Newsletter

Australian TGA Publishes Guidance on SPF Testing, FDA Launches Adverse Event Dashboard and More

Shereen Aboarkaba
September 25, 2025

FDA Launches Adverse Event Reporting Dashboard

On 12th September 2025, the U.S. Food and Drug Administration launched the 'FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products'. This dashboard allows public access of real-time adverse event data on cosmetic products. This is a step in the FDA's efforts to deliver 'radical transparency' as part of its modernisation strategy. Using product names or adverse event terms to search, users can view adverse event reports submitted by responsible persons, healthcare professionals, consumers, salon professionals, cosmetologists and others.

You may read the announcement here.

Australia's TGA Releases Information for Consmers and Sponsors about SPF Testing

On 16th September 2025, Australia's Therapeutic Goods Administration (TGA) released news articles on SPF testing for consumers and sponsors. This follows the previous CHOICE SPF report, which is currently still under investigation by the TGA. The article for consumers outlines corrective actions taken by the TGA and contains additional information on how SPF is determined. For sponsors of a listed sunscreen, the TGA article summarises regulatory requirements and what to do in the event of identifying a problem with a sunscreen. The TGA is currently developing guidance to assist sponsors in choosing a laboratory for SPF testing, which will be published in due course.

Click here for the consumer guide, and here for the sponsor guide.

Australia's TGA Consults on Proposed Amendments to the Poisons Standard

On 18th September 2025, the TGA opened a consultation for scheduling amendments to the Poisons Standard. The consultation period will end on 17th October 2025, and any submissions will be considered at the November 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS), the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint Meeting of ACMS and ACCS. Comments are sought for six substances, one of which - Hydroquinone - is relevant for cosmetic products.

Click here for the consultation overview.

China's NIFDC Solicits Public Opinions

Eighteen Draft Cosmetics Standards

On 15th September 2025, China's NIFDC (National Institutes for Food and Drug Control) released eighteen draft cosmetics staandards, including 'Limits for Total Colony Count in Eye Cosmetics, Lip Cosmetics, and Children's Cosmetics'. You may read the announcement here.

The Technical General Rules for Registration and Filing Materials for New Cosmetic Ingredients (Draft for Comments)

On 24th September 2025, the NIFDC released a new draft 'Technical General Rules for Registration and Filing Materials for New Cosmetic Ingredients', intended to optimise the technical requiremens for the registration of New Cosmetic Ingredients. Comments are accepted until 19th October 2025. You may read the announcement here.

China's NMPA Launches Second Phase Pilot Programme for Personalised Cosmetics Services

On 17th September 2025, China's National Medicinal Products Association announced the launch of the second phase of the pilot programme for personalised cosmetics services based on the summary of previous pilot work. This second phase will extend the programme to additional provinces and start on 1st October 2025. Participating cosmetic registrants or domestic responsible persons authorised by overseas registrants may, in their established stores, directly-operated stores, and other business locations, independently provide small-batch simple blending and repackaging services for two or more registered common cosmetics based on the personalised needs of consumers. You can find the NMPA announcement here.

NMPA Solicits Opinions on 'Opinions of the National Medical Products Administration on Deepening Cosmetics Regulatory Reform to Promote High-Quality Development of the Industry'

On 19th September 2025, the NMPA published a notice soliciting opinions on the draft document 'Opinions of the National Medical Products Administration on Deepening Cosmetics Regulatory Reform to Promote High-Quality Development of the Industry'. Comments are accepted until 10th October 2025. Click here for the NMPA notice.

South Korea's MFDS Adds Restricted Substance to Cosmetics Standards

On 18th September 2025, South Korea's MFDS (Ministry for Food and Drug Safety) released a notice adding restrictions for Phenylene bis-diphenyltriazine to the Regulation on Safety Standards, etc. for Cosmetics. You can find the notice here.

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