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

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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

Subsection 81(1) of the Act prohibits the manufacture or import of any substance that is not on the DSL or the confidential portion of the DSL unless the notifier manufacturing or importing the substance has provided the prescribed information within the prescribed time and with the prescribed fee (see Appendix 3 of these Guidelines); and the period for assessing the information has expired or has been terminated early (see section 9.3.5 of these Guidelines). The prescribed information specified in the Regulations (see Appendix 4 of these Guidelines) consists of both administrative and technical information (described in sections 6.2 through 6.7 of these Guidelines).

Fees are required to be provided with each NSN package submitted under the Regulations. The amount of fees required is dependent on the amount of annual sales in Canada for the notifier; the specific Schedule being submitted; and other services being requested (e.g., confidential searches on the DSL or NDSL or masked name application). A fee schedule, for different levels of service, and examples are 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.

Fee reductions are available for notifiers meeting the criteria for small- or medium-sized enterprises (SMEs) (see Appendix 3 of these Guidelines) and for matched or consolidated notifications, as described below in sections 5.1 and 5.3, respectively.

At this time, the fees do not apply to NSN packages submitted for biochemicals or biopolymers, research and development substances or substances that are regulated under any other Act of Parliament (e.g., F&DA).

5.1 Matched Notifications

A Matched Notification takes place when a notifier requests that the NS program use information that was previously provided by another notifier for the same substance. Such information may include test requirements or additional information. The notifier who is providing the information must submit a letter of authorization to the NS program indicating his or her NSN reference number as well as the name of the notifier whom he or she is supporting, together with the latter notifier's NSN reference number, if known. When files are matched, there may be a price reduction in the required fees (see Appendix 3 of these Guidelines). This is different from a Foreign Supplier Submission (see section 5.2 of these Guidelines).

5.2 Foreign Supplier Submissions (Confidential Information Provided by a Foreign Supplier)

Any information submitted to the NS program may be claimed as confidential (see section 7 of these Guidelines). In cases where the notifier is not given access to information that is considered confidential by the foreign supplier, the confidential information to support the NSN package must be supplied directly to the NS program by the foreign supplier and will be identified as a "Foreign Supplier Submission".

The procedure for submitting a Foreign Supplier Submission is as follows: The notifier must initiate the NSN process by providing all the administrative information (blocks A.1 to A.16 of the NSN reporting form; see section 6.2.1 of these Guidelines); all exposure information, including manufacture, importation, use, transport, exposure, release and disposal information requirements (Appendix I of the NSN reporting form); and any other information the notifier has in his or her possession pertaining to the substance.

The NSN package must also include reference to the pending Foreign Supplier Submission. Once the notifier has initiated the NSN process and has been provided with an NSN reference number, the confidential information required to complete the NSN package must be submitted directly to the NS program by the foreign supplier, referencing the appropriate NSN reference number to which the information is being provided.

If several companies are manufacturing or importing the same substance from the same foreign supplier, each notifier must submit individual NSN packages to the NS program, and each notifier is responsible for tracking their own manufacture or import volumes. Each NSN package will be assigned a different NSN reference number.

If the foreign supplier has already submitted the confidential information on a substance for one notifier, the same information does not need to be resubmitted for other notifiers. However, a letter of authorization from the foreign supplier must be sent to the NS program allowing the cross-referencing and use of the information within the original Foreign Supplier Submission to complete each subsequent NSN package by other notifiers for the same substance. Fee reductions may be applicable (see Appendix 3 of these Guidelines).

5.3 Consolidated Notifications

Consolidated Notifications take place when a notifier simultaneously provides two to six NSN packages for substances of the same class and where the technical information provided for one substance is used to address the technical information requirements for the remaining substances. Although not required, it is recommended that notifiers who wish to notify a number of very similar substances at one time as Consolidated Notifications do so after consultation with the NS program, through a PNC request (see section 8.8 of these Guidelines), to ensure that the technical information is sufficient to address the NSN requirements for all substances in question. In these cases, a separate NSN reference number is issued for each of the substances captured by the consolidated NSN, but the NSN packages are grouped together for the purposes of a common risk assessment. Consolidated Notifications are subject to reduced fees (see Appendix 3 of these Guidelines).

5.4 Test Data

Test data developed must be consistent with the conditions and procedures set out in the Organisation for Economic Co-operation and Development (OECD) Test Guidelines (TGs) that are current at the time the test data are developed (see section 8.1.1 of these Guidelines).

In addition, the development of certain test data must comply with the practices set out in the "Principles of Good Laboratory Practice" (GLP) that are current at the time the test data are developed (see section 8.3 of these Guidelines).

Protocols and laboratory practices that are recommended by the NS program for the generation of experimental data are described in section 8 of these Guidelines.

Explanations of the conditions under which waivers of prescribed information may be granted are described in section 8.7 of these Guidelines, and examples are given in Appendix 8 of these Guidelines.

Full test reports must be provided for all prescribed test data; summaries will not be accepted. It is important to ensure that the name and/or trade name of the substance indicated in the test report provided correspond to the name and/or trade name in the NSN package. Although the values for the test data will be included in the test reports, values and conditions should also be provided in sections B.1, B.2 and B.3 of the NSN reporting form (see section 6.3 of the Guidelines).

If literature papers are referenced, a copy of each paper must be provided. If software estimates/models are being used, information on the model (e.g., version of software, etc.), the input data and model output must be provided to allow for an assessment of the data by the NS program (see section 8.4.3 of these Guidelines).

Test data submitted in a previous NSN package, PNC request or notice under section 70 of the Act need not be resubmitted; however, the appropriate reference number must be supplied (see "P" code in section 6.1.2 of these Guidelines).

For polymers, two information requirements, "whether the substance is formulated for dispersal in water" and "physical state" do not require quantitative determinations. The requirement for dispersibility in water will be satisfied by indicating "yes" or "no", whereas the requirement for physical state will be satisfied with an appropriate term (e.g.,"solid," "wax" or "liquid"). These responses are to be provided in the appropriate value column of the NSN reporting form.

5.5 Record-Keeping Requirements

Pursuant to section 13 of the Regulations, a notifier who is required to provide information to the Minister or the NS program under the Regulations must keep a copy of that information and any supporting data at the notifier's principal place of business in Canada or at the principal place of business in Canada of a representative of that notifier. The information and the supporting data must be kept for a period of five years after the year in which the information is provided.