Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) response to comments

In April 2021, a draft of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers) was published online for a 90-day public consultation period. It included updated policies and recommendations from previous advisory notes published by the New Substances (NS) program, incorporated suggested improvements and addressed concerns identified by stakeholders over the years. A summary of received comments and program responses is accessible below.

Section 1.  Introduction and overview

Comment summary: Section 1.5.1 should include assessment periods for Pre-notification Consultations (PNC), masked name requests and confidential search requests.

Response: Section 1.5.1 (Table 1.1) focusses on prescribed timelines, for example NSN assessment periods as set out in the New Substances Notification Regulations (Chemicals and Polymers) (the Regulations). Services standards for PNC (section 8.8), masked name requests (section 7.2.2) and confidential search requests (section 2.3.1) are available in the related section of this Guidance Document.

Section 2. The inventories

Comment summary: Section 2 should include further details concerning amendments to the Non-domestic Substances List (NDSL).

Response: Section 2.2.3 was updated to clarify instances where substances can be added to or deleted from the NDSL, including information on the nomination of substances listed on the confidential portion of the United States Environmental Protection Agency’s (US EPA) Toxic Substances Control Act Inventory to the NDSL as well as the deletion of substances that are of potential concerns (for example, that are subject to risk management measures).

Comment summary: This Guidance Document should include a description of the Revised In Commerce List (R-ICL) and administrative status of substances on this list.

Response: The R-ICL is currently under revision and as such, it is not discussed in this Guidance Document. To obtain further information concerning substances on the R-ICL, please contact the Substances Management Information Line or refer to the R-ICL webpage.

Section 3. Substances

Comment summary: The definition of substances of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB) in the Guidance Document could conflict with the US EPA policy that allows UVCBs comprising only individually listed components to be covered by those collective individual listings.

Response: The definition of UVCBs was updated in the Guidance Document. As a result, it is expected to better align with the definitions used by other jurisdictions. For more tailored guidance on the notification of UVCBs, it is recommended to request a PNC with the NS program.

Comment summary: It is recommended to maintain the content that defines “shape” and “design” as they relate to manufactured items.

Response: Section 3.2.2 of the Guidance Document was clarified to include more information on the shape and design of manufactured items.

Comment summary: For greater clarity and consistency with the definition of “nanomaterial” in the Health Canada Working Definition for Nanomaterials, additional details from the Working Definition should be included in the definition presented in the Guidance document.

Response: The definition for nanomaterials in the Guidance Document has been clarified and aligned with the definition provided in the Health Canada Working Definition for Nanomaterials.

Comment summary: Notification requirements for substances manufactured at the nanoscale should be clarified, namely with regard to those not on the Domestic Substances List (DSL) and those on the DSL.

Response: The wording in section 3.3.1.4 with regard to notification requirements of nanomaterial was clarified in the Guidance Document.

Section 5. New Substances Notifications (NSNs)

Comment summary: Notifiers who are required to provide information to the Minister must keep a copy of that information and any supporting data at the notifier's principal place of business in Canada or at the representative of the notifier's principal place of business in Canada for a period of 5 years after the year in which the information is provided. Notifiers should be allowed to store records at any location in Canada regardless of whether the location is the principal place of business. This would allow notifiers the option to store their files on the decentralized server networks and cloud storage services increasingly used by companies.

Response: The proposed change would require amendments to the Regulations and is therefore beyond the scope of the consultation on the Guidance Document. This comment has been noted as an item to consider in future regulatory amendments.

Section 6. The New Substances Notification Form

Comment summary: Unlike synthetic polymers, the specific amino acid (monomer) sequence is less relevant for determining enzyme identity because enzymes are best identified by their function. It is recommended to remove the amino acid sequence requirement described in 6.2.21 and 6.5.4 for enzymes.

Response: The requirement to provide a structural formula (or an amino acid sequence as alternate data in the case of biochemicals and biopolymers) is set out in the Regulations. As such, the proposed change would require amendments to the Regulations and is therefore beyond the scope of the consultation on the Guidance Document. This comment has been noted as an item to consider in future regulatory amendments.

If the amino acid sequence or other suitable structural/molecular information cannot be provided for an enzyme, waiver requests can be submitted for the specific information element(s). Notifiers are encouraged to request a PNC to determine the acceptability of their waiver request(s) before submitting an NSN.

Comment summary: Section 6.4.2.4 indicates that group terms such as “protease” are not acceptable and that a substance name must uniquely identify a single enzyme (subtilisin produced by Bacillus subtilis). These 2 points should be removed since the International Union of Biochemistry and Molecular Biology (IUBMB) name and identifier are sufficient to identify an enzyme. Furthermore, hazard properties are the same within the IUBMB.

