Annex II (Restricted Substances and Maximum Concentration Values)

Annex II of Directive 2011/65/EU lists the ten restricted hazardous substances and their maximum concentration values (MCVs) in homogeneous materials. The ten substances and their MCVs are: Lead (Pb): 0.1% (1000 ppm); Mercury (Hg): 0.1% (1000 ppm); Cadmium (Cd): 0.01% (100 ppm); Hexavalent chromium (Cr⁶⁺): 0.1% (1000 ppm); Polybrominated biphenyls (PBBs): 0.1% (1000 ppm); Polybrominated diphenyl ethers (PBDEs): 0.1% (1000 ppm); Bis(2-ethylhexyl) phthalate (DEHP): 0.1% (1000 ppm); Butyl benzyl phthalate (BBP): 0.1% (1000 ppm); Dibutyl phthalate (DBP): 0.1% (1000 ppm); Diisobutyl phthalate (DIBP): 0.1% (1000 ppm). Directive (EU) 2025/2456 (December 12, 2025) requires the Annex II substance list to be reviewed by ECHA at least once every four years.

Directive 2011/65/EU, Article 4 and Annex II; Directive 2015/863/EU (adding four phthalates); Directive (EU) 2025/2456 (December 12, 2025, mandating regular ECHA review).

All EEE manufacturers and importers must ensure no homogeneous material in their products contains any Annex II substance above the applicable MCV. The MCV applies per homogeneous material, not per component or product. Technical documentation must include evidence of compliance (supplier declarations, test reports) for each substance per material. The Cd limit (0.01%) is ten times stricter than the other substances. The four phthalates (DEHP, BBP, DBP, DIBP) were added by Directive 2015/863/EU with full application from July 22, 2019.