Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Department of Agriculture and Water Resources Amends Food Surveillance Protocols
This Australian authority has completed a review of the surveillance tests applied to many imported food products. Fresh and frozen meat (to start screening for certain antibiotic residues identified as being of high importance to human medicine.); fruit, vegetables and dried herbs that are minimally processed and are ready to eat (to screen for presence of E. coli and Salmonella). As well, hemp seed and hemp seed products, which have been permitted for sale since 12 November 2017, will now have their own screening protocols. From 24 April 2018 the department will introduce testing to verify that imports are derived from low THC cannabis sativa seed and comply with the permitted levels for total THC and cannabidiol. Hemp seed and hemp seed protein powders/flour referred for inspection will be cleared where total THC is not more than 5 mg/kg, cannabidiol is not more than 75 mg/kg, &, hemp oil has a total THC not more than 10 mg/kg and cannabidiol is not more than 75 mg/kg. Source: Food surveillance
Australia’s New Country of Origin Information Standard: A Competitive Advantage for New Zealand?
The new Country of Origin (Food Labelling) Information Standard 2016 is mandatory from 1 July 2018. The effect of this Information Standard in combination with the Trans-Tasman Mutual Recognition Agreement could enhance a competitive trade advantage for New Zealand food companies over Australian companies globally. Under New Zealand law, any New Zealand country of origin claims are permitted but are voluntary. New Zealand has never made country of origin labelling mandatory. If a New Zealand company chooses to emphasize the New Zealand origin of its product, this is because of a belief in the marketplace that the claim can attract a price premium. New Zealand companies know that they can trade off the “clean, green” reputation of New Zealand food products without having to meet the technical burdens that are imposed on Australian companies by the CoOL Information Standard applicable to products that are manufactured in Australia. Source: Lederman & Fisher, Food Legal NZ CoOL (Editor’s note: This information is relevant to ‘foods’, but not to ‘complementary medicines’, which although classifed as ‘food supplements’ in some countries, are categorised as medicines in Australia. The Australian Competition and Consumer Commission is very shortly about to release new guidelines for complementary medicines’ country of origin claims and this will be detailed in our next newsletter. Stay tuned!)
Food Standards Australia & New Zealand has released a survey looking at the levels of seven plasticisers which may be used in food packaging materials. The plasticisers were inspected in a broad range of Australian foods. It found that migration of packaging chemicals into Australian foods is very low and presents a negligible risk for Australian consumers. Source: Plasticisers in food survey
NSW Food Authority Recalls – Source: Current recalls
Macro Chinese Honey Soy Flavoured Tofu: Woolworths has recalled Macro Chinese Honey Soy Flavoured Tofu due to the presence of an undeclared allergen (peanut).
Washed Rind Cheeses: Washed Rind Pty Ltd has recalled a variety of cheeses made in France due to potential Listeria monocytogenes contamination.
Home Ice Cream Coconutters Mango Vanilla: Home Ice Cream Pty Ltd has recalled Home Ice Cream Coconutters Mango Vanilla due to the presence of an undeclared allergen (milk).
The Whole Foodies SEA VEGETABLES Mixed Seaweed: Unique Health Products Pty Ltd has recalled The Whole Foodies SEA VEGETABLES Mixed Seaweed due to high level of Arsenic.
Macro Natural Sunflower Kernels: Woolworths has recalled Macro Natural Sunflower Kernels 500g due to the presence of an undeclared allergen (tree nut - walnut).
Planet Food Organic Hemp Vegan Protein - Rich Chocolate Flavour: Healthy Warrior Pty Ltd has recalled Planet Food Organic Hemp Vegan Protein - Rich Chocolate Flavour due to non compliant labelling (soy free claim made on the front of packaging but soy is included as an ingredient).
