Notification Template (Electronic Submission)

Notification Template (Electronic Submission)

Commercial Evaluation Permit

Notification Template (Electronic Submission)

This template has been provided by NICNAS as an aid in presentation of the required information for an application for a Commercial Evaluation Permit. This template should be filled in and provided in conjunction with a copy of Form 1-CEC filled out by each applicant for the permit, along with the CEC checklist and the Notification fee. A copy of the Customer Agreement form (Form 8) signed by each applicant and each customer should also be submitted, and supply of the notified chemical to customers under the permit cannot commence until the customer has provided a copy of Form 8 to NICNAS.

An application for Exempt Information may also accompany the notification, along with the appropriate fee, if the chemical name or details of the use are to be exempted from publication in the Chemical Gazette. Other information submitted in this template is for internal NICNAS use only, not for publication, and exemption for this information is not required. The publication of details in the Chemical Gazette will be under the following headings, and this is the only information that will be published.

PERMIT NUMBER / COMPANY NAME / POST CODE / CHEMICAL OR TRADE NAME / HAZARDOUS SUBSTANCE / QUANTITY / USE / PERIOD APPROVED

If information needs to be provided to NICNAS in confidence by a third party, e.g. if the manufacturer does not wish to disclose the chemical identity except to NICNAS, Form 5 (signed by the owner of the data) should accompany the third party data.

The template should be filled out completely; any missing information may result in delays in processing the application.

All relevant information (for example additional information relating to the hazards presented by the notified chemical, such as toxicological or ecotoxicological studies) is required to be submitted as part of the notification, and should be attached to the notification in electronic or paper versions. The completed template may be submitted in electronic form (by email, or CD-R), provided the required attachments are also present in paper or electronic form. Note also that NICNAS does not have a secure system for submission by email.

Highlighted headings[A1] in the form have associated guidance material, which may be seen by holding the mouse cursor over the highlighted area. The guidance material indicates what information should be included in each section.

The preferred name should be the name under which the permit will be issued, being the chemical name unless an application for exemption of the chemical name is attached; otherwise the trade name by which the chemical will be known in Australia (or the main trade name by which it will be known in Australia).

Oct2013

NICNAS

Preferred name

Part A

APPLICANT AND NOTIFICATION DETAILS

A.1 / Applicant(s) [A2]
[Write here]
A.2 / Mode of Introduction of Notified Chemical for the Duration of the Permit[A3]
A.3.1 / Introduction Volume of Notified Chemical[A4]
A.3.2 / Proposed Duration of Permit[A5]
A.4 / Justification for Proposed Volume and Duration[A6]
A.5 / Customer Agreements[A7]
A.6 / Previous Notification in Australia by Applicant(s)[A8]
A.7 / Notification in Other Countries[A9]
A.8 / Summary of Health and Environmental Effects
A.8.1 / Human Health Effects [A10]
A.8.2 / Environmental Effects [A11]

Part B

1.IDENTITY OF CHEMICAL

1.a / Chemical Name [A12] / Confidential/not confidential
1.b / Other Name(s)[A13] / Not for publication
1.c / Marketing Name(s)[A14]
1.d / CAS Number[A15] / Not for publication
1.e / Molecular Formula[A16] / Not for publication
1.f / Structural Formula[A17] / Not for publication

[Free Space for Structural Formula]

1.g / Molecular Weight[A18] / Not for publication
1.h / Spectral Data[A19] / Not for publication
AnalyticalMethod

3.PROPOSED USE INFORMATION

Use[A20] / Confidential
Use[A21] / Non-Confidential / For publication; this field is compulsory and must contain sufficient information to identify industry category and use scenarios.

6 Occupational Health and Safety Data

/ Not for publication
6.a.1 / Operation Description[A22]

[Free space for process flow diagram (where available)]

6.a.2 / Occupational Exposure
Number and Category of Workers[A23]
Category of Worker / Number / Exposure Duration
(hours per day) / Exposure Frequency
(days per year)
Exposure Details[A24]
6.a.3 / Safety Procedures[A25]
6.a.4 / Education and Training[A26]
6.b / Health Conditions[A27]
6.c / Occupational Health Monitoring[A28]
6.d / Observation on Human Exposure[A29]

7.ENVIRONMENT

/ Not for publication
7.a.1 / Manufacturing Process[A30]
Site Identity
Process at Site
Release from Site
Site Identity
Process at Site
Release from Site
7.b / Release to Environment for Each Use of the Chemical[A31]
7.c / Storage[A32]
7.d / Disposal[A33]

8.Public exposure[A34]

/ Not for publication

Additional Information

/ Please include here any additional information available to you outside Schedule requirements.

