Maryland’s house bill 643 “Public Health – Cosmetic Products – Ingredient Prohibition” is now state law. The bill, which goes into effect January 1, 2025, prohibits the production or sale of cosmetic and personal care products with more than trace amounts of two phthalates, formaldehyde, and over 20 other substances.

The state joins California in banning certain ingredients, except for unavoidable trace amounts, from cosmetics, as is already required by the European Union. 

California’s Toxic-Free Cosmetic Act went into law last September. Massachusetts, Michigan, New Jersey, and New York are also considering restrictions or requiring disclosure on chemicals of concern in cosmetics, including formaldehyde, parabens, PFAS, phthalates, mercury among others.

On a national level, U.S. Senators Susan Collins (R-ME) and Richard Blumenthal (D-CT) have introduced the “No PFAS in Cosmetics Act” which would ban the inclusion of PFAS chemicals in cosmetics products, such as make-up, moisturizer, and perfume.

Maine has passed an Extended Producer Responsibility (EPR) for Packaging bill, also known as LD 1541.

EPRs require producers to help fund and manage the collection and recycling of their products, often by requiring them to pay a stewardship organization that works on their behalf to fulfill their legal requirements. 

Several U.S. states have EPRs in place for specialized streams, such as electronics, carpet and paint, but no state has passed an EPR program for curbside paper and packaging streams. However, such programs for packaging do exist in more than 40 countries and five Canadian provinces. 

Once LD 1541 is enacted, government officials would have direct control over how much money producers would be required to pay to support the recycling of their packaging, and would empower the state’s Department of Environmental Protection to set the fee schedule based on per-ton collection and processing costs.

On the other side of the country, the Oregon state legislature has passed SB582, which establishes a producer responsibility program for packaging, paper for printing and writing, and food serviceware. It currently awaits the governor’s signature.

A document, titled “CDPH Information on Industrial Hemp (IH) Derivatives Including Cannabidiol (CBD)”, was published on the California Department of Public Health’s website in January, but was only recently publicized by industry media. The news of the ban of CBD in cosmetics is unexpected as California has allowed the use of cannabis derivatives in other sectors.

The document states:

“Hulled hemp seed, hemp seed protein, and hemp seed oil are the only components of hemp that are GRAS [“Generally Recognized as Safe”] and allowed in food. CBD derived from hemp or any other source is currently not allowed in any of the items regulated by the Food and Drug Branch of the California Department of Public Health, including foods, drugs, and cosmetics.”

The document also notes that at this time “the FDA has not approved the use of CBD in any of these products.”

However, the FDA neither approves cosmetics ingredients nor maintains a positive list of raw materials permitted in cosmetics. There are many unanswered questions concerning this ruling, so the regulatory team at Ithos Global will be analyzing the issue as more details become available.

Washington State Governor Jay Inslee has signed state Bill SB 5022, which requires plastic packaging producers to meet minimum post consumer recycled content for household and personal care product plastic packaging sold in the state. 

Plastic household cleaning and personal care product container means a bottle, jug, or other rigid container with a neck or mouth narrower than the base. It has a minimum capacity of eight fluid ounces or its equivalent volume, and a maximum capacity of five fluid gallons or its equivalent volume.

Manufacturers must meet the new requirements for minimum post consumer recycled content for affected packaging  according to the following timetable: 

  • 15% by January 1, 2025
  • 25% by January 1, 2028
  • 50% by January 1, 2031

The bill covers a wide range of products including personal care products, household products, food, and nutritional supplements. Other business sectors may have different deadlines. 

Companies selling products that are included in the bill must register with the Washington State Department of Ecology by April 1, 2022 and annually thereafter. A list of the producers of covered  products and the brand names of the covered products April 1, 2026, along with virgin and post consumer plastic content for each covered product must be reported.

Manufacturers that do not meet the minimum post-consumer recycled content requirements will face financial penalties for non-compliance.

The European Commission’s Scientific Committee On Consumer Safety notified the World Trade Organization (WTO) of updated opinions on substances that are classified as carcinogenic, mutagenic, or toxic for reproduction, or “CMRs”.

