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Guidelines for the Notification and Testing of New Substances: Chemicals and PolymersSECTION 6 - The New Substances Notification (NSN) Reporting Form
The NSN reporting form is intended to serve as an aid for complying with the Regulations. The NSN reporting form is divided into four sections: Part A- Administrative and Substance Identity Information Requirements; Part B - Technical Information Requirements; Part C - Biochemical or Biopolymer Information Requirements; and Part D - Additional Information Requirements. In addition, two Appendices are included in the NSN reporting form: Appendix I - Manufacture, Import, Use, Exposure and Release Information (Known and Anticipated), which includes all manufacture/import, use and disposal information; and Appendix II - New Substances Fee Payment Form. Please note that a complete NSN package must contain the specific information requirements of Part A, Part B, Part C and Appendix I, including all test data, laboratory reports, waiver justifications and other attachments necessary to fulfil the requirements set by the Regulations. Additional information must be listed in Part D. Appendix II is provided as an aid in determining the fee required for each specific NSN package. If the NSN reporting form is incomplete or is filled out incorrectly, the submission may be returned to the notifier, which will lead to delays in the assessment period. Information that will not fit in the appropriate block on the NSN reporting form should be included in an attachment. Subsection 14(3) of the Regulations states that all information (except for "Additional Information", as described in section 6.5 of these Guidelines) must be provided in English or French; and two copies of any information provided under the Regulations must be submitted to: Mailing Address: Director, New Substances Division Courier Deliveries: Director, New Substances Division The NS program will confirm receipt of the NSN package and provide an NSN reference number (see section 9.2.3 of these Guidelines) that is to be used in all further correspondence concerning that NSN package. The NSN reporting form or sections of the NSN reporting form may be reproduced as often as required without permission. An electronic version of the NSN reporting form can be obtained from the NS program web site at www.ec.gc.ca/substances/ or by contacting the NSN Information Line (see the Comments and Inquiries section of these Guidelines). 6.1 Data Codes, Attachments and Confidential InformationIn addition to the list of information requirements, Part B of the NSN reporting form contains five columns: Submit with Schedule; Data Codes; Value and Conditions; Attachment Number; and Confidential Information. The following explains the use for each of these columns. Explanations also appear on page 2 of the NSN reporting form. 6.1.1 Submit with ScheduleThis is a quick reference column that allows notifiers to determine, at a glance, which Schedule requires the information to be provided. Footnotes also provide additional guidance for certain exceptions and conditions associated with certain data elements. It is important to note that if lower Schedule notifications are not submitted, the information prescribed in them is still required to be submitted with the higher Schedule notifications.
6.1.2 Data CodesA Data Code is a reference to indicate whether data are provided; the type of data being submitted; or whether a request for waiver of information is being submitted. The Data Codes with explanatory notes are:
6.1.3 Value and ConditionsAlthough complete physical-chemical data must be submitted in test reports (physical state and whether the notified substance is formulated for dispersal in water excepted), the notifier must enter the value and conditions in the appropriate space provided. This information will assist the notifier in organizing data for use; in requesting waivers of information; in justifying cases when data are not applicable; and in discussing notifications with NS program officials. Physical-chemical values and corresponding conditions may be expressed in units cited within the laboratory report. In the event that the data are available, for example, only in degrees Fahrenheit, the notifier must strike the °C symbol printed in the entry and replace it with the °F symbol.
6.1.4 Attachment NumberNotifiers must clearly indicate a reference for accompanying documents (e.g., Attachment 6) so they may be readily located within the NSN package. Attachments include: justifications for waivers of information; reports of experimental procedures; reports of test results; rationale for alternative data; results and validation of modeling studies; rationales for why information is considered "not applicable"; and information supplemental to a request for confidentiality.
6.1.5 Confidential InformationNotifiers must check the appropriate box to indicate that the information provided is considered confidential (e.g., check "Y" to indicate that the information provided is considered confidential or check "N" to indicate that the information provided is not confidential). If the information provided is considered confidential, the notifier must provide, in the NSN package, the supplementary information detailed in section 7.2 of these Guidelines.
6.2 Part A: Administrative and Substance Identity Information RequirementsTo assist in completing the NSN reporting form, explanations of the various administrative and substance identity information requirements are provided. Subsection 14(1) of the Regulations states the information required for the administrative requirements of the NSN package. Blocks A.1 to A.20 of the NSN reporting form must be completed for all substances that are subject to any Schedule in the Regulations. 6.2.1 Administrative InformationThe alpha-numeric character associated with the following explanations corresponds with the appropriate block on the NSN reporting form. 6.2.1.1 A.1 Certification StatementThe person named in this block is the person who is manufacturing the notified substance in or importing the notified substance into Canada or, when the importer is not a Canadian resident, a person authorized to act on behalf of the "Non-resident Importer" as the "Canadian Agent" (see section 6.2.1.4 of these Guidelines). The person named in this block is the notifier. The Certification Statement includes the following phrase:
The notifier must sign and date this Certification Statement. The signature is a certification that the information provided in the NSN package is accurate and complete to the best of his or her knowledge. This block also allows the notifier to indicate the preferred language of correspondence and preferred mode of communication for correspondence. It is important to note that the Government of Canada does not consider facsimile a secure mode of communication; if facsimile is chosen, the notifier accepts the potential risks associated with this. If a preference for facsimile is indicated, no originals of the transmitted correspondence will be sent to the addressee unless the correspondence is from the Minister (see sections 9.5.2 and 9.5.3 of these Guidelines).
6.2.1.2 A.2 Corporate Headquarters of the Canadian Manufacturer or Importer (Principal Place of Business in Canada): (if the importer is not located in Canada skip to block A.3)A notifier who is a Canadian resident and is manufacturing a substance in or importing a substance into Canada must provide:
If the importer is not located in Canada, block A.2 must be left blank and blocks A.3 and A.4 must be completed, as described below.
