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National Industrial Chemicals Notification and Assessment Scheme- Australia NICNAS

  •   2 Jan 2018
  •    Ying Zhang
    Australian regulation:
    National Industrial Chemicals Notification and Assessment Scheme- Australia NICNAS 
    Competent Authority
    Department of Health
    History
    Published

    1990       

    Reforms
    Start from  May 2015
    The new scheme (AICIS) will commence on 1 July 2020
     

    (Last update 17 May 2019)
    The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is a statutory scheme regulating importing and manufacturing of Industrial chemicals in Australia. It was established in 1990 under the Industrial Chemicals (Notification and Assessment) Act 1989 to promote safe use of industrial chemicals by providing information and recommendations to other regulators. However, NICNAS does not regulate the use or disposal of chemicals.

    Administered by the Australian Government's Department of Health, NICNAS is responsible for the following laws:

    Type of authority

    Name

    Acts

    Industrial Chemicals (Notification and Assessment) Act 1989
    Industrial Chemicals (Registration Charge—General) Act 1997
    Industrial  Chemicals (Registration Charge—Customs) Act 1997

    Industrial Chemicals (Registration Charge—Excise) Act 1997

    Regulations

    Industrial Chemicals (Notification and Assessment) Regulations 1990

    Standards

    Cosmetics Standard 2007

    These laws empower NICNAS to assess new industrial chemicals for health and environmental risks, to maintain the Australian Inventory of Chemical Substances (AICS), to manage the register of industrial chemical introducers, and to compel commercial importers and/or manufacturers to notify industrial chemicals that are new to Australia.

    Contents

    The Scope of NICNAS

    NICNAS defines a 'chemical' according to the meaning given in the Industrial Chemicals (Notification and Assessment Act 1989 (ICNA Act). The following are not considered as a chemical, so they are outside the scope of NICNAS:

    1. An article: an item that has been manufactured into a certain shape or design, its chemical composition does not change during use. For example, steel ball bearings, compound plastic pipe, and adhesive film.
    2. A radioactive chemical, meaning a chemical with a specific activity greater than 35 becquerels/g.
    3. A mixture. NICNAS applies to individual substances in it.

    Also, NICNAS is not responsible for the following uses of chemicals (they are managed by other schemes): chemicals used solely for pesticides, agricultural products, veterinary medicine, food for animals/humans, food additives, pool sanitizers, medicines, medical devices, sterilants, disinfectants, primary sunscreens.

    NICNAS Reform

    On 26 May 2015, the Australian Government announced its decision to implement a range of reforms to the regulation of industrial chemicals which will be fully implemented by 1 July 2018. The reform aims to better reflect the risks posed by industrial chemicals while maintaining Australia’s robust health and safety standards. The reforms would include:

    • rebalancing pre-and post-introduction regulatory requirements to match the indicative risk profile of a new chemical,
    • streamlining the current risk assessment process for new and existing industrial chemicals,
    • greater use of international assessment materials, and
    • more appropriate monitoring and compliance tools.

    In mid-2017, Australia's Industrial Chemicals Bill 2017 provided that a new scheme known as the Australian Industrial Chemicals Introduction Scheme (AICIS) will replace the NICNAS and enable the Commonwealth to continue to regulate the introduction of industrial chemicals in the country. However on 9 March 2018, the Australian government announced to defer commencement of the AICIS, as well as the implementation of the Industrial Chemicals Bill 2017, until 1 July 2019, in a bid to help regulated entities adequately prepare for compliance with the new scheme. On 11 January 2019, the implementation of the new scheme was further delayed to 1 July 2020.

    Whilst the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under the NICNAS, including:

    • No more annual reporting for permit holders and self-assessed assessment certificate holders
    • Shorter time frames for Approved Foreign Scheme assessments
    • PLCs are exempt from notification
    • Expansion of the PLC criteria
    • Changes to the definition of a new synthetic polymer
    • No more Safety Data Sheets (SDS) and labels required for cosmetics introduced at low volumes

    By April 2019, all six parts of the Industrial Chemicals Bill 2017 have received royal assent and officially become law. Meanwhile, a new Australian industrial chemicals law — the Industrial Chemicals Act 2019 — has been in place, serving as the primary act for the establishment of AICIS.

    Introduction to AICS

    The Australian Inventory of Chemical Substances (AICS) is a database of chemicals available for industrial use in Australia. Before importing or manufacturing industrial chemicals, you must check AICS to see if it is on the list and if there are any specific use conditions/restrictions. All industrial chemicals not listed on AICS must be notified to NICNAS and assessed for risks to the environment and human health prior to their import or manufacture in Australia unless they are exempt.

