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Court Conviction After Coffee Berry Borer Imported Along With Illegal Seeds 

Cairns Magistrates Court convicted and fined Palm Plantations of Australia Pty Ltd $12,000 for illegally importing coffee seeds infested with Coffee Berry Borer. Department of Agriculture’s head of Compliance, Raelene Vivian, said Australia had stringent import conditions in place to manage the risk of exotic pests and diseases that could be brought into Australia. “It is disappointing and frustrating when intentional non-compliance is detected because the rules are there to protect our $51 billion agricultural industries, environment and way of life,” Ms Vivian said. Source


ACCC Acts on Conroys “Product of Australia” Misrepresentation 

The Australian Competition & Consumer Commission (ACCC) has issued Conroys Pty Ltd with a penalty of $10,200 following the issue of an infringement notice. In February 2015, Conroys supplied the Bacon Product labelled as a ‘Product of Australia’ when in fact it was produced using imported pig meat. Source


FSANZ Issues Recall for Buchi Kombucha 500ml 

Food Standards Australia & New Zealand has notified that the fermented tea product supplied by Roots in Nature Pty Ltd is being recalled due to potentially intoxicating high alcohol levels. Consumers should not drink this product and should return the products to the place of purchase for a full refund.  Source:


TGA Seeks to Improve GMP Clearance Application Process 

The TGA has experienced a significant increase in the number of GMP Clearance applications since 2010/11 when 2418 applications were received, compared to last year’s 5384 GMP Clearance applications. TGA is now focussing on reducing the largest part of the recent backlog, namely applications for manufacturers located in countries with whom Australia has Mutual Recognition Agreement (MRA applications). Accordingly, the average time taken to complete an MRA GMP Clearance application is about 11 weeks.  Source:


FSANZ Application A1115 – Irradiation of Blueberries & Raspberries 

The purpose of the Application is to seek permission to irradiate blueberries and raspberries for phyto-sanitary purposes against fruit flies and other critical plant pests. Source:


FSANZ Proposal P1039 – Microbiological Review of Infant Formula 

The purpose of the Proposal is to amend the Code to include food safety microbiological criteria for infant formula, aligning with international (Codex) standards. Source:


FSANZ Application A1097 – Food Derived from Herbicide-tolerant & Insect-protected Corn Line

The purpose of this Application is to seek approval for food derived from a genetically modified glyphosate-tolerant and corn rootworm-protected corn line. Source:


FSANZ Application A1098 – Serine Protease (Chymotrypsin) as a Processing Aid (Enzyme) 

The purpose of this Application is to seek approval of a new enzyme, serine protease (chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis as a processing aid in the production of protein hydrolysates.  Source:


FSANZ Application A1099 – Serine Protease (Trypsin) as a Processing Aid (Enzyme) 

The purpose of the Application is to approve a new enzyme, serine protease (trypsin), sourced from a genetically modified strain of Bacillus licheniformis as a processing aid in the production of protein hydrolysates. Source:


FSANZ Proposal P1031 – Allergen Labelling Exemptions 

The purpose of this Proposal is to allow for specific exemptions from allergen declarations for glucose syrups from wheat starch, fully refined soy oil, soy derivatives (tocopherols and phytosterols), and distilled alcohol from wheat or whey.  Source:


FSANZ Application A1100 – Maximum Permitted Level of Acesulphame Potassium in Chewing Gum 

The purpose of the Application is to increase the maximum permitted level of acesulphame potassium (Ace-K) in chewing gum to align with the international regulations and so standardise formulations. Source:


Researchers Develop Sunscreen Made From Aquatic Slime 

Ever wondered why fish don't get sunburnt? That question has inspired biotechnologists to develop a new type of sun protection that's made from the same amino acids found in some fish mucus, algae and bacteria. The scientists involved say this sunscreen is not only biodegradable and natural, it's more stable and actually works better than standard sunscreens. Source: Marcus Strom, SMH


CONUSBAT Issues Update on Current Regulatory Comparisons in Asia 

CONUSBAT is an international provider of regulatory services for cosmetics, personal health care products and fine chemicals. Here is an update on recent Asian cosmetic and chemical regulations. To be expected, each nation or economic area has its own institutions to form their own ‘evolutionary’ legislation. Source:


TGA Issues Compositional Guideline for Ingredient: Polaprezinc 

Also known as Zinc L-carnosine, this ingredient is now available for use in Listed Medicines. Specific details for this ingredient and compositional guidelines for other ingredients can be found on the TGA website. Source:; &


TGA Presentation on Evidence Guidelines Related to Pharmacopoeias & TGOs 

RFA Regulatory Affairs attended the Royal Australian Chemical Institute (RACI) sponsored seminar on 10th August. At this event, the TGA presented a clear discussion on how to choose between different pharmacopoeias and Therapeutic Goods Orders (TGOs) when searching for evidence in justifying claims for Listed Medicines.  Source:


China Food and Drug Administration Releases Draft Measures for the Registration and Filing of Health Foods 

This English translation of recent draft guidelines gives a comprehensive insight into how the authorities of the Peoples Republic of China is coming to terms with modernising its regulations regarding health related foods in this rapidly changing country. Source:


New Zealand Releases Final Version of Natural Health Products Bill 

The Bill currently aims to regulate natural health and supplementary products, which by definition contain only permitted ingredients (Schedule 1 substances). It is proposed that the Bill also regulates natural health products, which is similar in meaning, except that the Schedule 1 ingredients that constitute the product need not be permitted ingredients. A new term, permitted natural health product, is proposed in place of natural health and supplementary product. These proposed amendments are for the consideration of the Committee of the whole House and were tabled on 18th August 2015. Source:


Upcoming Trade Expo – Supply Side West October 5 – 9 Las Vegas, USA. 

As part of this massive annual trade expo the managing director of RFA Regulatory Affairs, Mr. Robert Forbes will be giving a public talk on the regulatory guidelines surrounding the supply of complementary medicines into Australia. Titled, “What! No Dietary Supplements in Australia?” this presentation will be conducted under the auspices of the Consultants Association for the Natural Products Industry (CANI) in the USA, of which Robert is Vice-President. Source:

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