Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


Heinz to Pay $2.25 Million Fine for 'Deceptive' Peddling of Toddler Snack

Food giant Heinz has been ordered by the Federal Court to pay $2.25 million in penalties after being found guilty of "misleadingly and deceptively" targeting sugar-heavy snacks at toddlers. But the Australian Competition and Consumer Commission (ACCC), which initiated the legal battle, remains unsatisfied with the result, having sought $10 million in penalties. Earlier this year, the Federal Court found Heinz had misled the public about the nutritional content of its Little Kids Shredz range, aimed at children aged one to three years. It found the statements and pictures of fruit and vegetables on the packaging "conjured up impressions of nutritiousness and health", even though the sticky snack was two-thirds sugar.    Source: Esther Han, SMH Heinz penalty

Labelling of Sugars on Packaged Foods and Drinks

The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is investigating labelling approaches for providing information on sugars to consumers. The Food Regulation Standing Committee (FRSC) is responsible for coordinating policy advice to the Forum and will facilitate stakeholder consultation on the labelling of sugars on packaged foods and drinks. FRSC is inviting stakeholders including industry, public health and consumer organisations and other interested parties to make submissions on the Consultation Paper. A summary of submissions will be produced and published on the Food Regulation website. Submissions close at 11:59pm on 19 September  2018 Australian Eastern Time.   Source: Sugar labelling    (Editor’s note: Please see also related story “Food Standards Agency Survey Highlights Sugar Fears”, courtesy of Rod Addy, Food Manufacture Sugar worries ).

FSANZ Called for Comment on Draft Cost Recovery Arrangements

Food Standards Australia New Zealand has called for comment on a revised approach to cost recovery arrangements. Less than two per cent of FSANZ’s total revenue is generated through cost recovery and only a small number of applications to amend the Code incur costs. The deadline for submissions was 2 August 2018 and results will be published when they come to hand.    Source: Cost recovery

Review of Fast Food Menu Labelling Schemes

The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is conducting a review of fast food menu labelling schemes in Australia. The review will consider the effectiveness of the fast food menu labelling schemes including implementation and emerging issues since the release of the endorsed National Principles for Introducing Point-of-Sale Nutrition Information in Standard Food Outlets in 2011. At its meeting of 29 June 2018, the Forum agreed that further targeted consultation is to be undertaken to develop policy options that aim to improve and strengthen fast food menu labelling in Australia. A broader range of stakeholders will be engaged in the next stage of consultation.   Source: Fast food labelling

FSANZ Notifications—

Application A1129 – Monk Fruit Extract as a Food Additive: ​The purpose of the Application is to permit monk fruit extract as a food additive, specifically as an intense sweetener.   Source: Monk fruit sweetener

Application A1144 – Re-categorising Coconut Milk for Food Additive Permissions: The purpose of the Application is to consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages.   Source: Coconut milk

Application A1146 – Thermolysin (Protease) as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of thermolysin (protease) from Anoxybacillus caldiproteolyticus as a processing aid in protein, dairy, egg, meat and fish processing and flavour production.   Source: Processing aid

Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid.   Source: B-Galctosidase

Application A1153 – Endo xylanase from T. reesei as a Processing Aid: The purpose of the Application is to include a genetically modified strain of Trichoderma reesei as a permitted source for Endo-1,4 (3) - ß -xylanase (E.C.   Source:  E-xylanase

Application A1154 – Food derived from insect-protected cotton line MON88702: The purpose of the Application is to seek approval for food derived from a genetically-modified insect-protected cotton line, MON88702   Source: GM cotton food

Application A1157 – Enzymatic production of Rebaudioside M: The purpose of this Application is to seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method.   Source: Rebaudioside enzyme

Application A1158 – Rosemary extract as a food additive: The purpose of this Application is to seek approval to permit the use of rosemary extract as a food additive (antioxidant).   Source: Rosemary antioxidant

Application A1168–Glucoamylase from GM Aspergillus niger as a Processing Aid (Enzyme): ​​​The purpose of the Application is to permit the use of glucoamylase produced from a genetically modified strain of Aspergillus niger as a Processing Aid.   Source: GM aspergillus

