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- New EU Cosmetic Restrictions: Late October and November 2025 update
Several amendments to Regulation (EC) 1223/2009 on cosmetic products will come into force in the coming weeks, affecting common ingredients in facial, body, and hair care formulations. Below, we review the main deadlines and requirements that brands must take into account. Table of contents Triclocarban and Triclosan Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin Retinol, Retinyl Acetate and Retinyl Palmitate Recommendations for Brands and Responsible People New EU Cosmetic Restrictions: Late October and November 2025 update Triclocarban and Triclosan Deadline: October 31, 2025 All cosmetic products containing triclocarban or triclosan , whether newly launched or already available in stores, must comply with new concentration and use restrictions established by the European Commission. From this date, products that do not comply with the new limits will not be allowed on the market . Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin Deadline: November 1, 2025 Products containing any of these ingredients must comply with updated usage and concentration conditions . As of November 1, 2025, non-compliant products, including stock already in stores or warehouses, may no longer be sold . Retinol, Retinyl Acetate and Retinyl Palmitate Application of Amendment (EU) 2024/996 This amendment introduces new concentration limits depending on the type of product and its area of application, in addition to requiring a specific warning on the label : “Contains vitamin A. Please take into account your daily intake before use.” New products launched on the market must immediately comply with these requirements. However, existing stock may remain on the market until supplies run out, and at the latest until May 1, 2027 . Recommendations for Brands and Responsible People Review the formulations and percentages of the affected ingredients. Update labeling and safety warnings . Modify the security assessment (CPSR) and the Product Information File (PIF) as appropriate. At Belab Services, we help brands adapt quickly to new regulatory changes in the European Union, the United Kingdom, and other international markets. If your products include any of these ingredients, our team can review your formulas and documentation to ensure compliance before deadlines. Get in touch with our team of experts today.
- Washington strengthens cosmetic safety with formaldehyde ban
Washington State has passed a new regulation banning the use of formaldehyde and formaldehyde-releasing substances in cosmetic products, strengthening its commitment to protecting public health and aligning itself with policies already adopted in the European Union and other international markets. This measure represents a significant change for brands operating in the United States, which will have to adapt their formulations and compliance strategies. Table of contents Cosmetic Regulation: Formaldehyde Progressive application of the measure Washington refuerza la seguridad cosmética con la prohibición del formaldehído Cosmetic Regulation: Formaldehyde Formaldehyde has historically been used as a preservative and antimicrobial agent in various product categories—including hair treatments, nail hardeners, and certain facial cosmetics. However, its potential to cause irritation, skin sensitization, and adverse respiratory effects, in addition to its classification as a possible human carcinogen, has led to its gradual withdrawal from the market in various jurisdictions. The new regulations not only ban the direct use of formaldehyde, but also the use of substances capable of releasing it under normal conditions of use. In total, the regulatory text identifies 25 formaldehyde-releasing compounds that will be restricted when intentionally added to cosmetic products. For companies with a presence or distribution in the state, this decision entails a detailed review of formulations, ingredient sheets, and supplier documentation, ensuring the deliberate absence of formaldehyde and its releasers. It is also recommended to strengthen traceability in the supply chain and keep all technical evidence that may be requested in the event of an inspection up to date. From a regulatory compliance perspective, this measure highlights the need for preventive chemical risk management and greater transparency in the composition of cosmetic products. Progressive application of the measure The regulation was approved in late August 2025 and will go into effect at the end of September. Mandatory restrictions will begin to apply in January 2027, allowing a sufficient transition period for product reformulation. Retailers in the state will be able to continue selling previous stocks until the end of that year. With this initiative, Washington is among the pioneering U.S. states in adopting stricter cosmetic safety criteria, reflecting a global trend toward safer, more transparent products that meet international standards. Contacta con nuestro equipo de expertos en regulación cosmética
- Microplastics in cosmetics: New global restrictions, deadlines, and exceptions under REACH
