Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
News From RFA:
RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available
RFA Office News
After nearly 20 years of loyal and valuable service to RFA Regulatory Affairs, Felizitas Parr has retired from her role as our office manager, in order to pursue other interests in her life. Most of our clients will have dealt with Felizitas over the years, and I know that you will be reading this notice with a tinge of sadness as we farewell a familiar and reliable presence from our team. Felizitas capably managed our office through some great changes, including moving our physical address, updating technology and streamlining our business systems. We will forever be grateful to Felizitas for her many years of loyal and dedicated service and wish her well in her new life endeavours.
Austrade Publishes Guide to Supplying Complementary Medicines in China
This report has been prepared by the Commonwealth of Australia represented by the Australian Trade and Investment Commission (Austrade). The guide has been developed to assist Australian companies interested in exploring the rapidly growing and evolving market in China for complementary medicines and nutritional supplements. It provides an overview of the drivers of demand, key channels of distribution and the regulatory environment that applies to these products, along with practical information about doing business in China. Source: Austrade China Report
Quote for the month:
“If goods don’t cross borders, armies will” Frederick Bastiak
The Regulatory Rules for Hemp as a Food in Australia
Following a lengthy review process by Food Standards Australia New Zealand (FSANZ), the Australia New Zealand Ministerial Forum on Food Regulation in March 2017 gave its approval to FSANZ to amend the Australia New Zealand Food Standards Code on the use of hemp in food products in Australia. The approval of hemp in food is not directly related to separate approvals by some Australian State and Territory laws for medicinal cannabis. This article explains the regulatory position. Source: Joe Lederman, Food Legal Hemp as food
Interested in Australia’s Food Regulatory System?
Food Standards Australia New Zealand (FSANZ) is seeking academics with a strong interest in food-related consumer and public health issues to be appointed to the Consumer and Public Health Dialogue (CPHD). If you are currently working in academia in public health nutrition, consumer behaviour or social science, health policy or a related discipline and have a keen interest in the issues and challenges for the food regulatory system, you might like to follow this link: Food dialogue
NSW Food Authority Food Labelling Website
This website helps you find the information you need to understand what a food label is telling you, to help you manage your food choices. If you are a food business, you’ll find information about what you need to include on a food label. Source: Food labelling
Businesses Urged: Use Your Noodle When It Comes To Food Safety
A Sydney noodle manufacturer has been fined a total of $27,000 and ordered to pay professional costs of $9,000 after he pleaded guilty in the Downing Centre Local Court to thirteen charges relating to failures in hygiene, construction failures and harbouring pests on food premises. Source: Noodles are off
NSW Food Authority Recalls:
Kids yoghurt pouches Parmalat Australia has recalled yoghurt pouches due to a packaging fault resulting in a potential choking hazard. Source: Yoghurt choke
Bean paste A South Korean seasoned garlic and sesame bean paste product (Chung Jung One) is being recalled because of the presence of undeclared peanut. Source: Bean paste
COYO Sea Salted Caramel Coconut Milk Ice Cream Alternative COYO Corporate Pty Ltd has recalled COYO Sea Salted Caramel Coconut Milk Ice Cream Alternatives due to the presence of an undeclared allergen (gluten). Source: Alt-Ice Cream
Application A1149 – Addition of Steviol Glycosides in Fruit Drinks The purpose of the Application is to seek approval to amend Schedule 15 relating to Standard 1.3.1 of the Australian New Zealand Food Standards Code to include the addition of steviol glycosides in Fruit Drinks at a level of 200 mg/kg steviol equivalents. Source: Steviol 1
Application A1127 – Processing Aids for Wine The purpose of this Application is to seek permission for the use of four processing aids, silver chloride, ammonium bisulphite, chitin-glucan and PVI/PVP as processing aids for wine. Source: Wine aids
