Lavanya
Dec 4, 2025
The European regulatory landscape just took another significant step forward. On November 18, 2025, the European Chemicals Agency (ECHA) announced its 12th REACH authorization update recommendation to the European Commission, proposing that four substances of very high concern should be added to the REACH Authorization List. This marks the first authorization recommendation in over two and a half years, signaling renewed regulatory focus after a lengthy pause.
For manufacturers, importers, and downstream users across multiple industries, this development carries substantial implications. While these chemicals are not yet formally restricted, they have moved significantly closer to requiring authorization for continued use within the European Union.
Understanding the Proposed REACH Authorization Update
The REACH authorization update ensures that substances of very high concern receive heightened regulatory scrutiny before companies can continue using them. This mechanism aims to protect human health and the environment by imposing strict requirements on chemical use while encouraging the adoption of safer alternatives.
When substances move to Annex XIV of the REACH Regulation, manufacturers and importers must apply for specific authorization if they wish to maintain their operations beyond designated deadlines. The authorization framework operates as a crucial control measure for managing chemicals already identified as SVHCs on the Candidate List.
Companies relying on chemical compliance management systems should pay close attention to this update. The transition from the SVHC Candidate List to the Authorization List represents a critical escalation in regulatory requirements.
The Four Substances Recommended for Authorization
Under the newly proposed REACH authorization update ECHA selected these specific chemicals from the Candidate List based on an agreed prioritization approach, determining they represent the highest priority for regulatory action at this time.
1. Barium Diboron Tetraoxide (CAS: 13701-59-2)
This substance faces recommendations primarily due to reproductive toxicity concerns classified under Category 1 B. ECHA notes that while the volumes and uses of barium diboron tetraoxide within the authorization scope are limited, the substance is recommended based on grouping considerations. It could potentially be used to replace other boron compounds already recommended for authorization, which would risk regrettable substitution.
Industries affected include ceramics and glass manufacturing, plastics and polymers, electronics (particularly dielectric and optical materials), and industrial inorganic chemical formulations.
2. S-(tricyclo[5.2.1.0²,⁶]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) Phosphorodithioate (CAS: 68649-42-3)
This complex phosphorodithioate compound is flagged for its persistent, bioaccumulative, and toxic (PBT) properties. The substance finds widespread application in automotive lubricants such as engine oils and gear oils, industrial oils and greases, metalworking fluids, machinery and manufacturing lubricants, and petrochemical or refinery additives.
With usage volumes ranging between 1,000 and 10,000 tonnes, this recommendation will significantly impact the lubricants and petrochemical sectors.
3. Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (CAS: 75980-60-8)
Known as TPO in the industry, this photoinitiator substance is recommended due to reproductive toxicity Category 1B concerns. TPO is extensively used in UV-cured resins, printing and packaging applications (UV inks and varnishes), electronics (photoresists and UV encapsulants), automotive coatings (UV-cure paints), dental materials (UV composites), and 3D printing resins.
The recommendation of TPO has generated considerable industry discussion, given its widespread application in modern manufacturing processes. Companies using compliance tracking software should immediately assess their TPO inventory and usage patterns.
4. Melamine (CAS: 108-78-1)
Perhaps the most controversial inclusion, melamine is recommended for authorization under Article 57f due to an equivalent level of concern stemming from very high persistence combined with high mobility and toxicity. This marks a significant shift in how ECHA approaches PMT (Persistent, Mobile, and Toxic) substances.
Melamine's industrial applications span the plastics industry (melamine-formaldehyde resins), laminates and surface coatings, adhesives and binders, textiles (flame retardants), automotive interiors, construction materials, and food contact materials. With usage volumes exceeding 10,000 tonnes, melamine's potential authorization represents one of the most impactful REACH compliance challenges for European industry in recent years.
ECHA appears to have prioritized melamine despite its complexity, citing concerns over its PMT properties and potential for long-range water contamination. While melamine serves as a production intermediate in many applications (which would be exempt from authorization requirements), authorization for other uses may substantially increase compliance burdens for businesses.
Why This Recommendation Matters Now
This announcement breaks a two-and-a-half-year silence on new authorization recommendations. ECHA had paused new Annex XIV recommendations largely to provide capacity for managing chromium (VI) authorizations. The recent shift to restricting chromium VI under Annex XVII (the restriction pathway rather than authorization) suggests ECHA is ready to resume its core authorization work.
The inclusion of melamine signals a renewed focus on PMT and very Persistent very Mobile (vPvM) substances under both authorization and restriction pathways. ECHA and the German UBA estimate that around 250 to 350 substances are strong candidates for PMT or vPvM classification based on current screening. These include pharmaceuticals, PFAS, pesticide metabolites, and industrial chemicals with high persistence and mobility.
For companies managing the REACH authorization update compliance, this represents a potential wave of future regulatory actions requiring proactive preparation.
What Happens Next: Timeline and Implications
The European Commission and EU Member States will now consider ECHA's recommendation. If the substances are added to Annex XIV, the Commission will establish specific timelines, including the Latest Application Date (LAD) and Sunset Date for each substance.
The Latest Application Date marks the deadline by which companies must submit authorization applications, while the Sunset Date represents the point after which use without authorization becomes prohibited. The Commission may also define any substance-specific exemptions during this process.
Companies that manufacture, import, or use these substances in the European Economic Area will need to verify whether their uses fall within the scope of the entries. Where relevant, they must prepare for authorization applications or consider alternatives in view of the future sunset dates. While the timeline for the next official update remains unclear, industry experts say that we can expect some movement in early 2026.
Industries That Will be Most Affected by This Update
The number of industries impacted by this recommendation itself underscores the complexity of modern chemical compliance management. Key sectors facing potential disruption include:
Manufacturing and Processing: Ceramics and glass production, plastics and polymer manufacturing, electronics and semiconductors, and 3D printing operations face direct impact from these recommendations.
Automotive Industry: Engine oil and gear oil formulations, UV-cure paint systems, and interior component manufacturing will require careful review and potential reformulation.
Printing and Packaging: UV ink and varnish producers
Construction and Materials: Laminate producers, surface coating manufacturers, adhesive formulators, and flame retardant suppliers face significant REACH compliance challenges.
Industrial Lubricants: Metalworking fluid producers, machinery lubricant manufacturers, and petrochemical additive suppliers must evaluate their use of phosphorodithioates.
Preparing for Authorization: Steps Companies Should Take
Organizations should not wait for final authorization before taking action. Proactive implementation of compliance-tracking software can help companies stay ahead of regulatory requirements.
Inventory Assessment: Conduct a comprehensive review of all substances in use, purchased materials, and finished products to identify whether any of the four recommended substances are present above threshold concentrations.
Supply Chain Communication: Engage with your suppliers to understand their use of these substances and request updated Safety Data Sheets from them reflecting the latest regulatory status.
Alternative Evaluation: Begin researching and testing safer alternative substances that could replace the recommended chemicals without compromising product performance or quality.
Documentation Preparation: Companies planning to apply for authorization should start gathering technical data, exposure assessments, and socioeconomic analyses that will support their applications.
Regulatory Monitoring: Implement systems to track the progression of this recommendation through European Commission deliberations and eventual publication of final authorization requirements.
The Role of Compliance Software in REACH Management
Managing the REACH authorization update manually becomes increasingly impractical as the SVHC Candidate List expands and authorization recommendations accelerate. The Candidate List now includes 251 substances, with additional chemicals added throughout 2025.
Modern compliance tracking software offers essential capabilities for navigating these complex requirements. These systems automatically update when ECHA publishes new recommendations, enable rapid screening of product portfolios against current and proposed restrictions, generate required notifications and reports, track application and sunset date deadlines, and facilitate supply chain communication.
Companies using chemical compliance management platforms report significantly reduced compliance risks or administrative burdens. As ECHA resumes regular authorization recommendations, getting your robust digital and AI-powered compliance systems ready for action, becomes not just advantageous but essential for maintaining market access.
Looking Ahead: The Future of REACH Authorization
This move doesn’t feel like a one-off. If anything, it reads like the first signal that Europe may be gearing up for a new wave of authorization activity. The fact that ECHA is zeroing in on PMT and vPvM substances isn’t random—it points to a much longer list waiting in the wings.
The REACH compliance challenges facing the European industry will intensify as screening identifies additional high-priority substances among the estimated 250 to 350 PMT or vPvM candidates. Sectors that rely heavily on persistent chemicals should definitely begin scenario planning for potential future restrictions from now on.
Notably, ECHA's documentation mentions that bis(2-ethylhexyl) tetrabromophthalate, covering all isomers and combinations, was not included in the final recommendation because it is being addressed through a parallel restriction initiative under the Restrictions Roadmap.
Conclusion
This recommendation marks a significant milestone. While these four substances are not yet subject to authorization, companies should treat this announcement as a clear signal to prepare.
Organizations that act now to assess their exposure, engage suppliers, evaluate alternatives, and implement robust compliance tracking software will definitely find themselves better positioned when final authorization requirements take effect. Those who delay risk facing compressed timelines, limited alternative options, and potential supply chain disruptions.
The REACH authorization process continues evolving to address emerging scientific understanding of chemical risks, particularly regarding persistent and mobile substances.
As always, staying informed through official ECHA communications and leveraging modern chemical compliance management systems like Certivo provides the foundation for navigating these complex regulatory waters successfully. Book a demo today.
Lavanya
Lavanya is an accomplished Product Compliance Engineer with over four years of expertise in global environmental and regulatory frameworks, including REACH, RoHS, Proposition 65, POPs, TSCA, PFAS, CMRT, FMD, and IMDS. A graduate in Chemical Engineering from the KLE Institute, she combines strong technical knowledge with practical compliance management skills across diverse and complex product portfolios.
She has extensive experience in product compliance engineering, ensuring that materials, components, and finished goods consistently meet evolving international regulatory requirements. Her expertise spans BOM analysis, material risk assessments, supplier declaration management, and test report validation to guarantee conformity. Lavanya also plays a key role in design-for-compliance initiatives, guiding engineering teams on regulatory considerations early in the product lifecycle to reduce risks and streamline market access.
Her contributions further extend to compliance documentation, certification readiness, and preparation of customer deliverables, ensuring transparency and accuracy for global stakeholders. She is adept at leveraging compliance tools and databases to efficiently track regulatory changes and implement proactive risk mitigation strategies.
Recognized for her attention to detail, regulatory foresight, and collaborative approach, Lavanya contributes significantly to maintaining product compliance, safeguarding brand integrity, and advancing sustainability goals within dynamic, globally integrated manufacturing environments.

