Commonwealth of Australia Explanatory Memoranda Commonwealth of Australia Explanatory Memoranda[Index] [Search] [Download] [Bill] [Help]
2004-2005-2006-2007
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT
(COSMETICS) BILL 2007
EXPLANATORY MEMORANDUM
(Circulated by the authority of the Parliamentary Secretary to the Minister for Health and
Ageing, Senator the Honourable Brett Mason)
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT
(COSMETICS) BILL 2007
OUTLINE
The Industrial Chemicals (Notification and Assessment) Amendment (Cosmetics) Bill 2007
(the Bill) amends the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act).
The proposed amendments to the Act are intended to:
· provide legislative underpinning for reforms to the regulation of cosmetics as part of the
National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Low
Regulatory Concern Chemicals Reform Program.
Recommendations on this issue were considered by Government in late 2005. The
reforms were implemented on a limited, interim, administrative basis (in relation to some
cosmetics only) through the NICNAS Cosmetics Guidelines until such time as the
legislation could be amended to enable the Guidelines to become enforceable standards
under the Act.
The amendments proposed in this Bill provide this legislative basis for the cosmetics
reforms.
While the ingredients in cosmetics have been regulated by NICNAS as industrial
chemicals for quite some time, the Bill represents an extension of the existing approach
by enabling the Minister to make standards, by legislative instrument, for cosmetic
products as a whole that are imported into, or manufactured in, Australia.
The Bill also includes a criminal offence for importing into, or manufacturing in,
Australia a cosmetic that is subject to the standard and does not meet the standard.
· make minor changes to the legislation to improve clarity, increase consistency in the
legislation and address minor technical anomalies or unintended effects of the legislation.
FINANCIAL IMPACT STATEMENT
The new initiatives that are implemented through this Bill are cost neutral.
1
REGULATION IMPACT STATEMENT RIS ID 7710
A. Background
The Act establishes a system of notification and assessment of industrial chemicals to protect
health, safety and the environment, and to provide for registration of certain persons
proposing to introduce industrial chemicals.
The legislation is administered by the Director, National Industrial Chemicals Notification
and Assessment Scheme (NICNAS).
As part of broader initiatives to reduce regulation, NICNAS established the Low Regulatory
Concern Chemicals Task Force to investigate reform of the regulation of chemicals of low
regulatory concern.
While many of the reforms recommended by the Task Force were implemented through
amendments to the legislation in 2004, reforms in relation to cosmetics regulation were
further developed through a Cosmetics Implementation Working Group. In particular, the
Working Group was tasked with examining reform options to address interface issues
relating to the regulation of cosmetics by the Therapeutic Goods Administration (TGA) and
NICNAS.
In November 2005, the proposed reform of cosmetic regulation in Australia was endorsed (as
reflected in the Regulation of Cosmetic Chemicals: Final Report and Recommendations)
including the establishment of NICNAS Cosmetic Guidelines. In relation to cosmetics, the
major objectives of the agreed reforms were to:
· clarify the interface between TGA and NICNAS in terms of the regulation of cosmetics;
· enable a greater range of cosmetics to be regulated by NICNAS rather than the TGA;
· improve regulation at the interface for identified product types, including changes that
could enhance the transparency and useability of existing regulatory documents; and
· specifically address issues dealing with antiperspirants, mass-market antidandruff
shampoos, moisturisers with SPF, antibacterial skin washes, and anti-acne cleansers.
These reforms were subject to a Regulation Impact Statement (RIS Reference Number 5053).
In the absence of legislative underpinning, the recommended reforms were implemented on
an administrative basis in relation to some cosmetic products. Permits have been issued by
NICNAS which allow for the specified product to be regulated as a cosmetic under the
interim arrangements, provided that the product complies with the NICNAS Cosmetic
Guidelines. At the time that the reforms were implemented administratively, Government
noted that it was intended that the reforms be underpinned with legislation.
B. Problem
As noted above, since the reforms to the regulation of cosmetics were agreed, the reforms
have been implemented on an interim, administrative basis (in relation to a limited set of
cosmetics only) through contractual arrangements between NICNAS and individual
2
companies. This arrangement has now been in place for 12 months and over 200 products
are subject to the arrangements.
It is undesirable for these administrative arrangements to continue in the absence of
legislative underpinning because:
· there are some categories of cosmetics that meet the NICNAS Cosmetic Guidelines (such
as skin-whitening products and anti-ageing products) that are not subject to the interim,
administrative arrangements and will not come within the remit of NICNAS unless
legislative changes are made.
The regulation of such products is not consistent with the level of regulation imposed
by Australia's major trading partners and this poses increased costs to manufacturers
marketing such products in Australia (and also has the potential to impose barriers to
trade).
Industry has expressed concern about the absence of a level playing field in relation to
these cosmetics.
