Definition
What is CMR Substances?
Carcinogenic, mutagenic and reprotoxic substances that face heightened restriction, workplace-control and substitution pressure across chemical regimes.
Carcinogenic, mutagenic and reprotoxic substances that face heightened restriction, workplace-control and substitution pressure across chemical regimes.
Foresight tracks CMR Substances developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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Last updated
15 May 2026, 17:46
Source-backed regulatory and guidance signals tracked by Foresight, with the newest developments first.
EU CLP – Swedish Chemicals Agency Supports RAC Opinions on Draft ATP 25 and Additivity Notes for Cyclamal and Bourgeonal Groups
Sweden’s Chemicals Agency has formally backed ECHA’s RAC opinions and the proposed harmonised classifications in the draft 25th Adaptation to Technical Progress to the EU CLP Regulation, including additive treatment of certain cyclamal and bourgeonal fragrance groups for reproductive toxicity. If these CLP changes are adopted, mixtures containing multiple substances from these groups may more often require classification and labelling as reproductive toxicants, tightening risk management obligations for EU chemical and product suppliers.
Industry Response to RAC Opinion on Harmonised Classification of 1,3‑Diphenylguanidine (CAS 102‑06‑7)
An industry association led by Draslovka has submitted a detailed position paper to EU CARACAL challenging ECHA’s RAC opinion that 1,3-diphenylguanidine should be classified as a Category 1B reproductive toxicant and skin sensitiser, arguing instead for a less severe Repr. 2 classification and no sensitisation hazard. If regulators accept some or all of these arguments, the final CLP harmonised classification for this accelerator could be softened, easing future labelling, risk-management and substitution pressures for manufacturers and downstream users while signalling how much weight regulators give to industry weight-of-evidence challenges.
ATC/EPPA Challenges CLP 25th ATP Classification of C4:C8 and C9 Substituted Diphenylamine Antioxidants
In early 2026, ATC/EPPA submitted new reproductive and aquatic toxicity analyses arguing that ECHA/RAC’s proposed CLP 25th ATP classifications for C4:C8 and C9 substituted diphenylamine antioxidants overstate both reproductive and aquatic hazards. If regulators accept these arguments and downgrade the classifications (for example from Repr. 1B to Category 2 and from Aquatic Chronic 1 to weaker or no aquatic hazard), SDPA-containing lubricants and related products would face significantly reduced labelling, SVHC and downstream risk-management pressure in the EU.
EU CLP: ORO Urges Postponement of Strontium Carbonate and Sulphate SCL Decision
An industry association has submitted further comments to ECHA challenging the uniform reproductive toxicity classification of 11 strontium salts under EU CLP and urging that specific concentration limit decisions for strontium carbonate and sulphate be delayed until new bioelution data become available in mid-2026. If regulators ultimately accept a higher 3% specific concentration limit for these poorly soluble salts, many mixtures using them could avoid Repr. 1B classification, so companies relying on strontium compounds should closely monitor the 26th ATP outcome and prepare to adjust labelling, hazard communication and substitution planning.
ECHA Opens CLH Consultations On Cobalt Oxide And Cobalt Bis(2-Ethylhexanoate)
ECHA has launched CLH public consultations under the CLP Regulation on proposed strengthened carcinogenicity and reproductive toxicity classifications for cobalt oxide and cobalt bis(2-ethylhexanoate), with comments due by 10 July 2026. If adopted, these higher classifications would tighten CLP labelling and risk management requirements and could affect downstream REACH duties and portfolio choices for EU users of cobalt-based substances.
EU: ECHA Opens CLH Consultation On Harmonised Classification Of Cobalt Bis(2-Ethylhexanoate) (136-52-7)
In May 2026, ECHA opened an EU CLH consultation on a Dutch proposal to classify cobalt bis(2-ethylhexanoate) (CAS 136-52-7) as both Carc. 1B (H350) and Repr. 1B (H360FD) under the CLP Regulation, with comments due by 10 July 2026. If adopted, this harmonised CMR classification would require EU suppliers using this cobalt salt to align CLP labelling, safety data sheets, and mixture classification with the new Carc. 1B/Repr. 1B status and to reassess affected uses accordingly.
