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The European Commission has officially confirmed that the first four EUDAMED modules will be mandatory from May 28, 2026 . This decision marks a turning point in the full implementation of the European traceability and transparency system for health products under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Table of contents What exactly happened? The four modules that will be mandatory Actor Registration UDI/Device Registration Notified and Certified Bodies Market Surveillance Legal basis What does this mean for manufacturers? Strategic Impact Conclusion EUDAMED: The first four modules will be mandatory from May 28, 2026 What exactly happened? On 26 November 2025, the Commission adopted the Decision declaring that certain EUDAMED modules meet the functional specifications required by the regulations. Following its publication in the Official Journal of the European Union on 27 November 2025, a six-month transition period was automatically activated. Result : From May 28, 2026 , the use of the following modules will no longer be voluntary and will become mandatory. The four modules that will be mandatory Actor Registration Includes: Manufacturers Authorized Representatives Importers Producers of systems/procedures Without a valid registration (SRN), you cannot operate in accordance with MDR/IVDR. UDI/Device Registration It requires: Register each device in EUDAMED Enter basic UDI-DI information Keep data up to date This module strengthens traceability and public transparency. Notified and Certified Bodies Includes: Publication of issued certificates Suspensions or withdrawals Public information regarding the certificate status This increases market control and visibility for authorities and competitors. Market Surveillance It allows authorities to: Share information Coordinate corrective actions Manage monitoring measures Although this module directly impacts authorities, economic operators may be affected by greater regulatory coordination. Legal basis The obligation is based on: Regulation (EU) 2024/1860 (transitional amendments) MDR (2017/745) IVDR (2017/746) The formal activation of the obligation could only occur after the official declaration of functionality by the Commission, which has now happened. What does this mean for manufacturers? As of May 28, 2026: Alternative national registries will not be enough. EUDAMED will be the only valid platform for: Operator registration Device registration Certificate Management Non-European manufacturers must ensure that: Your Authorized Representative is properly registered Your SRN is active Your devices are loaded into the UDI module The information should be consistent with the technical documentation. Strategic Impact Beyond the legal obligation, this implies: Greater public transparency Greater traceability between Member States Greater exposure of certifications and regulatory status Higher probability of detecting document inconsistencies For many companies that have postponed full registration, 2026 will be the true operational entry point into EUDAMED. Conclusion The mandatory implementation of the first four EUDAMED modules represents the definitive step towards the full digitalization and centralization of the European regulatory system for medical devices. May 28, 2026 is not just an administrative date: it is the moment when European traceability becomes fully operational. Get in touch with our team of experts today.

The European Union has adopted Regulation (EU) 2026/405 , introducing a modernised regulatory framework for detergents and surfactants placed on the EU market. The new regulation repeals and replaces the long-standing Detergents Regulation (EC) No 648/2004 , aligning the rules with current scientific, environmental, and digitalisation priorities. The updated legislation aims to strengthen consumer protection, improve environmental sustainability, and streamline compliance requirements for companies manufacturing or importing detergents into the EU. Below we summarise the key regulatory developments and their implications for manufacturers, importers, and regulatory teams. Tabla de contenidos Background: Why the EU Updated the Detergents Regulation Key Changes Introduced by Regulation (EU) 2026/405 1. Stricter Biodegradability Requirements for Surfactants 2. Introduction of Digital Product Passports and Digital Labelling 3. New Provisions for Microbial Cleaning Products 4. Improved Labelling and Consumer Information 5. Strengthened Market Surveillance and Import Controls Transition Period and Timeline Conclusion New EU Regulation on Detergents and Surfactants: What Regulation (EU) 2026/405 Means for Industry Background: Why the EU Updated the Detergents Regulation Detergents are essential products used daily in households and professional environments, but they are also chemical mixtures that can pose risks to human health and the environment if not properly regulated. The previous framework from 2004 no longer fully reflected: Advances in chemical safety and environmental protection New product types such as microbial cleaning products Digital tools for product traceability and consumer information Sustainability objectives under the European Green Deal Regulation (EU) 2026/405 therefore modernises the legislative framework while maintaining the core objective: ensuring detergents placed on the EU market are safe and environmentally responsible. Key Changes Introduced by Regulation (EU) 2026/405 These rules apply whether surfactants are marketed directly or incorporated into detergent formulations. The strengthened biodegradability standards aim to reduce environmental persistence and protect aquatic ecosystems. 1. Stricter Biodegradability Requirements for Surfactants One of the central elements of the new regulation is the reinforcement of environmental requirements. All surfactants used in detergents must comply with ultimate biodegradability criteria  before the product can be placed on the EU market. 2. Introduction of Digital Product Passports and Digital Labelling The regulation embraces digitalisation by introducing: Digital Product Passports (DPP) QR-code based digital labelling Improved data accessibility for authorities and poison centres Digital tools will provide easier access to detailed product information while reducing the amount of mandatory information required on physical labels. This change is expected to improve supply chain transparency and facilitate regulatory enforcement. 