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Notice 8

NOTICE OF DECISION TO INCLUDE ON THE AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES CERTAIN COSMETIC INGREDIENTS IN PRODUCTS PREVIOUSLY REGULATED BY THE THERAPEUTIC GOODS ADMINISTRATION

 

In accordance with Section 15AA(8) of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), this notice gives the final decision of the Director, NICNAS, to include on the public section of the Australian Inventory of Chemical Substances (AICS) 18 chemicals for cosmetic use only, along with associated conditions of use (see Tables 1 and 2).

 

Background

 

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. The intent of the reforms is that the transfer of responsibility would occur whilst maintaining health and safety standards and without posing unnecessary burden on industry.

 

As a result of this transfer, the chemicals in these cosmetic products that were not already on the AICS became new industrial chemicals, and therefore required notification and assessment unless exemptions applied. A mechanism to list certain chemicals on the AICS as existing chemicals came into force on 27 September 2011 with amendments to the Act.

 

In order to be considered by the Director, NICNAS, for placement on the AICS, these chemicals needed to meet two sets of criteria: a generic set under the amended legislation; and a second set specific to the cosmetic reforms. To ascertain which chemicals were to be considered for transfer, NICNAS undertook a call for information in the February 2010 Chemical Gazette. As a result of clarifying identity information and applying the eligibility criteria, the Director, NICNAS identified 62 chemicals or substances for possible listing on the AICS. In addition, the Director, NICNAS must consider whether these chemicals pose an unreasonable risk to occupational health and safety, public health or the environment.

 

The proposal for listing

 

These 18 chemicals were part of the group of 25 chemicals proposed for listing on the AICS via Notice 4 in the Chemical Gazette of 7 February 2012.

 

In this Notice the Director, NICNAS stated reasons why these chemicals were proposed for listing on the AICS in accordance with section 15AA(5)(e) of the Act. Briefly, these reasons were that:

 

  • listing these chemicals on the AICS fulfils the intent of the 2007 cosmetic reforms;
  • the chemicals fulfilled eligibility criteria; and
  • the Director considers that the chemicals do not pose an unreasonable risk to occupational health and safety, public health and the environment, when used in accordance with the proposed conditions of use.
    Statements on the proposal were due within 28 days of the notice, by 6 March 2012.

 

NICNAS also published a clarification Notice in the 6 March 2012 Chemical Gazette (Notice 2) concerning the conditions of use for two of these 25 chemicals and a further 28 days was provided for comment, to 3 April 2012.

 

Stakeholder response to the proposal for listing the 18 chemicals

 

Chemicals for which no statements were received

 

Of the 18 chemicals proposed for transfer, no statements were received objecting to the listing of one chemical with the proposed conditions of use.

 

Chemicals for which statements were received

 

Eight statements were received in regard to the remaining 17 chemicals within the 28 day period specified under section 15AA(5)(g) of the Act. The Director, NICNAS, proposed conditions of use for these chemicals, noting that some of the chemicals possessed certain properties that may pose a risk to human health and/or the environment when used outside of the proposed conditions of use. Whilst all eight submissions supported the listing of these chemicals on the AICS, the submissions all objected to the proposed conditions of use on the basis that:

 

  • NICNAS did not present any sound scientific evidence that these ingredients pose an unreasonable risk to public health and/or the environment;
  • NICNAS has no power to make risk management decisions in regard to these chemicals;
  • the NICNAS restrictions are inconsistent with the use of these chemicals internationally;
  • as these proposals will have a significant detrimental impact on the commercial operations of many companies and the supply of product into the market place, an impact assessment is required; and
  • the introduction of unique Australian requirements in the absence of any sound scientific evidence will provide a barrier to trade and could lead to challenges through the World Trade Organisation.

 

Moreover, the submitters did not agree that the chemicals listed in Groups 2, 3 and 4 of Table 1 to the proposal Notice of February 2012 may pose an unreasonable risk when, in the view of submitters, they are used in formulated cosmetic products in small amounts.

 

Finally, the submissions all included alternative proposed conditions of use within which any unreasonable risk was proposed to be mitigated.

 

NICNAS sought further information from the submitters and other interested businesses on the use of these chemicals in cosmetic products in Australia in order to give full consideration to the statements received.

