Lavanya
Feb 5, 2026
The European Commission has released a draft proposal that significantly expands REACH Annex XVII restrictions, adding newly classified Carcinogenic, Mutagenic, or Toxic for Reproduction substances to the list of chemicals restricted for public sale. Published on January 9, 2026, this omnibus update aligns REACH restrictions with the latest CLP Regulation hazard classifications, creating immediate REACH CMR substances compliance 2026 obligations for manufacturers across chemicals, consumer goods, cosmetics, textiles, and retail sectors.
This periodic technical update adds 22 substances to Entries 28, 29, and 30 of Annex XVII, with concentration limits ranging from 1,000 to 3,000 ppm depending on classification category. Organizations without robust regulatory change monitoring capabilities face market withdrawal requirements, labelling violations, and enforcement actions as the regulation moves toward final adoption later in 2026.
Table of Contents
Understanding the REACH Annex XVII CMR Update
Key Timeline and Adoption Process
Newly Restricted CMR Substances: Complete List
Concentration Limits and Classification Categories
Industries Facing Direct Compliance Impact
Labelling and Market Restrictions
Business and Supply Chain Implications
Strategic Preparation Checklist
How AI Transforms CMR Compliance Management
Understanding the REACH Annex XVII CMR Update
The REACH Annex XVII CMR substances update represents the European Commission's ongoing effort to protect public health by restricting consumer access to substances classified as carcinogenic, mutagenic, or toxic for reproduction. This omnibus technical update aligns Entries 28, 29, and 30 with the latest hazard classifications established under the 21st and 22nd Adaptation to Technical Progress to the CLP Regulation.
The European Commission REACH Restricted Substances page provides authoritative guidance on Annex XVII requirements. CMR chemical restrictions EU regulations specifically target substances that pose the most serious health hazards, prohibiting their sale to general consumers while allowing continued professional and industrial use under controlled conditions.
REACH CMR substances compliance 2026 requires understanding that these restrictions apply to substances, constituents of other substances, and mixtures. Manufacturers cannot circumvent requirements by incorporating restricted substances into formulations. The regulation captures both pure substances and any mixture containing restricted chemicals above specified concentration thresholds.
The primary objective extends beyond simple prohibition. By restricting consumer access while permitting professional use, the regulation acknowledges that some CMR substances serve essential industrial functions while recognizing that general consumers lack the training, equipment, and procedures necessary for safe handling.
Key Timeline and Adoption Process
The January 9, 2026 draft release initiates a regulatory process that will culminate in legally binding restrictions. Organizations must understand this timeline to prepare compliance activities appropriately.
January 9, 2026: Draft Proposal Release
The European Commission published the draft technical update, making the proposed substance additions publicly available for stakeholder review. This date marks the beginning of formal regulatory proceedings that will establish enforceable compliance obligations.
Feedback Period: Early 2026
Following the draft release, stakeholders may submit comments through the European Commission Better Regulation Portal. This feedback period allows industry participants to raise technical concerns, implementation challenges, or alternative approaches before final adoption.
Parliamentary and Council Scrutiny: Mid-2026
Based on currently available regulatory guidance, the proposal will undergo review by the European Parliament and Council following the feedback period. This scrutiny process may result in modifications before final adoption.
Final Adoption and Publication: Later 2026
Final adoption and publication in the Official Journal of the EU are anticipated later in 2026. The effective date for compliance will be established in the published regulation, typically providing a transition period for market adjustment.
Proactive compliance risk management enables organizations to begin preparation now rather than waiting for final publication. Early reformulation and supply chain adjustments prevent last-minute scrambles that compromise product quality and market continuity.
Newly Restricted CMR Substances: Complete List
The draft proposal adds 22 substances to REACH Annex XVII appendices based on their CMR classifications under CLP. Organizations must screen product portfolios against this complete list to identify compliance obligations.
