Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Useful resources for labelling of products
Label your products.    Source: business.gov.au

Labelling, SDS and packaging.    Source: Australian Industrial Chemicals Introduction Scheme (AICIS)

Cosmetic labelling.    Source: ACCC Product Safety Australia

 

Chemicals added to the Inventory 5 years after issue of assessment certificate. Updated 13th May5th    Source: AICIS

 

Variation of inventory listing following approval of application – CAS 96556-05-7, 1H-1,4,7-triazonine, octahydro-1,4,7-trimethyl-    Source: AICIS

 

Chemical added to the Inventory following issue of assessment certificate – CAS 121375-93-7, Silane, trichloromethyl-, hydrolysis products with amorphous fumed cryst.-free silica.    Source: AICIS

 

New Zealand

The Advertising Standards Authority released its 2021 annual report on 18 May 2022. A detailed summary of 1245 complaints about 570 ads. Review of Alcohol Advertising and Promotion Code is in effect. Influencer advertising: new reporting process for influencer ad identification breaches was introduced in August. Most of the complaints regarding influencers were about the lack of sufficient identification on influencer ad content.    Source: NZ Advertising Standards Authority

 

Therapeutic and Natural Health Products Update. Latest from the NZ Ministry of Health - Therapeutic Products

 

A Horowhenua milk business, MannaMilk has been fined $30,000 for not following the rules that regulate the supply and sale of raw milk.    Source: NZ Ministry for Primary Industries.

Research into vitamin D levels in the population

A number of FSANZ staff recently contributed to a journal article investigating vitamin D in Australian diets. This study showed that vitamin D intakes in Australia are low.    Source: Journal of Human Nutrition and Dietetics.

 

Call for submissions and comments - These are all available on the FSANZ website here

Food derived from EPA and DHA producing and herbicide-tolerant canola line LBFLFK

GM Aspergillus niger (gene donor: Gloeophyllum trabeum) as a processing aid

Polygalacturonase from GM Aspergillus oryzae as a processing aid

Pectinesterase from GM Aspergillus oryzae as a processing aid

Serine endopeptidase enzyme from GM Trichoderma reesei

Infant Formula

 

Energy labelling on alcoholic beverages Updated 2nd May.    Sources: FSANZ  and FSANZ

 

Undeclared allergen food recall statistics for the period 1 January 2016 – 31 December 2021.    Source: FSANZ

 

Food recall statistics for the period 1 January 2012 – 31 December 2021.    Source: FSANZ

 

Invitation to 2022 Stakeholder Forum - Future Ready Food Standards. To be held WED 29TH June in Sydney.    Source: FSANZ

 

Food Recalls Source: FSANZ

Deep Coriander Chutney 283g - presence of an undeclared allergen (sesame). 

INC Shred Max Raspberry Coconut Flavour 60G - undeclared allergen (peanut)

Chris' Homestyle Plant Based Dips 200g - undeclared allergen (milk). 

Hanami Prawn Crackers. Incorrect labels do not declare molluscs [squid], milk and/or soy. 

The Little Big Dairy Company Double Cream 300mL and 1L - potential microbial (Listeria monocytogenes) contamination.

Margaret River Gluten Free Muesli 500G - undeclared allergen (gluten).

INC Shred Max Raspberry Coconut Flavour 60G - undeclared allergen (peanut)

Guide to categorising your chemical importation and manufacture. Updates to the guide.    Source: AICIS

 

Draft evaluation of a chemical with CAS number 1428963-39-6. Call for comment, deadline 3rd June.    Source: AICIS

 

Guidance to help foreign companies interested in selling their chemicals and products in Australia and assist businesses that supply information in AICIS applications or declarations – but don’t wish to disclose their trade secrets.   Source: AICIS

 

Chemicals added to the Inventory 5 years after issue of assessment certificate. Updated 5th April.    Source: AICIS

 

Product safety rules and standards

Discover which products are banned. Check if your product has mandatory standards. Find out what standards you need to comply with. Learn what you need to do to comply with the Australian Consumer Law, including product safety. Includes product safety rules in the various state and territories.    Source: Australian Government Business

 

Biodegradable, degradable and recyclable claims on plastic bags. A very useful guidance document.    Source: ACCC

 

New Zealand

Proposed changes to recycling laws. The New Zealand Government is seeking feedback on three proposals the guidance to make it faster and easier for business elating to transforming recycling: 1. Container Return Scheme 2. Improvements to household kerbside recycling 3. Separation of business food waste.    Source: Cosmetics New Zealand.