Proposal A1150 – Glucosylated Steviol Glycosides The purpose of the Application is to permit the use of glucosylated steviol glycosides as an intense sweetener in various foods. Source: Steviol 2
Proposal M1015 – Maximum Residue Limits (2017) 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: MRL 2017
Proposal P1046 – L-amino acid acetate in Food for Special Medical Purposes The purpose of this proposal is to remove a negative impact on trade to enable sale of a food for special medical purposes (FSMP) by permitting acetate forms of L-amino acids. Source: Amino acetate
Call for submissions on genetically modified rice application FSANZ has called for submissions on an application to permit a genetically modified rice line that produces a form of provitamin A. Source: Mod rice
Consultation paper on infant formula products for special dietary use FSANZ has released a consultation paper on infant formula products for special dietary use. FSANZ Chief Executive Officer Mr Mark Booth said the paper was the next stage of a proposal looking at revising and clarifying standards relating to infant formula. Source: Infant formula
Consultation paper released on beta-glucan and blood cholesterol health claims FSANZ has released a consultation paper about beta-glucan and blood cholesterol health claims. The consultation paper follows a recent review by FSANZ of the food-health relationships between beta-glucan, oats and barley and blood cholesterol. The review found that a food-health relationship between oats (not barley) and blood cholesterol is substantiated, not the current pre-approved relationship for a high level health claim between beta-glucan and blood cholesterol. Source: Beta-glucans
Editor’s note: Submissions for all three consultations close at 6pm (Canberra time) 14 September 2017.
Cosmetics (& Household cleaning products):
Accord Launches BeadRecede - An Initiative for Responsible Industry Action on Plastic Microbeads
So, what’s the deal with plastic microbeads? Well, firstly there is a growing issue with plastics of all types, not just exfoliating beads in facial scrubs, getting into the marine environment. And related to this is the characteristic that plastic materials in general neither break down nor biodegrade with any ease, once they are in the marine environment. All of which can be bad news for our oceans. On 25 November 2016 Australia’s environment ministers formally endorsed a voluntary industry phase out of plastic microbead ingredients from cosmetic, personal care and household cleaning products. To help raise awareness of the minsters’ goal and facilitate widespread participation in the voluntary phase out project Accord Australasia has recently launched the ‘BeadRecede’ initiative. Via BeadRecede Accord is encouraging companies to actively support the phase out timing announced by Australia’s environment ministers, as relevant to the products they make and supply. Source: Esprit BeadRecede Editor’s note: Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic, and specialty products, their raw material suppliers and service providers.
Senate Committee Inquiry on Industrial Chemicals Report Tabled
This report concerns the legislation Industrial Chemicals Bill 2017 and the related Senate Inquiry, which is due to report on Tuesday 8 August. Source:Chemical bills
Canadian Cosmetics Industry Group Undertakes Name Change
CCTFA (Canadian Cosmetics, Toiletry & Fragrance Association) is now known as CAC (Cosmetics Alliance Canada): https://www.cosmeticsalliance.ca/
Complementary Medicines (“Dietary supplements”):
TGA to Change Online Listed Medicine Applications Process
The Therapeutic Goods Administration intends to remove the “free text” indication field which is currently available for online Listed Medicine applications. This field enables you to enter the wording you would like for product claims. The only indications that may be included in TGA product listing applications from 1st January 2018, will be from a database of permitted indications and the wording is specified. There will be a 3 year transition period to re-list products using only the permitted indications. From 1st January 2021, listed medicines will only be able to contain permitted indications. There will be no TGA fee for re-listing with permitted indications if sponsors re-list between 1st January 2018 and 30th June 2019. The AUST L number will remain the same.
