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A clear guide to understanding global regulatory differences. Over-the-counter (OTC) products are one of the main areas where the US market differs from the rest of the world. A sunscreen, antiperspirant, or acne treatment may seem like simple cosmetics from a brand's international perspective, but for the FDA, they fall under the OTC ("over-the-counter") classification , which in the United States is regulated as drugs . Understanding this context and its particularities is key to avoiding rejections, import delays, warning letters , or penalties. Table of contents 1. What is an OTC product according to the FDA? 2. In other markets, these same products are cosmetics 3. Main OTC “cosmetic” categories in the US. 4. Practical consequences for international brands OTC products in the United States that are cosmetics in other parts of the world These differences affect formulation, claims, manufacturing requirements, technical documentation, and the market entry process. For many international companies, this is one of the most critical points when exporting to the U.S.   1. What is an OTC product according to the FDA? In the United States, an OTC product is an over-the-counter drug regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) . To be considered an OTC product, it must: To treat, prevent or mitigate a disease , or affect the structure or function of the human body beyond a cosmetic effect. Most OTC products are governed by OTC Monographs , which state: permitted active ingredients, concentrations, authorized claims, how to use, mandatory warnings.   2. In other markets, these same products are cosmetics In jurisdictions such as the European Union, the United Kingdom, the UAE, or Australia , many products with non-medical effects are regulated as cosmetics , provided they do not claim therapeutic properties. That's why products sold as simple cosmetics in the US automatically become OTC drugs , with much stricter requirements. 3. Main OTC “cosmetic” categories in the US. Here are some of the most common cases: OTC Category (USA) Claims allowed under OTC Monograph Sunscreen (Sunscreens) UV protection (SPF), prevention of sunburn Acne Treatment Helps treat acne and reduce blemishes. Antiperspirants Reduction of sweat and related odor Anti-dandruff Helps control dandruff, flaking, and itching Skin Protectants Protects the skin, relieves minor irritation Anti-itch (Pruritus) Relief from itching, irritation, and mild inflammation Otic (Earwax removal) Helps remove earwax Eye Wash / Eye Irritation Relief Eye wash, mild relief Oral Care / Whitening Whitening/anti-stain effect First Aid / Minor Cuts Helps protect against minor cuts Hand Sanitizers Antiseptic / Reduces bacteria Hair Growth Stimulates hair growth Skin Bleaching/Hyperpigmentation Lightens stains 4. Practical consequences for international brands a) Manufacturing under GMP of medicines: An OTC product must be manufactured under pharmaceutical GMP (21 CFR Parts 210/211), not just cosmetic GMP. b) Facility registration as a drug establishment: The manufacturer must be registered as a drug facility and comply with FDA inspections. c) Formulator review: Many cosmetic ingredients are allowed, but if an active ingredient is in the monograph, its concentration must strictly adhere to it. d) Specific labeling for OTC: Higher cost and time to market entry Registering a cosmetic product globally can be relatively simple. However, making it OTC for the US involves: additional controls, process validation, CMC documentation, audits, longer preparation times. f) Controlled claims: When working with OTC products, it is vital to adapt claims to comply with applicable regulations. Any additional claims may require approval as a New Drug Application (NDA) . At Belab Services , we assist companies worldwide in accessing the US market, helping them determine whether their product will be cosmetic or OTC, reviewing formulations, claims, labeling, and supporting the entire registration and compliance process. Get in touch with our team of cosmetic regulation experts today.

