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

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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

1.1 Purpose of these Guidelines

These Guidelines provide assistance for complying with the New Substances Notification Regulations (Chemicals and Polymers) (the Regulations). They explain the information that a “person"¹ manufacturing or importing a new substance into Canada (the notifier) must provide to the Minister of the Environment (the NS program) under subsection 81(1) of the Canadian Environmental Protection Act, 1999 (the Act) before manufacturing or importing a chemical/biochemical² or polymer/biopolymer³ that is not on the Domestic Substances List (DSL)⁴. This information is required so that the NS program may determine whether the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Act. These Guidelines also discuss the obligations of the Minister of the Environment and the Minister of Health respecting assessment periods and those of the Minister of the Environment to add a chemical or polymer to the DSL under section 87 of the Act.

Please note that these Guidelines do not address the New Substances Notification Regulations (Organisms). Information pertaining to these can be found in the Guidelines for the Notification and Testing of New Substances: Organisms.

The New Substances (NS) program consists of officials from both Environment Canada and Health Canada. Each department conducts an assessment of the information provided to the Minister of the Environment in the New Substances Notification (NSN) package.

1.2 The Canadian Environmental Protection Act, 1999

The Act is a statute about sustainable development and pollution prevention. These purposes are achieved or furthered through many mechanisms, among them the new substances notification regime, a regime requiring that the Ministers of the Environment and of Health must assess substances that are not on the DSL in order to determine whether they should be subject to risk management measures. The assessment is based on the criteria set out in section 64 of the Act.

1.3 Overview of the New Substances Provisions under the Act

Notification is required if the substance proposed for manufacture or import is subject to sections 80-89 of the Act. Substances that require notification are:

1. substances new to Canada (e.g., those not on the DSL);
2. substances undertaking a significant new activity that are listed on the DSL with an "S" or " S' " flag (see section 2.1.4 of these Guidelines);
3. polymers being manufactured or imported that do not meet the conditions of a Reduced Regulatory Requirement (RRR) polymer (see section 3.4.1.3 of these Guidelines) that are listed on the DSL with a "P" flag (see section 2.1.4.1 of these Guidelines); and
4. substances regulated under any other Act of Parliament or regulations not listed on Schedule 2 to the Act (e.g., substances regulated under the Food and Drugs Act (F&DA)) and for which a) applies.

The Act features a number of provisions, including criteria for identifying substances requiring notification; notification obligations for manufacturers and importers; a detailed assessment mechanism; and enabling authorities for the implementation of risk management measures.

In the Act, the approach to the management of new substances is both proactive and preventative, employing a pre-manufacture or pre-import notification and assessment process. When this process identifies a new substance that may pose a risk to human health or the environment, the Act empowers the Government to intervene prior to or during the earliest stages of its introduction to Canada. This ability to act early makes the NS program a unique and essential component of the federal management of toxic substances.

The Regulations specify the information that must be provided to meet the notification obligations. The main regulatory features of the NS program are:

• establishment of categories of substances;
• identification of administrative and other information requirements;
• specification of conditions, test procedures and laboratory practices to be followed when developing test data;
• timing of notification before manufacture or import or a significant new activity that is defined in a Significant New Activity (SNAc) Notice; and
• requirements for the NS program to assess information within a set time.

To meet the need for evaluating different categories of substances, information requirements are determined by separating substances into categories and notification groups. Substances are first generically categorized by substance type (e.g., chemicals and polymers), and then each substance type is further separated into notification groups based on factors such as volume of manufacture or import or proposed use (e.g., research and development). This system of notification groups allows the NS program to match information requirements with anticipated concerns about quantities and characteristics of specific groups of substances.

The assessment process begins when the NS program receives an NSN package for a new substance proposed to be manufactured or imported. NSN packages must contain all required administrative and technical information prescribed in the Regulations, including the appropriate fee (if applicable), and must be provided to the NS program prior to the number of calendar days prescribed for the assessment of the notified Schedule and in advance of the prescribed trigger quantity for the same Schedule being exceeded.

Significant New Activity Notifications (SNANs) must contain all prescribed information specified in the SNAc Notice and must be provided within the prescribed time and prior to undertaking a significant new activity.

Environmental and human health assessments are conducted on the information provided and any other information that is available to the NS program to determine whether the substance is suspected of being toxic or capable of being toxic (see section 9.4.2 of these Guidelines). This assessment is required to be completed within the prescribed assessment period and may result in any of the following:

1. a determination that the substance is not suspected of being toxic or capable of becoming toxic;
2. a suspicion that the substance is toxic or capable of becoming toxic, which may require:
   1. the establishment of controls on the manufacture import, use or disposal of the substance;
   2. prohibition of manufacture and import of the substance; or
   3. prohibition pending submission and assessment of additional information determined to be required by the NS program; or
3. a suspicion that a significant new activity in relation to the substance may result in the substance becoming toxic. In such instances, a SNAc Notice will be issued for the substance.

1.4 Who Is Required to Notify?

Under the Regulations and Section 81 of the Act, any "person" manufacturing a new substance in or importing a new substance into Canada (notifier) must provide an NSN package to the NS program. This NSN package must contain all information specified in the Regulations.

1.4.1 Transfer of Notification Status - Interpretation of "Person"

Subsection 81(5) of the Act provides a rule of succession in the case of the transfer of certain rights in respect to substances subject to section 81 of the Act.

