RoHS vs LVD/EMC CE evidence What belongs in the RoHS file
RoHS is a substance-restriction file for electrical and electronic equipment: scope the EEE, check Annex II substances at homogeneous-material level, document exemptions, maintain technical documentation, issue the EU declaration, and affix CE marking when conformity is shown.
A single EU declaration can list several applicable acts, but the supporting evidence remains law-specific: RoHS addresses restricted substances, LVD addresses electrical safety within its voltage scope, and EMC addresses emissions and immunity.
A product can carry one CE mark and one while relying on separate evidence for each applicable law. Use RoHS records to prove restricted-substance conformity in covered EEE, LVD records to prove the safety objectives for electrical equipment rated between 50 and 1,000 V AC or 75 and 1,500 V DC, and EMC records to prove that equipment controls electromagnetic disturbance and has adequate immunity. Shared identifiers and document indexes do not make the underlying assessments interchangeable.
Side-by-side comparison
RoHS vs LVD/EMC CE evidence: cited split
A comparison for deciding what belongs in the RoHS evidence file, what can sit in the shared CE release pack, and what needs a separate LVD or EMC legal and technical basis.
Material, component, supplier, exemption, technical-documentation, EU declaration, CE-marking, and authority-response evidence for Directive 2011/65/EU.
Second framework
LVD/EMC CE evidence boundary
A boundary column for records that may live in the same CE package but need separate LVD or EMC legal and technical validation before they are relied on.
RoHS covers electrical and electronic equipment, including relevant cables and spare parts, and tests substance restrictions at homogeneous-material level against Annex II maximum concentration values.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
amending Annex II to Directive 2011/65/EU
LVD covers electrical equipment designed for use with a voltage rating of 50-1,000 V AC or 75-1,500 V DC, subject to its Annex II exclusions. EMC covers equipment, meaning apparatus or fixed installations, but uses different rules for apparatus placed on the market and fixed installations assembled for permanent use at a predefined location.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-3 support EMC exclusions and the distinction between apparatus and fixed installations.
Record three scope decisions where relevant: RoHS EEE and exclusions, LVD voltage range and exclusions, and EMC apparatus or fixed-installation status. A product can be outside LVD yet still within RoHS or EMC.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
RoHS names manufacturers, authorised representatives, importers, and distributors as economic operators. Manufacturers design and manufacture to Article 4, draw up technical documentation, issue the EU declaration, and affix CE marking when conformity is demonstrated.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
LVD and EMC separately assign duties to manufacturers, authorised representatives, importers, and distributors. Under EMC, a person placing apparatus on the market under its own name or trademark or modifying it in a conformity-affecting way is treated as the manufacturer; fixed installations also need an identified person responsible for compliance.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7-12 and 19 support EMC economic-operator duties, manufacturer-duty triggers, and the responsible person for a fixed installation.
Map the statutory role under each directive, then assign evidence owners. The same legal entity can hold all roles, but the file must show which duty and product configuration each approval covers.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
RoHS turns on when covered EEE is placed on the market and must not contain Annex II substances above the listed maximum concentration values in homogeneous materials, unless an exemption applies.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
amending Annex II to Directive 2011/65/EU
LVD turns on the equipment's designed voltage rating and exclusions. EMC turns on whether equipment can generate electromagnetic disturbance or have performance affected by it, with separate fixed-installation rules. Both use the placing-on-market point for apparatus and require conformity before release.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-6 support the electromagnetic-disturbance and immunity scope, market-placement controls, and separate fixed-installation rules.
