On October 27, 2022, ChemLinked held a webinar themed on the Industrial Chemicals Environmental Management Standard - IChEMS, which is a new way of managing the environmental risks of industrial chemicals in Australia. Mr. Nick Zovko, who has over 20 years of experience in chemical regulatory affairs, gave the attendees an impressive and informative presentation in this regard. Below are some of the FAQs collected in this webinar to facilitate your understanding of the industrial chemicals environmental management in Australia.
1. Can you briefly explain how the two regulations differ? Can I understand that IChEMS will exist in addition to the AICIS regulation? Thank you.
IChEMS operates in conjunction with the Department of Health’s Australian Industrial Chemicals Introduction Scheme (AICIS). AICIS is responsible for regulating the import and manufacture of industrial chemicals in Australia and assessing risks to human health and the environment across the lifecycle of industrial chemicals.
IChEMS uses AICIS risk assessments to schedule industrial chemicals on the IChEMS Register and recommends actions needed to protect the environment from different end uses.
2. When will IChEMS expected to be implemented? Is there any transition period?
IChEMS has been implemented at a national level for the most part. State and territories are still working though legislative provisions to adopt IChEM scheduling decisions. Transitional provisions are expected to be part of the process when a chemical is scheduled. Public commnet has began for the first tranche of chemicals to be listed on IChEMS.
CL news: Australia Consults on First Proposed IChEMS Scheduling Decisions, 3 POPs Shall be Prohibited
3. What information do you anticipate the market to expect to be on the SDS for this regulation?
There is a general duty to share, and use information on the environmental risks of industrial chemicals to ensure that any persons handling the chemical throughout the supply chain are aware of these risks, and enabled to undertake activities using industrial chemicals in an environmentally safe manner. Therefore if a chemical is scheduled, inclusion in section 15 of SDS (Regulatory Information) could be an appropriate manner for suppliers to communicate the scheduled decision down the supply chain. In saying that, businesses will usually have flexibility in how they meet risk management measures.
4. As Australia does not have a list of official GHS classifications, which is the classification considered by the government for the prioritization process in case different suppliers (manufacturers/importers) notify different classifications into the inventory? Thank you.
Just a slight correction. In Australia, the Hazardous Chemical Information System (HCIS) is an internet advisory service that assists you to find information on chemicals that have been classified in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) by an authoritative source, such as the European Chemicals Agency (ECHA) or the Australian Industrial Chemicals Introduction Scheme (AICIS), formerly the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). HCIS is provided for guidance only and is not a comprehensive database of all hazardous chemicals.
The priority focus areas for IChEMS as indicated by the authority for scheduling chemicals from 2022 and 2023 are as follows:
From 2022
From 2023
Chemicals assessed under the AICIS evaluation Rolling Action Plan
Aligning with existing or emerging Rotterdam, Stockholm and Minamata obligations.
Throughout 2022-23 they will consult to determine the next focus areas for scheduling, post-2023. This may include:
chemicals of emerging concern
lower concern chemicals, including alternatives for chemicals of concern
chemical groups based on their function or use.
They have noted that they will begin developing IChEMS scheduling work plans from 2023, including each year's focus areas and indicative chemical lists. These work plans will be informed by AICIS assessment activity as well as information gathered from our stakeholders.
5. How will IChEMS Register impact the process, criteria and outcome of the prioritization of chemicals in Australia?
The department has indicated two early priorities for scheduling on the website (DCCEEW):
1) Aligning IChEMS with existing chemical management frameworks. Risk assessments carried out under the Australian Industrial Chemicals Introduction Scheme (AICIS) will inform IChEMS scheduling decisions.
2) Globally recognized industrial chemicals of concern, such as those listed in international conventions. They will initially prioritize those that aren't consistently controlled in Australia. The conventions of most interest are the:
Stockholm Convention on Persistent Organic Pollutants
Minamata Convention on Mercury
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.
Before identifying the next priority areas, they will consult with risk managers, governments and the community to focus on providing information they find most useful. For example, scheduling could prioritize:
chemicals proposed for listing on international chemicals conventions
chemicals controlled in countries with comparable safety standards
chemicals of interest for supporting a safe circular economy
alternatives for chemicals of concern
opportunities for scheduling broad groups of chemicals, including low-concern chemicals
grouping chemicals for scheduling based on their function or use.
6. If there are differences between states/territories in terms of risk assessment, will IChEMS be the "moderator"?
In Australia, risk assessment (generally speaking) is managed at a national level. Risk management is usually handled by state and territories. Yes, there can be divergent approaches between jurisdictions in terms of risk management. The IChEMS is a national approach to manage chemical import, use and disposal. IChEMS is supposed to drive a more streamlined approach to managing environmental risks across the Commonwealth, states and territories.
7. Can a manufacturer outside Australia submit and get approval for an assessment, and cover their importers?
No, under AICIS, the responsibility lies with the introducer (importer/manufacturer). However, third-party confidential data can be kept from the introducer and directly supplied to AICIS.
8. What we can do if one of the ingredients is not listed in AICIS? And what kind of documents do we need to send the product with one ingredient not listed?
If you’re sure that your introduction isn’t ‘listed on the Inventory’ or excluded, it must be authorized under one of the unlisted introduction categories:
Exempted introduction
Reported introduction
Assessed introduction - if your chemical is already on the Inventory, you must apply to vary the Inventory terms of listing; if your chemical isn't on the Inventory, you must apply for an assessment certificate
Commercial evaluation – this is an alternative option to exempted, reported and assessed introductions – criteria and fee applies
A good starting point in navigating the process can be found here on the AICIS website: Basics of importing and manufacturing chemicals in Australia
The required documents for an unlisted chemical will be dependent on the risk of the substance and the unlisted introductory category.
9. What are the types of chemicals to go through IChEMS? You mentioned PFAs which have a large global interest. It’s there more information on the criteria that will be looked at such as CMR, and endocrine…?
Scheduling decisions are guided by the Industrial Chemicals Environmental Management (Register) Principles 2022 (the Principles). The Principles are a supporting instrument to the ICEMR Act and the basis for the classification of a chemical into one of seven schedules and for setting any management standards that apply to that chemical. The decision-maker must apply the criteria in the Principles when making scheduling decisions.
The Australian PBT Criteria are also part of the Principles. These Criteria inform the categorization of organic chemicals as persistent (P), bioaccumulative (B) and toxic (T). Below are useful links to the criteria of scheduling:
(PBT) https://www.dcceew.gov.au/environment/protection/chemicals-management/national-standard/australian-pbt-criteria
(The principles) https://www.legislation.gov.au/Details/F2022L01436
Also, information used to make scheduling decisions can include:
Risk assessments conducted by the Australian Industrial Chemicals Introduction Scheme (AICIS)
Information gathered through public consultation.
Advice from the IChEMS Advisory Committee.
Information from consultation with state and territory environment ministers.
Information from specific people, e.g. from chemical introducers.
Presentation slides are available for free.
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