Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Face Masks and Respirators that are Regulated by the TGA

This advice provides consumers, health professionals, and state and territory government officials with guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG). Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of disease between people, or are intended to be used in a healthcare environment, are medical devices and are regulated by the TGA. Face masks which are non-sterile and designed as safety or personal protective equipment (PPE) for use in the home or for recreational or occupational activities, and do not make healthcare claims, are excluded from regulation by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018.  However, labelling, or other information accompanying a face mask which identifies the mask as 'not for medical use' does not preclude it from being a 'medical device'.   Source: Face-mask regulation   (For a comprehensive review of all Coronavirus (COVID-19) information on medicines and medical devices, the TGA has published this helpful page: https://www.tga.gov.au/collection/covid-19 )

Complaints Handling for the Advertising of Therapeutic Goods to the Australian Public

As the rules related to the advertising of therapeutic goods continues to perplex many sponsors of medicines and medical devices, the Therapeutic Goods Administration has dedicated an extensive summary of supplier’s responsibilities and the reasoning these regulations. To protect the health and safety of Australian consumers, the advertising of therapeutic goods is subject to the 2018 Therapeutic Goods Advertising Code. Consumers are also protected from false or misleading advertising of products and services by the Competition and Consumer Act 2010, administered by the Australian Competition and Consumer Commission (ACCC), and associated state and territory laws. The ACCC also prioritises product safety issues which have the potential to cause serious harm to consumers.    Sources: Advertising complaints handling ; Advertising education

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

Review of the Therapeutic Goods Advertising Framework

The independent review of the advertising framework, led by Ms Rosemary Sinclair AM, has now concluded, with 22 recommendations which have all been accepted by the Australian Federal Government. The recommendations and outcomes are of relevance to all who engage with therapeutic goods advertising, including advertisers (sponsors, retailers, and other advertisers) and consumers. Key outcomes of this review indicate that the TGA will remain as the single complaints-handling body, which will introduce an updated complaints model and performance measures.    Source: Advertising framework review

Applications for New Substances in Listed Medicines

This guidance is for applicants requesting evaluation of a substance for use as an ingredient in listed medicines [AUST L listed medicines and AUST L(A) assessed listed medicines]. All listed medicines may only contain ingredients included in the Therapeutic Goods Permissible Ingredients Determination. Applications for evaluation of a substance to be used in listed medicines are categorised into four application levels (IN1, IN2, IN3 and IN4). Each application category has defined submission requirements. Less supporting information is required and shorter evaluation times apply to lower level applications.     Source: New substance application 

TGA Consultation: Permissible ingredients Changes Focus on Magnesium salts and Andrographis Herb

The purpose of this consultation is to provide an opportunity for consumers, health professionals, industry and other interested parties to comment on these proposed changes which are due to commence on 1 March 2021. Firstly, the TGA is proposing new restrictions for listed medicines, not indicated for laxative use, where those medicines contain higher doses of easily dissociable magnesium salts. Secondly, Andrographis paniculata is a herb commonly used in Indian and Chinese medicine and the TGA has advised that evidence indicates an association between Andrographis paniculata and loss of taste/taste disturbance, which may require further warnings on all labelling.    Source: Permissible ingredient consultation

Notice of Final Decisions to Amend the Current Poisons Standard

Of particular interest to sponsors of herbal products with ingredient herbs containing beta-arbutin (such as Bearberry - Arctostaphylos uva-ursi and Turnera diffusa – Damiana), is the introduction of acceptable limits for arbutin in listed medicines. Under the new changes, beta-arbutin has been classified as a Schedule 4 (Prescription Only) medicine and a Schedule 6 Poison EXCEPT when in oral preparations that are herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose. The change in Scheduling will be effective from 1 October 2020.   Source: Pages 14-15 of this PDF Arbutin re-scheduling

TGA and ACCC Continue Crackdown on Companies Seeking to Profit on COVID-19 ‘Therapies’

The TGA and the Australian Competition and Consumer Commission have been kept busy in recent months as they continue their prosecution of people and companies that use the Coronavirus pandemic in their product advertising:

Companies fined for alleged unlawful importation and advertising of covid-19 infrared thermometers

Australian companies, Beauty Group Pty Ltd and VeraTemp Pty Ltd for the alleged unlawful importation and advertising of medical devices in relation to COVID-19.   Source: COVID19 thermometer fines

A “quantum physics” based medical device that he claims prevents the transmission of the COVID-19 virus