In the United Kingdom, a food supplement is a food product designed to supplement the diet with concentrated sources of vitamins, minerals, or other substances. In England, Wales, Scotland, and Northern Ireland, these products are regulated by food safety authorities, such as the Food Standards Agency (FSA). For companies looking to enter the UK market with food supplements in 2025, understanding these basics is essential. Table of contents Basic Labeling Requirements for Food Supplements in the UK The Role of the Food Business Operator (FBO) in the UK How can Belab Services help you comply with British regulations? Frequently Asked Questions How to label a food supplement in the UK? Basic Labeling Requirements for Food Supplements in the UK Although each product requires individual assessment, a compliant label for the UK market must include: Product name , clearly identifying it as a Food Supplement . Full list of ingredients , with allergens highlighted . Amount of active ingredients per recommended daily dose (highly searched as “how to declare active ingredients in the UK”). Recommended daily dose and warning not to exceed it. Mandatory warnings (“do not replace a varied diet”, “keep out of reach of children”). Instructions for use and storage conditions . Name and address of the responsible operator in the United Kingdom (FBO) . These are the essential elements for any company seeking to meet the UK food supplement labelling requirements in 2025. The Role of the Food Business Operator (FBO) in the UK The Food Business Operator (FBO) is the legally responsible entity for the product in the UK. Their name and address must appear on the label because this operator assumes responsibility for: product safety, composition, traceability, labeled, compliance with British standards. For foreign brands looking to export dietary supplements to the UK, it's crucial to understand that the British importer automatically becomes the FBO (Fixed Bondholder), which entails immediate legal obligations. Therefore, a professional review is essential before launching a supplement on the British market. How can Belab Services help you comply with British regulations? At Belab Services we offer comprehensive solutions for companies that want to sell supplements in the UK: Review and adaptation of labeling to the British market Checking permitted ingredients Verification of nutritional and health claims Review of mandatory warnings FBO and import advice Evaluation of the safety of the dietary supplement If you're looking for how to launch a food supplement in the UK without regulatory risks, we'll guide you through the entire process. Frequently Asked Questions How do you label a food supplement for sale in the UK? You must include the product name, ingredients, allergens, daily dose, mandatory warnings, active ingredient content, and FBO details. What requirements must a dietary supplement meet to enter the British market? Compliance with labeling, composition, safety, and FBO liability. Is FBO mandatory if I export from outside the UK? Yeah. Get in touch with BELAB Services Today

California has updated the permissible exposure levels for respirable titanium dioxide under Proposition 65. These limits determine when a brand must include the familiar warning about exposure to potentially carcinogenic substances. A key point: this update does not affect pigmented titanium dioxide used in creams, lotions, sunscreens, compact makeup, or emulsion products. The change focuses solely on particles that can be inhaled, commonly found in loose powders, aerosols, or mists. Table of contents A) New Safe Harbor levels (permanent) B) Impact on cosmetics: who does it really affect? C) What should brands do to comply? New Safe Harbor Level for Breathable Titanium Dioxide in California   A) New Safe Harbor levels (permanent) California has set two daily exposure thresholds: Fine particles (≤10 µm): 440 µg/day Ultrafine particles (≤0.8 µm): 44 µg/day Below these values, a Proposition 65 warning is not required. If they are exceeded, the warning must appear on the label, on the website, and on any sales material or media where the product is marketed.   B) Impact on cosmetics: who does it really affect? Formats with a higher probability of generating inhalant exposure Loose powder Sprays, mists and aerosols Atomized or nebulizable products Formats that are normally out of reach Compact makeup (not loose) Creams, gels, lotions and any emulsion Products that do not generate suspended particles In general, if the product does not release dust or mist into the air during use, respirable exposure is minimal.   C) What should brands do to comply? Identify the form of titanium dioxide Confirm whether it is breathable or if it is integrated into a non-inhalable matrix. Assess the actual risk of inhalation It depends on both the particle size and the format and method of use. Store internal documentation Proposition 65 does not require prior registration, but it does require the ability to demonstrate compliance in the event of inspections or enforcement actions. Update labeling only when necessary The warning should only be applied if the estimated exposure exceeds the Safe Harbor Level.   Achieving results without overdoing it is possible. At Belab, we guide you with technical criteria and a practical approach. Get in Touch With BELAB Services Today.

The Member State Committee (MSC) of the European Chemicals Agency (ECHA) has confirmed the inclusion of an additional substance on the Candidate List of Substances of Very High Concern (SVHCs) pursuant to Regulation (EC) No 1907/2006 (REACH). With this update, the list now comprises a total of 251 entries. Table of contents New substance added to the SVHC Candidate List Obligations arising from inclusion in the List of Candidates ECHA confirms the addition of a new substance to the SVHC Candidate List New substance added to the SVHC Candidate List The incorporated substance is 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene] (DBDPE), identified with CAS 84852-53-9 and EC number 284-366-9. Its inclusion is due to the fact that it meets the criteria of very persistent and very bioaccumulative (vPvB) according to article 57(e) of REACH. DBDPE is primarily used as a flame retardant in various industrial applications, such as plastics, coatings, adhesives, sealants, and electronic equipment. Obligations arising from inclusion in the List of Candidates DBDPE's inclusion on the list triggers a series of obligations for economic operators within the EU/EEA market: Communication obligation in the supply chain: If an item contains the substance in a concentration greater than 0.1% (w/w), the supplier must provide the recipient with sufficient information to allow safe use of the item. Notification to ECHA: When a manufacturer or importer markets articles containing DBDPE above 0.1% and in volumes exceeding one tonne per year, they must make the corresponding notification to ECHA . Obligation to report to the SCIP database: From January 2021, items exceeding 0.1% of any SVHC must also be reported to the SCIP database, managed by ECHA. This update strengthens the European regulatory framework for the management of hazardous substances in articles and underlines the importance of regularly reviewing the presence of flame retardants and other persistent substances in supply chains. Get in touch with our international team of experts.