3. New Provisions for Microbial Cleaning Products The regulation now explicitly covers detergents containing microorganisms , a category that has grown significantly in recent years. Specific safety requirements will ensure that microorganisms used in detergents are: Non-pathogenic Safe for human health Environmentally acceptable This regulatory clarification supports innovation while maintaining safety standards. 4. Improved Labelling and Consumer Information The regulation aligns detergent labelling requirements with other EU chemical legislation , including CLP , to reduce duplication and improve clarity. Key improvements include: Harmonised labelling requirements Improved ingredient information Enhanced access to product data for medical professionals and authorities These measures aim to ensure that both consumers and healthcare professionals can access accurate safety information when needed. 5. Strengthened Market Surveillance and Import Controls Regulation (EU) 2026/405 also strengthens enforcement mechanisms across the EU. Authorities will benefit from improved access to product information and stronger tools to monitor compliance, particularly for imported products. This is expected to create a more level playing field between EU manufacturers and non-EU suppliers. Transition Period and Timeline The regulation includes a transition period of approximately 42 months  before full application, giving industry time to adapt to the new requirements. During this period, companies should review: Surfactant biodegradability data Labelling formats and digital information systems Product documentation and technical files Supply chain traceability and digital product passport requirements Early preparation will be essential to ensure smooth compliance once the regulation becomes fully applicable. Conclusion Regulation (EU) 2026/405 marks a major update to the EU’s regulatory approach to detergents and surfactants. By combining stronger environmental safeguards, digital transparency tools, and improved market surveillance, the regulation aims to ensure safer and more sustainable cleaning products across the European market. For companies operating in the detergents sector , proactive regulatory planning will be essential to ensure compliance before the end of the transition period. Contacta con nuestro equipo de Expertos en Regulación Cosmética

Registering cosmetic products in the European market requires compliance with current regulations through the CPNP (Cosmetic Products Notification Portal) . This registration is mandatory to comply with European Cosmetics Regulation (EC) 1223/2009 , ensuring the safe entry of products into the European Union. In this article, we will cover what CPNP is, how to register, the required information, and what happens once the product is registered. CPNP: What is CPNP? European Cosmetic Registration. Who can register in the CPNP? Which information is necessary to register a product? It is SAFE to share this information? What is the result of CPNP Registration? CPNP registration is eternal? Who can see the CPNP information? I no longer sell my product in the European Union, what happens? CPNP: What is CPNP? CPNP is the official European notification portal where the Responsible Persons register cosmetics products BEFORE their will being placed on the market. This CPNP registration is a legal obligation present in European cosmetic regulations (EC) 1223/2009 of the European Parliament. Its purpose is to centralize product information so that national authorities (customs, health entities, etc.) can verify regulatory compliance. Key benefits of CPNP registration: Legal access to the European market. Consumer protection through ingredient control. Transparency and traceability of cosmetic products. European Cosmetic Registration. Who can register in the CPNP? Only Responsible Persons can make a product registration in the portal. It means that foreign companies (outside of the European Union) cannot do this, because they are not legal entities based in the EU. Which information is necessary to register a product? To register a product, the following detailed information must be provided: General product details:  name, category, reference number. Responsible Person in Europe:  name, address, contact information. Product origin:  country of origin and first market entry. Composition:  ingredients listed under INCI nomenclature with concentrations. Product safety:  presence of nanomaterials and CMR substances (carcinogenic, mutagenic, or toxic to reproduction). Labeling:  design that complies with regulations. Product images:  a real picture of the final product. Is it SAFE to share this information? Absolutely. CPNP is a government official database and nobody can check the information that companies and Responsible Persons upload on it. What is the result of CPNP Registration? Once the product is successfully registered in the CPNP portal, a CPNP registration number is obtained. This number identifies your cosmetic product during its life in the European Union. Furthermore, a PDF report is generated, which contains a summary of all the product information uploaded on the portal. CPNP registration is eternal? No. The registration must be updated if there are any changes, such as: Product composition. Labeling. Responsible Person. Country of origin. If the product is no longer sold in the EU, it must be reported via the portal. Who can see the CPNP information? Nobody can check if your products are or are not registered in the CPNP database. Only national authorities (governments, customs, etc) can check it. The CPNP information, registration number, and registration Report are information only available for the Responsible Persons and product owners’ companies. I no longer sell my product in the European Union , what happens? If one company discontinues the sales of a reference in the EU , it must, through its Responsible Person, notify the CPNP portal that the product will no longer be sold in the EU. BELAB SERVICES: Your partner in cosmetic product registration BELAB SERVICES   specializes in regulatory compliance for cosmetic products, acting as the Responsible Person  for foreign brands looking to enter the European market. We handle the entire process, from conformity assessment to obtaining the CPNP registration number. Conclusion Registering with CPNP  is a crucial step for any company wanting to market cosmetic products in Europe. Complying with current regulations not only ensures legal product distribution but also builds consumer trust and facilitates access to one of the world's most demanding markets. Need help registering your products? Contact us  and ensure your brand's compliance in the European Union.

