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1. New Chemicals

1.1 GENERAL REQUIREMENTS

All new industrial chemicals must be notified to NICNAS, and an assessment certificate or permit obtained before they can be imported and/or manufactured in Australia. Certain new industrial chemicals are considered exempt from notifying to NICNAS but are subject to reporting requirements.

 

A new industrial chemical means an industrial chemical that is not a listed on the Australian Inventory of Chemical Substances (AICS).

 

Some chemicals listed on the AICS may be subject to conditions of use under section 13 of the Act. These chemicals are also defined as new industrial chemicals if their use is for other than that stated on AICS.

A chemical that is a reaction intermediate* or an incidentally produced chemical* is not considered a new industrial chemical.

 

Compliance Criteria

Evidence is required to demonstrate whether the chemical or product imported and/or manufactured is or contains a new industrial chemical. In the case of a new industrial chemical, you must hold a valid assessment certificate or permit for the new chemical.

 

There are other circumstances where you may introduce an industrial chemical without holding an assessment certificate of permit. For compliance guidance to these cases, see the Exemptions Section.

 

Checklist

Have you checked that all imported and manufactured industrial chemicals are listed on AICS?

The imported or manufactured chemical is an industrial chemical
       or is a constituent of a product having an industrial use

Industrial chemicals checked against AICS and documentation
       retained to verify presence on AICS eg. AICS record printout

If the chemical is a new industrial chemical, is it exempt from notification and assessment requirements?

See the Exemptions Section

If the chemical is a new industrial chemical, does the introducer hold a valid assessment certificate or permit?

 

New Chemical has a valid assessment certificate or permit

For permits, does the holder comply with the conditions
      (refer to Permits)

* See Definitions

1.2 EXEMPTIONS

There are certain circumstances where you may import and/or manufacture a chemical without holding an assessment certificate or permit. In these cases, the chemical may be introduced under a specific exemption category as defined in the Act under Section 21.

Compliance Criteria

Relevant data are required to show that the chemical is covered by a specific exemption under the Act.

Where a specific exemption applies (Section 2. to 4. below), you are required to provide a report to the Director on an approved format stating the name of the chemical and the quantity introduced. The report must be provided before or on 28 September of the following registration year. A registration year runs from 1 September to 31 August.

The introducer of the new chemical must provide an annual report detailing:

  • The name of the chemical

  • The volume of the chemical introduced during the year

 

Checklist

1. New chemical introduced for research, development or analysis

  1. Manufactured in a fixed apparatus in specific location

    Advice of introduction submitted to NICNAS (Form 6)

    Procedures related to safe disposal and any hazardous
           degradation products

    Records showing type and location of the apparatus

    Records showing that it is used for research,
          development or analysis

    Monitor manufactured volume of the chemical

  2. Imported and/or manufactured at a maximum of 100 kg in any 12 months

    Import and/or manufacture volumes are monitored

    Information on the research, development or analysis
         of the new chemical

    Annual reports using the approved NICNAS format
          provided at the end of the registration year (first
          report due by 28 September 2005)

 

2. New chemical intended for non cosmetic* use and does not exceed 100 kg in any 12 months

Evidence that the chemical poses no unreasonable risk to
      occupational health and safety, public health and the
      environment

(Optional) Advice submitted to NICNAS (Form NCE-1)

Import and/or manufacture volumes are monitored

Records relating to the use of the new chemical

Annual reports using the approved NICNAS format provided
      at the end of the registration year (first report due by 28
      September 2005)

 

3. New Chemical intended for cosmetic* use

A new chemical used in cosmetics as a preservative or colouring agent or an ultraviolet filter is not exempt from notification and should not be introduced under the exemption category.

  1. Introduction volume does not exceed 100 kg in any 12 months

    1. The chemical is introduced between 10 and 100 kg/annum:

      Evidence that the chemical poses no unreasonable
            risk to occupational health and safety, public
            health and the environment

      Advice submitted to NICNAS (Form15) including
            copies of :

      • Material Safety Data Sheet relevant to the chemical or product containing the chemical

      • Label to be attached to the packaging of the chemical or product containig the chemical

      Import and/or manufacture volumes are monitored

      Records relating to the use of the new chemical

      Records must be kept for 5 years after the
             introduction on all information available to the
             introducer on occupational health and safety,
             public health and the environmental effects of the
            chemical

      If the new chemical is introduced in a cosmetic at
           1% or more, you must have information that the
           chemical will be safe for use by potentially high risk
           groups (including infants, elderly persons and
          atopic persons)

      Annual reports using the approved NICNAS format provided at the end of the registration year (first report due by 28 September 2005)

    2. The chemical is introduced at less than 10 kg/annum:

      The chemical poses no unreasonable risk to occupational health and safety, public health and the environment

      Import and/or manufacture volumes are monitored annually

      Records relating to the use of the new chemical

      Records must be kept for 5 years after the introduction on all information available to the introducer on occupational health and safety, public health and the environmental effects of the chemical

      If the new chemical is introduced in a cosmetic at 1% or more, you must have information that the chemical will be safe for use by potentially high risk groups (including infants, elderly persons and atopic persons)

      Annual reports using the approved NICNAS format provided at the end of the registration year (first report due by 28 September 2005)

  2. Non hazardous and introduced at less than 1%

    The chemical is not a hazardous chemical*, is not a dangerous good and meets the prescribed environmental criteria

    The chemical meets other criteria prescribed in regulation* 6AB

    Records relating to the use of the new chemical and its percentage in the cosmetic

    using the approved NICNAS format provided at the end of the registration year (first report due by 28 September 2005)

 

4. New chemical introduced under the transhipment category

The chemical is stored at the port or airport or in a bonded warehouse for not more than 30 days and remains subject to Customs control during this time

Import and export records relating to the new chemical

Annual reports using the approved NICNAS format provided at the end of the registration year (first report due by 28 September 2005)

 

1.3 PERMITS

Commercial Evaluation Chemical (CEC), Low Volume Chemical (LVC) and Early Introduction Permits are available for new chemicals introduced under the permit category. Holders of the permit(s) must comply with the stipulated conditions.

