Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

CHOICE Makes Weighty Argument to Leave Food Labelling Alone

Consumer group CHOICE has turned its attention to the weight of your favourite supermarket items as the government initiates a review. The group has “weighed in”, so to speak, on an unfolding scenario that could see product weights removed from the front of packaging. That’s what the food industry wants but the government says it will canvas views of all consumers before making a decision. For CHOICE, the decision is simple: Do nothing.    Source: Weighty choice

Health Department Consults on the 'As Prepared' Rules for the Health Star Rating System

The Health Star Rating (HSR) Advisory Committee (HSRAC), responsible for overseeing the implementation, monitoring and evaluation of the HSR system, is reappraising the form of the food (‘as prepared’) rules in The Guide for Industry to the HSR Calculator . On 28 April 2017 the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) noted suggestions from stakeholders to improve the HSR system, including the ‘as prepared’ rules, and asked the HSRAC to address these concerns as a matter of priority. Consultation closes June 30th 2017    Source: As Prepared

Media in Overdrive as Health Star Rating System Goes From Sweet to Sour

Opinions swirl on all sides as the Australian Government announces that it will be reviewing its controversial Health Star Rating System. Typical of the complaints against the current HSRS is this from Peter FitzSimons: “(Recently) the government announced it would be conducting a review of its Health Star Rating System on food products, which, as you know, is meant to be the official guide as to just how healthy a product is, by virtue of the number of stars it displays on the package… The system is predicated on the notion that these stars are not handed out in a measure of overall health, but only how they measure up against other products in their food group. Say no more. And if your product doesn't measure up, no worries. You don't have to play because The Health Star Rating System is not mandatory. You can just opt out!”    Sources: SMH, Peter FitzSimons Health Star Rating ; Big Sugar; Read also from HSR2; and also from HSRS Homepage HSRS Gov.

Raw Milk Conviction Sweet Success for Food Safety

A woman has been fined a total of $28,000 and ordered to pay professional costs of $25,000 after she pleaded guilty to four charges relating to the sale of unpasteurised or ‘raw’ milk in Goulburn Local Court. She was fined under section 104 of the Food Act 2003 for selling milk which was not pasteurised in contravention of Food Regulation 2010, and for conducting a food business without a licence as required by the Regulation. She also pleaded guilty to two charges under section 21 of the Act for selling unpasteurised milk that exceeded acceptable microbiological limits for standard plate counts and Listeria.    Source: Raw deal

Biosecurity Officials Seize Concerning Amount of Contraband at Gold Coast Airport

Biosecurity officers seized more than 6760 items of biosecurity concern from the Gold Coast Airport in 2016, up 15 per cent from 2015. The increase in seizures at the airport was a concern for all Australians because exotic pests and diseases have the potential to hurt our way of life. Coolangatta isn’t the only airport to have increased seizures in 2016. About 273,000 items of biosecurity concern were seized across Australia’s international airports in 2016, up by more than 6 per cent from 2015.    Source: Biosecurity

Department of Agriculture Releases Latest ‘Failing Food Report’

This report details food that was found to fail under the Imported Food Inspection Scheme during the month of April. The following link details where noncompliant food was detected. The noncompliant food was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision. Where a product is found to be noncompliant because the label does not have the mandatory allergen declaration, the product must be destroyed, re-exported or re-labelled to include the mandatory declaration. Future consignments continue to be targeted at 100 per cent until a history of compliance is established. The source of ‘food fails’ were either microbiological contamination (e-coli, listeria, salmonella), toxins detected (histamine, aflatoxin), or illegal chemical additives (various).    Source: Food fails

NSW Food Authority Recalls –

Hershey's Chocolate Products -A & W Hollier Wholesale Distributors Pty Ltd has recalled assorted Hershey’s chocolate products from Aldi stores in NSW, ACT, QLD, VIC, SA and WA, due to the potential presence of allergens (peanuts and tree nuts) which are not declared on the allergen statement.    Source: Hershey's

Creative Gourmet Frozen Mixed Berries - Entyce Food Ingredients Pty Ltd is conducting a precautionary recall of Creative Gourmet Frozen Mixed Berries. The recall is due to potential Hepatitis A virus contamination.    Source: Hep Berries