6.2.1.3 A.3 Corporate Headquarters of the Non-resident Importer (if applicable, also complete block A.4)When a foreign company or "Non-resident Importer" is the "Importer of Record," as shown on the Canadian Customs coding form (Form B3-3) as issued by the Canada Border Services Agency, and:
the foreign company or "Non-resident Importer" must leave block A.2 blank and provide the following information in block A.3:
6.2.1.4 A.4 Canadian Agent (only needed if block A.3 is applicable)Subsection 14(3) of the Regulations states that if the notifier who provides the information under the Regulations is not a resident of Canada, the notifier must identify, under paragraph 14(1)(b) of the Regulations, a person resident in Canada who is authorized to act on the notifier's behalf as the "Canadian Agent". Therefore, when a "Non-resident Importer" (see section 6.2.1.3 of these Guidelines) is the "Importer of Record" on the Canadian Customs documentation for the notified substance being imported, information on the "Canadian Agent" must be provided. When a "Canadian Agent" is required, the following information must be provided:
If a "Non-resident Importer" provides the information under the Regulations and does not provide the required information on the "Canadian Agent", the NSN package will be considered incomplete and will be returned. If the "Non-resident Importer" has more than one Canadian customer for the same notified substance, NSN packages are not required for each customer as long as the "Non-resident Importer" is recognized as the "Importer of Record" for all shipments going to his or her customers. Yearly import volumes should be tracked by both the "Canadian Agent" and the "Non-resident Importer" to ensure that subsequent higher-volume notification obligations are met. The "Non-resident Importer" may request to be copied on all correspondence, however the "Canadian Agent" is required to receive all notices or correspondence that may be sent in relation to the NSN package and keep a copy of the complete NSN package including the confidential information (except in the case where a foreign supplier is used) and all correspondence and supporting data with respect to the NSN package, for the period of five years after the end of the year in which the information is provided (see section 13 of the Regulations). The "Canadian Agent" is legally responsible for complying with the Regulations.
6.2.1.5 A.5 Foreign Supplier (only needed if the technical information in Part B is provided by a third party)If any, or all, of the confidential technical information from Part B of the NSN reporting form is being provided by a third party or foreign supplier, the name and address of the third party or foreign supplier must be provided in block A.5. This information should include the civic and postal addresses, telephone and fax numbers (including area code) and e-mail address, if any.
6.2.1.6 A.6 Proposed Site of Manufacture in Canada / Proposed Port of Entry into Canada / Toll Manufacturer InformationFor notified substances that are manufactured in Canada, the notifier must provide the civic address of the site of manufacture of the notified substance in Canada. If there is more than one site of manufacture, all must be provided in an attachment. For notified substances that are manufactured in Canada on toll the notifier must provide the following information:
For notified substances that are imported into Canada , the notifier must provide the port of entry into Canada of the notified substance; this should include at least the city and province. If there is more than one port of entry, all must be provided in an attachment. Recognized ports of entry are listed at www.cbsa-asfc.gc.ca/contact/listing/indexpages/index-e.html .
6.2.1.7 A.7 Technical ContactThe name of a person who is familiar with the content of the NSN package and can assist in the resolution of issues pertaining to ambiguous, incomplete or missing information must be provided. This person must be identified by his or her name, title, civic and postal addresses, telephone and fax numbers (including area code) and e-mail address, if any. The technical contact need not be a resident of Canada but must be familiar with the nature and content of the NSN package.
6.2.1.8 A.8 Previous NSN Reference Number / PNC Reference NumberAll Schedules require the notifier to provide any previous NSN reference number(s) or PNC reference number(s), if one has been assigned, and the date (YYYY-MM-DD) of the submission of that information.
6.2.1.9 A.9 Fee Provided (if applicable)The notifier should indicate the amount of the fee provided as per the NSFR (see Appendix 3 of these Guidelines). Appendix II of the NSN reporting form should also be completed and accompany the NSN package.
6.2.1.10 A.10 Manufacture / ImportAn indication of whether the notified substance will be manufactured in and/or imported into Canada must be provided.
6.2.1.11 A.11 AmountThe notifier must indicate the prescribed annual quantity that triggers the requirement to notify.
6.2.1.12 A.12 Date that the Amount in Block A.11 is Expected to Be ExceededThe notifier must provide the date on which the trigger quantity noted in block A.10 is anticipated to be exceeded. This date should be entered in the form of YYYY-MM-DD.
6.2.1.13 A.13 Substance Information (check all that apply)The notifier must mark the appropriate box(es) with an "X" to indicate substance type (chemical, biochemical, polymer, biopolymer, special categories, on NDSL). If the notified substance is a polymer, additional boxes must be marked with an "X" for information pertaining to reactants and RRR polymer criteria (see section 3.4.1.3 of these Guidelines). If the notified substance is on the confidential portion of the NDSL, the notifier must also provide the confidential NDSL accession number. If the notified substance is intended for use in both industrial and F&DA products (dual use) the notifier must leave the box "Solely for F&DA use" blank and submit the NSN package with the appropriate fees to the NS program. The "solely for F&DA use" box must be checked only if the notified substance is solely for an F&DA use. Substances intended solely for an F&DA use are not subject to the NSFR. For more information regarding the notification of substances in products regulated by the F&DA contact the Environmental Assessment Unit of Health Canada by phone at 1-866-996-9913 or 613-948-3591 or by email at eau-uee@hc-sc.gc.ca .
6.2.1.14 A.14 Schedule NumberThe appropriate Schedule being provided must be circled for the type of substance that is being notified. NSN packages for notified substances that are biochemicals or biopolymers must also contain specific items from Schedule 2 of the Regulations. In these cases both the notified Schedule and Schedule 2 should be circled.
6.2.1.15 A.15 Anticipated, Historical and Other Likely Uses of the SubstanceAny anticipated, historical or other likely uses of the notified substance should be entered here. Additional information is also required for certain Schedules and should be provided in Part B1. of Appendix I of the NSN reporting form (see section 6.6.2.1 of these Guidelines).
6.2.1.16 A.16 Anticipated Annual Quantity to Be Manufactured and/or ImportedAn estimate of the annual manufacture or import quantities during the first 12 months after notification must be provided. Additional information should also be provided in Part A of Appendix I of the NSN reporting form (see section 6.6.1 of these Guidelines).
