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

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SECTION 3 - Substances

• 3.1 Definition of "Substance"
• 3.2 Exclusions from the Regulations
  • 3.2.1 Mixtures (Section 3 of the Act)
  • 3.2.2 Manufactured Items (Section 3 of the Act)
  • 3.2.3 Wastes (Section 3 of the Act)
  • 3.2.4 Substances Carried through Canada (Subsection 3(2) of the Regulations)
  • 3.2.5 Polymers Subject to the "Two Percent Rule"
  • 3.2.6 Proteins Subject to the "Two Percent Rule"
• 3.3 Substances Not Subject to the Regulations
  • 3.3.1 Other Acts of Parliament
  • 3.3.2 Transient Reaction Intermediates
  • 3.3.3 Impurities
  • 3.3.4 Incidental Reaction Products
  • 3.3.5 Low-Volume Exemptions
  • 3.3.6 Substances Occurring in Nature
• 3.4 Substances Subject to the Regulations
  • 3.4.1 Classification of Substances
    • 3.4.1.1 Chemicals and Biochemicals
    • 3.4.1.2 Polymers and Biopolymers
    • 3.4.1.3 Reduced Regulatory Requirement (RRR) Polymers
    • 3.4.1.4 Non-reduced Regulatory Requirement (non-RRR) Polymers
    • 3.4.1.5 Polymers Described in Schedule 7 of the Regulations
• 3.5 Special Category Substances
  • 3.5.1 Research and Development Substances
  • 3.5.2 Contained Site-Limited Intermediate Substances
  • 3.5.3 Contained Export-Only Substances

3.1 Definition of "Substance"

For the purposes of the new substances notification regime, section 3 of the Act defines a "substance" as:

any distinguishable kind of organic or inorganic matter, whether animate or inanimate, and includes

1. any matter that is capable of being dispersed in the environment or of being transformed in the environment into matter that is capable of being so dispersed or that is capable of causing such transformations in the environment;
2. any element or free radical;
3. any combination of elements of a particular molecular identity that occurs in nature or as a result of a chemical reaction; and
4. complex combinations of different molecules that originate in nature or are the result of chemical reactions but that could not practicably be formed by simply combining individual constituents.

In some instances, materials derived from natural sources and complex reactions cannot be characterized in terms of constituent chemical compounds because their composition is too complex or variable. These materials are commonly referred to as Unknown or Variable composition Complex reaction products and Biological materials (UVCB) and are considered a single substance for notification purposes.

3.2 Exclusions from the Regulations

For the purposes of the portion of the Act dealing with Substances and Activities New to Canada (sections 80 to 89 of the Act) limitations on the statutory definition of "substance" are stated under section 3 of the Act. Substances described by the following circumstances (see sections 3.2.1 through 3.2.6 of these Guidelines) are not subject to the Regulations and are therefore excluded from notification.

3.2.1 Mixtures (Section 3 of the Act)

Any mixture that is a combination of substances and does not itself produce a substance that is different from the substances that were combined.

Mixtures that are prepared formulations or reaction mixtures that are fully characterized in terms of constituent substances are not considered substances for the purpose of the Regulations and, consequently, do not require notification. However, if any constituent of a mixture, is a new substance, that constituent is subject to the Regulations. An example of a mixture is a solvent mixture.

Some mixtures, such as those derived from natural sources or complex reactions that cannot be characterized because their composition is too complex or variable (e.g., UVCB substances), are considered single substances and are subject to notification.

Other types of mixtures are:

1. Hydrates: Hydrates of a substance or hydrated ions formed by association of a substance with water are considered to be a mixture of that substance and water. Therefore, if the anhydrous form is listed on the DSL, all hydrated forms are not notifiable substances. An example of an anhydrous substance that is listed on the DSL is Carbonic acid, magnesium salt (1:1) (CAS No. 546-93-0), and therefore the hydrated form MgCO₃·nH₂O is not notifiable. Metallic hydroxides, often termed metal hydrates, do not contain water of hydration and are not considered hydrates for notification purposes. Such substances must be notified if not on the DSL. An example of a metal hydroxide is copper hydroxide, Cu(OH)₂.
2. Homogeneous and Heterogeneous Alloys: Homogeneous and heterogeneous alloys are considered mixtures and should not be notified. Alloys that are solid or liquid mixtures of two or more metals or are mixtures of one or more metals with certain non-metallic elements (e.g., certain carbon steels) are considered mixtures and are not notifiable. An example of a homogeneous alloy is CuZn; an example of a heterogeneous alloy is CuCo. Intermetallic compounds of well-defined stoichiometry are not considered alloys and should be notified. An example of an intermetallic compound is In-⁴⁹Sn.

3.2.2 Manufactured Items (Section 3 of the Act)

Any manufactured item that is formed into a specific physical shape or design during manufacture and has, for its final use, a function or functions dependent in whole or in part on its shape or design.

A material that meets the above criteria for a manufactured item will possess a definite shape or design necessary to its final use.

Shape describes the macrostructure (e.g., the physical three-dimensional structure) of the final item. Examples of items whose end use depends on final manufactured shape are clothing, storage containers, furniture, tiles, electrical wire, etc. However, solid substances formed into a particular shape to meet subsequent processing and manufacturing requirements, rather than final use (e.g., metal ingots and polymer pellets), are not considered to meet this definition of manufactured item and must be notified.

Design refers to the organization or arrangement of the solid components within the macrostructure (e.g., the weave of fabric and carpeting, layering of plywood or binding of paper fibres) that is not altered in any subsequent processing. For example, fabric retains its final physical design regardless of whether it is a bolt of cloth or an article of clothing, because the manufacture of the clothing does not alter the design (weave) of the cloth.

Manufactured items that undergo subsequent chemical reactions may still be excluded from the definition of a substance if they:

1. undergo surface chemical reactions only to increase stiffness, strength or flame resistance, to alter colour or to improve resilience or bacterial resistance, while maintaining their bulk structure (e.g., brake linings, fibres, leather, paper, yarns and dyed fabrics); or
2. undergo a change in chemical composition that is intrinsic to the intended end use (e.g., matches, flares, photographic films and batteries).

Fluids (e.g., gases, liquids, waxes, solutions and suspensions) and particles (e.g., dusts, powders, dispersions, granules, lumps, flakes and aggregates of unspecified size) are not considered items, even if the usefulness of the product depends on the particle's shape. However, a fluid or particulate matter that remains contained within a manufactured item during normal use is considered an integral part of that item and is thus not notifiable. Furthermore, a fluid or particulate matter is considered an integral part of the item if the normal release of the fluid or particulate matter is controlled and non-dispersive and is specific to the end use of the item (e.g., lubricants in motor vehicles, ink in pens and stamp pads).

3.2.3 Wastes (Section 3 of the Act)

Any animate matter that is, or any complex mixtures of different molecules that are, contained in effluents, emissions or wastes that result from any work, undertaking or activity

Material contained in effluents, emissions and wastes is excluded from the statutory definition of a new substance. However, if a material in this category is isolated and used in commerce and is not on the DSL, it is considered a notifiable substance, subject to the Regulations. An example of a waste is slags.

3.2.4 Substances Carried through Canada (Subsection 3(2) of the Regulations)

Subsection 3(2) of the Regulations states that notification is not required if a substance is loaded on a carrier outside Canada and moved through Canada to a location outside Canada, whether or not there is a change of carrier during transit. However, if a substance is brought into Canada and stored for subsequent distribution, the substance is subject to the Regulations.

3.2.5 Polymers Subject to the "Two Percent Rule"

A polymer listed on the DSL that is modified by adding reactants, none of which constitutes more than 2% by weight of the polymer, does not require the specific substance name to be changed and is therefore not subject to the Regulations. Note that the term modifying refers to the amount of additional reactant that has been incorporated into the structure of the polymer or the amount charged to the vessel. The specific substance name and CAS registry number identify a specific substance, and therefore a name or CAS registry number change may result in the substance being subject to the Regulations.

