Huh? Benzene in Sunscreen?

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May 6, 2022
2 min read

Updated: May 9, 2022

Are your organisation’s contamination management strategies up to the task? Your answer should be a resounding ‘yes’. However, for many organisations the answer may be more complicated.

On 28 April 2022, the Therapeutic Goods Administration (TGA) recalled certain batches of sunscreen products due to benzene contamination.

The relevant TGA safety alert highlights:

“Consumers and health professionals are advised that a number of sunscreen products, which are regulated as medicines in Australia, are being recalled due to the presence of benzene”.

Summarising the contaminant’s effects, the TGA stress:

“Benzene is a chemical that can cause cancer in humans, depending on the level and length of exposure. Benzene is not an ingredient in sunscreens but can be a contaminant in raw materials used in the manufacturing process”.

The TGA advise affected consumers to either: (a) “return [the product(s)] to the place of purchase”; or (b) “contact the Sponsor”. A tabulated list of affected products and batch numbers can be found here, alongside sponsor contact numbers and external links to recall statements.

Importantly, the TGA indicate the investigation is ongoing, and that the table of affected products could be expanded in the “next few weeks”.

This TGA recall action must serve as a wake-up call – no manufacturing or raw material process is immune from contamination. The best policy for manufacturers and sponsors remains effective prevention.

Essentially, organisations must question whether they are doing enough to prevent contamination risk in the first instance. From raw material sourcing, to packing and filling, organisations must install proper mechanisms to prevent contamination risk.

Where there is uncertainty or difficulty in contamination management processes, advice should be sought. Komply can help your organisation mitigate contamination risks arising during the material sourcing and the manufacturing process.

Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.

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