The commission’s final opinions are:

  • Resorcinol:
    • Use of resorcinol is safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos.  
  • Benzophenone-3 (BP-3):
    • Use of BP-3 as a UV-filter up to a maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray, is not safe for the consumer.
    • Use of BP-3 as a UV-filter up to a maximum concentration of 6% in face cream, hand cream, and lipsticks is safe for the consumer. 
    • Use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation is safe for the consumer.
    • Use of BP-3 as a UV filter is safe for the consumer up to a maximum concentration of 2.2% in sunscreen body creams, propellant sprays, and pump sprays, provided that there is no additional use of BP-3 at 0.5% in the same formulation for protecting the cosmetic formulation.
      • Where BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays.
  • Octocrylene:
    • Use of octocrylene is safe as a UV-filter at concentrations up to 10% in cosmetic products when used individually.
    • Use of octocrylene is also considered safe for a combined use of sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%. 
    • Use of octocrylene at 10% or above in sunscreen propellant spray is not considered safe for the combined use. As a reminder octocrylene was under review for endocrine disrupting properties.
  • Propylparaben:
    • Use propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %. Propylparaben was under review for endocrine disrupting properties.
  • Aluminium Compounds:
    • Use of aluminium compounds is safe at the following equivalent aluminium concentrations up to:
      • 6.25% in non-spray deodorants or non-spray antiperspirants
      • 10.60% in spray deodorants or spray antiperspirants
      • 2.65% in toothpaste
      • 14% in lipstick

France and Italy both issued legislation aimed at reducing packaging waste.  

In France, law No. 2020-105 introduces wide-ranging measures aimed at eliminating waste, encouraging reuse and recycling, and improving consumer information on environmental attributes of products and their packaging.

Several of the several rules that will affect personal care businesses include: 

  • Improving the collection of recyclable plastics by expanding refund systems.
  • Decreasing household trash by 15% per inhabitant by 2030
  • Decreasing waste from economic activity by 5%
  • Recycling 100% of plastics by 2025
  • Ending of single-use plastic packaging by 2040
  • Prohibiting “biodegradable” or “respectful of the environment” claims on packaging
  • Developing a mandatory methodology for environmental labeling 

The law also introduces a ban on the destruction of unsold non-food inventory, including beauty products. Manufacturers, distributors, and stores with unsold inventory will be required to donate or recycle it instead of incinerating it or dumping it in landfills. The law also expands incentives for manufacturers to design their products to be more easily recyclable.

The current decree expands requirements for the “Triman” logo, which has been in use on product packaging since 2015, to include new categories of product and labeling of disposal methods. 

Consequently, use of other recycling symbols such as the Green Dot were supposed to be terminated as of January 1, 2022. However, the French Supreme Administrative Court, the Conseil d’État, has granted urgent applications for the immediate suspension of the new French labelling regulation for packaging. 

Der Grüne Punkt, PRO Europe, or “Packaging Recovery Organisation Europe”, an umbrella organisation for European packaging and the general licensor of the Green Dot trademark for Europe, and other influential associations of the French consumer goods industry have filed such urgent applications. The discrimination of the Green Dot mark associated with the French labelling Ordinance is thus suspended. The Green Dot is mandatory in Spain and Cyprus. 

In Italy, legislative decree 116/2020 has come into force as of September 2020, amending Legislative Decree 152/2006 and implementing the European directive on waste (EU 2018/851) as well as the one on packaging and packaging waste (2018/852). This decree requires mandatory environmental labeling on each packaging.

The law states that all packaging must be appropriately labeled in accordance with the procedures established by the applicable UNI technical standards and in compliance with the decisions adopted by the European Union Commission.

The new labeling requirements are intended to facilitate the collection, reuse, recovery and recycling of packaging, as well as to provide correct information to consumers on the final destination of packaging. The alphanumeric code identifying the material represented by the Möbius cycle symbol must be affixed to the packaging of each product destined to the final consumer.

The new law requires manufacturers to indicate the nature of the packaging materials used, which will aid in the identification and classification of the packaging for recycling. It also states that the parts of the packaging that the consumer can separate manually without using tools must be labelled, such as a plastic bottle and its cap.

