Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Australian Labelling Requirements for Hazardous Chemicals in the Supply Chain

Chemicals manufactured or imported before 1 January 2017 can continue to be supplied without needing to meet the labelling requirements of the model Work Health and Safety Regulations. Safe Work Australia CEO Michelle Baxter said that Members agreed to this approach on 25 November 2016 in response to concerns raised by chemical suppliers. “This approach will ensure a smooth transition to the globally harmonised system, or GHS, and will avoid an unnecessary burden on suppliers to re-label existing chemical stock,” Ms Baxter explained.   Source:GHS WHS

ACCC Takes Action Over ‘Flushable’ Wipes

The Australian Competition and Consumer Commission is taking action against Kimberly-Clark and Pental alleging they made false or misleading representations and engaged in misleading and deceptive conduct in relation to “flushable” wipes. The ACCC alleges consumers were led to believe the products had similar characteristics to toilet paper, would break up or disintegrate in a time frame and manner similar to toilet paper, and were suitable to be flushed down the toilet — when this was not the case. The action follows a complaint by consumer group Choice, which singled out Kimberly-Clark’s Flushable Wipes for Kids for a “Shonky Award” in 2015.   Sources:Unflushable 'flushables' ; ACCC report

Department of Health Consults on Ban on Cosmetic Testing on Animals

During the 2016 Election campaign, the Australian Government committed to introduce a ban on animal testing of cosmetic products. The Government will ensure that the impact to business, trade and industry is taken into account and is minimised in the approach going forward, whilst continuing to maintain Australia’s high standards in protecting public health, worker safety and the environment. The Australian Government is in the initial stages of a phased consultation process to better understand and consider ideas, key issues and views in the development of the policy.   Source: Animal testing ban

ACCC Acts on ‘Oregano’ Misrepresentations

The Australian Competition and Consumer Commission has accepted court enforceable undertakings from ALDI Foods Pty Limited (Aldi) and Monde Nissin (Australia) Pty Ltd trading as Menora Foods (Menora) and resolved concerns with three other suppliers about the composition of their respective products labelled as ‘Oregano’. “By labelling their products as ‘Oregano’, both Aldi and Menora represented to consumers that their products contained only oregano. Test results provided to the ACCC identified the substantial presence of olive leaves in both Aldi and Menora’s oregano products,” ACCC Chairman Rod Sims said. “Suppliers of food products have an obligation to ensure ingredients of their products are accurately labelled and should be able to substantiate any representations made on the packaging that they approve,” Mr Sims said. The ACCC is continuing its investigation into other traders in relation to products labelled as oregano.   Source: Oregano fail 1

Spencers to Undertake Regular Testing of Oregano

During 2015, Spencers made representations on the front and back of the packaging of its oregano product that the product contained only oregano. These statements included the text ‘Oregano’ on the front of the package. Test results provided to the ACCC indicated the substantial presence of olive leaves in the Spencers’ ‘oregano’ product.   Source: Oregano fail 2

Need Training on Australia’s New Country of Origin Laws?

In order to prepare food companies for mandatory changes to Australia's Country of Origin Labelling Laws, FoodLegal has put together a comprehensive training package consisting of 8 video modules which will answer all your questions about the new laws. The first video is free and can be viewed here.   Source: Charles Fisher, Food Legal CoOL training

Australian Government Releases Latest Failing Food Report

This report details food that was found to fail under the Imported Food Inspection Scheme during the month of October. During this month, six foods were seized and destroyed due to the presence of pathogens (salmonella; listeria), and ten foods were confiscated due to the presence of various toxins or chemical residues. A further three foods were seized for non-compliance and remain on an increased-watch list. 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.   Source:Food fails

FSANZ Labelling Summary and Update

Food Standards Australia and New Zealand reports that in 2009, Australian and New Zealand food regulation ministers agreed to a comprehensive independent review of food labelling law and policy. An expert panel released their public report on 28 January 2011.The government response to this report was compiled and FSANZ went to work on a number of the recommendations.  Most of this work has now been completed.   Source: Food label review

FSANZ Provides Updated Advice on Imported Food

Food Standards Australia and New Zealand provides advice to the Department of Agriculture and Water Resources on whether foods pose a medium to high risk to public health. Check out this list of foods and reports on their potential for contamination.   Source: Imported food


FSANZ Notifications:

