Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

TGA Advises on Updating Medicine Ingredient Names

In order to bring the naming of medicine ingredients in line with international standards, the TGA instituted a programme in 2017 to harmonise Australia’s ingredient nomenclature with other jurisdictions. All medicines released for supply must carry the updated ingredient names by the time the transition period for updating medicine names ends on 30 April 2020. Sponsors need to be aware of which medicines will be affected by these changes and to ensure that all labelling and promotional materials are compliant by 1 May 2020. A complete list of affected ingredients can be read here Ingredient names affected .   Source: Updating ingredient names

Changes to Permissible Ingredients

As mentioned in last month’s edition of this newsletter the TGA has issued an updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019. As well as the changes to the 19 existing and 4 new ingredients referred to in that story, a number of changes to specific further ingredients should also be noted. Sponsors of products containing any of the following ingredients should take note: ingredients containing arbutin (arbutin will need to be disclosed as a component with associated specific requirements), poliglusam (maximum daily dosage of 1750 mg will apply), cysteine (its salts and cystine), caffeine (100 mg per dosage unit and 600mg total per day), methyl salicylate (not greater than 25% concentration), and menthol (oral, not more than 1g per day; topical, must not deliver more than 25% total menthol when administered according to the directions for use, label warnings required)   Source: Permissible ingredient update

TGA Updates Guidance on Medicines Labelling (TGO 91 & TGO 92)

Medicine label requirements are specified in two separate labelling Orders depending on whether they are for labels on prescription medicines (TGO 91) or for non-prescription medicines (TGO 92). These new Orders come with a transition period that ends on 31st August 2020. Listed medicines that are released for supply on or after 1 September 2020 must be fully compliant with TGO 92.    Source: TGO 92 label requirements

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in previous month’s newsletters. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently  $840 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA Regulatory Affairs provide training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

What Does 'TGA Assessed' Mean on my Medicine Label?

Regular readers of this newsletter will know that the “TGA assessed” claimer is now available for implementation. This new claimer indicates that a medicine has been assessed by the TGA for efficacy related to its indications. This claim is only applicable to ‘assessed listed’ and ‘registered’ complementary medicines, and not to those complementary medicines that have not undergone pre-market assessment. A sponsor seeking to use the TGA assessed claim on its label must seek pre-approval by providing a medicine label with the TGA assessed claim. For an existing registered complementary medicine, sponsors must have a new label assessed by the TGA before the claim can be used.    Source: 'TGA Assessed' fact sheet

TGA Rules on Advertising Health Products

The TGA reminds suppliers that the Therapeutic Goods Advertising Code (No.2) 2018 prevents advertisers from claiming that therapeutic goods (including medicines and medical devices) are safe, that their use cannot cause harm, or that they have no side-effects. Safety claims in advertising may be explicit or implicit - both are prohibited. The therapeutic goods legislation specifically prohibits the advertising of therapeutic goods as 'safe' or having 'no side effects', even for specific patient populations or particular dosages. This requirement applies even if suppliers think there is evidence to substantiate such a claim. Care must also be taken to ensure that using the term ‘natural’ does not imply that a product is safe, safer than other products or that excessive use cannot cause harm. Care is also needed to ensure that comparisons with other therapeutic goods do not imply that the other therapeutic goods are harmful or ineffective. For example, use of the word 'organic' may be acceptable if substantiated. However, it is not acceptable to compare the 'organic' product with non-organic products in a way that states or implies that the non-organic products could harm the consumer.    Source: Rules for advertising

TGA Issues Guidance on Use of Restricted Representations

The term ‘restricted representation’ refers to when a “serious form of disease, condition, ailment or defect” cannot be referred to in advertising on any medicine in any context, unless specifically approved, or permitted for use by the TGA prior to use. Generally, if an advertiser wishes to make reference to a restricted representation in advertising, including on labels, then a formal application to the Delegate of the Secretary is required. However, this guidance makes clear that applications to make restricted representations/reference to serious diseases or conditions are not required where the reference is contained or required in a mandatory label warning, contraindication or advisory statement.     Source: Restricted representations

