Arbutin Change Reverses Australia Product Ban

The BWES AICIS Compliance Team

Recently, the Therapeutic Goods Administration (TGA) released a very important update in the latest edition of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). It was released without much fanfare, but it was news that is tremendously important and exciting to the cosmetic industry, be it manufacturers, importers or distributors.

The TGA has clearly defined the parameters of use of arbutin by differentiating the different types of arbutin and their allowable concentration before mandatory SUSMP labelling must be used.

This action means that a significant number of products previously banned in Australia, can now be sold.

What is Arbutin?

Arbutin is a naturally occurring derivative of hydroquinone, used in cosmetics products for skin lightening. It works by slowly releasing hydroquinone through hydrolysis, which in turn blocks tyrosinase activity and reduces the skin’s melanin (pigmentation) production.

Whilst the TGA’s rollback is good news for the cosmetic industry, it is important to note that any supplier of the various types of arbutin used in cosmetics must be able to prove that the hydroquinone levels present in the arbutin are less than 10 mg/Kg.

BWES can assist cosmetic importers and distributors navigate their way through the new regulations.