Last week, on June 2nd 2025, The European Commission has adopted a restriction on DMAC and NEP by the Commission Regulation (EU) 2025/1090 amending Annex XVII to REACH Regulation (EC) 1907/2006 of the European Parliament and of the Council.
N,N-dimethylacetamide (DMAC), with CAS 127-19-6/ EC 204-826-4 is listed in Part 3 of Annex VI to CLP Regulation as toxic substance to reproduction category 1B based on developmental toxicity and as acute toxic substance, category 4.
DMAC is a dipolar aprotic solvent used for many organic reactions and industrial applications. It is miscible with water, ethers, esters, ketones and aromatics compounds. DMAC is used in the production of polyacrylonitrile and polyurethane based fibers, films and coatings. The polar nature of DMAC enables it to act as a combined solvent and reaction catalyst in many reactions producing high yields and pure product in short time periods.
1-Ethyl-2-pyrrolidone (NEP), with CAS 2687-91-4/ EC 220-250-6 is listed in Part 3 of Annex VI to CLP Regulation as toxic substance to reproduction category 1B. NEP is a polar, aprotic solvent known for its high solubility, low vapor pressure, and low dielectric constant. It’s used in various applications, including as a selective solvent, catalyst, and cationic surfactant. In the industry is used in refining oil products, producing drugs, dyes, pesticides, daily chemicals, coatings, and resins. It’s also used as a transdermal absorption-enhancing compound and for modifying coir fiber.
On 22 April 2022, the Netherlands (‘the dossier submitter’) submitted to the ECHA a dossier pursuant to Article 69(4) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’), in order to initiate the restriction process set out in Articles 69 to 73 of the REACH Regulation.
The Annex XV dossier demonstrated that action on a Union-wide basis was necessary to address risks to the health of workers exposed to DMAC and NEP. It proposed to restrict the manufacture, use, as well as placing on the market of DMAC and NEP on their own, as constituents of other substances or in mixtures.
The dossier submitter based its hazard assessment of DMAC and NEP on the systemic effects of the substances on several endpoints.
One year later, on 13 March 2023, the RAC (Risk Assessment Committee of the ECHA) confirms that a risk to human health is not adequately controlled for several industrial and professional uses of DMAC and NEP. The RAC concluds that the proposed restriction, as modified by them, is the most appropriate Union-wide measure to address the identified risks arising from exposure to DMAC and NEP in terms of its effectiveness in reducing the risk, its practicality and monitorability.
DMAC assessments:
* RAC agreed with the long-term inhalation DNEL of 13 mg/m3 based on animal data on developmental toxicity,
* RAC did not agree with the long-term dermal DNEL based on increased relative liver weight in rats.
* RAC recommended a long-term dermal DNEL of 1,8 mg/kg bw/day derived from animal data on oral prenatal developmental toxicity study in rats.
NEP assessments:
- RAC agreed with a long-term inhalation DNEL of 4,0 mg/m3 based on an oral 90-day toxicity study
- RAC agreed with a long term dermal DNEL of 2,4 mg/kg bw/day based on an animal liver toxicity data observed in a 90-day oral toxicity study.
RAC concluded that an indicative occupational exposure limit (OEL) of 36 mg/m3 for DMAC established at Union level in accordance with Commission Directive 2000/39/EC, which became a binding OEL under Directive (EU) 2022/431 of the European Parliament and of the Council is outdated and higher than the DNELs proposed by RAC. There is no binding OEL for NEP.
Three monyhs later, on 9 June 2023, the SEA (Socio-Economic Analysis Committe) concluded that the proposed restriction, as modified by RAC, is the most appropriate Union-wide measure to address the risk to the health of workers arising from DMAC and NEP, taking into account its socioeconomic benefits and costs.
On 31 August 2023, the ECHA submitted the opinions of RAC and SEAC to the Commission. The opinions confirmed that there is a risk to the health of workers in the manufacture and use of DMAC and NEP, which is not adequately controlled.
Looking for all above, in Annex XVII to REACH Regulation, the following entries are added:
For DMAC:
1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure.
- Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.
- By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres.
For NEP:
1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure.
- Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.’
