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Article 3.5. Chronic Health Effects Of Cosmetics of California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 7. >> Article 3.5.
This article shall be known, and may be cited, as the
California Safe Cosmetics Act of 2005.
For purposes of this article, the following terms have
the following meanings:
(a) "Authoritative body" means any agency or formally organized program or group recognized pursuant to Section 12306 of Title 22 of the California Code of Regulations as being authoritative for the purpose of identifying chemicals that cause cancer or reproductive toxicity.
(b) "Chemical identified as causing cancer or reproductive toxicity" means a chemical identified pursuant to Section 25249.8 or identified by an authoritative body as any of the following:
(1) A substance listed as known or reasonably anticipated to be a human carcinogen in a National Toxicology Report on carcinogens.
(2) A substance given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International Agency for Research on Cancer.
(3) A substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency.
(4) A substance identified as having some or clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction.
(c) "Division" means the Division of Environmental and Occupational Disease Control within the State Department of Health Services.
(d) "Ingredient" has the same meaning as that term is defined in subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21 of the Code of Federal Regulations and does not include any incidental ingredient as defined in subdivision (l) of Section 701.3 of Part 701 of Chapter 1 of Title 21 of the Code of Federal Regulations.
(e) "Manufacturer" means any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.
(a) "Authoritative body" means any agency or formally organized program or group recognized pursuant to Section 12306 of Title 22 of the California Code of Regulations as being authoritative for the purpose of identifying chemicals that cause cancer or reproductive toxicity.
(b) "Chemical identified as causing cancer or reproductive toxicity" means a chemical identified pursuant to Section 25249.8 or identified by an authoritative body as any of the following:
(1) A substance listed as known or reasonably anticipated to be a human carcinogen in a National Toxicology Report on carcinogens.
(2) A substance given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International Agency for Research on Cancer.
(3) A substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency.
(4) A substance identified as having some or clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction.
(c) "Division" means the Division of Environmental and Occupational Disease Control within the State Department of Health Services.
(d) "Ingredient" has the same meaning as that term is defined in subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21 of the Code of Federal Regulations and does not include any incidental ingredient as defined in subdivision (l) of Section 701.3 of Part 701 of Chapter 1 of Title 21 of the Code of Federal Regulations.
(e) "Manufacturer" means any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.
(a) The manufacturer of any cosmetic product subject to
regulation by the federal Food and Drug Administration that is sold
in this state shall, on a schedule and in electronic or other format,
as determined by the division, provide the division with a complete
and accurate list of its cosmetic products that, as of the date of
submission, are sold in the state and that contain any ingredient
that is a chemical identified as causing cancer or reproductive
toxicity, including any chemical that meets either of the following
conditions:
(1) A chemical contained in the product for purposes of fragrance or flavoring.
(2) A chemical identified by the phrase "and other ingredients" and determined to be a trade secret pursuant to the procedure established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations. Any ingredient identified pursuant to this paragraph shall be considered to be a trade secret and shall be treated by the division in a manner consistent with the requirements of Part 20 and Part 720 of Title 21 of the Code of Federal Regulations. Any ingredients considered to be a trade secret shall not be subject to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code) for the purposes of this section.
(b) Any information submitted pursuant to subdivision (a) shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained.
(c) If an ingredient identified pursuant to this section subsequently is removed from the product in which it was contained, is removed from the list of chemicals known to cause cancer or reproductive toxicity published under Section 25249.8, or is no longer a chemical identified as causing cancer or reproductive toxicity by an authoritative body, the manufacturer of the product containing the ingredient shall submit the new information to the division. Upon receipt of new information, the division, after verifying the accuracy of that information, shall revise the manufacturer's information on record with the division to reflect the new information. The manufacturer shall not be under obligation to submit subsequent information on the presence of the ingredient in the product unless subsequent changes require submittal of the information.
(d) This section shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of California, of less than one million dollars ($1,000,000), based on the manufacturer's most recent tax year filing.
