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EU Approved Commission Regulation Amending Annex XVII to REACH Regulation (EC) No 1907/2006 as Entry 76 Regards N,N-dimethylformamide (DMF)

On 22 November 2021, the European Commission has published Commission Regulation (EU) 2021/2030 to amend Annex XVII to REACH Regulation (EC) No 1907/2006 regards N,N-dimethylformamide (DMF, CAS No. 68-12-2, also abbreviated to DMFa, DMFo).

N,N–dimethylformamide (DMF, CAS No. 68-12-2) is an organic solvent with a high production volume used in many industrial settings and professional activities across Europe. It has been classified as classified as toxic to reproduction 1B, acute toxicant 4 (inhalation and dermal route) and as an eye irritant 2 in accordance with EU CLP Regulation (EC) No 1272/2008. The substance was identified as SVHC (Substances of Very High Concern) in 2012.

The amendment shall enter into force on 12 December 2021 and apply after 12 December 2023.The substance N,N-dimethylformamide shall be newly added in Annex XVII (Entry 76), with the following restrictions:

  1. The substance 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 12 December 2023, 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 6 mg/m3 for exposure by inhalation and 1.1 mg/kg/day for dermal exposure.
  2. The substance 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 12 December 2023 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.
  3. By way of derogation, starting from 12 December 2024, the obligation related to placing on the market for use, or use, as a solvent in direct or transfer polyurethane coating processes of textiles and paper material or the production of polyurethane membranes shall be applied. Starting from 12 December 2025, the obligation related to placing on the market for use, or use, as a solvent in the dry and wet spinning processes of synthetic fibres shall be applied.

Note:
REACH Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles

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