Product safety
The Australian regulatory system
Consumer products in Australia are regulated for safety, to protect human health and the environment.
There is regulation of ingredients, products, and of label and advertising claims. Australia’s regulatory system spans federal, state & territory and local governments.
A number of agencies within the federal Department of Health are responsible for human health protection.
The primary body responsible for ingredient regulation is the Australian Industrial Chemicals Introduction Scheme (AICIS). AICIS assesses all industrial chemicals that are new to Australia before they can be used. AICIS also assesses chemicals already in use on a priority basis, e.g. in response to concerns about their safety on health or environmental grounds.
All ingredients in cosmetic and other household products sold in Australia must be included in the Australian Inventory of Industrial Chemicals or be officially approved by AICIS, and all importers of products and ingredients used in cosmetic and other household products must be registered with AICIS. Both AICIS and the Federal Health Department monitor and assess any new scientific studies, media reports or even activist group allegations regarding chemical ingredients.
Ingredients used in cosmetic, personal care and household products are also regulated for safety by the Advisory Committee on Chemicals Scheduling (ACCS), which sets controls and use instructions for more hazardous ingredients, via the Poisons Standard. This national classification system controls how chemicals are made available to the public as well mandatory safety warnings on labels.[1]
Products that make a therapeutic or health benefit claim are regulated by the Therapeutic Goods Administration (TGA). Therapeutic products include those designed to prevent, diagnose, cure or alleviate a disease, ailment, defect or injury. Under current Australian law certain personal care products – such as some mouthwashes, toothpastes, sunscreens, medicated soaps and anti-dandruff shampoos – are regulated as therapeutic goods
The Australian Competition & Consumer Commission (ACCC) deals with products that are shown to be unsafe, or for which there is a tangible risk of significant safety concerns. Under the Australian Consumer Law passed in 2010, ACCC can act to immediately remove unsafe products from sale. The ACCC is also is responsible for cosmetic labelling. Cosmetics must be labelled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.
And from late 2022, the Industrial Chemicals Environmental Management Standard (IChEMS) will provide a nationally consistent approach to chemicals management for environmental protection.
Risk assessment
“Risk” means the likelihood of harm occurring as a result of a chosen action. Almost any action you take carries some risk including, of course, driving or being a passenger in a car. But the level of risk varies greatly depending on the action.
When determining whether or not an ingredient or product should be available to the public, a risk evaluation is undertaken.
For there to be a risk of harm occurring, it must be determined that a substance is likely to come in contact with the body in such a way that it could cause damage to cells.
A general approach would be to identify:
There is an important difference between “hazard” and “risk”, a difference that is often not realised.
For example, it is not uncommon to see warnings about “toxic chemicals” in everyday products, including cosmetics, personal care products and household products.
The source of such information is often chemical’s safety data sheet (SDS), which provides hazard information. However, SDSs are relevant for people who work with industrial quantities of concentrated chemicals; this information has little relevance to consumers who use products containing diluted and very small quantities.
Australia’s consumer watchdog CHOICE emphasises this point in its article “Chemicals in cosmetics - are they safe?” According to dermatology and toxicology experts CHOICE spoke to, cosmetics in the marketplace are safe to use as directed since their ingredients “are used in very small quantities and some, like shampoos and so on, for only a very short period of time”, and because “cosmetic products are defined by their temporary effects and inability to change our body’s physiology. Very little, if any, of the product would be able to penetrate the outer layer of the skin.”[2]
Control measures
Once risk assessment has been undertaken, it is possible to work out how risks can be controlled or minimised.
Control measures can range from bans, restrictions on use, workplace controls, classification and labelling measures, control of emissions to air, water and land, and waste disposal restrictions. Regulators are responsible for enforcing compliance with these controls by the makers and suppliers of products.
Example control measure: Restrictions on use
Safety factors on human exposure are worked out as follows:
Example control measure: Safety recalls
In Australia, another control measure is the process of product recalls for products that may be unsafe.
Voluntary safety-related recalls are the responsibility of the supplier. Under Australian Consumer Law, suppliers are required to notify the federal minister within two days of commencing recall action. The minister also has the power to order a compulsory recall of a product if it will or may cause injury to a person.
The ACCC is responsible for protecting the rights of consumers and business. The ACCC enforces product recalls for consumer goods and monitors their effectiveness. Information about product recalls is published on the Product Safety Recalls website www.recalls.gov.au.
Can we trust the system?
Individuals have varying amounts of scientific knowledge and training. And the vast majority of consumers lack the time and means to conduct their own informed risk assessment on each product that they use.
