Gazette APVMA 8, 2 August 2005 page 50

NOTICE

Reconsideration of Approvals and Registrations
Related to Polihexanide

The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, intends to reconsider all registrations of all products containing polihexanide and the approvals of all associated product labels.

Polihexanide is a chemical widely used in Agricultural and Veterinary (Agvet) products as a biocide for control of micro-organisms, and algae in swimming pools and spas. It is also used as a disinfectant in veterinary products, and as a sanitiser for milk handling equipment, which are regulated by the APVMA.

The basis of the reconsideration of the registrations of products containing polihexanide is whether or not the continued use of, or any dealing with, the product in accordance with the recommendations for its use or for such a dealing that the AMPVA has approved:
· would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
· would not be likely to have an effect that is harmful to human beings.

It also appears that labels for products containing polihexanide may not contain adequate instructions and warning statements.

The APVMA will therefore review the following aspects of product registrations and label approvals for polihexanide:

· Chemistry, including:

o The method by which products and constituent polihexanide are manufactured;
o Stability of manufactured products;
o The extent to which the constituent polihexanide will contain impurities; and
o The chemical composition of the constituent polihexanide, and results of analysis of the constituent polihexanide.

· Toxicology, including:

o The potential for polihexanide to be a carcinogen in humans through either dermal and/or oral exposure;
o Consideration of the need for an ARfD and ADI; and
o The S5 Poisons Schedule status of polihexanide appears to be incompatible with its toxicity and properties as a carcinogen and ocular corrosive and requires further consideration.

· Occupational health and safety, including:

o Worker exposure during handling and application of product containing polihexanide; and
o determination of appropriate personal protective equipment and Safety Directions.

· Residues, including:

o human dietary exposure to residues of polihexanide in food following the sanitation of milking machines.

The APVMA will also consider whether product labels carry adequate instructions and warning statements. The requirements for product labels are that the label contains adequate instructions. Such instructions include:

· the circumstances in which the product should be used;
· how the product should be used;
· the times when the product should be used;
· the frequency of the use of the product;
· the re-entry period after the use of the product;
· the withholding period after the use of the product;
· the disposal of the product and its container;
· the safe handling of the product and first aid in the event of an accident caused by handling the product;
· any other matter prescribed by the regulations.

The product registrations and label approvals to be reconsidered are listed in Table 1.

The APVMA’s detailed reasons for these reconsiderations can be found in the APVMA Polihexanide Review Scope document, available on the APVMA website (http://www.apvma.gov.au). Submissions specifically addressing the areas of concern noted in the polihexanide review scope document must be in writing and reach the APVMA by 2 September 2005, by email to chemrev@apvma.gov.au or by mail to:

Pesticides Review Manager
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

For further information please contact (02) 6272 3213 or chemrev@apvma.gov.au.

Table 1 Registered products containing polihexanide.

Product Number	Product Name	Registrant	Label Approval Numbers
48356	HTL Bio-Blu Swimming Pool & Spa Water treatment & Sanitiser	HTL Pty Ltd	48356/01
48888	Tropical 1 Pool Sanitiser Blackspot and Algae Killer	A M Ilarda T/A Morning Light Chemicals	48888/1097
49284	King Neptune’s Ozone pool Sanitiser	Isacc Technologies Pty Ltd	49284/1098
50301	Purex Baquacil	Price Chemicals Pty Ltd	50301/1097
54149	F10SC Veterinary Disinfectant	Health and hygiene (Pty) Ltd	54149/0502
54477	Delaval Low Foam Acid Milking Machine Detergent	Delaval Pty Ltd	54477/0202 54477/0703
57606	Lo-Chlor Aquacadabra Pool Sanitiser	M.I. International Pty Ltd T/A Lo-Chlor Chemicals	75606/0603
58543	F10 Germicidal Shampoo	Health and hygiene (Pty) Ltd	58543/250ml/0904 58543/500ml/0904 58543/5L/0904
58544	F10 Germicidal Barrier Ointment	Health and hygiene (Pty) Ltd	58544/100g/0904 58544/500g/0904