Entering the U.S. cosmetic market is an exciting opportunity, but labeling compliance is often one of the first regulatory hurdles brands encounter. Unlike some jurisdictions, the United States does not require preapproval of cosmetic products before they are marketed. However, this does not mean labeling rules are simple - or optional. Cosmetic labeling is heavily regulated under federal law, and non‑compliant products may be considered misbranded, leading to import refusals, warning letters, market recalls or enforcement actions. This article explains the key FDA labeling principles for cosmetics, what companies should understand before launching, and why compliance is often more complex than initially appears. Table of contents The Regulatory Framework Behind FDA Cosmetic Labeling The Two Core Label Sections: PDP and Information Panel Product Identity: More Than Just a Marketing Name Net Quantity of Contents: Technical Rules That Matter Name and Place of Business: Who Is Responsible? Ingredient Declaration: Transparency with Specific Rules Warnings and Safety Statements: When Are They Required? Language and Readability Requirements Imported Cosmetics: Country of Origin and Additional Considerations Common Labeling Mistakes Seen in the U.S. Market How U.S. Labeling Differs from EU and UK Requirements? The Impact of MoCRA on Cosmetic Labeling Why Cosmetic Label Compliance Is Often More Complex Than Expected? Final Thoughts FDA Labelling Guideline for Cosmetics: What Companies Need to Know Before Selling in the U.S. The Regulatory Framework Behind FDA Cosmetic Labeling Cosmetic labeling in the United States is primarily governed by three legal pillars: • Federal Food, Drug, and Cosmetic Act (FD&C Act) • Fair Packaging and Labeling Act (FPLA) • FDA regulations under 21 CFR Parts 701 and 740 These laws aim to protect consumers from misleading information and ensure transparency regarding product content and safety. Importantly, the FDA regulates labeling, meaning not only the physical label but also any written or graphic material accompanying the product. This includes packaging, inserts, and sometimes marketing claims linked to the product presentation. The Two Core Label Sections: PDP and Information Panel One of the most fundamental concepts in U.S. labeling (and one frequently misunderstood by international brands) is the distinction between the Principal Display Panel (PDP) and the Information Panel. The Principal Display Panel is typically the part of the packaging most visible to consumers at the point of sale. It must include key identifying information such as: • Product identity • Nature or function of the product • Net quantity of contents The remaining required information may appear on the Information Panel, which usually sits adjacent to the PDP and includes company details, ingredients, and other regulatory statements.   Product Identity: More Than Just a Marketing Name The identity statement must clearly describe what the product is and what it does. This requirement may seem simple, but it intersects directly with one of the most critical regulatory risks in the U.S.: cosmetic vs. drug classification. Claims suggesting therapeutic or physiological effects — such as treating acne, repairing skin damage, or stimulating collagen — may cause a cosmetic to be regulated as an over‑the‑counter drug instead. The distinction between cosmetic and drug claims is one of the most frequent causes of regulatory action in the U.S. market. Net Quantity of Contents: Technical Rules That Matter The net quantity declaration must accurately reflect the amount of product in the package and follow specific formatting requirements regarding measurement units, placement on the package, and visibility and prominence. For liquids, volume units are used; for solids or semi‑solids, weight units apply. U.S. customary units are mandatory, although metric equivalents may also be included. Many companies underestimate the complexity of this requirement, particularly when adapting labels originally designed for EU or Asian markets. Name and Place of Business: Who Is Responsible? Cosmetic labels must identify the name and address of the manufacturer, packer, or distributor responsible for marketing the product. If the company listed is not the manufacturer, wording such as “Manufactured for” or “Distributed by” is typically required to avoid misleading consumers. This requirement becomes particularly relevant for private label brands, importers, international distributors, and contract manufacturing arrangements. Ingredient Declaration: Transparency with Specific Rules Ingredient labeling is mandatory for most retail cosmetic products in the United States. Ingredients must generally be listed in descending order of predominance, with certain regulatory nuances for ingredients present at low concentrations and for color additives. While the U.S. system shares similarities with EU INCI labeling, there are important differences that can affect global label harmonization strategies. Warnings and Safety Statements: When Are They Required? Some cosmetic categories require specific warnings, particularly when misuse pose a safety risk. Additionally, if product safety has not been adequately substantiated, the label must include a statement indicating that safety has not been determined.   Companies sometimes overlook this requirement when relying on supplier data or incomplete safety documentation. Language and Readability Requirements All mandatory label information must appear in English for products marketed in the United States and must be presented prominently and clearly to consumers. Typography, contrast, and legibility all play a role in determining compliance — aspects that may seem purely aesthetic but can have regulatory implications. Imported Cosmetics: Country of Origin and Additional Considerations For imported cosmetics, country of origin marking is typically required under U.S. customs laws. Although not strictly an FDA requirement, failure to comply may still result in border issues or market access delays. Common Labeling Mistakes Seen in the U.S. Market Across international projects, several recurring compliance issues appear:   ·         Druglike claims on cosmetic labels ·         Incorrect or missing net quantity formatting ·         Improper ingredient declaration order ·         Missing company qualification wording (“distributed by”) ·         Non‑compliant placement of mandatory information ·         Labels copied from EU versions without adaptation   How U.S. Labeling Differs from EU and UK Requirements? For companies operating globally, understanding regulatory differences is essential. For example, the EU requires additional elements such as durability dates or Period After Opening symbols, which are not mandatory in the U.S. unless relevant. EU labeling is also linked to Responsible Person obligations and product notification systems. Although frameworks share similarities, assuming that one label works worldwide is rarely correct. The Impact of MoCRA on Cosmetic Labeling The Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant update to U.S. cosmetic regulation in decades. Among other provisions, MoCRA introduces new requirements related to adverse event reporting, safety substantiation expectations, facility registration and product listing, and potential future labeling updates.   Companies entering the U.S. market should consider these evolving requirements when designing labels today. Why Cosmetic Label Compliance Is Often More Complex Than Expected? At first glance, FDA labeling requirements may appear straightforward. However, in practice, compliance involves regulatory interpretation, claims assessment, safety documentation alignment, cross‑border regulatory strategy, and risk management decisions. Labeling is not simply a design task — it is a regulatory decision‑making process. Final Thoughts The U.S. cosmetic market offers significant opportunities, but labeling compliance is one of the most critical aspects of regulatory readiness. Understanding the FDA framework is the first step, but achieving compliance often requires deeper expertise, particularly for international brands navigating multiple regulatory systems simultaneously. If your company is planning to enter the U.S. market, update existing labels, or verify compliance under current FDA and MoCRA requirements, Belab Services can support you.   Our regulatory specialists provide: • FDA cosmetic label compliance assessments • Claims and classification risk evaluation • Global label harmonization strategies (USA, EU, UK and worldwide) • Regulatory support for market entry and ongoing compliance Contact our team to discuss your project and ensure your products meet U.S. regulatory expectations with confidence. Get in touch with our team of experts today.