Carcinogenic Substances (Appendix 1 & 2)
Substance Name | CAS Number | EC Number | REACH Appendix | Limit (PPM) |
|---|---|---|---|---|
Fluoroethylene | 75-02-5 | 200-832-6 | App 1 (Carc. 1A) | 1,000 |
Multi-walled carbon nanotubes (MWCNT) | — | — | App 2 (Carc. 1B) | 1,000 |
Acetone oxime | 127-06-0 | 204-820-1 | App 2 (Carc. 1B) | 1,000 |
Benthiavalicarb-isopropyl (ISO) | 177406-68-7 | — | App 2 (Carc. 1B) | 1,000 |
1,4-Dichloro-2-nitrobenzene | 89-61-2 | 201-923-3 | App 2 (Carc. 1B) | 1,000 |
Trimethyl phosphate | 512-56-1 | 208-144-8 | App 2, 4 & 6 | 1,000 |
Barium chromate | 10294-40-3 | 233-660-5 | App 2 (Carc. 1B) | 1,000 |
1,1-Dichloroethylene (Vinylidene chloride) | 75-35-4 | 200-864-0 | App 2 (Carc. 1B) | 1,000 |
Mutagenic Substances (Appendix 4)
Substance Name | CAS Number | EC Number | REACH Appendix | Limit (PPM) |
|---|---|---|---|---|
N,N'-Methylenediacrylamide | 110-26-9 | 203-750-9 | App 4 (Mut. 1B) | 1,000 |
Reproductive Toxicity Substances (Appendix 6)
Substance Name | CAS Number | EC Number | REACH Appendix | Limit (PPM) |
|---|---|---|---|---|
Trimethyl borate | 121-43-7 | 204-468-9 | App 6 (Repr. 1B) | 3,000 |
Sodium perborate (and various hydrates) | 15120-21-5 | 239-172-9 | App 6 (Repr. 1B) | 3,000 |
Sodium peroxometaborate | 7632-04-4 | 231-556-4 | App 6 (Repr. 1B) | 3,000 |
Reaction mass: 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol | — | — | App 6 (Repr. 1B) | 3,000 |
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one | 119344-86-4 | 438-340-0 | App 6 (Repr. 1B) | 3,000 |
Sodium 3-(allyloxy)-2-hydroxypropanesulphonate | 52556-42-0 | 258-004-5 | App 6 (Repr. 1B) | 3,000 |
Tert-butyl 2-ethylperoxyhexanoate | 3006-82-4 | 221-110-7 | App 6 (Repr. 1B) | 3,000 |
Nitrous oxide (Dinitrogen oxide) | 10024-97-2 | 233-032-0 | App 6 (Repr. 1B) | 3,000 |
2-Bromo-3,3,3-trifluoroprop-1-ene | 1514-82-5 | — | App 6 (Repr. 1B) | 3,000 |
2,3-Epoxypropyl isopropyl ether | 4016-14-2 | 223-672-9 | App 6 (Repr. 1B) | 3,000 |
α,α'-propylenedinitrilodi-o-cresol | 94-91-7 | 202-374-2 | App 6 (Repr. 1B) | 3,000 |
2-Ethylhexanoic acid, monoester with propane-1,2-diol | 85114-00-7 | 285-503-5 | App 6 (Repr. 1B) | 3,000 |
Tetrahydrofurfuryl methacrylate | 2455-24-5 | 219-529-5 | App 6 (Repr. 1B) | 3,000 |
9-Octadecenoic acid (Z)-, sulfonated, potassium salts | 68609-93-8 | 271-843-1 | App 6 (Repr. 1B) | 3,000 |
AI tools for compliance management help organizations screen extensive product portfolios against these CAS and EC numbers efficiently, identifying affected products within hours rather than weeks of manual review.
Concentration Limits and Classification Categories
REACH CMR substances compliance 2026 requires understanding the concentration thresholds that trigger restriction applicability. Different CMR classifications carry different limits reflecting hazard severity.
Category 1A and 1B Carcinogenic Substances: 1,000 ppm
Substances classified as Carcinogenic Category 1A (known human carcinogens) and Category 1B (presumed human carcinogens) face the most stringent concentration limit. Products containing these substances at or above 0.1% by weight cannot be sold to general consumers.
Fluoroethylene's Category 1A classification reflects confirmed human carcinogenicity, while substances like Multi-walled carbon nanotubes and Barium chromate carry Category 1B classifications based on presumed carcinogenic potential from animal studies and mechanistic evidence.
Mutagenic Substances: 1,000 ppm
Substances classified as Mutagenic Category 1B face equivalent concentration restrictions. N,N'-Methylenediacrylamide exemplifies this category, with chemical reformulation requirements affecting adhesive and polymer applications where this substance provides crosslinking functionality.
Reproductive Toxicity Substances: 3,000 ppm
Substances classified as Toxic for Reproduction Category 1B face a slightly higher concentration threshold of 0.3% by weight. This category includes the largest number of newly restricted substances, affecting diverse applications from cleaning products (sodium perborate) to industrial processing aids.
The differential thresholds reflect risk assessment approaches that consider both hazard severity and typical exposure scenarios. However, organizations should note that even the 3,000 ppm threshold represents a relatively low concentration that many commercial formulations may exceed. **Restricted substance list compliance** requires systematic portfolio screening rather than assumptions about formulation safety.
Industries Facing Direct Compliance Impact
The REACH Annex XVII CMR update creates varying compliance obligations across industries based on substance usage patterns and market channels. Executive leadership should evaluate organizational exposure within the following sector categories.