In recent years, various regulatory authorities have focused on microplastics present in cosmetic products, and have passed regulations that restrict or even ban certain poorly degradable functional ingredients. The goal is to mitigate the environmental impact these components generate when they end up in aquatic systems and ecosystems. Table of contents What ingredients are being affected? Deadlines, transition and difference in uses Microplastics in cosmetics: New global restrictions, deadlines, and exceptions under REACH What ingredients are being affected? Among the ingredients being targeted are, among others: Encapsulated active ingredients (microcapsules with functional ingredients) Exfoliating beads or solid exfoliating microbeads Film formers (poorly degradable film-forming agents) Glitters or plastic glitters These ingredients are undergoing phased restrictions or bans, depending on the type of use, application, and region. In some cases, the phase-out period has already passed; in others, they are still in the transition period until 2035. For example, plastic glitter is already being subject to stricter bans in many jurisdictions due to its high potential for environmental dispersal. Solid exfoliating microbeads (when not biodegradable) have also been subject to regulations in various countries for several years. The new regulatory draft seeks to revise entry 78 on synthetic polymer microparticles (SPMs), highlighting that the current information does not accurately reflect the regulatory objective of: Medicinal products Repeal all such products, including those used in clinical trials. R&D activities If they are used for research and development, product and process oriented. SPMs permanently embedded in a solid matrix If specified microplastics (SPMs ) are permanently embedded in a solid matrix and are not expected to be removed or replaced frequently, they are not considered repealed. The amendment clarifies that the exception in entry 78(5)(c) (which governs these cases) will only apply where the intended end-use lasts for one year or more. These exceptions aim to avoid a disproportionate impact on specialized or long-life products, while also allowing for the gradual elimination of the most problematic forms of microplastics in cosmetics. Deadlines, transition and difference in uses One of the key aspects of these new regulations is that not all affected ingredients disappear suddenly: legislators typically establish staggered deadlines, with transition stages for the industry to adapt formulations, assess sustainability, and make necessary modifications. In many cases, the deadlines extend to 2035 for uses permitted during the transition. Plastic glitter is already being banned outright in several areas without extended grace periods. Film formers are being subject to more careful evaluation, with tiered restrictions based on product type and scale of use. Encapsulated active ingredients and microbeads are also incorporated into these progressive measures. Get in touch with our team of experts easily.
- ECHA proposes restricting the use of octocrylene in cosmetic products
The European Chemicals Agency (ECHA) has proposed a specific restriction for Octocrylene ( CAS 6197-30-4, EC 228-250-8 ), one of the most widely used UV filters in sunscreens and cosmetics with secondary UV protection. The measure, presented within a restriction report prepared according to Annex XV of REACH, seeks to reduce the environmental impact of this substance, especially on aquatic ecosystems and possible groundwater contamination resulting from its extensive use. Table of contents Reasons for the proposal Content of the proposed restriction Public consultation process Next steps Implications for the cosmetics industry Official document ECHA proposes restricting the use of octocrylene in cosmetic products Reasons for the proposal Octocrylene is an effective organic filter against UVB radiation and part of the UVA spectrum, used not only in sunscreens but also in day creams, body lotions, makeup, and lip balms with sun protection. However, recent studies have shown that octocrylene can accumulate in aquatic organisms, disrupting the ecological balance and releasing persistent byproducts. Given this evidence, ECHA considers it necessary to implement control measures. The dossier indicates that technical alternatives are available, and that substitution is scientifically and economically viable, thus minimizing the impact on the industry. Content of the proposed restriction According to the proposal included in Annex XV (table 45, section 7): “Octocrylene may not be marketed or used in finished cosmetic products in concentrations equal to or greater than 0.001% w/w .” The restriction would take effect 24 months after its official publication, allowing manufacturers to adapt their formulations and use up stocks. The term “finished cosmetic product” is defined in accordance with Regulation (EC) No 1223/2009, i.e. the product ready for final use by the consumer. Public consultation process The public consultation on this proposal will open on September 24, 2025, and will last for six months. ECHA invites manufacturers, industry associations, academic bodies, and national authorities to submit comments based on scientific, technical, or socioeconomic data. It is recommended that comments be submitted by January 23, 2026, so that they can be analyzed during the evaluation phase by the Risk Assessment Committee (RAC) and Socioeconomic Analysis Committee (SEAC). All contributions and responses to the dossier will be published alongside the SEAC's draft opinion, ensuring the transparency of the regulatory process. Next steps Autumn 2026: ECHA plans to issue the joint opinion of the RAC and SEAC, which will include both an environmental risk assessment and socio-economic implications. The European Commission will then review the findings and decide whether to formally include octocrylene in Annex XVII of REACH, which lists substances subject to restrictions in the European Union. Implications for the cosmetics industry This proposal marks a significant shift in the management of cosmetic ingredients under environmental criteria. Although Octocrylene has been widely validated as a safe UV filter for consumers, its ecological impact is causing growing concern. Companies must: Evaluate their presence in sun protection or daily care products. Identify technical alternatives compatible with the same levels of protection. Participate in the public consultation , providing data on feasibility, costs or replacement. Official document The full restriction report (Annex XV Report) and its annexes are available on ECHA's official website: Annex XV restriction format with instructions Contact with our team of regulatory experts today.