6.2.1.17 A.17 Confidentiality RequestsNotifiers must check the appropriate box to indicate whether the information provided is confidential or not (e.g., "Y" or "N", respectively) . If the information is considered confidential, the notifier must provide, in the NSN package, the supplementary information detailed in section 7.2 of these Guidelines. Marking the "Y" box infers the following:
6.2.1.18 A. 18 Information-Sharing Agreement AuthorizationInstances may occur where a substance has been notified but has not been added to the DSL, because: the notified substance did not meet all of the criteria in section 87 of the Act; risk management measures were taken on the notified substance; or the assessment or processing of the NSN package is still in progress. In such cases, any other notifier intending to manufacture or import that substance will be required to provide a complete NSN package. To reduce both duplicate testing and the expense of developing information for an NSN package, the NS program provides an opportunity for notifiers of a common substance to exchange data through the use of an Information-Sharing Agreement (ISA). There are no additional fees required for using the ISA. An ISA starts when a notifier provides the NS program with 1) documentation of intent to manufacture or import a particular substance; and 2) authorization to release the name of the technical contact within the company to any other company that also meets these two criteria for that substance. Documentation of intent to manufacture or import a substance may be either an NSN package or a Notice of Bona Fide Intent to Manufacture or Import (see section 2.3.1 of these Guidelines). After receipt and acceptance of this documentation, the NS program will conduct a search for ISA candidates and, if any exist, will simultaneously provide each notifier with the name of the other company or companies and the name, address and phone number of the technical contact for each company. The NS program's contribution to the process will end at this point, and the notifiers may then proceed to negotiate an ISA. If a notifier is willing to enter into an ISA, the ISA Authorization box (Box A.18) must be signed and dated (YYYY-MM-DD). 6.2.2 Substance Identity InformationThe NS program must receive complete and unambiguous identification of the new substance (see section 3.4 of these Guidelines). If the notified substance is not adequately identified, the submission will be declared incomplete and returned. This block must be completed even if the substance identity is claimed as confidential. 6.2.2.1 A.19 CAS Registry Number and/or Enzyme Commission NumberAll Schedules of the Regulations require that the CAS registry number be provided, if such a number can be assigned to identify the notified substance. Schedule 2 of the Regulations requires an Enzyme Commission number to be provided for biochemicals that possess enzymatic capability, if it is available. 1. CAS Registry NumberThe most precise CAS registry number available for the notified substance must be obtained. For example, CAS registry number 68527-02-6 (chlorinated olefins (C12-C24)) would not be acceptable for (Z)-1-chloro-5-dodecene; the acceptable CAS registry number for this substance is 71673-24-0. Sources of existing CAS registry numbers are described in Appendix 6 of these Guidelines. To obtain information on CAS registry numbers, contact: Chemical Abstracts Service Telephone: Facsimile: 614-447-3713 Internet: www.cas.org 2. Enzyme Commission Number Designated by the IUBMBEnzyme Commission numbers, as designated by the nomenclature committee of the IUBMB, are also commonly referred to as IUBMB numbers. The Enzyme Commission number is the source for internationally accepted enzyme nomenclature and classification systems. The Enzyme Commission number is a four-figure set in which the first figure denotes one of the six main classes of catalytic substances based on the reaction catalyzed; the second and third figures indicate subclasses; and the fourth figure is the serial number of the catalytic substance in its subclass. The four-digit Enzyme Commission number is a unique number assigned to substances with catalytic activity. When biochemicals that are enzymes are being notified, the most precise fourth-level Enzyme Commission number available must be obtained and submitted. For example, Enzyme Commission number 1.1.2 would not be acceptable for Mannitol dehydrogenase (cytochrome); the acceptable Enzyme Commission number for this substance is 1.1.2.2. Enzyme Commission numbers can be obtained from a publication made for the IUBMB by Academic Press, Inc. To obtain a copy from the United States, contact: Academic Press, Inc. To obtain a copy from the United Kingdom, contact: Academic Press, Inc. Enzyme Commission numbers can also be obtained from the following web site: www.chem.qmw.ac.uk/iubmb/enzyme
6.2.2.2 A.20 Chemical Name of the SubstanceAll Schedules require that the exact name, established in accordance with the nomenclature rules of IUPAC, CAS or IUBMB, be used to identify substances. The name should enable an unambiguous chemical structural diagram to be drawn, unless the notified substance is considered a UVCB. For UVCB substances, the terms "reaction product of" "compounds with" or other acceptable nomenclature may be used. Examples of UVCB substances are:
Additional information on the naming of well-defined and UVCB chemicals can be found in Appendix 5 of these Guidelines. Biochemicals that are enzymes should be named in accordance with the IUBMB nomenclature conventions. Group terms such as protease are not acceptable. The name must uniquely identify a single enzyme (e.g., subtilisin produced by Bacillus subtilis). Polymer and biopolymer nomenclature, including pre-polymers, incorporates the identity of monomers and reactants used in the manufacture of the polymer or biopolymer. The name of the polymer may or may not include monomers or other reactants that are either incorporated into the polymer or charged to the reaction vessel at 2% or less by weight. However, these substances must be included in the description of the polymer composition (see section 6.2.2.8 of these Guidelines). Examples of polymer nomenclature are:
6.2.2.3 A.21 Proposed Masked Name (if the Chemical Name is Claimed Confidential)If the chemical name of the notified substance is claimed as confidential, a masked name must be provided in accordance with the Masked Name Regulations. Procedures for generating masked names are described in section 7.2 and Appendix 7 of these Guidelines. If the masked name includes multiple masking, then acceptable justification must also be provided in the NSN package. There is an additional fee required for a masked name application (see Appendix 3 of these Guidelines).
6.2.2.4 A.22 Known Trade Names or Synonyms of the Chemical Name of the SubstanceAll Schedules of the Regulations require that all known trade names or internal company codes must be provided, especially any such names or code numbers used in the test reports provided for the data requirements. Synonyms of the chemical name, if known, should also be provided.
6.2.2.5 A.23 Structural Formula of the SubstanceThe structural formula diagram must be provided for chemicals subject to Schedule 1, 5 or 6 of the Regulations. The structural formula diagram, if possible, or else a partial structural formula must be provided for polymers subject to Schedule 3, 9, 10 or 11 of the Regulations. In both cases, these diagrams must be made large enough to clearly indicate the identity of all atoms, types of bonds, ionic charges and relevant stereochemistry. If the structure is too large for this box, an attachment where the structure can be found should be indicated. Carbon atoms in ring systems and their attached hydrogen atoms need not be explicitly shown. Where applicable, proportions of isomers or tautomeric forms must be indicated. Additional information and examples of structural formulae are provided in Appendix 5 of these Guidelines. In addition, a reaction scheme showing a detailed description of the process for which the notified substance is made is required for polymers that meet the RRR polymer criteria (see section 3.4.1.3 of these Guidelines) and are subject to Schedule 9 of the Regulations, unless the polymers are polyesters manufactured solely from reactants listed in Schedule 8 of the Regulations (see subparagraph 9(c) of the Regulations). Additional information can be found on the NS program web site at www.ec.gc.ca/substances/. For UVCB substances, the name and, if known, the CAS registry number of immediate precursors must be provided. UVCB substance names may include a description of the synthesis (e.g., acetylation, alkaline hydrolysis) and, where applicable, the range of possible compositions (e.g., paraffins [petroleum], normal C5-20).
6.2.2.6 A.24 Molecular FormulaThe molecular formula is required for chemicals that are subject to Schedule 1, 5 or 6 of the Regulations and for polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations. The empirical formula must be provided and should identify each of the monomer units. Examples are:
6.2.2.7 A.25 Gram Molecular WeightThis information is required for chemicals that are subject to Schedule 1, 5 or 6 of the Regulations. The gram molecular weight should be provided for chemicals with a definite structural formula. For UVCB substances, an estimate or range of molecular weights must be provided, if known. The number average molecular weight for polymers is discussed in section 6.3.1.14 of these Guidelines and should be entered into section B.1 of the NSN reporting form and not in block A.25.
