New substances: chemicals and polymers waivers

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 500 notifications received.

The statutory criteria for a waiver of information requirements that are identified in subsection 81(8) or 106(8) of CEPA are:

  1. 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;
  2. 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
  3. it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.

Statistics of the waiver of information requirements granted per year

In 2018, a total of 55 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 42 waivers were granted for living organisms under subsection 106(8) of CEPA

In 2017, a total of 81 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 3 waivers were granted for living organisms under subsection 106(8) of CEPA.

In 2016, a total of 109 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 14 waivers were granted for organisms under subsection 106(8) of CEPA.

In 2015, a total of 109 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 26 waivers were granted for organisms under subsection 106(8) of CEPA.

In 2014, a total of 94 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 18 waivers were granted for organisms under subsection 106(8) of CEPA.

In 2013, a total of 94 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA, and 13 waivers were granted for organisms under subsection 106(8) of CEPA. Only one waiver was rejected for chemicals and polymers.

Chemicals and polymers
Information Requirement 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 13 23 35 25 26
Octanol/Water Partition Coefficient 12 12 21 21 19
Water Solubility 3 2 1 4 3
Water Extractability 1 2 16 3 3
Acute Aquatic Toxicity 0 2 10 4 2
Acute Mammalian Toxicity 4 3 2 4 2
In vivo Mammalian Mutagenicity 5 8 3 - 3
Vapour Pressure 4 9 6 16 15
Adsorption-Desorption 1 8 3 4 3
In vitro Mammalian mutagenicity 3 7 3 1 1
Ready Biodegradation 1 2 1 2 4
Skin Sensitization 2 1 - 2 2
Skin Irritation 1 1 - 1 1
Boiling Point 1 - 2 5 2
Melting Point 1 - - 4 2
Density - - 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 -
Living organisms
Information Requirement 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 14  1 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 14  1  3 5 2
Data from tests of antibiotic susceptibility 14 1 2 17 14
Data from a test conducted to determine its pathogenicity, toxicity, or invasiveness - 1 - - -

Examples of common rationale for granting waivers

Waivers may be granted for a variety of reasons depending on the substance or the living organism notified.

Some of the most common reasons for granting a waiver under paragraph 81(8)(a) or 106(8)(a) of CEPA are:

  • The substance is highly volatile.
  • The substance is a salt and changes to a different substance in water.
  • The substance decomposes or reacts dangerously during the performance of the test.
  • The substance cannot dissolve in any solvent suitable for use in an analytical method.
  • The substance has no readily hydrolysable groups and therefore is not expected to hydrolyze.
  • The living organism is known not to cause human health effects.

Some of the most common reasons for granting a waiver under paragraph 81(8)(c) or 106(8)(c) of CEPA are:

  • The substance is unstable in the purified form.
  • The substance reacts dangerously with water.
  • The substance is a salt and changes to a different substance in water.
  • The substance decomposes or reacts dangerously during the performance of the test.
  • The substance cannot dissolve in any solvent suitable for use in an analytical method.
  • The substance is explosive or reacts dangerously in the presence of light.

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.

Published waivers

The following is a list of Waivers published in the Canada Gazette, Part I:

Waivers from 2017 to 1997
2019 2018 2017 2016 2015 2014 2008 2007 2006 2005 2003 2001 2000 1999 1997

2008

2007

  • Waiver of information requirements published in the Canada Gazette, Part I, on July 7, 2007 - (PDF Format - 953 KB)
  • Waiver of information requirements published in the Canada Gazette, Part I, on January 6, 2007 - (PDF Format - 368 KB)

2006

  • Waiver of information requirements published in the Canada Gazette, Part I, on June 24, 2006 - (PDF Format - 980 KB)

2005

2003

  • Waiver of information requirements published in the Canada Gazette, Part I, on December 20, 2003 - (PDF Format - 835 KB)

2001

2000

  • Waiver of information requirements published in the Canada Gazette, Part I, on November 11, 2000 - (PDF Format - 392 KB)
  • Waiver of information requirements published in the Canada Gazette, Part I, on March 25, 2000 - (PDF Format - 1 340 KB)

1999

  • Waiver of information requirements published in the Canada Gazette, Part I, on October 23, 1999 - (PDF Format - 489 KB)
  • Waiver of information requirements published in the Canada Gazette, Part I, on March 6, 1999 - (PDF Format - 406 KB)

1997

  • Waiver of information requirements published in the Canada Gazette, Part I, on September 13, 1997 - (GIF Format)
  • Waiver of information requirements published in the Canada Gazette, Part I, on January 18, 1997 - (GIF Format)
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