 

Industry support for ending animal testing for cosmetics. New Zealand has not tested on animals for cosmetics for over 30 years and in 2015, NZ made it illegal to test cosmetics products or ingredients on animals.    Source: Cosmetics New Zealand and New Zealand Ministry for the Environment

 

New recall guidance. New Zealand Food Safety has updated the guidance to make it faster and easier for all food businesses.    Source: Ministry for Primary Industries

Advertising - testimonials and endorsements. This is a new TGA guidance document that explains the difference between testimonials and endorsements, and which types of each are permitted. For example, testimonials: Testimonials made by anyone engaged in the production, marketing or supply of the advertised therapeutic good, along with others as described in the Code, are not permitted. Advertisements for therapeutic goods must not contain a testimonial from anyone who has received ‘valuable consideration’ for making the testimonial or for marketing the goods. This includes social media influencers, bloggers and brand ambassadors. What is valuable consideration? This guidance provides many hypothetical examples of testimonials and endorsements and shows which are compliant and which are not permitted. A must-read guidance. Read it here.

 

Training course in advertising: RFA offers a one hour training course on advertising. Information is here.

 

Risks of intentional self-poisoning with paracetamol. (TGA) has commissioned a report on the risks of self-harm from intentional paracetamol misuse.    Source: TGA

 

Poisons schedules: final decisions including chromates and chromium trioxide.    Source: TGA

 

Public consultation on proposed amendments to the Poisons Standard

Item 1.1 - Cetirizine

Item 1.2 - Budesonide

Item 1.3 - MDMA

Item 1.4 - Psilocybine

Item 1.5 - Apronal (allylisopropylacetylurea)

Item 2.1 - Helional

Item 2.2 - Hydroxypinacolone retinoate

Item 2.3 - MDMA and MDA

Item 3.1 - Dichloromethane (methylene chloride)

Item 3.2 – Ipflufenoquin

Source: TGA

 

Product recalls

Swisse Beauty Collagen Glow Gummies.    Source: TGA

Medtronic Implantable Defibrillators - Implant Hazard - software update required.    Source: TGA

Multiple Sunscreens Recalled - Low levels of benzene detected. Updated list of products here.

 

Comparable overseas bodies for complementary medicines. An updated list is here.

 

Export of medicines. A guidance document including recent updates.    Source: TGA

 

Compliance enforcement

15 infringement notices totally $39,960 issued to a NSW person for alleged unlawful importation of ivermectin and doxycycline.  2,500 ivermectin tablets and nearly 10,000 doxycycline capsules were imported over the course of one month, far exceeding what is allowable under the Personal Importation Scheme.    Source: TGA

FatBlaster Max (AUST L 348163) cancelled from the Australian Register of Therapeutic Goods. The TGA considers that the name 'FatBlaster', would be understood to represent that the medicine causes loss of body fat and therefore weight loss, neither of which are indications listed for the product. Cat Media is appealing.    Source: TGA

Infringement notice of $2,664 issued to a Sydney based individual for alleged unlawful importation of unregistered anaesthetic products. The individual was previously a general practitioner but surrendered their registration in 2019 and did not have approval or authority to import the goods into Australia.    Source: TGA

Aussiewhip Pty Ltd fined $39,960 for alleged unlawful advertising of disposable nicotine vaping products which are prescription-only medicines and must only be dispensed by pharmacies to consumers who hold a valid prescription. After being contacted by the TGA the company shut down the website but reinstated the content on a new website.    Source: TGA

