On June 3, 2025, the European Commission officially enacted Regulation (EU) 2025/1090, introducing new restrictions on the use of N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). This regulation amends Annex XVII (the list of restrictions) of the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation, (EC) No 1907/2006), which was originally adopted by the European Parliament and the Council on December 18, 2006.
Amendment Content
Substance | CAS No. | EC No. |
Restrictive Clause |
N,N-dimethylacetamide (DMAC) | 127-19-5 | 204-826-4 |
1.Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure. |
1-ethylpyrrolidin-2-one (NEP) | 2687-91-4 | 220-250-6 | 1.Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure. 2.Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.’ |
This regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union, shall have general binding force, and shall be directly applicable in all Member States.