6.2.2.8 A.26 Monomers and Reactants with their ConcentrationThis information is required for polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations. Reactants include compounds such as free radical initiators, cross-linking agents, chain-terminating agents, neutralizing agents and chain-transfer agents that become part of the polymer. The name, CAS registry number and percentage by weight of each reactant must be given. Reactants, either incorporated into the polymer or charged to the reaction vessel at 2% or less by weight in the manufacture of the polymer, must also be reported, even if they were not included in the name of the polymer. The percentage by weight of the reactants must add up to 100%. 1. Pre-Polymer RuleThe Regulations allow for reduced information requirements if the polymer is manufactured solely from reactants listed on the DSL or NDSL. The term "reactant" is defined in subsection 1(1) of the Regulations as follows:
For the purpose of deciding whether or not a polymer will be eligible for the regulatory relief provided in section 11 of the Regulations (see section 4.7.1 of these Guidelines), the term "reactant" includes ultimate precursors of pre-polymers. If a pre-polymer is used in the manufacture of the notified substance and the pre-polymer rule is being used to reduce information requirements, the composition data for the pre-polymer must be provided and must include the names and CAS registry numbers for each component. This is necessary to determine if the pre-polymer exemption applies. For example, when a notified substance contains a pre-polymer that is not on the DSL or NDSL but all of the pre-polymer's reactants are listed on the DSL or NDSL, the notified substance would be considered for reduced information requirements. Polymer ABCDE contains reactants A and E which are listed on the DSL and pre-polymer BCD which is not on the DSL or NDSL. Pre-polymer BCD contains reactants B, C and D; pre-polymer reactants B and D are listed on the DSL; pre-polymer reactant C is listed on the NDSL. Therefore, in this case, the pre-polymer rule applies and the notified substance, Polymer ABCDE would be considered for reduced information requirements. The percentage by weight of the composition of the pre-polymer is also required if a group of concern is present in the pre-polymer. This is necessary to determine if the notified substance meets the RRR polymer criteria.
6.2.2.9 A.27 Additives, Stabilizers and Solvents with their ConcentrationThis information is required for chemicals that are subject to Schedule 1, 5 or 6 of the Regulations and polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations. Additives are substances that are deliberately introduced into a product and include, for example, stabilizers, emulsifiers, solvents and anti- oxidants that are present when the chemical is tested. The name, CAS registry number and concentration by weight of each must be provided.
6.2.2.10 A.28 Impurities with their ConcentrationThis information is required for chemicals that are subject to Schedule 1, 5 or 6 of the Regulations and polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations. Impurities are substances that are present but are not necessary for the intended use of the product. Impurities are usually present in the final product in low concentrations and may include unreacted starting materials and reaction by-products. The name, CAS registry number and percentage by weight of each impurity must be given, if known.
6.2.2.11 A.29 Degree of Purity in its Technical Grade CompositionThis information is required for chemicals that are subject to Schedule 1, 5 or 6 of the Regulations. The degree of purity in its technical grade composition must be provided here, if applicable.
6.2.2.12 A.30 Material Safety Data Sheet (MSDS)All Schedules of the Regulations require that a Material Safety Data Sheet (MSDS) be provided if available. An MSDS, as defined in subsection 11(1) of the Hazardous Products Act and detailed in the Controlled Products Regulations, must be provided if one has been prepared. If any of the information specified in section 6.6 of these Guidelines is described in sufficient detail on the MSDS, the appropriate section of the MSDS can be referred to in sections E1. and E2. of Appendix 1 of the NSN reporting form.
6.3 Part B: Technical Information RequirementsAll prescribed technical information must be addressed by submitting test data, alternative data or waivers (see section 8 of these Guidelines). The onus is on the notifier to provide acceptable information. Explanations of the information requirements, prescribed in the various Schedules of the Regulations, are provided to assist with the generation and compilation of the technical data prescribed in the Regulations. These explanatory notes elaborate details such as under which Schedules the information is required; the conditions under which various tests are required; and what constitutes complete and adequate information in the opinion of the NS program. Part B of the NSN reporting form contains four sections:
Explanatory notes for the technical information requirements are given in the following sections of these Guidelines. 6.3.1 B.1 Physical-Chemical Information Requirements6.3.1.1 Melting PointThis test is required for chemicals that are subject to Schedule 5 or 6 of the Regulations. A melting point between -25 °C and 300 °C must be provided as a single value or a range of values. However, if the value is outside this temperature range, the information may be indicated as "<-25 °C" or ">300 °C". In cases where the notified substance undergoes a chemical reaction (e.g., degradation, decomposition, rearrangement) other than melting, then the temperature at which the reaction occurs must be reported. As alternative data, a pour point, softening point or sublimation point should be provided instead of a melting point, when this is appropriate.
6.3.1.2 Boiling PointThis test is required for chemicals that are subject to Schedule 5 or 6 of the Regulations. A boiling point between -50 °C and 300 °C must be provided as a single value or a range of values. However, if the value is outside this temperature range, the information may be indicated as "<-50 °C" or ">300 °C". In cases where the notified substance undergoes a chemical reaction (e.g., degradation, decomposition, rearrangement) other than boiling, then the temperature at which the reaction occurs must be reported.
6.3.1.3 DensityDensity is required for chemicals that are subject to Schedule 5 or 6 of the Regulations.
6.3.1.4 Vapour PressureThis test is required for chemicals that are subject to Schedule 5 or 6 of the Regulations. However, the vapour pressure is not required if the chemical has a standard boiling point less than 0°C.
6.3.1.5 Water SolubilityWater solubility is required for chemicals that are subject to Schedule 5 or 6 of the Regulations.
6.3.1.6 Octanol-Water Partition CoefficientThe octanol-water partition coefficient is required for chemicals having a water solubility of less than or equal to 5 g/L that are subject to Schedule 5 or 6 of the Regulations. However, there is no water extractability cut-off for polymers; therefore, the octanol-water partition coefficient is required for all substances that are subject to Schedule 10 or 11 of the Regulations.
6.3.1.7 Ready Biodegradation 7A ready biodegradation test is required for chemicals that are subject to Schedule 5 or 6 of the Regulations. The identity of any known products of biodegradation must also be provided.This test is also required for polymers that are subject to Schedule 11 of the Regulations. The ready biodegradation test is required on the water-soluble portion of the polymer unless the polymer has a water extractability (see section 6.3.1.13 of these Guidelines) at pH 7 of less than or equal to 2% or is a branched silicone or siloxane polymer. In these cases, a waiver should be requested.
