Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


Failing Food Report

This report details food that was found to fail under the Imported Food Inspection Scheme. The noncompliant food was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision and at the importer’s expense. Future consignments continue to be targeted at 100 per cent until a history of compliance is established. Typical microbiological contamination was by E. coli,  salmonella, and Listeria monocytogenes. Toxin testing showed repeated instances of aflatoxin and histamine contamination, especially in peanut butters and dried anchovies. Of particular interest to suppliers of ‘formulated sports supplements’ was that 4 USA sourced products were found, after random sampling of imports, to contain either non-permitted ingredients or ingredients that were deemed to be ‘in excess of levels permitted’. Let the food importer beware.   Source:  Failing foods

Does the New Country of Origin Labelling Apply to Inner Packs?

The new Country of Origin Food Labelling Information Standard takes mandatory effect as of 1 July 2018. As with any new piece of legislation, there any many concerns and uncertainties as to how the Information Standard will be interpreted and enforced. However, this article does not tackle a grey area but rather a regulatory issue that appears to have been forgotten by the Department of Industry in drafting the Standard and currently ignored by the ACCC in guiding the food industry to achieve compliance. Namely: does the new country of origin labelling apply to inner packs?   Source: Charles Fisher, Food-Legal CoOL foods

Mandatory Labelling for Lupin Starts Soon

Food Standards Australia New Zealand (FSANZ) is reminding food businesses that mandatory allergen labelling requirements for lupin begin on 26 May 2018. FSANZ CEO, Mark Booth, said lupin is a legume which belongs to the same plant family as peanuts, and has the potential to be an allergen. “In Australia, lupin has not typically been used in food, however, due to its high protein and fibre content we are seeing an increase in its use,” Mr Booth said. “In 2017, lupin was added to the list of allergens that must be declared on food labels. Food businesses were given 12 months to meet these requirements. “Any foods that contain lupin must declare it on the label from 26 May 2018 – even if it’s already on the shelf. “Correct allergen labelling can mean the difference between life and death for people with food allergies so it is vital that food businesses get it right.   Source: Lupin labelling

UK Supermarket Chain Tesco to Ditch Best-Before Dates – Australia to Follow?

Supermarket chain Woolworths has indicated it is open to the possibility of removing best-before dates from some products following Tesco (UK) chain’s decision to ditch the labelling. Tesco said best-before dates would no longer appear on packaged produce because the labels were leading to shoppers throwing away “perfectly edible” food. Campaigners have welcomed the move by Tesco. Food donation organisation Oz Harvest told it was a “bold move” and encouraged Australian retailers to do the same. It has called on Australia’s food labelling regulations to be reassessed.   Source: Best-before

Australian (NSW) Food Authority RecallsSource: Current recalls

Sweet Bondi Tapioca Coconut Milk Puddings - due to the presence of an undeclared allergen (milk).

Mini Classics Ice Creams - due to potential contamination with metal fragments.

oh so natural Wholefoods Almond, Cashew and Cranberry Bites - due to the presence of an undeclared allergen (peanut).

Red Kellys Tasmania Creamy Caesar Dressing - due to the presence of undeclared allergens (egg, dairy and fish).

FSANZ Notifications —

Proposal P1048 – Code revision 2018 - The purpose of the Proposal is to make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references.   Source: Code revision

Application A1136 – Protein Glutaminase as a Processing Aid (Enzyme) - The purpose of the Application is to permit the use of protein-glutaminase from Chryseobacterium proteolyticum as a processing aid to improve protein functionality in baking, noodle, dairy, meat, fish and yeast products.   Source: Protein enzyme

Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch - The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch). Source: Resistant starch

A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811 - The purpose of the Application is to seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate.   Source: Tolerant cotton

Application A1161 – Potassium Polyaspartate as a food additive in wine - The purpose of the Application is to permit the use of Potassium Polyaspartate as a food additive in wine at levels of good manufacturing practice (GMP).   Source: Polyaspartate in wine


NICNAS Calls for Consultation on General Rules, Categorisation Guidelines and Transitional Rules

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) helps protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use. This covers a broad range of chemicals including those used in cosmetics, soaps and many other personal hygiene products.  As part of the Australian Government's reforms, NICNAS is seeking comments on the draft changes to the Industrial Chemicals (General) Rules 2018 (General Rules); the Industrial Chemicals Categorisation Guidelines (Categorisation Guidelines); and to the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2018 (Transitional Rules). Submission deadline is 31st May 2018.    Source: NICNAS changes

Voluntary Phase - Out of Microbeads a “Success”