For products that continue to be regulated by the TGA as therapeutic goods, no
environmental assessment is undertaken. By contrast, NICNAS undertakes an
environmental assessment of chemicals in cosmetic products.
· in the absence of legislative underpinning, compliance with the regulatory requirements
for cosmetics can not be properly enforced, and there is currently no capacity to penalise
companies for non-compliance; and
· there is no capacity to charge fees from the regulated companies for cosmetic permits
issued under interim administrative arrangements. As NICNAS is a fully cost-recovered
agency (and must recover all of its running costs from regulated entities), there may be a
degree of cross-subsidisation while the administrative arrangements continue. This is not
consistent with best practice.
C. Objectives of government action
The objectives of government action are to:
· maintain or enhance appropriate health, safety and environmental standards;
· as far as possible, align Australia's regulation of cosmetics with the international
regulatory standards of major trading partners, thereby minimising any trade barriers;
· enable full implementation of the agreed reforms for cosmetics at the interface (only
partial implementation has been possible under interim arrangements). A related
objective is to ensure that there is clarity and regulatory certainty regarding the regulation
of cosmetics;
· enable proper monitoring and enforcement of compliance with the requirements for
cosmetics; and
· enable NICNAS to recover the costs of the regulation of such cosmetics.
3
D. Impacted Parties
The groups likely to be affected by any changes to the regulation of cosmetics are:
· industry
The cosmetics industry is global, characterised by companies marketing branded
products across international boundaries. Australia accounts for approximately 1.2%
of worldwide sales of cosmetic products, with many cosmetic products imported as
fully formulated and packed products.
Obtaining aggregated data on the value of sales for this sector is extremely difficult as
there are multiple data sources disaggregating the retail sector into various
components. Most of this data is proprietorial. However, the Australian cosmetics
and toiletries market has been estimated by local industry organisations at $5,200
million (retail), covering about 700 million units consumed annually. The hair care
segment is the biggest, accounting for 24% of retail sales.
Subsidiaries of foreign companies are the main suppliers and the major sources of
imports are the United States (38%), France (19%), the United Kingdom (11%) and
Germany (4%).
There are approximately 55 companies involved in the marketing of the product
categories that have been subject to the NICNAS administrative arrangements for
cosmetics.
· consumers - The products that are subject to the reforms are very commonly used
products such as anti-perspirants, moisturisers and cleansers. It is therefore expected that
the majority of Australian consumers have the potential to be affected by any changes;
and
· the Australian Government - The three organisations most likely to be affected by any
changes will be NICNAS, TGA and the Australian Competition and Consumer
Commission (ACCC).
E. Options and Impact analysis
Options
Option 1: Maintain the status quo.
Option 2: Amend the Act to implement the reforms on a legislative rather than an
administrative basis and to extend the reforms to additional types of
cosmetics. This will involve:
· placing the responsibility for regulation of cosmetics with NICNAS;
· underpinning existing NICNAS Cosmetic Guidelines with legislation,
enabling the Guidelines to be enforced; and
· enabling NICNAS to recover the costs associated with the regulation of
certain cosmetics (those that are subject to the reforms and were
previously at the interface between TGA and NICNAS).
4
Impact analysis
Impacts of Option 1: Retain the status quo
Industry:
For companies who market products that are subject to the current administrative
arrangements, there are some negative impacts as the result of continuing the status quo. For
example, under the administrative arrangements, companies need to apply to NICNAS on a
product by product basis - this then gives rise to a permit (or contract) between the Director
of NICNAS and the company in respect of the particular cosmetic product. By contrast, if
the reforms were underpinned by legislation there would no longer be any need for product
by product applications to be made to NICNAS. Continuing the administrative arrangements
therefore has resource implications for companies.
One advantage of the administrative arrangement is that the companies subject to the
arrangements do not pay any fees for the administrative permits. By contrast, companies that
are subject to the Act are required to pay an annual registration fee. However, if they also
supply other products that are subject to NICNAS regulation, it is possible that they will be
cross-subsiding the regulation of products that are subject to the administrative arrangements.
This is also a negative impact for those companies that do not market cosmetics that are
subject to the administrative arrangements.
For companies that produce the types of cosmetics that are not subject to the interim
administrative arrangements, there would continue to be the negative impacts that were
identified in the RIS that was prepared when the cosmetics reforms were considered (refer
RIS Reference Number 5053). In summary, these include the following:
· higher regulatory compliance costs - the compliance costs for cosmetics treated as
therapeutics and regulated by the TGA are higher than the compliance costs of cosmetics
regulated by the NICNAS. This is because, in general: GMP requirements do not apply
to cosmetics regulated by NICNAS but if the product is considered a therapeutic good
and is regulated by the TGA then in some cases GMP requirements must be met. TGA
registration fees are generally higher than NICNAS fees with TGA evaluation fees being
based on the nature and size of the submission, but generally a minimum of $5,070 for
listed products and a minimum of $7,270 for registered products. The maximum for
registered products is $45,150. By contrast, NICNAS assessment fees are in the range of
$2,440 to $14,418. This range depends on, for example, whether a product contains one
or more "new" ingredients, the notification category and the nature of the chemical and
introduction volume. Further detail regarding differences in fees is included in Table A
(below).
