REACH Restriction List Updated: Regulation (EU) 2025/1090
On 2 June 2025, the European Commission adopted Regulation (EU) 2025/1090. This regulation introduces new restrictions on the use of N,N-dimethylacetamide (DMAC) (CAS No. 127-19-5, EC No. 204-826-4) and 1-ethylpyrrolidin-2-one (NEP) (CAS No. 2687-91-4, EC No. 220-250-6). With this regulation, Annex XVII (Restriction List) of the EU REACH Regulation has been amended. About the Newly Added Substances N,N-dimethylacetamide (DMAC) DMAC is classified as a Category 1B reproductive toxicant and a Category 4 acute toxicant. The new update introduces the following restriction for DMAC: 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. 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. 3. 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. 1-ethylpyrrolidin-2-one (NEP) 1-ethylpyrrolidin-2-one (NEP) is classified as a Category 1B reproductive toxicant. The following restriction applies to NEP: 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. When Will the Regulation (EU) 2025/1090 Enter into Force? Regulation No (EU) 2025/1090 will enter into force on 23 June 2025, and companies are advised to begin preparations accordingly. In this regard, you can find the roadmap we have prepared for companies below. Roadmap for Companies Companies should identify whether DMAC and NEP are used in their products and create an inventory accordingly. For each product or process, it should be checked whether the concentration exceeds 0.3%, and updated SDSs should be requested from upstream manufacturers and importers. Chemical Safety Reports (CSRs) and SDSs should be updated to include the correct DNEL values, and exposure scenarios should be prepared. Necessary personal protective equipment (PPE) should be determined with occupational safety experts. Technical measures such as ventilation, closed systems, gloves, and masks should be implemented in production processes to reduce worker exposure below DNELs. Training documents and work instructions should be revised, and updated SDSs should be shared with customers and distributors. From 23 December 2026, the placing on the market and use of products containing ≥0.3% DMAC or NEP will be prohibited unless DNEL-compliant SDSs, CSRs, and exposure control measures are in place. Companies are strongly advised to be prepared. For companies using DMAC as solvents in the production of man-made fibres, the obligations described above will apply from 2029. For all other sectors, the transition period ends in 2026. Plan Your Compliance Process with Chemleg At Chemleg, we support companies with DNEL calculations, CSR updates, REACH-compliant SDS preparation, and more. You can schedule a meeting with us and start your compliance process immediately. Click here to fill out the form. Related Services