12-Hydroxystearic acid Update

Navigating New Legislation: Understanding the Impact of 12-Hydroxystearic acid (12-HSA) Reclassification


Recent amendments to the classification of 12-Hydroxystearic acid (12-HSA) [EC No. 203-366-1, CAS No. 106-14-9] mark a pivotal shift in regulatory standards affecting a wide range of industries. Previously deemed non-hazardous, 12-HSA is now recognized as environmentally hazardous—specifically toxic to aquatic life—under the revised guidelines issued by the European Chemicals Agency (ECHA). This adjustment aligns with ADR class 9, UN 3077, indicating significant implications for businesses worldwide.


What Changed?

The reclassification of 12-HSA to an environmentally hazardous substance necessitates a thorough revision of the Material Safety Data Sheets (MSDS) associated with products containing this chemical. The urgency of updating safety protocols and compliance documentation cannot be overstated, as these revisions directly impact the supply chain and operational frameworks of industries utilizing this substance.


Why It Matters

The changes extend beyond mere regulatory compliance. They reflect a growing emphasis on environmental protection and sustainable practices within the chemical industry. This reclassification triggers a domino effect on the Global Harmonized System (GHS) standards, influencing not just European operations but also packaging and transportation regulations globally.


Impact on Supply Chain and Compliance

The shift has stirred a notable lack of awareness and preparedness among producers. Many stakeholders are still grappling with the new classification and its ramifications. Misinterpretations concerning compliance deadlines are widespread, with Castor International observing that many businesses are not adequately prepared to meet the April 2024 ECHA dossier update deadline.

As a result of the reclassification, packaging must now be modified from non-ADR to ADR standards, complete with the appropriate markings. Furthermore, storage restrictions will apply, requiring warehouses to obtain the necessary permits for proper compliance.

Recognizing these challenges, Castor International has taken proactive steps to support affected parties. By leveraging our expertise, we've facilitated smoother transitions for our clients and partners, ensuring that they understand and implement necessary changes without undue delay.

Castor International’s Role and Achievements

We at Castor International pride ourselves on our commitment to operational excellence and regulatory compliance. We are delighted to announce that we have successfully received the first shipment under the new regulatory framework, globally. This achievement underscores our dedication to leadership in safety and compliance, setting a benchmark in the industry.

Looking Forward

The reclassification of 12-HSA is not just a regulatory hurdle but an opportunity for companies to align their operations with contemporary environmental and safety standards. It serves as a reminder of the chemical industry's responsibility towards sustainable practices and the protection of natural ecosystems.

We urge all stakeholders to take immediate action to familiarize themselves with the new regulations and to update their practices accordingly. Castor International remains at the forefront, ready to assist with expertise and strategic guidance.


For businesses impacted by this change, the journey towards full compliance is critical. It involves understanding the intricacies of the new classification, updating safety data sheets, and reevaluating supply chain logistics. We appreciate the continued partnership and cooperation of all our clients and stakeholders as we navigate these changes together.

For further information or specific inquiries, please do not hesitate to contact Castor International. We are here to ensure a seamless transition and continued compliance with the highest standards of safety and environmental care.