At intake, record RoHS category and materials, rated input and output voltages, LVD exclusions, EMC status, intended electromagnetic environment, representative configurations, and whether the item is apparatus or part of a fixed installation.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
For RoHS, the core obligations include designing and manufacturing EEE to Article 4, drawing up technical documentation, carrying out internal production control, issuing an , affixing CE marking, controlling series production, tracking non-conforming EEE and recalls, and responding to authority requests.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Official source for EN IEC 63000:2018 as the harmonised RoHS technical-documentation standard for assessing materials, components, and EEE.
technical documentation required for assessing materials
LVD requires equipment to meet Annex I safety objectives for hazards from the equipment and external influences. EMC requires disturbance below the level that prevents radio, telecommunications, or other equipment operating as intended and enough immunity for the intended environment. Manufacturers perform the applicable conformity assessment, prepare technical documentation, issue the declaration, affix CE marking, and control production.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 3 and 6 and Annex I support the LVD safety objectives, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Articles 6-7 and Annex I support emissions, immunity, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Use separate acceptance rows for RoHS substance limits, LVD safety objectives, and EMC emissions and immunity. A shared release checklist should name the directive, requirement, evidence, configuration, standard edition, approver, and unresolved deviation.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
RoHS evidence should include BOM traceability, supplier material declarations, restricted-substance risk assessment, exemption register, testing or screening rationale, EN IEC 63000 technical documentation, , CE marking decision, and change-control records.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
IEC publisher page for the 2026 XRF screening edition, including lead, mercury, cadmium, total chromium, and total bromine in uniform materials. It replaced the 2013 edition.
IEC publisher page for phthalate determination in polymers by GC-MS and thermal desorption GC-MS methods.
phthalates in polymers
LVD evidence commonly includes the product description, drawings, safety risk assessment, applied harmonised standards or other solutions, design calculations, examinations, and test reports. EMC evidence includes the EMC assessment for relevant phenomena and normal operating conditions, representative configurations, drawings, standards or other solutions, and emissions and immunity evidence. Both require controlled production and declaration records.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7 and 14 and Annexes II-IV support the EMC assessment, representative configurations, technical documentation, conformity procedure, and declaration evidence.
Keep one evidence index if useful, but tag each artifact as RoHS-specific, LVD-specific, EMC-specific, shared administration, or unresolved. Record the tested model, firmware, accessories, cables, operating modes, and configuration so the evidence boundary is reviewable.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
RoHS timing includes the placing-on-the-market date, the 10-year retention period for technical documentation or EU declaration records, Annex II substance applicability dates, exemption expiry dates, and renewal application timing.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
Commission guidance on exemption request timing, application contents, confidentiality handling, categories, alternatives, and supporting documentation.
no later than 18 months before the exemption expires
LVD and EMC have applied under their current directives since 20 April 2016. Manufacturers keep technical documentation and the EU declaration for 10 years after placement. Reassess after design, component, firmware, intended-use, cable, enclosure, power, operating-mode, standard, or representative-configuration changes that may affect safety or EMC conformity.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7-9 and 46 support application from 20 April 2016 and the 10-year manufacturer, authorised-representative, and importer record duties.
Track the three evidence clocks separately, including harmonised-standard transition dates and the 10-year records. Use the earliest unsatisfied RoHS, LVD, or EMC condition as the release blocker.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
RoHS requires economic operators to take corrective measures for non-conforming EEE, withdraw or recall where appropriate, inform competent national authorities in relevant cases, and provide information and documentation after reasoned authority requests.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
EU market-surveillance source used only for authority-response and product-compliance context alongside RoHS obligations.
market surveillance and compliance of products
LVD and EMC authorities can evaluate products, require corrective action, restrict or prohibit availability, and require withdrawal or recall. Formal non-compliance also includes missing or incorrect CE marking, declaration, or technical documentation. Member States set penalties under each directive.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7, 9, 10 and 38-41 support corrective action, withdrawal, recall, safeguard procedures, and formal non-compliance.
