Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics, Personal Care and TGA Listed Sunscreens:
Cosmetic or therapeutic?
When does a cometic get regulated as a medicine, or a medical device? A new guidance document goes some way to clarifying this often grey area. You may think a product is a cosmetic, but it could be regulated as a therapeutic based on its primary use, the ingredients, the claims made and overall presentation and context. What is a cosmetic? How to advertise it? Source: TGA.
Draft evaluation of chemicals – comments invited
This includes a list of draft evaluations. Comment period closes on 17 December 2021. Source: AICIS
Chemicals of low concern that may not require further regulatory controls to manage risks to the environment
AICIS is seeking use and hazard information. Comment period closes 17th December 2021. Source: AICIS
Chemicals unlikely to need further human health risk management controls
AICIS is seeking use and hazard information. Comment period closes 17th December 2021. Source: AICIS
Reporting and record-keeping obligations and annual declarations for importers of chemicals
Relevant to importers of cosmetics and other personal care products. This is a comprehensive summary of reporting and record keeping obligations. Source: AICIS and also here.
Foods:
Failing food reports for September 2021
Risk food test results – aflatoxins, Salmonella and histamine continue to be commonly detected. Source: Dept of Agriculture, Water and the Environment
Surveillance food tests includes random inspection of imported foods. Includes non-permitted ingredients such as vitamins and minerals and prohibited plants. Source: Dept of Agriculture, Water and the Environment
Branded Food Database
FSANZ along with GS1 Australia are preparing a database that will enable consumers easy access to product information for thousands of foods and beverages, including nutrition information panel, listed ingredients, pack and serve size and health star rating along with dietary fibre and fruit, vegetable, nut and legume content. Source: FSANZ
Energy labelling of alcoholic beverages
Options are being considered. Unlike most other packaged food and beverages, labels on most packaged alcoholic beverages do not provide information about energy content. Source: FSANZ
Call for comment on Very Low Energy Diets
An application has been received to modify this standard to bring it into line with other international regulations for similar products. Source: FSANZ
Call for comment - new source for an enzyme processing aid
The enzyme beta-fructofuranosidase has a long history of safe use and is already sourced from microorganisms. This application is to seek approval to produce the enzyme from a strain of bacterium known as Aspergillus fijiensis. FSANZ's safety assessment found no health and safety concerns for Australian and New Zealand consumers. Source: FSANZ
Hemp
An application has been submitted to FSANZ to permit the sale of low-delta-9 tetrahydrocannabinol (THC) hemp leaf, seed sprout and root as food and food ingredients in Australia and New Zealand. Source: FSANZ
National food recalls
This month, two were due to undeclared allergens (milk in Fresh Food Enterprises IQ Bars, and egg in YBC Picola Strawberry), and three were due to contaminants (Vibrio parahaemolyticus in raw Pacific oysters from Coffin Bay, Listeria monocytogenes in Snackers Market Tasty Cheese and Mini Crackers and Pretzels, and also in Good to Go Tasty Cheese Salami and Cabanossi). Source: FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
AICIS publishes guidelines on “natural” and “organic”
Is my ingredient natural? This is often a difficult question to answer. This guideline explains the AICIS position on “natural” including what extraction processes cause a chemical change. If all the ingredients in your product meet AICIS’ legal definition of a naturally occurring chemical (and you don’t introduce any other industrial chemicals), then you do not need to register with AICIS. Source: Australian Industrial Chemicals Introduction Scheme (AICIS)
Chemicals with no known commercial use in Australia
AICIS has identified chemicals on the Australian Inventory that it believes are not being manufactured, imported or used in Australia for commercial purposes. If you are using one of the chemicals you can contact AICIS before 17th December. Source: AICIS general information, and list of chemicals
Complementary Medicines and Medical Devices:
Update to remote GMP inspections during the pandemic.
