Existing law, commencing January 1, 2025, prohibits a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients except under specified circumstances.

This bill would, commencing January 1, 2027, expand that prohibition by adding specified banned ingredients.

Existing law, commencing January 1, 2025, prohibits a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients except under specified circumstances.

This bill would, commencing January 1, 2027, expand that prohibition by adding specified banned ingredients.

Existing law, commencing January 1, 2025, prohibits a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients except under specified circumstances.

This bill would would, commencing January 1, 2027, expand that prohibition by adding specified banned ingredients.

Existing law, commencing January 1, 2025, prohibits a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients except under specified circumstances.

This bill would expand that prohibition by adding specified banned ingredients.

 THIRD READING  

Bill No: AB 496

Author: Friedman (D), et al.

Amended: 3/8/23 in Assembly

Vote: 21

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 6-0, 6/7/23

AYES: Allen, Dahle, Gonzalez, Hurtado, Menjivar, Skinner

NO VOTE RECORDED: Nguyen

ASSEMBLY FLOOR: 62-0, 3/23/23 - See last page for vote

SUBJECT: Cosmetic safety

SOURCE: Environmental Working Group

DIGEST: This bill prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the 26 intentionally added ingredients specified in this bill.

ANALYSIS:

Existing law:

1. Requires, pursuant to the federal Food, Drug & Cosmetic Act (FD&C Act), cosmetics produced or distributed for retail sale to consumers for their personal care to bear an ingredient declaration. (21 Code of Federal Regulations 701.3)
2. Defines, pursuant to the Sherman Act, "cosmetic" as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance. Provides that the term "cosmetic" does not include soap. Makes it unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated. Makes it unlawful for any person to adulterate any cosmetic. Makes it unlawful for any person to receive in commerce any cosmetic that is adulterated or to deliver or proffer for delivery any such cosmetic. (Health & Safety Code (HSC) § 109900)
3. Prohibits, commencing January 1, 2025, a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains 13 chemical ingredients banned from use in cosmetics by the European Union (EU).

UNCODIFIED INTENT LANGUAGE

1. Provides that it is the intent of the Legislature to enact a prohibition on the presence of intentionally added ingredients in cosmetics that is consistent with the prohibition on the presence of intentionally added ingredients in cosmetics that was enacted by the EU. (Added by AB 2762, Chapter 314, Statutes of 2020).

This bill prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the 26 intentionally added ingredients specified in this bill classified as carcinogenic, mutagenic, or toxic for reproduction.

Background

1. Public health concerns with cosmetics. Cosmetic products are sold to consumers across California, including to children who are still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids, and lips. Cosmetic products are most heavily used by women, including those of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity. That is why it is so important that cosmetic products are safe, properly labeled, and free of contamination.
2. State cosmetic regulatory requirement. California has two laws governing the safety of cosmetics. The first is the Sherman Act, which is administered by CDPH to regulate cosmetics. It broadly defines a cosmetic as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Pursuant to the Sherman Act, any cosmetic is considered to be adulterated "if it bears or contains any poisonous or deleterious substance that may render it injurious to users." However, adulteration, in many instances, refers to tampering with a product after the manufacturer has completed its manufacturing. Selling adulterated cosmetics can lead to civil and administrative penalties, embargoes, and even bans on products.

1. Federal cosmetics regulatory requirements. Neither the FDA nor CDPH require premarket safety testing, review, or approval of cosmetic products.

Under the FD&C Act, cosmetics and their ingredients are not required to be approved before they are sold to the public, and the FDA does not have the authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of a dangerous cosmetic product.

1. What we know about the chemicals listed in the bill vis-à-vis the EU. The EU, which includes 27 member countries mostly across Europe, develops policies to ensure the free movement of people, goods, services, and capital within the internal market, and enacts legislation to maintain common policies to have cohesion amongst the 27 members on things from trade to agriculture.

The EU Cosmetics Directive (Directive) was adopted in 1976 and formed on the basis of commonly agreed to safety standards relative to cosmetics. On September 15, 2022, the European Commission published Regulation (EU) 2022/1531 to amend Cosmetics Regulation (EC) No. 1223/2009 for the use of certain ingredients classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products.

The EU Directive requires member states to take all necessary measures to ensure that only cosmetic products which conform to the provisions of the Directive and its Annexes can be put on the market. Additionally, the Directive requires member states to prohibit the marketing of cosmetic products containing ingredients listed in the Directive and its Annexes. The regulation defines "cosmetic product" as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors." The scope of products covered under the EU's definition of cosmetics is broader than the scope of products covered under California's definition of cosmetics.

1. Prior legislation. AB 2762 (Muratsuchi, Chapter, 314, Statutes of 2020) bans a list of specified ingredients from cosmetics products consistent with the EU's Annex II of regulation No 1223/2009, which lists the substances prohibited in cosmetic products sold in the EU. While AB 2762 was moving through the legislative process, industry stakeholders weighed in and formally opposed the bill while it was being heard in the Assembly Environmental Safety and Toxic Materials Committee. Specifically in opposition to AB 2762, the Personal Care Products Council, Fragrance Creators Association, California Chamber of Commerce, and other industry groups were oppose unless the bill was further amended. They collectively stated,

"The undersigned organizations support better alignment with the health and safety standards set forth by the European Union that prohibit the intentional use of specified ingredients which are listed in the EU Cosmetics Regulation 1223/2009, ANNEX II, List of Substances Prohibited in Cosmetic Products. In order to achieve this goal, AB 2762 needs further amendments. The authors have already publicly committed to aligning California law with the EU regulation – not anything more or less. We remain committed to achieving this goal. As such, we have submitted draft language that we believe would fully align AB 2762 with the EU regulations."

