On June 3, 2025, European Commission announced the addition of N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) to the Restriction List under REACH (Annex XVII to Regulation (EC) No 1907/2006). This amendment was published in the Commission Regulation (EU) 2025/1090 on the Official Journal of the European Union. It will come into force on June 23, 2025.
DMAC and NEP are used in industrial settings and by professionals as solvents in the formulation of mixtures, for example in agrochemicals, pharmaceuticals and fine chemicals. According to Regulation (EC) No 1272/2008, both DMAC and NEP are classified as toxic to reproduction, category 1B.
According to the new regulation, an 18-month transitional period will be provided for stakeholders to fully implement the restriction requirements. The restriction details are shown below:
| Substance name | Details |
80. N,N-dimethylacetamide (DMAC) CAS No 127-19-5 EC No 204-826-4 | 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. 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. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres.
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81. 1-ethylpyrrolidin-2-one (NEP) CAS No 2687-91-4 EC No 220-250-6 | 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, 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. 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.
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