Proposed establishment of a new standard under section 6E of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Code)

This consultation closed on 31 May 2022.
Consultation period: 
3 May 2022 to 31 May 2022

The APVMA proposes to establish a new standard, the Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard, under section 6E of the Code.

Under regulation 8AF of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Regulations), the APVMA must publish a notice of its intention to establish a standard under section 6E in the APVMA Gazette and on the website. The draft standard must also be published on the website, and a period not less than 28 days must be allowed for comment on the proposed standard.

A link to the draft section 6E standard is available on our website. This notice has also been published in the APVMA Gazette on 3 May 2022.

Under recent changes made to the Code, section 5AA of the Agvet Code 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 is proposed), a standard published for a listed chemical product, a monograph in the British, European or US Pharmacopoeia, or a specification published by FAO and/or WHO.

Establishment of the proposed standard for allowable variations in concentrations of constituents in agricultural chemical products as a standard under section 6E of the Agvet Code would give the APVMA full control over the standard.

The proposed standard would prescribe the extent of the allowable variation in the concentrations of constituents (including active and non-active constituents) in registered agricultural chemical products. The proposed standard would not cover veterinary chemical products – it is envisaged that a similar standard will be created for veterinary chemical products in the near future.

The proposed allowable variations for concentrations of active constituents of agricultural chemical products are the same as those currently 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 would give them a more formal status.

The proposed 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 proposed 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 still allow the APVMA to be satisfied with respect to the safety, efficacy and trade criteria.

There are no proposed changes to processes for registration or assessment of agricultural chemical products in conjunction with this proposed new standard, beyond any consideration needed for a ‘non-standard’ allowable variation as discussed in the previous paragraph.

It should be noted that the proposed standard is intended to allow for reasonable variation from concentrations in the registered chemical product that are expected as a result of normal variability in manufacturing processes, and in analytical methods. It will 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.

Once made, the standard would be updated from time to time as required. All such changes would be consulted on as required by regulation 8AF.

Further information on the proposed standard can be obtained from the contact details given below. Links to the relevant legislative references are provided below:

In accordance with regulation 8AF of the Regulations, the APVMA therefore invites any person to make written submissions on the proposed standard.

Submissions must be received by the APVMA by 31 May 2022 and be directed to the contact listed below.

Please note that submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential (see public submission coversheet).

How to make a submission

Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or by post to:

Email: enquiries@apvma.gov.au

Post:

Director Chemistry and Manufacture
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001

For information on how the APVMA manages personal information when making a submission, see our privacy policy.

Submissions received

The APVMA sought comments from interested stakeholders on its proposed Agricultural and Veterinary Chemicals Code (Allowable Variation in Concentrations of Constituents in Agricultural Chemical Products) Standard under section 6E of the Code, in a consultation that closed on 31 May 2022.

Three submissions were received. One submitter requested that the attachment to their submission not be published.

A copy of the published submissions is available on our website.

Consultation feedback

The APVMA is currently considering all submissions received as part of this consultation.

Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.