PLC Self Assessment

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IMPORTANT: Your personal information is protected by law, including the

Privacy Act 1988. Important information about the privacy of your personal information is contained in our Privacy Collection Notice, available at www.nicnas.gov.au/privacy/app5 . You should ensure that you read and understand the Privacy Collection Notice before completing this form.

Application for Assessment Certificate Polymer of Low Concern (PLC) Self-Assessment

Use this form to apply for a self-assessed Assessment Certificate for a Polymer of Low Concern pursuant to paragraph 23A (1)(a) of the Industrial Chemicals (Notification and Assessment) Act 1989 .

For fees see http://nicnas.gov.au/regulation-and-compliance/fees-and-charges

Please make cheque payable to NICNAS.

If Exempt Information is proposed, Form 3 should accompany this application.

Please complete forms electronically and ensure that relevant fees are enclosed. Please provide to NICNAS by electronic means.

Return to: Director

NICNAS

GPO Box 58, Sydney NSW 2001 (postal address) or

Level 7, 260 Elizabeth Street, Sydney NSW 2010 (courier address)

Telephone (02) 8577 8800 / 1800 638 528 Fax (02) 8577 8888

Should you have difficulties completing this form, require further information or to provide feedback on this form, please contact the New Chemicals Programme on the above contact details, or visit http://www.nicnas.gov.au

.

Notifier Details

Business Name:

ACN / ABN: NICNAS Registration Number:

Business Address:

Postal Address ( if same as Business Address, state AS ABOVE ):

Position: Contact Name:

Phone:

Technical Contact Details

Fax: E-mail:

Postcode:

Postcode:

The technical contact is the primary contact for NICNAS and unless indicated otherwise is normally the sole contact for

NICNAS with regards to requests for additional information and the giving of the assessment certificate if the contact is in Australia.

Business Name:

Business Address:

Postal Address ( if same as Business Address, state AS ABOVE ) :

Contact Name:

Phone: Fax:

Position:

E-mail:

Postcode:

Postcode:

Yes No I/We, the Notifier (Applicant), authorise the technical contact to act on my/our behalf in all matters pertaining to my/our application for an assessment certificate (Note: this authorisation to act can be amended or cancelled at any time by notifying

NICNAS in writing)

Should correspondence between NICNAS and the technical contact be electronic where possible? Note certificates will be delivered to the contact via courier.

Yes No

Oct2013 Page 1 of 14

Chemical Details

Chemical Name:

Marketing or Other Name(s):

CAS Number ( if known ) :

POPS Criteria characteristics.

Page:

Note that self-assessment will lapse for polymers with these

Very few polymers degrade easily, and could be considered persistent. However, they are generally unlikely to bioaccumulate easily, as NAMW > 1000 by definition.

Answer YES to the question if there are concerns of persistence and bioaccumulation, mainly for breakdown products, for example brominated or fluorinated polymers.

2

Yes

Is the notified polymer or the breakdown products likely to be persistent and bioaccumulative?

Is the chemical an industrial nanomaterial under the NICNAS definition?

(Note: for the working definition please consult the NICNAS Handbook for

Notifiers)

Yes No

If yes, the chemical is not eligible for self-assessment and NICNAS assessment of the chemical in the appropriate certificate category is required.

Declaration

I declare that to the best of my knowledge all the information in this application is true, correct and complete. In relation to the notification statement and/or other documentation accompanying this application, I declare that I am entitled to use and give the Director all data in the statement.

I declare that I hold the supporting documentation used to fill in the application and will produce it on request from

NICNAS for a period of five years from the date of issue of a certificate for this polymer.

By submitting the attached PLC Self Assessment Report, I consent to its publication under section 38(1) of the Industrial

Chemicals (Notification and Assessment) Act 1989 (the Act), with modifications as required under section 33B(2) of the

Act, and adopted by NICNAS as the complete assessment report in accordance with section 36(2) of the Act.

No

Name

Signature

Position

Date

Note : It is an offence under the Act to supply a statement that is false or misleading.

