Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

IMESupports the Complementary Health Industry.

IME’s extensive experience as a leading insurance broker in the Complementary Medicine Industry, can provide you with the perfect insurance remedy for your Complementary Health Business. IME has over 20 years’ experience in assisting  businesses involved in the manufacturing and distributing of complementary medicines, vitamins and allied health products, along with practitioners of most modalities. No other insurance broker in Australia is better suited to arranging these types of insurances.

Visit or call Philip Watson mobile 0423791368 for a no-obligation chat to discuss the best ways to protect your products and your business.

RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have a new member of your regulatory or marketing team and would like them to be trained on food classifications and labelling in Australia? Do you want to supply cosmetics but aren’t quite sure what the label is required to look like? RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements. All courses are presented in a modular format of one to three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module. You can find more information at RFA Training Courses or email us This email address is being protected from spambots. You need JavaScript enabled to view it.  to discuss your requirements.


RFA Office News

After nearly 20 years of loyal and valuable service to RFA Regulatory Affairs, Felizitas Parr has retired from her role as our office manager, in order to pursue other interests in her life. Most of our clients will have dealt with Felizitas over the years, and I know that you will be reading this notice with a tinge of sadness as we farewell a familiar and reliable presence from our team. Felizitas capably managed our office through some great changes, including moving our physical address, updating technology and streamlining our business systems. We will forever be grateful to Felizitas for her many years of loyal and dedicated service and wish her well in her new life endeavours.

Accord Launches BeadRecede - An Initiative for Responsible Industry Action on Plastic Microbeads

So, what’s the deal with plastic microbeads? Well, firstly there is a growing issue with plastics of all types, not just exfoliating beads in facial scrubs, getting into the marine environment. And related to this is the characteristic that plastic materials in general neither break down nor biodegrade with any ease, once they are in the marine environment. All of which can be bad news for our oceans. On 25 November 2016 Australia’s environment ministers formally endorsed a voluntary industry phase out of plastic microbead ingredients from cosmetic, personal care and household cleaning products. To help raise awareness of the minsters’ goal and facilitate widespread participation in the voluntary phase out project Accord Australasia has recently launched the ‘BeadRecede’ initiative. Via BeadRecede Accord is encouraging companies to actively support the phase out timing announced by Australia’s environment ministers, as relevant to the products they make and supply.    Source: Esprit BeadRecede    Editor’s note: Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic, and specialty products, their raw material suppliers and service providers.

Senate Committee Inquiry on Industrial Chemicals Report Tabled

This report concerns the legislation Industrial Chemicals Bill 2017 and the related Senate Inquiry, which is due to report on Tuesday 8 August.    Source:Chemical bills

Canadian Cosmetics Industry Group Undertakes Name Change

CCTFA (Canadian Cosmetics, Toiletry & Fragrance Association) is now known as CAC (Cosmetics Alliance Canada):


Austrade Publishes Guide to Supplying Complementary Medicines in China

This report has been prepared by the Commonwealth of Australia represented by the Australian Trade and Investment Commission (Austrade). The guide has been developed to assist Australian companies interested in exploring the rapidly growing and evolving market in China for complementary medicines and nutritional supplements. It provides an overview of the drivers of demand, key channels of distribution and the regulatory environment that applies to these products, along with practical information about doing business in China.    Source: Austrade China Report


Quote for the month:

“If goods don’t cross borders, armies will”   Frederick Bastiak

The Regulatory Rules for Hemp as a Food in Australia

Following a lengthy review process by Food Standards Australia New Zealand (FSANZ), the Australia New Zealand Ministerial Forum on Food Regulation in March 2017 gave its approval to FSANZ to amend the Australia New Zealand Food Standards Code on the use of hemp in food products in Australia. The approval of hemp in food is not directly related to separate approvals by some Australian State and Territory laws for medicinal cannabis. This article explains the regulatory position.    Source: Joe Lederman, Food Legal Hemp as food

Interested in Australia’s Food Regulatory System?

Food Standards Australia New Zealand (FSANZ) is seeking academics with a strong interest in food-related consumer and public health issues to be appointed to the Consumer and Public Health Dialogue (CPHD). If you are currently working in academia in public health nutrition, consumer behaviour or social science, health policy or a related discipline and have a keen interest in the issues and challenges for the food regulatory system, you might like to follow this link: Food dialogue

NSW Food Authority Food Labelling Website

This website helps you find the information you need to understand what a food label is telling you, to help you manage your food choices. If you are a food business, you’ll find information about what you need to include on a food label.    Source: Food labelling

Businesses Urged: Use Your Noodle When It Comes To Food Safety

A Sydney noodle manufacturer has been fined a total of $27,000 and ordered to pay professional costs of $9,000 after he pleaded guilty in the Downing Centre Local Court to thirteen charges relating to failures in hygiene, construction failures and harbouring pests on food premises.    Source: Noodles are off

NSW Food Authority Recalls:

Kids yoghurt pouches  Parmalat Australia has recalled yoghurt pouches due to a packaging fault resulting in a potential choking hazard.    Source: Yoghurt choke

Bean paste A South Korean seasoned garlic and sesame bean paste product (Chung Jung One) is being recalled because of the presence of undeclared peanut.    Source: Bean paste

COYO Sea Salted Caramel Coconut Milk Ice Cream Alternative COYO Corporate Pty Ltd has recalled COYO Sea Salted Caramel Coconut Milk Ice Cream Alternatives due to the presence of an undeclared allergen (gluten).    Source: Alt-Ice Cream

FSANZ Notifications:

Application A1149 – Addition of Steviol Glycosides in Fruit Drinks The purpose of the Application is to seek approval to amend Schedule 15 relating to Standard 1.3.1 of the Australian New Zealand Food Standards Code to include the addition of steviol glycosides in Fruit Drinks at a level of 200 mg/kg steviol equivalents.    Source: Steviol 1

Application A1127 – Processing Aids for Wine The purpose of this Application is to seek permission for the use of four processing aids, silver chloride, ammonium bisulphite, chitin-glucan and PVI/PVP as processing aids for wine.    Source: Wine aids

Proposal A1150 – Glucosylated Steviol Glycosides The purpose of the Application is to permit the use of glucosylated steviol glycosides as an intense sweetener in various foods.    Source: Steviol 2

Proposal M1015 – Maximum Residue Limits (2017) The purpose of this proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities. Source: MRL 2017

Proposal P1046 – L-amino acid acetate in Food for Special Medical Purposes The purpose of this proposal is to remove a negative impact on trade to enable sale of a food for special medical purposes (FSMP) by permitting acetate forms of L-amino acids.    Source: Amino acetate

Call for submissions on genetically modified rice application FSANZ has called for submissions on an application to permit a genetically modified rice line that produces a form of provitamin A.     Source: Mod rice

Consultation paper on infant formula products for special dietary use FSANZ has released a consultation paper on infant formula products for special dietary use. FSANZ Chief Executive Officer Mr Mark Booth said the paper was the next stage of a proposal looking at revising and clarifying standards relating to infant formula.    Source: Infant formula

Consultation paper released on beta-glucan and blood cholesterol health claims FSANZ has released a consultation paper about beta-glucan and blood cholesterol health claims. The consultation paper follows a recent review by FSANZ of the food-health relationships between beta-glucan, oats and barley and blood cholesterol. The review found that a food-health relationship between oats (not barley) and blood cholesterol is substantiated, not the current pre-approved relationship for a high level health claim between beta-glucan and blood cholesterol.   Source: Beta-glucans

Editor’s note: Submissions for all three consultations close at 6pm (Canberra time) 14 September 2017. 



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