Comments

1. Purpose of bill. According to the author, "Personal care products and cosmetics should be non-toxic for everyone. If you consider that the European Union prohibits over 1,600 chemicals in such products, a ban in California on these noxious carcinogens and endocrine disrupters is long overdue. AB 496 continues our progress toward cleaner, healthier, and environmentally-safer products."
2. Consistency with the European Union. The intent of this bill is to be consistent with the approach of the EU's cosmetic regulation. All of the chemicals listed in AB 496 have been fully banned in the EU Directive and its Annexes and consequently have already been removed from cosmetic products sold in the EU. The approach in AB 496 is modeled after AB 2762 and reflects a strategy specifically requested by industry stakeholders when they were negotiating amendments to AB 2762 – aligning California's bans on cosmetic ingredients with ingredients that are also banned in the EU.
3. California does not have a rigorous scientific process to evaluate chemical ingredients in cosmetics. Until such time that California has a process, it seems reasonable to protect California consumers in the same manner that consumers in the EU have been protected. It is important to note that the cosmetic products for sale in the EU have been reformulated to remove the ingredients banned in the Directive and therefore could also be sold in California if this bill were to pass and become law.
4. Should California be different than the EU? Industry representatives who negotiated AB 2762 had argued that it would be helpful to industry if California conformed its list of banned ingredients to the EU's list. In a shift from industry's previous position on AB 2762, opposition to AB 496, is now asking for one of the chemicals in the bill to be removed even though it is already banned in the EU, so that it could continue to be sold in California. If the Legislature were to agree to remove a chemical banned in the EU from the state's ban list, this would effectively create a list in California that no longer aligns with the EU. This would arguably open the door to future conversations about additional chemicals that California would like to ban, even when these chemicals are not currently banned in the EU.
5. The case for and against the exclusion of lilial. The fragrance industry is opposed to AB 496 unless the bill is amended to remove lily aldehyde, also known as lilial, from the bill’s list of prohibited cosmetic ingredients. The industry maintains that the EU did not base their restriction on risk, but made a hazard-based decision. This hazard-based action “does not consider existing safety assessments of the Research Institute for Fragrance Materials nor the International Fragrance Association Standards that support the safe use on risk considerations.”
6. However, the sponsors of AB 496 counter that the EU’s Risk Assessment Committee and its Scientific Committee on Consumer Safety have evaluated both the hazards and risks of lilial and concluded that the chemical poses reproductive and developmental dangers to humans under industry standards of use. Moreover, the sponsors maintain that “lilial’s harmful effects in consumer products are recognized under California law and regulation, since lilial is listed as a Candidate Chemical under the Department of Toxic Safety Control’s Safer Consumer Products Program.”

Related/Prior Legislation

AB 2762 (Muratsuchi, Chapter 314, Statutes of 2020) prohibits, beginning January 1, 2025, the manufacture, sale, delivery, holding, or offering for sale in commerce of any cosmetic product containing specified intentionally added ingredients.

FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No

SUPPORT: (Verified 6/8/23)

Environmental Working Group (source)

Active San Gabriel Valley

Alliance of Nurses for Healthy Environments

American Bird Conservancy

American College of Obstetricians and Gynecologists District IX

As You Sow

Attn: Grace

Ban Sup

Beautycounter

Booni Doon

Brand Geek

California Health Coalition Advocacy

California Nurses for Environmental Health and Justice

California Product Stewardship Council

California Water Service

Calpirg

City and County of San Francisco

Clean Water Action

Codex Labs Corp

Consumer Federation of California

Dietrick Institute for Applied Insect Ecology

Eco Plum

Educate. Advocate.

Families Advocating for Chemical and Toxics Safety

Feminists in Action Los Angeles

Friends Committee on Legislation of California

Friends of the Earth

Green Science Policy Institute

Grove Collaborative

Healthy Highways

Indivisible Alta Pasadena

Indivisible California Green Team

Indivisible Ventura

Inna Organics

Intelligent Nutrients

Jonas Philanthropies

Just the Goods

Long Beach Environmental Alliance

Moms Across America

National Association of Environmental Medicine

National Stewardship Action Council

Nontoxic Neighborhoods

Olita

Osea Skincare

Poison Free Malibu

Prima

Queers 4 Climate

Rooted in Resistance

San Francisco Baykeeper

Save Our Shores

Seventh Generation

Sierra Club California

SoCal 350 Climate Action

Sonoma Safe Agriculture Safe Schools

The Keep a Breast Foundation

Women for A Healthy Environment

Women's Voices for the Earth

Worksafe

OPPOSITION: (Verified 6/8/23)

Fragrance Creators Association

Fragrance Science & Advocacy Council

ARGUMENTS IN SUPPORT: According to a coalition of supporters, including the sponsor of the bill, the Environmental Working Group:

This important bill will add to the list of chemicals that California does not allow in cosmetics sold in the state. In particular, AB 496 prohibits the sale in California of beauty and personal care products containing any one of 26 highly toxic chemicals that pose public health harms, such as increased risk of cancer, harm to the reproductive system, and harm to aquatic life with long-lasting effects. The environmental risks of these 26 chemicals are particularly concerning because cosmetics are regularly washed off after use. Because of their toxicity, all of the AB 496-listed chemicals are prohibited from being used in cosmetics sold in the European Union.

ARGUMENTS IN OPPOSITION: According to the Fragrance Creators Association, "We appreciate your goal of limiting the use of ingredients in cosmetics that pose a risk to California consumers. We would like to raise a concern regarding the proposal to prohibit the fragrance ingredient p-BMHCA (2-(tert-butylbenzyl propionaldehyde) (CAS Number: 80-54-6) commonly known as Lilial® and also known as Lily aldehyde. We must respectfully request that this ingredient be removed from the legislation, as the body of science does not show there is a risk to consumers when the ingredient is used in alignment with industry safety standards and applicable regulatory requirements.”

ASSEMBLY FLOOR: 62-0, 3/23/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner Horvath, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Grayson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Cervantes, Chen, Megan Dahle, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Hoover, Lackey, Mathis, McCarty, Jim Patterson, Joe Patterson, Sanchez, Ta, Wallis

Prepared by: Gabrielle Meindl / E.Q. / (916) 651-4108

6/9/23 9:49:08

**** END ****

SENATE COMMITTEE ON ENVIRONMENTAL QUALITY

Senator Allen, Chair

2023 - 2024 Regular

Bill No: AB 496

SUBJECT: Cosmetic safety

DIGEST: Prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the 26 intentionally added ingredients specified in this bill.

ANALYSIS:

Existing law:

1. Requires, pursuant to the federal Food, Drug & Cosmetic Act (FD&C Act), cosmetics produced or distributed for retail sale to consumers for their personal care to bear an ingredient declaration. (21 Code of Federal Regulations 701.3)
2. Defines, pursuant to the Sherman Act, "cosmetic" as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance. Provides that the term "cosmetic" does not include soap. Makes it unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated. Makes it unlawful for any person to adulterate any cosmetic. Makes it unlawful for any person to receive in commerce any cosmetic that is adulterated or to deliver or proffer for delivery any such cosmetic. (Health & Safety Code (HSC) § 109900)
3. Requires, pursuant to the Safe Consumer Cosmetic Act (Cosmetics Act), a manufacturer of a cosmetic that is subject to regulation by the federal Food and Drug Administration (FDA) to submit to the California Department of Public Health (CDPH) a list of its cosmetic products sold in California that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity. (HSC § 111792)
4. Prohibits, pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person, in the course of doing business, from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
5. Requires the Department of Toxic Substances Control (DTSC), under the state's Green Chemistry regulations, to establish a process to identify and prioritize chemicals or chemical ingredients in consumer products that may be considered a chemical of concern. (HSC § 25252)
6. Requires DTSC to develop and maintain a list of Candidate Chemicals that exhibit a hazard trait and/or an environmental or toxicological endpoint and is either 1) found on one or more of the statutorily specified authoritative lists or 2) is listed by DTSC using specified criteria. (California Code of Regulations § 69502.2 (b))
7. Prohibits, commencing January 1, 2025, a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains 13 chemical ingredients banned from use in cosmetics by the European Union (EU).

