Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetic, Personal Care and TGA Listed Sunscreens:
New video explains the basics of AICIS registration
This 2-minute video explains when you do – and don't – need to register your business with AICIS, and gives a quick overview of the fees and charges. Source: AICIS
AICIS Consultation on proposed amendments to the General Rules
Includes clarifying criteria for industrial chemicals introduced at the nanoscale - declarations about data ownership - annual declarations - clarifying record-keeping for listed introductions, specified classes, designated releases to the environment, internationally-assessed - the authorisation process for movement of industrial chemicals into or out of Australia that are subject to the Rotterdam Convention - transitional provisions. Source: AICIS
Annual declaration for all introducers
This is a declaration you make about the industrial chemicals you imported or manufactured during the previous registration year. AICIS has produced a video to explain what is required and how to lodge a declaration. Source: AICIS
Chemicals added to the Inventory 5 years after issue of assessment
Six chemicals added in August 2021. Source: AICIS
Correction of chemical names
Over 100 chemicals have had their names updated during August 2021. Source: AICIS
New Zealand news
Social media “influencers”: The advertising Standards Authority has released a reporting process for advertising breaches. Advertising content must be clearly identified no matter where it is published. Source: ASA.
Country of origin breach: New Zealand Health Food Company Ltd has been fined $377,000 after pleading guilty to engaging in conduct liable to mislead the public about the origin of ingredients in its royal jelly supplements. The royal jelly in the supplements came from China. Most of the other ingredients were sourced from countries other than New Zealand, including Indonesia, Malaysia, China, Papua New Guinea, North America, and Samoa. The royal jelly was put into capsules and packaged in New Zealand, the commission found. Source: Commerce Commission of New Zealand.
Applications, approvals and amendments to the Food Standards Code
FSANZ has commended assessing applications for:
The steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract. The bioconversion enzymes are derived from a genetically modified yeast strain, Pichia pastoris. Source: FSANZ
Maltogenic alpha amylase, sourced from GM Escherichia coli, as a processing aid in baking, brewing and starch processing. Source: FSANZ
Food derived from wheat line IND-00412-7, genetically modified for drought-tolerance. Source: FSANZ
Calls for comment on proposed changes
Summarises issues on which FSANZ has called for comment. The deadlines are mostly in September, and include nutrient composition of infant formula products, maltogenic alpha amylase enzyme from genetically modified Bacillus lichenformis, 2’-fucosyllactose in infant formula products, substances used in sports foods, and the safety of titanium dioxide as a food additive. Source: FSANZ
Failing Food Report – June 2021
Foods inspected at the border. Includes risk food test results and surveillance food test results. Source: Dept Agriculture, Water and the Environment
Current food recalls
Summarises recalls to up until 10th August. Four recalls in August include Leggo’s Fresh Napoli Sauce, Conroy’s smallgoods, Jordan Rover dates and Koo canned mixed vegetable varieties. Source: FSANZ.
Biosecurity import conditions
BICON is the Australian Government's database of more than 20,000 plants, animals, minerals and biological products. You can search the database to determine what import conditions may exist and if an import permit is required. Source: Dept of Agriculture, Water and the Environment
26th Australian Total Diet Study published
FSANZ has released the results of the study which looked at levels of persistent organic pollutants including dioxins, dioxin-like compounds and polychlorinated biphenyls (PCBs) in food. Chief Executive Officer Mark Booth said the results are good news. Source: FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
New sunscreen standard in force
New sunscreen standard in forceThe new sunscreen standard, AS/NZS 2604:2021, specifies requirements and test methods for broad spectrum and water resistant sunscreen products. Includes labelling requirements. Source: Standards Australia
Update to regulatory guidelines for sunscreens
This is relevant to primary sunscreens, which are regulated by the TGA. Most secondary sunscreens are cosmetics, and are excluded from the therapeutic goods regulations. Source: TGA
Using an "agent" to help you with AICIS obligations
From 1st August, manufacturers or importers of industrial chemicals (includes cosmetics) can now use an agent to help submit a 'post-introduction declaration' for exempted introductions on your behalf. Source: AICIS
Complementary Medicines and Medical Devices:
New permitted ingredients for listed medicines
The Permissible Ingredients Determination (ingredients that may be use in listed complementary medicines) has been revised. 61 ingredients have been either added to the list, or had names, restrictions or label statements changed. Source: TGA
Proposed changes to permitted ingredients list
Closing date for comments is Wednesday 15th September. Proposed changes address: Allergen statement for mollusc-derived ingredients - Peripheral neuropathy associated with lower dose vitamin B6 - Risk to infants from nasal use of benzalkonium chloride - Artemisinin and pregnancy risk. Click on link to view more details and respond to the consultation. Source: TGA.
Evolution Supplements Australia and its Director fined $12 million for advertising a range of unapproved sports products, including references to steroids, Selective Androgen Receptor Modulators (SARMs) and pre-workout products containing DMAA and other amphetamine derivatives. This is the largest penalty ever imposed by the Federal Court in relation to the Therapeutic Goods Act. The company Director failed to comply with TGA directions and attempted to conceal the unlawful advertising. Source: TGA
Canberra dental practice issued with 20 infringement notices totalling $266,400 for importation and supply of unapproved dental implants and bone grafts. Source: TGA
Gold Ant tablets seized and future shipments will be stopped at the border. The tablets contain the undeclared substance Sildenafil, a prescription-only medicine. Source: TGA
He Absolute King sachets will be intercepted and destroyed by Australian Border Force as they contain undeclared Tadalafil. Source: TGA
AB SLIM Slim-cellulose capsule tested and found to contain undisclosed sibutramine. Shipments will be destroyed at the border. Source: TGA
Local GMP inspections
Where appropriate, these will take remotely during the COVD pandemic in place of on-site inspections. Source: TGA.