- The European Commission has launched a consultation on the safety of Phytonadione Epoxide (Vitamin K Oxide).
On May 19, 2025, the European Commission launched an official Call for Data to assess the safety of Phytonadione Epoxide (Vitamin K Oxide)—CAS 25486-55-9, EC 247-022-9—used in cosmetic products. This initiative is part of Regulation (EC) No. 1223/2009, which requires ongoing evaluation of substances when concerns arise about their safety for consumers. Table of contents Background: from the use of vitamin K1 to its oxidized form A potential risk of awareness that worries the Commission Next steps in the regulatory process What should manufacturers do? Another sign of European proactive surveillance The European Commission has launched a consultation on the safety of Phytonadione Epoxide (Vitamin K Oxide). Background: from the use of vitamin K1 to its oxidized form Vitamin K1 (phytonadione) has been used in cosmetics for its moisturizing properties, its ability to reduce the appearance of bruises and blemishes, and its brightening effect. However, following several documented cases of allergic contact dermatitis (ACD), its topical use in cosmetics was banned in 2009. As an alternative, the industry introduced phytonadione epoxide, an oxidized form of vitamin K1, used primarily as a skin-conditioning agent in eye contour products, anti-aging serums, and treatments to reduce redness or improve skin tone. However, in recent years, new cases of sensitization and allergic reactions have been reported, especially with eye products, with reports originating from Spain. In some of these cases, conventional patch tests failed to detect the sensitization, requiring higher concentrations for a reliable diagnosis. A potential risk of awareness that worries the Commission In light of these reports, the Commission considers it necessary to thoroughly review the safety profile of this ingredient. The main concern lies in its sensitizing potential, which could pose risks to users with sensitive skin or those exposed repeatedly. Therefore, all stakeholders—including cosmetics manufacturers, raw material suppliers, academic institutions, national authorities, and consumer associations—have been asked to provide relevant data on: Physicochemical properties and purity characteristics. Toxicological and toxicokinetic data . Assessment of consumer exposure through cosmetic use. Proposed safe levels of use (suggested maximum concentrations). Next steps in the regulatory process The deadline for submitting data is 18 May 2026, at 23:59 (CET). Once the information has been received and validated, the Commission may request the Scientific Committee on Consumer Safety (SCCS) to issue a scientific opinion on the substance. Based on the findings, the Commission may adopt regulatory measures, such as limiting the maximum permitted concentration or including the ingredient in the annexes to Regulation 1223/2009 (for example, in Annex III on restricted substances). What should manufacturers do? Brands using Phytonadione Epoxide in their formulations should: Review your current presence and concentration in products already marketed. Evaluate alternatives if there is evidence of risk of sensitization. Contribute data to the collection process, especially if you have internal safety studies or toxicological information. Another sign of European proactive surveillance This new application confirms the European Commission's policy of acting early on potential emerging risks in cosmetics, ensuring that ingredients on the market remain under up-to-date scientific scrutiny. Contact with our team of cosmetic regulation experts today.
