On June 3, 2025, the EU Official Journal published (EU) 2025/1090, which adds items --N and N-DMAC, N-NEP to Annex XVII of the EU REACH Regulation. These additions impose restrictions on these substances. The regulation will automatically become binding for all member states 20 days after its publication in the EU Official Journal, and it is binding and directly applicable to all member states.
Regulatory content
|
Item |
Substance |
CAS Number |
EC Number |
Requirement for Restriction |
|
80 |
N,N-DMAC |
127-19-5 |
204-826-4 |
(1) Unless the manufacturer, importer, and downstream users have included the no-effect levels (DNELs) related to worker exposure in the relevant chemical safety reports and safety data sheets, with long-term inhalation exposure at 13 mg/m³ and long-term skin contact at 1.8 mg/kg body weight/day, the substance shall not be marketed as a separate substance, as a component of other substances, or as a mixture with a concentration equal to or greater than 0.3% after December 23,2026. (2) From December 23,2026, if the concentration is equal to or higher than 0.3%, the substance shall not be manufactured or used as a single substance, as a component of other substances, or as a mixture, unless the manufacturer and downstream users have taken appropriate risk management measures and provided corresponding operating conditions to ensure that worker exposure levels are below the DNEL values specified in paragraph 1. (3) As an exception to paragraphs 1 and 2, for the market release or use of the substance as a solvent in the production of artificial fibers, the above obligations shall apply from June 23,2029. |
|
81 |
N-NEP |
2687-91-4 |
220-250-6 |
(1) Unless the manufacturer, importer, and downstream users include no-effect levels (DNELs) for worker exposure in the relevant chemical safety reports and safety data sheets, with long-term inhalation exposure at 4.0 mg/m³ and long-term skin contact at 2.4 mg/kg body weight/day, they must not be marketed as a separate substance, as part of another substance, or as a mixture with a concentration equal to or greater than 0.3% after December 23,2026. (2) After December 23,2026, unless the manufacturer and downstream users implement appropriate risk management measures and provide suitable operating conditions to ensure that worker exposure is below the DNELs specified in paragraph 1, they must not be produced or used as a separate substance, as part of another substance, or as a mixture with a concentration equal to or greater than 0.3%. |
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