6.3.1.8 SpectroscopyThis test is required for chemicals that are subject to Schedule 6 of the Regulations. At least one spectrum suitable for characterization of the chemical is required ( e.g., infrared [IR], ultraviolet [UV], nuclear magnetic resonance [NMR], etc.). Details of the methodology used ( e.g., solvent, ionization technique, field strength, band width, instrumentation) must also be provided. UV spectra should include the range down to 290 nm.
6.3.1.9 Adsorption-DesorptionThis test is required for chemicals having a water solubility of greater than or equal to 200 µg/L and that are subject to Schedule 6 of the Regulations. This test is also required for chemicals having a water solubility of greater than or equal to 200 µg/L, that are listed on the NDSL and that are released into the aquatic environment in a quantity greater than 3 kg/day, per site, averaged monthly and after wastewater treatment (subsection 7(2) of the Regulations) (see section 4.4.3.1 of these Guidelines).
6.3.1.10 Hydrolysis as a Function of pHThis test is required for chemicals having a water solubility of greater than or equal to 200 µg/L that are subject to Schedule 6 of the Regulations. The identity of any known hydrolysis products must also be provided. This test is also required for chemicals having a water solubility of greater than or equal to 200 µg/L, that are listed on the NDSL and that are released into the aquatic environment in a quantity exceeding 3 kg/day, per site, averaged monthly and after wastewater treatment (subsection 7(2) of the Regulations) (see section 4.4.3.1 of these Guidelines). The identity of any known hydrolysis products must also be provided. This test is also required for polymers that are subject to Schedule 10 or 11 of the Regulations and have a water extractability (see section 6.3.1.13 of these Guidelines) determined to be greater than 2%. The identity of any known hydrolysis products must also be provided.
6.3.1.11 Physical StateThe physical state of the polymer is required for polymers subject to Schedule 3, 10 or 11 of the Regulations. The requirement for physical state will be satisfied with an appropriate term ( e.g., "solid," "wax" or "liquid").
6.3.1.12 Formulated for Dispersal in WaterThis information is required for polymers subject to Schedule 3, 10 or 11 of the Regulations. The degree of dispersibility need not be determined; however, if the polymer is formulated for dispersal in water, this must be stated. The requirement for this data point will be satisfied by indicating "yes" or "no".
6.3.1.13 Water ExtractabilityWater extractability is required for polymers that are subject to Schedule 10 or 11 of the Regulations. Water extractability at pH 7 is required for anionic and neutral polymers; water extractability at pH 2 and 7 is required for cationic polymers; and water extractability at pH 2, 7 and 9 is required for amphoteric polymers. If the water extractability is <2%, the result must be reported as <2%. Note: For notified substances that are highly dispersed in water, a water extractability study will not be feasible; however, ecotoxicity studies would still be required, as the substance would be bioavailable in the aquatic environment. Additional information will be made available on the NS program web site at www.ec.gc.ca/substances
6.3.1.14 Number Average Molecular Weight (Mn)This test is required for polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations. Generally, if the polymer is available in a series of different molecular weight compositions, information must be developed using the lowest Mn composition. However, pre-existing information developed on higher-molecular-weight compositions should also be submitted.The Mn must be determined on the composition having the lowest number average molecular weight of any composition intended for manufacture or import. The Mninformation must include the test procedures used and the chromatogram, calibration curve and slice tables produced during the test. If the notified substance has low water extractability (<2%), the Mndoes not need to be submitted however the water extractability data must be provided as alternative data for the molecular weight requirements. If the notified substance has a water extractability of greater than or equal to 2%, the Mn must be determined on the extractable portion of the notified substance (e.g., if 5% of the polymer is soluble then the Mn must be determined on this 5% portion). Only a target Mn is required for polymers that are manufactured or imported as research and development substances and that are subject to Schedule 3 of the Regulations.
6.3.1.15 Residual Constituents with Molecular Weights Less than 500 Daltons and Less than 1000 DaltonsThis information is required for polymers that are subject to Schedule 3, 9, 10 or 11 of the Regulations, except for research and development substances. The percentage of residual constituents must be determined on the composition that has the lowest number average molecular weight of any composition intended for manufacture or import.
6.3.2 B.2 Ecotoxicity Information RequirementsThe actual number and type of ecotoxicity tests that must be performed on a substance depend on Schedule number and/or the most sensitive species with regard to the substance. Full test reports must be provided; summaries will not be accepted. 6.3.2.1 Acute Fish, Daphnia and Algal Toxicity8One or more of these tests are required for chemicals subject to Schedule 5 or 6 of the Regulations and for polymers subject to Schedule 10 or 11 of the Regulations. For chemicals subject to Schedule 5 of the Regulations, data from one acute fish, daphnia or algal toxicity test are required. For chemicals subject to Schedule 6 of the Regulations, data from the remaining two ecotoxicity tests (that were not completed for the submission of Schedule 5) are required. For polymers subject to Schedule 10 of the Regulations, data from an acute toxicity test for the most sensitive species (fish, daphnia or algae) or, if the sensitivity of these three species is unknown, an acute algal toxicity test are required, unless the polymer has a water extractability at pH 7 of less than or equal to 2%. For polymers subject to Schedule 11 of the Regulations and that have a water extractability at pH 7 of greater than 2%, data from the following tests are required:
6.3.2.2 Acute Algal Toxicity8An acute algal toxicity test, performed on regular growth medium, may be required for chemicals subject to Schedule 5 or 6 of the Regulations and for polymers subject to Schedule 10 or 11 of the Regulations (see section 6.3.2.1 of these Guidelines). Since the toxicity of polycarboxylic acids may be mitigated by the presence of Ca2+ or Mg2+ ions, algal toxicity of polycarboxylic acids can also be conducted using a modified algal growth medium (Ca, or Ca and Mg, added to attain a measured hardness of 150.0 mg/L as CaCO3).