This includes a summary of the options for the Compliance Verification (CV) pathway and the Mutual Recognition Agreement (MRA) pathway. Source: TGA
Amendment to the independent report on the therapeutic use of psilocybin and MDMA
A final decision may be published the first week of December 2021. Source: TGA
Compliance enforcement
Criminal cartel charges - a follow up to last month’s story about an individual pleading guilty to criminal cartel charges: on the 16th November the company itself, Alkaloids of Australia Pty Ltd, also pleaded guilty to criminal cartel conduct. Alkaloids of Australia produces and supplies SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide). SNBB is manufactured from the Duboisia plant, which is native to Australia. Source: ACCC
Ivermectin – A chiropractor in New South Wales has been issued an infringement notice for $2,664 for alleged importation of ivermectin product not included on the Australian Register of Therapeutic Goods. Source: TGA
Counterfeit erectile dysfunction medicines - Performance Online Services Pty Ltd fined $53,280 for exporting, supplying and advertising Xcalibur XXX Gold 8000 and Wicked Triple Platinum – products that were not entered in the Australian Register of Therapeutic Goods (ARTG). The products contained the undeclared ingredient sildenafil, a prescription only substance. Source: TGA
Adulterated products seized and destroyed by customs
S.W.A.G II Platinum 33K - undeclared substance sildenafil. Source: TGA
Panther Power Platinum 11000 – same as above. Source: TGA
777K – as above. Source: TGA
One Night Love tablets – as above. Source: TGA
COVID – Queensland individual issued infringement notice for $2,664 for advertising a homeopathic product for the treatment and prevention of COVID-19. Source: TGA
Nicotine vaping products (Source for items below: TGA):
Australia Utopia issued with 7 infringement notices totalling $93,240 for alleged advertising breaches of nicotine vaping products on its website
RV Global Ecommerce Pty Ltd fined $39,960 – same as above
Sydney company Mason Online Pty Ltd fined $106,560 for alleged advertising breaches – as above
Melbourne individual responsible for the Vapespot website has been issued seven infringement notices totalling $18,648
Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products
Reclassification of some medical devices
On the 25th November a number of medical devices were re-classified, including active medical devices for therapy with a diagnostic function; spinal implants for motion preservation; devices in direct contact with the heart, central circulatory system, central nervous system; devices that administer medicines or biologicals by inhalation; active medical devices; and substances introduced into the body, body orifice or applied to the skin. Source: TGA
Medicinal cannabis
Regulations are being refined. Here some links to various relevant topics:
New streamlined process for medicinal cannabis applications
Changes to Special Access Scheme (SAS) and Authorised Prescriber applications
Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia
Importation, manufacture and supply of unapproved medicinal cannabis products
Foods:
Sports foods containing DMAA
It is already illegal for sports food brands containing DMAA to be sold. It has been included in Appendix C of the Poisons Standard which means the sale, supply and use of DMAA will be prohibited. Source: NSW Food Authority
Recalls
South Island White Mist Sauvignon Blanc has been recalled due to the presence of an undeclared allergen – sulphites.
Barossa Fine Foods ham products – “No Added Nitrite Ham 100g” due to possible (listeria monocytogenes) microbial contamination, and “Double Smoked Ham 100g” due to due to (listeria monocytogenes) microbial contamination.
Weis Dairy Free Dark Chocolate & Coconut Multipack due to the presence of an undeclared allergen (soy).
Banks and Burbidge Alcohol Free Gin – potential for microbial contamination
Devondale 100% Sparkling Apple Juice due to a packaging fault resulting in the potential for glass breakage.
Source: New South Wales Food Authority.
Nature's Delight Xmas Liquorice Mix 500G - the product contains gluten but the label has a ‘Gluten Free’ claim.
Fruit X Berries Blueberry Chocs - presence of an undeclared allergen (tree nuts [macadamia]).
HLY Brown Sugar Cake - presence of an undeclared allergen (soy)
Essential Ingredient Corn Tortillas - presence of an undeclared allergen (wheat).
Source: Food Standards Australia New Zealand
FSANZ calls for comment on changing definitions for genetically modified foods
Current definitions of ‘food produced using gene technology’ and ‘gene technology’ lack clarity and need to be updated. In the first of two rounds of public consultation, FSANZ invites interested parties to comment on its proposed approach to (a) revise and expand the process-based definition for ‘gene technology’ to capture all methods for genetic modification other than conventional breeding; and (b) revise the definition for ‘food produced using gene technology’ to include specific product-based criteria for excluding certain foods from pre-market safety assessment and approval as GM food. Foods that do not meet all relevant exclusion criteria would still require an application to FSANZ. Source: FSANZ
Amendments and applications to amend the Food Standards Code
Including nicotinamide riboside chloride as Vitamin B3 in foods for special medical purposes, β Galactosidase from Bacillus subtilis (Enzyme) as a processing aid in dairy food applications, Source: FSANZ. Also Low-THC hemp leaf, seed sprout and root as food and food ingredients - FSANZ