ECHA Opens CLP Consultation On Carcinogenicity And Reproductive Toxicity Classification For Cobalt Oxide (1307-96-6)
ECHA has opened a CLP harmonised classification consultation proposing to classify cobalt oxide (CAS 1307-96-6) as a Category 1B carcinogen and reproductive toxicant, with comments due by 10 July 2026. If adopted, this would tighten labelling and mixture classification triggers for cobalt oxide uses such as coatings, catalysts, batteries and magnets, requiring reassessment of worker exposure, product portfolios and supply chain communications.
Estonia Adopts Regulation on Hazardous Chemicals Occupational Safety, Exposure Limits and Measurement Procedures
From 16 May 2026, Estonia will enforce a new government regulation that consolidates occupational health and safety requirements, workplace exposure limits and measurement procedures for hazardous chemicals. Employers across sectors will need to update chemical risk assessments, monitoring, worker training and lead exposure controls to comply with the tightened and harmonised framework for carcinogenic, mutagenic and reprotoxic substances.
EU Council Coreper I To Debrief on Trilogue Outcome for Sixth Batch Revision of Carcinogens and Mutagens at Work Directive
The Council’s Permanent Representatives Committee is scheduled on 13 May 2026 to be briefed on the outcome of trilogue negotiations on the sixth batch revision of the EU Carcinogens, Mutagens and Reprotoxic Substances at Work Directive. This indicates that negotiations on revised EU rules for workplace exposure to carcinogenic and reprotoxic substances are entering their final phase, so companies with relevant exposures should expect a consolidated legal text and compliance deadlines to follow and plan ahead.
GB CLP Article 37 Technical Report — Propamocarb Hydrochloride (MCL-ABGZ-1119)
In April 2026 the UK HSE published a GB CLP Article 37 technical report recommending harmonised classification of the fungicide propamocarb hydrochloride as Repr. 2, Acute Tox. 4 (oral) and Skin Sens. 1B. If added to the GB mandatory classification and labelling list, this would tighten hazard labelling and risk‑management expectations for plant protection products using this active, so companies should anticipate future label changes and possible knock-on impacts in other markets.
Great Britain: HSE Issues GB CLP Technical Report On Methyl Isothiocyanate
In April 2026 the UK HSE, acting as the GB CLP Agency, issued an Article 37 technical report concluding that methyl isothiocyanate warrants broader and more stringent classification, including Carc. 2, STOT RE 1, Fatal if inhaled and very high acute and chronic aquatic toxicity (M-factors 10 and 100). If these conclusions are adopted into the GB MCL list, suppliers and users of MITC-based plant protection and biocidal products will need to update labels, safety data sheets and risk controls, while monitoring emerging divergence from the EU RAC position on acute aquatic hazard stringency.
ECHA Closes Consultation on TMAD Candidate for Substitution Under BPR
ECHA has closed the Biocidal Products Regulation consultation on TMAD (formaldehyde released from glyoxal–urea reaction products) as a potential candidate for substitution and archived it on the previous consultations list following a 09 March to 08 May 2026 information period. This signals that assessment of TMAD for BPR product types 06, 11 and 13 is advancing and that future EU authorisation decisions may require substitution or tightly defined derogations for detergents, paints, adhesives, cooling systems and metalworking fluids using this active substance.
California OEHHA Issues Proposition 65 Notice of Intent to List Hydrochlorothiazide, Voriconazole and Tacrolimus via Labor Code Mechanism
California's environmental health agency has opened a Labor Code-based Proposition 65 listing process for the pharmaceuticals hydrochlorothiazide, voriconazole, and tacrolimus, with public comments due by 8 June 2026. If the listings move forward, companies using these actives in products or processes that expose Californians will face new warning and exposure-control obligations, requiring reassessment of affected pharmaceutical and chemical portfolios.
EU Council COREPER to Debrief Trilogue Outcome on Sixth Batch Revision of Carcinogens and Mutagens Directive
The Council of the EU has scheduled a COREPER (Part 1) meeting on 13 May 2026 where the Presidency will debrief member states on the outcome of trilogue negotiations for the sixth batch revision of the Carcinogens, Mutagens and Reprotoxic Substances Directive. This signals that EU-level political work on updated workplace exposure limits for carcinogens and reprotoxic substances is nearing completion, so companies should anticipate a final amending directive and prepare to review OEL compliance once the legal text is adopted and published.