Use one incident index with three legal tracks. Preserve the affected models and configurations, evidence available at release, risk evaluation, corrective action, withdrawal or recall decision, authority communication, customer notice, and proof of closure for each applicable directive.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
RoHS can share administrative artifacts with a CE file, such as product identifiers, technical documentation indexes, EU declaration management, CE marking controls, and authority-response logs.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
LVD and EMC can share identifiers, drawings, manuals, risk-management administration, change control, declaration management, CE artwork, and authority logs with RoHS. Their technical conclusions still depend on LVD safety and EMC disturbance-and-immunity evidence.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 6, 15-17 and Annex IV support controlled reuse of product identity, technical documentation, EU declaration, and CE-marking records without replacing the safety assessment.
Articles 7, 16-18 and Annex IV support shared product identity, documentation administration, EU declaration, and CE-marking records while preserving EMC-specific evidence.
Reuse controlled facts and administration, then link each requirement to its own evidence. One declaration and CE mark can cover multiple acts only after every applicable assessment is complete.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Treat RoHS as controlling when the open issue is Annex II substance content, homogeneous-material assessment, supplier evidence, exemption validity, EN IEC 63000 technical documentation, RoHS EU declaration wording, or RoHS authority response.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
Commission implementation source for RoHS exemptions, renewal timing, assessment studies, and evaluation procedure.
Exemptions are limited in time
Use LVD when the issue is in-scope voltage equipment and Annex I safety objectives. Use EMC when the issue is electromagnetic disturbance, immunity, apparatus configuration, or fixed-installation practice. Use both where both triggers apply.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-6 and 19 support routing disturbance, immunity, apparatus-configuration, and fixed-installation questions to the EMC assessment.
Close the RoHS, LVD, and EMC decisions independently, then issue one EU declaration and CE release only when the declaration identifies every applicable act and the evidence index points to a current, product-specific conformity record for each.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Scope and covered activity
RoHS evidence
RoHS covers electrical and electronic equipment, including relevant cables and spare parts, and tests substance restrictions at homogeneous-material level against Annex II maximum concentration values.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
amending Annex II to Directive 2011/65/EU
LVD/EMC CE evidence boundary
LVD covers electrical equipment designed for use with a voltage rating of 50-1,000 V AC or 75-1,500 V DC, subject to its Annex II exclusions. EMC covers equipment, meaning apparatus or fixed installations, but uses different rules for apparatus placed on the market and fixed installations assembled for permanent use at a predefined location.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-3 support EMC exclusions and the distinction between apparatus and fixed installations.
Operational implication
Record three scope decisions where relevant: RoHS EEE and exclusions, LVD voltage range and exclusions, and EMC apparatus or fixed-installation status. A product can be outside LVD yet still within RoHS or EMC.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Who must act
RoHS evidence
RoHS names manufacturers, authorised representatives, importers, and distributors as economic operators. Manufacturers design and manufacture to Article 4, draw up technical documentation, issue the EU declaration, and affix CE marking when conformity is demonstrated.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
LVD/EMC CE evidence boundary
LVD and EMC separately assign duties to manufacturers, authorised representatives, importers, and distributors. Under EMC, a person placing apparatus on the market under its own name or trademark or modifying it in a conformity-affecting way is treated as the manufacturer; fixed installations also need an identified person responsible for compliance.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7-12 and 19 support EMC economic-operator duties, manufacturer-duty triggers, and the responsible person for a fixed installation.
Operational implication
Map the statutory role under each directive, then assign evidence owners. The same legal entity can hold all roles, but the file must show which duty and product configuration each approval covers.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Trigger or threshold
RoHS evidence
RoHS turns on when covered EEE is placed on the market and must not contain Annex II substances above the listed maximum concentration values in homogeneous materials, unless an exemption applies.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
amending Annex II to Directive 2011/65/EU
LVD/EMC CE evidence boundary
LVD turns on the equipment's designed voltage rating and exclusions. EMC turns on whether equipment can generate electromagnetic disturbance or have performance affected by it, with separate fixed-installation rules. Both use the placing-on-market point for apparatus and require conformity before release.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-6 support the electromagnetic-disturbance and immunity scope, market-placement controls, and separate fixed-installation rules.
