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

Table of Contents (TOC)

• List of Tables
• List of Figures
• Contact Information for the New Substances Program
• Comments and Inquiries
• NSN Reporting Forms and Guidelines
• Abstract
• How to Use these Guidelines

SECTION 1 - Introduction and Overview

• 1.1 Purpose of these Guidelines
• 1.2 The Canadian Environmental Protection Act, 1999
• 1.3 Overview of the New Substances Provisions under the Act
• 1.4 Who Is Required to Notify?
  • 1.4.1 Transfer of Notification Status - Interpretation of "Person"
  • 1.4.2 Canadian Agent - Subsection 14(3) of the Regulations
  • 1.4.3 Toll Manufacturer
• 1.5 When to Submit an NSN Package to the NS Program
  • 1.5.1 New Substances Notification Assessment Periods
  • 1.5.2 New Substances Notification Fees
  • 1.5.3 Substances Not Subject to the Notification Fees
• 1.6 Enforcement

SECTION 2 - The Inventories

• 2.1 Role of the Domestic Substances List (DSL)
  • 2.1.1 The DSL - Definition of a "New" Substance
  • 2.1.2 Confidential Portion of the DSL
    • 2.1.2.1 Justification for Masking a Substance that is Listed on a Public Inventory
  • 2.1.3 Amendments to the DSL
  • 2.1.4 DSL Flags
    • 2.1.4.1 Regulatory Flags
    • 2.1.4.2 Administrative Flags
• 2.2 Role of the Non-domestic Substances List (NDSL)
  • 2.2.1 The NDSL
  • 2.2.2 Confidential Portion of the NDSL
  • 2.2.3 Amendments to the NDSL
    • 2.2.3.1 Updates Based on the USEPA TSCA Inventory
    • 2.2.3.2 Nominating a Substance to the NDSL or the Confidential Portion of the NDSL
    • 2.2.3.3 Applications Under the Four Corners Arrangement (4CA)
  • 2.2.4 NDSL Flag
    • 2.2.4.1 Administrative Flags
• 2.3 Determining the Presence of Substances on Inventories
  • 2.3.1 Notice of Bona Fide Intent to Manufacture or Import
  • 2.3.2 Copies of the DSL and NDSL

• 3.1 Definition of "Substance"
• 3.2 Exclusions from the Regulations
  • 3.2.1 Mixtures (Section 3 of the Act)
  • 3.2.2 Manufactured Items (Section 3 of the Act)
  • 3.2.3 Wastes (Section 3 of the Act)
  • 3.2.4 Substances Carried through Canada (Subsection 3(2) of the Regulations)
  • 3.2.5 Polymers Subject to the "Two Percent Rule"
  • 3.2.6 Proteins Subject to the "Two Percent Rule"
• 3.3 Substances Not Subject to the Regulations
  • 3.3.1 Other Acts of Parliament
  • 3.3.2 Transient Reaction Intermediates
  • 3.3.3 Impurities
  • 3.3.4 Incidental Reaction Products
  • 3.3.5 Low-Volume Exemptions
  • 3.3.6 Substances Occurring in Nature
• 3.4 Substances Subject to the Regulations
  • 3.4.1 Classification of Substances
    • 3.4.1.1 Chemicals and Biochemicals
    • 3.4.1.2 Polymers and Biopolymers
    • 3.4.1.3 Reduced Regulatory Requirement (RRR) Polymers
    • 3.4.1.4 Non-reduced Regulatory Requirement (non-RRR) Polymers
    • 3.4.1.5 Polymers Described in Schedule 7 of the Regulations
• 3.5 Special Category Substances
  • 3.5.1 Research and Development Substances
  • 3.5.2 Contained Site-Limited Intermediate Substances
  • 3.5.3 Contained Export-Only Substances