UNCODIFIED INTENT LANGUAGE:

1. Provides that it is the intent of the Legislature to enact a prohibition on the presence of intentionally added ingredients in cosmetics that is consistent with the prohibition on the presence of intentionally added ingredients in cosmetics that was enacted by the EU. (Added by AB 2762, Chapter 314, Statutes of 2020).

This bill:

1. Prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the 26 intentionally added ingredients specified in this bill classified as carcinogenic, mutagenic, or toxic for reproduction.

Background

1. Public health concerns with cosmetics. Cosmetic products are sold to consumers across California, including to children who are still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids, and lips. Cosmetic products are most heavily used by women, including those of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity. That is why it is so important that cosmetic products are safe, properly labeled, and free of contamination.
   
2. State cosmetic regulatory requirement. California has two laws governing the safety of cosmetics. The first is the Sherman Act, which is administered by CDPH to regulate cosmetics. It broadly defines a cosmetic as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.
   

Pursuant to the Sherman Act, any cosmetic is considered to be adulterated "if it bears or contains any poisonous or deleterious substance that may render it injurious to users." However, adulteration, in many instances, refers to tampering with a product after the manufacturer has completed its manufacturing. Selling adulterated cosmetics can lead to civil and administrative penalties, embargoes, and even bans on products.

The other law is the California's Cosmetics Act, established by SB 484 (Migden, Chapter 729, Statutes of 2005). It requires that for all cosmetic products sold in California, the manufacturer, packer, and/or distributor named on the product label shall provide CDPH a list of all cosmetic products that contain any ingredients known or suspected to cause cancer, birth defects, or other reproductive harm. CDPH maintains an active, searchable database with all of the data collected from manufacturers under the Cosmetics Act. It is required to make that data user-friendly and available to the public. To date, 867 companies have reported 119,089 products to CDPH. CDPH does not have any enforcement authority or penalty authority over the manufacturers that are covered, so not all manufacturers are currently complying and submitting their products' information. State law does not currently contain a mechanism that would allow the state to compel these manufacturers to comply.

1. Federal cosmetics regulatory requirements. Neither the FDA nor CDPH require premarket safety testing, review, or approval of cosmetic products.

Under the FD&C Act, cosmetics and their ingredients are not required to be approved before they are sold to the public, and the FDA does not have the authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of a dangerous cosmetic product.

1. What we know about the chemicals listed in the bill vis-à-vis the EU. The EU, which includes 27 member countries mostly across Europe, develops policies to ensure the free movement of people, goods, services, and capital within the internal market, and enacts legislation to maintain common policies to have cohesion amongst the 27 members on things from trade to agriculture.
   

The EU Cosmetics Directive (Directive) was adopted in 1976 and formed on the basis of commonly agreed to safety standards relative to cosmetics. On September 15, 2022, the European Commission published Regulation (EU) 2022/1531 to amend Cosmetics Regulation (EC) No. 1223/2009 for the use of certain ingredients classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products.

The EU Directive requires member states to take all necessary measures to ensure that only cosmetic products which conform to the provisions of the Directive and its Annexes can be put on the market. Additionally, the Directive requires member states to prohibit the marketing of cosmetic products containing ingredients listed in the Directive and its Annexes. The regulation defines "cosmetic product" as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors." The scope of products covered under the EU's definition of cosmetics is broader than the scope of products covered under California's definition of cosmetics.

1. Prior legislation. AB 2762 (Muratsuchi, Chapter, 314, Statutes of 2020) bans a list of specified ingredients from cosmetics products consistent with the EU's Annex II of regulation No 1223/2009, which lists the substances prohibited in cosmetic products sold in the EU. While AB 2762 was moving through the legislative process, industry stakeholders weighed in and formally opposed the bill while it was being heard in the Assembly Environmental Safety and Toxic Materials Committee. Specifically in opposition to AB 2762, the Personal Care Products Council, Fragrance Creators Association, California Chamber of Commerce, and other industry groups were oppose unless the bill was further amended. They collectively stated,

"The undersigned organizations support better alignment with the health and safety standards set forth by the European Union that prohibit the intentional use of specified ingredients which are listed in the EU Cosmetics Regulation 1223/2009, ANNEX II, List of Substances Prohibited in Cosmetic Products. In order to achieve this goal, AB 2762 needs further amendments. The authors have already publicly committed to aligning California law with the EU regulation – not anything more or less. We remain committed to achieving this goal. As such, we have submitted draft language that we believe would fully align AB 2762 with the EU regulations."

Comments

1. Purpose of Bill. According to the author, "Personal care products and cosmetics should be non-toxic for everyone. If you consider that the European Union prohibits over 1,600 chemicals in such products, a ban in California on these noxious carcinogens and endocrine disrupters is long overdue. AB 496 continues our progress toward cleaner, healthier, and environmentally-safer products."
   
2. Consistency with the European Union. The intent of this bill is to be consistent with the approach of the EU's cosmetic regulation. All of the chemicals listed in AB 496 have been fully banned in the EU Directive and its Annexes and consequently have already been removed from cosmetic products sold in the EU. The approach in AB 496 is modeled after AB 2762 and reflects a strategy specifically requested by industry stakeholders when they were negotiating amendments to AB 2762 – aligning California's bans on cosmetic ingredients with ingredients that are also banned in the EU.
   
   California does not have a rigorous scientific process to evaluate chemical ingredients in cosmetics. Until such time that California has a process, it seems reasonable to protect California consumers in the same manner that consumers in the EU have been protected. It is important to note that the cosmetic products for sale in the EU have been reformulated to remove the ingredients banned in the Directive and therefore could also be sold in California if this bill were to pass and become law.
   
3. Should California be different than the EU? Industry representatives who negotiated AB 2762 had argued that it would be helpful to industry if California conformed its list of banned ingredients to the EU's list. In a shift from industry's previous position on AB 2762, opposition to AB 496, is now asking for one of the chemicals in the bill to be removed even though it is already banned in the EU, so that it could continue to be sold in California. If the Legislature were to agree to remove a chemical banned in the EU from the state's ban list, this would effectively create a list in California that no longer aligns with the EU. This would arguably open the door to future conversations about additional chemicals that California would like to ban, even when these chemicals are not currently banned in the EU.
   