Operational implication
At intake, record RoHS category and materials, rated input and output voltages, LVD exclusions, EMC status, intended electromagnetic environment, representative configurations, and whether the item is apparatus or part of a fixed installation.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
amending Annex II to Directive 2011/65/EU
Core obligations
RoHS evidence
For RoHS, the core obligations include designing and manufacturing EEE to Article 4, drawing up technical documentation, carrying out internal production control, issuing an , affixing CE marking, controlling series production, tracking non-conforming EEE and recalls, and responding to authority requests.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Official source for EN IEC 63000:2018 as the harmonised RoHS technical-documentation standard for assessing materials, components, and EEE.
technical documentation required for assessing materials
LVD/EMC CE evidence boundary
LVD requires equipment to meet Annex I safety objectives for hazards from the equipment and external influences. EMC requires disturbance below the level that prevents radio, telecommunications, or other equipment operating as intended and enough immunity for the intended environment. Manufacturers perform the applicable conformity assessment, prepare technical documentation, issue the declaration, affix CE marking, and control production.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 3 and 6 and Annex I support the LVD safety objectives, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Articles 6-7 and Annex I support emissions, immunity, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Operational implication
Use separate acceptance rows for RoHS substance limits, LVD safety objectives, and EMC emissions and immunity. A shared release checklist should name the directive, requirement, evidence, configuration, standard edition, approver, and unresolved deviation.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Evidence and records
RoHS evidence
RoHS evidence should include BOM traceability, supplier material declarations, restricted-substance risk assessment, exemption register, testing or screening rationale, EN IEC 63000 technical documentation, , CE marking decision, and change-control records.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
IEC publisher page for the 2026 XRF screening edition, including lead, mercury, cadmium, total chromium, and total bromine in uniform materials. It replaced the 2013 edition.
IEC publisher page for phthalate determination in polymers by GC-MS and thermal desorption GC-MS methods.
phthalates in polymers
LVD/EMC CE evidence boundary
LVD evidence commonly includes the product description, drawings, safety risk assessment, applied harmonised standards or other solutions, design calculations, examinations, and test reports. EMC evidence includes the EMC assessment for relevant phenomena and normal operating conditions, representative configurations, drawings, standards or other solutions, and emissions and immunity evidence. Both require controlled production and declaration records.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7 and 14 and Annexes II-IV support the EMC assessment, representative configurations, technical documentation, conformity procedure, and declaration evidence.
Operational implication
Keep one evidence index if useful, but tag each artifact as RoHS-specific, LVD-specific, EMC-specific, shared administration, or unresolved. Record the tested model, firmware, accessories, cables, operating modes, and configuration so the evidence boundary is reviewable.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Timing and cadence
RoHS evidence
RoHS timing includes the placing-on-the-market date, the 10-year retention period for technical documentation or EU declaration records, Annex II substance applicability dates, exemption expiry dates, and renewal application timing.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
Commission guidance on exemption request timing, application contents, confidentiality handling, categories, alternatives, and supporting documentation.
no later than 18 months before the exemption expires
LVD/EMC CE evidence boundary
LVD and EMC have applied under their current directives since 20 April 2016. Manufacturers keep technical documentation and the EU declaration for 10 years after placement. Reassess after design, component, firmware, intended-use, cable, enclosure, power, operating-mode, standard, or representative-configuration changes that may affect safety or EMC conformity.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7-9 and 46 support application from 20 April 2016 and the 10-year manufacturer, authorised-representative, and importer record duties.
