Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


Government Grant Round Opens to Enhance Food Chain Traceability

The Department of Agriculture is inviting applications for grants to fund projects to enhance traceability in the food supply chain, enhancing trust in Australian-grown products and boosting the competitiveness of agricultural exporters. An initial $4 million round of Traceability Grants Program funding, opening from January 8, will be available to individuals, communities, government or private sector organisations, as well as agricultural export industries, to enhance traceability in supply chains. The program will provide opportunities for successful applicants to carry out projects that enhance product traceability and the competitiveness of Australian produce, for example by supporting assertions around organic or location-specific production.    Source: Food traceability grants

Food Importers and Food Allergen Management

Importers of foods are reminded of the importance of understanding the supply chain for foods they import and any potential for allergen cross contact to inform risk management including appropriate allergen labelling. There have been several food recalls related to undeclared allergens, in Australia and internationally. Most recently, pesto and associated products were recalled because they contained an undeclared allergen (peanut). Peanut had contaminated one of the ingredients (processed cashew) used in these products. The recall included imported products and product manufactured in Australia from imported ingredients.    Source: Food allergy contamination

ACCC Announces 2020 Compliance and Enforcement Priorities

The Australian Competition and Consumer Commission (ACCC) has outlined its priorities for 2020 and has stated that the growing community attention to health-related issues has led the ACCC to take a more active role in preventing deceptive conduct in the marketing of food products. “Misleading claims about health or nutritional benefits harm consumers as they often pay a higher price for products without receiving the benefits claimed,” said ACCC Chair, Rod Sims.   Source: ACCC 2020 priorities

FSANZ Notifications—

Application A1155 – 2’-FL and LNnT in infant formula and other products: The purpose of the application is to permit the voluntary use of 2’-O-fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation using genetically modified Escherichia coli (E.coli) strains, in infant formula products and formulated supplementary foods for young children.   Source: GM E. coli in FSFYC

Application A1171 – Endo-inulinase from GM Aspergillus oryzae as a Processing aid (Enzyme): The purpose of this Application is to permit the use of Endo-Inulinase produced from a GM modified strain of Aspergillus oryzae as a Processing aid.    Source: GM aspergillus 1

Application A1176 – Enzymatic production of Steviol Glycosides: The purpose of this application is to seek approval for a new specification for steviol glycosides produced by an enzymatic conversion method using enzymes derived from genetically modified strains of Escherichia coli (E. coli).    Source: GM E. coli

Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm.   Source: Barley MRL

Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): ​​​The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata.   Source: GM aspergillus 2

Application A1185 – Alpha-amylase from GM Aspergillus niger as a processing aid (enzyme): ​​​​The purpose of this application is to approve the use of Alpha-amylasee sourced from Rhizomucor pusillus in GM Aspergillus niger.   Source: Aspergillus enzyme

Proposal P1050 – Pregnancy warning labels on alcoholic beverages: This proposal seeks to revise the warning statement to read: “Alcohol can cause lifelong harm to your baby” from, “Any amount of alcohol can harm your baby”, and also to revise the specific colour printing requirements of that warning text.   Source: Warning statement


Reminder – Farewell NICNAS and Hello to AICIS

As regular readers of this newsletter will already know, the Australian Industrial Chemicals Introduction Scheme (AICIS) will replace NICNAS on 1 July 2020 as the new national regulator of the importation and manufacture of industrial chemicals in Australia. The ban on the use of new animal test data for ingredients solely used in cosmetics will also begin on 1 July 2020. As such, NICNAS is holding information sessions in capital cities to help stakeholders understand and comply with the new scheme. At this stage the Sydney and Melbourne information sessions are fully subscribed but new sessions may yet be arranged, and a Brisbane information session is being planned for April or May.    Source: NICNAS session   (Breaking news: New workshops now available: AICIS workshop dates )


