Categorisation of chemicals with an end use in articles that are children’s toys or children’s care products
Read this extra information in conjunction with the categorisation guide to help you categorise the introduction of chemicals with an end use in articles that are children’s toys or children’s care products.
Who should read this and when?
Importers and manufacturers of industrial chemicals who are working out if their introduction will be exempted, reported or assessed, and either:
- import or manufacture industrial chemicals that are then used in the manufacture of articles that are children’s toys or children’s care products or
- import articles that are children’s toys or children’s care products and those articles are designed to release chemicals
This information should be read before the chemical is introduced in Australia. You must read this in conjunction with the categorisation guide.
What is a children’s toy or children’s care product?
A children’s toy is an object for children to play with.
A children’s care product is a product intended to facilitate:
- children’s sleep, relaxation or hygiene
- the feeding of children
- sucking by children
Introductions of an industrial chemical for end use in articles that are children’s toys or children’s care products are a ‘specified class of introduction’. We have an increased level of concern for specified classes of introductions, due to a greater potential for particular hazards or high levels of human or environmental exposure. For this reason, there may be additional or different requirements when working out your category of introduction as well as additional record keeping obligations.
Our increased level of concern for introductions of chemicals for an end use in children’s toys or care products is because children may be more vulnerable to potentially hazardous chemicals. We also have increased concern because children often put their toys or care-products in their mouth. Certain chemicals can release from toys or care products and enter children’s bodies via their mouths. We outline the additional or different requirements arising from these concerns below.
Is your introduction exempted, reported or assessed?
You must work out if your introduction meets the criteria for the exempted or reported category by going through steps 1-6 of the categorisation guide. If your introduction does not meet the criteria for the exempted or reported category, it will be an assessed introduction. It cannot be introduced using the commercial evaluation authorisation introduction category.
The additional or different requirements to be aware of when working out your category of introduction are at Step 4.4: Work out your human health hazard characteristics.
Information you need to demonstrate that your introduction does not have human health hazard characteristics
If the human health exposure band for your introduction is 4, you’ll need additional or different information to show your chemical doesn’t have the human health hazard characteristic specific target organ toxicity after repeated exposure - human health hazard band B.
The information you need for all other human health hazard characteristics (and introductions in other human health exposure bands) is the same as other chemical introductions.
Specific target organ toxicity after repeated exposure - human health hazard band B
If the human health categorisation volume for your introduction is greater than 100kg, and your introduction is to be categorised as exempted or reported, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need the information required and set out under human health hazard band B hazard characteristics – specific target organ toxicity after repeated exposure. For example, you could show that your chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives. The human health exposure expected from the industrial use of your chemical must be no higher than the human health exposure expected from food use.
Additional record keeping obligations for exempted and reported introductions
If your introduction is of a chemical for an end use in an article that is a children’s toy or children’s care product, and:
- you worked out your introduction category as exempted or reported by following steps 4-6 of our categorisation guide steps, and
- your introduction is not internationally-assessed for human health, then, you must keep the following records:
- whether the article can be placed in the mouth of a child
- if it can be placed in the mouth, the potential for the chemical to be released into the mouth during end use or mouthing. This means quantitative information on the extent of the chemical’s transfer from the article to the mouth. This should include study results where migration of the chemical into saliva is measured.
For all other record keeping requirements that apply to your chemical introduction see our guidance on reporting and record keeping obligations.
Can the article be placed in a child’s mouth?
This means that the article or parts of it can be brought to the mouth and kept in the mouth by a child to be sucked or chewed (not just licked). An article can be placed in the mouth of a child if it is smaller than 5cm in one dimension or has a detachable or protruding part of that size. However, the shape of the article, e.g. the existence of detachable or protruding parts and its resistance to compression or deformation also needs to be given consideration.
What studies can be used to measure the migration of the chemical into saliva?
Examples can be found in these publications:
- US EPA (2017), Indoor Exposure Product Testing Protocols Version 2.0, Office of Chemical Safety and Pollution Prevention – Document #740-S1-7002, Washington DC
- Simoneau, C. et al. (2001), Validation of methodologies for the release of di-isononylphthalate (DINP) in saliva simulant from toys, European Commission DG-Joint Research Center, Food Products Unit, Institute for health and Consumer Protection, I-2102