TGA Provides e-Learning Modules on Permitted Indications for Listed Medicines

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. This set of three e-learning modules provide information on the transition arrangements for permitted indications and instructions on how to create an application on the TGA Business Services portal to include permitted indications for listed medicines.    Source: e-Learning modules for permitted indications

TGA Issues Compositional Guidelines for Resveratrol and Calcified Lithothamnion species

A TGA compositional guideline is a summary of descriptions, tests and appropriate acceptance criteria that define the characteristics and specify the composition of an ingredient permitted for use in listed medicines. The TGA have recently published compositional guidelines for Resveratrol (an ingredient used widely in complementary medicines and manufactured by bacterial fermentation of genetically modified baker’s yeast - Cerevisiae), and also for Lithothamnion species (AAN) and Calcified Lithothamnion tophiforme (AAN). ‘Lithothamnion spp.’ is derived from skeletal deposits of Lithothamnion spp (L. corallioides, L. tophiforme) sourced from the Atlantic Ocean. ‘Calcified Lithothamnion tophiforme', is the skeletal deposits of Lithothamnion tophiforme sourced from Arnarfjordur fjord in Iceland.     Sources: Resveratrol & Lithothamnion-species

TGA Issues Compositional Guideline for Streptococcus salivarius M18

Streptococcus salivarius is a gram-positive bacterium found as part of the normal human oral microflora, predominately colonising the oral cavity (teeth, tongue). BLIS M18™ is a freeze-dried culture of Streptococcus salivarius M18 (NLT 1 x 1011 CFU/g) in a protective matrix of food-grade maltodextrin, trehalose dihydrate and lactitol. S. salivarius can be cultivated and used as an ingredient in listed medicines. The compositional guideline lists the appearance, particle size, morphology, biochemical profile and virulence of this organism.    Source: Compositional guideline for s. salivarius

TGA Issues Guidance on the Regulation of Exempt Disinfectants in Australia

The regulation of disinfectants depends on the claims made by the product on labels, packaging and product information leaflets. The following guidance relates to products that meet the definition of an exempt disinfectant. Exempt disinfectants are not required to be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, but must still meet all regulatory requirements including The ‘Poisons Standard’ (The SUSMP) and The Australian Dangerous Goods Code.    Source: Exempt disinfectants guidance . (Please see also related articles concerning ‘Listed Disinfectants’ which are disinfectants that make specific claims and must be included in the ARTG.     Sources: Listed disinfectants guidance and Specific and non-specific disinfectant claims )

TGA Changes Rules Concerning Nappy Rash Products

Changes will be made to the regulation of nappy rash products commencing 1st January 2020. These changes will apply to listed medicines and Class I medical devices which are indicated for the relief of nappy rash symptoms via a barrier effect only. The exemption will not apply to nappy rash preparations that are also indicated for other skin conditions, such as psoriasis, eczema or dermatitis. If relief of nappy rash symptoms are provided via another mechanism of action (e.g. the product has a physiological effect) it would not be exempt. The nappy rash products that are declared exempt will still be subject to any applicable standards for product quality, labelling and packaging, and with advertising requirements. They will also be subject to TGA recall provisions.    Source: Nappy-rash changes

TGA Safety Advisories- Source: https://www.tga.gov.au/current-year-alerts

GoLean Detox capsules: contain the undeclared substances sibutramine and phenolphthalein.

Slim Perfect Legs + High Fiber capsules: contain the undeclared substance sibutramine.

TGA Recall: Neutrogena Visibly Clear Light Therapy Acne Mask and Activator

Consumers and health professionals are advised that Johnson & Johnson Pacific, in consultation with the TGA, is recalling Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. The device is also being withdrawn from the market. This product is a reusable non-sterile device, intended for home-use to treat mild to moderate acne on the face. The device comprises an ‘acne face mask’ and detachable corded ‘activator’. It delivers a combination of red and blue light via light-emitting diodes (LEDs). It has been identified that, for a small subset of potentially susceptible people, repeated exposure may cause varying degrees of retinal damage that could be irreversible and could accelerate peripheral vision impairment or loss. Other potential adverse events that may be associated with use of this device are eye pain, eye discomfort, eye irritation, tearing, blinding, blurring of vision, seeing spots/flashes and other changes in vision (for example vision colour).    Source: Light-mask fail

