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Environmental News>

The European Commission has added N,N-dimethylformamide to the list of REACH Annex XVII

  • 2025-07-14

N,N-dimethylformamide (DMF) has reproductive and hepatotoxic properties, and long-term exposure can cause harm to human health.

N, N-二甲基甲醯胺 (N,N-dimethylformamide, DMF) 具有生殖毒性及肝毒性特性,在長期接觸下會對人體健康造成傷害。

This legal proposal was first proposed by the Italian government to the European Chemical Agency (ECHA) on October 5, 2018, to restrict the industrial use of this substance and its placing on the market as a substance or mixture. The purpose is to reduce the risks to human health posed by its use as a solvent.

After extensive consultation and discussion, the proposal was announced by the European Commission on November 19, 2021, officially adding N,N-dimethylformamide to Annex XVII of the REACH Regulation. It was newly added as item 76 in Annex XVII, restricting its use as a substance, as an ingredient in other substances, or in mixtures at a concentration equal to or greater than 0.3%. The regulation will take effect 20 days after its publication in the Official Journal.

The relevant regulations for N, N-dimethylformamide in REACH Annex 17 entry 76 are mainly described as follows:

化學物質 (群組)或混合物中之
化學物質名稱)
Designation of the substance, of the groups of substances or of the preparation
限制條件 (Conditions of Restriction)
76. N, N-二甲基甲醯胺
N,N-dimethylformamide
CAS No 68-12-2
EC. No 200-679-5
 
在2023年12月12日之後,不得作為單獨的物質、作為其他物質的成分或在混合物中濃度等於或大於0.3%的形式投放市場,除非製造商、進口商和下游用戶已將工人暴露的無效應劑量值(DNEL)吸入接觸為6 mg/m3and dermal exposure of 1.1 mg/kg/day as disclosed in the relevant chemical safety reports and safety data sheets. After December 12, 2023, it shall not be manufactured or used as a substance, as a component of other substances, or in mixtures at a concentration equal to or greater than 0.3%, unless manufacturers and downstream users implement appropriate risk management measures and provide an appropriate operating environment to ensure that worker exposure is below the DNEL specified in paragraph 1. As a derogation from paragraphs 1 and 2, the regulatory obligations shall apply from December 12, 2024, to solvents placed on the market or used in processes for direct or transfer polyurethane coating of textiles and paper, or in the production of polyurethane films, and from December 12, 2025, to solvents placed on the market or used in processes for dry and wet spinning of synthetic fibers.

Note: The above Chinese translation is for reference only. In case of any discrepancies, the original text of the regulations shall prevail.

SGS offers comprehensive testing and other services for REACH Annex XVII, allowing you to easily adapt to the new requirements and complete early deployment. SGS looks to the future with you. If you have any questions, please contact us.

Sources:EUR-Lex – European Union

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