TGA Database Publishes Listed Medicine Compliance Review Results

To monitor the safety, quality and efficacy of listed medicines and ensure they meet all requirements once they are on the market, the TGA conducts listed medicine compliance reviews on a proportion of those on the Australian Register of Therapeutic Goods (ARTG). This database makes information publicly available about the results of TGA's compliance reviews of individual listed medicines. Publication of results only occurs once the compliance review has been concluded, after the sponsor has had the opportunity to consider our findings and actions have been undertaken to address any identified issues and the results are released quarterly.    Source: LM reviews  (Please see also: Compliance Actions and Outcomes)

‘Health Products Regulation Group’ Details Regulatory Science Strategy for Next Five Years

The HPRG comprises the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC). Regulatory scientists in HPRG use highly developed knowledge and skills from a range of disciplines to make, or contribute to, risk-managed and evidence-based decisions about health products. This document outlines a strategy for how HPRG will maintain and build regulatory science capability over the next five years. It identifies ways to make sure that they continue to make the best possible decisions, and that they are prepared for future regulatory challenges. This will help meet the vision of better health and wellbeing for all Australians through regulatory excellence.     Source: HPRG 5 year strategy

Increased Online Access to Ingredient Information Following TGA Response to Consultation

Throughout 2019, the TGA sought feedback from interested parties on a proposal to increase access to ingredient information. It was proposed to publish the names of excipient (or 'inactive') ingredients in the public view of therapeutic goods on the Australian Register for Therapeutic Goods (ARTG). All submissions and survey responses that were not marked as confidential are available here: TGA consultation responses

Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project

A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR) where the TGA examined whether the regulations and restrictions in place for various ‘low risk’ registered therapeutic goods are still appropriate. This recommendation related to several different types of therapeutic goods, including registered OTC medicines. The TGA undertook to review classes of registered OTC medicines, that have a higher amount of regulation applied to them, to assess whether they may be suitable for becoming listed medicines (listed medicines have less strict regulatory guidelines applied to them). A pilot project was proposed to provide further clarity on the resource requirements, limitations and impacts on medicine sponsors as well as to address additional issues raised by industry during the consultation. 'Antimicrobial throat lozenges' were identified as the medicine group to be considered for the pilot project and the results may be read here: OTC pilot project

Consultation: Adoption of European Union guidelines in Australia

The TGA confers with other overseas regulators in order ensure, where possible, maximal regulatory conformity.  Currently, the TGA is conducting a consultation to determine whether it will adopt a range of guidance systems used by the EU. In Australia, the listed medicine system is not monograph based, however the proposed guidance may be relevant to new substance applications, listed assessed medicines or registered medicines, as these application types may use EU monographs as supportive documentation. Consultation closes 7 February 2020.    Source: EU guidelines consultation

Consultation: Proposed Amendments to the Poisons Standard

Substances which may be of interest include: Arbutin (α and β); Picramic acid (new item); and, marker dyes or pigments (new interpretation). This consultation closes on 10 February 2020.    Source: SUSMP consultation



RFA Provides Comprehensive Training in Regulatory Affairs

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from our Glebe, Sydney office, at your office or remotely via Skype. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on our training courses.


PUBLIC NOTICE – Australian Bushfires - Update

Following on from last month’s note of RFA’s appreciation of support from our many readers, here and overseas, this is the latest news update regarding Australia’s long hot summer of bushfires. The good news is that over the last few weeks, much of Eastern Australia has received widespread soaking rains that have snuffed out the last of these dreadful bushfires. However, the drought persists in many places and will take more rain still before we can declare the drought to be properly ‘broken’. For now, the rebuilding can begin.

Thank you once again for all your interest and care shown to us through this difficult time.

