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On December 5, 2024, the European Commission revised the Carcinogenic, Mutagenic, or toxic to Reproduction (CMR) substances list within REACH's Annex XVII (Regulation (EC) No 1907/2006), introducing three key changes.

The changes will become effective 20 days after publication and will be fully implemented by September 1, 2025. Despite the formal enforcement of the new Category 1B CMR substances provisions starting from September 1, 2025, the European Union urges operators to act proactively.

EU,REACH,CMRSubstances,Chemicals, Annex XVII

The three key changes are:

Public Sale and Use Restrictions: The updated regulation strictly bans the public sale and use of Category 1A or 1B carcinogens, germ cell mutagens, or reproductive toxins, as detailed in Articles 28, 29, and 30 of Regulations (EC) No 1272/2008 and 1907/2006. It also imposes stringent controls on the concentration of these substances in mixtures.
Annex XVII Appendices Expansion: The regulation adds substances to Appendices 2, 4, and 6 of Annex XVII, reflecting the inclusion of newly classified Category 1B CMR substances.
Isopropylbenzene Use Exemptions: According to Regulation (EU) 2023/1132, from December 1, 2023, isopropylbenzene is not to be marketed or used in aviation fuel at concentrations of 0.1% w/w or higher for non-professional pilots. However, this does not apply to automotive fuel for non-professional drivers. Given the similarities between non-professional drivers and small aircraft pilots, and the smaller number of the latter, isopropylbenzene in aviation fuel is exempt from restrictions in Articles 28, 29, and 30 of Annex XVII to Regulation (EC) No 1907/2006.

Annex XVII is amended as follows:

The following substances are to be incorporated into Appendix 2.

Substances	Index No	EC No	CAS No
‘diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea	006-015-00-9	206-354-4	330-54-1’
‘2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A	604-074-00-0	201-236-9	79-94-7’
‘N,N-dimethyl-p-toluidine	612-296-00-4	202-805-4	99-97-8’
‘4-nitrosomorpholine	613-346-00-8	-	59-89-2’
‘4-methylimidazole	613-349-00-4	212-497-3	822-36-6’

The following substance is to be incorporated into Appendix 4.

Substance	Index No	EC No	CAS No
‘dimethyl propylphosphonate	015-208-00-7	242-555-3	18755-43-6’

The following substances are to be incorporated into Appendix 6.

Substances	Index No	EC No	CAS No
‘diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide	015-203-00-X	278-355-8	75980-60-8’
‘benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate	015-204-00-5	479-100-5	577705-90-9’
‘benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)	015-205-00-0	278-305-5	75768-65-9’
‘reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1)	015-206-00-6	-	-’
‘dimethyl propylphosphonate	015-208-00-7	242-555-3	18755-43-6’
‘dibutyltin maleate	050-034-00-5	201-077-5	78-04-6’
‘dibutyltin oxide	050-035-00-0	212-449-1	818-08-6’
‘reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane	603-244-00-1	-	-’
‘4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF	604-099-00-7	216-036-7	1478-61-1’
‘1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.;	612-298-00-5	273-227-8	68953-84-4’
‘4-methylimidazole	613-349-00-4	212-497-3	822-36-6’

The following substances are to be incorporated into Appendix 11.

Substances

Derogations

‘2. Cumene

CAS No 98-82-8

EC No 202-704-5

As a substance on its own or as a constituent of other substances in either of the following:

kerosene used as aviation fuel conforming to DEF STAN 91-091, ASTM specification D1655 or equivalent recognised standards and marketed under descriptions such as Jet-A, Jet-A1 or JP-(x);
gasoline used as aviation fuel conforming to DEF STAN 91-090, ASTM D910, ASTM D7547, EN 228 or equivalent recognised standards.’

You can freely access the EU CMR substances list via the provided link on ChemRadar.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com.

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REACH Annex XVII Testing

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Imminent Update to CMR Substances List in EU REACH Regulation Annex XVII

Annex XVII is amended as follows:

Further Information

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