For biopolymers, monomer units and reactants are considered to be the repeating units within the polymeric substance, which are produced in situ by the microorganism or are added to the reaction vessel.

3.2.6 Proteins Subject to the "Two Percent Rule"

A protein that is manufactured by modifying a protein that is listed on the DSL may not be subject to the Regulations if:

1. the function of the new protein has not been changed from the protein listed on the DSL; and
2. 1. the new protein has 98% amino acid sequence homology with the listed protein, based on amino acid or DNA sequence; or
   2. the new protein is 98% identical to the listed protein based on all of the following analytical endpoints: molecular weight, isoelectric point, amino acid composition, peptide map and N-terminal sequence. This does not apply to enzymes.

Any proposed alternatives to those in the list of analytical endpoints described in item b) ii) above should be discussed with the NS program through a Pre-notification Consultation (PNC) submission (see section 8.8 of these Guidelines) to ensure acceptability.

In certain circumstances, other modified proteins could also be exempt from notification beyond the established 2% limit. A scientifically defensible rationale for exemption above the 2% limit must be presented to the NS program, which will determine whether it is applicable in those circumstances.

3.3 Substances Not Subject to the Regulations

The Regulations do not apply to substances described by the following circumstances (see sections 3.3.1 through 3.3.5 of these Guidelines). However, outside these descriptions, substances are still subject to the Regulations.

3.3.1 Other Acts of Parliament

A substance that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given before the manufacture, import or sale of the substance and for an assessment of whether it is toxic or capable of becoming toxic [paragraph 81(6)(a) of the Act and subsection 3(1) of the Regulations].

Subsection 3(1) of the Regulations states that these Regulations do not apply in respect of a substance that is manufactured or imported for a use that is regulated under any other Act of Parliament or regulation listed in Schedule 2 to the Act.

Precursor materials excluded from the scope of other Acts of Parliament or regulations are subject to the Regulations. This includes isolated reaction intermediates, feedstocks and other starting materials used in the manufacture of any new substance.

Under subsection 81(7) of the Act, the Governor in Council has the exclusive responsibility for determining whether these criteria are met by another federal Act of Parliament or regulations and, if so, adding them to Schedule 2 to the Act. Once added to Schedule 2 to the Act, substances regulated by the listed Acts are exempt from the "Substances New to Canada" reporting requirements of the Act.

Notifiers of new substances regulated under other Acts of Parliament or regulations should monitor federal government web sites (www.ec.gc.ca/ceparegistry/) and/or the Canada Gazette to determine whether the use for the substance remains under the jurisdiction of other Acts of Parliament or regulations or if it is subject to the Regulations.

Substances that are subject to more than one Act of Parliament or regulation must be in compliance with the requirements of those Acts of Parliament or regulations. For example, a pesticide substance that is regulated under the Pest Control Products Act may also have non-pesticidal applications that could be subject to the Regulations.

3.3.2 Transient Reaction Intermediates

Transient reaction intermediates that are not isolated and are not likely to be released into the environment [paragraph 81(6)(b) of the Act].

Transient reaction intermediates are substances produced within a sequence of chemical reactions between the starting materials and the end product and are:

1. contained in a reaction vessel or a closed manufacturing system (including process holding tanks) located within a single building or single process area;
2. intended to be fully consumed in the course of the chemical reaction;
3. part of an uninterrupted manufacturing process (e.g., at any one time, starting materials or intermediates within the reaction sequence are being processed, except in the event of an unscheduled shutdown); and
4. not likely to be released into the environment during normal operations, and measures are in place to minimize releases during accidental breaches of the closed manufacturing system.

Notifiers are advised to maintain technical data (process and environmental release information) to support their exemption on the basis of the statements "reaction vessel or closed manufacturing system," "single process area," "fully consumed," "uninterrupted manufacturing process" and "not likely to be released".