6.3.3 B.3 Health Toxicity Information RequirementsFor all health toxicity information requirements, the following test information must also be provided:
6.3.3.1 Acute Mammalian Toxicity9This information is required for chemicals subject to Schedule 5 or 6 of the Regulations and for polymers subject to Schedule 10 or 11 of the Regulations. For polymers subject to Schedule 10 or 11 of the Regulations the test animals must be dosed by the oral route. For chemicals subject to Schedule 5 or 6 of the Regulations, test animals must be dosed using the same route or routes of exposure that are anticipated to be the most significant route or routes for potential human exposure (e.g., oral, dermal and/or inhalation). The most significant route of potential human exposure for the Regulations refers to exposure of the general population in Canada. To select the most appropriate route or routes for testing, the expected concentration of the notified substance in the various environmental media and consumer products and the bioavailability of the substance through ingestion, inhalation and dermal absorption must be considered. The most significant route of exposure to a substance for the general population may be different from exposures for workers in an occupational setting. Consequently, data generated for occupational exposures may not meet the requirement for "the most significant route of potential human exposure" specified in the Regulations. If it is not evident which route or routes would be the most appropriate for testing under the Act, the NS program (see section 8.8 of these Guidelines) should be consulted. Note: Acute toxicity test data generated after December 16, 2002, utilizing OECD TG 401 will not be considered acceptable to fulfil the regulatory requirements for this endpoint. 6.3.3.2 Information Sufficient to Assess Skin Irritation9Information sufficient to assess skin irritation is required for chemicals subject to Schedule 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. This information could be obtained from data from validated test methods for the following endpoints:
The above is not intended to be an exhaustive list. As new methods are developed and validated, the NS program will assess whether they provide sufficient information to permit an assessment of skin irritation. Properly conducted human patch tests (positive or negative response) may be an acceptable alternative to animal testing. The concentration of notified substance to which individuals were exposed will be a critical factor regarding the acceptability of human patch tests. Human use experience may also be an acceptable alternative (positive response only), provided the human use experience is well described, including quantifying the exposure and dermal response as accurately as possible. Anecdotal information from persons handling or exposed to the substance is not an acceptable alternative. In addition, information for the assessment of skin irritation may be obtained from (Q)SARs, with adequate scientific justification provided by the notifier regarding the validation and applicability domain of the model. 6.3.3.3 Skin Sensitization10This information is required for chemicals subject to Schedule 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. Properly conducted human patch tests (positive or negative response) may be an acceptable alternative to animal testing. The concentration of notified substance to which individuals were exposed will be a critical factor regarding the acceptability of human patch tests. Human use experience may also be an acceptable alternative (positive response only), provided the human use experience is well described, including quantifying the exposure and dermal response as accurately as possible. Anecdotal information from persons handling or exposed to the substance is not an acceptable alternative. 6.3.3.4 Repeated-Dose Mammalian Toxicity10This information is required for chemicals subject to Schedule 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. A test report from a study of at least 28 days duration must be submitted unless a 14-day test was performed before publication of the original Regulations in the Canada Gazette, Part II, on April 6, 1994. In that case, data from the 14-day test would be acceptable. As described in section 6.3.3.1 of these Guidelines, "Acute Mammalian Toxicity", test animals must be dosed using the most significant route of potential exposure for the general population in Canada. This test is also required for a chemical that is listed on the NDSL and for a polymer that is listed on the NDSL or all of whose reactants are listed on the DSL or NDSL and where the substance is released into the aquatic environment in a quantity greater than 3 kg/day, per site, averaged monthly and after wastewater treatment; and/or the public may be significantly exposed to the substance in a product (subsections 7(2), 7(3), 11(2) or 11(3) of the Regulations). For additional information on these data points, see sections 4.4.3 and 4.9.2 of these Guidelines.
6.3.4 B.4 Genotoxicity Information Requirements10The actual number and type of genotoxicity tests that must be performed on a substance depend on the results of other genotoxicity tests; the structural similarity of the substance to known mutagens or carcinogens (or non-mutagens and non-carcinogens); and the anticipated human exposure to the substance. If it can be demonstrated that the information from a genotoxicity test is not needed for the assessment or that the test is not technically feasible, a waiver of that information will be granted (see section 8.7 of these Guidelines). Examples of conditions under which waivers may be granted for genotoxicity tests are given in Appendix 8 of these Guidelines. 6.3.4.1 In Vitro Test for Gene MutationsAn in vitro test, with and without metabolic activation, for gene mutation is required for chemicals subject to Schedule 5 or 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. This test is also required for a polymer that is listed on the NDSL or all of whose reactants are listed on the DSL or NDSL and where the substance is released into the aquatic environment in a quantity greater than 3 kg/day, per site, averaged monthly and after wastewater treatment; and/or the public may be significantly exposed to the polymer in a product (subsections 11(2) and 11(3) of the Regulations). For additional information on the determination of these data points, see section 4.9.2 of these Guidelines. When this information is required under subsection 11(2) of the Regulations, the notifier may provide, in lieu of this test, an in vitro test, with and without metabolic activation, for chromosomal aberrations (see next section). 6.3.4.2 In Vitro Mammalian Test for Chromosomal AberrationsAn in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells is required for chemicals subject to Schedule 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. This test is also required for a chemical that is listed on the NDSL and for a polymer that is listed on the NDSL or all of whose reactants are listed on the DSL or NDSL and where the public may be significantly exposed to the substance in a product (subsections 7(3) and 11(3) of the Regulations). For additional information on these data points, see sections 4.4.3.2 and 4.9.2.2 of these Guidelines. When this information is required under subsections 7(3) or 11(3) of the Regulations, the notifier may, in lieu of an in vitro test for chromosomal aberrations, submit data from a previously existing in vivo mammalian test for chromosomal aberrations, together with data substantiating that the tissue investigated was exposed to the notified substance or its metabolites. 6.3.4.3 In Vivo Mammalian Test for Chromosomal Aberrations or Gene MutationsAn in vivo mammalian test for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the substance or its metabolites, permits an assessment of in vivo mutagenicity acceptable to the NS program is required for chemicals subject to Schedule 6 of the Regulations and for polymers subject to Schedule 11 of the Regulations. Criteria for "evidence that the tissue investigated was exposed to the substance or its metabolites" and for what constitutes an "indicator of mutagenicity" and an assessment "acceptable to the NS program" are described in Appendix 10 of these Guidelines. Some flexibility is given in the choice of in vivo test to permit the most appropriate test to be chosen for the substance. The choice of in vivo test should be based on results from in vitro genotoxicity tests; the structure and mechanism of action of the substance; and developments in the field of genotoxicity.
6.3.5 Regulatory Exemptions: Health Toxicity Tests Not Required for Certain PolymersThe information required for polymers with significant exposure and high release (see section 4.9.2 of these Guidelines) that is prescribed in subsections 11(2) and 11(3) of the Regulations as well as the health toxicity tests described in section 6.3.3 and 6.3.4 of these Guidelines is not required for polymers that fall under one of the classes listed in Table 6-1.
Additions to this list may be made through regulatory amendments.
6.3.6 Waivers for Health Hazard Toxicity Data for PolymersTable 6-2 lists some examples of polymers for which waivers will likely or will not be granted for health toxicity tests. This table is subject to change as more information becomes available. These updates will be provided through the NS program web site at www.ec.gc.ca/substances/. These waivers are evaluated on a case-by-case basis; although not required, the NS program provides the opportunity for notifiers to submit a PNC request (see section 8.8 of these Guidelines), while the NSN package is being prepared, to determine if the waivers are acceptable.
