Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics and TGA Listed Sunscreens
Sunscreen Chemicals Found in Blood Plasma
The results of a study by the US Food and Drug Administration (FDA) were released recently and confirmed concerns raised in a study last year by the same researcher (JAMA sunscreen study ). The trial used 48 volunteers to assess the absorption of six ingredients - avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate - in four sunscreen products, lotions and sprays. All six chemicals administered were absorbed and had blood concentrations so high the FDA decided further safety studies were required to determine the effect of exposure to these ingredients. Australian industry body Accord Australasia commented that the FDA study is part of ongoing work being undertaken by the US regulator and the Therapeutic Goods Administration is aware of these studies. Additionally, Accord notes that the study used elevated dosing regimes, which do not reflect the normal use of sunscreens by consumers. Source: Toby Crockford, Brisbane Times Sunscreen study . (Please see also Personal Care Products Council response to this reported study: PCPC study response )
Pristine Pacific Paradise the First Country to Ban Alleged Reef-Bleaching Sunscreen
Pacific holiday spot Palau has taken a radical step towards protecting its marine life by banning sunscreen chemicals linked to concerns about potential coral bleaching. From 1 January 2020, sunscreen that includes ingredients like oxybenzone and octinoxate is no longer allowed to be worn or sold. The compounds are commonly used in sunscreen formulas as they absorb ultraviolet-A rays. It isn’t the only nation leading the way, with Hawaii revealing in 2018 it was also legislating a ban against sunscreen that contained the alleged toxic chemicals. That law comes into effect from January 1, 2021. Source: Emilia Mazza, News.com.au Sunscreen ban (The Australian Industry body Accord Australasia response says that Australian regulators and a number of prominent Queensland reef scientists remain unconvinced by the evidence supporting these overseas bans. Accord cites the following article by Prof Terry Hughes in The Conversation as a balanced, independent view on the science behind the real-world challenges to the Great Barrier Reef - Accord response )
Odd Spot: Dead Monkey in NZ Shipping Container
A dead monkey in a shipping container saw biosecurity officers swing into action in Whāngārei, New Zealand. A staff member at BBS Timbers found the dehydrated monkey body squeezed between sawn timber packs upon opening the container. The fumigated container had arrived from Guyana. The facility quickly alerted Biosecurity New Zealand, which advised how to remove the monkey. A biosecurity officer followed up with an inspection and picked up the body for disposal. "The whole response worked extremely well. We were contacted by the business very early and our officers quickly jumped into gear," says Biosecurity New Zealand spokesperson Stu Rawnsley. Source: Hey, hey, it's a monkey!
Training: RFA Provides Comprehensive Training in Regulatory Affairs
PUBLIC NOTICE – Australian Bushfires
RFA Regulatory Affairs would like to thank all our readers, colleagues and concerned friends for their many levels of support that they have conveyed to us over recent summer months. We much appreciate it.
As you may know, record-breaking temperatures and years of severe drought have fuelled a series of massive bushfires across south-east Australia. Although recent cooler conditions and rain have brought some respite, more than 60 fires are still burning in the states of New South Wales, Victoria and South Australia. Hot and windy conditions are forecast to return to many parts of New South Wales this week. Some 30 people have so far been killed - including four firefighters - and more than 10 million hectares (100,000 sq km or 24.7 million acres) of bush, forest and parks across Australia has burned.
This long hot summer is far from over. While our Sydney office is in no danger, it seems that all our staff know someone personally affected by this environmental disaster. Thank you all for your patience, thoughts and best wishes in these difficult times.
