Update on developing an alternative quality standard for sunscreen excipients

In June 2018, the TGA released a range of reform activities for the future regulation of low risk products and announced that there would be no changes to the way sunscreens are regulated. However, the TGA committed to pursuing a number of de-regulatory activities. One of the proposed activities was to explore the development of alternative quality standards for sunscreen excipients. This was proposed in response to industry's concerns that the current requirement that all sunscreen ingredients comply with pharmacopoeial standards is not consistent with their risk.

Consideration of an alternative quality standard for sunscreen therapeutic products

In September 2018 the TGA sought comments from industry associations: the Consumer Healthcare Products Australia (CHPA; prior to 3 June 2019 this was the Australian Self Medication Industry - ASMI); and Accord, to seek their input on possible alternative quality standards for sunscreen excipients.

Outcome

Feedback from industry associations confirmed that the TGA's recent amendments to the GMP requirements for sunscreen manufacturing, which includes information on minimum sampling and testing of sunscreen agents, excipients and preservatives, adequately deals with previous industry concerns relating to sunscreen manufacturing. As such, industry agreed there would be limited benefit in the TGA pursuing the development of an alternative quality standard for sunscreen excipient ingredients.

Accordingly, the TGA will not pursue the development of an alternative quality standard for sunscreen excipient ingredients at this time.

Further information

If you have any questions, please contact the Complementary and OTC Medicines Branch via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.