New Study Uncovers “Potent Allergens” in Nail Acrylates
Recent scrutiny surrounding the use of Acrylates in nail treatments has uncovered their potential as potent allergens, triggering Allergic Contact Dermatitis (ACD) and prompting the need for enhanced safety measures, according to a newly published study.
The surge in popularity of nail techniques based on acrylates has notably increased the occurrence of sensitization, particularly among nail technicians and users. This phenomenon has garnered the attention of governmental bodies and dermatology organisations.
The study, conducted at the First Department of Dermatology and Venereology of Andreas Syggros Hospital in Athens, Greece, investigated 30 patients with ACD caused by acrylates in nail techniques. The results highlighted the prevalence of allergens such as 2-hydroxyethyl methacrylate (HEMA), 2-hydroxypropyl methacrylate (HPMA), and ethyleneglycol dimethacrylate (EGDMA).
In response to growing concerns, the UK government's Office of Product Safety and Standards initiated an investigation in April 2023. This move was prompted by an increased number of individuals seeking dermatological treatment for allergy-related symptoms linked to gel nail products, including skin rashes and nail loosening.
Simultaneously, the British Association of Dermatologists (BAS), which had issued a warning about these products in 2018, emphasised the risk associated with the growing trend of using at-home nail kits. BAS expressed concerns about the lack of experience the general public has with (meth)acrylate chemicals, underlining the need for caution in their usage.
The Latest on EU PPWR
This year, the European Union is gearing up for significant changes in packaging regulations with the impending enforcement of the EU Packaging and Packaging Waste Regulation (PPWR). This comprehensive framework, designed to combat packaging pollution and foster a circular economy, has a clear goal of ensuring all packs are recyclable by January 1st, 2030, and fully recycled five years later.
In a noteworthy development in November, the European Parliament, in its concerted effort to address the escalating waste issue and promote reuse and recycling, voted in favour of substantial measures. These include a reduction in packaging, restrictions on specific packaging types, and the prohibition of "forever chemicals" in cosmetic and personal care packaging. The vote saw 426 Members of the European Parliament (MEPs) supporting the move, with 125 against and 74 abstentions.
The revised regulation introduces key provisions:
- Targets for reducing packaging by 5% by 2030, 10% by 2035, and 15% by 2040.
- A ban on lightweight plastic carrier bags, unless necessary for hygiene or as primary packaging for loose food to combat food wastage.
- Stringent limitations on certain single-use packaging formats, such as hotel miniature packaging for beauty and personal care products.
- Prohibition of "forever chemicals" (PFASs) and Bisphenol A in food contact packaging.
- Mandatory recyclability for all packaging, meeting specific criteria outlined in secondary legislation.
- A directive for 90% of materials in packaging (plastic, wood, metals, aluminium, glass, etc.) to be separately collected by 2029.
HSE: Live Online Workshop on Biocides and Disinfectants Efficacy
Mark your calendar for the Live Online Workshop on Biocides and Disinfectants Efficacy, scheduled for 22nd and 23rd January 2024. This insightful workshop spans two half-days, offering a comprehensive exploration of the regulatory approach to evaluating the efficacy of disinfectant products (Main Group 1) within the framework of the GB Biocidal Products Regulations (GB BPR).
The workshop will provide a holistic overview of efficacy requirements for disinfectant products, with specific guidance for the five product types in this category. Topics covered include common issues related to labelling, efficacy testing, and practical advice tailored to these product types.
Facilitated by regulatory specialists from HSE, this workshop is designed to empower attendees to enhance the quality of their submissions and gain insights into the review process by the GB regulator.
Who should attend? The workshop is tailored for individuals involved in creating and submitting efficacy data packages for disinfectant biocidal product applications. This includes test houses, applicants, consultants, and more. No prior experience is assumed, but the workshop will delve specifically into the efficacy of disinfectants, excluding coverage of other product types or general principles of efficacy assessment.
Topics covered include:
- General considerations affecting the labelling, testing, and assessment of efficacy for disinfectant products.
- Specific outlines of standard testing required for surface disinfectants in product types 2, 3, and 4.
- Specific outlines of standard testing needed for product type 1.