4. The case for and against the exclusion of lilial. The fragrance industry is opposed to AB 496 unless the bill is amended to remove lily aldehyde, also known as lilial, from the bill’s list of prohibited cosmetic ingredients. The industry maintains that the EU did not base their restriction on risk, but made a hazard-based decision. This hazard-based action “does not consider existing safety assessments of the Research Institute for Fragrance Materials nor the International Fragrance Association Standards that support the safe use on risk considerations.”
   
   However, the sponsors of AB 496 counter that the EU’s Risk Assessment Committee and its Scientific Committee on Consumer Safety have evaluated both the hazards and risks of lilial and concluded that the chemical poses reproductive and developmental dangers to humans under industry standards of use. Moreover, the sponsors maintain that “lilial’s harmful effects in consumer products are recognized under California law and regulation, since lilial is listed as a Candidate Chemical under the Department of Toxic Safety Control’s Safer Consumer Products Program.”

Related/Prior Legislation

AB 2771 (Friedman, Chapter 804, Statutes of 2022). Prohibits any person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any per- or polyfluoroalkyl substance (PFAS).

AB 2762 (Muratsuchi, Chapter 314, Statutes of 2020). Prohibits, beginning January 1, 2025, the manufacture, sale, delivery, holding, or offering for sale in commerce of any cosmetic product containing specified intentionally added ingredients.

SOURCE:

Environmental Working Group

SUPPORT:

Active San Gabriel Valley
Alliance of Nurses for Healthy Environments
American Bird Conservancy
American College of Obstetricians and Gynecologists District Ix
As You Sow
Attn: Grace
Ban Sup (single Use Plastic)
Beautycounter
Booni Doon
Brand Geek
California Health Coalition Advocacy
California Nurses for Environmental Health and Justice
California Product Stewardship Council
California Water Service
Calpirg
City and County of San Francisco
Clean Water Action
Codex Labs Corp
Consumer Federation of California
Dietrick Institute for Applied Insect Ecology
Eco Plum
Educate. Advocate.
Environmental Working Group
Families Advocating for Chemical and Toxics Safety
Feminists in Action Los Angeles
Friends Committee on Legislation of California
Friends of The Earth
Green Science Policy Institute
Grove Collaborative
Healthy Highways
Indivisible Alta Pasadena
Indivisible California Green Team
Indivisible Ventura
Inna Organics
Intelligent Nutrients
Jonas Philanthropies
Just the Goods
Long Beach Environmental Alliance
Moms Across America
National Association of Environmental Medicine
National Stewardship Action Council
Nontoxic Neighborhoods
Olita
Osea Skincare
Poison Free Malibu
Prima
Queers 4 Climate
Rooted in Resistance
San Francisco Baykeeper
Save Our Shores
Seventh Generation
Sierra Club California
Socal 350 Climate Action
Sonoma Safe Agriculture Safe Schools (Sonoma Sass)
The Keep a Breast Foundation
Women for A Healthy Environment
Women's Voices for The Earth
Worksafe

OPPOSITION:

Fragrance Science & Advocacy

ARGUMENTS IN SUPPORT:

According to a coalition of supporters, including the sponsor of the bill, the Environmental Working Group:

"This important bill will add to the list of chemicals that California does not allow in cosmetics sold in the state. In particular, AB 496 prohibits the sale in California of beauty and personal care products containing any one of 26 highly toxic chemicals that pose public health harms, such as increased risk of cancer, harm to the reproductive system, and harm to aquatic life with long-lasting effects. The environmental risks of these 26 chemicals are particularly concerning because cosmetics are regularly washed off after use. Because of their toxicity, all of the AB 496-listed chemicals are prohibited from being used in cosmetics sold in the European Union.

Out of the more than 10,000 chemicals used to formulate beauty and personal care products, the United States Food and Drug Administration has only ever banned or restricted 11. In contrast, the European Union prohibits or restricts the use of nearly 1,600 chemicals including the AB 496 chemicals in cosmetics, and many other countries tightly regulate cosmetics sold to their citizens. According to CDPH's Safe Cosmetics Program, at least 88 different carcinogens and reproductive toxicants are intentionally added to thousands of cosmetic products sold in California today. Also, even after a manufacturer has reformulated a product to comply with European standards, the manufacturer often continues to sell the originally-formulated product to Californians."

ARGUMENTS IN OPPOSITION:

According to the Fragrance Creators Association:

"Fragrance Creators Association (Fragrance Creators) is writing to express our opposed unless amended position on AB 496. We appreciate your goal of limiting the use of ingredients in cosmetics that pose a risk to California consumers. We would like to raise a concern regarding the proposal to prohibit the fragrance ingredient p-BMHCA (2-(tert-butylbenzyl propionaldehyde) (CAS Number: 80-54-6) commonly known as Lilial® and also known as Lily aldehyde. We must respectfully request that this ingredient be removed from the legislation, as the body of science does not show there is a risk to consumers when the ingredient is used in alignment with industry safety standards and applicable regulatory requirements.

AB 496 seeks to align cosmetic ingredient restrictions with those adopted by the European Union (EU). Unfortunately, the EU did not base their restriction on risk, but made a hazard-based decision. For over 50 years, the Research Institute for Fragrance Materials (RIFM)s purpose has been to gather and analyze scientific data, engage in testing and evaluation, distribute information, cooperate with official agencies and to encourage uniform safety standards related to the use of fragrance ingredients. According to RIFM’s assessment, Lilial may be safely used in cosmetic products below certain specific concentration limits set in an IFRA Standard."

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 496

Author:(Friedman)

As Amended Ver:March 8, 2023

Majority vote

SUMMARY

Prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the ingredients specified in this bill.

Major Provisions

COMMENTS

Public health concerns with cosmetics: Cosmetic products are sold to consumers across California, including to children who are still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids, and lips. Cosmetic products are most heavily used by women, including those of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity. That is why it is so important that cosmetic products are safe, properly labeled, and free of contamination.

State cosmetic regulatory requirements: California has two laws governing the safety of cosmetics. The first is the Sherman Act, which is administered by the California Department of Public Health (CDPH) to regulate cosmetics. It broadly defines a cosmetic as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Pursuant to the Sherman Act, any cosmetic is considered to be adulterated "if it bears or contains any poisonous or deleterious substance that may render it injurious to users." However, adulteration, in many instances, refers to tampering with a product after the manufacturer has completed its manufacturing. Selling adulterated cosmetics can lead to civil and administrative penalties, embargoes, and even bans on products.

