International courses: Click on links to view agenda.

We now have four courses on USA regulations:

5.01. US Dietary Supplements Ingredients and Labelling (one hour 20 minutes)

5.02. US Dietary Supplement and Food Claims (one hour)

5.03. US Overview of Advertising Regulations (one hour)

5.04. US Cosmetics – State Laws on Plastics, Recycling, Ingredients Bans, VOC and Producer Responsibility (one hour)

US courses are pre-recorded, you can do these courses in your own time.

And three courses on New Zealand regulations:

3.01. NZ Cosmetic Labelling and Claims (one hour)

3.02. NZ Dietary Supplement Labelling and Claims (one hour)

3.10. NZ Pet food, animal feed, and nutritional supplements (one hour)

New Zealand courses are conducted live via Zoom by appointment.

A recent addition to our global courses:

4.02. New Product Development – Stage Gate Process (one hour 30 mins)

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

TGA financial deadlines. For all products on the ARTG, deadline for payment is 15 September 2024. For manufacturing licences: 1 October 2024. Details on TGA website Important annual charge deadlines

Safety alerts

Garcinia gummi-gutta (Garcinia cambogia) and hydroxycitric acid (HCA). Products containing these ingredients may cause liver injury in some people, however it is a “rare” risk. Five cases resulted in liver transplantation, one of which was an Australian case. Other ingredients affected are Garcinia quaesita, hydroxycitrate complex, calcium hydroxycitrate, sodium hydroxycitrate, and potassium hydroxycitrate. TGA is monitoring the situation .. read the press release here.

Changes to TGA guidance documents. Feedback from industry indicates that guidance documents are difficult to navigate and find; are unclear, as to what the ‘rules are’ ; and difficult to know what’s been updated. Changes to be implemented from September include improved page navigation, so that you can easily jump to headings on long pages; colourful indicators, so you can see when content is new or has been updated; and headings that will allow you to bookmark and share parts of content. Source: TGA

MDMA and psilocybine: new quality standards. Specify the minimum quality requirements for both the active ingredient and in the finished product. For psilocybin, includes both natural and synthetic psilocybine. For MDMA: TGO 112. For psilocybine: TGO 113.

Medical devices affected by closure of 3G network for mobile phones. Some medical device equipment, as well as products such as personal medical alarms could be affected as network operators shut down their 3G networks. More information TGA

Medical devices webinar on 11 and 12 September: Essential Principles for Safety and Performance. Providing information on proposed changes to align with European regulations. Register here.

Consultations

* Listed complementary medicines: Proposed changes to the Permissible Ingredients. Proposals include: Herbal ingredients with pregnancy contraindications and other toxic effects; Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury; Xanthium species; Phenoxyethanol; Clarification of hydration state for Rutoside. Consultation closes 13 September, details here.

* Medical devices containing medicinal substances or materials of animal, microbial or recombinant origin. TGA inviting input for new draft guidance. Consultation closes 9 October. Details here.

Spinal cord stimulatory devices. Post market reviews have led to 12 devices being cancelled and 70 having conditions applied. Cancelled devices are not being recalled and do not need to be removed if already implanted.

Warning on advertising of prescription-only weight loss products. Advertising any prescription-only medicine to the public is illegal. Source: TGA

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

New or revised TGA forms

Clinical Trial Notification Form

Change of Sponsor Name—Notification Form

Change of Sponsorship—Notification Form – following death, bankruptcy or winding up; or transfer or assignment of business

Compliance action

10,000 nicotine pouches and hundreds of illicit vaping goods seized in a joint operation between the TGA and Queensland Health. Nine retailers were raided. Source: TGA

Vaping

The Pharmaceutical Society of Australia is facilitating a series of free webinars and interactive workshops to help pharmacists to understand their obligations and support pharmacists. Open to all. Source: Pharmaceutical Society of Australia.

