Australia Reach Regulation For Various Sectors

Introduction

National Industrial Chemicals Notification & Assessment Scheme.

Australian Chemical Inventory - AICS

Australia has a list of chemical inventory known as “AICS – Australia Inventory of chemical substances”. This is a list of all industrial chemicals in use in Australia between 1 January 1977 and 28 February 1990. It also includes new assessed chemicals. All chemicals on the Inventory are defined as existing industrial chemicals, while industrial chemicals not on the Inventory are defined as new industrial chemicals.

AICS is maintained under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). AICS is a database of more than 40,000 industrial chemicals and it holds chemical identity information and regulatory obligations associated with that chemical.

It consists of the non-confidential (public) section and the confidential section. Public list of chemicals is available on : http://www.nicnas.gov.au/regulation-and-compliance/ aics. If a chemical is not on the public list then an application needs to be made for search in confidential inventory. There are no charges for this confidential inventory searching and application forms are available on NICNAS official site.

Chemicals listed on the Inventory can be imported or manufactured (introduced) without notifying provided it meets relevant conditions. If a chemical falls outside the scope of its stated purpose in the Inventory, then it should be notified and applies.

Like many countries Australia also has its own chemical regulation for assessing the chemicals. It covers assessing and registering by national chemicals and to minimize duplication or unnecessary regulatory on industry. The main aim of the regulation is to protect workers, public and environment from the harmful effects of industrial chemicals.

NICNAS will be replaced by Australian industrial chemical introduction scheme (AICIS) from 1 July 2020.

Chemicals listing on the AICS inventory:

A chemical that is assessed by NICNAS will not be listed on the public or confidential Inventory for the first 5 years after an assessment certificate is issued for that chemical, unless there is a request of early listing.

After 5 years, the following information about the chemical will be available on the Inventory:

-- Chemical name -- Associated (other) name

-CAS number -Molecular formula

Once a chemical is listed on the Inventory, it is available for anyone who is with NICNAS introduces without notification and assessment, subject to conditions of use and secondary notification requirements.

AICS Inventory fees:

Description	Fees
Confedential listing of new chemical	$3,990
Application to retain confedential listing	$3,990
Application for early non-confedental listing with fee	$920
Application to be holder of confidence	$870

Globally Harmonized System (GHS) in Australia:

Australia implemented GHS for workplace hazardous chemicals (both substances and mixtures) from 1 Jan 2017. There is no separate guidance on chemical Classification in Australia. It is recommended to use 3rd revised version of GHS for classifying the substances. Australia GHS is administered by Safe work of Australia https://www.safeworkaustralia.gov.au Manufacturers and importers of chemicals supplied to workplace:

• Must classify the substances correctly - according to UN GHS Rev
• Must label hazardous chemicals in workplace – according to Code of Practice for Labeling of Workplace Hazardous
• Must provide safety data sheets – according to Model Code of Practice for Preparation of Safety Data Sheets for Hazardous

Labeling Requirements:

• Must include Australian contact details of the manufacturer or importer;
• Must include signal word, P-statements, H- statements, pictograms
• number of P-STATEMENTS:-10;
• Additional info required if available: the expiry date of the chemical (if applicable), overseas supplier's contact info, emergency contact number, website address and reference to SDSs;
• Small containers (size not defined):
• Size requirement

It is important to note that there are two non- GHS hazard classes in Australia: AUH070- Toxic by eye contact and AUH071 - Corrosive to the respiratory tract. These shall be included in SDSs or on labels if applicable.

A new inventory called Australian inventory of industrial chemicals (AIIC) is going to be established under new AICIS scheme. This AIIC inventory will replace existing AICS inventory

GlSDS Requirements:

The format and content of Safety Data Sheets (SDS) are set by the Code of Practice for the Preparation of Safety Data Sheets for Hazardous Chemicals.

Following are some important points to note:

• Standard 16-SECTION SDSs
• Emergency phone number: Must include Australian emergency contact information which is available outside of working hours
• Pictogram size: >1CM X1 cm and <2CM X2 cm;
• Section 15: Indication of whether a hazardous chemical is subject to the control of International conventions and domestic regulations such
• If the Classification of a hazardous chemical changes or new information comes to light, the label and be reviewed and revised without undue

The picture below is an example of Australian GHS label given by Safe Work Australia. It explains all the label elements.

Business Registration:

All importers and/or manufacturers of industrial chemicals for commercial purposes shall register themselves with NICNAS. Registration can be done online through NICNAS Business service account system. The registration year runs from 1 September to 31 August.

Once registered with NICNAS, details will be added to the Register of Industrial Chemical Introducers. (https://www.nicnas.gov.au/register-your-business/register-of-industrial-chemical-introducers)

New Chemical Substance types of Approvals / Notifications:

The substances which are not on the AICS inventory are subject to notification before its manufacture or import. Two or more manufacturers or importers may make a joint application (with a single fee).