Advertising nicotine vaping products
TGA has allowed pharmacies and pharmacy marketing to groups to promote that they are able to dispense nicotine vaping products (such as nicotine e-cigarettes, nicotine pods and liquid nicotine) on prescription. Source: TGA
Post-market review of face masks
TGA is continuing its post-market reviews. List of cancelled products, non-compliance notices and other action are detailed. Source: TGA
Guidance on regulation of personal protective equipment
Includes overview of regulations, manufacturing and standards, relevant to surgical masks and respirators, surgical gowns and gloves. Source: TGA
Borderline disinfectant and related products with antiviral claims including COVID-19
This is a guide to those products that sit at the interface between consumer goods and therapeutic goods. Source: TGA
TGA launches new information podcasts.
This is a 5 part series "Navigating Therapeutic Goods Regulations" to explain how the TGA works and includes "everything from how to supply therapeutic goods to the TGA Laboratories and remote GMP inspections". Source: TGA
Independent review on MDMA and psilocybin
The Independent Expert Panel has been established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions. Source: TGA
Proposed refinements to the regulation of personalised medical devices
This is a comprehensive summary of 137 responses from a variety of stakeholders to the three proposals put forward. A number of alternative approaches were put forward. Submissions that gave permission to be published can be viewed here. Source: TGA
New biosecurity website
A new website - biosecurity.gov.au - details measures in place to protect Australia from harmful pests, diseases and weeds. This gathers information previously found on different state and federal websites. Source: Dept of Agriculture, Water and the Environment.
Failing Food Report - May 2021
Foods inspected at the border. Includes risk food test results (the usual suspects were identified - Salmonella, aflatoxin, hydrocyanic acid, histamine) and surveillance food test results. This month many products were found to contain vitamins and minerals not permitted. Source: Dept Agriculture, Water and the Environment
Imported food inspection scheme
This summarises data from imported food inspections conducted from 1 January to 31 December 2020. Includes information on compliance, analytical testing (contaminants, microbiological) and other tests. Interestingly, most non-compliance was for labels that did not comply with Australian food standards, including 38.8% of labels lacked or listed either incomplete or incorrect nutritional details; 18.4% of labels lacked or listed either incomplete or incorrect ingredient lists; 16.6% of labels were non-compliant with country of origin labelling requirements; 12.4% of labels lacked importer details. Source: Dept of Agriculture, Water and the Environment
Imported food - virtual inspections of labels
The government is accepting expressions of interest from parties interested in engaging in virtual visual label inspections for eligible imported surveillance food. This is done in real time via Microsoft Teams. Food eligible for a virtual label and visual inspection is surveillance food. However the following surveillance foods are not eligible for virtual inspections: formulated supplementary sport foods; food subject to a holding order; food subject to analytical testing. Risk food is also not eligible for label and visual virtual inspections. Source: Dept of Agriculture, Water and the Environment.
Approvals and amendments to the Food Standards Code and calls for comment on proposed changes
Call for comment on an application to allow an existing enzyme processing aid (maltogenic alpha-amylase, which has a long history of safe use and is already approved to be sourced from another microorganism) to be produced from a new genetically modified (GM) source - a GM strain of bacterium known as Bacillus licheniformis. Source: Food Standards Australia New Zealand
Very Low Energy Diet (VLED) Products: Application to amend the Food Standards Code to include food suited for Very Low Energy Diets (VLEDs) in foods for special medical purpose (FSMPs) Source: Food Standards Australia New Zealand
Gazetted amendments resulting from previous applications:
Irradiation as a phytosanitary measure for all fresh fruit and vegetables
Subtilisin from GM Bacillus licheniformis as a processing aid (enzyme) Variation
Rebaudioside M as Steviol (Glycoside) Variation
Food derived from herbicide-tolerant canola line MON94100 Variation
Formulated Supplementary Sports Foods - FSANZ is now calling for data on substances for use in sports foods. Source: Food Standards Australia and New Zealand
Restrictions on marketing of infant formula
The ACCC has reauthorised an agreement among infant formula manufacturers and importers that prohibits them from advertising and promoting infant formula directly to the public. The ACCC states "A continued ban on infant formula advertising is likely to result in public benefits by protecting rates of breastfeeding, which has significant public health benefits". Source: ACCC
Permitted novel foods
Some foods that have been deemed to be "novel" can be used in certain circumstances. This Standard lists permitted novel foods, and specifies conditions for their use. Source: Federal Register of Legislation.
New Zealand - comments invited on import requirements
This is relevant to "importing personal consignments of products for human consumption and personal effects". This applies to fresh and stored plant products and personal effects (not otherwise already covered by a standard) and applies to items brought into New Zealand via passengers' luggage, and air and sea freight. Source: New Zealand Ministry for Primary Industries.