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Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020
Scheduling of chemicals and poisons
3.1. Marker dyes and pigments
3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)
3.1. Interim decision in relation to marker dyes and pigments
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Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to marker dyes and pigments as follows:
Part 1 of the Poisons Standard, Interpretation - New Entry
Proposed date of effect of the proposed amendment
1 October 2020
Reasons for the interim decision (including findings on material questions of fact)
In making this interim decision, the Delegate considered the following material:
- The scheduling proposal to amend the current Poisons Standard with respect to marker dyes and pigments;
- Joint Meeting of the Advisory Committee on Chemicals Scheduling and the Advisory Committee on Medicines Scheduling's advice; and
- The public submissions received in response to the pre-meeting consultation.
Summary of Joint ACCS-ACMS advice/recommendations to the Delegate
The Joint Meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling recommended that a new entry for marker dyes and pigments in the Poisons Standard as follows:
Part 1 of the Poisons Standard, Interpretation - New Entry
The Committee also recommended that the Delegate go out for further consultation with key stakeholders with regards a suitable definition based on the amendments proposed above.
The Committee recommended that an implementation date was not relevant.
Members agreed that as this item relates to Part 1 of the SUSMP, rather than to an actual substance, assessment of the Section 52E criteria was not required.
Reasons for interim decision
I agree with the Committee's finding that the provisions of section 52E of the Therapeutic Goods Act 1989 do not apply in this situation as the item relates to Part 1 of the Poisons Standard only.
I have made a decision to amend the Poisons Standard to include an explicit definition of 'marker dyes and pigments' in Part 1, Interpretation. In making this decision, I find that there is a lack of clarity with regards the scheduling of pigments and markers dyes used in the agricultural and veterinary (agvet) sectors as these substances are not covered by the existing Poisons Standard definition of 'paints and tinters'.
Marker dyes and pigments are widely used in animal and plant industries to assist in the identification of treated versus untreated objects, land or organisms. They are also used to give colour to baits and fertilisers and to identify different cultivars of seeds and different individual animals. Advice from the APVMA is that there are several categories of agricultural and veterinary marker dyes and pigments and that there are also a range of products where colour is either included as part of a product's formulation with other actives or are standalone products that are purely dye markers designed to be added to a product to help the farmer/contractor see where they have sprayed or not. Historically, many of these chemicals have been considered under paints and tinters.
I am satisfied, however, that pigments and marker dyes are not paints. Paints, as per the definition in the Poisons Standard, are substances applied as a colouring or protective coating to a surface. In contrast, agvet pigments and marker dyes are added to a liquid that is subsequently applied to a surface (inert or living) to aid identification of the application of that liquid.
In determining the scope of for a definition for marker dyes and pigments in the Poisons Standard, I have taken into consideration that that these substances have many specific and niche uses both within and outside of the agvet space. I have also taken into account public submissions from three peak industry bodies representing agvet products and human hygiene products indicating in principle support for a definition for pigments and marker dyes in the Poisons Standard. These submissions, while seeing value in a clear definition of marker dyes and pigments used in animal and plant industries, raised concerns around the scope of the definition and the terminology used. To minimise risk and avoid confusion, I have determined that it is appropriate that the scope of the definition be specific to agvet situations and restricted to covering a limited range of uses with similar exposure conditions. A potential risk highlighted in the public submissions was that the use of the term 'any substance' in the proposed definition could result in substances being applied post-registration to agricultural chemicals which are not appropriate for use on potential food crops. To address this, I have decided, to replace the term 'any substance' with 'any product'.
I have also given consideration to whether or not 'marker dyes and pigments' should have a specific cross reference in the Index of the Poisons Standard, identifying the specific marker dyes and pigments capture by the proposed definition. However, I agree with the Committee that cross-referencing in the Index is not appropriate and that uses should be restricted to creating exceptions from a schedule entry, noting that these are not generally cross-referenced.
I note that while the Poisons Standard currently includes references to 'hair dye' products, 'dyeing of eye lashes and eyebrows', 'azo dyes' and a number of dyes which are specifically named, there is currently no explicit definition for 'hair dyes' or 'dyeing' in Part 1 of the Poisons Standard. Given the variety of situations in which pigments and dye markers are used, I am satisfied that it is appropriate to include an explicit definition for these chemicals when used in agvet situations. The creation of a definition for agvet pigments and marker dyes does not exempt these substances from scheduling and does not alter any current substance entries in the Poisons Standard. The definition will however, provide clarity to industry stakeholders and facilitate compliance with the legislative framework that the APVMA, as the relevant government regulator, administers and to the requirements of the Poisons Standard.
I have decided that an implementation date of 1 October 2020 is appropriate.