Industrial Chemical

REACH Regulation (EU) 2025/1731: 16 New CMR Substances Added

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EU Chemical Compliance | REACH Annex XVII Restrictions

On August 11, 2025, the Official Journal of the European Union published Commission Regulation (EU) 2025/1731, amending REACH Regulation Annex XVII as regards carcinogenic, germ cell mutagenic or reproductive toxicant substances subject to restrictions.

The amendment adds 16 new CMR substances to the Annex XVII restriction list and introduces a derogation for specific uses of cumene in certain aviation fuels. Companies placing substances, mixtures or finished products on the EU market should review product portfolios, concentration thresholds, labels, SDSs and downstream use restrictions.

News Brief    |    Main Amendments    |    CMR Substance List    |    Cumene Derogation    |    Business Impact    |    How REACH24H Can Help

News Brief

Regulation (EU) 2025/1731 formally amended Articles 28, 29, and 30 of Annex XVII to Regulation (EC) No 1907/2006, in order to align REACH restrictions with the latest changes in the EU CLP Regulation.

The newly added substances are classified as CMR category 1B under the CLP framework. Under REACH Annex XVII Entries 28, 29 and 30, substances classified as carcinogens, germ cell mutagens or reproductive toxicants category 1A or 1B, and mixtures containing them above specified concentration limits, are restricted for supply to the general public.

Regulatory update: Regulation (EU) 2025/1731 is already in force. The restrictions related to newly classified CMR category 1B substances introduced through the amendment apply from September 1, 2025. Companies should now treat these requirements as active EU market access obligations.

Main Amendments under Regulation (EU) 2025/1731

The amendment updates Appendices 2, 4 and 6 of Annex XVII to include newly classified CMR substances and updates Appendix 11 to introduce a specific derogation for cumene in certain aviation fuels. The change reflects the harmonized classification and labeling updates introduced by Commission Delegated Regulation (EU) 2024/197.

REACH Annex XVII AppendixAmendmentCompliance Implication
Appendix 2Adds 5 carcinogenic category 1B entries.Products supplied to the general public should be checked against carcinogen restrictions and concentration thresholds.
Appendix 4Adds 1 germ cell mutagen category 1B entry.Companies should assess mixtures and downstream uses involving the listed substance.
Appendix 6Adds 12 reproductive toxicant category 1B entries.Suppliers should review product formulations, SDSs, labels and sales channels for consumer supply restrictions.
Appendix 11Adds a derogation for cumene in specified aviation fuels.Fuel suppliers should verify whether products meet the specific aviation fuel standards listed in the derogation.

16 New CMR Substances Added to REACH Annex XVII

The amendment adds new entries to Appendices 2, 4 and 6 of REACH Annex XVII. Two substances appear in more than one CMR category: 4-methylimidazole is both a carcinogen and reproductive toxicant, while dimethyl propylphosphonate is both a germ cell mutagen and reproductive toxicant. Therefore, the amendment involves 16 unique substances, while the category entries span multiple appendices.

Appendix 2: 5 New Carcinogens Category 1B

SubstanceIndex No.EC No.CAS No.
diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea006-015-00-9206-354-4330-54-1
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A604-074-00-0201-236-979-94-7
N,N-dimethyl-p-toluidine612-296-00-4202-805-499-97-8
4-nitrosomorpholine613-346-00-8-59-89-2
4-methylimidazole613-349-00-4212-497-3822-36-6

Appendix 4: 1 New Germ Cell Mutagen Category 1B

SubstanceIndex No.EC No.CAS No.
dimethyl propylphosphonate015-208-00-7242-555-318755-43-6

Appendix 6: 12 New Reproductive Toxicants Category 1B

SubstanceIndex No.EC No.CAS No.
diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide015-203-00-X278-355-875980-60-8
benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate015-204-00-5479-100-5577705-90-9
benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)015-205-00-0278-305-575768-65-9
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--
reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1)015-207-00-1--
dimethyl propylphosphonate015-208-00-7242-555-318755-43-6
dibutyltin maleate050-034-00-5201-077-578-04-6
dibutyltin oxide050-035-00-0212-449-1818-08-6
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 butane603-244-00-1--
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF604-099-00-7216-036-71478-61-1
1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.612-298-00-5273-227-868953-84-4
4-methylimidazole613-349-00-4212-497-3822-36-6

Exemption for Specific Uses of Cumene

Regulation (EU) 2025/1731 also amends Appendix 11 of Annex XVII to add a derogation for cumene. The derogation applies when cumene is present as a substance on its own or as a constituent of other substances in certain aviation fuels, including kerosene used as aviation fuel conforming to DEF STAN 91-091, ASTM D1655 or equivalent recognized standards, and gasoline used as aviation fuel conforming to DEF STAN 91-090, ASTM D910, ASTM D7547 or equivalent recognized standards.