For this reason it is vital that decisions about risk and safety be delegated to experts – and that there is public trust in this process. Experts include regulatory scientists and expert scientific bodies as well as, of course, safety experts involved in the design and making of products.
This does not negate the need for a well-informed and empowered public – but it is impossible for anyone to be across everything they need to know about every ingredient in every product that they buy.
In this age of communication technologies, there is so much information available that it can be difficult to sort relevant information from the irrelevant and exaggeration, misinformation or unfounded opinions from fact.
There are some real downsides when perceptions of risk are not based on evidence and facts. Or are driven by fear arising from media scares or politically-motivated activist claims. For example, is it helpful to give undue attention to a hypothetical and unproven risk, such as nanoparticle zinc in sunscreen, and ignore a proven risk, for example the known and serious health impacts of unprotected sun exposure?
The governments of advanced nations like Australia have all put in place regulatory systems to deliver safety to consumers.
In our increasingly global world, where products flow from country to country, this means an even greater level of regulatory scrutiny than occurred decades ago. And with greater global scrutiny and cooperation between safety regulators, unsafe products are more quickly identified and removed from sale.
For example, certain hair straightening products found to have very high levels of the carcinogenic ingredient were removed from sale in the US, UK and Australia, all with the support of the ‘mainstream’ cosmetics industry.
Australia is one of the healthiest nations in the world.[3] Our generations have a longer life expectancy than any previous generations. Given these facts, coupled with our unprecedented level of choice when it comes to products, it seems reasonable to continue to trust our regulatory system to continue to safeguard public health.
Sources
[1] www.tga.gov.au/industry/scheduling.htm
[2] Dr Rosemary Nixon, Australasian College of Dermatologists, cited in CHOICE 2009, “Chemicals in cosmetics - are they safe?” https://www.choice.com.au/health-and-body/beauty-and-personal-care/skin-care-and-cosmetics/articles/chemicals-in-cosmetics
[3] According to the 2010 State of the Nation Report, Australian Institute of Health and Welfare. www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=6442452962
Consumer products in Australia are regulated for safety, to protect human health and the environment.
There is regulation of ingredients, products, and of label and advertising claims. Australia’s regulatory system spans federal, state & territory and local governments.
A number of agencies within the federal Department of Health are responsible for human health protection.
The primary body responsible for ingredient regulation is the Australian Industrial Chemicals Introduction Scheme (AICIS). AICIS assesses all industrial chemicals that are new to Australia before they can be used. AICIS also assesses chemicals already in use on a priority basis, e.g. in response to concerns about their safety on health or environmental grounds.
All ingredients in cosmetic and other household products sold in Australia must be included in the Australian Inventory of Industrial Chemicals or be officially approved by AICIS, and all importers of products and ingredients used in cosmetic and other household products must be registered with AICIS. Both AICIS and the Federal Health Department monitor and assess any new scientific studies, media reports or even activist group allegations regarding chemical ingredients.
Ingredients used in cosmetic, personal care and household products are also regulated for safety by the Advisory Committee on Chemicals Scheduling (ACCS), which sets controls and use instructions for more hazardous ingredients, via the Poisons Standard. This national classification system controls how chemicals are made available to the public as well mandatory safety warnings on labels.[1]
Products that make a therapeutic or health benefit claim are regulated by the Therapeutic Goods Administration (TGA). Therapeutic products include those designed to prevent, diagnose, cure or alleviate a disease, ailment, defect or injury. Under current Australian law certain personal care products – such as some mouthwashes, toothpastes, sunscreens, medicated soaps and anti-dandruff shampoos – are regulated as therapeutic goods
The Australian Competition & Consumer Commission (ACCC) deals with products that are shown to be unsafe, or for which there is a tangible risk of significant safety concerns. Under the Australian Consumer Law passed in 2010, ACCC can act to immediately remove unsafe products from sale. The ACCC is also is responsible for cosmetic labelling. Cosmetics must be labelled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.
And from late 2022, the Industrial Chemicals Environmental Management Standard (IChEMS) will provide a nationally consistent approach to chemicals management for environmental protection.
Risk assessment
“Risk” means the likelihood of harm occurring as a result of a chosen action. Almost any action you take carries some risk including, of course, driving or being a passenger in a car. But the level of risk varies greatly depending on the action.
When determining whether or not an ingredient or product should be available to the public, a risk evaluation is undertaken.
For there to be a risk of harm occurring, it must be determined that a substance is likely to come in contact with the body in such a way that it could cause damage to cells.
A general approach would be to identify:
- The hazard – the inherent potential of the ingredient or product to cause harm.
