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 MoU design imperative was that no overseas supplier would accept being bound by a written undertaking to reveal trade secrets to a government body. They would sooner scrap their Australian market.

Larger introducers would obtain 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, all introductions where the introducer didn't hold source documentation were subject to a written undertaking.

The big change is source documentation is only required if AICIS request it for particular chemicals.

Now, the introducer only needs to document the basis of their belief that it will be provided.

Such belief cannot be held unless the overseas supplier knows what might be requested**

The local introducer whose business depends on the supplier not scrapping their Australian market can quite legitimately and honestly say to an overseas supplier ...

"Sign this MoU which describes information which MAY be requested by AICIS for this particular chemical. Further, this MoU will be the basis of my belief that, also understanding the particular consequences involved, you intend to provide that information if AICIS requests it."

As indicated, the MoU sets out the consequences of failing to provide AICIS-requested information.

There is therefore a real and properly informed choice to be made by the overseas supplier in their role as the Chemical Information Holder - if AICIS request the information.