Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
FSANZ Apologises to Nanotechnology Experts for Misrepresenting Views About Nanoparticles in Baby Formula
Australia's food regulator had to apologise to its own advisory group of nanotechnology experts after it "misrepresented" the group's views in its public slapdown of a study that found needle-like nanoparticles in baby formula. Tests by an Arizona State University team showed the presence of needle-shaped hydroxyapatite nanoparticles – which the European Union's Scientific Committee on Consumer Safety had concluded was potentially toxic – in two formula products. Source: Ester Han, SMH Nanoparticles
Australian Government Failing Foods Report
The Department of Agriculture and Water Resources Imported Food Inspection Scheme (IFIS) compiles and publishes data from inspections of imported food consignments in its monthly failing food reports. Future consignments of the food from producers of failing foods will be inspected at the rate of 100 per cent of consignments until the food demonstrates compliance with Australian food standards. Failing food reports identify foods that have failed analytical testing or do not meet the compositional requirements of the Australia New Zealand Food Standards Code. The reports do not list foods that have failed for noncompliant labels. The latest report is for December 2017 and details the failings of 36 different foods stopped at Australian borders. Various sea-foods and spices were the main culprits and microbial contamination with salmonella, E. coli and even vibrio cholera being found in the product. Source: Food fails
NSW Food Authority Recalls —
De Bortoli Woodfired Heathcote Sparkling Shiraz: De Bortoli Wines has recalled Woodfired Heathcote Sparkling Shiraz due to exposure to sustained heat for extended periods which may cause the bottle to shatter. Source: Hot wine
Coconut Milk Powder Non Organic / Non GMO: Murray River Organics Pty Ltd has recalled Coconut Milk Powder Non Organic / Non GMO from The Source Bulk Foods stores due to the presence of undeclared allergen (milk). Source: Coconut milk
Tasmanian Smokehouse Australia Sliced Smoked Salmon: Tassal Operations Pty Ltd has recalled Tasmanian Smokehouse Australia Sliced Smoked Salmon for sale in Food Works Summerland Point NSW store only, due to the application of incorrect use by date. Source: Tassal hassle
Golden North Ice Cream - assorted products: Golden North Pty Ltd has recalled assorted frozen ice cream products (various flavours and sizes) due to the possible presence of small metal pieces in the ice cream. Source: Metal ice-cream
Mamee Monster Rice Sticks Vegetable Flavour: The recall is due to the presence of an undeclared allergen (gluten). Source: Gluten allergy
Fruit Mince Tarts: The recall is due to the presence of an undeclared allergen (tree nuts - pistachios). Source: Nut allergy
Coles Potato Salad: Coles has recalled Coles Potato Salad due to the presence of an undeclared allergen (gluten/wheat). Source: Potato salad
NZ Sausage Smuggler Sent Packing
A Belgian air passenger has been forced to leave New Zealand after attempting to smuggle 3 sausages into Auckland. Ministry for Primary Industries (MPI) staff intercepted the sausages on Sunday after the passenger attempted to conceal them in a backpack when passing through biosecurity checks at Auckland Airport. "One of our x-ray operators spotted the risk items. They turned out to be pork and salami sausages, both of which could have carried diseases with the potential to cause major harm to New Zealand agriculture," says Craig Hughes, MPI's north passenger manager. The passenger was refused entry to New Zealand after the man admitted he intended to hide the sausages from biosecurity officials. Source: Silly sausage
Fine for NZ Plant Smuggler
An air passenger has been fined $2250 for following his cousin's advice to smuggle plant cuttings and seeds into New Zealand. Deo Rajan Gounder appeared in the Manukau District Court on Wednesday after pleading guilty of trying to bring 4 plants and 11 seeds into Auckland Airport in July last year. MPI biosecurity officers found the plant material at the bottom of a chilly bin containing food. Two of the cuttings were Neem plants. The others were unidentified. Source: Plant smuggler
FSANZ Calls for Comment on Changes to Maximum Residue Limits
Food Standards Australia & New Zealand has called for submissions on a proposal to change maximum residue limits for some agricultural and veterinary chemicals. The closing date for submissions is COB 26 February 2018. Source: MRL comments
FSANZ Notifications —
Application A1130 – Triacylglycerol Lipase as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of triacylglycerol lipase from Candida cylindracea as a processing aid in baking, dairy foods processing and fats and oils processing. Source: Food enzyme 1
Application A1131 – Aqualysin 1 (Protease) as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus for use as a processing aid in the manufacture of bakery products. Source: Food enzyme 2
Application A1155 – 2’-FL and LNnT as novel foods in infant formula and other products: The purpose of the Application is to permit voluntary use of 2’-O-Fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by similar but independent proprietary fermentation processes, as novel foods in infant formula (IF), follow-on formula (FOF) and formulated supplementary foods for young children (FSFYC) (specifically milk products). Source: Novel infant food
Codex Committee on Food Additives Convenes in Xiamen, Fujian Province, China
The 50th Session of the Codex Committee on Food Additives will be held from the 26th to the 30th March 2018 in Xiamen, Fujian Province China. The Session will begin at 9:00 on Monday 26 March 2018. The Session will be conducted in English, French, Spanish and Chinese. All participants should provide their information (names and addresses) through the online registration system by 26 February 2018. Source: Codex conference
Cosmetics (& Household cleaning products):
An Historical View of Ointments, Creams & Lotions
RFA’s regulatory colleagues in Europe have provided a very interesting article on the historical development of topical applications down the ages. From Hippocrates and Galen, all the way to modern global cosmetic regulations, you can read about the fascinating development of cosmetic applications. Source: CONUSBAT Topical history
Robert Forbes & Associates, T/A RFA Regulatory Affairs wishes all of our clients a Happy and Holy Christmas Holiday break.
