EU REACH Regulation adds 16 new restriction lists, effective September 1st!

Date：2025-08-19 11:25:17 Classification ：【Statute】 Visits：

On August 11, 2025, the European Commission officially published Regulation (EU) 2025/1731 in the Official Journal of the European Union, amending the restricted list of carcinogenic, mutagenic, and reprotoxic (CMR) substances in Annex XVII of the REACH Regulation. The amendment will take effect on September 1.

Official Website Screenshot

I. Scope of Regulated Substances

This amendment adds 16 new Category 1B CMR substances (13 specific substances + 3 reaction materials), such as tetrabromobisphenol A and dibutyltin oxide. It also introduces an exemption for cumene for specific uses.

II. Regulatory Control and Restriction Requirements

According to EU CLP Regulation (EC) No. 1272/2008, the limits for different categories of substances are clearly defined:

Carcinogens Category 1B: ≥ 0.1% (weight percentage)

Mutogens Category 1B: ≥ 0.1% (weight percentage)

Reproductive Toxics Category 1B: ≥ 0.3% (weight percentage)

Cumene is not subject to this restriction when used as a component of aviation fuel (such as kerosene and gasoline) that meets specific industry standards.

III. Compliance Recommendations for Enterprises

Starting September 1, 2025, 16 CMR substances will be prohibited from sale in the EU if their concentration in a mixture exceeds the specified limits. Enterprises must act swiftly. Jiayu Testing recommends promoting compliance efforts in the following three areas:

Comprehensive Supply Chain Screening

Immediately initiate substance screening across the entire supply chain, focusing on verifying the use of the above-mentioned high-risk substances. Establish a bill of materials (BOM) and substance database (SDS) to ensure compliance with the limit requirements.

Alternative Solution Evaluation and Verification

For restricted substances, we evaluate the feasibility of environmentally friendly alternative materials (such as halogen-free flame retardants and new thermal stabilizers) and verify the performance and compliance of these alternatives through laboratory testing.

Pre-testing and Certification Planning

Utilize specialized REACH regulatory services from third-party testing agencies to conduct precise testing of products and raw materials, issue compliance reports, and mitigate market access risks.

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EU REACH Regulation adds 16 new restriction lists, effective September 1st!

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