Substance Restriction (Annex II Review)

Substance restriction under RoHS refers to the prohibition of restricted hazardous substances in homogeneous materials above maximum concentration values (MCVs) per Annex II of Directive 2011/65/EU. Under Article 6, the Commission may amend Annex II to add new substances following a review and assessment of available evidence. Directive (EU) 2025/2456 (December 12, 2025) significantly changes the process: ECHA is now formally entrusted with preparing restriction dossiers; restriction proposals may be prepared by Member States or by ECHA on Commission request; and Annex II must be reviewed at least once every four years.

Directive 2011/65/EU, Articles 5 and 6; Directive (EU) 2025/2456 (December 12, 2025).

The four-year mandatory Annex II review cycle introduced by Directive (EU) 2025/2456 creates a predictable timeline for potential new substance additions. Industry should actively monitor ECHA’s work programme and restriction proposals under development. When ECHA publishes a substance restriction dossier for consultation, the window for industry input is critical. Companies using substances potentially under consideration (e.g., TBBPA, MCCPs) should prepare substitution plans and engage in public consultations.