Bills Digest no. 41 2011–12
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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.
Law and Bills Digest Section
2 September 2011
Date introduced: 6 July 2011
House: House of Representatives
Portfolio: Health and Ageing
Commencement: Commences on the day after Royal Assent.
Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill's home page, or through http://www.aph.gov.au/bills/. When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the ComLaw website at http://www.comlaw.gov.au/.
The Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011 amends the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) to:
- to enable the Director of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to include new industrial chemicals in the Australian Inventory of Chemical Substances (the Inventory) or previously regulated industrial chemicals that are transferred from other Commonwealth regulatory agencies
- require that notification statements for ultraviolet filters used in cosmetics to include specified matters
- remove the requirement in the Act to prepare summary assessment reports as the practice is redundant
- amend the Schedule to the Act which sets out matters related to the information requirements to be included in notification statements about chemicals. This will make the requirements consistent with international hazard classification requirements and international test protocols.
NICNAS was established in 1990 and is located within the Australian Government Department of Health and Ageing. NICNAS ‘provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effect of industrial chemicals and assesses all chemicals new to Australia and assesses those chemicals already used (existing chemicals) on a priority basis, in response to concerns about their safety on health and environmental grounds.’
The current Bill is concerned with completing the regulatory reforms which were largely implemented in 2007 as part of the Low Regulatory Concern Chemicals (LRCC) reform initiative. This Bill provides a mechanism for the Therapeutic Goods Administration (TGA) to transfer the industrial chemicals in cosmetic products onto the Australian Inventory of Chemical Substances.
The LRCC reform initiative commenced on 19 November 2002 when Trish Worth MP, Parliamentary Secretary to the Minister for Health and Ageing announced that a task force would be set up to investigate the reform of the regulation of industrial chemicals. An implementation strategy was developed and published in 2003. A number of recommendations were implemented quickly while others required a longer time frame. Several processes were gone through such as technical working groups, consultations and a series of discussion papers, which culminated with the publication of an overview paper, Low Regulatory Concern Chemicals Implementation of Outstanding Reforms—Overview of the Planned Reforms (Outstanding Reforms Discussion Paper) which was published in October 2006. In November 2007, the final report and recommendations were published.
The ingredients contained in cosmetics are regulated by NICNAS and/or the TGA. The NICNAS website notes the following concerning cosmetics:
Ingredients in cosmetic products are classed as industrial chemicals, even those described as naturally occurring. To make sure these products are safe for the workers handling them, the environment and for use by consumers, the Australian Government assesses the ingredients used in the manufacture and importation of cosmetics in Australia.
Amendments to the Industrial Chemicals (Notification and Assessment) Act 1989 for cosmetics came into force on 17 September 2007 and introduced a Cosmetics Standard which sets the standards for six cosmetic product categories. The NICNAS Cosmetics Guidelines provide a plain English guide about the legislative requirements and apply to all cosmetics. The NICNAS Cosmetics Guidelines were last updated on 28 July 2011 to include a List of sunscreening agents for use in cosmetic products (Part G).
All cosmetic products and their ingredients must comply with the changed legislative requirements for cosmetics and all NICNAS requirements must also be met. New cosmetic ingredients (not on the Australian Inventory of Chemical Substances) are subject to notification and assessment unless they qualify for an exemption. Companies and/or individuals who are introducing (importing or manufacturing) cosmetic ingredients or importing cosmetic products must be registered with NICNAS.
Cosmetics must be labelled in accordance with the Competition and Consumers Act 2010. The ACCC publish a booklet which explains the standards, the responsibilities of suppliers and retailers under it, and the ACCC's role in enforcing it.
The Cosmetics Standard is a legislative Instrument made under subsection 81(1) of the Industrial Chemicals (Notification and Assessment) Act 1989.
The explanatory statement to the Cosmetics Standard notes:
On 20 August 2007, the Industrial Chemicals (Notification and Assessment) Amendment (Cosmetics) Act 2007 received Royal Assent. This legislation amended the ICNA Act 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.
While the ingredients in cosmetics had been regulated by NICNAS as industrial chemicals for quite some time, the amending legislation represented an extension of the existing approach by enabling the relevant Minister to make standards, by legislative instrument, for cosmetic products as a whole that are imported into, or manufactured in, Australia.
The Cosmetics Standard is based on the requirements detailed in administrative arrangements which have been in place since 2006 (and have been reflected in the NICNAS Cosmetics Guidelines). These administrative guidelines will be updated to reflect the new legislative environment including the making of the Cosmetics Standard.
It is important to note that the requirements in the Cosmetics Standard are not the only requirements applying to cosmetics. For example, the product must also have full ingredient disclosure in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991 and the product must not contain chemicals prohibited for use in cosmetics (or the product must meet any restrictions specified for chemicals used in cosmetics).
The Senate Selection of Bills Committee resolved that the Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011 not be referred to Committees.
Senate Standing Committee for the Scrutiny of Bills had no comment to make on the Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011.
The Explanatory Memorandum states that the initiatives implemented through this Bill are cost neutral.