• 4.1 How to Identify the Required Notification Information
  • 4.1.1 Annual Quantities
• 4.2 Notification of Special Category Substances
  • 4.2.1 Lower-Volume Special Category Notifications for Chemicals
    • 4.2.1.1 Lower-Volume Research and Development Biochemicals
    • 4.2.1.2 Lower-Volume Contained Site-Limited Intermediate Biochemicals
    • 4.2.1.3 Lower-Volume Contained Export-Only Biochemicals
  • 4.2.2 Higher-Volume Special Category Notifications for Chemicals
  • 4.2.3 Higher-Volume Special Category Notifications for Polymers
    • 4.2.3.1 Higher-Volume Research and Development Biopolymers
    • 4.2.3.2 Higher-Volume Contained Site-Limited Intermediate Biopolymers
    • 4.2.3.3 Higher-Volume Contained Export-Only Biopolymers
• 4.3 Notification of Chemicals
• 4.4 Information Requirements for Chemicals Listed on the NDSL
  • 4.4.1 Lower-Volume Chemicals
  • 4.4.2 Higher-Volume Chemicals
  • 4.4.3 NDSL Chemicals with High Release and/or Significant Exposure
    • 4.4.3.1 Chemicals Released to the Aquatic Environment
    • 4.4.3.2 Where the Public May Be Significantly Exposed to the Chemical in a Product
• 4.5 Information Requirements for Chemicals Not on the NDSL
  • 4.5.1 Lower-Volume Chemicals
  • 4.5.2 Higher-Volume Chemicals
• 4.6 Information Requirements for Chemicals that are Subsequently Added to the NDSL
• 4.7 Notification of Polymers
  • 4.7.1 Monomers and Reactants Listed on the DSL or the NDSL
• 4.8 Information Requirements for Polymers
  • 4.8.1 Lower-Volume Polymers
• 4.9 Information Requirements for Non-reduced Regulatory Requirement (non-RRR) Polymers
  • 4.9.1 Higher-Volume Non-RRR Polymers Either Listed on the NDSL or Manufactured from Reactants Listed on the DSL or NDSL
  • 4.9.2 Polymers with High Release and/or Significant Exposure
    • 4.9.2.1 Polymers Released to the Aquatic Environment
    • 4.9.2.2 Where the Public May Be Significantly Exposed to the Polymer in a Product
  • 4.9.3 Higher-Volume Non-RRR Polymers Not on the NDSL and Not Manufactured Solely from Reactants Listed on the DSL or NDSL

SECTION 5 - New Substances Notification (NSN) Packages

• 5.1 Matched Notifications
• 5.2 Foreign Supplier Submissions
• 5.3 Consolidated Notifications
• 5.4 Test Data
• 5.5 Record-Keeping Requirements