 

The Director’s consideration of statements received

 

General considerations

 

In relation to the range of statements provided above by the submitters:

 

  • the Director noted in the proposal Notice 4 of February 2012 that “some of the chemicals possessed certain properties that may pose a risk to human health and/or the environment when used outside of the proposed conditions of use”. This observation was informed by the application of a hazard screening process involving Quantitative Structure Activity Relationship (QSAR) modelling and a review of key literature, along with modelling of the likely volumes of these chemicals when used in formulated cosmetic products in Australia. Finally, in response to the statements received, the Director obtained further information on the likely hazards, volumes and therefore risks posed by these chemicals;
  • the new legislative mechanism provides the power for the Director to annotate the AICS with conditions of use under Section 15AA(2);
  • introduction of the chemicals proposed for listing outside of the conditions of use means the chemical is a new chemical and that the current Sn21 provisions of the Act then apply (see “Next Steps” further in this Notice); and
  • further information on the impact on business was sought and was taken into account in formulating the conditions of use.

 

Considerations regarding unreasonable risk

 

Section 15AA (3) requires the Director to consider whether the use of the chemical poses an unreasonable risk to occupational health and safety, public health or the environment. In relation to submitters’ comments that the chemicals in Groups 2, 3 and 4 do not pose an unreasonable risk as they are used in small amounts in formulated cosmetic products, it was noted that the risk posed by a chemical is related to both its intrinsic properties as well as the quantity used.

 

For one chemical, the data provided addressed the concerns regarding its environmental impacts to some extent, but concerns regarding aquatic chronic toxicity remained. For another chemical, submitters agreed with the Director’s concerns regarding the toxicity of a predicted metabolite.

 

For the remaining 15 chemicals, the Director considered that the additional information was insufficient to conclude that these chemicals do not pose an unreasonable risk to human health and the environment within the conditions of use proposed by submitters. As a result, the Director decided, on the basis of the available information, that the original view about the risk to human health and the environment which may be posed by these chemicals remains unchanged, and therefore appropriate conditions of use to mitigate this risk should be maintained.

 

Submitters also noted the practical difficulties in complying with a condition of use limiting introduction of the chemical to one product type. The Director determined that an adequate mitigation of risk could be achieved by extending the introduction of these chemicals to all cosmetic products, as requested by submitters, whilst:

 

  • limiting the annual volume a company could introduce for chemicals or
  • limiting the concentration of the chemical in products either based on that previously imposed by the original regulator (TGA) or on the levels that companies indicated were being used in Australia.

 

The Decision

 

The Director makes the following decisions regarding the listing of chemicals on the public AICS in accordance with Section 15AA(7):

 

Decision on chemical for which no statements were received (Table 1)

 

Table 1 of this Notice contains the Director’s decision on the chemical for which no statements were received. The Director has decided to include the chemical on the public section of the AICS with the condition of use identical to that originally proposed, namely that the chemical be available for cosmetic use only.

 


Decision on chemicals for which statements were received

 

Table 2 contains the Director’s decisions on the 17 chemicals for which statements were received. Having taken account of the statements received, the Director has decided to include the chemicals in Table 2 in the public section of the AICS.

 

Table 2 is divided into groups of chemicals in accordance with the groupings used in the February proposal Notice 4. Moreover, each group is prefaced with a statement concerning how the Director took account of statements received.

 

For ease of reference, Table 2 contains:

 

  • the CAS number and INCI name/AAN in the first column;
  • the original conditions of use proposed by the Director in the February/March Notices along with the conditions proposed in the stakeholder submissions in the second column; and
    the final conditions of use decided by the Director in the third column.

 

Your right to apply for a review of this Decision

 

Under Section 15AB(1) of the Act, for each decision to include a chemical listed in Tables 1and 2 on the AICS, a period of at least 28 days is allowed for persons to apply to the Administrative Appeals Tribunal (AAT) for a review of that decision. Information concerning the right to apply to the AAT and the means of doing so is included in an attachment to this notice. In particular, you must apply to the AAT within 28 days of the date of this notice.

 

Next Steps

 

Under Section 15AB, after at least 28 days has passed since the publication of the Director’s decision and if 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 public section of the AICS, along with any conditions of use, and give notice of this action in the Chemical Gazette. Pending any application for review to the AAT, NICNAS expects these processes to occur in August 2012.

 

If listed on the AICS, 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.

 

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 or volume 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.

 

In order to reduce the impact of the uncertainty on business about the annual reporting arrangements for 2011-12 while the chemicals are in the process of proposed transfer to the AICS, the Director, NICNAS, has decided not to seek reports under s21AA for the chemicals in Tables 1 and 2 that are introduced as new chemicals for cosmetic use within the specified conditions of use during the current registration year between 1 September 2011 and 31 August 2012.

 

If you require further information please contact:

 

Dr Bill Diver
Reform Section
NICNAS
GPO Box 58
Sydney
NSW 2110

 

Phone 02 8577 8862
Fax: 02 8577 8888
email: bill.diver@nicnas.gov.au

 

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