The Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard 2022 is a new legislative instrument made on 9 August 2022 under section 6E of the Agvet Code. The instrument commenced on 16 August 2022, the day after it was registered on the Federal Register of Legislation.
As required by regulation 8AF(1) of the Agricultural and Veterinary Chemicals Code Regulations (the Regulations), the proposal to establish the new standard was released for public consultation on the Australian Pesticides and Veterinary Medicines Authority (APVMA) website and in the APVMA Gazette on 3 May 2022. Comments received in response to the public consultation were generally supportive of the new standard and were published on the APVMA website. Some minor changes from the draft standard were made in response to the comments.
Under regulation 8AF(4) of the Regulations, the APVMA must publish a notice in the APVMA Gazette and on its website when it makes a standard under section 6E of the Code, stating that the standard has been made. This notice was published in the APVMA Gazette on 23 August 2022.
Under recent changes made to the Agvet Code, section 5AA states that concentrations of constituents in registered chemical products must not differ from the concentrations entered into the Register at the time of product registration by more than the extent prescribed by the Regulations (the prescribed extent).
Regulation 41(2) of the Regulations states that the prescribed extent is the extent permitted by the standards prescribed by Regulation 42.
In turn, Regulation 42(3) specifies the standard prescribed for a chemical product as being the standard published in any of a ‘cascade’ of publications, with a publication higher in the cascade taking precedence over one lower down. The publications are, in order, a standard specified in an Order made under section 7 of the Agricultural and Veterinary Chemicals Code Act 1994 (of which there are none currently), a standard made under section 6E of the Code (as has been done), a standard published for a listed chemical product, a monograph in the British, European or US Pharmacopoeia, or a specification published by the Food and Agriculture Organization (FAO) and/or the World Health Organisation (WHO).
The establishment of the standard for allowable variations in concentrations of constituents in agricultural chemical products as a standard under section 6E of the Agvet Code gives the APVMA full control over the standard.
The standard prescribes the extent of the allowable variation in the concentrations of constituents (including active and non-active constituents) in registered agricultural chemical products. The standard does not cover veterinary chemical products – it is envisaged that a similar standard will be created for veterinary chemical products in the future.
The allowable variations for concentrations of active constituents of agricultural chemical products are the same as those listed in the guideline for chemistry and manufacture requirements for agricultural chemical products. These allowable variations are already applied in the chemistry assessment of agricultural chemical products and inclusion in a standard under section 6E of the Code gives them a more formal status.
The allowable variations for concentrations of non-active constituents of agricultural chemical products are harmonised with regulations of overseas authorities, including the US EPA and New Zealand Ministry of Primary Industries. Until now, there has been no defined allowable variation in the concentrations of non-active constituents, which has created challenges for the APVMA and industry.
In addition, the standard includes provision for applicants to nominate non-standard allowable variations for the concentrations of both active and non-active constituents, where this can be justified and will allow the APVMA to be satisfied with respect to the safety, efficacy and trade criteria.
There are no changes to processes for registration or assessment of agricultural chemical products in conjunction with the new standard, beyond any consideration needed for a ‘non-standard’ allowable variation as discussed in the previous paragraph.
It should be noted that the standard allows for reasonable variation from concentrations in the registered chemical product that are expected from normal variability in manufacturing processes, and in analytical methods. It does not allow the ‘target’, nominal, or declared concentrations of constituents to be varied from those on the Register without appropriate application to the APVMA for variation of relevant particulars of the product under an Item 12 or 14 (Schedule 6, Part 2, Clause 2.1 of the Regulations) as appropriate, even where such a change is within the allowable variations defined in the standard.
Further, this standard does not specify a level of difference in concentrations that constitute closely similar product formulations.
The standard will be updated from time to time as required. All such changes will be consulted on as required by regulation 8AF.
Enquiries about the new legislative instrument may be directed to enquiries@apvma.gov.au.
Links to the relevant legislative references are provided below: