Europe - REACH Annex XVII Entry 80 DMAC and Entry 81 NEP (NEW)

On June 3, the EU Commission published Regulation (EU) 2025/1090, which amends Annex XVII of Regulation (EC) No 1907/2006 with regard to N,N-dimethylacetamide (DMAC) and 1-ethyl-3-pyrrolidinyl-2-propanol (NEP).

The amendment includes two new entries for N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)

N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) are dipolar aprotic solvents. DMAC is listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council(2)as toxic to reproduction category 1B based on developmental toxicity and as acute toxic category 4. NEP is listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as toxic to reproduction category 1B based on developmental toxicity.

Entry 80 - N,N-dimethylacetamide (DMAC) - CAS No 127-19-5

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 December 23, 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.

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 December 23, 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.

3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from June 23, 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres.

Entry 81 - 1-ethylpyrrolidin-2-one (NEP) - CAS No 2687-91-4

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 December 23, 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 December 23, 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.​