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FAQEU

RoHS FAQ EU RoHS 0.1% and 0.01% Substance Limits

EU RoHS Annex II sets maximum concentration values by weight in homogeneous materials, not as an average across the finished electrical or electronic product.

This FAQ helps separate the 0.1% limits from cadmium's 0.01% limit and record the material-level evidence behind the conclusion.

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Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
4 sections5 primary sources
Overview

Under EU RoHS, the 0.1% and 0.01% values are maximum concentration values by weight in each . Lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) are listed at 0.1%; cadmium is listed at 0.01%. A product-level average does not establish compliance. Each relevant homogeneous material must meet its applicable limit or be covered by a valid exemption.

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4 of 4 questions
Question 1

What do the 0.1% and 0.01% substance limits mean under EU RoHS?

Article 4 of Directive 2011/65/EU points to Annex II for the maximum concentration values tolerated by weight in homogeneous materials. That means the threshold is checked against each separable material, coating, solder, plastic, alloy, wire, or other , not against the finished product as a whole.

Cadmium has the tighter 0.01% limit; the other Annex II substances are listed at 0.1%. In mass-concentration terms, 0.01% equals 100 mg/kg and 0.1% equals 1,000 mg/kg. The four phthalates added by Delegated Directive (EU) 2015/863, DEHP, BBP, DBP, and DIBP, also sit at 0.1% in Annex II.

  • Use 0.1% by weight (1,000 mg/kg) for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP.
  • Use 0.01% by weight (100 mg/kg) for cadmium.
  • Apply the value to each separately; do not dilute a restricted substance by averaging it across an assembly, component, or finished .
  • If an Annex III or Annex IV exemption is used, record the exact exemption entry, product category, substance, material, and validity condition that makes the higher concentration acceptable.

What do the 0.1% and 0.01% substance limits mean under EU RoHS?

They are maximum concentration values by weight in each . Cadmium is limited to 0.01% (100 mg/kg); lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP are limited to 0.1% (1,000 mg/kg), unless the specific use is covered by a valid RoHS exemption.

How do you convert a RoHS percentage to mg/kg?

Multiply the percentage by 10,000 to convert percent by weight to mg/kg. A result of 0.1% equals 1,000 mg/kg, and 0.01% equals 100 mg/kg. Compare the converted result with the limit for the same and substance; do not compare a coating result with the weight of the whole component.

Does a RoHS exemption change the 0.1% or 0.01% limit?

An Annex III or Annex IV exemption does not rewrite the general Annex II limit. It permits the restricted substance in the specific material or component application, category, and period described by the exemption. Record the exact entry and show that the product, use, category, and timing all match; otherwise apply the ordinary 0.1% or 0.01% limit.

What evidence should support this EU RoHS Directive decision?

Keep the homogeneous-material breakdown, restricted-substance matrix, supplier material declarations, substance test reports where used, exemption entry if relied on, EN IEC 63000 technical documentation, EU declaration of conformity, and change-control records. The evidence should show which material was checked against which Annex II value.

Question 2

What evidence should be kept for RoHS 0.1% and 0.01% limits?

Evidence should let a reviewer trace the conclusion from the finished down to the homogeneous materials that matter for Annex II. A supplier statement that only says "RoHS compliant" is weak if it does not identify covered parts, materials, substances, exemptions, or the basis for the declaration.

The technical file should connect the bill of materials (BOM), homogeneous-material list, material declarations, substance risk assessment, selected test reports, exemption register, EU declaration of conformity, and change-control history. Manufacturers must keep the technical documentation and EU declaration of conformity for 10 years after the has been placed on the market.

  • Map each relevant to the applicable Annex II substance and limit: 0.01% for cadmium or 0.1% for the other listed substances.
  • Keep supplier declarations specific to the part, material, revision, and restricted substances they cover.
  • When testing is used, retain the sample description, preparation logic, test method, units, reporting or detection limits where provided, measurement uncertainty where reported, and the material-level result being compared with the Annex II threshold.
  • For exemptions, retain the Annex III or Annex IV entry, applicability category, expiry or renewal status, and the product/material facts that support use of the exemption.
  • Recheck the record after material changes, supplier changes, product redesign, exemption changes, or a change to the harmonised standard used for the technical documentation.
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Question 3

How to apply the RoHS 0.1% and 0.01% limits

Use the limits as a material-level screening question before release, supplier approval, design change, or exemption review. Record a pass, an exemption-supported conclusion, or a nonconforming-material decision for each material-substance pair. If the evidence cannot support a conclusion, record the missing supplier information or test result and hold the decision open.

