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Placing cosmetic products in the United Kingdom  (England, Wales, Scotland, and Northern Ireland) requires obtaining SCPN (Submit Cosmetic Product Notification)  registration. This step is mandatory  to pass UK customs and legally access the market. In this guide, we will cover everything you need to know about the SCPN registration process, who can register, what information is required, and how to ensure compliance with UK Cosmetic Regulations (EC) No. 1223/2009 (UKCR). SCPN: What is it? Who can register in the SCPN? Which information is necessary to register a product in the UK? It is SAFE to share this information? What is the result of SCPN Registration? Who can see the SCPN information? I no longer sell my product in the United Kingdom, what happens? What is SCPN and why is it important? SCPN is the official British notification portal where the UK Responsible Persons register cosmetics products BEFORE their will being placed on the market. This SCPN registration is a legal obligation present in the UK Cosmetic Regulations (EC) No. 1223/2009 (UKCR). It ensures that all cosmetics comply with the required safety and labeling regulations set by the UK government. Who can register in the SCPN? Only Responsible Persons based in the UK can make a product registration in the portal. It means that foreign companies (outside of the United Kingdom) cannot do this because they are not legal entities based on the country. Which information is necessary to register a product in the UK? To register a cosmetic product, the following details must be submitted: Product details:  Name, reference number, and category. Responsible Person information:  Name, address, and contact details in the UK. Product origin:  Country of manufacture and first market placement. Ingredient composition:  Full formula using INCI names and concentrations (%). Safety compliance:  Presence of nanomaterials and CMR substances (e.g., CAS number). Label design:  Compliance with UK labeling requirements. Product image:  A clear and accurate product picture. Providing accurate and complete information is critical to avoid delays or regulatory issues. It is SAFE to share this information? Absolutely. SCPN is a government official database and nobody can check the i nformation that companies and Responsible Persons upload on it. What is the result of SCPN Registration? Upon successful registration, you will receive: A unique SCPN registration number,  which serves as the product's identification in the UK market. A detailed registration report (PDF),  summarizing the submitted information, which can be used for regulatory inspections. This number remains valid as long as the product details do not change. SCPN registration is eternal? You have to update the registration if one of the points shown in the part “Which information is necessary to register a product?” changes. It includes, for example, changes in the Responsible Person, label, formula, country of origin, etc. Who can see the SCPN information? Nobody can check if your products are or not registered in the SCPN database. Only national authorities (governments, customs, etc) can check it. The SCPN information, registration number, and registration Report are information only available for the Responsible Persons and product owners' companies. SCPN Registration I no longer sell my product in the United Kingdom, what happens? If one company discontinues the sales of a reference in the UK, it must, through its Responsible Person, notify on the SCPN portal that the product will no longer sold on in the UK. How can BELAB SERVICES help with SCPN registration? BELAB SERVICES  is a regulatory consultancy specializing in cosmetic compliance. As a UK Responsible Person,  we manage the entire registration process for foreign brands, ensuring compliance with UK regulations and a smooth market entry. Our services include: Product safety assessments. SCPN registration management. Ongoing compliance support and documentation updates. If you need expert assistance with SCPN registration, don't hesitate to contact BELAB SERVICES today. Conclusion SCPN registration is a critical step for legally placing cosmetic products on the UK market. Compliance with UK Cosmetic Regulations (EC) No. 1223/2009 ensures consumer safety and smooth business operations. Whether you are a manufacturer, importer, or distributor, appointing a trusted Responsible Person  is essential to navigate regulatory requirements efficiently. Need help with SCPN compliance?  Contact BELAB SERVICES  for expert guidance and support.

Safety in cosmetic products is a priority in the industry, and cosmetovigilance has emerged as a key mechanism to ensure it. This system, implemented in both the European Union (EU) and the United Kingdom (UK), ensures the detection, assessment and prevention of risks associated with the use of cosmetics. In this article, we will explore the crucial role of cosmetovigilance and its impact in both regions. Table of contents What is cosmetovigilance? Regulatory framework in the European Union Cosmetovigilance in the UK Importance of cosmetovigilance Challenges and future prospects Conclusion What is cosmetovigilance? Cosmetovigilance is a system that monitors and evaluates undesirable effects associated with the normal use of cosmetic products. Its aim is to detect potential risks, establish corrective measures and ensure consumer safety. This ranges from the initial evaluation of the product to the monitoring of possible incidents after it has been placed on the market. Regulatory framework in the European Union In the European Union , cosmetovigilance is regulated by Regulation (EC) No 1223/2009 , a comprehensive regulation that sets strict standards to ensure the safety of cosmetic products. Key points of the regulation Responsible Person (RP): Each cosmetic product must have a responsible person or entity within the EU to ensure its compliance with the regulations. Safety Assessment: Before being placed on the market, all products must undergo a comprehensive safety assessment documented in a Product Information File (PIF). Reporting of serious adverse events: Article 23 requires companies to report any serious adverse events to the competent authorities, together with all relevant information. The notification procedure The cosmetovigilance system in the EU is based on: Data collection: Detailed information on adverse events, including the nature of the incident and the history of the product. Causality assessment: Determination of the relationship between the observed effect and the cosmetic product. Corrective actions: Product reformulation, labeling changes or even withdrawal from the market. Cosmetovigilance in the UK Following Brexit, the UK adopted its own legislation for cosmetic products, although it is largely based on the European regulation. The UK Cosmetics Regulation sets the standards to ensure the safety of products in this