Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Raw Potential? New Zealand Opens Raw Milk Regulations Review for Consultation
The New Zealand Ministry of Primary Industries (MPI) has launched an online survey seeking public consultation on the efficacy of current regulations surrounding raw milk. Source (Copyright): Pearly Neo, Food Navigator-Asia NZ raw milk
Formulated Supplementary Sports Food Ingredient Restrictions Have Been Updated
As reported in the February 2019 edition of this newsletter under the story heading “Importers of Formulated Supplementary Sports Foods Receive Warning”, some formulated supplementary sports foods currently being imported are not compliant with the Australia New Zealand Food Standards Code (the Code) and may pose a risk to human health. As an update to this story, importers of Supplementary Sports Foods are now advised that 1,4-dimethylpentylamine (DMPA) and Phenpromethamine have been added to the list of substances considered to pose a risk to human health, when found present as an ingredient in formulated supplementary sports foods. Source: SSF ingredient update
FSANZ Invitation to Have Your Say on Australia’s Food Safety Management Standards
Food Standards Australia New Zealand (FSANZ) has released an information paper on its proposed approach to a review of food safety standards in the Food Standards Code. The review will focus on the requirements for food safety management in the food service sector and closely related retail sectors, and potential development of a primary production and processing standard for high-risk horticulture products to introduce requirements to manage food safety on-farm, including requirements for traceability. FSANZ has extended the deadline which is now 14 June 2019. Source: Food safety review
FSANZ Calls for Comment on Minimum Protein in Follow-On Formula
Food Standards Australia New Zealand is calling for comment on an application to reduce the minimum protein requirement for milk-based follow-on formula in the Australia New Zealand Food Standards Code (the Code). Follow-on formula is suitable for infants aged 6 to less than 12 months and is intended to be consumed with complementary food, not as a sole source of nutrition. Source: Follow-on formula
FSANZ Launches 3rd Biennial Stakeholder Survey
FSANZ Chief Executive Officer Mark Booth said the stakeholder survey measures satisfaction with FSANZ’s performance and explores understanding of FSANZ’s role in the food regulation system. “As always we are seeking responses from all our stakeholders but we are particularly keen this year to expand our reach to small and medium-sized food businesses,” Mr Booth said. “Our stakeholders play an extremely important role in the development of food standards and in other work FSANZ undertakes, so it’s important for us to know how they think we are performing in our key role of developing food standards.” Source: FSANZ survey
Application A1102 – L-carnitine in Food: The purpose of this Application is to permit the sale of L-carnitine in a variety of food categories Source: L-carnitine in food
Application A1168–Glucoamylase from GM Aspergillus niger as a Processing Aid: The purpose of the Application is to permit the use of glucoamylase produced from a genetically modified strain of Aspergillus niger as a Processing Aid. Source: Aspergillus enzyme
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 bioconversion method using enzymes derived from genetically modified strains of Escherichia coli Source: E. coli enzyme
Proposal M1016 – Maximum Residue Limits (2018) : The purpose of this Proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities. Source: MRL revision
Cosmetics and TGA Listed Sunscreens
Early Regulatory Changes Affecting Chemical Importers and Manufacturers Now in Affect
Whilst the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under the current scheme (NICNAS). These changes will reduce the regulatory burden for introducers of some lower risk chemicals such as polymers of low concern. The following changes are now in effect: no more annual reporting for permit holders and self-assessed assessment certificate holders; shorter timeframes for Approved Foreign Scheme assessments; polymers of low concerns (PLCs) are exempt from notification; expansion of the PLC criteria; changes to the definition of a new synthetic polymer; and no more Safety Data Sheets (SDS) and labels required for cosmetics introduced at low volumes. Source: NICNAS reforms
Complementary Medicines (“Dietary supplements”):
TGA Issues Guidance for TGO 101 (Standard for tablets, capsules and pills)
This guidance includes clarification on, and information relating to, mandatory requirements. It also includes additional information to assist medicine sponsors in meeting their obligations and best practice recommendations. This information may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality. When the words 'must' or 'required' are used, a legal requirement is being described. The TGO 101 requirements that apply to pills commence on 31 March 2021.The delayed commencement allows sponsors two years to update their manufacturing documentation and ensure that their goods will comply with the new requirements. Source: TGO 101 guidance
TGA Issues GMP Clearance Guidance
This guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine intended for supply in Australia. Source: GMP clearance
REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!
