Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Failing Food Reports November and December 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme. Once again, the usual pathogens were detected especially histamine, and the illegal addition of vitamins to foods including long grain rice from USA. Source: November and December.
Department of Agriculture announces changes to import conditions of some types of animal products
This notice mainly affects birds nests, table eggs, and goods that are imported in temperature-controlled containers below 10°C, that are imported for human consumption. These goods will undergo a more rigorous inspection. Source: Department of Agriculture, Water and the Environment
Department of Agriculture reviews biosecurity risks associated with importing dairy products
This review includes dairy products for human consumption manufactured from milk obtained from cattle, buffalo, sheep and goats. Source: Department of Agriculture, Water and the Environment
Pregnancy warnings on alcoholic beverages
Businesses have three years from 31 July 2020 to implement the requirements, FSANZ has published guidelines on design elements of the label and downloadable labels, and Q & A on Code requirements for pregnancy warning labels. Source: FSANZ
FSANZ Notifications and amendments
Call for comment on a new source for an enzyme processing aid - maltogenic alpha-amylase derived from Saccharomyces cerevisiae
Call for comment for food from genetically modified herbicide-tolerant canola
β-Galactosidase from Bacillus subtilis (Enzyme)
Alpha-amylase from GM Bacillus licheniformis as PA (Enzyme):
Beta-amylase from Bacillus licheniformis
Phospholipase A1 from Aspergillus niger
Source: FSANZ media centre
New Zealand Ministry of Primary Industry fines edible birds nest seller NZ$31,500
Birds nest are a potential source of avian pathogens. Source: NZ MPI
Complementary Medicines and Medical Devices:
Permitted Indications – Reminder – not much time left!
The deadline for all listed medicines to transition to only including permitted indications for their products is 5th March 2021. Any products that are non-compliant after this period will be cancelled by the TGA. The very minimum you need to do is access your TGA product record, delete any free text indications, and ensure the only ones remaining are those on the list of permitted indications. Don’t forget - it is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice!
Update list of indications for use permitted in Listed Medicines
An update to the list of permitted indications - Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 - was released on 21st January. A link to the updated list and a summary of changes can be found on TGA website.
ACCC takes Lorna Jane to court over 'Anti-virus Activewear' claims
ACCC has launched legal proceedings against Lorna Jane Pty Ltd due its publication on social media platforms, in its stores and on its website “Cure for the Spread of COVID-19? Lorna Jane Thinks So”, “With Lorna Jane Shield on our garments it meant that we were completely eliminating the possibility of spreading any deadly viruses”, and “LJ Shield – Protecting you with ANTI-VIRUS ACTIVEWEAR”. Source: ACCC
Post-market review of face masks
TGA has summarised the results of its post-market review of face masks including a list of face masks that have been cancelled. Source: TGA
Life Biotech Pty Ltd fined $106,560 for alleged non-compliance with requests for information and face mask samples in relation to COVID-19
The TGA has been conducting a post-market review of face masks. The TGA alleges that Life Biotech failed to provide samples to the TAG, failed to provide information and also provided partial, late and misleading responses to other requests. Source: TGA
Safety advisory – medicines containing Eucommia ulmoides
Medicines containing Eucommia ulmoides - (known as Du-Zhong or Tu-chung), may pose a risk for individuals with a latex allergy or sensitivity. Source: TGA
Product recall – Infants’ Friend
Due to the presence of a small amount of chloroform, there was a potential for children to consume an unacceptably high level of chloroform. Source: TGA
Quality and safety of medicinal cannabis products
The TGA is consulting on introducing GMP requirements for products manufactured overseas so they are equivalent to those manufactured domestically. Source: TGA
Test methods for cannabinoids
This method describes the analysis of samples derived from Cannabis species, specifically the assay of the primary compounds of regulatory interest [Tetrahydrocannabinolic Acid (THCA), Tetrahydrocannabinol (THC), Cannabidiolic Acid (CBDA) and Cannabidiol (CBD)] by UPLC coupled with UV or PDA. Source: TGA
Nicotine e-cigarettes now only available by prescription only
This aims to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation on their doctor's advice. The products will be available from a pharmacy on presentation of a medical doctor’s prescription. Source: TGA
Amendments to the SUSMP (“the Poisons Standard”)
Has just been released. The change to scheduling of boric acid will be of interest to suppliers of complementary medicines, cosmetics and oral hygiene products. Source: TGA
Pharmacovigilance obligations of medicine sponsors
Sponsors of medicines (including complementary medicines) have an obligation to collect and report adverse events. A “Frequently asked questions” page has been published on the TGA website here.
Australia and New Zealand Ministerial Forum on Food Regulation (Forum) Communiqué
The outcomes from the Australia and New Zealand Ministerial Forum on Food Regulation meeting held on 27 November 2020 have been released. This included approval of Application A1155 – to permit the voluntary addition of oligosaccharides 2’0-fucosylactose (2’FL) and Lacto-N-neotetraose (LNnT) to infant formula products in Australia and New Zealand. Source: Ministerial Forum Outcomes
Australia Food Safety Week
Held from 14 to 21 November 2020 with a theme ‘Food Safety – it’s in your hands’ this year, the focusing was on reducing the amount of foodborne disease. Four key tips to reduce foodborne illness:
- CLEAN: Wash your hands before, during and after food preparation, and before eating. Wash your cutting boards, utensils and countertops too.
- SEPARATE: Keep raw food (especially raw meats) separate from cooked and ready-to-eat food.
- COOK: Cook foods thoroughly, especially chicken and minced meat products.
- CHILL: Foods that should be kept cold should be kept cold.
Source: Food Safety Week
Failing Food Reports October 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of October. Among the usual pathogens detected in these imported foods are such organisms E.coli (found in Indonesian and Vietnamese clam), salmonella (Indian chilli powder) and assorted toxins such as histamine (found in dried shaved bonito from Japan), and the illegal addition of vitamins to foods (in beverages from India). Source: Dept Agriculture
FSANZ Notifications and amendments
Application 1193 - Irradiation as a phytosanitary measure for all fresh fruit and vegetables: to extend the option of phytosanitary irradiation to all types of fresh fruits and vegetables. Source: Application A1214
Application 1204 - Beta-amylase from soybean (Glycine max) as a processing aid (enzyme): to permit the use of beta-amylase sourced from soybean (Glycine max) as a processing aid (enzyme) in starch processing for maltose syrup production. Submissions close
Application 1207 - Rebaudioside M as a Steviol Glycoside from Saccharomyces cerevisiae: to permit the use of the steviol glycoside, Rebaudioside M, produced by fermentation from a GM Saccharomyces cerevisiae (S. cerevisiae), expressing steviol glycoside biosynthesis pathway genes, as a general purpose sweetening agent.
Application 1212 – Beta-fructofuranosidase enzyme from Aspergillus fijiensis: To permit a new source microorganism, Aspergillus Fijiensis, being an updated name of Aspergillus niger, for the permitted enzyme beta-fructofuranosidase
Application 1214 – Nicotinamide riboside chloride as Vitamin BS in FSMP: To amend the Food Standards Code to permit the use of nicotinamide riboside chloride as a permitted form of Vitamin B3 in food for special medical purposes (FSMPs).
Application A1215 – Cetylpyridinium chloride as washing processing aid: To request the addition of Cetylpyridinium chloride (CPC) to Schedule 18 of the Australia New Zealand Food Standards Code.