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 food

Australian (NSW) Food Authority RecallsSource: Current recalls

Frozen Vegetable Product Recalls: Contain a ‘particularly dangerous strain’ of Listeria monocytogenes     (Full list: Frozen food recall )

Woombye Cheeses: due to microbial (high E.coli count) contamination

Gary Gumball (Ice cream): due to the potential presence of foreign matter (glass)

Rafferty’s Garden Organic Baby Rice Cereal: due to incorrect packaging information and the presence of an undeclared allergen (gluten / oats)

Lactose Free Whole Milk Powder: due to the presence of foreign matter (metal)

White Mill Pancake Shake: due to the presence of an undeclared allergen (egg)

Lotus Certified Organic Millet Meal: due to the presence of an undeclared allergen (gluten).

Food Allergen Portal

Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For this reason there are laws in place, for example mandatory labelling to help people who have a food allergy avoid food allergens. Many sectors in the community also have a role in assisting in managing food allergies including the food industry, health professionals, and schools. This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors.   Source: Food allergen portal

July 2018 Failing Food Report

The Department of Agriculture and Water Resources targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at the rate of 100 per cent until a history of food safety compliance is established. When an emerging human health and safety hazard is identified in food, the department may temporarily increase monitoring and testing. This report details food that was found to fail under the Imported Food Inspection Scheme during the month of July. Among the pathogenic organisms detected in these imported foods were, Salmonella, Bacillus cereus and E. coli as well as the toxins Aflatoxin, Histamine, caffeine, betel nut and more.   Source: July Failing foods


To Be or Not To Be—‘Natural’. What’s in a Name?

A naturally-occurring chemical is one of the following: Either, an unprocessed chemical occurring in a natural environment — chemicals obtained from plants, microorganisms, the earth, sea or animals without any processing at all, for example blood and milk from animals, minerals, ores, crude oil, coal and natural gas obtained without any processing; OR, a chemical occurring in a natural environment that is extracted using a process that does not cause a chemical change in the substance — this refers to chemicals that occur in nature but which have been extracted using certain processes without changing their chemical composition. If introducers and suppliers extract a chemical by some other means, such as steam distillation or solvent extraction, it will not be a naturally-occurring chemical.    Source: Natural chemicals (See also: Examples of naturally occurring chemicals)

Details at the bottom of this newsletter.


Chinese Millenials Key Demographic for Aussie Supplements

Australian supplement firms should target Chinese millennials if they want to maximise their growth opportunities in the country, the founder and president of the Australia-China SME Association has argued.    Source: Cheryl Tay, Nutraingredients-Asia Marketing in China


Quote for the month:

“The entry point for desktop internet is the search bar. The entry point for the mobile internet is the QR code”   WeChat founder, Allen Zhang



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TGA Launches New Advertising Hub and Online Complaints Form

Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1 July 2018, the Therapeutic Goods Administration launched a web hub bringing together news and information about the regulation of therapeutic goods advertising. This online resource contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting unfair or misleading advertising and submitting enquiries. The new complaint form makes it easy for anyone to lodge complaints about advertisements for therapeutic goods. The TGA is now the sole body for handling complaints about medicine and medical device advertisements aimed at the public, with new sanctions and penalties for advertisers who do not comply with regulations. Consumers can use the hub to educate themselves on the rules that protect them against unfair or misleading ads for therapeutic goods. Fact sheets such as "The top 10 things to look out for in medicine advertisements" explain the controls in place to protect the health and safety of consumers. Advertisers can learn how to meet the requirements of a compliant advertisement through e-learning modules on the hub. The first module on the basics of therapeutic goods advertising regulation is now available, with future modules planned for the coming months. Advertisers can also check whether a particular therapeutic good can be advertised to the public by using a simple online decision tool.   Source: TGA advertising hub (You can also choose to attend one of our training courses specific to advertising:

TGA Provides Medicine Labelling Guidance

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they're used. In recognition of this, medicine label requirements are specified in two separate labelling Orders: Therapeutic Goods Order No. 91 (prescription), and, Therapeutic Goods Order No. 92 (non-prescription). Transition period ends 1 September 2020.   Source: Medicine labelling (RFA also offers training courses on labelling )

