I. Two New Restricted Substances Added to the REACH Restriction List
On June 2, 2025, the European Commission officially adopted Regulation (EU) 2025/1090, imposing new restrictions on the use of N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). This regulation amends Annex XVII (Restriction List) of the Regulation of the European Parliament and the Council of December 18, 2006, concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH Regulation, (EC) No 1907/2006).
Background
DMAC plays a crucial role in the formulation of agrochemicals, pharmaceuticals, and fine chemical mixtures. It is indispensable in the production of artificial fibers, films, and high-performance insulating paints. NEP is widely used in cleaning agents, oil field exploitation, and polymer processing, among other fields. Both DMAC and NEP are strong polar non-protonic solvents and are classified as Category 1B reproductive toxicants, posing a potential threat to the human reproductive system. DMAC is also listed as a Category 4 acute toxicant.
Revisions
The following entries have been added to the restriction list of (EC) No 1907/2006:
Substance | CAS No & EC No | Restrictive Clause |
80. N,N-dimethylacetamide (DMAC) | CAS No 127-19-5 EC No 204-826-4 | 1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. 3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres. |
81. 1-ethylpyrrolidin-2-one (NEP) | CAS No 2687-91-4 EC No 220-250-6 | 1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. |
This regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union, shall have general binding force, and shall be directly applicable in all Member States.
Further Information
II. Public Consultation to Be Launched on Three SVHC Candidate Substances
In May 2025, the European Chemicals Agency (ECHA) recently announced that it has received intention notices for the inclusion of three chemicals in the candidate list of Substances of Very High Concern (SVHC). Currently, the SVHC Candidate list contains a total of 247 substances, please view the full list via Chemradar.
The specific substances and related information are as follows:
No. | Chemical Name | EC No. | CAS No. | Estimated Submission Date |
1 | 4,4'-methylenediphenol | 210-658-2 | 620-92-8 | August 2025 |
2 | 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF) and its salts | - | - | August 2025 |
3 | 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]（DBDPE） | 284-366-9 | 84852-53-9 | June 2025 |
To promote the SVHC identification process for DBDPE, ECHA will organize a dedicated public consultation. This measure aims to support the restriction efforts on brominated flame retardants and aligns with the potential timeline of the revision of the Classification, Labelling and Packaging (CLP) Regulation. According to the announcement, the consultation is expected to start on June 27, 2025, and the deadline is August 11, 2025.
Further Information
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