Commission Regulation (EU) 2025/1090 of 2 June 2025 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)

• CELEX: Regulation (EU) 2025/1090
• Articles: 3

Article 1

Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In Annex XVII to Regulation (EC) No 1907/2006, the following entries are added:

‘80. N,N -dimethylacetamide (DMAC)

CAS No 127-19-5

EC No 204-826-4

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/m 3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure.

2.

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.

3.

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.

81. 1-ethylpyrrolidin-2-one (NEP)

CAS No 2687-91-4

EC No 220-250-6

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/m 3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure.

2.

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.’