Application A1137 – Polysorbate 20 as a Food Additive

The purpose of the Application is to permit the use of polysorbate 20 as an emulsifier.   Source: Polysorbate 20

ApplicationA1134 – Increased Concentration of Plant Sterols in Breakfast Cereals

​The purpose of the Application is to seek approval for the exclusive use for 15 months of an increased concentration of plant sterols to be added to breakfast cereals under the novel food provisions.   Source: Plant sterols

Application A1123 – Isomalto-oligosaccharide as a Novel Food

The purpose of the Application is to permit  isomalto-oligosaccharide as a novel food for use as an alternative (lower calorie) sweetener and bulk filler in a ranger of general purpose and special purpose foods.   Source: Lo-cal sweetener

Application A1117 – Extension of Use of L-Cysteine as a Food Additive

The purpose of this Application is to extend the use of the food additive, L-cysteine, to limit enzymatic browning of cut avocado and banana and so extend the shelf life.   Source: L-cysteine

Application A1119 – Addition of Water to Facilitate Wine Fermentation 

The purpose of the Application is to permit the addition of water to dilute high sugar to aid fermentation in the production of wine, sparkling wine and fortified wine.   Source: Water into wine

Application A1128 – Food Derived from Reduced Acrylamide Potential & Browning Potato Line E12

The purpose of the Application is to seek approval for food derived from a genetically modified potato line, E12 which has reduced acrylamide potential and reduced browning (black spot).   Source: Potato blackspot

 NSW Food Authority Recall

The New South Wales Food Authority advises that Flush Fitness has recalled Lenny & Larry’s Complete Cookie Chocolate Chip due to the presence of an undeclared allergen (milk).   Source: Choc chip biscuits

Civil Group Accuses Anti-Sugar Lobby of ‘Post-Truth Virtue-Signalling’

A New Zealand taxpayers’ lobby group has accused those who are pushing for a tax on sugary drinks tax of “post-truth virtue-signalling”, citing evidence that many of their claims are demonstrably wrong.   Source: RJ Whitehead, Food navigator-Asia Sugar tax



Robert Forbes & Associates, T/A RFA Regulatory Affairs will be closing its office over the Christmas break on the following dates: Closed Friday 23rd December 2016 and reopening on Tuesday 3rd January 2017.


China Infant Formula Uncertainty Claims Another Victim: Murray Goulburn and Mead Johnson Deal Scrapped

Australian dairy co-operative Murray Goulburn and Mead Johnson Nutrition have scrapped an agreement signed in March to supply infant formula to Asia. (This story has particular interest to all food suppliers into China as The Middle Kingdom continues to modernise its food regulations).   Source: Gary Scattergood, Food-Navigator Asia China milk

Tracking the Mobile Millennial Shopper

In this fun and informative single page graphic you can find out all about the 21st Century shopper. Millennials are tech savvy and have never really known life without being online. Millennials know they have options and like to be in control of the shopping and buying process. They want to interact with your brand and expect you to understand them on an individual level, which is key to capturing this group’s epic $170 billion in purchasing power.   Sources: via Direct Selling Australia Millennial shopper profile ; Brand relevance

Consumers Willing to Pay 75% More for Known Ingredients: Survey

Branding ingredients has a mixed record of success but a survey reveals worldwide demand for recognisable ingredients.   Source: Louis Gore-Langton, Food Navigator Branding challenges


Quote for the month:

“If you’re not branding yourself, you can be sure that others are doing it for you”   Anon


TGA Issues Overview of Regulations for Medicinal Cannabis Products

This information about medicinal cannabis is for patients, health professionals, cultivators, manufacturers and researchers. The Australian Government is working towards facilitating access to medicinal cannabis products for patients with a medical condition for which there is evidence to support its use. Access to medicinal cannabis is highly regulated and is also affected by regulations of individual states and territories.   Sources: CBD regulations ; CBD access 


More news on medical cannabis can be found further into this newsletter



TGA Warns of TBS Planned Outage in December 2016

The Therapeutic Goods Administration is implementing a new financial system, SAP, which will go live in early December 2016. There will be a planned outage of the TGA Business Systems (TBS) portal from 17:00 (AEDST) 30 November 2016 to 09:00 (AEDST) 5 December 2016. If you need to submit an application at the start of December 2016, please ensure it is lodged before 5pm (AEDST) 30 November 2016.   Source: TGA planned outage