This is a question we receive quite often from clients who are already selling their cosmetic products in the European Union and are looking to expand into new markets. Norway is usually one of the first countries brands consider when entering the Nordic region, mainly because the regulatory pathway is relatively straightforward — if you already comply with EU rules. The short answer is: yes, in most cases you can sell cosmetics in Norway using the same EU CPNP notification. But, as always in regulatory affairs, there are a few details worth understanding before placing products on the market.   Table of Contents Is Norway Covered by EU Cosmetic Regulations? Is CPNP Notification Valid in Norway? Responsible Person Requirements Import and Logistics: What Changes? Common Mistakes We See in Practice Why Norway Is an Attractive Expansion Market? Can You Sell Cosmetics in Norway with Your EU CPNP Notification? Is Norway Covered by EU Cosmetic Regulations? Norway is not part of the European Union, but it belongs to the European Economic Area (EEA) . This means the country has adopted the EU Cosmetics Regulation (Regulation (EC) No 1223/2009), including ingredient restrictions, safety requirements, GMP expectations, and documentation obligations. From a compliance perspective, Norway behaves very similarly to an EU Member State. If your product is already compliant in the EU — with a valid Responsible Person, Product Information File (PIF), Cosmetic Product Safety Report (CPSR), and CPNP notification — you are already most of the way there.   Is CPNP Notification Valid in Norway? Yes. Because Norway participates in the EEA regulatory framework, CPNP notification also covers the Norwegian market. This means: No separate national cosmetic notification is required Norwegian authorities have access to CPNP data EU-compliant products can be placed on the market However, notification alone does not guarantee compliance. Authorities can still request documentation during market surveillance.   Responsible Person Requirements Your cosmetic product must have a Responsible Person established in the EU or EEA . One important point we regularly clarify with clients: since Brexit, a UK Responsible Person alone does not cover Norway or the EU . Companies that initially entered the UK market sometimes overlook this when expanding into Europe. The Responsible Person remains legally accountable for product safety, documentation, vigilance, and compliance. Import and Logistics: What Changes? Norway is outside the EU customs union. This does not change cosmetic compliance itself, but it does affect: Import procedures VAT handling Customs documentation Identification of the importer Companies should clearly define who acts as importer and who holds regulatory responsibility before placing products on the market.   Common Mistakes We See in Practice In our experience, the biggest challenges are rarely regulatory complexity. They are usually small gaps that could have been avoided with early planning, such as: Assuming UK Responsible Person coverage still applies Missing Norwegian language labelling Incomplete PIF documentation Unclear importer roles Believing Norway requires a separate notification system A short compliance review before launch often prevents much larger problems later. Why Norway Is an Attractive Expansion Market? For brands already compliant in the EU, Norway is typically considered a low-barrier market  because: The regulatory framework is harmonised with EU law CPNP notification remains valid No additional registration fees are required Compliance costs are relatively limited This makes Norway a logical first step when expanding into the Nordic region.   If your cosmetic products are compliant with EU regulations and correctly notified in CPNP, entering the Norwegian market is usually straightforward. The key is ensuring that your Responsible Person, labelling, and documentation remain fully aligned with EEA requirements. If you are planning to expand into Norway or other international markets, reviewing your compliance status before launch can save significant time and cost later. At Belab , we regularly support brands with EU and global market access, including Responsible Person services, PIF preparation, and international regulatory strategy. If you have questions about Norway or any other market, our team will be happy to help. Get in touch with our team of experts today.

