by Ziannah Pasion
On June 23, 2025, EC Regulation 2025/1090 came into force, adding two new restriction entries to Annex XVII of REACH.
Two substances are subject to restriction: N,N-dimethylacetamide (DMAC) and N-ethyl-2-pyrrolidone (NEP), both with harmonized classification as toxic for reproduction type D (May damage the unborn child). They enter Annex XVII of REACH under entries 80 and 81 respectively.
| Entry | INDEX | Name | EC | CAS | Classification | H statement |
| 80 | 616-011-00-4 | N,N-dimethylacetamide (DMAC) | 204-826-4 | 127-19-5 | Repr. 1B Acute Tox. 4* Acute Tox. 4* | H360D*** H332 H312 |
| 81 | 616-208-00-5 | N-ethyl-2-pyrrolidone (NEP) | 220-250-6 | 2687-91-4 | Repr. 1B | H360D |
DMAC is a solvent widely used in the textile industry due to its solubility and properties of supporting certain chemical reactions.
NEP is a solvent used in a variety of industrial and retail settings, such as in washing and cleaning products, coating products, laboratory chemicals and polymers.
What do the new restrictions require?
DMAC and NEP may not be placed on the market or used on their own or as components of mixtures in concentrations equal to or greater than 0.3% (w/w) unless:
1. the following DNEL values have been entered in the chemical safety report and safety data sheet:
| Substance | Long-term exposure by inhalation | Long-term exposure dermal |
| DMAC | 13 mg/m3 | 1.8 mg/kg bw/d |
| NEP | 4.0 mg/m3 | 2.4 mg/kg bw/d |
2. and in addition, manufacturers and downstream users must adopt the appropriate risk management measures and operational conditions that ensure worker exposure below the values indicated above.
Application dates and derogations
The two restrictions apply from 23 December 2026.
For item 80 there is an exception: DMAC can be used and placed on the market without limits until 23 June 2029 only if used as a solvent in the production of man-made fibres. After this date, this application will also have to comply with the new restriction.
Implication for companies
Companies will need to revise their SDS and chemical safety reports to include the DNEL values set by the regulation, by the established dates. In places where these two substances are used or produced, employers should already start taking all the necessary measures aimed at protecting the health of workers by ensuring that the concentrations of DMAC and NEP do not exceed the values allowed by the regulation.
EPY is preparing an update that allows the imposed DNEL to be automatically brought into the SDSs.
It will be the responsibility of each company to verify that the risk management measures reported in section 8 are sufficient to ensure the maximum exposure values established, taking into account the exposure scenarios received from suppliers.
