Hua test has patted you | Attention! N, N-dimethylformamide (DMF) is proposed to be included in the REACH regulation restrictions

European Union plans to include N, N-dimethylformamide in REACH regulation

On September 24, 2020, the European Union submitted notification G/TBT/N/EU/749 to the WTO, proposing to include N, N-dimethylformamide (DMF) in the control of Annex XVII (Restrictions) of the REACH Regulation.

Background

The notification began with a proposal submitted by Italy to the European Chemicals Agency on 5 October 2018 to restrict the industrial and professional use of DMF.

On 20 September 2019, the Authority's threat and risk assessment committee (RAC) adopted its Opinion No. 4 on the DMF.

On December 5, 2019, the Authority's Socio-Economic Analysis Committee (SEAC) adopted its Opinion No. 5 on the DMF.

On 1 April 2020, the Authority submitted the RAC and SEAC comments to the Commission.

The above observations confirm that risks to workers' health in all occupational settings are not adequately controlled during the production and use of DMF.

Material Information

N, N - dimethylformamide

CAS No.: 68-12-2

EC. No.: 200-679-5

According to Regulation (EC) 1272/2008, DMF is an aprotic medium-polar organic solvent classified as Category 1B - Reproductive Toxic, Category 4 - Acute Toxic Substances (Inhalation and Skin Routes) and Category 2 - Eye Irritants.

Main Limitations

  • Not to be placed on the market as a substance alone, as a component of other substances, or in mixtures at concentrations equal to or greater than 0.3%, unless manufacturers, importers and downstream users have listed no effect levels (DNELs) of 6 mg/m3 inhalation exposure and 1.1 mg/kg/day dermal exposure to workers in relevant chemical safety reports and safety data tables.
  • Not to be placed on the market as a substance alone, as a component of other substances, or in mixtures at concentrations equal to or greater than 0.3%, unless the manufacturer and downstream users take appropriate risk management measures and provide appropriate operating conditions to ensure that worker exposure is below the no-effect levels (DNELs) specified in paragraph 1.

This amendment will be implemented after 24 months of entry into force.

Note: DNELs: Derived No-Effect Levels, Derived No-Effect Levels.

DMF Use

DMF is a high-yield substance used in many industrial environments and professional activities in Europe. It is both a very versatile chemical raw material and an excellent solvent for a wide range of uses.

In the petrochemical industry, dimethylformamide can be used as a gas absorber to separate and purify gases; in organic reactions, dimethylformamide is not only widely used as a reaction solvent, but also an important intermediate in organic synthesis.

DMF has been included in the SVHC eighth batch candidate list in December 2012, with a threshold of 0.1%. Articles exceeding the threshold shall be subject to the obligation to notify ECHA and inform downstream users when entering the European market.

CTI testing recommendations

According to the content of this WTO notification, it is recommended that enterprises pay attention to the impact of DMF on workers' health and safety during use.

It is foreseeable that law enforcement agencies will increase the control and enforcement of carcinogens such as N, N-dimethylformamide. Enterprises should investigate the compliance of N, N-dimethylformamide in materials as soon as possible in combination with the control of regulations to ensure that the materials placed on the market meet the control requirements of regulations and avoid economic losses caused by violations after the materials are placed on the market.