Oct2013 Page 2 of 14

Payment Details

Electronic Funds

Transfer

Credit Card

Please quote Notification number / Registration number / Invoice number when making the payment

Account Name Department of Health Official Departmental NICNAS Special

Account

Bank

BSB Number

Reserve Bank of Australia, London Circuit, Canberra ACT 2600

092-009 Account Number 11608-5

Mastercard Visa

Credit card no.

Amount:

Print Name:

$ Expiry Date:

Authorised Signature:

Cheque

Enclosed Yes No

Cheques are to be made payable to the National Industrial Chemicals Notification and

Assessment Scheme (NICNAS) in $AUD.

Please note: If payment is being made from an overseas bank, all bank charges/fees are payable by the payee.

Applications will not be processed until correct payment has been received.

Oct2013 Page 3 of 14

Brief instructions for the completion of a Self-Assessment

N OTIFICATION PROCEDURE

The self-assessment application must consist only of a hard copy and an electronic copy of this form with the attached self-assessment report (Attachment 1), the relevant fee, and a copy of the material safety data sheet for the notified polymer. If supporting data (e.g. physiochemical and toxicological studies) are submitted then this application would not be considered a self-assessed application. In addition, the applicant(s) may claim certain information to be exempt from publication, in which case Form 3 - Exempt Information and the relevant fee should also be submitted with the application.

The attached self-assessment report consists of two Parts:

Part 1- should contain information for which an exemption is claimed. Do not complete Part 1 if no information is being claimed as exempt.

Part 2- should contain information suitable for publication.

Note that PLC self-assessment applications may not be Joint Notifications, or make use of a Variation of

Schedule Requirements or Third Party Information Lodgement. If these options are required, then a non selfassessment PLC notification must be applied for. A rebate of up to 15% of the assessment fee may be paid to the notifier if a completed PLC self-assessment template is attached to a non-self-assessed PLC application form.

C OMPLIANCE

The following obligations apply to certificate holders under the self-assessment system:

Supporting documentation must be retained for at least five years from the date of the certificate; and

The introduction volume (import and/or manufacture) of the notified polymer and any adverse health or environmental effects must be reported to NICNAS before the end of the NICNAS registration year (i.e. before 28 Sept the following year); and

Inform the director within 28 days of becoming aware of changes in circumstances under Section 64.

NICNAS may audit/inspect the certificate holders to monitor compliance with the obligations associated with the self-assessment category.

G UIDANCE

Please contact NICNAS on phone 1800 638 528 or email info@nicnas.gov.au

if you have any questions.

S CREENING

On receipt of a self-assessment application, NICNAS will screen the notification for three issues:

1. correct application of the PLC criteria, including confirmation of the identity of the polymer; and

2. that the risk assessment section addresses all issues and concerns in a scientific manner; and

3. completeness of the self-assessment.

During screening if it is determined that the PLC criteria have been incorrectly applied to the polymer, or if there is a possibility of unreasonable risk, the application will be refused and the notifier advised to re-notify in the correct category.

Note that a polymer will not be accepted for self-assessment if it can be predicted to be persistent and/or bioaccumulative or to have breakdown products that can be predicted to be persistent and/or bioaccumulative, under the Stockholm Convention on Persistent Organic Pollutants (further guidance on this can be found in the

January 2004 Gazette). Currently fluorinated and brominated chemicals are of particular concern with respect to persistence and bioaccumulation.

The self-assessment application is required to be a complete record of the risk assessment for the notified polymer. If NICNAS is not satisfied with the assessment, the notifier may be requested to revise the document and re-submit it. The assessment clock will not be started until NICNAS has accepted that the report is complete.

Upon receiving a complete application, NICNAS will prepare an Assessment Report, Full Public Report,

Summary Report and certificate within 28 days.

Oct2013 Page 4 of 14

Attachment 1 - PLC Self Assessment Report

File No:

(NICNAS use only)

Day Month Year

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

ASSESSMENT REPORT

(Exempt Information and Full Public Report)

Preferred name for the notified polymer

This Self Assessment has been compiled by the applicant and adopted by NICNAS in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and

Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals

Notification and Assessment Scheme (NICNAS), administered by the Department of Health and the Department of the Environment has screened this assessment report. The data supporting this assessment will be subject to audit by NICNAS.

