Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics, Personal Care and TGA Listed Sunscreens:
Conditions placed on sunscreens that were tested by AMA Laboratories in the USA.
Sunscreens must be tested to validate the SPF claims. In August 2019 the US FDA announced that several executives and supervising laboratory technicians of AMA Laboratories had pleaded guilty to fraudulent laboratory testing. In September 2020, the TGA contacted all sponsors of Australian sunscreens notifying them of its post-market review of sunscreens. Sponsors must provide adequate justification for ongoing supply of products that have been tested by AMA Laboratories, such as additional supportive testing data conducted by an independent testing laboratory. Source: TGA
A list of chemicals added to the Inventory 5 years after issue of assessment certificate
AICIS has released a list of chemicals added to the database from 23rd February to 10th March 2021. Source: AICIS news.
Guide to categorisation of fluorinated chemicals
This is relevant to importers of products that are fluorinated chemicals. A fluorinated chemical is a chemical that contains one or more fluorine atoms. Source: AICIS
Soap making and importing
This is a useful guide for importers and manufacturers of soaps and explains when you need to register your business details. It includes information on the processes used to make soaps, and soaps made from natural or organic ingredients. Source: AICIS
Banned or restricted chemicals
Bans and restrictions on chemicals and consumer product ingredients – including cosmetics – are regulated by each state and territory authority. This explains how different chemical are regulated, and lists over 10 different government authorities that may be involved including The Standard for the Uniform Scheduling of Medicines and Poisons, The Therapeutic Goods Administration, The Australian Pesticides and Veterinary Medicines Authority, Food Standards Australia and New Zealand, The Department of the Environment and Energy, Safe Work Australia, The National Transport Commission, Australian Border Force, The Australian Competition and Consumer Commission and Australian National Security. Source: AICIS
Review of the 2013 Australian Dietary Guidelines
The National Health and Medical Research Council (NHMRC) has received $2.5 million from the federal government to review the guidelines. The first step will be a scan of the latest nutrition science research and evidence. Source: NHMRC.
Advertising of “toddler milk”
The Victorian Health Department is calling for an end to aggressive marketing of toddler milk formulas, as new research reveals some products are up to four times more expensive than regular milk, but with more sugar and fewer key nutrients. Also, the Australian Competition and Consumer Commission (ACCC) proposes to re-authorise a longstanding agreement by manufacturers to not promote infant formula, to protect rates of breastfeeding. There is concern the industry is trying to “work around” the restriction on infant formula advertising by promoting “toddler milk”. Source: VicHealth and ACCC
New Zealand man fined for biosecurity breaches
An Auckland businessman Sanjive Ramavtar Kapoor from Divine Logistics was sentenced after pleading guilty to three charges which included unauthorised opening of shipping containers and falsifying documents. Mr Kapoor redirected containers from Approved Transitional Facilities 22 times between 21 June 2018 and 31 January 2019. Mr Kapoor admitted to opening and unpacking 12 of these containers. He was fined NZ$30,000. Source: New Zealand Ministry of Primary Industries.
Declaration of allergens on food labels – changes
There is a move to plain English labelling. There are some new allergens, “nuts” or “tree nuts” must now contain the names of these nuts, specific cereals must be listed by name rather than grouped together as “cereals” – and many other changes .Summary of work to date can be found here, here, and here. Source: FSANZ. Relevant legislation is here.
Failing food report for January 2021
This report lists food that has failed under the Imported Food Inspection Scheme (IFIS) during January 2021. Table 1 shows results of tests on rick foods. Salmonella, E. coli, aflatoxin and histamine levels remain a problem. Table 2 lists other surveillance issues, including non-permitted additives. Source: Dept Agriculture.
Approvals and amendments to the Food Standards Code
A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme)
P1051 – Code Revision (2020)
A1555 – 2’-FL and LNnT in infant formula and other products
A1175 – Rapeseed protein isolate as a novel food
A1180 – Natural Glycolipids as a preservative in non-alcoholic beverages
A1186 – Soy Leghaemoglobin in analogue meat
FSANZ has published a summary of food recalls over the last 10 years. The main reasons for recalls were microbial contamination, labelling, foreign matter, chemical/other contaminants, undeclared allergen, biotoxin and “other”. During 2020, there were 33 recalls due to undeclared allergens. FSANZ Sources: recalls due to allergens, current food recalls.