Due to the importance of this information we are repeating the story that we placed in previous month’s newsletter. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently $820 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG. Source: Permitted indications
TGA Lists Important Dates for Suppliers of Complementary Medicines
May 2019 - TGA notifies of fees and charges for 2019-20 (becoming effective from 1 July 2019);
1 July to 22 July 2019 – Period for sponsors to submit their declarations of $0 turnover for any relevant ARTG entries;
1 August 2019 – Annual charge invoices for all non-exempt ARTG entries will be issued;
15 September 2019 – Deadline to pay annual charges invoices.
TGA Updates the Permissible Ingredients Determination for Listed Medicines
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in April 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019. A total of 16 changes have been made in the updated Determination. These changes include: Addition of 8 new ingredient entries; and changes to 8 existing ingredient entries, including making requirements clearer and less restrictive. For more details go to: Permissible ingredients update
TGA Consultation: Proposed New Medical Device Classification for Substances Introduced Into the Body via a Body Orifice or Applied to the Skin
Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device’s intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues. This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Source: Medical devices consultation
TGA Consultation: Proposed Amendments to the Poisons Standard (SUSMP)
The TGA is inviting comment on The Poisons Standard which is also referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Of particular relevance to some suppliers of complementary medicines are the proposed changes related to *arbutin and sanguinarine from Sanguinaria Canadensis ('bloodroot'). This consultation closes on 13 May 2019. Source: SUSMP consultation (Editor’s note: *Arbutin is a constituent of a number of herbs, however the scheduling has particularly affected the supply of herbal preparations of Bearberry (Arctostaphylus uva ursi) and Damiana (Turnera diffusa)).
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
Meizitang Botanical Soft Gel Capsules: contain the undeclared substance Sildenafil & Sildenafil N-Oxide.
JOYSMI Capsules: contain the undeclared substances sibutramine, phenolphthalein and frusemide.
X Power 3 Tablets: contain the undeclared substance Sildenafil.
BMSW 4600MG Black Ant Capsules: contain Sildenafil.
Double Maxx D.B.M. Capsules: contain Sildenafil.
Japan Tengsu tablets: contain Sildenafil.
Magnum XXL Capsules: contain the undeclared substance Tadalafil.
Horny Little Devil Capsules: contain both Sildenafil and Tadalafil.
Lotus Flower Capsules: contain a derivative of fenfluramine. (Fenfluramine is a prescription-only (S4) synthetic anorexic drug, which is no longer available for sale in Australia following its withdrawal from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension were associated with its use).
TGA Safety Advisory - Fallopia multiflora (he shou wu)
Fallopia multiflora (also called Polygonum multiflorum, Fo ti, Reynoutria multiflora and Chinese fleece-flower root) is a herb, also known by the Chinese name 'he shou wu'. Although it is still permitted for use in listed medicines in Australia Fallopia multiflora has been associated with a low risk of liver damage in rare cases. As a consequence, it is a requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.' The TGA has received reports of nine cases of liver damage in consumers taking products containing Fallopia multiflora, in the period spanning 2008 to 2018. Source: fallopia-multiflora-he-shou-wu
Significant Decrease in the Amount of Codeine Supplied to Australians
The up-scheduling of codeine to a Prescription Only Medicine (Schedule 4) in February 2018 has resulted in a significant decrease in the amount of codeine supplied to Australian patients. The decision to up-schedule codeine products to prescription only was taken after evidence showed that medicines containing low-dose codeine combined with paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs) - such as ibuprofen or aspirin - were generally no more effective than other non-codeine medicines. The codeine-containing combinations were also associated with a number of health risks including addiction leading to misuse, liver damage, gastrointestinal perforations, blood potassium imbalances and respiratory depression. These risks were judged to be too high for the codeine combination products to be supplied without oversight from a doctor. Source: Codeine consumption drops
Thinking of importing a medicine for personal use in Australia?
Answer: Yes, you can! Provided all appropriate rules are followed, you can import many medicines for personal use. This includes some medicines that have not been approved for supply in Australia. Usually, it depends on the ingredients in the medicine. There are more restrictions on higher risk ingredients such as ingredients with potential for abuse. This article from the TGA, explains the rules around importing medicines for personal use, including how to find out whether you will be able to import a particular product. Source: Personal use importation
Do You Need an Australian Sponsor for Your Complementary Medicine or Medical Device?
The TGA requires that any therapeutic product supplied in Australia must be supplied by an Australian “sponsor”. The sponsor may be an individual resident in Australia, or an entity incorporated in Australia and conducting business in Australia where the representative of the entity also resides in Australia. The label of any medicine supplied in Australia must include the name and contact details of the Australian sponsor or distributor. For overseas companies, appointing an independent distributor as your sponsor may potentially present a serious disadvantage. Independent distributors may act for any number of companies supplying similar therapeutic products, which can potentially become a conflict of interest. The Australian sponsor/distributor controls the product registrations and can cancel or amend them at any time. The sponsor also has access to confidential product information held by the TGA. RFA Regulatory Affairs can help you set up your own independent Australian sponsor company.
