FDA Opens Cosmetics Direct Registration Portal for MoCRA
On December 18, 2023, the U.S. Food and Drug Administration (FDA) introduced the Cosmetics Direct electronic registration portal, aligning with the stipulations outlined in the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA).
The Cosmetics Direct platform serves as an FDA Structured Product Labelling (SPL) authoring tool, designed with intuitive data entry forms. This tool streamlines the process of registering and listing cosmetic product facilities and products. The FDA highlights the user-friendly interface, emphasising its capability to generate, validate, save, submit, process, and automatically transmit SPL submissions internally to the FDA. Notably, users can achieve these tasks without relying on the Electronic Submissions Gateway (ESG). Nevertheless, the FDA remains open to SPL-formatted submissions through the ESG and is actively developing SPL-X forms for imminent release. Furthermore, the agency is in the process of creating paper forms as an alternative submission method, with availability anticipated in the near future. Emphasising efficiency and timeliness, the FDA strongly encourages electronic submissions to expedite data processing and management.
It is crucial to note that the FDA has extended a grace period for compliance with the MoCRA regulations related to cosmetic product facility registration and product listing. The enforcement of these requirements is deferred until July 1, 2024. This extension provides the regulated industry, including owners or operators of facilities that commenced cosmetic product manufacturing or processing after December 29, 2022, with additional time to align with the regulatory mandates. As part of this delay, products first introduced to the market after the mentioned date are also encompassed by the extended deadline. For more information on ongoing activities related to MoCRA, the FDA has released updates on Serious Adverse Event Reporting.
PFAS Alert: No PFAS in Cosmetics Act Reintroduced in the House
Earlier this month Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA), and Annie Kuster (D-NH) reintroduced the bipartisan No PFAS in Cosmetics Act (H.R.6519). This legislation aims to prohibit the use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products. Notably, the bill mandates the Food and Drug Administration (FDA) to enforce the ban within 270 days of the legislation being enacted.
India Unveils Chemical Inventory Platform
In November, the Department of Chemicals and Petrochemicals (DCPC), Government of India, launched the Indian Chemical Inventory through the ChemIndia platform.
This initiative aims to gather comprehensive data on the chemical and petrochemical industry, including production, capacity, exports, imports, and chemical properties. The database includes additional qualifiers like CAS and IUPAC names for import-export data. This project empowers industries by providing real-time data collection, analysis, and storage, significantly reducing manual processes' costs and administrative burden. The Indian Chemical Inventory enhances data processing capabilities, encourages collaboration, and promotes informed decision-making and strategic planning.
Octocrylene Faced Potential Ban - Call for Evidence
Regulatory authorities in Europe, led by the French Agency for Food, Environmental, and Occupational Health & Safety (ANSES), increased efforts to potentially ban the use of octocrylene. Octocrylene, known for its water-resistant properties, was a common ingredient in cosmetic formulations, especially sunscreens.
The European Chemicals Agency (ECHA) initiated a call for evidence to gather essential information for France's proposal to restrict octocrylene.
FDA Position: The US FDA, in its 2021 evaluation, identified only zinc oxide and titanium dioxide as safe and effective sunscreen ingredients. Octocrylene, among others, faced classification challenges due to insufficient data.
Contamination Concerns: Octocrylene was often found to be contaminated with benzophenone, a known carcinogen, raising serious safety concerns.
Environmental Impact: The UV filter was linked to aquatic toxicity and potential harm to coral reefs, although conflicting evidence existed regarding its environmental impact.
Industry Response: As discussions unfolded, the market witnessed a surge in "reef-safe" alternatives. Companies like Advance ZincTek and Reef Relief introduced products designed to not only protect coral reefs but also contribute positively to aquatic ecosystems.
Canada Bans Animal Testing
Canada passed measures through the Budget Implementation Act to ban cosmetics animal testing. The ban prohibited the sale of cosmetic products that had been tested on animals and those that relied on new animal testing data.
The Canadian government worked closely with organisations such as the Humane Society International, Lush, The Body Shop, Cruelty Free International, Cosmetics Alliance Canada, and Animal Alliance Canada to implement this ban.
Jean-Yves Duclos, Minister of Health, Government of Canada, explained:
“Testing cosmetics on animals was both cruel and unnecessary. That is why we were proud to move forward on our promise to ban cosmetic animal testing and trade. Protecting animals then and in the future was something many Canadians had been advocating for, and now, we could all be assured that cosmetics in Canada were cruelty-free, and we would continue to take all necessary measures to improve animal welfare.”
New Zealand Consulted on Revised Cosmetic Products Group Standard
New Zealand's Environmental Protection Authority (EPA) released a draft of the revised Cosmetic Products Group Standard for public consultation.
The Cosmetic Products Group Standard (2020) applied to any substance imported or manufactured for use as a cosmetic product, where that cosmetic product is classified as hazardous under the Hazardous Substances (Hazard Classification) Notice (2020). The Group Standard established labelling requirements, ingredient restrictions, supply, storage, and use restrictions, and safety data sheet standards.
The new draft included the following revisions:
The applicable scope was expanded to include products not classified as hazardous but containing hazardous ingredients.
Both flammable and non-flammable aerosol cosmetic products and non-hazardous aerosol cosmetic products that contained hazardous components fell within the scope of the Standard.
To align with the EU Cosmetic Regulation (1223/2009), colourants, preservatives, and UV filters were further restricted.