TGA Changeover to Therapeutic Goods Advertising Code 2018

The following information is provided for advertisers to explain what will happen in the changeover from the 2015 Code to the 2018 Code. The 2018 Code takes effect from 1 January 2019. On this date, the 2015 Code will be repealed. However, the 2015 Code will still be relevant in some situations. Delaying the date for when the 2018 Code takes effect allows advertisers time to familiarise themselves with it and to bring existing advertising material into compliance. The delay will also allow advertisers to undertake the training and education offered by the TGA.   Source: Advertising code .   Editor’s Note: See the latest updates in two most recent TGA presentations--Code update

TGA Advises on the Future Regulation of Low Risk Products

When the Australian Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applying to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products, over 1,000 submissions were received in response. The proposed options for reform spanned from retaining the status quo to exclusion or exemption from the therapeutic goods regulatory framework. Following analysis of consultation responses, a range of reform activities have been endorsed by Government. It has been decided that there will be no changes concerning the regulation of water soluble vitamins / minerals, nor sunscreens. However there are changes affecting tampons and menstrual caps, nappy rash creams, and hard-surface disinfectants. Anti-perspirants and ear-candles will become exempt from regulation under this code.   Source: Low-risk future

Australia Leads the Way in Regulatory Standards for Complementary Medicines

Mr Carl Gibson, CEO of Complementary Medicines Australia (CMA) syas that Australia leads the way in regulatory standards for complementary medicines. “Whilst criticism can be healthy, increasingly our industry has become the target of irresponsible and ill-informed commentary that appears to stem from a misunderstanding of the existing stringent regulatory standards that apply to complementary medicines in Australia and the recent regulatory changes that have strengthened regulatory controls even further.” “The fact remains that Australian complementary medicines industry operates within one of the most tightly regulated systems in the world, where products are manufactured to a pharmaceutical standard under Good Manufacturing Practice (GMP), and strict safety and quality regulations are enforced by the Department of Health’s Therapeutic Goods Administration (TGA).” “This regulatory approach demands that manufacturers are licensed and inspected and follow the highest standard of GMP, not only for products for the Australian market but also for those exported overseas.”  Source: CMA media release Vitamins in Australia

TGA's Compliance Review Of Sunscreens

Consumer information - In May 2017, the Therapeutic Goods Administration published the laboratory testing results of 31 commonly used sunscreens. These included lotions, creams and aerosol sprays sourced from Australian pharmacies and supermarkets. All of the products tested contained the levels of active ingredients specified on their labels. Since May, the TGA has completed a desktop review of 94 listed sunscreen products, examining the quality, safety and efficacy of sunscreens on the Australian market. TGA found no compliance deficiencies in relation to quality, safety and efficacy in every-day use of these products. (Background: Last Summer there were many media reports of consumers suffering significant sunburn even after using authorised sunscreens in Australia. Consumers are reminded that suncreens will under-perfrom unless the following advice is followed: Apply sunscreen liberally (at least 1 teaspoon/5 ml) to each area (arm, leg, back, etc.) for full coverage and effectiveness; Re-apply sunscreen regularly (every two hours), especially after swimming or towelling (water activities or activities that may cause perspiration require more frequent application); Sunscreen products do not block 100% of UV radiation. You will become sunburnt if your skin is exposed to the sun for extended periods).    Source: Sunscreen effectiveness

Submissions Received: ‘Options For The Implementation Of A Claimer For Efficacy Assessed Non-Prescription Medicines’

Between 10 May and 21 June 2018, the TGA sought comments from interested parties on the review of Consultation: Options for the implementation of a claimer for efficacy assessed non-prescription medicines. All submissions that gave permission to be published on the TGA website are available online in PDF format. The outcomes of this consultation will be published on the TGA website in due course.   Source: TGA submissions

New Zealand Supplement Rules: New Members' Bill Proposes Raft of New Regulations to Replace 1980s Laws

The long-running saga of proposed new regulations for New Zealand's supplement industry has taken another turn, with a new Members' Bill being laid out in parliament detailing a whole new set of proposals.   Source: Gary Scattergood, Nutra Ingredients-Asia NZ rules

TGA Safety Advisories—   Source:

Need for Seal tablets: the tablets contain the undeclared substance sildenafil.

Gold Maka tablets: the tablets contain the undeclared substance sildenafil

One Night Lover tablets: the tablets contain the undeclared substance sildenafil


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