How to determine a chemical poses no unreasonable risk
Chemicals not considered for exemption are those:
- classified as a carcinogen, mutagen or reprotoxin under the UN's Globally Harmonised System of Classification and Labelling of Chemicals, 3rd edition (GHS).
Chemicals that might not be suitable for exemption—except if a strong case can be made that they do not pose unreasonable risk in use—are those:
- likely to be persistent or bioaccumulative, or have breakdown products with these characteristics
- containing elements other than:
- aluminium, boron, caesium, calcium, carbon, copper, gallium, germanium, hydrogen, iron, lithium, magnesium, nitrogen, oxygen, phosphorus, potassium, rubidium, selenium, silicon, sodium, sulphur, strontium, tin, titanium, zinc, zirconium
- bromine, chlorine and iodine, only as anions
- containing these high-concern, reactive functional groups:
- pendant acrylates and methacrylates, aziridines, carbodiimides, halosilanes, hydrosilanes, hydrazines, isocyanates, isothiocyanates, alpha or beta lactones, vinyl sulfones or analogous compounds, partially-hydrolysed acrylamides, acid halides, acid anhydrides, aldehydes, epoxides, amines, or other reactive functional groups identified as of high concern
- alkoxysilanes with C1 or C2 alkoxy groups
- having,or expected to have, high acute or chronic ecotoxicity to any aquatic species, including those having cationic chemicals/polymers and LC50 values of less than 1 mg/L (acute) or 0.01 mg/L (chronic)—for uses where concentrated discharge is possible, more stringent ecotoxicity limits apply
- having low biodegradability
- suspected of having carcinogenic, mutagenic or repro-toxic effects.
Exemption might be justified for such chemicals if the volume is very low (substantially less than 100 kg/yr).
Assessing the risk of a chemical
In assessing risk, you need to consider:
- potential exposure to humans and the environment
- potential risk (the maximum risk the chemical may pose)
- how to minimise potential risk (such as through specific handling techniques).
In estimating risk, concentrate on the risk associated with the chemical being introduced, rather than due to the hazards of other components in a product.
If the potential risk is high and cannot be minimised, the chemical may pose an unreasonable risk. In this case, you need to apply for an assessment permit or certificate.
Occupational health and safety risk
To assess the occupational health and safety risk you need to first determine the hazardous nature of the chemical, using the UN's Globally Harmonised System of Classification and Labelling of Chemicals, 3rd edition (GHS).
- If the chemical is imported as part of a formulated product, determine the hazardous nature of the product.
- If the chemical (or product) is not classified as hazardous, and does not have significant physico-chemical hazards or reactivity, then—given the maximum volume of 100 kg/year of chemical introduced—the potential risk is low.
- If the chemical (or product) is classified as hazardous, evaluate the level of exposure to workers during processes such as manufacture, formulation, end-use and disposal.
Public health risk
You need to assess the public health risk in the same way as you assess the occupational health and safety risk.
Critically assess chemicals to be used in cosmetics and soaps for deliberate application to the human body.
Cosmetic exemption application form CE-1 [Word 1.07MB] lists additional criteria that cosmetic chemicals must meet for the no unreasonable risk, low-volume exemption less than or equal to 100 kg.
You need to assess the environmental impact of the chemical during each release route (manufacture, use and disposal of waste) and on all environment aspects (air, soil and water).
Evaluate parameters such as volatility, solubility, mobility and the potential for biodegradation and bioaccumulation.
Consider any known ecotoxicity of the chemical and its behaviour in air, soil and water.
You need to consider the potential exposure of the chemical, where appropriate, during manufacture and/or importation, formulation, end use and disposal, as well as its hazards, including toxicity.
- measures in place to minimise or eliminate exposure of workplace personnel, to determine if unreasonable risk exists
- how risk can be minimised by using engineering controls or by wearing personal protective equipment such as gloves and safety spectacles
- ways to reduce risk in the first instance, such as through measures to prevent the chemical's release into the environment (for example, manufacture of the chemical in a closed system), or through reducing public exposure by decreasing the concentration in a formulated product
- ways to minimise risk, where environmental release occurs, such as by treating or converting the chemical to a less harmful form (for example, treating production effluent on site before discharging it into a sewer).
How to assess risks posed by a chemical—example
Although relating to a chemical used in cosmetics, this example guides you on how to consider occupational health and safety, public and environmental risks posed by a non-cosmetic.
Scenario: A new chemical is to be imported as a concentrate for formulation into a skin moisturiser. It comprises 1% of the finished product. The annual importation volume is proposed to be 80kg. The chemical is a liquid under ambient conditions and does not satisfy the criteria for a hazard class in the GHS.
The chemical is transported in 500 ml bottles packed in impact-resistant containers. It is dispensed directly from the bottle through an open-pour method during manufacture of the cosmetic product.
Occupational health and safety considerations
Evaluate the potential for worker exposure through scenarios such as spillage or splashing, for all facets of the production process—from handling the concentrate to packaging the final product.
Extend the occupational health assessment to the end use of the cosmetic product if it is to be used in workplaces such as hairdressing and beauty salons.
In this case the chemical is not a high occupational health and safety risk, even if some exposure should occur. It is:
- not a hazardous substance
- present at a relatively low concentration in the final product
- dispensed through a relatively safe open-pour method.
In cases where finished products only are imported, occupational health and safety considerations are usually minimal, perhaps restricted to warehousing arrangements.
Public health considerations
Evaluate the hazardous nature of the chemical, its concentration in the finished product and its behaviour (for example, mobility) on the surface of the skin, remembering that the potential for public exposure to the cosmetic product is high.
In this case the chemical is not a hazardous substance and the concentration in the moisturiser is relatively low (1%). For most individuals the risk of repeated use is low.
Examine possible routes for release of the chemical into the environment, including accidental spillage of the chemical or finished product during transport and loss during manufacture, including through disposal of waste product.
Examine the ecotoxicity and physico-chemical properties in relation to possible release volumes, to determine if the impact of any local release is unacceptable, remembering that most chemicals in consumer products are released to the environment through normal product use.
In this case, since only a small volume of chemical is involved, the chemical is highly diluted when it enters the aquatic environment through washing or showering and the pattern of release is highly dispersed. Environmental concern is therefore extremely low in view of the amount of chemical involved (less than 100 kg/year).
When assessing whether no unreasonable risk applies you will need to obtain data on the hazards of the chemical or likely hazard based on structure. While no specific requirements are set out for hazard data, we expect you to make an informed determination of hazard.
Last update 8 April 2019