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Issue 111

July 2012

Published by Robert Forbes & Associates Pty Ltd. www.robert-forbes.com

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Latest Regulatory News

Chemicals used in medicines now added to list of ingredients to be used in cosmetics

NICNAS has added the following chemicals to the Australian Inventory of Chemicals Substances (AICS) that are for cosmetic use: Acetyl Carnitine HCL (Acetyllevocarnitine hydrochloride), Algae Extract, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Lauryl laurate, Orange roughy oil, Sanguisorba Officinalis Root Extract (Poterium officinale) and Whey Protein.

Increased fees and charges for chemical registrations, permits and certificates

NICNAS has published the new schedule of fees on their website. This potentially affects suppliers of some cosmetic products.

Action on DMAA

Concern has been raised internationally about the use of DMAA (1,3-dimethylamylamine), found in some sports supplements and foods. FSANZ and the various State and Territory health departments have written warning letters to suppliers of sports foods, and the TGA has made an interim decision to declare DMAA as a schedule 9 poison. Proposed implementation date is 1st August 2012, and the closing date for comments is 25th July 2012.

Maximum residue limits in foods – call for comments

Food Standards Australia New Zealand (FSANZ) routinely reviews maximum residue limits to harmonise the food code with international standards. The close date for submissions is 13th August 2012.

False claims made about hair straightening product

The ACCC has taken action against Dateline Imports for claims made about Keratin Complex Smoothing Therapy. The importer claimed the product did not contain formaldehyde, however there was a level of formaldehyde much greater then the maximum permitted limits. The importer also falsely claimed that the product did not contain any toxic chemicals and it complied with all health and safety regulations in the world.

False claims relating to duck meat – action to be taken

The ACCC has instituted legal action against Pepe’s Ducks Ltd for allegedly making false claims that their ducks are “open range”, “grown nature’s way” and pictorially suggesting that the ducks lived outdoors and had access to a lake. In fact, the ducks are raised indoors in sheds and have no access to the outdoors.

Freedom of Information documents released and published

The latest batch of documents released after an FOI request have been published on the TGA site. Included are procedures the TGA refers to when referring work to expert committees, and procedures relating to how the TGA processes “new substance” applications for ingredients in listed medicines– an area where the TGA’s performance has of late been less than satisfactory.

TGA revises guidelines for evidence for listed medicine claims

The TGA has revised the contentious guidelines for claims for listed medicines in response to concerns from industry. Feedback received by the TGA and their response can be viewed on-line at the TGA website.

TGA announces new fees and charges

Significant rises in all TGA fees and charges. Fees for the 2012/2013 financial year are now posted on TGA website: http://www.tga.gov.au/about/fees-120701.htm

Complementary medicines regulation

As a response to recommendations from the Auditor General’s department, the TGA is holding ongoing consultation with stakeholders on proposed reforms to regulation of complementary medicines. The controversial draft guidelines for evidence requirements for claims, widely considered to be unnecessarily onerous, will be part of these reforms.

Reforms to the advertising regulations for therapeutic products

This paper describes the government’s response to the proposed changes to the pre-approvals process for advertising of therapeutic products, complaints handling, and the range of penalties and sanctions available.

TGA invites comments on improving medicine labels

The discussion paper, published on the TGA’s website, aims to canvas opinions on how the information on a medicine label can be made clearer to the consumer of the medicine. Comments close 24th August 2012.

Olive oil company fined – product was not “extra virgin”

After action taken by the ACCC, The Big Olive Company has paid a total of $13,200 in fines for falsely labelling 500ml bottles of “Oz Olio” oil as being extra virgin. The Australian Olive Association had complained that many olive oils sold in Australia as extra virgin olive oil were not in fact extra virgin. Testing indicated that the olives used to make Oz Olio oil were old, damaged or otherwise of poor quality.

Health Dept calls for comment on improvements to chemical notification scheme

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and includes the management of the Australian Inventory of Chemical Substances (AICS). This review is relevant to manufacturers and suppliers of cosmetic products (along with all other “industrial chemicals” – but excluding ingredients in medicines and foods).

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Copyright 2012 Robert Forbes & Associates Pty Ltd. All rights reserved.

Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate,
errors may appear and are inadvertent.

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