territory. Key differences with the EU Registration with SCPN: All products must be notified to the UK Submit Cosmetic Product Notification (SCPN) before being placed on the market. Responsible Person in the UK: Companies must appoint a Responsible Person within the UK to ensure the compliance of their products. Specific labelling: Labelling must include the PR's UK address and, if applicable, the country of origin of the product. Incident reporting Serious adverse events should be reported to the Office for Product Safety and Standards (OPSS), which assesses the situation and recommends action as necessary. Importance of cosmetovigilance Benefits for the industry Proactive risk management: Companies can identify problems before they become major crises. Regulatory Compliance: Compliance with regulations avoids legal penalties and protects brand reputation. Advantages for consumers Increased confidence: Consumers are confident that products meet high safety standards. Effective protection: Continuous monitoring reduces the risk of exposure to unsafe products. Challenges and future prospects The future of cosmetovigilance is linked to technological progress and the globalization of trade. The main challenges include: International Data Management: As businesses operate in global markets, they must comply with multiple regulatory frameworks. Products in e-commerce: Ensuring the security of products sold online requires more sophisticated monitoring systems. Conclusion Cosmetovigilance is essential to ensure the safety of cosmetic products in the European Union and the United Kingdom. This system protects both consumers and the industry, ensuring that products meet the strictest standards. In a constantly evolving environment , companies must be prepared to adapt to new regulations and take advantage of emerging technologies to strengthen their surveillance systems. Contact a Cosmetovigilance Expert

The cosmetic industry in the UAE operates under strict regulations to ensure product safety and compliance with cultural and religious norms. This article highlights critical regulatory considerations for cosmetics containing alcohol, halal-certified products, those with pork or animal derivatives, allergens, and whether laboratory testing in Dubai is mandatory. Table of contents Are Cosmetics Containing Alcohol Permitted in Dubai, UAE? Halal Cosmetics: A Growing Demand in the UAE Cosmetics with Pork or Animal Derivatives: What’s Allowed? Allergen Disclosure: Is It Mandatory? Is Laboratory Testing in Dubai Mandatory? Essential Compliance Steps for Cosmetic Manufacturers Conclusion Alcohol, Halal, Animal Derivatives, and More Are Cosmetics Containing Alcohol Permitted in Dubai, UAE? Yes, alcohol-based cosmetics are allowed in the UAE as long as the alcohol is denatured and used solely for external application. While legally permissible, brands should take into account the cultural sensitivity around alcohol use. Offering alcohol-free alternatives can be a smart move to appeal to a broader market segment that prefers such products. Halal Cosmetics: A Growing Demand in the UAE The UAE’s large Muslim population has driven significant demand for halal-certified cosmetics . Halal products must not contain: Pork or its derivatives Non-halal animal ingredients Alcohol (in certain cases, depending on its use) Obtaining halal certification  enhances a product's credibility and marketability, making it easier to build trust with consumers. Cosmetics with Pork or Animal Derivatives: What’s Allowed? Using pork derivatives in cosmetics is strictly prohibited in the UAE . Furthermore, other animal-derived ingredients must be sourced from halal-certified suppliers. Failure to comply with these regulations can result in product rejection during the Dubai Municipality registration process. Manufacturers must also clearly label all animal-derived ingredients to help consumers make informed choices. Allergen Disclosure: Is It Mandatory? The UAE follows the best international practices regarding allergen disclosure. Manufacturers are required to: Clearly list all ingredients on the product label and place them on labels when present in concentrations above the specified threshold. Is Laboratory Testing in Dubai Mandatory? Laboratory testing isn’t universally required for all cosmetic products. However, certain products—especially those containing high-risk or potentially controversial ingredients—may be subjected to Dubai Municipality laboratory testing . The authorities may request lab reports to verify compliance with safety standards before approving a product for sale.   Essential Compliance Steps for Cosmetic Manufacturers Transparency in Ingredients : Ensure all ingredients are accurately listed, particularly animal-derived substances and potential allergens. Consider Halal Certification : With a growing demand for halal products, obtaining certification is a key step toward market success. Monitor Regulatory Changes : Stay updated on new regulations issued by the UAE’s Ministry of Industry and Advanced Technology (MoIAT) and Dubai Municipality. Prepare for Possible Testing : Be ready to provide product samples and lab reports when requested by authorities.   Conclusion To succeed in the UAE’s highly regulated market, manufacturers must navigate a complex landscape of ingredient restrictions, certifications, and labeling requirements. Whether it's ensuring products are halal-compliant, avoiding prohibited substances like pork derivatives, or preparing for possible lab testing, understanding these regulations is crucial. Adhering to these guidelines not only ensures legal compliance but also builds brand credibility in a market where consumers value safety, transparency, and ethical sourcing.   Contact with BELAB Services easily

The European Commission recently approved magnesium L-threonate as a novel food ingredient for adult food supplements, marking a significant advancement in the nutritional supplement industry. Following an in-depth safety review by the European Food Safety Authority (EFSA), the approval allows its use with a maximum daily intake of 250 mg. Known for its enhanced bioavailability and potential cognitive benefits, magnesium L-threonate offers new possibilities in brain health support. Table of contents What is Magnesium L-Threonate? Regulatory Context and Approval Criteria Exclusive Market Rights Implications for the Supplement Industry Future Prospects Key Takeaways European Commission Authorizes Magnesium L-Threonate as a Food Supplement What is Magnesium L-Threonate? What is Magnesium L-Threonate? Magnesium L-threonate is a unique formulation of magnesium bound with L-threonic acid, a metabolite derived from vitamin C. Unlike other magnesium compounds, this version is praised for its superior ability to cross the blood-brain barrier, making it particularly effective in supporting neurological functions and memory. This feature has spurred interest in its potential role in cognitive enhancement, making it a popular choice in nootropic supplements. Regulatory Context and Approval Criteria The authorization, formalized through an official regulation, sets specific conditions: Target Audience : Adults only. Maximum Daily Dosage : 250 mg of magnesium L-threonate. Exclusions : Not suitable for pregnant or breastfeeding women. Labeling Requirements : Products must indicate clear usage restrictions and specify the ingredient as "Magnesium L-threonate." EFSA’s risk assessment included evaluations of the compound’s bioavailability, genotoxicity, and tolerability. Results demonstrated that magnesium L-threonate is safe when consumed under the defined guidelines. Exclusive Market Rights As part of the approval, AIDP Inc., the company that submitted the application, has been granted exclusive rights to market the compound in the EU for five years. This exclusivity provides a strategic advantage, positioning AIDP as a leading supplier of magnesium L-threonate in the region. Implications for the Supplement Industry This approval opens new doors for supplement manufacturers looking to offer innovative brain health solutions. With growing consumer demand for cognitive enhancers, magnesium L-threonate is likely to become a key ingredient in premium supplement lines targeting memory improvement, focus, and overall mental clarity. Future Prospects As scientific interest in magnesium L-threonate continues to grow, further research may unlock additional health benefits. Beyond cognitive support, studies could explore its impact on stress reduction, sleep quality, and neuroprotection. Key Takeaways: Innovative Ingredient : Offers enhanced magnesium absorption in the brain. Market Opportunity : New ingredient approval provides a competitive edge for supplement brands. Consumer Demand : Rising interest in cognitive health products aligns well with this new regulatory milestone. This regulatory milestone highlights the European Union’s commitment to fostering innovation in the health and wellness sector while ensuring consumer safety. Expect to see magnesium L-threonate featured in more brain-focused supplement formulations in the coming years. Contact BELAB Services today!

Throughout 2024, the Office of Information and Regulatory Affairs (OIRA) has made significant changes to the timeline for implementing essential cosmetic regulations resulting from the Cosmetic Modernization Regulation Act of 2022 (MoCRA) . These provisions seek to update the safety, quality, and labeling standards for cosmetic products available in the U.S. market. Table of contents MoCRA: Details of the Regulations Under Review Test methods for detection of asbestos in talc-based products Mandatory labelling of fragrance allergens Good Manufacturing Practices (GMP) for cosmetic facilities Ban on formaldehyde and its releasers in hair straightening products Implications and Challenges for the Cosmetics Sector Recommendations for Compliance FDA: Nuevos Cronogramas para MoCRA MoCRA: Details of the Regulations Under Review The first revision of the timelines was announced in the Spring Unified Agenda for Regulatory and Deregulatory Actions published in July 2024. This document highlighted some initial delays in the regulatory process. Further extensions were announced in December 2024 with the release of the Fall Unified Agenda, affecting the publication schedule of several key rules, including those related to fragrance allergen labelling, the use of formaldehyde, and testing methods for identifying the presence of asbestos in cosmetic products containing talc. This timeline adjustment not only reflects the technical complexity of these regulations, but also the need to give cosmetic companies sufficient time to implement the necessary changes to their operational and compliance processes. Test methods for detection of asbestos in talc-based products The regulation seeks to establish uniform and reliable testing protocols to identify the presence of asbestos in talc-based cosmetics. The detection of this substance has been a cause for concern due to its potential health risks, which has prompted a more rigorous approach to its control. Original proposed date : December 2023 Spring Agenda Review : July 2024 New target date : December 2024 Mandatory labelling of fragrance allergens This rule aims to provide transparency in the labelling of certain allergenic compounds present in fragrances, so that consumers can make informed decisions regarding their health and safety. Original proposed date : June 2024 Spring Agenda Review : October 2024 New target date : January 2025 Good Manufacturing Practices (GMP) for cosmetic facilities In order to ensure that cosmetic products are produced under controlled and safe conditions, this regulation establishes a set of guidelines on their production, storage and distribution. Original proposed date : December 2024 Fall Agenda Review : October 2025 Ban on formaldehyde and its releasers in hair straightening products The ban on the use of formaldehyde and substances that release it in hair products responds to the risks that these compounds pose to health, particularly in straightening treatments that involve frequent exposure to toxic fumes. Original proposed date : October 2023 Spring Agenda Review : September 2024 New target date : March 2025 Implications and Challenges for the Cosmetics Sector These timeline changes offer the cosmetics industry additional scope to adapt its processes to new regulatory requirements. However, they also represent a significant challenge, as manufacturers will need to review their production practices, adjust their product labelling and ensure compliance with strict quality standards. From a business perspective, compliance with these new regulations will be crucial not only to avoid sanctions, but also to maintain consumer confidence in cosmetic products. The new regulations are expected to foster greater transparency and security in the market, which could strengthen the competitiveness of those companies that manage to adapt effectively. Recommendations for Compliance Since these dates are still subject to possible changes, it is highly recommended that companies closely follow FDA updates . Being prepared for regulatory compliance from an early stage could be a competitive advantage, as well as minimizing the risk of supply chain and product marketing disruptions. Key areas that companies should focus on include: Review and adaptation of labelling : Especially with regard to the disclosure of fragrance allergens. Manufacturing Process Improvement : Ensuring that facilities comply with Good Manufacturing Practices defined by the FDA . Implementation of new safety tests : Particularly those related to the detection of hazardous substances such as asbestos. Ultimately, these regulations seek to improve the safety of cosmetic products, promote transparency towards consumers and raise quality standards throughout the industry. Contact a MoCRA / FDA expert today.

Cosmetic claims in the UK refer to statements made by cosmetics manufacturers or marketers about the effects or benefits of their products. These claims are crucial to attract consumers, but they must meet strict requirements of veracity and scientific support to avoid misleading or unethical practices. Following Brexit, although regulations in the UK have largely aligned with previous EU regulations, there are important differences to consider regarding cosmetic product claims. Table of contents 1. Legislation Applicable to Claims in the United Kingdom 2. Types of Claims in Cosmetic Products 3. Requirements for Cosmetic Product Claims in the United Kingdom 4. Advertising Standards Agency (ASA) Claims Guide 6. Post-Brexit Implications Conclusion Claims on Cosmetic Products in the United Kingdom 1. Legislation Applicable to Claims in the United Kingdom Cosmetic product claims in the UK are mainly regulated under the following regulations: UK Cosmetics Regulation : Adapted from Regulation (EC) No 1223/2009 of the European Union, it sets out the general rules for cosmetic products in the United Kingdom, including rules for claims. Cosmetic Products Enforcement Regulations 2013 (amended) : These regulations govern the safety and marketing of cosmetic products in the United Kingdom and also cover the control of claims. In addition to the specific regulations for cosmetics, claims are also subject to the Consumer Protection Act and the Misleading Advertising Act , which prohibit fraudulent or misleading marketing practices. 2. Types of Claims in Cosmetic Products There are different types of claims that cosmetics manufacturers can use to highlight the benefits of their products, but all claims must be justified and verified: Functional claims : These are statements related to the effectiveness of the product. For example, "reduces wrinkles", "moisturizes for 24 hours" or "eliminates stains". Sensory claims : These refer to the user experience, such as "light formula", "smooth texture" or "refreshing smell". Claims of natural or sustainable origin : Such as "100% natural", "vegan", "biodegradable" or "cruelty-free". Safety claims : These refer to the absence of certain ingredients, such as "paraben-free," "sulfate-free," or "hypoallergenic." Ethical claims : These may include statements about the production process, such as "cruelty-free," "sustainable," or "animal welfare approved." 3. Requirements for Cosmetic Product Claims in the United Kingdom To ensure that cosmetic product claims are transparent and verifiable, UK regulations set out criteria that must be met: Truthfulness and non-deception : Every claim must be honest and must not mislead consumers. This means that any claims about the benefits of the product must be accurate and reflect the actual results of using the product. For example, a product cannot be claimed to be "anti-wrinkle" if there is no evidence to support this. Scientific evidence : Claims must be supported by scientific evidence or clinical studies that demonstrate the effects of the product. This is especially important for functional claims, such as "reduces wrinkles" or "lightens skin." Companies must have documentation available to support the claims made about their products. Testing and documentation : The manufacturer must retain all studies, tests, and data necessary to support the claims. This documentation should include clinical trial results, consumer studies, or scientific data supporting the product's efficacy. Do not disparage the competition : Claims should not disparage other brands' products or suggest that competing products are unsafe or ineffective. Ingredient-free claims : Claims that a product is “free of” certain ingredients, such as “paraben-free” or “sulfate-free,” must be clear and not misleading. Additionally, the product must not contain any alternative ingredients that may have similar effects to the ingredients it is claimed not to contain. Environmental and ethical claims : Environmental or ethical claims, such as “sustainable,” “eco-friendly,” or “cruelty-free,” must also be supported by verifiable evidence and should not be vague or ambiguous. In the case of “cruelty-free” products, this means complying with UK regulations on animal testing. 4. Advertising Standards Agency (ASA) Claims Guide The Advertising Standards Authority (ASA) is the body responsible for monitoring advertising in the UK and ensuring that advertising claims comply with current laws and regulations. The ASA regulates the way cosmetic products are promoted in advertising media, including television, print and online. Advertising claims must be verifiable, honest and not misleading. Claims of efficacy must be based on solid scientific evidence. Penalties for misleading claims include bans on certain advertisements and monetary penalties. 5. Examples of Common Claims and their Regulation "Anti-wrinkle" : This type of claim must be supported by clinical studies demonstrating that the product effectively reduces the appearance of wrinkles after continued use. "Dermatologically tested" : Indicates that the product has been tested on human skin, but does not necessarily imply that it is safe for all people, so the group of people on which it was tested must be specified. "Hypoallergenic" : Implies that the product has a lower risk of causing allergic reactions, but must be supported by skin and allergy tolerance studies in representative test groups. "Natural" or "100% organic" : To make this claim, the product must contain ingredients that come from natural sources, without significant artificial chemical processes, and must meet certification standards that support this claim. 6. Post-Brexit Implications Following Brexit, although UK regulations are largely based on EU rules, businesses need to be aware of some important differences: Cosmetic products marketed in the UK must comply with specific UK regulations and not just EU regulations. Advertising and claims must comply with the requirements of the UK Cosmetics Regulations and be supported by verifiable evidence. Companies operating in both markets (EU and UK) must ensure that their products comply with the regulations of each territory, as the rules and control systems are independent. Conclusion Claims on cosmetic products in the UK are subject to strict regulations to ensure consumer protection and prevent misleading marketing practices. Companies must support all claims about the efficacy, safety or characteristics of their products with solid, documented scientific evidence. In addition, post-Brexit, companies must pay particular attention to the differences in UK regulations compared to the EU, ensuring that claims comply with the specific regulations of each market. Contact a cosmetic regulatory expert today.

Following the UK's exit from the European Union (Brexit), regulations and requirements for cosmetic products in the UK have undergone some changes. Although many rules remain similar to those in the EU, the UK has established its own regulatory framework to ensure that cosmetic products marketed in its territory comply with safety, quality and labelling standards. Below are the specific labelling requirements for cosmetic products in the UK, as set out by the UK Cosmetic Regulations. Table of contents Mandatory Information on Labeling Language on Labeling Additional Symbols on Labeling Cosmetics in the UK: Post-Brexit Adaptations OPSS: Compliance and Sanctions Conclusion Labeling requirements in the UK Cosmetic Product in the United Kingdom: Mandatory Information on Labeling The labelling of cosmetic products must include a number of key information, which must be clearly visible and legible on the product packaging or container. These requirements ensure that consumers have access to the information necessary for the safe use of the product. Name and Address of the Controller Name and address : The name and address of the Responsible Person must be included. The Responsible Person is the entity that ensures that the product complies with UK cosmetic regulations and may be the manufacturer, importer or a designated third party. Post-Brexit difference : Following Brexit, cosmetic products sold in the UK must list a UK-based Responsible Person, even if the manufacturer or distributor is based outside the UK. Nominal Content Product quantity : The packaging must indicate the nominal content of the product. This information must be visible on both the external packaging and the primary packaging, except in the case of small packages of less than 5 grams or 5 ml. Minimum Durability Date or Period After Opening (PAO) Expiry date : A minimum shelf life date must be indicated, i.e. the date up to which the product continues to perform its original function safely when stored under appropriate conditions. This date is expressed by the phrase "Best before" or "Use before" and is followed by the date. Period After Opening (PAO) : If the product has a shelf life of more than 30 months, it is mandatory to display the PAO symbol, which is an image of an open jar, accompanied by the number of months during which the product remains safe and effective once opened. Precautions for Use Warnings and precautions : If a cosmetic product requires specific conditions of use or warnings to ensure consumer safety, these must be clearly stated. This is especially important for products that contain ingredients that could cause irritation or that are sensitive to specific storage conditions. Examples of warnings may include "Avoid contact with eyes" or " Do not apply to damaged skin." Ingredients List of ingredients : It is mandatory to list all the ingredients of the product in descending order of weight at the time of their incorporation into the product. The ingredients must be indicated using their INCI nomenclature (International Nomenclature of Cosmetic Ingredients). Also fragrances and colorants and their allergens. Batch Identification Batch number : A batch number or manufacturing reference must be included to identify the batch of the product. This is crucial for product traceability in case it needs to be recalled for safety reasons. Product Function Product Function : If it is not clear from the product presentation, the labeling should include a description of its function. This ensures that the consumer understands the purpose of the product, whether it is a moisturizer, shampoo, deodorant, etc. Cosmetic Labelling in the UK: Language on Labelling Cosmetic product labelling must be in English, as it is the official language of the United Kingdom. Any other information in additional languages may be included, but mandatory information must be available in English to ensure that consumers can understand instructions for use, warnings and ingredients. Cosmetics in the UK: Additional Symbols on Labelling In addition to the mandatory information above, cosmetic products in the UK may include certain standard symbols that help consumers understand the product and how to handle it correctly: PAO Symbol (Period After Opening) As mentioned above, the PAO symbol is an open jar with a number of months in or near it, indicating how long the product is safe after it has been first opened. Green Dot Symbol The Green Dot symbol may appear on some cosmetic product packaging, indicating that the manufacturer contributes to recycling and waste recovery systems. Recycling Symbol (Mobius Loop) This symbol, represented by a triangle with arrows, indicates that the packaging is recyclable. It is important to promote sustainable practices in the disposal of packaging. "Not tested on animals" symbol In the UK and EU, testing cosmetics on animals is prohibited. Some products may carry symbols indicating that the product has not been tested on animals, such as the Leaping Bunny logo, to reassure ethical consumers. Cosmetics in the UK: Post-Brexit Adaptations Following Brexit, the UK has adopted its own regulatory framework for cosmetics, known as the UK Cosmetics Regulation (an adaptation of EU Regulation (EC) 1223/2009). Key changes include: UK Responsible Person: The regulations state that there must be a Responsible Person based in the UK. If the product is manufactured outside the UK, the company must appoint an entity or person in the UK to be responsible for the product's compliance with UK regulations. Notification of cosmetic products : Cosmetic products marketed in the UK must be notified on the UK notification portal, known as Submit Cosmetic Product Notification (SCPN), in a similar way to how it was done on the European portal before Brexit. OPSS: Compliance and Sanctions UK authorities, such as the Office for Product Safety and Standards (OPSS), are responsible for ensuring that cosmetic products comply with all labelling regulations. If a product does not comply with labelling requirements, the manufacturer or distributor may face penalties, which may include product recall or financial penalties. Conclusion Labelling of cosmetic products in the UK remains a key aspect to ensure consumer safety and compliance with local regulations. Companies must ensure that they include all mandatory information, from the list of ingredients to warnings for use, as well as comply with new post-Brexit UK provisions, such as the appointment of a Responsible Person in the country. Complying with these requirements is not only essential to avoid legal penalties, but also to maintain consumer confidence and encourage safe use of products.

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance for registration of cosmetic facilities and products in compliance with the Cosmetics Regulatory Modernization Act of 2022 (MoCRA). This guidance provides key clarifications for companies in the cosmetics sector seeking to comply with new regulatory requirements. Table of contents FDA: Cosmetic Facility Registration FDA: Deadlines FDA: Updates FDA: List of Cosmetic Products FDA: Listing Contents FDA: Submission Process FDA: Establishment Identifier FDA Draft Guidance FDA: Cosmetic Facility Registration The FDA requires manufacturers and processors of cosmetic products intended for distribution in the United States to comply with a rigorous facility registration process. This step ensures proper oversight of products and strengthens safety in the marketplace. It is crucial for companies, even small ones, to understand the specific exceptions and rules to avoid noncompliance. Some of the products that require special attention include: Those that come into contact with the mucous membrane of the eye. Injectable products, regulated under additional regulations such as those of MoCRA Cosmetics. Cosmetics for internal use. Products that alter the appearance for more than 24 hours and cannot be removed by the consumer. FDA: Deadlines All facilities operating before December 29, 2022 must register on the Cosmetics Direct portal by December 29, 2023. Facilities opening after that date have 60 days from the start of operations or until February 27, 2024, as required by FDA MOCRA regulations. In addition, renewal is required every two years. FDA: Updates Changes to registered information, such as the address or owner of the facility, must be reported through the FDA Cosmetics Direct Registration platform within a maximum period of 60 days. FDA: List of Cosmetic Products Product listing is an essential step for manufacturers and distributors wishing to market cosmetics in the United States. This process, managed through the Cosmetics Direct Portal , allows the FDA to monitor the safety of products on the market. FDA: Listing Contents The product listing must include: Product name and category. Complete list of ingredients, including fragrances and flavors. Facility registration number, obtained through the FDA Cosmetic Registration Search. Contact details of the person responsible. FDA: Submission Process The FDA, under the MOCRA framework, has developed digital tools such as the Cosmetics Direct Portal to facilitate registration and listing submissions. FDA: Establishment Identifier The FDA Establishment Identifier (FEI) is essential for registration. Owners must obtain this number before starting the process in the FDA Cosmetics Direct Registration system.

The Cosmetic Products (Restriction of Chemicals) (No. 2) Regulations 2024 were published on 11 December 2024, setting out new measures to protect public health by restricting the use of certain chemicals in cosmetic products. These regulations, which come into force on 31 January 2025 , introduce significant changes to the regulations applicable to cosmetic products in England, Wales and Scotland. Table of contents 1. Summons and Application 2. Key Modifications 3. Transitional Provisions 4. Prohibited and Restricted Substances Implications for the Cosmetics Industry Conclusion Restrictions on Chemicals in Cosmetic Products in the United Kingdom 1. Summons and Application The regulations may be cited as "The Cosmetics Products (Restriction of Chemicals) (No. 2) Regulations 2024". Its implementation covers England, Wales and Scotland . 2. Key Modifications Annex 2 Extension of the list of prohibited substances in cosmetic products. These include substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) categories 1A, 1B and 2. Annex 3 Restrictions on the use of kojic acid , limiting it to 1% in face and hand products, due to potential risks to human health. 3. Transitional Provisions Products containing regulated substances may be placed on the market within specific time periods before being withdrawn: Substances with reference numbers 1680 to 1730: permitted until 20 October 2025. Substances with reference numbers 1731 to 1743: permitted until 2 March 2026. Existing products affected by other restrictions: may remain on the market until 1 November 2025. 4. Prohibited and Restricted Substances List of Prohibitions (Annex 2) Tetrafluoroethylene Desmedipham (ISO) 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) Tellurium dioxide Pyriophenone Tellurium Tolpyralate Fluopicolide (ISO) 3-methylpyrazole Daminozide (ISO) Pydiflumetofen Benzophenone Sedaxane Acetamiprid (ISO) Thiophanate-methyl (ISO) Dibutyltin di(acetate) Mancozeb (ISO) Dibutyltin bis(2-ethylhexanoate) Trinickel disulfide Cumene 1,2-epoxy-4-epoxyethylcyclohexane Barium diboron tetraoxide Isobutyl methyl ketone (MIBK) Quinolamine (ISO) Carbendazim (ISO) Pendimethalin (ISO) Dimethomorph (ISO) Isoflucypram (ISO) 1,2,4-triazole Dimoxystrobin (ISO) Flumioxazin (ISO) Perfluoroheptanoic acid Imazamox (ISO) Bisphenol S Thiamethoxam (ISO) Melamine Triticonazole (ISO) Restricted Substances (Annex 3) Kojic Acid: Limited to 1% in cosmetic products for face and hands. Implications for the Cosmetics Industry Manufacturers and distributors must review their formulas to comply with the new regulations. Chemical analysis and label adaptation are crucial to ensure compliance. Those who use kojic acid in their products must reformulate or limit their concentration to 1%. Conclusion This regulation marks a significant step towards consumer protection by establishing stricter criteria for safety in cosmetic products. Although it represents a challenge for the industry, it also ensures greater confidence in the products available on the market. ¡Get in touch with an expert easily! Sources: Official UK Legislation: legislation.gov.uk Scientific Advisory Group on Chemical Safety

The U.S. Food and Drug Administration (FDA) has announced a proposal establishing standardized testing methods for identifying and detecting asbestos in cosmetic products containing talc. This measure responds to requirements set forth in the Cosmetics Regulatory Modernization Act of 2022 (MoCRA). Table of contents What does this new regulation entail? Talc and Asbestos Risk: Important Context Background and scientific support Why are Advanced Methods like PLM and TEM/EDS/SAED Necessary? What is expected from manufacturers? Impact of Regulation on the Cosmetics Industry Contact an agent La FDA propone métodos avanzados para detectar el amianto en los cosméticos a base de talco, protegiendo la salud de los consumidores y mejorando la seguridad del sector. What does this new regulation entail? The draft rule, titled “Test Methods for Detecting and Identifying Asbestos in Cosmetic Products Containing Talc,” proposes requiring manufacturers to analyze their talc-containing products using specific methods. If adopted, this regulation would ensure that cosmetic products do not contain traces of asbestos, a known human carcinogen. The ultimate goal is to protect the health of consumers by reducing the risk of asbestos-related diseases. Currently, the FDA does not require specific methods to test for asbestos in cosmetic products. Under this proposal, manufacturers will be required to employ advanced techniques such as Polarized Light Microscopy (PLM) and Transmission Electron Microscopy combined with Energy Dispersive Spectroscopy and Selected Area Electron Diffraction (TEM/EDS/SAED). Talc and Asbestos Risk: Important Context Talc, a mineral widely used in cosmetics for its smooth texture and absorbent properties, is mined where it is often found near asbestos. This proximity poses an inherent risk of contamination. Since asbestos is a known carcinogen that can cause serious diseases such as mesothelioma and lung cancer, the presence of even small amounts in cosmetic products is a cause for concern. Until now, there was no mandatory standard in the United States to test for the presence of this contaminant, leaving a regulatory gap that could have put consumers at risk. Background and scientific support This proposal is supported by scientific opinions from an Interagency Working Group on Asbestos in Consumer Products (IWGACP), established in 2018. In 2020, during a public meeting, the initial findings of this group were presented and finally compiled into a peer-reviewed technical document in 2022. Why are Advanced Methods like PLM and TEM/EDS/SAED Necessary? Traditional asbestos detection methods often lack the sensitivity needed to identify minute traces of the mineral in complex products such as cosmetics. Polarized Light Microscopy (PLM): This method allows the detection of mineral fibers through optical analysis. While useful, it does not always accurately distinguish between asbestos and other similar minerals. Transmission Electron Microscopy (TEM/EDS/SAED): This is more advanced and precise, combining chemical and structural analysis to specifically identify asbestos at the microscopic level. This technique is especially effective on very small samples, making it ideal for cosmetics. The joint use of these methods ensures a more rigorous and reliable approach , strengthening the ability of testing to protect the consumer. What is expected from manufacturers? Manufacturers will be required to carry out tests on representative samples of each batch of product or on the talc used as an ingredient. Alternatively, they may rely on certificates of analysis provided by their suppliers, provided that they verify the reliability of these documents by means of additional tests. Failure to comply with these provisions could result in a product being considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). If asbestos is detected in a cosmetic product or the talc used to make it, it will be declared unfit for distribution. Impact of Regulation on the Cosmetics Industry Implementation of this regulation will require cosmetics manufacturers to adjust their quality control processes. Key challenges include: Compliance Costs: The need for specialized equipment and trained personnel to carry out testing can represent a significant expense, especially for small and medium-sized businesses. However, these costs are expected to be offset by reduced product recalls and reputational damage. Greater Transparency in the Supply Chain: Manufacturers will need to work more closely with their talc suppliers to ensure that raw materials meet established purity standards. This could strengthen trust between companies and consumers. Boosting Consumer Confidence: With previous scandals involving talc and its safety, this regulation could be an important step in regaining consumer confidence in products that have historically been questioned. Need more information? Contact us!

With the implementation of amendment SOR/2024-63, effective April 2024, the definition of “Manufacturer” in the Cosmetics Regulations has been expanded to include the designation of a “Responsible Person.” This figure is a representative established in Canada, authorized to act on behalf of foreign companies and assume legal responsibilities related to regulatory compliance. Table of contents Responsibilities of the Responsible Person in Canada Benefits and Implications Our conclusion As of October 9, 2024, new regulatory provisions allow foreign companies to appoint a representative established in Canada as their Responsible Person. This representative, by assuming this role, can operate as if it were the manufacturer itself with regard to compliance with local regulations. Responsibilities of the Responsible Person in Canada The Responsible Person acts as the primary link between foreign companies and Health Canada. Their primary responsibilities include: Regulatory Compliance : Ensure products comply with all regulatory requirements, including labeling, safe formulations, and ingredient restrictions. Post-market Claims and Safety Management : Monitor and report adverse events associated with products, following pharmacovigilance requirements. Interaction with Authorities : Facilitate audits, respond to regulatory queries and provide additional documentation to Health Canada when required. Recall Management : Coordinate corrective actions in case of defective or unsafe products. Responsible Person in Canada: Benefits and Implications The introduction of the Responsible Person offers several benefits, including: Facilitates access to the Canadian market : Allows foreign brands to operate without the need to establish a local corporate entity. Improves oversight and traceability : Provides Health Canada with a clear contact to manage regulatory incidents and inquiries. Promotes consumer safety : Strengthens controls to prevent non-compliant products from entering the market. However, it also poses challenges, such as the need to adequately train and educate entities designated as Responsible Persons and increased operating costs for foreign companies. Our conclusion The Responsible Person model in Canada represents a significant step towards stricter and more effective regulation of consumer products. This model not only strengthens consumer confidence, but also ensures a level of regulatory compliance in line with international best practices. Contact an Expert in Canadian Cosmetic Regulation Companies interested in operating in Canada should carefully consider selecting a competent Responsible Person prepared to assume the legal and regulatory obligations in this dynamic market.

On December 3, 2024, the United States Environmental Protection Agency (EPA) announced a major update to regulations for new chemicals under the Toxic Substances Control Act (TSCA). This measure aims to improve the efficiency of the review process for new chemicals and strengthen environmental and public health protection against potentially hazardous substances. Table of contents Key Changes: Exclusion of PFAS and PBT Chemicals from Exemptions Alignment with the Chemical Safety Act for the 21st Century Impact on Industry and Society Towards a more efficient and preventive regulation U.S. EPA Updates Chemical Regulations Under TSCA to Strengthen Oversight and Environmental Protection Key Changes: Exclusion of PFAS and PBT Chemicals from Exemptions One of the most significant amendments in the final rule is the exclusion of per- and polyfluoroalkyl substances (PFAS) and certain persistent, bioaccumulative and toxic (PBT) chemicals from the LVE (Low Volume Exemptions) and LoREX (Reduced Release and Exposure Exemptions) exemptions. These changes ensure that such substances, known for their environmental and health risks, are subject to more rigorous reviews before they are placed on the market, closing regulatory loopholes that previously allowed their production or use under specific conditions without thorough evaluation. Alignment with the Chemical Safety Act for the 21st Century The update also seeks to align regulations with the 2016 TSCA Amendment, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This landmark amendment strengthened requirements for the evaluation of chemicals in the United States, introducing a more precautionary, risk-based approach to chemical management. By modernizing review procedures, EPA is ensuring that decisions are supported by the latest knowledge and best practices gained in implementing the New Chemicals Program. Impact on Industry and Society These amendments have significant implications for the chemical and manufacturing industries. The exclusion of PFAS and PBT substances from certain exemptions means that companies will have to undergo more extensive review processes, which could lengthen approval times and increase operating costs. However, these measures also drive the transition to safer and more sustainable alternatives. For society, the updated regulations represent a step forward in environmental protection, as PFAS chemicals , known as "forever chemicals" for their persistence in the environment, have been linked to serious health impacts, including cancer, hormonal problems and organ damage. Towards a more efficient and preventive regulation With these amendments, the EPA is not only seeking to strengthen chemical safety, but also to streamline its review process. This ensures that a balance is maintained between industrial innovation and environmental responsibility, while reinforcing the United States' commitment to more rigorous and proactive management of chemicals. This decision marks a crucial step towards a cleaner economy and a safer chemical environment, aligning with the expectations of a society that demands greater sustainability and environmental responsibility. ¿Necesitas más información?