AICIS news items
AICIS fines cosmetic importer - October 2023
AICIS publish their latest Inventory snapshot - July 2023
OECD Test 125 added for nanomaterial solubility - May 2023
AICIS adopts OECD information waivers - February 2023
AICIS "clarifies" flavours/fragrances guidance - February 2023
New category: Reported <= 10kg - November 2022
News from the trenches - August - September 2022
AICIS will accept INCI name as the proper chemical name - April 2022
AICIS record keeping checklist changes for Exempted and Reported - April 2022
Approval required for Mercury import/export - March 2022Listed chemicals spreadsheet - March 2022
Rotterdam/Stockholm - late 2021
Nanoscale changes - late 2021
International assessments - late 2021
Release to the environment - record keeping changes - late 2021
Advice on NICNAS exemptions - expires August 2022
Snippets from AICIS emails in late 2021
All AICIS Guidelines changes to March 2022
Please note that Chemintro is continuously updated to incorporate all AICIS changes.
60 Penalty points ($16,500) for contravening section 13.1 the Act by importing without being registered with AICIS as an introducer. See https://www.industrialchemicals.gov.au/news-and-notices/melbourne-business-issued-16500-infringement-unlawful-cosmetic-imports for published detail.
Each month AICIS publish their changes to the Inventory as required by the Act. The downloadable snapshot brings those changes together as a complete database in a spreadsheet. The previous one was dated 1 September 2022. This one is 30 June 2023.
There is no real change here. In deciding if a nano-material is soluble or not, OECD Test 125 is already one of the determining mechanisms. AICIS is just including it in their online guidance.
For Assessed category, AICIS requires a dossier of information on your chemical. An IUCLID6 dossier is acceptable. In Chemintro we provide an AICIS-tailored workflow and checklists to manage collection of the same IUCLID6 information.
IUCLID6 has some built-in justifications for not providing (waiving) certain information.
In the interests of international best practice, AICIS has adopted many of these waiver justifications which are used by a number of OECD member countries.
AICIS also has some of their own waivers not built into IUCLID6 which may be applied for. These waivers are now included in the above-mentioned Chemintro workflow.
In the low-risk blend guidance, AICIS says "your chemical does not have any of the hazard characteristics in the highest human health and the environment hazard bands". Use of the word and in that statement is logically clumsy because it could be easily misread as meaning both.
We asked and they replied "your chemical must not have any of the hazard characteristics in the highest human health hazard band (hazard band C) and must not have any of the hazard characteristics in the highest environment hazard band (hazard band D)."
Essentially they are using "and" to join two separate statements instead of using two separate dot points!
BREAKING (March 2023) - AICIS guidance has now been updated as we suggested!
Following industry feedback AICIS has eased the way for imports not exceeding 10 kilograms. We have scanned the changes and written Chemintro ticket#29 which describes our findings in some detail. In summary, this AICIS change removes the almost impossible burden of remote documentation or proof for categorisation of overseas chemicals where 10kg or less cannot be a substantial risk to Australia.
AICIS have clarified their use of the word 'significantly' for chemical listings that have a specific information requirement – and added examples to help comply with this obligation.
AICIS says the transition period for chemicals introduced under the NICNAS exemptions which ended on 31 August 2022 is not being extended. They are considering rule changes and publish a flowchart for the currently available pathways
One of our users,a Consultant, reports a client introduced a product as Reported based on the overseas supplier saying they are perfectly willing to provide their chemical data to AICIS.
However, when the consultant dug a little deeper on behalf of their client, it turned out that the supplier had not done any studies and was relying exclusively on publically available data.
The Pre-introduction Report had been submitted already so the client was faced with performing the studies or withdrawing the product. The product was withdrawn.
There are four criteria to meet before AICIS will accept an INCI name as the proper name for the chemical. In Chemintro the INCI name field help-text summarises these criteria.
Chemintro already automatically creates clickable links to the appropriate checklist after categorisation. It appears the links themselves have not changed, just the content. Therefore no change is needed in Chemintro.
The Minamata Convention came into force in Australia on 7 March 2022 and is governed by AICIS for industrial and cosmetic uses. We have catered for it by detecting Hg in the molecular formula and triggering a "prohibited" status. You can defeat that in a couple of ways.
Download the Minamata text here
AICIS has published an already out-of-date snapshot of their listed chemicals including a notice to that effect. We agree and that is why we automatically construct a search URL for you based on the CAS number to find it if listed together with any listing obligations.
Download the AICIS spreadsheet here
Reported or Exempted category is only possible for a chemical listed in either Rotterdam or Stockholm Convention if the total annual volume is <= 100kg AND it is solely for research or analysis.
Reported category R&D introductions now must declare whether the chemical is at the nanoscale.
Another slight change is that you can now say 'Yes' this is a known nanoscale introduction without - at the time of introduction - needing a study to confirm it. Prior to 2022 a study was necessary prior to introduction.
If international assessments are relied on for categorisation, introducers now need to declare they have permission to use them - in their entirety - from the owners of such reports.
Quantity, frequency and location records are now required for 'Designated kind of release into the environment' introductions. But there is also an 'if practicable' rider to cover those situations where it is really not possible to keep track of such releases. Presumably you would need to justify that if requested!
Until August 2022 introducers may still be able to use some of the old exemption criteria that existed under NICNAS ... Chemicals introduced under NICNAS exemptions
AICIS will regard these exemptions as reported introductions ... Some NICNAS exemption provisions available until 31 August 2022
However, introducers will still need to keep records about their introductions ... Record keeping obligations for chemicals introduced under exemptions.