- FDA: New Real-Time Dashboard for Reporting Adverse Effects in Cosmetics
The U.S. Food and Drug Administration (FDA) has introduced a new public tool: a real-time dashboard for viewing adverse event reports related to cosmetic products. This panel—called the FAERS Public Dashboard for Cosmetic Products—updates data daily and allows users to view adverse event reports for products such as creams, shampoos, hair dyes, and tattoos. Table of contents More transparency and public access What kind of data does it contain? Regulatory and industry importance Conclusion FDA: New Real-Time Dashboard for Reporting Adverse Effects in Cosmetics More transparency and public access With this launch (September 12, 2025), the FDA strengthens its strategy of radical transparency in public health matters. Anyone can now search and download data from recent reports, filtering by product, type of event, or severity. FDA Commissioner Marty Makary noted that citizens “deserve greater understanding about the safety of the cosmetics they use every day,” and that this dashboard is a way for the public to help identify potential signs of risk. What kind of data does it contain? The dashboard includes both mandatory reports—submitted by “responsible persons” under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) —and voluntary reports from healthcare professionals, consumers, aestheticians, salons, and more. Some key features: Entries can be filtered by product, type of adverse event, date, or severity level. The data have not been verified by the FDA ; publication does not imply that the product caused the effect. The dashboard should not be interpreted as an absolute indicator of safety, but rather as a source of preliminary signals. Regulatory and industry importance This step represents a reinforcement of post-market surveillance in cosmetics. For manufacturers and distributors, it represents an increase in responsibility: reports received by the system could draw attention to specific products. For consumers and professionals, it's a powerful tool: they'll be able to examine potential problems with cosmetic products firsthand, boosting industry accountability. Conclusion The FDA's creation of this dashboard symbolizes a shift toward more active and participatory oversight of cosmetic safety. Although it is not a definitive risk assessment, it provides public visibility into reported effects and can serve as a warning to manufacturers, regulators, and consumers. Contact an expert in international cosmetics regulation.
- FDA proposes revoking authorization of "Orange B" coloring due to abandonment of use
Washington, DC — On September 17, 2025, the Food and Drug Administration (FDA) announced its intention to revoke the authorization of the food coloring Orange B, used as a food additive, determining that its use has been abandoned by the industry and that the regulations authorizing it have become obsolete. Table of contents What is Orange B and why is it being revoked? Key dates and public participation Impacts and motivations What can companies do? FDA proposes revoking authorization of "Orange B" coloring due to abandonment of use What is Orange B and why is it being revoked? Orange B is a petroleum-derived colorant that was previously approved for use in foods under the current food additive regulations. However, according to the FDA, the industry has virtually stopped using it, leading the agency to conclude that maintaining its approval no longer makes sense from a regulatory perspective. The proposed revocation is part of a broader strategy to eliminate synthetic, petroleum-derived dyes from the U.S. food supply. In that context, the FDA has also added six other widely used dyes (including FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3 ) to its list of chemicals under review . Key dates and public participation The FDA has opened a 30-day public comment period, which runs until October 16, 2025. After reviewing the comments received, the agency will determine whether to formally revoke Orange B. Interested parties may submit comments through the Federal eRulemaking Portal , citing docket FDA-2025-C-3543 , or by submitting written comments to the FDA's Dockets Management staff. Impacts and motivations By revoking Orange B, the FDA is aligning itself with a regulatory trend to restrict or eliminate the use of petroleum-based synthetic colors, especially in products with direct exposure to the consumer public. The argument for revocation is not based on new toxicological findings, but rather on the fact that the use of this colorant has been virtually abandoned in commercial practice, making its authorization considered "unnecessary and outdated." The measure also sends a strong signal to the food industry: for manufacturers that still use synthetic colorings derived from petroleum, increasing regulatory pressure is anticipated toward cleaner or more natural alternatives. What can companies do? Review current formulations to identify if they use Orange B (although few likely do today). Anticipate the future regulatory framework that could extend to other colorants under review. Prepare and submit comments if the company has relevant experience or data, especially during the public comment period. Explore safe and accepted colorant alternatives to avoid risks of regulatory discontinuity. Contact our team of experts in international cosmetics regulation.
