Regulatory Review: Australian Regulations Update

Just as the US Food and Drug Administration (FDA) was issuing its Proposed Rules for Sunscreens in the United States, Australia issued its new Cosmetics Standard 2007. These new standards move six categories of products from the “therapeutic drugs” arena to “cosmetics” in Australia. These changes were made after the Australian Parliament consulted with industry stakeholders.

Product Categories
The following is a breakdown of products originally considered as therapeutic drugs if they made SPF claims, and that will now be regulated as secondary sunscreens.

Face and nails: These products include tinted bases or foundations, i.e., liquids, pastes or powders, and products intended for application as sunscreens on the lips. These products must meet the definition of a secondary sunscreen, which is: “a product [that] is represented on the label as protecting the skin from certain harmful effects of the sun’s rays while fulfilling another primary function.” Furthermore, they must meet labeling requirements describing their level of sun protection, as shown in Table 1.