Polymers with insignificant amounts of low-molecular-weight species (e.g., <0.1% species <1000 daltons) and that are not expected to break down, for which waivers for health data have been granted, on that basis, will only be eligible for listing on the DSL if there is a SNAc Notice issued. This will ensure that health hazard toxicity data are provided for polymers that do not meet the cut-off criteria for low-molecular-weight species.
6.4 Part C: Biochemical or Biopolymer Information RequirementsAdditional information is required for biochemicals and biopolymers manufactured or imported, including substances being manufactured or imported under one of the special categories indicated in section 3.5 of these Guidelines. The following information is required to address the nature of the production process (e.g., living organism) and the potentially unique biological activity of enzymes and nucleic acids. 6.4.1 Identification, Source and HistoryThe identification of the production organism and the organ, if applicable, from which the substance is isolated is information required for biochemicals and biopolymers subject to any Schedules of the Regulations. An accurate identification of the organism used to produce the biochemical or biopolymer must be provided. The identification should include a taxonomic designation to at least the species level. Taxonomic designations should follow International Codes of Nomenclature and standard taxonomic sources. Where the organism is genetically modified, the host organism and all organisms that were sources of genetic material must be identified. In addition this information should include:
Where the substance's name is claimed as confidential, an acceptable masked name must be provided in accordance with the Masked Name Regulations. Guidance for masking microorganism names is given in section 8 of the Guidelines for Notification of New Substances (Organisms).
6.4.2 Adverse Environmental or Human Health EffectsThis information is required for biochemicals and biopolymers subject to any Schedules of the Regulations. This information should include a description of any known adverse environmental or human health effects associated with exposure to the production organism.
6.4.3 Concentration of the Viable Production OrganismThis information is required for biochemicals and biopolymers subject to any Schedules of the Regulations. The concentration of the viable production organism in the biochemical or biopolymer and, if known, in end-use products must be provided. Production organisms that are present in the notified substance are considered impurities, and the level of these organisms should therefore be determined and provided, together with a description of the assay method. The presence of viable organisms in a substance is of potential concern because of the potential health hazard that may result from exposure to an organism or its metabolic products. During the research and development stage of manufacturing, the number of persons exposed to a substance is usually limited, and the pilot-scale manufacturing process is not necessarily representative of the conditions that will pertain during full-scale production. For these reasons, determination of the level of production organism(s) in the notified substance is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.4 Method Used to Separate the Production OrganismThis information is required for biochemicals subject to Schedule 1, 5 or 6 of the Regulations and biopolymers subject to Schedule 3, 10 or 11 of the Regulations. This information must include a description of the method(s) used to separate the production organism from the biochemical or biopolymer. This information is not required for research and development substances.
6.4.5 Identification of Encoded ProductsThis information is required for biochemicals that are nucleic acids (repeating units of deoxyribonucleotides or ribonucleotides) and are subject to Schedule 1, 5 or 6 of the Regulations and for biopolymers that are nucleic acids and are subject to Schedule 3, 10 or 11 of the Regulations. This information must include the identification of the encoded products, if known. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.6 Description of Biological ActivityThis information is required for biochemicals that are nucleic acids (repeating units of deoxyribonucleotides or ribonucleotides) and are subject to Schedule 1, 5 or 6 of the Regulations and for biopolymers that are nucleic acids and are subject to Schedule 3, 10 or 11 of the Regulations. This information must include a description of any known biological activity (e.g., antibiotic resistance) or adverse environmental or human health effects associated with the nucleic acid or with the encoded products, specified under item 5 of Schedule 2 of the Regulations. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.7 Catalytic FunctionsA description of all known catalytic functions is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.8 Enzyme Commission NumberThe four-digit Enzyme Commission number, if available, is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. Additional information on Enzyme Commission numbers can be found in section 6.2.2.1 of these Guidelines. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.9 Substrate SpecificityThis information is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information must include the known substrate specificity for each known catalytic function specified under item 7 of Schedule 2 of the Regulations. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.10 Optimum pH and TemperatureThis information is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information must include the optimum pH and temperature for the substrates specified under item 9 of Schedule 2 of the Regulations. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.11 Catalytic Constants KM and KcatThis information is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information must include the catalytic constants KM (Michaelis-Menten constant) and Kcatand the conditions under which they were measured. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.12 CofactorsThis information is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information must include the known cofactors necessary for enzymatic activity (e.g., NADPH, coenzyme Q). This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.4.13 Enzymatic ActivityThis information is required for biochemicals that possess enzymatic capability and that are subject to Schedule 1, 5 or 6 of the Regulations. This information must include the activity per unit weight of products and, if known, of end-use products. This information is not required for research and development substances or contained site-limited intermediates that are manufactured and consumed at the site of manufacture.
6.5 Part D: Additional Information Requirements6.5.1 D.1 Other Requirements6.5.1.1 Other Agencies Notified, the Agency's File Number and the OutcomeThis information is required for all substances subject to any Schedules of the Regulations. This information must include:
For example, the Ontario Ministry of Labour may have been notified of the import of a new substance for use in an occupational setting, or an American supplier may have notified the USEPA under the Pre-Manufacture Notification provisions of the TSCA. 6.5.1.2 Other Information and Test Data in the Possession of the Manufacturer or ImporterThis information is required for substances subject to any Schedule of the Regulations. This information must include a summary of all other information and test data in respect of the substance that are in the possession of the manufacturer or importer or to which they ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the substance. Summaries must provide sufficient detail regarding methodology and results to permit the NS program to determine the relevance of the information. The NS program may ask to see the full report after reviewing the summaries provided. "In the possession of the manufacturer or importer" means the information in the company's offices in Canada if the NSN package was submitted by a Canadian company or the information in the offices in the country where the notification originated if the NSN package was submitted by a foreign company through a "Canadian Agent". The phrase "to which they ought to have access" means information in any of the company's offices worldwide or other locations where the notifier can access the information.