- Washington: Ban on formaldehyde releasers in cosmetics
Washington, USA — Washington state has taken a pioneering step in cosmetics matters: starting January 1, 2027, the manufacture, sale, offering, or distribution of cosmetics containing formaldehyde-releasing chemicals will be prohibited under the newly passed Toxic-Free Cosmetics Act (TFCA) . Retailers will have until December 31, 2027, to deplete their existing stock. Table of contents What are formaldehyde releasers and why are they regulated? A period to adapt… with clear obligations What impact can this measure have on the national and international levels? What should brands do and what opportunities are emerging? Washington: Ban on formaldehyde releasers in cosmetics What are formaldehyde releasers and why are they regulated? Formaldehyde releasers are preservatives that gradually release formaldehyde in cosmetic products. They have been used in shampoos, conditioners, gels, hair treatments, and nail polish. The problem is that formaldehyde is classified as a recognized carcinogen, linked to cancers of the nose, throat, and leukemia, in addition to causing asthma and skin irritation. The regulatory effort seeks to protect those most at risk: beauty salon workers, hairstylists, nail technicians, and men and women who regularly use these products. A period to adapt… with clear obligations The regulations will allow a transition period for the industry to adapt. Manufacturers must reformulate products that use these ingredients; distributors must ensure that new products comply with the standard; and retailers must manage the closure of current stock within the legal deadline. State authorities have announced they will collaborate with manufacturers, distributors, and industry professionals to provide implementation guides. What impact can this measure have on the national and international levels? Although the law applies only to Washington State, it is symbolic and strategic in nature. Industry experts consider it a precedent that could lead to similar regulations in other states and countries. This type of ban establishes stricter standards for the safety of cosmetic ingredients. Furthermore, some cosmetic formulations that currently contain these preservatives could be forced to revise their product data sheets, toxicological profiles, and preservation tools several times under commercial pressure. What should brands do and what opportunities are emerging? Review portfolio: Identify products with formaldehyde releasers and anticipate their replacement. Smart reformulation: Explore safer alternatives and demonstrate the reduced risk profile to authorities or consumers. Regulatory monitoring: Be alert to similar laws that may emerge in other U.S. states or international markets. Proactive communication: Explain the change to customers and channels, emphasizing that the new products are safer and more responsible. For international companies with a presence in the US, this measure is a clear signal that the standard for cosmetic safety is rising. Those who act early have a competitive advantage: strengthening the perception of a brand committed to health can open doors. Contact our team of experts in cosmetic regulation
- Guide to the regulation of food supplements in the European Union
Launching dietary supplements in the European Union means entering a harmonized market, but one that still retains important national nuances. This article guides companies through the key aspects new brands must understand to stay safe, comply with regulations, and be ready for market entry. Table of contents 1) What is a “food supplement” in the EU? 2) The legal pillars you should know 3) Formulation: what is allowed and how to justify safety 4) Labeling: the non-negotiable 5) Statement strategy: what you can (and can't) say 6) Market access and national crossings 7) Practical and realistic roadmap Common mistakes to avoid How does Belab help new brands succeed in the EU? Guide to the regulation of food supplements in the European Union 1) What is a “food supplement” in the EU? According to European legislation, food supplements are foods presented in dosage form (e.g., capsules, tablets, or liquids in measured units) designed to complement the normal diet. They are not medicinal products and cannot claim to prevent, treat, or cure diseases. 2) The legal pillars you should know The European regulatory framework for food supplements ensures their safety, transparency, and consistency across the market. It defines which ingredients can be used, requires clear and verifiable labeling, regulates the use of nutrition and health claims, and requires the prior assessment of new ingredients not traditionally consumed in Europe. Although harmonization of maximum and minimum nutrient levels is planned, national differences continue to play a key role in market access requirements. 3) Formulation: what is allowed and how to justify safety Vitamins and minerals: Uses only nutrients and chemical forms authorized under the Food Supplements Directive. Purity criteria apply. Other substances (botanicals, bioactives): The Directive focuses on vitamins and minerals; other substances may be regulated nationally or under other European legislation (e.g., novel foods). Early assessment is essential. Safe intake levels: Build your safety case based on the Dietary Reference Values (DRVs) and Tolerable Upper Intake Levels (ULs) defined by EFSA, which provide guidance on safe daily intake levels. 