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The Cosmetic Regulatory Updates in the United States from January to July 2021

ChemLinked rounded up the cosmetic regulatory news in the United States from January to July 2021.

Updates on Animal Testing Ban


1. Virginia Bans Animal Testing on Cosmetics

On March 12, 2021, the Virginia Governor signed the HB 2250 Humane Cosmetics Act into law, banning the testing of cosmetics on animals.

  • From January 1, 2022, the conducting of animal testing for cosmetic ingredients or finished products will be prohibited, and the manufacture and import of cosmetics that are developed using animal testing will be prohibited.

  • From July 1, 2022, the sale of cosmetics tested on animals will be prohibited.

Virginia now becomes the fourth U.S. state that puts an end to cosmetic animal testing after similar laws were introduced in California, Nevada, and Illinois. [Reference Link]

2. Maryland to Ban Cosmetic Animal Testing

After California, Nevada, Illinois, and Virginia, Maryland passed new legislation on 29 March 2021 to ban cosmetic animal testing. The legislation, called SB282 HB 611 "Prohibition on Testing Cosmetics on Animals," will ban animal testing in cosmetic development from 1 January 2022 and ban the sale of cosmetics or individual ingredients tested on animals from 1 July 2022. [Reference Link]

3. Maine Becomes the Sixth U.S. State to Ban Cosmetic Animal Testing

On June 10, 2021, Maine Governor signed the LD 1551 into law banning the testing of cosmetics on animals, which makes Maine the sixth U.S. state to pass such a ban. The legislation (LD 1551) will prohibit the sale of cosmetics tested on animals across the state from 1 November 2021. Violators of the new law will be fined $5,000, with an additional $1,000 for each day the violation continues. [Reference Link]

4. Hawaii to End Cosmetic Animal Testing

Following Maine’s lead, Hawaii introduced a cosmetic animal testing ban on 1 July 2021 by passing a new legislation—SB345 HB1088. According to the new legislation, the manufacture, import, or sale of cosmetics tested on animals will be prohibited from January 1, 2022. Violators will be subject to a fine of $5,000 and an additional $1,000 for each day the violation continues.

Hawaii now becomes the seventh U.S. state that puts an end to cosmetic animal testing. Several other states, including New York, New Jersey, and Rhode Island, are considering similar bans. [Reference Link]

Other Cosmetic Regulatory Updates


5. Oregon's Toxic-Free Kids Act Enters its Final Phase of Implementation

In 2015, Oregon passed the Toxic-Free Kids Act (TFKA), which requires manufacturers of children’s products sold in the state to report and eventually phase out the use of the high priority chemicals of concern for children’s health (HPCCCH), unless the product or manufacturer is exempted. The Oregon Health Authority (OHA) is responsible for developing specific administrative rules to guide manufacturers in implementing this law. The rulemaking and implementation process was divided into three phases. Notably, the first two phases have been completed with relevant rules implemented.

  • Phase 1: Establish a list of HPCCCH and the criteria, according to which the list can be updated in the future.

  • Phase 2: Specify manufacturer reporting requirements and required components of the Manufacturing Control Program. Establish penalties for non-compliance with reporting requirements.

On March 1, 2021, the OHA started Phase 3 with the implementation of the final rules of the TKFA. One of the most important rules is that three specific categories of children's products—products for children under three years old, "mouthable" products, and children's cosmetics—are subject to new requirements, which asks their manufacturers to remove HPCCCH from the three categories or substitute it with an alternative to make the product less hazardous by January 1, 2022, unless they obtains an exemption. [Reference Link]

6. Hawaii House Fails a Bill to Ban More Sunscreen Ingredients

To save coral reefs and protect marine ecosystems, Hawaii passed a law prohibiting the sale and distribution of sunscreens containing oxybenzone and octinoxate in June 2018, which went into effect on January 1, 2021.

Amidst growing awareness of common sunscreen ingredients’ impact on marine life, supporters of Hawaii’s sunscreen ingredient ban look to expand the existing restrictions. On March 9, 2021, Senate Bill 132 passed the Hawaii State Senate, proposing to ban two additional sunscreen ingredients—avobenzone and octocrylene, from Jan. 1, 2023. However, the House vetoed the bill, due to concerns about the ban's impact on sunscreens that are still available and the lack of sufficient data to link these sunscreen agents to adverse coral effects. The House committee decided to wait for more scientific evidence before considering legislating the ban expansion. [Reference Link]

7. Maryland Prohibits the Use of 24 Ingredients in Cosmetics

Following California's passage of Assembly Bill 2762 last year, Maryland became the second U.S. state to ban 24 harmful ingredients in cosmetics by approving House Bill 643 on May 30, 2021. The bill will take effect on January 1, 2025.

The 24 ingredients are:

  1. Dibutyl phthalate

  2. Diethylhexyl phthalate

  3. Formaldehyde

  4. Paraformaldehyde

  5. Methylene glycol

  6. Quaternium-15

  7. Mercury

  8. Isobutylparaben

  9. Isopropylparaben

  10. m-Phenylenediamine and its salts

  11. Phenylenediamine and its salts

  12. 13 types of per- and polyfluoroalkyl substances (PFASs) and their salts, including PFOS and PFOA

Notably, all the above ingredients are already banned from using in cosmetics for selling in the European Union. [Reference Link]

8. California Updates the Senate Bill 312 Ingredient List

Senate Bill 312 (SB 312) is known as the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) that will take effect on January 1, 2022. It requires the manufacturers who distribute cosmetics in the state to report to California Department of Public Health (CDPH) if their products contain fragrance or flavor ingredients included on one or more of the 23 designated lists in the California Health and Safety Code Section 111792.6. CDPH has compiled a list of reportable ingredients based on lists and reports available from the authoritative scientific bodies cited in the Act to assist companies with reporting. On June 30, 2021, CDPH updated the SB 312 Reportable Ingredient List, which now contains 3,096 chemicals. [Reference Link]

9. Senators Propose a Bill to Strengthen the FDA's Oversight of Personal Care Products

On June 17, 2021, senators Dianne Feinstein and Susan Collins introduced the Personal Care Products Safety Act, a new bill designed to replace the outdated 83-year-old federal law that governs personal care products. Once adopted, the bill will protect consumers' health, bring regulatory certainty for manufacturers, and strengthen the Food and Drug Administration’s (FDA) oversight of personal care products and their ingredients.

As per the bill, FDA and companies will be subject to the following obligations:

FDA

Companies

  • Review the safety of product ingredients, and recall harmful products;

  • Establish a definition of the term “natural” in the labeling of cosmetics;

  • Ban products containing harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substances);

  • Issue regulations outlining GMP for personal care products;

  • Provide technical assistance and additional flexibility for smaller businesses;

  • Collect user fees from manufacturers to fund oversight activities

  • Register with FDA, disclose the ingredients used, and attest that they have safety records for products;

  • Report serious adverse events to FDA within 15 days and conduct annual reporting of all reported adverse health events;

Currently, the bill has received widespread support from the industry, including top brands such as Johnson & Johnson, Procter & Gamble, L'Oreal, Estee Lauder, and Unilever. [Reference Link]


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