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Gazette APVMA 2, 1 February 2005 page 23
NOTICEDraft Operational Notice: Policy on Consequential Claims
The APVMA invites comment on the following draft operational notice titled: Policy on consequential claims (DRAFT). Policy on consequential claims (DRAFT)
Sections 4 and 5 respectively of the Agvet Code define an agricultural and veterinary chemical product. There are three ways by which a product may fall within the definition of an agricultural or veterinary chemical product:
· the product is represented as having effects falling within the definition (ie claims made about the product); and/or
· the product contains known active constituents, irrespective of any claims made about its effects (ie because of the product’s formulation); and/or
· the product is a substance or mixture of substances that is declared by the Agvet Code Regulations to be an agricultural or veterinary chemical product.
For example, a product containing a known anthelmintic at therapeutic concentrations would require registration even if no anthelmintic claims were made for the product.
The APVMA assesses product label claims related to effects that can be directly ascribed to the active constituent acting singly or conjointly with other constituents in a product. From time to time the APVMA receives applications to register products and approve labels that make claims not related to the direct effects of the product, but rather to secondary and/or downstream consequences of using the product. The APVMA considers these to be ‘consequential claims’.
Some examples of secondary effects which may lead to consequential claims are:
(i) productivity benefits arising from the fact that animals are restored to health, or cleared of a parasite burden;
(ii) environmental claims such as the lack of deleterious effects on species that are not target species or part of an integrated pest management program;
(iii) claims to improve crop vigour or yield from lack of competition from weeds.
The APVMA will not approve consequential claims on an agricultural or veterinary chemical product label. Examples of the type of consequential claims the APVMA will not approve are:
Safe to dung beetles (anthelmintic products)
Improves milk yield (anthelmintic products)
Improves crop yield (herbicide products)
END OF DRAFT NOTICE
Please send comments on this draft notice by 11 March 2005 to:
Thea Reiman
Contact Officer, Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
Kingston ACT 2604
Phone: 02 6272 3744
Fax: 02 6272 5249
email: thea.reiman@apvma.gov.au