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EU proposes to include DMAC and NEP in REACH regulation

Time：

2024-08-02

The EU proposes to include N, N-dimethylacetamide (DMAC) and N-ethylpyrrolidone (NEP) in the REACH regulation.

On July 30, 2024, the European Commission submitted a notification G/TBT/N/EU/1079 to the TBT Committee of the WTO, proposing to update Annex XVII of the REACH regulation to add restrictive measures for N, N-dimethylacetamide (DMAC) and N-ethylpyrrolidone (NEP), as follows:

Material name

Restriction requirements

N,N-dimethylacetamide

(DMAC)

CAS No 127-19-5

EC No 204-826-4

1. After [OP, please insert date: 18 months after the effective date of this regulation], it shall not be placed on the market as a standalone substance, as a component of other substances, or as a mixture with a concentration equal to or greater than 0.3%, unless the manufacturer, importer, and downstream user have included a no effect level (DNEL) related to worker exposure in the relevant chemical safety reports and safety data sheets, which is 13 mg/m3 for long-term inhalation exposure and 1.8 mg/kg body weight/day for long-term skin exposure.

2. Unless manufacturers and downstream users have taken appropriate risk management measures and provided appropriate operating conditions to ensure that workers' exposure to DNELs is lower than that specified in paragraph 1, it shall not be produced or used as a substance alone, or as a component of other substances, or in mixtures with a concentration equal to or greater than 0.3% after [OP, insert date: 18 months after the effective date of this regulation].

3. As an exemption from paragraphs 1 and 2, the obligations stipulated therein shall apply from [OP, insert date: 48 months after the entry into force of this regulation] to the use on the market or as solvents in the production of artificial fibers.

1-ethylpyrrolidin-2-one

(NEP)

CAS No 2687-91-4

EC No 220-250-6

After [OP, please insert date: 18 months after the effective date of this regulation], it shall not be placed on the market as a standalone substance, as a component of other substances, or as a mixture with a concentration equal to or greater than 0.3%, unless the manufacturer, importer, and downstream user have included a no effect level (DNEL) related to worker exposure in the relevant chemical safety reports and safety data sheets, with a long-term inhalation exposure of 4.0 mg/m3 and a long-term skin exposure of 2.4 mg/kg body weight/day.

1. After [OP, insert date: 18 months after the effective date of this regulation], unless the manufacturer and downstream users have taken appropriate risk management measures and provided appropriate operating conditions to ensure that workers' exposure to DNELs is lower than that specified in paragraph 1, it shall not be produced or used as a substance alone, or as a component of other substances, or in mixtures with a concentration equal to or greater than 0.3%.

DMAC and NEP applications

DMAC and NEP are used by professionals as solvents in mixture formulations in industrial environments, such as in agricultural chemicals, pharmaceuticals, and fine chemicals. DMAC is also used as a solvent for coatings, widely used in the production of synthetic fibers and films, as well as in the production of polyamide imide paints (varnishes) for wire insulation. NEP is applied in cleaning agents and serves as an adhesive and release agent. NEP is also used in oilfield drilling and production processes, functional fluids, polymer processing, water treatment, auxiliary materials for agricultural chemicals, as well as road and building applications.