Compliance note: The cumene derogation is specific and conditional. Companies should not treat it as a general exemption for cumene-containing products. Fuel type, applicable technical standard, intended use and market supply route should be verified before relying on the derogation.

Corporate Response Measures and Preparations

For substances included in Annex XVII of the EU REACH Regulation, the EU restricts the placing on the market and use of the substances themselves, as well as mixtures containing those substances above specified concentration limits. Where a substance or mixture falls within the restriction and exceeds the applicable concentration threshold, it may be prohibited from being supplied to the general public.

For relevant substances intended for professional use, packaging must be marked with “For professional use only” before the substance or mixture is placed on the market. Companies should review not only substance identity and concentration, but also product use, customer type, labeling, packaging and sales channels.

Compliance AreaRecommended ActionRelated Compliance Topic
Substance screeningCheck whether products exported to the EU contain any of the newly restricted CMR substances.EU REACH restriction compliance
Concentration reviewVerify whether the substance or mixture exceeds the relevant concentration limits under the CLP framework.EU CLP classification and labeling
SDS and label updatesUpdate safety data sheets, labels and package markings, including “For professional use only” where applicable.Global GHS/SDS/MSDS/Label Compliance
Sales channel controlConfirm whether the product is supplied to the general public or restricted to professional users.REACH Annex XVII market access control
Substitution strategyPrepare substitute substances or formulation adjustments where products may be affected by restrictions.Product reformulation and market continuity planning

The newly added CMR substances are used across multiple sectors, including pesticides, coatings, automotive manufacturing, electronics and electrical products, polymers and industrial chemical formulations. Companies supplying these sectors should pay particular attention to EU market restrictions, SDS and label updates, and downstream communication requirements.

  • Screen EU-bound substances, mixtures and products against the latest REACH Annex XVII restriction list.

  • Review whether any listed CMR substance exceeds applicable concentration thresholds.

  • Confirm whether products are supplied to the general public or only to professional users.

  • Update SDSs, labels, packaging statements and downstream use instructions where necessary.

  • Prepare substitution or formulation adjustment plans for affected products.

  • Monitor future CLP harmonized classification updates and REACH Annex XVII amendments.

Need to assess whether your EU-bound products are affected by Regulation (EU) 2025/1731?

REACH24H can help you screen restricted substances, review concentration thresholds, update SDSs and labels, and prepare EU REACH restriction compliance strategies.

   Contact Our Regulatory Specialists  

How REACH24H Can Help

REACH24H provides EU chemical regulatory compliance support for companies placing substances, mixtures and finished products on the EU market. Our services cover REACH registration, restriction screening, CLP classification, SDS and label compliance, SVHC monitoring, supply chain communication and EU market access strategy.

Support AreaREACH24H Services
REACH Restriction ScreeningScreen substances, mixtures and products against REACH Annex XVII, including CMR substances and sector-specific restrictions.
EU CLP Classification ReviewReview classification under EU CLP, including harmonized classifications and newly updated Annex VI entries.
SDS and Label UpdatesPrepare or update SDSs, labels, package markings and professional-use statements for EU market compliance.
EU REACH Registration and OR ServicesSupport EU REACH registration and Only Representative services for non-EU chemical suppliers.
SVHC and Restriction MonitoringMonitor EU SVHC notification, REACH restriction updates and future CLP harmonized classification changes.
Integrated EU Chemical ComplianceProvide integrated support for EU CLP, Global GHS/SDS/MSDS/Label Compliance, and EU market access risk assessment.

Conclusion

Regulation (EU) 2025/1731 further strengthens the connection between CLP harmonized classification updates and REACH Annex XVII restriction obligations. Companies placing chemicals on the EU market should not only track new REACH restrictions, but also monitor CLP Annex VI updates that may trigger future restrictions.

For affected substances and mixtures, timely product screening, concentration review, SDS and label updates, sales channel control and substitution planning are essential to maintaining compliant access to the EU market.

Recommended Reading

Official References