Response: Each substance, including enzymes, must be uniquely identified for the proper application and enforcement of the Canadian Environmental Protection Act, 1999 (the Act) and the Regulations as well as for the purpose of the DSL and the NDSL.

Comment summary: What were the criteria used to establish the classes and relevant additional technical information presented in Table 6-3? This could be useful for notifiers who are trying to determine whether this information may be required during the assessment of their NSN submission.

Response: Based on program experience, including the additional technical information for the classes listed in Table 6-3 has often been beneficial for the risk assessments on substances belonging to these classes. While this additional information is not mandatory, it is often of benefit to the notifier to provide this information as it may allow for the use of less conservative assumptions, and fewer assessment factors or models. 

Comment summary: Disclosing information on the Canadian sites of greatest quantity, including the company names and site addresses, could result in the unintentional release of Confidential Business Information (CBI).

Response: Information on the 3 sites in Canada where the greatest quantity of the chemical or polymer is anticipated to be used or processed and the estimated quantity by site is required under the Regulations.

Under section 313 of the Act, any notifier who provides information to the government may, at the same time, submit a written request that the information be treated as confidential. This ensures that CBI is protected from public disclosure. The degree of protection given to information claimed to be confidential will be consistent with sections 314 to 321 of the Act and the provisions of the Access to Information Act.

Section E of the NSN form has been updated to simplify the identification of CBI. The NS program only discusses CBI with the parties or designated technical contacts permitted to view this content.

Comment summary: The calculations used to estimate the number of release days can be overly conservative especially for the example that indicates “releases occur only during one week a year”. The Guidance Document notes that 5 days/month will be used as the worst case scenario to calculate the release days per month. This is concerning because a substance is considered 'high release to the aquatic environment' if the quantity exceeds 3 kg/day/site averaged monthly. That worst case scenario can possibly put the substance in the high release category but it only happens in 1 week (month) out of the year.

Response: Daily releases, after wastewater treatment, from just 5 days that yield a monthly averaged daily release over the High Release (HR) threshold would be very high, and therefore could be of concern to the surrounding environment. If there exists other factors that could affect the release calculations, notifiers may provide their own calculations and justifications in their NSN submission. The NS program will determine the acceptability of the calculations during the NSN assessment period.

Section 7. Confidential information

Comment summary: The release of trade names can undermine the confidentiality of the notifier’s corporate identity. The trade name or common name associated with a substance should be considered CBI.

Response: The NS program considers that trade names or common names associated with a substance are not CBI as per the “Organisation for Economic Co-operation and Development (OECD) Recommendation of the Council concerning the OECD List of Non-Confidential Data on Chemicals.” Section 7.2.1.1 of the Guidance Document further states that “it is understood that there will be exceptions” and accordingly, if a notifier wishes that a trade name be treated as CBI then this should be indicated and substantiated. The degree of protection given to information claimed to be confidential will be consistent with sections 314 to 321 of the Act and the provisions of the Access to Information Act.

For more information, please refer to the NS program’s approach to disclose confidential information and promote transparency in chemicals management.

Comment summary: The last bullet of section 7.2.2.1 suggests that notifiers may need to submit non-confidential summaries for any health, safety or environmental study that is claimed as CBI.

Response: The last bullet of section 7.2.2.1 indicates that the submitter “has the option of preparing a non-confidential summary.” This option applies in cases where the NS program intends to publish a risk assessment summary and should not be inferred as a new expectation for any studies claimed as CBI. The degree of protection given to information claimed to be confidential will be consistent with sections 314 to 321 of the Act and the provisions of the Access to Information Act.

More information is available on the NS program’s risk assessment summaries webpage.

Comment summary: In some cases, 30 days may not be enough time for a notifier to determine whether to renew a 10-year old confidentiality claim for substance identity. More time may be necessary before a company can confirm if the substance's identity needs to remain confidential for an additional 10 years.

Response: The NS program recognizes that reviewing the submission history of a substance and determining whether a confidentiality claim for substance identity requires extension may take more than 30 days. As such, the NS program would provide a minimum of 30-days notice and consider requests of extension if more time is required by the notifier to reach their decision.

Section 8. Recommended test protocols and alternative approaches

Comment summary: The criteria provided in sections 8.4.1 and 8.4.2 suggest that justifying the use of alternate approaches will be a significant burden on notifiers and could unintentionally discourage notifiers from using alternative testing methods that adhere to the Reduction, Refinement and Replacement principles.