Regulatory impact on cosmetics and personal care products The United Kingdom continues to strengthen its environmental legislation to reduce plastic pollution, introducing restrictions that will directly affect manufacturers and brands of personal hygiene, cleaning and cosmetic products. On February 10, 2026, Scotland adopted the Environmental Protection (Wet Wipes Containing Plastic) (Scotland) Regulations 2026, which establishes a ban on selling or supplying to consumers wet wipes containing plastic from August 11, 2027. Table of contents Which products are affected? One key point: Exceptions are very limited 1. Medical or health uses 2. Certain industrial or professional uses Calendar and regulatory forecast Why is this regulation important for the cosmetics sector? What should companies do now? Conclusion This measure is part of a broader UK strategy to reduce marine pollution, blockages in sewer systems and the release of microplastics into the environment. The UK will ban Wet Wipes that Contains Plastic Which products are affected? The regulation targets single-use wet wipes that contain plastic . For regulatory purposes, a “wet wipe” is understood to mean: A pre-moistened non-woven fabric that is not designed for reuse. This may include: Cosmetic makeup remover or facial cleansing wipes Baby wipes or personal hygiene products Household cleaning wipes Pre-moistened face masks (sheet masks) For the cosmetics sector, the potential inclusion of masks is especially relevant, since many substrates contain synthetic fibers derived from plastic polymers such as polyester or polypropylene. One key point: Exceptions are very limited Although the prohibition is broad, the legislation provides for very few exceptions, and these are designed for specific situations, not for the general consumer market. Key exceptions identified: 1. Medical or health uses Exceptions are foreseen for products used in healthcare settings or by medical professionals, where plastic-free alternatives may not be suitable. In Scotland, impact documentation also considers the possibility of access to certain products through pharmaceutical channels for people with specific medical needs. 2. Certain industrial or professional uses Limited exceptions may exist for business-to-business (B2B) supplies or specialized industrial applications, provided they meet established regulatory criteria. However, for the vast majority of cosmetic brands that sell to consumers, the practical conclusion is clear: it will be necessary to use plastic-free substrates, unless an applicable exception can be demonstrated. Calendar and regulatory forecast Although implementation in Scotland is scheduled for August 2027, the regulatory context indicates a trend towards alignment across the UK. This means that companies that market products in England, Wales, Scotland or Northern Ireland should anticipate similar requirements in the future. Since product development cycles in cosmetics can last between 12 and 24 months, early planning is essential. Why is this regulation important for the cosmetics sector? This regulation is not an isolated case, but part of a broader trend towards: Reduction of plastics and microplastics Environmental regulation of consumer products Sustainability claims review Circular economy and ecological design Companies that anticipate They will have competitive advantages, both regulatory and commercial. What should companies do now? It is recommended to start an internal analysis as soon as possible: ✔ Audit the portfolio of products that may be considered “wet wipes” ✔ Verify the composition of the substrates with suppliers ✔ Evaluate plastic-free alternatives (cellulose, natural fibers, etc.) ✔ Plan reformulation or change of materials ✔ Review technical documentation and environmental claims ✔ Evaluate the impact on the UK market strategy Conclusion The UK's ban on plastic-wrapped baby wipes represents a significant change that will also affect the cosmetics sector. Although there are some exceptions, these are limited and specific, so most consumer products will need to adapt by using plastic-free materials before 2027. Companies that begin the transition now will be better positioned to comply with regulations and respond to the market's growing sustainability expectations. Get in touch with our team of experts today.

The European Commission continues to make progress in updating the CLP Regulation and, at the end of November 2025, notified the World Trade Organization of a new draft corresponding to the 24th Adaptation to Technical Progress (ATP). This proposal introduces new harmonized classifications for certain substances as carcinogenic, mutagenic or toxic to reproduction (CMR), which automatically generates regulatory implications in other legislative frameworks, especially in cosmetics. Table of contents Why is this relevant to the cosmetics industry? Substances included in the new ATP Ingredients under special regulatory attention 24th CLP ATP: New CMR classifications and their impact on the Cosmetic Industry Why is this relevant to the cosmetics industry? This is particularly important because, according to Article 15 of Regulation (EC) 1223/2009, substances classified as CMR under CLP are prohibited by default in cosmetic products, unless the Scientific Committee on Consumer Safety (SCCS) assesses their safety and confirms that they can be used under specific conditions. Substances included in the new ATP This new ATP includes eight substances with CMR classification: Lithium carbonate (CAS 554-13-2) — CMR 1A (toxic to reproduction) Potassium borate (CAS 1332-77-0) — CMR 1B (toxic to reproduction) Sodium EDTMP (CAS 22036-77-7) — CMR 1B (carcinogenic) Potassium EDTMP (CAS 34274-30-1) — CMR 1B (carcinogenic) Potassium bromide (CAS 7758-02-3) — CMR 1B (toxic to reproduction) 2-pyrrolidone (CAS 616-45-5) — CMR 1B (toxic to reproduction) Heliotropin (CAS 120-57-0) — CMR 1B (toxic to reproduction) Melaleuca alternifolia / Tea Tree Oil (CAS 68647-73-4 and 85085-48-9) — CMR 1B (toxic to reproduction) Not all of these substances are commonly used in cosmetics, but some do generate direct interest in the industry, especially Heliotropin and Tea Tree Oil, which are currently at the center of regulatory discussions. Ingredients under special regulatory attention In the case of Tea Tree Oil, the SCCS has previously published an opinion concluding that it can be considered safe at certain concentrations and conditions of use, so it is likely that it will eventually be included in Annex III (list of restricted substances) of the Cosmetic Regulation rather than being banned. Heliotropin, meanwhile, is currently under evaluation by the SCCS. The outcome of this evaluation will be key in determining whether it can remain on the market with concentration limits or whether it will end up in Schedule II (prohibited substances). This type of situation reflects very well how the European regulatory system works: a toxicological classification under CLP does not automatically imply a definitive ban in cosmetics, but it does activate a scientific review process that may end in restriction or prohibition depending on the risk assessment. From an industry perspective, although the ATP is not yet fully adopted, this is a good time to review ingredient portfolios, identify potential regulatory exposures, and anticipate reformulation strategies if necessary. Experience shows that companies that anticipate these changes avoid supply problems, product recalls, or hasty decisions later on. The regulatory trend in the EU remains clear: the strengthening of the principle of preventive consumer protection and the increasing interconnection between horizontal chemical legislation (CLP) and sectoral regulations, such as cosmetics. Get in touch with our team of experts today

