Malaysia Amends Cosmetic Ingredient Use Requirements
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has recently introduced crucial amendments to the Guidelines for Control of Cosmetic Products. These changes encompass various annexes detailing the use of ingredients in cosmetics. The updates, effective immediately, comprise additions, revisions, and deletions to enhance consumer safety and product quality.
Summary of Amendments:
- Annex II: List of Prohibited Ingredients
- Additions: 15 prohibited ingredients, including N,N-diethyl-m-toluamide (DEET) and Tetrafluoroethylene.
- Revisions: Names of 4 prohibited ingredients amended.
- Notified cosmetic products containing newly added ingredients have specific sell-by dates.
- Annex III: List of Restricted Ingredients
- Revisions: 5 restricted ingredients, such as Hydrogen peroxide and Tagetes minuta flower extract, with alterations in conditions of use.
- Annex IV: List of Permitted Colourants
- Revisions: 1 permitted colorant updated with concentration and other limitations.
- The permitted colorant, Red (CI 45430), has specific restrictions on the presence of 2 derivatives.
- Annex VI: List of Permitted Preservatives
- Deletion: 1 permitted preservative, Methenamine 3-chloroallylochloride (INN), with its maximum authorised concentration removed.
- Amendment: Preamble to Annex VI revised to clarify the purpose of preservatives and the labelling requirements for formaldehyde-containing products.
- Annex VII: List of Permitted UV Filters
- Additions: 2 permitted UV filters, including Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine.
- Revisions: Conditions for 1 permitted UV filter, Benzophenone-3 (Oxybenzone), adjusted with specific concentration limits for various product categories.
Immediate Actions for Industry Members:
- Cosmetic manufacturers and distributors are advised to review their product formulations in line with the updated annexes.
- Products containing newly prohibited ingredients must adhere to the stipulated sell-by dates.
- Strict compliance with revised concentrations and conditions for restricted and colorant ingredients is crucial.
- For UV filters, the introduction of new filters requires careful consideration, and compliance with concentration limits is imperative.
Consumer Impact:
- Consumers can expect enhanced safety standards and transparency in cosmetic products.
- Clear labelling requirements for formaldehyde-containing products aim to inform users adequately.
HSE Biocides E-bulletin - Key Updates for Northern Ireland
Overview: EU BPR vs. GB BPR
It's crucial to note that the EU BPR operates independently from the GB Biocidal Products Regulation (GB BPR), applicable in Great Britain. Separate e-bulletins are issued for GB, containing information specific to biocide regulation in that region.
Upcoming EU Active Substance Open Invitation Deadlines
Act now to support active substances in the EU Review Programme. The ECHA has opened invitations for individuals, companies, or task forces/consortiums to participate in the EU Review Programme for various active substance/product type combinations. For NI stakeholders, submitting notifications for the specified active substances/product types by the deadlines is imperative:
- DCEMH (Product Type 11): 14th November 2024
- DCDMH (Product Type 11): 14th November 2024
- Pyrithione Zinc (Product Types 2 and 10): 21st December 2024
Failure to notify participation may lead to EU non-approval decisions, requiring the removal of biocidal products and treated articles from the NI market. Stay informed as the HSE provides updates on these developments.
Upcoming EU Active Substance Expiry Dates
Attention NI stakeholders: Biocidal products featuring active substances with upcoming expiry dates under the EU BPR must be phased out from the market. Key dates include:
- Margosa Extract (Product Type 18): 30th April 2024
- Undecan-2-one (Product Type 19): 30th April 2024
- Carbendazim (Product Types 7 and 10): 31st January 2025
- Powdered Corn Cob (Product Type 14): 31st January 2025
- Thiamethoxam (Product Type 18): 31st January 2025
- Chlorfenapyr (Product Type 8): 30th April 2025
Affected EU BPR product authorisations or Control of Pesticides Regulations (COPR) product approvals will prompt communication from the HSE regarding necessary steps for cancellation or revocation. Stakeholders are advised to stay vigilant and ensure compliance with these critical timelines.
Beauty Industry Giants Unite to Boost Traceability: Chanel Drives the Formation of TRASCE Consortium
Chanel, in collaboration with 15 major cosmetics brands including Dior, Estée Lauder, L’Oréal, and Shiseido, has launched the Traceability Alliance for Sustainable Cosmetics (TRASCE). This initiative aims to enhance traceability within the beauty industry's ingredient and packaging supply chains. Triggered by recent global events impacting supply chains, TRASCE seeks to fortify the understanding of these chains, evaluate related social and environmental risks, and implement strategic plans for standard progress. The alliance plans to map its supply chains comprehensively, logging details such as ingredient origins, supplier activities, and places of transformation. The digital platform Transparency-One will facilitate the tracking of product data, ensuring data ownership, security, and confidentiality for all suppliers involved. The move is expected to boost transparency and responsible sourcing across the cosmetics sector.
