Categorisation of polymers

Who should read this?

Importers and manufacturers of industrial chemicals (and products that release industrial chemicals) who are working out if the importation/manufacture (introduction) of their polymer will be in the listed, exempted, reported or assessed category. You must read this in conjunction with the categorisation guidance.  

Polymer introductions that are categorised as exempted

The introduction of these polymers are in the exempted category:

• Polymers that meet our polymer of concern (PLC) criteria and are not high molecular weight polymers with lung overloading potential
• Polymers that meet our criteria of a ‘low concern biological polymer’
• Polymers that are comparable to listed polymers

Is your introduction listed, exempted, reported or assessed?

There are different criteria for each category and you must work out which one applies to your introduction by going through our categorisation guide, starting at 'Step 0: introductions that are in the listed category'. If your introduction does not meet the criteria for the listed, exempted or reported category, it will be an assessed introduction(unless you meet the criteria for a commercial evaluation authorisation).

For polymers, 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

Step 5.4: Work out your environment hazard characteristics

Work out the human health hazard band

You will need to work through the hazard characteristics described for step 4.4 to determine the human health hazard band for your introduction. Start with the hazard characteristics in human health hazard band C and work down.

If your polymer is a high molecular weight polymer that is water absorbing

Unless your polymer is in human health hazard band C, the human health hazard band is B if your polymer is all of the following:

• has a number average molecular weight that is greater than or equal to 10,000g/mol
• can absorb its own weight, or more, in water
• contains particles with a particle size less than10 microns

If your polymer is a high molecular weight polymer that has lung overloading potential

Unless your polymer is in human health hazard band C or B, the human health hazard band is A if your polymer is all of the following:

• has a number average molecular weight that is greater than 70,000g/mol
• has a solubility in water of less than 0.1mg/L
• becomes aerosolised during end use

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

If your polymer has a number average molecular weight less than 1000 the information you need will be the same as for any other non-polymer chemical. For some high molecular weight polymers, we accept ‘information waivers’. This means that you don’t need to have test results to prove that your polymer doesn’t have particular human health hazard characteristics. This is because the high molecular weight tends to limit how much they can be absorbed into humans and what sorts of health effects they can cause.

See Part 6 of the Categorisation Guidelines for more details about each human health hazard characteristic.

• skin corrosion – Human health hazard band B
• eye damage – Human health hazard band B
• skin sensitisation – Human health hazard band B
• acute toxicity (fatal or toxic) – Human health hazard band B
• specific target organ toxicity after repeated exposure – Human health hazard band B
• acute toxicity (harmful) – Human health hazard band A

Skin corrosion – Human health hazard band B

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the skin corrosion hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has any of these reactive functional groups with a combined functional group equivalent weight of less than 1,000 g/mol: 

• anhydride 
• epoxide
• sulfonic acid or 
• amine

Eye damage – Human health hazard band B

Most high molecular weight polymers don’t need any test results to demonstrate they don’t have the eye damage hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has any of these reactive functional groups, with a combined functional group equivalent weight of less than 1,000 g/mol: 

• anhydride 
• epoxide
• sulfonic acid or 
• amine

Skin sensitisation – Human health hazard band B

Many high molecular weight polymers don’t need any test results to demonstrate they don’t have the skin sensitisation hazard characteristic. 

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it contains any high concern reactive functional groups, or, contains any moderate concern reactive functional groups (other than unsubstituted positions ortho and para to phenolic hydroxyl groups), with a combined functional group equivalent weight of less than 1,000g/mol.

Acute toxicity (fatal or toxic) — Human health hazard band B

Many high molecular weight polymers don’t need any test results to demonstrate that they don’t have the acute toxicity (fatal or toxic) hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has greater than or equal to 5% by mass of molecules with molecular weight less than 1,000g/mol, or, greater than or equal to 2% by mass of molecules with molecular weight less than 500g/mol.

