Bills Digest no. 189 2007–08
Industrial Chemicals (Notification and Assessment)
Amendment (Cosmetics) Bill 2007
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage history
Purpose
Background
Financial implications
Main provisions
Concluding comments
Endnotes
Contact officer & copyright details
Passage history
Industrial
Chemicals (Notification and Assessment) Amendment (Cosmetics) Bill
2007
Date introduced:
13 June 2007
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
Sections 1 to 3 commence
on Royal Assent. Schedules 1 and 2 (containing the main operative
provisions) commence 28 days after the Act receives the Royal
Assent.
The purpose of
the Bill is to amend the Industrial Chemicals (Notification and
Assessment) Act 1989 to:
- provide legislative underpinning for recent reforms to the
regulation of cosmetics in Australia, which currently only exist on
a limited, interim, administrative basis. The reforms concern
chemicals in cosmetics which are considered to be of low regulatory
concern.
- enable the Minister to make standards by legislative
instrument, for cosmetic products as a whole that are imported
into, or manufactured in, Australia.
- include 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 Act of a technical or uncontroversial
nature, so as to improve the clarity, increase consistency, and
address minor technical anomalies or unintended effects of the
legislation.
The Industrial Chemicals (Notification and
Assessment) Act 1989 (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 people or companies proposing to introduce industrial chemicals
into Australia. (1)
The National Industrial Chemicals Notification
and Assessment Scheme (NICNAS) administers the Act and is located
within the Commonwealth Department of Health and
Ageing. Established in
1990, it sits within the Office of Chemical Safety, which in turn
sits within the Therapeutic Goods Administration (TGA) Group of
Regulators.(2) NICNAS deals directly with the industry
and the public in issuing permits, providing advice, and publishing
the Chemical Gazette.
As part of the Government s broader
initiatives to reduce regulation, NICNAS established the Low
Regulatory Concerns Chemical Taskforce. The Taskforce was enlisted
to examine possible reforms to the systems of regulation of
chemicals that were deemed to be of low regulatory concern
.(3) The Taskforce, with the aid of the Cosmetics
Implementation Working Group, subsequently released a report in
2005 entitled
Regulation of Cosmetic Chemicals: Final Report and
Recommendations.(4) The report s recommendation
for reforms to cosmetics regulation was endorsed by Government. It
was understood that the reforms would be achieved by legislative
reform. In addition, a
Regulatory Impact Statement was produced.(5)
The Explanatory Memorandum details the major
objectives of the agreed reforms suggested by the final report.
(6)One of the primary objectives of the reforms is to
clarify the respective roles and responsibilities of NICNAS and TGA
in regards to regulation of cosmetic chemicals, with an appropriate
apportionment of regulatory effort depending on the chemical s
level of risk. The final report explained the relative roles of the
organisations:
NICNAS is a chemical entity based notification and
risk assessment scheme (as opposed to the TGA that operates a
product registration scheme), where all ingredients in a product
require assessment if not already entered on the Australian
Inventory of Chemical Substances (AICS) (unless subject to
exemptions, when various compliance safeguards apply). Where
products are reclassified as cosmetics, each individual ingredient
not already listed on the AICS will require assessment or transfer
onto the inventory through another acceptable mechanism.
Therefore, NICNAS and the TGA, in consultation
with all industry stakeholders will establish an appropriate
mechanism for the transfer of chemicals not listed on the AICS and
currently included in products proposed for reclassification
ensuring minimum impact on industry.
Other
objectives of the reforms are:(7)
- improved regulation at the interface for identified product
types, including changes that could enhance the transparency and
useability of existing regulatory documents; and
- specifically addressing issues dealing with antiperspirants,
mass-market antidandruff shampoos, moisturisers with SPF,
antibacterial skin washes, and anti-acne cleansers.
In 2006, the NICNAS Cosmetic Guidelines were
introduced. The Guidelines, which implement the recommendations of
the final report, provide for the current system of regulating
cosmetics. However, permits issued under the Guidelines are
administrative in nature; no penalties can be imposed for
non-compliance.(8) The current system depends on
industry compliance to meet the standards within the Guidelines.
Further,
there are some categories of cosmetics (such as
skin whitening products and anti-ageing products) that are not
subject to the interim arrangements and will not come within the
remit of NICNAS until the legislative changes take
effect.(9)
The current administrative system of
regulation was introduced as an interim measure, to eventually be
replaced by a legislative framework. The Industrial Chemicals
(Notification and Assessment) Amendment (Cosmetics) Bill ( ICAC
Bill ) puts forward that framework.
The intended effect of the reforms is to
also
increase international harmonisation with
Australia s key trading partners and ensure greater access to the
reforms for all relevant cosmetics products (reducing the
regulatory burden and costs to industry).(10)
On 14 June 2007, the Sydney Morning
Herald published an article regarding the release of a Federal
Government warning about a brand of imported toothpaste which was
found to contain a toxic substance. The article was coincidently
released in the same week as the ICAC Bill s introduction in
Parliament. The article reported:
A spokeswoman for the Department of Health and
Ageing said the scheme already had the power to restrict the use of
(the toxic substance) in products, but was now considering
launching an in-depth review of the chemical to determine whether
further regulatory action was needed, either through labelling or
restriction on use in products. (11)
The article proceeded to outline the proposed
new powers of the Government under the ICAC Bill, to set a national
standard for cosmetic products.