    There are two sections of AICS- public AICS and confidential AICS. Over 40000 chemicals are listed on public AICS and can be searched on the NICNAS website in the search bar on the top of the website page. For confidential AICS, you can request a search of the confidential AICS if you cannot locate a chemical on the public AICS. It is free to request a search of the confidential AICS. Click here for the application form.

    Chemicals on AICS are listed by their CAS Registered number and CAS name. As chart 1 shows, you will find the following information on AICS files.

     

    How to List Chemicals On AICS

    For early listing:

    If you are a certificate holder you can apply for an assessed chemical to be listed on the public AICS before the 5 year period expires (click here for application form). You cannot apply for an early listing on the confidential AICS.

    If you apply within 28 days of the assessment certificate's given date (i.e. the date you received the certificate from us), no fee applies. After this 28-day period, a fee of $900 applies.

    During the review process, NICNAS will contact any other certificate holders to check if they agree with your request. If no objections are received—your application will be approved and the chemical will be listed on the public AICS with notification of its listing published in the Chemical Gazette. If objections are received—your application will be rejected and the chemical will remain unlisted for the 5 year period.

    For Public ACIS:

    At the end of the 5-year non-listing period, you will receive notification from NICNAS to list the chemical on the public AICS. The chemical will be listed on the public AICS and on the chemical gazette unless you apply for a confidential listing.

    For Confidential ACIS:

    If you hold an assessment certificate for an industrial chemical, you may apply for the chemical's name, CAS Number, and molecular formula to remain confidential for a period of 5 years (after its initial 5 year period of non-listing). Application for a re-listings can also be made. A $3,900 fee applies.

    An application for confidential AICS listing doesn't mean it will automatically be accepted. Each application will be considered individually using a statutory test that considers both commercial and public interests (Click here for the application form).

    See chart 2 below for listing fees.

    Description

    Fee (AUD)

    Confidential listing of a new industrial chemical

    $3,900

    Application to retain confidential listing

    $3,900

    Application for early non-confidential listing

    (within 28 days of the assessment certificate’s given date) 

     

    Free

    Application for early non-confidential listing

    (outside the 28-day-period)

    $900

    Application to be a holder of a confidence

    $850

    Chart 2

    Bussiness Registration

    Who Should Register

    You must register with NICNAS before you import and/or manufacture relevant industrial chemicals, or products containing relevant industrial chemicals, for commercial purposes, regardless of the amount of industrial chemicals in that registration year.

    If you are not sure whether you need to register, click here for an online questionnaire to find an answer or contact NICNAS for further information.

    Noticeably, you must register with NICNAS before you manufacture or import industrial chemicals in Australia. If you fail to do so, NICNAS can seek to prohibit you from introducing industrial chemicals until you meet your registration requirements. A court could also impose penalties for non-compliance with your legal obligations; these penalties are up to $63,000 for an individual and $315,000 for a business.

    Registration Fee

    There are four registration levels based on the total value of industrial chemicals you intend to import and/or manufacture in a registration year (which runs from 1 September to 31 August in the following year). Chart 3 shows the registration levels and how to estimate the total value of industrial chemicals.

    It is recommended that you record how the calculation was made, as you are subject to random audits and it is an offense to provide false or misleading information. All relevant commercial documents must be kept for at least five years.  

    You should first determine whether you need to register with NICNAS. If so, the next step is to calculate your registration levels. Then register with NICNAS online and pay the fee that applies to your registration level. Here is a detailed guide containing step-by-step instructions on how to access and use NICNAS Business Services to register or renew your business.

    Renew Registration

    If you are continuing to import and/or manufacture industrial chemicals you must renew your NICNAS registration by 31 August each year. If you renew after the 31 August deadline, you may be liable to pay a late renewal penalty—an additional 15% of the total registration fee. If you do not intend to import and/or manufacture industrial chemicals, you will not be required to register for the following year. However, a notice of intent not to renew registration is needed.

    New Chemical Notification

    A new chemical is an industrial chemical that is not listed on the Australian Inventory of Chemical Substances (AICS) or is a  listed chemical substance subject to a condition of use. You can find out if you need to notify your chemical before answering the questionnaire. Only domestic manufacturers and importers can submit new substance notifications to NICNAS.

    Exemption list

    New chemicals introduced to Australia need to notify to NICNAS unless they are exempted. The following chemicals are exempt from notification:

    1. For research, development or analytical purpose:

      1. Category 1. Manufactured in a fixed apparatus in a specific location (no volume restriction).
      2. Category 2. Imported and/or manufactured at a maximum of 100kg in a 12-month period.
    2. At ports subject to the control of Customs (max 30 days).
    3. Posing no unreasonable risk and not exceeding 100kg in 12 months (exclude industrial nanomaterial).
    4. Posing no unreasonable risk for cosmetic use at a concentration of 1% or less (exclude hazardous chemicals, dangerous good or industrial nanomaterial).

