Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Melbourne e-commerce business fined $13k for unauthorised imports. Investigators from AICIS have fined a Melbourne e-commerce order fulfilment business more than $13,000 for allegedly importing industrial chemicals without the required registration.    Source: AICIS

Review of import policy for mushrooms an trifles. The review will consider permitted and prohibited species, country of origin differences, target and hitchhiker pests, substrates approved for use, sterilisation requirements; and on-arrival management.    Source: Department of Agriculture, Water and the Environment


Imported food requirements.  Information for food importers and brokers acting on behalf of food importers.    Source: Department of Agriculture, Water and the Environment


Australia’s Food Safety Report Card. Release for the UN World Food Safety Day. Items noted included ︎Less diagnosed salmonella. ︎We are washing raw chicken less. ✖︎Handwashing decreases ✖︎Need to close the gender gap. (Women sanitised more often than men) ✖︎Stop picking or eating those wild mushrooms. ✖︎Finally, a big fail for some of the social media giants such as Facebook and WeChat who continue to advertise unregulated food for sale.    Source: Food Safety Information Council.


Public consultations that are still open

Food derived from EPA and DHA producing and herbicide-tolerant canola line LBFLFK.    Source: FSANZ

Glucoamylase from GM Aspergillus niger (gene donor: Gloeophyllum trabeum) as a processing aid.    Source: FSANZ

Alpha-amylase from GM Bacillus licheniformis as a processing aid.    Source: FSANZ


Approvals – variations arising from applications and proposals

Maximum Residue Limits (2021).    Source: FSANZ

Cetylpyridinium chloride (CPC) as a processing aid.    Source: FSANZ


Changes to Health Star Rating system. The Health Star Rating is a front-of-pack labelling system that rates the overall nutrition profile of packaged foods with a rating from ½ a star to 5 stars. Changes are due to come into effect by 14 November 2022.    Source: NSW Food Authority newsletter.


New applications

Bovine lactoferrin in infant formula products.    Source: FSANZ

Very Low Energy Diets (VLED). This application seeks to amend the Food Standards Code to include foods suited for Very Low Energy Diets in foods for special medical purposes.    Source: FSANZ


Food Recalls

Dineamic Creamy Pesto Pumpkin Gnocchi With Broccoli – presence of a foreign matter – plastic.    Source: FSANZ

Useful resources for labelling of products
Label your products.    Source:

Labelling, SDS and packaging.    Source: Australian Industrial Chemicals Introduction Scheme (AICIS)

Cosmetic labelling.    Source: ACCC Product Safety Australia


Chemicals added to the Inventory 5 years after issue of assessment certificate. Updated 13th May5th    Source: AICIS


Variation of inventory listing following approval of application – CAS 96556-05-7, 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl-    Source: AICIS


Chemical added to the Inventory following issue of assessment certificate – CAS 121375-93-7, Silane, trichloromethyl-, hydrolysis products with amorphous fumed cryst.-free silica.    Source: AICIS


New Zealand

The Advertising Standards Authority released its 2021 annual report on 18 May 2022. A detailed summary of 1245 complaints about 570 ads. Review of Alcohol Advertising and Promotion Code is in effect. Influencer advertising: new reporting process for influencer ad identification breaches was introduced in August. Most of the complaints regarding influencers were about the lack of sufficient identification on influencer ad content.    Source: NZ Advertising Standards Authority


Therapeutic and Natural Health Products Update. Latest from the NZ Ministry of Health - Therapeutic Products


A Horowhenua milk business, MannaMilk has been fined $30,000 for not following the rules that regulate the supply and sale of raw milk.    Source: NZ Ministry for Primary Industries.

TGA Website Redevelopment. The TGA is “modernising” its website. Some links will change, and some old pages removed. The TGA is presenting a webinar on 7th and 12th July. To register for the webinar follow this link.


New poisons standard published 1st June.    Source: TGA.


TGA fees and charges – increase on the 1st of July each year. Summarised here.


Post-market review of antigen and rapid antigen tests. A summary of the results of testing on 97 products.    Source: TGA


Revised evidence guidelines for listed medicines. How to demonstrate the efficacy of listed complementary medicines is acceptable.    Source: TGA

Also refer to Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines.


