on the EU market. REACH (Regulation (EC) 1907/2006) restricts hundreds of substances via Annex XVII, requires authorisation for high-concern uses (Annex XIV) and obliges Article 33 communication when an article contains a Substance of Very High Concern (SVHC) on the candidate list above 0.1% (w/w). The SCIP database (Article 9(1)(i) of the Waste Framework Directive) requires SVHC notification for any article placed on the EU market. RoHS (Directive 2011/65/EU) restricts ten substances in electrical and electronic equipment (EEE). Both regimes update continuously — the SVHC candidate list grows twice a year, RoHS exemptions expire and renew on a rolling basis. This guide is written for QA, regulatory and supply-chain leads at brands selling consumer goods into the EU.
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REACH Annex XVII: the restriction list
Annex XVII lists substances restricted by use — currently more than 70 entries covering specific substances (cadmium in plastics, lead in jewellery, formaldehyde in textiles, PFOA, microplastics intentionally added) and broad groups (CMR substances Category 1A/1B in articles supplied to the general public, restrictions on tattoo inks, restrictions on PAHs in rubber and plastic articles). Annex XVII restrictions are use-conditional — a substance may be permitted in one use and restricted in another at the same concentration. The recurring failure is treating Annex XVII as a static list rather than a moving target; entries are added or amended via Commission Regulation on a rolling basis and several major amendments are expected in 2026 (notably on intentionally added microplastics implementation and a new general restriction on PFAS in consumer textiles and footwear).
SVHC candidate list and the Article 33 duty
ECHA publishes the SVHC candidate list — substances identified as Substances of Very High Concern (CMR Category 1A/1B, PBT, vPvB, endocrine disruptors, equivalent level of concern). The list updates twice a year, in January and June. Article 33(1) requires any supplier of an article containing an SVHC above 0.1% (w/w) per article to communicate to industrial recipients sufficient information to allow safe use, including at minimum the name of the substance. Article 33(2) requires the same information to be provided to consumers on request within 45 days, free of charge. The CJEU's 2020 ruling on the 'once an article, always an article' (O5A) interpretation means the 0.1% threshold applies per component article, not per finished product — a small SVHC-containing component does not get diluted by the rest of the product. SVHC tracking against the live candidate list is now standard retailer-audit due diligence.
SCIP database notification
The SCIP database, established under Article 9(1)(i) of the Waste Framework Directive (EU) 2018/851, requires every supplier placing an article on the EU market containing an SVHC above 0.1% (w/w) to submit a notification to ECHA. The notification includes article identification, substance identification, location of the substance in the article, and safe-use information. The duty falls on each economic operator in the chain (manufacturer, importer, distributor) and is independent of the Article 33 communication duty — both apply. SCIP entries are publicly searchable and increasingly used by recyclers, market surveillance authorities and NGOs to identify non-compliant placements. Submission is via the ECHA IUCLID Cloud or System-to-System integration.
RoHS Directive 2011/65/EU: the 6+4 substances and exemptions
RoHS restricts the use in electrical and electronic equipment (EEE) of six original substances (lead, mercury, cadmium, hexavalent chromium, PBB, PBDE) plus four phthalates added in 2015 (DEHP, BBP, DBP, DIBP). Maximum concentration values apply at the homogeneous-material level: 0.1% for all except cadmium at 0.01%. The EEE scope is broad — any equipment dependent on electric currents or electromagnetic fields. Annex III lists time-limited exemptions (specific uses where no acceptable alternative exists); each exemption has its own expiry date and renewal process. The CE-marking technical file must include the RoHS Declaration of Conformity referencing harmonised standard EN IEC 63000. Brands selling consumer EEE (lighted toys, USB devices, Bluetooth accessories, small kitchen appliances) often miss that they sit under RoHS in addition to GPSR and any sector-specific directive.
Supplier declarations and the data-quality problem
Compliance with REACH SVHC, RoHS and Annex XVII is data-driven — the brand needs per-component substance information from every upstream supplier. The widely used industry exchange standards are IPC-1752A (Materials Declaration) and IEC 62474 (declaration for products of the electrotechnical industry). The recurring failure is accepting blanket 'compliance certificates' from suppliers that do not include the substance-level breakdown needed to defend the brand's own declaration. Best practice: require IPC-1752A Class C or higher (or IEC 62474 with full substance disclosure) at component qualification, re-collect annually, and re-collect on every SVHC candidate list update for any substance newly added that the supplier did not previously certify against.
A 75-day REACH/RoHS readiness path
Days 1–15: substance master refresh — sync current SVHC candidate list, Annex XVII restrictions and RoHS 6+4; cross-check against the bill of materials for every EU-placed SKU. Days 16–35: supplier declaration refresh on the top 100 components by usage; chase non-conformant suppliers. Days 36–55: O5A per-component SVHC analysis for the top 30 SKUs; Article 33 communication to industrial customers and consumer-request response procedure. Days 56–70: SCIP database notification submission for all in-scope articles; RoHS Declaration of Conformity refresh for EEE SKUs. Days 71–75: freeze baseline, prepare for the next bi-annual SVHC update.
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Frequently asked
Is the 0.1% SVHC threshold calculated on the finished product or each component?
Per component (article), following the CJEU's 'once an article, always an article' (O5A) interpretation of 2020. A small rubber gasket containing 0.5% of a candidate-list SVHC triggers Article 33 communication and SCIP notification even though the SVHC is well below 0.1% of the finished product mass. This was the largest single change in REACH practical compliance and many supply chains have not fully adjusted.
We are a US brand selling on Amazon EU. Do REACH and RoHS apply to us?
Both apply to any article placed on the EU market regardless of the brand's establishment. REACH duties fall on the EU importer (which under GPSR Article 4 is the responsible operator); Article 33 communication must be in place along the supply chain in the EU. RoHS applies if the product is EEE — and the EU Declaration of Conformity must be available. Amazon and other marketplaces enforce both as part of EU compliance programmes; missing DoCs and missing SCIP entries are common delisting triggers.
How does the EU PFAS restriction proposal interact with Annex XVII?
ECHA's 2023 PFAS restriction proposal (the 'universal PFAS restriction'), submitted by five Member States, would restrict the manufacture, placing on the market and use of approximately 10,000 PFAS substances in articles. ECHA's RAC and SEAC committees worked through 2024–2025 on the opinions; a Commission Regulation amending Annex XVII is expected in late 2026 with a multi-year transitional period and use-specific derogations. Consumer-product sectors most affected: outdoor textiles, footwear, cookware, cosmetics packaging, electronics. Brands should be mapping PFAS use in their bill of materials now, not at the restriction's entry into force.
Does RoHS apply to battery-operated toys?
Yes. Battery-operated toys are EEE within the meaning of RoHS Article 3 and fall under Category 7 (toys, leisure and sports equipment) of Annex I. The Toy Safety Directive 2009/48/EC applies in parallel for the toy-specific safety aspects, plus the Battery Regulation (EU) 2023/1542 for the battery itself. Three parallel regimes on one toy; the technical file should reference all three.
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