Chemicals and Plastics
Chemical manufacturers and formulators face the most direct REACH CMR substances compliance 2026 obligations. Organizations producing raw materials containing listed substances must evaluate whether products are sold to general consumers or restricted to professional users. Automated regulatory monitoring CMR capabilities enable tracking across extensive product catalogs.
Trimethyl phosphate's multi-appendix listing affects flame retardant formulations, plasticizer applications, and chemical synthesis intermediates. Organizations must trace this substance through supply chains to identify all affected products.
Consumer Goods
Producers of DIY products, adhesives, and coatings face immediate reformulation pressure. Consumer-grade products containing restricted substances above concentration limits must either be reformulated or withdrawn from retail channels. Building future-ready compliance infrastructure enables systematic product portfolio assessment.
The nitrous oxide restriction particularly affects consumer aerosol products where this propellant serves functional purposes. Chemical reformulation requirements may necessitate packaging redesign alongside formulation changes.
Cosmetics and Personal Care
Cosmetics manufacturers must evaluate ingredient lists for potential CMR overlaps. While many substances on this list have limited cosmetics applications, comprehensive screening ensures no restricted substances appear in consumer-facing products. Global cosmetics industry regulatory shifts continue reshaping formulation requirements beyond CMR restrictions.
Textiles and Apparel
Textile manufacturers face restricted substance list compliance obligations affecting processing chemicals, finishing agents, and dyes. Carcinogenic substances compliance requires screening textile processing inputs against the newly restricted list. Compliance and regulation managers should coordinate with supply chain partners to verify compliance throughout production chains.
Retail
General retailers selling chemical mixtures to the public face market access restrictions for affected products. Retail compliance requires supplier verification ensuring that consumer-grade products meet CMR restrictions. Effective supplier collaboration enables retailers to maintain compliant product assortments.
Labelling and Market Restrictions
REACH CMR substances compliance 2026 imposes specific labelling requirements for products that remain available to professional users. Organizations must implement these requirements alongside market channel restrictions.
Professional Use Labelling Requirement
Packaging of substances and mixtures containing restricted CMR substances must be marked visibly, legibly, and indelibly with the statement: "Restricted to professional users."
This labelling requirement applies when products contain restricted substances at or above concentration limits but are legitimately supplied to professional users rather than general consumers. The label serves both regulatory compliance and practical functions, alerting handlers to restricted status and preventing inadvertent consumer sale.
Market Channel Restrictions
The restriction prohibits placing listed substances on the market for supply to the general public when concentrations meet or exceed specified limits. This prohibition encompasses:
Direct consumer sales through retail channels
Online sales to non-professional purchasers
Distribution through channels that cannot verify professional user status
Organizations must implement market channel controls ensuring restricted products reach only qualified professional users. AI compliance software chemicals capabilities help track product distribution and flag potential channel violations.
Compliance Duty for Manufacturers
Manufacturers must review product portfolios against newly added CAS/EC numbers to ensure consumer-grade products are reformulated or withdrawn from public markets before the effective date. This compliance duty requires:
Comprehensive ingredient and formulation review
Concentration testing where composition uncertainty exists
Reformulation planning for affected consumer products
Market withdrawal procedures for non-reformulatable products
Labelling updates for professional-use products
Streamlined supplier documentation processes ensure raw material suppliers provide accurate composition data supporting compliance assessments.
Business and Supply Chain Implications
REACH CMR substances compliance 2026 creates business consequences extending beyond direct regulatory obligations. Organizations must understand these implications to secure executive support for compliance investments.
Product Reformulation Costs
Products requiring reformulation to eliminate restricted substances incur development costs, testing expenses, and potential performance compromises. Early identification of affected products enables reformulation planning that maintains product quality while achieving compliance.
Chemical reformulation requirements vary significantly by substance and application. Some restricted substances have readily available alternatives, while others serve unique functions requiring extensive development to replace. **Procurement and supply chain leaders** should evaluate alternative material availability early in compliance planning.
Market Access Implications
Products failing to meet CMR restrictions face EU market exclusion for consumer sales. Organizations must decide whether to reformulate for continued consumer market access, transition to professional-only distribution, or withdraw products entirely.
Supply Chain Verification
CMR chemical restrictions EU regulations require supply chain transparency that many organizations lack. Manufacturers must verify that raw materials and components do not contain restricted substances above concentration limits. This verification requires supplier engagement and potentially third-party testing where supplier data proves insufficient.
Replacing spreadsheets with scalable systems enables systematic supply chain compliance management across multiple suppliers and materials.