Facts sheet on GM Foods
How they are made, labelling, and what types of GM foods are sold in Australia and New Zealand. Source: FSANZ
Cosmetics and TGA Listed Sunscreens:
Kimberley-Clark fined $200,000 for misleading country of origin statement
The website claimed the products were made in Australia. Source: ACCC
Correction of chemical names – updated to terminology. Source: AICIS
New Industrial chemicals – guide to preparing report
Guide to completing the most common type of pre-introduction report (PIR) – ‘highest indicative risk is low risk’. Source: AICIS
Complementary Medicines and Medical Devices:
Artemisia annua and Artemisia absinthium updated product recalls
A further 8 products have been cancelled and recalled. It seems there is an unacceptable risk if these products are used during pregnancy, and the cancelled products did not include the mandatory label warning statement about pregnancy. Source: TGA News
Updated guide to medicine labelling requirements
This is an updated guide to the two labelling orders Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) (including complementary medicines). Source: TGA guidance document
Industry Forum on Good Manufacturing Practice (GMP)
TGA has announced the third GMP forum, which will be held over three half days on Wednesday, 12 May - Friday, 14 May 2021. This will be a virtual event and it will be free to attend. TGA states “This Forum will be of interest to industry personnel involved in the quality assurance, regulation, risk assessment and good manufacturing practice of medicines and biological products.” Source: TGA news
Changes to ingredients permitted in listed medicines
This is a summary of the changes to 169 ingredients. Source: TGA news
TGA compliance activity
CW IP Pty Ltd fined $53,280 for alleged advertising breaches on the Chemist Warehouse and My Chemist websites. They allegedly advertised Fatblaster Clinical capsules, a therapeutic good, on four pages of its Chemist Warehouse and My Chemist websites. At the time of advertising, Fatblaster Clinical capsules were not entered in the Australian Register of Therapeutic Goods. The TGA cancelled Fatblaster Clinical capsules from the ARTG on 20 December 2019. Source: TGA news
Newcastle-based retailer Junction Rx trading as My Community Pharmacy (Junction Rx) has been issued an infringement notice for $13,320 for alleged advertising of an unlisted complementary medicine after they failed to comply with a cease and desist notice by the set deadline. They advertised a therapeutic good called ‘FatBlaster Apple Cider Vinegar and Garcinia Max' which is not included on the Australian Register of Therapeutic Goods. Source: TGA news
Epharmacy Group fined $26,640 for alleged unlawful advertising on the ePharmacy website. The fines were issued for the alleged unlawful advertising of Fatblaster Clinical, a complementary medicine cancelled from the Australian Register of Therapeutic Goods. Source: TGA News
Bulk Buys fined $13,320 for alleged unlawful importation of surgical face masks. TGA claims they breached a condition of the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 by importing surgical face masks that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile. Source: TGA news
Medicine packaging definitions
A useful guide to understanding packaging terms which do not always align between different regulations. What is the difference between “primary packaging” and “primary pack”? What is “tertiary packaging”? Source: TGA
New standard for serialisation and data matrix codes on medicines
1st January 2023 is the commencement date for the new Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021. This order does not make the use of data matrix codes or serialisation of medicines mandatory, but sets out requirements if medicine sponsors choose to do either of these. Medicines must comply with TGO 106 by 1st January 2023 if they are serialised, or include a dot matrix code that encodes the Global Trade Item Number (GTIN). Sources: TGA news, and Federal Register of Legislation
Medical devices – essential principles checklist
Available in either word or pdf format – this 28 page checklist will be very helpful for sponsors of medical devices. It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices. Source: TGA news
Standard for unapproved vaporiser nicotine products
TGA is proposing a standard and proposed safety and quality requirements. This is a copy of an online presentation. Source: TGA news
Post-market review of face masks
The TGA is continuing its review of face masks and this page summarises the findings. The TGA states some … “are not performing as intended, i.e. as claimed by the manufacturer. Some masks may pose a risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from contaminated fluids and airborne particulates is required”. Some products require no action, some have been cancelled, others need corrective action. Source: TGA face mask review
Summary of a recent online presentation on medicinal cannabis advertising compliance has been published. TGA presented along with professional experts. Find it here.
New Zealand guards against imported agricultural pests
New Zealand continues to be vigilant with imported foods that may damage their agricultural industry:
Bus driver fined NZ$4,500 for smuggling seeds and cigarettes
Auckland woman sentenced to intensive supervision for 12 months and 100 hours' community work for smuggling succulents and endangered cacti into New Zealand
And brown marmorated stink bugs continue to be a problem in both New Zealand and Australia. (Editor’s note: they are a pest on my two citrus shrubs and yes they do stink)
Maximum residue limits
Food Standards Australia New Zealand (FSANZ) today released its annual call for comment on proposed changes to Maximum Residue Limits (MRLs) for some agricultural and veterinary chemicals in food.
FSANZ Notifications and amendments
New applications: Application A1222 – Steviol glycosides from Yarrowia lipolytca:
Approval and notifications:
A1191 – Mono- and diglycerides of fatty acids (471) as a surface coating
A1202 – Food derived from insect-resistant and herbicide-tolerant corn line DP23211
Source: FSANZ media centre