Lupin: New Requirement for Mandatory Allergen Labelling

Last month lupin was added to the list of nine allergens that must be declared on food labels. The changes mean all food businesses will need to declare lupin on food labels whenever it is present as an ingredient or as a component of food additives or processing aids. Australia and New Zealand have one of the highest rates of allergic disorders in the world, so it’s critical that food businesses get their allergen labelling right. Food business will have 12 months from 25 May 2017 to meet these requirements.    Source: Lupin allergy    

Consultation on Draft Guidance to Food Regulators in Conducting Their Compliance, Monitoring and Enforcement Activities

The Implementation Subcommittee for Food Regulation (ISFR) is updating its guidance on compliance, monitoring and enforcement. This updated material will provide guidance to food regulators in conducting their compliance, monitoring and enforcement activities. The updated guidance will establish expectations for industry stakeholders on the approach taken by food regulators to compliance, monitoring and enforcement. In this context, ISFR is now seeking comments from stakeholders on the draft revised guidance on compliance, monitoring and enforcement. Submissions close at COB 28 July 2017    Source: Food regulators

Consultation Paper Released: New framework for Regulation of Nutritive Substances and Novel Foods

Food Standards Australia New Zealand (FSANZ) today released a consultation paper on a framework for regulating nutritive substances and new (or novel) foods. The proposed new framework was developed following feedback from stakeholders on Proposal P1024: Revision of the Regulation of Nutritive Substances & Novel Foods. The consultation paper is available from the Food Standards website and is available for comment until 6:00pm (Canberra Time) 28 July 2017.    Source: Novel foods

NICNAS Reforms

The reforms to NICNAS aim to reduce regulatory burden on the industrial chemicals sector by streamlining assessment processes and refocusing assessment effort on higher risk industrial chemicals, while also ensuring that Australia's robust safety standards are maintained. Consultation period closes on 12 July 2017. Have your say here:

Health Department Updates Ban on Cosmetic Testing on Animals

As part of the 2017-18 budget package, the Australian Government will implement a ban on cosmetic testing on animals by introducing legislation to enable a national ban on the use of new animal test data to support the introduction of chemicals used exclusively as cosmetic ingredients. The aim will be to work with the cosmetics industry, in consultation with key animal welfare stakeholders, to develop a voluntary code of practice on the sale of cosmetic products.    Source: Animal testing


If you are going to be in Sydney on 4th – 5th June, 2017 then you simply must check out this year’s Naturally Good Expo (trade-only) being held at the brand new International Convention Centre in Darling Harbour. This is the biggest trade show in the Southern Hemisphere for Everything Healthy. Previous NGE shows have been held at the old Sydney Show Grounds but due to the great demand, this show has been moved to the much larger and oh-so-modern ICC. This will be a fantastic opportunity to not only check out Sydney’s most cutting-edge new building but more particularly, get a first-hand look at all the latest products and services in the natural goods space.

There will be all manner of vendors of everything to do with the supply of natural products in Australia. In fact, there will be more than 450 companies showcasing thousands of the newest and most innovative products all under one roof.

Even RFA Regulatory Affairs will be there! Come and visit us at booth #B43 for a face-to-face chat about your current and future projects.

This year, there is even a dedicated Complementary Health Pavilion along with a Beauty & Living Pavilion and a Food & Drink Pavilion! So, if you’re in the industry and want to keep in touch with all of the latest trends and connected people, then check out all the details and start making your plans:

Australian Supplements Exports to China Double in Two Years

More than half of all Australia’s supplements exports are now going to China or to Hong Kong, with the overall value of industry exports doubling in the past two years.    Source: Gary Scattergood+, Nutra Ingredients-Asia China trade


Quote for the month:   “We haven’t had a recession for 25 years in Australia. It’s partly because of our trade with China”   Many commentators

Report - Omega-3 Long-Chain Polyunsaturated Fatty Acid Content and Oxidation State of Fish Oil Supplements in New Zealand

Forty-seven fish oil products available on the New Zealand market were analysed for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) content, as well as for oxidative status in a collaborative effort by several analytical laboratories. The results are in stark contrast to the very low percentage of fish oil products reported to be in compliance with primary oxidation limits and EPA/DHA content by a recently published assessment of fish oil supplements in New Zealand. Possible reasons for this discrepancy are evaluated and discussed.    Source: NZ fish oils

Three E-Cigarette Companies Cop Fines Over Misleading Health Claims in World-First