Competitive Positioning
Early compliance achievement creates competitive advantages as restrictions take effect. Organizations demonstrating REACH CMR substances compliance 2026 readiness can assure customers of continued supply while competitors struggle with reformulation delays.
Strategic Preparation Checklist
Organizations should implement systematic preparation activities to achieve REACH CMR substances compliance 2026 before final adoption. The following checklist provides framework for compliance program development.
Portfolio Assessment
Screen all product formulations against the 22 newly restricted substances
Identify products sold to general consumers versus professional users
Prioritize affected products by revenue exposure and reformulation complexity
Document current concentrations where composition data exists
Supply Chain Verification
Request material declarations from suppliers covering restricted substances
Identify supply chain exposure to newly restricted CAS/EC numbers
Qualify alternative suppliers for substances requiring replacement
Establish ongoing monitoring for supplier compliance status
Reformulation Planning
Evaluate alternative substances for restricted ingredient replacement
Assess reformulation impact on product performance and cost
Develop reformulation timelines aligned with regulatory adoption schedule
Plan testing programs to verify reformulated product compliance
Labelling and Distribution
Identify products transitioning to professional-use-only status
Update packaging with required "Restricted to professional users" labelling
Implement distribution controls preventing consumer channel sales
Train sales and distribution personnel on market restrictions
VPs and directors of quality should coordinate these activities across functional areas to ensure comprehensive preparation.
How AI Transforms CMR Compliance Management
Manual compliance approaches cannot scale to address the complexity of REACH CMR substances compliance 2026 across extensive product portfolios and global supply chains. AI compliance software chemicals platforms fundamentally transform organizational capabilities for regulatory monitoring, portfolio screening, and documentation maintenance.
Intelligent Regulatory Monitoring
CMR classifications evolve continuously as toxicological evidence accumulates and CLP Adaptations to Technical Progress expand hazard designations. Automated regulatory monitoring CMR capabilities track these developments across relevant jurisdictions, alerting compliance teams to changes requiring response.
Understanding **why people-only compliance cannot scale** helps executives appreciate strategic value of AI-powered monitoring that operates continuously across regulatory domains.
Automated Portfolio Screening
Product portfolios spanning thousands of SKUs require systematic screening against CAS/EC numbers. AI platforms enable automated screening that identifies affected products within hours rather than weeks of manual review. This capability proves particularly valuable when omnibus updates add multiple substances simultaneously.
Supply Chain Compliance Automation
Supply chain compliance automation extends organizational visibility beyond internal operations to encompass supplier practices and material compositions. AI platforms automate supplier data collection, verify compliance certifications, and flag gaps requiring remediation.
Certivo's platform incorporates CORA, an intelligent assistant that automates supplier follow-ups and data completion workflows. Rather than manual email chasing, CORA systematically engages suppliers to collect required composition data, reducing administrative burden while improving data completeness for carcinogenic substances compliance verification.
Audit-Ready Documentation
Compliance documentation must demonstrate current practices aligned with CMR restrictions. AI platforms maintain audit-ready documentation that evolves as regulations change. Staying audit-ready across frameworks becomes systematic compliance practice rather than episodic scramble before inspections.
Conclusion: Strategic Imperatives for CMR Compliance Readiness
The REACH Annex XVII CMR substances update represents the European Commission's continuing commitment to protecting public health by restricting consumer access to carcinogenic, mutagenic, and reproductive toxicity substances. The January 2026 draft proposal adds 22 substances to Entries 28, 29, and 30, with final adoption anticipated later in 2026.
Organizations maintaining REACH CMR substances compliance 2026 must screen product portfolios against newly restricted CAS/EC numbers, implement reformulation or market channel changes for affected products, and establish labelling compliance for professional-use items. The complexity of these requirements across extensive product catalogs exceeds what manual processes can reliably manage.
The business consequences of non-compliance extend beyond regulatory penalties to include EU market exclusion for consumer products, supply chain disruption, and reputational damage affecting customer relationships. Organizations recognizing these stakes invest in AI compliance software chemicals capabilities that automate regulatory monitoring, portfolio screening, and documentation management.
CMR chemical restrictions EU regulations will continue expanding as toxicological science advances and CLP classifications evolve. Organizations building robust compliance infrastructure today position themselves to address not only the current update but ongoing evolution of REACH Annex XVII restrictions.
Executive leadership must recognize that restricted substance list compliance represents ongoing operational reality rather than one-time project. The periodic omnibus updates that align REACH with CLP classifications will continue adding substances, requiring compliance programs capable of systematic adaptation.
Explore how Certivo can support your compliance readiness and develop AI-powered strategies ensuring EU market access while reducing manual compliance burden across your product portfolio.