Sunscreen testing already adequate, says TGA


Recent media suggestions that the TGA does not adequately test sunscreens is incorrect, the TGA says

The reports have expressed concern about the safety and efficacy of certain sunscreen products as well as the TGA’s testing process, after some consumers expressed adverse reactions to the products.

Last month consumers expressed concern about the Cancer Council’s Peppa Pig sunscreen and Banana Boat sunscreens after they were left “red raw” by the products.

Michael Moore, chief executive of the Public Health Association of Australia, has told the ABC that the TGA needs to “examine its processes” to ensure sunscreens were adequately tested.

“We can see there are problems, it does point to an inadequate system with the TGA and I think it requires the TGA themselves to look at what they’re doing,” he told the ABC.

But the TGA says that it already tests sunscreens in its laboratories, “using random samples of sunscreens from the market (pharmacies etc).

“Samples from the market reflect what is being applied to people and also enables us to look at stability if we need to.

“The TGA does require sponsors to undertake SPF (efficacy) testing of sunscreens but because of the highly specialised nature of the testing the TGA does not do it in house. All testing is done under an international ISO standard.

“If there was a problem with the SPF testing then all samples of that product would be affected and we would see much greater numbers of sunburn.”

The TGA says that most of the adverse reactions reported to it relate to allergic-type reactions.

“The TGA undertakes toxicological (safety) assessment of these ingredients in accordance with the safety guidelines as covered in the Australian Regulatory Guidelines for Sunscreens.

“These safety reviews include assessment of the potential for sunscreen ingredients to cause skin irritation, corrosion or skin sensitisation.

“It is possible that a small number of people may experience an adverse reaction to particular ingredients contained in topical medicines, insect repellents, cosmetics or sunscreen products.

“Given this it is advisable that, when first using a new product, to apply a small amount to a patch of skin first.”

“The balance of evidence relating to the use of sunscreens indicates that the ingredients used in sunscreens contribute to safe and effective protection from sun damage when used in accordance with the directions on the label.

“The TGA continuously monitors the safe use of sunscreens, as well as the emerging scientific literature, and works cooperatively with international regulatory agencies.

“If concerns relating to the quality, efficacy or safety of a therapeutic product arise, the TGA can require that the product is removed from supply on the Australian market.”

The TGA also highlighted the importance of applying sunscreen liberally and regularly, as these products are commonly under-applied.

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