Checking a Chemical on the Canadian DSL

If your substance is on the NDSL, it counts as a new substance in Canada. CEPA 1999 s. 81(1) says that where a substance is not on the DSL, "no person shall manufacture or import the substance" until the prescribed information and fee have been provided and the assessment period has run out ^[6]. NDSL listing means notification is still required, but the volume triggers are higher and the information packages are smaller than for a substance on neither list.

Chemicals and biochemicals (New Substances Notification Regulations (Chemicals and Polymers), SOR/2005-247)

Annual quantity (manufacture or import)	On the NDSL (s. 7)	Not on the NDSL (s. 8)
Over 100 kg	No trigger	Schedule 4 information at least 5 days before; 5-day assessment
Over 1 000 kg	Schedule 4 information at least 30 days before; 30-day assessment	Schedule 5 information at least 60 days before; 60-day assessment
Over 10 000 kg	Schedule 5 information at least 60 days before; 60-day assessment	Schedule 6 information at least 75 days before; 75-day assessment

Sources: s. 7(1) ^[7], s. 8(1) ^[8], and the assessment periods in s. 16(2) ^[9].

• Biochemicals: you also provide the listed items of Schedule 2 at each step ^[7].
• Extra data above 50 000 kg (NDSL substances): the person "must" provide more information at least 75 days before the quantity exceeds 50 000 kg in a calendar year. This applies in two cases:
  • The chemical is released to the aquatic environment at more than 3 kg per day, per site, averaged monthly, after wastewater treatment. You then need adsorption-desorption screening and hydrolysis data (if water solubility is at least 200 µg/L) plus a repeated-dose mammalian toxicity test of at least 28 days (s. 7(2)).
  • The public may be significantly exposed to it in a product. You then need the 28-day repeated-dose data plus chromosomal-aberration data (s. 7(3)) ^[7].
• Section 5 substances: sections 7 and 8 do not cover chemicals referred to in section 5, which deals with research and development substances, contained site-limited intermediates and contained export-only substances ^[7].
• If the substance is added to the NDSL partway through: if you filed under s. 8(1)(b) (with item 10 of Schedule 5) and the substance is later added to the NDSL, you "may" tell the Minister in writing to treat that filing as made under s. 7(1)(b) ^[8].

Polymers and biopolymers

• On the NDSL, or all reactants on the DSL or NDSL: you provide Schedule 10 information at least 60 days before the quantity exceeds 10 000 kg in a calendar year. More data is required above 50 000 kg where there is aquatic release or significant public exposure (s. 11) ^[10].
• Not on the NDSL: you provide Schedule 11 information at the same 10 000 kg / 60-day trigger (s. 12). This does not apply to reduced regulatory requirement polymers or to polymers whose reactants are all on the DSL or NDSL ^[11].
• Assessment period: 60 days after receipt in both cases (s. 16(4)) ^[9].

Other points that follow from NDSL status

• SNAc for non-DSL substances: the Minister can still publish a Canada Gazette notice applying SNAc provisions under s. 81(4). Then "no person shall use the substance" for the significant new activity in the notice without notifying first ^[6].
• Exclusions from notification: s. 81(6) excludes:
  • uses regulated under another Act listed in Schedule 2;
  • transient reaction intermediates that are not isolated;
  • impurities and incidental reaction products;
  • quantities at or below the prescribed exempt maximum.
• Waivers: s. 81(8) lets you ask for a waiver of information requirements ^[6].
• Excess-quantity notice: once you exceed a s. 87(1)(b) quantity, you "shall" notify the Minister within 30 days (s. 81(14)) ^[12].
• Moving to the DSL: once the s. 87(1) conditions are met, the Minister "shall add" the substance to the DSL and delete it from the NDSL ^[4]. A substance can also go the other way. Under s. 66.2(1), the Minister may delete a DSL substance that is no longer in Canadian commerce and may add it to the NDSL, after a Gazette notice and a 60-day comment period ^[13]. That is another reason to check the current list.
• What the inventory entry says: ECCC's NDSL entries state that manufacture or import "may be subject to notification" under SOR/2005-247, followed by a joint ECCC and Health Canada assessment. One example is CAS 999-55-3, listed in Canada Gazette Part I, Vol. 132, No. 5, 1998-01-31 ^[14].

Approach: I read CEPA 1999 and the New Substances Notification Regulations (Chemicals and Polymers) as consolidated on Justice Laws, and ECCC's DSL/NDSL inventory. I did not cover the separate rules for living organisms on the NDSL.

If a substance is on neither list, it is new to Canada and faces the strictest notification rules. CEPA 1999 s. 81(1) says "no person shall manufacture or import the substance" until you have given the Minister the prescribed information and fee, and the assessment period has expired ^[6]. Compared with the NDSL route, the first trigger is lower (100 kg instead of 1 000 kg), the data packages are larger and the assessment periods are longer.