In April 2018, the Department of the Environment and Energy, conducted an assessment of progress toward the voluntary industry-led phase-out of microbeads from rinse-off cosmetic, personal care and cleaning products. Australian Federal and State Environment Ministers have expressed satisfaction with the achievements of the voluntary industry phase out; and, have quoted the ‘94 percent microbead-free’ finding of this report’s independent in-store survey of personal care products.    Source:  Microbeads phasing out



Nature's Care Sale: Chinese Private Equity Firms Take Majority Stake In Aussie Supplement Brand

Two Chinese private equity firms, JIC Investments and Tamar Alliance Fund, have bought a majority stake in Australian vitamin manufacturer Nature's Care for a reported A$800m.   Source: Cheryl Tay, Nutraingredients-Asia Nature's Care sale

Blackmores Buys Catalent Tablet-Making Plant as Profit Rises

Vitamins company Blackmores has acquired a tablet and soft-gel capsule making plant in Melbourne from United States giant Catalent to gain more control over its supply chain after frustrations with supply shortages for some products. The acquisition was recently announced as Blackmores also revealed that its sales into China were below expectations because of supply constraints and the impact of re-negotiations of trading terms with customers. But its Australian business made market share gains, strengthening its hold as the No.1 brand in the Australian market. Blackmores chief executive Richard Henfrey said the acquisition of the 30,000 square metre tablet-making facility at Braeside in Melbourne would give the company much greater control and flexibility after frustrations over the past six months.   Source: Simon Evans, AFR Blackmores new plant

Three Myths to Bust About Supplements — Blackmores Institute

The industry needs to do more to bust three common myths around supplements, namely that products lack evidence of efficacy, that a healthy diet removes the need for supplementation and that products can lead to health risks. Watch this short video.   Source: Gary Scattergood, Nutraingredients-Asia Supplement myths


Quote for the month:

“The good physician treats the disease; the great physician treats the patient who has the disease”  William Osler


RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney

Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.

NGE18 logo



Pharmacovigilance Obligations Training


In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. TGA guidance. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.  All required documents including SOPs and reporting templates will be provided for your future use.

This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance.  This is all included in the price.

For more information or to schedule a training time, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it.


'Unofficial' Exports Of Aussie Supplements To China Estimated At $800m

Daigou shoppers are believed to have accounted for $800m of 'unofficial' supplement exports from Australia to China in the past year, dwarfing the $320m figure for official exports. ‘Daigou’ are personal shoppers who buy products overseas to ship back to China to sell, usually via e-commerce.   Source: Garry Scattergood, Food Navigator-Asia Daigou shoppers

Organic Growth: Australian Industry Tops $2.4bn With Exports To China And Japan Skyrocketing

The Australian organic industry has been ‘conservatively’ estimated to stand at $2.4bn this year, an 88% increase from 2012, with exports to Asia – most notably China and Japan – enjoying strong growth.   Source: Gary Scattergood, Food Navigator-Asia Oz organics in Asia

Vegan Trend Takes Hold in Australia

 "Every man and his dog is interested in veganism," says Sydney dietitian Nicole Dynan, who predicts the rise in veganism in Australia will only grow. It's backed by market research firm Euromonitor International which predicts that by 2020, Australia's packaged vegan food market would be worth $215 million. It also found Australia was the third fastest growing vegan market in the world after the United Arab Emirates and China. The diet, which excludes the use of animal products, is particularly popular with female millennials in Australia, Ms Dynan says. The Dietitian's Association of Australia spokeswoman says the veganism trend is starting to trickle into older age groups. The hype around gut- and micro-health has made everyone more aware of the value of plant foods, she says.   Source: Aussie vegans


Quote for the month:

“If it came from a plant, eat it; If it was made in a plant, don’t!”   Michael Pollan


RFA Regualtory Affairs is proud to be a Gold sponsor of Nordoff Robbins Music Therapy


False Flush: Company Behind White King 'Flushable Wipes' Fined $700k

Pental Limited and Pental Products Pty Ltd is the manufacturer behind White King's "flushable" toilet and bathroom cleaning wipes. It's been ordered to pay penalties totalling $700,000 for making false and misleading representations about its product; namely, that it would disintegrate in the sewage system "just like toilet paper". Packaging and promotional materials for the White King wipes included statements like “flushable”, “Simply wipe over the hard surface of the toilet … and just flush away”, and “White King Toilet Wipes are made from a specially designed material, which will disintegrate in the sewage system when flushed, just like toilet paper”. Those statements, the Federal Court ruled, are false.     Source: Jenny Noyes, SMH False flushable wipes



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