Regulatory Developments

California and New York Require Manufacturers to Disclose Ingredients in Cleaning Products

October 20, 2017

On October 15, 2017, California Governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017 (S.B. 258). The new law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020. The product label disclosure requirements would apply to a designated product sold in California on or after January 1, 2021. Earlier this year, on April 25, 2017, New York Governor Andrew Cuomo (D) announced an initiative to require manufacturers of household cleaning products sold in New York to disclose the chemical ingredients on their websites. New York State Department of Environmental Conservation (NYSDEC) is expected to release final guidance shortly.

California’s Cleaning Product Right to Know Act of 2017

Section 108954(a) of California’s Cleaning Product Right to Know Act of 2017 requires a manufacturer of a designated product sold in California to disclose the following information:

  (1) (A) A list of each intentionally added ingredient contained in the product that is included on a designated list;
    (B) A list of each fragrance allergen included on Annex III of the European Union (EU) Cosmetics Regulation No. 1223/2009 as required to be labeled by the EU Detergents Regulation No. 648/2004 on January 1, 2018, when present in the product at a concentration at or above 0.01 percent (100 parts per million (ppm)). The manufacturer shall determine the total concentration of each fragrance allergen by adding contributions of the fragrance allergen from all fragrance ingredients and other ingredients in the designated product, including its presence in essential oils; and
    (C) Notwithstanding subparagraph (A), an intentionally added ingredient that is known to California to cause cancer or reproductive toxicity and is included on a designated list pursuant to Proposition 65 (Prop 65) shall not be required to be listed on the designated product label until January 1, 2023; or
  (2) (A) A list of all intentionally added ingredients contained in the designated product, unless it is confidential business information (CBI);
    (B) A statement that reads “Contains fragrance allergen(s)” shall be included on the product label when a fragrance allergen included on Annex III of the EU Cosmetics Regulation No. 1223/2009 as required to be labeled by the EU Detergents Regulation No. 648/2004, or subsequent updates to those regulations, is present in the product at a concentration at or above 0.01 percent (100 ppm). The manufacturer shall determine the total concentration of each fragrance allergen by adding contributions of the fragrance allergen from all fragrance ingredients and other ingredients in the designated product, including its presence in essential oils;
    (C) Notwithstanding subparagraph (A), fragrance ingredients or colorants may be listed on the product label as “fragrances” or “colorants,” respectively; and
    (D) Notwithstanding subparagraph (A), an intentionally added ingredient that is known to the state of California to cause cancer or reproductive toxicity and is included on Prop 65 shall not be required to be listed on the designated product label until January 1, 2023.

Under the Act, a designated product is “a finished product that is an air care product, automotive product, general cleaning product, or a polish or floor maintenance product used primarily for janitorial, domestic, or institutional cleaning purposes.” Excluded products include foods, drugs, and cosmetics, including personal care products such as toothpaste, shampoo, and hand soap; trial samples of designated products that are not packaged for individual sale, resale, or retail; and industrial products specifically manufactured for, and exclusively used in, oil and gas production, steel production, heavy industry manufacturing, industrial water treatment, industrial textile maintenance and processing other than industrial laundering, food and beverage processing and packaging; and other industrial manufacturing processes.

An intentionally added ingredient is “a chemical that a manufacturer has intentionally added to a designated product and that has a functional or technical effect in the designated product, including, but not limited to, the components of intentionally added fragrance ingredients and colorants and intentional breakdown products of an added chemical that also have a functional or technical effect in the designated product.” A nonfunctional constituent is defined as one of the following substances that is an incidental component of an intentionally added ingredient, a breakdown product of an intentionally added ingredient, or a byproduct of the manufacturing process that has no functional or technical effect on the designated product:

(1) 1,4 dioxane;

(2) 1,1 dichloroethane;

(3) Acrylic acid;

(4) Benzene;

(5) Benzidine;

(6) 1,3 Butadiene;

(7) Carbon tetrachloride;

(8) Chloroform;

(9) Ethylene oxide;

(10) Nitilotriacetic acid;

(11) Butyl benzyl phthalate;

(12) Butyl decyl phthalate;

(13) Di(2-ethylhexyl) phthalate;