Updated as of December 2025 The implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has completely changed the regulatory landscape for cosmetics in the United States. MoCRA expands the obligations of manufacturers, importers, and distributors, and strengthens the FDA's role in safety, oversight, and market control. Table of contents 1. Who is affected by MoCRA? 2. Registration of facilities and product list 3. Product safety and technical documentation 4. Obligation to report serious adverse events 5. New labeling requirements 6. Good Manufacturing Practices (GMP) 7. Key deadlines according to the FDA 10. Practical checklist for companies MoCRA: New Cosmetic Regulation in the United States This guide summarizes the essential elements that companies wanting to market cosmetics in the U.S. should know—and also consumers seeking greater transparency.   1. Who is affected by MoCRA? MoCRA applies to any company that manufactures, processes, packages, distributes, or places its name on a cosmetic product marketed in the U.S. The law formally introduces two key figures: Facility : establishment that manufactures or processes cosmetics for distribution in the U.S. Responsible Person : manufacturer, packer or distributor whose name appears on the product label. Both figures are subject to new obligations that were not previously enforceable at the federal level.   2. Registration of facilities and product list MoCRA incorporates into section 607 of the FD&C Act the requirement to: Registration of facilities All facilities—including foreign manufacturers exporting to the U.S.—must register with the FDA through a U.S. Agent. The registered information must be updated every two years. Product list Each cosmetic product must be listed, providing: Trade name Category Ingredients Facility where manufacturing or processing Responsible Person Details This must be updated annually. MoCRA provides a partial exemption for small businesses, but it does not apply to higher-risk products (e.g., cosmetics requiring sterile hygiene, certain children's products, etc.).   3. Product safety and technical documentation MoCRA requires that the Responsible Person have adequate safety substantiation . The FDA does not impose a specific methodology, but it does require evidence supporting the product's safety under normal or foreseeable conditions of use. This evidence may include: Toxicological evaluation of the ingredients Review of historical data Compatibility tests, stability tests, and other relevant studies Expert review according to accepted scientific standards Not having this documentation now constitutes a legal breach.   4. Obligation to report serious adverse events One of the pillars of MoCRA is the strengthening of post-market surveillance. The Responsible Person must notify the FDA of any serious adverse event within 15 business days of becoming aware of it. In addition, if they receive additional medical information during the following year, they must resubmit that data in a new report. This requirement allows the FDA to react more quickly to emerging safety issues.   5. New labeling requirements MoCRA incorporates several changes to the information that must appear on the label: Contact details of the Responsible Person (address, telephone number or email) to allow the consumer to report adverse events. Future obligation to declare fragrance allergens , once the FDA publishes the corresponding rule. Additional requirements for talc-containing products, related to the new asbestos analysis standards. Ongoing review of the use of PFAS in cosmetics, which may involve new restrictions or labeling.   6. Good Manufacturing Practices (GMP) MoCRA requires the FDA to publish a specific Good Manufacturing Practices (GMP) standard for cosmetics. Until the final regulation is published, the agency has already stated that it expects the facilities to operate under adequate controls of quality, hygiene, traceability and risk management. For many companies, especially small and medium-sized ones, this involves reviewing internal procedures, batch documentation, and supplier controls. 7. Key deadlines according to the FDA According to the FDA itself, the main milestones are: Registration of facilities: mandatory for facilities active from December 29, 2023. Product list: mandatory for products marketed from that same date. Updates: Registration of facilities: every 2 years Product list: annual Talc: implementation of standardized testing methods to detect asbestos. PFAS: Assessment report by December 29, 2025. The FDA issued a transition policy announcing that it would not enforce strict registration/listing enforcement measures before July 1, 2024, to allow the industry time to adapt.   10. Practical checklist for companies Before marketing in the US: Confirm if your facility needs to be registered (includes foreign manufacturers). Review labels and add contact information. Prepare the security documentation. Create a list of each product. Establish a procedure for managing adverse events. Ensure that your manufacturing processes meet standards equivalent to GMP. Prepare for future changes (allergens, PFAS, talc).   The entry into force of MoCRA has led to a culture of greater control, scientific evidence and monitoring. For brands that operate internationally, MoCRA requires adapting internal processes, documenting the safety of their products, and maintaining an active relationship with the FDA. At Belab Services, we assist companies worldwide in accessing the US market, managing everything from facility and product registration to label review, safety substantiation preparation, and communication with the FDA. If you need a personalized assessment or support at any of these stages, our team will be happy to help you. Get in touch with our international cosmetic regulation team.

