On 2nd June 2025, the European Commission adopted Regulation (EU) 2025/1090 concerning two dipolar aprotic solvents, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). It amends Annex XVII of Regulation 1907/2006 (REACH) of the European Parliament and of the Council.
In particular, Restriction 80 concerns the substance N,N-dimethylacetamide (DMAC) (CAS 127-19-5; EC 204-826-4) and states that DMAC may not be placed on the market as a substance on its own or as a component of other substances or mixtures in a concentration of 0,3% or more, unless manufacturers, importers and downstream users include in the CSAs (Chemical Safety Assessments) and SDSs of their products a DNEL (Derived No-Effect Levels) for worker exposure of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure.
Meanwhile, Restriction 81 concerns the substance 1-ethylpyrrolidin-2-one (NEP) (CAS 2687-91-4; EC 220-250-6) and states that NEP may not be placed on the market, either on its own or as a constituent of other substances or mixtures, in a concentration equal to or greater than 0.3%, unless manufacturers, importers and downstream users include in the CSA and SDS of their products a DNEL for worker exposure of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure.
Regulation 2025/1090 entered into force on 23 June 2025 and will apply after 23 December 2026
Traceone has planned a regulatory analysis in this regard and will keep you updated.
For more information on Regulation 2025/1090, see the following link: