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The US Food and Drug Administration (FDA) has once again focused on the safety of cosmetic products after detecting six new products marketed as "gel nail polish remover" that contain methylene chloride, a substance banned in cosmetics in the United States. This detection is part of the agency's regular market surveillance programs, in which products available to consumers are analyzed to verify their regulatory compliance. Table of contents Why is this worrying? What this reveals (and worries) And in Europe? Key for brands: trust is not enough FDA Identifies New Nail Polish Removers with a Banned Ingredient Why is this worrying? Methylene chloride is not a "gray" or "under evaluation" cosmetic ingredient. It is clearly prohibited. It is a substance used in industrial processes such as: Paint strippers Metal cleaning Industrial degreasing Its use in cosmetics is prohibited due to its toxicological profile: Evidence of carcinogenic potential in animal studies Risks to human health from inhalation and dermal exposure Possible effects on the central nervous system What this reveals (and worries) These types of findings are not isolated, and reflect several current challenges in the sector: 1. Control problems in global supply chains Many of these products are marketed online or through marketplaces, where prior control is limited. 2. Gap between formulation and actual compliance There is not always adequate verification of the final composition against the applicable regulations. 3. Reputational risk for brands and distributors Even without manufacturing directly, marketing non-compliant products can have significant regulatory consequences. And in Europe? Although this news comes from the USA, the message is fully applicable to the European market. Dichloromethane is also restricted under Regulation (EC) No 1223/2009, meaning that similar products would not be compliant in the EU. Key for brands: trust is not enough This type of case reinforces an idea that is already evident in regulation: Responsibility does not end with the supplier. To avoid similar situations, it is essential to: Verify formulations with reliable suppliers Review ingredients against updated regulatory lists Ensure adequate testing and technical documentation Implement additional controls on imported products The FDA's action is not just a one-off alert: it is a clear reminder that market surveillance is real and constant. And in an increasingly demanding environment, Compliance is no longer just a requirement — it's a competitive advantage. Get in touch with our team of experts now.

Unlike many other markets where sunscreens are regulated as cosmetics, in the U.S. they are legally classified as over-the-counter (OTC) drugs because they are intended to prevent sunburn and reduce the risk of skin cancer and premature skin aging caused by ultraviolet radiation. This classification significantly impacts product development, labeling, testing, manufacturing, and market entry strategy. Understanding how the FDA OTC sunscreen monograph works is essential for companies planning to commercialize sunscreen products in the United States. Table of contents Why Sunscreens Are Regulated as OTC Drugs in the U.S. What Is the OTC Sunscreen Monograph? Active Ingredients: GRASE vs Non-GRASE Categories Claims and Labeling Requirements Testing Requirements for Sunscreens Manufacturing Requirements: Drug GMP Compliance FDA Registration and Listing Obligations OMUFA Fees for Sunscreen Products The Role of the U.S. Agent for Foreign Companies Strategic Considerations for International Sunscreen Brands Common Challenges in U.S. Sunscreen Market Entry Why Regulatory Expertise Is Often Needed OTC Sunscreen Monograph: How Sunscreens Are Regulated in the United States Why Sunscreens Are Regulated as OTC Drugs in the U.S. Under U.S. law, products intended to diagnose, cure, mitigate, treat, or prevent disease are considered drugs. Because sunscreens are intended to prevent sunburn and protect against UV-induced skin damage, they fall within the drug category rather than cosmetics. This means sunscreen products must comply with: FDA drug regulations OTC monograph requirements Drug Good Manufacturing Practices (cGMP) Drug labeling standards Establishment registration and product listing The regulatory burden is therefore significantly higher than for cosmetic products. What Is the OTC Sunscreen Monograph? The OTC sunscreen monograph is the regulatory framework that defines the conditions under which sunscreen products can be marketed in the United States without individual FDA product approval. It specifies requirements related to: Permitted active ingredients Concentration limits Dosage forms SPF labeling Broad spectrum claims Required warnings and directions Testing methods Labeling structure Products that comply with the monograph conditions are considered Generally Recognized as Safe and Effective (GRASE) and may be marketed without a New Drug Application (NDA). Active Ingredients: GRASE vs Non-GRASE Categories One of the most critical aspects of sunscreen regulation involves the status of active ingredients. FDA has categorized sunscreen actives into different regulatory groups: Ingredients considered GRASE Ingredients requiring additional safety data Ingredients not considered GRASE Mineral UV filters such as zinc oxide and titanium dioxide are widely recognized as acceptable under current conditions. Several organic UV filters require further safety evaluation before definitive classification. Ingredient selection therefore plays a major role in regulatory strategy and product positioning. Claims and Labeling Requirements Sunscreen claims are tightly regulated in the United States because they relate directly to health protection. Permitted claims depend on compliance with testing standards and monograph conditions. The wording, placement, and formatting of these claims are highly controlled. Unlike cosmetics, companies cannot freely develop marketing language outside monograph parameters. Testing Requirements for Sunscreens Demonstrating compliance with monograph conditions requires specific testing approaches. These may include: SPF testing Broad spectrum testing Water resistance testing Stability data Microbiological quality Safety assessments Companies often underestimate the technical complexity involved in generating acceptable data packages. Testing must follow recognized methodologies and appropriate study design to support labeling claims. Manufacturing Requirements: Drug GMP Compliance Drug GMP standards are significantly more demanding than cosmetic GMP and typically require: Validated manufacturing processes Quality systems and documentation Batch records and traceability Laboratory controls Change control systems Complaint and recall procedures Foreign manufacturers are also subject to FDA inspection authority. FDA Registration and Listing Obligations Companies marketing sunscreen products must complete several regulatory steps before commercialization. These typically include: Establishment registration with FDA Product listing in FDA databases NDC number assignment Label compliance verification Facility fee obligations under OMUFA Although sunscreen products under the monograph do not require pre-approval, they are still subject to post-market oversight. OMUFA Fees for Sunscreen Products The Over-the-Counter Monograph User Fee Program (OMUFA) applies to facilities manufacturing OTC monograph drugs, including sunscreens. Annual facility fees support FDA regulatory activities related to OTC oversight. These fees apply to both domestic and foreign manufacturing sites and must be considered during financial planning. The Role of the U.S. Agent for Foreign Companies Foreign manufacturers of OTC sunscreen products must designate a U.S. Agent when registering with the FDA. The U.S. Agent serves as the FDA’s domestic contact point and facilitates communication between the agency and the foreign establishment. However, the U.S. Agent does not assume regulatory responsibility for compliance unless contractually defined. Clarifying responsibilities between brand owners, manufacturers, and regulatory representatives is essential for successful market entry. Strategic Considerations for International Sunscreen Brands Companies entering the U.S. sunscreen market should consider several strategic factors: Ingredient selection and regulatory status Manufacturing capabilities and GMP readiness Claims positioning and marketing strategy Labeling design aligned with FDA requirements Regulatory ownership (brand vs manufacturer) Long-term portfolio expansion plans Early regulatory planning can significantly reduce delays and compliance risks. Common Challenges in U.S. Sunscreen Market Entry Across international projects, several recurring challenges appear: Assuming sunscreens are cosmetics rather than drugs Using non-permitted active ingredients Claims exceeding regulatory allowances Underestimating testing complexity Manufacturing sites not meeting drug GMP standards Misalignment between brand owner and manufacturer responsibilities These issues can delay market entry or create compliance exposure. Why Regulatory Expertise Is Often Needed Although the OTC monograph pathway avoids individual product approval, compliance still requires coordination across multiple regulatory areas: Formulation and ingredient compliance Testing and performance validation Drug GMP manufacturing Labeling and claims FDA registration systems Post-market obligations Sunscreen regulation is therefore both technical and strategic. Despite the fact that the FDA OTC sunscreen monograph provides a pathway for marketing sunscreen products in the US, the full compliance involves more than simply selecting approved ingredients. It requires alignment across formulation, testing, manufacturing, labeling, and regulatory systems. Companies planning to enter the U.S. sunscreen market should approach regulatory strategy early to ensure efficient and compliant commercialization. If your company is planning to commercialize sunscreen products in the United States or needs support navigating FDA OTC requirements, Belab Services can assist you. Our regulatory specialists support international companies with: Sunscreen regulatory strategy and classification OTC monograph compliance assessment FDA establishment registration and product listing NDC assignment and labeling review OMUFA compliance support U.S. Agent services End-to-end market entry strategy Contact our team to discuss your project and ensure a smooth regulatory pathway into the U.S. market.

In March 2026, the Government of Canada published a new framework for the risk assessment of nanomaterials under the Canadian Environmental Protection Act (CEPA). At first glance, it might seem like just another technical update. However, this document marks a significant evolution in how authorities expect companies to assess and document the safety of nanomaterials. Table of contents What really changes with the new nanomaterials framework in Canada? Nanomaterials: why they cannot be evaluated like conventional substances Nanoform assessment: the major regulatory shift Life cycle and transformation of nanomaterials What happens when there is not enough data? New challenges: metrics and lack of consensus Conclusion: more technical requirements, not more regulation Nanomaterials in Canada: New CEPA 2026 Framework and its Regulatory Impact What really changes with the new nanomaterials framework in Canada? One of the most relevant aspects is that no new specific regulation has been created for nanomaterials . Instead, Canada has opted for: Maintaining the existing framework (CEPA) Adapting it to the particularities of materials at the nanoscale This approach follows the OECD line and confirms a global trend: 👉 there won't be completely new laws, but there will be much more demanding technical requirements. Nanomaterials: why they cannot be evaluated like conventional substances The framework makes it clear that nanomaterials exhibit properties that cannot be predicted from their "bulk" form. Factors such as: particle size shape surface chemistry can completely modify: toxicity bioavailability environmental behavior Furthermore, the document highlights that the CAS number is not sufficient to identify the actual risk . In practice: two materials with the same CAS number may require different regulatory assessments. Nanoform assessment: the major regulatory shift One of the most important changes is the focus on individual nanoforms . This means that: It is no longer enough to simply evaluate the substance It is necessary to evaluate each relevant nano variant. To that end, the authorities expect detailed information on: size distribution shape of the particles surface characteristics This level of characterization will become increasingly key in regulatory dossiers. Life cycle and transformation of nanomaterials The framework places special emphasis on a critical aspect: nanomaterials change throughout their life cycle . During use they may: to aggregate or cluster dissolve reacting to the environment This directly affects exposure and risk. Therefore, the evaluation should no longer focus solely on the original material, but on its behavior under real conditions. New challenges: metrics and lack of consensus Another relevant point is the lack of international harmonization. Unlike traditional substances, in nanomaterials the effect can depend on: number of particles surface volume This complicates things: comparison of studies data generation the regulatory justification What happens when there is not enough data? The document confirms the usual approach in regulation: use of read-across weight of evidence predictive models application of the precautionary principle In other words: if there is no data, uncertainty works against the company. Conclusion: more technical requirements, not more regulation The new Canadian framework does not introduce new direct legal obligations, but it does significantly raise the expected technical level. This reflects a clear global trend: The regulation of nanomaterials will become increasingly demanding in scientific terms For companies, this means that the evaluation of nanomaterials ceases to be a theoretical exercise and becomes a key strategic element in market access. Get in touch with our team of experts easily

The state of New Jersey has taken a firm step in regulating persistent chemicals with the passage of law S1042 – Protecting Against Forever Chemicals Act, in effect since January 12, 2026. Within this regulation, the cosmetics sector faces a significant change: the marketing of products containing intentionally added PFAS will be prohibited from January 12, 2028. Table of contents What is considered a PFAS under this law? Are there any exceptions? Transition period: key to taking action Risks of non-compliance Strategic approach: reformulation and traceability Conclusion New Jersey bans PFAS in cosmetics starting in 2028 What is considered a PFAS under this law? The legislation defines PFAS as fluorinated organic compounds that contain at least one fully fluorinated carbon atom. Furthermore, the concept of "intentionally added" is broad and includes: Ingredients incorporated for their functionality (e.g., water repellency, texture, sensory qualities) Substances that generate PFAS degradation byproducts This means that not only is the final formula evaluated, but also the chemical behavior of the ingredients over time. Are there any exceptions? Yes, but very limited. The law only considers the presence of technically unavoidable traces, provided they originate from: Impurities Migration from materials This puts the focus directly on the quality of raw materials and the control of suppliers. Transition period: key to taking action Companies have a 2-year adaptation period (until January 2028). During this time, it will be critical: Audit existing formulations Identify surfactants or fluorinated polymers Validate supplier declarations Evaluate PFAS-free alternatives Risks of non-compliance Failure to comply with the regulations may result in: Significant administrative sanctions Product recall Beyond the legal impact, there is a clear reputational risk in a context of increasing pressure on persistent substances. Strategic approach: reformulation and traceability This regulation confirms a clear trend in the US: Greater state control over critical chemicals, even outside the federal framework (FDA). For brands, this translates into an urgent need to: Improve supply chain traceability Implement raw material verification processes Betting on proactive reformulation Conclusion New Jersey is positioning itself as one of the most restrictive states regarding PFAS in cosmetics, setting a precedent that other states will likely follow. Companies that anticipate these changes will not only ensure compliance, but will also gain a competitive advantage in an increasingly demanding market in terms of safety and sustainability. Get in touch with our team of experts today and stay compilant

The regulation of fragrance allergens in cosmetic products has evolved in recent years in multiple jurisdictions. Following updates introduced in the European Union and the growing interest in improving the information available to consumers, Canada has also incorporated new regulatory requirements regarding transparency on fragrance allergens. However, following the publication of these modifications, Health Canada has decided to introduce greater flexibility in how certain requirements will be applied, especially regarding the declaration of allergen concentration on the cosmetic notification form. Below we analyze what Canadian regulations require, what aspects have been made more flexible, and what companies that market cosmetics in Canada should take into account. Table of contents New requirements for fragrance allergens in Canada Concerns of the cosmetics industry Health Canada's response: greater regulatory flexibility Cases in which concentration will still be mandatory Planned changes to the Cosmetic Notification Form (CNF) Implementation schedule The schedule will be as follows: As of April 12, 2027 What should cosmetic companies do now? Conclusion Canada: Fragrance Allergen Notification in Cosmetic Products New requirements for fragrance allergens in Canada Recent amendments to the Cosmetic Regulations under the Food and Drugs Act introduce the obligation to declare certain fragrance allergens on cosmetic labels when they exceed certain concentration limits. Specifically, allergens must be indicated in the product's ingredient list when they are present above: 0.01% in rinse-off products (products that are rinsed off, such as shampoos or gels) 0.001% in leave-on products (products that remain on the skin, such as creams or perfumes) The aim of this measure is to protect consumers who are sensitive or allergic to certain fragrance components, allowing them to easily identify their presence in cosmetic products. In addition to labeling, the regulations also initially introduced the requirement that the presence and concentration of these allergens be declared in the Cosmetic Notification Form (CNF) submitted to Health Canada. Concerns of the cosmetics industry Following the publication of the regulatory changes, Health Canada received comments and concerns from the cosmetics industry, especially related to the obligation to report the exact concentration of fragrance allergens in the CNF. Among the main problems identified by manufacturers and importers were: Difficulties in obtaining accurate concentration data from fragrance suppliers Protection of confidential business information Supply chain complexity Increased administrative burden for businesses In many cases, fragrances are complex mixtures protected as trade secrets, and suppliers do not always share the exact concentrations of each allergen present in the formulation. This created a situation where manufacturers could know the presence of certain allergens but not necessarily their exact concentration, which complicated compliance with the initial requirement. Health Canada's response: greater regulatory flexibility Taking into account these concerns and the current economic and commercial context, Health Canada has decided to adopt a more flexible approach in interpreting the concentration notification requirement. It is important to note that: Health Canada will not formally modify the text of the regulation, but will make the interpretation of the requirement to declare the concentration of fragrance allergens in the Cosmetic Notification Form more flexible. In practice, this means that: The declaration of the concentration of most fragrance allergens in the CNF will be optional. However, this flexibility does not eliminate the obligation to declare allergens as individual ingredients. Therefore, companies must continue to comply with two fundamental obligations: Fragrance allergens must continue to be listed as individual ingredients on the Cosmetic Notification Form. Allergens must appear in the list of ingredients on the label when they exceed the established limits. Cases in which concentration will still be mandatory Although Health Canada is introducing flexibility for most cases, there are situations where concentration will still be mandatory at the CNF. This occurs when the fragrance allergen also appears as a restricted ingredient on the Cosmetic Ingredient Hotlist. In these cases, compliance with the restriction depends on specific concentration limits, so Health Canada continues to require the relevant information. Some examples mentioned by the authority include: Eucalyptus Camphor Methyl salicylate When an ingredient is subject to conditions linked to a specific concentration in the Hotlist, the concentration range code or the exact concentration must still be indicated in the CNF. Planned changes to the Cosmetic Notification Form (CNF) Currently, the Cosmetic Notification Form requires entering a concentration (exact or by range) for all ingredients, including fragrance allergens. However, Health Canada has indicated that the next revision of the form will allow certain fragrance allergens to be entered without the need to indicate their concentration. While this update is being implemented, Health Canada recommends that: If the concentration is known, it should be provided in the CNF. If this is unknown, companies may submit an amended notification when the form is updated. In addition, the form currently allows you to select a "Fragrance Allergen" option, which identifies the ingredient as a fragrance allergen and prevents its concentration from being counted within the total minimum concentration of the product. Implementation schedule The new requirements will officially come into effect on: April 11, 2026 However, Health Canada will apply a phased, risk-based approach to regulatory compliance and enforcement. The schedule will be as follows: April 12, 2026 – April 11, 2027 During this period, Health Canada will prioritize promoting compliance, helping regulated businesses adapt to the new requirements. As of April 12, 2027 Inspection, compliance, and enforcement activities will follow the department's standard risk-based approach. What should cosmetic companies do now? For companies that market cosmetics in Canada, these changes involve several key actions. Among the most important are: Review formulations to identify fragrance allergens present above regulatory limits Verify that allergens are correctly included in the product labeling Confirm that allergens are listed as separate ingredients in the CNF Evaluate whether any of these ingredients are also subject to restrictions on the Cosmetic Ingredient Hotlist Prepare for the Cosmetic Notification Form update Although Health Canada has introduced some flexibility, transparency obligations to the consumer remain a central element of the Canadian regulatory framework. Conclusion Health Canada's decision to relax the reporting of fragrance allergen concentrations reflects an attempt to balance two key objectives: to protect the health of consumers reduce unnecessary regulatory burdens for the industry Cosmetic companies must understand that, although the concentration in the Cosmetic Notification Form will be optional in many cases, the obligation to declare these allergens in the labeling and notification remains fully in force. For international manufacturers and importers, this change represents a partial simplification of the notification process, but still requires careful management of information on fragrances and allergens.

Many cosmetic brands expanding into the United States already have a Cosmetic Product Safety Report (CPSR) prepared for the European Union or the United Kingdom. A common question is whether this documentation can be reused for the U.S. market — and if so, how. While EU and UK safety assessments provide a strong scientific foundation, regulatory frameworks differ significantly between jurisdictions. Successfully entering the U.S. market requires more than simply translating or reformatting an existing CPSR. This article explains the key differences and what companies should consider when adapting EU or UK safety documentation for the United States. Table of Contents Do Cosmetics Require a CPSR in the United States? Key Differences Between EU/UK CPSR and U.S. Requirements 1. Regulatory Framework 2. Ingredient Regulatory Landscape 3. Exposure and Risk Assessment Assumptions 4. Claims and Product Classification Risks 5. Labeling Requirements and Safety Warnings Can an EU&UK CPSR Be Used as a Starting Point? The Impact of MoCRA on Safety Documentation Additional Considerations for International Brands Common Challenges When Adapting CPSRs Strategic Approach to U.S. Safety Substantiation How to adapt cosmetics CPSR from the EU and the UK to the USA Do Cosmetics Require a CPSR in the United States? Unlike the EU and UK, the United States does not legally require a formal CPSR document with the same structure defined under Regulation (EC) No. 1223/2009. However, U.S. law requires that cosmetic products be safe for their intended use, and companies must maintain adequate safety substantiation to support that conclusion. Under the Modernization of Cosmetics Regulation Act (MoCRA), companies responsible for marketing cosmetics in the U.S. must ensure they possess: Safety data supporting product use Evidence demonstrating safe formulation Documentation supporting ingredient safety Records available for FDA inspection if requested Therefore, while the format differs, scientific expectation remains comparable. Key Differences Between EU/UK CPSR and U.S. Requirements Several regulatory differences must be considered when adapting documentation. 1. Regulatory Framework EU and UK cosmetics operate under detailed regulatory frameworks requiring: CPSR Parts A and B Qualified safety assessor sign-off Responsible Person obligations Product Information File (PIF) The U.S. system focuses more on substantiation of safety rather than prescribed documentation formats. This difference often creates confusion when companies attempt to reuse EU documentation directly. 2. Ingredient Regulatory Landscape Ingredient restrictions differ between jurisdictions. Examples include: Color additives approval requirements in the U.S. Different prohibited and restricted ingredient lists Varying preservative and UV filter regulatory status Fragrance allergen disclosure expectations (evolving under MoCRA) Even when a formulation is compliant in the EU, additional evaluation may be required for the U.S. 3. Exposure and Risk Assessment Assumptions Risk assessment methodologies are similar globally, but exposure assumptions may differ due to: Consumer usage patterns Product positioning and claims Concentration limits under U.S. regulatory expectations Population considerations A direct transfer of exposure calculations may not always be appropriate. 4. Claims and Product Classification Risks One of the most critical differences between EU/UK and U.S. regulatory environments involves claims. In the United States, cosmetic claims that imply therapeutic or physiological effects may cause a product to be classified as a drug. This risk is higher than in EU/UK markets and must be evaluated carefully when adapting documentation. 5. Labeling Requirements and Safety Warnings Safety substantiation must align with U.S. labeling requirements. Differences may include: Mandatory warning statements Product identity positioning Ingredient declaration formatting Regulatory terminology differences Safety documentation and labeling must be consistent. Can an EU&UK CPSR Be Used as a Starting Point? Yes. An EU or UK CPSR can provide valuable scientific information, including: Toxicological profiles Ingredient safety data Exposure assessments Stability and microbiological data Manufacturing information However, adaptation is usually required to ensure alignment with U.S. regulatory expectations. The extent of adaptation depends on: Product category Ingredients used Claims strategy Target consumer group Manufacturing location The Impact of MoCRA on Safety Documentation MoCRA introduced new regulatory expectations that influence safety substantiation requirements. Companies must now maintain documentation demonstrating that cosmetic products have been adequately evaluated for safety. Additionally, FDA now has expanded authority to request access to certain safety records under specific circumstances. This increases the importance of structured documentation aligned with U.S. expectations. Additional Considerations for International Brands Companies adapting EU or UK safety documentation should also consider: Facility registration requirements Cosmetic product listing obligations Responsible Person roles under MoCRA Adverse event reporting systems Importation and supply chain structure Safety documentation is only one component of overall compliance. Common Challenges When Adapting CPSRs Across international projects, several recurring challenges appear: Assuming EU compliance equals U.S. compliance Overlooking color additive regulations Claims creating unintended drug classification Inconsistent labeling and safety documentation Missing alignment with MoCRA requirements Lack of clarity regarding regulatory responsibility These issues can delay market entry or create compliance risks. Strategic Approach to U.S. Safety Substantiation Companies entering the U.S. market benefit from a structured regulatory strategy that considers: Ingredient regulatory status evaluation Claims positioning assessment Exposure and toxicological review Labeling alignment MoCRA compliance requirements Documentation readiness for FDA inspection A proactive approach reduces regulatory uncertainty. Why Regulatory Expertise Is Often Needed Although EU CPSRs provide strong scientific foundations, adapting them to the U.S. market involves regulatory interpretation rather than simple conversion. Companies must align scientific data with U.S. legal frameworks, market positioning, and evolving regulatory expectations. This combination of scientific and regulatory considerations often requires specialized expertise. EU and UK CPSRs can serve as valuable starting points for U.S. cosmetic safety substantiation, but they cannot usually be transferred without modification. Understanding regulatory differences, ingredient requirements, claims risks, and MoCRA obligations is essential for successful adaptation. Companies planning to enter the U.S. cosmetic market should evaluate safety documentation early to ensure efficient compliance and market access. If your company already has EU or UK cosmetic safety documentation and is planning to enter the United States market, Belab Services can support you. Our regulatory specialists assist international brands with: Adaptation of EU/UK CPSR documentation for the U.S. Cosmetic safety substantiation strategy MoCRA compliance support Labeling and claims review Facility registration and product listing U.S. market entry planning Contact our team to discuss your project and ensure a smooth transition into the U.S. regulatory framework. Get in touch with our team of experts today

On 15 January 2026, the UK Government adopted Statutory Instrument SI 2026/23, introducing amendments to the Annexes of the UK Cosmetics Regulation (UKCR). From a regulatory perspective, this amendment is part of the UK’s ongoing process of maintaining alignment with technical updates introduced under Regulation (EC) No 1223/2009 , while implementing them through domestic legislation. Below is our technical analysis of the key implications for cosmetic manufacturers and Responsible Persons operating in the UK market. Table of contents Update to Annex II – Prohibited Substances Technical implications Amendment to Annex V – Formaldehyde-Releasing Preservatives What this means in practice? Transitional Periods UK Updates the Cosmetics Regulation Annexes: Technical Overview of SI 2026/23   Update to Annex II – Prohibited Substances The amendment introduces new entries into Annex II (List of substances prohibited in cosmetic products), including: 4-methylbenzylidene camphor (4-MBC) Trimethylbenzoyl Diphenylphosphine Oxide (TPO) 15 additional substances classified as CMR Technical implications From a safety assessment standpoint: Ingredients newly classified as CMR under UK CLP can no longer be used in cosmetic formulations unless specific derogations apply (which, in this case, do not). Safety Assessors must review existing CPSRs where these substances may be present as: intentional ingredients impurities residuals degradation products Particular attention should be paid to UV filter systems and raw material specifications where 4-MBC may historically have been used. Amendment to Annex V – Formaldehyde-Releasing Preservatives The preamble to Annex V has been updated, strengthening the labelling requirements related to formaldehyde-releasing preservatives. What this means in practice? The warning statement requirements have been clarified. Responsible Persons must verify: Free formaldehyde levels in the finished product Correct triggering of warning statements Alignment between analytical data and label wording This amendment reinforces enforcement expectations rather than introducing an entirely new concept. However, it increases the compliance risk for products relying on older labelling templates. Transitional Periods The SI establishes staggered compliance deadlines: Mid-2026 (July–August)  → Deadline for placing non-compliant products on the UK market Early 2027 (January–February)  → Deadline for making non-compliant products unavailable (off-shelf compliance) For companies managing UK and EU portfolios simultaneously, stock management planning is critical to avoid stranded inventory.   If your company requires a technical screening of UK formulas or assistance updating CPSRs and labelling documentation, our regulatory team can support a structured compliance transition plan ahead of the 2026 deadlines.

The United States represents one of the largest markets for over-the-counter (OTC) medicines globally, offering significant opportunities for companies developing non-prescription therapeutic products. Understanding what qualifies as an OTC drug, how OTC monograph’s function, and what regulatory obligations apply is essential for companies planning to enter the U.S. market. Table of Contents What Is an OTC Drug? Two Regulatory Pathways for OTC Products 1. OTC Monograph Pathway (Most Common) 2. New Drug Application (NDA) What Are OTC Monographs? Categories Covered by OTC Monographs The Role of Claims in OTC Compliance Overview of the OTC Registration Process OMUFA User Fees: What Companies Must Know Facility Fees OMOR Fees Registration Fees vs OMUFA Fees The Role of the U.S. Agent for Foreign OTC Companies Manufacturing Compliance: cGMP Requirements Why OTC Regulatory Strategy Is More Complex Than It Appears Common Challenges in OTC Market Entry What Is an OTC Drug and the Role of OTC Monographs in the United States What Is an OTC Drug? An over-the-counter (OTC) drug is a medicine that can be sold directly to consumers without a prescription from a healthcare professional and are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. Unlike cosmetics or dietary supplements, OTC products are legally classified as drugs , meaning they must meet specific standards for: Safety Effectiveness Quality Labeling Manufacturing controls Two Regulatory Pathways for OTC Products In the United States, OTC drugs can reach the market through two primary regulatory routes: 1. OTC Monograph Pathway (Most Common) Products marketed under an FDA monograph do not require individual product approval if they comply with established conditions. These conditions include: Permitted active ingredients Dosage levels and formulations Labeling statements and warnings Indications and claims Directions for use Monographs essentially function as a regulatory “rulebook” for categories of OTC drugs. 2. New Drug Application (NDA) If a product does not fit within an existing monograph — for example, due to a novel ingredient or new therapeutic claim, the company must pursue a full New Drug Application (NDA), similar to prescription drugs. Most international companies entering the OTC market use the monograph pathway due to its lower regulatory burden. What Are OTC Monographs? OTC monographs are regulatory documents issued by the FDA that define the conditions under which OTC drugs are considered: Generally Recognized as Safe and Effective (GRASE): If a product complies with an applicable monograph, it can be marketed without prior FDA approval. Categories Covered by OTC Monographs Monographs exist across many therapeutic areas, including: Sunscreen drug products Topical antimicrobial products External analgesics Acne drug products Antifungal treatments Skin protectants Oral healthcare products Antiperspirants Cough, cold, and allergy medicines Each category has specific requirements that must be followed precisely. The Role of Claims in OTC Compliance Claims are one of the most critical aspects of OTC regulatory compliance. Unlike cosmetics, where claims are largely marketing-driven, OTC claims must: Align with the applicable monograph Follow approved wording structures Include mandatory warnings Reflect authorized indications Companies cannot create new therapeutic claims outside monograph conditions without regulatory authorization. Claims strategy is therefore not only a marketing decision but also a regulatory constraint. Overview of the OTC Registration Process While OTC drugs under monographs do not require product approval, companies still must complete several regulatory steps before marketing. These typically include: Establishment registration with FDA Drug product listing NDC assignment Labeling compliance verification Manufacturing compliance (cGMP) Safety documentation Post-market obligations The process involves multiple FDA systems and identifiers, and coordination between manufacturers, brand owners, and regulatory representatives. OMUFA User Fees: What Companies Must Know The Over-the-Counter Monograph User Fee Program (OMUFA) funds FDA oversight of OTC monograph drugs. OMUFA includes two main types of fees: Facility Fees Annual fees paid by facilities that manufacture or process finished OTC monograph drugs. These fees apply to both U.S. and foreign facilities. OMOR Fees Fees paid when companies request changes to OTC monographs, such as new ingredients or indications. User fees help support FDA review timelines and regulatory activities related to OTC products. The program is authorized for multiple fiscal years and continues to evolve through legislative updates. Companies often underestimate the financial planning required for OMUFA compliance. Registration Fees vs OMUFA Fees It is important to distinguish OMUFA fees from other regulatory costs. Companies may encounter: Facility registration costs Regulatory consulting costs Manufacturing compliance costs Testing and validation costs U.S. Agent services OMUFA fees specifically relate to FDA oversight of OTC monograph drugs. Understanding which entities are responsible for paying which fees is essential in OEM and contract manufacturing models. The Role of the U.S. Agent for Foreign OTC Companies Foreign drug establishments must designate a U.S. Agent when registering with the FDA. The U.S. Agent: Serves as FDA’s communication contact in the United States Facilitates regulatory correspondence Supports coordination during inspections or questions However, the U.S. Agent does not assume regulatory responsibility for product compliance unless contractually defined. Manufacturing Compliance: cGMP Requirements OTC drugs must be manufactured in compliance with FDA drug Good Manufacturing Practices (cGMP). These requirements are significantly more stringent than cosmetic GMP expectations and may include: Quality systems and documentation Validation processes Stability programs Laboratory controls Batch records Complaint handling and recalls Foreign manufacturers must be prepared for FDA inspections. Common Challenges in OTC Market Entry Across international projects, several recurring issues appear: Misclassification between cosmetics and OTC drugs Incorrect assumptions about monograph applicability Underestimating GMP requirements Claims that exceed monograph conditions Lack of clarity regarding regulatory ownership Confusion about FDA identifiers and registration steps These challenges often lead to delays or compliance risks. Why OTC Regulatory Strategy Is More Complex Than It Appears At first glance, OTC products marketed under monographs may appear easier than prescription drugs. However, successful compliance requires alignment across multiple regulatory dimensions. OTC regulation sits at the intersection of drug law and consumer health products, making it uniquely complex. OTC drugs represent a major opportunity in the U.S. healthcare market, offering accessible treatment options for consumers without prescriptions. The OTC monograph system provides a pathway to market without individual product approval, but compliance still requires careful planning, regulatory expertise, and strategic decision-making. Understanding monographs, user fees, claims limitations, and registration obligations is essential for companies seeking successful entry into the U.S. OTC sector. If your company is planning to commercialize OTC products in the United States or needs support navigating FDA requirements, Belab Services can assist you. Our regulatory specialists support international companies with: OTC regulatory strategy and classification Monograph assessment and compliance evaluation FDA establishment registration and drug listing NDC assignment and labeling review OMUFA compliance support U.S. Agent services End-to-end market entry strategy Contact our team to discuss your project and ensure a smooth regulatory pathway into the U.S. market. Get in touch with our team of experts today.

The U.S. Food and Drug Administration (FDA) has announced a significant regulatory update affecting the labeling and use of food color additives in the United States. The agency has introduced a new enforcement policy allowing more flexibility for “no artificial colors” claims , while also approving additional natural color additives  to support industry reformulation efforts. These developments reflect a broader regulatory and market trend toward replacing petroleum-based synthetic dyes with naturally derived alternatives. Table of contents A New FDA Approach to “No Artificial Colors” Claims Approval of New Natural Color Additives A Wider U.S. Regulatory Trend Regulatory Considerations for Food Businesses What This Means for the Industry FDA Updates Policy on “No Artificial Colors” Claims and Approves New Natural Color Additives A New FDA Approach to “No Artificial Colors” Claims Under the FDA’s updated enforcement policy, food manufacturers may now label products as “no artificial colors”  provided they do not contain FD&C certified synthetic dyes , which are typically derived from petroleum sources. Previously, the regulatory interpretation was much stricter. Companies were generally allowed to make such claims only if the product contained no added color at all , including colors from natural sources. This change is intended to remove regulatory barriers that discouraged companies from switching to natural color alternatives. According to the FDA, the updated approach aims to facilitate the industry’s transition toward ingredients derived from natural sources while maintaining truthful and non-misleading labeling. Examples of claims that may fall under this enforcement discretion include: “No artificial colors” “Made without artificial food coloring” “No added artificial colors” However, manufacturers remain responsible for ensuring that such claims are accurate and not misleading under the Federal Food, Drug, and Cosmetic Act (FFDCA) . Approval of New Natural Color Additives Alongside the labeling update, the FDA has approved additional natural color additives to expand the options available to food manufacturers. Key developments include: Approval of beetroot red  as a new color additive derived from natural sources. Expanded permitted uses for spirulina extract , a naturally derived blue colorant. These approvals form part of the FDA’s broader initiative to facilitate the replacement of synthetic dyes with alternatives sourced from plants, algae, or minerals. A Wider U.S. Regulatory Trend The policy update is also aligned with broader federal initiatives encouraging the phase-out of petroleum-based synthetic dyes  in the U.S. food supply. Regulators are working with industry to gradually eliminate commonly used FD&C dyes and promote the adoption of natural colorants. Several major food companies have already committed to reformulating their products to remove synthetic dyes within the coming years, reflecting increasing consumer demand for “clean label” foods. Regulatory Considerations for Food Businesses Food manufacturers and ingredient suppliers operating in the U.S. market should consider several compliance aspects following this update: 1. Labeling strategy Companies may now leverage “no artificial colors” claims when their products contain only non-certified color additives (e.g., plant-derived colors). 2. Ingredient selection The approval of additional natural color additives provides greater flexibility for reformulating products previously reliant on synthetic dyes. 3. Safety and purity requirements Manufacturers remain responsible for ensuring that color additives meet safety standards and are free from unacceptable impurities such as heavy metals or solvent residues. 4. Reformulation planning Companies using FD&C certified dyes may need to evaluate alternative color sources as regulatory and consumer pressures continue to increase. What This Means for the Industry The FDA’s updated policy signals a clear regulatory direction: facilitating the transition from synthetic dyes to naturally derived color additives  while providing companies with more flexibility in labeling. For food manufacturers, this shift creates both opportunities and challenges. While natural colorants may support clean-label positioning, they can also present formulation difficulties related to stability, color intensity, and cost. As the regulatory landscape continues to evolve, companies entering or operating in the U.S. food market should closely monitor developments related to color additive approvals, labeling policies, and synthetic dye restrictions . Get in touch with our team of experts today

The US Food and Drug Administration (FDA) has published the applicable fees for fiscal year 2026 within the OMUFA (Over-the-Counter Monograph Drug User Fee Program), which affect both facilities that manufacture OTC drugs under a monograph and companies that request modifications to an existing monograph. Companies operating in the US over-the-counter drug market must take these regulatory costs into account in their strategic planning. Table of contents What is the OMUFA program? Annual fees for facilities that manufacture OTC drugs OMOR fees for modifying an OTC monograph   FDA 2026: New OMUFA Program Fees and OTC Drugs What is the OMUFA program? The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is the fee system established by the FDA to fund the management and modernization of the OTC monograph system. OTC monographs define the conditions under which an over-the-counter drug can be marketed in the United States without prior NDA authorization, provided the product meets the following requirements: Permitted active ingredients Approved indications Established concentrations and pharmaceutical forms Labeling requirements With the reform introduced by the CARES Act, companies can now request modifications or updates to these monographs through so-called OTC Monograph Order Requests (OMOR). The OMUFA program primarily includes two types of regulatory fees : Annual fees for facilities that manufacture OTC drugs under a monograph Fees for monograph modification requests (OMOR)     Annual fees for facilities that manufacture OTC drugs Facilities that manufacture or process OTC drugs under a monograph must pay a mandatory annual fee under the OMUFA program. This obligation applies to: Facilities located in the United States Foreign facilities that manufacture OTC for the US market It also includes contract manufacturers that produce OTC drugs for third parties. The rates are divided into two main categories Monograph Drug Facility (MDF) Facilities that manufacture OTC products under a monograph. Contract Manufacturing Organization (CMO) Contract manufacturers that produce OTC products for other companies. These fees are updated annually and are normally due during the month of June of each fiscal year. Facility User Fee Rates FY 2024 FY 2025 Monograph Drug Facility (MDF) Fee $34,166 $37,556 Contract Manufacturing Organization (CMO) Fee $22,777 $25,037 Paying these fees is mandatory to maintain the ability to manufacture OTC drugs for the US market.     OMOR fees for modifying an OTC monograph In addition to annual facility fees, companies must pay a fee when they file an OTC Monograph Order Request (OMOR). An OMOR is used when a company requests the FDA to modify an existing monograph, for example to Add a new active ingredient Add a new indication Introduce new terms of use Modify dosages or pharmaceutical forms For fiscal year 2026, the FDA has established the following rates Tier 1 OMOR: approximately $587,000 Tier 2 OMOR: approximately $117,000 Tier 1 applications typically involve significant changes to the monograph, such as the introduction of new active ingredients or indications. Tier 2 requests correspond to minor modifications. The OMOR fee must be paid at the time of submitting the application to the FDA. Get in touch with our team of experts today.

