F2024C00396 Chemical information holder when introducer does not know

[Mike Dewhirst]

1. An eligible INCI name has been added to the mix of permissable names if CAS and IUPAC names are not known. No change to the software is required beyond slightly updating the help-text.

2. If none of the above is known to the introducer then we need a name of a person in the Chemical information holder (CIH) field who has provided or is expected to provide identifying information to the Executive Director.

3. We also need a note indicating the basis of the expectation that the person named will give the identifying information to the Executive Director if requested.

The records being kept are actually in the Chemintro Data report.

Thus, with the Information availability field set to "Introducer does not know ..." and with a non-blank Chemical information holder field, the only two changes to the software will be to:

Produce a templated Chemical information holder: Basis of expectation note where the Chemical information holder field is not blank.

and

Under all circumstances it will be an error if all three of CAS, IUPAC and INCI names are blank and the Chemical information holder field is also blank.

Correction here: There is no point raising an error if the only issue is the user happens to be saving data entered before (yet) entering those names. In fact the error will will be raised if the user selects "Introducer does not know ..." in the Information availability field while simultaneously leaving the Chemical information holder field blank.

If there is a CAS number and the three fields are blank it will certainly be anomalous but not an error. CAS number appears to satisfy AICIS requirements.

These April 2024 amendments to the Rules make similar changes to record keeping (mentioned in a comment below) where the basis of belief also needs to be documented. At this stage, a single note for documenting that basis ought to be sufficient.

[Mike Dewhirst]

This ticket also covers a Chemical identity holder: Basis of expectation note for:

• <= 10kg introductions (section 42A(2) (4.d))
• other 'low risk' introductions (section 43(4))
• chemicals imported and subsequently exported (section 47(4))
• R&D > 10kg (section 48(3) (3.b))
• Polymers comparable to listed polymers (section 49 (2B))
  • Extra note indicating basis of belief that requirements of 26(4) are being met including ... the name of a person who would provide the records to demonstrate it AND the basis of the belief that person would provide those records if requested.
• Chemicals comparable to listed chemicals (section 49A (4.b))
  • Extra note indicating basis of belief that requirements of 26(5) are being met including ...
• Polymers of low concern (section 49A (4.b))
  • Extra note indicating basis of belief that requirements of 26(6) are being met including ...
• Biopolymers of low concern (section 49A (4.b))
  • Extra note indicating basis of belief that requirements of 26(7) are being met including ...
• Chemicals resulting from non-functionalised surface treatment of listed chemicals (section 50 (3.e))
  • Extra note indicating basis of belief that requirements of 26(8) are being met including ...
• Exempted category
  • UCVB description or extra note per section 51(2) table item 6.e including ...
  • High molecular weight polymer extra note per section 51(2) table item 7.d including ...
  • Categorisation records extra note per section 51(2) table item 10.b including ...
  • Absence of hazard - detailed info demonstrating hazards
    • Full study reports per section 51(2) table item 24.e including ...
  • Specified classes per section 51(5) including ...
    • Biochemical
    • GM product
    • Food contact
    • Child contact

• Reported category
  • Internationally-assessed (health + environment section 52, health only section 53, environment only section 54 ) extra note per section 52(3.c)/53(3.c)/54(3.c) including ...
    • Not in Rotterdam, not in Stockholm, not listed, info not requested by Executive Director per section 25
    • Not medium to high risk per section 28(1) table items 1 to 3 or section 29(1) table items 1 to 5
      • Basis of belief including ...
    • Absence of hazard - detailed info demonstrating hazards per section 53(2)(i).i (also 54)
      • Full study reports as per MoU including ...
  • R&D > 100kg section 55
    • Not nano particles section 55(2.d) including ...
  • Flavour or fragrance blends section 56 including ...
  • Other reported introductions section 57
    • High molecular weight polymer section 57(2) item 5
    • Absence of hazard - detailed info demonstrating hazards per section 57(2) item 13
      • Full study reports as per MoU (57(4).c/d) including ...

[Mike Dewhirst]

The current Chemintro approach of producing a Memorandum of Understanding (MoU) between local introducer and overseas supplier was designed as a pragmatic device to semi-satisfy the AICIS requirement of a written undertaking.

The original MoU design notion was that no-one is going to accept being bound by a written undertaking to reveal trade secrets to a government body.

Overseas suppliers would prefer to scrap their Australian market.

Larger introducers would obtain the source documentation or not bother importing in the first place. Only smaller introducers are likely caught by written undertakings.

These April 2024 amendments suddenly make the MoU exactly the instrument required for those smaller players.

Previously, a legally binding written undertaking was required for all introductions where the introducer didn't hold source documentation.

Now, source documentation is only required if AICIS request it for particular chemicals and the introducer now only needs to document the basis of their belief that it will be provided.

The local introducer whose business depends on the supplier not scrapping their Australian market can say

"Here is our MoU which describes the information which MAY be requested for this chemical and sets out the consequences involved. You don't have to get lawyers involved for a written undertaking to actually reveal your trade secrets, just sign the MoU so I am covered according to the Rules and I can introduce the chemical"

"Each MoU will be the basis of my belief that you understand exactly what the Rules require and that you will provide AICIS-requested information."

As indicated, the MoU sets out the consequences of failing to provide AICIS-requested information and there is therefore a valid and informed choice to be made by the overseas supplier in their role as the Chemical Identity Holder.

[Mike Dewhirst]

• The templated "Basis of expectation" note is auto-created if there is a value in Chemical information holder
• An error is raised if there is no value in Chemical information holder when the Information availability field indicates there should be, ie., the introducer does not have the information.
• The MoU has been simplified (and will evolve in response to user comments)