FSANZ Food Recall Statistics
FSANZ has collected data on Australian food recalls since 1990, including the causes of all recalls and their domestic or overseas origins. This data can be used to identify trends and common problems occurring in the food industry, so that steps can be taken to prevent future issues. These statistics are updated each year. Source: Food recall stats
Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch: The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch). Source: Resistant starch
Application A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811: The purpose of the Application is to seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate. Source: Herbicide tolerant cotton
Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid. Source: Pap enzyme
Proposal P1044 – Plain English Allergen Labelling: FSANZ is working on a proposal to make allergen labelling requirements clearer, which will help food allergen-sensitive consumers and food businesses. The Food Standards Code already contains a mandatory requirement to label 10 allergens; however it does not include requirements for the terminology that should be used. The proposal aims to make allergen labelling clearer so that food allergen-sensitive consumers have the information they need to make informed and safe food choices. The first consultation paper for the proposal was released in February 2018. Source: Allergen labelling
Cosmetics (& Household cleaning products):
NICNAS Invites Feedback on General Rules, Categorisation Guidelines and Transitional Rules
In Australia, all cosmetics and personal care products are regulated by The National Industrial Chemicals Notification and Assessment Scheme. As part of the Australian Government's reforms to NICNAS, all relevant stakeholders are invited to submit comment before the reforms are finalised. The new scheme is expected to be implemented by 1st July 2019. Sources: NICNAS reform process; &, NICNAS legislation\
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ACCC Publication: “Advertising and Selling—A Guide for Business”
The Australian Competition & Consumer Commission has released this very helpful and comprehensive document outlining all of the important consumer related issues that need to be considered when advertising or promoting products in Australia. While there is the usual advice to avoid misleading or deceptive claims or conduct, there are particular issues that will be of special interest to our readers. (See especially pages 17+ “Marketing claims that require extra care—premium and credence claims”). Health claims, Premium claims, Animal welfare claims, ‘Not tested on animals’, Environmental and organic claims, and, Country and place of origin claims are among the many topics covered. Using detailed examples and case studies, the ACCC takes the guesswork out of just what is and what isn’t acceptable as a marketing claim for your product. Source: ACCC marketing guide
Quote for the month:
“Let us prove to the world that good taste, good art, and good writing can be good selling” William Bernbach
Business Name for Sale
‘Australian Health Products Pty Ltd’ is available for sale as a company name. Please address any and all inquiries to Rob Haines at New Zealand Health Food Company
RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney
Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.
Pharmacovigilance Obligations Training
In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use.
This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
Complementary Medicines (“Dietary supplements”):
BREAKING NEWS! Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Update
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. These are the most significant changes to the legislation affecting complementary medicines in Australia since the Therapeutic Goods Act was first introduced. The Bill establishes a new ‘intermediate’ pathway for ‘complementary medicines sitting between Aust-Listed and Aust-Registered, and introduces improvements in the way new substances are processed. In next month’s newsletter we will include a detailed and comprehensive summary of the changes and how they might affect you. Source: Legislation passed
TGA Complementary Medicines Reforms – Permitted Indications, Including Traditional Indications
The reforms are designed to give greater certainty and protection for consumers regarding traditional medicines, such as Chinese and Indigenous medicines. The guidelines for traditional medicines are in line with World Health Organisation guidelines on the role of complementary medicines. This will make it easier for consumers to differentiate between traditional orcomplementary medicines which have had scientific evidence assessed and those that have not. Once the new system is in place any companies which make claims that are found not to have the evidence to support their statements, will have their products removed from the Australian Register of Therapeutic Goods unless corrective action is taken. Source: TGA evidence
TGA Pharmacovigilance Inspection Program Risk Assessment Survey
The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete. The survey will remain open until 31st March 2018. Medicine sponsors that do not complete the TGA Pharmacovigilance Inspection Program Risk Assessment Survey before 31 March 2018 will be given the highest risk score and prioritised for inspection. Source: Pharmacovigilance survey Editor’s note: Please see newly created RFA training course on pharmacovigilance – details at foot of this newsletter.