A few weeks ago the European Commission published a rather interesting technical report on the future harmonised system of labelling of packaging waste in the European Union, within the new Packaging and Packaging Waste Regulation (PPWR). In short: Europe wants consumers to be able to easily understand how to recycle packaging, regardless of the country they are in. Today we have different symbols, different colors, different instructions… and that creates confusion, errors in waste separation and also additional costs for companies that sell in multiple markets. The goal is to create a common language across the EU. Table of contents Single Recycling Labelling in the EU: The Proposal New labelling requirements for packaging in the EU The European Union is moving towards a single recycling label for packaging Single Recycling Labelling in the EU: The Proposal Labels based on the container material (plastic, glass, metal, etc.) Pictograms that match the waste containers Minimal text and intuitive design Solutions for multi-component packaging All of this has been developed using consumer behavior studies and industry consultations, which is relevant because it shows that the Commission wants it to work in practice, not just in theory. The important thing for companies is that, although the final implementing act does not yet exist, the regulatory message is already clear: New labelling requirements for packaging in the EU Changing packaging involves: Redesign of artworks Technical validations Transition costs Coordination with manufacturers and suppliers But in the medium term it should also simplify life for brands that sell in several European countries, because it will reduce regulatory fragmentation. From a regulatory point of view, we are seeing a very clear trend: packaging is becoming a critical element of compliance, not just of marketing. PPWR, recyclability, recycled content, EPR, environmental labeling… everything is connected. My recommendation for companies that sell in Europe is simple: start looking at this now, not when it becomes mandatory. Because when the time comes, the deadlines will probably be tight. Get in touch with our team of experts today

In January 2026, the Food and Drug Administration (FDA) published draft guidance that provides greater clarity regarding its authority to access and copy records related to cosmetic products marketed in the United States. This document was developed under the Modernization of Cosmetics Regulation Act (MoCRA), the most significant reform of the U.S. cosmetics industry in more than 80 years. Although this is a preliminary guide open to comments, its content confirms an important regulatory trend: the FDA is strengthening its documentary oversight and inspection capabilities in the cosmetics sector, progressively bringing it closer to regulatory models already consolidated in food and medical devices. For international manufacturers, brands, and distributors operating in the US market, understanding these new expectations is key to ensuring compliance. Table of contents Legal framework: sections 605, 610 and 704 of the FD&C Act Access to adverse event records (Section 605) Access to records for serious health risks (Section 610) Strengthening FDA inspections on cosmetics (Section 704) Practical implications for international companies Regulatory trend: greater supervision and accountability Conclusion FDA: New Guidance on Access to Records for Cosmetics under MoCRA Legal framework: sections 605, 610 and 704 of the FD&C Act The guide describes how the FDA will exercise its authority under three main provisions: Section 605 — Adverse Event Records Section 610 — Risk of serious health consequences (SAHCOD) Section 704 — Inspections These provisions significantly expand the agency's ability to request documentation from responsible companies and registered facilities. Access to adverse event records (Section 605) The FDA may request access to and a copy of records related to adverse event reports associated with the use of a cosmetic in the United States. One of the most relevant aspects for the industry is the record retention requirement: 6 years for standard companies 3 years for small businesses This includes not only the adverse event report, but also: Internal investigations Causality assessments Related communications Corrective actions implemented Many international companies still do not have structured cosmetovigilance systems aligned with these expectations, which can pose a risk during an inspection or investigation. Access to records for serious health risks (Section 610) The FDA may also request registrations when there is a reasonable belief that a cosmetic product may be adulterated in a way that poses a risk of: Serious Adverse Health Consequences or Death (SAHCOD) In these cases, the agency may require documentation from both the Responsible Person and the manufacturing facility, after presentation of credentials and written notification. This point connects directly with other MoCRA requirements such as: Safety substantiation Good Manufacturing Practices (GMP) Traceability systems Product recall procedures Strengthening FDA inspections on cosmetics (Section 704) The guide confirms that the FDA is consolidating its documentary inspection capabilities in the cosmetics sector. Historically, inspections in cosmetics were limited compared to other regulated industries. However, MoCRA introduces a structural change that requires companies to adopt more robust approaches to quality management and documentation. Practical implications for international companies One of the most frequent mistakes we observe in companies that export to the United States is assuming that the European Product Information File (PIF) automatically covers US requirements. In reality, MoCRA introduces additional expectations, especially in: Adverse event management Document retention Preparation for inspections Traceability systems in the USA. Recall procedures Structured safety substantiation Registering on the FDA portal is only the first step in compliance. Regulatory trend: greater supervision and accountability The publication of this guide confirms a clear evolution of the US regulatory model: Greater inspection authority Greater responsibility of the Responsible Person Stricter documentation requirements Greater FDA intervention capacity For international brands, this implies a strategic change: moving from a reactive approach to a preventive approach based on quality systems. Conclusion The FDA's new guidance on access to records represents another step in the implementation of MoCRA and confirms that the regulatory environment for cosmetics in the United States is entering a new stage of greater control and oversight. Companies that anticipate these changes will be better positioned to operate safely in the US market. Do you need support to comply with MoCRA or prepare your company for FDA inspections? At Belab Services we help international brands comply with regulatory requirements in the United States and more than 60 global markets. Get in touch with our team of experts today

