Titanium-containing Substances Group - information sheet

Publications summarized:

• Draft Assessment for the Titanium-containing Substances Group (published on October 28, 2023 for a 60-day public comment period ending on December 27, 2023).
• Associated notice: Canada Gazette, Part I: Vol. 157, No. 43 – October 28, 2023

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Consideration of subpopulations who may have greater susceptibility or greater exposure
• Risk assessment outcomes
  • Proposed assessment conclusions
• Related resources

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment.
  • The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent that people or the environment are exposed.
  • When needed, the Government applies risk management instruments under CEPA and other federal acts to help prevent or reduce potential harm.
• The ecological hazard and exposure potentials of the 13 titanium-containing substances in this group were classified using the Ecological Risk Classification of Inorganic Substances (ERC-I) Approach.
• Substances in the Titanium-containing Substances Group are associated with health effects through inhalation; however, at levels of exposure considered in the assessment, the Government is proposing that they are not harmful to human health or to the environment.

About these substances

• Details on the substance names and CAS RNs are found in the summary of publications section of the Titanium-containing Substances Group web page.
• The assessment focuses on 13 substances, referred to collectively as the Titanium-containing Substances Group under the third phase of the Chemicals Management Plan (CMP).
• Nanomaterials containing titanium are not explicitly considered in this assessment. Nanomaterials have different physicochemical and toxicological properties, as well as use patterns, compared to larger materials with the same chemical composition (also known as bulk materials). The Government of Canada has committed to addressing nanoscale forms of substances on the Domestic Substances List (DSL) including nanoscale titanium dioxide, which will be considered in a future assessment.
• Titanium is a naturally occurring metal that is present in the environment predominantly as titanium oxides.
• According to information gathered by the Government, activities and uses involving these substances in Canada include metal mining and refining, processing intermediates, laboratory substances, fabric and textiles, adhesives and sealants, paints and coatings, water repellants, apparel and footwear care, automotive care, cleaning and furnishing care, building materials, floor coverings, food packaging materials and electronics.
• In addition, some of the substances in the Titanium-containing Substances Group are permitted food additives and are present in a range of products available to consumers including self-care products (cosmetics, natural health products, and non-prescription drugs), pest control products, do-it-yourself (DIY) products, cleaning products, plastics and rubber products, paper products, inks and printing supplies, toys and arts and crafts products.

Human and ecological exposures

• The assessment indicates that people in Canada may be exposed to substances in the Titanium-containing Substances Group from air, drinking water, food, soil, house dust, as well as through the use of products available to consumers.
• Food is a major contributing source of titanium exposure for people in Canada.
• Internal exposure to substances in the group from all routes and sources for the general population of Canada was characterized using a science approach based upon biomonitoring data, as described in the biomonitoring-based approach 2 document. In the approach, human biomonitoring data (as a measure of exposure) are compared against biomonitoring guidance values (associated with health effects) that are protective of human health.
• Human biomonitoring is the measurement of substances in blood, urine or other human tissues and fluids (such as human milk, nails or hair) through health studies or surveys, such as the Canadian Health Measures Survey. The information on measured levels in humans is important for estimating exposure to people in Canada.
• Air concentrations of titanium-containing substances in ambient air and from the use of products available to consumers were estimated to assess the risk of inhalation health effects.
• For these substances, the ecological exposure was characterized in the ERC-I Approach using predictive modelling and an analysis of measured concentrations of metals. Information was gathered from surveys issued under section 71 of CEPA 1999, the National Pollutant Release Inventory (NPRI), the Canada Border Services Agency, market research and a number of federal and provincial water quality monitoring datasets.

Key health and ecological effects (hazard)

• National and international reports on these substances, among other sources of information, were considered to inform the health effects characterization in the screening assessment. This included assessments by Health Canada's Food Directorate, the European Food Safety Authority, and the European Commission's Scientific Committee on Consumer Safety, among others.
• The biomonitoring guidance value derived for characterizing the risk to human health from internal exposure to substances in the Titanium-containing Substances Group was based on no adverse effects at the highest doses tested through the oral or dermal routes of exposure in available laboratory studies.
• The critical effects identified for characterizing the risk to human health for substances in the Titanium-containing Substances Group through inhalation exposure are non-cancer effects on tissue in the nasal cavity and lungs.
• The ecological hazard of the 13 substances in the Titanium-containing Substances Group was characterized using the ERC-I Approach. The approach uses published predicted no-effect concentrations (PNECs; the concentration below which exposure to a substance is not expected to cause adverse effects in the environment) from domestic and international assessments and water quality guidelines. When no suitable PNECs were available, new ones were derived considering multiple sources of information.

Consideration of subpopulations who may have greater susceptibility or greater exposure

• There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
• Certain subpopulations are routinely considered throughout the assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. These subpopulations were taken into account in the risk assessment outcomes of titanium-containing substances.
• In addition, the potential for elevated exposure in certain Indigenous communities and for people living near industrial releases were considered in the assessment.

Risk assessment outcomes

• Assessments focus on information critical to determining whether substances are harmful to human health or the environment under CEPA. This is done by considering scientific information, including information, if available, on subpopulations who may have greater susceptibility or greater exposure, vulnerable environments and cumulative effects and by incorporating a weight of evidence approach and precaution. The potential for cumulative effects was considered in the assessment by examining cumulative exposures from the broader moiety of titanium.
• It was determined that the risk to human health from the 13 substances in the Titanium-containing Substances Group was low at levels of exposure considered in the assessment:
  • For internal exposure from all routes and sources, this was based upon a comparison of titanium levels measured in blood and levels associated with no health effects.
  • For inhalation exposure, this was based upon a comparison of levels to which people in Canada may be exposed and levels associated with non-cancer inhalation health effects.
• Based on the outcome of the ERC-I Approach, these 13 substances were characterized as unlikely to be causing ecological harm.

Proposed assessment conclusions

• The Government is proposing that the 13 substances in the Titanium-containing Substances Group are not harmful to human health or the environment at levels of exposure considered in the assessment.

Related resources

• The substances in the Titanium-containing Substances Group may be found in products available to consumers. People in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly.
• Visit Healthy home for information on chemical safety in and around the home.
• Certain products available to consumers containing substances in the Titanium-containing Substances Group are subject to the provisions of the Food and Drugs Actand the Pest Control Products Act:
  • Notification of ingredients in cosmetics is required under the Cosmetic Regulations under the Food and Drugs Act. Under section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10days after they sell a cosmetic in Canada.
  • Use of substances in the Titanium-containing Substances Group in drugs including natural health products requires pre-market approval under the Food and Drugs Act.
  • The permitted uses of the substances as food additives are set out in the List of Permitted Colouring Agents..
  • Use of the substances in pest control products requires assessment and registration under the Pest Control Products Act.
• Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.
• The assessment focused on potential risks from exposure of the general population of Canada. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, people in Canada should consult their employer or the Occupational Health and Safety Regulator in their jurisdiction.