In recent days, the European Union has published two corrections to previous amendments to Regulation (EC) No 1223/2009 on cosmetic products. Although these are minor adjustments, they are relevant for professionals responsible for regulatory compliance and the correct naming of ingredients on labels. Table of contents Correction of November 6, 2025 Correction of November 11, 2025 Importance to the sector European Commission: Corrections to Regulation (EC) No 1223/2009 Correction of November 6, 2025 The first correction, published on November 6, 2025 , refers to Regulation (EU) 2022/2195 . In this case, the common name included in the glossary for the antioxidant BHT (CAS 128-37-0) is modified, with the aim of maintaining consistency between the different regulatory references and ingredient databases used in the European market. Official Journal L 2025/90869 – Correction of 6 November 2025 Correction of November 11, 2025 The second correction was published on November 11, 2025 and refers to Regulation (EU) 2023/1545, which updates the list of fragrance allergens. This new text corrects the information included in the glossary for the following substances: Rose ketones Pelargonium graveolens oil Pogostemon cablin oil Official Journal L 2025/90876 – Correction of 11 November 2025 Importance to the sector Although these modifications do not imply substantial changes to usage restrictions, they are important to ensure consistency between labeling, PIF files, and regulatory databases. Keeping ingredient names updated according to the official glossary helps avoid discrepancies during CPNP notifications or market inspections. Get in touch with our team of experts today and be ahead of regulation.

UK announces new restrictions on cosmetics from 2026 The British government has published the draft of The Cosmetic Products (Restriction of Chemical Substances) Regulations 2026, a proposal that once again focuses on chemical safety within the cosmetics sector. If ultimately approved, the new regulations will come into force on July 15, 2026, and will entail several significant changes for manufacturers, importers, and distributors who market products in Great Britain. Among the most notable measures are the prohibition of the sunscreen Enzacamene (3-(4-Methylbenzylidene)-camphor), the reduction of the warning threshold for formaldehyde-releasing preservatives—which will now be required when concentrations exceed 0.001%—, and the inclusion of several substances classified as CMR (carcinogenic, mutagenic or toxic to reproduction), such as tetrabromobisphenol-A, dibutyltin compounds or 4-methylimidazole, within the list of prohibited ingredients. These modifications are based on recommendations issued by the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), the British scientific committee that assesses the safety of non-food and non-medicinal consumer products. Their aim is to strengthen consumer protection against substances that, although still used in a limited way, are causing increasing concern within the scientific community. The draft also includes transition periods until early 2027, during which products already on the market before the regulation comes into effect can continue to be sold. This will allow companies a reasonable amount of time to adapt their formulas, labels, and technical documentation. Although the United Kingdom continues to base much of its legislation on the old Regulation (EC) 1223/2009, this new step confirms an increasingly clear trend: the country is moving towards its own regulatory framework, more dynamic and with decisions independent of the European Union. For brands and laboratories exporting to the British market, these changes mean a mandatory review of their Product Information Files (PIFs) and Cosmetic Product Safety Reports (CPSRs), as well as their labels if they use formaldehyde-releasing preservatives. It will also be crucial to review the UV filters used and verify whether any of the added CMR compounds are listed in their product portfolio. At Belab Services, we are closely monitoring the development of this draft and any public consultations that may be launched in the coming months. Our recommendation is that companies begin now to identify potentially affected products and plan for the necessary reformulations or updates, especially if they sell in the UK through retail or e-commerce channels. This move confirms a global trend: the cosmetics industry is moving towards greater control over ingredients, with potential long-term risks. Anticipating these changes will be the best strategy to avoid regulatory issues and maintain consumer confidence. Contact our team of experts in international cosmetic regulation