3.3.3 Impurities

Impurities, contaminants and partially unreacted materials, the formation of which is related to the preparation of a substance [paragraph 81(6)(c) of the Act]

Impurities and contaminants are substances that are normally found in minimal concentration in the starting materials or are the result of secondary reactions that occur during the manufacturing process. These substances and partially unreacted starting materials that are present in the final product are the direct result of the preparation; are not necessary to the end use of the product; have not been intentionally added to the substance; and do not enhance the value of the substance.

3.3.4 Incidental Reaction Products

Substances produced when a substance undergoes a chemical reaction that is incidental to the use to which the substance is put or that results from storage or from environmental factors [paragraph 81(6)(d) of the Act].

Examples of incidental reaction products include substances formed from chemical reactions during:

1. exposure to environmental factors such as air, moisture, microbial organisms and sunlight (substances produced from deliberate reactions with water are subject to the Regulations, e.g., metal hydroxides formed from a metal oxide and water);
2. storage (e.g., partial polymerization of drying oils);
3. the intended use of a substance or mixture (e.g., adhesives, paints, cleansers, combustion products from fuels, fuel additives and water softeners); and
4. the blending of a formulation when there is no intention to produce new substances and any ensuing chemical reactions do not enhance the value of the formulation (e.g., blending monomers to a precise ratio for customer convenience would not result in a notifiable substance even if some reactions occurred; however, intentional manufacture of a pre-polymer to satisfy a customer's processing specifications would produce a notifiable substance).

3.3.5 Low-Volume Exemptions

A substance that is manufactured or imported in a quantity that does not exceed the maximum quantity prescribed as exempt from this section [paragraph 81(6)(e) of the Act and section 4 of the Regulations]

The Regulations do not apply to substances manufactured or imported in a quantity less than the lowest amount that first triggers a requirement to provide information under the Regulations. The specific quantities and Schedules that trigger notification requirements under the Regulations can be found in Table 1-1 of these Guidelines.

3.3.6 Substances Occurring in Nature

As specified in the Canada Gazette, Part I Supplement dated January 26, 1991, the NS program considers that substances occurring in nature are not subject to the Regulations. These substances are defined as naturally occurring and must be unprocessed; processed only by manual, gravitational or mechanical means, by dissolution in water, by flotation or by heating solely to remove water; or extracted from air by any means.

Further guidance is provided in Chapter 3 of "Reporting for the Domestic Substances List". To obtain a copy of the document, please contact the NSN-Infoline.

3.4 Substances Subject to the Regulations

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

1. substances new to Canada (e.g., those not on the DSL);
2. substances proposed for a significant new activity, defined in the SNAc Notice, that are listed on the DSL with a "S" or " S' " flag (see section 2.1.4.1 of these Guidelines);
3. polymers being manufactured or imported that do not meet the conditions of an RRR polymer (see section 3.4.1.3 of these Guidelines) that are listed on the DSL with a "P" flag (see section 2.1.4.1 of these Guidelines); and
4. substances regulated under any other Act of Parliament or regulations not listed on Schedule 2 to the Act (e.g., substances regulated under F&DA) and for which a) applies.⁶

3.4.1 Classification of Substances

For the purposes of the Regulations, new substances are grouped into two major classes, each subject to its own specific information requirements. These classes are non-polymeric substances (referred to in these Guidelines as chemicals and biochemicals) and polymeric substances (referred to in these Guidelines as polymers and biopolymers). These Guidelines describe the notification requirements and processes for chemicals, biochemicals, polymers and biopolymers.

3.4.1.1 Chemicals and Biochemicals

The information requirements for chemicals and biochemicals (substances produced by microorganisms as defined in subsection 1(1) of the Regulations) are prescribed in the Regulations and apply to all substances subject to the Regulations that are neither polymers nor organisms. Note that chemicals derived from a whole plant or animal or from parts of a whole plant or animal are not biochemicals for the purpose of the Regulations. An example of a biochemical is the enzyme subtilisin produced by Bacillus subtilis.

