EU: Restriction updating Annex XVII REACH regarding CMRs

 

The EU Commission has updated the REACH Regulation by adding newly classified CMR (carcinogenic, mutagenic, toxic to reproduction) substances to the lists of CMR substances restricted for consumer use.

Entries 28, 29, and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market and use—when intended for supply to the general public—of substances classified as carcinogenic, germ cell mutagenic, or toxic to reproduction (CMR) in categories 1A or 1B, as listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008, and included in Appendices 1 to 6 of Annex XVII to Regulation (EC) No 1907/2006. This prohibition also applies to mixtures containing such substances above the specified concentration limits.

To reflect the updated CMR classifications in Regulation (EC) No 1272/2008, as amended by Commission Delegated Regulation (EU) 2024/1973, Appendices 2, 4, and 6 of Annex XVII to Regulation (EC) No 1907/2006 must be updated. Accordingly, newly classified category 1B CMR substances will be added to those appendices.

The updated classifications in Regulation (EC) No 1272/2008, as amended by Delegated Regulation (EU) 2024/1973, will take effect on 1 September 2025. The related restrictions in this Regulation for category 1B CMR substances will apply from the same date, without preventing operators from implementing them earlier.

Commission Regulation (EU) 2023/11324 added cumene to Appendix 2 of Annex XVII to Regulation 1907/2006, effective 1 December 2023. Cumene is found in certain aviation fuels used in small aircraft operated by non-professional pilots—who fall within the definition of “general public” under entries 28, 29, and 30. Consequently, from 1 December 2023, it may not be placed on the market or used in aviation fuels for such pilots in concentrations of 0.1 % w/w or higher.

However, entries 28, 29, and 30 do not apply to several fuels and oil products, including motor fuels regulated by Directive 98/70/EC, such as petrol and diesel for road vehicles. Therefore, the cumene restriction does not affect motor fuels supplied to non-professional car drivers.

Given the similarities between motor fuel use by non-professional car drivers and aviation fuel use by non-professional small-aircraft pilots—and considering the smaller number of pilots, as well as the absence of cumene restrictions in motor fuels under Directive 98/70/EC—it is appropriate to exempt aviation fuel from the cumene restriction in entries 28, 29, and 30.

Regulation (EC) No 1907/2006 should be amended accordingly.

To find out more about chemical compliance in the EU, do not hesitate to contact the Product Compliance Institute.