FSANZ Final Report - Review of Food Derived Using New Breeding Techniques
Food Standards Australia New Zealand today released the Final Report on its review of food derived using new breeding techniques (NBTs). FSANZ CEO Mark Booth said the Final Report is the result of a significant amount of work by FSANZ, including extensive consultation with stakeholders and the community on whether the current definitions in the Code for genetically modified foods are fit for purpose given recent advancements in genetic technologies. “The Review found that while there are diverse views in the community about the safety and regulation of food derived from NBTs, many agreed the current definitions are no longer fit for purpose and lack clarity," Mr Booth said. “Based on these findings, FSANZ will prepare a proposal to amend the definitions in the Code in the New Year”. Source: NBT report
Order Amendment to Classify Pure and Highly Concentrated Caffeine Products as Risk Food
Importers and brokers are advised that the Imported Food Control Order 2019 (the Order) was amended to classify pure and highly concentrated caffeine products as risk food, on 12 December 2019. A pure and highly concentrated caffeine product is a food in which caffeine is present at a concentration of 5% or greater, if the food is a solid or semi-solid food (non-liquid); or 1% or greater, if the food is a liquid food. This change enables the department to enforce the prohibition in Standard 1.1.1 of the Australia New Zealand Food Standards Code (the Code) on imports of pure and highly concentrated caffeine products intended for retail sale. Source: Pure caffeine regulation
October 2019 Failing Food Report
This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of October. Among the usual pathogenic organisms detected in these imported foods are such organisms as Vibrio cholerae, Listeria, and E. coli and assorted toxins such as histamine, aflatoxin and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals. There are also failed ‘blended honeys’, as well as a smorgasbord of residual agricultural chemicals. Source: October 2019 food fails
Proposal M1017 – Maximum Residue Limits (2019): 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 2019
Proposal P1054 – Pure and highly concentrated caffeine products: Urgent Proposal P1054 was prepared to amend the Australia New Zealand Food Standards Code to prohibit the retail sale of pure and highly concentrated caffeine food products. Source: Caffeine restriction
Application A1161 – Potassium Polyasparatate as a food additive in wine: The purpose of the Application is to permit the use of Potassium Polyaspartate as a food additive in wine at a maximum permitted limit of 100mg/L. Source: Wine additive
Application A1164 – Pullulanase from Bacillus licheniformis as a processing aid (enzyme): The purpose of this Application is to seek approval to permit the use of the enzyme Pullulanase from Bacillus licheniformis as a processing aid in brewing and starch processing. Source: Brewing enzyme
Application A1166 - Reduction in minimum alcohol for Tequila: The purpose of this application is to lower the minimum alcohol percentage by volume specified in Standard 2.7.5 of the Australia New Zealand Food Standards Code for spirits using the Tequila geographical indication (GI) from 37% to 35%. Source: Tequila alcohol minimum
Application A1173 – Minimum protein in follow-on formula: The purpose of the application is to seek approval to vary the minimum protein requirement in follow-on formula. Source: Baby formula protein
Call for comment on a new steviol glycoside: the application is seeking permission for the use of rebaudioside E, produced using enzymes derived from a genetically modified strain of the yeast, Pichia pastoris. Source: Steviol glycoside
Second call for comment - Plain English Allergen Labelling: The purpose of this proposal to make allergen information clearer, more consistent and prominent on food labels. Source: Food allergen labelling
Complementary medicines ('Dietary supplements')
Safety Review of Coumarin in Topical Listed Medicines and Sunscreens
Coumarin is a naturally occurring chemical found in several food products such as cinnamon. Coumarin is currently permitted for use in listed medicine as an active homoeopathic ingredient (with a maximum concentration of 0.001%) and as an excipient in topical medicines for dermal application. The safety review has established that the appropriate tolerable daily limit for coumarin exposure from all sources (including diet, cosmetic products and sunscreens) is 0.1 mg/kg bodyweight. In the absence of a reliable estimation of Australian intake of coumarin from dietary and cosmetic sources, the requirements for listed medicines will specify that topical products may not exceed a concentration of 0.001% coumarin. Sponsors of existing listed medicines and sunscreens will have until 2 March 2021 to bring their products into compliance. This transition time will align with the March 2020 low-negligible risk changes to the Permissible Ingredients Determination. Source: Coumarin safety review
Changes to the Label Warning Statement Requirements for Menthol and Methyl Salicylate
The Therapeutic Goods Administration (TGA) will be amending the requirements for menthol and methyl salicylate, to be less restrictive, in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). The amendments will mean that some of the existing label warning statements will not be required when these ingredients are present at very low amounts such as when included in topical proprietary ingredient (PI) formulations. Sources: Menthol & salicylate changes and LM's ingredients update
High-Moderate Risk Changes to Permissible Ingredient - Andrographis Paniculata
Andrographis paniculata (also known as ‘green chireta’) is a herb that is currently permitted for use in listed medicines as an active or homeopathic ingredient. Andrographis paniculata is typically used in relation to immune support and immune stimulating effects, such managing colds. The TGA published a safety review in 2015 that suggested an association between Andrographis paniculata and anaphylactic/allergic reactions and also published a safety alert. Since the review in 2015, the TGA has continued to receive adverse event reports concerning anaphylactic/allergic reactions associated with medicines that containing this herb. This further supports a causal association between this ingredient and anaphylactic/allergic reactions. Given the nature of the risk to some consumers, all listed medicines containing Andrographis paniculata, released for supply from 2 May 2020, will need to show the following label warning statement: 'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention' (or words to that effect). Source: Andrographis warning statement
