Vietnam's National EPR Web Portal: A Game-Changer for Environmental Responsibility
Vietnam has embarked on a transformative journey towards environmental sustainability with the launch of its groundbreaking National Extended Producer Responsibility (EPR) Web Portal on January 29, 2024. This digital platform marks a pivotal shift in the country's approach to waste management, offering a streamlined and efficient solution for enterprises to fulfil their EPR obligations in accordance with the Law on Environmental Protection and its associated regulations.
The launch of the National EPR Web Portal represents a significant milestone in Vietnam's efforts to address environmental challenges and promote sustainable development. The portal provides a centralised platform for enterprises to register, declare, and report EPR-related information, streamlining administrative processes and enhancing transparency in compliance.
One of the key features of the portal is its user-friendly interface, designed to facilitate easy navigation and accessibility for enterprises of all sizes. To further support businesses in navigating the EPR requirements, the Ministry of Natural Resources and Environment (MONRE) has released a comprehensive video tutorial on February 20, 2024. This tutorial offers step-by-step guidance on using the portal and completing EPR-related tasks, ensuring that enterprises can comply with regulations effectively.
Under Vietnam's EPR framework, manufacturers and importers are obligated to manage the recycling and waste treatment of specific products and packaging materials. These include electrical and electronic equipment, batteries, tires, end-of-life vehicles, and various types of packaging. Through the National EPR Web Portal, enterprises can now register, declare, and report their EPR information online, replacing traditional paper-based submissions.
The portal encompasses both recycling and waste treatment responsibilities, providing enterprises with the flexibility to choose between self-organised recycling or making financial contributions to the Vietnam Environment Protection Fund (VEP Fund). By offering a digital platform for EPR compliance, the portal aims to enhance the efficiency and effectiveness of waste management efforts in Vietnam, ultimately contributing to a cleaner and more sustainable environment.
In addition to facilitating EPR reporting, the National EPR Web Portal serves as a hub for regulatory updates, FAQs, and resources related to environmental responsibility. Enterprises can access valuable information and guidance to ensure compliance with evolving environmental regulations and best practices.
Cosmetics Europe and EFfCI Release Comprehensive Guidance for EU Microplastics Restriction
Cosmetics Europe and the European Federation for Cosmetic Ingredients (EFfCI) have jointly unveiled guidance aimed at aiding businesses in navigating the impending EU REACH microplastics restriction, set to come into effect in October 2027.
This guidance document is a crucial resource for players in the cosmetics industry, offering clarity on key aspects such as the definition of synthetic polymer microparticles (SPM), exceptions to the ban, the "industrial sites" derogation, and modifications in physical properties during consumer use.
The guidance outlines essential points, including a detailed definition of SPM that focuses on the composition and parameters of solid polymers, rather than using the term "microplastics" explicitly. It also identifies categories of polymers exempt from the ban, such as natural, water-soluble, carbon-free, and biodegradable polymers. Furthermore, the document discusses the derogation for "industrial sites," where SPM undergoes changes during manufacturing, and addresses permanent modifications during consumer use, such as in nail polish.
Offering practical support, the guidance provides a step-by-step approach for businesses to determine whether their polymer qualifies as an SPM. It includes case studies, legal interpretations, and frequently asked questions to assist companies in compliance efforts. However, it emphasises that its contents should not be construed as legal advice.
In addition to this guidance, recent developments in EU legislation underscore the increasing focus on addressing microplastic pollution in cosmetics. The EU Council and Parliament's provisional political agreement on revising the urban wastewater treatment directive will require cosmetic firms to cover micropollutant costs. Furthermore, following last year's microplastic ban, the European Commission has also restricted plastic-based glitter in cosmetics, promoting the use of eco-friendly alternatives.
Cosmeto Pack Unveils SafePAC: A Game-Changer for Assessing Cosmetic Plastic Packaging Health Risks
Cosmeto Pack has revolutionised the cosmetics industry with the launch of SafePAC, a groundbreaking web application designed to assess the health risks associated with plastic packaging materials used in cosmetics. This innovative solution provides a specific, simple, and cost-effective protocol for evaluating the interaction between plastic compounds and cosmetic products, addressing a significant challenge for brands and consumers alike. SafePAC caters to all stakeholders in the cosmetics industry, including manufacturers of raw materials, packaging, cosmetic ingredients, and formulas, as well as packagers, laboratories, and toxicologists.
By combining an application programming interface (API) with four comprehensive databases, SafePAC ensures compliance with European quality and safety standards for cosmetics. It offers a standardised protocol, supported by over 2,000 tests, to compare skin and product exposure against substance-specific toxicological reference thresholds. Notably, SafePAC establishes distinct thresholds for plastics manufacturers and cosmeticians, enabling users to determine acceptable risks. The application is currently undergoing testing and debugging, with plans to expand its database through collaboration with partners. Through its sophisticated analysis and predictive capabilities, SafePAC empowers users to make informed decisions about cosmetic packaging materials, ensuring the safety and well-being of consumers.
