New substances: Waivers of information requirements
Overview
Under subsection 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999 (CEPA), Canadian importers, manufacturers or users of substances may request waivers for any of the prescribed information under subsection 81(1), (3) or (4) or 106(1), (3) or (4) if certain conditions are met.
The decision to grant a waiver is made on a case-by-case basis by Environment and Climate Change Canada, following consultation with Health Canada. On average, approximately 100 waivers are granted yearly for an average of 400 notifications received.
The statutory criteria for a waiver of information requirements that are identified in subsection 81(8) or 106(8) of CEPA are:
- in the opinion of the Ministers, the information is not needed in order to determine whether the substance or the living organism is toxic or capable of becoming toxic;
- a substance or living organism is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the notifier requesting the waiver is able to contain the substance or living organism so as to satisfactorily protect the environment and human life; or
- it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.
Examples of rationales for granting waivers
Notifications of new substances (including chemicals, polymers and living organisms) may have waivers granted for a variety of reasons.
Some examples of rationales for granting a waiver under paragraph 81(8)(a) or 106(8)(a) of CEPA are:
- The substance is an ionic solid and therefore has negligible vapour pressure.
- The substance contains no carbon atoms and is therefore not susceptible to biodegradation.
- The substance does not have readily hydrolysable groups and is expected to be stable.
- The substance belongs to a class comprising certain cationic polymers is expected to have low toxicity to human health based on a sufficient body of available information.
- The living organism is known not to cause human health effects.
Some common reasons for granting a waiver under paragraph 81(8)(c) or 106(8)(c) of CEPA are:
- The substance reacts dangerously during the performance of the test.
- The substance is a salt that is stable only as an aqueous solution.
- The substance is surface active.
Waivers may also be granted under paragraph 81(8)(b) or 106(8)(b) of CEPA when it is demonstrated that the substance or living organism is to be manufactured at a location where it is contained so as to satisfactorily protect the environment and human life.
Yearly statistics
Total waivers granted per year
| Year | Chemicals and polymers (subsection 81(8) of CEPA) | Living organisms (subsection 106(8) of CEPA) |
|---|---|---|
| 2019 | 77 | 23 |
| 2018 | 55 | 42 |
| 2017 | 81 | 3 |
| 2016 | 109 | 14 |
| 2015 | 109 | 26 |
| 2014 | 94 | 18 |
Waivers granted for chemical and polymers
| Information requirement | Number of times granted 2019 | Number of times granted 2018 | Number of times granted 2017 | Number of times granted 2016 | Number of times granted 2015 | Number of times granted 2014 |
|---|---|---|---|---|---|---|
| Hydrolysis as a function of pH | 15 | 13 | 23 | 35 | 25 | 26 |
| Octanol/Water Partition Coefficient | 20 | 12 | 12 | 21 | 21 | 19 |
| Water Solubility | 3 | 3 | 2 | 1 | 4 | 3 |
| Water Extractability | 4 | 1 | 2 | 16 | 3 | 3 |
| Acute Aquatic Toxicity | 3 | 0 | 2 | 10 | 4 | 2 |
| Acute Mammalian Toxicity | 2 | 4 | 3 | 2 | 4 | 2 |
| In vivo Mammalian Mutagenicity | 6 | 5 | 8 | 3 | - | 3 |
| Vapour Pressure | 5 | 4 | 9 | 6 | 16 | 15 |
| Adsorption-Desorption | 2 | 1 | 8 | 3 | 4 | 3 |
| In vitro Mammalian mutagenicity | 3 | 3 | 7 | 3 | 1 | 1 |
| Ready Biodegradation | 2 | 1 | 2 | 1 | 2 | 4 |
| Skin Sensitization | 2 | 2 | 1 | - | 2 | 2 |
| Skin Irritation | 1 | 1 | 1 | - | 1 | 1 |
| Boiling Point | 2 | 1 | - | 2 | 5 | 2 |
| Melting Point | 2 | 1 | - | - | 4 | 2 |
| Density | 3 | - | - | 6 | 6 | 2 |
| Number average molecular weight | - | 1 | - | - | - | 2 |
| Molecular weight percent of oligomers between 500 and 1000 daltons | - | 1 | 1 | - | - | 2 |
| Repeated-dose mammalian toxicity | 1 | 1 | 1 | - | 1 | - |
| Optimum pH and temperature | 1 | - | - | - | - | - |
Waivers granted for living organisms
| Information requirement | Number of times granted 2019 | Number of times granted 2018 | Number of times granted 2017 | Number of times granted 2016 | Number of times granted 2015 | Number of times granted 2014 |
|---|---|---|---|---|---|---|
| Data from tests conducted to determine the effects of the micro-organism on aquatic plant, invertebrate and vertebrate species likely to be exposed to it | 5 | 14 | 1 | 3 | 4 | 2 |