Under subsection 38(5) of the Act the Director NICNAS publishes this assessment report by giving a copy of it to the:

 Secretary of the Department of Environment; and

Secretary of the Department of Health.

This assessment report will not be available for inspection by the public.

Director

NICNAS

Day Month Year

Part 1 –PLC Self Assessment Exempt Information

DISTRIBUTION

Technical contact

NICNAS

Department of Environment

Preferred name

1. APPLICANT DETAILS

A PPLICANT

[Write here]

2. IDENTITY OF CHEMICAL

C HEMICAL N AME

O THER N AME ( S )

CAS N UMBER

M OLECULAR F ORMULA

S TRUCTURAL F ORMULA

[Free Space for Structural Formula]

M OLECULAR W EIGHT (MW)

Number Average Molecular Weight (NAMW)

Weight Average Molecular Weight (WAMW)

Polydispersity Index (WAMW/NAMW)

% of Low MW Species < 1000

% of Low MW Species < 500

P OLYMER C ONSTITUENTS

Chemical Name CAS No. Weight % starting

4. PHYSICAL AND CHEMICAL PROPERTIES

Comments

NICNAS

Weight % residual

SELF-ASSESSMENT REPORT: EXEMPT INFORMATION: PLC/ Page 6 of 14

Day Month Year

5. INTRODUCTION AND USE INFORMATION

M AXIMUM I NTRODUCTION V OLUME OF N OTIFIED C HEMICAL (100%) O VER N EXT 5 Y EARS

Year

Tonnes

1 2 3 4

U SE AND M ODE OF I NTRODUCTION AND D ISPOSAL

5

NICNAS

SELF-ASSESSMENT REPORT: EXEMPT INFORMATION: PLC/ Page 7 of 14

File No:

(NICNAS use only)

Day Month Year

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

FULL PUBLIC REPORT

Preferred Name

This Self Assessment has been compiled by the applicant and adopted by NICNAS in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and

Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals

Notification and Assessment Scheme (NICNAS), administered by the Department of Health and the Department of the Environment have screened this assessment report. The data supporting this assessment will be subject to audit by NICNAS.

For the purposes of subsection 78(1) of the Act, this Public Report may be inspected at our NICNAS office by appointment only at Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.

This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and inquiries please contact the NICNAS

Administration Coordinator at:

Street Address: Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, AUSTRALIA.

Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.

TEL:

FAX:

Website:

+ 61 2 8577 8800

+ 61 2 8577 8888 www.nicnas.gov.au

Director

NICNAS

Day Month Year NICNAS

Part 2 –PLC Self Assessment

Preferred name

1. APPLICANT AND NOTIFICATION DETAILS

A PPLICANT

[Write here]

N OTIFICATION C ATEGORY

Self Assessment: Polymer of Low Concern

E XEMPT I NFORMATION (S ECTION 75 OF THE A CT )

No details are claimed exempt from publication.

Or

Data items and details claimed exempt from publication:

Chemical Name, Other Names, CAS Number, Molecular and Structural Formulae, Molecular Weight,

Polymer Constituents, Residual Monomers/Impurities, Use Details, Manufacture/Import Volume, and

Site of Manufacture/Reformulation

P REVIOUS N OTIFICATION IN A USTRALIA BY A PPLICANT ( S )

N OTIFICATION IN O THER C OUNTRIES

2. IDENTITY OF CHEMICAL

(delete if confidential) C HEMICAL N AME

O THER N AME ( S ) (delete if confidential)

M ARKETING N AME ( S )

CAS N UMBER (delete if confidential)

(delete if confidential) M OLECULAR F ORMULA

S TRUCTURAL F ORMULA (delete if confidential)

[Free Space for Structural Formula]

M OLECULAR W EIGHT (MW) (delete if confidential)

Number Average Molecular Weight (NAMW)

Weight Average Molecular Weight (WAMW)

Polydispersity Index (WAMW/NAMW)

% of Low MW Species < 1000

% of Low MW Species < 500

SELF-ASSESSMENT REPORT: PLC/ Page 9 of 14

Day Month Year NICNAS

M OLECULAR W EIGHT (MW)

Number Average Molecular Weight (NAMW) >1000 or >10000

P OLYMER C ONSTITUENTS (delete if confidential)

Chemical Name CAS No.