Consumer Story: Tim and Selective Androgen Receptor Modulators (SARMS)
Selective androgen receptor modulators (SARMs) are a group of experimental, prescription-only medicines sometimes used illegally by bodybuilders. People who use SARMs purchased online risk their health because SARMS haven't been approved for human use (they are still being researched, and have documented health risks), they are an illegal medicine sold online and may not contain what the seller says it will (It could contain other, potentially dangerous ingredients, or a different dose to the one on the label), and access to SARMs without a valid prescription, license or authority is illegal, and in some cases may result in fines and/or jail time. SARMs also require a permit to import. Tim's story explains the risks of using SARMs, and how to find reliable information about the safety, effectiveness and legality of a medicine. Read Tim's story here: Tim's story
TGA Suggests Three Questions to Ask Natural Health Practitioners About Testing Services
If you are thinking about visiting a natural health practitioner for a diagnosis, some practitioners may offer to diagnose a range of health conditions using tests like live blood analysis, bioresonance, electrodermal testing or hair analysis. Before you consent to this type of test, it's important to do your research about the test and the practitioner offering it. Here are three questions to get you started. Who is conducting the test? Is the test conducted in an accredited laboratory? What are the risks? Source: Three questions
Imports Still Impress: Survey Reveals Chinese Consumers Place Premium on Overseas Supplements
More than half (53.7%) of the Chinese consumers surveyed said they bought imported nutrition supplements, while only 7.9% preferred to buy local products, according to a white paper released by the Chinese Nutrition Society. Source: (Copyright) Tingmin Koe, Nutra Ingredients-Asia China prefers
Quote for the month:
“The best time to plant a tree was 20 years ago. The next best time is today” Chinese proverb
Naturally Good Expo Coming to Sydney in June 2019
Attention to all of our colleagues and customers from outside Australia! This might be just the business opportunity you’ve been waiting for to visit sunny Sydney, Australia. Naturally Good Expo is not open to the public and is ‘trade only’. It’s a total business event that’s 100% devoted to all things healthy, organic and natural. As the largest annual event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. RFA Regulatory Affairs has enjoyed being an exhibitor at Naturally Good Expo in previous years and once again we will be part of the action, helping to support our industry. Plan your calendar now. This is your chance to not only get a first-hand look at the current state of our industry in Australia but also a wonderful opportunity to meet with colleagues and friends down-under. Make sure to call in to our Booth #B43 to chat with us about your latest plans.
Special Report: Strawberry Tampering and its Aftermath
This article from Food Legal addresses the February 2019 report by government body Food Standards Australia New Zealand (FSANZ). FSANZ had been commissioned to examine regulatory deficiencies in relation to the Australian horticultural supply chain and food incident response protocols following a major strawberry tampering incident in 2018. This article examines the lack of progress. Source: Joe Lederman, Food Legal Strawberry tampering
FSANZ Conducts Biennial Stakeholder Survey
Food Standards Australia & New Zealand regulates the supply of foods in these countries and wants to know how you think they are performing in their key role of developing food standards, your understanding of their role and how well they are communicating what they do. Please take a moment and complete the survey which should take about 4 minutes: FSANZ survey
Application A1160 – Aspergillopepsin I from Trichoderma reesei as a processing aid (enzyme): The purpose of this Application is to seek approval to permit the enzyme Aspergillo-pepsin-I from Trichoderma reesei as a processing aid for the production of potable alcohol products and protein processing. Source: Enzyme
Application A1170 – Rebaudioside MD as a Steviol Glycoside from Saccharomyces cerevisiae: The purpose of the Application is to seek approval for a steviol glycoside mixture (Reb MD) for use as an intense sweetener, produced from a genetically modified Saccharomyces cerevisiae. Source: Sweetener
Premium New Zealand Honey Producer Admits Adding Chemicals
A New Zealand company has pleaded guilty to charges of adding artificial chemicals to its premium manuka honey, in a flagship prosecution over a product that is a high-value export for the country. New Zealand Food Safety filed the case against Auckland-based Evergreen Life, whose products were pulled from shelves in 2016 by the Ministry for Primary Industries, which said they might contain "non-approved substances". Evergreen Life and a company manager, Jason Lee, have pleaded guilty to seven representative charges of selling adulterated honey with intent to deceive for material gain and of selling non-compliant honey. Source: Lidia Kelly, SMH NZ honey dope