The other law is the California's Cosmetics Act, established by SB 484 (Migden), Chapter 729, Statutes of 2005. It requires that for all cosmetic products sold in California, the manufacturer, packer, and/or distributor named on the product label shall provide CDPH a list of all cosmetic products that contain any ingredients known or suspected to cause cancer, birth defects, or other reproductive harm. CDPH maintains an active, searchable database with all of the data collected from manufacturers under the Cosmetics Act. CDPH is required to make these data user-friendly and available to the public. To date, 867 companies have reported 119,089 products to CDPH.

Federal cosmetics regulatory requirements: Neither the Food and Drug Administration (FDA) nor CDPH require premarket safety testing, review, or approval of cosmetic products.

Under the Food Drug and Cosmetic Act (FD&C Act), cosmetics and their ingredients are not required to be approved before they are sold to the public, and the FDA does not have the authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of a dangerous cosmetic product.

What we know about the chemicals listed in this bill vis-à-vis the EU: The European Union (EU), which includes 27 member countries mostly across Europe, develops policies to ensure the free movement of people, goods, services, and capital within the internal market, and enacts legislation to maintain common policies to have cohesion amongst the 27 members on things from trade to agriculture.

The EU Cosmetics Directive (Directive) was adopted in 1976 and formed on the basis of commonly agreed to safety standards relative to cosmetics. On September 15, 2022, the European Commission published Regulation (EU) 2022/1531 to amend Cosmetics Regulation (EC) No. 1223/2009 for the use of certain ingredients classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products.

The intent of this bill is to be consistent with the approach of the EU's cosmetic regulation. All of the chemicals listed in AB 496 have been fully banned in the EU Directive and its Annexes and consequently have already been removed from cosmetic products sold in the EU.

Prior legislation: AB 2762 (Muratsuchi), Chapter, 314, Statutes of 2020 bans a list of specified ingredients from cosmetics products consistent with the EU's Annex II of regulation No 1223/2009, which lists the substances prohibited in cosmetic products sold in the EU.

As AB 2762 moved through the legislative process, industry stakeholders weighed in and formally opposed the bill while it was being heard in the Assembly Environmental Safety and Toxic Materials Committee. Specifically, the Personal Care Products Council, Fragrance Creators Association, California Chamber of Commerce, and other industry groups opposed unless the bill was further amended. They collectively stated:

"The undersigned organizations support better alignment with the health and safety standards set forth by the European Union that prohibit the intentional use of specified ingredients which are listed in the EU Cosmetics Regulation 1223/2009, ANNEX II, List of Substances Prohibited in Cosmetic Products. In order to achieve this goal, AB 2762 needs further amendments. The authors have already publicly committed to aligning California law with the EU regulation – not anything more or less. We remain committed to achieving this goal. As such, we have submitted draft language that we believe would fully align AB 2762 with the EU regulations."

AB 496 is consistent with AB 2762 and aligns with the EU regulations along the same lines as requested during the debate of AB 2762.

Consistency with the European Union: AB 2762 included the following intent language: "It is the intent of the Legislature to enact a prohibition on the presence of intentionally added ingredients in cosmetics that is consistent with the prohibition on the presence of intentionally added ingredients in cosmetics that was enacted by the European Union." The approach in AB 496 is modeled after AB 2762 and reflects a strategy specifically requested by industry stakeholders when they were negotiating amendments to AB 2762 – aligning California's bans on cosmetic ingredients with ingredients that are also banned in the EU. California does not have a rigorous scientific process to evaluate chemical ingredients in cosmetics. Until such time that California has a process, it seems reasonable to protect California consumers in the same manner that consumers in the EU have been protected. It is important to note that the cosmetic products for sale in the EU have been reformulated to remove the ingredients banned in the Directive and therefore could also be sold in California if this bill were to pass and become law.

Should California be different than the EU? Industry representatives who negotiated AB 2762 argued that it would be helpful to industry if California conformed its list of banned ingredients to the EU's list. In a shift from industry's previous position on AB 2762, opposition to AB 496 is now asking for one of the chemicals in this bill to be removed even though it is already banned in the EU, so that it could continue to be sold in California. If the Legislature were to agree to remove a chemical banned in the EU from the state's ban list, this would effectively create a list in California that no longer aligns with the EU. This would arguably open the door to future conversations about additional chemicals that California would like to ban, even when these chemicals are not currently banned in the EU.

According to the Author

"Personal care products and cosmetics should be non-toxic for everyone. If you consider that the European Union prohibits over 1,600 chemicals in such products, a ban in California on these noxious carcinogens and endocrine disrupters is long overdue. AB 496 continues our progress toward cleaner, healthier, and environmentally-safer products."

Arguments in Support

According to a coalition of supporters, including the sponsor of this bill, the Environmental Working Group:

"This important bill will add to the list of chemicals that California does not allow in cosmetics sold in the state. In particular, AB 496 prohibits the sale in California of beauty and personal care products containing any one of 26 highly toxic chemicals that pose public health harms, such as increased risk of cancer, harm to the reproductive system, and harm to aquatic life with long-lasting effects. The environmental risks of these 26 chemicals are particularly concerning because cosmetics are regularly washed off after use. Because of their toxicity, all of the AB 496-listed chemicals are prohibited from being used in cosmetics sold in the European Union.

"Out of the more than 10,000 chemicals used to formulate beauty and personal care products, the United States Food and Drug Administration has only ever banned or restricted 11. In contrast, the European Union prohibits or restricts the use of nearly 1,600 chemicals including the AB 496 chemicals in cosmetics, and many other countries tightly regulate cosmetics sold to their citizens. According to CDPH's Safe Cosmetics Program, at least 88 different carcinogens and reproductive toxicants are intentionally added to thousands of cosmetic products sold in California today. Also, even after a manufacturer has reformulated a product to comply with European standards, the manufacturer often continues to sell the originally-formulated product to Californians."

Arguments in Opposition

"Fragrance Creators Association (Fragrance Creators) is writing to express our opposed unless amended position on AB 496. We appreciate your goal of limiting the use of ingredients in cosmetics that pose a risk to California consumers. We would like to raise a concern regarding the proposal to prohibit the fragrance ingredient p-BMHCA (2-(tert-butylbenzyl propionaldehyde) (CAS Number: 80-54-6) commonly known as Lilial® and also known as Lily aldehyde. We must respectfully request that this ingredient be removed from the legislation, as the body of science does not show there is a risk to consumers when the ingredient is used in alignment with industry safety standards and applicable regulatory requirements.

"AB 496 seeks to align cosmetic ingredient restrictions with those adopted by the European Union (EU). Unfortunately, the EU did not base their restriction on risk, but made a hazard-based decision. For over 50 years, the Research Institute for Fragrance Materials (RIFM)s purpose has been to gather and analyze scientific data, engage in testing and evaluation, distribute information, cooperate with official agencies and to encourage uniform safety standards related to the use of fragrance ingredients. According to RIFM’s assessment, Lilial may be safely used in cosmetic products below certain specific concentration limits set in an IFRA Standard."