Three e-cigarette companies have been ordered to pay a total of $175,000 in penalties for making false and misleading health claims, following legal action launched by the consumer watchdog. In separate proceedings against online retailers Jostick, Social-Lites and Elusion, the Federal Court found all three companies misled consumers by claiming their products did not contain harmful carcinogens and toxins, when this was not the case. The Australian Competition and Consumer Commission says it is the first time any regulator globally has successfully taken action for false and misleading claims about the presence of carcinogens in e-cigarettes.    Source: Vape penalty

TGA Consultation – Proposed Amendments to the Poisons Standard  The TGA is seeking comments from interested parties on proposed amendments to the Poisons Standard concerning Chloroacetamide CAS Number 79-07-2; Docusate sodium CAS Number 577-11-7; Vinyl acetate CAS Number 108-05-4; amongst other substances.    Source: New substances

TGA Presentation - Regulatory Reforms at the Therapeutic Goods Administration (TGA)

Speaking at the recent ARCS webinar, Dr Mark McDonald presented an overview of recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods. Slides and a complete transcript can be read here: TGA - ARCS webinar;  National Institute of Complementary Medicine (NICM) response: NICM response

TGA Recalls –

Span-K (potassium chloride) 600 mg tablets - bottles supplied without child-resistant caps   Source: Span-K

Hyland's Baby homeopathic teething tablets - Hyland's homeopathic teething tablets are complementary medicines marketed to provide temporary relief of teething symptoms in children. This recall is being undertaken following an investigation by the United States Food and Drug Administration that products supplied in the US contained inconsistent amounts of belladonna alkaloids, a toxic substance, which may differ from the calculated amounts listed on the products' labels.   Source: Teething troubles

TGA Safety Advisories –

Editor's note: This month, a record 19 different products claiming to be “natural” and aimed at erectile dysfunction have been listed on TGA website. There are too many to list individually here, but they mostly contain undeclared sildenafil and/or tadalafil and other prescription-only drugs.   Source: TGA safety alerts

Slim-Vie Slimming Capsules -the capsules contain the undeclared substances sibutramine, sildenafil and phenolphthalein.   Source: Slimming caps

TGA Code of Practice for Tamper-Evident Packaging of Therapeutic Goods

The purpose of tamper-evident packaging is to alert consumers of possible safety concerns before they purchase or use goods. This code of practice provides guidance on tamper-evident packaging for therapeutic goods. Compliance with the code improves the security of therapeutic goods supplied in Australia and increases the likelihood that consumers can identify when a product has been tampered with. These guidelines are not currently mandatory.    Source: Tamper evident

NHMRC Undertakes Homeopathy Review

National Health & Medical Research Council has reviewed the scientific evidence for the effectiveness of homeopathy in treating a variety of clinical conditions with the aim of providing Australians with reliable information about its use.  The evidence identified in this assessment of the evidence has been summarised in a NHMRC Information Paper, which informed the development of NHMRC’s position on homeopathy. A NHMRC Statement has also been developed, based on the assessment of the evidence.    Source: Homeopathy review;   Read also the response from NICM: NICM reviews homeopathy

GOED Study Shows New Zealand Fish Oil Supplements Meet Label Claims

The Global Organization of EPA and DHA Omega-3s (GOED), in conjunction with several of its members, has published a paper in Scientific Reports that shows the results of oxidation and EPA/DHA content testing on 47 fish oil supplements purchased at retail in New Zealand. The paper concluded that nearly all products met the regulatory limits for oxidation and label claims about EPA and DHA content, and compliance with stricter voluntary industry standards was also high. The study was carried out in response to a report published in January 2015 by Albert et al that stated that nearly all fish oil supplements in the New Zealand market did not contain the EPA and DHA stated on the label and were excessively oxidized.    Source: Fish oils

NPNZ Issues Warning for Suppliers of Iron Supplements

Natural Products New Zealand warns that if you have an iron supplement in your range please check it meets regulatory requirements in New Zealand as some companies are being asked to recall stock. The Dietary Supplements Regulations 1985 state that products must not contain more than 24mg daily dose, however the Medicines Regulations 1984 has additional requirements regarding restrictions on the dose units and the pack sizes. Dietary supplements must not contain more than 24mg per recommended daily dose, and as well, the tablets cannot contain more than 5 mg per dose unit, and, as well, the pack size cannot be more than 750mg in total.    Source: NPNZ Iron supplements


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