Hazard Information and Classification[A35]

/ Not for publication

MSDS and Label

Oct2013Page 1 of 4

NICNAS

11.Label[A36]

A copy of the chemical/product label should be attached to this application. The label should be compiled in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances.
Label Checklist
Signal word eg ‘hazardous’ or ‘warning’ (where appropriate)
Ingredient disclosure for NOHSC Type I hazardous ingredient
Risk and Safety phrases, if hazardous
Australian contact details
Information on label consistent with information detailed in MSDS
If hazardous, does label refer to MSDS

12Material Safety Data Sheet[A37]

A Copy of the chemical/product MSDS should be attached to this application. The MSDS should be compiled in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets.
MSDS Checklist
Permit statement (i.e. permit granted under 21G of the Act)
Australian contact details
Hazardous statement on MSDS
Risk and Safety phrases, if hazardous
Ingredient disclosure for NOHSC Type I hazardous ingredient
Information on MSDS consistent with information detailed on label

Oct2013Page 1 of 4

[A1]1Example of highlighting

[A2]1Please include company name, ACN or ABN, and address for each applicant for the permit.

[A3]1Indicate if the notified chemical is introduced by import or local manufacture. Give formulation details if the notified chemical is not introduced in 100% form.

[A4]1Total volume (of notified chemical, not formulated product) to be introduced over the duration of the permit; must not be greater than 4 tonnes (in total).

[A5]1Total duration of period for introduction for Commercial Evaluation; must not be greater than 2 years.

[A6]1A justification must be provided in terms of discussion of why the proposed amount is needed for commercial evaluation purposes. Additional justification should be provided if the total quantity requested under the permit is greater than 1 tonne, also if the requested time is greater than 1 year.

[A7]1Please write below the names of all customers with whom agreements have been or will be made for purposes of this commercial evaluation permit application. Please attach all completed copies of Form 8, including one from each notifier. Customers will not be able to participate in commercial evaluation under the permit until signed copies of Form 8 have been submitted to NICNAS. In the case of direct sale of the product containing the notified chemical to the public, the presence of mechanisms to receive feedback such as a prominently displayed consumer hotline number should be mentioned here.

[A8]1Included here details of any notifications which have previously been submitted by any notifier for this chemical, including current or expired permits, current certificates or certificate notifications which are still in progress.

[A9]1Include country, level at which notified and year of completion (if known).

[A10]1The summary should highlight the toxic effects and hazards of the chemical and its impact on occupational health and safety and public health. Any available toxicity data should be briefly summarised here.

[A11]1The summary should highlight the ecotoxic effects and hazards of the chemical and its impact on the environment. Any available ecotoxicity data should be briefly summarised here.

[A12]1The chemical name should be provided in CA Preferred Index Name format (eg as obtained from a CAS Registry search). The chemical name may be claimed as confidential and in this case will not be published in the Chemical Gazette.

[A13]1Other names include any other names by which the chemical is known apart from the CA Index name and trade names which will be used in Australia, such as chemical synonyms, internal codes or trade names not used in Australia. These names will not appear in the Chemical Gazette.

[A14]1All trade names used in Australia for the chemical or products incorporating the chemical should be included here. The preferred name will be published in the Chemical Gazette if exemption has been claimed for the chemical name.

[A15]1If a CAS number has been assigned please include it here. The CAS number will not appear in the Chemical Gazette.

[A16]1Include a molecular formula for the notified chemical if it is possible to assign one; for polymers or reaction products write the formulae of all of the ingredients; it may not be possible to provide a formula for complex natural products. The molecular formula will not appear in the Chemical Gazette.

