Final Assessment

1. Introduction

CEPA requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that meet the categorization criteria set out in the Act to determine whether the substances present or may present a risk to the environment or to human health. A screening assessment involves an analysis of a substance using available information to determine whether the substance is harmful to human health or the environment as defined in section 64 of CEPA.

Triclosan (phenol, 5-chloro-2-(2,4-dichlorophenoxy); CAS RN 3380-34-5) is a substance on the Domestic Substances List that was identified as a priority for action under CEPA since it met the categorization criteria set out in the Act based on ecological concerns. Health Canada and Environment and Climate Change Canada conducted a scientific assessment of available information relevant to the assessment of triclosan. This  assessment report provides the basis for conclusions under CEPA.

The assessment of human health effects was informed by foreign reviews conducted by the United States Environmental Protection Agency (US EPA 2008a,b,c,d; 2014), the European Union (EU) Scientific Committee on Consumer Products (SCCP 2009), the Scientific Committee on Consumer Safety (SCCS 2011), and the Australian Department of Health and Ageing National Industrial Chemicals Notification and Assessment Scheme (NICNAS 2009).

Exposure of the Canadian population to triclosan was assessed by Health Canada using the available biomonitoring data for triclosan from the Canadian Health Measures Survey (CHMS) Cycle 2 (2009-2011), the Plastics and Personal-Care Product Use in Pregnancy (or P4) Study, and the Maternal-Infant Research on Environmental Chemicals (or MIREC) Study. These data encompass exposures to triclosan from all potential sources and routes, and are considered the most accurate estimates of total exposure of the general population in Canada to triclosan. Some deterministic exposure estimates were also conducted by Health Canada to more fully characterize the human health effects and exposure of the general population of Canada.

Data relevant to the ecological assessment of triclosan were identified in original literature, review documents, and commercial and government databases. In addition to retrieving the references from reviews and a literature database search, efforts were made to contact researchers, academia, industry and government agencies to obtain relevant information on triclosan.

Studies that form the basis of this assessment have been critically evaluated by Health Canada and Environment and Climate Change Canada. The assessment does not present an exhaustive review of all available data; rather, it presents the critical studies and lines of evidence pertinent to the conclusions. Relevant data obtained as of April 2016 were considered in this document.

The human health and ecological portions of this assessment have undergone external written peer review or consultation. Comments on the technical portions relevant to human health were received from scientific experts who were selected and directed by Toxicology Excellence for Risk Assessment, Risk Sciences International Inc. These included ToxEcology - Environmental Consulting Ltd, Tetra Tech, and Summit Toxicology. Outcomes of the US Environmental Protection Agency’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) panel were also taken into consideration in the development of this assessment. Comments on the technical portions relevant to the environment were received from Cecilie Rendal (Unilever), Donna Randall (US Environmental Protection Agency), Theo Traas (Dutch National Institute for Public Health and the Environment (RIVM)), and Magnus Løfstedt (Danish Environmental Protection Agency). The conclusions presented in this document are those of Health Canada and Environment and Climate Change Canada and do not necessarily reflect the opinions of the external reviewers. Additionally, a preliminary version of this assessment was subject to a 60-day public comment period. This assessment report for triclosan includes the conclusion as to whether triclosan meets any of the criteria in section 64 of CEPA.

Triclosan, as an active ingredient in pest control products, was also scheduled for re-evaluation under Health Canada's Pest Management Regulatory Agency (PMRA) pesticide re-evaluation program pursuant to the PCPA. As of December 31, 2014, pest control products containing triclosan are no longer registered in Canada under the Pest Control Products Act since the registrants voluntarily discontinued the sales of these products in Canada.