4) Labeling: the non-negotiable Beyond the general food labeling requirements, dietary supplements must display additional information intended to promote safe and informed consumption. Ensuring these elements are properly implemented requires the expertise of a qualified professional familiar with the specifics of dietary supplement regulation. 5) Statement strategy: what you can (and can't) say Only authorized nutrition and health claims may be used, with their exact wording and under the established conditions of use (dosage, target population, etc.). Plan your formulation and daily dose from the start, taking into account the conditions of use associated with the claim you intend to use. 6) Market access and national crossings Although EU legislation is harmonized, two critical issues remain for startups: Maximum levels of vitamins and minerals are not yet harmonized at European level → some Member States apply their own limits or guidelines. Notifications: Article 10 allows countries to require notification of the label to the competent authority upon first introduction of the product into their market. 7) Practical and realistic roadmap Evaluate the formula: verify limits and compliance for use of minerals and vitamins; check novel food status; exposure to UL. Define the declarations from the start and adjust the dosage/format to the authorized conditions of use. Design the label according to the horizontal and plugin-specific rules. Check national requirements (maximum level policies; notification where appropriate). Prepare the documentation package: specifications, certificates of analysis, stability/shelf-life justification, and UL/DRV safety dossier. Common mistakes to avoid Treat botanicals or bioactives the same as vitamins: different rules may apply (including those for novel foods). Designing the marketing strategy first, then the marketing statements can lead to non-compliance or the need for reformulation. Ignoring national notifications or local limits may delay market entry. How does Belab help new brands succeed in the EU? We transform regulatory complexity into a launch plan: Formula review and safety justification (Annex I/II approved forms, UL exposure, novel food evaluation). Declarations and labeling aligned with specific regulations. Market access by Member State (notification support; analysis of local specificities). Ready to enter the European dietary supplement market with confidence? Let's build your compliant and secure route to market together. Get in touch with our team of experts today.
- Guide to the Regulation of Food Supplements in the United Kingdom
Entering the UK food supplement market means navigating a system that retains many of the EU's historic rules, but with specificities following Brexit. This guide highlights what new brands need to know to stay safe, comply with regulations, and be ready to launch in Great Britain (England, Scotland, and Wales), as well as the differences in Northern Ireland. Table of contents 1) What is considered a food supplement? 2) The legal pillars (Great Britain) 3) Essential elements of labelling (Great Britain) 4) Declaration strategy 5) Key points in the formulation 6) Particularities of Northern Ireland 7) Simplified route to market (Great Britain) Common mistakes How does Belab help new entrants succeed in the UK? Guide to the Regulation of Food Supplements in the United Kingdom 1) What is considered a food supplement? In the UK, supplements are regulated as foods in dosage form intended to supplement the diet (e.g., capsules, tablets, or dosed liquids). 2) The legal pillars (Great Britain) Food Supplements Regulation: defines which vitamins/minerals and chemical forms are permitted, in addition to establishing the specific mandatory labeling declarations. Food Information Standards: These establish horizontal labeling requirements (food name, list of ingredients, allergens, food operator information, consumption date, etc.). Nutrition and Health Claims: Great Britain uses the GB Nutrition & Health Claims (NHC) Register . Only claims authorized in that register may be used, in their exact wording and under the specified conditions. Novel Foods (NF): Ingredients without a significant history of consumption prior to 15 May 1997 require authorisation in NF through the FSA's regulated products process (traditional NF notification or full application). 3) Essential elements of labelling (Great Britain) Beyond the general food labeling requirements, the British guide emphasizes that supplements must be clearly identified as "food supplement" (not "dietary supplement" ) and include the name and address of the food operator on the label or packaging. They must also include additional consumer-facing information to encourage safe and informed consumption. Ensuring these elements are properly implemented requires the expertise of a qualified professional familiar with the specifics of food supplement regulations. 4) Declaration strategy Marketing must be aligned with the GB NHC Register . The formula and daily dose must be designed around the conditions of use of the intended claims (e.g., minimum nutrient content per daily serving). Disease risk reduction or medicinal claims are prohibited. 