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Bromsalans review history and regulatory outcomes
Nomination for review
In 1989 the National Health and Medical Research Council (NHMRC) began a reconsideration of the bromsalans, in particular diaphene, based on concerns over the lack of toxicological and residues data. As part of the reconsideration the NHMRC requested more toxicological data from registrants to support the continued registration and use of their bromsalans products.
The registrants failed to provide the additional data and in March 1993 the NHMRC advised the Australian Agricultural and Veterinary Chemicals Council (AAVCC) of their concerns and recommended withdrawing the Maximum Residue Limits (MRLS) for the bromsalans and placing them in Appendix M of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); the appendix applied to ‘substances for which registration under agricultural and veterinary chemicals legislations cannot be supported by scheduling until further toxicological information becomes available’.
In January 1994 the APVMA (formerly the NRA) began a Special Review of Bromsalans to formally consolidate the previous regulatory action by the AAVCC and NHMRC.
Bromsalans review
Status: Review Completed
The APVMA completed the Special Review of Bromsalans in September 1994 but did not publish a final report due to the small number of registrants involved. The APVMA found that there were insufficient toxicological and residues data to support the continued registration and use of bromsalans, and in particular, the use of diaphene.
In the report the APVMA recommended:
- cancelling the active constituent approval, with effect from 1 November 1994
- cancelling the MRLs for bromsalans (tribromsalan and dibromsalan), with effect from 1 November 1994
- cancelling all registrations and relevant approvals of products containing bromsalans, with effect from 1 November 1994.
For more information please contact the Chemical Review Program on (02) 6210 4749 or by email to chemrev@apvma.gov.au