Global Cosmetics Regulatory Updates-Vol. 21 (September-October 2024)

Europe

September 6, the Russian Ministry of Industry and Trade proposed mandatory labeling for certain types of perfumery, cosmetics, and household chemicals.

This proposal aims to implement measures outlined in the "Strategy to Counter Illegal Circulation of Industrial Products in the Russian Federation until 2025", approved by Russian Government Order No. 256-р on February 6, 2021. The labeling experiment began on January 15, 2024, and will continue until February 28, 2025. The project includes labeling for soaps and detergents, hair care and shaving products, deodorants, cosmetics and skin care products (including sun protection and tanning products, manicure or pedicure products), toothpaste, and other oral care products.

September 19, the European Commission published Regulation (EU) 2024/2462, adding Entry 79 to Annex XVII of the EU REACH Regulation, which restricts perfluorohexanoic acid (PFHxA), its salts, and related substances.

PFHxA, its salts, and related substances possess various hazardous properties. Current research indicates that PFHxA far exceeds the "high persistence" standard defined in point 1.2.1 of Annex XIII of the REACH Regulation. It is highly mobile in aquatic environments and poses potential adverse effects on human health and the environment. In October 2024, the European Commission officially included PFHxA, its salts, and related substances in the restriction list under Annex XVII of the REACH Regulation. (*PFHxA-related substances are those considered to have the potential to degrade or transform into PFHxA based on their molecular structure.) The specific restriction requirements and effective date for PFHxA, its salts, and related substances under REACH are as follows:

September 23, the European Commission adopted amendments to Regulation (EC) No 440/2008, which outlines the test methods under the REACH Regulation.

This amendment includes seven new and revised test methods designed to assess the physicochemical, toxicological, and ecotoxicological properties of substances, aligning the EU with globally recognized testing standards. The update aims to adapt testing methods to the latest technological advancements, enhancing the accuracy of chemical substance evaluations under REACH, while promoting more humane scientific practices by limiting the need for animal testing. In accordance with Directive 2010/63/EU, the revised regulation prioritizes reducing the use of animals in scientific experiments, updating in vitro methods for immunotoxicity and skin sensitization, as well as ecotoxicity testing, to ensure more ethical and accurate assessments of the impact of chemicals on human health and the environment. The revised regulation will come into effect 20 days after its publication.

September 26, the EU implemented stricter regulations on talc by reinforcing its carcinogenic classification.

The European Chemicals Agency (ECHA) Risk Assessment Committee (RAC) concluded that talc should be classified as Category 1B carcinogen and STOT RE1 under the CLP Regulation. The Category 1B classification indicates that talc (CAS No. 14807-96-6) is suspected of causing cancer in humans, potentially designating it as a Substance of Very High Concern (SVHC). This new classification could significantly impact industries reliant on talc, particularly in cosmetics, pharmaceuticals, and other consumer products. RAC's decision is expected to influence regulatory frameworks across Europe and beyond. As authorities continue to assess the safety of talc, manufacturers will need to prepare for stricter regulations and closer scrutiny of talc-containing products.

October 2, the Norwegian Food Safety Authority implemented regulations on substances such as Vitamin A, α-arbutin, and genistein in cosmetics and personal care products.

Key points include: (1) Scope: Manufacturers and importers of cosmetics and personal care products. (2) Vitamin A has been added to the list of permitted substances with specific usage restrictions (Cosmetics Regulation Annex III). All products containing Vitamin A must be labeled with “Contains Vitamin A. Check your daily intake before use.” α-arbutin is permitted in cosmetics, with a maximum concentration of 2% in face creams and 0.5% in body lotions. Arbutin is allowed at a maximum concentration of 7% in face creams. Genistein is allowed at a maximum concentration of 0.007% in cosmetics. Daidzein is allowed at a maximum concentration of 0.02% in cosmetics.

October 3, the UK amended the 2024 Cosmetics (Chemical Restrictions) (No. 2) Regulations to expand restrictions on chemicals.

