Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

Government
of Canada

Gouvernement
du Canada

Environment
Canada

Environnement
Canada

Health
Canada

Santé
Canada

This form is to be used for fulfilling the information requirements prescribed in the New Substances Notification Regulations (Chemicals and Polymers) of the Canadian Environmental Protection Act, 1999.

The New Substances Notification (NSN) package must be submitted to:

Mailing Address:

Director, New Substances Division
Department of the Environment
Ottawa ON K1A 0H3

Courier Deliveries:

Director, New Substances Division
Department of the Environment
14th Floor, Place Vincent Massey
351 St. Joseph Blvd.
Gatineau QC J8Y 3Y5

Department Use Only

NSN Reference No.

Date Received:

Total number of pages:

INSTRUCTIONS FOR COMPLETING THE NOTIFICATION FORM

The New Substances Notification (NSN) Reporting Form serves as an aid for complying with the New Substances Notification Regulations (Chemicals and Polymers) (NSNR) of the Canadian Environmental Protection Act, 1999. Notifiers may reproduce this form, or portions thereof, for notification purposes. The form is also available electronically from the New Substances Web site (http://www.ec.gc.ca/substances).

Additional explanations necessary for fulfilling prescribed information requirements and completing this notification form are included in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (Guidelines). Hard copies of the Guidelines may be obtained, for a fee, from Environment Canada by contacting the Environmental Protection Publications at (800) 734-3232 or for callers outside Canada, (819) 953-5750 or by e-mail at epspubs@ec.gc.ca. The Guidelines are also available electronically on the New Substances (NS) program website (http://www.ec.gc.ca/substances).

This form is divided into four sections: Part A to D. Part A is used for administrative and substance identity information while Part B and Part C are for technical information. Part D is used for any additional information that may be provided with the notification.

Before completing Part B or Part C of the form, you should ensure that you are providing information appropriate for the quantity and category of substance you intend to manufacture or import (refer to Section 3.4 of the Guidelines). Part B contains four sections: (1) Physical and Chemical Information requirements; (2) Ecotoxicity Information requirements; (3) Health Toxicity Information requirements; and (4) Genotoxicity Information requirements. Part C contains one section: Biochemical or Biopolymer Information Requirements. Part B contains five columns and Part C contains four columns of which consist of: Submit with Schedule; Data Codes; Value & Conditions; Attachment Number; and Confidential Information. Explanations of the use of these columns are provided on page 2 of this form. Part D contains two sections: (1) Other Requirements; and (2) Additional Information and Attachments.

Also included are two appendices. Appendix I is for Manufacture, Import, Use, Exposure and Release Information (Known and Anticipated) and Appendix II is the New Substances Fee Payment Form.

Ce formulaire est disponible en français, sur demande, en communiquant avec La ligne d'information des déclarations de substances nouvelles au 1-800-567-1999 (sans frais au Canada) ou au (819) 953-7156 (de l'étranger). Le formulaire est aussi disponible en ligne au http://www.ec.gc.ca/substances.

Data Codes, Attachments and Confidential Information

In addition to the list of information requirements, Part B contains five columns and Part C contains four columns of which consist of: Submit with Schedule; Data Codes; Value & Conditions; Attachment Number; and Confidential Information. The following explains the use for each of these columns.

Submit with Schedule: This is a quick reference column that allows you to determine, at a glance, which Schedule requires the information to be provided. Take note of the footnotes for certain exceptions and conditions associated with certain data elements. It is important to note that if lower Schedule notifications are not submitted, the information prescribed in them is still required to be submitted with the higher Schedule notification.

Data Codes: A Data Code is a reference to indicate: whether data are provided; the type of data being submitted; or whether a request for waiver of information is being submitted. The Data Codes with explanatory notes are:

D = test data on notified substance
This code is used when the data provided were generated on the notified substance using protocols consistent with these listed in Tables 8-1 to 8-4 of the Guidelines. This code is to be used even if the information is provided under the Additional Information requirements of the Schedules (refer to section 6.5 of the Guidelines).

A = alternative procedures
This code is used when the data provided were generated using: (1) an alternative test protocol; (2) structure-activity relationships (SARs) including surrogate data and quantitative structure-activity relationships (QSARs); or (3) other calculation methods (refer to section 8.4.3 of the Guidelines). This code is to be used even if the information is provided under the Additional Information requirements of the Schedules (refer to section 6.5 of the Guidelines).

W = waiver requested
This code is used when the data required is being requested to be waived. Requests for a waiver of prescribed information must be accompanied by justifications that satisfy any of the waiver criteria listed in subsection 81(8) of the Act (refer to section 8.7 of the Guidelines).

N/A = not applicable
This code is used if the NSNR specify that the provision of information is not required under certain conditions. For example, the adsorption-desorption screening test data is not required when water solubility is less than 200 µg/L. This code cannot be used as an abbreviation for "not available".