The publication of Regulation (EU) 2025/2650 in the Official Journal of the European Union marks a significant point in the operational evolution of the Regulation on deforestation-free products (EUDR – Regulation (EU) 2023/1115). Although the amendment does not alter the fundamental objectives of the regulations — to prevent products linked to deforestation from entering or leaving the European market — it does introduce significant changes in application deadlines, material scope and distribution of obligations within supply chains. From a compliance perspective, the key element is not just the time delay, but the regulatory signal on how the European Union intends to balance sustainability, traceability and operational viability for economic operators. Table of contents Regulatory Context: Operational Simplification without Change in Regulatory Objective Calendar Adjustment: Delay for Implementation, Not for Objectives Modification of Material Scope: Exclusion of Printed Products Redistribution of Responsibilities in the Supply Chain Specific Simplification for Small Primary Operators Strategic Reading: What Regulatory Signal Is the EU Sending Practical Impact for Businesses Regulatory Conclusion EUDR: Regulatory Analysis of the Reform Introduced by Regulation (EU) 2025/2650 Regulatory Context: Operational Simplification without Change in Regulatory Objective The revision adopted by the EU Council aims to facilitate the practical implementation of the EUDR, while maintaining its environmental purpose intact: ensuring that certain raw materials and derived products are not linked to deforestation or forest degradation. The amendment primarily addresses concerns expressed by Member States and economic actors regarding: the administrative burden of the due diligence system the level of preparedness of the authorities and operators the operational availability of the European computer system The result is an “operational”, not structural, review: application mechanisms are adjusted without modifying the core of the regulatory model. Calendar Adjustment: Delay for Implementation, Not for Objectives One of the most relevant changes is the postponement of the effective application of the main obligations. The new schedule sets the application from: December 30, 2026 for larger operators and companies June 30, 2027 for micro and small businesses existing as of December 31, 2024 This delay aims to allow for the adaptation of IT systems, internal processes, and traceability mechanisms in both operators and public administrations. From a regulatory point of view, this type of delay usually indicates a pragmatic approach: ensuring effective compliance rather than premature formal implementation. Modification of Material Scope: Exclusion of Printed Products The reform also introduces a specific modification to the scope of Annex I, eliminating certain products associated with Chapter 49 of the tariff system, including books, newspapers and other printed products. This exclusion is based on the assessment of the low risk of deforestation associated with these products and aligns with the objective of concentrating regulatory resources on commodities with a real impact on global deforestation. For the publishing and printing sectors, this amendment provides direct legal certainty by formally excluding them from the EUDR due diligence regime. Redistribution of Responsibilities in the Supply Chain The amendment also clarifies the distribution of obligations among actors in the chain. The model maintains the primary responsibility for due diligence on operators who introduce the product to the market, while downstream actors maintain obligations mainly related to traceability and information, reducing administrative duplication. In regulatory terms, this reflects an increasingly visible trend in European legislation: centralizing critical obligations at key market entry points, while maintaining traceability obligations for the rest of the chain. Specific Simplification for Small Primary Operators The reform also introduces simplified mechanisms for micro and small primary operators, including simplified declaration options and more flexible geolocation requirements under certain conditions. This approach reflects the legislative effort to reduce disproportionate regulatory barriers for smaller operators without weakening the global traceability system. Strategic Reading: What Regulatory Signal Is the EU Sending From a regulatory intelligence perspective, the message is twofold: On the one hand, the EU reaffirms the political and environmental objective of the EUDR. On the other, it recognizes the global operational complexity of implementing forest traceability systems on an international scale. The amendment also introduces the obligation of future review of the administrative impact of the regulation, including a specific assessment of the burden on small operators. This suggests that the EUDR will continue to evolve in progressive phases. Practical Impact for Businesses The temporary delay should not be interpreted as a regulatory pause. The EUDR continues to require, in the medium term: complete supply chain mapping robust traceability systems verifiable data governance internal processes aligned with environmental due diligence The European regulatory approach remains clearly focused on controlling environmental risk throughout the value chain. Regulatory Conclusion Regulation (EU) 2025/2650 does not redefine the EUDR, but it does redefine its practical implementation. From a compliance perspective, the most relevant change is not the time delay, but the confirmation of a regulatory model based on: full traceability responsibility structured by levels of the chain progressive risk-based supervision The EUDR remains, in essence, one of the most demanding environmental traceability regulations globally. Get in touch with our team of comsetic regulation experts today!