TGA Flags Changes to the Permissible Ingredients Determination
All ingredients available for use in listed medicines and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Ingredients) Determination. Of special interest is the recent addition of 4 new ingredients; and in addition, the new ingredient name “curcuminoids” (for turmeric extracts) should be noted by many complementary medicine suppliers in Australia. Changes that will be made in the first half of 2018 include: herbal naming standard for new herbal ingredients; and removal of some ingredients; and other measures. Source: Permissible ingredients
TGA Guidance on Types of Ingredients in Listed and Registered Complementary Medicines
In this statement, the TGA attempts to specify such items as: active ingredients in complementary medicines; excipient ingredients; colourings permitted; “incidental minor excipients”; proprietary ingredients; labelling associated with proprietary ingredients; GMP requirements for proprietary ingredients; active herbal extracts; amino acid chelates; ingredients in listed CMs; Australian native and endangered species in CMs; and genetically modified substances. Source: CM ingredient types
TGA Proposes Changes to the Current Good Manufacturing Practice (GMP) Fees and Charges
The Therapeutics Goods Administration operates on a fully cost-recovery basis. The TGA engaged Deloitte to undertake a review of its current Good Manufacturing Practice (GMP) fees and charges for medicines and Active Pharmaceutical Ingredients (APIs). The purpose of the review was to improve the accuracy and transparency of the cost recovery arrangements for that regulatory function and address a significant under-recovery over the past four financial years. Deloitte has also examined the fees and charges levied by the TGA's international counterparts for comparable functions. The selection of one option as preferred has been made by Deloitte on the grounds that this option encourages a higher level of compliance by manufacturers and sponsors in order to reduce regulatory fees and charges and addresses all major areas of under recovery. Source: GMP cost recovery. Please see also: Information sessions: Proposal to change GMP fees and charges
The Poisons Standard (the SUSMP) Update
The Poisons Standard February 2018 is the current edition, this supersedes the Poisons Standard October 2017. The current Poisons Standard incorporates numerous changes to the Poisons Standard October 2017. Source: SUSMP 2018
TGA insists that GPs Will Still be Able to Prescribe High-Dose Opioids
The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids. As part of the discussion paper the TGA has issued on the use and misuse of opioids, there is an option about the level of training for potentially dangerous drugs which is being discussed in consultation with the AMA, the RACGP and other appropriate bodies. Source: Prescribing opioids
CMA Publishes Advocacy Booklet, “The Science of Complementary Medicines”
Complementary Medicines Australia (CMA) is the peak industry body for the complementary medicines industry in this country. This handy booklet summarises the use of CMs in Australia and looks at traditional and scientific evidence behind their use. Source: CMA advocacy
AHPA Publishes Botanical Safety Handbook Promoting Safe Use of Herbal Supplements
To help ensure the safe use of herbal supplements and prevent drug interactions, the American Herbal Products Association (AHPA) produced the Botanical Safety Handbook to summarise the latest research on the safety of more than 500 species of herbs. Source: Botanical safety handbook
Medsafe Early Warning on Wormwood Product
New Zealand Medicines & Medical Devices Safety Authority (Medsafe), warns of potential risk of harm to the liver for users of the product ‘Arthrem’. Arthrem is marketed as a natural dietary supplement in New Zealand for maintaining and supporting joint health and mobility. (It is also marketed as a complementary medicine in Australia with the claim “May help to reduce osteoarthritis symptoms of joint pain and stiffness and to improve physical function of the joints”) Arthrem soft gel capsules contain 150 mg of concentrated Artemisia annua extract in grape seed oil. The Centre for Adverse Reactions Monitoring (CARM) has received 14 reports of liver toxicity associated with the use of Arthrem. To date all the reports of harm to the liver have involved patients taking Arthrem specifically. Since the chemical composition of the Artemisia annua extract is not disclosed it is not clear if other products containing Artemisia annua extract have similar effects. Source: Arthrem artemesia