Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Failing Food Report – February 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of February. Among the usual pathogenic organisms detected in these imported foods are such organisms as Salmonella (found in various Asian spices), and assorted toxins such as histamine (found in Thai and Vietnamese fish and spice pastes), aflatoxin (found in Turkish peanuts and Thai spice paste), antibiotics (found in Thai dried fish) and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of heavy metals (including lead) and added vitamins and or minerals (found in many foods). Source: February 2020 food fails
Proposal P1050 – Pregnancy warning labels on alcoholic beverages: This is a summary of this proposal aiming to better inform pregnant women of the dangers of drinking alcohol. Source: Alcohol warning statement
A1196 – Food derived from nematode-protected and herbicide-tolerant soybean GMB151: The purpose of the application is to seek approval for food derived from nematode-protected and herbicide-tolerant soybean line GMB151, genetically modified to provide resistance to nematodes and the HPPD group of herbicides. Source: GM soybeans
Cosmetics and TGA Listed Sunscreens
Reminder: NICNAS Turns into AICIS on 1 July 2020 – Training Videos Available
Regular readers of this newsletter will be aware that the regulation of the chemical ingredients used in cosmetics, has been controlled by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and that this is to change when the new regulatory framework for industrial chemicals will be called the Australian Industrial Chemicals Introduction Scheme (AICIS) commencing on 1 July 2020. Due to the absence of face to face training while the Coronavirus pandemic rages, NICNAS has provided several short videos covering different elements of the new scheme. These video sessions are each 25 minutes long. Copies of the slides and presentations can be read and downloaded here: NICNAS to AICIS videos
Cosmetics and TGA Listed Sunscreens
Guidance on the New Scheme, AICIS (Starts 1 July 2020)
The government body responsible for the regulation of cosmetics in Australia has been known as the National Industrial Chemicals Notification Scheme (NICNAS). This body will change to the Australian Industrial Chemicals Introduction Scheme (AICIS) on 1 July 2020. Due to the growing impact of COVID-19, NICNAS/AICIS has decided to replace the planned stakeholder information sessions with educational videos you can watch at your own pace. These educational videos will be published in the coming weeks. Source: NICNAS / AICIS videos
Training: RFA Provides Comprehensive Training in Regulatory Affairs
COVID-19 (Coronavirus) update:
In order to protect the integrity of our company so that we can continue to provide you with regulatory advice, our technical team members are now working remotely from our office, and we have cancelled all face to face meetings and training sessions at our office.
We are still operating during normal business hours, communicating via emails and conducting training courses via Skype (www.rfareg.com/training-courses ). Throughout this community health crisis, we continue to offer regulatory support remotely - no need to visit our office! – via skype or phone call – as well as international advice with no need for physical contact.
COVID-19 (Coronavirus) News:
Hand Sanitiser Update
Hand sanitisers in Australia are regulated as ‘cosmetics’, ‘therapeutic‘ or ‘excluded’ goods via the new Therapeutic Goods (Excluded Goods-Hand Sanitisers) Determination 2020 . This means these products are excluded from Therapeutic Goods Administration regulation for the duration of the COVID-19. These excluded hand sanitisers must contain only the following ingredients:
- EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
- sterile distilled water or boiled cold water;
- glycerol 1.45% v/v (pharmacopoeial grade);
- hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
- cannot contain any other active or inactive ingredients, including colours, fragrances or emollients.
There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping.
Product Claims in a Time of Corona Virus
If you are looking to promote your health or hygiene products in relation to the treatment of COVID-19 please check out the following links: TGA requirements for hard surface disinfectants and alcohol based hand sanitisers (i.e. claims, any additional test data required, label updates, process for change etc.); TGA Advertising requirements as detailed in the Therapeutic Goods Advertising Code, and, Australian Consumer Law provisions relevant to product claims. (Please see also: The risk of infection via surfaces and the new coronavirus )
Warning About Products Claiming to Treat or Prevent the Novel Coronavirus
The Therapeutic Goods Administration (TGA) has identified certain therapeutic goods such as complementary medicines or disinfectants being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia. The advertising of therapeutic goods to consumers in Australia is subject to legislative requirements administered by the TGA. The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation. The TGA reminds advertisers to be very careful when considering making therapeutic claims related to novel coronavirus. Source: COVID-19 advertising (Please see also: COVID-19: China, Vietnam, Australia and Singapore caution against fraudulent health claims )
Surrogate Viruses for Use in Disinfectant Efficacy Tests to Justify Claims Against COVID-19
Sponsors and manufacturers wishing to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices, the following surrogate viruses can be used: Human coronavirus 229E, and, Murine hepatitis virus. Consideration will also be given to use of other human or animal coronaviruses. Viruses that have been suggested include Bovine coronavirus and Feline coronavirus. Source: Virus disinfectants
Australian and New Zealand Complementary Medicine Firms Seek Clarification on ‘Essential Services’ Status
The complementary medicine (dietary supplement) industry bodies in both Australia and New Zealand are seeking clarification that the sector is classed as an ‘essential service’, with both countries imposing movement restriction to curb the spread of COVID-19. Source: (Copyright): Tingmin Koe, NutraIngredients-Asia 'Essential service' status