| Data from tests conducted to determine the effects of the micro-organism on terrestrial plant, invertebrate and vertebrate species likely to be exposed to it | 5 | 14 | 1 | 3 | 5 | 2 |
| Data from tests of antibiotic susceptibility | 5 | 14 | 1 | 2 | 17 | 14 |
| Data from a test conducted to determine its pathogenicity, toxicity, or invasiveness | 1 | - | 1 | - | - | - |
Published waivers
The following waivers were published in the Canada Gazette, Part I:
Waivers from 2020 to 1997
2020
- Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on October 3, 2020
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on October 3, 2020
2019
- Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on December 14, 2019
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on December 14, 2019
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on June 29, 2019
- Waiver of information requirements for substances (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on March 30, 2019
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on March 30, 2019
- Waiver of information requirements for substances (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on January 12, 2019
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on January 12, 2019
2018
- Waiver of information requirements for substances (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on October 20, 2018
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on October 20, 2018
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on June 30, 2018
- Waiver of information requirements for substances (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on March 31, 2018
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on March 31, 2018
2017
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on December 30, 2017
- Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on September 30, 2017
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on September 30, 2017
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on June 24, 2017
- Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999), Part I on April 15, 2017
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I on April 15, 2017
2016
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)), Part I on November 19
- Waiver of information requirements for substances (subsection 106(9) of the Canadian Environmental Protection Act, 1999)), Part I on November 19
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)), Part I on August 27
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)), Part I on June 11
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)), Part I on February 27
2015
- Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999)), Part I on December 26
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)), Part I on December 26
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I, on May 30, 2015
- Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999), Part I, on February 28, 2015
2014
- Waiver of information requirements for substances published in the Canada Gazette, Part I, on November 1, 2014
- Waiver of information requirements for substances published in the Canada Gazette, Part I, on August 2, 2014
- Waiver of information requirements for substances published in the Canada Gazette, Part I, on May 31, 2014
- Waiver of information requirements published in the Canada Gazette, Part I, on February 8, 2014
- Waiver of information requirements published in the Canada Gazette, Part I, on February 8, 2014
2008
2007
- Waiver of information requirements published in the Canada Gazette, Part I, on July 7, 2007 [PDF]
- Waiver of information requirements published in the Canada Gazette, Part I, on January 6, 2007 [PDF]
2006
2005
2003
- Waiver of information requirements published in the Canada Gazette, Part I, on December 20, 2003 [PDF]
2001
2000
- Waiver of information requirements published in the Canada Gazette, Part I, on November 11, 2000 [PDF]
- Waiver of information requirements published in the Canada Gazette, Part I, on March 25, 2000 [PDF]
1999
- Waiver of information requirements published in the Canada Gazette, Part I, on October 23, 1999 [PDF]
- Waiver of information requirements published in the Canada Gazette, Part I, on March 6, 1999 [PDF]
1997
- Waiver of information requirements published in the Canada Gazette, Part I, on September 13, 1997 [GIF]
- Waiver of information requirements published in the Canada Gazette, Part I, on January 18, 1997 [GIF]