TGA Moves Ahead With Implementation of Complementary Medicine Reforms

The TGA is expecting to release public consultation papers to allow feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR). Because of the tight program to implement the reforms, public consultations will typically be open for a six week period. Targeted consultations will also be held with stakeholders to identify areas of regulatory burden that could be removed or business processes that could be streamlined to encourage innovation and improved access to products in the medicines sector. This forecast shows anticipated consultations for CMs commencing in the October 2016 - March 2017 period.   Source: CMA notice MMDR consultation ; TGA email list


TGA Consultation: The Regulatory Framework for Advertising Therapeutic Goods

The TGA is seeking comments from interested parties on the appropriate body or bodies for the handling of complaints under a new complaints-management system for therapeutic goods advertisements. This consultation closes on 21 December 2016.    Source:  TGA consultation


TGA Issues Safety Evaluation - Fennel oil

This Alert is to advise that the TGA has completed a safety evaluation of fennel oil, an ingredient used in a number of listed medicines. Fennel oil is currently available for use in listed medicines without restriction and is used as an active and/or excipient ingredient in various listed medicines. The TGA recently carried out a compliance review of a listed medicine containing fennel oil as an active ingredient intended for oral use in infants. During the review it was noted that several international regulatory agency reports state that fennel oil is contraindicated in children and adolescents under the age of 18.   Source: CMA Technical Alert Fennel oil safety


TGA Announces Delegates' Final Decisions on the Scheduling of Medicines and Poisons

Notice has been given of the delegates' final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision. Of most interest to the complementary medicines industry is the fate of Geraniol (and related compounds), and Isoeugenol.   Source: SUSMP final


TGA Answers: What is Pharmacovigilance?

The World Health Organization (WHO) describes pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This includes collection and evaluation of spontaneous case reports of suspected adverse events, as well as, pharmaco-epidemiology studies. Read this assessment from a regulators point of view:   Pharmacovigilance


TGA Issues List of Compositional Guidelines for Ingredients Permitted for Use in Listed Medicines.

In addition to the ingredients published in this list, suppliers should also refer to the default standards recognised in the Therapeutic Goods Act 1989, that is, the British Pharmacopoeia, United States Pharmacopoeia - National Formulary and the European Pharmacopoeia.  Source: Compositional guidelines  


TGA Presentation: Regulatory Reform - an Update

An update on TGA performance statistics, medicine labelling changes and the Review of Medicines and Medical Devices Regulation was given by John Skerritt, Deputy Secretary for Health Products Regulation, Commonwealth Department of Health at the recent ASMI Annual Conference. Topics covered included an update on TGA performance statistics, medicine labelling changes and the Review of Medicines and Medical Devices Regulation.   Source: TGA update


TGA Stakeholder Survey Results for 2016

This report provides a summary of findings from the 2016 Therapeutic Goods Administration stakeholder survey. An online survey was conducted amongst TGA stakeholders in July 2016. The survey provided opportunities for stakeholders to feedback to TGA across a range of service and activity areas. A total of 2,797 responses to the survey were received during the survey period, representing a response rate of 15%. Respondents represented a broad range of groupings, including strong representation from the medical products industry, community members, health professionals, academics and government stakeholders. Within these groupings, a broad range of participation was identified, including both large and small organisations, consumers, patients, carers, industry association representatives, advocates and sponsors.   Source: TGA survey


TGA Consultation: Designation of Australian Conformity Assessment Bodies for Medical Devices – Implementation

The Therapeutic Goods Administration is seeking comments from interested parties on the consultation paper for Designation of Australian conformity assessment bodies for medical devices. Interested parties should respond by close of business Wednesday, 11 January 2017.   Source: TGA consultation


TGA Recalls:

Health World Limited — Metagenics Nasoclear Nasal Spray 30mL

This recall effects a complementary medicine product that contains a saline solution scented with essential oils, having batch #80789, expiry date May 2018, and AUST L 166858. Some products from the affected batch may contain a pathogenic organism, Staphylococcus aureus, commonly known as golden staph.   Source: Nasoclear recall

Kaiser Pharmaceutical Traditional Chinese Medicine Products

Kaiser Pharmaceutical, in consultation with the TGA, is recalling one batch of each of three of their traditional Chinese medicine products. These products include certain Asarum species, which have been documented to contain aristolochic acid(s). There is no established safe exposure level to aristolochic acids, which have been linked to kidney problems and urinary tract cancers.   Source: Kaiser recall


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