Waivers (Chemicals and Polymers)

Contents

Waivers of Information Requirements

Overview

Under subsection 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), Canadian importers, manufacturers or users of New Substances may request "waivers" for any of the prescribed information (under subsection 81(1), (3) or (4) or 106(1), (3) or (4)) if they can demonstrate that the information is unnecessary to determine whether the substance is toxic, that the substance will be contained throughout its life-cycle or that it is technically impossible to perform the required tests.

The decision to grant a waiver is made on a case-by-case basis by Environment Canada and Health Canada. On average, approximately 100 waivers are granted yearly for chemicals and polymers and organisms for an average of 450 notifications received. 

The statutory criteria for a waiver of information requirements that are identified in subsection 81(8) or 106(8) of CEPA 1999 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 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 in 2013

In 2013, a total of 94 waivers were granted for chemicals and polymers under subsection 81(8) of CEPA 1999, and 13 waivers were granted for organisms under subsection 106(8) of CEPA 1999. Only one waiver was rejected for chemicals and polymers.

Chemicals and Polymers
Information requirementNumber of times granted
Hydrolysis as a function of pH16
Octanol/Water Partition Coefficient21
Water Solubility6
Water Extractability2
Acute Aquatic Toxicity5
Acute Mammalian Toxicity1
In vivo Mammalian Mutagenicity11
Vapour Pressure11
Adsorption-Desorption2
Acute Inhalation Mammalian Toxicity1
Ready Biodegradation2
Acute Dermal Mammalian Toxicity1
Skin Sensitization1
Boiling Point5
Melting Point4
Density5
Living Organisms
Information requirementNumber of times granted
Data from tests conducted to determine the effects of the micro-organism on aquatic plant, invertebrate and vertebrate species likely to be exposed to it2
Data from tests conducted to determine the effects of the micro-organism on terrestrial plant, invertebrate and vertebrate species likely to be exposed to it2
Data from tests of antibiotic susceptibility8
Data from a test conducted to determine its pathogenicity, toxicity, or invasiveness1

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 1999 when the information is not needed 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 1999  when the information is not feasible or practical to obtain 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 1999 when it is demonstrated that the substance or living organism to be manufactured at a location where, the substance is contained so as to satisfactorily protect the environment and human life.

Canadian importers or manufacturers of New Substances may request "Waivers" for any of the prescribed information if they can demonstrate that the information is unnecessary to determine whether the substance is toxic, that the substance will be contained throughout its life-cycle or that it is technically impossible to perform the required tests.

The decision to grant a waiver is made, on a case-by-case basis by Environment Canada and Health Canada.

Published Waivers

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

Waivers from 2014 to 1997
2014200820072006200520032001200019991997

2014

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

  • Waiver of information requirements published in the Canada Gazette, Part I, on March 12, 2005 - (PDF Format - 1 230 KB)

2003

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

2001

  • Waiver of information requirements published in the Canada Gazette, Part I, on July 28, 2001 - (PDF Format - 1 620 KB)

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)

Related Links