Our office will be closed from end of business day on Thursday 21st of December 2017 and reopen on Tuesday 2nd of January 2018
Training Course Update:
NEW COURSE NOW AVAILABLE
Pharmacovigilance Obligations Training. For details see foot of this newsletter
Chinese State-Run Sovereign Fund Among Bidders for Australian Supplement Firm Nature's Care
A division of China's state-run investment fund is believed to be among the front runners to snap up Australian vitamin maker Nature's Care, as it embarks on its second sale attempt with a price tag of around $1bn. The Australian supplement company first attempted to find a buyer in 2016. Source: Garry Scattergood, Food-Navigator, Asia Nature's Care
Food Trends to Watch in 2018
Knowing what’s hot and what’s not can help food and beverage companies to better develop, position and market products. Listed are 10 food trends expected to create buzz at retail and foodservice in 2018. Topics include: Colour Is the New Sugar; Cracked Pepper Is the New Sea Salt; Pistachio Country Transcontinental; &, Vegan and Non-GMO Are the New Green Badges of Food Formulation Courage, amongst others. Source: Judie Bizzozero, Food Insider Journal 2018 food trends
Quote for the month:
“Eating organic isn’t a trend, it’s a return to tradition” Anon.
A New Zealander has a “shell” company structure in Australia called Australian Health Products PTY Ltd. (ABN 67 092 335 638). It is maintained through an accountant and all taxes have been paid etc. but this company has not traded for some time and it never had branded products. The name/company is for sale as it’s no longer required. Please contact RFA if you are interested and we can link you to the seller.
RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available
RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.
All courses are presented in a modular format of either two or three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.
NEW COURSE NOW AVAILABLE!
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 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”):
ACCC Sues Voltaren Makers GlaxoSmithKline and Novartis for Misleading Consumers
The Australian Competition and Consumer Commission watchdog is taking GlaxoSmithKline and Novartis to the Federal Court, alleging the global pharma giants misled consumers about their Voltaren Osteo Gel and Voltaren Emulgel pain relief products. GSK and Novartis marketed Osteo Gel as a specific osteoarthritis medication more effective at treating the condition than Emulgel, when the two products had in fact the same pain-relief ingredient, the Australian Competition and Consumer Commission claims. In a similar case, in December 2016, the Full Federal Court ordered the Australian branch of Reckitt Benckiser to pay a $6 million penalty for making false representations that Nurofen Specific Pain products were each formulated to specifically treat particular types of pain. Source: Voltaren charge
USA Industry Rallies Behind FDA’s Warning on SARMS
The FDA has recently issued a consumer warning about the use of SARMs, or selective androgen receptor modulators, in bodybuilding products. The administration warns against the potentially dangerous ingredients that pose serious health concerns to consumers, including (but not limited to) increased risk of heart attack, stroke, and life-threatening liver toxicity. Five major trade associations serving the natural products industry have banded with the U.S. Anti-Doping Agency (USADA) in solidarity with the FDA. The trade associations in support of the FDA’s consumer warning include the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA), and the USADA. Source: WholeFoods Magazine SARMS warning
TGA Updates the Permissible Ingredients Determination for Listed Medicines
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in November 2017. A total of 85 changes have been made in the updated Determination. These changes include: The addition of 32 new ingredients; &, Changes to 53 existing ingredient entries (including: making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer. A complete list of changes to ingredient availability can be found here: Permissible ingredients
TGA Presentations: Complementary Medicine Reforms Information Sessions, November-December 2017
The TGA held a series of information sessions on reforms to the complementary medicines framework. The presentation topics included: Background and progress of complementary medicine reforms; Permitted indications for listed medicines; &, The assessed listed medicines pathway. Source: Listed medicine presentations
Update on Child-Resistant Packaging Requirements for Medicines 2017 (TGO 95)
TGO 95 makes minor changes, of which there are no perceived changes for complementary medicines. Source: Child-proof
TGA Safety Advisories –
Editor’s Note: It has been a big year for Australian Customs (AQIS) & the Therapeutic Goods Administration (TGA) after a record number of bogus medications have arrived on Australian shores in 2017. Far and away the most common offenders are fake-medicines containing varying undeclared amounts of Viagra-like chemicals. The next most common category violators are weight-loss medicines containing undeclared amounts of often banned stimulants and prescription drugs. For this year’s full list go to: 2017 alerts