The European Commission has published, on November 19th, in the official Gazette, the complete text concerning the new restriction for the substance N,N-dimethylformamide (DMF). The introduction of DMF in the Annex XVII of the REACH Regulation, proposed in 2017 by Italian authorities, has been approved for the purpose of preventing risks for workers and supervising its use, thus far not adequately controlled.

This solvent, widely used in industries for the production of acrylic fibers, plastic, surface coatings, adhesives, paint removers, and much more, represent indeed a known danger for human health and, as a consequence, it’s classified as toxic to reproduction (Repr. 1B – H360D), noxious for skin contact and inhalation (Acute Tox. 4 – H312, H332) and eye irritant (Eye Irrit. 2 – H319).

As stated in the text of the new restriction, that will enter in force from 12 December 2023, at the end of a two years transition period, the DMF may no longer be placed on the market as a substance as such, as a constituent of other substances or in mixtures in a concentration equal to or greater than 0,3 % by weight; except where manufacturers, importers and downstream users have included in the chemical safety reports and safety data sheets the derived no-effect levels (DNEL) for worker exposure of 6 mg/m3 for inhalation exposure and 1,1 mg/kg/day for dermal exposure, or where appropriate risk management measures are taken and appropriate operating conditions are provided to ensure that the exposure of workers is lower than the DNEL specified above.

However, in order to facilitate certain sectors where the use of MFD is more firmly established and thus in view of the longer time required for companies to comply, the transitional period has been extended as follows:

  • Until 12 December 2024 as regards placing on the market for use, or use, as a solvent in direct coating or transfer processes for polyurethane coating of textile or paper materials or in the production of polyurethane membranes;
  • Until 12 December 2025 as regards the placing on the market for use as a solvent in the dry and wet spinning of synthetic fibers.

The proposed restriction for DMF and the final opinions of RAC and SEAC can be found on the ECHA website, at this link.