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Guidelines for the Notification and Testing of New Substances: Chemicals and PolymersSECTION 4 - Notification Information Requirements
4.1 How to Identify the Required Notification InformationThe Regulations prescribe information requirements tailored to the use and quantity of the chemical or polymer being manufactured or imported. These requirements are listed in the "Schedules" of the Regulations which are presented in Appendix 4 of these Guidelines. To help select the appropriate Schedule, decision flowcharts are provided in this section and also in Appendix 1. It is important to note that although the Regulations provide a tiered approach to notification, which links information requirements to factors such as quantity, use, intrinsic properties and class, it is not a requirement to follow this tiered notification approach. A notifier may, if he or she wishes, opt to immediately submit the highest notification Schedule required, as long as the lowest prescribed trigger quantities for the lowest Schedule are respected and the NSN package is submitted within the timeframe prescribed for the highest Schedule. As indicated in the decision diagrams presented in this section and in Appendix 1, there are a number of factors that must be considered when identifying the nature of information to be submitted and when this information should be submitted. These factors include:
4.1.1 Annual QuantitiesThe Regulations prescribe a pre-manufacture/pre-import notification scheme. As such, the notifier must develop an accurate estimate of the annual (calendar year) quantities of the new substance to be manufactured or imported in Canada and submit an NSN package before each of the prescribed "trigger" quantities are exceeded. The prescribed "trigger" quantities relate to the actual amount of new substance manufactured or imported, not to the quantity of the formulation containing the substance. For example, if 10 000 kg of Formulation A are to be imported during a calendar year and this formulation contains 13% of new substance X, then the annual import quantity of substance X would be 1300 kg. The following sections will help identify both the Schedule requirements necessary to comply with the Regulations and the date before which NSN packages must be submitted to the NS program.
4.2 Notification of Special Category Substances (See Figure 4-1)Substances being manufactured or imported for activities defined under the special categories umbrella (see section 3.5 of these Guidelines) must be notified as indicated below. Once the special category activities have concluded, the substance is subject to notification under the appropriate Schedules based on the type of substance and its volumes (see sections 4.3 to 4.9 of these Guidelines).These requirements are specified in the Schedules in Appendix 4 of these Guidelines. 4.2.1 Lower-Volume Special Category Notifications for ChemicalsEvery notifier who manufactures or imports a chemical for research and development purposes, as a contained site-limited intermediate substance or as a contained export-only substance must provide to the NS program the information prescribed in Schedule 1 of the Regulations at least 30 days prior to the quantity of the chemical exceeding 1000 kg in a calendar year. 4.2.1.1 Lower -Volume Research and Development BiochemicalsIf the substance is a research and development biochemical, the notifier is required to provide, in addition to the Schedule 1 information, items 1 and 2 of Schedule 2 of the Regulations. 4.2.1.2 Lower-Volume Contained Site-Limited Intermediate BiochemicalsIf the substance is a contained site-limited intermediate biochemical that is not manufactured and consumed at the site of manufacture, the notifier is required to provide, in addition to the Schedule 1 information, items 1-4 of Schedule 2 of the Regulations; and
If the substance is a contained site-limited intermediate biochemical that is manufactured and consumed at the site of manufacture, the notifier is required to provide, in addition to the Schedule 1 information, items 1, 2 and 4 of Schedule 2 of the Regulations. 4.2.1.3 Lower-Volume Contained Export-Only BiochemicalsIf the substance is a contained export-only biochemical, the notifier is required to provide, in addition to the Schedule 1 information, items 1-4 of Schedule 2 of the Regulations; and
4.2.2 Higher-Volume Special Category Notifications for ChemicalsIn addition, the notifier must update all of the information that was previously provided at least 30 days prior to exceeding 10 000 kg in a calendar year. If there is no change in the information, this must also be indicated at this time.