Australian Inventory of Chemical Substances
Part 2 of the Act deals with the Australian Inventory of Chemical Substances, while Part 1 is concerned with the keeping of the Inventory. Item 10 inserts new Division 1A into Part 2 of the Act. New Division 1A consists of proposed sections 15AA and 15AB which relate to the inclusion of previously regulated chemicals into the Inventory and the procedures for doing so. Proposed section 15AA sets out the procedures for the Director of the National Industrial Chemicals Notification and Assessment Scheme to propose to include or not include a new industrial chemical in the Inventory. He or she may make a proposal if the chemical has previously been regulated, and there is no assessment certificate in force and the chemical is currently in use in Australia. The Director may include any conditions of use or other conditions to which the importation or manufacture of the chemical is subject or conditions prescribed in regulations (proposed subsection 15AA(2)). The Director must take into consideration any unreasonable risk to occupational health and safety, public health or the environment (proposed subsection 15AA(3)).
Proposed subsection 15AA(4) provides that the Director must give notice of the proposal in the Chemical Gazette. The information required in the notice is set out in proposed subsection 15AA(5). The information required includes the following:
- chemical name
- number assigned to the chemical by the Chemical Abstracts Service or any number assigned by an alternative numbering system
- common name of the chemical
- whether the Director proposes to include, or not include, the chemical in the Inventory
- the Director’s reasons for including, or not including the chemical in the Inventory
- if the chemical is to be included in the Inventory, any particulars that the Director proposes in respect of the chemical, and the reasons why the Director proposes to include those particulars, and
- that a person may give a statement to the Director within 28 days after the notice is published, giving reasons why the person objects to the Director’s proposal.
Proposed subsection 15AA(6) provides that the Director must send a copy of the notice to the person introducing the chemical if contact details are known to the Director.
After the 28 day period which is provided by subsection 15AA(5) has passed, proposed subsection 15AA(7) requires the Director to consider any statements received and make a final decision about whether to include the chemical in the Inventory, and if so, any specified particulars associated with the chemical. The Director must publish a notice of the final decision in the Chemical Gazette and give a copy of the notice to any person who provided a statement (proposed subsection 15AA(8)).
Proposed section 15AB deals with the inclusion of a previously regulated chemical in the Inventory. Once the Director has published the notice of final decision in the Chemical Gazette as required by proposed subsection 15AA(8), there is a right of appeal against the decision to the Administrative Review Tribunal (AAT). Proposed subsection 15AB(1) requires that the Director include the chemical in the Inventory, along with any particulars in respect of the chemical either:
- if there has been no application for review to the AAT— 28 days after the notice of final decision has been published, and
- if there has been an application for review to the AAT—when the application for review of the Director’s decision has been finalised.
Proposed subsection 15AB(2) provides that the chemical is to be included in the non-confidential section of the Inventory and the Director must give notice in the Chemical Gazette of the chemical’s inclusion in the Inventory and any particulars relating to the chemical. Placing the chemical in the non-confidential section of the Inventory is ‘to ensure public scrutiny over the inclusion of chemicals onto the Inventory that have not been assessed by NICNAS’.
Item 11 inserts proposed subsections 23(9) and 23(9A). Existing section 23 deals with an application for an assessment certificate for a new industrial chemical. Proposed subsection 23(9) provides that a notification statement that relates to a new industrial chemical used as an ultraviolet filter in a cosmetic to be applied to the skin must contain the matters specified in:
- Parts A, B, C and E of the Schedule, and
- if the chemical is a polymer—Part D of the Schedule.
- According to the Explanatory Memorandum:
Under the cosmetic reforms in 2007, it was agreed that the data requirements which applied under the TGA be maintained when these chemicals were assessed by NICNAS. As some of the data required by TGA were not listed in the NICNAS Schedule to the Act, this Bill inserts a new Part E to the Schedule to cater for these additional requirements.
Division 3 of the Act deals with assessment, self assessment and reporting requirements. Items 12–24 of the Bill amend various sections of Division 3. In particular, item 16 repeals existing section 35. Section 35 deals with summary reports. Items 25–36 make additional amendments to reporting requirements in the Act. There is no need to issue summary reports anymore, as NICNAS now publishes the full public report on its website.
Item 55 inserts proposed Part E to the Schedule of the Act. Part E contains the data requirements in relation to UV filters in cosmetics. These requirements relate to item 11 and the data required in notification statements for new industrial chemicals relating to UV filters in cosmetics.
. Explanatory Memorandum, Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011, p. 8.
. For the policy and information background to the 2007 reforms, see P Tan, ‘Industrial Chemicals (Notification and Assessment) Amendment (Cosmetics) Bill 2007’, Bills Digest, no. 189, 2006–07, Parliamentary Library, Canberra, 20 June 2007, viewed 1 September 2011, http://www.aph.gov.au/library/pubs/bd/2006-07/07bd189.pdf
. Low Regulatory Concern Chemicals (LRCC), Implementation of outstanding reforms, Final report and recommendations, Commonwealth of Australia Gazette, October 2007, no. C121, 6 November 2007, p. 7.
. Explanatory Memorandum, p. 1.
. Item 37 of the Bill inserts proposed paragraph 102(1)(e) into the Act to provide this appeal right.
. Explanatory Memorandum, p. 5.
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