6.5.2 D.2 Additional Information and AttachmentsAdditional information requirements refer to any information and data relevant to environmental and health hazard identification, such as:
Information on possible environmental benefits resulting from the manufacture or use of the notified substance may also be provided. Examples of such benefits include:
Any information provided as "Additional Information" may be provided in the language in which the information was originally prepared. The NS program requests that at least a summary of any additional information be provided in English or French. 6.5.2.1 Other Technical InformationDuring the 1999-2001 multistakeholder consultation on the 1994 Regulations and the NS program, revisions were recommended to the technical information requirements that are reflected in the 2005 Regulations. It was agreed that information elements that have wide applicability in assessing substances and have internationally accepted test protocols should be included in the Regulations. It was also recognized that in certain cases, information in addition to the required technical information may be needed by the NS program to conduct an assessment. Since these other information elements apply to a small subset of notified substances, they have not been included in the Regulations. Instead, the NS program's web site lists additional data elements and the types of substances where this information may be needed. For example, data on ozone-depleting potential would be needed to conduct the risk assessment for a new substance that is a member of a class of compounds known to be associated with ozone depletion (e.g., halons, as defined in the Montreal Protocol). It is intended that these descriptions will alert notifiers to the potential need for generating additional data. Additional data that may be needed under certain circumstances include:
The NS program provides the opportunity for and encourages notifiers to submit a PNC request (see section 8.8 of these Guidelines), while the NSN package is being prepared, to discuss these data elements prior to generating the information.
6.6 NSN Reporting Form - Appendix I - Manufacture, Import, Use, Exposure and Release Information (Known and Anticipated)Appendix I of the NSN reporting form lists all of the manufacture, import, use, exposure and release information (known and anticipated) that is necessary for an evaluation and that is prescribed by the Regulations. 6.6.1 Part A - Manufacture and/or Importation Information RequirementsInformation submitted for the following sections is required for substances subject to any of the Schedules prescribed in the Regulations and should provide sufficient detail to help predict releases into the environment and potential human exposures. 6.6.1.1 A1. Canadian Manufacture and Processing InformationThe following information, if known, is required for substances manufactured in Canada that are subject to any Schedule of the Regulations:
6.6.1.2 A2. Anticipated Annual Production / Import Quantities of Notified SubstanceThe following information is required for substances that are subject to any Schedule of the Regulations:
The following information is required for chemicals that are subject to Schedule 5 or 6 of the Regulations and non-RRR polymers subject to Schedule 9, 10 or 11 of the Regulations:
6.6.2 Part B - Uses of the Substance6.6.2.1 B1. Anticipated, Historical and Other Likely Uses of the SubstanceInformation on the anticipated uses of the substance is required for substances subject to any Schedule of the Regulations. Information on the historical and other likely uses of the substance is required for substances subject to Schedule 6, 10 or 11 of the Regulations and for NDSL chemicals subject to Schedule 5 of the Regulations. The location of use is required for substances that are contained site-limited intermediates subject to Schedule 1 or 3 of the Regulations. In addition, the following information should be submitted, for each use, for all Schedules:
6.6.2.2 B2. Concentration in ProductsInformation must be provided on the anticipated concentration of the notified substance in products; and, if known, the concentration or range of concentrations of the notified substance as manufactured or imported and the anticipated concentration in end-use products. This information is required for substances subject to Schedule 1, 3, 4, 5 or 6, (See NSN form also) of the Regulations and non-RRR polymers subject to Schedule 9, 10 or 11 of the Regulations. 6.6.2.3 B3. Anticipated to be Used in Products Intended for Use by or for ChildrenThis information is required for chemicals subject to Schedule 5 or 6 of the Regulations and non-RRR polymers subject to Schedule 9, 10 or 11 of the Regulations. This can be answered by indicating either yes or no; however, if the answer is yes the types of products that these may be should also be indicated.
6.6.3 Part C - Human Exposure Information Requirements6.6.3.1 C1. Whether the Public Is Anticipated to Be Significantly Exposed to the SubstanceThis information is required for substances subject to Schedule 1, 3 or 10 of the Regulations or for NDSL chemicals subject to Schedule 5 of the Regulations. This information should include whether the public is anticipated to be significantly exposed to the substance in a product (see sections 4.4.3.2 and 4.9.2.2 of these Guidelines) and should 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). Conversely, information substantiating that the public is not anticipated to be significantly exposed must, likewise, be submitted. Additional data may be required at higher manufacture or import volumes, depending on the outcome of the assessment of this information (see subsections 7(3) and 11(3) of the Regulations). 6.6.3.2 C2. Anticipated Degree of Direct Human ExposureThis information is required for chemicals subject to Schedule 5 or 6 and non-RRR polymers subject to Schedule 9, 10 or 11 of the Regulations and must include:
The following additional information should also be provided, if known:
6.6.4 Part D - Environmental Exposure Information6.6.4.1 D1. Components of the Environment into which Release Is AnticipatedThis information is required for chemicals subject to Schedule 1, 5 or 6 of the Regulations and for polymers subject to Schedule 3 or 11 of the Regulations. This information must include an identification of the components of the environment into which the substance is anticipated to be released. The following additional information should also be provided, where applicable:
6.6.4.2 D2. Anticipated Releases of the Substance into Municipal Wastewater SystemsWhether the substance will be released directly to the Municipal Wastewater Treatment Facility or directly to surface waters must be indicated. This information is required for chemicals subject to Schedule 1, 5 or 6 of the Regulations and for polymers subject to Schedule 3, 10 or 11 of the Regulations. This information must include:
6.6.4.3 D3. Factors that May Limit Environmental ExposureThis information is required for substances subject to Schedule 6, 10 or 11 or NDSL chemicals subject to Schedule 5 of the Regulations. This information must describe conditions during the life cycle of the substance that may limit environmental exposure. 6.6.4.4 D4. Releases of the Substance to the Aquatic EnvironmentThis information is required for NDSL chemicals subject to Schedule 5 of the Regulations and for polymers subject to Schedule 10 of the Regulations. This information must include:
The following additional information must also be provided:
6.6.5 Part E - Transportation, Storage and Disposal Information RequirementsThe information in sections 6.6.5.1 to 6.6.5.2 of these Guidelines is required for chemicals subject to Schedule 1, 5 or 6 of the Regulations and for polymers subject to Schedule 3, 10 or 11 of the Regulations. 6.6.5.1 E1. Transport and Storage ContainersInformation on the transport and storage containers for the substance must include the following: 1. Transport2. Storage
6.6.5.2 E2. Anticipated Disposal of the SubstanceInformation on the recommended disposal procedures for the substance must include the following:
The following additional information should also be provided, if known:
6.7 NSN Reporting Form - Appendix II - New Substances Fee Payment Form with Credit Card AuthorizationAppendix II is a form that has been provided to aid in determining the fee amount required for a specific NSN package. It also contains a credit card authorization form if this is the chosen method of payment by the notifier. Additional information on the fees required and methods of payment available can be found in Appendix 3 of these Guidelines.
7, 8, 9, 10 Must comply with GLP (see section 8.3 of these Guidelines). 11 The United Nations (UN) Number is a four-digit code used to describe materials being transported in Canada. These codes are in "Dangerous Goods: Guide to Initial Emergency Response," available through the Canada Communication Group Publishing.
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Who Should and How To
Notify
Chemicals and Polymers
