EU Overhauls Drug Precursor Regulation to Combat Designer Chemicals and Ease Compliance
EU launches new Regulation on drug precursors, targeting designer chemicals and reducing admin burden with digital systems for chemical industry compliance.
Australia’s Industrial Chemicals Introduction Scheme (AICIS) has launched a public consultation on proposed revisions to its Categorisation Guidelines, due to take effect in 2026. Open until 28 January 2026, the consultation aims to refine the assessment framework for chemicals introduced in Australia, with significant implications for chemical manufacturers, importers, and downstream users.
Key Insights
The changes cover updates to the list of chemicals with high hazards for categorisation, additions and removals of specific substances, definitional clarifications, and minor editorial edits. Industry stakeholders are encouraged to review and comment to ensure that regulatory adjustments are scientifically sound and operationally feasible.
Updates to High-Hazard Chemical Lists
The most impactful element of the revision is the proposed update to the list of high-hazard chemicals, which guides the categorisation of introductions under the AICIS framework. These substances typically require additional scrutiny due to human health or environmental risks.
Additions include nine chemicals, such as:
- Ethanesulfonic acid, 2-chloro- (CAS 924-44-7)
- 1H-benzotriazole-1-methanol, 5-chloro-2-(2H-tetrazol-5-yl)- (CAS 956585-40-9)
These have been identified due to their hazardous salt or ester forms, which may present comparable risks to their parent compounds.
Two chemicals will also be removed from the current list:
- 1H-1,2,4-triazole-3-thiol (CAS 4000-54-6)
- 2H-1,2,3-triazole, 4,5-dihydro-1-(phenylmethyl)- (CAS 620-97-7)
These are no longer deemed to meet the relevant hazard criteria under updated assessments.
Clarification of Regulatory Definitions
To streamline regulatory compliance, AICIS proposes a single updated definition of “chemical identity holder”. The revision simplifies two previous definitions into one, covering both standard and non-commercial introductions. This move aims to reduce ambiguity and ensure consistent interpretation across industry submissions.
Technical Edits and Alignment with Safe Work Australia
The guidelines also include minor editorial corrections and updated links to align with the most recent Safe Work Australia documentation. For instance, text in Section 2.1.5 has been revised to improve clarity around known hazard classifications.
The guideline will now reference updated human health hazard tables under Section 8.2, replacing older resources that may not reflect current scientific evidence.
Access the original source
Have your say: revisions to the Categorisation Guidelines in 2026
Foresight continuously tracks 1000s of sources and maps updates to your portfolio:
- Get alerted when changes affect your products or operations
- Access source documents with full citations
- Collaborate with your team on alerts and decisions
Related Articles
EU Overhauls Drug Precursor Regulation to Combat Designer Chemicals and Ease Compliance
EU Launches RESourceEU Action Plan to Tackle Critical Raw Materials Dependency
EU Defers Key Labelling Rules in CLP Regulation Amendment to Ease Industry Burden
EU Launches RESourceEU Action Plan to Tackle Critical Raw Materials Dependency
The EU’s RESourceEU Action Plan aims to reduce critical raw materials dependency, boost recycling and accelerate diversification for industrial resilience.
EU Defers Key Labelling Rules in CLP Regulation Amendment to Ease Industry Burden
The EU has delayed labelling and classification deadlines under the CLP Regulation to reduce compliance pressure. Changes affect fuel labelling and online sales.