(14) Diethyl phthalate;

(15) Diisobutyl phthalate;

(16) Di(n-octyl) phthalate;

(17) Diisononyl phthalate;

(18) Dioctyl phthalate;

(19) Butylparaben;

(20) Ethylparaben;

(21) Isobutylparaben;

(22) Methylparaben;

(23) Propylparaben;

(24) Formaldehyde;

(25) 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride;

(26) DMDM hydantoin;

(27) Diazolidinyl urea;

(28) Glyoxal;

(29) Imidazolidinyl urea;

(30) Polyoxymethylene urea;

(31) Sodium hydroxymethylglycinate;

(32) 2-Bromo-2-nitropropane-1,3-diol;

(33) N-Nitrosodimethylamine; and

(34) N-Nitosodiethylamine.

CBI means any intentionally added ingredient or combination of ingredients for which a claim has been approved by the U.S. Environmental Protection Agency (EPA) 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. CBI shall not include an intentionally added ingredient or combination of ingredients that is on a designated list; a nonfunctional constituent; or a fragrance allergen included on Annex III of the EU Cosmetics Regulation No. 1223/2009 as required to be labeled by the EU Detergents Regulation No. 648/2004, or subsequent updates to those regulations, when present in the product at a concentration at or above 0.01 percent (100 ppm).

A designated list is any of the more than 20 state, federal, and international lists identified:

  • Prop 65;
     
  • Chemicals classified by the EU as carcinogens, mutagens, or reproductive toxicants;
     
  • Chemicals included in the EU Candidate List of Substances of Very High Concern (SVHC) for endocrine disrupting properties, persistent, bioaccumulative, and toxic (PBT) properties, or very persistent and very bioaccumulative (vPvB) properties;
     
  • Chemicals for which the EPA Integrated Risk Information System (IRIS) has developed a reference dose or reference concentration based on neurotoxicity, or identified as carcinogenic to humans, likely to be carcinogenic to humans, or as Group A, B1, or B2 carcinogens;
     
  • Chemicals identified as persistent, bioaccumulative, and inherently toxic to the environment by the Canadian Environmental Protection Act (CEPA) Environmental Registry Domestic Substances List;
     
  • Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer (IARC);
     
  • Neurotoxicants that are identified in the federal Agency for Toxic Substances and Disease Registry’s (ATSDR) Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens, Nervous System;
     
  • Reproductive or developmental toxicants identified in Monographs on the Potential Human Reproductive and Developmental Effects published by the National Toxicology Program (NTP) Office of Health Assessment and Translation;
     
  • Chemicals identified by EPA’s Toxics Release Inventory (TRI) as PBT chemicals that are subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA);
     
  • The Washington Department of Ecology’s PBT chemicals identified in Chapter 173-333 of Title 173 of the Washington Administrative Code;
     
  • Chemicals that are identified as known to be, or reasonably anticipated to be, human carcinogens by the 13th Report on Carcinogens prepared by NTP. Subsequent revisions to this list shall not be incorporated;
     
  • Chemicals for which primary maximum contaminant levels have been established and adopted;
     
  • Chemicals that are identified as priority pollutants in the California water quality control plans, or identified as pollutants by the state or EPA for one or more water bodies in California;
     
  • 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 (OEHHA); and
     
  • Chemicals identified as priority chemicals by the California Environmental Contaminant Biomonitoring Program.
     

The online disclosure requirements will apply to designated products sold in California on or after January 1, 2020. The product label disclosure requirements will apply to designated products sold in California on or after January 1, 2021. A designated product manufactured before these dates will be deemed in compliance if the designated product displays either the date of manufacture or a code indicating the date of manufacture. Manufacturers may label designated products manufactured before January 1, 2021, in accordance with the requirements.

New York’s Household Cleansing Product Information Disclosure Program

Governor Cuomo announced New York’s Household Cleansing Product Information Disclosure Program on April 25, 2017. According to the press release, manufacturers are required to identify all the ingredients and impurities in their products, including those that are chemicals of concern, as well as their content by weight in ranges. Manufacturers must post the information on their websites. In addition, New York will work with the Interstate Chemicals Clearinghouse to develop and maintain a database of links to company information.