Specific target organ toxicity after repeated exposure – Human health hazard band B

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the ‘specific target organ toxicity after repeated exposure’ hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has the skin corrosion hazard characteristic.

Acute toxicity (harmful) – Human health hazard band A

Many high molecular weight polymers don’t need any test results to demonstrate that they don’t have the acute toxicity (harmful) hazard characteristic. 

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has greater than or equal to 5% by mass of molecules with molecular weight less than 1,000g/mol, or, greater than or equal to 2% by mass of molecules with molecular weight less than 500g/mol.

Work out the environment hazard band

You will need to work through the hazard characteristics described for step 5.4 to determine the environment hazard band for your introduction. Start with the hazard characteristics in environment hazard band D and work down.

If your polymer doesn’t have low cationic density

Your polymer is in environment hazard band A if it does not have low cationic density and it is not in one of the higher environment hazard bands (D, C or B). Low cationic density means that the polymer:

• is not cationic or potentially cationic or
• the polymer contains 1 or more cationic, or potentially cationic, groups and at least 1 of the following applies:
  • the total combined functional group equivalent weight of any cationic or potentially cationic groups is at least 5,000 g/mol
  • the polymer has a solubility in water of less than 0.1 mg/L and will be used only in its solid phase (for example ion exchange beads)
  • the chemical is not dispersible in water and will only be used in its solid phase

Cationic polymer is a polymer containing a net positively-charged atom/s or associated group/s of atoms covalently linked to its polymer molecule. Examples are ammonium, phosphonium and sulfonium cations.

Potentially cationic polymer is a polymer containing groups likely to become cationic. Examples:

• all amines (for example primary, secondary, tertiary and aromatic)
• all isocyanates (which hydrolyse to form carbamic acids, then decarboxylate to form amines)

If your polymer is not stable

Your polymer is in environment hazard band A if it is not stable and it is not in one of the higher environment hazard bands (D, C or B). A polymer is not stable if it substantially degrades, decomposes or depolymerises during use. That is, the polymer is considerably, meaningfully or to a significantly large extent, changed into simpler, smaller molecular weight chemicals as a result of processes including:

• oxidation
• hydrolysis
• heat
• sunlight
• attack by solvents
• microbial action

Most of the other hazard characteristics in the environment hazard bands apply to both chemicals and polymers.

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

For some high molecular weight polymers, we accept ‘information waivers’. This means that you don’t need test results to prove that your polymer doesn’t have particular environmental hazard characteristics.

See Part 6 of the Categorisation Guidelines for more details about each environmental hazard characteristic.

• persistent, bioaccumulative and toxic – Environment hazard band D
• very toxic to any aquatic life – Environment hazard band C
• persistent and bioaccumulative – Environment hazard band C
• toxic to any aquatic life – Environment hazard band B
• bioaccumulation potential – Environment hazard band A
• harmful to any aquatic life – Environment hazard band A

Persistent, bioaccumulative and toxic – Environment hazard band D

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the persistent, bioaccumulative and toxic hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has relatively high levels of low molecular weight species. They either have greater than or equal to 25% low molecular weight oligomeric species less than 1,000g/mol, or, greater than or equal to 10% low molecular weight oligomeric species less than 500g/mol.

Very toxic to any aquatic life – Environment hazard band C

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the very toxic to any aquatic life hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it does not have a low cationic density (see heading ‘If your polymer doesn’t have low cationic density’).

Persistent and bioaccumulative – Environment hazard band C

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the persistent and bioaccumulative hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has relatively high levels of low molecular weight species. They either have greater than or equal to 25% low molecular weight oligomeric species less than 1,000g/mol, or, greater than or equal to 10% low molecular weight oligomeric species less than 500g/mol.

Toxic to any aquatic life – Environment hazard band B

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the toxic to any aquatic life hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it does not have a low cationic density (see heading ‘If your polymer doesn’t have low cationic density’).

