Sunscreen SPF Testing by AMA Laboratories - Update

In August 2019, the United States Department of Justice announced that an investigation by the United States Food and Drug Administration (FDA) led to several executives and supervising laboratory technicians of AMA Laboratories pleading guilty to wire fraud resulting from alleged fraudulent laboratory testing. Since then, the TGA has been conducting post-market compliance reviews of sunscreens that may potentially be affected by fraudulent testing by AMA Laboratories. All sunscreens on the Australian Register of Therapeutic Goods (ARTG) must be tested to verify the claimed sun protection factor (SPF) rating prior to marketing. The sponsors of some sunscreens on the ARTG have in the past engaged AMA Laboratories. At the present time, the TGA does not have any evidence that those sunscreens that have been tested by AMA Laboratories are less effective than claimed. The TGA now requires sponsors to provide adequate justification for ongoing supply of their products that have been tested by AMA Laboratories. This could include additional supportive testing data on comparable products in their product line or from product development studies, or other robust scientific justification that substantiates the claimed SPF rating.   Source: AMA Labs exposed

NICNAS / AICIS Reminder: No More Annual Reporting for Exemptions

If you are currently introducing a chemical under a NICNAS exemption category, you do not submit an annual report at the end of this registration year. But you must still keep records to demonstrate that you meet the criteria under the NICNAS exemption provisions. Refer to the NICNAS website, due to be archived at the end of this month for more information about the new scheme - The Australian Industrial Chemicals Introduction Scheme (AICIS).  Source: Annual reporting ends  

Contesting Views as Industry Gets More Say in New Safe Chemicals Code

As NICNAS transitions to AICIS, concern has been raised regarding the new industrial chemicals laws that will take effect from 1 July 2020. Decisions about whether new chemicals entering the Australian marketplace pose a danger to consumers or workers will be left in the hands of private industry, as a major overhaul of chemical regulation takes effect. Changes to the rules will allow companies to classify more chemicals as "very low risk", meaning they can be introduced without public disclosure or first telling the regulator. Cancer Council Australia, public health experts, environmentalists, academics, and unions have expressed alarm about the new system, with fears it could unleash the next toxic chemical disaster on the public.   Source: Carrie Fellner, SMH Cosmetic chemicals transition

 

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