Celebrity publicist Max Markson is under investigation by the health regulator.   Source: Quantum healing

Cleaning company fined for unlawful advertising of a disinfectant product in relation to COVID-19

Melbourne-based company Yarra Valley Cleaning Co Pty has been issued three infringement notices totalling $39,960 for unlawful advertising of a disinfectant product in relation to COVID-19.    Source: Disinfectant

Sydney company fined for unlawful importation of KN95 face masks in relation to COVID-19

Sydney-based company, GenesisCare Clinical CRO Pty Ltd, has been issued an infringement notice for $12,600 for the alleged unlawful importation of KN95 face masks in relation to COVID-19.   Source: Face-masks 1

Brisbane company fined for unlawful importation of medical face masks in relation to COVID-19

Brisbane-based company Cordelia International Pty Ltd has been issued an infringement notice for $13,320 for the alleged unlawful importation of medical face masks in relation to COVID-19.    Source: Face-masks 2

TGA Clarifies the Use of Disinfectants During Coronavirus Pandemic

This page provides guidance for new sponsors in relation to the supply, import, and export of disinfectant products. Some sponsors may be seeking to supply disinfectants for the first time during the COVID-19 pandemic. This page answers frequently asked questions for new sponsors in relation to the supply, import, and export of disinfectant products. This page provides consumers with answers to frequently asked questions in relation to disinfectants.

Adelaide Woman Fined $5,040 for Alleged Unlawful Importation of Cosmetic Injectables

The TGA, has issued two infringement notices totalling $5,040 to an Adelaide woman for the alleged unlawful importation of cosmetic injectables. As part of a TGA compliance initiative, the Australian Border Force detected and intercepted two separate deliveries of imported cosmetic medical devices. The woman allegedly imported medical devices that were not, at the time of the relevant importation, included in the Australian Register of Therapeutic Goods (ARTG) and those goods were neither exempt nor excluded from the operation of the Therapeutic Goods Act 1989 (the Act). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported and supplied in Australia.    Source: Cosmetic import fine    (See also related background information regarding TGA penalties and how they are calculated and administered: TGA infringement notices )

Product Recall - BioCeuticals Vitamin D3 Drops Forte Liquid 20mL

Consumers and health professionals are advised that FIT-BioCeuticals, in consultation with the TGA, is undertaking a recall of one batch of BioCeuticals Vitamin D3 Drops Forte Liquid 20 mL due to inconsistent mixing of the medicine. A manufacturing issue led to some samples from the batch being insufficiently mixed and separating into its component liquids. The variation in Vitamin D3 content across the batch may affect consumers who rely on the correct dose for treating health conditions. The affected batch number is 002918 and it was manufactured in November 2019. No other batches are affected by this issue.    Source: FIT product 'unfit'

American Botanical Council Warns Consumers about High Toxicity of Oleander

The non-profit American Botanical Council (ABC) recently warned the public about the substantial toxicity associated with all parts of the oleander (Nerium oleander) plant. ABC warns consumer not to ingest any parts of the plant, or capsules, tablets, teas, or extract preparations made from leaves or other parts of the oleander plant because it contains chemicals that can cause serious effects to the human heart, including death. The ABC warning came as a result of recent media reports that USA President Trump may be considering asking (or may have asked) the Food and Drug Administration (FDA) to approve the drug product called oleandrin as a potential treatment for COVID-19.     Source: Oleander toxicity

USA Brands Top List of Problematic Supplements in South Korea’s Online Market Inspection

An inspection and review conducted by South Korea’s authorities found that most of the supplements of questionable quality being sold were from USA brands.   Source: (Copyright) Tingmin Koe, FoodNavigator-Asia USA brands fail

Robert Forbes Acknowledged in CANI Lifetime Achievement Awards

The Consultants Association for the Natural Products Industry (CANI) in the USA, recently announced Lifetime Achievement award honours for four of its members. Robert Forbes, managing director and founder of RFA Regulatory Affairs and the publisher of this newsletter, was one of the recipients of this prestigious award.    Sources: Wholefoods Magazine Robert Forbes honour ; &, Nutraceuticals World CANI awards

 

 

