Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Animal testing ban explained

Laws that banned testing cosmetics on animals in Australia came into effect in July 2020, this is a helpful article for consumers which highlights the role that the industry association ACCORD has played in this outcome.    Source: Sydney Morning Herald.


AICIS has published news for the month of June, including (follow links):

2021-22 registration and application fees

Cost Recovery Implementation Statement (CRIS) 2021-22

Chemicals added to the Inventory 5 years after issue of assessment - 28 June 2021

New national chemicals management standard

New chemical assessment statement published - 23 June 2021

Correction of chemical names - 22 June 2021

Variation of Inventory listing following evaluation — 15 June 2021

Business, hobby or personal use - understanding the differences (will be relevant to some small companies)

Version 1.2 of the Categorisation Guide released

Changes on testing of imported foods

Particularly relevant to powdered infant food formula (Cronobacter testing commenced and Salmonella testing continuing), infant follow formulas (Salmonella testing commencing) and milkfish (Chanos chanos) -antimicrobial residue testing commencing).    Source: Dept Agriculture, Water and the Environment


Proposed changes to regulation of electrolyte drinks – composition and labelling

FSANZ is proposing allowing manufactures to reduce sugar content and make label claims clearer to the consumer. They also propose to permit three specific health claims, and prohibit all other health claims.    Source: FSANZ


Failing Food Report – April 2021

Foods inspected at the border, includes risk food test results (prohibited plants, Salmonella and other pathogens including aflatoxin) and surveillance food test results (including additives and vitamins not permitted in certain foods).    Source: Dept Agriculture, Water and the Environment


Call for comment on food additive sweetener

An application has been received to allow an already permitted food additive sweetener (steviol glycosides) to be produced by fermentation from a genetically modified Yarrowia lipolytica strain.    Source: FSANZ


Approvals and amendments to the Food Standards Code

FSANZ notifications

FSANZ has notified these approvals to the Food Ministers’ Meeting:

A1210 – Maltogenic alpha amylase enzyme from GM Saccharomyces cerevisiae

M1018 – Maximum Residue Limits (2020)

New applications:

Application A1226 – Food derived from insect-protected corn line MON95379

Proposal P1056 – Caffeine review

Food code amendments due to:

Application A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme)

Proposal P1051 – Code Revision (2020)


Current recalls

Five recalls added in June.    Source: FSANZ

Registration of a business that imports industrial chemicals

This is relevant to any business that imports cosmetics or ingredients to be used in cosmetics. This summary guide explains who must register, and which chemicals do not require categorisation and registration.    Source: AICIS


List of chemicals added to the Inventory during May 2021

10 chemicals listed by name and CAS numbers.    Source: AICIS


Banned or restricted chemicals

In Australia, there is no single list of banned or restricted chemicals that you can view or download. Bans and restrictions on chemicals and consumer product ingredients – including cosmetics – are regulated by each state and territory authority. This guide lists a number of sources of chemical legislation.    Source: AICIS


Cosmetics and therapeutics

Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:

  • the primary use of the product
  • the ingredients in the product
  • the claims made about the product

A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth – to change its odour or appearance, cleanse it, keep it in good condition or protect it.    Source: AICIS

New TGA fees now in place

TGA fees rise at the beginning of the financial year i.e. the 1st July. For nonprescription medicines go here. The application fee for a listed complementary medicine has risen by $10 is now AUD$870 and the annual charge has also increased by $10 to $1,170. For all other fees for medicines including complementary medicines and medical devices, go here and select “2021-22”


Guidance on regulation of vaping products

For health practitioners, consumers and importers.    Source: TGA


Button batteries in medical devices for domestic use

Button batteries continue to be of concern due to the potential for young children to ingest them.    Source: TGA


Compliance enforcement

Aidacare fined $26,640 for alleged non-compliance with requests for face masks information TGA

V P & Associates fined $26,640 for alleged unlawful advertising of Liquim in relation to SARS-CoV-2 coronavirus TGA

Queensland man fined $7,992 for alleged unlawful importation of nootropic 'smart drugs'. Three infringement notices have been issued to a Queensland man for the alleged unlawful importation of a medicine containing Armodafinil, which is a prescription only medicine and popularly known as a “smart drug”. TGA. See also TGA alert on “smart drugs”.

Dentist fined $5,328 for alleged unlawful importation of injectables TGA.


Compliance reviews of listed complementary medicines

This list published in June summarises the outcomes of 15 medicines compliance reviews. Some products passed, others needed some corrective action, and some were cancelled.    Source: TGA. Search by “Publication date” to see recent entries.


Laboratory test results

There is a minimum delay of 6 months between the testing and publication of results, to allow the TGA to undertake any investigations and follow-up action in response to non-complying test results.    Source: TGA. Click on “Release date” for latest entries.


More news on regulation of faecal microbiota transplant products

What are FMT products, what are they used or, when does the regulation commence, what action is required, how can you source these products.    Source: TGA


Counterfeit human growth hormone products

The TGA, in conjunction with Sandoz and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation. The product is labelled as “Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of Somatropin)”.    Source: TGA

Australian and New Zealand honey producers in dispute over the word Manuka

The New Zealand government is throwing its support behind the Manuka Honey Appellation Society, which represents a group of New Zealand producers, for a certification mark on the word “manuka”. The Australian Manuka Honey Association is opposing the application. Manuka honey is produced from the nectar of Leptospermum scoparium, which is indigenous to both Australia and New Zealand.    Source: Sydney Morning Herald


Recall of “Yummy” snacks due to presence of soy and wheat

Yummy Snack Foods has recalled their Pink Berry Bliss, Drake Brand Strawberry Yoghurt Mix, Yummy Brand Choc Orange Lounge Mix, and Drake Brand Chocolate Orange Mix (400g) with all best before dates. The recall was due to the presence of undeclared allergens, soy and wheat.    Source:


FSANZ calls for comment: Processing aid from a new source

FSANZ is calling for comment on an application to allow an already approved processing aid to be produced from a new genetically modified (GM) source. The enzyme β-galactosidase is already approved in the Food Standards Code and has a long history of safe use. This application is looking to produce the same enzyme from a GM strain of Bacillus subtilis.    Source: FSANZ


Review of the standard for Infant Formula

FSANZ is calling for comments on Proposal P1028– Infant Formula Products Consultation paper 1. To read about the background and learn how to make a submission, refer to FSANZ website. Also at this site there is information on a proposed new method of analysing for dietary fibre - the AOAC method 2017.16 (Rapid Integrated Total Dietary Fibre Method).


Failing Food Report – March 2021

Foods inspected at the border, includes risk food test results (Listeria monocytogenes, Salmonella, E. coli, aflatoxin, hydrocyanic acid, iodine) and surveillance food test results (including additives and vitamins not permitted in certain foods).    Source: Dept of Agriculture, Water and Environment


Approvals and amendments to the Food Standards Code

A1193 – Irradiation as a phytosanitary measure for all fresh fruit and vegetables

A1206 – Subtilisin from GM Bacillus licheniformis as a PA (enzyme)

A1207 – Rebaudioside M as Steviol Glycoside

A1216 – Food derived from herbicide-tolerant canola line MON94100

Application A1205 – Disodium Adenosine 5’ Triphosphate as a nutritive substance in sport foods: Application to amend the Food Standards Code to permit the use of Disodium Adenosine 5’ Triphosphate (Na2ATP) as a nutritive substance in Standard 2.9.4 - Formulated Supplementary Sports Foods.


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