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Outcome of public consultation on the 2025 Categorisation Guidelines
Summary of outcome
Between 24 October and 5 December 2024, we asked for your feedback on changes to the AICIS Industrial Chemicals Categorisation Guidelines (the Guidelines) for 2025 and a proposal to annually update the Guidelines with set timeframes.
We received 5 submissions, which mostly supported the proposals. After considering the feedback, we will implement all the original proposals without change. These are described below. You can read the full details in last year’s consultation.
2025 Industrial Chemicals Categorisation Guidelines
- The next Guidelines will be issued in September 2025.
- An extra 116 entries will be added to the ‘list of chemicals with high hazards for categorisation’ (the list) based on updates to external sources, plus another 4 AICIS-assessed chemicals.
- No chemicals will be added to part 6 of the Guidelines. This means introducers do not need to check any additional esters and salts of chemicals on the list.
The 2025 Guidelines will also include editorial changes such as fixed footnotes and minor text changes in some sections to improve clarity.
Annual updates to the Guidelines
- An updated version of the Guidelines will be issued in September each year to coincide with the AICIS registration cycle.
- The updated version will include changes that have been consulted on publicly. All stakeholder feedback will be considered before deciding on the final changes.
- The public consultation period on proposed changes to the Guidelines will start in September-October of the year before the updated Guidelines come into effect. This will include a public notice about any chemicals that will be added to the list due to updates to external sources.
- The finalised changes to the Guidelines will be announced 6 months in advance each year (February-March) to give introducers time to transition.
Comments we received and our response
Timing of annual updates to the Guidelines
Comment 1: The transition period (6 months) should apply to all changes, not just those that have an adverse regulatory impact on chemical introducers. Response: In general, the 6-month transition period will apply to all the Guidelines changes each year to give introducers time to prepare.
Comment 2: What would AICIS consider to be an urgent change needing an unscheduled update of the Guidelines? Response: There may be situations when the AICIS Executive Director decides to implement a rapid change, such as when the changes benefit introducers. For example, we added in-silico options to appendix 8.2 earlier than the September 2024 release. In such cases, we will inform affected introducers as soon as possible.
Comment 3: Industry should get more time to prepare for the changes to the Guidelines before they come into effect. Response: We believe the timeframes outlined in last year’s consultation provide enough notice for affected introducers. Further, changes to the list are based on updates to external sources that are publicly available in advance of being added to AICIS’s list.
Comment 4: AICIS should give training and information sessions. Response: We will provide information sessions or training if the changes are substantial or complex.
Comment 5: Make it clear what the changes are by publishing a separate document detailing the changes implemented in the Guidelines. Response: The endnotes in the Guidelines note which parts have changed between versions and briefly describe the changes. For the 2025 Guidelines being issued in September, there are no changes to the proposals made in last year’s consultation. We recommend stakeholders review these proposals to see full details. We will also update any relevant website guidance and clearly describe the changes before the Guidelines are issued.
Comment 6: Will AICIS consult each time the Guidelines are updated, or will the annual changes be automatic? Response: We will invite public feedback if we propose changes to the Guidelines that may affect the categorisation outcome of introductions.
Updates to the list of chemicals with high hazards for categorisation (the list)
We did not receive any feedback about the 4 AICIS-assessed chemicals that we proposed adding to the list. The main comments were about how the entries are displayed for the chemicals that will be added to the list due to the updates to external sources of the list. Many comments were outside the scope of the consultation. These suggestions will be considered during future updates of the Guidelines. Brief responses to some of these comments are included below.
Comment 7: There is a lack of CAS numbers, including for group entries. Response: This is because some of the external sources of the list do not include CAS numbers for some entries. We will maintain the entries as they are for the 2025 Guidelines.
Comment 8: Address the naming of entries on the list, where they do not follow internationally accepted nomenclature such as CAS or IUPAC. Response: We use the names as they appear in the external sources of the list. The external sources do not include CAS names or IUPAC names for some entries. We will consider ways to make it easier to search for chemicals on the list in the next update.
Comment 9: Multiple additions have the same name, which could make it confusing for introducers. Response: We have reproduced the entries as they appear in the sources. Note that each entry with the same name has a separate CAS number. Introducers should search for these CAS numbers to determine if any chemicals they may be introducing will be added to the list. This is consistent with our guidance on how to check if your chemical is on the list.
Comment 10: AICIS should reach out to affected introducers as soon as possible. Response: We have contacted potentially affected introducers that we were able to identify.
High-hazard esters and salts of chemicals on the list
We did not receive any suggestions to add more chemicals to part 6 of the Guidelines.
Comment 11: Identify specific esters and salts captured by the current entries in part 6 of the Guidelines to the extent possible. Response: We will consider this for future updates of the Guidelines.
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