The European regulatory framework for medical devices continues to evolve, and with it, the technical standards that underpin compliance with Regulation (EU) 2017/745. On 17 October 2025 , the European Commission published in the Official Journal of the European Union Implementing Decision (EU) 2025/2078 , which introduces a relevant update to the list of harmonised standards applicable to the MDR. Key additions include the new 2025 versions of key industry standards, such as EN 13795-1 and EN 13795-2 , relating to cloths, surgical gowns and clean air suits; EN 14683 , which regulates surgical masks; and EN 14180 , focused on sterilizers for medical use. From the moment of their publication, these rules confer a presumption of conformity with the essential requirements of the Regulation. This change means that Notified Bodies will begin requiring reference to updated versions within manufacturers' technical documentation, test reports, and quality management systems. Those still working with previous versions should review their internal procedures to ensure that documentation and performance evidence are aligned with the new edition. At Belab Services , we recommend that manufacturers and distributors review their list of applicable standards and conduct a gap analysis to plan for a smooth transition. This step is especially relevant for sterile devices and surgical masks, where the update can have a direct impact on performance testing and sterilization process validation. The publication of this decision confirms the European Commission's commitment to strengthening the safety and quality of medical devices on the European market . In an increasingly demanding regulatory environment, staying up-to-date is key to maintaining compliance and avoiding issues during audits by Notified Bodies.

Lactobacillus paragasseri is added to the European Union's Novel Food Catalogue The European Commission has recently updated the Novel Food Catalogue with a new entry concerning the use of the microorganism Lactobacillus paragasseri in food supplements. According to the published information, the European Commission considers that this microorganism was already being used in food supplements before May 15, 1997, a key date established by Regulation (EU) 2015/2283 on novel foods. Therefore, its use is not considered "novel" and does not require prior marketing authorization under the aforementioned regulation. This recognition has significant practical relevance for manufacturers and holders of supplements, as it allows the use of Lactobacillus paragasseri in the formulation of food supplements without the need to undergo the Novel Food procedure, provided that the general safety, labeling and quality requirements applicable in the European Union are respected. Until recently, this microorganism was considered a subspecies of Lactobacillus gasseri , but after the recent taxonomic revision of lactobacilli, L. paragasseri has come to be recognized as an independent species. Furthermore, in France, the Directorate General for Competition, Consumer Affairs and Fraud Repression (DGCCRF) has confirmed that the claim "promotes the balance of intestinal flora", usually tolerated for probiotic strains, can also be applied to Lactobacillus paragasseri . This change represents a further step in consolidating the evidence for the use and safety of probiotic strains within the European market, and confirms the Commission's willingness to clarify the regulatory status of microorganisms traditionally used in food and supplements, but whose scientific classification has evolved in recent years. At Belab Services, we closely monitor updates to the Novel Food Catalogue and decisions made by Member States regarding probiotics. These types of changes, even if subtle, can have a direct impact on launch planning, the justification of traditional use, and the labeling strategy for products containing active microorganisms.

The California Office of Environmental Health Hazard Assessment (OEHHA) has officially approved Negligible Risk Levels (NSRLs) for titanium dioxide in its airborne, unbound, respirable form. This measure, effective October 1, 2025, establishes clear limits that define exposures considered safe under the state's Proposition 65. Table of contents New benchmark values Conclusion Proposition 65, California: Safe Exposure Levels for Titanium Dioxide New benchmark values 440 µg/day for unbound and airborne particles with a diameter equal to or less than 10 µm 44 µg/day for unbound and airborne particles with a diameter equal to or less than 0.8 µm Titanium dioxide is a widely used ingredient as a white pigment in cosmetics, personal care products, and other industrial sectors. However, only its airborne particulate form was included on Proposition 65's list of carcinogens in 2011. This classification particularly affects aerosolized or sprayable products, such as hairsprays, aerosol sunscreens, and cosmetic powders. Since its inclusion on the list, the substance has been the subject of more than 500 non-compliance notices and numerous lawsuits, primarily against manufacturers and distributors in the cosmetics sector. In response, the Personal Care Products Council (PCPC) filed a constitutional challenge in 2024 requesting the definition of safe levels to reduce legal uncertainty and the litigation burden for companies. The OEHHA published a proposed regulation in May 2024, which has now been adopted without modification. With this decision, companies now have a clearer regulatory framework: products that keep exposures below the NSRLs will not be required to include Proposition 65 warnings. Conclusion This update represents a significant step forward for the cosmetics and personal care industry, by offering scientific and consistent criteria that balance consumer protection with the legal certainty of manufacturers.