· continued lack of regulatory consistency with major trading partners may present a
barrier to trade. When some products are defined as therapeutic goods in Australia, but
cosmetics in other countries, additional data and assessment may be required in Australia
beyond that which would be required if the product were regulated as a cosmetic.
One industry group has estimated that the delays in passing the legislation could result in a
minimum of $21 million loss in sales. This figure is based on approximately 100 new
products that meet the NICNAS Cosmetic Guidelines but are not subject to administrative
arrangements, that marketers were planning to introduce, having anticipated that the
5
reformed regulatory framework would have been finally established by the end of 2006.
These products are primarily anti-ageing and skin-whitening products which are regarded as
cosmetics elsewhere, but are currently regulated as therapeutic goods in Australia.
Consumers:
For those products that are subject to the administrative arrangements, retaining the status
quo is unlikely to have a significant impact on consumers. There would continue to be
oversight by NICNAS and although it could be argued that the absence of any capacity by
NICNAS to enforce compliance with the NICNAS Cosmetics Guidelines may undermine
consumer confidence, this is unlikely to be a significant issue for consumers particularly
while there continues to be strong compliance by industry.
For those products that are not subject to the administrative arrangements, there is the
potential that manufacturers may choose not to market certain products in Australia because
of the costs associated with meeting the TGA's requirements for regulation of such cosmetics
(where these differ to the requirements of Australia's major trading partners - particularly the
EU). This could have flow on effects to consumers in terms of limiting choice and reducing
product range relative to consumers in some other countries.
Government:
There are risks to Government if the status quo is maintained. This is because the
Government would have no capacity to take legal action or impose penalties in the event that
a manufacturer does not comply with the conditions specified in the NICNAS Cosmetic
Guidelines under existing administrative arrangements. Government would also continue to
be criticised for applying the administrative arrangements to some cosmetics and not to
others. Any further extension of the administrative arrangements would only add to the
potential risks to government (because more products would be subject to the unenforceable
arrangements).
Impacts of Option 2: Amend the Act to implement the reforms on a legislative
rather than an administrative basis and to extend the
reforms to additional types of cosmetics
Industry:
For the manufacturers of cosmetics who have not previously been subject to the NICNAS
administrative arrangements, benefits will include: lower compliance costs; greater
harmonisation with international cosmetics regulation (reducing trade barriers); and greater
regulatory certainty regarding those chemicals that are regulated by NICNAS as cosmetics
and those that are regulated by the TGA as therapeutic goods.
Companies producing cosmetics will also be required to pay an annual registration fee to
NICNAS. While most companies that produce cosmetics already produce other products that
are regulated by NICNAS (and therefore already pay an annual fee), in some cases this fee
may increase where a company may need to register at a higher NICNAS Registration Tier
when additional products are regulated as cosmetics.
Consumers:
Regulation of cosmetics by NICNAS will ensure continued protection of public health,
occupational health and safety and the environment.
6
For those cosmetics that have not previously been subject to NICNAS oversight (and will be
moving from TGA regulation to NICNAS regulation), the main benefit to consumers is that
there will be full ingredient disclosure on product labels (as opposed to the requirement for
medicines which involves listing only of active ingredients and ingredients known to cause
adverse reactions in some persons). This will enhance consumer knowledge and the ability to
make informed choices.
The success of the cosmetics reforms relies on cosmetic products being marketed and
presented within defined parameters. By making these legally enforceable this provides
added consumer confidence and assurances that any non-compliance can be adequately
policed. This approach ensures that not only are appropriate controls in place for cosmetic
products, but that there is ability to "police" compliance though legislative underpinning of
these guidelines.
Government:
This option reduces risks to government because the Government would have the capacity to
monitor and enforce compliance with the NICNAS Cosmetics Guidelines and to take action
in the event of non-compliance. This option also enables NICNAS to recover the costs
associated with the regulation of the cosmetics that are subject to the NICNAS Cosmetics
Guidelines. This option also enhances clarity of the regulatory roles and responsibilities
between NICNAS and the TGA with respect to cosmetic chemicals.
