Secondary notification: ?-D-Glucopyranoside, ?-D-fructofuranosyl, octadecanoate

In the August 2016 Chemical Gazette, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published a notice announcing a secondary notification of the existing chemical ?-D-Glucopyranoside, ?-D-fructofuranosyl, octadecanoate (CAS No. 37318-31-3). In the October 2016 Chemical Gazette, NICNAS varied the August 2016 Gazette notice such that secondary notification in respect of the existing chemical ?-D-Glucopyranoside, ?-D-fructofuranosyl, octadecanoate(CAS No. 37318-31-3) is only required by the specified persons. The chemical is regarded as being of unknown or variable composition (UVCB). Who does the secondary notification apply to? Ingredients Plus Pty Ltd BASF Australia Ltd Unilever Australia & New Zealand Chemical details The chemical is also known as sucrose stearate. It consists of C18 mono, di, tri and poly esters of sucrose. This chemical was originally assessed by NICNAS for printing applications, with no reformulation occurring in Australia at that time. No human health or environmental data were submitted for assessment; however, the chemical was not considered to pose a risk to human health or the environment when used for this purpose. Reasons for secondary notification Secondary notification is required for this chemical as the chemical is now proposed to be reformulated in Australia and used in cosmetic products. Furthermore, proposed introduction volumes significantly exceed those previously assessed. Therefore, a reassessment of the chemical is warranted. Secondary notification requirements The specified persons to whom this notice applies must: submit a completed Form 1a-SN. provide the following information pursuant to section 65(4) described below. If the specified persons to whom this notice applies have already submitted a completed Form 1a-SN in response to the August 2016 Gazette notice they do not need to resubmit the same information in response to this notice. Non-compliance The penalty for non-compliance may include prohibition from further importation or manufacture of the chemical. Information required for secondary notification Identity, properties and uses Trade names under which the chemical is marketed by the introducers Proposed uses of the chemical, including: Description of end-use products, concentration in end-use products Types of end uses including whether in leave on or rinse off products Amount of the chemical introduced annually Details of reformulation, including: Concentration of the chemical that is imported and in resulting end-use products Package sizes imported Description of the reformulation and repackaging process and disposal of wastes Composition data for the UVCB chemical Description of transportation and storage Human health and environment data Physico-chemical data available for the notified chemical. Toxicology data available for the notified chemical or suitable analogue(s). Ecotoxicology data available for the notified chemical or suitable analogue(s). (M)SDS Copies of (M)SDS for the chemical and products containing the chemical. Exempt information applications To apply for some or all of this information to be treated as exempt from publication, use Form 3 Application for Exempt Information. Note that certain items of ‘basic information’, as defined in section 75(2) of the ICNA Act, cannot be exempted from publication. Application fee An application should be accompanied by an application fee of $1,100. Additional persons with relevant information In addition to the requirement that the specified persons give secondary notification, any persons with information relevant to the assessment of the chemical and not covered in the original assessment report are encouraged to submit the information for consideration. Information collected Information collected by NICNAS may be provided to State, Territory or Commonwealth regulatory agencies for the purposes of monitoring compliance under relevant legislation. Information that is designated as ‘exempt’ will not be disclosed by NICNAS except in the circumstances set out in sections 76 and 79 of the ICNA Act. All information provided to NICNAS will be used only for the purposes for which it was provided under the ICNA Act.

NICNAS Chemical Gazette, 5 October 2016 ; http://www.nicnas.gov.au ;