3.4.1.2 Polymers and Biopolymers

Polymers are defined in subsection 1(1) of the Regulations as substances that consist of:

1. molecules characterized by the sequence of one or more types of monomer units;
2. greater than 50% by weight of molecules having three of more monomer units that are covalently bound to one or more other monomer units or reactants;
3. less than 50% by weight of molecules of the same molecular weight; and
4. molecules distributed over a range of molecular weights whose differences in molecular weights are primarily attributable to differences in the number of monomer units.

For biopolymers, monomer units and reactants are considered to be the repeating units within the polymeric substance, which are either produced in situ by the organism or added to the reaction vessel. An example of a biopolymer is the polysaccharide xanthan gum, produced by Xanthomonas camprestris.

Note that polymers derived from a whole plant or animal or from parts of a whole plant or animal are not biopolymers for the purpose of the Regulations and must be notified as polymers.

3.4.1.3 Reduced Regulatory Requirement (RRR) Polymers

RRR polymers are polymers with a high number average molecular weight (M_n) that have a limited percentage of low-molecular-weight components (<1000 daltons), are chemically stable and do not contain certain reactive or cationic moieties.

An RRR polymer is one of the following:

1. a polymer that is not one of the types listed in items 1 to 4 of Schedule 7 (see section 3.4.1.5 of these Guidelines) and that has a number average molecular weight greater than 10 000 daltons, with less than 2% of its components having molecular weights less than 500 daltons and less than 5% of its components having molecular weights less than 1000 daltons;
2. a polymer that is not one of the types listed in Schedule 7 (see section 3.4.1.5 of these Guidelines) and that has a number average molecular weight greater than 1000 daltons and equal to or less than 10 000 daltons, with less than 10% of its components having molecular weights less than 500 daltons and less than 25% of its components having molecular weights less than 1000 daltons; or
3. a polymer that is a polyester manufactured solely from reactants listed in Schedule 8 or an anhydrous form of those reactants, other than the reactants or their anhydrous forms that include both 1-butanol and fumaric or maleic acid.

Polymers that meet the RRR polymer criteria above require only one notification to be submitted (see section 4.8.1 of these Guidelines).

3.4.1.4 Non-reduced Regulatory Requirement (non-RRR) Polymers

Polymers that do not meet the above-mentioned criteria are referred to as non-RRR polymers. Non-RRR polymers require additional notification requirements at higher manufacture and import volumes (see Table 1-1 of these Guidelines).

3.4.1.5 Polymers Described in Schedule 7 of the Regulations

Schedule 7 of the Regulations outlines some of the criteria used to determine whether a polymer meets the RRR polymer criteria. In particular, items 1 and 5 of Schedule 7 describe circumstances where cationic or reactive polymers fail to meet the criteria. Part of this determination involves calculating the functional group equivalent weight (FGEW) of resident cationic or reactive functional groups.

The FGEW is the weight of the polymer that contains one equivalent weight (one mole) of a particular functional group. Consequently, large FGEW values represent polymers having relatively few functional groups. Before the FGEW can be calculated, it is useful to establish the type of distribution of functional groups within the polymer. This includes determining if the polymer is linear or branched. Functional groups can be located at terminal positions, randomly distributed throughout the polymer or equally distributed within the repeating unit.

Table 3-1 lists various types of functional group distributions within a polymer and provides equations to calculation FGEW for each type.

Table 3-1 Equations for Different Functional Group Calculations

Type of functional group distribution	Throughout polymer		At terminal ends
	Randomly distributed	Within structural repeating unit	Linear polymer	Branched polymer
FGEW equations
Combined FGEW equation
Branched FGEW equation
Number of moles of a substance

mw_mon = molecular weight of monomer
wt%_mon= weight percent of monomer
nFG_mon = number of functional groups within monomer
eq.wt._RU = equivalent weight of repeating unit
nFG_RU = number of functional groups within repeating unit
M_n = number average molecular weight
nEG = number of end groups
nRS = number of reactive sites within branching reagent
wt%_BR = weight percent of branching reagent
mw_BR = molecular weight of branching reagent
FGEW_n = functional group equivalent weight calculation (n = 1, 2, 3, ...)
FGEW_comb = combined functional group equivalent weight calculation
FGEW_BR = branched functional group equivalent weight calculation

1. End-Group Analysis for Linear Polymers

An end-group analysis applies to linear polymers containing functional groups only at chain ends. The FGEW for these polymers depends on the M_n of the polymer.