5) Key points in the formulation Vitamins and minerals: Use only authorized nutrients and chemical forms. Other substances (botanicals/bioactives): Outside of vitamins and minerals, novel food status must first be assessed. If considered novel , British approval will be required before marketing. Safety narrative: Adjust daily dose and exposure to recognized scientific reference points. 6) Particularities of Northern Ireland Under current arrangements, EU food law continues to apply in Northern Ireland in areas such as novel foods and claims. Novel foods in Northern Ireland follow the EU process (submission via the European Commission/EFSA). NI products must include an NI or EU address (or that of the importer in NI/EU) on the labeling/operator details. Planning SKUs and label designs with GB/NI distribution in mind helps avoid subsequent relabeling. 7) Simplified route to market (Great Britain) Formula review: confirm authorized forms of vitamins/minerals and analyze the novel food risk in other substances. Declarations: Select only those present in the GB NHC Register and comply with its terms of use. Label construction: FIC base + specific supplement declarations + operator/importer data in GB; no disease declarations. GB vs NI division: If also marketed in NI, check compliance with EU legislation (claims/novel foods) and the operator's address format. Documentation package: specifications, certificates of analysis, stability/shelf-life justification, and a short safety/declaration dossier to support potential inquiries from UK competent authorities. Common mistakes Assuming that EU approvals automatically cover novel foods in Great Britain—this isn't the case; Great Britain has its own procedure. Using EU declarations without checking their adoption or conditions in the GB NHC Register . Apply a single label for GB and NI—regulatory direction and pathways may differ. How does Belab help new entrants succeed in the UK? We transformed the regulations into a practical launch plan: Review of formulas and safety justification. Declarations and labeling aligned with the GB NHC Register and FIC requirements in the UK. Advising on the GB/NI division (art, operator management, documentation) to optimize compliance and logistics. Ready to launch in Great Britain (and Northern Ireland) with confidence? Let's build your compliant and secure route to market together. Get in touch with our cosmetic regulation experts today.
- EFSA: Safety of Food Supplements in Europe
The use of food supplements in the European Union has grown steadily over the last decade. Consumers are seeking products that promise better health, but authorities must ensure they are safe, effective, and correctly labeled. In this context, the European Food Safety Authority (EFSA) plays a key role as the scientific body responsible for assessing risks and supporting EU policymakers in their decision-making. Table of contents EFSA's mission on supplements Why is this important for businesses? EPSA: The challenge of staying in compliance How can Belab Services help you? EFSA: Safety of Food Supplements in Europe EFSA's mission on supplements EFSA does not legislate directly, but issues independent scientific opinions that influence how food supplements are regulated. EFSA covers three main areas Ingredient safety : EFSA reviews new vitamins, minerals, botanical extracts, or other bioactive substances before they can be incorporated into supplements. This includes assessing purity, toxicity, and bioavailability. Safe intake levels : EFSA establishes Dietary Reference Values (DRVs) and Tolerable Upper Intake Levels (ULs) that serve as a guide for consumers and regulators on how much can be safely consumed. Health claims : Many companies want to highlight the benefits of their supplements, but claims such as “supports the immune system” or “contributes to normal energy-yielding metabolism” must be scientifically supported. EFSA assesses the evidence before such claims can appear on labels. Why EFSA this important for businesses? For supplement manufacturers, EFSA's role goes beyond the scientific: it has a direct impact on business. An unapproved ingredient or rejected claim may involve: Reformulate products. Reprint labels and packaging. Delay market entry. In addition, certain ingredients fall into the category of novel foods, which require additional evaluations before being authorized in the EU. Examples include some botanical extracts or new sources of nutrients. EFSA: The challenge of staying in compliance The European regulatory framework is complex: multiple regulations (on supplements, food fortification, novel foods, and health claims) interrelate with EFSA assessments. Companies must stay up to date with guidance, scientific opinions, and updates to the lists of authorized substances. This is where specialized regulatory support is key. How can Belab Services help you? At Belab Services, we help companies navigate the European regulatory landscape for food supplements: We evaluate whether your formula and ingredients comply with regulations. We guide you in the correct use of health claims. We provide support in the preparation of dossiers related to EFSA evaluations. We verify that your labels and documentation are aligned with EU requirements. With our experience, you can focus on your product innovation while we take care of regulatory strategy and compliance. Contact us today and ensure your supplements are safe, compliant, and ready for the European market. Experts in international cosmetic regulation