Table A: Summary of key differences between Option 1 and Option 2
Option 1 Option 2
Compliance costs - Fees1
Evaluation fees TGA NICNAS
Min: $5070 (listed product with $2440 - $14418
new substance) [$520 for listed
product without new substance],
$7270 (registered)
Max: $5070 (listed), $45150
(registered)
Annual fees (per product) TGA: $690 (listed), $880 NICNAS: N/A
(registered)
Annual fees (per company) TGA: $8630 (for GMP NICNAS: $367 - $8186
manufacturing licence - for
manufacturers only)
Audit fees TGA: $460 per hour NICNAS: N/A
Differences in nature of
assessment/regulation
International harmonisation More onerous data requirements Better harmonisation of
in Australia than in other major the regulation of
trading partners of Australia cosmetics with major
trading partners
Consumer information Limited ingredients disclosure Full ingredients
disclosure
Environmental assessment N/A Undertaken as part of
cosmetics assessment
1
Please note that this table is intended to provide a snapshot of some of the TGA fees for the purposes of
comparison with the NICNAS fees. There are a number of TGA fees which have not been included in this table
such as travel costs for auditors etc.
7
F. Consultation
Both NICNAS and the TGA have consulted widely with a broad range of stakeholders
including: the cosmetics industry and its industry bodies; government and non-government
organisations; and worker and community representatives.
In May 2004 NICNAS and the TGA wrote to stakeholders seeking preliminary comment on
the Review of the Regulation of Products at the Interface between Cosmetics and Therapeutic
Goods. An independent consultant was also engaged to undertake one-on-one interviews
with interested parties in government, industry (including industry associations) and the
community. In March 2005, a detailed draft discussion paper entitled "Review of the
Regulation of Products at the Interface between Cosmetics and Therapeutic Goods" was
released for public comment.
NICNAS also consulted with the NICNAS Industry Government Consultative Committee,
the Community Engagement Forum and the NICNAS States and Territories Memorandum of
Understanding Group.
Eighty-five written responses were received from a wide range of stakeholders and responses
to issues raised were published on the TGA and NICNAS web sites. In general, stakeholders
considered that the arrangement for regulating products at the cosmetic-therapeutic interface
was inadequate and open to interpretation and that there was an urgent need for clarity in the
demarcation between cosmetic products and medicines. Industry submissions were
supportive of the reform options presented in the Review because of the benefits they would
bring to industry through a more efficient and effective regulatory system.
As noted previously in this RIS, some of the key elements of the reforms have been
implemented through administrative arrangements (including through the NICNAS
Cosmetics Guidelines). At the time that NICNAS published these Guidelines it was noted
that they were interim only and that they would be underpinned by legislation. This was
fully supported by all stakeholders.
Since the publication of the NICNAS Cosmetics Guidelines, NICNAS has continued to
consult with stakeholders including through the NICNAS Industry Government Consultative
Committee and the Community Engagement Forum. All stakeholders strongly support the
reforms being underpinned by legislation to:
· provide greater clarity;
· increase regulatory certainty;
· enable extension of the reforms to additional cosmetics; and
· enable action to be taken in the event of non-compliance.
G. Conclusion and Recommended option
Option 1 does not address the existing problems which are described in Part C of this RIS, is
not supported by stakeholders and is not consistent with the objectives of government action.
8
Option 2 is the preferred option. Amending the Act to extend the reforms to additional
cosmetics and to provide a legislative basis for the NICNAS Cosmetics Guidelines will
deliver:
· greater clarity and certainty for industry;
· capacity for NICNAS to take action in the event of non-compliance and, by so doing,
ensure the protection of public health, occupational health and safety and the
environment;
· increased international harmonisation with Australia's key trading partners;
· greater access to the reforms for all relevant cosmetics products (reducing the regulatory
burden and costs to industry); and
· enhanced consumer information. All products regulated as cosmetics by NICNAS will
require full ingredients disclosure on the labels (this is not currently the case for products
regulated as therapeutics by the TGA).
H. Implementation and review
It is proposed that the preferred option (Option 2) be implemented through legislative
amendments to the Act.
In order to ensure that the preferred option is clear, consistent, comprehensible and accessible
to users, NICNAS proposes to:
· publish, and circulate widely, detailed guidance to explain the legislative changes;
· continue to work in partnership with community, industry and Government consistent
with its Community Engagement Charter; and
· seek ongoing advice from experts on matters relating to the NICNAS Cosmetic
Guidelines.
In order to ensure that the preferred option is sufficiently flexible to adapt to changing
circumstances, it is proposed that the legislation create the power to make standards relating
to cosmetics and that the actual standards be made in delegated legislation.
This will ensure that changes can be made more readily, in order to adapt to any changing
circumstances or new classes of cosmetic products. This is particularly important in light of
the fact that the cosmetics industry is an extremely competitive one, with a high level of
innovation, high product turnover and market driven style changes.
NICNAS will monitor the effectiveness of the legislation on an ongoing basis and will
provide routine reports on the operation of, and compliance with, the new requirements to the
following groups:
· the Industry Government Consultative Committee;
· the Community Engagement Forum;
· States and Territories Memorandum of Understanding Group: and
· a proposed new Cosmetics Advisory Group.
Each of these committees (collectively comprising all of the key stakeholders) will be able to
provide advice on implementation issues.
