Our first issue was in December 1998. Read issue number 1 here.

Cosmetics in the EU and UK: we have a collaborative partnership with Cosmetic Consultants Europe. Please refer to their website for a list of online courses which are presented by university graduates with years of industry experience.

New substances – this particularly suits a supplier of an ingredient which is not currently on the list of ingredients permitted in complementary medicines in Australia, as the successful applicant has exclusive use of the ingredient in complementary medicines for two years. Read about the course here.

We now have almost 30 regulatory affairs courses, you can view them here and book online here

New poisons standard October 2024 is published here. There is an explanatory statement here.

Update to ingredients permitted in listed complementary medicines. One new ingredient: Akkermansia muciniphila. Sixteen ingredients have had a change to their conditions. Source: TGA

Can I advertise a therapeutic good to the public? a TGA guide for advertisers here.

Consultations

* Proposed amendments to poisons schedule including Atropa belladona, pyridoxine, pyridoxal or pyridoxamine, and Symphytum officinalis (comfrey) – and other ingredients. Consultation closes 22nd October. More information and form for submitting comments can be found here.

* Artificial intelligence: The Australian Government has provided $39.9 million over 5 years to support safe and responsible adoption of AI Technology. Closes 13th October. More information here.

* Draft guidance document: Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin. Closes 9th October. More here.

* Regulation of assistive technologies. household and personal aids, or furniture and utensils, for people with disabilities are currently “excluded” goods – should they become therapeutic goods? Closes 13th October. More here.

* Essential Principles for Safety and Performance of medical devices – input sought on alignment with European General Safety and Performance Requirements. Closes 13th November. Read more here.

TGA GMP Forum. 19th – 20th November in Melbourne. Details here

Compliance action

* Largest ever penalty for unlawful supply of therapeutic goods. The Federal Court of Australia has ordered Medtronic Australia to pay $22 million for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020. They must also pay $1 million towards TGA legal costs. Read more here.

* Sun Herbal fined $18,780 for unlawful supply of a complementary medicine missing a warning statement. The medicine included the ingredient Artemisia frigida, which should not be taken by women who are pregnant or likely to become pregnant. The medicine has been recalled and is no longer permitted to be supplied. Source: TGA

Counterfeit Ozempic pens have been imported into Australia, and one overseas bought pen resulted in a report of an life-threatening adverse event. Source: TGA

Vaping

* Webinar – 3rd October – overview of changes to product standards commencing in 2025 – book here

* Patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, Source: TGA

* Enhanced product standards for therapeutic vapes coming in March 2025. Includes vaping substances, vaping substance accessories, vaping devices and vaping device accessories. Read more here

National Symposium on Australian Traditional Medicine. This will be held at the NICM Research Institute, Western Sydney University, on 11th-12th November 2024. Full details at westernsydney.edu.au more details here

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.

* What should companies do with adulterated or defective material? Send it back to the supplier who might forward it to another manufacturer? This article discusses the BAPP SOP “Disposal/Destruction of Irreparably Defective Articles“. Source: Nutritional Outlook

* Similar article to above, Managing supply chain adulteration risks with the BAPP Best Practices SOP: SupplySide Supplement Journal.

* Over 50% of Ginkgo leaf extract samples may be adulterated: BAPP review
10-Sep-2024 By Stephen Daniells. A new systematic literature review of five popular botanical ingredients indicates a wide range of estimated adulteration rates, with the highest reported for Ginkgo leaf extract samples at 56.7%. Nutraingredients

* Estimating the extent of adulteration of the popular herbs black cohosh, echinacea, elder berry, ginkgo, and turmeric, published in Herbalgram.

To access freely available botanical and technical resources from BAPP,  click here

In the press:

* Over-the-counter medications for heartburn, reflux and morning sickness are at the centre of a class action investigation over alleged links to stomach cancer and kidney damage that could involve an estimated 100,000 Australians. Published in Sydney Morning Herald

* Lack of satisfaction with current treatments: a presentation given by John O’Doherty, CEO of complementary Medicines Australia and published on LinkedIn.

The annual cost of foodborne illness in Australia by food commodities and pathogens. FSANZ commissioned the University of Melbourne and the Australian National University to report. View final report from University of Melbourne here, and Australian National University here.

Infant formula review. The revised regulation for infant formula products came into effect on 13 September 2024 and applies in Australia only. New Zealand has opted out of this standard. Read about the changes made here.

Tomato brown rugose fruit virus (ToBRFV) has been detected in tomato crops in South Australia. FSANZ states that it does not pose a food safety risk. FSANZ media statement.

Call for comment or submissions

*Draft 2025-26 Cost Recovery Implementation Statement – revised regulatory charges to recover costs for paid applications. Closing date 25 October. Details here.

* To consider varying maximum residue limits (MRLs) for residues of specific agricultural and veterinary (agvet) chemicals that may occur in food commodities. Closing date 29 October. More details here.

