Complementary Medicines and Medical Devices:

Updated list of ingredients permitted in listed complementary medicines

A revised list has been published. You can find it here: https://www.legislation.gov.au/Details/F2022L00173. There is one new ingredient - Euglena gracilis whole cell dry; an updated name - ‘Cistus ladaniferus’ becomes ‘Cistus ladanifer’; and there are changes to requirements for several ingredients. To see these, open “Explanatory Statement” at https://www.legislation.gov.au/Details/F2022L00173/Download. If your products contain Andrographis paniculata, inorganic magnesium salts, ‘benzalkonium chloride’, mollusc and mollusc-derived ingredients, ‘pyridoxal 5-phosphate’, ‘pyridoxal 5-phosphate monohydrate’, or ‘pyridoxine hydrochloride’, or Artemisia species, you should note these important changes.

 

New Compositional guideline: Euglena gracilis whole cell dry    Source: TGA

 

Compliance enforcement

JMIT Distributors fined $79,920 for alleged advertising breaches involving nicotine vaping products. The company was contacted on multiple occasions but failed to come into compliance and continued to advertise nicotine vaping products for supply.    Source: TGA

NSW based executive officer fined $10,656 for alleged unlawful advertising of nicotine vaping products. The individual failed to bring the company's advertising into compliance with the Act.    Source: TGA

TGA has issued an infringement notice of $13,320 to Victorian-based company TCF Trading for alleged unlawful importation of 70,000 COVID-19 rapid antigen tests that were not included in the Australia Register of Therapeutic Goods (ARTG).    Source: TGA

The TGA has issued two infringement notices totalling $5,328 to a Melbourne-based individual for alleged unlawful importation more than 19kg of nicotine vaping products which were not registered on the ARTG to the individual and were not exempt from being registered.    Source: TGA

 

Should it be mandatory for healthcare facilities to report adverse events/safety problems with medical devices to the TGA? Feedback on discussion paper closed in December 2021. Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device related adverse events.    Source: TGA. You can read responses from stakeholders here.

 

Recall: SFI Australasia, in consultation with the TGA, has initiated a recall for one batch of Ellura capsules (active ingredient: Vaccinium macrocarpon) due to the presence of ethylene oxide.    Source: TGA.

 

Supplying medicinal cannabis in Australia: this is a recording and transcript of a TGA webinar presentation in October 2021.    Source: TGA

 

TGA is seeking feedback on a proposed priority pathway for assessment of certain novel and life-savingbiologicals.    Source: TGA

 

A new Poisons Standard has been published. The changes are detailed in the explanatory statement to SUSMP No. 35 February 2022.    Source: TGA. Explanatory statement is here.

 

Importing COVID-19 rapid antigen tests (RATs) – a fact sheet.    Source: TGA

 

Surgical mesh devices: information for medical practitioners on “up-classification”.    Source: TGA

 

Post-market review of face masks: the latest outcomes and action taken due to product defects.    Source: TGA.

 

 

Foods:

Import and labelling of kava. Import permit required, mandatory label warnings. Source: Dept Agriculture, water and Environment

 

Australian Food Composition Database: an easy to search database of the nutrient content of Australian foods. Updated data for bread, fruits, cereals, yoghurts, and poultry, plus foods not previously included such as nut based beverages, and plant based meat alternatives.    Source: FSANZ

 

Energy labelling of alcoholic beverages: results of an evidence assessment and consumer literature review. Options include on-label energy content information and a shortened nutrition information panel, containing average energy content only (preferred by most stakeholders)    Source: FSANZ

 

General information on labelling of alcoholic beverages published by FSANZ.

 

FSANZ approvals, general procedures, variations and notifications:

A1240 – Polygalacturonase from GM Aspergillus oryzae

A1246 – Phospholipase A1 from Aspergillus oryzae​

A1248 – Glucoamylase from GM Aspergillus niger

A1226 – Food derived from insect-protected corn line MON95379​​

A1219 – Alpha-amylase from GM Bacillus licheniformis: ​To permit the use of Alpha-amylase from GM Bacillus licheniformis as an enzyme processing aid for use in brewed beverages, potable alcohol production and starch processing.

A1249 – Addition of phytosterols, phytostanols or their esters to plant-based milk alternatives: To seek approval for the addition of phytosterols, phytostanols or their esters as a novel food to plant-based milk alternatives.

The following application has been withdrawn by the applicant: Enzymatic production of rebaudioside I: To seek approval for a new specification for the steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract.

 

Food Recalls

Tohato Caramel Corn Original Flavour 80g - presence of an undeclared allergen (tree nut [almond])    Source: FSANZ

Bondi Protein - Vegan Protein Bar Peanut Butter - undeclared allergen (tree nut [cashew]).    Source: FSANZ

L'Artisan Organic Marcel - due to microbial (E.coli) contamination.    Source: FSANZ

EleCare, Similac and Alimentum infant formula products - due to potential microbial contamination (Cronobacter and Salmonella).     Source: FSANZ

Bestow Powdered Drink Products - due to the presence of an undeclared allergen (gluten).    Source: NSW Food Authority

 

Failing imported food reports for November 2021

Risk food test results – similar problems found as last month.    Source: Dept Agriculture, water and Environment

Surveillance food tests – non-permitted ingredients including vitamins and minerals, and caffeine.    Source: Dept Agriculture, water and Environment

“Use by” and “Best before” – do consumers understand the difference? Interesting article on food waste published in the local press.     Source: News.com.au.

 

 

Cosmetics, Personal Care and TGA Listed Sunscreens:

Draft evaluations open for comment:

10 draft evaluation statements that AICIS has:

  • identified as possibly posing a risk to human health and/or the environment
  • are unlikely to require further regulation in Australia to manage environmental risks
  • are not considered for in depth evaluation because they are not commercially active in Australia

Source: AICIS

 

Equivalent CAS names and numbers. AICIS has published a list of 6 ingredients that have different CAS numbers and names but are actually identical.    Source: AICIS

 

Additional information published by AICIS on their website

Call for information: chemicals with no known commercial use in Australia – AICIS has identified chemicals on the Inventory that they believe are not being manufactured, imported or used in Australia for commercial purposes. Read draft evaluation provide comments by 28 March 2022 if you are using any of these chemicals.

Call for information on chemicals unlikely to need further environmental risk management controls – AICIS completed a draft evaluation on certain chemicals that they believe do not require further regulatory controls to manage environmental risks. Read draft evaluation and provide comments 28 March 2022 if you have relevant use and hazard information.

Final evaluations and updates to the Rolling Action Plan – AICIS has finalised and published 24 evaluations in January, which covered 1,382 unique chemicals. Evaluations focused on human health and environmental risks associated with the use of certain chemicals listed on Inventory.

Withdrawing pre-introduction reports online – AICIS has updated AICIS Business Services so users can now withdraw a PIR they've already submitted in certain circumstances.

Chemicals added to the Inventory 5 years after issue of assessment certificate.

 

Join our Newsletter



catchme refresh

Spambot Captcha Protection
Joomla Extensions powered by Joobi
Go to top