Caffeine Supplement Death Triggers Health Warning

The Australian government has ordered an urgent review of the open sale of pure caffeine powder following the freak overdose death of a young man. Lachlan Foote collapsed on the bathroom floor of his family’s Blackheath home and never regained consciousness after making himself a protein drink that contained powdered caffeine. Just one teaspoon of the extremely potent but legal and widely available substance — popular among fitness enthusiasts — is enough to kill.    Source: Shannon Molloy, News.com.au Caffeine powder fatality

TGA Confirms that it has no Role in Regulating Fluoridated Drinking Water in Australia

The Therapeutic Goods Administration has clarified that state and territory governments will continue to be responsible for regulating fluoride in reticulated drinking water ('tap water'). Legislative amendments made on 11 July 2019 put an end to any uncertainties about regulatory responsibility by explicitly excluding fluoridated drinking water from the scope of Australia's therapeutic goods legislation.    Source: Fluoridated drinking water

NICM Confirms its Place as a World-Leader in Research

The National Institute of Complementary Medicine (NICM) Health Research Unit, run out of Western Sydney University, is Australia’s leader in integrative and complementary medicine research and policy. The Australian Research Council’s (ARC) latest ‘Excellence in Research for Australia’ (ERA) report confirms, for the third consecutive triennium of rating, NICM as a world-leading research institution, rated the highest possible - ERA 5. The NICM Director, Professor Alan Bensoussan, welcomed the report’s confirmation of NICM’s world-leading research and reputation for excellence. “NICM’s team of interdisciplinary world-class researchers, are included in the world’s best and brightest in the field of complementary medicine. We are thrilled to be recognised for our research in this field, and for our very significant contribution to an additional ERA 5 ranking in Pharmacology at Western Sydney University. We are the only research institute in complementary medicine that has achieved consistent ERA 5 rating since evaluation commenced in 2012 for our field of research”.    Source: NICM a world leader

Associations Forum Declares CMA Winner of the ‘2019 Association of the Year’

Established in 2004, Associations Forum is a commercial, member-based network of 500 associations, charities, clubs, societies and other not-for-profit organisations. The mission of Associations Forum is 'bringing associations together to boost performance', by assisting associations and charities in governance, operations, membership and finances. RFA Regulatory Affairs was very glad to hear that this year’s winner was awarded to the peak body, Complementary Medicines Australia (CMA), working in the complementary medicine space. Congratulations to Carl Gibson and all of the team at CMA for receiving this deserved recognition for all of the excellent work carried out on behalf of this sector. Well done!    Associations Forum website

ConsumerLab Tests Find 19% of B Vitamin Supplements Supplied in the USA Failed Quality Standard

USA based company ConsumerLab LLC. purchased and tested B complexes and individual B vitamins. The tests revealed that five of the 26 supplements selected for testing contained as little as 53% to as much as 223% of the listed amounts of certain B vitamins. This review also summarises the clinical evidence for B vitamin supplementation for uses such as helping to prevent birth defects, lowering cholesterol levels, and slowing age-related cognitive decline. The report goes on to explain important differences among forms of B vitamins, such as those of niacin (nicotinic acid, niacinamide, and inositol hexanicotinate), folate (natural folate, folic acid, and L-5-methyltetrahydrofolate), and B-12 (methylcobalamin and cyanocobalamin).    Source: Nutraceuticals World B-vitamin fails

Civil Penalties Ordered Against Peptide Clinics Pty Ltd for Advertising Breaches

Peptide Clinics Australia (Peptide Clinics Pty Ltd) has been ordered by the Federal Court to pay $10 million to the Commonwealth for breaches of the mandatory rules for advertising of medicines, including the ban on advertising prescription-only medicines to the public. The significant financial penalties serve as a reminder to businesses that prescription-only medicines cannot be advertised to the public without significant consequences. This includes being issued with infringement notices, being charged with criminal offences or having civil court proceedings commenced against them.    Source: Peptide clinics fail

USA Congressional Committee Discusses How to Legalize Cannabis

In a first-of-its-kind hearing, a key congressional committee met recently to discuss how to finally put an end to federal cannabis prohibition. Titled “Marijuana Laws in America: Racial Justice and the Need for Reform,” it was the latest indication of just how far Congress has come on cannabis reform after decades of intransigence.     Source: Cannabis law reform

