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Open for public comment: proposed amendments to the General Rules – closes 17 September 2021.

Categorisation of UV filters

Extra information to help categorise the importation and manufacture (introduction) of UV filters.

Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets any terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions

Who should read this?

Importers and manufacturers (introducers) of industrial chemicals (and products that are designed to release industrial chemicals) that are for use as UV filters. This guidance will help you work out whether your introduction will be an exempted, reported or assessed introduction. You must read this in conjunction with our categorisation guide.

What is a UV filter?

An industrial chemical is a UV filter if it is meant to protect the skin against ultraviolet radiation in the range of 290 to 400 nm by absorption, reflection or scattering of ultraviolet radiation. 

Introductions of an industrial chemical that is a UV filter are referred to as 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 that are UV filters, is because there is a potential for adverse effects mediated by exposure of the chemical to ultraviolet light (such as sunlight). This could include skin reactions or other effects following absorption through the skin. We outline the additional or different requirements arising from these concerns below.

Is your introduction exempted, reported or assessed?

If your UV filter is not a listed introduction, you must work out if your introduction meets the criteria for the exempted or reported category by going through steps 1-6 of our categorisation guide. If your introduction does not meet the criteria for the exempted or reported category, it will be an assessed introduction.

You can find the additional or different requirements you need to be aware of when working out your introduction category at:

What is the human health risk?

The indicative human health risk for the introduction of your UV filter could be medium to high or low risk (step 4.5 of the categorisation guide). The indicative human health risk for your introduction cannot be very low risk.

Information you need to demonstrate that your chemical does not have human health hazard characteristics

If the human health exposure band for the introduction of your UV filter is 4, you’ll need additional or different information to show your chemical doesn’t have the following human health hazard characteristics:

  • carcinogenicity - Human health hazard band C
  • genetic toxicity - Human health hazard band C
  • skin sensitisation - 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.

Carcinogenicity - Human health hazard band C

If the indicative human health risk for your introduction is to be low, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need: 

  • the same information that is required for other chemicals in Part 6.3.2 of the Categorisation Guidelines. For example, confirmation that your chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its carcinogenicity and
  • information to justify why the chemical would not cause carcinogenicity mediated by exposure to UV light. This may include one or more of the following:
    • that your chemical has a molar extinction/absorption coefficient of less than1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vivo carcinogenicity studies where the methods have been modified to include photoactivation

Genetic toxicity - Human health hazard band C

If the indicative human health risk for your introduction is to be low, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need: 

  • the same information that is required for other chemicals in Part 6.7.2 of our Categorisation Guidelines. For example, test results that demonstrate the absence of mutagenic or genotoxic effects from studies on your chemical (or from suitable read across information) conducted following acceptable test guidelines for gene mutation and chromosomal abnormalities and
  • information to justify why the chemical would not cause genetic toxicity mediated by UV light. This may include one or more of the following: 
    • that your chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vitro or in vivo genetic toxicity studies where the methods have been modified to include photoactivation

Skin sensitisation - Human health hazard band B

If the indicative human health risk for your introduction is to be low, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need: 

  • the same information that is required for other chemicals in Part 6.14.2 of our Categorisation Guidelines. For example, non-sensitising predictions for the chemical (or suitable read-across information), in studies conducted following acceptable test guidelines for the 1st, 2nd and 3rd key events in skin sensitisation and
  • information to justify why your chemical would not cause skin sensitisation mediated by UV light. This may include one or more of the following:
    • that your chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or
    • results from in vitro phototoxicity studies, or 
    • results from in vitro or in vivo skin sensitisation studies where the methods have been modified to include photoactivation

Additional record keeping obligations for reported introductions

If the human health exposure band for the introduction of your UV filter is 4, then you must keep the following records, which are detailed in our Categorisation Guidelines:

  1. Toxicokinetics information about your chemical – you need to keep information (the full study report or the outcomes of the study and a written undertaking that the full study report will be provided to the Executive Director, if requested) for:
  • the bioavailability of your chemical by the dermal route (determined using any of the studies in the following table):
Study OECD test guideline of study
Skin absorption (in vitro) study on your chemical 428
Toxicokinetics (in vivo) study on your chemical or suitable read-across information 417
Skin absorption (in vivo) study on your chemical or suitable read-across information 427
An in vivo study on your chemical or suitable read-across information that tests for specific target organ toxicity following repeated dermal exposure, in which toxicokinetic parameters are also measured -

and

  • any available information on the toxicokinetics of your chemical, which may include information on its absorption into the body, distribution and metabolism within the body and excretion from the body

      2. Photo stability information about your chemical - you need to keep information on your chemical to demonstrate its stability in light, including the degree to which it degrades after exposure to UV light.

For all other record keeping requirements that apply to your chemical introduction see our guidance on reporting and record keeping obligations.

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