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

2019

2018

2017

2016

2015

2014

2008

Waiver of information requirements published in the Canada Gazette, Part I, on March 29, 2008 [PDF]

2007

2000

1999

1997

Page details

2021-02-08

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