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Department of Toxic Substances Control
Safer Products and Workplaces Program
P.O. Box 806
Sacramento, CA 95812-0806
 

 

Authoritative Lists

 

Authoritative Lists

Section 69502.2(a) of the Safer Consumer Products Regulations enumerates 23 lists (“authoritative lists”). Subsection (a)(1) identifies 15 hazard trait-based lists of chemicals; and subsection (a)(2) identifies eight lists that were developed based on exposure potential concerns. The regulations provide that a chemical that appears on one or more of these authoritative lists and exhibits a Chapter 54 “hazard trait and/or an environmental or toxicological endpoint” is a Candidate Chemical, except for chemicals exempted under Health and Safety Code section 25251 (e.g., pesticides and prescription drugs). With two exceptions noted below, the informational list includes the information that was on the source lists as of June 12, 2013. DTSC will update the informational list periodically to reflect changes in the authoritative lists.

Dynamic Hazard Trait-Based Lists

New chemicals added to these source lists automatically become Candidate Chemicals.

§69502.2(a)(1)(A). Chemicals known to cause cancer and/or reproductive toxicity that are listed under Health and Safety Code section 25249.8 of the California Safe Drinking Water and Toxic Enforcement Act of 1986

California’s Office of Environmental Health Hazard Assessment (OEHHA) publishes and updates the Proposition 65 list of chemicals known to the state to cause cancer, or developmental or reproductive toxicity. It adopts safe harbor levels for the listed chemicals and provides guidance for calculating a safe harbor level when one has not been promulgated in regulations. Businesses that cause exposures greater than the safe harbor level must notify persons prior to exposure by providing a warning that complies with Proposition 65.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: April 19, 2013  (refer to OEHHA’s Prop 65 web page)


§69502.2(a)(1)(B). Chemicals classified by the European Commission as carcinogens, mutagens, and/or reproductive toxicants Category 1A and 1B in Annex VI to Regulation (EC) 1272/2008

Annex VI is maintained by the European Chemicals Agency (ECHA), an international authoritative organization working with the European Commission and the European Union (EU) Member States for the safety of human health and the environment by identifying the needs for regulatory risk management at the EU-wide level. Annex VI includes lists of harmonized classification and labeling for certain substances or groups of substances that are legally binding in the EU. The listed categories are identified as meeting the following criteria:

  • Carcinogens- Substances that may cause cancer
    1A: Substances known to have carcinogenic potential for humans
    1B- Substances presumed to have carcinogenic potential for humans
  • Mutagens- May cause genetic defects
    1A: Substances known to induce heritable mutations in the germ cells of humans
    1B: Substances to be regarded as if they induce heritable mutations in the germ cells of humans
  • Reproductive toxicants- May damage fertility or the unborn child
    1A: Known human reproductive toxicant
    1B: Presumed human reproductive toxicant

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: January 16, 2012  (to view the list used by DTSC, download Table 3.1 of Annex VI the regulation)



§69502.2(a)(1)(C). Chemicals included as Category 1 endocrine disruptors by the European Commission in the candidate list of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006

As part of implementing its Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations, the European Commission initiated a strategy to identify and address Substances of Very High Concern, which include chemicals with the following hazard traits:

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances)
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII)
  • Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances

Designating a chemical as a “Substance of Very High Concern” is the first step of the REACH authorisation procedure. After the second step, these chemicals may be included in the Authorisation List (Annex XIV of the REACH Regulation).

For the purposes of the Safer Consumer Product regulation, a chemical appearing on the Candidate List of Substances of Very High Concern that is Category 1 endocrine disruptor would be a Candidate Chemical.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: June 12, 2013 (refer to the European Chemical Agency’s Candidate List Table of Substances of Very High Concern)


§69502.2(a)(1)(D). Chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in the United States Environmental Protection Agency’s Integrated Risk Information System

Integrated Risk Information System (IRIS) is a human health assessment program that evaluates quantitative and qualitative information about effects from exposure to environmental contaminants. U.S. Environmental Protection Agency’s (US EPA) IRIS database is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. To identify the list of chemicals, DTSC staff used the search term “neurotoxicity” in the IRIS database and reviewed the resulting chemical “tox reviews” for neurotoxicity as Critical Endpoint(s).

