Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

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

 

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

 

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

 

Your Questions About the New NICNAS Scheme Get Answered

As reported in May 2019 edition of this newsletter, there is now a new Australian industrial chemicals law – the Industrial Chemicals Act 2019. From 1 July 2020, NICNAS will be replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). This law also gives effect to the ban on the use of new animal test data for ingredients solely used in cosmetics. Please note that the ingredients in cosmetics are still regarded as industrial chemicals under the new scheme.     Source: AICIS Q&A

Delegate-only Decisions on Agricultural and Veterinary Chemicals may Affect Cosmetics

The latest version of the Poisons Standard (1 June 2019) indicates that the following two substances - N,N-dimethyloctanamide (CAS number 1118-92-9); and N,N-dimethyldecanamide (CAS number 14433-76-2), have gone from unscheduled to Schedule 6 Poisons, with no cut-off concentrations or exemptions from scheduling. This was a delegate-only decision that was not subject to a public consultation period. The substances were referred for scheduling by the APVMA, however the final decision applies to all uses of the substances, not just the AgVet use. Uses other than in AgVet products were identified as part of the scheduling consideration, including in coatings, industrial cleaning products, and processing aids. The European Chemicals Agency (ECHA) has also identified uses in polishes and waxes, washing & cleaning products including machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners. As such, manufacturers of cosmetic products may need to review their methods.   Source: Cosmetic ingredient rescheduling

ACCC Recalls Phytoplex Nourishing Skin Cream

The Australian Competition and Consumer Commission has recalled a cosmetic product supplied by Medline Two International Australia. Phytoplex Nourishing Skin Cream has been recalled due to the presence of certain species of mould, Penicillium chrysogenum and Penicillium flavigenum. The affected products are not likely to have any adverse effects in healthy individuals, but may pose a risk to people with weakened immune systems.    Source: Skin cream recall

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