Application 1175 – Rapeseed protein isolate as a novel food
Application 1180 – Natural Glycolipids as a preservative in non-alcoholic beverages
Application 1186 – Soy Leghemoglobin in meat analogue products
Application 1198 – Food derived from enhanced yield & glufosinate-tolerant corn line DP202216
Proposal 1044 – Plain English Allergen Labelling
Proposal 1054 – Pure and highly concentrated caffeine products (Amendment Report)
Application 1192 - Food derived from herbicide-tolerant corn line MON87429
Application 1194 - Glucoamylase from GM Trichoderma reesei as a PA (enzyme)
Application 1195 - Alpha-amylase from GM Trichoderma reesei as a PA (enzyme)
Application 1196 - Food derived from nematode-protected and herbicide-tolerant soybean line GMB151
Application 1199 – Food Derived from Innate potato lines V11 and Z6
Source: various releases posted on FSANZ website
Cosmetics and TGA Listed Sunscreens:
Australian Industrial Chemicals Introduction Scheme (AICIS) Inventory Notices
Chemicals added to the Inventory 5 years after issue of assessment certificate:
CAS 169118-66-5 and 144093-88-9 (published 11 November)
Chemicals added to the Inventory following issue of assessment certificate:
CAS 119275-52-4, 1384165-05-2 and 1471316-72-9 (published 13 November)
Variation of Inventory listing following revocation of CBI approval:
CAS 35483-86-4, 1195979-93-1, 1203451-13-1, 77699-82-2, 2000198-09-2, 518045-13-1 (published 25 November)
ACIS draft evaluation report for public comment
The AICIS has published an amended draft evaluation report of:
Ethanol, 2-[2-(2-methoxyethoxy)ethoxy]-1,1',1''-triester with boric acid (H3BO3). It is available for public comment until 21 December. This is the second consultation on this evaluation. Source: AICIS news and notices
AICIS Release Guidance
The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients. The AICIS have released a guidance document to assist when determining if a toothpaste and/or oral hygiene product is regulated as a cosmetic or therapeutic good. Source: Guidance on toothpaste and oral hygiene classification
Consumer Goods (Cosmetics) Information Standard 2020 - alcohol-based hand sanitisers
The Consumer Goods (Cosmetics) Information Standard 2020 was made on 24 November with a transitional period of 180 days applicable to the date of manufacture i.e. until 23 May 2021. The new Up until 23 May 2021, suppliers have the option to comply with the requirements from either the previous information standard or the new information standard. From 24 May 2021, suppliers must only comply with the requirements in the new information standard.
The new information standard maintains all of the requirements of the previous standard and now requires hand sanitiser containing alcohol as the primary active ingredient, to display the percentage of alcohol contained in the product, along with safe use and storage warning information. Source: Product Safety Australia website and Explanatory Statement.
*** Learn more about AICIS and cosmetic regulatory changes***
Complementary Medicines and Medical Devices:
Permitted Indications - Reminder
The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice!
Update list of Ingredients permitted in Listed Medicines
An update to the list of permitted ingredients - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020) - was released on 16th December. A link to the updated list and a summary of changes can be found here.
Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices
The Therapeutic Goods Administration (TGA) has released a guidance document to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete. Source: Guidance for Declaration of Conformity
How to Respond to a Post Market Review for a Medical Device
This compliance dashboard gives very detailed guidance on how to review and reply to a TGA notification. Source: TGA
Listed medicines required to be tested for Aristolochic acids
For safety reasons Aristolochic acids and all plant species that might contain Aristolochic acids are prohibited from supply, sale or use in medicines in Australia. Some listed medicines are at risk of containing aristolochic acids due to inadvertent substitution. To address this risk, the Therapeutic Goods Administration (TGA) places a condition of listing which requires that sponsors of these medicines confirm the absence of aristolochic acids in their medicine and get TGA approval before releasing each batch of the medicine. If you are the sponsor of listed medicines which have the aristolochic acids condition of listing, you should review your records and ensure that you:
- hold evidence to confirm the absence of aristolochic; and
- provide this evidence to us at the TGA for evaluation and approval, prior to supply of each batch in Australia.
