NOTICE OF PROPOSAL NOT TO TRANSFER TO THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES CERTAIN COSMETIC INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE THERAPEUTIC GOODS ADMINISTRATION
In accordance with section 15AA(1) of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) the Director proposes not to include the chemicals listed in Table 1 in the Australian Inventory of Chemical Substances (AICS). These chemicals are currently regulated by NICNAS as new chemicals.
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, one is proposed to be transferred and is the subject of a separate notice. The current notice relates to the remaining two chemicals.
In accordance with section 15AA(1) of the Act, the Director proposes not to include the chemicals listed in Table 1 on the AICS.
Section 15AA(5)(e) requires the Director, NICNAS, to state the reasons why these chemicals are not proposed for listing on the AICS. The reason is that the Director considers that:
Further details relating to this view are given in Table 1.
This notice is published in the Chemical Gazette in accordance with section 15AA(4) of the Act.
Statements about the Proposal
For the chemicals 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 20122. The statement should provide relevant argument relating to the stated reasons given in this notice as to why the Director, NICNAS, is proposing not to list the chemicals on the AICS. The statement should address a specific chemical (ie not be a generic statement).
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 any 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. Given the close of comments is COB 3 July 2012, the earliest opportunity to publish the notice will be the August 2012 Chemical Gazette. An application can then be made to the Administrative Appeals Tribunal (AAT) for a review of a final decision by the Director.
Arrangements for annually reporting of chemicals under Sn15AA process
The chemicals in Table 1 not proposed for transfer to the AICS under section 15AA of the Act are currently considered new chemicals and so are 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 chemicals, however if the chemicals are ultimately transferred to the AICS, annual reports will no longer be required if used in cosmetic products under the specified conditions of use.
Given the chemicals in Table 1 are not proposed for listing on the AICS, the Director has decided to continue seeking reports under Sn21AA for these chemicals when introduced as new chemicals for cosmetic use during the current registration year between 1 September 2011 and 31 August 2012.
If you require further information please contact:
Dr Bill Diver
Phone 02 8577 8862
2 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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