9
At the time that Option 2 is implemented, it is also proposed that the following amendments
be made to the Act to improve clarity and consistency within the Act:
(a) Amend the Act to improve consistency regarding the use of the term "calendar year"
and "12 month period";
(b) Amend the Act to ensure consistency in the categories of information that may be
claimed as exempt in connection with a permit;
(c) Amend the Act to ensure consistency in respect of the Director's ability to require
further information from an applicant for a permit and to ensure that in all cases the
Director may refuse a request for a permit should the applicant fail to comply with a
notice;
(d) Amend paragraphs 23(8)(a) and 23(8)(b) of the Act to change the word "biopolymer"
to read "polymer" and in so doing address an unintended consequence of previous
amendments to the Act;
(e) Amend section 30A of the Act to rectify unintended omissions from the section by
detailing the matters that the Director should consider when determining whether to
grant an early introduction permit in respect of a polymer of low concern;
(f) Repeal section 77 of the Act as this section is not currently utilised and is not necessary
for compliance monitoring;
(g) Amend the Act to ensure consistency between the publication obligations in relation to
permits granted; and
(h) Amend the Act to ensure consistency regarding NICNAS reporting obligations and
protections for confidential commercial information
The Office of Best Practice Regulation has advised that a RIS is not required for these
technical amendments.
These proposed amendments will have no significant impact on business, do not place any
restriction on competition and do not place any significant additional requirements on the
industrial chemicals industry.
1
0
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT
(COSMETICS) BILL 2007
NOTES ON CLAUSES
Clause 1 - Short title
This clause provides that the Act may be cited as the Industrial Chemicals (Notification and
Assessment) Amendment (Cosmetics) Act 2007.
Clause 2 - Commencement
This clause provides that Sections 1 to 3 of the Act commence on the day that the Act
receives Royal Assent. Schedules 1 and 2 commence on the 28th day after this.
Clause 3 - Schedules
This clause provides that each Act that is specified in a Schedule to this Act is amended or
repealed as set out in the relevant Schedule. Any other item operates according to its terms.
Schedule 1 - Cosmetics
Industrial Chemicals (Notification and Assessment) Act 1989
Item 1
This item amends the long title of the Act to reference the fact that the legislation will, as a
result of the amendments described in Schedule 1, provide for national standards for
cosmetics imported into, or manufactured in, Australia.
Item 1 amends the long title to read `An Act to establish a national system of notification and
assessment of industrial chemicals, to provide for registration of certain persons proposing to
introduce industrial chemicals, to provide for national standards for cosmetics imported into,
or manufactured in, Australia and for related purposes'.
Item 2
This item repeals section 3 (Objects of the Act) and replaces the section with a new objects
clause.
Section 3 Objects of Act
While the ingredients in cosmetics have been regulated by NICNAS as industrial chemicals
for quite some time, the Bill represents an extension of the existing approach by enabling the
Minister to make standards, by legislative instrument, for cosmetic products as a whole that
are imported into, or manufactured in, Australia (refer proposed section 81).
The extension of regulation from cosmetic ingredients to cosmetic products has necessitated
consequential amendments to various provisions in the Act, including the objects of the Act.
The proposed section 3 replicates the existing objects section, but adds an additional object
which is to provide for national standards for cosmetics imported into, or manufactured in,
Australia and the enforcement of those standards.
1
1
Item 3
Section 4 of the Act describes the additional operation of the Act. This item amends this
section by inserting references to cosmetics alongside existing references to chemicals. This
is a consequential amendment that has resulted from the extension of regulation under the
Act from chemicals (including cosmetic ingredients) to cosmetic products.
Item 4
This item repeals the existing definition of cosmetic within subsection 5(1) and inserts a new
definition.
The amendment achieves three main purposes:
· it defines cosmetic in full by drawing on the wording currently contained in the definition
of chemical product within the Trade Practices (Consumer Product Information
Standards) (Cosmetics) Regulations 1991 (which aligns with the European definition of
cosmetics). Previously the definition of cosmetic in the Act simply cross-referenced this
definition. For the purpose of clarity, it is now considered desirable that the definition be
included, in full, in the Act. The inclusion of the definition does not represent any change
in policy;
· the definition clarifies that a cosmetic does not include a therapeutic good within the
meaning of the Therapeutic Goods Act 1989. Again, this has been included for clarity,
and to address interface issues between NICNAS and the Therapeutic Goods
Administration. It is intended that once the amendments to the definition of cosmetic in
the Act take effect, a change will also be made to the therapeutic excluded goods order, to
provide that any product meeting the requirements in the cosmetics standard will be
excluded from the definition of a therapeutic good. It is also intended that the references
to the Therapeutic Goods Act 1989 will be replaced with a reference to the new trans-
Tasman therapeutic goods legislation, if and when this legislation comes into effect; and
· the definition expressly includes, and excludes, any substance or preparation prescribed
in Regulations. This has been included to ensure flexibility, enabling the legislation to
respond, where appropriate, to:
- any significant changes in the nature of the cosmetics industry (which is
recognised as an evolving and innovative industry); and
- any changes in national or international definitions that may occur over time.