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

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

* FDA Adds More Cinnamon Products to Public Health Alert Due to Elevated Lead Levels. Source: Nutraceuticals World

* The adulteration of oregano herbs with olive leaves. How to detect and test for this adulteration. Promoted by BAPP and source document here.

* Ingredient watch list. Twenty “suspect” botanicals and fungi that are often adulterated. Research by Alkemist Labs, published in NutraIngredients

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

What to look for in lab? Includes an article by one of our trainers Rend Al-Mondhiry, plus US industry stalwart Len Monheit. Source: Alkemist Labs.

USA news provided by Michael Levin, Health Business Strategies.

* Just because FDA reports the frequency of sudan dyes found in palm oil has reduced, they remain a reasonably anticipated contaminant that must be controlled by inclusion in ingredient specifications and suitable testing on incoming lots. Read more here.

* FDA holding public meeting concerning assessment of chemicals in foods on September 25, 2024; FDA will later publish an ANPR (advanced notice of proposed rule making) regarding new limits for allowable chemicals in foods, to include spices and herbs. Source: National Law Review

* Chemical limits in herbal medicines from FDA that would impact exporters and importers? More from FDA on Food Chemical Safety – FDA

* Per FDA, Lead concentrations found in retail ground cinnamon products recently recalled ranged between 2.32 ppm and 7.01 ppm; this is far lower than previously reported and, some say, may be a naturally occurring level for this contaminant in this commodity. Are these recall actions appropriate to protect the public health or are they an over-reaction? You be the judge. Source: FDA

Food Ministers’ Meeting. The members are all Australian and New Zealand ministers responsible for food regulations. Key discussions included (click on links for more details):

* regulation of infant formula products
* improving commercial foods for infants and young children
* the Health Star Rating system
* carbohydrate and sugar claims on alcohol
* the FSANZ Act review
* modernising the food regulatory system.

Nutrition labelling: FSANZ “is set to progress a package of work on nutrition labelling standards to better support consumers to make informed and healthy dietary choices”.

Work will be done to improve front- and back-of-pack nutrition information labelling and finalising alcohol labelling proposals. FSANZ will begin preparatory work to support mandating the front-of-pack Health Star Rating (HSR) system should industry not meet voluntary uptake targets. Source: FSANZ media release.

New video guide to Nutrition Panel Calculator. A number of “How to” videos released by FSANZ, including “Nutrition Panel Calculator Quick Start Guide, Nutrition Panel Calculator Custom Ingredient Guide, Nutrition Panel Calculator Backup and Restore Guide, and Nutrition Panel Calculator Ingredient Search Guide. View them here.

Food inspections in NSW 2023/2024:

Meat: 2,856 inspections, 95% compliance

Seafood and shellfish: 336 inspections, 95% compliance

Dairy: 462 inspections, 99% compliance

Eggs: 486 inspections, 95% compliance

Plant products: 50 inspections, 90% compliance

Licensed hospitals and aged care: 1,137 inspections, 99% compliance

Source: Foodwise, NSW Food Authority

New applications and proposals

* A1311-Prolyl oligopeptidase from GM Trichoderma reesei as a processing aid: To amend the Australia New Zealand Food Standards Code to permit prolyl oligopeptidase from GM Trichoderma reesei for use as a processing aid in the production of brewed beverages

* Application A1260 – 2-methyloxolane as a processing aid

* A1247 D-allulose as a novel food – To permit D-allulose manufactur​​​​​​ed by an enzymatic conversion of fructose to D-allulose using Microbacterium foliorum SYG27B-MF containing allulose-3-epimerase.

* A1284 – Triacylglycerol lipase from GM Trichoderma reesei as a processing aid in baking and cereal-based processes

* A1307- Milk fat globule membrane as a nutritive substance in infant formula products

* A1308 – 2′-FL from GM Escherichia coli W in infant formula products

* A1306 – Chitosan from Agaricus bisporus as a processing aid for wine, beer, cider, spirits and other alcoholic beverage production.