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: September 26, 2012  (refer to EPA’s IRIS Web page)


§69502.2(a)(1)(E). Chemicals that are identified as “carcinogenic to humans”, “likely to be carcinogenic to humans”, or Group A, B1, or B2 carcinogens in the United States Environmental Protection Agency’s Integrated Risk Information System

IRIS is a human health assessment program that evaluates quantitative and qualitative information about effects from exposure to environmental contaminants. US EPA’s IRIS database is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects.

To identify the list of chemicals, select the 1986 Guidelines (Group A, B1, and B2), 1999 Guidelines (“carcinogenic to humans” or “likely to be carcinogenic), and the 2005 Guidelines (“carcinogenic to humans” or “likely to be carcinogenic”).

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: September 26, 2012 (refer to EPA’s IRIS Web page)


§69502.2(a)(1)(G). Chemicals included as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative by the European Commission in the candidate list of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006

As part of implementing its Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations, the European Commission initiated a strategy to identify and address Substances of Very High Concern, which include chemicals with the following hazard traits:

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances)
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII)
  • Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances

Designating a chemical as a “Substance of Very High Concern” is the first step of the REACH authorisation procedure. After the second step, these chemicals may be included in the Authorisation List (Annex XIV of the REACH Regulation).

For the purposes of the Safer Consumer Product regulation, the chemicals in the Candidate List of Substances of Very High Concern that are persistent, bioaccumulative and toxic, or are very persistent and very bioaccumulative are Candidate Chemicals.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: June 12, 2013 (refer to the European Chemical Agency’s Candidate List Table of Substances of Very High Concern)


§69502.2(a)(1)(H). Chemicals that are identified as Persistent, Bioaccumulative, and Inherently Toxic to the environment by the Canadian Environmental Protection Act Environmental Registry Domestic Substances List

Using information from Canadian industry, academic research and other countries, Government of Canada scientists from the Existing Substances Program at Health Canada and Environment Canada worked with partners in applying a set of rigorous tools to each of the approximately 23,000 chemicals on the Domestic Substances List. These chemicals are persistent, bioaccumulative, and inherently toxic to non-human organisms.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: September 5, 2006  (refer to Environment Canada’s Web page)


§69502.2(a)(1)(I). Chemicals classified by the European Commission as respiratory sensitizers Category 1 in Annex VI to Regulation (EC) 1272/2008

Annex VI is maintained by the European Chemicals Agency (ECHA), an international authoritative organization working with the European Commission and the European Union (EU) Member States for the safety of human health and the environment by identifying the needs for regulatory risk management at the EU-wide level. Annex VI includes lists of harmonized classification and labeling for certain substances or groups of substances that are legally binding in the EU.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: January 16, 2012 (refer to Table 3.1 in Annex VI in the regulation).


§69502.2(a)(1)(J). Groups 1, 2A, and 2B carcinogens identified by the International Agency for Research on Cancer

The International Agency for Research on Cancer (IARC) promotes international collaboration in cancer research and developed criteria to evaluate carcinogenic risks to humans and publishes monographs describing these evaluations. It also maintains a summary list of agents classified by IARC monographs, but recommends consulting the monograph itself for full interpretation of the classification. The listed categories are identified as meeting the following criteria:

  • Group 1: Carcinogenic to humans
  • Group 2A: Probably carcinogenic to humans
  • Group 2B: Possibly carcinogenic to humans

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: April 10, 2013 (refer to IARC's webpage)


§69502.2(a)(1)(K). Neurotoxicants that are identified in the Agency for Toxic Substances and Disease Registry’s Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, Nervous System

The Agency for Toxic Substances and Disease Registry (ATSDR) is a federal public health agency of the U.S. Department of Health and Human Services that provides health information to prevent harmful exposures and diseases related to toxic substances. ATSDR produces “toxicological profiles” for hazardous substances found at National Priority sites, and for the Department of Defense and Department of Energy on substances related to federal sites.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: March 3, 2011 (refer to ATSDR webpage)


§69502.2(a)(1)(L). Persistent Bioaccumulative and Toxic Priority Chemicals that are identified by the United States Environmental Protection Agency’s National Waste Minimization Program

U.S. EPA established the National Waste Minimization Program, which supports efforts to promote a more sustainable society, reduce the amounts of waste generated, and lower the toxicity and persistence of wastes that are generated. The National Waste Minimization Program established a list of Priority Chemicals that were determined to be persistent, bioaccumulative, and toxic. U.S. EPA is receptive to any waste minimization efforts for these chemicals.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: November 15, 2012 (refer to U.S. EPA's Waste Minimization Program’s Web page)


