New Substances Notification Regulations (Chemicals and Polymers)

1 The information specified in Schedule 4 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.

2 The following identification information in respect of the chemical:

• (a) its molecular formula;

• (b) its structural formula;

• (c) its gram molecular weight;

• (d) the degree of purity in its technical grade composition, if applicable;

• (e) known impurities present and their concentration by weight; and

• (f) any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight.

3 The following physical and chemical data in respect of the chemical:

• (a) its melting point or the temperature at which the chemical decomposes

  • (i) expressed in degrees Celsius if its melting point or the temperature at which it decomposes is –25°C or greater but not greater than 300°C, and

  • (ii) in any other case, expressed as less than –25°C or greater than 300°C, as appropriate;

• (b) its boiling point or the temperature at which the chemical decomposes

  • (i) expressed in degrees Celsius if its boiling point or the temperature at which it decomposes is –50°C or greater but not greater than 300°C, and

  • (ii) in any other case, expressed as less than –50°C or greater than 300°C, as appropriate;

• (c) its density;

• (d) its vapour pressure if it has a standard boiling point of 0°C or greater;

• (e) its water solubility; and

• (f) for chemicals having a water solubility of less than or equal to 5 g/L, its octanol/water partition coefficient.

4 Ready biodegradation test data in respect of the chemical and, if known, identification of the products of biodegradation. ^*

5 Data from one acute fish, daphnia or algae toxicity test in respect of the chemical. ^*

6 Data from an oral, dermal or inhalation type of acute mammalian toxicity test in respect of the chemical, selected on the basis of the most significant route of potential human exposure to the chemical and the following information:

• (a) the age, sex, number, species, strain and source of the animals tested;

• (b) the route by which the chemical is administered and the conditions under which the test is conducted; and

• (c) the dose of the chemical, the vehicle by means of which the chemical is administered and the concentration of the chemical in the vehicle. ^*

7 Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for gene mutations. ^*

8 The following exposure information respecting the chemical:

• (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) whether it is anticipated to be used in products intended for use by or for children;

• (g) the anticipated degree of direct human exposure to the chemical, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure; and

• (h) if known, the three sites in Canada where the greatest quantity of the chemical, manufactured or imported by the person, is anticipated to be used or processed and the estimated quantity by site.

9 A summary of all other information and test data in respect of the chemical 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 chemical.

10 If the chemical is on the NDSL, the following additional exposure information respecting the chemical:

• (a) its historical and other likely uses;

• (b) any factors that may limit environmental exposure;

• (c) 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

• (d) whether the public is anticipated to be significantly exposed to the chemical in a product taking into account factors including the concentration of the chemical, 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.

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).