- The dose – the amount of substance that will reach a particular biological system, as determined by the concentration of the substance, duration of contact, route of exposure, and the ability of the body’s defences to eliminate enough of the substance before it can have an impact.
There is an important difference between “hazard” and “risk”, a difference that is often not realised.
For example, it is not uncommon to see warnings about “toxic chemicals” in everyday products, including cosmetics, personal care products and household products.
The source of such information is often chemical’s safety data sheet (SDS), which provides hazard information. However, SDSs are relevant for people who work with industrial quantities of concentrated chemicals; this information has little relevance to consumers who use products containing diluted and very small quantities.
Australia’s consumer watchdog CHOICE emphasises this point in its article “Chemicals in cosmetics - are they safe?” According to dermatology and toxicology experts CHOICE spoke to, cosmetics in the marketplace are safe to use as directed since their ingredients “are used in very small quantities and some, like shampoos and so on, for only a very short period of time”, and because “cosmetic products are defined by their temporary effects and inability to change our body’s physiology. Very little, if any, of the product would be able to penetrate the outer layer of the skin.”[2]
Control measures
Once risk assessment has been undertaken, it is possible to work out how risks can be controlled or minimised.
Control measures can range from bans, restrictions on use, workplace controls, classification and labelling measures, control of emissions to air, water and land, and waste disposal restrictions. Regulators are responsible for enforcing compliance with these controls by the makers and suppliers of products.
Example control measure: Restrictions on use
Safety factors on human exposure are worked out as follows:
- Determine what dose of the substance has no effect on a test animal population (or for cosmetics via an approved alternative safety test that does not use lab animals) e.g. 0.5 mg/kg bodyweight.
- Apply a 10-fold safety factor for humans i.e. 0.05 mg/kg
- Apply a further 10-fold safety factor to account for variability within the human population i.e. 0.005 mg/kg
- Apply further factors depending on data limitations.
Example control measure: Safety recalls
In Australia, another control measure is the process of product recalls for products that may be unsafe.
Voluntary safety-related recalls are the responsibility of the supplier. Under Australian Consumer Law, suppliers are required to notify the federal minister within two days of commencing recall action. The minister also has the power to order a compulsory recall of a product if it will or may cause injury to a person.
The ACCC is responsible for protecting the rights of consumers and business. The ACCC enforces product recalls for consumer goods and monitors their effectiveness. Information about product recalls is published on the Product Safety Recalls website www.recalls.gov.au.
Can we trust the system?
Individuals have varying amounts of scientific knowledge and training. And the vast majority of consumers lack the time and means to conduct their own informed risk assessment on each product that they use.
For this reason it is vital that decisions about risk and safety be delegated to experts – and that there is public trust in this process. Experts include regulatory scientists and expert scientific bodies as well as, of course, safety experts involved in the design and making of products.
This does not negate the need for a well-informed and empowered public – but it is impossible for anyone to be across everything they need to know about every ingredient in every product that they buy.
In this age of communication technologies, there is so much information available that it can be difficult to sort relevant information from the irrelevant and exaggeration, misinformation or unfounded opinions from fact.
There are some real downsides when perceptions of risk are not based on evidence and facts. Or are driven by fear arising from media scares or politically-motivated activist claims. For example, is it helpful to give undue attention to a hypothetical and unproven risk, such as nanoparticle zinc in sunscreen, and ignore a proven risk, for example the known and serious health impacts of unprotected sun exposure?
The governments of advanced nations like Australia have all put in place regulatory systems to deliver safety to consumers.
In our increasingly global world, where products flow from country to country, this means an even greater level of regulatory scrutiny than occurred decades ago. And with greater global scrutiny and cooperation between safety regulators, unsafe products are more quickly identified and removed from sale.
For example, certain hair straightening products found to have very high levels of the carcinogenic ingredient were removed from sale in the US, UK and Australia, all with the support of the ‘mainstream’ cosmetics industry.
Australia is one of the healthiest nations in the world.[3] Our generations have a longer life expectancy than any previous generations. Given these facts, coupled with our unprecedented level of choice when it comes to products, it seems reasonable to continue to trust our regulatory system to continue to safeguard public health.
Sources
[1] www.tga.gov.au/industry/scheduling.htm
[2] Dr Rosemary Nixon, Australasian College of Dermatologists, cited in CHOICE 2009, “Chemicals in cosmetics - are they safe?” https://www.choice.com.au/health-and-body/beauty-and-personal-care/skin-care-and-cosmetics/articles/chemicals-in-cosmetics
[3] According to the 2010 State of the Nation Report, Australian Institute of Health and Welfare. www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=6442452962