SECTION 6 - The New Substances Notification (NSN) Reporting Form

• 6.1 Data Codes, Attachments and Confidential Information
  • 6.1.1 Submit with Schedule
  • 6.1.2 Data Codes
  • 6.1.3 Value and Conditions
  • 6.1.4 Attachment Number
  • 6.1.5 Confidential Information
  6.2 Part A: Administrative and Substance Identity Information Requirements
  • 6.2.1 Administrative Information
    • 6.2.1.1 A.1 Certification Statement
    • 6.2.1.2 A.2 Corporate Headquarters of the Canadian Manufacturer or Importer
    • 6.2.1.3 A.3 Corporate Headquarters of the Non-resident Importer
    • 6.2.1.4 A.4 Canadian Agent
    • 6.2.1.5 A.5 Foreign Supplier
    • 6.2.1.6 A.6 Proposed Site of Manufacture in Canada / Proposed Port of Entry into Canada / Toll Manufacturer Information
    • 6.2.1.7 A.7 Technical Contact
    • 6.2.1.8 A.8 Previous NSN Reference Number / PNC Reference Number
    • 6.2.1.9 A.9 Fee Provided (if applicable)
    • 6.2.1.10 A.10 Manufacture / Import
    • 6.2.1.11 A.11 Amount
    • 6.2.1.12 A.12 Date that the Amount in Block A.11 is Expected to Be Exceeded
    • 6.2.1.13 A.13 Substance Information
    • 6.2.1.14 A.14 Schedule Number
    • 6.2.1.15 A.15 Anticipated, Historical and Other Likely Uses of the Substance
    • 6.2.1.16 A.16 Anticipated Annual Quantity to Be Manufactured or Imported
    • 6.2.1.17 A.17 Confidentiality Requests
    • 6.2.1.18 A.18 Information-Sharing Agreement Authorization
  • 6.2.2 Substance Identity Information
    • 6.2.2.1 A.19 (CAS) Registry Number and/or Enzyme Commission Number
    • 6.2.2.2 A.20 Chemical Name of the Substance
    • 6.2.2.3 A.21 Proposed Masked Name
    • 6.2.2.4 A.22 Known Trade Names or Synonyms of the Chemical Name of the Substance
    • 6.2.2.5 A.23 Structural Formula of the Substance
    • 6.2.2.6 A.24 Molecular Formula
    • 6.2.2.7 A.25 Gram Molecular Weight
    • 6.2.2.8 A.26 Monomers and Reactants with their Concentration
    • 6.2.2.9 A.27 Additives, Stabilizers and Solvents with their Concentration
    • 6.2.2.10 A.28 Impurities with their Concentration
    • 6.2.2.11 A.29 Degree of Purity in its Technical Grade Composition
    • 6.2.2.12 A.30 Material Safety Data Sheet (MSDS)
  6.3 Part B: Technical Information Requirements
  • 6.3.1 B.1 Physical-Chemical Information Requirements
    • 6.3.1.1 Melting Point
    • 6.3.1.2 Boiling Point
    • 6.3.1.3 Density
    • 6.3.1.4 Vapour Pressure
    • 6.3.1.5 Water Solubility
    • 6.3.1.6 Octanol - Water Partition Coefficient
    • 6.3.1.7 Ready Biodegradation
    • 6.3.1.8 Spectroscopy
    • 6.3.1.9 Adsorption-Desorption
    • 6.3.1.10 Hydrolysis as a Function of pH
    • 6.3.1.11 Physical State
    • 6.3.1.12 Formulated for Dispersal in Water
    • 6.3.1.13 Water Extractability
    • 6.3.1.14 Number Average Molecular Weight (M_n)
    • 6.3.1.15 Residual Constituents with Molecular Weights Less than 500 Daltons and Less than 1000 Daltons
  • 6.3.2 B.2 Ecotoxicity Information Requirements
    • 6.3.2.1 Acute Fish, Daphnia and Algal Toxicity
    • 6.3.2.2 Acute Algal Toxicity
  • 6.3.3 B.3 Health Toxicity Information Requirements
    • 6.3.3.1 Acute Mammalian Toxicity
    • 6.3.3.2 Information Sufficient to Assess Skin Irritation
    • 6.3.3.3 Skin Sensitization
    • 6.3.3.4 Repeated-Dose Mammalian Toxicity
  • 6.3.4 B.4 Genotoxicity Information Requirements
    • 6.3.4.1 In Vitro Test for Gene Mutations
    • 6.3.4.2 In Vitro Mammalian Test for Chromosomal Aberrations
    • 6.3.4.3 In Vivo Mammalian Test for Chromosomal Aberrations or Gene Mutations
  • 6.3.5 Regulatory Exemptions: Health Toxicity Tests Not Required for Certain Polymers
  • 6.3.6 Waivers for Health Hazard Toxicity Data for Polymers
  6.4 Part C: Biochemical or Biopolymer Information Requirements
  • 6.4.1 Identification, Source and History
  • 6.4.2 Adverse Environmental or Human Health Effects
  • 6.4.3 Concentration of the Viable Production Organism
  • 6.4.4 Method Used to Separate the Production Organism
  • 6.4.5 Identification of Encoded Products
  • 6.4.6 Description of Biological Activity
  • 6.4.7 Catalytic Functions
  • 6.4.8 Enzyme Commission Number
  • 6.4.9 Substrate Specificity
  • 6.4.10 Optimum pH and Temperature
  • 6.4.11 Catalytic Constants K_M and K_cat
  • 6.4.12 Cofactors
  • 6.4.13 Enzymatic Activity
  6.5 Part D: Additional Information Requirements
  • 6.5.1 D.1 Other Requirements
    • 6.5.1.1 Other Agencies Notified, the Agency's File Number and the Outcome
    • 6.5.1.2 Other Information and Test Data in the Possession of the Manufacturer or Importer
  • 6.5.2 D.2 Additional Information and Attachments
    • 6.5.2.1 Other Technical Information
  6.6 NSN Reporting Form - Appendix I - Manufacture, Import, Use, Exposure and Release Information (Known and Anticipated)
  • 6.6.1 Part A - Manufacture and/or Importation Information Requirements
    • 6.6.1.1 A1. Canadian Manufacture and Processing Information
    • 6.6.1.2 A2. Anticipated Annual Production / Import Quantities of Notified Substance
  • 6.6.2 Part B - Uses of the Substance
    • 6.6.2.1 B1. Anticipated, Historical and Other Likely Uses of the Substance
    • 6.6.2.2 B2. Concentration in Products
    • 6.6.2.3 B3. Anticipated to be Used in Products Intended for Use by or for Children
  • 6.6.3 Part C - Human Exposure Information Requirements
    • 6.6.3.1 C1. Whether the Public Is Anticipated to Be Significantly Exposed to the Substance
    • 6.6.3.2 C2. Anticipated Degree of Direct Human Exposure
  • 6.6.4 Part D - Environmental Exposure Information
    • 6.6.4.1 D1. Components of the Environment into which Release Is Anticipated
    • 6.6.4.2 D2. Anticipated Releases of the Substance into Municipal Wastewater Systems
    • 6.6.4.3 D3. Factors that May Limit Environmental Exposure
    • 6.6.4.4 D4. Releases of the Substance to the Aquatic Environment
  • 6.6.5 Part E - Transportation, Storage and Disposal Information Requirements
    • 6.6.5.1 E1. Transport and Storage Containers
    • 6.6.5.2 E2. Anticipated Disposal of the Substance
  6.7 NSN Reporting Form - Appendix II - New Substances Fee Payment Form with Credit Card Authorization