 

Everything You Ever Wanted to Know About Sunscreens (but were too afraid to ask)

This article explains what to look for when choosing a sunscreen, and steps you can take to maximise your sun protection. If you live in Australia, your risk of skin cancer is high. Regular use of sunscreen should be a habit for every Australian.   Source: Sunscreen sense

TGA Issues Guidance on Sunscreen Manufacturing

In Australia, many sunscreens are regulated as therapeutic goods because of their important role addressing public health issues. Sunscreens that are regulated as therapeutic goods under the Therapeutic Goods Act 1989 are referred to as 'therapeutic sunscreens'. Included in this category are: primary sunscreens with SPF 4 or more; secondary sunscreens - except those regulated as cosmetics; primary or secondary sunscreens with SPF 4 or more that contain an insect repellent; and, sunscreens with SPF less than 4 that are exempt from being listed under the Therapeutic Goods Act 1989 because they come within an exemption.    Source: Manufacturing sunscreens

NICNAS Announces New Fees Effective From 1 August 2019

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the use of all industrial chemicals including those used in cosmetics. The full costs of administering NICNAS are recovered through fees and charges paid by industrial chemical importers and manufacturers. New fees starting on 1st August 2019 can be found here: NICNAS new fees

Reminder: NICNAS to be Replaced by AICIS

Far reaching legislative changes are underway in relation to the regulation of industrial chemicals in Australia. A new regulatory scheme, the Australian Industrial Chemicals Introduction Scheme (AICIS), is being implemented. AICIS will replace and simplify the current National Industrial Chemicals Notification and Assessment Scheme (NICNAS). AICIS will commence on 1 July 2020. On the same date, a ban will commence on the use of new animal test data for ingredients which are only used in cosmetics.   Source: AICIS to replace NICNAS

Court Finds Kimberly-Clark Did Not Mislead Consumers with 'Flushable' Claims

The Australian Competition & Consumer Commission (ACCC) had alleged that in describing its products as ‘flushable’ on product packaging and its website, Kimberly-Clark had misled consumers about the suitability of its wipes to be flushed down the toilet. However, the Court found that Kimberly-Clark’s claims were not false or misleading. The Court ruled there was insufficient evidence to show that Kleenex Cottonelle ‘flushable’ wipes in this case, as opposed to ‘wipes’ products more broadly, had contributed to the problems in municipal sewerage systems. The Court noted that Kimberly-Clark did not expect its wipes to fully disperse in the sewerage system and that Kimberly Clark’s wipes had inferior properties of breakdown and dispersion than toilet paper. The Court noted this was consistent with a conclusion the wipes posed a risk of harm to the sewerage system but there was insufficient evidence this harm actually occurred, except in limited circumstances.   Source: Flushable wipes tested

Unilever All in a Sweat Over New Player's 'Clinical' Efficacy Claims

The Federal Court recently examined whether representations alleged by Unilever to have been made by Beiersdorf about Beiersdorf’s Nivea ‘Stress Protect Clinical Strength’ deodorant were false, misleading or deceptive under the Australian Consumer Law. Whilst Unilever was ultimately unsuccessful, the case provides useful guidance on the use of the term ‘clinical’ as a product descriptor and what sort of scientific substantiation is required to support a ‘clinical’ claim. Unilever has appealed the decision!    Source: Laura Hartley & Sarah Best, Addison’s Lawyers 'Clinical' efficacy test

 

TGA Advises on Using 'Natural' Claims When Advertising to the Public

The TGA has released guidance on the use of 'natural' and related claims when advertising medicines and medical devices to the public. It is recognised that If the advertising does not explain what the term 'natural' (as well as related claims such as 'naturally occurring', 'sourced from nature' and 'naturally derived') means in relation to the particular product being promoted, interpretations by consumers will vary, especially if 'natural' is used as a stand-alone claim. When advertisers use a 'natural' claim, they will either have to provide sufficient information to explain the claim or use it in accordance with the definitions set out in the TGA's guidance. Specific information for consumers on the use of 'natural' claims in relation to medicines and medical devices will be published in coming weeks. Stay tuned!    Source: 'Natural' claim    (Please also read the TGA’s humorous take on this topic, Bee Aware: what’s the buzz on natural claims?)

