Categorisation of polyhalogenated organic chemicals

Who should read this?

Importers and manufacturers of industrial chemicals (and products that are designed to release industrial chemicals) who are working out whether their importation/manufacture (introduction)of a polyhalogenated organic chemical will be an exempted, reported or assessed introduction. This information should be read before the chemical is introduced in Australia. You must read this in conjunction with our categorisation guide. 

What is a polyhalogenated organic chemical? 

A polyhalogenated organic chemical is a carbon-based chemical that contains more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine or iodine. 

The fluorinated chemicals (some of which are known as PFAS) are commonly used in products to add resistance to heat, resistance to other chemicals, and resistance to abrasion, and also act as dispersion, wetting or surface treatment agents. Other polyhalogenated organic chemicals are commonly used as flame retardants in plastics, textiles, and electronic circuitry.

Your introduction is a ‘specified class of introduction’ if it is a polyhalogenated organic chemical. 

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 polyhalogenated organic chemicals is because these chemicals, or their degradation products, may be persistent in the environment, bioaccumulate and be highly toxic. The additional or different requirements arising from these concerns are outlined below.

Is this 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 (unless you meet the criteria for a commercial evaluation authorisation.

The additional or different requirements to be aware of when working out your category of introduction are at: 

• Step 4.1: Introductions that are always medium to high risk for human health 
• Step 4.4: Work out your human health hazard characteristics 
• Step 5.1: Introductions that are always medium to high risk for environment
• Step 5.5 Your environment risk for categorisation 

What is the human health risk?

The indicative human health risk for the introduction of chemicals containing a sequence of greater than or equal to 4, but no more than 20, fully fluorinated carbon atoms is medium to high risk. 

The indicative human health risk for the introduction of other polyhalogenated organic chemicals, is also medium to high risk if: 

• you are introducing > 100kg of your chemical in a registration year and
• your chemical (or any of its known environmental degradation products) is persistent.

Otherwise, the indicative human health risk for the introduction of other polyhalogenated organic chemicals could be medium to high, low or very low risk (step 4 of the categorisation guide). 

Notes:

• Known environmental degradation products are the expected breakdown products of the chemical under environmentally relevant conditions. These breakdown products are ones that have been found in studies or reported in scientific literature. 
• A persistent chemical remains intact in the environment for long periods of time. A chemical is persistent if its degradation half-life (T1/2) is greater than or equal to:  
  • 2 days in air or 
  • 2 months in water or 
  • 6 months in soil or 
  • 6 months in sediment.

You need to have test results that prove that your chemical and any of its known environmental degradation products are not persistent. You need either: 

• a study conducted following an acceptable test guideline for Ready Biodegradability that results in 1 of the following pass levels being reached within the: 
  • specified time period such that the chemical is considered to be readily biodegradable or 
  • duration of the test, but not within the specified time period for the chemical to be considered readily biodegradable, provided biodegradation has started within the specified time period or 
  • a study conducted following an acceptable test guideline for Aerobic and Anaerobic Transformation in Aquatic Sediment Systems that results in both a degradation half-life of less than: 
    • 2 months in water and 
    • 6 months in sediment

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

If you’ve worked out that the indicative human health risk for your introduction is not always medium to high risk (step 4.1 of the categorisation guide), then you’ll need to work out if it can be low or very low risk. When doing this, 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 following human health hazard characteristics: 

• reproductive toxicity – Human health hazard band C 
• developmental toxicity – Human health hazard band C

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.

Reproductive toxicity – Human health hazard band C

If the indicative human health risk for your introduction is to low or very low, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need to have an in vivo test result on your chemical (or suitable read across information), conducted following an acceptable test guideline for reproductive toxicity (see the Categorisation Guidelines), which results in none of the adverse effects on sexual function or fertility described in chapter 3.7 of the GHS. 

Developmental toxicity – Human health hazard band C

If the indicative human health risk for your introduction is to low or very low, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need to have an in vivo test result on your chemical (or suitable read across information) conducted following an acceptable test guideline for developmental toxicity or reproductive toxicity (see the Categorisation Guide) which results in none of the adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS.

What is the environment risk?

The indicative environment risk for the introduction of chemicals containing a sequence of greater than or equal to 4, but no more than 20, fully fluorinated carbon atoms is medium to high risk. 

The indicative environment risk for the introduction of other polyhalogenated organic chemicals, is also medium to high risk if:

• you are introducing > 100kg of your chemical in a registration year and 
• your chemical (or any of its known environmental degradation products) is persistent.

Otherwise, the indicative environment risk for the introduction of other polyhalogenated organic chemicals could be medium to high or low risk (step 5 of the categorisation guide). The indicative environment risk for your introduction can’t be very low risk.

Additional record keeping obligations

There are no unique records that must be kept based on the introduction of a polyhalogenated organic chemical. For record keeping requirements that apply to all chemical introductions see our guidance on compliance, reporting and record keeping obligations.