    *Note: If the chemicals are for cosmetic use, the chemicals must not be prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC or in the United States under the Food and Drugs Cosmetics Act 1938.

     The chart below helps you to determine whether a new chemical needs notification.

    Annual Report/Declaration 

    The annual report is due on 28 September annually and details activity based on your previous NICNAS registration year (1 September to 31 August).

    You need annual reporting if:

    A. you have introduced new chemicals that are exempt from notification:

    1. chemicals are introduced solely for research, development or analysis in quantities of not more than 100 kg/year (category 2)  
    2. At ports subject to the control of Customs (max 30 days)
    3. chemicals introduced in quantities of less than 100 kg/year and pose no unreasonable risk to human health and the environment
    4. Chemicals are used for non-cosmetic purposes, introduced in quantities of less than 100 kg/year and pose no unreasonable risk to human health and the environment.

    B. you are the holder of a Low volume commercial evaluation (LVC permits), controlled use permits, self-assessment certificates.

    Your annual report must state the name and volume of the chemical and any adverse effect the chemical may have on human health or the environment.

    Type of Assessment

    There are two broad categories for assessing a new chemical—permits and assessment certificates. To decide which to apply, you have to consider the following factors: type of chemical, the amount you are introducing, use of the chemical, period of use, and your company's business needs and commitments.

    Table 5 shows the comparison between permits and assessment certificates. Having a certificate means eventually listing on the AICS and publication of a risk assessment report on the NICNAS website, while a permit means reduced data requirements, no listing on AICS, and publication of notice in the Chemical Gazette instead. A permit also has shorter statutory approval timeline (about 14-28 days) while a certificate's timeline is longer (about 29-90 days).    

    Permit

    The following two charts provide information about 6 types of permits, their application fees, chemical introduced amount, valid duration, assessment timeframe, and application forms to be downloaded.

    Permit

    Description

    Chemical amount introduced

    Duration

    Assessment timeframe

    Application Form

    Commercial evaluation chemical (CEC)

    $4,500 applies

    The commercial evaluation chemical (CEC) permit allows you to use the chemical for a specified performance or product trial only (for example, to test a new polymer in a surface coating when a large quantity is required to fill paint lines or to evaluate a new process that requires a new industrial chemical). 

    <4 tonnes

    Up to 2 years

    Usually within 14 days

    CEC application form

    Low volume chemical (LVC)

    $4,500 applies

    A 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.

    <100 kg/yr or
    >100 but ≤1000 kg/yr (low-hazardous criteria apply)

    3 years

    20 days

    LVC application form

    Controlled use permit (CUP)

    $4,500 applies

    Controlled use permits are issued for the introduction of low-risk new chemicals used in highly controlled circumstances for a maximum of 3 years (note certain prescribed criteria apply);

    Unlimited

    3 years

    Usually within

    28 days

    CUP application form

    Controlled use—Export only permit (EOP)

    $4,500 applies

    Industrial chemicals will be eligible for the controlled use (export only) permit (EOP) if the entire quantity of the new chemical:

    • imported into Australia will be exported
    • imported into Australia for use in formulating  products will be exported
    • manufactured in Australia will be exported
    • manufactured in Australia for use in formulating products will be exported.

    Unlimited

     

     

    3 years

    Usually within

    20 days

    EOP application form

    Early introduction permit (EIP)—this category accompanies Polymer of low concern (PLC), Limited (LTD) or Standard (STD)

    A section 30A EIP permit ($2,700 applies) is issued in conjunction with an LTD, STD or PLC notification for chemicals meeting prescribed criteria (eg hazard or use).

    Under strict circumstances, special EIPs (section 30 of the Act, $9,600 applies) may be issued for new chemicals where you can show that their immediate introduction is in the public interest. Ministerial approval is required.

    This permit is issued only for the period until a certificate is issued; it cannot be renewed.

    As for PLC, LTD or STD

    Until certificate issued, or permit rescinded

    28 days

    EIP application form

    Permit renewal:

    $2350 applies

     You can renew LVC, EOP and CUP permits any number of times, but a CEC permit can only be renewed once.

    As for previous LVC, CEC, CUP, EOP

    3 years (LVC/CUP/EOP)

    and up to 2 years (CEC)

    20 days (LVC/EOP), and usually 28 days (CUP) and 14 days (CEC)

    LVC renewal application;

     CEC renewal application;

    Contact

    NICNAS

    For EOP/CUP form

    table 6

    Table 7 below concludes the application requirements for each permit.