The Explanatory Memorandum states that the
legislative underpinning of the current system is to be supported
by all interest groups. NICNAS 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.(12)
The Explanatory Memorandum states that the
initiatives are cost neutral.(13)
The Explanatory Memorandum provides detailed
coverage of the provisions of the Bill. The following analysis
summarises the provisions on a general basis.
Schedule 1 amends the Act so
that it applies to cosmetics, as well as industrial chemicals.
These amendments ensure that the Act applies to cosmetics products
that have been imported into, or manufactured in, Australia (as
well as the basic chemical ingredients used in manufacturing them).
The extension of the Act s scope enables NICNAS to easily deal with
chemicals that are already contained within finished cosmetic
products.
Item 2 proposes amendment to
section 3 Objects of Act . The proposed new
section contains an additional object which is to provide for
national standards for cosmetics imported into, or manufactured in,
Australia and the enforcement of those
standards.(14)
Item 11 proposes the
insertion of Part 3B Standards for cosmetics imported into,
or manufactured in,
Australia. Proposed
section 81 allows the Minister to set national standards
for cosmetic products, by legislative instrument. The Explanatory
Memorandum states that the NICNAS will make the standard publicly
available this is in addition to registration of the instrument on
the Register of Legislative Instrument and publication in the
Chemical Gazette.
Enforceability of section 81 is supported by
an offence provision (proposed section 81A) for
non-compliance with the standard, punishable with 120 penalty units
- equating to $66,000 for a corporation. This penalty is comparable
in size to an existing penalty for a similar offence of
non‑compliance in relation to chemicals (section 15A of the
Act).
Part 1of Schedule 2
(Items 1-9) amends various sections to replace
references to calendar year with 12 month period . This amendment
is to create consistency in drafting throughout the Act and prevent
confusion.
Part 2 (Items
10-13) also promotes consistency in drafting, by bringing
sections 21ZB and 22O in line with section 21P. All three sections
allow permit applicants to request that certain information they
provide be treated as exempt information under section 75 of the
Act.(15)
Part 3 (Items
14-16) also promotes consistency in drafting, by bringing
section 21F in line with similar sections 21SA and 22D. All three
sections allow the Director to request further information from an
applicant for the purposes of considering an application for a
permit.
Item 17 changes references in
paragraphs 28(8)(a) and (b) from biopolymer (16) to
polymer . The Explanatory Memorandum notes that this amendment
corrects an unintended exclusion of polymers that are not
biopolymers. While it is noted that the provision was not intended
to exclude other polymers, the consequences of widening the scope
of this provision are unclear.
Item 20 repeals section 77 of
the Act, that 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.
The Explanatory Memorandum states that the
section is being repealed due to lack of necessity, as compliance
with the section is not linked to any NICNAS regulatory activities.
It is also noted that there has been limited compliance with the
section since it was introduced in 1990. The provision does not
contain any penalties for non-compliance; it is unclear how
instances of non-compliance have been dealt with by the agency to
date.
Items 21-27 introduce the
concept of chemical name in relation to the publication of notices
about chemicals. A chemical name of a chemical can vary according
to the type of chemical (pure vs. unpure). The amendments clarify
the source of a chemical name, and allow for its use in various
circumstances.
Items 28 33 deal with exempt
information in relation to annual reporting obligations. The
amendments facilitate the confidential treatment of information
that is exempt from reporting requirements, for reasons of
commercial confidentiality.
Concluding comments
This Bill seeks to enforce a system that has
been administratively practiced by NICNAS since early 2006. The
amendments to the Act enable the system for regulating cosmetics to
be enforced, supporting it with penalties and Ministerial powers to
set standards. Legislating these measure will increased certainty
for industry and provide clarity about industry obligations, rights
and responsibilities under legislation regarding cosmetic
chemicals.
- Peter Prince,
Industrial Chemicals (Notification and Assessment) Amendment Bill
2003, Bills Digest No.167 2002-03,
Parliamentary Library, Canberra, 4 June 2003, at http://www.aph.gov.au/library/pubs/bd/2002-03/03bd167.htm,
accessed 18 June 2007
- Theraputic Goods
Administration organisational structure. at http://www.tga.gov.au/docs/html/orgchart.htm,
accessed 19 June 2007
- Hon Chris Pyne MP,
Minister for Ageing, Industrial Chemicals (Notification and
Assessment) Amendment (Cosmetics) Bill 2007 (Second reading
speech), House of Representatives, Debates,
13 June 2007.
-
http://www.nicnas.gov.au/Cosmetics/Regulation_Cosmetic_Chemicals
Final_Report_PDF.pdf, accessed 18 June 2007.
-
http://www.nicnas.gov.au/About_NICNAS/Reforms/LRCC/Regulation
Impact_Statement_PDF.pdf, accessed 20 June 2007.
- Explanatory
Memorandum, p. 2.
- ibid.
- Hon Chris Pyne, op.
cit.
- ibid.
- ibid.
- Kelly Burke, Alert
issued over toxic toothpaste, Sydney Morning Herald, p.
5.
- Explanatory
Memorandum, p. 8.
- ibid, p. 1.
- ibid, p. 11.
- A section 75
exemption allows for information to be exempt from publication, if
publication could reasonably be expected to prejudice substantially
the commercial interests of the applicant; and if the prejudice
outweighs the public interest in the publication of the
information.
- A biopolymer is any
polymeric chemical manufactured by a living organism, as proteins
and polysaccharides.
PaoYi Tan
Law and Bills Digest Section
20 June 2007
Parliamentary Library
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