Outcomes: Changes to Permissible ingredients that are Classified as Low-Negligible Risk
On 30 August 2019, the TGA sought comments on proposed changes to the permissible ingredients: Boron, Withania somnifera, Vitex agnus-castus (VAC), Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC'), as well as a number of permissible ingredients relating to Ispaghula, Plantago, Psyllium, Cymbopogon and Malus species. A total of 4 consultation submissions were received in response, from: Accord Australasia, Complementary Medicines Australia, Consumer Healthcare Products Australia, and Naturopaths and Herbalists of Australia. All comments received for this consultation have now been considered and the changes will commence on 2 March 2020. Sources: Permissible ingredients changes & Permissible ingredients determination
Comparable Overseas Bodies (COBs) for Complementary Medicines
The TGA makes use of assessments from comparable overseas bodies (COBs), where possible, in evaluations for complementary medicines and listed OTC medicines (e.g. sunscreens). In response to the Medicines and Medical Devices Review (MMDR) the TGA has implemented transparent criteria for identifying comparable overseas bodies (COBs), as well as a process for using reports from nominated COBs. The TGA can use evaluation reports from comparable overseas bodies (COBs) to evaluate registered complementary medicines assessed listed medicines and substances for use as ingredients in listed medicines. Source: COBs for CMs
TGA Training Course - Evidence Requirements for Listed Medicines
This online training resource is designed for sponsors of listed medicines and aims to supplement the information in the Evidence Guidelines for Listed Medicines. It also seeks to provide additional information in response to common questions and issues encountered by sponsors. It is helpful to have a copy of the Evidence Guidelines for Listed Medicines available to you for reference when completing this 30 minute module. Source: Evidence training module [For more comprehensive training for complementary medicine regulations please see courses listed on our website: RFA Training Courses ]
Technical Guidance on Medicinal Cannabis Manufacture
In 2016 the Australian Government amended the Narcotic Drugs Act 1967 to allow the cultivation and production of cannabis for medicinal purposes. This guidance is for manufacturers of medicinal cannabis products. It outlines and provides information on manufacturing license and certification requirements; differences between the TGA and the Office of Drug Control (ODC) requirements; and TGA interpretation and expectations for compliance with specific sections of the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products (PIC/S Guide to GMP). Source: Medicinal cannabis manufacture
TGA Safety Advisories- Source: TGA current year alerts
Kulchaya Sheaya Lender capsules: The capsules contain the undeclared substance fluoxetine.
Black Storm tablets: The tablets contain the undeclared substance sildenafil.
Brauer Teething Gel 20g: One batch of Brauer Teething Gel 20 g due to bacterial contamination.
NZ Assesses Impact of Medicinal Cannabis Scheme
New Zealand’s Ministry of Health has issued a paper detailing the regulatory impact of the Medicinal Cannabis Scheme which enables domestic cultivation and manufacture of medicinal cannabis, and the import of overseas products. Regulations specific to medicinal cannabis are required to establish the scheme. These will set minimum quality standards for products and set medicinal cannabis licensing requirements. The impact assessment provides supporting analysis for the Cabinet paper seeking approval for policy decisions required to draft the medicinal cannabis regulations. Source: NZ medicinal cannabis
Conflict of Interest: Top Medical Journal takes on Big Pharma
A leading medical journal (The BMJ) is launching a global campaign to separate medicine from big pharma, linking industry influence to the pelvic mesh scandal that injured hundreds of women in Australia. The BMJ says doctors are being unduly influenced by industry-sponsored education events and industry-funded trials for major drugs. Those trials cannot be trusted, the journal's editor and a team of global healthcare leaders write in an editorial published earlier this month. Sources: Liam Mannix, SMH Big pharma & Cochrane study
Potential Herb-Drug Interactions for Commonly Used Herbs
While many useful databases are commonly held behind expensive paywalls, this publicly available chart from Mediherb is easy to read, simple to print and acts as a helpful reminder of what can happen when herbal medicines and prescribed drugs interact in the human body. Source: Herb-drug interactions
ABC-AHP-NCNPR Botanical Adulterants Prevention Program Examines Saw Palmetto and Oregano
The American Botanical Council – American Herbal Pharmacopoeia - National Center for Natural Products Research collaboration has recently published two papers examining product substitution of saw-palmetto (Serenoa repens) and oregano (Origanum vulgare subsp. hirtum, or O. onites). This is the 19th in the series of the Botanical Adulterants Prevention Bulletin (BAPB) and underlines the widespread dilution and/or substitution of herbal ingredients in the supply chain. Sources: Saw palmetto lab guidance & Oregano substitution
Cosmetics and TGA Listed Sunscreens
NICNAS Requests Information on Industrial Uses of Certain Chemicals on the Inventory
The new scheme called the Australian Industrial Chemicals Introduction Scheme (AICIS) commences on 1 July 2020 and replaces the Australian Inventory of Chemical Substances (AICS, which is the current Inventory). Only industrial chemicals will be retained on the AICIS. NICNAS proposes that over 1600 chemicals that are not considered industrial chemicals should be removed e.g. medicines, agricultural or veterinary chemicals and foods. These substances are classified as “excluded use” chemicals. Source: Rationalising the chemical inventory (Please see also: AICIS guidance )
For an introduction to cosmetic regulations please view: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)