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Cosmetics - Call for Information

** Call for Information 2 February – 2 May 2010 **

This notice is directed to those persons or companies with an interest in products affected by the cosmetic reforms, i.e. those involved with chemicals in products previously regulated by the Therapeutic Goods Administration (TGA), that are now regulated by NICNAS as cosmetics.

This notice applies ONLY:

  • To certain products that were previously regulated under TGA and, as a result of the introduction of the reforms to the cosmetic-therapeutic interface in September 2007, are now regulated under NICNAS, and
  • The product contains an ingredient(s) not listed on the Australian Inventory of Chemical Substances (AICS).

This notice does not apply to:

  • Other products regulated under TGA ie categories that were not affected by the cosmetic reforms, and remain therapeutic.
  • Chemical ingredients already listed on the Australian Inventory of Chemical Substances (AICS).

Purpose

NICNAS is seeking your assistance to provide information on cosmetic ingredients that were in commerce in certain products previously regulated by the Therapeutic Goods Administration (TGA), in order to identify those chemicals that meet the criteria for recognition as an industrial chemical. The process for recognition as an industrial chemical involves three stages:

  • The first stage is to identify chemicals eligible for listing on the Australian Inventory of Chemical Substances (AICS).
  • The second stage is to verify eligibility for listing on the inventory. A list of eligible chemicals will be published.
  • The third and final stage is to recognise the chemicals under the industrial chemicals scheme.

This call for information is Stage 1.

Background

Reforms to the cosmetic-therapeutic interface took effect on 17 September 2007 with the introduction of the Cosmetic Standard 2007 under the Industrial Chemicals (Notification and Assessment Act 1989 (the Act). That is, chemicals in some products that were previously regulated by TGA are now considered industrial (cosmetic) chemicals and are regulated by NICNAS. This includes chemicals in some:

  • Secondary sunscreens of SPF up to 15
  • Anti-bacterial skin products
  • Anti-acne products
  • Anti-dandruff products
  • Antiperspirants.

The reforms are now in operation.

 

One consequence of the reforms is that obligations under the Act now apply to products which have moved from being therapeutics to cosmetics. In particular, these products may contain ingredients that are not listed on the AICS and are therefore new industrial chemicals. Such new chemicals generally require assessment before being imported or manufactured.

 

However, as a part of the cosmetics reform package, it was agreed that any change in regulatory requirements would not pose an unnecessary burden on industry, while maintaining or enhancing health and safety standards. Therefore it was agreed that chemicals in those products that were regulated as therapeutics and were in commerce up to the time of the legislative amendments would be recognised as industrial chemicals, subject to meeting eligibility requirements.

Criteria for chemicals eligible for recognition as an industrial chemical

Each of the following criteria must be met to be eligible for listing on the AICS:

  • The chemical was an ingredient in at least one of the products that were regulated under TGA (see Background section); and
  • The product(s) meets the definition of a cosmetic under the Act and any requirements in the Cosmetic Standard 2007; and
  • The product(s) was in commerce at some time during the three-year period preceding the cosmetic reforms, that is, September 2004 to September 2007; and
  • The chemical is not currently listed on the AICS.

Guidance material including the definition of a cosmetic is at http://www.nicnas.gov.au/Current_Issues/

Cosmetics/Cosmetic_Guidelines_PDF.pdf (PDF PDF Icon 100 kb)

and requirements for certain categories of cosmetics are included in the Cosmetic Standard 2007 at http://www.nicnas.gov.au/Current_Issues/Cosmetics/

Cosmetic_Standard_PDF.pdf (PDF PDF Icon 18 kb)

Indicative list of cosmetic ingredients

NICNAS has compiled an indicative list of chemicals that are potentially eligible for listing on AICS, divided into two sections:

List A

  • Chemicals with known identity i.e. Chemical Abstracts Service (CAS) name and CAS number and the International Nomenclature Cosmetic Ingredient (INCI) name; and

List B

  • Chemicals with incomplete identity information, e.g. INCI name only.

This initiative was undertaken to provide a starting point to help industry nominate chemicals. It is important to note that your assistance and cooperation is needed to complete and verify eligibility against the criteria for listing on AICS.

What is the process for nominating chemicals to NICNAS?

Persons and companies are invited to nominate chemicals(s) on List A or B (provided in a downloadable form as part of the Nomination Form) and/or to nominate additional chemicals which may be eligible for listing on AICS.

Please do not nominate any chemicals that are already listed on the AICS. To search if a chemical is on the AICS, please go to http://www.nicnas.gov.au/Industry/AICS/Search.asp.

All nominations must be made in the Form (see link below), accompanied by the CAS name and CAS number of the chemical.

Synonyms may be provided if available, such as the INCI name. You must ensure that the INCI name corresponds accurately to the CAS name for that chemical. Some INCI names that are too broad (e.g. the ceramides) cannot be accepted, therefore, please provide more specific names for those chemicals.

What information do I submit to NICNAS?

List A

  • Verification* of the chemical’s use in a TGA-regulated product during the specified time period and that the product would now be regulated as a cosmetic.

List B

  • Verification* of the chemical’s use in a TGA-regulated product during the specified time period, and that the product would now be regulated as a cosmetic.
  • Information on chemical identity (CAS name and CAS number).

Additional chemicals

  • Full chemical identity information (CAS name and CAS number) and verification* of chemical’s use, as for Lists A and B.

* Verification
At the time of nomination, the following information is requested (via the form): Name of product regulated under TGA, Product type and AUST-L or AUST-R number, if applicable. NICNAS may request further information for verification of certain chemicals.

How do I nominate the chemicals?

Please use the provided form:

Nominations will be accepted until 2 May 2010 (a period of three months).

Nominations can be provided to NICNAS in any of the following ways:

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