Operational implication
Track the three evidence clocks separately, including harmonised-standard transition dates and the 10-year records. Use the earliest unsatisfied RoHS, LVD, or EMC condition as the release blocker.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Commission guidance on exemption request timing, application contents, confidentiality handling, categories, alternatives, and supporting documentation.
no later than 18 months before the exemption expires
Enforcement or assurance route
RoHS evidence
RoHS requires economic operators to take corrective measures for non-conforming EEE, withdraw or recall where appropriate, inform competent national authorities in relevant cases, and provide information and documentation after reasoned authority requests.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
EU market-surveillance source used only for authority-response and product-compliance context alongside RoHS obligations.
market surveillance and compliance of products
LVD/EMC CE evidence boundary
LVD and EMC authorities can evaluate products, require corrective action, restrict or prohibit availability, and require withdrawal or recall. Formal non-compliance also includes missing or incorrect CE marking, declaration, or technical documentation. Member States set penalties under each directive.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 7, 9, 10 and 38-41 support corrective action, withdrawal, recall, safeguard procedures, and formal non-compliance.
Operational implication
Use one incident index with three legal tracks. Preserve the affected models and configurations, evidence available at release, risk evaluation, corrective action, withdrawal or recall decision, authority communication, customer notice, and proof of closure for each applicable directive.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
EU market-surveillance source used only for authority-response and product-compliance context alongside RoHS obligations.
market surveillance and compliance of products
Overlap and reuse
RoHS evidence
RoHS can share administrative artifacts with a CE file, such as product identifiers, technical documentation indexes, EU declaration management, CE marking controls, and authority-response logs.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
LVD/EMC CE evidence boundary
LVD and EMC can share identifiers, drawings, manuals, risk-management administration, change control, declaration management, CE artwork, and authority logs with RoHS. Their technical conclusions still depend on LVD safety and EMC disturbance-and-immunity evidence.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 6, 15-17 and Annex IV support controlled reuse of product identity, technical documentation, EU declaration, and CE-marking records without replacing the safety assessment.
Articles 7, 16-18 and Annex IV support shared product identity, documentation administration, EU declaration, and CE-marking records while preserving EMC-specific evidence.
Operational implication
Reuse controlled facts and administration, then link each requirement to its own evidence. One declaration and CE mark can cover multiple acts only after every applicable assessment is complete.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Practical decision rule
RoHS evidence
Treat RoHS as controlling when the open issue is Annex II substance content, homogeneous-material assessment, supplier evidence, exemption validity, EN IEC 63000 technical documentation, RoHS EU declaration wording, or RoHS authority response.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
Commission implementation source for RoHS exemptions, renewal timing, assessment studies, and evaluation procedure.
Exemptions are limited in time
LVD/EMC CE evidence boundary
Use LVD when the issue is in-scope voltage equipment and Annex I safety objectives. Use EMC when the issue is electromagnetic disturbance, immunity, apparatus configuration, or fixed-installation practice. Use both where both triggers apply.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Articles 2-6 and 19 support routing disturbance, immunity, apparatus-configuration, and fixed-installation questions to the EMC assessment.
Operational implication
Close the RoHS, LVD, and EMC decisions independently, then issue one EU declaration and CE release only when the declaration identifies every applicable act and the evidence index points to a current, product-specific conformity record for each.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Practical decision rule
How should teams separate RoHS evidence from LVD/EMC evidence?
Start from the EEE, homogeneous-material, Annex II substance, exemption, supplier, and placing-on-the-market facts for the RoHS decision.
Map each RoHS action to a RoHS cited duty before combining it with a wider CE release package.
Open a separate LVD or EMC evidence review when the claim depends on voltage limits, electrical safety objectives, electromagnetic disturbance, immunity, or directive-specific tests.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Binding source for routing electromagnetic disturbance, immunity, apparatus, fixed-installation, and EMC-specific technical evidence to a separate EMC review.
1
Section 1
What should RoHS evidence prove before it is reused in a CE file?
RoHS evidence should prove that covered electrical and electronic equipment does not exceed Annex II maximum concentration values in homogeneous materials, unless a valid Annex III or Annex IV exemption applies. The RoHS file is therefore material- and supply-chain-heavy, not a substitute for electrical-safety or electromagnetic-compatibility evidence.