Darrell Lea Removes Controversial Palm Oil Ingredient from Chocolate

The iconic Australian chocolate brand will change the ingredients for over 100 of its products – and is now calling on other companies to do the same. Darrell Lea will change more than 100 of its products to remove palm oil, citing the “major devastation” the controversial ingredient causes. Darrell Lea’s marketing director Tim Stanford said the company had listened to feedback from customers and “wanted to do the right thing”. “There is no doubt that palm oil production causes major devastation to rainforests and endangered animals, such as the orangutan,” he said.    Source: Hannah Paine, News.com.au Palm oil dropped

Changes to Tests Applied to Surveillance Food

The tests applied to surveillance foods change periodically so that compliance against different standards is monitored over time. These changes take into account the results of testing conducted and new or updated risk advice from Food Standards Australia New Zealand (FSANZ). Removing lead and tin testing from preserved and canned fruit and vegetables has allowed other foods to be targeted for compliance. Testing of fresh and frozen vegetables for lead is being introduced because vegetables are considered an important contributor to lead dietary exposure. The department will verify imported vegetables are compliant with the limits of lead in the Food Standards Code. Date of effect: 7 September 2020.  Source: Changes to FSC

Pregnancy Warning Labels on Alcoholic Beverages

Food Standards Australia New Zealand (FSANZ) has announced the start of a three-year transition period for mandatory pregnancy warning labels on alcohol. FSANZ CEO Mark Booth said that the new requirements are now in effect following gazettal in the Australia New Zealand Food Standards Code (the Code). “Following a request for review, Minister's responsible for food regulation have agreed to a revised warning label and an extended transition period for industry from two years to three years”.   Source: Pregnancy and alcohol warning label    (Please see also: Downloadable warning labels )

Imported Food Inspection Scheme Data Annual Report (2019) Focuses on Label Non-Compliance

From 1 January to 31 December 2019, the compliance rate for all food inspected under the Department of Agriculture, Water and the Environment Imported Food Inspection Scheme (IFIS) was 98.4%. During this period: 22,635 entries of imported food were referred for inspection or analysis and 132,002 tests (including label and visual checks) were conducted. Non-compliant labelling accounted for most non-compliance (74.1%). There were two main reasons for label non-compliance: 37% of labels lacked or listed either incomplete or incorrect nutritional details, and, 27.8% of labels did not comply with country of origin requirements. A lack of importer details and having a non-compliant ingredient list were the next main reasons for label non-compliance (12.4% and 10.2%, respectively).    Source: Food inspection data

FSANZ Notifications –

Application A1175 – Rapeseed protein isolate as a novel food:   Source: Rapeseed protein

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: Glycolipid preservative

Application A1186 – Soy Leghemoglobin in meat analogue products: The purpose of the application is to allow the use of soy leghemoglobin derived from P.pastoris as a component in meat analogue products.   Source: Vego meat

Application A1194 – Glucoamylase from GM Trichoderma reesei as PA (Enzyme): The purpose of the Application is to permit the use of glucoamylase sourced from GM Trichoderma reesei as a processing aid.    Source: Processing aid

Application A1198 – Food derived from enhanced yield & herbicide-tolerant corn line DP202216: ​The purpose of the Application is to permit the use of corn (maize) line DP202216 as a new food produced using gene technology. The line has enhanced yield potential and glufosinate-tolerance.    Source: GM corn

Application A1206 - Subtilisin from GM Bacillus licheniformis as a processing aid (enzyme): The purpose of this application is to permit the use of subtilisin from a genetically modified strain of Bacillus licheniformis containing the subtilisin gene from Pyrococcus furiosus, as a processing aid in the production of potable alcohol.   Source: GM enzyme

Application A1207 - Rebaudioside M as a Steviol Glycoside from Saccharomyces cerevisiae: The purpose of this application is to permit the use of the steviol glycoside, Rebaudioside M, that is produced by fermentation from a genetically modified Saccharomyces cerevisiae, expressing steviol glycoside biosynthesis pathway genes, as a general purpose sweetening agent.   Source: GM sweetener

Proposal P1054 – Pure and highly concentrated caffeine products: Urgent Proposal P1054 to prohibit the retail sale of pure and highly concentrated caffeine food products.    Source: Concentrated caffeine

Proposal M1018 - Maximum Residue Limits 2020: 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: MRLs 2020

 

 

GMP for Overseas Manufacturers of Medicines and Biologicals During the COVID-19 Pandemic