SECTION 7 - Confidential Information

• 7.1 Claiming Confidentiality
• 7.2 Information Supplemental to a Confidentiality Claim
  • 7.2.1 General Confidentiality Claims
  • 7.2.2 Confidential Substance Identity Claims
    • 7.2.2.1 Masking Substance Identity
• 7.3 Determining Presence of Confidential Substances on Lists

SECTION 8 - Recommended Test Protocols and Alternative Approaches

• 8.1 Test Protocols
  • 8.1.1 Organisation for Economic Co-operation and Development (OECD) Test Guidelines (TG)
• 8.2 Accepted Test Methods
• 8.3 Good Laboratory Practice (GLP)
  • 8.3.1 Accreditation of Laboratories
• 8.4 Alternative Approaches
  • 8.4.1 Alternative Test Protocols
  • 8.4.2 Reduction, Refinement and Replacement
  • 8.4.3 Structure-Activity Relationships (SARs)
    • 8.4.3.1 Qualitative Structure-Activity Relationships
    • 8.4.3.2 Acceptance of Surrogate Data
    • 8.4.3.3 Examples of Surrogate Data
    • 8.4.3.4 Quantitative Structure-Activity Relationship (QSAR) Estimates
    • 8.4.3.5 Other Calculation Methods
• 8.5 Test Data on UVCBs and Impure Substances
• 8.6 Sources of Test Methods
  • 8.6.1 Organisation for Economic Co-operation and Development (OECD)
  • 8.6.2 Environment Canada Biological Test Methods
  • 8.6.3 U.S. Environmental Protection Agency
• 8.7 Waiver Requests for Information Requirements
  • 8.7.1 Introduction
    • 8.7.1.1 Waivers Requested under Paragraph 81(8)(a) of the Act
    • 8.7.1.2 Waivers Requested under Paragraph 81(8)(b) of the Act
    • 8.7.1.3 Waivers Requested under Paragraph 81(8)(c) of the Act
  • 8.7.2 Class Considerations of Waivers
    • 8.7.2.1 Cationic Class Waivers
• 8.8 Pre-notification Consultation (PNC)

SECTION 9 - Processing a New Substances Notification (NSN)

• 9.1 Overview of the New Substances Nofification (NSN) Assessment Process
• 9.2 Receipt of a New Substances Notification (NSN) Package
  • 9.2.1 Assessment Period
  • 9.2.2 Mail Log Number
  • 9.2.3 NSN Reference Number
• 9.3 Correspondence
  • 9.3.1 Notice of Initiation
  • 9.3.2 Notice of Acknowledgement of Complete Package
  • 9.3.3 Notice of Missing Information
  • 9.3.4 Notice of Rejection
  • 9.3.5 Notice of Early Termination of Assessment Period
  • 9.3.6 Final Assessment Outcome Letter
  • 9.3.7 Notice of Extension of Assessment Period
  • 9.3.8 Withdrawing an NSN Package
• 9.4 Assessment of the NSN Package
  • 9.4.1 Information Review
  • 9.4.2 Determination of Toxicity
• 9.5 Assessment Conclusions
  • 9.5.1 No Suspicion of Toxicity and No Action Taken
  • 9.5.2 Significant New Activity (SNAc) Notices
  • 9.5.3 Risk Management Measures
    • 9.5.3.1 Conditions under Paragraph 84(1)(a) of the Act
    • 9.5.3.2 Prohibitions under Paragraph 84(1)(b) of the Act
    • 9.5.3.3 Request for Additional Information under Paragraph 84(1)(c) of the Act

SECTION 10 - Post-Notification Responsibilities

• 10.1 Notifier's Responsibilities
  • 10.1.1 Correction of Information
  • 10.1.2 Section 70 of the Act
  • 10.1.3 Notice of Excess Quantity (NOEQ)
    • 10.1.3.1 Trigger Quantities
  • 10.1.4 Notice of Manufacture or Import (NOMI)
  • 10.1.5 Content and Submission of the Notices
• 10.2 The NS Program's Responsibilities
  • 10.2.1 Additions to the DSL
• APPENDIX 1: Flowcharts
• APPENDIX 2: NSN Reporting Form
• APPENDIX 3: Guide to Paying Fees Associated With The Regulations
• APPENDIX 4: Schedules under the Regulations
• APPENDIX 5: Naming Substances
• APPENDIX 6: Locating Chemical Abstracts Service (CAS) Registry Numbers
• APPENDIX 7: Masking of Substance Names
• APPENDIX 8: Examples of Waiver Conditions
• APPENDIX 9: International Arrangements
• APPENDIX 10: Glossary and Acronyms
• APPENDIX 11: Environment Canada Regional Offices
• Library and Archives Canada Cataloguing in Publication