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EU REACH Appendix XVII proposes to add CMR substances
Time：
2024-12-11
The EU proposes to add newly classified CMR (carcinogenic, teratogenic, and reproductive toxic) substances to the restricted substance list in Appendix XVII of the EU REACH regulation to protect consumer health and safety.
On December 5, 2024, the European Union proposed a draft regulation that plans to add newly classified CMR (carcinogenic, teratogenic, reproductive toxic) substances to Appendix XVII of the EU REACH regulation's list of restricted substances to protect consumer health and safety. The main updates are as follows:
In Appendix 2 (for Appendix XVII, item 28- Carcinogenicity: Add the following substances in sequence to Class 1B:
In Appendix 4 (regarding Appendix XVII, Item 28- Teragenesis: Add the following substances to Class 1B:
In Appendix 6 (regarding Appendix XVII, Item 28- Reproductive Toxicity: Add the following substances in sequence to Class 1B:
Add the following substances to Appendix 11 (exemptions for specific substances in items 28 to 30 of Appendix XVII):
The draft bill will be open for feedback for 4 weeks from December 5, 2024 to January 2, 2025 (midnight Brussels time), and the feedback will be taken into account when finalizing this proposal.
[Background]
According to Annex XVII, items 28, 29, and 30 of the REACH regulation, it is prohibited to put on the market or provide to the public mixtures containing substances classified as carcinogenic, teratogenic, or reproductive toxic (CMR) or substances exceeding specific concentrations. These substances are listed in Part 3 of Annex VI of the EU CLP Regulation, defined as CMR Class 1A and CMR Class 1B; These substances are also listed in Appendices 1 to 6 of Annex XVII of the EU REACH regulation.
Due to the revision and supplementation of CMR substances in the EU CLP regulation in 2024/197, and the addition of new substances that will be applicable from September 1, 2025, the relevant list of CMR substances in the REACH regulation should also be updated accordingly and applied from the same date.
Starting from December 1, 2023, the European Commission Regulation (EU) 2023/1132 includes cumene in Appendix 2 of Annex XVII of Regulation 1907/2006. Some small aircraft (including those piloted by non professional pilots) contain isopropylbenzene in their aviation fuel. These non professional pilots are members of the general public as described in Annex XVII, Articles 28, 29, and 30 of the REACH regulation. Therefore, from December 1, 2023, it is not allowed to release aviation fuel with a concentration of isopropylbenzene exceeding 0.1% w/w on the market or supply it to non professional pilots.
Annex XVII, items 28, 29, and 30 of the REACH regulation do not apply to several fuels and petroleum products, including automotive fuels covered by Directive 98/70/EC of the European Parliament and of the Council. This type of automotive fuel includes gasoline and diesel fuel, used for road vehicles equipped with positive ignition and compression ignition engines. Therefore, the restrictions on isopropylbenzene do not apply to automotive fuel that is put on the market or supplied to non professional drivers.
Based on the similarity between the use of automotive fuel by non professional car drivers and the use of aviation fuel by non professional small aircraft pilots, the application of isopropylbenzene in aviation fuel is also exempted.
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