Both the French and Italian decrees align with the goals of Extended Producer Responsibility programs. Most provisions go into effect January 1, 2022 for France, and December 31, 2021 for Italy.

Six countries in Central America are planning to update their technical regulations for the registration and labelling of cosmetic products. The regulations establish lists of banned and restricted substances for cosmetics in the region.

The group of countries includes Costa Rica, Guatemala, El Salvador, Honduras, Nicaragua and Panama. The planned regulatory changes fall under the umbrella 2007 Central American technical regulation 71.01.35:06. 

Among the changes is that, in order to register a cosmetic product in one of the Central American countries, a company must present a certificate of good manufacturing practices to the country’s competent authority and detail the amount of any restricted substances present in the product.

The regulation also requires compliance with the lists of banned or restricted substances from the European Union’s cosmetics regulation, which sets out more than 1,300 substances that cannot be included in cosmetics and 250 for which there are volume or use limitations.

There is also a new requirement to state the expiration date of cosmetics on the product’s label in month/year format.

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) have called on the U.S. Food and Drug Administration (FDA) to withdraw its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.

In an effort to address the COVID-19 pandemic in the spring of 2020, the agency issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products, including the “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”.

In their letter to the agency, the two industry groups call out the numerous quality and safety issues with hand sanitizers manufactured under the temporary policy throughout the pandemic and cite the lack of compliance of certain Current Good Manufacturing Practice requirements (cGMPs) as the likely cause. 

Elsewhere in hand sanitizer news, drugstore chain CVS is facing a class action lawsuit over its CVS Health brand hand sanitizer, which it claims kills 99.99% of germs. The plaintiff in the case argues that there are a number of pathogens it cannot kill.

A California’s U.​S. District judge approved the certific­ation, which suggests a future class action suit against the company. The suit was first submitted to California state court in May 2020 and moved to the federal court in October. 

It is noteworthy that CVS voluntarily recalled hand sanitizers under the brand name “Next Hand Sanitizer” after the FDA added it to its warning list of sanitizers consumers should not use due to contamination. 

The outcome of this lawsuit may affect the hand sanitizer market. It is important that appropriate testing to substantiate effectiveness claims are conducted. It will be interesting to observe how current testing protocols are affected.

The FDA has given advance notice of publication of a notice titled “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use.”

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in March 2020, requires FDA to issue a proposed order addressing sunscreens by September 27, 2021, which prompted the notice.

The FDA intends to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain octinoxate and oxybenzone over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS. Instructions for making comments may be found here. A 30-day comment period from the date of publication, expected to be on or about May 13, 2021.

The FDA identifies four potential outcomes for use of these ingredients without a new drug application: 

  • both oxybenzone and octinoxate are permissible
  • both oxybenzone and octinoxate are impermissible
  • oxybenzone is permissible and octinoxate is impermissible
  • oxybenzone is impermissible and octinoxate is permissible

Picture of bottle of talc to illustrate latest Health Canada Talc Assessment screening.

Health Canada released the Final Screening Assessment for Talc on April 24, 2021. Under certain conditions of use, talc was found to be CEPA toxic.

The final screening assessment describes the potential areas of concern as:

  1. Inhalation of fine particles of talc when using loose powder products like baby powder, body powder, and loose face powder, which can damage the lungs; and
  2. Exposure of the female genital area to products containing talc such as body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs and bubble bath.

These areas of concern affect certain cosmetics, natural health products, and non-prescription drugs in Canada.

Based on the information available, the final screening assessment concluded that there are no human health risks from ingestion (e.g., talc in food or drugs), or dermal or inhalation exposures from pressed powders (e.g., pressed powder makeup).  

Health Canada is proposing appropriate risk management action. These measures include revising the existing entries for talc on the Cosmetic Ingredient Hotlist and the Natural Health Products Ingredients Database and applicable monographs. This will provide information to manufacturers on the expanded restrictions on the use of talc in cosmetics, natural health products and non-prescription drugs that can be inhaled or used in the female genital area.

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Ithos Global is a business unit of Cordance Operations LLC