Guide to categorising your chemical importation and manufacture

Step 4.1 and Step 5.1

The draft OECD TG 125 on particle size and particle size distribution on nanomaterials is now final and part of our guidance. We've updated the content related to nanoscale introductions as a result.

Step 6

Clearer instructions on how to use the health and environment risk to work out the introduction category.

Step 3 - Introductions that are in the reported category

Added the following 2 chemicals to question 2, part 3.1 Introductions of 10 kg or less in an AICIS registration year.

Benzene, 1,2,3,4,5-pentachloro-
CAS no. 608-93-5

Benzene, hexachloro-
CAS no. 118-74-1

Step 0 - Introductions that are in the listed category

Improvements made to the page around next steps if you have categorised your introduction as listed by adding links to a new page in the guide 'Your obligations after categorisation'. 

Step 2 - Introductions that are in the exempted category

Improvements made to the page around next steps if you have categorised your introduction as exempted by adding links to a new page in the guide 'Your obligations after categorisation'.

Step 3 - Introductions that are in the reported category

Criteria added for a new type of low-volume reported introduction of 10 kg or less per year.

We've also provided more clarity around next steps depending on the outcome at step 3. This includes adding links to a new page 'Your obligations after categorisation' if an introducer has categorised their introduction as reported at this step. 

Step 6 - Complete your categorisation

We've moved some content on this page on reporting and record-keeping obligations to the new page 'Your obligations after categorisation'.

Your obligations after categorisation

This new page gives an overview about reporting and record-keeping obligations for introducers after they've categorised their introduction as one of the following:

• listed
• exempted
• reported
• assessed

Steps 4.1 and 5.1 – Is your chemical a certain chemical at the nanoscale?

More options added in a question and answer format to help introducers work out if they are introducing this type of chemical.

Steps 4.1 and 5.1 – Where an introduction is a specified class of introduction

More information added, including when introductions are specified classes, our concerns about them, and that extra information will be required from introducers when submitting an assessment application for a specified class of introduction.

Content has been added under these headings:

• Does your chemical contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)?
• Is your chemical a certain polyhalogenated organic chemical?
• Is your chemical a certain chemical at the nanoscale?
• Is your chemical a certain gas? (step 5.1 only)

Steps 4.5 and 5.5 – Special cases - introductions that cannot have a very low indicative human health risk and introductions that cannot have a very low indicative environment risk

Added this extra point to make it clear this type of chemical cannot have a very low indicative risk for human health or the environment:

'OR

• chemical that is introduced as a solid or a dispersion where there is no information available on its water solubility or its particle size, and the introduction of any nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion'

Step 6 – Next steps: If your introduction is categorised as assessed

Added the next step required if the chemical is on the Inventory. Clarified the outcome when the chemical is not on the Inventory.

Step 1: added words shown in bold text:

'...can not be categorised as an exempted or reported introduction unless it is both of the following:

1. the industrial chemicals are to be introduced solely for use in research or analysis
2. the total volume of the industrial chemicals you introduce in a registration year does not exceed 100 kg'

Step 2: clearer explanation of the nanoscale criteria for research and development and chemicals resulting from non-functionalised surface treatment of listed chemicals; removed 'Tylosin, (2R,3R)-2,3-dihydroxybutanedioate (1:1)' with CAS number 74610-55-2 from the comparable chemicals table and improved the instructions on how to use the table.

Step 3: clearer explanation of the nanoscale criteria for research and development.

Step 5.3: added statement to clarify that a chemical with an end use in an air freshener is not a 'designated kind or release into the environment'

Correction: Environment hazard band A hazard characteristics.

Under bulleted list 'information that demonstrates that all of the following applies to the polymer:...'

indented the following paragraphs to correctly align as follows:

• information that demonstrates that all of the following applies to the polymer...
  • if it is a polymer that contains polyethylene glycol (PEG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade, and 
  • if it is a polymer that contains polypropylene glycol (PPG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade.

• New step : 'Step 0 - Introductions that are in the listed category'
• Added 'Who is this guide for' in 'Before you start categorising your introduction' and removed information covered in step 0.
• Removal: 'Information you need to work out your introduction category' (covered in Step 0)
• Clearer guidance on outcomes and next steps in step 4.1 and 5.1.
• More information in step 4.4 including restrictions on use of animal test data.
• More information in step 5.4 including restrictions on animal test data.
• Replaced references to checking the General Rules with more explanatory text.
• More information about water treatment products and designated kind of release to the environment in the context of working out your environment categorisation volume.

Replaced references to Categorisation Guidelines in step 4.4 and 5.4 with the details (from the Guidelines) about hazard bands; improvements and more information in 'Before you start categorising your introduction'. Added appendices: acceptable test guidelines for categorisation and in silico predictions for categorisation.