TGA Provides Summary of Fees and Charges Effective from 1 July 2019

The Therapeutic Goods Administration is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A fee is charged for a service, such as a product evaluation. A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year. This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation.     Source: TGA fees & charges

Changes to Ingredient Names: End Of Transition Period - Are You Ready?

The transition period for updating medicine ingredient names ends on 30 April 2020. This means that from 1 May 2020 all medicines released for supply in Australia must use the new ingredient names. The four year transition period has provided sufficient time for sponsors to move over to using the new names. With less than 12 months left, consumers and health professionals are expecting to see the new ingredient names on medicine labels and relevant documentation. Questions that listed medicine suppliers need to ask themselves should be: “Do I have a medicine that contains an ingredient on the affected ingredients list?”; “If the ingredient is used as an active ingredient, is the right ingredient name displayed on my medicine labels?”; “If the ingredient is used as an excipient and I include the names of excipients on my labels, is the right ingredient name displayed?”; “If the medicine has an associated product information or consumer medicine information document, is the right ingredient name used in those documents?”; and “If I have advertising materials for my medicine that include ingredient names, is the right ingredient name used in those materials?”.    Source: Ingredient naming deadline

TGA Answers FAQs on Issues Raised by Industry in Relation to Permitted Indications for Listed Medicines

As regular readers of this newsletter are now well aware, the TGA has revised the guidance related to indications for listed complementary medicines in Australia. 'Indications' are statements that describe the specific therapeutic use for a medicine, i.e. a medicine's claimed purpose or health benefit. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. Since this new standard has been implemented there have been many questions raised by stakeholders and these are addressed here: Permitted indications FAQs . Also, the TGA has announced the introduction of the ability to use the "TGA Assessed" claimer for complementary medicines that are either ‘registered’ or ‘listed assessed’. Information regarding ‘TGA assessed’ claims for assessed listed and registered complementary medicines can be read here: 'TGA assessed' claims  

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 has added 4 new ingredient entries and changed 19 existing ingredient entries to make requirements clearer and less restrictive. Two of the new active ingredients are only available with written authorisation provided by DSM Nutritional Products Pty Ltd (until 30 June 2021). There is also an expansion of the permissible concentration of menthol for dermal application to 25%.    Source: Permissible ingredient update

TGA Seizes Bloodroot Salve (Black Salve) and Bloodroot Capsules on the Gold Coast

The Therapeutic Goods Administration, in conjunction with Queensland Police Services and the Australian Taxation Office, executed a search warrant at a business premises on the Gold Coast, Queensland. During the search, the TGA seized various items. This included 27 jars of suspected Bloodroot Salve (commonly known as Black Salve), 84 bottles of product suspected to be Triple Strength Bloodroot Capsules and 30 bottles of suspected Double Strength Bloodroot Capsules. The operation was part of an investigation into the alleged importation, advertising and unauthorised supply of unapproved therapeutic goods, including scheduled medicines. A number of items and devices were also uncovered and seized, allegedly relating to manufacturing of therapeutic goods. Enquiries are still underway and further action will be dependent upon the outcome of investigations. (Bloodroot Salve, more commonly known as Black Salve, is a topical paste. It is commonly classified as an 'escharotic', as it is corrosive and can destroy skin tissue, causing disfigurement. Application can result in dead skin tissue and a thick dark scar. Bloodroot capsules may contain several of the same ingredients as Black Salve).    Source: Bloodroot salve raid

TGA Seizes SARMs and Nootropics Using Search Warrants

The Therapeutic Goods Administration (TGA) executed four search warrants connected to a business operating in the Sutherland Shire, Sydney. This was undertaken in conjunction with NSW Police, the Australian Federal Police (AFP), the Australian Taxation Office (ATO) and NSW Health. During the search, various items were seized. These items allegedly include raw materials and finished Selective Androgen Receptor Modulators (SARMs), and Nootropic products. The products are not included in the Australian Register of Therapeutic Goods (ARTG) and therefore cannot be supplied in Australia. The operation was part of an investigation into the alleged importation, advertising and supply of unapproved therapeutic goods, including scheduled medicines.   Source: TGA SARM bust    (Please also see related story (copyright) by Cheryl Tay, NutraIngredients-Asia SARMs harm )