Response: In recognition of tests intended to replace, reduce or refine the use of animals in traditional toxicity tests, the NS program accepts appropriate alternative approaches to meet technical information requirements (consult section 8.4).

The NS program supports the use of alternate test protocols for minimizing use and suffering of animals, whenever possible.

Nonetheless, similar to data generated using the conventional OECD Test Guidelines recommended by the NS program, the quality of the data generated by alternate approaches must be sufficient for the purposes of the risk assessment. The descriptions of data quality expectations in section 8.4.1 and 8.4.2 are consistent with the level of scientific rigour expected in the conventional OECD Test Guidelines.

Notifiers are encouraged to request a PNC to determine the acceptability of all data generated using alternate approaches before submitting an NSN.

Comment summary: The comparison table is an interesting tool for structuring justifications for the use of surrogate data and analogue substances. However, all of this information is rarely available when preparing notifications. Therefore, it is recommended that this table not become an expectation for read-across justifications.

Response: Tables 8-5 and 8-6 have been included as tools to help notifiers concisely structure their surrogate data comparisons. These tables are not lists of required surrogate data endpoints; however, it is expected that notifiers provide sufficient information for the NS program to perform an accurate assessment of the acceptability of the proposed analogue substance(s). Notifiers can structure their justifications for using surrogate data in the manner of their choice, provided that it is sufficiently clear for evaluation purposes.

Notifiers are encouraged to submit a PNC to verify the acceptability of proposed surrogate data or analogue substances before submitting an NSN.

Appendix 5. Masking of substance names

Comment summary: The recommended limit of 5 masks per masked name could disproportionally affect notifiers of complex chemicals and polymers. It is recommended not to impose a limit on the number of masks since this may result in the inadequate masking of proprietary chemical moieties in substances with long explicit chemical names. 

Response: The Masked Name Regulations provides that the number of masks “shall not exceed the minimum number necessary to ensure confidentiality.” In an effort to balance the need for transparency with the notifier’s need to maintain confidentiality of their proprietary chemistry, the NS program encourages notifiers to limit the number of masks.

Based on the program's experience with the administration of the Masked Name Regulations, 5 or less masks have typically been sufficient to adequately obfuscate the identity of most chemical names. However, it is recognized that 5 masks may not always be adequate to mask all confidential chemical moieties in an explicit chemical name, especially in the case of substances with complex names. As such, a notifier may request more than 5 masks if sufficient justification is provided.

Appendix 6. Examples of waiver requests

Comment summary: The Schedule 5 requirements for boiling point, vapour pressure and octanol-water partition coefficient are not always obtainable values for enzymes. Additionally, they are often irrelevant to determining whether a substance is toxic.

Response: As with technical information elements for other substances, notifiers may also submit waiver requests for prescribed information on biochemicals if it is impractical or technically infeasible to obtain the test data necessary to generate the information, or if the information is not needed in order to determine whether the substance is toxic or capable of becoming toxic.

Notifiers are encouraged to request a PNC to determine the acceptability of waiver requests before submitting an NSN.

Appendix 7. Fulfilling number average molecular weight requirements with Gel Permeation Chromatography data

Comment summary: Gel Permeation Chromatography (GPC) or Size Exclusion Chromatography (SEC) calibration standards can be expensive to run and it is often not financially viable to run a standard before testing each new sample. It is recommended to also allow the use of positive controls to demonstrate that the system is suitable for measurement.

Response: The NS program recognizes that running calibration standards before each sample run can be both ineffective and costly to the notifier. As such, a new paragraph has been added outlining the use of positive controls as a way to demonstrate that a SEC system is suitably calibrated for measurement purposes.

Appendix 9. Guidance on testing water extractability following the Organisation for Economic Co-operation and Development Test Guideline 120

Comment summary: The expanded testing requirements with respect to OECD Test Guideline 120 recommends the testing of liquid polymers and would make it difficult to ask for waivers for viscous polymers. Furthermore, the new version of these instructions suggest that substances that react with water under the test conditions should also undergo testing.

Response: As is the case with any waiver request, the NS program will recommend that a waiver for the water extractability information requirement be granted only when sufficient supporting information has been provided.

The NS program recommends testing liquid polymers and does not typically grant waivers for liquid polymers.

In the case of reactive polymers, if a notifier can demonstrate that the polymer reacts with water then the NS program will typically recommend that a waiver be granted.

Contact us

If you have any questions regarding the Guidance Document or wish to request a PNC to consult with the NS program before submitting an NSN, please contact the Substances Management Information Line.