One end: FGEW = Mn/1	Two ends: FGEW = Mn/2

M_n = number average molecular weight
FG = functional group of concern
A, B = arbitrary monomer units

An example of a linear polymer is described below:

Example 1: A linear polyurethane polymer contains aliphatic isocyanate groups only at the chain ends. The polymer is potentially cationic, since aliphatic isocyanates can hydrolyze to aliphatic amines. The M_n of the polymer is 100 000 daltons. In a linear polymer, there are only two end groups, and therefore:

Given that this polymer contains aliphatic isocyanate groups (a functional group of concern) and is therefore potentially cationic, it falls under items 1 and 5 of Schedule 7. Since the FGEW was determined to be greater than 5000, this polymer would meet the RRR polymer criteria based on this criterion.

2. End-Group Analysis for Branched Structures

An end-group analysis is performed for branched polymers containing functional groups only at chain ends. An appropriate calculation and illustration of such a polymer are provided below:

M_n = number average molecular weight
nRS = number of reactive sites within branching reagent
wt%_BR = weight percent of branching reagent
mw_BR = molecular weight of branching reagent

	representation of branching reagent
	representation of polyurethane backbone

The following example demonstrates the determination of the FGEW for a branched polymer containing a cationic functional group.

Example 2: A branched polyurethane polymer contains isocyanate groups at chain ends that are derived solely from hydrogenated methylene diisocyanate (molecular weight = 262). The branching reagent is trimethylolpropane (C₂H₅C(CH₂OH)₃, molecular weight = 134), which accounts for 10% by weight of the polymer and has three reactive sites. The M_n of the polymer is 20 000 daltons.

Given that this polymer contains isocyanate groups (a functional group of concern) and is therefore potentially cationic, it falls under items 1 and 5 of Schedule 7. Since the FGEW was determined to be less than 5000, this polymer would not meet the RRR polymer criteria based on this criterion.

3. Groups Throughout Polymer

3a. The following example demonstrates the determination of the FGEW for a polymer containing one type of cationic functional group throughout the structure.

mw_mon = molecular weight of monomer
wt%_mon = weight percent of monomer
nFG_mon = number of functional groups in monomer

Example 3a: An acrylic polymer contains aliphatic amines that are derived solely from 2-aminoethyl acrylate (H₂C=CHCO₂CH₂CH₂NH₂, molecular weight = 115), which accounts for 2% by weight of the polymer.

Given that this polymer contains aliphatic amines and is therefore potentially cationic, it falls under item 1 of Schedule 7. Since the FGEW was determined to be greater than 5000, this polymer would meet the RRR polymer criteria based on this criterion.

3b. The following example demonstrates the determination of the FGEW for a polymer containing one type of functional group that is not considered cationic throughout the structure.

Example 3b: A polymer that contains aliphatic acrylates has an M_n = 2500. There is a maximum amount of 28.9% by weight of the acrylate monomer (molecular weight = 72). Therefore, we can determine the FGEW of the acrylate functional group to be:

Given that this polymer contains aliphatic acrylates, which are considered a functional group of concern, it falls under subitem 5(a) of Schedule 7. Since the FGEW of the acrylate was determined to be less than 5000, this polymer would not meet the RRR polymer criteria based on this criterion.

4. Functional Groups within Structural Repeating Units

The following example demonstrates the determination of the FGEW for a polymer with functional groups within structural repeating units.

Example 4: An addition polymer is made by reacting an excess of hexamethylene diamine with diglycidyl ether. A linear polymer is formed with a simple repeating unit of 246 daltons. There are two potentially cationic nitrogen atoms per unit, as illustrated below:

eq.wt._RU = equivalent weight of repeating unit
nFG_RU = number of functional groups within repeating unit

eq. wt._RU = 246

Therefore,

The FGEW here is independent of the amount of diamine monomer or the M_n of the polymer, as long as there is a molar excess of the diamine. If diglycidyl ether is used in excess, the polymer will be epoxy terminated, and the FGEW will require more complex calculations.