European Commission Launches Initiative on Restricting CMR Substances in Childcare Articles
The European Commission has added a new Have your say initiative to prepare an EU regulation restricting carcinogenic, mutagenic or reprotoxic (CMR) substances in childcare articles, with a public feedback phase signalled on the portal. This points to tighter future chemical limits for baby and childcare products in the EU Single Market, so manufacturers and importers should monitor the consultation and anticipate stricter material and supply-chain controls.
Nebraska Legislature Indefinitely Postpones LB831 on Ethylene Oxide Civil Actions
Nebraska’s LB831, a bill to establish limitations and requirements for civil actions related to ethylene oxide exposure, was indefinitely postponed by the Legislature on 17 April 2026, ending its progress this session. For operators with ethylene oxide risk in Nebraska, there are no new statutory liability shields or constraints on lawsuits, so existing tort and exposure-control regimes continue to apply while political scrutiny of ethylene oxide remains elevated.
EU / ECHA Opens CLP Harmonised Classification Consultation on 2,4,6,8-Tetramethyl-1,3,5,7-Tetraoxacyclooctane
ECHA has opened an EU CLP consultation on the harmonised classification of 2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane, a plant protection active substance, with comments due by 03 July 2026. If the proposal is accepted, companies using this substance in plant protection products may see changes to Annex VI classification that affect labelling, risk management measures and authorisation conditions across the EU.
EU SCCS Working Group Minutes Record New Mandates on Glyoxylic Acid and Hydroxycitronellal and Data Call for Phytonadione Epoxide
EU SCCS Working Group minutes from April 2026 record new scientific mandates on glyoxylic acid and hydroxycitronellal, an imminent data-call deadline for phytonadione epoxide, and key milestones for multiple cosmetic ingredient opinions and nanomaterial assessments. These steps foreshadow potential changes to permitted uses and concentration limits for several UV filters, hair-straightening agents, fragrances and silver- or nano-based ingredients in EU cosmetics, making timely data submissions and close monitoring of forthcoming SCCS opinions important for portfolio and compliance planning.
Philippines FDA Issues Circular 2026-0001 Implementing ASEAN Cosmetic Directive Ingredient Amendments
In May 2026, the Philippine FDA issued Circular No.2026-0001 to implement ASEAN Cosmetic Directive ingredient and labelling amendments from recent ACC meetings, introducing new bans and stricter limits for UV filters, preservatives and other CMR or endocrine-active substances. Cosmetics manufacturers, importers and brands selling into the Philippines now face staged reformulation and withdrawal deadlines through 2025–2028, making early portfolio impact reviews and supplier alignment critical to avoid non-compliant products remaining on the market.
EU Council Mandate to Amend Carcinogens Directive OELs for Cobalt, PAHs, Isoprene and 1,4-Dioxane
In May 2026 the EU Council tabled its mandate on a Directive amending the Carcinogens, Mutagens and Reprotoxic Substances at Work Directive to introduce binding EU-wide occupational exposure limits for cobalt, PAH mixtures, isoprene and 1,4-dioxane and to extend coverage to welding fumes and hazardous medicinal products. If adopted broadly as drafted, these changes will tighten exposure controls for metals, chemical and healthcare workplaces, requiring earlier investment in monitoring, engineering controls, PPE programmes and worker training ahead of six-year transitional periods for some limits.
These are just a few of the most recent CMR Substances alerts. Foresight tracks every jurisdiction, every day — and surfaces only what affects your portfolio, with full citations and evidence.
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Definition
Carcinogenic, mutagenic and reprotoxic substances that face heightened restriction, workplace-control and substitution pressure across chemical regimes.
Industry relevance
CMR Substances developments can change product scope, supplier expectations, market access, reporting duties, and risk ownership. Foresight tracks the signals early so teams can respond before obligations become urgent.
Foresight tracking
Foresight monitors official sources, extracts structured regulatory intelligence, and maps alerts to a customer's products, substances, markets, and priorities so teams see the relevant signal with source evidence for review.
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