Secondary Notification of Chemical in Reagent S-10104

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has, in accordance with section 65(2) of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), published a secondary notification of the existing chemical in Reagent S-10104.

The Director has decided that secondary notification is required, as NICNAS has been informed that new toxicological studies are available for several health and environmental endpoints that were not available at the time of the assessment as a new chemical. The chemical was originally assessed under the standard notification category for use in the mining industry. It is not manufactured in Australia but imported from overseas. In addition, variations in the manufacturing process have resulted in a change in the hazardous impurities in the chemical. All persons who introduce Chemical in Reagent S-10104 into Australia either by import or manufacture must provide secondary notification. Failure to comply with the requirement for secondary notification is an offence against the Act. The penalty for non-compliance may include prohibition from further importation or manufacture. Secondary notification may be given by completing the secondary notification assessment form for an existing chemical, accompanied by any information relevant to an assessment of Chemical in Reagent S-10104 not included in the original assessment report. In addition, importers and manufacturers of Chemical in Reagent S-10104 must provide the following information pursuant to section 65(4):

1) Identity, Properties and Uses

a) Name(s) under which the chemical is marketed by the introducer

b) All of the introducer’s uses of the chemical, specifying uses not covered in the original assessment of the chemical

c) Proposed annual import quantity of the chemical for the next 5 years

d) The concentration and purity (including details of any hazardous impurities) of the chemical in imported products

e) If reformulation will occur in Australia, the concentration of the chemical in finished products

f) Information on occupational exposure during the proposed new uses, including handling procedures and any monitoring data

g) Information on whether handling procedures for the existing uses have changed and if so the impact on occupational exposure

h) If any new uses, provide information on any likely public exposure

i) Details of any adverse health effects observed since the assessment certificate was issued

j) Australian SDS(s) and Labels for the chemical and any product containing the chemical

 

2) Toxicity

a) Full studies on the chemical for acute oral toxicity, skin and eye irritation, skin sensitisation and genotoxicity. Studies previously provided to NICNAS need not be included

b) Any additional data available on toxicological and/or ecotoxicological effects of the chemical

The secondary notification form can be found on the NICNAS website at: http://www.nicnas.gov.au/__data/assets/word_doc/0018/4347/Form1a_SN_TAP_Word.docx.

An application for some or all of this information to be treated as exempt from publication may be made by applying under section 75 of the Act, and using the approved form accompanied by an application fee of $1,100: http://www.nicnas.gov.au/__data/assets/word_doc/0012/4350/Form3_Exemption_Information_Word.doc,

Secondary notification of the chemical must be received by NICNAS no later than 3 December 2014.

In addition to the requirement to give secondary notification, any persons with information relevant to the assessment of Chemical in Reagent S-10104 and not covered in the original assessment report are encouraged to submit the information as outlined above for consideration by NICNAS. Information collected by NICNAS may be provided to State, Territory or Commonwealth regulatory agencies for the purposes of monitoring compliance under relevant legislation. All information collected is treated confidentially and in accordance with the Privacy Act 1988.

NICNAS Chemical Gazette, 4 November 2014 ;<ahref=”http://www.nicnas.gov.au/Publications/Chemical_Gazette”>http://www.nicnas.gov.au/Publications/Chemical_Gazette ;