(e) On or before December 31, 2013, the State Department of Public Health shall develop and make operational a consumer-friendly, public Internet Web site that creates a database of the information collected pursuant to this section. The database shall be searchable to accommodate a wide range of users, including users with limited technical and scientific literacy. Data shall be presented in an educational manner with, among other things, hypertext links that explain the meanings of technical terms, including, but not limited to, "carcinogenic" and "reproductive toxicity." The Internet Web site shall be designed to be easily navigable and to enable users to compare and contrast products and reportable ingredients. The Internet Web site shall include hypertext links to other educational and informational Internet Web sites to enhance consumer understanding.
(1) A chemical contained in the product for purposes of fragrance or flavoring.
(2) A chemical identified by the phrase "and other ingredients" and determined to be a trade secret pursuant to the procedure established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations. Any ingredient identified pursuant to this paragraph shall be considered to be a trade secret and shall be treated by the division in a manner consistent with the requirements of Part 20 and Part 720 of Title 21 of the Code of Federal Regulations. Any ingredients considered to be a trade secret shall not be subject to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code) for the purposes of this section.
(b) Any information submitted pursuant to subdivision (a) shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained.
(c) If an ingredient identified pursuant to this section subsequently is removed from the product in which it was contained, is removed from the list of chemicals known to cause cancer or reproductive toxicity published under Section 25249.8, or is no longer a chemical identified as causing cancer or reproductive toxicity by an authoritative body, the manufacturer of the product containing the ingredient shall submit the new information to the division. Upon receipt of new information, the division, after verifying the accuracy of that information, shall revise the manufacturer's information on record with the division to reflect the new information. The manufacturer shall not be under obligation to submit subsequent information on the presence of the ingredient in the product unless subsequent changes require submittal of the information.
(d) This section shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of California, of less than one million dollars ($1,000,000), based on the manufacturer's most recent tax year filing.
(e) On or before December 31, 2013, the State Department of Public Health shall develop and make operational a consumer-friendly, public Internet Web site that creates a database of the information collected pursuant to this section. The database shall be searchable to accommodate a wide range of users, including users with limited technical and scientific literacy. Data shall be presented in an educational manner with, among other things, hypertext links that explain the meanings of technical terms, including, but not limited to, "carcinogenic" and "reproductive toxicity." The Internet Web site shall be designed to be easily navigable and to enable users to compare and contrast products and reportable ingredients. The Internet Web site shall include hypertext links to other educational and informational Internet Web sites to enhance consumer understanding.
(a) In order to determine potential health effects of
exposure to ingredients in cosmetics sold in the state, the division
may conduct an investigation of one or more cosmetic products that
contain chemicals identified as causing cancer or reproductive
toxicity or other ingredients of concern to the division.
(b) An investigation conducted pursuant to subdivision (a) may include, but not be limited to, a review of available health effects data and studies, worksite health hazard evaluations, epidemiological studies to determine the health effects of exposures to chemicals in various subpopulations, and exposure assessments to determine total exposures to individuals in various settings.
(c) If an investigation is conducted pursuant to subdivision (a), the manufacturer of any product subject to the investigation may submit relevant health effects data and studies to the division.
(d) In order to further the purposes of an investigation, the division may require manufacturers of products subject to the investigation to submit to the division relevant health effects data and studies available to the manufacturer and other available information as requested by the division, including, but not limited to, the concentration of the chemical in the product, the amount by volume or weight of the product that comprises the average daily application or use, and sales and use data necessary to determine where the product is used in the occupational setting.
(e) The division shall establish reasonable deadlines for the submittal of information required pursuant to subdivision (d). Failure by a manufacturer to submit the information in compliance with the requirements of the division shall constitute a violation of this part.
(b) An investigation conducted pursuant to subdivision (a) may include, but not be limited to, a review of available health effects data and studies, worksite health hazard evaluations, epidemiological studies to determine the health effects of exposures to chemicals in various subpopulations, and exposure assessments to determine total exposures to individuals in various settings.
(c) If an investigation is conducted pursuant to subdivision (a), the manufacturer of any product subject to the investigation may submit relevant health effects data and studies to the division.
(d) In order to further the purposes of an investigation, the division may require manufacturers of products subject to the investigation to submit to the division relevant health effects data and studies available to the manufacturer and other available information as requested by the division, including, but not limited to, the concentration of the chemical in the product, the amount by volume or weight of the product that comprises the average daily application or use, and sales and use data necessary to determine where the product is used in the occupational setting.