* A1287 – Food derived from short-stature corn line MON94804 modified to have reduced overall plant height

Infant formulas – summary of recent review is here

Added sugars – Proposal P1063 – Code revision (2024) – To amend the Code to remove “sugars’, and amend the table entry dealing with “Sugar or sugars” in section S4-3. More here

Recalls

* Byford Flour Mill – Strong Bakers Flour, Sourdough Flour, Wholemeal Flour, Organic Flour – due to presence of undeclared allergen (soy) Source: FSANZ

* Lee Sun Seng Food – Sun Dae – due to presence of undeclared allergen (gluten) Source: FSANZ

* Akula Foods – Savan Cinnamon Sticks and Powder – due to chemical (metals) contamination. Source: FSANZ

* Pernod Ricard Winemakers – Screwball Peanut Butter Whiskey Flavoured Liqueur – due to presence of undeclared allergen (sesame) Source: FSANZ

* Calbee Australia – Harvest Snaps Baked Pea Crisps – due to undeclared allergen (soy)Source: FSANZ

* Gippsland Jersey – Unhomogenised Jersey Milk – due to Microbial (Listeria monocytogenes) contamination. Source: FSANZ

* Paradise Beach Purveyors Smoked Trout and Chive – due to Microbial (Listeria monocytogenes) contamination

More food news supplied by Gary Kennedy of Correct Food Systems

Proposal P1055 is a proposal to amend the definitions in the Australia New Zealand Food Standards Code (the Code) for ‘food produced using gene technology’ and ‘gene technology’ to:
•    make it clear which foods are genetically modified (GM) foods for Code purposes
•    accommodate new technologies
•    regulate foods according to the risk they pose.
FSANZ released a first public call for submissions in 2021. The feedback from that first consultation was that the initial approach to amending the definitions was unclear and too complex. Following further assessment, they have simplified the approach and are now proposing a new definition for ‘genetically modified food’.
•    The second public call for submissions: P1055 – Definition for gene technology and new breeding techniques is now open on the FSANZ Consultation Hub, closing 10 September 2024. Submissions need to be made by using the Consultation Hub.

New Zealand

* List of foods recalled in New Zealand is published on Ministry of Primary Industries website here

* Safety warning – regarding consumption of mini jelly cups containing konjac as they may present a significant choking hazard. Source: NZ Ministry for Primary Industries

Zinc oxide for UV protection. Another very informative article from sunscreen “guru” John Staton … read it here on LinkedIn

A new version of the Industrial Chemicals Categorisation Guidelines will be published on 24 September 2024. Version 3 will include revisions and updates delayed by 6 months to give introducers time to prepare for the changes. It will also include updates prompted by the recent vaping reforms. Read more about the changes and the differences between the new and previous version on AICIS site 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.

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply)

As at 23 August: three chemicals, including a dehydrated polymer of castor oil, listed here.

Variation of Inventory listing following revocation of CBI approval – as at 22 August 2024: one chemical, CAS 592479-38-4

Variation to inventory listing after evaluation, as at 9 Aug: one chemical, phosphoric acid, bis(2-ethylhexyl) phenyl ester. Info here.

Chemicals added to the inventory 5 years after issue of assessment certificate as at following issue of assessment certificate as at 23 Aug: three chemicals listed here

List of new chemical assessment statements as at 12 Aug – 12 chemicals listed here

Consumer rights and guarantees. An update, includes products and services and the consumer rights that apply.  Did you know that guarantees are different from warranties? Source: ACCC

Infant formula: Interim authorisation granted to the Infant Nutrition Council to enable the Marketing in Australia of Infant Formula: Manufacturers and Importers Agreement (MAIF Agreement) and its associated guidelines to continue to operate pending the ACCC’s assessment of the substantive application for authorisation. Source: ACCC

Published by Regulatory Training Direct  www.regulatorytrainingdirect.com

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

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