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Notifying a New Chemical in Australia and Canada
John Hislop, Budapest, June 2014
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Content
Brief comparison of the schemes with REACH
Authorities and notification schemes
Inventories
Exemptions / exclusions
Types of notification
Data requirements
Notification practicalities
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Comparisons with REACH
Like REACH
Notify (Register) new substances before manufacture / import
Mandatory data requirements dependent on tonnage (and other factors)
New studies should be conducted according to standard OECD guidelines
Unlike REACH
No need to notify “existing chemicals”
No phase-in
Need to notify polymers
Risk assessment is undertaken by the authorities
No IUCLID
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Australia
Authority and Scheme
National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
http://www.nicnas.gov.au/
Industrial Chemicals (Notification and Assessment) Act 1989
Registering with NICNAS
If you are an importer and/or manufacturer (introducer) of industrial chemicals
for commercial purposes you must register with the NICNAS Register of
Industrial Chemicals Introducers in order to introduce relevant industrial
chemicals into Australia
To register you pay a yearly registration fee (regardless of the amount of
industrial chemicals imported and/or manufactured in that registration year)
and a charge for the value of the chemical you are introducing (this varies
depending on the value)
The NICNAS registration year runs from 1 September to 31 August
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Australian Inventory of Chemical Substances (AICS)
AICS is the legal device that distinguishes new from existing chemicals
It is a listing of all industrial chemicals in use in Australia between 1 January
1977 and 28 February 1990
A “live” inventory, it includes new assessed chemicals and corrections as
required, as well as chemicals that were regulated by other Australian
regulators and have since become industrial chemicals
It currently contains around 40,000 chemicals
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Confidential and Non-confidential AICS listings
All certificate-assessed chemicals are included on the non-confidential section
of AICS five years after the certificate date unless the notifier exercises the
option for immediate listing
At the end of five years the notifier is given the opportunity to request that the
chemical be listed on the confidential section
In order to list a chemical in the confidential section of the AICS, an
application to the Director of NICNAS is required
If the application is approved, the chemical is confidentially listed for five
years. At the end of five years, the company can apply to extend for another
five years
Chemicals for which no confidential applications are received or where the
Director does not agree to confidential listing, are listed on the nonconfidential AICS, and their listing is reported in the Chemical Gazette
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Searching AICS
The non-confidential section of AICS can be searched online:
http://www.nicnas.gov.au/regulation-and-compliance/aics/aics-search-page
It is possible to apply to NICNAS for a search of the confidential Inventory
Natural chemicals (ones that are extracted from natural sources in such a way
that their chemistry won't have changed during the extraction process) do not
need to be listed on the AICS
Mixtures, including alloys, are also not eligible for listing, and can only be
introduced without notification if their component chemicals are on the AICS
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Australia: Exemptions from Notification
R&D substances (< 100 kg per year) or those manufactured in a fixed
apparatus in a specific location (no volume limit)
Transhipment under customs control at port (30 days maximum)
Cosmetic ingredient substances that pose no unreasonable risk to
occupational health and safety, public health or the environment*
Non-cosmetic substances that pose no unreasonable risk to occupational
health and safety, public health or the environment (< 100 kg per year)*
Non-hazardous cosmetics contained in products at < 1% concentration
*Subject to exclusions, check the NICNAS Handbook for details and for details of
what is considered to be “unreasonable risk”
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Australia: Permit or Assessment Certificate?
Two broad categories exist for assessing a new chemical; permits and
assessment certificates.
To decide which to use, you need to consider;
type of chemical
amount you are introducing
use of the chemical
period of use
your company's business needs and commitments
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Australia: Comparison of Permit and Assessment
Certificates
Certificate
Permit
Assessment certificate issued
Permit issued with conditions stipulated,
including duration and volume
Data requirements as per category
Reduced data requirements
Eventual listing on the AICS
No eventual listing on the AICS
Publication of a risk assessment report (with
recommendations) on the NICNAS website
Publication of notice in the Chemical Gazette
with summary details
Statutory timelines: 29–90 days
Shorter statutory timelines: 14–28 days
Higher cost
Reduced cost
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Australia: Permits
Outcome
Chemical amount
introduced
Duration of
certificate or
permit
Assessment timeframe
Permit
<4 tonnes
Up to 2 years
Usually within 14 days
Low volume chemical (LVC) Permit
<100 kg/yr
3 years
20 days
Low volume chemical (LVC) Permit
>100 but ≤1000 kg/yr
3 years
20 days
Controlled use permit
(CUP)
Permit
Unlimited
3 years
Usually within
28 days
Controlled use—Export
only permit (EOP)
Permit
Unlimited
3 years
Usually within 20 days
Commercial evaluation
chemical (CEC)
Early introduction permit
(EIP)—this category
accompanies Polymer of
Permit
low concern (PLC), Limited
(LTD) or Standard (STD)
Until certificate
As for PLC, LTD or STD issued, or permit 28 days
rescinded
Permit renewal
As for previous LVC,
CEC, CUP, EOP
Permit
3 years
(LVC/CUP/EOP) 20 days (LVC/EOP), and usually 28 days
and up to 2
(CUP) and 14 days (CEC)
years (CEC)
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Australia: Certificates
Outcome
Chemical amount
introduced
Duration of certificate Assessment
or permit
timeframe
Certificate
Unlimited
5 years
90 days
Limited (LTD)
Certificate
<1 tonne/yr
<10 tonne/yr for
site limited
chemicals
5 years
90 days
Standard (STD)
Certificate
>1 tonne/yr
5 years
90 days
Self assessment
Certificate
As for PLC, LTD
or STD
5 years
28 days
Extension of an
Original
Assessment
Certificate (in
short: EX)
Certificate
As for PLC, LTD
or STD
5 years from
granting of
45 days
original certificate
Polymer of low
concern (PLC)
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Australia: Assessment Categories
Non self-assessment categories
Polymer of low concern (PLC)
Limited (LTD)
Standard (STD)
Self-assessment certificate categories
PLC
Non-hazardous chemicals or polymers
Note that there are record keeping obligations if undertaking self-assessment.