In recent years, the classification of tea tree essential oil (INCI: Melaleuca alternifolia Leaf Oil, CAS 68647-73-4) has begun to diverge between the regulatory framework of the European Chemicals Agency (ECHA) in the European Union and that of the Health and Safety Executive (HSE) in Great Britain. This regulatory evolution has a direct impact on manufacturers, importers, and distributors of cosmetics that use this natural ingredient in their formulations. Table of contents What has really changed? A regulatory scenario that separates A practical perspective for businesses Tea Tree Oil: Classification and Key Differences between the EU and the UK What has really changed? In November 2023, the ECHA —through its Risk Assessment Committee (RAC)— adopted the opinion to classify tea tree oil as a Reproductive Toxicity Category 2 (Repr. 2) substance under the EU CLP Regulation. However, in August 2025, the HSE published its technical proposal under Article 37 of the British CLP, establishing a future mandatory classification (GB MCL) for this essential oil. Although the British authority recognizes risks such as skin irritation, dermal sensitization, acute toxicity and aquatic environmental impact, it does not currently propose a classification for reproductive toxicity. A regulatory scenario that separates Since Brexit, the EU and the UK have been pursuing parallel regulatory paths. This means that the same substance—such as Tea Tree Oil —can be subject to different classification criteria depending on the market. For the cosmetics industry, this translates into very specific challenges: Different labels and SDS: Safety data sheets and hazard warnings may vary between the UK and the EU. Review of concentrations and formulations: applicable usage limits and warnings may differ depending on the new European classification. Complex export flows: the border between the UK, Northern Ireland and the EU will require stricter controls to prevent non-conformities. A practical perspective for businesses More than a to-do list, this situation calls for a strategic review. If your company uses Melaleuca alternifolia Leaf Oil in cosmetic products, it is advisable to: Evaluate the concentrations and function of the ingredient within each formula, especially in products distributed in both the EU and the UK. Update the safety data sheets (SDS) and review the labeling texts according to the CLP criteria applicable in each region. Coordinate with suppliers and importers to ensure that safety declarations and technical documentation are consistent between both markets. Maintain active regulatory monitoring, as the HSE may reconsider the reproductive toxicity classification in future revisions of Article 37A. The divergence in the classification of Tea Tree Oil is a clear example of how the post-Brexit framework is beginning to generate substantial differences in the management of cosmetic ingredients. Get in touch with our team today.

The French Agency for Health and Safety (ANSES) has submitted a proposal to ECHA to restrict the use of octocrylene (INCI: Octocrylene ) in cosmetic products containing concentrations equal to or greater than 0.001% w/w. The goal of this measure is to reduce the environmental risks associated with this ultraviolet filter, widely used in sunscreens and personal care products. Table of contents Risks identified by ANSES Assessment according to REACH criteria France proposes restricting the use of octocrylene in cosmetic products Risks identified by ANSES According to the submitted dossier, octocrylene represents a significant risk to the aquatic environment, especially for sensitive species such as Daphnia magna , for which a no observed effect concentration (NOEC) of 2.66 μg/L has been determined. Furthermore, the analysis concludes that the substance can affect freshwater ecosystems, marine environments, sediments, and agricultural soils due to its persistence and toxicity. Assessment according to REACH criteria Under the REACH Regulation, octocrylene meets the criteria of Annex XIII to be considered a very persistent (vP) and toxic (T) substance. However, it is not classified as bioaccumulative (B) as the available data do not demonstrate significant accumulation in living organisms. However, the combination of its widespread use, high chemical stability, and toxic effects on aquatic organisms has motivated the need for regulatory action at the European Union level. The French proposal is currently under public consultation as part of ECHA's restriction assessment process. Once the analysis by the relevant scientific committees (RAC and SEAC) is complete, an opinion will be issued that could lead to a restriction on the use or concentration of octocrylene on the European market. Octocrylene is an organic UV filter used to protect skin and cosmetics from ultraviolet radiation. Although effective and stable, recent studies have highlighted its persistence in the environment and toxicity to aquatic organisms, prompting this new regulatory review. Get in touch with our team of experts today.