According to the New York State Department of Environmental Conservation (NYSDEC), authority for the Program derives from Article 35 of the Environmental Conservation Law and New York Code of Rules and Regulations Part 659. NYSDEC published a draft 2017 Household Cleansing Product Information Disclosure Certification Form and Guidance Document for public comment. The comment period closed on July 14, 2017.

The draft Guidance Document states that information should be grouped into the following categories:

  • Product and Manufacturer Information: A description of the product, including its use and form (e.g., liquid, powder, foam, aerosol); whether the product contains fragrance ingredients, including ingredients added to mask the scent of other ingredients (solvents, surfactants) in so-called “unscented” products; and the complete name of the company that manufactures the final product. If the company is a subsidiary, include the name of the parent company; and the name, title, e-mail address, telephone number, and mailing address of the staff person responsible for preparation of the information required to be disclosed under the Program;
     
  • Level of Disclosure:
     
    • All ingredients intentionally added to a covered product should be disclosed, including those present in trace quantities, unless they are withheld as CBI;
       
    • All ingredients present only as an unintentional consequence of manufacturing and present above trace quantities should be disclosed where the manufacturer knows or should reasonably know of such ingredients, impurities, or contaminants, unless they are withheld as CBI; and
       
    • All ingredients present only as an unintentional consequence of manufacturing and present in trace quantities should be disclosed where the manufacturer knows or should reasonably know of such ingredients, impurities, or contaminants and such ingredients have received a GreenScreen® for Safer Chemicals score of “Benchmark 1” or “Possible Benchmark 1,” or appear on one or more of the Priority Hazard Lists, or meet one or more of the specified Hazard Characteristics

        
  • Ingredients: The following information should be disclosed for all ingredients unless such information is not available, not known, or withheld as CBI:
     
    • Chemical Abstracts Index Name and Chemical Abstracts Service Registry number;
       
    • Percentage of content by weight;
       
    • GreenScreen® benchmark;
       
    • Nano; and
       
    • Role.
       
  • Chemicals of Concern: If a product or an ingredient in a product is present on one or more of the lists of chemicals of concern named below, or a product or ingredient meets one or more of the hazard characteristics listed below, such information should be disclosed, regardless of whether the specific name or other information about the product or ingredient is being withheld as CBI:
     
    • AOEC Asthmagen List: A chemical designated as an asthma causing agent by the Association of Occupational and Environmental Clinics (AOEC);
       
    • ATSDR Neurotoxicant List: A chemical identified by ATSDR as a neurotoxicant and listed in their Toxic Substances Portal under “Health Effects of Toxic Substances and Carcinogens, Nervous System”;
       
    • EPA Chemical of Concern List: A chemical for which EPA has issued a Chemical of Concern Action Plan pursuant to TSCA;
       
    • EPA PBT Toxin List: A chemical listed as a PBT by EPA;
       
    • EPA Priority Chemicals List: A chemical listed by EPA as a priority chemical under the National Partnership for Environmental Priorities program, also known as the Waste Minimization Priority Chemical List;
       
    • EPA Ozone Depleting List: A chemical listed by EPA as a Class I or Class II Ozone-Depleting Substance;
       
    • EU Endocrine Disruptor List: A chemical listed by the EU as a Category 1 chemical on the priority list of chemicals developed by the EU Community Strategy for Endocrine Disruptors;
       
    • EU SVHCs List: A chemical identified by the EU as an SVHC as part of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annex XIV;
       
    • IARC Carcinogen List: A chemical classified as a Group 1, Group 2a, or Group 2b carcinogenic agent by IARC in Monographs on the Evaluation of Carcinogenic Risks to Humans;
       
    • NTP Carcinogen List: A chemical listed as known, as reasonably anticipated to be, or as a possible human carcinogen by NTP;
       
    • California Cancer, Reproductive Toxicity List: A chemical listed as known to cause cancer or reproductive toxicity (including developmental, female and male toxicity) by California under Prop 65;
       
    • GHS Skin Irritant: A chemical or product classified according to the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) Chapter 3.2, Skin Corrosion/Irritation, as a Category 1, 2, or 3 skin corrosive or skin irritant. A product should be classified as corrosive to the skin if it has a pH of two or less or a pH of 11.5 or greater, unless tested or proven otherwise;
       