Postscript: The loss of lives, including three American pilots; the massive loss of wildlife and habitat; and the severe impact on our communities after several months of bushfire has left us physically strained and emotionally frazzled. So, it was with much joy and gratitude that that we tuned in to the internationally supported Fire Fight Australia concert held recently in Sydney. Artists from around the world gave freely of their time and talent in order to entertain more than 75,000 people in the audience as well as millions more via media. 22 acts performed over 10 hours and raised more than $10 million for bushfire relief. Rock band Queen reprised the same set they played in the 1984 Live Aid concert! On behalf of all Australians, we would like to thank once again the many global citizens who have responded to our trials with such generous care and concern. It has been very much appreciated. Concert review 



Soft Drinks and Junk Foods Forced to Ditch 'Misleading' Energy Labels

Soft drink and junk food manufacturers will be forced to remove "misleading" energy icons from labels, in a move welcomed by public health advocates as a step forward in fighting Australia's obesity epidemic. A majority of state and federal ministers agreed the energy icon displayed on confectionery products and sugary drinks instead of the health star rating was "making it difficult for consumers to compare like products" and its use should be discontinued. Manufacturers will have two years to remove energy icons from their products.    Source: Dana McCauley, SMH Energy icon dropped

FSANZ Review of Food Derived Using New Breeding Techniques

Food Standards Australia and New Zealand is reviewing the Food Standards Code as it applies to food derived using new breeding techniques (NBTs). A consultation paper was issued in February 2018. The final report was released in December 2019 with three recommendations: to revise and modernise the definitions in the Code; to ensure that NBT foods are regulated in a manner that is commensurate with the risk they pose; and, to ensure there is open communication and active engagement with all interested parties and also explore ways to raise awareness about GM and NBT foods.    Source: GM & NBT food review

Food Allergen Portal

Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For these reasons there are laws in place, for example mandatory labelling to help people who have a food allergy avoid food allergens. This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors.    Source: Food allergen portal

Food Recalls – Is Your Business Prepared?

If you’re a food business, you should have a written plan in place to manage a potential product recall. It’s a legal requirement and the responsibility of all food businesses to ensure their recall plan is up to date. The start of the year is the perfect time to review and update your plan. Remember - it should cover the procedures, records and staff responsibilities that are in place for a food recall. A Food Recall Template is available at Food recall

End of 2019 Failing Food Reports

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the months of November and December. Among the usual pathogenic organisms detected in these imported foods are such organisms as Salmonella, Listeria, and E. coli and assorted toxins such as histamine, aflatoxin and others.  Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals as well as a formulated supplementary sports food that contains synephrine.   Source: November 2019 food fails  ; December 2019 food fails

FSANZ Calls for Comment on Soy Leghemoglobin Permission

Food Standards Australia New Zealand (FSANZ) is calling for comment on an application by Impossible Foods Inc. to permit soy leghemoglobin in meat analogue products that is produced using a genetically modified strain of yeast. Soy leghemoglobin is a protein naturally present in the roots of soybean plants that is not currently consumed in the diets of Australians and New Zealanders. The applicant uses an original method of production where the genetically modified yeast is fermented to express soy leghemoglobin.    Source: GM soy protein

FSANZ Notifications—

Proposal P1044 – Plain English Allergen Labelling: The purpose of this proposal is to make allergen labelling requirements clearer and more consistent, to help food allergen-sensitive consumers and food businesses.    Source: Allergen labelling

Proposal P1054 – Pure and highly concentrated caffeine products: This urgent Proposal was prepared to amend the Australia New Zealand Food Standards Code to prohibit the retail sale of pure and highly concentrated caffeine food products.   Source: Caffeine ban

Application A1193 – Irradiation as a phytosanitary measure in food: The purpose of the Application is to extend the option of phytosanitary irradiation to all types of fresh fruits and vegetables.    Source: Food irradiation

Application A1194 – Glucoamylase from GM Trichoderma reesei as PA (Enzyme): The purpose of the Application is to permit the use of glucoamylase sourced from GM Trichoderma reesei as a processing aid.   Source: GM enzyme

Application A1195 – Alpha-amylase as a processing aid (enzyme): The purpose of the application is to permit the use of Alpha-amylase as a processing aid in brewed beverages and potable alcohol production.   Source: Brewing enzyme

Application A1199 – Food derived from Innate potato lines V11 & Z6: The purpose of this Application is to seek approval for food derived from genetically modified potato lines V11 & Z6, which have lower reducing sugars, low acrylamide potential, reduced browning (black spot) and late blight protection.    Source: GM spuds



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