New Substances Notification Regulations (Chemicals and Polymers)

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.

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.

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. ^*

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. ^*

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.

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).