Specific Implementation Timeline:

NICNAS is undergoing reform and from July 2019 a new scheme known as the Australian industrial chemicals introduction scheme (AICIS) is due to come into effect A consultation on the draG regulations that will comprise AICIS runs until May 2018, this can be accessed from the AICIS notification below. NICNAS remains in force.

Annual Reporting Date: 28 September (every year) Report shall contain introduction activities for the period 1SEPTEMBER to 31 August of next year. 

There are two different types of approvals for new chemical substances which do not qualify for exemptions viz. Certificates and Permits.

Once the notification is made under a certificate category, an assessment report will be published on NICNAS website. This report will contain a summary of health, safety and environmental matters considered in the assessment.

Types of Permit and certificates are mentioned below:

PENALTY

Offence or Penalties:

Manufacturing and/or importing a new industrial chemical in Australia without a NICNAS assessment certificate, permit or exemption can result in a substantial fine for businesses.

Permits	Type	Chemical amount introduced	Duration of certificate or permit	Assessment time frame
	Commercial Evaluation Permit(CEP)	≤ 4 tons	Up to 2 Years	Usually within 14 days
	Low Value Chemical(LVC)	≤ 100 kg/yr	3 Year	20 days
		≥ 100 but ≤ 1000 kg/yr.(if low hazard cri-	3 Year	20 days
	Controlled Used Permit(CUP)	Unlimited	3 Year	Usually within 28 days
	Controlled use -Exports only permit(EOP)	Unlimited	3 Year	Usually within 20 days
	Early Introduction Permit (EIP) - this category accompanies Polymer of law concern (PLC) Limited (LTD) or standard (STD)	As for PLC, LTD or STD	Until certificate issued, or permit rescinded	28 days
Certificates	Polymer of law concern(PLC)	Unlimited	5 Year	90 days
	Limited Notification Certificate(LTD)	≤ 1 ton/yr ≤ 10 ton/yr.for site limited chemicals	5 Year	90 days
	Standard Notification Certificate	> 1 ton per year	5 Year	90 days
	Self-Assessment Certificate	As for PLC, LTD or STD	5 Year	28 days
	Extention of an original assessment certificate

Offence under the Industrial Chemicals (Notification and) Assessment) Act 1989	Penalty units

System in which data need to be submitted:

Forms in word format are available on NICNAS official site for each category of permit/certificate. Relevant forms for each notification category shall be used to submit the required data and information.

For some notification categories, applicant can attach data such as toxicity studies, SDS and occupational data using their own format. The applications shall be sent by post on the NICNAS address and shall be submitted in loose-leaf form rather than bound.

• Application must be legible and submitted in
• Two copies of complete notification statement is required
• Two copies of supporting physicochemical and environmental effect data are required
• Once copy of supporting health effect data is required to be

Annual Reporting:

If a new chemical is introduced to the Australia which is exempt from notification or under permit or certificate then annual report or online declaration must be submitted. Annual reporting date is 28 September 2019. Annual reporting can be submitted online on:

https://secure.nicnas.gov.au/arm/WebForms/SignIn.aspx

Online declaration: Online declaration can be submitted if annual report is done previously and if the chemicals introduced in 2018-19 are the same as those introduced and reported for the 2017-18 registration year, including using the same category of exemption.

Assessment of Priority Existing Chemicals (PEC's):

PEC’s are the Industrial chemicals which has been identified as requiring an assessment because there are reasonable grounds for believing that, handling, storing, using or disposing of the chemical could be a risk to health and/or the environment. If any substance of manufacturer or importer is declared as PEC then they must apply for assessment certificate.

List of PEC is available on https://www.nicnas.gov.au/chemical-information/pec-assessments

What needs to be reported?

• Chemicals introduced solely for research, development or analysis in quantities of not more than 100kg/year
• Chemicals introduced at a port or airport that remain subject to Customs and Border Protection Service control, are at a port or airport at all times, and leaves Australia less than 30 days after the day they are
• Chemicals used for non-cosmetic purposes, introduced in quantities of less than 100kg/year and pose no unreasonable risk to human health and the environment
• Chemicals in quantifies of less than 100kg for cosmetic purposes which meet prescribed requirements and pose no unreasonable risk to human health and the environment
• Non-hazardous chemicals introduced in a cosmetic at a concentration of up to 1%.
• Low volume, commercial evaluation, controlled use permits, self-assessment certificates
• If introducing under these categories, an annual report must state the name and volume of the chemical and any adverse effect the chemical may have on occupational health and safety, public health or the Report must be provided within 28 days from the end of the registration year (31 August).

