NOTICE OF PROPOSED TRANSFER TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES OF CERTAIN COSMETIC INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE THERAPEUTIC GOODS ADMINISTRATION
In accordance with sections 15AA(1) and 15AA(2) of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) the Director proposes to include the chemical listed in Table 1 in the public section of the Australian Inventory of Chemical Substances (AICS) for cosmetic use only, along with certain conditions of use. This chemical is currently regulated by NICNAS as a new chemical.
The regulatory responsibility for chemicals in certain cosmetic products that were previously regulated by the Therapeutic Goods Administration (TGA) was transferred to NICNAS under the cosmetic reforms in 2007. As a result of the transfer, those chemicals not already on the AICS were recognised as new industrial chemicals and therefore required notification and assessment as new chemicals before being imported or manufactured, and/or are subject to post market reporting.
The intent of the cosmetic reform was that the transfer of responsibility would occur whilst maintaining health and safety standards and without posing unnecessary burden on industry. Therefore, it was envisioned that those chemicals not already on the AICS would be recognised as existing industrial chemicals by listing them on the public AICS subject to controls that are not less stringent than those previously required by the TGA.
A mechanism to list certain chemicals on the public section of the AICS that were previously regulated by another Commonwealth regulator came into force on 27 September 2011. This occurred following modification of the Act by the Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011. NICNAS published a notice in the October 2011 Chemical Gazette detailing the resulting changes to the Act and how NICNAS will be implementing those changes.
Requirements for proposing to list chemicals on the AICS
In order to be considered by the Director, NICNAS for possible transfer onto the AICS under the cosmetic reforms, chemicals need to meet two sets of criteria.
The first set of criteria is legislated under Section 15AA of the Act, and applies to any group of chemicals proposed by the Director, NICNAS for listing on the AICS as a result of regulatory reform. These criteria are:
In addition, consideration must be given as to whether the chemical poses an unreasonable risk to occupational health and safety, public health or the environment.
The second set of criteria is specific to the particular circumstances of the cosmetic reforms. These criteria are:
To ascertain which chemicals are to be considered for transfer, NICNAS undertook a call for information as outlined in a notice in the February 2010 Chemical Gazette. The call contained various eligibility criteria which needed to be fulfilled in order to be considered for possible transfer. NICNAS further clarified the identity of the nominated chemicals through a request for information in the December 2010 Chemical Gazette. At the close of nominations on 2 May 2010, NICNAS received nominations for 179 unique chemicals or substances from 14 businesses. As a result of clarifying identity information and applying the two sets of criteria, NICNAS is actively considering 62 chemicals or substances for possible listing on the AICS.
In the Chemical Gazette of 7 February 2012, the Director, NICNAS, advised that an initial group of 34 chemicals for use in cosmetic products along with proposed controls had been listed on the AICS.
The Director, NICNAS, proposed the listing of a further group of 25 chemicals for use in cosmetic products along with proposed conditions of use in the 7 February 2012 Chemical Gazette. Of the remaining three chemicals, two are proposed not to be transferred and are the subject of a separate notice. This current notice proposes the transfer of the remaining chemical.
In accordance with sections 15AA(1) and 15AA(2) of the Act, the Director proposes to include a chemical and associated conditions of use as listed in Table 1 in the public section of the AICS for cosmetic use only.
Section 15AA(5)(e) requires the Director, NICNAS, to state the reasons why this chemical is proposed for listing on the AICS. These reasons are:
In determining that this chemical poses no unreasonable risk when used within the proposed conditions of use, the Director noted that certain components of the extract have possible endocrine disrupting activity and estrogen receptor binding effects, in addition to other biological effects. However, the uncertainty in these effects on human health or the environment may be mitigated at low concentrations, as similar chemicals are commonly found in food at low levels.
The Director proposes conditions of use for this chemical that cover its use in a broad range of cosmetic products, but which limits its concentration in those products. The concentration limit proposed is that which poses no unreasonable risk to health or the environment, and is close to the concentrations known to be currently in use in Australia.
This notice is published in the Chemical Gazette in accordance with section 15AA(4) of the Act.
Statements about the Proposal
For the chemical listed in Table 1, in accordance with section 15AA(5)(g) of the Act, a person may give a statement to the Director, within 28 days of the date of publication of this notice, giving reasons why the person objects to the Director’s proposal.
Persons who wish to make a statement in relation to this proposal should do so in writing by close of business (5.30pm) Tuesday 3 July 20121 . The statement should provide relevant argument relating to the stated reasons given in this notice as to why the Director, NICNAS, is proposing to list the chemical on the AICS.
Statements should be provided to the contact officer detailed below.
In accordance with section 15AA(7) of the Act, once the 28 days have passed, the Director will, having regard to any statements received, make a final decision to include or not include the chemical and associated conditions of use on the AICS for which a statement has been received.
Under section 15AA(8), the Director will then publish a notice in the Chemical Gazette listing any final decisions that have been made. An application can be made to the Administrative Appeals Tribunal (AAT) for a review of a final decision by the Director. Given the close of comments is COB 3 July 2012, the earliest opportunity to publish the notice will be the August 2012 Chemical Gazette.
Under Section 15AB, after at least 28 days has passed since the publication of the Director’s decision and an application to the AAT has not been made, or with regard to the finalisation of any appeal that has been made to the AAT, the Director must include the chemical in the AICS, along with any conditions of use, and give notice of this action in the Chemical Gazette.
Following these processes, the chemical will be regarded as an existing chemical within the context of the conditions of use, and so can be introduced into Australia without pre market notification or post market reporting to NICNAS if it is used in accordance with the conditions of use. Under Section 15A of the Act, failure to comply with these conditions of use is an offence, and will require the chemical to be notified to NICNAS as a new industrial chemical, unless an exemption applies.
In determining that the chemical will pose no unreasonable risk when used within the conditions of use listed on the AICS, the Director has noted that the chemical possesses certain toxicological properties that may pose a risk to human health or the environment when used outside of these conditions. Introduction of a chemical for such other uses (for example, for a non-cosmetic use; or for a cosmetic use but at a higher concentration than specified in the condition of use) would mean the chemical is a new chemical as defined under Section 5 of the Act. The introduction of such a new chemical is subject to Section 21 of the Act and the associated requirements prescribed in the Industrial Chemicals (Notification and Assessment) Regulations 1990.
Arrangements for annually reporting of chemicals proposed for listing on the AICS
The chemical in Table 1 proposed for transfer to the AICS under section 15AA of the Act is currently considered a new chemical and so is subject to the premarket notification and assessment requirements and/or post market reporting obligations under Part 3 Division 1 of the Act. These reporting obligations currently apply for the chemical, however if the chemical is ultimately transferred to the AICS, annual reports will no longer be required if used in cosmetic products under the specified conditions of use.
In order to reduce the impact of the uncertainty on business about the annual reporting arrangements for 2011-12 while the chemical is being proposed for transfer to the AICS, the Director, NICNAS, has decided not to seek reports under s21AA for the chemical in Table 1 that is introduced as a new chemical for cosmetic use within the specified conditions of use during the current registration year between 1 September 2011 and 31 August 2012.
This decision was described in more detail in a separate notice in the November 2011 Chemical Gazette for ease of reference.
If you require further information please contact:
Dr Bill Diver
Phone 02 8577 8862
1 The Acts Interpretation Act 1901 requires that a time period commences with day 1 being the day after the publication of a notice. Therefore 28 days from publication of this notice is 3 July 2012
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