  • Identify the , category, part number, supplier, revision, and date of placing on the market.
  • Break the relevant assemblies into homogeneous materials, including plastics, metals, coatings, solder, insulation, cables, and phthalate-relevant polymer parts.
  • For each , mark whether cadmium, lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, or DIBP is relevant.
  • Compare cadmium results or declarations to 0.01% by weight (100 mg/kg) and all other Annex II substance results or declarations to 0.1% by weight (1,000 mg/kg).
  • Example - leaded solder: 0.20% lead in one solder material exceeds the 0.1% lead limit even if the finished contains less than 0.1% lead by total weight. The solder needs an applicable exemption or the product is nonconforming.
  • Example - cadmium result: 80 mg/kg cadmium equals 0.008% by weight, below the 100 mg/kg or 0.01% limit. The file still needs to show that the sample represents the and that the reported method, detection capability, and uncertainty support the decision.
  • Example - plated metal: treat a mechanically separable or separately assessable coating and the underlying metal as distinct material layers for the substance decision; do not average the coating concentration across the whole fastener.
  • If a value exceeds the Annex II limit, stop treating the material as compliant unless an exact Annex III or Annex IV exemption covers that use.
  • Store the conclusion in the RoHS technical documentation package used to support the CE marking and EU declaration of conformity.
Question 4

Common mistakes to avoid when documenting EU RoHS 0.1% and 0.01% substance limits

Most mistakes come from using the right percentage at the wrong level of detail. Annex II limits are material-level values, so a finished-product calculation can hide a nonconforming coating, solder, plastic, or cable material.

  • Do not apply 0.1% to cadmium; Annex II lists cadmium at 0.01%.
  • Do not average a restricted substance across a component or finished when separable homogeneous materials should be checked individually.
  • Do not forget DEHP, BBP, DBP, and DIBP when reviewing phthalate-relevant polymers; they are listed in Annex II at 0.1%.
  • Do not rely on an exemption unless the exact material use, product category, and exemption timing still match Annex III or Annex IV.
  • Do not reuse supplier declarations after a material, coating, cable, adhesive, solder, or supplier revision changes unless the declaration still covers the changed material.
Primary sources

References and citations

Commission Delegated Directive (EU) 2015/863 adding phthalates to RoHS Annex II
data.europa.eu5 citations
Referenced sections
  • Binding source for adding DEHP, BBP, DBP, and DIBP to RoHS Annex II.
  • Binding amendment that added DEHP, BBP, DBP, and DIBP to the RoHS Annex II restriction list.
  • Binding amendment that added the four phthalates now checked at the 0.1% homogeneous-material limit.
Show 2 more
  • Binding source for the four phthalate restrictions that must be included in Annex II material checks.
  • Binding source confirming that DEHP, BBP, DBP, and DIBP are part of the Annex II limit checks.
"amending Annex II to Directive 2011/65/EU"
Commission Implementing Decision (EU) 2020/659 on EN IEC 63000
data.europa.eu5 citations
Referenced sections
  • Official source for EN IEC 63000 as the harmonised technical-documentation standard for assessing RoHS-restricted substances.
  • Official source identifying EN IEC 63000 for technical documentation used to assess RoHS-restricted substances.
  • Official source for EN IEC 63000 as the harmonised technical-documentation standard for RoHS assessment.
Show 2 more
  • Official source for EN IEC 63000 as the RoHS technical-documentation standard.
  • Official source for technical-documentation expectations when assessing restricted substances.
"technical documentation required for assessing materials"
Directive 2011/65/EU on restriction of hazardous substances (RoHS)
eur-lex.europa.eu5 citations
Referenced sections
  • Binding consolidated RoHS source for Article 4, Annex II threshold values, homogeneous materials, exemptions, technical documentation, CE marking, and EU declaration of conformity.
  • Binding source for Article 4 and Annex II maximum concentration values by weight in homogeneous materials.
  • Binding source for Annex II limits and manufacturer obligations to keep technical documentation and the EU declaration of conformity.
Show 2 more
  • Binding source for Article 4 restrictions, Annex II limits, CE marking, and EU declaration of conformity obligations.
  • Binding source for the homogeneous-material threshold structure and Annex II substance list.
"maximum concentration values tolerated by weight in homogeneous materials"
More quoted passages
"keep the technical documentation and the EU declaration of conformity for 10 years"
"draw up an EU declaration of conformity and affix the CE marking"
"Lead (0,1 %)"
European Commission - RoHS Directive implementation
environment.ec.europa.eu5 citations
Referenced sections
  • Commission implementation source for RoHS exemption requests, renewals, and time-limited exemption context.
  • Commission implementation source explaining that RoHS exemptions are time-limited and subject to application or renewal.
  • Commission implementation source for exemption request and renewal process context.
Show 2 more
  • Commission source for checking whether an exemption request or renewal affects the material decision.
  • Commission implementation source for exemption timing and review context.
"Exemptions are limited in time"
European Commission - harmonised standards overview
single-market-economy.ec.europa.eu
Referenced sections
  • Official Commission overview for how harmonised standards and OJEU references support EU product-law conformity assessments.
"The references of harmonised standards must be published in the Official Journal of the European Union (OJEU)."

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