Rather than needing to amend the Act (which can take a considerable period of time)
regulations can be made more quickly to ensure that products do not "fall through the
gaps". Any regulations would be developed in consultation with relevant stakeholders,
and would also be subject to consideration by the Parliament.
Items 5 to 10
These items amend the definitions of `disposal', `handling' and `import' so that these
definitions are no longer specific to chemicals and also apply to cosmetics. Changes to these
definitions have been necessary because these words are used within section 86, which
relates to searches to monitor compliance with the legislation. Items 12 to 15 further amend
section 86 to ensure that it applies not only to industrial chemicals but also to cosmetics.
1
2
Item 11
This item inserts a new Part after Part 3A, namely Part 3B--Standards for cosmetics
imported into, or manufactured in, Australia.
Part 3B--Standards for cosmetics imported into, or manufactured in, Australia
Section 81 Setting standards
This section provides that the Minister may, by legislative instrument, determine standards
for cosmetics imported into, or manufactured in, Australia, having regard to Australia's
international obligations.
A standard must not only be registered in accordance with the Legislative Instruments Act
2003, but a copy of the instrument must also be published in the Chemical Gazette. This is
consistent with current operating practice whereby NICNAS publishes important notices in
the Chemical Gazette. The section clarifies that failure to publish a copy in the Chemical
Gazette does not affect the validity or enforceability of the instrument.
NICNAS intends to publish the standard on the NICNAS website, and to make it available in
hard copy on request (along with, for example, any Australian Standards that are referenced
in the cosmetics standard, such as the joint Australian/New Zealand sunscreen standard
(AS/NZS 2604:1998)).
It is proposed that the standard will be consistent with the current NICNAS Cosmetics
Guidelines (which have been implemented on an informal and administrative basis pending
these legislative amendments). It is further proposed that the detail of the standard will be
developed in consultation with relevant stakeholders and that it will come into force at the
same time as the amendments come into force (that is, 28 days after Royal Assent).
Section 81A Complying with standards
This section provides that a person commits an offence if, at a particular time:
· the person imports into, or manufactures in, Australia a cosmetic;
· the cosmetic is subject to a standard set under section 81; and
· the cosmetic does not meet the standard.
The maximum penalty for failure to comply is 120 penalty units. This equates to the penalty
for failing to comply with a condition of use listed on the Australian Inventory of Chemical
Substances and is equivalent to $66,000 for a corporation.
Items 12 to 15
These items amend section 86 of the Act (Searches to monitor compliance with the Act etc.)
to enable an inspector to monitor compliance with the legislation not just in relation to
industrial chemicals, but also in relation to cosmetics.
1
3
Schedule 2--Other measures
Part 1--Periods relevant to certain permit systems
Industrial Chemicals (Notification and Assessment) Act 1989
Items 1 to 8
Within the Act, reference is made in various provisions to permits being issued for certain
industrial chemicals by reference to the quantity within "a calendar year", and to the volume
within a "12 month period". This inconsistency has created confusion within industry as to
the precise effect of these sections. The proposed amendments to sections 21Q, 21S, 21U,
21W and 22C (identified in items 1 to 8) ensure that reference is consistently made to a 12
month period.
In particular:
· Item 1 amends paragraph 21Q(a) (object of permit system for low volume chemicals) to
reference any 12 month period (rather than any calendar year).
· Items 2 and 3 amend sub-subparagraphs 21S(2)(a)(iv)(A) and (B) to provide that an
application for a low volume permit is taken not to be duly made unless the applicant
states the quantity of the chemical proposed to be introduced by the applicant in the 12
month period beginning on the date on which the application is made, and in each of the
next two 12 month periods. This replaces the requirement for the applicant to state the
quantity of the chemical proposed to be introduced by the applicant in the period
beginning on the date on which the application is made, and ending at the end of the
calendar year in which that date occurs, and in each of the next three calendar years.
The amendments have no effect on the duration of the permit (three years) nor on the
volume to be introduced (100 kg/year, or 1000 kg/year in special cases). In practice,
applicants for the low volume permit usually provide estimates for the three years
following the date of application, that is, applicants usually align their volume estimates
with the three-year duration of the permit.
· Item 4 amends paragraph 21U(2)(c) to provide that the Director must grant an application
for a low volume permit if the Director is satisfied, among other things, that the total
quantity of the chemical that is proposed to be introduced by the applicant during any 12
month period does not exceed the amounts specified in the provision (currently, the
provision refers to the quantity of the chemical proposed to be introduced during any
calendar year).
