EU Extends Chemical Regulations to Embrace DMAC and NEP under REACH Annex XVII

The European Commission announced updates to Annex XVII of the REACH Regulation with new restrictions on N,N-dimethylacetamide (DMAC) and N-ethylpyrrolidone (NEP). It submitted Notification G/TBT/N/EU/1079 to the WTO on July 30, 2024. These changes are set to take effect 20 days after publication in the EU Official Journal.

Annex XVII restricts the use of certain hazardous chemicals in the EU market. The inclusion of DMAC and NEP will subject these chemicals to strict regulatory oversight, ensuring that all products containing them, whether produced or sold in the EU, meet stringent safety standards to protect health and the environment.

The specific updates are as follows.

Substance name	CAS No./ EC No.	Restrictive measure
Dimethylacetamide (DMAC)	127-19-5 204-826-4	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 [date] unless manufacturers, importers and downstream users have included in the 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 0.53 mg/kg/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 [date as in paragraph 1] unless manufacturers and downstream users take the appropriate risk management measures and take the appropriate operational conditions to ensure that exposure of workers is below both the DNELs specified in paragraph 1.
1-ethyl-2-pyrrolidinon (NEP)	2687-91-4 220-250-6	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 [date] unless manufacturers, importers and downstream users have included in the 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 and 4.6 for acute exposures by inhalation and 2.4 mg/kg/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 [date as in paragraph 1] unless manufacturers and downstream users take the appropriate risk management measures and take the appropriate operational conditions to ensure that exposure of workers is below both the DNELs specified in paragraph 1.

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