The latest amendment imposes restrictions on 13 chemicals classified as Carcinogenic, Mutagenic, or Toxic to Reproduction (CMR) under the GB Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008). These changes expand the original list of 52 prohibited substances, further protecting consumer health and safety. The 13 substances include Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) (CAS No. 75768-65-9), 4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol; bisphenol AF (CAS No. 1478-61-1), Transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyltrans-2-(2,2-dichlorovinyl)-3,3-dimethylcyclopropanecar boxylate (CAS No. 118712-89-3), N,N-dimethyl-p-toluidine (CAS No. 99-97-8), 4-nitrosomorpholine (CAS No. 59-89-2), and 3,3'-dimethylbiphenyl 4,4'-diyl diisocyanate (CAS No. 91-97-4), etc.

October 25, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinions on the safety of five substances used in cosmetics.

The SCCS released documents, including SCCS/1670/24, detailing the safety assessments of substances such as Biphenyl-2-ol and Sodium 2-biphenylolate. These opinions were approved by the SCCS on October 25, 2024, and will come into effect following their publication.

October 25, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued the final opinion for the new coating of titanium dioxide (nano form), including raw material control details.

SCCS issued the final safety assessment results (SCCS/1667/24) for a new coating of titanium dioxide (nano form), known as Eclipse 70. SCCS stated that due to existing data gaps and uncertainties, the current information could not demonstrate the similarity of Eclipse 70 to previously assessed titanium dioxide (nano) materials (SCCS/1516/13-Revision of 22 April 2014) in terms of physicochemicalcharacteristics, coating stability, and skin absorption. Therefore, a conclusion on the safety of Eclipse 70 as a UV filter cannot be drawn.

In October, the European Chemicals Agency (ECHA) conducted a review of prohibited substances in cosmetics, identifying PFOA and D5 as the most common violations.

The ECHA Enforcement Forum found that over 6% of products contained harmful substances banned under the EU POPs and REACH regulations. These components pose serious health risks to consumers, including carcinogenic and reproductive toxicity. From November 2023 to April 2024, enforcement authorities from 13 EU member states, including Germany, Sweden, and Italy, inspected 4,686 products from 345 companies. The focus was on perfluorooctanoic acid (PFOA), perfluorocarboxylic acids (PFCAs) and related substances, as well as cyclic siloxanes D4 and D5. Due to their persistence, bioaccumulation, and toxicity, these substances are restricted under the POPs and REACH regulations and are explicitly prohibited in cosmetics.

America

September 23, the Brazilian Agencia Nacional de Vigilancia Sanitaria(ANVISA) published two cosmetic regulations in the government gazette.

The regulations are as follows: (1) Resolution RDC No. 906: This outlines the registration procedures and requirements for hair straightening and curling cosmetic products. Key points include: Both domestic and imported hair straightening and curling products must be registered with the Brazilian ANVISA; Registration should be submitted through ANVISA's electronic system; Manufacturers or importers must provide various documents when applying for registration, including the product analysis certificate, stability test data, product labels and instructions for use, skin and eye safety assessment materials, final product safety declaration, and product labels; There are also specific labeling and warning requirements for these products.

(2) Resolution RDC No. 907: This regulation pertains to the management of personal care cosmetics and perfumes. It includes: Terms and definitions, product classification, and categories of personal care cosmetics and perfumes that require official registration; Required product information, technical documentation, and registration procedures; General and specific labeling requirements (e.g., aerosol cosmetics must include warnings like "Do not inhale directly" and "Flammable"); Microbiological hygiene standards (e.g., cosmetics for children, eye cosmetics, and products in contact with mucous membranes must not contain Pseudomonas aeruginosa, Staphylococcus aureus, or Escherichia coli, and the total count of aerobic mesophilic microorganisms must be <100 CFU/g (ml)). Both resolutions will take effect from the date of publication.

October 5, the Canadian government proposed a draft of Plan of Priorities.

The government stated that when determining which chemicals to prioritize for review, several factors will be considered, including the hazard of the substances, their potential impact on vulnerable populations, and the likelihood of consumer exposure. The draft lists 14 specific substances, including dichloromethane (DCM; CAS 75-09-2), octocrylene (CAS 6197-30-4), and tetrachloroethylene (PERC; CAS 127-18-4), etc. It also includes certain substances under 18 categories, such as alkylphenols, coumarins, and salicylic acid. These substances and categories may be prioritized for review to protect public health and environmental safety.

Asia Pacific

September 14, China’s National Medical Products Administration (NMPA) released the " Cosmetics Safety Risk Monitoring Management Measure (Draft for Comments)".