* An application to permit the sale and use of food made from a new genetically modified (GM) sugar beet. Closing date 14 October. Read more here.

* An application to permit the use of Vitamin K2 (Menaquinone-7) as a permitted form of Vitamin K in food for special medical purposes (FSMP). Closing date 11 October. Read more here

* Application A1301 – Triacylglycerol lipase from GM Komagataella phaffii as a processing aid to be used as a processing aid in bread and bakery products. Closing date 14 October. Details here.

New applications and proposals

* A1309 – Specification for lacto-N-tetraose (LNT) from GM Escherichia coli K-12 in infant formula products: to amend the specification for lacto-N-tetraose (LNT) sourced from a permitted genetically modified source of Escherichia coli K-12. Source: FSANZ

* A1310- Food derived from insect-protected soybean line MON94637: To seek approval for the sale and use of food derived from soybean line MON94637, genetically modified for protection from lepidopteran insect pests. Source: FSANZ

* A1312- 2′-FL from GM Escherichia coli BL21 in infant formula products: To amend the Australia New Zealand Food Standards Code to permit a new genetically modified source of Escherichia coli BL21 for the production of 2′-Fucosyllactose (2′-FL) for use as a nutritive substance in infant formula products. Read more here

Recalls  

* McCain Foods – Pickers Nacho Cheese Triangles – due to presence of foreign matter (plastic) FSANZ

* Birchan – BBQ Kurobuta Pork Buns – due to undeclared allergens (gluten, egg, milk) FSANZ

* Grand Eastern Group – Mie Sedaap Rasa Baso Special – due to presence of an undeclared allergen (milk). FSANZ

* Ausfresh – Epic Oddisee Santorini Marinated Pitted Olive Mix – due to the presence of an undeclared allergen (milk) FSANZ

* The Food Trade – Papa Jax Shepherds Pie Mashed Potato – due to the presence of an undeclared allergen (milk). FSANZ

New Zealand

* New Zealand food safety bulletins published each fortnight here.

* List of foods recently recalled in New Zealand:

Wako Shokai, Yamanaka Foods and Ichbiki brand Seaweed products
A1 Chips On the Go brand Chips and Snacks Range
Pams brand Cracked Pepper Hot Smoked Salmon
Arran Farm brand Raw Drinking Milk (unpasteurised)
Origin brand Salmon Products
All Good brand Barista Oat Milk

*Source: NZ Ministry for Primary Industries

Sunscreens: formulations, regulations and behaviours Pre-Conference Workshop. Tuesday 10th September 10:00 am at QIMR Berghofer Medical Research Institute, Herston, QLD. Register here.

The SPF – Vitamin D Conflict! An interesting and very informative article published by sunscreen expert John Staton on LinkedIn, read it here.

Submit your annual declaration for 2023-2024 – due by 30 November 2024. Every industrial chemical introducer (importer or manufacturer) – includes cosmetics – must make an annual declaration. Some chemicals are exempt. Read more here.

Update to categorisation guidelines and guidance. See Guide to categorising your chemical importation and manufacture and Industrial Chemicals Categorisation
Guidelines.

Listed introductions: improved guidance. See Introductions that are in the listed category and Your obligations after categorisation for listed introductions

Do you need to submit a post-introduction declaration (PID) for 2023-24? If you worked out that your introduction is in the ‘exempted’ category and you manufactured or imported the chemical for the first time between 1 September 2023 and 31 August 2024, then you must submit a PID if your introduction is: a polymer of low concern; a low-concern biological polymer; or categorised as very low risk for human health and the environment. More information here.

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) as at 25 September: CAS 82339-26-2 and CAS 17 September 2024. Source: AICIS

Variation of Inventory listing following revocation of CBI approval – none this month

Variation to inventory listing after evaluation– none this month

Chemicals added to the inventory following issue of assessment certificate (early listing): as at 27 September 2024: CAS 1226911-73-4 a fragrance component with linits on content. Source: AICIS

Sigma Healthcare has proposed to buy Chemist Warehouse. ACCC states “Sigma is one of the largest wholesalers of prescription medicines, over the counter and front of store products. Sigma is also a franchisor of pharmacies under banners including ‘Amcal +’ and ‘Discount Drug Store’. Chemist Warehouse is a franchisor, wholesaler and distributor to pharmacies and retail stores under its brands ‘Chemist Warehouse’, ‘MyChemist’, ‘Ultra Beauty’, ‘My Beauty Spot’ and ‘Optometrist Warehouse’. ACCC has expressed concerns about this proposed acquisition and is inviting comment on their “remedy”. Source: ACCC

Infant formula: The ACCC is proposing to deny the authorisation sought by the Infant Nutrition Council for an industry code which seeks to restrict the advertising and promotion of infant formula. Source: ACCC

ACCC Product Safety Website has been “refreshed” – refinements to site structure, content and messaging. View the website here.

Published by Regulatory Training Direct  www.regulatorytrainingdirect.com

Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.

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