Categorisation of biocidal active chemicals

Who should read this? 

Importers and manufacturers (introducers) of industrial chemicals (and products that are designed to release industrial chemicals) that are for end use as a biocidal active chemical. 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 the categorisation guide.  

What is a biocidal active chemical? 

Biocidal actives (often known as biocides) are chemicals used to control harmful organisms by destroying them or by preventing or inhibiting their growth (see glossary for full definition). Most biocides are highly toxic to various aquatic organisms and are often resistant to microbial degradation after release into the environment. Some end uses of biocidal actives that present the highest environmental concern are use in: 

• recirculated cooling water systems in air conditioners or heat rejecting equipment
• water storage for mining operations
• paper milling to control slime

Your introduction is a ‘specified class of introduction’ if it has an end use as a biocidal active. 

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.

We have an increased level of concern for introductions of biocidal active chemicals because they are usually highly toxic to various aquatic organisms and are often resistant to microbial degradation. Large volumes of biocidal actives are used in some industrial applications so there is the potential for environmental release of significant quantities of these highly toxic and persistent chemicals. We outline the additional or different requirements arising from these concerns below.

Is this introduction exempted, reported or assessed? 

To work out if your introduction meets our reported category criteria (low indicative risk), you need to follow steps 1-6 of the categorisation guide. If your introduction does not meet reported category criteria, it will be an assessed introduction (medium to high indicative risk) (unless you meet the criteria for a commercial evaluation authorisation). 
    
You can find the additional or different requirements you need to be aware of when working out your category of introduction at:

• Step 4.2: Introductions that can be low risk for human health (based on its international assessment)
• Step 5.2: Introductions that can be low risk to the environment (based on its international assessment)
• Step 5.4: Work out your environment hazard characteristics
• Step 5.5: Your environment risk for categorisation

What is the environment risk? 

The indicative environment risk for the introduction of your biocidal active chemical could be medium to high risk or low risk (step 5.5 of the categorisation guide, but it cannot be very low risk.

Do you have an international assessment?

If your biocidal active chemical has had a European risk assessment (that was reviewed by the European Chemicals Agency (ECHA) Biocidal Products Committee) and this assessment was the basis for the European Commission approving it, your introduction might be internationally assessed for environment and for human health. This would mean that the indicative environment risk or human health risk, or both, is low risk. If this relates to your introduction, you need to read our ‘Guide to categorising internationally assessed introductions’. This guide will help you work out if you meet all the criteria to be internationally assessed for the environment and for human health. 

If the international report you have does not meet criteria in our guide on international assessments, you need to continue with the categorisation process to work out the indicative risk.

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

You’ll need additional or different information to show your biocidal active chemical doesn’t have toxicity to any aquatic life as part of the following environment hazard characteristics:

• Persistent, bioaccumulative and toxic - Environment hazard band D
• Very toxic to any aquatic life - Environment hazard band C
• Toxic to any aquatic life - Environment hazard band B
• Harmful to any aquatic life - Environment hazard band A

You cannot use in silico predictions to demonstrate the absence of aquatic toxicity for biocidal active chemicals - only in vivo chronic toxicity studies conducted according to approved test methodology are acceptable. To see information you need for all other environment hazard characteristics, follow step 5.4 of the categorisation guide.

Persistent, bioaccumulative and toxic - Environment hazard band D

For the indicative environment risk of your introduction to be low, you need to show that your chemical doesn’t have this hazard characteristic. If your introduction is in environment exposure band 2 (and you want to demonstrate that it has low indicative environment risk), or if the environment exposure band is 3 or 4, you might choose to demonstrate the absence of the persistent, bioaccumulative and toxic hazard characteristic by demonstrating the absence of the aquatic toxicity hazard characteristic.

To do this, you’ll need test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with a NOEC or EC10 greater than 0.1mg/L for all 3 trophic levels.

Very toxic to any aquatic life - Environment hazard band C

To demonstrate the absence of this hazard characteristic you’ll need test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all 3 trophic levels:

• NOEC or EC10 greater than 0.1mg/L (for chemicals that are not readily biodegradable), or 
• NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable).

Toxic to any aquatic life - Environment hazard band B

To demonstrate the absence of this hazard characteristic, you’ll need test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all 3 trophic levels: 

• NOEC or EC10 greater than 1mg/L (for chemicals that are not readily biodegradable), or 
• NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable).

Harmful to any aquatic life - Environment hazard band A

To demonstrate the absence of this hazard characteristic, you’ll need test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all 3 trophic levels: 

• NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable).

Additional record keeping obligations 

There are no additional records that must be kept for this class of specified introduction. However, if your introduction is internationally assessed there are additional record keeping obligations. See our reporting and record keeping obligations section for more information.