To implement the "Cosmetics Supervision and Administration Regulations" and the "Measures for the Supervision and Administration of Cosmetics Production and Operation," the NMPA issued the draft, which includes six chapters and 30 articles: General Provisions, Plan Formulation, Sampling and Testing, Investigation and Handling, Application of Monitoring Results, and Supplementary Provisions.

September 20, China’s National Institutes for Food and Drug Control issued the "Notice on Adjusting the Acceptance and Review Consultation Services for Cosmetics and New Ingredients."

The main content focuses on optimizing and adjusting the consultation services for the acceptance and review of special cosmetics and new cosmetic ingredients. This includes telephone consultations, on-site consultations, email inquiries, meetings, remote support, and other considerations. The adjustments will be implemented from October 1, 2024.

September 20, Japan initiated a public consultation on updating labels and safety data sheets.

The Ministry of Health, Labor, and Welfare (MHLW) proposed adding 155 substances to the classification list, currently including substances listed before March 31, 2024. Additionally, the draft suggests removing two substances from the list. Substances classified before March 31, 2021, were previously added to the list. By April 2027, these 155 chemicals are expected to be included. However, MHLW has not yet announced the date for the removal of sodium stearate and triphenyl phosphate from the list.

September 23, Indonesia issued regulation on the permissible limits of contaminants in cosmetics.

The regulation specifies the maximum allowable limits for microorganisms, heavy metals, and harmful chemicals in cosmetics, with details provided in the table below. The regulation takes effect from the date of its publication in the government gazette, with a transition period of 12 months.

September 24, the South Korean Ministry of Food and Drug Safety (MFDS) issued Announcement No. 2024-388, proposing amendments to the Enforcement Rules of the Cosmetics Act. The public comment period ends on November 4, 2024.

The main proposed amendments include: (1) Incorporating electronic documents such as registration certificates into cosmetics production-related civil affairs; (2) Establishing procedures for the application and review of designating (or changing) prohibited ingredients in cosmetics; (3) Developing detailed standards for the information and labeling on cosmetic packaging; (4) Imposing stricter requirements on cosmetic labeling and advertising, along with administrative penalties for violations. The revised Enforcement Rules of the Cosmetics Act are set to take effect on February 7, 2025.

September 24, the Korean Ministry of Food and Drug Safety (MFDS) issued Announcement No. 2024-51, revising the regulations on usage precautions and allergen labeling for cosmetics.

The main revisions include: (1) Designating "mascara" and "external genital cleansers" as products that must include all information required by Article 10 of the Cosmetics Act, even for cosmetics with a net content of 10mL (g) or 50mL (g) or less. (2) Adding usage precautions for eyelash perm products: Avoid self-use, strictly follow the prescribed method and dosage, avoid contact with eyes when using the product. If chemicals come into contact with the eyes or face, rinse immediately with running water or saline solution, etc.

September 27, the General Office of China’s National Medical Products Administration (NMPA) issued a notice on the 2024 Cosmetics Standards Project Plan.

To implement the Cosmetics Supervision and Administration Regulation and meet the requirements of the "14th Five-Year Plan for National Drug Safety and High-Quality Development", the NMPA has released the 2024 Cosmetics Standards Project Plan. According to the plan, revisions will be made to 31 cosmetic standards, including limits on total bacterial count for eye cosmetics, lip cosmetics, and children's cosmetics, as well as limits on dioxane and the maximum allowable concentration of salicylic acid. Additionally, 23 new standards will be established, covering substances such as perfluorooctane sulfonate and its salts, pearl extract, and lyophilized powder.

October 30, China’s National Medical Products Administration (NMPA) announced the inclusion of five testing methods into the Safety and Technical Standards for Cosmetics (2015 Edition) (Announcement No. 45 of 2024).

Among these, three new testing methods—"Testing Method for Azelaic Acid and Its Salts in Cosmetics", "Testing Method for Phenacetin in Cosmetics", and "Testing Method for Hydroxydecanoic Acid in Cosmetics"—will be added to the Safety and Technical Standards for Cosmetics (2015 Edition) and will take effect on July 1, 2025. The "Testing Method for Asbestos in Cosmetics" and "Testing Method for 14 Ingredients Including Glucuronic Acid in Cosmetics" are revised methods, replacing the existing ones in the 2015 edition. From July 1, 2025, these methods must be used for cosmetic registration, filing, and sampling inspections.

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