Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Young Men Shun Products with Health Claims, Spanish Study Suggests

Young, healthy men are more likely to actively avoid, rather than be attracted to, products with prominent health claims such as reduced-fat or high-fibre, according to new research in Spain.   Source: Eliot Beer, Food navigator-Asia Spanish men

Quote of the Month:

“The food that you eat can be either the safest and most powerful form of medicine or the slowest form of poison”   Ann Wigmore

 

TGA Fact Sheet: Folate and Folic Acid for Use in Listed Medicines

This fact sheet has been created for sponsors who wish to list folate products on the ARTG. It is intended to provide general information on the most commonly used folates and answer the most frequently asked questions. Folate, or vitamin B9, is an essential vitamin required by the human body for normal growth and development as it plays a critical role in the synthesis of DNA and RNA, and in the metabolism of certain amino acids. The term "folate" is actually a generic name for a group of related compounds with similar nutritional properties. The three most commonly used forms are folic acid, calcium folinate and levomefolate salts. All three forms can be incorporated into the body's metabolic pathways and may provide sources of the same biologically active form of folate – a compound known as 5-methyltetrahydrofolate (5-MTHF) or levomefolic acid.   SourceFolate

'Painful' Sunscreen Burn Cases Ignite Call for Review of Product Testing in Australia

More stories are emerging of people being left "red raw" despite using popular sunscreen products, prompting calls from a leading public health advocate for a review of the way Australia regulates sunscreens. Michael Moore, chief executive of the Public Health Association of Australia, said the reports were extremely concerning. He said it was time for the Therapeutic Goods Administration (TGA) — Australia's sunscreen regulator — to examine its processes to make sure sunscreens were being adequately tested before going on the market. The director of the only company carrying out independent laboratory testing of sunscreen in Australia wants an overhaul of international testing standards. John Staton runs Dermatest, a Sydney laboratory which tests the SPF factor of sunscreens. He said the problem is that many sunscreens sold in Australia are tested in the United States and Europe.   Source: Amy Bainbridge, ABC News Sunburn

TGA Approves Permissible Ingredients (26BB) Determination No.1 of 2017

Complementary Medicines Australia advises that The Therapeutic Goods Administration (TGA) has approved the new Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017. TGA anticipates that the updated Determination will be published and available on the Federal Register of Legislation (FRL) after 30 January 2017. The new Determination includes a total of 293 changes to ingredients available for use in listed medicines including the addition of 11 new ingredients and the deletion of one ingredient.   Source: via CMA, Permissible ingredients

TGA Consultation: Scheduling Medicines and Poisons

The Therapeutic Goods Administration is seeking comments from interested parties on proposed amendments to the Poisons Standard. The TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. This consultation closes on 10 February 2017.   SourceSUSMP consultation

TGA Reviews Scientific Literature on Sunscreen Actives

This scientific review report is limited to the review of safety concerns surrounding zinc oxide (ZnO) and titanium dioxide (TiO2) nanoparticles (NPs) present in sunscreens. The two main issues considered in this review are the evidence for the ability of these NPs to penetrate the skin to reach viable cells and the potential toxicity exerted by them. The TGA has been continuously monitoring the emerging scientific literature in this area and working cooperatively with international regulatory agencies to ensure that appropriate regulatory action is undertaken if any unacceptable risk of harm/toxicity is identified.   SourceSunscreen lit-review

TGA Recalls:

Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) - Consumers and health professionals are advised that Beijing Tong Ren Tang Australia, in consultation with the TGA, is recalling one batch of its Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) due to the presence of aristolochic acid. There is no established safe exposure level to aristolochic acids.   Source: Sports pill

The Cider Lab (assorted beverages) - Asahi Premium Beverages Pty Ltd has recalled The Cider Lab assorted beverages sold by liquor stores nationwide due to the presence of an undeclared allergen (sulphites)   Source:CiderLab

 

 

Are Perfumes a Potential Health Hazard?

North American activist groups are the primary source of concerns surrounding perfumes. There have been suggestions that perfumes contain chemicals that are either not disclosed to the consumer (“secret chemicals”); or, have not been thoroughly tested for safety and have serious health implications (including hormone disruption, allergic reactions, health effects resulting from accumulation in the body). In Australia, cosmetics and personal care products must be labelled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. This requires that all intentionally added ingredients must be listed on the product label. However, there is no legal requirement that each individual component of a fragrance be listed on the product label. In recognition that many consumers want to know what is in the products they use, the fragrance industry has published the list of over 3000 fragrance ingredients from which fragrances are formulated, and which are used in consumer products worldwide. All ingredients on this list have passed the International Fragrance Association (IFRA) safety standards and are used in consumer goods worldwide.   Source: Furphies.org Perfume ingredients

What Does NICNAS Require From a Chemical Importer?