The Therapeutic Goods Administration has updated information for foreign manufacturers and the remote GMP Inspections of their facilities. Manufacturers of medicines and biologicals are routinely inspected using a risk-based approach against the appropriate Manufacturing Principles. Following the suspension of on-site inspections due to COVID-19 restrictions, the TGA has developed new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections. The domestic program demonstrated that it would be possible to replicate this approach for overseas medicine and biological manufacturers. However, it is recognised that broadening this program may bring additional challenges and the same number of manufacturers cannot be inspected using this approach. From July 2020, the TGA will begin the remote GMP inspections program for some overseas manufacturers.    Source: COVID-19 GMP inspections    (Also refer to: Expectations for overseas manufacturing sites hosting remote inspections during covid-19 pandemic )

*** Please contact RFA Regulatory Affairs if you need assistance with your GMP ***

System for Australian Recall Actions

The System for Australian Recall Actions (SARA) provides consumers, health care professionals, sponsors, wholesalers, hospitals, and retailers with access to information about recall actions occurring in Australia for therapeutic goods. The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. In July 2020, the TGA completed an enhancement to SARA database's search facility. Users are now able to download search results of summary recall data in editable, MS Excel format, in addition to the existing PDF reports. This project was undertaken in response to requests from a range of external stakeholders to provide better access to TGA recall data.    Source: SARA database

Regulation of Thermometers and Other Temperature Measuring Medical Devices for COVID-19

Any temperature measuring product for use on humans, for the intended purpose of screening potentially febrile individuals during a pandemic, meets the legal definition of a medical device and is required to comply with the Australian regulatory requirements, including listing in the Australian Register of Therapeutic Goods (ARTG), before importing or supply. Should the product not be intended by the manufacturer for a medical purpose, suppliers and retailers cannot represent the product as a medical device and cannot promote the product for the purpose of screening potentially febrile individuals. Additionally, it is an offence to advertise to any person a medical device for purposes other than the manufacturer's intended purpose. Before sponsors submit an application for inclusion of a thermometer or any other temperature measuring medical device in the ARTG, they should establish the classification of their product. An online classification tool is available to help determine the classification of a particular device.    Sources: COVID19 medical device & Medical device classification tool 

TGA Consultation - Therapeutic Goods Order 106 - Data Matrix Codes and Serialisation of Medicines

The TGA is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. Data matrix codes are an important first step towards a medicine traceability system. To make sure the standard is clear, meaningful and fit for purpose, the TGA is seeking feedback on its suitability and potential impacts. This consultation closes 13 August 2020.  Source: TGO 106 consultation

Review of Listed Medicines with Traditional Indications

Over the remainder of 2020, the TGA will be initiating targeted compliance reviews on listed medicines that are based on TCM, Ayurveda or other traditional paradigms. If you are a sponsor of a listed medicine with traditional indications, you are encouraged to re-evaluate the evidence you currently hold, particularly in relation to the active ingredients in your products and their dosages; and also to reconsider the indications made for your medicines with reference to the ‘Evidence guidelines for listed medicines’.    Source: Traditional medicines review

Pharmacovigilance Inspection Program Risk Assessment Survey

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete and will remain open until 30 September 2020. The TGA's PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance processes, inspection history and compliance with Australian pharmacovigilance legislation and guidelines and will serve as a tool to help prioritise and schedule pharmacovigilance inspections. Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score. Please also note that the survey questions relate only to sponsor’s medicines (not medical devices or biologicals) in the ARTG. This includes all listed, registered and provisionally registered medicines.    Source: Pharmacovigilance inspection program

End of Advertising Pre-Approval Scheme: Questions and Answers

Up until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' required approval under the Therapeutic Goods Regulations 1990 before they could be published or broadcast. This advertising pre-approval scheme has been stopped in favour of a more self-regulatory regime. Please note, all advertisements for therapeutic goods are still required to comply with the therapeutic goods regulatory requirements. This helpful Q & A page responds to sponsor queries regarding the new scheme: Therapeutic advertising Q&A

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

TGA Guidance on Directing Advertising Exclusively to Health Professionals

This information explains how to direct therapeutic goods advertising exclusively to health professionals so that the consumer advertising requirements do not apply. Any advertisement for therapeutic goods that is accessible by consumers must meet the Act's requirements for advertising to consumers, even if the goods are not available for purchase by consumers or you think the content clearly targets health professionals.    Source: Ads for health professionals

Consent to Import, Supply or Export Therapeutic Goods That Do Not Comply with TGA Standards

Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia and it is an offence to import, supply or export therapeutic goods that do not comply unless an exemption is given. Consent to not complying with an applicable standard will not be given unless the TGA is satisfied that the safety, quality, safety and efficacy and/or the safe and effective use of the product will not be adversely affected. Special processes have been set up for medicines affected by COVID-19 delays.   Source: Non-standard consent

Cochlear Calls for Low-Risk Health Apps to be Exempt from TGA Register

Australian company, Cochlear Ltd. has called for some low-risk health apps to be exempt from the therapeutic goods register, joining a push by medtechs, including Roche Holding AG, for greater certainty on the regulation of medical and healthcare software. Over the past two years regulators have been grappling with the oversight of medical software amid a boom in healthcare apps, clinical products and health trackers. Last year a new set of requirements was established that categorised software based on the level of risk the product poses to patients. In June 2020, the government flagged it would delay the rollout of new medical device regulation, including for software, until next year due to COVID-19. It is not clear which health app products are set to be excluded or exempted from regulation, however. In March the TGA asked businesses where they thought the line should be drawn.    Source: Emma Koehn, SMH Health apps exemptions

TGA Issues Fines of Nearly $1.8 Million for Alleged Illegal Activity In 2019-20

The TGA has taken strong action against alleged illegal import, manufacture, supply and advertising of therapeutic goods in Australia during 2019-20 when 187 infringement notices were issued for alleged breaches of the therapeutic goods legislation, totalling almost $1.8 million. In the same period, the TGA pursued civil court action against three companies, with the Federal Court of Australia ordering one company to pay the Commonwealth $10 million for breaches of therapeutic goods advertising requirements. A further five criminal matters were referred to the Commonwealth Department of Public Prosecution.    Source: TGA acts on lawbreakers    (Please see also TGA infringement notices ; Database of TGA listed medicine compliance review results   and this example case: False evidence claim )

Pfeffer Contracting Fined $25,200 for Alleged Advertising Breaches in Relation to COVID-19

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Pfeffer Contracting Pty Ltd for alleged unlawful advertising in relation to COVID-19. Advertisements on the company's website for a test kit and surgical masks allegedly referred to COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to COVID-19 (and related terms) about therapeutic goods are restricted representations. A restricted representation refers to a serious form of a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without an approval or permission from the TGA.    Source: Pfeffer fail

Lorna Jane Fined for Alleged Advertising Breaches in Relation to COVID-19 "Anti-Virus Activewear"

The TGA has issued three infringement notices totalling $39,960 to Brisbane clothing company Lorna Jane Pty Ltd for alleged unlawful advertising in relation to COVID-19. Lorna Jane allegedly claimed, on its website, that its 'anti-virus activewear' prevents and protects against infectious diseases, implying it is effective against COVID-19. The TGA alleges that Lorna Jane represented its 'anti-virus activewear' for therapeutic use and therefore believes that it is a therapeutic good within the meaning of the Therapeutic Goods Act 1989. Therapeutic goods, including advertising, are subject to the regulations administered by the TGA. The advertisement referred to therapeutic goods that were not included in the Australian Register of Therapeutic Goods (ARTG). This is required before they can be lawfully supplied or advertised in Australia.    Source: Therapeutic clothing fail

Arborvitae Health And Wellbeing Fined $12,600 for Alleged Advertising Breaches in Relation to COVID-19

Arborvitae Health And Wellbeing allegedly claimed, on the company's website, that Arborvitae Health and Wellbeing Supplement (Arborvitae) is an effective treatment for COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to treating COVID-19 (and related terms) are restricted representations.    Source: Arborvitae advertising fail

Strapit fined $37,800 for alleged advertising breaches in relation to COVID-19

The TGA has issued three infringement notices today totalling $37,800 to Melbourne-based company Strapit Medical and Sports Supplies Pty Ltd, for alleged unlawful advertising in relation to COVID-19. Strapit Medical and Sports Supplies allegedly claimed, on its website, that a Zafe Zone product for use on surfaces and skin killed COVID-19, without having the necessary authorisations from the TGA.    Source: Strapit hit with fine

Zafe Zone fined for alleged advertising breaches for disinfectant products in relation to COVID-19

The TGA has issued three infringement notices today totalling $39,960 to Melbourne-based company Italian Princess Coffee Brands Pty Ltd (trading as Zafe Zone), for alleged unlawful advertising in relation to COVID-19. Zafe Zone allegedly promoted its disinfectant as effective against coronavirus, without having the necessary authorisation from the TGA.    Source: Zafe Zone fined