EU SCCS Finalises Opinion on Hydroxypropyl p-Phenylenediamine: What You Need to Know
The European Scientific Committee on Consumer Safety (SCCS) has concluded its assessment of Hydroxypropyl p-Phenylenediamine (CAS No. 73793-79-0) and its dihydrochloride salt (CAS No. 1928659-47-5) in oxidative hair colouring products, with significant implications for the cosmetics industry. Initially, the SCCS published a preliminary opinion on November 7, 2023, raising concerns about potential genotoxicity and eye irritation associated with these substances. Following a consultation period, the SCCS released its final opinion on March 5, 2024, reaffirming its earlier conclusion.
These substances, commonly used as hair dyes, underwent scrutiny after the industry submitted a dossier in 2018 to support their safe use in cosmetics. The SCCS's opinion (SCCS/1608/19) highlighted concerns regarding genotoxicity and potential eye irritation, leading to a cautious approach towards their use in oxidative hair colouring products.
In response to industry-provided data addressing genotoxicity concerns in June 2022, the SCCS conducted another safety assessment, leading to the recent final opinion. According to the SCCS, Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt are deemed safe for use in oxidative hair colouring products at concentrations of up to 2% on the head. However, the committee maintains reservations regarding the potential for eye irritation from these substances.
EU SCCS Seeks Input on Acetylated Vetiver Oil: What You Need to Know
The European Scientific Committee on Consumer Safety (SCCS) has issued a call for comments on the inhalation toxicity of Acetylated Vetiver Oil (AVO) in sprayable cosmetics. Released on March 5, 2024, the preliminary opinion is open for feedback until May 3, 2024.
AVO serves as a common perfuming agent in cosmetics, prompting the SCCS to adopt Opinion SCCS/1599/18 in February 2019, with a subsequent corrigendum in June of the same year. This opinion deemed AVO (with 1% alpha-tocopherol) safe as a fragrance ingredient in leave-on and rinse-off cosmetic products, provided they adhere to specified maximum concentrations outlined by the International Fragrance Association (IFRA).
However, the SCCS noted that the inhalation toxicity of AVO had not been assessed due to insufficient data in Opinion SCCS/1599/18. In response to a new assessment dossier submitted by the industry in March 2023, specifically addressing AVO's inhalation toxicity in sprayable cosmetic products, the SCCS conducted a subsequent safety evaluation and formulated this preliminary opinion.
Based on the data provided regarding inhalation toxicity and aggregate exposure, the SCCS now opines that AVO (with 1% alpha-tocopherol) is safe for use at the following maximum concentrations:
- 0.9% (w/w) in fragrance pump sprays
- 0.05% (w/w) in deodorant sprays
- 0.1% (w/w) in hairsprays and body lotion sprays
As the SCCS invites comments on this preliminary opinion, stakeholders in the cosmetics industry have the opportunity to contribute valuable insights and perspectives, shaping the final assessment and ensuring the continued safety of cosmetic products containing AVO
Indonesia Proposes Amendments to Cosmetic Ingredient Regulations
Indonesia's regulatory landscape for cosmetics is poised for significant revisions with proposed amendments targeting ingredient usage requirements. The Indonesian Agency for Food and Drug Control (BPOM) has put forth a draft of amendments to the Technical Requirements for Cosmetic Ingredients, inviting public consultation until March 19, 2024.
The proposed changes encompass a spectrum of alterations, including the addition of 75 newly prohibited ingredients, the amendment of restrictions on two preservatives, and the deletion of requirements linked to cosmetics containing alpha arbutin or beta arbutin.
Here's a breakdown of the key amendments:
- Prohibited Ingredients: The list of prohibited ingredients in Appendix V is set to expand from 1,606 to 1,681, with 75 new entries. Notable additions include substances like Cis-1-(3-chlorallyl)-3,5,7-triaza-1-azoniaadamantane chloride and Octamethylcyclotetrasiloxane.
- Revised Restrictions: Appendix I, which outlines restricted ingredients, will see a revision, along with the deletion of two preservatives (Methenamine 3-chloroallylochloride and 2-Benzyl-4-chlorophenol) from Appendix III.
- Sunscreen Amendments: The use requirements for Benzophenone-3 in Appendix IV will be amended, specifying different maximum concentrations for various product types.
- Arbutin-Related Deletions: Requirements specifically associated with cosmetics containing alpha arbutin or beta arbutin, such as mandatory hydroquinone content test results and labelling of storage conditions, are proposed to be removed.