European Chemicals Agency Updates Candidate List
The European Chemicals Agency (ECHA) has expanded its Candidate List by adding five hazardous chemicals, taking the total count to 240 substances of very high concern. These chemicals, which present potential risks to both human health and the environment, impact industries like personal and home care due to their presence in washing and cleaning formulations, inks, toners, adhesives, and sealants. Notably, two of the new substances find application in cleaning products. The Candidate List acts as a reference for businesses, necessitating their responsibility in managing and communicating the risks linked to these chemicals to consumers. The recent additions include a reproductively toxic chemical, three classified as very persistent and very bioaccumulative (vPvB), and one identified as toxic for reproduction and persistent, bioaccumulative, and toxic.
Implications for Industries:
The Candidate List, which comprises substances with serious potential harm, serves as a critical point of reference for businesses. It places the onus on companies to manage and communicate the risks associated with these chemicals to consumers. The recent additions include a chemical toxic for reproduction, three classified as very persistent and very bioaccumulative (vPvB), and one identified as toxic for reproduction and persistent, bioaccumulative, and toxic.
Newly Added Substances:
Two of the five new substances are used in cleaning products. Additionally, the existing entry for dibutyl phthalate has been updated. The 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol is classified as vPvB. According to ECHA, it is found in air care products, coating products, adhesives, sealants, lubricants, greases, polishes, waxes, and washing and cleaning products. Umeterzole, a second substance classified as vPvB, can be found in coatings, adhesives, sealants, cleaning and washing products. Dibutyl phthalate’s updated entry includes its endocrine-disrupting properties and environmental impacts. ECHA notes its use in metalworking fluids, washing and cleaning products, laboratory chemicals, and polymers.
Regulatory Implications:
Under the REACH regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), companies face legal obligations when their substances make it to the Candidate List. This includes informing consumers about the safe use of products containing these substances. Importantly, consumers have the right to ask about these substances in the products they buy. ECHA emphasises that companies dealing with substances on the Candidate List must notify the agency, and EU and European Economic Area suppliers must update the safety data sheets for the substances they supply. The potential addition of these substances to the Authorization List in the future may further restrict their use, requiring companies to seek specific authorization from the European Commission. The Authorization List comprises substances in Annex XIV of REACH. Companies that want to continue using a substance on the Authorization List must prepare an authorization application and wait for the European Commission to permit them to do so.
California Safe Cosmetics Program (CSCP) Reportable Ingredients List Updated
In a recent development, the California Safe Cosmetics Program (CSCP) introduced an update to its Reportable Ingredients List (RIL) on January 19. This update includes a new tab, "Summary of Updates," in the downloadable spreadsheet, providing a comprehensive list of ingredients added to or removed from the RIL since the last revision. Notably, the list now encompasses fragrance allergens most recently incorporated into the EU list. For California, it's crucial to report fragrance allergens present in rinse-off cosmetic products at or above 0.01 percent (100 parts per million) and in leave-on cosmetic products at or above 0.001 percent (10 parts per million).
Timeline: When the Reportable Ingredients List is updated, companies have 6 months to comply.
Download the Updated CSCP Reportable Ingredients List
FTC Initiates Informal Hearing on Proposed Rule Against Fake Reviews and Testimonials
In a significant move against deceptive marketing practices, the Federal Trade Commission (FTC) announced an informal hearing on its proposed rule aimed at curbing the use of illicit review and endorsement tactics. The proposed rule, published in the Federal Register on July 31, 2023, targets practices such as the creation of fake reviews, manipulation of honest negative reviews, and payment for positive reviews. These practices mislead consumers seeking authentic product or service feedback, adversely impacting honest businesses. Notably, three entities, namely the Interactive Advertising Bureau, Fake Review Watch, and a group of academic researchers, have requested to present their positions during the hearing, scheduled for February 13, 2024, at 10 a.m. ET. The event will be open to the public and accessible via webcast.
CA SB 54 CalRecycle December Public EPR Workshop Summary
In a crucial development regarding California's Senate Bill 54 (SB 54), CalRecycle conducted a comprehensive public Extended Producer Responsibility (EPR) workshop on December 14, 2023. The workshop shed light on the statutory overview of the Needs Assessment and its component studies. It also provided insights into existing data and solicited additional information. The workshop materials, including slides, are accessible on CalRecycle's SB 54 website, categorically listed under the "Past Events" section.
Key Highlights:
- Draft Regulatory Text:
- CalRecycle unveiled the draft regulatory text, a pivotal step in the SB 54 implementation process.
- The draft regulations, aligned with SB 54 (Allen, Chapter 75, Statutes of 2022), are open for public review and comments. The formal 45-day comment period will commence when CalRecycle initiates the formal rulemaking process.
- CalRecycle will organize a question and answer session in early 2024 to present the complete draft regulatory text, offering clarification on specific articles of the regulations.
