Disinfectants regulation

A meeting of the TGA/Industry Disinfectant Working Group, on 5 July 2001, finalised the review of the guidance document Guidelines for the Evaluation of Sterilants and Disinfectants. The Guidelines include revised toxicological and microbiological requirements for sterilants and disinfectants. The Guidelines will be available soon with a 6-month transition period for the new requirements.

Changes to the Therapeutic Goods Regulations 1990 are now being progressed to transfer hospital and household/commercial grade disinfectants with specific microbial efficacy claims from the registrable to the listable category on the Australian Register of Therapeutic Goods (ARTG). This transfer was recommended as part of the 1998 review of the regulatory controls for disinfectants and sterilants by the National Coordinating Committee on Therapeutic Goods (NCCTG). The requirements set out in Therapeutic Goods Order No. 54/54A/54B Standard for composition, packaging, labelling and performance of disinfectants and sterilants will not change for these goods, only their categorisation on the ARTG.

The change to the Therapeutic Goods Regulations 1990 was dependent on the finalisation of the Allowable Claims document, which is used to determine which listable disinfectants require a safety assessment by the TGA. The Allowable Claims document was finalised at the Working Group meeting with the Regulations change to be progressed as soon as possible. It should be noted that all sponsors of disinfectant products are required to hold evidence that their products meet any microbiological claims made.

The draft Therapeutic Goods (Excluded Goods) Order of 2001 for household/commercial grade disinfectant products making low-level microbial claims was also finalised by the Working Group. The Order is used to assist industry in determining whether disinfectant products fall within the TGA's regulatory scope. Products excluded from TGA regulation (and therefore included in the Order) will be treated as consumer goods and subject to the controls of the Australian Competition and Consumer Commission (ACCC).

The Australian Chemical Specialties Manufacturers Association (ACSMA), in cooperation with specialist microbiologists and the ACCC, has developed a draft industry code of practice for excluded products making antibacterial claims. The Code will provide guidance on technical requirements, standards for product efficacy, labelling and claims, assisting companies wishing to make antibacterial claims for products outside of the TGA's regulatory scope.

Revised Breast Implant Information Booklet

Copies of the third edition of the Breast Implant Information Booklet <http://www.tga.gov.au/docs/html/breasti.htm> are now available.

The booklet provides guidance for women considering the use of breast implants. In particular, the booklet provides information about saline-filled and silicone gel-filled breast implants to enable patients to make an informed decision about having breast implants.

The third edition contains updated information, including the history of silicone gel-filled breast implants and the findings of the clinical studies which examined whether or not there is an association between silicone gel-filled breast implants and systemic diseases.