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REACH Annex XVII adds restrictions on DMAC and NEP

2025-07-08

On June 3, 2025, the European Commission published in its Official Journal the amending Regulation (EU) 2025/1090 to Annex XVII (Restrictions, Annex 17) of the REACH Regulation, adding item 80, N,N-dimethylacetamide (DMAC), and item 81, 1-ethylpyrrolidin-2-one (NEP), to Annex 17 of the REACH Regulation.

The new provisions are as follows:

Reference Link: [ECHA News][Original text of regulations]

Restricted Background

DMACBoth N,N-dimethylacetamide (DMAC) and NEP (1-ethylpyrrolidone) are dipolar aprotic solvents commonly used in the production of various formulations, including agrochemicals, pharmaceuticals, and fine chemicals. DMAC is also used as a coating solvent and is widely used in the production of man-made fibers and films, as well as in the production of wire insulation varnishes. NEP can be used as a cleaning agent, adhesive, and release agent. Under EU CLP Regulation (EC) No. 1272/2008, DMAC is classified as a Category 1B reproductive toxicant and a Category 4 acute toxicant, while NEP is classified as a Category 1B reproductive toxicant.

The restriction proposal points out that the health risks of DMAC (N,N-dimethylacetamide) and NEP (1-ethylpyrrolidone) used in industrial and professional applications, particularly those involving high-temperature processes, open processes, and processes requiring manual operation, are not adequately controlled. Therefore, the restriction report proposes setting binding derived no-effect levels (DNELs) for the exposure risks of these two substances through inhalation and dermal contact as the best risk management option.

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