- EU: New warning signs in the proposed PFAS restriction
In recent weeks, the European Chemicals Agency (ECHA) released an update to its dossier on the restriction of per- and polyfluoroalkyl compounds (PFAS) in the European Union. While the regulatory effort aims to control one of the most persistent and concerning chemical groups from an environmental and health perspective, the document contains a series of critical points that merit special attention from academics, regulators, and those interested in green chemistry and innovation. Below, we analyze five problematic aspects (“red flags”) that emerge from the revised text, as well as their implications for regulation, industry, and sustainability. Table of contents 1. Comprehensive restrictions are urgently needed—but is this a practical reality? 2. Leaks to export: export as an escape route 3. Excessive focus on industrial emissions control 4. Too many exceptions and diluted extensions 5. Poor promotion of innovation as a driver of transition Implications and recommendations for the future EU: New warning signs in the proposed PFAS restriction 1. Comprehensive restrictions are urgently needed—but is this a practical reality? The new version of the dossier clearly underscores the "urgent need to minimize" the production and use of PFAS, as their persistence in the environment poses a threat of irreversible damage to future generations. This urgency reinforces the argument that partial measures are not enough. However, translating this ambitious vision of role into practical and effective regulation presents technical, legal, and operational challenges: how to define the scope, timeframes, and control mechanisms that are operational in the industry without creating interpretative gaps? 2. Leaks to export: export as an escape route One of the most controversial points of the revised document is the possibility for European producers to continue manufacturing PFAS for countries outside the European Economic Area (EEA), without restrictions on their use. This provision allows the substances to continue being produced for export without any evaluation of their subsequent use. This type of exemption undermines the restriction's central purpose: to "turn off the tap" on PFAS. If production continues for external markets, the global environmental impact—and the EU's indirect liability—could continue to grow. 3. Excessive focus on industrial emissions control The recent record continues to favor regulating emissions in the manufacturing process as the preferred mitigation method. However, historical experience shows that this approach is insufficient. Control measures fail to prevent all leakage or the externalities of associated pollution—such as environmental migration, leaching, or atmospheric transport. Furthermore, this strategy can entail high infrastructure costs (underground walls, capture systems, continuous monitoring) that many companies are not yet prepared to assume. 4. Too many exceptions and diluted extensions One of the document's most notable weaknesses is the proliferation of long-term exemptions for specific uses of PFAS. With a total of 86 derogations contemplated, some even without a time limit, the regulatory effect is weakened. For example, the "wire and cable" category could benefit from a 13.5-year exception, which would perpetuate the use of PFAS in a key sector with no clear motivation for rapid substitution. These time gaps are in direct conflict with the urgency declared in the dossier itself. 5. Poor promotion of innovation as a driver of transition Although multiple less hazardous alternatives to PFAS have emerged in recent years, the revised text lacks clear signals to encourage innovation. Regulation should be aligned with incentives (financial, fiscal, or regulatory) that encourage the gradual substitution of safer technologies. Without this dual approach—control and incentives for innovation—the restriction risks limiting European competitiveness by penalizing use without facilitating the shift toward viable solutions. Implications and recommendations for the future The updated PFAS dossier represents a significant—and necessary—regulatory advance, but its effectiveness will depend largely on the final design of the restriction. To ensure the regulations are not distorted, it is necessary to: Closing export loopholes that allow unlimited production outside the EEA. Reduce the number and scope of exemptions , especially those with long terms. Combine control with incentives for innovation , so that viable alternatives gain ground quickly. Ensure mechanisms for periodic review of available limits and techniques (principle of best available techniques). Articulate a regulatory strategy that not only curbs the use of PFAS but also promotes a more sustainable chemical economy in Europe. The transition to effective and holistic regulation of PFAS could become a milestone in European chemical policy. But only if the "grand goal" is not diluted by lax clauses, lengthy exemptions, and a lack of real incentives for change. Contact our team of experts in cosmetic regulation today.