What needs to be done now? The TGA proposed permitted indications list is available on the TGA website for comment until 31st October 2017, and sponsors can apply to have new indications included in this list without any TGA fees. After this date, an application fee will apply. If you cannot find the indications for a product that is an existing Listed Medicines on the Australian Register of Therapeutic Goods on the list we suggest you submit your proposed indications to the TGA during the fee-free period, or RFA Regulatory Affairs can assist with applying for the indications to be included in the permitted indications list. Let us know! Source: RFA Regulatory Affairs – Technical Report
TGA Provides Guidance on Pre-submission Meetings
This guidance is for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications to enter therapeutic goods on the Australian Register of Therapeutic Goods (ARTG); and for TGA Conformity Assessment Certification (for the manufacture of medical devices). It does not apply to applications for a manufacturing licence or Good Manufacturing Practice certification or clearance. Source: TGA pre-meetings
TGA Provides Guidance on the Regulation of Tampons in Australia
Tampons are therapeutic products which are regulated as 'Other Therapeutic Goods'. Before they can be supplied in Australia, they must be listed on the Australian Register of Therapeutic Goods (ARTG). Tampons supplied in Australia must comply with Therapeutic Goods Order No.82 - Standard for Tampons - Menstrual. This aims to ensure that tampons are manufactured in a manner that will minimise recognised risks to health associated with the use of these products. Source: Tampons
TGA Changes Ruling on Vitamin A – Beta Carotene Naming
Did you know that a Listed Medicine label can now refer to the retinol equivalents of betacarotene? They can! The maximum daily dose of 3000 RE/microgram of vitamin A does not apply to this source of vitamin A and the TGA has advised that this is due to the unique action of betacarotene (where it is converted in the body to vitamin A selectively, depending on reserves of vitamin A). In the case of a combination product that contains betacarotene and another source of vitamin A, the dose of the other sources of vitamin A may not exceed 3000 RE/microgram, however the addition of betacarotene does not contribute to this quantity. Currently, in the Permissible ingredients determination 26BB, if vitamin A is declared as an equivalent of betacarotene, then the VITA3 and VIT warnings are required on the product label and the equivalent vitamin A should be expressed in the relevant R.E. units. The TGA have advised that the requirement for the VIT warning will be removed from betacarotene in the October 2017 update to the Permissible Ingredients Determination. As you are not required to declare the vitamin A content of betacarotene, it is also not a requirement to declare its quantity on the label even if it is included on the Australia Register of Therapeutic Goods entry for the product. If you would like your label reviewed or more advice on betacarotene or Vitamin A, get in contact with RFA. This is a significant policy change from the TGA, as previously betacarotene could not be stated in retinol equivalence. Source: RFA Regulatory Affairs – Technical Report
TGA Announces Labelling Changes: Information for Health Professionals
The TGA has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and to use them more safely. Source: Label changes
TGA Addresses Issues Related to Supply of Medicinal Cannabis in Australia
The (recent ABC) Lateline story made claims that patients are turning to the black market for medicinal cannabis products because of excessive red tape, principally in seeking approvals under the Special Access Scheme Category B. This scheme has operated for many years and the TGA provides over 20,000 approvals per year for doctors to prescribe a range of unregistered medicines. The TGA claims that the approval system can and does work efficiently to meet the needs of patients so why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, 'There is a great paucity of evidence in the literature, at least when it comes to human trials'. Source: Medicinal cannabis Editor’s note: See also related stories from TGA Presentations: Legislation and patient access schemes for medicinal cannabis ; &, Medicinal cannabis cultivation and manufacture update
TGA Safety Advisories
Bittermelon Slimming Capsules; Herbal Max Real Slim Capsules; Majestic African Mango capsules: the capsules contain the undeclared substance sibutramine &/or phenolphthalein.
Germany Black Gorilla tablets; Maxidus capsules; Rhino 9 capsules: the tablets contain the undeclared substance sildenafil.
M Distribution - male herbal supplements: M Distribution, in consultation with the TGA, has initiated a recall of Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules as they contain tadalafil, dimethylaminoethanol (DMAE or Deanol), &/or sildenafil and dapoxetine.
Source: TGA alerts