Chemicals and biochemicals: s. 8(1) of SOR/2005-247

Quantity in a calendar year	What you "must" provide, and when	Assessment period (s. 16(2))
Over 100 kg	Schedule 4, at least 5 days before	5 days
Over 1 000 kg	Schedule 5, at least 60 days before	60 days
Over 10 000 kg	Schedule 6, at least 75 days before	75 days

Sources: s. 8(1) ^[8] and s. 16(2) ^[9].

• Biochemicals also need parts of Schedule 2 at each step. That means items 1 to 3 at 100 kg, then items 1 to 4 at the higher steps. Nucleic acids add items 5 and 6, and substances with enzymatic capability add items 7 to 13 ^[8].
• If the substance is later added to the NDSL: if you filed Schedule 5 including its item 10 and the substance is then listed, you "may" tell the Minister in writing to treat that filing as made under s. 7(1)(b) (s. 8(2)) ^[8]. The assessment period is then 60 days from that notice (s. 16(3)) ^[9].

Polymers and biopolymers

• Over 1 000 kg: Schedule 9 information is due at least 30 days before (s. 10) ^[15]. The assessment period is 30 days (s. 16(4)) ^[9].
• Over 10 000 kg: Schedule 11 information is due at least 60 days before, with a 60-day assessment (s. 12(1), s. 16(4)) ^[11].
  • When it is not required: for section 6 polymers, reduced regulatory requirement polymers, and polymers whose reactants are all on the DSL or NDSL (s. 12(2)).
  • Partial relief: items 5 to 10 of Schedule 11 are not needed if the polymer misses the reduced-requirement criteria only because of certain aldehyde, vinyl ether or sulphonic acid groups (s. 12(3)).
• Reduced regulatory requirement polymers are defined in s. 9 by molecular-weight criteria, plus certain polyesters made only from reactants listed in Schedule 8 ^[16].

Lighter regimes and exemptions

• R&D, contained site-limited intermediate and contained export-only substances:
  • Chemicals: Schedule 1 at least 30 days before exceeding 1 000 kg, plus an update 30 days before exceeding 10 000 kg (s. 5) ^[17].
  • Polymers: Schedule 3 at least 30 days before exceeding 10 000 kg (s. 6) ^[18].
  • Assessment period: 30 days (s. 16(1)).
• Below the first trigger: a substance is exempt from s. 81(1) if the quantity does not exceed the one that first triggers an information requirement (s. 4) ^[19].
• Statutory exclusions (CEPA s. 81(6)):
  • uses regulated under another Act that provides its own notification and assessment;
  • transient intermediates that are not isolated;
  • impurities and partially unreacted materials;
  • incidental reaction products ^[6].
• Schedule 2 uses and transit: the Regulations do not apply to uses regulated under an Act listed in Schedule 2 to CEPA, or to goods moved through Canada in transit (s. 3) ^[20].
• Waivers: you can ask for a waiver under s. 81(8). Granted waivers are published in the Canada Gazette (s. 81(9)) ^[12].

Filing mechanics (SOR/2005-247)

• Test data: must follow current OECD Test Guidelines. The main toxicity, ecotoxicity and biodegradation tests must follow OECD GLP (s. 15) ^[21].
• Certification and Canadian agent: the filing must be certified. A non-resident must name a person resident in Canada who is authorized to act on their behalf (s. 14) ^[22].
• Record keeping: keep the information and supporting data in Canada for five years after the year you provide it (s. 13) ^[23].

After you notify

• Assessment: the Ministers "shall" assess within the prescribed period. They can extend it once, by no more than that period (s. 83) ^[24].
• If they suspect the substance is toxic (s. 84) ^[25], the Minister may:
  • allow it with conditions;
  • prohibit it. A prohibition expires after two years unless a proposed regulation is published first;
  • ask for more information. You then cannot manufacture or import until you supply it and the later of the assessment period or 90 days has passed.
• Notice of excess quantity: once you exceed a s. 87(1)(b) quantity, you "shall" notify the Minister within 30 days (s. 81(14)) ^[12].
• Listing on the DSL: the Minister "shall add" the substance to the DSL within 120 days once four conditions are met ^[4]:
  • your information is in;
  • you have exceeded 1 000 kg in a calendar year or 5 000 kg in total;
  • the assessment period has expired;
  • no s. 84(1)(a) conditions remain.
• SNAc on listing: the Minister may add a Significant New Activity flag when listing it (s. 87(3)). Even before listing, a Canada Gazette notice under s. 81(4) can bar using it for a significant new activity without prior notice ^[6].

s. 81(1) requires a "prescribed fee" with the notification. I did not retrieve the fee amounts, so I give none here.

Approach: I read CEPA 1999 Part 5 and the New Substances Notification Regulations (Chemicals and Polymers), SOR/2005-247, as consolidated on Justice Laws. The separate regulations for living organisms and the fee regulations are not covered.