Companies can be subject to NICNAS audits so it is important to maintain
comprehensive records.
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Australia: Data requirements for Certificates
Schedule
Data requirements
A
LTD
STD
PLC
Summary of health and
Yes
environmental effects. Describe
how the substance meets the
definition of a hazardous substance
Yes
Yes
B
Chemical identity, information on
use, occupational health and
safety, environmental impact,
public health, physico-chemical
properties
Yes
Yes
No
C
Toxicity and environmental testing
No
Yes
No
D
Polymer specific data
Yes (if
polymer)
Yes (if
polymer)
Yes
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Australian notification: Practicalities
Item
Requirement
Notification fees
Up to AUS$17,400 (plus extras)
Confidentiality of information from the notifier
Yes
Original signature required on form?
Copy is acceptable
Assessment period
Up to 90 days
How to submit notification
Hard and electronic copies by post
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Canada
Authority and Scheme
New Substances Notification Regulations (Chemicals and Polymers)
(SOR/2005-247)
Environment Canada
https://www.ec.gc.ca/lcpe-cepa/eng/regulations/detailreg.cfm?intReg=92
NSN-Infoline@ec.gc.ca
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Canadian Inventories: DSL
Domestic Substances List (DSL)
Approximately 23 000 substances manufactured in, imported into or used in
Canada on a commercial scale. It is based on substances present in Canada,
under certain conditions, between January 1, 1984 and December 31, 1986
A “live” inventory: substances are added providing certain criteria are met,
including provision of a Notice of Manufacture of Import (NOMI) or a Notice of
Excess Quantity (NOEQ)
The sole basis for determining if a substance is “new” for the purpose of the
Regulations
Substances listed on the inventory do not require notification unless they are
subject to a Significant New Activity (SNAc) notice or no longer qualify as a
Reduced Regulatory Requirement (RRR) polymer
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Canada: Confidential and Non-confidential DSL listings
A notifier may request that their substance be added to the confidential portion
of the DSL using a “masked name”
Justification has to be provided if the substance name is already listed on
another public inventory
The non-confidential section of the inventory can be searched online at
http://www.ec.gc.ca/lcpe-cepa/eng/substance/chemicals_polymers.cfm
The confidential section of the DSL (or the NDSL) can be checked by a
request to Environment Canada via a Bona Fide Intent to Manufacture or
Import notice
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Canadian Inventories: NDSL
Non Domestic Substances List
Based on the United States Environmental Protection Agency's (USEPA)
Toxic Substances Control Act (TSCA) Chemical Substances Inventory for
1985, and contains more than 58 000 entries
Substances that are not on the DSL but are listed on the NDSL are subject to
lesser information requirements
The NDSL undergoes annual revisions based on revisions to the TSCA
inventory
Substances on the TSCA inventory that have restrictions imposed on their
manufacture or import as a result of a risk assessment by the U.S. EPA are
not added to the NDSL
Substances can be listed on the confidential NDSL only if the nominating
company demonstrates that the substance exists on the confidential TSCA
inventory and is not listed on any other public chemical Inventory
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Canada: Exclusions and Exemptions
Exclusions:
Mixtures (includes hydrates and alloys)
Manufactured items
Wastes
Substances carried through Canada
Polymers and proteins subject to the “Two Percent Rule”
Substances not subject to the regulations:
Substances falling under other Acts of Parliament
Transient reaction intermediates
Impurities
Incidental reaction products
Low volume exemptions
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Canada: Choice of Notification Schedule
Questions to ask:
Is the substance a chemical or biochemical / Or a polymer or a biopolymer?
Is the substance on the NDSL?
What is the supply level?
For a polymer or biopolymer are all of the reactants on the DSL or the NDSL?
Does the polymer or biopolymer meet the criteria to qualify for Reduced
Regulatory Requirement (RRR) status?
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Canada: Reduced Regulatory Requirement Polymers
RRR Criteria*:
High number average molecular weight polymer
Low proportion of low MW components
Chemically stable
Does not contain certain reactive or cationic moieties
* Can be rather complicated so it is recommended to check the guidance carefully
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Canada: Data requirements*
Technical and commercial information
Physical & chemical properties
Ecotoxicity data
Human health toxicity data
Genotoxicity data
Polymer specific data
* Requirements are specific to the Schedule of notification. Refer to guidance
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Canada: Significant New Activity Notices (SNAcs)
SNAcs are a flag put on a substance so that any major changes in the way it
is used are reported to the Government of Canada
SNAc provisions will be considered for use where there is reasonable
suspicion that new activities with respect to a substance may result in new or
increased risks to the environment or human health
The SNAc Notice or Order will define the significant new activity either
inclusively by describing those activities that will require notification or
exclusively by describing those activities that will not require notification
The SNAc will be written as specifically as possible so as to target only those
potential activities that are suspected of posing risk to the environment or
human health
The information requirements set out in the SNAc Notice or Order will be
selected to address relevant areas of uncertainty identified during the original
risk assessment
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Canadian notification: Practicalities
Item
Requirement
Notification fees
Up to C$3,500 (plus extras)
Confidentiality of information from the notifier
Yes
Original signature required on form?
Yes
Assessment period
5 to 75 days
How to submit notification
Hard copy by post
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Any questions?
jhislop@uk.exponent.com
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