R EACTIVE F UNCTIONAL G ROUPS

Insert more rows for FGs if required

Functional Group Category

Moderate/High Concern

OR

The notified polymer contains only low concern functional groups.

Weight % starting

Weight % residual

Equivalent Weight (FGEW)

3. PLC CRITERIA JUSTIFICATION

Molecular Weight Requirements

Functional Group Equivalent Weight (FGEW) Requirements

Low Charge Density

Approved Elements Only

Criterion

Stable Under Normal Conditions of Use

Degradation Products

Criterion met

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

OR

Not Water Absorbing

Not a Hazard Substance or Dangerous Good

Criterion

Low MW Polyester Manufactured from Allowable Reactants

The notified polymer meets the PLC criteria.

4. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20°C and 101.3 kPa

Melting Point/Glass Transition Temp

Density

Water Solubility

Criterion met

Yes/No

…°C

… kg/m 3 at …°C

(Note: units are kg/m 3 ; density in kg/m 3 is 1000 x density in g/cm 3 )

… g/L at 20°C

(Include a brief description of the test, including the method used) pKa = …

Dissociation Constant

Particle Size

(delete if no acid or base groups are present)

(delete if liquid or solution)

Reactivity eg Stable under normal environmental conditions eg None under normal conditions of use

Comments

SELF-ASSESSMENT REPORT: PLC/ Page 10 of 14

Day Month Year NICNAS

5. INTRODUCTION AND USE INFORMATION

M AXIMUM I NTRODUCTION V OLUME OF N OTIFIED C HEMICAL (100%) O VER N EXT 5 Y EARS

Year

Tonnes

1 2 3 4

U SE AND M ODE OF I NTRODUCTION AND D ISPOSAL

Mode of Introduction

In what form, and in what containers will the polymer be imported/manufactured?

How is the imported/manufactured product transported?

5

Reformulation/manufacture processes

Does reformulation/manufacture occur in Australia, and if so, what procedures occur?

Following reformulation, in what form is the polymer, and in what containers?

Use

What is the function of the notified polymer?

What are the applications of the finished product, and which sectors will use the polymer or formulations?

Where there are multiple uses, what proportion of the total imported volume goes towards each use?

6. HUMAN HEALTH IMPLICATIONS

Exposure Assessment 6.1.

O CCUPATIONAL E XPOSURE Please use point form if possible.

P UBLIC E XPOSURE

6.2. Toxicological Hazard Characterisation

No toxicological data were submitted. The notified polymer meets the PLC criteria and can therefore be considered to be of low hazard.

OR

The notified polymer meets the PLC criteria and can therefore be considered to be of low hazard. This is supported by toxicological endpoints observed in testing conducted on the notified polymer or analogue chemical.

Endpoint

1. Rat, acute oral

2. Rat, acute dermal

3. Rat, acute inhalation

4. Rabbit, skin irritation

5. Rabbit, eye irritation

6. Skin sensitisation - adjuvant test/non-adjuvant test/LLNA.

[Delete as appropriate]

7. Rat, <route of exposure> repeat dose toxicity - … days.

8. Genotoxicity - bacterial reverse mutation

Result

LD50 … mg/kg bw

LD50 … mg/kg bw

LC50 … mg/L/4 hour irritating/non-irritating irritating/non-irritating evidence/ no evidence of sensitisation.

NOEL/NOAEL/

LOAEL mutagenic/non mutagenic

Classified? Effects

Observed? yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no

Test Guideline

(Choose one)

OECD TG 401

OECD TG 423

OECD TG 402

OECD TG 403

OECD TG 404

OECD TG 405

OECD TG 406

(Buehler and

Maximisation tests)

OECD TG 429

(LLNA)

OECD TG 407 – 409,

422, 410 – 411, 412 –

413

OECD TG 471 – 472

SELF-ASSESSMENT REPORT: PLC/ Page 11 of 14

Day Month Year NICNAS

9. Genotoxicity – in vitro <test type>

10. Genotoxicity – in vivo <test type>

11. Developmental and reproductive effects

12. Carcinogenicity

12. Other genotoxic/non genotoxic genotoxic/non genotoxic

NOEL/NOAEL/

LOAEL yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no yes/no

OECD TG 473, 476,

479 – 482

OECD TG 474, 475,

486

All results were indicative of low hazard.

