EU Implementing Regulation 2024/1435: Product Recall Notices.
The European Commission has introduced Implementing Regulation 2024/1435, which mandates a standardised template for product recall notices, effective from 13th December 2024. This regulation is a critical component of the General Product Safety Regulation 2023/988 (GPSR) which aims to enhance the clarity and consistency of recall communications across the European Union. The standardised template ensures that all recall notices contain essential information, including the product's hazard, necessary actions for consumers, and contact details for further assistance.
The GPSR was implemented on May 23rd 2023, succeeding the General Product Safety Directive, and is also set to take effect on December 13th, 2024. The GPSR aims to significantly improve product safety standards across the EU market, particularly for beauty accessories. This new regulation introduces stringent requirements for manufacturers and importers, including comprehensive risk analysis, detailed technical documentation, and clear safety instructions for consumers.
Regulation 2024/1435 marks a significant step in consumer protection within the EU. By providing clear and uniform guidelines for recall notices, the Commission aims to mitigate risks associated with unsafe products more effectively. The template is designed to be used both in physical shops and online, ensuring that consumers are promptly informed about potential dangers regardless of where they purchased the product. This uniform approach helps to eliminate confusion and ensures that consumers receive accurate and actionable information.
Additionally, the regulation emphasises the responsibility of manufacturers and distributors in ensuring product safety. They are required to use the standardised template when issuing recall notices, thereby maintaining high safety standards across the market. This initiative not only enhances consumer safety but also fosters trust in the regulatory system. By prioritising clear communication and swift action in the case of product recalls, the European Commission aims to safeguard public health and maintain a high level of consumer confidence in the market.
For further details, visit the official document.
SCCS Final Scientific Opinion on Titanium Dioxide in Cosmetics.
On 23rd May 2024, the Scientific Committee on Consumer Safety (SCCS) published its final scientific opinion on the use of titanium dioxide (TiO2) in cosmetic products. This comprehensive evaluation followed concerns about the genotoxicity and safety of TiO2, especially when used in products that may result in inhalation or ingestion by consumers. The SCCS reviewed various grades of TiO2, including nano and non-nano forms, and their potential health risks.
The committee's findings were significant. They determined that two specific nano forms of TiO2 (referred to as RM09 and RM11) did not demonstrate genotoxic effects. However, the SCCS highlighted the need for additional data to conclusively confirm the safety of other TiO2 grades used in cosmetics. This is particularly relevant for products such as powders and sprays, where inhalation exposure is more likely. The committee's advice aims to ensure that all forms of TiO2 meet stringent safety standards to protect consumer health.
Moreover, the SCCS recommended updating the specifications for TiO2 used in cosmetics to align with the latest scientific data. These updates include detailed assessments of particle size distribution, coating materials, and other physicochemical properties that can influence the safety profile of TiO2. The recommendations by the SCCS are crucial for guiding regulatory frameworks and ensuring that cosmetic products containing TiO2 do not pose a risk to consumers.
For more detailed information, visit the European Commission's publication.
MoCRA Cosmetic Product Compliance Deadline Approaches.
In December 2023 the U.S. Food and Drug Administration (FDA) extended the compliance deadline for cosmetic product facility registration and product listing under the Modernization of Cosmetics Regulation Act (MoCRA) to 1st July 2024. Initially, the deadline was set for December 29th 2023, however the new extension was put in place to provide businesses additional time to align with the new regulatory requirements.
In less than a month, companies will be required to submit their cosmetic product listings within 120 days of introducing a product to interstate commerce. However, small businesses, as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), are exempt from these registration and listing requirements. The revised compliance schedule applies to all cosmetic products marketed before December 29th 2022, as well as new products introduced after this date.
The delay in enforcement aimed to ensure a smoother transition for cosmetic companies to meet the updated regulatory standards. Businesses are encouraged to review their product market dates, verify compliance eligibility, and adjust internal processes to meet the new deadline. By doing so, companies can ensure their products remain compliant and continue to be marketed within the U.S. while adhering to the updated safety and regulatory standards.
Opportunities and Challenges in Japan’s Rapidly Growing CBD Market.
The CBD market in Japan is experiencing rapid growth, driven by recent legal amendments. From 2019 to 2023, the market expanded six-fold, thanks to increasing consumer demand for products promoting relaxation, better sleep, and stress relief. CBD's legality in Japan allows its importation and sale if produced overseas, providing a significant market opportunity.
Despite this growth, companies face challenges related to consumer education and quality control. Many Japanese consumers still have limited understanding of CBD and its benefits. Additionally, safety concerns persist due to past health issues linked to synthetic cannabinoids. Overcoming these hurdles requires robust consumer education, stringent quality control, and compliance with regulatory standards.
The revision of the Cannabis Control Law is pivotal, offering clearer guidelines for CBD product sales and distribution. This regulatory clarity is expected to attract major companies and foster the development of CBD products in various sectors, including health, beauty, and food. As consumer interest in natural and organic products rises, the market for CBD-infused cosmetics, such as skincare and haircare, presents significant opportunities. Companies must invest in marketing, innovation, and supply chain stability to succeed in this competitive landscape.
Sri Lanka Implements ISO 22716 Certification for Cosmetics Manufacturing Sites.
On 29th May 2024, Sri Lanka's National Medicines Regulatory Authority (NMRA) announced a new requirement for cosmetic manufacturing sites to obtain ISO 22716 certification from the Sri Lanka Standards Institute (SLSI), effective from 1st May 2024. This certification, which aligns with Good Manufacturing Practices (GMP), replaces the previous NMRA GMP inspections.
ISO 22716 is an international standard that provides guidelines for the production, control, storage, and shipment of cosmetic products. It outlines Good Manufacturing Practices (GMP) for cosmetics and ensures that products are consistently produced and controlled to meet quality standards. Compliance with ISO 22716 helps companies maintain product safety, efficacy, and regulatory compliance throughout the manufacturing process.
The transition plan includes a two-year grace period until 31st May 2026 for existing approved sites to comply. Sites with pending applications will still undergo NMRA inspections but must secure ISO 22716 certification within two years. New applicants need to submit a comprehensive site master file for NMRA review before proceeding with ISO 22716 certification.
This move aims to standardise quality and safety in the cosmetics industry, enhancing consumer protection and ensuring compliance with international standards. The adoption of ISO 22716 underscores Sri Lanka's commitment to maintaining high standards in cosmetic manufacturing practices.
For further details, visit.