Three infringement notices totalling $39,960 issued to New South Wales company Khazanah Nasional Pty Ltd for alleged unlawful advertising of disposable liquid nicotine vaping products.    Source: TGA

TMF Cosmeceuticals Pty Ltd fined $26,640 for alleged unlawful importation of ivermectin.    Source: TGA

FuturePro convicted and its director was convicted and fined $25,000 for unlawful conduct relating to alternative medicines. In particular for the banned substance Sanguinaria canadensis (bloodroot) which is used to make black salve, a corrosive topical paste, and unregistered gumby gumby. Claims were being made for the prevention and treatment of cancer.    Source: TGA

Individual fined $2,664 for unlawful importation of nicotine vaping pods.    Source: TGA

 

NSW Health has seized more than $1 million worth of illegal e-cigarettes and liquids containing nicotine since January 2022.    Source NSW Health

 

Approved COVID-19 rapid antigen self-tests. This list is regularly updates by the TGA.    Source: TGA

 

Unique device identification. A TGA presentation of “real world experiences”.    Source: TGA

 

Personalised medical device framework. Overview of medical device regulations. A TGA presentation available here.

 

Medical devices or surfaces with anti-viral or anti-microbial claims. A TGA presentation on what anti-viral claims can be made, evidence required, advertising requirements and documentation required.    Source: TGA

 

Regulation of software based medical devices. A factsheet for digital mental health: Software based medical devices is here.

Imported kava – update to the definition of permitted kava products and labelling requirements for retail ready packs and bulk imported kava not for immediate retail sale.    Source: Dept Agriculture, water and Environment

 

Failing imported food reports for January 2020

List of – 22 products that failed testing.    Source: Dept Agriculture, water and Environment

 

Call for submissions and comments

Proposal – P1028 Infant Formula: To revise and clarify standards relating to infant formula products comprising category definitions, composition, labelling and representation of products. Deadline 10th June.    Source: FSANZ

M1019 - Review of Schedule 22 – Foods and classes of foods.    Source: FSANZ

A1244 - Chymosin from GM Trichoderma reesei as a processing aid (enzyme).    Source: FSANZ

 

Plasticisers in Australian Foods. A survey of the levels of seven plasticisers which may be used in food packaging materials found the levels were generally low. Estimated dietary exposure for Australian consumers was below internationally recognised safe levels.    Source: FSANZ

 

Food Recalls

Kahlua Espresso Martini – alcohol content mislabelled.    Source: NSW Food Authority

Coles Baby Spinach - potential microbial (Salmonella) contamination.    Source: NSW Food Authority

Coles Organic Unsweetened Coconut Milk - undeclared allergen - milk. The label also incorrectly advises the product is suitable for vegans.    Source: NSW Food Authority

Various Ferrero Kinder chocolate products - potential microbial (Salmonella) contamination.    Source: NSW Food Authority

Malt Brewing Co PTY LTD (Revel Brewing Co) Pine Lime Sour Ale - potential secondary fermentation.    Source: NSW Food Authority

Trans Oriental Import and Export Garden Fortune Cookies - chemical (naphthalene) contamination.   Source: FSANZ

Macro Certified Organic plant-based milks - presence of an undeclared allergen (milk).    Source: NSW Good Authority

Barossa Fresh Lamb Mince and Beef Mince - presence of foreign matter (plastic, metal).    Source: FSANZ

Vegan Perfection Golden Crunch Vegan Honeycomb - presence of an undeclared allergen (milk) (milk is not vegan!).    Source: NSW Food Authority

Terra Madre Organic Vegan Chocolate Coated Almonds - undeclared allergens (tree nuts [cashew and hazelnut].    Source: FSANZ

 

Call for submissions and comments

Proposal – P1028 Infant Formula: To revise and clarify standards relating to infant formula products comprising category definitions, composition, labelling and representation of products. Deadline 10th June.    Source: FSANZ

M1019 - Review of Schedule 22 – Foods and classes of foods.    Source: FSANZ

A1244 - Chymosin from GM Trichoderma reesei as a processing aid (enzyme).    Source: FSANZ

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