New restrictions for N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)

On 3 June 2025, Regulation (EU) 2025/1090 was published in the Official Journal of the European Union. This regulation amends Annex XVII of REACH by requiring mandatory and detailed restrictions on the use and placing on the market of the following substances:

• N,N-Dimethylacetamide (DMAC) – CAS 127-19-5;
• 1-Ethylpyrrolidin-2-one (NEP) – CAS 2687-91-4.

These two substances are widely used in various industrial and professional contexts, e.g. in the formulation of mixtures of agrochemical and pharmaceutical products or in the production of polyamide-imide-based paints used for the insulation of electrical cables.

The need for this amendment stems from a dossier submitted by the Netherlands to the European Chemicals Agency on 22 April 2022, in accordance with Article 69(4) of Regulation (EC) No 1907/2006 and Annex XV. This dossier highlighted the need for measures at EU level that go beyond existing actions to limit the health risks for workers exposed to DMAC and NEP.

The Authority’s assessment focused on the systemic effects of these substances and on the derived no-effect levels (DNELs) calculated for various routes of exposure, both short-term and long-term. In particular, the following values were evaluated:

• long-term inhalation DNEL;
• long-term dermal DNEL;
• for NEP, an acute inhalation DNEL was also proposed by the dossier-submitting Member State.

Based on this assessment, the European Commission deemed the risk to workers from exposure to these substances unacceptable, and redefined the long-term DNEL values for both inhalation and dermal exposure at appropriate levels.

The new restrictions (n. 80 and 81) state that, as from 23 December 2026, DMAC and NEP:

- Must not be placed on the market in concentrations ≥0.3%
- Must not be used in industrial or professional settings, unless strict technical conditions (including harmonised DNELs) are met
- Must not be used for the production of synthetic or artificial fibers using DMAC (a transitional period applies until June 23, 2029 in this case)

Below is the list of the newly mandatory long-term DNEL values:

These values must be included in Safety Data Sheets (SDS) and Chemical Safety Reports. Furthermore, it will be necessary to demonstrate that operational conditions and risk management measures ensure exposure remains below the DNELs.

Companies are urgently required to:

- Review the regulatory status of substances currently in use
- Verify the adequacy of updated SDSs and REACH dossiers
- Implement appropriate technical measures (e.g., local exhaust ventilation, effective PPE)
- Communicate effectively throughout the supply chain (upstream and downstream)

Prompt action is required to avoid production disruptions, regulatory non-compliance, and health risks to workers.