Low volume chemical permit

A low volume chemical (LVC) permit allows a chemical to be introduced at a maximum quantity of 100 kg per year, or 1000 kg where certain criteria are met, for a maximum of 3 years.

More than 1 company can hold a LVC permit allowing the introduction of the maximum quantity per year for the same chemical. However, if 2 or more companies submit a joint application, the maximum quantity would be shared among the applicants.

Eligibility criteria

The LVC permit allows the chemical to be introduced at a maximum quantity of 1000 kg a year where the low-hazardous criteria in the table are met (if they are not met, the volume limit is 100 kg) or the polymer criteria (see table below) are met:

Low hazardous criteria for chemicals including polymers with a Number-average Molecular Weight (NAMW) <1000 Da

Endpoint

Criteria

Acute oral toxicity

Not classified as hazardous*

Acute dermal toxicity

Not classified as hazardous*

Acute inhalation toxicity

Not classified as hazardous*

Skin irritation

Not classified as hazardous* or classified:

  • R38 (irritating to skin) under the Approved criteria; or
  • Skin irritation – category 2 under the GHS

Note: irritation must be reversible

Eye irritation

Not classified as hazardous* or classified:

  • R36 (irritating to eyes) under the Approved criteria; or
  • Eye irritation – category 2A under the GHS

Note: irritation must be reversible

Respiratory irritation

Not classified as hazardous*

Sensitisation

Not classified as hazardous*

Repeat dose toxicity

Not classified as hazardous*

Mutagenicity

Not classified as hazardous*

Carcinogenicity

Not classified as hazardous*

Developmental and reproductive toxicity

Not classified as hazardous*

Other toxicological endpoints

Not classified as hazardous*

Aquatic toxicity

Toxicity to fish (LC50[1]), as determined using the Fish Acute Toxicity Test, is >100 mg/L

Toxicity to aquatic invertebrates (EC50[2]), as determined using the Daphnia sp, Acute Immobilisation Test, is >100 mg/L

Toxicity to algae (i.e., EC50), as determined using the Algal Growth Inhibition Test, is >100 mg/L

Flammability

Not a dangerous good or classified as a Class 3 flammable liquid only

Other physical and chemical properties

Not a dangerous good

* In accordance with the Globally Harmonised System of Classification and Labelling of Chemicals, 3rd edition (GHS) or Approved Criteria for Classifying Hazardous Substances 3rd edition (Approved Criteria), NOHSC:1008(2004)

[1] Median lethal concentration / dose - test specified in the Act.

[2] Half maximal effective concentration – see details as for above footnote

Based on their known health and environmental concerns, these chemicals are not eligible for a LVC permit for volumes exceeding 100 kg a year:

  • chemicals likely to be persistent and/or bioaccumulative, or have breakdown products with these characteristics
  • chemicals covered by data requirements for notification of new chemical substances containing a per fluorinated carbon chain
  • chemical classes with an exposure standard (for example isocyanates or tin compounds).

Low hazardous criteria for polymers with a NAMW that is 1000 Da or greater

These polymers must:

  • have<10% by mass of molecules with molecular weight that is <500 Da
  • have <25% by mass of molecules with molecular weight that is <1000 Da
  • have a low charge density, that is:
    • not cationic or not likely to become cationic in an aquatic environment that has a pH value >4 and <9, or
    • a solid that is not soluble or dispersible in water and is to be used only in its solid phase, or
    • for a polymer that includes 1 or more cationic groups, the total combined functional group equivalent weight of any cationic group is at least 5000, and

In addition these polymers must not have certain hazard classifications (under the Approved Criteria), or hazard classes (under the GHS), as set out in the following table:

Risk phrases/Hazard classes low hazardous polymers must NOT have

Hazard

Risk phrase under approved criteria

Hazard class in the GHS

Carcinogenic effects

R40, R45, R49

Carcinogen - category 1A, 1B or 2

Mutagenic effects

R46

Germ cell mutagen - category 1A or 1B

Reproductive effects

R60-64

Reproductive toxicant – category 1A, 1B or 2; or Effects on or via lactation

Very toxic and toxic acute lethal effects

R23-28

Acute toxicity – category 1, 2 or 3

Corrosive effects

R34, R35, R41

Skin corrosion – category 1A, 1B or 1C; or Eye damage – category 1

Sensitising effects

R42, R43

Respiratory sensitiser – category 1A or 1B; or Skin sensitiser – category 1A or 1B

Non-lethal irreversible effects after a single exposure

R39, R68

Specific target organ toxicity single – category 1 or 2; or Germ cell mutagen – category 2

Severe effects after repeated or prolonged exposure

R48

Specific target organ toxicity repeat – category 1 or 2

Based on known health and environmental concerns, these polymers are not eligible for a LVC permit for volumes exceeding 100 kg a year:

  • polymers likely to be persistent and/or bioaccumulative, or have breakdown products with the characteristics- read our information on International persistent organic pollutants criteria and national environmental persistent bioaccumulative and toxic criteria for further information
  • polymers covered by data requirements for notification of new chemical substances containing a perfluorinated carbon chain
  • polymer classes with an exposure standard (for example isocyanates or tin compounds).

Special requirements for azo colourants

Azo colourants are a class of concern for their potential induction of mutagenicity and carcinogenicity. Several azo dyes have been demonstrated to be skin sensitisers in humans, using clinical patch tests.