R§69502.2(a)(1)(M). Reproductive or developmental toxicants identified in Monographs on the Potential Human Reproductive and Developmental Effects, National Toxicology Program, Office of Health Assessment and Translation

The National Toxicology Program (NTP) is an interagency program managed by the U.S. Department of Health and Human Services whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. The NTP Office of Health Assessment and Translation (OHAT) conducts technical assessments focused on understanding the potential for adverse effects of substances on human health. Assessments of potential adverse effects of environmental substances on reproduction or development are published as NTP Monographs.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: May 24, 2013 (refer to OHAT’s Web page)


§69502.2(a)(1)(N). United States Environmental Protection Agency’s Toxics Release Inventory Persistent, Bioaccumulative and Toxic Chemicals that are subject to reporting under the Emergency Planning and Community Right-to-Know Act section 313

U.S. EPA maintains the Toxics Release Inventory (TRI) database, which summarizes releases reported to U.S. EPA to provide communities with information about toxic chemical releases and waste management activities and to support informed decision-making by industry, government, non-governmental organizations and the public.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: August 30, 2012 (refer to US EPA’s TRI Web page)


§69502.2(a)(1)(O). Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic (PBT) Chemicals identified in the Washington Administrative Code, title 173, chapter 173-333

Washington’s PBT initiative aims to reduce and phase-out the use, release, and exposure to PBTs in Washington in order to reduce and eliminate threats to human health and the environment. The PBT List is published and Chemical Action Plans are being created for each substance currently on the list.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: January 13, 2006 (refer to Washington Department of Ecology's Web site)

Static Hazard Trait-Based List

Updates and revisions to this list do not affect DTSC’s Candidate Chemicals list unless/until DTSC adopts regulations to incorporate them.

§69502.2(a)(1)(F). Chemicals that are identified as “known to be” or “reasonably anticipated to be” a human carcinogen in the 12th Report on Carcinogens, United States Department of Health and Human Services, Public Health Service, National Toxicology Program

The Report on Carcinogens (RoC) is a congressionally mandated, science-based, public health report that identifies agents, substances, mixtures, or exposures in our environment that are “known” or “reasonably anticipated” to cause cancer in humans. For every substance listed, the RoC contains a profile including cancer studies (mechanism, human, animal), potential sources of exposure, and current Federal regulations to limit exposures.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: June 10, 2011 (refer to NTP's Web page, download 12th Report on Carcinogens)

Dynamic Exposure Indicator Lists

New chemicals added to these source lists automatically become Candidate Chemicals.

§69502.2(a)(2)(A). Chemicals for which Notification Levels, as defined in Health and Safety Code section 116455, have been established by the California Department of Public Health (CDPH)

Notification Levels (NLs) are health-based advisory levels for chemicals in California drinking water for which there are no formal regulatory standards (i.e., Maximum Contaminant Levels (MCLs); see below).

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: December 14, 2010 (refer to CDPH's Web site)


§69502.2(a)(2)(B). Chemicals for which primary Maximum Contaminant Levels have been established and adopted under sections 64431 or 64444 of chapter 15 of Title 22 of the California Code of Regulations

Pursuant to Health and Safety Code §116365(a), the California Department of Public Health (CDPH) establishes MCLs – health protective drinking water standards to be met by California public water systems. MCLs must be reviewed every five years and take into account not only a chemical’s health risks but also factors such as detectability and treatability, as well as costs of treatment.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: November 28, 2008 (refer to DPH's Chemicals and Contaminants in Drinking Water Web page, the related regulations can be found using this search page)


§69502.2(a)(2)(C). Chemicals identified as Toxic Air Contaminants under sections 93000 and 93001 of Title 17 of the California Code of Regulations

The California Air Resources Board (ARB) regulates Toxic Air Contaminants (TACs), or “air pollutants which may cause or contribute to an increase in mortality or an increase in serious illness, or may pose a present or potential hazard to human health.” In addition to the list of TACs it developed in collaboration with the Office of Environmental Health Hazard Assessment (OEHHA), ARB has also designated chemicals identified as hazardous air pollutants under the federal Clean Air Act. (pursuant to subsection (b) of Section 112 of 42 U.S.C. Sec. 7412(b)) as TACs.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: July 18, 2011 (refer to ARB's TAC Web page, the related regulations can be found using this search page.)


