EU RoHS Directive Restricted Substances and Thresholds

Annex II to Directive 2011/65/EU lists the restricted substances referred to in Article 4(1) and the maximum concentration values tolerated by weight in homogeneous materials. The threshold is checked against each relevant homogeneous material in the EEE, not against the total product weight.

The current consolidated Annex II list contains six original RoHS substance groups and four phthalates added by Commission Delegated Directive (EU) 2015/863. Treat the phthalates as separate 0.1% checks, especially for polymer, cable, insulation, adhesive, and flexible-plastic materials.

Directive 2011/65/EU defines a homogeneous material as one material of uniform composition throughout, or a combination of materials that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes. That definition is the reason a compliant assembly can still contain a nonconforming solder, coating, plastic, alloy, or cable insulation material.

For a release review, break the product into the materials that can reasonably carry each restricted substance. Then compare each material-substance result, declaration, or exemption claim to the applicable Annex II value.

A useful RoHS threshold record lets a reviewer trace the conclusion from the finished EEE to the homogeneous materials that carry Annex II risk. A supplier statement that only says "RoHS compliant" is weaker than evidence that identifies the part, material, revision, substance, threshold, exemption if any, and assessment method.

Commission Implementing Decision (EU) 2020/659 publishes EN IEC 63000:2018 as the harmonised standard for technical documentation required for assessing materials, components, and EEE against RoHS restricted-substance requirements. The technical file should connect declarations, material assessment, selected testing, exemption use, CE marking, and the EU declaration of conformity.

The four RoHS phthalates are in Annex II at 0.1%, but their application rules include transition and overlap caveats. Delegated Directive (EU) 2015/863 states that the DEHP, BBP, DBP, and DIBP restrictions apply to medical devices, in vitro medical devices, and monitoring and control instruments from 22 July 2021.

The same Annex II text states that the DEHP, BBP, DBP, and DIBP restrictions do not apply to certain cables or spare parts for repair, reuse, functional updating, or capacity upgrading of EEE placed on the market before 22 July 2019, or of medical devices and monitoring/control instruments placed on the market before 22 July 2021. It also states that the DEHP, BBP, and DBP RoHS restriction does not apply to toys already subject to the corresponding REACH Annex XVII entry.