If you are an importer of chemicals into Australia for commercial purposes then you will already be registered with NICNAS and paying an annual fee based on the quantity of “relevant industrial chemicals” imported. But are you paying too much? Make sure that you are not simply declaring the total quantity of ingredients in the entire formulation of your product. There are five types of ingredient that need to excluded before calculating your annual chemical import quantities and this difference could save big money every year.   Source: Relevant chemicals

NZ Government Regulation of Microbeads in Personal Care Products

The Government is seeking views on its proposed ban on the sale and manufacture of plastic microbeads in personal care products in New Zealand. Submissions close at 5.00pm on Tuesday 28 February 2017.   Source: NZ Microbeads

 

Cosmetic Suppliers Unite!

Are you in the business of supplying Cosmetics or Personal Care products into Australia & New Zealand? Did you know that Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers? Get information, support, protection and power under one united organisation, especially for you.  Visit http://accord.asn.au/ for more.

Hiring a Social Media Management Team

Hiring a team of experts who understand and live and breathe social media helps you avoid the frustration of staying current on the latest dos and don’ts and keeps your social media channels running smoothly so you’re free to run your business. One social media channel can take numerous hours to run effectively. Now multiply that by the number of social media channels you have, or want, and you can see how quickly the hours stack up. By bringing a social media management company to join your team, you can stay ahead of the curve and quickly jump start your marketing program.   Source: Sheldon Baker, The Garner Group Social media

 

Quote for the Month:

“Everything that you post on social media impacts your personal brand. How do you want to be known?”   Lisa Horn, a.k.a. The Publicity Gal

 

Titanium Dioxide Food Additive Under Review, After Study Finds Cancer Links

Titanium dioxide or E171 is used by the food industry to whiten and brighten food and other consumer products, such as sunscreen and cosmetics. Exposure to nanoparticles of titanium dioxide and other additives has previously been shown to interfere with the immune system and cause cell damage, however such impacts remain under debate. But a study by the French National Institute for Agricultural Research, recently published in the journal Nature, has shown for the first time that titanium dioxide nanoparticles are absorbed by the intestine and passed into the bloodstream of animals after oral exposure.   Source: Lucy Cormack, SMH titanium dioxide

Department of Agriculture Updates Date Marking and Other Labelling Requirements for Imported Food

The purpose of this notice is to provide detail to importers about some of the labelling non-compliances that are regularly identified by the department regarding imported food. The department conducts a label assessment on all food products that are referred for inspection under the Imported Food Inspection Scheme (IFIS). Of all the noncompliance detected under the IFIS, food product labelling amounts to over 75 per cent of all failures!   Source: Imported food labelling

FSANZ Notifications -

Application A1140 – Food derived from Herbicide-tolerant Canola Line MS11

The purpose of the Application is to seek approval for food derived from herbicide-tolerant, male-sterile canola line MS11, genetically modified to provide tolerance to the herbicide glufosinate-ammonium.   Source: Canola roundup

Application A1090 – Voluntary Addition of Vitamin D to Breakfast Cereal

The purpose of this Application is to permit the voluntary addition of vitamin D to breakfast cereal.    Source: Vit D cereals

Application A1113 – Extension of Use of Propionates in Processed Meat

The purpose of the Application is to request the extension of use of propionates as anti-microbial preservatives in processed meat products.  SourceProceessed meats

Application A1115 – Irradiation of Blueberries & Raspberries

The purpose of the Application is to seek permission to irradiate blueberries and raspberries for phytosanitary purposes against fruit flies and other critical plant pests.   SourceBerry irradiation

Proposal P1044– Plain English Allergen Labelling

The purpose of the Proposal is to standardise the use of plain English terminology for allergen declarations on food labels.  SourceFood labelling

NSW Food Recalls -

Coles Beetroot Dip - Coles Supermarkets Australia Pty Ltd has recalled Coles beetroot dip from Coles stores due to the presence of an undeclared allergen (sesame).  Source :Dip recall

George Weston Foods (assorted garlic bread) - George Weston Foods has recalled assorted garlic breads due to the presence of foreign matter (plastic pieces).   Source: Garlic bread

Picky Picky Peanuts Mexican Salsa Peanuts - Peanut Company of Australia Limited has recalled Picky Picky Peanuts Mexican Salsa Peanuts due to the presence of an undeclared allergen (milk).   Source: Peanuts

Target Cookie Mix in Mason Jars -Target Australia Pty Ltd has recalled Christmas Sprinkles Cookie Mix with a Mason Jar and Triple Chocolate Chip Cookie Mix with a Mason Jar due to foreign matter (insect) contamination.   SourceTarget cookies

Edible Insect Industry Group Set Up to Support Southeast Asia

For those suppliers of food products always looking for the next new thing sometimes it pays to think out of the box and then link up with like minds in order for a fad to go globally viral. In the last few years, dozens of edible insect start-ups have popped up in western countries to supply a new wave of interest in bugs as food. This market is now in need of regulation, promotion and support.   Source: Massimo Reverberi, Food Navigator – Asia Edible insects

Bega's Mondelēz Purchase Takes Vegemite Back Into Australian Hands

Vegemite will return to Australia after its American parent agreed to sell most of its regional grocery business, including the iconic yeast spread, to Bega Cheese.   Source:  BRJ Whitehead, Food Navigator-Asia Vegemite

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