NR = not required
This code is used when the information has not been provided and is not required for that specific Schedule of the NSNR.

P = previous New Substances Notification (NSN) reference number / Pre-notification Consultation (PNC) reference number or notice under section 70 of the Act
This code is to be used when the notifier has already provided the information to the NS program in a previous NSN package, a previous PNC request and/or a notice under section 70 of the Act. The applicable NSN, PNC or notice under section 70 reference number must be entered in the Attachment column.

Value and Conditions: Although complete physical-chemical data must be submitted in test reports (physical state and whether the notified substance is formulated for dispersal in water excepted) the notifer must enter the value and conditions in the appropriate space provided. This information will assist the notifier in organizing data for use; in requesting waivers of information; in justifying cases when data are not applicable; and in discussing notifications with NS program officials. Physical-chemical values and corresponding conditions may be expressed in units cited within the laboratory report. In the event that the data are only available in degrees Fahrenheit, the notifier must strike out the °C symbol printed in the entry and replace it with the °F symbol.

Attachment Number: Notifiers must clearly indicate a reference for accompanying documents (e.g., Attachment 6) so they may be readily located within the NSN package. Attachments include: justifications for waivers of information; reports of experimental procedures; reports of test results; rationale for alternative data; results and validation of modeling studies; rationale for why information is considered "not applicable"; and information supplemental to a request for confidentiality.

Confidential Information: Notifiers must check the appropriate box to indicate that the information provided is considered confidential (i.e., check "Y" to indicate that the information is considered confidential or check "N" to indicate that the information is not confidential). If the information provided is considered confidential, the notifier must provide, in the NSN package, the supplementary information detailed in section 7.2 of the Guidelines.

A.1. Certification Statement:

I hereby certify to the best of my information, knowledge and belief that all information provided in this form, as well as any attachments to the form, is accurate and complete; and the information for which confidentiality is claimed, meets the criteria for determining confidentiality as outlined in section 7 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers).

Name and Title of the Person authorized to act on behalf of the corporation of block A.2 or A.3

Name and Title of the Person in Canada authorized to act on behalf of the corporation of block A.4

Preferred Language of Correspondence:

English   French

Preferred Mode of Communication for Correspondence:

Mail   Facsimile (non secure)

A.2. Corporate Headquarters of the Canadian Manufacturer or Importer (Principal Place of Business in Canada):

(if the importer is not located in Canada, skip to block A.3)

Company Name:

E-Mail:

Street:

City:

Province:

Postal Code:

Telephone No:

Facsimile No:

A.3. Corporate Headquarters of the Non-resident Importer

(if applicable, also complete block A.4):

Company Name:

E-Mail:

Street:

City:

State / Country:

Zip / Postal Code:

Telephone No:

Facsimile No:

A.4. Canadian Agent

(only needed if block A.3 is applicable):

Company Name:

E-Mail:

Street:

City:

Province:

Postal Code:

Telephone No:

Facsimile No:

A.5. Foreign Supplier

(only needed if the technical information in Part B is provided by a third party):

Company Name:

E-Mail:

Street:

City:

State / Country:

Zip / Postal Code:

Telephone No:

Facsimile No:

A.6. Proposed Site of Manufacture in Canada / Proposed Port of Entry into Canada / Toll Manufacturer Information :

Company Name/Port of Entry:

Toll Manufacturer Contact Name:

Street:

City:

Province:

Postal Code:

Telephone No:

Facsimile No:

Toll Manufacturer E-Mail:

Toll Manufacturer Statement of Responsibilities:
Enclosed
Attachment Number:

A.7. Technical Contact

(Name of a person who can assist in the resolution of issues pertaining to the information provided):

Person's Name/Title:

E-Mail:

Street:

City:

Province / State Country:

Zip / Postal Code:

Telephone No:

Facsimile No:

A.8 Previous NSN Reference Number / PNC Reference Number:

A.9 Fee Provided (if applicable): $

(Please complete Appendix II - New Substances Fee Payment Form)

A.10 Manufacture/Import:

Manufacture Import Manufacture and Import

A.11 Amount (Indicate the quantity that triggered this notification):

A.12 Date that the Amount in Block A.11 is Expected to be Exceeded:

A.13 Substance Information: (check all that apply)

Present on the NDSL or Confidential NDSL

NDSL Accession Number:

Solely for F&DA¹ use

Chemical   Polymer   All reactants specified on the DSL or NDSL

Biochemical   Biopolymer   Meets the RRR polymer criteria

Special Category:

Research & Development   Contained Export Only
Contained Site Limited Intermediate

A.14 Schedule Number:

Special Category: 1 2 3

Chemical / Biochemical: 2 4 5 6

Polymer / Biopolymer: 2 9 10 11

A.15 Anticipated, Historical and Other Likely Uses of the Substance:

A.16 Anticipated Annual Quantity to be Manufactured and/or Imported:

A.17 Confidentiality Requests:

Corporation Y    N

Manufacture Y    N

Import Y    N

Amount Y    N

Substance Identity Y    N

A.18 Information Sharing Agreement Authorization:

I hereby grant the Minister of the Environment permission to release the name, address and phone number of the technical contact indicated in block A.7 of this form to any person who has provided the Minister of the Environment with: (1) documentation of intent to manufacture or import the substance described in block A.20 of this form; and, (2) a statement granting the Minister of the Environment permission to release the name, address and phone number of their technical contact.