    • GHS Eye Irritant. A chemical or product classified according to GHS Chapter 3.3, Serious Eye Damage/Eye Irritation, as a Category 1 or 2 eye irritant. A product should be classified as capable of causing serious eye damage if it has a pH of two or less or a pH of 11.5 or greater, unless tested or proven otherwise;
       
    • GHS Respiratory or Skin Sensitizer: A chemical or product classified according to GHS Chapter 3.4, Respiratory and Skin Sensitization, as Category 1A -- High frequency of occurrence or sensitization rate in humans; or Category 1B -- Low to moderate frequency of occurrence or sensitization rate in humans;
       
    • GHS Mutagen: A chemical or product classified according to GHS Chapter 3.5, Germ Cell Mutagenicity, as Category 1A -- Chemicals known to induce heritable mutations in the germ cells of humans; or Category 1B -- Chemicals that should be regarded as if they induce heritable mutations in the germ cells of humans; and
       
    • GHS Aquatic Toxin: A chemical or product classified according to GHS Chapter 4.1, Hazardous to the Aquatic Environment, as a Category 1, 2, or 3 acute or chronic aquatic toxin with a median lethal concentration of less than 100 milligrams per liter
       
  • Human Health and Environmental Effects: Manufacturers should post information on their websites regarding the nature and extent of investigations and research performed by or for the manufacturer concerning the effects on human health and the environment of covered products or the chemical ingredients of such products.
     
  • Date of Disclosure: Manufacturers should post all required information by [date no less than six months following publication of the final guidance document]. Manufacturers should update their disclosures each time the ingredients in a product are changed, or a new product is introduced to the market. Legacy data for discontinued products should be posted until the expiration date of the product. All disclosed information should be reviewed, at a minimum, once every two years, including the presence of a product or ingredients on a priority hazard list, or whether a product or ingredient meets a hazard characteristic.
     

Commentary

There are several critical differences between California’s Cleaning Product Right to Know Act of 2017 and the proposed guidance for New York’s Household Cleansing Product Information Disclosure Program. While there is some overlap in the lists identified -- Prop 65, carcinogens identified by IARC, SVHCs, neurotoxicants identified by ATSDR, PBT chemicals covered by EPA’s TRI Program -- New York’s Program is more expansive, including chemicals meeting certain hazard characteristics. In addition, under New York’s Program, ingredients with a GreenScreen® Benchmark and nanomaterial ingredients must be identified on the label. For each ingredient, a term describing its functional use or reason for inclusion should be disclosed.

As noted above, California requires the disclosure of intentionally added ingredients -- “a chemical that a manufacturer has intentionally added to a designated product and that has a functional or technical effect in the designated product, including, but not limited to, the components of intentionally added fragrance ingredients and colorants and intentional breakdown products of an added chemical that also have a functional or technical effect in the designated product.” Nonfunctional constituents -- certain substances that are incidental components of intentionally added ingredients, breakdown products of intentionally added ingredients, or byproducts of the manufacturing process that have no functional or technical effect on the designated product -- must also be identified. New York would require the disclosure of all ingredients intentionally added to a covered product, including those present in trace quantities, unless they are withheld as CBI; all ingredients present only as an unintentional consequence of manufacturing and present above trace quantities where the manufacturer knows or should reasonably know of such ingredients, impurities, or contaminants, unless they are withheld as CBI; and all ingredients present only as an unintentional consequence of manufacturing and present in trace quantities where the manufacturer knows or should reasonably know of such ingredients, impurities, or contaminants and such ingredients have received a GreenScreen® for Safer Chemicals score of “Benchmark 1” or “Possible Benchmark 1,” or appear on one or more of the Priority Hazard Lists, or meet one or more of the specified Hazard Characteristics. The manufacturer requirements are much more clear-cut under California’s program than New York’s, and manufacturers will be able to label their products with a high degree of accuracy. Under New York’s Program, it is unclear what a manufacturer should reasonably know of impurities or contaminants present only as an unintended consequence of manufacturing.


 
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