Links to 15 presentations given by the TGA at the 2022 ARCS Annual Conference.    Source: TGA


Supply of unapproved therapeutic goods: a guide to completing the reporting form.    Source: TGA


Advice for consumers on purchasing COVID-19 rapid antigen tests. How to ensure you are using an approved test.    Source: TGA


Therapeutic Goods Advertising Code: the 6 month transition period from the 2018 code to the 2021 code ends 30th June.    Source: TGA. Also refer to Complying with advertising requirements and Testimonials and endorsements in advertising


Product recalls

Multiple Sunscreens Recalled - Low levels of benzene detected. The investigation has finished and no other brands have been affected.    Source: TGA


Compliance enforcement

Eight infringement notices totalling $106,560 have been issued to Hough Pharma for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs and failing to provide appropriate customer support.    Source: TGA

HERO Instant Energy for Male products were tested and found to contain undeclared Tadalafil. The Australian Border Force will seize and destroy future shipments as it is intercepted at the Australian border.    Source: TGA

The TGA has commenced court proceedings in the Federal Court of Australia against Prefixx and its sole director, Mr Brad Anthonisz, for alleged unlawful advertising of nicotine vaping products. Several warnings were issued but the advertising and selling of the products continued for some months.    Source: TGA

TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19.    Source: TGA

The TGA has issued one infringement notice of $2,664 to a NSW based individual for the alleged unlawful advertising of a medicine that was not included in the Australian Register of Therapeutic Goods and was not exempt from being on the ARTG.    Source: TGA

The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of 13,500 COVID-19 rapid antigen tests.    Source: TGA

Philips Electronics Australia issued with ten infringement notices totalling $133,200 for failing to provide information on Philips CPAP and bi-level PAP (Continuous or bi-level Positive Airway Pressure) machines used for individuals with sleep apnoea, and mechanical ventilators.    Source: TGA


Implementation of the Review of Medicines and Medical Devices Regulation. 9 reviews and reforms listed here.


Street sales, online dealers and convenience stores: Inside the thriving black market for nicotine vapes. An interesting article in the press.    Source: Sydney Morning Herald.

And: Vape websites send buyers to ‘easy’ online prescriptions, bypassing local GPs.    Source: Sydney Morning Herald.


As the Coalition (the former federal government) feuded over vaping, 'personal' donations were made by the pro-vape lobby. A national vaping lobby group donated a total of $44,000 to the Liberal Party but the money was declared as personal gifts from its director on electoral returns.    Source: ABC news.

Research into vitamin D levels in the population

A number of FSANZ staff recently contributed to a journal article investigating vitamin D in Australian diets. This study showed that vitamin D intakes in Australia are low.    Source: Journal of Human Nutrition and Dietetics.


Call for submissions and comments - These are all available on the FSANZ website here

Food derived from EPA and DHA producing and herbicide-tolerant canola line LBFLFK

GM Aspergillus niger (gene donor: Gloeophyllum trabeum) as a processing aid

Polygalacturonase from GM Aspergillus oryzae as a processing aid

Pectinesterase from GM Aspergillus oryzae as a processing aid

Serine endopeptidase enzyme from GM Trichoderma reesei

Infant Formula


Energy labelling on alcoholic beverages Updated 2nd May.    Sources: FSANZ  and FSANZ


Undeclared allergen food recall statistics for the period 1 January 2016 – 31 December 2021.    Source: FSANZ


Food recall statistics for the period 1 January 2012 – 31 December 2021.    Source: FSANZ


Invitation to 2022 Stakeholder Forum - Future Ready Food Standards. To be held WED 29TH June in Sydney.    Source: FSANZ


Food Recalls Source: FSANZ

Deep Coriander Chutney 283g - presence of an undeclared allergen (sesame). 

INC Shred Max Raspberry Coconut Flavour 60G - undeclared allergen (peanut)

Chris' Homestyle Plant Based Dips 200g - undeclared allergen (milk). 

Hanami Prawn Crackers. Incorrect labels do not declare molluscs [squid], milk and/or soy. 

The Little Big Dairy Company Double Cream 300mL and 1L - potential microbial (Listeria monocytogenes) contamination.

Margaret River Gluten Free Muesli 500G - undeclared allergen (gluten).

INC Shred Max Raspberry Coconut Flavour 60G - undeclared allergen (peanut)


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