[A17]1A structural formula must be included unless it is impossible to assign one, eg for complex natural products. For polymers or reaction products, a structural formula showing the essential details of the types of bonds present should be drawn. The formula may be embedded in the document, and preferably also separately submitted electronically. A structure in ChemDraw .cdx format is preferred. Alternatively, a structure may be drawn on a sheet of paper and provided as a hard copy attachment. The structural formula will not appear in the Chemical Gazette.

[A18]1Formula weight for the chemical, or, in the case of reaction products or natural products, molecular weight range. For polymers, please write the Number Average Molecular Weight and attach a copy of the molecular weight characterisation report (paper copy or electronic).

[A19]1In the space below, write the methods used for characterising the notified chemical. Attach copies of the spectra (paper copy or electronic).

[A20]1If an application for exempt information has been made for this item, the details of the use of the chemical should be provided here, eg anti-oxidant in marine diesel engine oils. The non confidential box must also be filled in and should contain a use defined in enough detail as to indicate the industry sector and type of application for the notified chemical, eg in this case “oil additive”.

[A21]1The details of the use of the chemical should be provided here, eg anti-oxidant in marine diesel engine oils. Less detail should be provided here if an application for confidentiality for the use has been made; in which case the detailed use will be recorded in the confidential box above.

[A22]1Concisely describe the manufacturing, processing, reformulation, repackaging, handling and end use operations involved with the notified chemical; a process flow diagram may be inserted if available.

[A23]1In the following table, please write all categories of workers who will handle the notified chemical, including transport and storage, along with the number of workers in each category, the predicted length of time each will handle the chemical, and the frequency of handling the chemical; to insert additional rows place the cursor in the last box and press Tab.

[A24]1Describe the activities carried out by each category of workers and the types of exposure to the notified chemical that may result; include the concentration of notified chemical in the formulation at each step. Describe how exposure may occur (eg drips and spills, splashes, vapours, aerosols or dusts – give particle size) and the route of exposure (eg inhalation, ocular, dermal). Give these details even if protective equipment which will minimise exposure is used.

[A25]1Describe the safe work practices which will be used, such as automated enclosed systems or codes of practice, engineering controls such as local exhaust ventilation, and any personal protective equipment which will be used by workers during each step.

[A26]1Briefly describe the training and education given to workers to ensure proficiency in safe working practices related to the notified chemical.

[A27]1Include detail on health conditions (if any) which indicate that the worker should not handle the notified chemical.

[A28]1Include particulars of any procedures proposed for atmospheric or health effects monitoring for the notified chemical.

[A29]1Include detail on any known human health hazards eg information from overseas use of the notified chemical.

[A30]1Discuss the releases during manufacturing or reformulation processes under the following headings. You may need to copy and paste the boxes below to give sufficient boxes for including all processes. All releases, eg to sewer, spills, residues in containers etc should be covered. The manner of disposal should also be addressed.

[A31]1Discuss releases upon end use of the products containing the notified chemical. Discuss the fate of the releases, eg landfill, sewer. Releases include eg washing off to the sewer, disposal of objects containing (or coated with) the notified chemical to landfill, disposal of containers with residue.

[A32]1Describe the manner of storage for the products containing the notified chemical; include any information on storage requirements, such as the need for storage in a cool, ventilated place.

[A33]1Summarise the likely final fate of the notified chemical. Include any recommendations, eg that the notified chemical should be incinerated rather than sent to landfill.

[A34]1Include all routes by which the public will be exposed; indicate the likely frequency of exposure and the expected quantities; include the concentration of the notified chemical in the consumer products.

[A35]1Please summarise any available information on the toxicity or environmental hazard of the notified chemical. Attach all study reports which are available in paper or electronic copies. Provide the classification details for the notified chemical under the NOHSC Approved Criteria for Classifying Hazardous Substances; also any dangerous goods classification.

[A36]1Please check the proposed label for the notified chemical against the checkbox. All of the items are required to be present if applicable for the chemical. Attach a copy of the proposed label.

[A37]1Please check the proposed MSDS for the notified chemical against the checkbox. All of the items are required to be present if applicable for the chemical. Attach a copy of the proposed MSDS for the notified chemical and each product in which it is present. All ingredients of a product should be listed (totalling 100%) although generic names may be used where allowed by the Code of Practice.