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Receives NutraIngredients-USA Editors Award for Industry Initiative of the Year

RFA Regulatory Affairs congratulates the American Botanical Council - American Herbal Pharmacopoeia – and the National Center for Natural Products Research on being awarded the 2019 Industry Initiative of the Year for their Botanical Adulteration Prevention Program. This newsletter has repeatedly run stories on this excellent industry initiative and we are delighted that this group has been recognised within the industry. The BAPP focuses on educating herb and natural product industry members to identify unethical sellers of adulterated and fraudulent raw botanical materials, botanical extracts, and essential oils. This is achieved via the publication of 50 (to date) credible and authoritative peer-reviewed documents; plus interviews with trade media; speeches at industry, scientific and professional conferences; and direct consultation with members of the industry.    Source: BAPP award

Aloe Vera Bulletin Published by Botanical Adulterants Prevention Program

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announces the publication of a new Botanical Adulterants Prevention Bulletin (BAPB) on aloe vera (Aloe vera) leaf gel- and juice-derived ingredients. This new publication documents adulteration of aloe vera leaf gel and juice with undeclared maltodextrin and ingredients from other Aloe species.    Source: Aloe vera adulteration

 

RFA Provides Comprehensive Training In Regulatory Affairs - Late Winter Special! 20% discount on September and October bookings

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website www.rfaregulatoryaffairs.com/training-courses . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from within our Glebe, Sydney office, at your office or remotely via Skype. We are offering a special 20% discount on all courses if you enrol in the month of September or October. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on these training courses at this discount offer. See you in the classroom!

Top Four Dietary Supplement Trends in New Zealand Revealed by National Industry Organisation

Natural Health Products NZ has identified four trends driving dietary supplement market growth in the country, ranging from emerging vitamins and minerals, the Ayurveda medicine revival, gut health and the incorporation of hemp seeds.    Source: (Copyright) Tingmin Koe, NutraIngredients-Asia NZ supplement trends

NPS MedicineWise Surveys Complementary Medicine Use in Australia

NPS MedicineWise is an independent, not-for-profit, evidence-based, consumer-centred organisation that was established in 1998 as the National Prescribing Service (NPS) Limited. According to a Galaxy survey conducted by NPS MedicineWise, only 20% of Australians never take a complementary medicine and around 8 million Australians take two or more forms of complementary medicines in a typical week. The same survey found that of Australians taking complementary medicines every day, the majority (59%) also take prescription medicine daily.     Source: CM use in Oz

National Measurements Survey

The National Measurement Institute (NMI) - Australia's peak measurement body, responsible for coordinating the national system of units and measurement standards, is conducting a survey. In 2015/2016, a review found Australia’s measurement legislation is very prescriptive and recommended updates be considered to simplify the regulatory framework. Ernst & Young (EY) has been engaged by the NMI to conduct analysis into the current measurement framework and they have created a survey to provide information to establish the regulatory burden to businesses as a result of measurement regulatory requirements. That survey can be undertaken here: NMI/EY survey

 

Quote for the month:

“Everything that can be counted doesn’t necessarily count. Everything that counts is not necessarily measurable” Albert Einstein

 

Calls for Health Star Ratings on Packaged Food to be Compulsory

The current use of ‘Health Star Ratings’ on packaged foods is not mandatory and is only being displayed on around 30 per cent of foods. Most of these products have scored at the upper end of the five-star scale and public health experts are concerned some producers are "gaming the system" by exploiting loopholes around sugar, salt and fat content. The federal government has commissioned an independent five year review into the health star ratings, which is due this month. There is concern that the dietary guidelines are skewed towards the interests of food companies. There have been calls for the algorithm to be improved in order to incorporate added sugars, increase penalties on salt content, and remove undue benefits from protein.    Source: Daniel McCulloch, Good Food Health star ratings

