Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.
This article shall be known, and may be cited, as the California Safe Cosmetics Act of 2005.
Article 3.5 - Chronic Health Effects of Cosmetics
California Health and Safety Code — §§ 111791-111793.5
Sections (7)
Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.
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.
Amended by Stats. 2021, Ch. 615, Sec. 277. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.
(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 (Division 10 (commencing with Section 7920.000) 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 website 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 website shall be designed
to be easily navigable and to enable users to compare and contrast products and reportable ingredients. The internet website shall include hypertext links to other educational and informational internet websites to enhance consumer understanding.
Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.
(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.
Amended by Stats. 2021, Ch. 615, Sec. 278. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.
(a)For purposes of this section, the following definitions apply:
(1)“Cosmetic product” means an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
(2)“Designated list” means any of the following, including subsequent revisions when adopted by the authoritative body:
(A)Chemicals known to the State of California to cause cancer or reproductive toxicity that are
listed pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Chapter 6.6 (commencing with Section 25249.5 of Division 20)).
(B)Chemicals classified by the European Union as carcinogens, mutagens, or reproductive toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC) 1272/2008.
(C)Chemicals included in the European Union Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(f) for endocrine disrupting properties.
(D)Chemicals for which a reference dose or reference concentration has been developed based on neurotoxicity in the federal Environmental Protection Agency’s Integrated Risk Information System.
(E)Chemicals that are identified as carcinogenic to humans, likely to be carcinogenic to humans, or as Group A, B1, or B2 carcinogens in the federal Environmental Protection Agency’s Integrated Risk Information System.
(F)Chemicals included in the European Chemicals Agency Candidate List of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006 on the basis of Article 57(d), Article 57(e), or Article 57(f) of Regulation (EC) 1907/2006 for persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, properties.
(G)Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to the environment by the Canadian Environmental Protection Act
Environmental Registry Domestic Substances List.
(H)Chemicals classified by the European Union in Annex VI to Regulation (EC) 1272/2008 as respiratory sensitizer category 1.
(I)Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer.
(J)Neurotoxicants that are identified in the federal Agency for Toxic Substances and Disease Registry’s Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, Nervous System.
(K)Persistent bioaccumulative and toxic priority chemicals that are identified by the federal Environmental Protection Agency National Waste Minimization Program.
(L)Reproductive or developmental toxicants identified in Monographs on the Potential Human Reproductive and Developmental Effects published by the federal National Toxicology Program, Office of Health Assessment and Translation.
(M)Chemicals identified by the federal Environmental Protection Agency’s Toxics Release Inventory as Persistent, Bioaccumulative and Toxic Chemicals that are subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. Sec. 11001, et seq.).
(N)The Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic (PBT) Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code.
(O)Chemicals that are identified as known to be, or reasonably anticipated to be, human carcinogens by the 13th Report on Carcinogens prepared by the federal National Toxicology Program.
(P)Chemicals for which notification levels, as defined in Section 116455, have been established by the State Department of Public Health or the State Water Resources Control Board.
(Q)Chemicals for which primary maximum contaminant levels have been established and adopted under Section 64431 or 64444 of Title 22 of the California Code of Regulations.
(R)Chemicals identified as toxic air contaminants under Section 93000 or 93001 of Title 17 of the California Code of Regulations.
(S)Chemicals that are identified as priority pollutants in the California water quality control plans pursuant to subdivision (c) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and in Section 131.38 of Title 40 of the Code of Federal Regulations, or identified as pollutants by the state or the federal Environmental Protection Agency for one or more water bodies in the state under subdivision (d) of Section 303 of the federal Clean Water Act (33 U.S.C. Sec. 1341) and Section 130.7 of Title
40 of the Code of Federal Regulations.
(T)Chemicals that are identified with noncancer endpoints and listed with an inhalation or oral reference exposure level by the Office of Environmental Health Hazard Assessment pursuant to paragraph (2) of subdivision (b) of Section 44360.
(U)Chemicals identified as priority chemicals by the California Environmental Contaminant Biomonitoring Program pursuant to Section 105449.
(V)Chemicals that are identified on Part A of the List of Chemicals for Priority Action prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic.
