- Binding source for the four phthalates added to RoHS Annex II.
"amending Annex II to Directive 2011/65/EU"
RoHS evidence intake starts with the bill of materials, but the legal restriction is applied to homogeneous materials, not just purchasable part numbers.
This workflow helps decide what supplier evidence, material declarations, exemption records, or test reports are needed before the RoHS technical file and EU declaration are trusted.
Structured answer sets in this page tree.
Cited legal and guidance references.
A RoHS BOM intake workflow turns supplier paperwork into an auditable evidence file. Start with the finished EEE and economic-operator role, then break relevant purchased parts down to each . Apply the Annex II substance limits, check any Annex III or IV exemption, select evidence that resolves the material risk, and record the owner, decision, limitation, and reassessment trigger.
Open a BOM intake record when a new EEE is planned for the EU market, when a supplier or material changes, or when the technical file cannot show why a RoHS conclusion was accepted. Record whether the company is acting as manufacturer, importer, distributor, or authorised representative because RoHS assigns different checks and document-retention duties to those roles.
For each BOM item, break the compliance question down to homogeneous materials where practical. Directive 2011/65/EU defines a as one uniform material, or a material combination that cannot be separated into different materials by mechanical action. Supplier declarations that only say a finished assembly is compliant are weaker when they do not identify the materials, substances, exemptions, and supporting basis behind that statement.
Confirm scope before material intake. EEE must depend on electric currents or electromagnetic fields for at least one intended function and stay within the 1,000 V AC or 1,500 V DC design limits. Record the Annex I category, including category 11 where relevant, and any exact Article 2 exclusion. Military or space equipment, qualifying means of transport, large-scale tools or fixed installations, certain non-road mobile machinery, active implantable medical devices, qualifying photovoltaic panels, and custom-built business-to-business research equipment are examples of exclusions, not generic labels to apply without the facts.
BOM intake should not accept every supplier document at the same value. Match the evidence type to the risk and decision being made: low-risk catalog parts may be supported by current supplier declarations, while uncertain alloys, solders, coatings, plastics, phthalate-sensitive materials, or exemption claims may require deeper material declarations, targeted test reports, or engineering review.
The intake record should make the restricted-substance check explicit. RoHS Annex II sets maximum concentration values by weight in homogeneous materials for lead, mercury, hexavalent chromium, PBB, PBDE, BBP, DBP, DIBP, and DEHP at 0.1%, and cadmium at 0.01%. If the evidence does not reach the homogeneous-material level, state the limitation instead of treating the BOM line as closed.
Do not average a compliant material against a non-compliant material in the same component. Apply the concentration limit to each , then check whether a specific Annex III or Annex IV exemption covers the substance, application, EEE category, and relevant validity conditions. An exemption for one solder, coating, or application does not clear the rest of the component.
Treat the four phthalates as part of current Annex II coverage. Their restriction applied from 22 July 2019 for most EEE and from 22 July 2021 for medical devices and monitoring and control instruments, subject to the Directive's cable, spare-part, and toy carve-outs. A declaration covering only the original six substance groups does not establish current ten-substance coverage.
Convert supplier declarations, material records, exemption claims, and test decisions into a RoHS evidence pack that supports technical documentation, release reviews, and authority responses.
The workflow is finished only when the BOM evidence can be traced into the RoHS technical documentation and the EU declaration decision. Manufacturers must draw up technical documentation, carry out the internal production control procedure, draw up the EU declaration of conformity when conformity is demonstrated, affix CE marking, and keep the technical documentation and EU declaration for 10 years after the EEE has been placed on the market.
Use EN IEC 63000:2018 as the technical-documentation anchor where applicable. Commission Implementing Decision (EU) 2020/659 lists EN IEC 63000:2018 for technical documentation used to assess materials, components, and EEE with respect to hazardous-substance restrictions, and the Commission harmonised-standards page explains that RoHS harmonised-standard references are published through Commission implementing decisions.
EN IEC 63000 is a voluntary documentation standard, not a rule that every material must be laboratory-tested. Close a line when the combined supplier information, material knowledge, exemption evidence, prior testing, and risk assessment resolve the question. Escalate when the evidence is missing, stale, contradictory, outside the supplied revision, or unable to distinguish a screened element from the regulated substance form.
"amending Annex II to Directive 2011/65/EU"
"technical documentation required for assessing materials, components and electrical and electronic equipment"
"The manufacturer is responsible for the conformity assessment"
"keep the technical documentation and the EU declaration of conformity for 10 years"
"references of harmonised standards are published"
"The RoHS Directive allows for exemptions from its restrictions"