FISCAL COMMENTS

This bill is keyed non-fiscal by the Legislative Counsel.

VOTES

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 7-0-2

YES: Lee, Arambula, Bauer-Kahan, Connolly, McKinnor, Pacheco, Zbur

ABS, ABST OR NV: Hoover, Ta

UPDATED

VERSION: March 8, 2023

CONSULTANT: Josh Tooker / E.S. & T.M. / (916) 319-2965 FN: 0000029

Date of Hearing: March 14, 2023

ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS

Alex Lee, Chair

ABPCA Bill Id:AB 496 (

Author:Friedman) – As Amended Ver:March 8, 2023

SUBJECT: Cosmetic safety

SUMMARY: Prohibits, commencing January 1, 2027, a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the specified ingredients. Specifically, this bill:

Prohibits, beginning January 1, 2027 a person or entity from manufacturing, selling, delivering,

holding, or offering for sale, in commerce any cosmetic product that contains any of the

following intentionally added ingredients:

(1) Lily aldehyde (CAS no. 80-54-6).

(2) Acetaldehyde (CAS no. 75-07-0).

(3) Cyclohexylamine (CAS no. 108-91-8).

(4) Cyclotetrasiloxane (CAS no. 556-67-2).

(5) Phytonadione (CAS no. 84-80-0).

(6) Sodium perborate (CAS no. 15120-21-5).

(7) Styrene (CAS no. 100-42-5).

(8) Trichloroacetic acid (CAS no. 76-03-9).

(9) Tricresyl phosphate (CAS no. 1330-78-5).

(10) Vinyl acetate (CAS no. 108-05-4).

(11) 2-Chloracetamide (CAS no. 79-07-2).

(12) Allyl isothiocyanate (CAS no. 57-06-7).

(13) Anthraquinone (CAS no. 84-65-1).

(14) Malachite green (CAS no. 569-64-2).

(15) Oil from the seeds of Laurus nobilis L. (CAS no. 84603-73-6).

(16) Pyrogallol (CAS no. 87-66-1).

(17) C.I. disperse blue 1 (CAS no. 2475-45-8).

(18) Trisodium nitrilotriacetate (CAS no. 5064-31-3).

(19) The following boron substances:

(A) Perboric acids:

(i) Sodium salt (CAS no. 11138-47-9).

(ii) Sodium salt, monohydrate (CAS no. 12040-72-1).

(iii) Sodium perborate monohydrate (CAS no. 10332-33-9).

(B) Boric acid (CAS nos. 10043-35-3 and 11113-50-1).

(C) Borates, tetraborates, octaborates, and boric acid salts and esters, including all of the following:

(i) Disodium octaborate anhydrous (CAS no. 12008-41-2).

(ii) Disodium octaborate tetrahydrate (CAS no. 12280-03-4).

(iii) 2-Aminoethanol, monoester with boric acid (CAS no. 10377-81-8).

(iv) 2-Hydroxypropyl ammonium dihydrogen orthoborate (CAS no. 68003-13-4).

(v) Potassium borate, boric acid potassium salt (CAS no. 12712-38-8).

(vi) Trioctyldodecyl borate.

(vii) Zinc borate (CAS no. 1332-07-6).

(viii) Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt (CAS no. 1330-43-4).

(ix) Tetraboron disodium heptaoxide, hydrate (CAS no. 12267-73-1).

(x) Orthoboric acid, sodium salt (CAS no. 13840-56-7).

(xi) Disodium tetraborate decahydrate; borax decahydrate (CAS no. 1303-96-4).

(xii) Disodium tetraborate pentahydrate; borax pentahydrate (CAS no. 12179-04-3).

(20) C.I. disperse blue 3 (CAS no. 2475-46-9).

(21) Basic green 1 (CAS no. 633-03-4).

(22) Basic blue 7 (CAS no. 2390-60-5).

(23) 3(or 5)-((4-(benzylmethylamino)phenyl)azo)-1,2 -(or 1,4)-dimethyl-1H-1,2,4-triazolium and its salts (CAS nos. 89959-98-8 and 12221-69-1).

(24) Basic violet 4 (CAS no. 2390-59-2).

(25) Basic blue 3 (CAS no. 33203-82-6).

(26) Basic blue 9 (CAS no. 61-73-4).

EXISTING LAW:

1. Requires, pursuant to the federal Food, Drug & Cosmetic Act (FD&C Act), cosmetics produced or distributed for retail sale to consumers for their personal care to bear an ingredient declaration. (21 Code of Federal Regulations 701.3)
2. Defines, pursuant to the Sherman Act, "cosmetic" as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance. Provides that the term "cosmetic" does not include soap. Makes it unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any cosmetic that is adulterated. Makes it unlawful for any person to adulterate any cosmetic. Makes it unlawful for any person to receive in commerce any cosmetic that is adulterated or to deliver or proffer for delivery any such cosmetic. (Health & Safety Code (HSC) § 109900)
3. Requires, pursuant to the Safe Consumer Cosmetic Act (Cosmetics Act), a manufacturer of a cosmetic that is subject to regulation by the federal Food and Drug Administration (FDA) to submit to the California Department of Public Health (CDPH) a list of its cosmetic products sold in California that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity. (HSC § 111792)
4. Prohibits, pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person, in the course of doing business, from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
5. Requires the Department of Toxic Substances Control (DTSC), under the state's Green Chemistry regulations, to establish a process to identify and prioritize chemicals or chemical ingredients in consumer products that may be considered a chemical of concern. (HSC § 25252)
6. Requires DTSC to develop and maintain a list of Candidate Chemicals that exhibit a hazard trait and/or an environmental or toxicological endpoint and is either 1) found on one or more of the statutorily specified authoritative lists or 2) is listed by DTSC using specified criteria. (California Code of Regulations § 69502.2 (b))
7. Prohibits, commencing January 1, 2025, a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of the following ingredients.

(1) Dibutyl phthalate (CAS no. 84-74-2).

(2) Diethylhexyl phthalate (CAS no. 117-81-7).

(3) Formaldehyde (CAS no. 50-00-0).

(4) Paraformaldehyde (CAS no. 30525-89-4).

(5) Methylene glycol (CAS no. 463-57-0).

(6) Quaternium-15 (CAS no. 51229-78-8).

(7) Mercury (CAS no. 7439-97-6).

(8) Isobutylparaben (CAS no. 4247-02-3).

(9) Isopropylparaben (CAS no. 4191-73-5).

(10) m-Phenylenediamine and its salts (CAS no. 108-45-2).

(11) o-Phenylenediamine and its salts (CAS no. 95-54-5).