(3)“Flavor
ingredient” means any intentionally added substance or complex mixture of aroma chemicals, flavor chemicals, natural
essential oils, and other functional ingredient or ingredients for which the purpose is to impart a flavor or taste, or to counteract a flavor or taste.
(4)“Fragrance ingredient” means any intentionally added substance or complex mixture of aroma chemicals, natural essential oils, and other functional ingredient or ingredients for which the purpose is to impart an odor or scent, or to counteract an odor.
(5)“Manufacturer” means any entity 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.
(6)“Professional cosmetic” has the same meaning as provided in paragraph (3) of subdivision (b) of Section 110371.
(b)(1) Commencing January 1, 2022, a manufacturer of a cosmetic product sold in the state shall disclose all of the following information to the Division of Environmental and Occupational Disease Control within the State Department of Public Health:
(A) A list of each fragrance ingredient or flavor ingredient that is included on a designated list, as defined in paragraph (2) of subdivision (a), and present in the cosmetic product. This section does not require a manufacturer of a cosmetic product to disclose the presence of any fragrance ingredient or flavor ingredient that is not included on a designated list.
(B) A list of each fragrance allergen included in Annex III of the EU Cosmetics Regulation
No. 1223/2009, as required to be disclosed pursuant to the EU Detergents Regulation No. 21 648/2004, and subsequent updates to those regulations, that is present in a rinse-off cosmetic product at a concentration at or above 0.01 percent (100 parts per million) or in a leave-on cosmetic product at a concentration at or above 0.001 percent (10 parts per million). Those ingredients shall appear on the database in a unique manner that distinguishes those ingredients from other reportable ingredients and indicates that they are hazardous only to individuals who suffer from fragrance allergies.
(C) Whether the cosmetic product is intended for professional use or retail cosmetic use.
(D) The Chemical Abstracts Service (CAS) number for each ingredient or allergen that requires
disclosure pursuant to subparagraph (A) or (B).
(E) The corresponding Universal Product Code (UPC) for the cosmetic product described in subparagraph (A).
(2)(A) To protect trade secrets, this section does not require a manufacturer to disclose the weight or amount of an ingredient that requires disclosure pursuant to subparagraph (A) or (B) of paragraph (1) or to disclose the manner in which a cosmetic product or intentionally added fragrance ingredient or flavor ingredient is formulated. A manufacturer may protect as a trade secret, and is not required to disclose, any ingredient or combination of ingredients that is not on a designated list or required to be disclosed pursuant to subparagraph (A) or (B) of paragraph (1). A fragrance ingredient or flavor
ingredient that is included in a designated list, or a fragrance allergen that requires disclosure pursuant to subparagraph (B) of paragraph (1), does not constitute a trade secret.
(B)Pursuant to Section 7927.705 of the Government Code, a fragrance ingredient or flavor ingredient that constitutes a trade secret is not subject to disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code).
(3)(A) A manufacturer that is required to disclose a fragrance ingredient or flavor ingredient pursuant to paragraph (1) due to a change in a designated list shall disclose the ingredient no later than six months after the revised list is adopted by the authoritative body, or six months after the
revised list becomes effective, whichever is later.
(B)The State Department of Public Health shall create a voluntary electronic mailing list for the department to provide updates on the inclusion or deletion of fragrance allergens, fragrance ingredients, and flavor ingredients on the designated lists.
(c)(1) Commencing January 1, 2022, the Division of Environmental and Occupational Disease Control shall post on the database created pursuant to Section 111792, in an easily readable format, all of the following information related to a cosmetic product described in, and disclosed pursuant to, subparagraph (A) of paragraph (1) of subdivision (b):
(A) A list of all fragrance ingredients and
flavor ingredients that are included on a designated list and all fragrance allergens required to be disclosed pursuant to subparagraph (B) of paragraph (1) of subdivision (b).
(B) The health hazards associated with each fragrance ingredient or flavor ingredient.
(2)The division shall identify whether an ingredient is a fragrance ingredient or a flavor ingredient.
Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.
(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.
Added by Stats. 2005, Ch. 729, Sec. 2. Effective January 1, 2006.
(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.).