4.2.3 Higher-Volume Special Category Notifications for Polymers (see Figure 4-2)Every notifier that manufactures or imports a polymer for research and development purposes, as a contained site-limited intermediate substance or as a contained export-only substance must provide the NS program the information prescribed in Schedule 3 of the Regulations at least 30 days prior to the quantity of the polymer exceeding 10 000 kg in a calendar year. Figure 4-1 Required Information
for Research and Development (R&D), Contained Site-Limited Intermediate
(CSLI) or Contained Export-Only (CEO) Chemicals/Biochemicals (s. 5 of
the Regulations) (See section 4.2 of the Guidelines) Click to enlarge (PDF Version) 4.2.3.1 Higher-Volume Research and Development BiopolymersIf the substance is a research and development biopolymer, the notifier is required to provide, in addition to the Schedule 3 information, items 1 and 2 of Schedule 2 of the Regulations. 4.2.3.2 Higher-Volume Contained Site-Limited Intermediate BiopolymersIf the substance is a contained site-limited intermediate biopolymer that is not manufactured and consumed at the site of manufacture, the notifier is required to provide, in addition to the Schedule 3 information, items 1-4 of Schedule 2 of the Regulations; and
If the substance is a contained site-limited intermediate biopolymer that is manufactured and consumed at the site of manufacture, the notifier is required to provide, in addition to the Schedule 3 information, items 1, 2 and 4 of Schedule 2 of the Regulations. 4.2.3.3 Higher-Volume Contained Export-Only BiopolymersIf the substance is a contained export-only biopolymer, the notifier is required to provide, in addition to the Schedule 3 information, items 1-4 of Schedule 2 of the Regulations; and
Figure 4-2 Required Information for Research
and Development (R&D), Contained Site-Limited Intermediate (CSLI)
or Contained Export-Only (CEO) Polymers/Biopolymers (s.6 of the Regulations)
(See section 4.2 of the Guidelines) Click to enlarge (PDF Version)
4.3 Notification of ChemicalsAs indicated in section 4.1 of these Guidelines, the Regulations prescribe information requirements tailored to the use and quantity of the chemical. These requirements are listed in the "Schedules" of the Regulations which are presented in Appendix 4 of these Guidelines. Decision flowcharts are provided in this section and in Appendix 1 of these Guidelines to help select the appropriate notification Schedule. Before using the flowcharts, Table 1-1 and sections 2.2, 3.4, 3.5, 4.2.1, 4.2.2, 4.4 and 4.5 of these Guidelines should be reviewed to determine:
The following sections apply only to chemicals that are manufactured or imported for a purpose other than as a special category listed in section 3.5 of these Guidelines.
4.4 Information Requirements for Chemicals Listed on the NDSL (see Figures 4-3(a) and 4-3(b))4.4.1 Lower-Volume ChemicalsEvery notifier who manufactures or imports a chemical that is listed on the NDSL must provide the NS Program the information prescribed in Schedule 4 of the Regulations at least 30 days prior to the quantity of the chemical exceeding 1000 kg in a calendar year. If the substance is a biochemical, the notifier is required to provide, in addition to the Schedule 4 information, items 1-3 of Schedule 2. 4.4.2 Higher-Volume ChemicalsEvery notifier who manufactures or imports a chemical that is listed on the NDSL must provide the NS program the information prescribed in Schedule 5 of the Regulations at least 60 days prior to the quantity of the chemical exceeding 10 000 kg in a calendar year. If the substance is a biochemical, the notifier is required to provide, in addition to the Schedule 5 information, items 1-4 of Schedule 2 of the Regulations; and
4.4.3 NDSL Chemicals with High Release and/or Significant ExposureEvery notifier who manufactures or imports a chemical that is listed on the NDSL and:
must provide the NS program additional test information as prescribed in subsections 7(2) and 7(3) of the Regulations at least 75 days prior to the quantity of the chemical exceeding 50 000 kg in a calendar year. The additional required information is indicated in the following sections. 4.4.3.1 Chemicals Released to the Aquatic EnvironmentIt is the notifier's responsibility to submit evidence in item 10(c) of the Schedule 5 NSN package to support a claim of the substance not being released to the aquatic environment in the quantity indicated above. This information should include any envisioned future use by multiple customers and/or a variety of applications. To calculate daily release to the aquatic component, the estimated daily release should be determined, per site, as follows: EDR = (AV/NPD) x L x (1-T) where: EDR = estimated daily release (kg/day) The NS program will assess this information and will perform an additional calculation based on information available to the program. If it is determined that the substance is released to the aquatic environment in quantities greater than indicated above or where the information provided is not acceptable, the additional information prescribed in subsection 7(2) of the Regulations must be provided. The NS program's determination of whether the substance is subject to all or some of the additional information requirements given below will be indicated in the final assessment outcome letter. The notifier may submit additional information to support his or her claim and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this information. The additional information required, as prescribed in subsection 7(2) of the Regulations, must include the following:
4.4.3.2 Where the Public May Be Significantly Exposed to the Chemical in a ProductIt is the notifier's responsibility to submit evidence in item 10(d) of the Schedule 5 NSN package to support a claim of the public not being significantly exposed to the substance in a product. The NS program will assess this information and determine if it is acceptable. If it is determined that the public may be significantly exposed to the chemical in a product or where the information provided is not acceptable, the additional information prescribed in subsection 7(3) of the Regulations must be provided. The NS program's determination of whether the substance is subject to all or some of the additional information requirements given below will be indicated in the final assessment outcome letter. The notifier may submit additional information to support his or her claim and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this information. Since public exposure is dependent on many factors, it is difficult to give a calculation to determine what is "significant" without being extremely conservative. Therefore, the definition of "significantly exposed" will be assessed, by the NS program, on a case-by-case basis. This assessment will take into consideration such factors as type of use, duration and frequency of use, concentration of the chemical in the product and circumstances of exposure that may limit direct human exposure (e.g., whether the chemical is consumed during use or is able to migrate from the product). To determine if the public may be significantly exposed to the chemical in a product, the NS program provides the opportunity for notifiers to submit a PNC request (see section 8.8 of these Guidelines). Some examples of consumer applications where significant exposure of a substance may occur include, but are not limited to, dishwashing detergent, laundry products, soaps, toilet paper, cleaning solutions, waxes, polishes, air fresheners, paints, oils, greases and ink. The additional information required, as prescribed in subsection 7(3) of the Regulations, must include the following:
4.5 Information Requirements for Chemicals Not on the NDSL (see Figures 4-3(a) and 4-3(b))4.5.1 Lower-Volume Chemicals
4.5.2 Higher-Volume ChemicalsEvery notifier who manufactures or imports a chemical that is not on the NDSL must provide the NS program the information prescribed in Schedule 6 of the Regulations at least 75 days prior to the quantity of the chemical exceeding 10 000 kg in a calendar year. If the substance is a biochemical, the notifier is required to provide, in addition to the Schedule 6 information, items 1-4 of Schedule 2 of the Regulations; and
4.6 Information Requirements for Chemicals that are Subsequently Added to the NDSLIt is important to note that, should a chemical be added to the NDSL after a complete Schedule 4 and 5 NSN package has been submitted (including item 10 of Schedule 5) but prior to a Schedule 6 being submitted, the notifier is obligated, under subsection 8(2) of the Regulations, to inform the NS program, in writing, that the chemical is now listed on the NDSL. Once the appropriate fee has been submitted (see Appendix 3 of these Guidelines), a 60-day assessment period will commence to re-assess the substance as a final NSN package. Alternatively, in the case where a chemical is added to the NDSL after a complete Schedule 4 and 5 NSN package has been submitted (without item 10 of Schedule 5) but prior to a Schedule 6 being submitted, the NS program will inform the notifier that the chemical was added to the NDSL and that subsection 16(3) of the Regulations applies. Subsection 16(3) of the Regulations states that the notifier must ensure that all prescribed data requirements (item 10 of Schedule 5) and fees, as prescribed for NDSL substances, are provided to the NS program. Once all the required information and appropriate fee have been submitted and accepted, a 60-day assessment period will commence to re-evaluate the final NSN package in consideration of the new information. In addition, once the chemical is added to the NDSL, it may require the additional data prescribed in subsection 7(2) or 7(3) to be submitted if the chemical is released to the aquatic environment in a quantity exceeding 3 kg/day, per site, averaged monthly and after wastewater treatment; and/or where the public may be significantly exposed to the chemical in a product (see section 4.4.3 of these Guidelines). For example, a complete Schedule 4 and 5 NSN package is submitted for a chemical not on the NDSL. Subsequently, the substance is added to the NDSL. The NS program will inform the notifier that the substance is now listed on the NDSL and that the notifier is required to provide item 10 of Schedule 5 and the appropriate fee (see Appendix 3 of these Guidelines). Once this information is received and accepted, the NS program then has an additional 60 days to assess the new information and take action, if necessary. Figure 4-3(a) Required Information for