· Items 5 and 6 amend paragraph 21W(1)(b), which relates to conditions that may be
applied to low volume permits, to remove the references to `calendar year' and `period'
and replace with references to `12 month period'.
· Items 7 and 8 amend paragraphs 22C(2)(c) and (d) (which relate to matters to be included
in applications for a controlled use permit) so that the application must state:
- the quantity of the chemical proposed to be introduced by the applicant in the 12
month period beginning on the date on which the application is made; and
1
4
- the quantity proposed to be introduced in each of the next two 12 month periods.
This replaces the requirement for the application to state the quantity of the chemical
proposed to be introduced in the period beginning on the date on which the application is
made and ending at the end of the calendar year in which that date occurs, and in each of
the next three calendar years. This amendment has no effect on the duration of the
permit. Applicants will be able to align their volume estimates with the three year
duration of the permit, consistent with current practice for other applications.
Item 9
This item ensures that the amendments do not have any retrospective effect. The
amendments apply only to applications made, and permits granted, after the commencement
of the amendments.
This item provides that the amendments made by:
· items 2 to 4 of the Schedule apply to an application for a low volume permit, or a renewal
of a low volume permit, made on or after the commencement of those items;
· items 5 and 6 of the Schedule apply to a low volume permit granted as a result of the
determination of an application made on or after the commencement of those items; and
· items 7 and 8 of the Schedule apply to an application for a controlled use permit, or a
renewal of a controlled use permit, made on or after the commencement of those items.
Part 2--Exempt information
Industrial Chemicals (Notification and Assessment) Act 1989
Items 10 to 13
Sections 21P, 21ZB and 22O of the Act each allow applicants for permits to request that
certain information provided in connection with the permits be treated as exempt information
under section 75 of the Act. However, there are inconsistencies between the various
categories of information that may be claimed as exempt between each of these three
sections.
As there is no policy reason to support the inconsistencies, sections 21ZB and 22O are
proposed to be amended to follow the form of section 21P, and allow all three broad
categories of information to be the subject of an application that the information be treated as
exempt information, if required.
Part 3--Commercial evaluation permit system
Industrial Chemicals (Notification and Assessment) Act 1989
Item 14
Sections 21F, 21SA and 22D allow the Director to request further information from an
applicant for the purposes of considering the application for a permit. The amendment
described in item 14 repeals existing section 21F and replaces it with a new section to ensure
consistency across all three provisions.
1
5
Section 21F Director may request further information about application
This section provides that the Director may give an applicant, or another person who agrees
(jointly or otherwise) to be bound by the conditions of the permit, a written notice requiring
the person to give the Director further information about a matter referred to in subsection
21D(2), or a matter referred to in the application for the renewal of the commercial
evaluation permit, within the period specified in the notice. Subsection 21F(2) provides that
the notice must specify a period of at least 14 days.
Item 15
This item makes a consequential amendment to section 21H to reflect the inclusion of the
new section 21F. A new subsection 3AA is inserted, which provides that the Director may
refuse a request for a permit should the applicant fail to comply with a notice requesting
further information under section 21F (as per item 14).
Item 16
This item provides that the amendments made by items 14 and 15 of the Schedule apply in
relation to an application for a commercial evaluation permit or a renewal of a commercial
evaluation permit made on or after the commencement of those items.
Part 4--Notification statements
Industrial Chemicals (Notification and Assessment) Act 1989
Item 17
In 2004, amendments were made to the Act to implement reforms proposed as part of the
Low Regulatory Concern Chemicals Reform Program. As part of these amendments,
changes were made to the legislation to distinguish, in certain circumstances, between
polymers and non-polymers.
As a result of these amendments, subsection 23(8) inadvertently applies only to biopolymers,
and not to all polymers.
This item therefore amends paragraphs 23(8)(a) and (b) to refer to polymers generally (not
just to biopolymers).
Part 5--Application for early introduction of non hazardous chemicals
Industrial Chemicals (Notification and Assessment) Act 1989
Item 18
Section 30A of the Act establishes a means by which an applicant for an assessment
certificate may apply for a permit to introduce certain chemicals before a full assessment of
the particular chemical is completed. As a result of the history of amendments to the Act,
matters previously included in section 30A that governed whether a permit should be granted
were moved to other areas of the Act, namely subsections 5(2) and 5(3).
At the same time, new categories of chemicals eligible for an early introduction permit were
introduced in subsection 30A(1A). This had the unintended consequence that matters for
consideration previously listed in section 30A (as to whether a permit should be granted) no
longer applied to certain chemicals.
1
6
This item therefore specifically reinstates the matters previously included in section 30A, for
a polymer of low concern, because the matters to be taken into account by the Director in
deciding whether to issue a permit are not necessarily covered by the definition of a non-
hazardous chemical in subsection 5(1).
The notes at the end of the item insert various headings throughout section 30A to make the
section clearer and easier to read.