321 ingredients were listed as prohibited, including some classified as CMR substances.
A blanket ban on the use of PFAS (perfluoroalkyl and polyfluoroalkyl substances) in all cosmetic products.
A requirement to maintain records of nanomaterials present in a cosmetic product and a declaration of the product's compliance with the Standard.
A requirement for all finished cosmetic products containing formaldehyde releasers to be labelled with the additional warning "contains formaldehyde" or "releases formaldehyde" where the formaldehyde concentration exceeded 0.001% (10 ppm).
China Finalised New Toothpaste Regulations
China's State Administration for Market Regulation (SAMR) has issued the finalised Administrative Measures on Toothpaste.
Under the Cosmetic Supervision and Administration Regulation (CSAR), toothpastes are classified as general cosmetics but are subject to a more stringent management scheme. In contrast to other general cosmetics, toothpaste requires efficacy evaluation, new ingredient applications, and notifications.
The new Measures clarify:
The definition of toothpaste
The responsibilities of all stakeholders
The management requirements for toothpaste products and new ingredients
The requirements for toothpaste safety assessments, efficacy claims, and labelling
The continued use of the existing toothpaste production licensing system
The Administrative Measures on Toothpaste were fully implemented on December 1, 2023.
Countries Raised Concerns with EU Deforestation Legislation
A group of South American, African, and Asian countries jointly submitted a letter to the EC Commission, expressing "multiple concerns" about the EU's newly introduced regulation on deforestation-free products.
The EU Deforestation Regulation (EUDR), enacted on June 29, 2023, mandates companies involved in the trade of cattle, cocoa, coffee, palm oil, rubber, soya, and wood, along with their derivatives, to scrutinise their value chains. They are required to ensure that goods do not originate from recent (post-December 31, 2020) deforestation, forest degradation, or violations of local environmental and social laws.
The substances covered by the Regulation are extensively used in personal care and cosmetic products. Cosmetic companies marketing products containing these substances must collect precise geographical information on the farmland where the sourced commodities were grown to ensure compliance.
The letter primarily criticises the EUDR for imposing an "excessive administrative burden related to geolocation and traceability requirements, certifications, and customs procedures."
The letter states:
“The legislation disregards local circumstances and capabilities, national legislations and certification mechanisms of developing producer countries, their efforts to fight deforestation and multilateral commitments, including the principle of common but differentiated responsibilities.”
The letter is accompanied by signatures from ambassadors of Argentina, Bolivia, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Paraguay, Peru, Thailand, Nigeria, Ghana, Ivory Coast, and Honduras.
New York Banned Mercury in Cosmetics
In December 2022, the Governor of New York signed Senator Bill 8291A, amending the Environmental Conservation Law to restrict the use of mercury in cosmetics and personal care products.
Exposure to mercury is known to cause damage to the nervous system, kidneys, liver, and immune system. Despite the strict ban on the use of mercury in cosmetic products, contamination may still occur.
Starting from the effective date of June 1, 2023, the distribution and sale of cosmetic and personal care products containing mercury will be prohibited in the state. New York becomes the third state, following Minnesota and California, to introduce a ban on cosmetic and personal care products containing mercury.
EU CLP New Hazard Classes Published
Regulation (EU) 2023/707, which amended the EU Classification, Labelling, and Packaging Regulation (CLP) to introduce new hazard classes, entered into force on April 20, 2023. The CLP aligned the classification, labelling, and packaging of chemicals and mixtures with the Globally Harmonised System. It determined whether a chemical displayed properties leading to a hazardous classification. Once a chemical was classified, identified hazards had to be clearly and uniformly communicated to other actors in the supply chain, ensuring a high level of protection for human health and the environment.
The new hazard classes introduced included:
- Endocrine disruptors
- PBT (persistent, bioaccumulative, toxic) and vPvB (very persistent, very bioaccumulative)
- PMT (persistent, mobile, toxic) and vPvM (very persistent, very mobile)
Manufacturers, importers, and downstream users of chemicals, substances, and mixtures had to identify relevant information to determine whether the substance entailed a physical, health, or environmental hazard. This information should relate to the forms or physical states in which the substance or mixture was placed on the market or reasonably expected to be used.
All substances on the market are required to be classified by May 1, 2025. However, substances placed on the market before May 1, 2025, do not require classification until November 1, 2026.
All mixtures on the market are required to be classified by May 1, 2026. However, mixtures placed on the market before May 1, 2026, do not require classification until May 1, 2028.
Brazil Prohibited Animal Testing
Brazil's National Council for the Control of Animal Experimentation has announced measures prohibiting animal testing for cosmetic products. The measure encourages Brazilian cosmetic manufacturers or those importing cosmetics into Brazil to adopt alternative methods.
The Humane Society International, which helped push the bill through in Brazil, states the measure is only a partial ban:
"This new Brazilian norm is a welcome next step in the right direction and something for which we have long advocated. However, a domestic testing ban on its own will not prevent the import and sale of newly animal-tested cosmetics from other countries. This will put our personal care industry at a competitive disadvantage and fall short of the cruelty-free beauty sector that Brazilian consumers have made clear that they want. For this reason, our work to secure a federal law must continue."
Animal testing on cosmetics is currently banned in the EU and several states across the US. It is worth noting animal testing is a requirement for certain cosmetic products placed on the Chinese market.
