EU Publishes REACH Restriction on DMAC and NEP Due to Reproductive Toxicity

On 3 June 2025, the European Commission published Commission Regulation (EU) 2025/1085 in the Official Journal of the European Union. The regulation introduces a new restriction under Annex XVII to REACH, targeting two aprotic solvents: N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). These substances are classified as toxic to reproduction and are widely used in industrial applications, prompting regulatory action to mitigate risks to workers and unborn children.

Substances of Concern

DMAC (CAS No. 127-19-5) and NEP (CAS No. 2687-91-4) are classified as reproductive toxicants (Category 1B) under the CLP Regulation, indicating a high level of concern for human health. These substances are commonly used as solvents in the chemical and textile industries, and there is potential for harmful exposure through inhalation and dermal contact.

New Restriction under Annex XVII

From 23 December 2026, placing DMAC and NEP on the market, manufacturing them, and using them in concentrations ≥ 0.3% will only be permitted if strict conditions are met. Companies must:

• Demonstrate that worker exposure is kept below the Derived No-Effect Levels (DNELs) for inhalation and dermal routes.

• Implement and maintain appropriate risk management measures and operational controls.

Additional Ban on Use in Fibre Production

A further restriction applies specifically to DMAC used as a solvent in the manufacture of man-made fibres. This use will be fully prohibited after 23 June 2029, irrespective of any exposure controls.

Health and Regulatory Objectives

The restriction supports the EU’s objective of protecting workers and vulnerable populations from hazardous chemicals. It also aligns with the EU Chemicals Strategy for Sustainability, promoting safer chemical use and a toxic-free environment.

The full text of the regulation can be found here.