- Covered Material Categories List and Supplemental Materials:
- As per Public Resources Code Section 42061(b) through (c), CalRecycle released essential documents on the SB 54 Covered Material Categories webpage.
- These documents include the Covered Material Categories List, incorporating evaluations of potential recyclability and compostability for each Covered Material Category (CMC), along with Supplementary Materials providing relevant background information.
- SB 54 Report to Legislature:
- Pursuant to Public Resources Code Section 42061(a)(3)(B), CalRecycle issued the Report to Legislature, offering insights into the status of material types concerning the requirements of PRC 42355.51(d)(2)(A) through (B).
- The report specifically addresses the recyclability of single-use packaging and single-use plastic food service ware in California.
The SB 54 implementation marks a significant stride toward EPR in California, emphasizing the state's commitment to managing its waste sustainably and promoting recycling initiatives. Stakeholders are encouraged to actively participate in the upcoming comment period and engage with CalRecycle's initiatives for a more environmentally responsible future.
For more detailed information, interested parties can refer to the materials available on CalRecycle's SB 54 webpage.
Annual Reporting Deadline for PIC Chemicals: Submission Deadline March 31, 2024
Exporters and importers of Prior Informed Consent (PIC) chemicals are reminded to submit their annual reports to the Health and Safety Executive (HSE) by March 31, 2024. This reporting requirement, mandated under Article 10 of the GB PIC Regulation, necessitates companies to furnish details on the quantities (in kilograms) of PIC chemicals exported from or imported into Great Britain (GB) during the year 2023.
Key Points for Annual Reporting:
- Submission Deadline: All companies involved in the export or import of PIC chemicals should provide the necessary data to HSE by the specified deadline of March 31, 2024.
- Reporting Exemptions: Certain transactions are exempt from this reporting requirement, including special reference identification number (RIN) requests for exports not exceeding 10kg per year per importing country for research or analysis purposes. Similarly, imports for research and analysis in quantities not exceeding 10kg per year from any country are also exempt.
- Details to be Reported:
- EU Exports and Imports: For movements within the European Union (EU), specific country details are not required. However, it would be beneficial to indicate the destination or origin if the chemical is moving to or from Northern Ireland (NI).
- Mixtures and Articles: Report only the quantity of the PIC chemical within the mixture or article.
- NIL Return Confirmation: If a particular PIC-listed chemical was notified for export in 2023, but no actual export took place, a NIL return confirming this should be submitted.
- Submission Process: Completed templates should be sent to ukdna@hse.gov.uk with the subject line format: "GB PIC - Annual Reporting - Article 10 - 2023 - [Your Company Name]."
HSE emphasizes the importance of timely and accurate reporting to ensure compliance with regulatory obligations. The data provided will be published on the HSE website in a non-confidential, anonymized, and aggregated format later in the year.
Companies are urged to refer to the templates available on the HSE website for comprehensive guidance on data submission. Failure to comply with reporting obligations may result in regulatory implications, making it essential for businesses to meet the stipulated deadline.
China Releases the Inventory of Existing Toothpaste Ingredients
In a significant move towards refining regulations in the cosmetics sector, China has released the initial Inventory of Existing Toothpaste Ingredients. This development follows the implementation of the Administrative Measures on Toothpaste and Provisions for Management of Toothpaste Notification Dossiers on December 1, 2023, bringing forth a comprehensive framework for the regulation of toothpaste ingredients.
Background:
The Cosmetic Supervision and Administration Regulation (CSAR), effective since January 1, 2021, mandated that toothpaste adheres to general cosmetics regulations. Three years later, China ushered in a new era for toothpaste regulation with the introduction of specific administrative measures.
Key Regulatory Changes:
The newly implemented Measures establish a registration and notification system for new toothpaste ingredients. Ingredients, whether natural or artificial, utilized in toothpaste for the first time within China must undergo this registration or notification process. Notably, ingredients with preservative or coloring functions necessitate registration with the National Medical Products Administration (NMPA), while others are subject to notification administration.
To facilitate the implementation of toothpaste administration regulations and provide clarity on the regulatory status of ingredients, the NMPA authorized the China Oral Care Products Industry Association (COCIA) to compile the Inventory of Existing Toothpaste Ingredients.
The Inventory:
Released on January 12, 2024, the initial version of the Inventory comprises 1,026 ingredients. It includes vital information such as the Chinese name, INCI/English name, highest historical use concentration, and relevant notes. Importantly, all ingredients listed in the Inventory boast a usage history of three years or more.
For ingredients not included in the Inventory, the regulatory approach varies:
- If the marketed product contains such ingredients and has undergone simplified notification, the company is responsible for monitoring adverse reactions.
- If these ingredients have not been used in toothpaste products, the company must either register or notify the ingredients in accordance with the Provisions for Management of Toothpaste Notification Dossiers.