(12) The following per- and polyfluoroalkyl substances (PFAS) and their salts:

(A) Perfluorooctane sulfonate (PFOS); heptadecafluorooctane-1-sulfonic acid (CAS no. 1763-23-1).

(B) Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate (CAS no. 2795-39-3).

(C) Diethanolamine perfluorooctane sulfonate (CAS 70225-14-8).

(D) Ammonium perfluorooctane sulfonate; ammonium heptadecafluorooctanesulfonate (CAS 29081-56-9).

(E) Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate (CAS 29457-72-5).

(F) Perfluorooctanoic acid (PFOA)(CAS no. 335-67-1).

(G) Ammonium pentadecafluorooctanoate (CAS no. 3825-26-1).

(H) Nonadecafluorodecanoic acid (CAS no. 355-76-2).

(I) Ammonium nonadecafluorodecanoate (CAS no. 3108-42-7).

(J) Sodium nonadecafluorodecanoate (CAS no. 3830-45-3).

(K) Perfluorononanoic acid (PFNA) (CAS no. 375-95-1).

(L) Sodium heptadecafluorononanoate (CAS no. 21049-39-8).

(M) Ammonium perfluorononanoate (CAS no. 4149-60-4). (HSC § 108980 (a))

1. Provides that a cosmetic product shall not be in violation of the law, if the cosmetic product made through manufacturing processes intended to comply with the law contains a technically unavoidable trace quantity of an ingredient listed in HSC 108980 § (a) and that trace quantity stems from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging. (HSC § 108980 (b))

UNCODIFIED INTENT LANGUAGE:

1) Provides that it is the intent of the Legislature to enact a prohibition on the presence of

intentionally added ingredients in cosmetics that is consistent with the prohibition on the

presence of intentionally added ingredients in cosmetics that was enacted by the European Union

(EU). (Added by AB 2762, Chapter 314, Statutes of 2020).

FISCAL EFFECT: Unknown.

COMMENTS:

Need for the bill: According to the author, "Personal care products and cosmetics should be non-toxic for everyone. If you consider that the European Union prohibits over 1,600 chemicals in such products, a ban in California on these noxious carcinogens and endocrine disrupters is long overdue. AB 496 continues our progress toward cleaner, healthier, and environmentally-safer products."

Public health concerns with cosmetics: Cosmetic products are sold to consumers across California, including to children who are still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids, and lips. Cosmetic products are most heavily used by women, including those of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity. That is why it is so important that cosmetic products are safe, properly labeled, and free of contamination.

State cosmetic regulatory requirements: California has two laws governing the safety of cosmetics. The first is the Sherman Act, which is administered by CDPH to regulate cosmetics. It broadly defines a cosmetic as any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Pursuant to the Sherman Act, any cosmetic is considered to be adulterated "if it bears or contains any poisonous or deleterious substance that may render it injurious to users." However, adulteration, in many instances, refers to tampering with a product after the manufacturer has completed its manufacturing. Selling adulterated cosmetics can lead to civil and administrative penalties, embargoes, and even bans on products.

The other law is the California's Cosmetics Act, established by SB 484 (Migden, Chapter 729, Statutes of 2005). It requires that for all cosmetic products sold in California, the manufacturer, packer, and/or distributor named on the product label shall provide CDPH a list of all cosmetic products that contain any ingredients known or suspected to cause cancer, birth defects, or other reproductive harm. CDPH maintains an active, searchable database with all of the data collected from manufacturers under the Cosmetics Act. It is required to make that data user-friendly and available to the public. To date, 867 companies have reported 119,089 products to CDPH. CDPH does not have any enforcement authority or penalty authority over the manufacturers that are covered, so not all manufacturers are currently complying and submitting their products' information. State law does not currently contain a mechanism that would allow the state to compel these manufacturers to comply.

Federal cosmetics regulatory requirements: Neither the FDA nor CDPH require premarket safety testing, review, or approval of cosmetic products.

Under the FD&C Act, cosmetics and their ingredients are not required to be approved before they are sold to the public, and the FDA does not have the authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of a dangerous cosmetic product.

What we know about the chemicals listed in the bill vis-à-vis the EU: The EU, which includes 27 member countries mostly across Europe, develops policies to ensure the free movement of people, goods, services, and capital within the internal market, and enacts legislation to maintain common policies to have cohesion amongst the 27 members on things from trade to agriculture.

The EU Cosmetics Directive (Directive) was adopted in 1976 and formed on the basis of commonly agreed to safety standards relative to cosmetics. On September 15, 2022, the European Commission published Regulation (EU) 2022/1531 to amend Cosmetics Regulation (EC) No. 1223/2009 for the use of certain ingredients classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in cosmetic products.

The EU Directive requires member states to take all necessary measures to ensure that only cosmetic products which conform to the provisions of the Directive and its Annexes can be put on the market. Additionally, the Directive requires member states to prohibit the marketing of cosmetic products containing ingredients listed in the Directive and its Annexes. The regulation defines "cosmetic product" as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors." The scope of products covered under the EU's definition of cosmetics is broader than the scope of products covered under California's definition of cosmetics.

The Directive and its Annexes cover the following cosmetic products:

• Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
• Face masks (with the exception of peeling products).
• Tinted bases (liquids, pastes, powders).
• Make-up powders, after-bath powders, hygienic powders, etc.
• Toilet soaps, deodorant soaps, etc.
• Perfumes, toilet waters and eau de Cologne.
• Bath and shower preparations (salts, foams, oils, gels, etc.).
• Depilatories.
• Deodorants and anti-perspirants.
• Hair care products: hair tints and bleaches, products for waving, straightening and fixing, setting products, cleansing products (lotions, powders, shampoos), conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines).
• Shaving products (creams, foams, lotions, etc.).
• Products for making up and removing make-up from the face and the eyes.
• Products intended for application to the lips.
• Products for care of the teeth and the mouth.
• Products for nail care and make-up.
• Products for external intimate hygiene.
• Sunbathing products.
• Products for tanning without sun.
• Skin-whitening products.
• Anti-wrinkle products.

The intent of this bill is to be consistent with the approach of the EU's cosmetic regulation. All of the chemicals listed in AB 496 have been fully banned in the EU Directive and its Annexes and consequently have already been removed from cosmetic products sold in the EU.

Prior legislation: AB 2762 (Muratsuchi, Chapter, 314, Statutes of 2020) bans a list of specified ingredients from cosmetics products consistent with the EU's Annex II of regulation No 1223/2009, which lists the substances prohibited in cosmetic products sold in the EU. All of the ingredients listed in this bill have been fully banned in the EU under Annex II.

