2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 7.5 - Menstrual Products › Section 111822.

111822. For purposes of this chapter, the following definitions apply:
(a) “Confidential business information” means an intentionally added ingredient or combination of ingredients for which a claim has been approved by the federal Environmental Protection Agency for inclusion on the Toxic Substances Control Act (TSCA) Confidential Inventory or for which the manufacturer or its supplier claim protection under the Uniform Trade Secrets Act (Title 5 (commencing with Section 3426) of Part 1 of Division 4 of the Civil Code). “Confidential business information” shall not include any of the following:
(1) An intentionally added ingredient or combination of ingredients that is on a designated list, as defined in subdivision (b).
(2) A fragrance allergen included on Annex III of the European Union (EU) Cosmetics Regulation No. 1223/2009 or subsequent updates to those regulations, when present in the product at a concentration at or above 0.001 percent (10 parts per million).
(b) “Designated list” means any of the following, including subsequent revisions when adopted by the authoritative body:
(1) 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).
(2) Chemicals classified by the EU as carcinogens, mutagens, or reproductive toxicants pursuant to Category 1A or 1B in Annex VI to Regulation (EC) 1272/2008.
(3) Chemicals included in the EU 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.
(4) 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.
(5) 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.
(6) Chemicals included in the EU 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) for persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, properties.
(7) Chemicals that are identified as persistent, bioaccumulative, and inherently toxic to the environment by the Canadian Environmental Protection Act Environmental Registry Domestic Substances List.
(8) Chemicals classified by the EU in Annex VI to Regulation (EC) 1272/2008 as respiratory sensitizer category 1.
(9) Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer.
(10) 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.
(11) Persistent bioaccumulative and toxic priority chemicals that are identified by the federal Environmental Protection Agency National Waste Minimization Program.
(12) 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.
(13) 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.).
(14) The Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic (PBT) Chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code.
(15) 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.
(16) 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.
(17) 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.
(18) Chemicals identified as toxic air contaminants under Section 93000 or 93001 of Title 17 of the California Code of Regulations.
(19) 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.
(20) 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.
(21) Chemicals identified as priority chemicals by the California Environmental Contaminant Biomonitoring Program pursuant to Section 105449.
(22) 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.
(c) (1) “Fragrance ingredient” means an intentionally added substance or complex mixture of aroma chemicals, natural essential oils, and other functional ingredient present in a menstrual product for which the sole purpose is to impart an odor or scent, or to counteract odor, and that is any of the following:
(A) Present in a menstrual product at a concentration at or above 0.01 percent (100 parts per million), unless the substance is confidential business information, in which case the manufacturer may identify the ingredient by its common name to protect its confidential identity pursuant to subdivision (b) of Section 111822.2.
(B) Included on a designated list.
(C) A fragrance allergen included in Annex III of the EU Cosmetics Regulation No. 1223/2009 or subsequent updates to that regulation when present in the menstrual product in a concentration at or above 0.001 percent (10 parts per million).
(2) The manufacturer shall determine the total concentration of each fragrance ingredient by calculating the total amount of fragrance ingredient as a percentage of the total weight of the menstrual product.
(d) “Ingredient” means a fragrance ingredient or other intentionally added substance or combination of substances present in the menstrual product, unless the intentionally added substance or combination of substances is confidential business information, in which case the manufacturer may identify the ingredient by its common name to protect its confidential identity pursuant to subdivision (b) of Section 111822.2.
(e) “Intentionally added” means a substance that serves a technical or functional purpose in the finished menstrual product.
(f) “Manufacturer” means either of the following:
(1) A person or entity that manufactures the menstrual product and whose name appears on the product label.
(2) A person or entity for whom the product is manufactured or distributed, as identified on the product label pursuant to the federal Fair Packaging and Labeling Act.
(g) “Menstrual product” means a product used to collect menstruation and vaginal discharge, including, but not limited to, tampons, pads, sponges, menstruation underwear, disks, and menstrual cups, whether disposable or reusable.
(Added by Stats. 2020, Ch. 272, Sec. 1. (AB 1989) Effective January 1, 2021.)