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Categorisation of polymers

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

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 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 exempted, reported or assessed category. You must read this in conjunction with the categorisation guidance.  

Read our definition of a polymer

Polymer introductions that are automatically categorised as exempted

The introduction of these polymers are automatically in the exempted category:

Is your introduction exempted, reported or assessed?

For all other polymers, you must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 1-6 of the categorisation guidance. 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).

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 ≥10,000g/mol
  • can absorb its own weight, or more, in water
  • contains particles with a particle size <10 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 >70,000g/mol
  • has a solubility in water of < 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 < 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 < 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 < 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 ≥ 5% by mass of molecules with molecular weight <1,000g/mol, or, ≥ 2% by mass of molecules with molecular weight <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 ≥ 5% by mass of molecules with molecular weight <1,000g/mol, or, ≥ 2% by mass of molecules with molecular weight <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 ≥ 25% low molecular weight oligomeric species <1,000g/mol, or, ≥ 10% low molecular weight oligomeric species <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 ≥ 25% low molecular weight oligomeric species <1,000g/mol, or, ≥ 10% low molecular weight oligomeric species <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 ≥ 25% low molecular weight oligomeric species <1,000g/mol, or, ≥ 10% low molecular weight oligomeric species <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.

Example: during a registration year you start introducing 8 polymers that meet our PLC criteria and 4 that meet our low concern biological polymers criteria. After the end of this registration year you will need to submit a single post-introduction declaration that tells us that you introduced 12 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 <1,000g/mol
  • the percentage by mass of molecules with a molecular weight <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 or IUPAC) for your chemical. You must provide these records within 20 working days if we ask for them.

Records to keep if you know the CAS number and/or proper name for your chemical Records to keep if you do not know the proper name for your chemical

1a. If you know the CAS number, a record of it, plus the CAS name or INCI name or    

1b. If you know the proper name (CAS or IUPAC) but no CAS number is assigned – a record of the proper name

2. Records to prove the polymer meets the criteria to be a polymer of low concern or a low concern biological polymer.

1. The names you use to refer to your chemical and a written undertaking from the supplier or manufacturer that they will provide the proper name (CAS or IUPAC) for the chemical and the CAS number (if assigned) if we ask for them.

2. A written undertaking from the supplier or manufacturer that the introduction of your chemical is not covered by any of the provisions of section 25 of the General Rules, and that the person who holds the information will give us the records to prove this, if we ask for them.

3. A written undertaking from the supplier or manufacturer that the chemical is a polymer of low concern or a low concern biological polymer and the person who holds the information will give us the records to prove this, 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.

Records to keep if you know the CAS number and/or proper name for your chemical Records to keep if you DO NOT know the proper name for your chemical

1a. If you know the CAS number, a record of it, plus the CAS name or INCI name or

1b. If you know the proper name (CAS or IUPAC) but no CAS number is assigned – a record of the proper name

2. Records to prove your introduction is not covered by any of the provisions of section 25 of the General Rules

3. Records to prove the polymer meets the criteria to be comparable to a listed polymer

1. The names you use to refer to your chemical  and a written undertaking from the supplier or manufacturer that they will provide the proper name (CAS or IUPAC) for the chemical and the CAS number (if assigned) if we ask for them

2. A written undertaking from the supplier or manufacturer that the introduction of your chemical is not covered by any of the provisions of section 25 of the General Rules, and that the person who holds the information will give us the records to prove this, if we ask for them

3. A written undertaking from the supplier or manufacturer that the polymer meets the criteria to be comparable to a listed polymer

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 <1,000g/mol
  • the percentage by mass of molecules with a molecular weight <500g/mol

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

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