EU News |
EU Issues Draft Regulation on Cosmetic Ingredients: New Classifications May Lead to Restrictions On 25 September 2024, the European Union issued a draft Regulation representing the 23rd Adaptation to Technical and Scientific Progress (ATP) under the Classification, Labelling, and Packaging (CLP) Regulation. This draft focuses on classifying eight chemical substances, several of which are widely used in cosmetics and other sectors. Among these, three substances have been newly classified under the Carcinogenic, Mutagenic, or Reproductive Toxicants (CMR) category, known for its stringent regulatory implications. Substances classified as CMR typically face strict restrictions or even outright bans in cosmetic formulations, as they pose potential health risks. This draft regulation signals a possible shift in the regulatory landscape for cosmetic manufacturers, who may need to take proactive measures to assess and possibly reformulate their products to remain compliant with EU regulations. The final adoption of this regulation could result in significant changes for the industry, including the need for reformulation, ingredient substitution, and updated safety assessments. Manufacturers and stakeholders in the cosmetics industry should closely monitor the progression of this draft regulation and prepare for potential impacts on product development and market availability. EU Adopts New REACH Regulation to Restrict PFHxA and PFHxA-Related Substances Today, the European Commission introduced new restrictions under the REACH Regulation aimed at limiting the use of undecafluorohexanoic acid (PFHxA) and related substances, which belong to the broader group of per- and polyfluoroalkyl substances (PFAS). Known for their persistence in water and environmental mobility, these chemicals pose significant risks to human health and the environment. The new measures ban the sale and use of PFHxA in consumer products like textiles (e.g., rain jackets), food packaging (e.g., pizza boxes), waterproofing sprays, cosmetics, and some firefighting foam applications. The restriction focuses on areas where safer alternatives are available and balances socio-economic costs with public health and environmental benefits. However, PFHxA use in critical industries such as semiconductors and green hydrogen production is exempt. The restriction will come into force 20 days after publication in the Official Journal, with transitional periods ranging from 18 months to 5 years, allowing the industry time to adapt. This move is part of the EU’s broader strategy to address PFAS pollution, following its commitment under the Chemicals Strategy for Sustainability. |
UK News |
HSE Proposes Harmonised Classification of Substances, Including Key Cosmetic Ingredients On 21 August 2024, the Health and Safety Executive (HSE), responsible for overseeing the Classification, Labelling, and Packaging (CLP) Regulation in Great Britain, published its opinions on the proposed harmonized classification and labeling of nine substances. Among these substances, several are relevant to the cosmetics industry, potentially impacting product formulations and regulatory compliance. Key ingredients under review include Benzoyl peroxide, widely used in acne treatments, and o-phenylphenol, often found in preservatives for personal care products. Additionally, the review encompasses 16 “carbaldehydes,” a group of chemicals that may also be incorporated in cosmetic formulations. These proposals could change how these substances are classified regarding their health and environmental hazards, potentially resulting in more stringent labeling and handling requirements for cosmetics manufacturers. Cosmetic companies using these substances must closely follow the HSE’s recommendations and prepare for any changes in product labeling and safety assessments arising from these harmonized classifications. This marks another step in the ongoing effort to align product safety with updated scientific insights in the UK post-Brexit regulatory landscape. |
USA News |
New York Sets Precedent with 1,4-Dioxane Ban in Personal Care Products. In a groundbreaking move, New York has become the first state in the US to implement strict limits on 1,4-dioxane, a potentially harmful contaminant found in household and personal care products. Effective December 31, 2023, this law mandates that personal care products, including cosmetics, must contain less than two parts per million (ppm) of the substance, with household cleaning products restricted to less than one ppm. By 2025, these limits will become even more stringent, reducing allowable levels to 1 ppm for cosmetics and 0.35 ppm for cleaning products. This initiative is part of New York’s more significant effort to tackle toxic chemicals and reduce potential health risks for consumers. 1,4-Dioxane, often present as a byproduct in manufacturing processes, is classified as a likely human carcinogen and has raised environmental concerns due to its persistence in water sources. The new regulation will push manufacturers to adopt safer alternatives and refine production processes to meet compliance, potentially leading to broader reform across the personal care industry. As the rest of the US monitors New York’s leadership in this area, companies must stay proactive in adjusting formulations to meet these evolving standards. Stay tuned for further updates as the cosmetic and personal care sectors adapt to this crucial regulatory change. Status of MoCRA and Fragrance Allergens Regulation: July 2024 Update The US FDA still needs to release the draft regulation on fragrance allergens in cosmetic products, as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). While the Office of Information and Regulatory Affairs (OIRA) released its Spring 2024 Unified Agenda, which includes FDA’s proposal for fragrance allergens labeling, testing for asbestos in talc-containing cosmetics, and the regulation of formaldehyde in hair products, the exact timing remains unclear. The FDA tentatively targets October 2024 for the fragrance allergens rule but has not confirmed a final date for implementation. California and Fragrance Allergen Reporting Meanwhile, California’s “Cosmetic Fragrance and Flavor Ingredient Right to Know Act” mandates that any EU fragrance allergen must be reported starting January 1, 2024. However, the allergens will only be listed on a state website, which limits the immediate transparency for consumers purchasing products. With MoCRA’s deadlines approaching, the industry is watching closely for further FDA action on fragrance allergen disclosures. |