    Permit

    Application Requirements

     

     

    Commercial evaluation chemical (CEC) permit

    1. CEC application form (include a statement that you are entitled to use and to give NICNAS all the data; a declaration that you have submitted all available information)
    2. the total quantity of chemical to be introduced
    3. the total time period for introduction
    4. use of the chemical
    5. details of previous or current permits for the chemical
    6. a User Agreement (Form 8)
    7. a summary of the chemical's effects on health and the environment
    8. information about the chemical, comprising the data items listed in paragraphs 6(a)(i) to 6(N), 7,8, 11 and 12 of Part B of the Schedule
    9. any application for exempt (confidential) information, with your payment
    10. the CEC checklist indicating which items on CEC application form you have completed and items for which you are applying for confidential information

    Low volume chemical(LVC) permit

    LVC application form

    Controlled use permits (CUP)

    1. Evidence to demonstrate that you have satisfactorily addressed each environmental hazard criterion.
    2. For introduction volumes exceeding 10 tonnes per year, you must provide all available toxicological and eco-toxicological data with your application. 
    3. The evidence you supply for close analogues must include a sound scientific justification, including discussion of comparability of the physico-chemical properties of the chemical and proposed analogue.
    4. 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). 

    Controlled use (export only) permit (EOP)

    EOP application form

    Early introduction permit (EIP)

    Under strict circumstances, special EIPs (section 30 of the Act) may be issued for new chemicals where you can show that their immediate introduction is in the public interest. Ministerial approval is required.

    permit renewal

    Criteria for CEC renewal

    1. Complete renewal application
    2. a copy of your current permit and including conditions
    3. any application, with the required fee, for information to be exempt based on confidentiality—you do not need to resubmit an application for exemption if one was included with your original permit submission
    4. a statement indicating you are entitled to use and will give NICNAS on request, all the data in your notification statement
    5. a declaration (in the application form) you have submitted all relevant information
    6. Payment.
    7. new User Agreements (Form 8)—you and each proposed user must sign a User Agreement indicating you will comply with permit conditions (for CEC renewal only)

    Conditions for LVC, CUP and EOP renewa

    table 7

    Assessment certificate

    Table 8 below introduces 5 types of assessment certificates, giving detailed information about chemical amount introduced, duration, assessment timeframe, and application forms: 

    Certificates

    Description

    Chemical amount introduced

    Duration

    Assessment timeframe

    Application form

    Polymer of low concern (PLC)

    $6,300 applies

    Click PLC flowchart to see if the chemical is a new PLC

    Unlimited

    5 years

    90 days

    Form

    Limited (LTD)

    $13,600 applies

    LTDs are for chemicals fitting one of these categories:

    • small-volume chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)—that is, chemicals to be imported or manufactured at a rate of up to 1 tonne/12-month period
    • site-limited chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)—that is, chemicals restricted to their manufacturing site and manufactured at a rate of not more than 10 tonnes/12-month period
    • synthetic polymers with NAMW >1000 Da that do not meet the PLC criteria.

     

    <1 tonne/yr3

    <10 tonne/yr3 for site limited chemicals

     

     

     

    5 years

     

     

    90 days

     

     

    Form

    Standard (STD)

    $19,000 applies

    STDs are for chemicals, biopolymers and low MW synthetic polymers (NAMW<1000 Da) imported or manufactured at greater than 1 tonne/year that do not fulfill the requirements of any other category.

    >1 tonne/yr

    5 years

    90 days

    Form

    Self assessment

    You can submit a self-assessment application for a PLC ($4,300), non-hazardous chemicals ($11,800) and non-hazardous polymers ($11,000). However, your application will not be accepted if the chemical or polymer can be predicted to be persistent and bioaccumulative, or if there are breakdown products that can be predicted to be persistent and bioaccumulative.

    As for PLC, LTD or STD

    5 years

    28 days

    Forms and guidance

    Extension of an original assessment certificate (EX)

    $5,800 applies

    Extension of a current assessment certificate may cover other companies intending to import or manufacture a notified chemical, where the holder of the original certificate agrees and as long as certain criteria are met.

    As for PLC, LTD or STD

    5 years from granting of original certificate

    45 days

    Form

    table 8

     

    Assessment certificate

    Application requirements

     

     

    Polymer of low concern (PLC) notifications

    1. the completed application form for an assessment certificate (PLC Assessment Certificate Application (Form PLC-1))  with new chemical data items listed
    2. any other information about the polymer available to you
    3. (where required) applications to exempt information based on confidentiality or to vary the schedule of data requirements
    4. Any application for third party information (Form 5).