Source: Presence of aristlochic acids
Changes to requirements for listed medicines – Magnesium and Andrographis paniculata
The Therapeutic Goods Administration has published ‘Outcomes: Low-negligible risk changes to Permissible Ingredients - 2020-2021’. This impacts magnesium salts and Andrographis paniculate. The changes will commence on 1 March 2021. Source: Outcomes of Consultation.
Applications now open for the Manufacturing Modernisation Fund Round 2
The Modern Manufacturing Strategy is funding $1.5 billion for eligible manufacturers. Manufacturers can apply for co-funding under the initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. The Manufacturing Modernisation Fund is the first program to open under the Modern Manufacturing Strategy which will assist Australian manufacturers to scale-up, improve their competitiveness and to build resilient supply chains. Subscribe to updates at the Department of Industry, Science and Energy – here.
Therapeutic Goods Administration COVID-19 Proceedings
The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). There is now a TGA page which lists all face masks that have been cancelled from the ARTG during the review. Source: Cancelled face masks
Man fined $10,656 for alleged unlawful advertising of cannabidiol including COVID-19 claims
Infringement notices totalling $10,656 have been issued to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD). The man allegedly advertised, on websites and a social media platform, various oils containing CBD that were prescription only medicines. The Act prohibits consumer advertising of substances included in Schedule 4 (prescription only medicine) or Schedule 8 (controlled drug) of the Poisons Standard. The TGA alleges that the man referred to prohibited representations in promoting the CBD oils on a social media platform as a treatment for cancer and a cure for brain tumours. Source: TGA media release
GMP annual report
The TGA has released its annual GMP report for the financial year 2019-2020. This includes information on the number of different types of GMP licensing applications received and inspections carried out, processing times for both local and overseas manufacturers, and outcomes of the inspections. On page 13 there is a list of common deficiencies. Interestingly, 29 local manufacturers were given an A1 compliance rating based on inspections conducted during the 2019¬20 financial year. Source: TGA news release
Laboratory Testing Results
The TGA has posted their database of laboratory testing results. Although numerous products passed the tests applied, many did not, and results included bacterial contamination, presence of prohibited substances such as Aristolochic Acid and Amygdalin. Source: TGA.
Country of Origin
On 10th December the country of origin regulations were updated, providing clarity to manufacturers of complementary medicines as to what is a “process of substantial transformation”. The updated legislation can be viewed here.
Alkaloids of Australia Pty Ltd and its former export manager, Christopher Kenneth Joyce, have each been charged with 33 criminal cartel offences, contrary to the Competition and Consumer Act 2010, formerly the Trade Practices Act 1974, following a criminal investigation by the ACCC. The ACCC alleges that Alkaloids of Australia and other overseas suppliers of SNBB made and gave effect to arrangements to fix prices, restrict supply, allocate customers and/or geographical markets, and/or to rig bids for the supply of SNBB to international manufacturers of generic antispasmodic medications. Alkaloids of Australia produces and supplies the active pharmaceutical ingredient SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide), which is the active pharmaceutical ingredient in antispasmodic medications taken to relieve stomach pain and bowel cramps. Source: ACCC media release
Unlawful Importation of Cosmetic Injectables
The Magistrates Court of Victoria has convicted a Melbourne woman on three charges of unlawful importation of therapeutic goods, namely dermal filler medical devices (pre-filled syringes containing hyaluronic acid) and hyaluronidase (enzymes that can be used to dissolve dermal fillers), which is a therapeutic good for cosmetic use in humans. At the time of importation, the woman had not included the goods in the Australian Register of Therapeutic Goods (ARTG). Fines were issued but were unpaid. Criminal prosecutions are an enforcement tool the TGA can use to address serious non-compliance and in cases where infringement notices have not been paid. Source: TGA
Down-schedule of low dose cannabidiol (CBD) preparations
The Therapeutic Goods Administration (TGA) has down-scheduled certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine). Low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures. Source: TGA media release
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