OR briefly discuss any observed effects in a few sentences.

6.3. Human Health Risk Assessment

O CCUPATIONAL H EALTH AND

E NVIRONMENTAL F ATE

S AFETY

P UBLIC H EALTH

7. ENVIRONMENTAL IMPLICATIONS

7.1. Exposure Assessment

E NVIRONMENTAL R ELEASE

7.2. Environmental Hazard Characterisation

No ecotoxicological data were submitted. PLCs without significant ionic functionality are of low concern to the aquatic environment.

OR

The notified polymer meets the PLC criteria and can therefore be considered to be of low hazard. This is supported by environmental endpoints observed in testing conducted on the notified or analogue polymer.

Endpoint Result Effects Observed?

Fish Toxicity

Daphnia Toxicity

Algal Toxicity

Inhibition of Bacterial Respiration

Other

EC50 … mg/L

EC50 … mg/L

EC50 … mg/L

EC50 … mg/L yes/no yes/no yes/no yes/no yes/no

Test Guideline

(Choose one)

OECD TG 203

OECD TG 202

OECD TG 201

OECD TG 209

All results were indicative of low hazard.

OR briefly discuss any observed effects in a few sentences.

7.3.

8.1.

Environmental Risk Assessment

8. CONCLUSIONS

Level of Concern for Occupational Health and Safety

There is No Concern/Low Concern to occupational health and safety under the conditions of the occupational settings described.

SELF-ASSESSMENT REPORT: PLC/ Page 12 of 14

Day Month Year NICNAS

8.2. Level of Concern for Public Health

There is Negligible Concern/No Significant Concern to public health when used in the proposed manner.

8.3. Level of Concern for the Environment

The polymer is not considered to pose a risk to the environment based on its reported use pattern.

9. MATERIAL SAFETY DATA SHEET

9.1. Material Safety Data Sheet

The notifier has provided MSDS as part of the notification statement. The accuracy of the information on the MSDS remains the responsibility of the applicant.

10. RECOMMENDATIONS

C ONTROL M EASURES

Occupational Health and Safety

No specific engineering controls, work practices or personal protective equipment are required for the safe use of the notified polymer itself, however, these should be selected on the basis of all ingredients in the formulation.

Guidance in selection of personal protective equipment can be obtained from Australian,

Australian/New Zealand or other approved standards.

Service personnel should wear cotton or disposable gloves and ensure adequate ventilation is present when removing spent printer cartridges containing the notified polymer and during routine maintenance and repairs.

 Atmospheric monitoring should be conducted [by ……] to measure workplace concentrations of nuisance dust/decomposition products during (manufacture, formulation, use) of the notified polymer.

A copy of the SDS should be easily accessible to employees.

If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances , workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation.

Environment

 The following concentration limits should be implemented [by ……] for release of the notified polymer to the environment:

[List limits]

 The following control measures should be implemented by [by ……] to minimise environmental exposure during (manufacture, formulation, use) of the notified polymer:

[List control measures]

The following monitoring should be conducted [by ……] to measure environmental release during (manufacture, formulation, use) of the notified polymer:

[List methods of monitoring]

Disposal

The notified polymer should be disposed of by [method of disposal].

SELF-ASSESSMENT REPORT: PLC/ Page 13 of 14

Day Month Year NICNAS

Storage

 The following precautions should be taken [by ……] regarding storage of the notified polymer:

[List]

Emergency procedures

Spills/release of the notified polymer should be handled by [method of treatment].

Transport and Packaging

(if necessary)

10.1. Secondary Notification

This section for NICNAS use only.

SELF-ASSESSMENT REPORT: PLC/ Page 14 of 14

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