01
EU market access.
Placing EEE on the EU market without demonstrable RoHS compliance is unlawful and triggers product withdrawal. The CE marking for RoHS relies on RoHS conformity evidence in the technical file.
Product & Regulatory
RoHS — substance restriction, proven.
Material declarations, testing coordination, and technical documentation to demonstrate compliance with the Restriction of Hazardous Substances directive and its Indian equivalent.
What it is
The EU directive restricting hazardous substances in electrical and electronic equipment.
The RoHS directive (2011/65/EU, as amended) restricts the use of specific hazardous substances in electrical and electronic equipment placed on the EU market. The restricted substances are lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, and four phthalates added by Commission Delegated Directive (EU) 2015/863: DEHP, BBP, DBP, and DIBP. Restrictions apply at the homogeneous-material level — each individual component material in a product must meet the maximum concentration value.
India operates its own equivalent under the E-Waste (Management) Rules, substantially aligned to EU RoHS with national variation. RoHS compliance is a legal requirement for marketing electrical and electronic equipment into the EU and, under E-Waste Rules, for placing such equipment on the Indian market. Non-compliance is not a documentation issue — it is a market-access issue with enforcement by customs and market surveillance.
Who needs it
Manufacturers, importers, and distributors of electrical and electronic equipment.
Original equipment manufacturers, contract electronics manufacturers, electronic component manufacturers, and assembly houses; importers placing EEE on the EU or Indian market; OEMs and brand owners acting as legal manufacturer; and distributors whose name or mark appears on product. Scope covers household appliances, IT and telecommunications equipment, consumer electronics, lighting, electrical and electronic tools, toys with electrical or electronic function, medical devices (now fully in scope), monitoring and control equipment, automatic dispensers, and any other EEE.
Benefits
What a well-built BIFMA system earns you.
02
India market access.
Under the E-Waste Management Rules, manufacturers and brand owners must demonstrate RoHS-like substance compliance. CPCB oversight is real and tightening.
03
Supply-chain evidence.
Material declarations from component suppliers — IPC-1752A, IEC 62474, CDX — become a managed evidence base rather than ad-hoc requests.
04
Customer acceptance.
Enterprise and OEM customers increasingly require documented RoHS evidence (not just declarations) in supplier onboarding.
05
Product liability defence.
A properly constituted RoHS technical file — material declarations, test reports, risk assessment — is the first line of defence in any RoHS-related enforcement action.
06
Platform for REACH and WEEE.
The supply-chain substance evidence needed for RoHS is largely the same evidence base needed for REACH SVHC screening. Building one well serves both.
Requirements, in outline
What the standard actually asks of you.
Compliance must be demonstrated at the homogeneous-material level. Maximum concentration values are 0.1% by weight for lead, mercury, hexavalent chromium, PBB, PBDE, and the four phthalates, and 0.01% for cadmium. Exemptions (Annex III and IV) permit specific restricted substance uses in particular applications, typically with expiry dates and renewal regimes.
Evidence can take several forms: supplier declarations of conformity (typically inadequate on their own), material declarations (IPC-1752A, IEC 62474), analytical test reports from accredited laboratories (XRF screening as first-pass, followed by wet chemistry for confirmation), and internal process controls (segregation, change-management of component specifications). The EU requires the manufacturer to compile a technical documentation file under Module A of Annex II, to perform the conformity assessment procedure, to issue an EU Declaration of Conformity, and to affix the CE marking. The directive requires the technical file to be kept available to market surveillance authorities for ten years.
Our approach
Five stages, from discovery to certificate.
01
Scope & product identification
Identify RoHS applicability by product category, determine homogeneous-material boundaries, and baseline existing supplier declaration coverage.
02
Supplier data collection
Issue material declaration requests using standard formats (IPC-1752A, IEC 62474). Follow up, validate, and identify components requiring testing rather than declaration alone.
03
Testing coordination
Where supplier declarations are inadequate or high-risk components require verification, coordinate accredited-lab testing. XRF screening followed by confirmatory wet chemistry for exceedances.
04
Technical file & exemptions
Compile the technical documentation file per Annex II Module A. Document applicable exemptions, their scope, and any expiry-related risk.
05
DoC, CE, ongoing change management
Draft the EU Declaration of Conformity, and build the ongoing change management discipline — component substitutions must not silently break compliance.
Timeline & investment
Honest ranges, not placeholder pricing.
A product with well-managed supplier declarations typically reaches documented RoHS compliance in six to ten weeks. Products with deep supply chains, component-substitution history, or inherited designs without substance records typically run to three to five months, driven by supplier response times and any necessary testing.
Fees depend on product complexity (component count), supplier population, and the scale of testing required. Laboratory testing fees are separate and vary with component material profile.
Frequently asked
Questions we answer on most BIFMA calls.
Sometimes, but typically no. Market surveillance expects traceable evidence down to homogeneous material level. Supplier DoCs without supporting material declarations or test data are a weak evidence base — especially for high-risk components.
RoHS restricts ten specific substances in electrical and electronic equipment, at the homogeneous-material level, under a directive. REACH is a broader chemicals regulation covering any substance placed on the EU market, with specific restrictions (Annex XVII), authorisation (Annex XIV), and SVHC disclosure (Article 33) obligations across product categories.
Yes. Category 8 (medical devices) and Category 9 (monitoring and control instruments) were brought into full RoHS scope through successive amendments. In vitro diagnostic medical devices have been in scope since 2016; active implantable medical devices remain excluded.
The E-Waste (Management) Rules in India adopt similar substance restrictions and concentration values, with some procedural differences in exemptions and documentation. CPCB is the central enforcement authority. Most EU-RoHS-compliant products are substantively compliant with India RoHS, subject to documentation alignment.
Test-purchase campaigns, customs intercepts, competitor complaints, and periodic sectoral sweeps are all common triggers. Market surveillance can — and does — request the technical file at short notice. Absence of a file is a prima-facie compliance failure.
Related services
Often pursued alongside BIFMA.
CE Marking
Directive selection, technical file preparation, testing liaison, and declaration of conformity.
Learn moreREACH
SVHC screening, substance registration strategy, and supply-chain data collection.
Learn moreISO 9001
Embed a quality management system that customers, regulators, and auditors recognise on sight.
Learn moreGet a readiness assessment for RoHS.
Half a day with a senior consultant, a clause-level gap report, and a candid timeline. No commitment beyond the assessment itself.