Successors to which subsection 81(5) applies are requested to sign a Certification Form prior to change of ownership if they wish to take advantage of the current notification status of a substance. This form indicates the transfer of rights or privileges, in relation to information provided for the substance, from the original notifier to the successor. The transfer of rights or privileges includes the responsibility of any risk management actions taken or SNAc Notices issued on the substance. This form can be obtained by contacting the NSN Information Line. The Certification Form must be signed by an officer of the successor and must be completed for each NSN package to which the change of ownership applies.

This provision reduces duplication of work for industry as well as the NS program, since it allows successors to continue manufacturing or importing a new substance without having to "renotify" and wait for the assessment period to expire. (www.ec.gc.ca/substances/nsb/eng/cp_advisory_e.shtml).

1.4.2 Canadian Agent - Subsection 14(3) of the Regulations

If the notifier providing the NSN package is not a Canadian resident they must identify, under paragraph 14(1)(b) of the Regulations a Canadian resident who is authorized to act on their behalf as the “Canadian Agent”. All notices and correspondence from the NS program will be sent to the "Canadian Agent" and he or she will be required to keep the information and any supporting data for a period of five years as per section 13 of the Regulations.

As an example, a notifier who is not a Canadian resident but, for the substance being imported, possesses “Canadian Importer Status” and is listed as the “Importer of Record” on the Canadian Customs coding form (Form B3-3) as issued by the Canada Border Services Agency, must identify a person resident in Canada who is authorized to act on their behalf as the “Canadian Agent”.

1.4.3 Toll Manufacturer

Toll manufacturing occurs when a company contracts a manufacturer to process its raw materials and create a new substance. Ownership of the raw materials and resulting substance remains with the contracting company throughout the activity. For new substances that are manufactured on toll, the contracting company is: designated as the notifier; is responsible for complying with the Regulations; and must submit the appropriate NSN package corresponding to the quantities of the substance being manufactured. The notifier is also required to provide the information indicated in section 6.2.1.6 of these Guidelines and all required information on the manufacturing facility as described in section 6.6.1 of these Guidelines.

By signing the certification statement (block A.1) on the NSN reporting form, the notifier accepts all other compliance responsibilities, including filing any subsequent schedules that may be required and providing the appropriate fee. Furthermore, if any risk management actions are taken as a result of the NSN review, the notifier must inform the toll manufacturer of these actions and the toll manufacturer will be responsible for complying with these risk management actions, if necessary.

1.5 When to Submit an NSN Package to the NS Program

The timing of an NSN package depends on the Schedule of information required, the time needed by the notifier to develop the information specific to the Schedule and when the trigger quantity specified by the Schedule is likely to be exceeded.

1.5.1 New Substances Notification Assessment Periods

Assessment periods range from 5 to 75 calendar days, depending on the type and amount of substance being manufactured or imported (see section 4 of these Guidelines). NSN packages must be provided prior to the number of calendar days prescribed and in advance of the prescribed trigger quantity being exceeded. These are shown in Table 1-1.

^a Additional information is required from Schedule 2 if the substance is a biochemical or biopolymer for all notified substances (see sections 4.2 through 4.9 of these Guidelines).

^b Special categories include research and development, contained site-limited intermediate and contained export-only substances (see section 4.2 of these Guidelines).

^c NDSL - Non-domestic Substances List.

^d There may be an additional assessment period for those substances that exceed 50 000 kg/year if they meet one of the following criteria: releases anticipated to exceed 3 kg/day into the aquatic environment after wastewater treatment; or significant public exposure (see section 4.4.3 or 4.9.2 of these Guidelines). If these criteria are not met, then Schedule 5 or 10 is the final requirement.

^e Non-RRR polymers - Non-reduced Regulatory Requirement Polymers (see section 3.4.1.4 of these Guidelines).

1.5.2 New Substances Notification Fees

The New Substances Fees Regulations (NSFR) were developed to incorporate service fees; these fees must be provided with each NSN package submitted under the Regulations. The amount of fees required is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted and other services being requested (e.g., confidential search on the DSL or Non-domestic Substances List [NDSL] or masked name application). A fee schedule, for different levels of service, is provided in Appendix 3 of these Guidelines. Additional information can also be found in the NSFR and the Regulations Amending the New Substances Fees Regulations. Table 1-2 shows the maximum amount payable for each Schedule, excluding any other services.

a See Appendix 3 for fee reductions, graduated fees and other service fees.

1.5.3 Substances Not Subject to the Notification Fees

In general, all substances subject to the Regulations require fees. However, at this time, the NSFR do not apply to biochemicals, biopolymers, research and development substances and substances that are regulated under any other Act of Parliament (e.g., F&DA).

The fees also do not apply to SNANs (see sections 1.3 and 9.5.2 of these Guidelines) or to the submission of additional information required for special category Schedule 1 notifications (at 10 000 kg/yr) and for high release to the aquatic environment or significant high exposure to the substance (at 50 000 kg/yr) (see sections 4.2.2, 4.4.3 and 4.9.2 of these Guidelines, respectively).

1.6 Enforcement

For information on the enforcement of the Act and the Regulations notifiers should consult The Compliance and Enforcement Policy (www.ec.gc.ca/CEPARegistry/documents/policies/candepolicy/toc.cfm). This policy was established to ensure that the Act is applied throughout Canada in a manner that is fair, predictable and consistent.

¹ The term "person" includes legal and natural persons.

² When the term chemical(s) is used in these Guidelines, it refers to both chemicals and biochemicals.

³ When the term polymer(s) is used in these Guidelines, it refers to both polymers and biopolymers.

⁴ The term Domestic Substances List (DSL) is used inclusively in these Guidelines to specify substances listed on either the public or confidential portions of the inventory.