Such exemptions will need to categorise under the AICIS introduction categories (e.g. as Exempted, Reported or Assessed) to continue to be imported or manufactured beyond August 2022
AICIS have advised that it may be beneficial to just categorise now according to those AICIS introduction categories (rather than have to re-categorise later).
Regarding the import of samples -
"The introductions of all industrial chemicals must be categorised, unless they are an excluded introduction under Section 11 of the Industrial Chemicals Act 2019 (for example, if the chemical is introduced solely for an individual’s personal use)."
"The introductions may be categorised as exempted, reported, assessed or commercial evaluation introductions, depending on the circumstances of each of the introductions. For example, if the chemicals are introduced at low volumes, the introductions may be able to be categorised as exempted or reported. Our categorisation guide should be used to help introducers to categorise their introductions."
Regarding use of an ECHA dossier -
"The Industrial Chemicals Categorisation Guidelines (‘the Guidelines’) give both the definition of each hazard characteristic and the amount and type of information that is required to demonstrate the absence of each characteristic. Typically, introductions in higher exposure bands require more information to demonstrate the absence of a hazard compared to introductions in lower exposure bands"
"Whilst ECHA dossiers may be used to demonstrate the suspected presence of a hazard (e.g. a GHS classification on the REACH website), they are unfortunately not a suitable form of information to demonstrate the absence of certain hazards (where required by the Guidelines)."
Change 1.4 on 30 March 2022 -
"Steps 4.1 and 5.1 – Is your chemical a certain chemical at the nanoscale? 7 questions and answers added to help an introducer work out if they are introducing this type of chemical.
Steps 4.1 and 5.1 – Where an introduction is a specified class of introduction. More information added, including our concerns about them and extra information required from introducers. Content has been added under the following headings:
- Does your chemical contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)?
- Is your chemical a certain polyhalogenated organic chemical?
- Is your chemical a certain chemical at the nanoscale?
- Is your chemical a certain gas? (step 5.1 only)
Steps 4.5 and 5.5 – Special cases - introductions that cannot have a very low indicative human health risk and introductions that cannot have a very low indicative environment risk. Added this extra point to make it clear this type of chemical cannot have a very low indicative risk for human health or the environment: 'OR chemical that is introduced as a solid or a dispersion where there is no information available on its water solubility or its particle size, and the introduction of any nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion' Steps 6 – Next steps: If your introduction is categorised as assessed Added the next step required if the chemical is on the Inventory. Clarified the outcome when the chemical is not on the Inventory. "
This Guideline information is built into Chemintro; Tylosin has been removed from the Chemintro list of comparable chemicals; nanoscale criteria have been adjusted to permit categorisation prior to acquisition of the necessary study results; and air fresheners in Chemintro were already correctly tagged as not a 'designated kind or release into the environment'.
Change 1.3 on 23 November 2021 -
"Step 1: added words shown in bold text:'...can not be categorised as an exempted or reported introduction unless it is both of the following:
1.) the industrial chemicals are to be introduced solely for use in research or analysis, and
2.) the total volume of the industrial chemicals you introduce in a registration year does not exceed 100 kg
Step 2: clearer explanation of the nanoscale criteria for research and development and chemicals resulting from non-functionalised surface treatment of listed chemicals; removed 'Tylosin, (2R,3R)-2,3-dihydroxybutanedioate (1:1)' with CAS number 74610-55-2 from the comparable chemicals table and improved the instructions on how to use the table.
Step 3: clearer explanation of the nanoscale criteria for research and development.
Step 5.3: added statement to clarify that a chemical with an end use in an air freshener is not a 'designated kind or release into the environment'
Correction: Environment hazard band A hazard characteristics.
Under bulleted list 'information that demonstrates that all of the following applies to the polymer:...' indented the following paragraphs to correctly align as follows: information that demonstrates that all of the following applies to the polymer... if it is a polymer that contains polyethylene glycol (PEG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade, and if it is a polymer that contains polypropylene glycol (PPG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade."
This Guideline information is built into Chemintro; Tylosin has been removed from the Chemintro list of comparable chemicals; nanoscale criteria have been adjusted to permit categorisation prior to acquisition of the necessary study results; and air fresheners in Chemintro were already correctly tagged as not a 'designated kind or release into the environment'.
Change 1.2 on 28 May 2021 -
"New step : 'Step 0 - Introductions that are in the listed category'. Added 'Who is this guide for' in 'Before you start categorising your introduction' and removed information covered in step 0. Removal: 'Information you need to work out your introduction category' (covered in Step 0) Clearer guidance on outcomes and next steps in step 4.1 and 5.1. More information in step 4.4 including restrictions on use of animal test data. More information in step 5.4 including restrictions on animal test data. Replaced references to checking the General Rules with more explanatory text. More information about water treatment products and designated kind of release to the environment in the context of working out your environment categorisation volume."
This Guideline information is built into Chemintro including where appropriate a note to be acknowledged regarding the use of recent animal test data.
Change 1.1 on 22 December 2020 -
"Replaced references to Categorisation Guidelines in step 4.4 and 5.4 with the details (from the Guidelines) about hazard bands; improvements and more information in 'Before you start categorising your introduction'. Added appendices: acceptable test guidelines for categorisation and in silico predictions for categorisation."
This Guideline information is built into Chemintro as well as URLs to each OECD Test for users in the 'OECD' role.