Item 19
This item provides that the amendment made by item 18 of the Schedule applies in relation to
an application for a permit made on or after the commencement of that item.
Part 6--Notice of introduction of chemical under assessment certificate
Industrial Chemicals (Notification and Assessment) Act 1989
Item 20
Section 77 of the Act requires a person who introduces a chemical pursuant to an assessment
certificate to, within 7 days, give written notice to the Director that they have done so.
Since coming into effect in 1990, there has been very limited compliance with this section.
In addition, the information that would be provided by companies under this section is not
necessary for NICNAS compliance activities. Hence this item repeals section 77.
Part 7--Publication of notices
Industrial Chemicals (Notification and Assessment) Act 1989
Item 21
This item inserts within subsection 5(1) of the Act (which is the definitions section of the
Act), a definition for the term `chemical name'. This is a new phrase proposed to be used in
amended sections 21J, 21Y and 30A.
`Chemical name', in relation to a chemical, is proposed to mean:
· in the case of a pure chemical--the Chemical Abstracts preferred Index Name, or, if such
a name is not available, the name used, or to be used, by the International Union for Pure
and Applied Chemistry; or
· in any other case--a complete description of the chemical;
including, in the case of a biopolymer, a description of the biological source of the
biopolymer.
This definition is currently in use within the industry, and is based on the definition in the
Schedule to the Act, which relates to matters required for a notification statement under
section 23.
Items 22 to 25
Currently there is an inconsistency between the four sections of the Act that require details of
different types of permits to be published. These inconsistencies have resulted from previous
amendments to the Act to incorporate the different permit systems. These items amend
sections 21J, 21Y, 22L and 30A to ensure greater consistency in the operation of the permit
systems.
1
7
In each section, the Director's notice in the Chemical Gazette must set out:
· the name of the holder, or holders, of the permit; and
· either a trade name of the chemical or the chemical name of the chemical; and
· the period of the permit.
Item 26
This item provides that the amendments made by items 22 to 25 of the Schedule apply in
relation to permits issued on or after the commencement of those items.
Part 8--Annual reporting obligations and list of chemicals
Industrial Chemicals (Notification and Assessment) Act 1989
Item 27
Subsection 21AA(1) requires that a person who introduces a new industrial chemical under
subsection 21(4) or 21(6) must provide a report to the Director. This item alters paragraph
21AA(1)(a) to clarify that the name of the chemical required in this report is the chemical
name. This is a consequential amendment that is consistent with the changes made in Part 7.
Item 28
Currently the Act requires NICNAS to report about permits and assessment certificates.
Recognising that such permits and certificates may include confidential commercial
information, provision is made for applicants to apply to have certain information treated
confidentially and not disclosed as part of the reporting undertaken by NICNAS.
The Act also requires NICNAS to report annually about chemicals that are exempt from
notification, yet there is no provision for information in relation to such exemptions to be
treated confidentially.
Item 28 therefore inserts a new section 21AAA (inserted after section 21AA) to enable
applications to be made for exempt status for information supplied under section 21AA.
Section 21AAA Exempt information supplied under section 21AA
This section provides that a report under section 21AA may be accompanied by an
application for some or all of the information to be treated as exempt information under
section 75. If the requested exempt information includes the chemical name of a chemical
introduced during a registration year, the application must include a trade name of the
chemical. This enables the chemical to be properly identified even if its full chemical name is
exempt from disclosure because it is commercial in confidence.
Item 29
Item 29 repeals subsection 21AB(2), enabling the Director's summary of information to
exclude any exempt information, and to include any information prescribed in Regulations
made under the Act. The summary must be published in the Chemical Gazette.
Subsection 21AB(4) provides that where the Director has refused an application for exempt
information, and the applicant applies to the Tribunal under section 102 for a review of the
decision, the Director must delay the preparation of the summary until the application for
review has been finalised
1
8
Items 30 to 32
These items amend section 75 to reflect the inclusion of the new section 21AAA and to make
it clear that the Director of NICNAS must not grant an application for exempt information
under section 21AAA in relation to information about the chemical name of a chemical
unless the application includes a trade name of the chemical.
Item 33
This item inserts paragraph 110(1)(fa) after paragraph 110(1)(f) to allow regulations to
prescribe fees to be paid to the Commonwealth where an application for information to be
treated as exempt information is made under section 21AAA. This enables a different fee to
be prescribed for applications for exempt information under section 21AAA (as opposed to
applications for exempt information under other sections). This recognises that there is likely
to be less work involved in the consideration of applications under section 21AAA and as
such it may be appropriate for the fee to be lower than in other cases.
Item 34
This item provides that the amendments made by items 27 to 29 of this Schedule apply in
relation to registration years beginning on or after the commencement of those items.
1
9
Index]
[Search]
[Download]
[Bill]
[Help]