In 2024, Which New Cosmetic Regulations will Draw Global Attention?

In 2023, the global cosmetics market achieved steady growth despite economic downturns, with various regions and countries adapting their laws and regulations to accommodate the market, introducing a series of new regulatory policies. Significant new regulations emerged across major global cosmetics markets from the EU’s microplastics ban and updated skincare ingredient usage to the US’s MoCRA and China’s Technical Guidelines for Children Cosmetics. Within these new regulations, what trends can we see? And what new regulations might draw attention in 2024?

China: Attention on regulation of children’s cosmetics

Since the beginning of this year, China has issued a series of regulations related to cosmetics, including the Supervision and Administration Measures on Online Operation of Cosmetics, Administrative Measures on Toothpaste, Guidelines for the Approval of Registration of Cosmetics and New Cosmetic Ingredients, and the Technical Guidelines for Children Cosmetics (Guidelines). Among them, the most attention-grabbing are the toothpaste management measures and regulations related to children’s cosmetics.

Children’s cosmetics have always been a focal point of cosmetic safety regulation. In 2012, the former State Food and Drug Administration issued the Guidance on Application and Review of Children’s Cosmetics, proposing fundamental requirements for the formulation design and safety of children’s cosmetics. It played an important role in regulating the declaration and technical evaluation of children’s cosmetics and guiding enterprises in formulating these products. In September 2021, the National Medical Products Administration issued the Supervision and Administration Provisions on Children Cosmetics. The recently released guidelines in 2023 further clarify certain aspects of the content outlined in the 2021 regulations.

The Guidelines highlight that children in different stages have varying physiological characteristics. Compared to adults, infants aged 0-1 year have thinner skin, fewer sebaceous glands, incomplete development, a larger surface area, and poorer skin moisture retention and buffering abilities. Skin structures of infants aged 1-3 years tend to be more complete, but the stratum corneum and epidermis remain thin, and the skin barrier function has not matured, making them more susceptible to microbial contamination and external stimuli. They are more prone to adverse reactions such as contact dermatitis and require longer recovery periods.

Therefore, the Guidelines explicitly state that the formulation design of children’s cosmetics should employ relatively simple formulations while prioritizing safety and essential efficacy. Considering the incomplete development of infants’ tear glands and their reduced frequency of blinking, which results in insufficient tear secretion for eye protection, the guidelines propose stricter toxicology test requirements for cosmetics claiming ‘tear-free’ formulas for infants.

Additionally, infants exhibit certain specific behaviors (such as sucking or scratching). The Guidelines specify that safety assessments for infant cosmetics should, when necessary, consider risks associated with oral exposure. Some infant cosmetics are used in specific scenarios, such as skin folds or diaper areas, where factors like tight clothing, diapers, uncontrolled urination, and defecation may lead to skin damage. Therefore, safety assessments for such products should consider changes in skin absorption rates due to these unique circumstances.

Regarding ingredients, the Guidelines prohibit the use of materials prepared using new technologies like genetics or nanotechnology. Infant cosmetics are not permitted to contain certain ingredients, including iodopropynyl butyl carbamate (except in bath products and shampoos), salicylic acid and its salts (except in shampoos), and silver chloride deposited on titanium dioxide.

Furthermore, considering that infants and children are in a phase of rapid growth and development, certain materials with specific safety risks (such as formaldehyde releasers) and substances prohibited in other countries or regions due to risks of teratogenicity, carcinogenicity, or mutagenicity, which might impact lifelong health hazards during the period when normative documents like the Safety and Technical Standards for Cosmetics are not promptly updated, it is generally not advisable to use them in children’s cosmetics.

In terms of label requirements, considering the potential risks of ingestion or misuse of cosmetics by infants and children, cosmetics enterprises are required to take measures to avoid confusion between the characteristics and appearance of children’s cosmetics with food, drugs, or other products. It is prohibited to label them with terms like “food-grade,” “edible,” or use patterns associated with food.

Reportedly, in 2022, the market size of China’s infant and child care market reached 36 billion yuan, and it’s projected to increase to 52.1 billion yuan by 2026. The category itself shows resilience and represents a relatively untapped market. Benefiting from increased penetration rates, age-specific product segmentation, and refined functional scenarios, the future outlook for the children’s skincare market is promising. This year, companies like Runben Bio in children’s skincare went public, and LVMH’s fund invested in the Chinese children’s skincare company Hi!papa, indicating the expansive potential of China’s children’s skincare market.

A continuously improving market requires ongoing enhancement of regulations to mutually support its growth. These Guidelines represent more standardized regulations for children’s cosmetics developed under current laws, technical standards, and the prevailing scientific understanding. This move is conducive to the regulated development of the children’s cosmetics market in China.

MoCAR: A significant regulatory initiative in the US for over 80 years in cosmetic regulation

Compared to the food and pharmaceutical industries, the safety of cosmetics has not been a priority for the United States Food and Drug Administration (FDA).

On December 29, 2022, President Joe Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), marking the first significant legislation for cosmetics in the United States since the Federal Food, Drug, and Cosmetic Act of 1938 and a transformative phase in cosmetics regulation, granting the FDA greater authority and introducing fresh mandates for personal care businesses. MoCRA empowers the FDA to strengthen regulation over cosmetic products sold in the United States.

Indeed, by 2023, policies related to MoCRA were still being progressively implemented, albeit with some delays.

As per the initial provisions, by December, brands and manufacturers producing cosmetics for sale in the United States will need to register their facilities with the FDA, including third-party logistics companies handling cosmetic processing, and provide a list of products and their corresponding ingredients on the market. Companies will also be required to establish a contact point for consumers to report adverse events related to the products, as MoCRA mandates responsible parties to report such incidents to the FDA within 15 working days.

