Cosmetic or therapeutic?

When does a cometic get regulated as a medicine, or a medical device? A new guidance document goes some way to clarifying this often grey area. You may think a product is a cosmetic, but it could be regulated as a therapeutic based on its primary use, the ingredients, the claims made and overall presentation and context. What is a cosmetic? How to advertise it?    Source: TGA.

 

Draft evaluation of chemicals – comments invited

This includes a list of draft evaluations. Comment period closes on 17 December 2021.    Source: AICIS

 

Chemicals of low concern that may not require further regulatory controls to manage risks to the environment

AICIS is seeking use and hazard information. Comment period closes 17th December 2021.     Source: AICIS

 

Chemicals unlikely to need further human health risk management controls

AICIS is seeking use and hazard information. Comment period closes 17th December 2021.    Source: AICIS

 

Reporting and record-keeping obligations and annual declarations for importers of chemicals

Relevant to importers of cosmetics and other personal care products. This is a comprehensive summary of reporting and record keeping obligations.    Source: AICIS and also here.

RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

Recall: 'Banana Boat' Sunscreen Sprays SPF 50+ (aerosol) Benzene was detected in 4 batches of three products supplied. Benzene is classified as a human carcinogen, a substance that could potentially…

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Foods:

Company pays penalties of $36,640 for misleading claim on “pure” vanilla extract HBC Trading labelled the product as “alcohol free pure vanilla extract” and placed an image of vanilla beans…

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Complementary Medicines and Medical Devices:

Revised list of ingredients permitted in listed complementary medicines. Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2022, which…

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Cosmetics, Personal Care and TGA Listed Sunscreens:

Step by step guide to categorising your chemical importation and manufacture With supporting self-guided decision tools helps you categorise your chemical introduction as listed or exempted or reported or assessed.    Source: AICIS   Infringement notice issued to…

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Foods:

Changes to the inspection of some imported food Kava products are classified as “risk food”. Commercial imports of kava will be inspected to verify compliance with food standards. Other foods…

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Complementary Medicines and Medical Devices:

New advertising code New Therapeutic Goods Advertising Code commences 1 January 2022. Advertisers have until 30 June 2022 to transition to the new code. Key changes include simplifying mandatory statements,…

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