Bioaccumulation potential – Environment hazard band A

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the bioaccumulation potential hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it has relatively high levels of low molecular weight species. They either have greater than or equal to 25% low molecular weight oligomeric species less than 1,000g/mol, or, greater than or equal to 10% low molecular weight oligomeric species less than 500g/mol.

Harmful to any aquatic life – Environment hazard band A

Most high molecular weight polymers don’t need any test results to demonstrate that they don’t have the harmful to any aquatic life hazard characteristic.

However you must have test results to prove that your high molecular weight polymer doesn’t have this hazard characteristic if it does not have a low cationic density (see heading ‘If your polymer doesn’t have low cationic density’).

Unique reporting obligations

There are some reporting obligations that only apply to polymers. You must ensure that you also meet other relevant reporting obligations for your introduction.

Post-introduction declarations for exempted introductions

Exempted (post-introduction) declarations are not needed for polymers that are comparable to listed polymers.

Exempted introduction declarations are needed for PLCs and low concern biological polymers. You only need you to tell us the number of unique polymers you introduced. You don’t need to tell us the chemical identity of individual polymers.

Pre-introduction reports for reported introductions

You’ll have to provide extra information in your pre-introduction report if your introduction is of a high molecular weight polymer that is in human health exposure band 4 and is it one of the following:

• internationally assessed for the environment but not internationally assessed for human health (after working through steps 4-6 of our categorisation steps)
• the highest indicative risk is low risk (after working through steps 4-6 of our categorisation steps)

For these introductions you need to provide the following information in your pre-introduction report:

• number average molecular weight
• weight average molecular weight
• polydispersity index
• the percentage by mass of molecules with a molecular weight less than 1,000g/mol
• the percentage by mass of molecules with a molecular weight less than 500g/mol

Additional record keeping obligations

There are some record keeping obligations that only apply to polymers. You must also ensure that you meet the other relevant record keeping obligations.

Record keeping for exempted introductions

Introduction of a polymer that is a PLC or a low concern biological polymer The following table provides information about the records you must keep for PLCs and low concern biological polymers.

The type of records you must keep depends on whether you know the CAS number or the proper name (CAS, IUPAC or INCI for plant extracts under certain criteria) for your chemical. You must provide these records within 20 working days if we ask for them.

Introduction of a polymer that is comparable to a listed polymer

The type of records you must keep are different depending on:

• if you know the CAS number or the proper name (CAS or IUPAC) for your chemical
• when you first introduced the polymer — if it was before 1 July 2020 or after

You must provide the records within 20 working days if we ask for them. 

If the first time you introduced the polymer was before 1 July 2020

The records you have to keep relate to the chemical identity of the polymer listed on the Inventory that your polymer is comparable to (the listed polymer) rather than the polymer you are introducing. 

If you know the CAS name and CAS number of the listed polymer, you must keep records of this.

If you do not know the CAS name and CAS number of the listed polymer, you must keep records of:

• the names you use to refer to the listed polymer
• a written undertaking from the supplier or manufacturer that they will provide us with the CAS name and CAS number (if assigned) if we ask for them.

If the first time you introduce the polymer is on or after 1 July 2020

The following table provides information about the records you must keep.

Record keeping for reported introductions

For high molecular weight introductions with a human health exposure band of 4 where it is one of the following:

• it is internationally assessed for the environment but not internationally assessed for human health (after working through steps 4-6 of our categorisation steps)   
• the highest indicative risk is low risk (after working through steps 4-6 of our categorisation steps)  

You must keep records to prove this information about the polymer (or a written undertaking from the supplier or manufacturer that this will be provided to us if we ask for it):

• number average molecular weight 
• weight average molecular weight
• polydispersity index
• the percentage by mass of molecules with a molecular weight less than 1,000g/mol
• the percentage by mass of molecules with a molecular weight less than 500g/mol

For example, you might keep a record of a gel permeation chromatography (GPC) test report showing this information about the polymer.