The publication of the Draft Guidance on mandatory cosmetic recalls by the US Food and Drug Administration represents one of the most relevant interpretative developments since the entry into force of MoCRA. Although the document does not introduce new legal requirements, it does constitute the first structured explanation of how the agency plans to apply, in operational terms, the mandatory recall authority incorporated into the US legal framework. From a regulatory point of view, these types of documents usually anticipate the enforcement model that will later be consolidated in final guidelines, inspections and administrative actions. Table of contents Regulatory Context: MoCRA and the Legal Authority for Mandatory Recall Legal Nature of Draft Guidance Operational Interpretation: What the Draft Guidance Really Explains Regulatory Implications for the Cosmetics Industry Strategic Reading: What Regulatory Signal Is the FDA Sending Regulatory Conclusion FDA Draft Guidance on Cosmetic Recalls under MoCRA Regulatory Context: MoCRA and the Legal Authority for Mandatory Recall The legal authority does not originate from the Draft Guidance, but from the Modernization of Cosmetics Regulation Act (MoCRA) itself, which introduced section 611 in the FD&C Act. Under this legal basis, the FDA can order a mandatory recall when it determines that there is a reasonable probability that a cosmetic is adulterated or mislabeled and that its use could cause serious health consequences or death, especially if the Responsible Person does not conduct a voluntary recall after being given the opportunity to do so. Historically, cosmetic recall policies in the US have been based on voluntary mechanisms, and the The FDA continues to indicate that it expects most recalls to continue occurring under this model. The real change, therefore, is not the replacement of the voluntary system, but the introduction of a coercive tool when the health risk justifies it. Legal Nature of Draft Guidance The draft published in December 2025 is presented in a Q&A format and aims to clarify the agency's approach to: The criteria that could justify a mandatory recall The regulatory procedure that the FDA would follow Industry compliance expectations Like any FDA guidance, the document reflects the agency's current thinking , is not legally binding, and may be modified before its final version following the public comment process. From a compliance perspective, this does not diminish its relevance: in practice, this type of guide usually anticipates the inspection and enforcement behavior of the authority. Operational Interpretation: What the Draft Guidance Really Explains The document does not expand the law, but it does add clarity on regulatory operations. For example, it describes how, before issuing a mandatory recall order, the FDA will provide the Responsible Person with the opportunity, in writing, to voluntarily cease distribution of the product. It also contemplates the possibility of informal hearings to discuss the scientific or regulatory basis for the agency's decision. This approach reinforces a progressive enforcement model: Health risk assessment Opportunity for voluntary action Escalation to mandatory measures if the risk persists From a comparative regulatory perspective, this model is consistent with other FDA sectors (e.g., medical devices or food safety). Regulatory Implications for the Cosmetics Industry The Draft Guidance should be interpreted within a broader context: MoCRA has significantly strengthened post-market control over cosmetics. Among other elements, the legislation introduced: Obligation to report serious adverse events within 15 days Greater FDA access to safety records Expanded monitoring capabilities over facilities and products Taken together, this points to a regulatory model focused on the entire product lifecycle, not just the initial marketing phase. Strategic Reading: What Regulatory Signal Is the FDA Sending From a regulatory strategy perspective, the main message of the Draft Guidance is regulatory predictability. The FDA is: Formalizing decision criteria Standardizing performance processes Preparing the ground for more consistent enforcement It does not imply an immediate increase in mandatory recalls, but it does reduce uncertainty about when and how they might be applied. Regulatory Conclusion The Draft Guidance on cosmetic recalls should be interpreted as a transitional document between the legal basis created by MoCRA and its future consolidated operational application. For the industry, the real impact lies not only in the authority for mandatory recalls, but also in the consolidation of a supervisory model based on: Continuous risk assessment Defensible security evidence Actual operational capacity for post-market management Get in touch with our team of experts today!

At the end of December 2025, the United Kingdom took a significant regulatory step in controlling substances used in tattoo inks and permanent makeup products (PMUs). The decision confirms the introduction of a new restriction under UK REACH, through an amendment to Schedule XVII. Beyond the regulatory holder, this measure will have a direct impact on formulators, importers, distributors and tattoo professionals, especially in terms of reformulation, testing, traceability and supply chain management. Table of contents Why is this restriction being introduced? Regulatory scope: broad approach and alignment with other regulations Concentration limits: a more precautionary approach than initially proposed End of derogations for some key pigments New labeling requirements: more mandatory information Transition schedule Conclusion REACH Confirms New Restrictions on Tattoo Inks and Permanent Makeup Why is this restriction being introduced? The decision is based on previous technical assessments that conclude that certain substances present in tattoo inks may pose insufficiently controlled risks to human health. The identified risks include substances with the following profiles: Carcinogenic Mutagenics Toxic to reproduction Skin sensitizers Corrosive or with potential for eye damage Furthermore, the risk is considered especially relevant due to the intradermal exposure route and the long-term presence of the pigments in the body, including possible migration to organs such as lymph nodes or the liver. Regulatory scope: broad approach and alignment with other regulations The restriction takes a very broad approach. It covers not only substances classified under GB CLP, but also substances restricted under the Cosmetics Regulation, as well as additional specific lists of substances with defined concentration limits. For example, the draft includes extremely low limits for certain heavy metals and contaminants, in some cases in the parts per billion range, which will require strengthening analytical control and the purity of raw materials. Concentration limits: a more precautionary approach than initially proposed One of the key changes compared to previous proposals is the adoption of stricter limits. The authority decided to apply lower values to reduce residual risks, even assuming this will generate additional testing and reformulation costs for the industry. In practice, this means: Greater pressure on the selection of raw materials Need for more sensitive analytical methods Possible disappearance of certain current formulations End of derogations for some key pigments Another relevant point is the elimination of derogations that had initially been considered for certain pigments (including widely used blue and green pigments). Although there is no direct evidence of specific unsafety in these cases, the authorities have opted for a preventive approach based on hazard classification and lack of sufficient safety evidence for intradermal use. New labeling requirements: more mandatory information The new framework introduces stricter labeling requirements. These include: Lot identification Complete list of ingredients Safety and usage instructions Specific warnings if nickel or chromium VI are present below the limit Identifying pH regulators when applicable The goal is to improve traceability and the information available to professionals and end users. Transition schedule Two main windows are established: Approximately 2 years for placing on the market Approximately 3 years for the use of existing products This gives the industry room to adapt formulations, validate alternatives, and adjust supply chains. Conclusion This restriction confirms a clear trend: the United Kingdom is consolidating a regulatory approach very much in line with preventive chemical safety, especially in products with direct and prolonged exposure to the human body. For companies in the sector, the message is clear: anticipation will be key. Waiting until the final deadlines could lead to real business continuity problems. Get in touch with our team of experts today.