A.19 CAS Registry Number and/or Enzyme Commission Number:

A.20 Chemical Name of the Substance:

Nomenclature: IUPAC   CAS   IUBMB

A.21 Proposed Masked Name

(If the Chemical Name of the Substance is Claimed Confidential):

Multiple Masking: Justification Enclosed

Attachment Number:

A.22 Known Trade Name or Synonyms of the Chemical Name of the Substance:

A.23 Structural Formula of the Substance:

RRR Polymer: Reaction Scheme Enclosed

Attachment Number:

A.24 Molecular Formula:

A.25 Gram Molecular Weight:

A.26 Monomers and Reactants with their Concentration:

Substance Name

CAS Registry Number

% by weight

______________________
100 %

A.27 Additives, Stabilizers and Solvents with their Concentration:

Substance Name

CAS Registry Number

% by weight

A.28 Impurities with their Concentration:

Substance Name

CAS Registry Number

% by weight

A.29 Degree of Purity in its Technical Grade Composition:

A.30 Material Safety Data Sheet (MSDS):

Enclosed

Attachment Number:

Melting Point

5,6

°C

Y   N

Boiling Point

5,6

°C

Y   N

Density

5,6

g/cm @ °C

Y   N

Vapour Pressure

5,6

@ °C

Y   N

Water Solubility

5,6

g/L @ °C

Y   N

Octanol/Water Partition Coefficient

5,6,10,11

Y   N

Ready Biodegradation

5,6,11

Y   N

Spectroscopy

6

Y   N

Adsorption-Desorption²

6

Y   N

Hydrolysis as a Function of pH²

6, 10, 11

Y   N

Physical State

3, 10, 11

Y   N

Formulated for Dispersal in Water

3, 10, 11

Y N

Y   N

Water Extractability

10, 11

%

Y   N

Number average Molecular Weight (M_n)

3, 9, 10, 11

Y   N

Weight Percent < 1 000 Daltons

3^a, 9, 10, 11

Y   N

Weight Percent < 500 Daltons

3^a, 9, 10, 11

Y   N

Acute Toxicity

Fish   Daphnia   Algal

6, 10

Y   N

Other Acute Toxicity (check two that apply)

Fish   Daphnia   Algal

6, 11

Y   N

Acute Mammalian Toxicity

Oral   Dermal   Inhalation

5, 10, 11

Y   N

Other Acute Mammalian Toxicity

Oral   Dermal   Inhalation

6

Y   N

Information Sufficient to Assess Skin Irritation

6, 11

Y   N

Skin Sensitization

6, 11

Y   N

Repeated Dose Mammalian Toxicity⁴

Oral   Dermal   Inhalation

6, 11

Y   N

In Vitro Test for Gene Mutations⁴

5, 6, 11

Y   N

In Vitro Mammalian Test for Chromosomal Aberrations⁴

6, 11

Y   N

In Vivo Mammalian Test for Chromosomal Aberration OR Gene Mutations⁴

6, 11

Y   N

Identification

Y   N

Source and History

1, 3, 4, 5, 6, 9, 10, 11

Y   N

Adverse Environmental or Human Health Effects

1, 3, 4, 5, 6, 9, 10, 11

Y   N

Concentration of the Viable Production Organism

1^b, 3^b, 4, 5, 6, 9, 10, 11

Y   N

Methods Used to Separate the Production Organism

1^c, 3^c, 5, 6, 10, 11

Y   N

Identification of Encoded Products⁵

1^d, 3^d, 5, 6, 10, 11

Y   N

Description of Biological Activity⁵

1^d, 3^d, 5, 6, 10, 11

Y   N

Catalytic Functions⁶

1^d, 5, 6

Y   N

Substrate Specificity⁶

1^d, 5, 6

Y   N

Optimum pH and Temperature⁶

1^d, 5, 6

Y   N

Catalytic Constants KM and Kcat⁶

1^d, 5, 6

Y   N

Cofactors⁶

1^d, 5, 6

Y   N

Enzymatic Activity⁶

1^d, 5, 6

Y   N

Other agencies notified, the agency's file number and the outcome

1, 3, 4, 5, 6, 9, 10, 11

Other information and test data in the possession of the manufacturer or importer

1, 3, 4, 5, 6, 9, 10, 11