Exclusions from the New Substances Notification Regulations

(Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, 2005)

There are two broad circumstances under which a substance can be excluded from compliance with the New Substances Notification Regulations (NSNR):

1. Exclusions from the definition of “substance”: the substance does not meet the definition of a “substance” as set out under Section 3 of CEPA ’99.
   
2. Exclusions from compliance with the Act: the substance meets the definition but is excluded from compliance with the Act by virtue of Paragraph 81(6)(a – e). 

Exclusions from the Definition of "Substance"

A “substance” is defined in Section 3 of CEPA '99 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 addition, materials derived from natural sources and complex reactions that cannot be characterized in terms of constituent chemical compounds because their composition is too complex or variable 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.

There are six types of materials that otherwise meet the definition of “substance” but which are excluded from notification because of limitations on the statutory definition of “substance” as set out under Section 3 of CEPA '99.  These are: mixtures; manufactured items; wastes; substances carried through Canada; polymers subject to the “two percent rule”; and, proteins subject to the “two percent rule”.  Each of these is explained in turn, below.  Further detail on each exclusion can be found in Section 3.2 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (2005).

1. Mixtures
   “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 fully characterized in terms of constituent substances, whether they are prepared formulations or reaction mixtures, are not considered substances and therefore do not require notification of the mixture per se.  However, all constituents of the fully characterized mixture are considered substances and are subject to the NSNR.  If the constituent substance is “new” then it will require notification under the NSNR.
   
   Mixtures that cannot be fully characterized because of complexity or variability in their composition are considered to be single substances and are subject to the NSNR (e.g. UVCB).
   
    
2. Manufactured Items
   “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.”
   
   “Shape” refers to the physical three-dimensional structure or macrostructure of the final item. Solid substances that are formed into a particular shape in order to meet subsequent processing and manufacturing requirements rather than as a requirement of the final item are not considered to meet the definition of a manufactured item and require notification under the NSNR if they are “new”.
   
   “Design” refers to an organization or arrangement of solid components within a macrostructure that will not be altered in subsequent processing.
   
   Manufactured items which do undergo subsequent chemical reactions may still meet the definition of a “manufactured item” and be excluded from compliance with the NSNR if: 

   a) they undergo surface chemical reactions only to increase stiffness, strength or flame resistance, to alter colour or improve resilience or bacterial resistance   while their bulk structure is maintained; or,
   b) they undergo a change in chemical composition that is intrinsic to the intended end use.

   Fluids (including gases, liquids, waxes, solutions and suspensions) and particles (including dusts, powders, dispersions, granules, lumps, flakes and aggregates) are not considered items, even if its function is “dependent in whole or in part on its shape”. The exceptions are fluids or particulates that remain contained within a manufactured item during normal use, or that are released from the item in a controlled and non-dispersive manner which is specific to the end use of the item, during normal use. Such fluids or particulates are considered to be integral parts of the manufactured item and are therefore not subject to the NSNR.
   
    
3. Wastes
   “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.”
   
   Materials that are considered wastes are excluded from notification, unless a material is isolated from waste and subsequently used in commerce. Such a commercialized material would be subject to the NSNR.
   
    
4. Substances Carried Through Canada
   Notification is not required for substances which are loaded on a carrier vessel outside of Canada and which are moved through Canada to a final destination outside of Canada. This applies whether or not there is a change of carrier during transit, but does not apply if the substance is brought into Canada and then stored for subsequent distribution.
   
    
5. Polymers Subject to the “Two Percent Rule”
   Polymers that are modified by adding reactants, none of which constitutes more than 2% by weight of the polymer, do not require the substance name to be changed, and therefore, if the polymer is on the DSL, the modified polymer does not require new notification under the NSNR. If the name or CASRN change, the substance may be subject to the NSNR.
   
   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 which are added to the reaction vessel.
   
    
6. Proteins Subject to the “Two Percent Rule”
   Proteins which are manufactured by modifying a protein listed on the DSL may not be subject to the NSNR if:
   1. the function of the 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 sequences; or,
      2. the new protein is 98% identical to the listed protein based on all of the following analytical endpoints: molecular weight, isoelectic point, amino acid composition, peptide map and N-terminal sequence (this last exception does not apply to enzymes).
         
   The New Substances Program suggests that a Pre-notification Consultation (PNC) be arranged prior to using any analytical alternatives to those proposed in b) 2.
   
   Circumstances may exist in which modified proteins could be exempted from notification beyond the established 2% limit.  A scientific rationale for exemption above this limit must be presented to the New Substances Program for their approval.

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 Exclusions from Compliance with CEPA '99

There are 6 conditions under which a substance does not require compliance with the NSNR and/or CEPA.  These are: substances that are regulated under other (specified) Acts of Parliament; transient reaction intermediates; impurities/ incidental reaction products; low-volume substances; and, substances occurring in nature.  Each of these is explained in turn, below.  Further detail on each exclusion can be found in Section 3.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers (2005).

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.”
   
   The Acts which meet this definition currently are the Pest Control Products Act, the Fertilizers Act, and the Feeds Act, as listed in Schedule 2 to CEPA '99.
   
   Precursor materials thja are excluded from the scope of these Acts are still subject to the NSNR. This would include isolated reaction intermediates, feedstocks and other starting materials used to manufacture a substance.  Substances which are subject to more than one Act must comply with the requirements of all applicable Acts or regulations.
   
    
2. Transient Reaction Intermediates
   “Transient reaction intermediates that are not isolated and are not likely to be released into the environment.”
   
   These are substances which are produced within a chemical reaction sequence and which are:
   1. contained in a reaction vessel or 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.
      
      Technical data supporting the exclusion should be maintained.
    
3. Impurities
   “Impurities, contaminants, and partially unreacted materials, the formation of which is related to the preparation of a substance.”
   
   Such impurities are usually found in minimal concentration in the starting materials, or they are the result of secondary reactions occurring during the manufacturing process. These substances must be present in the final product only as a direct result of the preparation, must not be necessary to the end use of the product, must not have been intentionally added to the substance and must not enhance the value of the product.
   
    
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.”
   
   Incidental reaction products include substances which are 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 not excluded from compliance with the NSNR);
   2. storage;
   3. the intended use of a substance or mixture; 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
       
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.”
   
   If substances are imported or manufactured in quantities that are less than the lowest amount that triggers a requirement to notify under the NSNR, then the NSNR do not apply to those substances.  These amounts are 100 kg/yr for chemicals and 1,000 kg/yr for polymers.
   
    
6. Substances Occurring in Nature
   Substances occurring in nature are not subject to the NSNR.  Such 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”.