§69502.2(a)(2)(D). Chemicals that are identified as priority pollutants in the California Water Quality Control Plans under section 303(c) of the federal Clean Water Act and in section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by California or the United States Environmental Protection Agency for one or more water bodies in California under section 303(d) of the federal Clean Water Act and section 130.7 of title 40 of the Code of Federal Regulations

California Water Quality Control Plans are adopted under section 303(c) of the federal Clean Water Act and section 131.38 of Title 40 of the Code of Federal Regulations to preserve water resources and prevent and control pollution to California waters. Section 303(c) requires states to develop water quality standards and review and update those standards every three years. Water quality standards must include designated uses of water bodies, and water quality criteria that are necessary to protect those uses.

Pursuant to section 303(d) of the federal Clean Water Act, the California State Water Resources Control Board has developed a list of water bodies in California that do not meet applicable water quality standards after the application of certain controls. The 303(d) lists the pollutant or pollutants that cause the listed water bodies not to meet these standards. Chemical pollutants with a hazard trait that are identified for one or more water bodies on the 303 (d) list are Candidate Chemicals.

Date of the Clean Water Act section 303(c) list used for the informational Candidate Chemicals list published on September 26, 2013: July 1, 2011 (refer to SWRCB’s 303(c) Web page)

Date of the Clean Water Act section 303(d) list used for the informational Candidate Chemicals list published on September 26, 2013: November 12, 2010 (refer to SWRCB’s 303(d) Web page)


§69502.2(a)(2)(E). Chemicals that are identified with non-cancer endpoints and listed with an inhalation or oral Reference Exposure Level by the California Office of Environmental Health Hazard Assessment under Health and Safety Code section 44360(b)(2)

OEHHA is responsible for conducting health risk assessments of chemical contaminants found in air and develops Reference Exposure Levels (RELs) for a variety of non-cancer health impacts. These RELs are required to be used in risk assessments for stationary sources for airborne emissions and are the basis for regulatory action.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: February 2012 (refer to OEHHA’s REL Web page)


§69502.2(a)(2)(F). Priority Chemicals that are identified under the California Environmental Contaminant Biomonitoring Program

The California Biomonitoring Program is a multi-agency program involving California Department of Public Health, OEHHA, and DTSC to monitor priority chemicals identified by the Centers for Disease Control and Prevention (CDC), see below, and recommended by their Scientific Guidance Panel. The program collects blood, urine, or other human samples to analyze the prevalence and levels of these identified chemicals and/or their metabolites in the state population to establish the trends of the levels of these chemicals, and to assess the effectiveness of public health efforts. Results of these findings are available on the California Biomonitoring Program webpage.

Date of the list used for the informational Candidate Chemicals list published on September 26, 2013: May 2013 (refer to the  California Biomonitoring Program Web page)


§69502.2(a)(2)(H). Chemicals that are identified on Part A of the list of Chemicals for Priority Action, Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic

The OSPAR Convention is the current legal instrument guiding international cooperation on the protection of the marine environment of the North-East Atlantic. In 2002, the OSPAR Convention adopted the OSPAR List to protect the marine environment by indicating the substances on the OSPAR list, providing a background document to assess the uses and risks for the substances, and to conclude what actions OSPAR should take to move towards the cessation target.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: 2002  (refer to OSPAR's Web page)

Static Exposure Indicator List

Updates and revisions to this list do not affect DTSC’s Candidate Chemical list unless/until DTSC adopts regulations to incorporate them.

§69502.2(a)(2)(G). Chemicals that are identified on the Centers for Disease Control and Prevention’s Fourth National Report on Human Exposure to Environmental Chemicals  and Updated Tables

The Centers for Disease Control and Prevention (CDC) is part of the U.S. Department of Health and Human Services, and produces the National Exposure Report as a series of ongoing assessments of the U.S. population’s exposure to environmental chemicals. Scientists measure chemicals or their metabolites in blood and urine samples obtained by random sample participants in CDC’s National Health and Nutrition Examination Survey (NHANES). The Fourth National Report on Human Exposure to Environmental Chemicals was revised to include new and updated tables, reflecting data from the 2005-2006, 2007-2008, 2009-2010 survey periods, and data for a few chemicals from the 2003-2004 survey period. The chemical list used by DTSC is found on pages 9 and 10 of the Fourth National Report.

Date of list used for the informational Candidate Chemicals list published on September 26, 2013: March 2013 (refer to CDC's Biomonitoring Web page)