(e) The division shall establish reasonable deadlines for the submittal of information required pursuant to subdivision (d). Failure by a manufacturer to submit the information in compliance with the requirements of the division shall constitute a violation of this part.
(a) If the division determines pursuant to an investigation
that an ingredient in a cosmetic product is potentially toxic at the
concentrations present in the product or under the conditions used,
the division shall immediately refer the results of its investigation
to the Division of Occupational Safety and Health in the Department
of Industrial Relations and the Office of Environmental Health Hazard
Assessment.
(b) Within 180 days after it receives the results of an investigation pursuant to subdivision (b), the Division of Occupational Safety and Health shall, pursuant to Section 147.1 of the Labor Code, develop and present one or more proposed occupational health standards to the Occupational Safety and Health Standards Board in the Department of Industrial Relations, unless the Division of Occupational Safety and Health affirmatively determines, in a written finding within 90 days, that a standard is not necessary to protect the health of an employee who has regular exposure to the hazard for the period of his or her working life. The written finding shall identify the reasons for determining the standard is not necessary and the factual basis for the finding.
(b) Within 180 days after it receives the results of an investigation pursuant to subdivision (b), the Division of Occupational Safety and Health shall, pursuant to Section 147.1 of the Labor Code, develop and present one or more proposed occupational health standards to the Occupational Safety and Health Standards Board in the Department of Industrial Relations, unless the Division of Occupational Safety and Health affirmatively determines, in a written finding within 90 days, that a standard is not necessary to protect the health of an employee who has regular exposure to the hazard for the period of his or her working life. The written finding shall identify the reasons for determining the standard is not necessary and the factual basis for the finding.
(a) The Legislature finds and declares the following:
(1) The Cosmetic Ingredient Review (CIR) panel is a nongovernmental body established and funded by the cosmetics industry to review the safety of cosmetic ingredients.
(2) According to a 2004 analysis of the 2003 CIR Compendium by the Environmental Working Group, 54 cosmetic products violate the CIR's own safe use recommendations to manufacturers by containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label.
(3) Federal regulations (21 C.F.R. 740.10) require every ingredient in a cosmetic product and every finished cosmetic product to be adequately substantiated for safety prior to marketing, and state that any ingredient or product whose safety has not been adequately substantiated prior to marketing is misbranded unless it displays a warning statement declaring, "The safety of this product has not been determined."
(b) The division may, as early as feasible within existing resources, determine whether the products identified in paragraph (2) of subdivision (a) have been adequately substantiated for safety pursuant to Section 740.10 of Title 21 of the Code of Federal Regulations. For any product adequately substantiated for safety, the division shall determine if the product contains any ingredient that the CIR has found is not safe for the specific use indicated on the product's label.
(c) If the division finds that a product has been adequately substantiated for safety despite containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label, the division shall refer its findings to the Attorney General and the federal Food and Drug Administration for possible enforcement action pursuant to this part and the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(1) The Cosmetic Ingredient Review (CIR) panel is a nongovernmental body established and funded by the cosmetics industry to review the safety of cosmetic ingredients.
(2) According to a 2004 analysis of the 2003 CIR Compendium by the Environmental Working Group, 54 cosmetic products violate the CIR's own safe use recommendations to manufacturers by containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label.
(3) Federal regulations (21 C.F.R. 740.10) require every ingredient in a cosmetic product and every finished cosmetic product to be adequately substantiated for safety prior to marketing, and state that any ingredient or product whose safety has not been adequately substantiated prior to marketing is misbranded unless it displays a warning statement declaring, "The safety of this product has not been determined."
(b) The division may, as early as feasible within existing resources, determine whether the products identified in paragraph (2) of subdivision (a) have been adequately substantiated for safety pursuant to Section 740.10 of Title 21 of the Code of Federal Regulations. For any product adequately substantiated for safety, the division shall determine if the product contains any ingredient that the CIR has found is not safe for the specific use indicated on the product's label.
(c) If the division finds that a product has been adequately substantiated for safety despite containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label, the division shall refer its findings to the Attorney General and the federal Food and Drug Administration for possible enforcement action pursuant to this part and the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