These amendments aim to streamline and update Indonesia's regulatory framework in line with evolving scientific understanding and industry practices. Stakeholders are encouraged to provide feedback during the public consultation period to ensure that the final regulations effectively balance safety, efficacy, and compliance within the cosmetics sector. Stay tuned for further developments as Indonesia progresses towards enhancing consumer protection and regulatory clarity in the cosmetics industry.
India Unveils Comprehensive Regulatory Guidelines for Cosmetics and Drugs Sampling
India's Central Drugs Standard Control Organisation (CDSCO) has recently released the finalised version of the Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices, marking a significant step towards enhancing standardisation and efficiency in the sampling process across the country. This comprehensive set of guidelines, comprising 10 parts and 5 annexes, aims to streamline various aspects of sampling procedures for drugs, cosmetics, and medical devices.
Key highlights of the Guidelines include:
- Addressing Methodological Gaps: The Guidelines rectify previous shortcomings by introducing a defined methodology for the selection of sampling products and locations. This uniform approach ensures effective surveillance of the quality and efficacy of drugs and cosmetics available in the market.
- Informed Sampling Decisions: Unlike the past, where sampling decisions relied heavily on the knowledge of individual drug inspectors, the new Guidelines leverage available information and identified risks to guide sampling decisions. This ensures comprehensive coverage of products across diverse regions.
- Structured Sampling Plans: The Guidelines mandate the preparation of monthly and annual sampling plans by drug inspectors in consultation with the controlling authority. These plans cover the entire jurisdiction under their office, including rural and tribal areas, and undergo review to prevent repetitive sampling and ensure comprehensive coverage of brands and categories.
- Sampling Numbers and Quantities: Each month, a minimum of 10 samples must be collected, with specific allocations for drugs, cosmetics, and medical devices. Moreover, the Guidelines specify the quantities of samples required for complete analysis of various cosmetics, ensuring consistency and thoroughness in sampling procedures.
- Sampling Timelines: Samples must be delivered to the laboratory on the same day as sampling, with provisions for timely delivery even in cases of transit delays from rural or distant locations.
These Guidelines represent a significant milestone in India's regulatory framework, aiming to enhance consumer safety and product quality through standardised and systematic sampling procedures. By promoting consistency and efficiency, these guidelines are poised to bolster regulatory oversight and ensure compliance across the cosmetics and drugs industry in India.
Philippines FDA Proposes Enhanced Requirements for Licensing Cosmetic Product Establishments
The Philippines Food and Drug Administration (FDA) has embarked on a consultation process for a new draft of rules governing the application for License to Operate (LTO) of Covered Health Product Establishments. This draft aims to refine and update the existing administrative order, Administrative Order No. 2020-0017, which outlines the procedures and requirements for obtaining an LTO. Interested stakeholders have been invited to provide feedback on the proposed changes until March 12, 2024.
In the Philippines, companies involved in the manufacture, importation, distribution, or sale of cosmetic products are mandated to secure an LTO from the FDA. Over time, the regulatory landscape has evolved, with amendments introduced in 2022 and 2023 to streamline the application process. The latest draft, dated 2024, introduces significant modifications, primarily focusing on two key areas:
- Updated Requirements and Validities: The draft introduces a new classification for renewal applications, termed automatic renewal. This entails the issuance of a recommendation letter following a pre-licensing inspection, paving the way for automatic renewal. Additionally, the draft revises the requirements and validities for different types of LTO applications, distinguishing between Micro and Small Enterprises and Medium and Large Enterprises.
- Initial applications are granted a validity of 3 years for Micro and Small Enterprises and 6 years for Medium and Large Enterprises.
- Renewal applications now have a validity of 6 years for Micro and Small Enterprises and 12 years for Medium and Large Enterprises. Notably, automatic renewal is introduced, subject to specific conditions outlined in the draft.
- Variation applications maintain the validity period of the existing LTO.
- Clarification of FDA Decision Grounds: The draft enhances transparency by specifying the grounds for FDA decisions regarding LTO applications. These include approval, disapproval, and suspension or cancellation/revocation. Grounds for disapproval encompass instances where the applicant fails to meet technical requirements or provides false information, among others.
In addition to these key changes, the draft updates the glossary of term definitions, provides supplementary annexes on payment procedures and charging rules, and reorganises existing provisions to improve clarity and logic.
Overall, the proposed amendments aim to streamline and enhance the LTO application process, ensuring greater compliance with regulatory standards and fostering transparency in decision-making. Stakeholder feedback gathered during the consultation period will be crucial in finalising these regulatory guidelines, ultimately contributing to a more robust regulatory framework for cosmetic products in the Philippines.