Given that this polymer contains diamines and is therefore potentially cationic, it falls under item 1 of Schedule 7. Since the FGEW was determined to be less than 5000, this polymer would not meet the RRR polymer criteria based on this criterion.

5. FGEW Combined

If there is more than one functional group of concern in the polymer, the FGEW must be calculated for each monomer separately, and then the combined FGEW is calculated.

FGEW1,2...n = FGEW for each particular functional group
mw_mon = molecular weight of monomer
wt%_mon = weight percent of monomer
nFG _mon = number of functional groups within monomer

The following example demonstrates how the equation should be used to determine the FGEW of a polymer containing more than one cationic functional group of concern.

Example 5: An acrylic polymer contains aliphatic amines from 1% of 2-aminoethyl acrylate (H₂C=CHCO₂CH₂CH₂NH₂, molecular weight = 115) and 2% of dimethylaminoethyl methacrylate (H₂C=C(CH₃)CO₂CH₂CH₂N(CH₃)₂, molecular weight = 157)

Given that this polymer contains two different amine groups and is therefore potentially cationic, it falls under item 1 of Schedule 7. Since the FGEW_comb was determined to be less than 5000, this polymer would not meet the RRR polymer criteria based on this criterion.

3.5 Special Category Substances

A special category substance is defined as any substance that is manufactured or imported as:

1. a research and development substance;
2. a contained site-limited intermediate substance; or
3. a contained export-only substance.

3.5.1 Research and Development Substances

Section 1(1) of the Regulations defines a research and development substance as one that is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following:

1. to create or improve a product or process;
2. to determine the technical viability or performance characteristics of a product or process; or
3. to evaluate a substance prior to its commercialization, by pilot plant trials, production trials (including scale-up) or customer plant trials, so that technical specifications can be modified in response to the performance requirements of potential customers.

This category includes chemicals or polymers being manufactured on toll for domestic or foreign customers that are conducting research (see section 1.4.3 of these Guidelines, Toll Manufacturer).

The Regulations also define "Test marketing," in respect of a product as referred to above, as "the exploration of its market capability in a competitive situation where the creation or improvement of the product is not the primary objective."

3.5.2 Contained Site-Limited Intermediate Substances

Subsection 1(1) of the Regulations defines a contained site-limited intermediate substance as one that is consumed in a chemical reaction used for the manufacture of another substance and that is:

1. manufactured and consumed at the site of manufacture;
2. manufactured at one site and transported to a second site where it is consumed; or
3. imported and transported directly to the site where it is consumed.

The Regulations also define:

• "contained" as "an absolute release limit of the substance of 1 kg per day per site to the aquatic environment after wastewater treatment"; and
• "consumed" as "destroyed or completely converted to another substance".

If a substance is classified as a site-limited intermediate, it must, at all times during its existence (manufacture, importation, storage, transport, handling, use and disposal) be contained, as defined above, to prevent any significant environmental release.

A substance that is a direct precursor in the manufacture of an item defined in section 3.2.2 is not considered a site-limited intermediate and would be subject to the regular notification requirements. However, if the direct precursor of the item meets the criteria of a "transient reaction intermediate" (see section 3.3.2 of these Guidelines), it would not be subject to notification.

3.5.3 Contained Export-Only Substances

Contained export-only substances are limited to new substances manufactured in or imported into Canada that are destined solely for foreign markets and that are contained.

Contained is defined in subsection 1(1) of the Regulations as an absolute release limit of the substance of 1 kg/day per site to the aquatic environment after wastewater treatment.

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⁶ NSN packages for substances intended for use in both industrial and F&DA products (dual use) must be submitted to the NS program and are subject to the appropriate fees. NSN packages for substances intended solely for use in F&DA products are not subject to the NSFR and should be submitted directly to Health Canada. 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