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EU REACH Annex XVII adds two new restricted substances

Time：

2025-06-04

The EU REACH Annex XVII has added Articles 80 and 81, which respectively impose restrictions on N, N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP).

On June 3, 2025, the European Union issued the revised REACH regulation (EU) 2025/1090, which added Articles 80 and 81 to Annex XVII of REACH, respectively, imposing restrictions on N, N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP). The revised regulation will come into effect 20 days after publication.

01. Add main content

Term

Restriction Requirements

80. N, N-dimethylacetamide (DMAC)

CAS number: 127-19-5

EC number: 204-826-4

1. Unless manufacturers, importers, and downstream users include no effect levels (DNELS) related to worker exposure in relevant chemical safety reports and safety data sheets, with a long-term inhalation exposure of 13mg/m ³ and a long-term skin exposure of 1.8mg/kg body weight/day, they 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% after December 23, 2026.

Starting from December 23, 2026, if the concentration is equal to or higher than 0.3%, the substance shall not be used as a single substance, as a component of other substances, or manufactured or used in the form of a mixture, unless the manufacturer and downstream users have taken appropriate risk management measures and provided corresponding operating conditions to ensure that the worker's exposure level is below the DNEL value specified in paragraph 1.

3. As an exception to paragraphs 1 and 2, the above obligation applies from June 23, 2029, for the market release or use of the substance as a solvent in the production of artificial fibers.

81.1-Ethylpyrrolid-2-one (NEP)

CAS number: 2687-91-4

EC number: 220-250-6

1. Unless manufacturers, importers, and downstream users include no effect levels (DNELs) related to worker exposure in relevant chemical safety reports and safety data sheets, with long-term inhalation exposure of 4.0 mg/m ³ and long-term skin exposure of 2.4 mg/kg body weight/day, they 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% after December 23, 2026.

2. After December 23, 2026, it shall not be produced or used 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 manufacturers and downstream users take appropriate risk management measures and provide appropriate operating conditions to ensure that workers' exposure is below the DNELs specified in paragraph 1.

02. Introduction to REACH Appendix XVII

EU REACH Appendix XVII - Restrictions on the manufacture, placing on the market, and use of certain hazardous substances, mixtures, and articles.

REACH Appendix XVII (Restriction) is a tool used by the European Union to protect public health and the environment from unacceptable risks posed by chemicals. According to Article 67.1 of the REACH regulation, when a chemical substance is included in Annex XVII (Restriction) of the EU REACH for restriction control, products involving the substance must comply with its prescribed restriction conditions before they can be produced, used, and placed on the market within the EU. The EU's restriction and control of chemicals is a continuous process, and REACH Appendix XVII has undergone dozens of updates and revisions since the REACH regulation came into effect. The authorities have also been evaluating the addition of more restriction requirements. At the same time, it is particularly important to note that there are significant differences in the control of REACH Appendix XVII and SVHC, mainly reflected in the following two aspects:

1. Scope of Control: The control requirements for SVHC apply to products manufactured within the EU or exported to the EU, while REACH Appendix XVII specifies the scope of application for different provisions of the product.

2. Control requirements: When the SVHC content in a product exceeds the threshold, the product can still enter the EU market as long as the relevant enterprises fulfill their responsibilities and obligations to notify the authorities or transmit supply chain information. For products involving restricted substances in REACH Appendix XVII, they must comply with their prescribed restrictions (such as limit requirements for the substance) before they can be produced, used, and placed on the market within the European Union.

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03. Jiayu Testing Reminder

With the continuous updating of REACH regulations, enterprises are facing more and more control requirements. It is recommended that companies conduct an early investigation into their supply chain to cope with regulatory changes with ease.

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