On November 8, The FDA declared a postponement in implementing the cosmetic product facility registration and product listing obligations outlined in the MoCRA, extending the deadline by an extra six months beyond December 29, 2023 (until July 1, 2024). This extension aims to provide the industry with adequate time to submit the required information.

Moreover, the FDA does not intend to enforce mandatory registration requirements for owners or operators of facilities engaging in cosmetic production or processing for the first time after December 29, 2022, nor does it plan to enforce listing requirements for cosmetics introduced to the market after this date.

While cosmetic brands do not require FDA approval to bring products to market, they are expected to maintain records confirming the safety of their products by the year’s end. Harold Chase, Regulatory Affairs Manager for Global Certification at NSF International, a non-profit consultancy and third-party certification organization, stated that cosmetic manufacturers should already have kept such records. However, they now need to document them in a manner accessible to the FDA.

On December 14, 2023, the FDA issued an update containing further details regarding the reporting of serious adverse events under the MoCRA, which became mandatory from December 29, 2023. As per MoCRA regulations, the “responsible person” (i.e., the “manufacturer, packer, or distributor whose name appears on the label of a cosmetic product”) must submit a report detailing all serious adverse events related to the intended use of the cosmetic product within 15 working days upon receipt of such information.

Apart from the report, the responsible person is also required to provide a copy of the label and any medical or other information they have received. For any newly received medical information within one year of the reported event, the responsible person must submit this information to the FDA within 15 working days of receipt. As per MoCRA provisions, the responsible person can also opt to include a statement denying that the cosmetic caused or contributed to the event. If the FDA publicly discloses adverse event information, this statement becomes part of the record.

Additionally, beyond domestic companies in the United States, MoCRA requirements also apply to international firms wishing to sell cosmetics in the U.S. Global manufacturers producing goods for the U.S. market need to register with the FDA and establish a representative in the United States to address safety concerns.

European Union: regulations for sustainable development

Differing from specific regulatory changes in China and the U.S., the regulations in the European Union are more focused on sustainable development.

In November this year, the European Parliament voted to reduce packaging, restrict certain types of packaging, and ban the use of ‘forever chemicals’ in packaging for cosmetics and personal care products as part of its response to escalating waste issues and efforts to promote reuse and recycling programs.

The EU Packaging and Packaging Waste Regulations (PPWR) aim to reduce packaging pollution and establish a circular packaging economy. The overarching goal is to ensure that all packaging is designed to be recyclable by January 1, 2030, with recyclability achievable within five years.

According to this regulation, European Parliament members have set targets to reduce packaging by 5% by 2030, 10% by 2035, and 15% by 2040. They also call for reductions in plastic packaging by 10% by 2030, 15% by 2035, and 20% by 2040. There’s a ban on lightweight plastic carrier bags (less than 15 micrometers) unless needed for hygiene or as primary packaging for loose food to help prevent food waste.

Strict limitations are imposed on the use of certain single-use packaging formats, such as miniatures for beauty and personal care products in hotels. All packaging must be recyclable and meet stringent criteria set by secondary legislation. There are expected to be some temporary exemptions, such as wooden and wax-based food packaging.

In addition to the PPWR, on September 27, 2023, the European Commission approved and issued Regulation (EU) 2023/2055, introducing a new restriction in Appendix XVII of the EU REACH Regulation (EC) No 1907/2006, known as restriction 78, to limit synthetic polymer microparticles (SPMs), commonly referred to as “microplastics,” for various purposes. This ban has been effective since October 17, 2023.

The microplastics restriction involves synthetic polymer particles (“microplastics”) themselves or intentionally added to mixtures. The EU prohibits the sale of cosmetics containing glitter made from non-biodegradable, insoluble plastics.

The EU has stated that the “purpose is not to ban all glitter but replace plastic glitter with more environmentally friendly glitter that does not pollute our oceans. The EU also stated that existing products in stores or suppliers’ inventory can be sold until supplies are exhausted. Additionally, glitter categorized as biodegradable, soluble, natural, or inorganic is excluded from the definition of microplastics and can remain on sale.

In addition, in January, the European Commission presented a new roadmap to the European Citizens’ Initiative (ECI) “Save Cruelty-Free Cosmetics” to protect and strengthen the ban on animal testing for cosmetics.

It proposes launching research, education, and training to expedite the reduction of animal testing. This initiative might involve coordinating with member states and national authorities in this field, providing exploratory workshops and new training measures for early-career scientists. Since March 2009, the EU has prohibited animal testing for cosmetic ingredients. However, this law doesn’t extend to the safety testing required to meet the EU REACH chemical regulations, which mainly focus on chemical risks to workers and the environment.

Overall, the regulations introduced by China, the EU, and North America also reflect the developmental stages of the cosmetics industry in these regions. China’s cosmetics market is growing rapidly, but specific regulations are not yet comprehensive, leaning towards specific categories like children’s cosmetics and toothpaste. The U.S. cosmetics market is relatively mature, with comprehensive regulations. However, due to discrepancies in FDA responsibilities in cosmetic regulation, regulations undergo overall modifications. As a leader in the global cosmetics market, the EU has highly sophisticated cosmetic regulatory policies, focusing more on sustainability in regulations.

During discussions on economic and financial cooperation in China, French Finance Minister Bruno Le Maire expressed a desire to establish a joint structure aimed at encouraging the development of common standards for cosmetics’ efficiency claims and safety between China and France, as revealed by an unnamed official from Le Maire’s department, complying with government regulations to remain anonymous.

Some European Union countries also aspire to align their cosmetics regulations with those of China. If the Chinese cosmetics market seeks healthy and substantial growth, alignment with international standards in regulations is essential. While this alignment demands time and effort, it is indeed imperative.