Match each record to the duty it proves. A supplier material declaration, restricted-substance test report, and exemption register can support RoHS. LVD instead requires evidence against the Annex I safety objectives, including hazards arising from the electrical equipment and hazards caused by external influences. EMC requires evidence that disturbance stays below the level at which radio, telecommunications, or other equipment cannot operate as intended, and that the equipment has enough immunity for its intended electromagnetic environment.
Start with the RoHS scope: EEE category, cables, spare parts, homogeneous materials, Annex II substances, and any Annex III or IV exemption claim.
Keep the RoHS conclusion tied to Article 4, Article 7 manufacturer duties, Article 13 EU declaration requirements, Article 15 CE marking rules, and Article 16 presumption-of-conformity rules where they apply.
Check LVD scope against the rated input or output voltage and its exclusions; do not assume that every mains-powered product is in scope.
For EMC, distinguish apparatus from a fixed installation and document the intended electromagnetic environment, emissions, immunity, configuration, and conformity-assessment route.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.
Binding LVD source for the 50-1,000 V AC and 75-1,500 V DC scope, Annex I safety objectives, manufacturer technical documentation, EU declaration, CE marking, and 10-year retention.
Binding EMC source for apparatus and fixed-installation scope, emissions and immunity requirements, technical documentation, EU declaration, CE marking, and 10-year retention.
Recommended next step
Turn RoHS evidence into a defensible CE-file input
This RoHS-focused comparison helps separate substance evidence, supplier documentation, exemptions, technical documentation, EU declarations, and CE-file reuse decisions before release.
A RoHS evidence pack should let a reviewer trace the product from BOM and supplier inputs to a documented conformity conclusion. The core file should include the product identifier, EEE category, material and component evidence, exemption analysis, technical documentation approach, EU declaration, CE marking decision, and change-control triggers.
EN IEC 63000:2018 is the harmonised standard identified by Commission Implementing Decision (EU) 2020/659 for technical documentation used to assess materials, components, and EEE against RoHS substance restrictions. Testing can support the file, but the record should explain why each declaration, screening result, or lab report is sufficient for the material risk being assessed.
Use bills of materials (BOMs), material declarations, restricted-substance matrices, supplier declarations, exemption registers, and change notices to show traceability.
Use IEC 62321 methods when testing is needed, such as X-ray fluorescence (XRF) screening for several restricted elements or phthalate determination in polymers.
Manufacturers retain the technical documentation and EU declaration for 10 years after placing EEE on the market. Importers retain a copy of the declaration for that period and ensure technical documentation can be made available to authorities on request.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
IEC publisher page for the 2026 XRF screening edition, including lead, mercury, cadmium, total chromium, and total bromine in uniform materials. It replaced the 2013 edition.
IEC publisher page for phthalate determination in polymers by GC-MS and thermal desorption GC-MS methods.
phthalates in polymers
3
Section 3
Decision workflow for RoHS vs LVD/EMC evidence reuse
Use a short bridge note when one release package contains RoHS, LVD, EMC, and other CE evidence. State which record demonstrates RoHS conformity, which record is shared administrative evidence, and which LVD or EMC conclusion still needs its own legal or technical basis.
Do not let a single CE mark hide missing substance evidence. RoHS requires manufacturer technical documentation and a declaration that Article 4 requirements have been met; importers and distributors have their own checks and authority-cooperation duties. Exemptions also need calendar control because renewal applications must be made before expiry and Commission implementation material describes the evaluation process.
Classify each document as RoHS-specific, CE-administrative, LVD-specific, EMC-specific, or unresolved.
For RoHS-specific documents, cite the RoHS article, Annex II substance, exemption entry, harmonised standard, or IEC test method being supported.