Chemicals (ss.7 and 8 of the Regulations) (See sections
4.3 through 4.5 of the Guidelines) Click to enlarge (PDF Version)
4.7 Notification of PolymersSimilar to the notification of chemicals and biochemicals, the Regulations prescribe information requirements tailored to the use and quantity of the polymer. These requirements are listed in the “Schedules” of the Regulations which are presented in Appendix 4 of these Guidelines.. Decision flowcharts are provided at the end of this section and in Appendix 1 of these Guidelines to help select the appropriate notification Schedule. Before using the flowcharts, Table 1-1 and sections 2.2, 3.4, 3.5, 4.2.3 and 4.7 through 4.9 of these Guidelines should be reviewed to determine:
4.7.1 Monomers and Reactants Listed on the DSL or the NDSLTo determine whether a polymer notification is eligible for reduced information requirements, it is necessary to find out if the monomers and reactants of the substance are listed on the DSL or NDSL. To determine the presence of monomer and reactants on the confidential or public portions of the DSL and NDSL, the CAS registry number or Enzyme Commission number can be entered into a search engine located on the NS program web site at www.ec.gc.ca/substances/nsb/eng/sub_e.htm Alternatively, a Notice of Bona Fide Intent to Manufacture or Import can be sent to the NS program (see section 2.3.1 of these Guidelines). It is important to note that if a substance is listed on the DSL, the onus is on the notifier to look at the Canada Gazette publication to ensure that there are no flags associated with the substance (see section 2.1.4 of these Guidelines) and therefore no further notification responsibilities. The NS program is working on having these flags added to the search engine.
4.8 Information Requirements for Polymers (See Figures 4-4(a) and 4-4(b))4.8.1 Lower-Volume PolymersEvery notifier who manufactures or imports any polymer must provide the NS program the information prescribed in Schedule 9 of the Regulations at least 30 days prior to the quantity of the polymer exceeding 1000 kg in a calendar year. If the substance meets the RRR polymer criteria (see section 3.4.1.3 of these Guidelines), the Schedule 9 NSN package is the final notification requirement. If the substance is a biopolymer, the notifier is also required to provide, in addition to the Schedule 9 information, items 1-3 of Schedule 2 of the Regulations.
4.9 Information Requirements for Non-reduced Regulatory Requirement (non-RRR) Polymers (see Figures 4-4(a) and 4-4(b))The following sections do not apply to polymers that meet the RRR polymer criteria. 4.9.1 Higher-Volume Non-RRR Polymers Either Listed on the NDSL or Manufactured from Reactants Listed on the DSL or NDSLEvery notifier who manufactures or imports a non-RRR polymer (see section 3.4.1.4 of these Guidelines) that is either listed on the NDSL or manufactured solely from monomers or reactants listed on the DSL or NDSL must provide the NS program the information prescribed in Schedule 10 of the Regulations at least 60 days prior to the quantity of the polymer exceeding 10 000 kg in a calendar year. If the substance is a biopolymer, the notifier is also required to provide, in addition to the Schedule 10 information, the information specified in items 1-4 of Schedule 2 of the Regulations. If the biopolymer is a nucleic acid, the notifier is also required to provide the information specified in items 5 and 6 of Schedule 2 of the Regulations. The health toxicity endpoint referred to in item 4 of Schedule 10 is not required if the polymer is a non-RRR polymer solely due to the presence of any of the following functional groups:
4.9.2 Polymers with High Release and/or Significant ExposureEvery notifier who manufactures or imports a polymer that is either listed on the NDSL or manufactured solely from monomers or reactants listed on the DSL or NDSL and:
must provide the NS program additional test information as prescribed in subsections 11(2) and 11(3) of the Regulations at least 60 days prior to the quantity of the polymer exceeding 50 000 kg in a calendar year. The additional information required is indicated in the following sections. This additional information is not required if the polymer is a non-RRR polymer solely due to the presence of any of the following functional groups:
4.9.2.1 Polymers Released to the Aquatic EnvironmentIt is the notifier's responsibility to submit evidence in item 5(g) of the Schedule 10 NSN package to support a claim of the substance not being released to the aquatic environment in the quantity indicated above. This information should include any envisioned future use by multiple customers and/or a variety of applications. To calculate daily release to the aquatic component, the estimated daily release should be determined, per site, as follows: EDR = (AV/NPD) x L x (1-T) where: EDR = estimated daily release (kg/day) The NS program will assess this information and will also perform an additional calculation based on information available to the program. If it is determined that the substance is released to the aquatic environment in quantities greater than indicated above or where the information provided is not acceptable, the additional information prescribed in subsection 11(2) of the Regulations must be provided. The NS program's determination of whether the substance is subject to all or some of the additional information requirements given below will be indicated in the final assessment outcome letter. The notifier may submit additional information to support his or her claim and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this information. The additional information required, as prescribed in subsection 11(2) of the Regulations, must include the following:
4.9.2.2 Where the Public May Be Significantly Exposed to the Polymer in a ProductIt is the notifier's responsibility to submit evidence in item 5(h) of the Schedule 10 NSN package to support a claim of the public not being significantly exposed to the substance. The NS program will assess this information and determine if it is acceptable. If it is determined that the public may be significantly exposed to the polymer in a product or where the information provided is not acceptable, the additional information prescribed in subsection 11(3) of the Regulations must be provided. The NS program's determination of whether the substance is subject to all, or some, of the additional information requirements given below will be indicated in the final assessment outcome letter. The notifier may submit additional information to support his or her claim and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this information. Since public exposure is dependent on many factors, it is difficult to give a calculation to determine what is "significant" without being extremely conservative. Therefore, the definition of "significantly exposed" will be assessed, by the NS program, on a case-by-case basis. This assessment will take into consideration such factors as type of use, duration and frequency of use, concentration of the substance in the product and circumstances of exposure that may limit direct human exposure (e.g., whether the substance is chemically consumed during use or is able to migrate from the product). To determine if the public may be significantly exposed to the polymer in a product, the NS program provides the opportunity for notifiers to submit a PNC request (see section 8.8 of these Guidelines). Some examples of consumer applications where significant exposure of a substance may occur include, but are not limited to, dishwashing detergent, laundry products, soaps, toilet paper, cleaning solutions, waxes, polishes, air fresheners, paints, oils, greases and ink. The additional information required, as prescribed in subsection 11(3) of the Regulations, must include the following:
4.9.3 Higher-Volume Non-RRR Polymers Not on the NDSL and Not Manufactured Solely from Reactants Listed on the DSL or NDSLEvery notifier who manufactures or imports a non-RRR polymer (see section 3.4.1.4 of these Guidelines) not on the NDSL and that contains one or more reactants not on either the DSL or the NDSL must provide the NS program the information prescribed in Schedule 11 of the Regulations at least 60 days prior to the quantity of the polymer exceeding 10 000 kg in a calendar year. If the substance is a biopolymer, the notifier is also required to provide, in addition to the Schedule 11 information, items 1-4 of Schedule 2 of the Regulations. If the biopolymer is a nucleic acid, the notifier must also provide the information specified in items 5 and 6 of Schedule 2 of the Regulations. Health toxicity endpoints referred to in items 5-10 of Schedule 11 are not required if the polymer is a non-RRR polymer solely due to the presence of any of the following functional groups:
Figure 4-4(a) Required Information for
Polymers (ss. 10, 11 and 12 of the Regulations) (See sections
4.7 through 4.9 of the Guidelines) 
Click to enlarge (PDF Version)
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Disclaimer: Although care has been taken to ensure that the information found on this website accurately reflects the requirements prescribed, you are advised that, should any inconsistencies be found, the legal documents, printed in the Canada Gazette, will prevail. |
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The Green LaneTM, Environment Canada's World Wide Web site
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Who Should and How To
Notify
Chemicals and Polymers