Compliance Criteria - all Permits

Evidence is required that the holder(s) of the Permits are complying with the standard Permit conditions, as well as any special conditions.

Holders of permits (CEC and LVC) are required to provide a report to the Director stating the name of the chemical and the quantity introduced. The report must be provided before or on 28 September of the following registration year. A registration year runs from 1 September to 31 August.

Checklist

Introduction volumes are regularly monitored

Relevant commercial documents are held supporting import volumes below the specified amount eg Customs records, records of annual import volumes

Records of import and/or manufacture volumes to show that the amounts and duration did not exceed the permit condition

For LVC and CEC permits, annual reports to the Director stating the name and introduction volume of the chemical, together with any adverse effects on occupational health and safety, public health or the environment

The report must be provided before or on 28 September of each registration year.

Are the workers handling the new chemical aware that it is being introduced under a Permit system, and what safety measures are in place?

Workers at all sites are provided with the relevant Material Safety Data Sheets (MSDS), containing a permit statement

Any other relevant documents, eg worker training manuals, safety guides and labels

How is the chemical disposed of?

Disposal of the chemical is consistent with Local, State and Federal laws

Records of disposal procedures

Is there continuous monitoring of the use and health and environmental effects of the chemical?

Copies of the Permit are kept at each site where the chemical is used

Documents indicating the identity of sites where the chemical is used, and the quantity of the chemical used at each site

Use of the chemical is in accordance with all relevant State or Territory occupational health and safety, environmental and poisons legislation.

Keep records of any adverse occupational health and safety, public health and environmental effects

1.3.1 Commercial Evaluation Chemical Permits

Commercial Evaluation Chemical (CEC) Permits are issued for new industrial chemicals to be introduced solely for the purpose of commercial evaluation where the maximum quantity to be introduced is 4000 kg in a maximum period of two years.

Compliance Criteria - CEC Permits

Evidence is required that the holder(s) of the Commercial Evaluation Permit are complying with the Permit conditions.

Evidence is required that the annual report was submitted to NICNAS.

Checklist

Was the chemical used only for commercial evaluation, and what were the results?

Have records showing that the chemical was only used for commercial evaluation such as evaluation reports

Annual reports and a Final Evaluation Report are submitted to the Director, NICNAS, containing information on any occupational health and safety, public health or environmental effects observed, the amount of the chemical used and the means of disposal of any surplus

The annual report is required by the end of the registration year; however, the Final Evaluation Report is required at the end of the permit period.

Do all users of the chemical have signed user agreements in place?

A user agreement has been signed and submitted to NICNAS by all users prior to commencement of the chemical's use (NICNAS Form 8)

Copies of the signed user agreements are available at each site

1.3.2 Low Volume Chemical Permits

Low Volume Chemical Permits (LVC) are issued for new industrial chemicals to be introduced at a maximum volume of 100 kg/year (1000 kg/year in certain cases) for a period of 3 years.

Compliance Criteria - LVC Permits

Evidence is required that the holder(s) of the Low Volume Chemical Permit are complying with the Permit conditions.

Evidence is required that the permit holder keeps records for up to 5 years and an annual report is submitted to NICNAS.

Checklist

Records to indicate that, if the use or introduction methods of the chemical changed significantly throughout the duration of the permit, NICNAS was informed within 28 days of the permit holder(s) becoming aware of the change

Records must be kept for five years after the issue of the permit, to support any statement made in connection with the application for the permit

1.3.3 Early Introduction Permits

Application for an Early Introduction Permit (EIP) can be made in conjunction with a Limited (LTD), Standard (STD) or Polymer of Low Concern (PLC) Notification. The holder of an EIP may commence introduction of the chemical before the assessment is completed.

Compliance Criteria - Early Introduction Permits

Evidence is required that the holder(s) of the Early Introduction Permit are complying with the Permit conditions.

Checklist

Were the volume and period of introduction within the limits specified in the permit conditions?

Relevant commercial documents supporting import/manufacture volumes below the specified amount e.g. Customs records, records of annual import volumes

If stated as a condition on the permit, at the end of the permit period, the holder(s) of the Permit must report to the Director any adverse occupational health as safety, public health or environmental effects reported from the use of this chemical

1.4 SELF ASSESSED ASSESSMENT CERTIFICATE

A manufacturer and/or importer may apply for a self-assessed assessment certificate for a polymer of low concern; or any other chemical or class of chemical for which the criteria are prescribed in the regulations.

Compliance Criteria

A person issued a self-assessed assessment certificate must keep records to support any statement made in or in connection with the application for the certificate.

Records must be kept for 5 years.

The holder of the certificate must provide an annual report detailing:

  • the name of the chemical

  • the volume of the chemical introduced during the year; and

  • any adverse effect of the chemical on occupational health and safety, public health or the environment of which the holder has become aware during the year

The report must be provided before or on 28 September of the following registration year.

 

Checklist

Keeping of records relating to application for self-assessed certificate

Relevant documents supporting information in the application are available

Relevant records to support the assessment report are kept for 5 years

 

Annual reporting requirements

Annual reports submitted on or before 28 September of each following registration year while the certificate remains current

 

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