Escalate if a claim depends on LVD voltage limits, EMC disturbance or immunity, safety objectives, or EMC test standards; those questions must be decided under the applicable LVD or EMC requirements.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
maximum concentration value by weight in homogeneous materials
Binding EMC source for apparatus and fixed-installation scope, disturbance and immunity requirements, economic-operator duties, EMC assessment, technical documentation, EU declaration of conformity, CE marking, retention, and corrective action.
Binding EMC source for apparatus and fixed-installation scope, emissions and immunity requirements, technical documentation, EU declaration, CE marking, and 10-year retention.
Articles 2-3 support EMC exclusions and the distinction between apparatus and fixed installations.
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Articles 7-12 and 19 support EMC economic-operator duties, manufacturer-duty triggers, and the responsible person for a fixed installation.
Articles 2-6 support the electromagnetic-disturbance and immunity scope, market-placement controls, and separate fixed-installation rules.
Articles 6-7 and Annex I support emissions, immunity, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Articles 7 and 14 and Annexes II-IV support the EMC assessment, representative configurations, technical documentation, conformity procedure, and declaration evidence.
Articles 7-9 and 46 support application from 20 April 2016 and the 10-year manufacturer, authorised-representative, and importer record duties.
Articles 7, 9, 10 and 38-41 support corrective action, withdrawal, recall, safeguard procedures, and formal non-compliance.
Articles 7, 16-18 and Annex IV support shared product identity, documentation administration, EU declaration, and CE-marking records while preserving EMC-specific evidence.
Articles 2-6 and 19 support routing disturbance, immunity, apparatus-configuration, and fixed-installation questions to the EMC assessment.
Binding source for routing electromagnetic disturbance, immunity, apparatus, fixed-installation, and EMC-specific technical evidence to a separate EMC review.
Binding LVD source for voltage scope and exclusions, safety objectives, economic-operator duties, conformity assessment, technical documentation, EU declaration of conformity, CE marking, retention, and corrective action.
Binding LVD source for the 50-1,000 V AC and 75-1,500 V DC scope, Annex I safety objectives, manufacturer technical documentation, EU declaration, CE marking, and 10-year retention.
Article 1 and Annex II support the LVD voltage scope and exclusions.
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Articles 6-11 support the LVD duties of manufacturers, authorised representatives, importers, and distributors.
Articles 1, 3 and 6 support the voltage trigger, safety objectives, and pre-market conformity duty.
Articles 3 and 6 and Annex I support the LVD safety objectives, conformity assessment, technical documentation, EU declaration, CE marking, and production controls.
Article 6 and Annex III support the LVD technical-documentation contents, conformity assessment, EU declaration, and production-control evidence.
Articles 6-8 and 27 support application from 20 April 2016 and the 10-year manufacturer, authorised-representative, and importer record duties.
Articles 6, 8, 9 and 19-21 support corrective measures, withdrawal, recall, formal non-compliance, and safeguard procedures.
Articles 6, 15-17 and Annex IV support controlled reuse of product identity, technical documentation, EU declaration, and CE-marking records without replacing the safety assessment.
Articles 1, 3 and 6 and Annex I support routing in-scope voltage equipment and electrical-safety questions to the LVD assessment.
Binding source for routing in-scope voltage equipment, Annex I safety objectives, and LVD-specific technical evidence to a separate LVD review.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values. Consolidations are documentation tools; the Official Journal acts are the authentic legal texts.
Consolidated RoHS source for Article 4 substance restrictions, economic-operator duties, technical documentation, EU declarations, CE marking, retention, exemptions, and Annex II concentration values.
"maximum concentration value by weight in homogeneous materials"
Binding amendment that added DEHP, BBP, DBP, and DIBP to Annex II and states applicability rules for medical devices, monitoring and control instruments, cables, spare parts, and toys.
General EU product-law guidance for CE marking, EU declarations, technical documentation, economic operators, and applicable Union harmonisation legislation.
"The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements."
IEC publisher page for the 2026 XRF screening edition, including lead, mercury, cadmium, total chromium, and total bromine in uniform materials. It replaced the 2013 edition.