- Guidance for generating adapted or novel methods for less standard products in product types 2, 3, and 4.
- Advice on testing for product type 5, where limited standard methods are available.
- Common issues and problems faced in these product types.
Registration: Learn more and register for this fee-based workshop by the closing date of 15 January 2024.
China Suspends Imports from Japanese Cosmetics Firm Hoyu Co
China's medical regulator, the National Medical Products Administration (NMPA), has taken a significant step by suspending imports from the Japanese cosmetics company Hoyu Co. The decision comes after an online inspection of Hoyu's factory in Japan, focusing on ensuring compliance with technical requirements for cosmetics production.
Details of the inspection were scrutinised by the NMPA, questioning whether Hoyu was adhering to the necessary standards in cosmetics manufacturing. While Hoyu Co acknowledged the inspection, it refrained from providing comments on the suspension of imports.
The suspension unfolds against the backdrop of intricate trade dynamics between China and Japan, where China stands as Japan's leading source of imports and its largest export market. This development also takes place in the context of recent political and environmental tensions between the two nations.
EU SCCS Finalises Opinion on Silver Zinc Zeolite
The EU Scientific Committee on Consumer Safety (SCCS) concluded its assessment of Silver Zinc Zeolite (CAS No. 130328-20-0) in cosmetics, publishing the preliminary opinion on April 4, 2023. After considering feedback received during the commenting period, the SCCS issued the final opinion on December 22, 2023.
Silver Zinc Zeolite, classified as a carcinogenic, mutagenic, or toxic substance for reproduction (CMR), faced restrictions due to its inclusion in Regulation 1272/2008 on Classification, Labelling, and Packaging of Substances and Mixtures (CLP Regulation) in May 2017. Subsequently, it was added to the prohibited ingredient list in Regulation (EC) No 1223/2009 (Cosmetics Regulation) in May 2019. In August 2020, the European Commission received an industry dossier concerning the substance's use in cosmetics, particularly in spray deodorant and powder foundation. In response, the Commission tasked SCCS with conducting a safety assessment.
The SCCS, after a thorough evaluation of available information, has determined in its final opinion that the use of Silver Zinc Zeolite, with a maximum silver content of 2.5%, as a preservative in spray deodorant and powder foundation is considered safe at the proposed concentration of 1%.
Philippines FDA Seeks Input on Cosmetics Recall Guidelines
The Philippines Food and Drug Administration (FDA) has unveiled draft guidelines for the recall of health products, including cosmetics, with a focus on bolstering public health protection and consumer awareness. Released on December 22, 2023, the Guidelines, comprising 11 sections, delineate precise procedures for product recalls and outline the responsibilities of Marketing Authorization Holders (MAHs) in this process.
Originally introduced in 2016, Circular (FC) No. 2016-012 guided product recalls; however, the evolving landscape of global trade and the FDA's expanded regulatory scope prompted the need for an updated framework. The Guidelines aim to repeal the Circular, providing a comprehensive and modern approach to recall processes.
Key Highlights of the Guidelines:
Recall Procedures:
- Health products failing to meet FDA standards or posing risks are subject to recalls, categorized as MAH-initiated/voluntary or FDA-ordered/mandatory. The Guidelines detail procedures for both scenarios.
- MAH's Responsibilities:
- Operational Recall System: MAHs must establish a recall system as a risk management tool, enabling activation and operation by a qualified team. It should include monitoring, evaluation, and communication protocols.
- Communication Requirements: MAHs are required to communicate clear, consistent, and accurate information about recalls to all concerned parties in the supply chain. A communication plan, including identification of channels and template documents, is integral to the initial recall report.
- Reporting Obligations: MAHs have reporting obligations throughout the recall process. After deciding on a recall, they must report all relevant information to the FDA. During the recall, MAHs monitor effectiveness and submit status reports to the FDA, with copies sent to specified email addresses.
The FDA invites comments on the draft Guidelines until January 24, 2024, through pfpid@fda.gov.ph. This initiative reflects a proactive approach to refining recall processes in response to the dynamic nature of the industry and ensuring the highest standards of health and safety for consumers.