The European Commission has recently added eight new entries to the Novel Food Catalogue , an update that may have a direct impact on the development and marketing of food supplements in the European Union. Although the Novel Food Catalogue is not legally binding, it is a key reference tool for interpreting the application of Regulation (EU) 2015/2283 on novel foods. Therefore, any changes to this catalogue must be carefully analyzed from a regulatory perspective. Table of contents Which ingredients have been updated? Isolated substances classified as Novel Food Botanicals with "non-novel" status limited to food supplements Relevant case: confirmation of the status of Chelidonium majus European Commission updates the Novel Food Catalogue: 8 new ingredients under review Which ingredients have been updated? Among the new entries, two different regulatory situations stand out: Isolated substances classified as Novel Food Three plant-based compounds have been identified as Novel Foods , which means they require prior authorization before being marketed in the EU: Apigenin (isolated, for example, from chamomile) Cycloastragenol (derived from the root of astragalus) Pterostilbene (present in certain plant species) The key here is not the traditional use of the plant itself, but the fact that these are isolated and concentrated substances , for which there is insufficient evidence of significant consumption before May 15, 1997 (the cut-off date established by European regulations). In these cases, marketing in food supplements will require the submission and approval of a Novel Food authorization dossier , including toxicological and safety data. Botanicals with "non-novel" status limited to food supplements Five plant species have been classified as non-Novel Food for their specific use in food supplements , but not necessarily for other food categories (e.g., infusions or conventional foods). This distinction is especially relevant from a regulatory point of view: an ingredient may be acceptable in supplements, but not in other food formats. Relevant case: confirmation of the status of Chelidonium majus The update also reaffirms that Chelidonium majus (greater celandine), a plant that has been under scrutiny for potential liver risks, maintains its status as a Novel Food not authorized in food supplements. This confirms that its use is still not permitted in the EU under the current framework. The European regulatory environment for food supplements continues to evolve, particularly regarding concentrated botanicals and phytochemicals. Anticipating these changes is key to avoiding trade barriers or subsequent product recalls. Get in touch with our team of experts today.

For companies entering the U.S . over-the-counter (OTC) drug market, one of the first regulatory concepts that appears is the NDC Labeler Code . Although widely referenced, it is also frequently misunderstood - particularly by international companies working under OEM or private label manufacturing models. Understanding what the NDC Labeler Code is, who needs it, and how it interacts with other FDA identifiers is essential for successful market entry and compliance. Table of contents Why the Labeler Code Is Required for OTC Products? Who Should Obtain the Labeler Code: Manufacturer or Brand Owner? How It Works for Foreign Companies? How Long Does It Take to Obtain a Labeler Code? NDC Labeler Code vs FEI Number vs DUNS Number The Role of the U.S. Agent Why Companies Often Need Regulatory Support? NDC Labeller Code: What It Is, Why It Matters, and How It Works for OTC Companies Why the Labeler Code Is Required for OTC Products? For OTC drugs marketed under FDA monographs, companies must: Register their establishment with FDA List their drug products electronically Assign NDC numbers The Labeler Code is the prerequisite for the listing process because it identifies the company submitting the product information to FDA databases. Without a Labeler Code, a company cannot generate valid NDC numbers for its products. Who Should Obtain the Labeler Code: Manufacturer or Brand Owner? This is one of the most common questions in OEM and private label scenarios. In FDA terminology, the “labeler”  is the firm whose name appears on the product label as responsible for the product. Therefore, the Labeler Code may belong to: The brand owner (private label distributor) The manufacturer A repackager or relabeler The determining factor is commercial responsibility , not physical manufacturing. For many international companies using contract manufacturers, the brand owner typically obtains the Labeler Code because they market the product under their own name in the United States. How It Works for Foreign Companies? Foreign companies can obtain a Labeler Code, but additional regulatory elements apply, such as appoint an U.S. Agent , who acts as the FDA’s primary domestic contact but does not own the Labeler Code unless the agent is also the labeler. This distinction is important because some companies incorrectly assume the U.S. Agent holds regulatory ownership. How Long Does It Take to Obtain a Labeler Code? In practice, obtaining a Labeler Code may take several weeks, although planning should account for longer timelines when coordinated with full OTC registration activities. NDC Labeler Code vs FEI Number vs DUNS Number Another common source of confusion is the difference between FDA identifiers. Identifier Assigned By What It Identifies Purpose / Use Key Notes NDC Labeler Code FDA The company responsible for marketing the drug product Used to create NDC numbers and list drug products in the FDA system Required for OTC drug listing. Linked to the regulatory “labeler,” not necessarily the manufacturer. FEI Number (FDA Establishment Identifier) FDA A physical facility (manufacturing, packaging, testing, etc.) Used for establishment registration and FDA inspections A company may have multiple FEI numbers if it operates multiple facilities. DUNS Number (Dun & Bradstreet) Private organization (Dun & Bradstreet) A business entity globally Used for company identification in regulatory and commercial systems, including FDA registrations Supports identity verification but is not an FDA regulatory identifier itself.   The Role of the U.S. Agent For foreign OTC companies, the U.S. Agent plays an important regulatory role but is frequently misunderstood. The agent: Serves as FDA’s communication contact in the United States Facilitates interactions during inspections or regulatory questions Supports administrative coordination However, the U.S. Agent is not automatically responsible for product compliance and does not replace the regulatory responsibilities of the labeler. Why Companies Often Need Regulatory Support? While the concept of a Labeller Code is simple, the regulatory context surrounding OTC products is significantly more complex. Companies must align: Establishment registration Drug listing requirements Monograph compliance Labeling rules Post-market obligations For international companies, coordinating these elements across jurisdictions adds further complexity. If your company is planning to commercialize OTC products in the United States or needs support with FDA registration, NDC assignment, or regulatory strategy, Belab Services can help. Our specialists support international companies with: NDC Labeller Code applications OTC establishment registration and drug listing Regulatory strategy for OEM and private label models U.S. Agent services End-to-end FDA compliance support Contact our team to discuss your project and ensure a smooth regulatory pathway into the U.S. market. Get in touch with our team of experts today.