GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
New Substances Notification Regulations (Chemicals and Polymers) — 5
5 A polymer (a) that has reactive functional groups other than carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered “ordinary” * , butenedioic acid groups, blocked isocyanates including ketoxime-blocked isocyanates, thiols, unconjugated nitrile groups, halogens excluding reactive halogen groups such as benzylic or allylic halides, and conjugated olefinic groups present in naturally occurring fats, oils and carboxylic acids, in combined equivalent weights of less than 5 000 daltons; or (b) in which the only reactive functional groups present are part of acid halides, acid anhydrides, aldehydes, hemiacetals, methylol-amides, methylol-amines, methylol-ureas, alkoxysilanes with alkoxy greater than C2-alkoxysilanes, allyl ethers, conjugated olefins, cyanates, epoxides, imines, unsubstituted positions ortho or para to phenolic hydroxyl, in combined equivalent weights of less than 1 000 daltons. * Not specially activated either by being part of a larger functional group, such as a vinyl ether, or by other activating influences, for example, strongly electron-withdrawing sulfone group with which the olefinic groups interact.
New Substances Notification Regulations (Chemicals and Polymers) — 1
1 The type of polymer: (a) a reduced regulatory requirement polymer; (b) a polymer on the NDSL; (c) a polymer with all of its reactants on the DSL or the NDSL; or (d) a polymer with one or more reactants not on either the DSL or NDSL.
New Substances Notification Regulations (Chemicals and Polymers) — 8
8 The reaction scheme if the polymer is a reduced regulatory requirement polymer, unless it is a polymer referred in paragraph 9(c) of these Regulations.
New Substances Notification Regulations (Chemicals and Polymers) — 9
9 The following physical and chemical data in respect of the polymer: (a) its number average molecular weight (Mn); and (b) the maximum concentrations, expressed as a percentage, of all residual constituents having molecular weights of less than 500 daltons and of all residual constituents having molecular weights of less than 1 000 daltons.
New Substances Notification Regulations (Chemicals and Polymers) — 13
13 The following exposure information respecting the polymer: (a) the anticipated annual quantity to be manufactured, if applicable; (b) the anticipated annual quantity to be imported, if applicable; (c) the anticipated uses within Canada; and (d) if the polymer is not a reduced regulatory requirement polymer, (i) the anticipated concentration of the polymer in products and, if known, in end-use products, (ii) the anticipated degree of direct human exposure to the polymer, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure, (iii) whether the polymer is anticipated to be used in products intended for use by or for children, and (iv) if known, the three sites in Canada where the greatest quantity of the polymer, manufactured or imported by the person, is anticipated to be used or processed and the estimated quantity by site.
New Substances Notification Regulations (Chemicals and Polymers) — 14
14 A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the polymer.
New Substances Notification Regulations (Chemicals and Polymers) — 15
15 The identification of the other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the polymer and, if known, the agency’s file number, the outcome of the assessment and the risk management actions imposed by those agencies.
New Substances Notification Regulations (Chemicals and Polymers) — 1
1 The information specified in Schedule 9 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number.
New Substances Notification Regulations (Chemicals and Polymers) — 2
2 The following physical and chemical data in respect of the polymer: (a) its physical state; (b) whether it is formulated for dispersal in water; (c) its water extractability measured at (i) pH 7 for anionic and neutral polymers, (ii) pH 2 and 7 for cationic polymers, or (iii) pH 2, 7 and 9 for amphoteric polymers; (d) its octanol-water partition coefficient; and (e) if water extractability is determined to be greater than 2%, its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis.
New Substances Notification Regulations (Chemicals and Polymers) — 3
3 Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, an acute toxicity test of the polymer for the most sensitive species: fish, daphnia or algae or, if the sensitivity of these three species is unknown, an acute algae toxicity test. *
New Substances Notification Regulations (Chemicals and Polymers) — 4
4 Data from one acute mammalian oral toxicity test of the polymer and the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. *
New Substances Notification Regulations (Chemicals and Polymers) — 5
5 The following exposure information respecting the polymer: (a) a description of the expected modes for its transportation and storage; (b) a description of the size and type of container used for its transportation and storage; (c) its anticipated releases into municipal wastewater systems; (d) a description of the methods recommended for its destruction or disposal; (e) its historical and other likely uses; (f) any factors that may limit environmental exposure; (g) whether it is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and, if the release is less than or equal to 3 kg per day, per site, the data substantiating the quantity released; and (h) whether the public is anticipated to be significantly exposed to the polymer in a product taking into account factors including the concentration of the polymer, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed.
New Substances Notification Regulations (Chemicals and Polymers) — 6
6 A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they may reasonably be expected to have access and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the polymer. Note: The asterisks (*) appearing at the end of certain provisions indicate that laboratory practices to be followed in developing data for the test referred to in that provision must comply with those practices set out in the “Principles of Good Laboratory Practice”. See subsection 15(2) of the New Substances Notification Regulations (Chemicals and Polymers) .
New Substances Notification Regulations (Chemicals and Polymers) — 3
3 Data from a ready biodegradation test on the water-soluble portion of the polymer, unless the polymer has a water extractability at pH 7 of less than or equal to 2% or is a branched silicone or siloxane polymer. *
New Substances Notification Regulations (Chemicals and Polymers) — 4
4 Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, the following tests: (a) if the sensitivity of the three species is known, an acute toxicity test of the polymer for each of the two most sensitive species: fish, daphnia or algae; (b) if the sensitivity of only one species is known and that species is not algae, an acute algae toxicity test and either a fish or daphnia acute toxicity test selected on the basis of the most sensitive of these species; or (c) if the sensitivity of only one species is known and that species is algae or if the sensitivity of the three species is unknown, an acute algae toxicity test and either a fish or daphnia acute toxicity test. *
New Substances Notification Regulations (Chemicals and Polymers) — 5
5 Data from one acute mammalian oral toxicity test of the polymer. *
New Substances Notification Regulations (Chemicals and Polymers) — 6
6 Information sufficient to assess skin irritation in respect of the polymer. *
New Substances Notification Regulations (Chemicals and Polymers) — 7
7 Data from a skin sensitization test in respect of the polymer. *
New Substances Notification Regulations (Chemicals and Polymers) — 8
8 Data from one repeated-dose mammalian toxicity test in respect of the polymer, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the polymer, namely, oral, dermal or inhalation. *
New Substances Notification Regulations (Chemicals and Polymers) — 9
9 For the tests referred to in items 5 to 8, the following additional information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. *
New Substances Notification Regulations (Chemicals and Polymers) — 10
10 Mutagenicity data obtained from each of the following tests of the polymer: (a) one in vitro test, with and without metabolic activation, for gene mutations; (b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and (c) one 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 polymer or its metabolites, permits an assessment of in vivo mutagenicity. *
New Substances Notification Regulations (Chemicals and Polymers) — 11
11 The following exposure information respecting the polymer: (a) a description of the expected modes for its transportation and storage; (b) a description of the size and type of container used for its transportation and storage; (c) an identification of the components of the environment into which it is anticipated to be released; (d) its anticipated releases into municipal wastewater systems; (e) a description of the methods recommended for its destruction or disposal; (f) its historical and other likely uses; and (g) any factors that may limit environmental exposure.
New Substances Notification Regulations (Chemicals and Polymers) — 12
12 A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they may reasonably be expected to have access and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the polymer. Note: The asterisks (*) appearing at the end of certain provisions indicate that laboratory practices to be followed in developing data for the test referred to in that provision must comply with those practices set out in the “Principles of Good Laboratory Practice”. See subsection 15(2) of the New Substances Notification Regulations (Chemicals and Polymers) .
New Substances Notification Regulations (Chemicals and Polymers) — 1
1 The information required under the New Substances Notification Regulations (Chemicals and Polymers) is divided into three flowcharts according to the type of substance: (a) research and development, contained site-limited intermediate and contained export-only substances — Flowchart 1; (b) chemicals and biochemicals other than research and development, contained site-limited intermediate and contained export-only substances — Flowchart 2; and (c) polymers and biopolymers other than research and development, contained site-limited intermediate and contained export-only substances — Flowchart 3.
New Substances Notification Regulations (Chemicals and Polymers) — 2
2 Choose the appropriate flowchart according to the type of substance. Each flowchart identifies the information to be provided and the quantity that triggers the regulatory obligation to provide it.
New Substances Notification Regulations (Chemicals and Polymers) — 3
3 References in the flowcharts are to provisions of the Regulations, in italics, and to schedules to the Regulations. Note that certain words and expressions used in the flowcharts are defined in section 1 of the Regulations.
New Substances Notification Regulations (Chemicals and Polymers) — 4
4 The shapes used in the flowcharts distinguish their contents as follows: (a) the ovals identify the type of substance referred to in the flowchart, as more particularly described in the flowchart’s title; (b) the diamonds identify the timeline and quantity trigger; and (c) the rectangles identify the required information.
New Substances Notification Regulations (Chemicals and Polymers) — 5
5 Shapes outlined with a broken line signal that information is required only in certain circumstances.
New Substances Notification Regulations (Chemicals and Polymers) — 6
6 Additional information is set out in footnotes to each flowchart.
New Substances Notification Regulations (Chemicals and Polymers) — 7
7 The Minister of the Environment and the Minister of Health must assess the information within the same number of days as are afforded to the manufacturer or importer for provision of that information — see section 16 of the Regulations. For example, if a manufacturer or importer is required to provide information at least 30 days before the day on which a certain quantity is exceeded, then the Ministers must assess that information within 30 days after receiving it.
New Substances Notification Regulations (Chemicals and Polymers) — 6
6 (1) In this section, former Regulations means the New Substances Notification Regulations (Chemicals and Polymers) as they read immediately before the day on which these Regulations come into force. (2) These Regulations do not apply to a person that manufactures or imports a chemical or a polymer if the person manufactures or imports it on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of sections 131, 134 and 136 of that Act, and if the person would not, were the former Regulations in force at the time, be in contravention of the former Regulations.
New Substances Notification Regulations (Organisms) — a
Whereas, pursuant to subsection 332(1) a of the Canadian Environmental Protection Act, 1999 b , the Minister of the Environment published in the Canada Gazette , Part I, on October 30, 2004, a copy of the proposed New Substances Notification Regulations (Organisms) , substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection; a S.C. 2004, c. 15, s. 31 b S.C. 1999, c. 33
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 114(1) of the Canadian Environmental Protection Act, 1999 b , hereby makes the annexed New Substances Notification Regulations (Organisms) .
New Substances Notification Regulations (Organisms) — 1
ecifications can be modified in response to the performance requirements of potential customers. ( destiné à la recherche et au développement ) test marketing , in respect of a product, means the exploration of its market capability in a competitive situation in which the creation or improvement of the product is not the primary objective. ( test de marché ) Government agencies (2) The definition of government in subsection 3(1) of the Act does not apply to the expression “government agencies” in these Regulations. SOR/2018-11, s. 33
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
Act means the Canadian Environmental Protection Act, 1999 . ( Loi )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
Canadian Biosafety Standards and Guidelines means the documents entitled Canadian Biosafety Standard , 2nd Edition, published in 2015, and the Canadian Biosafety Guideline: Containment Level 1: Physical Design and Operational Practices , published in 2017, both developed by the Public Health Agency of Canada and the Canadian Food Inspection Agency, as amended from time to time. ( Normes et lignes directrices canadiennes sur la biosécurité )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
confinement procedures means any physical, chemical, biological or operational control, or combination of those controls, to restrict the exit or dispersal of a micro-organism. ( méthodes de confinement )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
contained facility means an enclosed building with walls, floor and ceiling, or an area within such a building, where the containment is in accordance with the physical and operational requirements of a level set out in either the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines. ( installation étanche )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
ecozone means one of the ecozones shown on the map entitled Terrestrial Ecozones and Ecoregions of Canada 1995 , dated May 6, 1999, Catalogue No. cas016e, whose boundaries are more particularly described in the National Soil Data Base (NSDB) of the Canada Soil Information System (CanSIS), developed by the Department of Agriculture and Agri-Food and the Department of the Environment, as amended from time to time. ( écozone )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
experimental field study means a study of a research and development organism that is a micro-organism, which study uses the minimum area, consisting of one or more sites whose total area does not exceed one hundred hectares, and the minimum quantity of the micro-organism as are required to meet the objectives of the study. ( étude expérimentale sur le terrain )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
indigenous , in respect of a micro-organism, means occurring naturally in the ecozone into which the micro-organism is intended to be introduced. ( indigène )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
Laboratory Biosafety Guidelines [Repealed, SOR/2018-11, s. 33]
New Substances Notification Regulations (Organisms) — (a)
micro-organism means a microscopic organism that is (a) classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts; (b) a virus, virus-like particle or sub-viral particle; (c) a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or (d) any culture other than a pure culture. ( micro-organisme )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
NIH Guidelines means the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994 , published in the Federal Register by the U.S. Department of Health and Human Services, 59 FR 34472 (July 5, 1994), as amended from time to time. ( NIH Guidelines )
New Substances Notification Regulations (Organisms) — (a)
organism means a living organism as defined in section 104 of the Act, except in the following provisions: (a) paragraph (c) of the definition micro-organism ; (b) paragraphs 2(4)(b) and (c); (c) paragraph 1(d) and subparagraphs 1(e)(vi) and (viii) of Schedule 5; (d) paragraph 2(d) of Schedule 5; (e) subparagraph 3(d)(iii) and paragraph 3(f) of Schedule 5; and (f) items 5 to 7 in Schedule 5. ( organisme )
New Substances Notification Regulations (Organisms) — (a)
research and development organism means an organism 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: (a) to create or improve a product or process; (b) to determine the technical viability or performance characteristics of a product or process; or (c) to evaluate the organism 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. ( destiné à la recherche et au développement )
New Substances Notification Regulations (Organisms) — New Substances Notification Regulations (Organisms)
test marketing , in respect of a product, means the exploration of its market capability in a competitive situation in which the creation or improvement of the product is not the primary objective. ( test de marché )
New Substances Notification Regulations (Organisms) — 2
Avoiding regulatory duplication 2 (1) For greater certainty, these Regulations do not apply in respect of an organism that is manufactured or imported for a use that is regulated under any other Act or regulations listed in Schedule 4 to the Act. Transit (2) These Regulations do not apply in respect of an organism that 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. Research and development micro-organisms (3) These Regulations do not apply in respect of a micro-organism that is a research and development organism not for introduction outside a contained facility, if (a) the containment of the micro-organism is in accordance with the Canadian Biosafety Standards and Guidelines or Appendix K of the NIH Guidelines; and (b) the micro-organism is (i) imported to a contained facility in a quantity that, at the time of the import, is less than 50 mL or 50 g, or (ii) manufactured in a contained facility under one of the following conditions: (A) the micro-organism does not require containment level 2, 3 or 4 as identified in the Canadian Biosafety Standards and Guidelines and at any given moment there is less than 1 000 L of the micro-organism present at that facility, and (B) the micro-organism requires containment level 2, 3 or 4 as identified in the Canadian Biosafety Standards and Guidelines, its manufacture is a controlled activity authorized under a licence issued under section 18 of the Human Pathogens and Toxins Act whose conditions of licence are complied with and at any given moment there is less than 250 L of the micro-organism present at that facility. Research and development organism other than a micro-organism (4) These Regulations do not apply in respect of an organism, other than a micro-organism, that is a research and development organism and is imported to or manufactured in a facility from which there is no release into the environment of (a) the organism; (b) the genetic material of the organism; or (c) material from the organism involved in toxicity. SOR/2018-11, s. 34