While AB 2762 was moving through the legislative process, industry stakeholders weighed in and formally opposed the bill while it was being heard in the Assembly Environmental Safety and Toxic Materials Committee. Specifically in opposition to AB 2762, the Personal Care Products Council, Fragrance Creators Association, California Chamber of Commerce, and other industry groups were oppose unless the bill was further amended. They collectively stated,

"The undersigned organizations support better alignment with the health and safety standards set forth by the European Union that prohibit the intentional use of specified ingredients which are listed in the EU Cosmetics Regulation 1223/2009, ANNEX II, List of Substances Prohibited in Cosmetic Products. In order to achieve this goal, AB 2762 needs further amendments. The authors have already publicly committed to aligning California law with the EU regulation – not anything more or less. We remain committed to achieving this goal. As such, we have submitted draft language that we believe would fully align AB 2762 with the EU regulations."

AB 496 is consistent with AB 2762 and aligns with the EU regulations along the same lines as requested during the debate of AB 2762.

Consistency with the European Union: AB 2762 included the following intent language: "It is the intent of the Legislature to enact a prohibition on the presence of intentionally added ingredients in cosmetics that is consistent with the prohibition on the presence of intentionally added ingredients in cosmetics that was enacted by the European Union." The approach in AB 496 is modeled after AB 2762 and reflects a strategy specifically requested by industry stakeholders when they were negotiating amendments to AB 2762 – aligning California's bans on cosmetic ingredients with ingredients that are also banned in the EU. California does not have a rigorous scientific process to evaluate chemical ingredients in cosmetics. Until such time that California has a process, it seems reasonable to protect California consumers in the same manner that consumers in the EU have been protected. It is important to note that the cosmetic products for sale in the EU have been reformulated to remove the ingredients banned in the Directive and therefore could also be sold in California if this bill were to pass and become law.

Should California be different than the EU? Industry representatives who negotiated AB 2762 had argued that it would be helpful to industry if California conformed its list of banned ingredients to the EU's list. In a shift from industry's previous position on AB 2762, opposition to AB 496, is now asking for one of the chemicals in the bill to be removed even though it is already banned in the EU, so that it could continue to be sold in California. If the Legislature were to agree to remove a chemical banned in the EU from the state's ban list, this would effectively create a list in California that no longer aligns with the EU. This would arguably open the door to future conversations about additional chemicals that California would like to ban, even when these chemicals are not currently banned in the EU.

Arguments in Support: According to a coalition of supporters, including the sponsor of the bill, the Environmental Working Group:

"This important bill will add to the list of chemicals that California does not allow in cosmetics sold in the state. In particular, AB 496 prohibits the sale in California of beauty and personal care products containing any one of 26 highly toxic chemicals that pose public health harms, such as increased risk of cancer, harm to the reproductive system, and harm to aquatic life with long-lasting effects. The environmental risks of these 26 chemicals are particularly concerning because cosmetics are regularly washed off after use. Because of their toxicity, all of the AB 496-listed chemicals are prohibited from being used in cosmetics sold in the European Union.

Out of the more than 10,000 chemicals used to formulate beauty and personal care products, the United States Food and Drug Administration has only ever banned or restricted 11. In contrast, the European Union prohibits or restricts the use of nearly 1,600 chemicals including the AB 496 chemicals in cosmetics, and many other countries tightly regulate cosmetics sold to their citizens. According to CDPH's Safe Cosmetics Program, at least 88 different carcinogens and reproductive toxicants are intentionally added to thousands of cosmetic products sold in California today. Also, even after a manufacturer has reformulated a product to comply with European standards, the manufacturer often continues to sell the originally-formulated product to Californians."

Arguments in Opposition: According to the Fragrance Creators Association:

"Fragrance Creators Association (Fragrance Creators) is writing to express our opposed unless amended position on AB 496. We appreciate your goal of limiting the use of ingredients in cosmetics that pose a risk to California consumers. We would like to raise a concern regarding the proposal to prohibit the fragrance ingredient p-BMHCA (2-(tert-butylbenzyl propionaldehyde) (CAS Number: 80-54-6) commonly known as Lilial® and also known as Lily aldehyde. We must respectfully request that this ingredient be removed from the legislation, as the body of science does not show there is a risk to consumers when the ingredient is used in alignment with industry safety standards and applicable regulatory requirements.

AB 496 seeks to align cosmetic ingredient restrictions with those adopted by the European Union (EU). Unfortunately, the EU did not base their restriction on risk, but made a hazard-based decision. For over 50 years, the Research Institute for Fragrance Materials (RIFM)s purpose has been to gather and analyze scientific data, engage in testing and evaluation, distribute information, cooperate with official agencies and to encourage uniform safety standards related to the use of fragrance ingredients. According to RIFM’s assessment, Lilial may be safely used in cosmetic products below certain specific concentration limits set in an IFRA Standard."

Related legislation:

1) AB 2771 (Friedman, Chapter 804, Statutes of 2022). Prohibits any person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any per- or polyfluoroalkyl substance (PFAS).

2) AB 2762 (Muratsuchi, Chapter 314, Statutes of 2020). Prohibits, beginning January 1, 2025, the manufacture, sale, delivery, holding, or offering for sale in commerce of any cosmetic product containing specified intentionally added ingredients.

REGISTERED SUPPORT / OPPOSITION:

Support

Environmental Working Group (Sponsor)

A Voice for Choice Advocacy
Active San Gabriel Valley
Alliance of Nurses for Healthy Environments
American Bird Conservancy
As You Sow
Ban SUP (Single Use Plastic)
Booni Doon
California Nurses for Environmental Health and Justice
California Product Stewardship Council

California Health Coalition Advocacy
CALPIRG
Codex Labs Corp
Consumer Federation of California
Dietrick Institute for Applied Insect Ecology
Educate. Advocate.
Families Advocating for Chemical and Toxics Safety
Feminists in Action Los Angeles
Friends Committee on Legislation of California
Friends of The Earth
Green Science Policy Institute
Grove Collaborative
Healthy Highways
Indivisible Alta Pasadena
Indivisible California Green Team
Indivisible Ventura
Intelligent Nutrients
Jonas Philanthropies
Just the Goods
Long Beach Environmental Alliance
Moms Across America
National Association of Environmental Medicine (NAEM)
National Stewardship Action Council
Non-toxic Neighborhoods
Olita
Osea Skincare
Poison Free Malibu
Prima
Queers 4 Climate
Rooted in Resistance
San Francisco Baykeeper
Save Our Shores
Seventh Generation
So Cal 350 Climate Action
Sonoma Safe Agriculture Safe Schools
The Keep a Breast Foundation
Women for A Healthy Environment
Women's Voices for The Earth
Worksafe

Opposition

Fragrance Creators Association
Fragrance Science & Advocacy Council

Analysis Prepared by: Josh Tooker / E.S. & T.M. /