Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

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


'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



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.



ACCC Specifies Country of Origin Labelling Laws

The Australian Competition & Consumer Commission (ACCC) has stressed that under Australian Consumer Law (ACL), certain food products offered or suitable for retail sale will be required to display country of origin information. The ACL doesn’t require non-food products to carry country of origin labelling, although other laws may do so. All businesses, whether they are legally required or choose to display country of origin labelling, are prohibited from making false or misleading representations or engaging in misleading or deceptive conduct about the origin of goods (both food and non-food). It’s up to individual businesses to work out what type of origin claim they can make about their products. From 1 July 2018, businesses must label their products according to the requirements of the Food Standards Code.   Sources: CoOL claims & CoOL foods (Editor’s notePlease see related story under "Complementary Medicines", in this newsletter)

Australian Department of Industry to Apply Country of Origin Requirements to NZ Products

The Department of Industry says that it intends that the new Australian Country of Origin requirements will apply to products from New Zealand, despite a free trade arrangement existing between the two countries. This article, by FoodLegal, examines the extraneous nature of the points made by the Department of Industry and the ineffectual aspects on New Zealand imports. FoodLegal maintains the view that New Zealand remains an advantageous jurisdiction to make and sell products destined for the Australian market without bearing the same regulatory burden as Australian products face under the new Country of Origin regime applicable to Australian packaged foods.   Source: Joe Lederman, Food Legal CoOL NZ

Agriculture Department Gets Tough on Foods Arriving Without a Permit

The Department of Agricultur & Water Resources has alerted importers of conditionally non-prohibited goods that require an import permit and agents acting on importers’ behalf, of recent changes. From 9 April 2018, the department will no longer facilitate the clearance of conditionally non-prohibited goods that arrive without the required import permit. Goods that require a permit, but arrive without one, including where an application is currently under consideration, will be directed for export from Australian territory or required to be destroyed in an approved manner.   Source: Food permits

NSW Food Authority RecallsSource: Current recalls

Washed Rind Cheeses - Washed Rind Pty Ltd has recalled a variety of cheeses made in France due to potential Listeria monocytogenes contamination.

Inghams Sweet Chilli Chicken Breast Tender - Ingham’s has recalled Ingham's Sweet Chilli Chicken Breast Tenders as the product may contain pieces of hard plastic.

Creative Gourmet Pomegranate - Entyce Food Ingredients is conducting a precautionary recall of its Creative Gourmet Pomegranate Arils 180g, due to potential Hepatitis A contamination. (Editor's note: Check your freezer!)

New Zealand in Focus: Exports, Regulations and Innovation Take Centre Stage at NHPNZ Summit

RFA Regulatory Affairs was delighted to participate in the recent Natural Health Products New Zealand, Annual Summit, held in Nelson. We not only met with friends old and new but also learnt so much about NZ’s booming exports, the sector's commitment to innovation, and ongoing frustration over a lack of domestic regulatory advances.     (An excellent summary of the NHPNZ Summit can be read here via this Special Edition - Nutraingredients Asia NHPNZ Summit )

Busy Summer for Frontline Biosecurity Officers in New Zealand

New Zealand's border biosecurity defenders have just been through their busiest summer on record, says the Ministry for Primary Industries (MPI). MPI biosecurity officers screened some 2 million passenger arrivals for risk goods between December 2017 and February 2018, a 5% increase on last summer.   Source: NZ bio-security

FSANZ Notifications—

Proposal P1044 – Plain English Allergen Labelling: The aim of this proposal is to make allergen labelling requirements clearer, which will help food allergen-sensitive consumers and food businesses. The Food Standards Code already contains a mandatory requirement to label 10 allergens; however it does not include requirements for the terminology that should be used. Submissions on this proposal have been extended to 6pm (Canberra time) 10 May 2018.   Source: Plain English allergens

Proposal P1047– Review of regulatory nutrient reference values: ​The purpose of the Proposal is to review and update the regulatory nutrient reference values in the Australia New Zealand Food Standards Code in light of the 2006 and 2017 Australia/New Zealand nutrient reference values.   Source: Nutrient reference values

Call for submissions on new processing aid: Food Standards Australia New Zealand (FSANZ) has called for submissions on an application to allow the use of thermolysin as a processing aid. The enzyme would be used in the manufacture or processing of foods including dairy, egg, meat, fish, yeast, protein products and flavourings. The closing date for submissions is 6pm (Canberra time) 24 May 2018.   Source: Thermolysin enzyme

Call for requests: 2018 Maximum Residue Limits (MRLs) harmonisation requests [Australia only]: FSANZ considers changes to maximum residue limits in the Code to harmonise with MRLs established by Codex Alimentarius Commission or by a regulatory authority in a recognised jurisdiction where the food commodity is produced. These changes are considered through an MRL harmonisation proposal and FSANZ usually undertakes one harmonisation proposal a year. The call for MRL harmonisation requests is now open for 2018 for all stakeholders and interested persons. Requests must be lodged with FSANZ by 6pm (Canberra time) Wednesday 6 June 2018.   Source: MRL harmonisation

NZ Vineyard Workers Pay the Price for Labelling Banned Pork Sausages as Squid

Two Thai vineyard workers have both been fined NZ$1,900 and ordered to pay court costs of NZ$130 each after bringing in high-risk pork sausages to New Zealand from Asia. The pair's offending came to light after they arrived in New Zealand on separate flights directly from Singapore one day apart from each other in October last year. The court heard that when biosecurity staff checked both women's luggage, they discovered a sealed package labelled 'dried squid' but which actually contained pork sausages as well as dried squid. The women denied knowledge of the hidden sausages and both blamed their mothers for putting the product into the same packet as the dried squid. Pork is prohibited from entry into New Zealand and is considered especially risky due to the prevalence of foot-and-mouth disease in Thailand.   Source: Prohibited pork


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