     

     

     

    LTD notifications

    1. the completed application form for an assessment certificate (Form-1), including the information about the chemical—comprising parts AB, and C* of the schedule (* for STD only, unless available for LTD), Part D for synthetic polymer or biopolymer, and Part E for an ultraviolet filter used in a cosmetic and applied to the skin
    2. any other information about the chemical available to you
    3. (where required) applications to exempt information based on confidentiality or to vary the schedule of data requirements
    4. Any application for third party information (Form 5).

     

     

     

    STD notifications

    1. the completed application form for an assessment certificate (Form-1), including the information about the chemical—comprising parts AB, and C* of the schedule (* for STD only, unless available for LTD), Part D for synthetic polymer or biopolymer, and Part E for an ultraviolet filter used in a cosmetic and applied to the skin
    2. any other information about the chemical available to you
    3. (where required) applications to exempt information based on confidentiality or to vary the schedule of data requirements
    4. Any application for third party information (Form 5).

    Self-assessment certificate

    a self-assessment application form

     

     

    Extension of an original assessment certificate (EX)

    1. the completed application form for an extension (Form EXT-1)
    2. supplementary information on matters affecting occupational, public and environmental exposure (if the application contains significant differences from the original assessment)
    3. any new health and environmental effects information available about the notified chemical
    4. confirmation that you have access to the public assessment report for the notified chemical
    5. The written agreement of all holders of the original assessment certificate for the extension application (Form 14)—one form is required for each holder of the original assessment.

     

    table 9

    Secondary Notification

    You are obliged to notify NICNAS when you become aware of a significant change in circumstances relating to an assessed new or existing chemical and do it within 28 days of becoming aware of such a change. These obligations apply regardless of the AICS status of a chemical. You have to notify NICNAS director of significant changes even if the chemical is listed on the AICS. You can request certain content confidential as long as you justify your request.

    How to Notify a chemical 

    Now that you have determined you must notify NICNAS about your new chemical, you need to follow the following steps. Click on the links to see further information:

    Two or more manufacturers or importers may make a joint application (with a single fee). NICNAS issues a permit or certificate to each successful applicant. However, a joint application is not allowed for self-assessment.

    PECs (Prioty Existing Chemicals)

    A Priority Existing Chemical (PEC) is an industrial chemical which has been declared by the Health Minister for NICNAS to assess in detail. It can be assessed as one single chemical or a group of chemicals to improve assessment efficiency.

    Nominations to declare a PEC may come from a company, union, industry body, individual, government department or nongovernment organization. In the selection of a PEC, NICNAS may nominate a chemical on AICS as a PEC at any time. In the past, NICNAS has collected nominations of chemicals as potential PECs from the public. Those chemicals were screened against set criteria including the volume of use, potential exposure and severity of occupational health and safety, public health and environmental effects. A chemical can be declared as a PEC following NICNAS’s recommendation to the Health Minister, prior to NICNAS publishing a notice in Chemical Gazette to obtain information about a particular chemical or a group of chemicals.

    If you are importing or manufacturing chemicals declared as PECs, you must apply for NICNAS to assess the chemicals. If no application is lodged after a chemical is declared a PEC, the NICNAS Director can request the assessment report to commence. The overall assessment involves consultation with PEC applicants, other suppliers of information, regulatory agencies and other interested or relevant persons. If there is no application for a PEC assessment within 12 months since a chemical has been declared as a PEC, NICNAS will remove the chemical from the AICS. Also, a chemical declared as a PEC will be removed from AICS if it has not been assessed under NICNAS’s instructions.

    Once a PEC assessment has been published, the chemical is no longer a current PEC. Instead, it will be a chemical previously listed as PEC. If an enterprise wants to import or export an assessed PEC, it should follow the requirements and recommendations in the assessment report of the PEC. However, a secondary notification is required if there is any change to the circumstances. Click here to see the list of assessed PECs.

    The contents of all PEC assessment reports differ, but mostly the reports contain important information as follows:

    • chemical identity, physical and chemical properties,
    • manufacture, importation and use,
    • health and environmental exposure and hazards,
    • human health and environmental risk characterization,
    • current health and environmental risk management,
    • recommendations for risk management,
    • post-assessment reporting obligations for secondary notifications.

    If you want to apply for assessment of an Existing Industrial Chemical within 28 days of its declaration as a PEC, click here for the application form. If it exceeds 28 days of its declaration as a PEC, click here for the application form. When providing information for a PEC assessment, you can submit an application claiming that certain content should be confidential, as long as you justify your request.