REACH: EU restricts the use of two reprotoxic solvents in industrial applications

On June 3, 2025, the European Commission published a new regulatory measure that strengthens the protection of occupational health against hazardous chemical substances. Regulation (EU) 2025/1090 officially includes two industrial solvents—N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)—in Annex XVII of the REACH Regulation, marking their prohibition for certain uses as of December 23, 2026.

Both substances are classified as toxic to reproduction (category 1B) under the CLP Regulation (EC No. 1272/2008), which poses a serious risk to human fertility and embryonic development. Their current use is primarily in industrial settings, particularly in the formulation of agrochemicals, pharmaceuticals, and specialized chemicals.

Table of contents

1. What does this restriction entail?

2. What should companies do?

3. A clear sign of regulatory tightening

REACH: EU restricts the use of two reprotoxic solvents in industrial applications

What does this restriction entail?

The measure establishes that, starting in December 2026, DMAC and NEP may not be marketed or used in concentrations equal to or greater than 0.3% unless:

• DNEL limit values are included in safety data sheets (SDS) and chemical safety reports;

• Effective risk management measures are implemented in the workplace;

• Ensure that worker exposure remains below the specified DNEL values.

The defined DNEL values are as follows:

Substance	DNEL Inhalation	Dermal DNEL
DMAC	13 mg/m³	1.8 mg/kg bw/day
NEP	4.0 mg/m³	2.4 mg/kg bw/day

For very specific uses, such as the production of artificial fibers using DMAC as a solvent, the regulation allows for an additional period of adaptation: until June 2029.

What should companies do?

Manufacturers, importers, and downstream users should urgently review their mixtures and processes if they work with these substances. It will be essential to:

• Evaluate the concentrations present in marketed or used products;

• Adapt SDSs to updated requirements;

• Apply appropriate technical controls and specific training to personnel;

• Re-evaluate the feasibility of use or consider safer substitutions.

A clear sign of regulatory tightening

This decision is part of a growing trend in European chemical policy: strengthening regulations on CMR substances (carcinogenic, mutagenic, or reprotoxic), especially those still widely used in key sectors. The Commission has emphasized that the protection of workers and the environment is a priority in the upcoming comprehensive reform of REACH, scheduled for 2026.