You must meet special requirements for these colourants. In addition to genotoxicity and sensitisation data proving the chemical meets the low hazardous criteria, you must prove that the chemical contains negligible aromatic amine content (impurities).

You also need to provide information on the identity and genotoxicity profile of the potential metabolic breakdown products, that is the component amines, to demonstrate the chemical meets the low-hazardous criteria.

Application requirements

Go to the LVC application form

Joint applications can be made with the fee shared between the applicants or notifiers.

Fee

$4,600

Payment is required at the time of applying.

You can apply to have certain information exempt from being published in the Chemical Gazette (for confidentiality reasons) on application form. If accepted, only certain information will be published. You do not have to request exemption for data items not published.

When applying you must summarise the potential for the chemical to cause adverse local (irritation and sensitisation) and systemic (acute and chronic) health effects.

If the chemical or polymer contains a structural alert for a certain human health endpoint (for example, sensitisation) you need to provide data for this endpoint in applications for substances >100 kg a year.

However, for polymers, you may not need to provide data for an endpoint where there is a structural alert, where the percentage by mass of molecules with a molecular weight <1000 Da is less than the concentration cut-offs (used to determine whether a mixture is hazardous on the basis of its ingredients) for that endpoint.

Read our of structural alerts for permit categories

Where a repeat dose study has been conducted, you must provide a copy of the study summary (not the full study report) to us. For all other endpoints, you only need to provide the original data to us where a structural alert exists for this endpoint.

We may ask for copies of original data to determine no unreasonable risk.

You can also provide data sourced from published literature, but this must be accompanied by a copy of the relevant source (such as a journal article or document). It must be in English and attached to your application.

For applications for >100 kg a year you must provide evidence to demonstrate that you have satisfied each environmental hazard criterion. Acceptable evidence is one of the following:

  • an ecotoxicity test report for the chemical
  • published literature data for the chemical
  • an ecotoxicity test report for an accepted close analogue
  • published literature data for an accepted close analogue
  • quantitative structure activity-relationship (QSAR) data generated for the chemical by an appropriate, validated QSAR model.

You must also provide a copy of all available eco-toxicological data to us.

Evidence you supply for close analogues must include a sound scientific argument for why the analogue should be acceptable, including discussion of comparability of the physico-chemical properties of the chemical and proposed analogue.

For data generated by QSAR (including ecotoxicity data) to be considered, you must supply full details of the QSAR model used (including the version), and input values used by the model, including the Simplified molecular input line entry specification string (SMILES). These requirements would be satisfied, for example, if you provide an electronic copy of the full report generated by the United States Environmental Protection Agency's EPISuite (United States Environmental Protection Agency 2008. Estimation Programs Interface Suite for Microsoft® Windows, v3.20).

Assessment process and permit conditions

We issue LVC permits within 20 days of receiving a complete notification, provided it satisfies all requirements.

Your permit is granted with the requirement that you notify us if:

  • the function or use of the chemical has changed—or is likely to change—significantly
  • the amount of the chemical being manufactured or imported has exceeded—or is likely to exceed—the volume limit per year
  • a chemical subject to a LVC permit for import only has begun to be manufactured in Australia
  • the method of manufacture has changed—or will be changed—resulting in a possible increased risk of adverse occupational health and safety, public health or environmental effects
  • you become aware of additional information relating to adverse occupational health and safety, public health or environmental effects of the chemical.

As the holder of the permit, you must notify us  within 28 days of becoming aware of any changed circumstances.

LVC permits include these standard conditions (in addition to those specific to individual chemicals):

  • total quantity of chemical that can be introduced in a year
  • length of time the permit will remain in force
  • need to:
    • use the chemical in accordance with all relevant state or territory occupational health and safety, public health and environmental and poisons legislation
    • prevent or, where this is not practicable minimise, the risks to human health where a suitable and sufficient workplace risk assessment indicates that control measures are necessary and that control of exposure to workers is adequate
    • inform workers who will be exposed to the chemical and products containing it that it is being introduced into Australia under a permit
    • make the (M)SDS for the chemical available at all sites where the chemical is used
    • include in the (M)SDS for the chemical, and products containing it, advice that the chemical is being manufactured or imported under a LVC permit granted under Section 21U of the Act, with this suggested wording:
      • [name of chemical] is being introduced under a low volume chemical permit granted under Section 21U(2) of the Industrial Chemicals (Notification and Assessment) Act 1989.
    • dispose of waste in accordance with Australian Government, state and territory government and local government regulations.

We  may, by written notice, cancel a permit, impose further conditions or revoke or vary any condition after the permit has been issued. Under the Act you can be penalised if you contravene a permit condition without good reason.

Note: Chemicals that are the subject of a LVC permit are not eligible to be listed on the AICS.

Publication

We publish LVC permits notices in in the Chemical Gazette, including:

  • name of the chemical (or trade name)
  • whether the chemical is a hazardous substance
  • name and postcode of the company to which the permit is issued
  • duration of the permit (maximum 3 years)
  • general use of the chemical.

Record keeping

You must keep records to support any statement made in, or in connection with, your application for 5 years from the date your permit is issued.

Learn more about record keeping requirements here

Renewing your LVC permit

You can renew your LVC permit any number of times provided certain criteria are met.


Last update 8 April 2019