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REACH Appendix XVII adds restricted substances DMAC and NEP
Author.
LCS
Source:
Post time:
2025-07-22
On June 3, 2025, the European Union published the revised EU 2025/1090 in its official journal, adding Articles 80 and 81 to Annex XVII of REACH to restrict N, N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) in substances and mixtures. This amendment will come into effect on June 23, 2025.
The newly added terms are as follows:
one
N. N-Dimethylacetamide (DMAC)
(N,N-dimethylacetamide (DMAC))
CAS number: 127-19-5
EC number: 204-826-4
After December 23, 2026, DMAC shall not be placed on the market as a standalone substance, as an ingredient of other substances, or as a mixture with a concentration ≥ 0.3%, unless the manufacturer, importer, and downstream user include a derived no effect level (DNEL) related to worker exposure in the relevant chemical safety report and safety data sheet, which is a DNEL of 13mg/m ³ for long-term inhalation exposure and 1.8mg/kg bw/day for long-term skin exposure.
2. After December 23, 2026, DMAC shall not be manufactured or used alone as a substance, as a component of other substances, or in a mixture with a concentration ≥ 0.3%, unless the manufacturer and downstream users have taken appropriate risk management measures and provided appropriate operating conditions to ensure that workers' exposure is below the DNEL specified in paragraph 1.
two
1-Ethylpyrrolid-2-one (NEP)
(1-ethylpyrrolidin-2-one (NEP))
CAS number: 2687-91-4
EC number: 220-250-6
1. After December 23, 2026, NEP shall not be placed on the market as a standalone substance, as an ingredient of other substances, or as a mixture with a concentration ≥ 0.3%, unless manufacturers, importers, and downstream users include a derivative no effect level (DNEL) related to worker exposure in relevant chemical safety reports and safety data sheets, i.e. a DNEL of 4.0 mg/m ³ for long-term inhalation exposure and 2.4 mg/kg bw/day for long-term skin exposure.
After December 23, 2026, NEP shall not be placed on the market as a standalone substance, as a component of other substances, or as a mixture with a concentration ≥ 0.3%, unless manufacturers and downstream users take appropriate risk management measures and provide appropriate operating conditions to ensure that workers' exposure is lower than the DNEL specified in paragraph 1.
LCS Tips:
With the continuous updating of the REACH regulation restrictions, enterprises are facing more and more control requirements. Enterprises need to improve their risk awareness of their products. After the substance is listed in the restrictions, enterprises within their control scope need to actively respond. It is recommended that enterprises investigate their supply chain as soon as possible to cope with regulatory changes calmly.
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