NICNAS Assessment Report: If a notification is made under a certificate category, an assessment report will be published on NICNAS's website containing a summary of health, safety and environmental matters considered in the assessment and such recommendations as may reasonably be made to ensure safe use of the chemical. These reports can be assessed on:

http://www.nicnas.gov.au/chemical-information/new-chemical-assessments

Objectives

• Regulate the introduction of industrial chemicals in
• Protection of human health and the environment through restriction, regulation, assessment, evaluation and by managing risks arising due to introduction of chemical in Australian
• Provide for the collection and publication of information and statistics relating to industrial chemicals; and
• Give effect to Australia's obligations under international agreements and arrangements relating to the regulation of industrial

Australian Industrial chemical Act 2019:

This Act establishes the AICIS (Australian Industrial Chemicals Introduction Scheme), and an Executive Director, to control the manufacture or import of industrial chemicals.

The industrial chemical means any chemical element, a compound or complex of a chemical element, UVCB substance, and a chemical released from an article, a naturally-occurring chemical that has an industrial use or proposed to have an industrial use. This Act does not regulate chemicals which are used for agricultural, veterinary or therapeutic purposes, or in food or feed.

Introducers must be registered for a registration year (which begins on 1 September). A registration charge must be paid for registration. Penalties apply if a person introduces an industrial chemical when not registered. Introduction category is based on the level of risk to human health and environment if exposed. The introducers must comply with requirements of category of the chemical.

Medium-to-high risk introductions require an assessment certificate issued by the Executive Director and must comply with the terms of the certificate. Whereas, lower risk introductions such as, Exempted and reported introductions can be made without being assessed by the Executive Director. However, record keeping and reporting obligations apply. A person can also apply for commercial evaluation authorizations and exceptional circumstances authorizations.

After 5 years of Industrial chemicals covered by an assessment certificate, are listed on the Australian industrial chemical inventory. However, early listing is also done in certain other circumstances. Registered importer or manufacturer can introduce chemicals which are listed in inventory but must comply with the terms of the Inventory listing and record keeping and reporting requirements.

Results based on the evaluations on industrial chemicals done by the Executive Director, may bring the changes in the assessments certificate or inventory listings. All the required changes done in assessments, evaluations or any other information, by the Executive Director will publish under this Act.

Annual Reporting

An annual declaration must be submitted by the introducers to the authorities for the introductions made during the registration year and the categorization. For chemicals falling with the scope of reported introductions, a one-off pre-introduction report must be submitted to authority before a person starts introducing an industrial chemical in the category.

Key changes from 1 July 2020

• There will be 6 categories of introduction with different regulatory requirements based on likely level of risk they are :

1. Listed introductions: Introduction in Australian territory is only authorized when it is listed in
2. Exempted introductions: An exempted introduction is an industrial chemical introduction that poses a very low risk to human health and the
3. Introduction of industrial chemical that is solely for use in research and development
4. Introduction of polymer that is comparable to a polymer that is listed on the Inventory
5. Introduction of industrial chemical that is comparable to a listed industrial chemical
6. Introduction of polymer of low
7. Introduction of low concern
8. Reported introductions: A reported introduction is an industrial chemical introduction that poses a low risk to human health or the
   1. Introduction of industrial chemical that is internationally-assessed for human health and the environment
   2. Introduction of industrial chemical at the nanoscale that is solely for use in research and
9. Assessed introductions: An assessed introduction is generally an industrial chemical introduction that poses a medium to high risk to human health or the environment. If an introduction of an industrial chemical does not fall within the definition of an exempted or reported introduction and is not listed on the Inventory, it is generally an assessed
10. Commercial evaluation introductions: The holder must have commercial authorization for chemical for testing the market viability of the chemical before full
11. Exceptional circumstances introductions : Require Ministerial authorization to allow urgent introduction to protect public health or the environment

This category system has focused on the pre-introduction assessments on expected higher risk chemical introductions and also focuses on the post introduction evaluation and monitoring to help maintain the protection of health and safety of the public, workers and the environment

• Lower risk chemical introductions (exempted and reported introductions): Authority has streamlined introduction pathways, which will reduce the regulatory burden on industries by reducing the charges to businesses and consumers, and by reducing the compliance time for
• Higher risk chemicals (Assessed introductions): This Act under categorization will focus on improved protection of users, workers and the environment. This Act will regulate chemicals, by imposing conditions on introductions –or stop introduction based on the human and environmental
• Greater use of international assessment materials: Any chemical having internationally assessed materials for health hazard and environment hazard from trusted body can be used for introduction of chemical in
• Improved monitoring and compliance powers: The new guidelines have increased compliance power with civil and criminal penalties for any breaches, which also help in identify non-compliance.
• Improved approaches to reviewing chemicals on the market: The current NICNAS scheme also has post reviewing of chemicals after placing it in market. However, AICIS post-market assessment process with a more responsive and flexible evaluation
• Greater transparency by striking a balance between confidentiality and publicly available information: The Executive director will publish our assessments and evaluations, with confidentiality achieved through masking the chemical name or end use on AICIS

Restricting the use of animal test data for supporting the introduction of ingredients used in cosmetics: This Act has banned data generated for chemicals from testing on animal after 1 July 2020 for supporting the categorization or assesassessment of chemicals used Ensure Australia meets its obligations under international agreements about chemicals.