On 03 June 2025, the Official Journal of the European Union (OJ) published the amendment (EU) 2025/1090 to REACH Regulation (EC) No 1907/2006, which mainly amends Appendix 17 (Annex XVII) by adding new item 80 N,N-dimethylacetamide (DMAC) and item 81 N-ethylpyrrolidone ( N,N-Dimethylacetamide (DMAC) and N-Ethylpyrrolidone (NEP), and will enter into force on 23 June 2025.
Control requirements
80. N,N-Dimethylacetamide (DMAC)
CAS No 127-19-5 EC No 204-826-4
1. From 23 December 2026, DMAC shall not be placed on the market as a substance by itself, as a constituent of other substances, or in mixtures at concentrations greater than or equal to 0.3%. Unless the manufacturer, importer and downstream users have included a Derived No Effect Level (DNEL) of 13 mg/m3 for chronic inhalation exposure and 1.8 mg/kg bw/day for chronic dermal exposure in the relevant chemical safety reports and safety data sheets, which are relevant to worker exposure.
2. From 23 December 2026, DMAC shall not be manufactured or used as a substance by itself, as a constituent of other substances, or in mixtures at concentrations greater than or equal to 0.3%, unless the manufacturer and downstream users have taken appropriate risk management measures and provided adequate operating conditions to ensure that worker exposure is below the DNEL specified in paragraph 1.
3. By way of exemption from paragraphs 1 and 2, the obligations of the above two provisions will apply from 23 June 2029 to solvents placed on the market for use or used in the production of man-made fibres.
81.N-ethylpyrrolidone (NEP)
CAS No 2687-91-4 EC No 220-250-6
1. From 23 December 2026, NEP shall not be placed on the market as a substance by itself, as a component of other substances, or in mixtures at concentrations greater than or equal to 0.3%. Unless the manufacturer, importer and downstream users have included a Derived No Effect Level (DNEL) of 4.0 mg/m3 for chronic inhalation exposure and 2.4 mg/kg bw/day for chronic dermal exposure in the relevant chemical safety reports and safety data sheets related to worker exposure.
2. From 23 December 2026, NEP shall not be manufactured or used as a substance by itself, as a constituent of other substances, or in mixtures at concentrations greater than or equal to 0.3% unless the manufacturer and downstream users take appropriate risk management measures and provide suitable operating conditions to ensure that worker exposures are below the DNELs specified in paragraph 1.
Common Uses
DMAC and NEP are used by professionals in industrial environments as solvents in the formulation of mixtures, for example in agrochemicals, pharmaceuticals and fine chemicals. DMAC is used as a solvent in coatings and is widely used in the production of man-made fibres and films, as well as in the production of polyamideimide lacquers (varnishes) for wire insulation.NEP is used as a cleaning agent, as an adhesive and a release agent, and in oilfield drilling and production processes, functional fluids, polymer processing, water treatment, excipients for agrochemicals, and road and construction applications.
Suggestions for Response
Appendix 17 is part of the REACH regulation and one of the mandatory requirements for exporting to the EU. This update has a greater impact on the paint, cleaners, adhesives and other industries. Anbotek testing reminds the relevant enterprises to layout in advance, adjust the production formula in time to avoid the risk!
Post time: Jun-19-2025
