The European Commission has added 2 new substances to Annex XVII of REACH. From 23.12.2026 operators who want to use these substances must meet the conditions described in the Annex.
In June, the European Commission published COMMISSION REGULATION (EU) 2025/1090 of 2 June 2025 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP).
The Regulation adds entries 80 and 81 to Annex XVII of the REACH regulation, which contains a list of restrictions on the manufacture, placing on the market and use of certain hazardous substances, mixtures and articles. This means that those who want to use substances in the EU must comply with the restrictions described in Annex XVII of REACH.
Therefore, their manufacture and use (as a substance or constituent of a mixture at a concentration of > 0.3%) will be prohibited after 23.12.2026, unless manufacturers and downstream users take the necessary risk management measures to ensure worker exposure levels below the following derived no-effect levels (DNELs):
DMAC: 13 mg/m3 (long-term inhalation exposure) and 1.8 mg/kg/day (long-term dermal exposure),
NEP : 4 mg/m3 (long-term inhalation exposure) and 2.4 mg/kg/day (long-term dermal exposure).
Ekotox Website: https://ekotox.eu/restrictions/
REACH Conference 2025: https://ekotoxtraining.com/events/reach-conference-2025/