TGA Safety Advisories-

AuLion Energy Candy: The candies contain the undeclared substance sildenafil.    Source: AuLion energy candy

Fostering innovation in Australia’s Listed Medicines’ Industry

The Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, which amends the Therapeutic Goods Act 1989, was passed by both houses on 25 June. This amendment introduces a mechanism to protect new research data for low risk complementary medicines that have proven novel efficacy claims. This represents regulatory innovation that the sector has been striving to achieve for many years.  The usual intellectual property patenting process is not as readily amenable to protect research investment for ingredients that are already in the public domain. “This extraordinary regulatory reform represents one of the most exciting improvements in the complementary medicine landscape that we have witnessed in decades," said Professor Alan Bensoussan, Director, NICM Health Research Institute.     Source: LM regulatory innovation

 

 

AICIS Issues Extra Guidance on Categorising Chemicals Used in Cosmetics

Just to remind readers, that on 1 July 2020 the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was replaced by the new Australian Industrial Chemicals Introduction Scheme (AICIS). If you are planning to introduce industrial chemicals (and products that release industrial chemicals) for use in cosmetics, you might like to check out this extra guidance on categorising cosmetic introductions. It will give you tips to help you work out your introduction category. The first step to categorisation is to check if your chemical is on the Inventory. Otherwise, all introducers must work out if their introduction is exempted, reported or assessed.    Source: Cosmetic ingredient guidance

 

Failing Food Reports – May and June 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the months of May and June. Among the usual pathogens detected in these imported foods are such organisms as Salmonella (found in Si Lankan chili), Bacillus cereus (found in Chinese tofu – again!), Listeria monocytogenes  (found in French cheese – again!), and assorted toxins such as Tebuconazole (found in USA oranges),  histamine (found in many varying dried seafoods), lead (found in Taiwanese salted plums) and the illegal addition of vitamins to many foods.      Sources: May 2020 failed foods ; June 2020 failed food

ANZ Ministerial Forum on Food Regulation Communiqué

The Australia and New Zealand Ministerial Forum on Food Regulation is a joint organisation that makes the laws, policies, standards and processes used to make sure our food is safe to eat. The Forum has published two important outcomes from its most recent meeting held on 17 July 2020:

Proposal P1050 - Pregnancy warning labels on alcoholic beverages: The Forum accepted the proposed draft standard for pregnancy warning labels, subject to two amendments: a change to the signal words from ‘HEALTH WARNING’ to ‘PREGNANCY WARNING’, and an extended transition period for implementation, from two years to three years;

Health Star Rating (HSR) Five Year Review: Ministers endorsed the Review Implementation Plan (concerning definitions of ‘fresh’ foods, Health Star Rating calculator, and interim update targets), and an implementation start date of 15 November 2020.     Source: Forum communique

Winemaker Backs Tough New Pregnancy Warning Label Ahead of Tight Vote

Winemaker Chris Carpenter has broken ranks with alcohol industry lobbyists to back the food regulator's proposed new mandatory pregnancy warning label for alcohol bottles, as politicians prepare to vote on the hotly contested issue. State, territory, federal and New Zealand food ministers are expected to be closely split when they next meet to weigh up the label recommended by Food Standards Australia and New Zealand. It has black, white and red text stating "PREGNANCY WARNING: Alcohol can cause lifelong harm to your baby".    Source: Dana McCauley, SMH Alcohol and pregnancy warning statement    (Please see also Alcohol pregnancy warning debate )  

Community Detention and Fine for Selling Potentially Hazardous Goat Meat in NZ

A dairy owner, Ananda Krishna, and a company, Shop ND Save Limited, have been sentenced in Christchurch District Court for processing and selling goat meat outside of food safety rules and having unhygienic practices. Mr Krishna, 54, was convicted and sentenced to 200 hours' community work and the company was fined $2,250. During a search of the premises on 19 June 2019, 50 kilograms of diced goat meat were found in a freezer. Mr Krishna admitted processing goat meat himself on the band saw. Maggots fell out from the band saw equipment when it was opened. The equipment also contained bird faeces, which are known to harbour pathogenic bacteria.    Source: NZ food fail

FSANZ Notifications –

P1050 – Pregnancy warning labels on alcoholic beverages (REVIEW): Following the latest review, FSANZ has reaffirmed the amendment with a change to the signal words from 'HEALTH WARNING' to 'PREGNANCY WARNING', and an extended transition period for implementation from two years to three years.    Source: Alcohol pregnancy label warning

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