Sugary Cereals Targeted Under Health Star Proposal

Sugary breakfast cereals that seem healthy could lose up to 2.5 stars if the ministers reviewing the Health Star Rating system adopt a proposal to differentiate between naturally occurring sugars and added sugar. New modelling from consumer advocacy group Choice shows how the proposed change to the system's algorithm would penalise products such as Kelloggs' Nutri-Grain and Nestle's Milo cereal, while increasing ratings for "healthier" products that contain naturally occurring sugars, such as yoghurt and fruit.    Source: Jenny Noyes, SMH Sugars aint sugars

NSW Food Authority Publishes 50th Edition of Foodwise Publication

From humble beginnings as a printed newsletter in December 2005, The New South Wales’ Foodwise publication has evolved into an interactive digital information resource for the NSW food industry. The aim of Foodwise remains unchanged: communicating regularly and directly with readers to keep the local food industry partners informed about important issues across their sector.    Source: Foodwise

April 2019 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 latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of April. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, coagulase positive Staphylococci E coli, Bacillus cereus, and Salmonella, as well as the toxins chlorpyrifos and aflatoxin and many more.   Source: Latest failed foods

FSANZ Notifications—

Application A1163 - Food Irradiation definition of herbs and spices: The purpose of this Application is to vary Food Standard 1.5.3 Irradiation of Food to remove the reference to Schedule 22 in relation to the definition of Herbs and Spices.    Source: Herb & spice irradiation

Application A1164 – Pullulanase from Bacillus licheniformis as a processing aid (enzyme): ​​The purpose of this Application is to seek approval to permit the use of the enzyme Triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal-based products.    Source: Bacillus enzyme

Application A1169 - Alpha-glucosidase from Trichoderma reesei as a PA (enzyme): The purpose of this application is to consider whether to permit the use of Alpha-glucosidase enzyme from a recombinant strain of Trichoderma reesei as a processing aid.    Source: Alpha-glucosidase  

Application A1178 – Method AOAC 2017.16 as a new method of analysis for total dietary fibre: The purpose of this Application is the addition of a new total dietary fibre method, AOAC 2017.16, as a permitted method in Schedule 11 of the Australia and New Zealand Food Standards Code.    Source: Measuring dietary fibre

Application A1180 – Natural Glycolipids as a preservative in non-alcoholic beverages: The purpose of this application is to permit the use of long-chain glycolipids from Dacryopinax spathularia (Natural Glycolipids) as a preservative in non-alcoholic beverages.   Source: Natural glycolipid

Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm.   Source: Imazapyr

Legal: Australian Tariff Classification Update

What do baby wipes, vitamins, weight loss tablets and apple cider have in common? They have all been the subject of Australian legal decisions regarding their tariff classification. The relevance of the decisions goes beyond just the goods that are the subject of the decision, but extends to all importers for goods into Australia. The classification principles set out in the following cases need to be kept in mind no matter what the product. Some important take-home messages drawn from these examples are: if the term in dispute (e.g. ‘Food’) is an everyday item, the decision maker should not apply technical or strained meanings. The decision maker should apply their everyday understanding of the word; and, a product not clearly identifiable as food and consumed for a reason other than nutrition, may not be classified as a food.  This has significant impact for the health food industry.    Source: Hunt & Hunt Lawyers Legal definitions

Odd Spot: DNA Discovery Traces Most of the World's Macadamias Back to One Australian Tree

Queensland researchers are shocked to discover the global macadamia industry may have originated from nuts from a single tree or small number of trees, taken from Queensland to Hawaii in the 19th century. Given the lack of genetic diversity in the $3 billion crop, the race is on to preserve wild macadamia trees to improve traits like disease resistance, size and climate adaptability. Using DNA analysis from commercial macadamia orchards in Hawaii the macadamia ancestry could be traced all the way back to a tiny patch of wild trees which still exist on private property at Mooloo, near Gympie in south east Queensland.    Source: Jennifer Nichols, ABC News Macadamia origins

NZ Food Notice: Food for Export - Exemptions from Domestic Compositional Requirements No. 2 2019

The purpose of this Notice, issued by the New Zealand Department of Primary Industries, is to exempt food for export from certain requirements of the New Zealand standards where the importing country requirements differ. This includes, but is not limited to, exempting product from certain requirements of the Australia New Zealand Food Standards Code. This Food Notice came into force on 5 June 2019. This Notice should be read by operators of businesses that process or package food for export from New Zealand.     Source: NZ food export exemptions

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