Regulatory information | EU REACH Regulation Annex XVII restricted substances added item 76

On November 22, 2021, the European Union issued the (EU) Regulation 2021/2030 in its official gazette, adding the restriction clause of item 76 of Annex XVII of REACH Regulation on N,N-dimethylformamide, and officially reducing N,N -Dimethylformamide is included in the REACH regulatory restriction list. The regulations will come into effect on the 20th day after the official gazette is published and will be directly applicable to all member states.

New substance information

N,N-dimethylformamide (English name: N,N-dimethylformamide)

CAS No: 68-12-2

EC. No: 200-679-5

Common uses and hazards

Uses: Mainly used as a reaction solvent, organic synthesis intermediate, used as a solvent in the production process of leather, PCB, textiles, paper, polyurethane materials and synthetic fibers.

Hazard: After the poison is absorbed through various ways, it is mainly demethylated by the mixed functional oxidase of the granular body in the liver, and a methyl group is removed. The metabolites are monomethylformamide and formamide. The metabolism is rapid. It stays in the blood for a little longer, and is then metabolized into formic acid and ammonia to be excreted. Part of the dimethylformamide is excreted in the urine and breath as the original substance. Irritating to eyes, skin and respiratory tract. After invading the body, it is mainly metabolized in the liver, the main target organ is the liver, and the kidneys are also damaged to some extent, which is toxic

Main restriction requirements

1. Starting from December 12, 2023, substances and substances and mixtures with a content of ≥0.3% of this substance shall not be placed on the market, unless manufacturers, importers and downstream users have already set the Derivative No Effect Level (DNEL) (inhalation) on workers’ exposure The exposure is 6 mg/m3 and the skin exposure is 1.1 mg/kg/day) listed in the relevant chemical safety report and safety data sheet.

2. Starting from December 12, 2023, substances and substances or mixtures containing the substance concentration ≥ 0.3% shall not be produced or used unless the manufacturer and downstream users adopt appropriate risk management measures and provide appropriate operating conditions to ensure Worker exposure is lower than the DNEL specified in paragraph 1.

3. As an exemption from paragraphs 1 and 2, the control date for direct or transferred polyurethane coating processes for textiles and paper materials or solvents in the production of polyurethane films will be extended to December 12, 2024. The control date for the market to be used as a solvent in the dry and wet spinning process of synthetic fibers has been extended to December 12, 2025.

Reminder

With the continuous update of the Annex XVII restriction list of REACH regulations, enterprises are facing more and more control requirements. ZRLK recommends that relevant enterprises increase their risk awareness of their products, pay attention to the update of the Annex XVII restriction list of REACH regulations in a timely manner, adjust production strategies, and ensure exports Products containing restricted substances comply with the latest regulatory requirements and avoid trade risks!