| Targeted audience | EU/EEA manufacturers, EU/EEA importers and their upstream providers |
| Products concerned | Substances, mixtures |
| Key industries concerned with this insight | Chemicals |
| Application date | 24 December 2026 |
| Main content or requirements |
On 3 June 2025, the EU amended REACH Annex XVII by adding Entries 80 and 81 to restrict N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) in substances and mixtures. The DMAC and NEP content limits are 0.3% (3000 mg/kg) each, unless derived no-effect levels (DNELs) have been included in relevant chemical safety reports and safety data sheets and/or the exposure of workers to DMAC and NEP has been demonstrated to be below the derived no-effect levels (DNELs) |
| Reference | Click here |
On 3 June 2025, the European Commission approved and published Commission Regulation (EU) 2025/1090 to add Entry 80 and Entry 81 to Annex XVII to the EU REACH Regulation (EC) No 1907/2006, which restrict N,N-dimethylacetamide (DMAC, CAS No. 127-19-5) and 1-ethylpyrrolidin-2-one (NEP, CAS No. 2687-91-4) respectively, in substances and mixtures to be placed on the EU market. The amendment shall enter into force on 23 June 2025 and will apply after 23 December 2026.
N,N-Dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) shall not be placed on the EU 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% (3000 mg/kg) each, unless EU 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 (4 mg/m3 for NEP) for long-term exposure by inhalation and 1.8 mg/kg bw/day (2.4 mg/kg bw/day for NEP) for long-term dermal exposure.
Besides, the two substances 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% (3000 mg/kg) unless EU 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 above.
For N,N-dimethylacetamide (DMAC) for use, or use, as a solvent in the production of man-made fibres, the above obligations will apply from 23 June 2029.
N,N-Dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) are solvents, which were used in the formulation of mixtures, for example in agrochemicals, pharmaceuticals and fine chemicals. DMAC is also used as a solvent in coatings and is extensively used in the production of man-made fibres and films and during the production of polyamide-imide enamels (varnishes) used for electrical wire insulation. NEP is applied in cleaning agents and as a binder and a release agent. NEP is also used in oil field drilling and production operation processes, in functional fluids, in polymer processing, in water treatment, as an excipient in agrochemicals and in road and construction applications. Both substances are classified as toxic to reproduction category 1B (Repr. 1B) in the EU CLP Regulation (EC) No 1272/2008.
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