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The European Chemicals Agency (ECHA) has presented a draft of its Community Roll-Up Action Plan (CoRAP) for the period 2025-2027, which provides for the evaluation of eight priority chemicals in 2025. This step, aligned with the regulatory framework of the REACH Regulation, reinforces the European Union's efforts to protect human health and the environment from potential risks associated with chemicals. Table of contents What does this new plan entail? What Substances Will Be Evaluated and Why? The Evaluation Process ECHA: Implications for Industry and Society ECHA: A Continuing Commitment to Chemical Safety ECHA: Evaluación de ocho sustancias químicas prioritarias en 2025 What does this new plan entail? The evaluation of chemical substances is an essential component of the REACH Regulation , the regulatory framework that governs the production and use of chemicals in Europe. According to the draft plan, the eight selected substances will be subject to detailed scrutiny, aimed at determining whether they pose significant risks. This assessment is based on key criteria, such as: Persistence in the environment : The ability of substances to remain intact in ecosystems for long periods. Bioaccumulation : Its tendency to accumulate in living organisms. Toxicity : Identified negative impacts on human health or ecosystems. The main objective is to collect additional data and, if necessary, recommend restrictions or prohibitions to ensure an adequate level of protection.   ECHA: Which Substances Will Be Evaluated and Why? The eight substances selected have been identified for their worrying characteristics, such as their carcinogenic, mutagenic, toxic for reproduction (CMR) potential or their ability to persist and bioaccumulate in the environment. Some even show signs of being endocrine disruptors. These are the substances that will be evaluated and the reasons behind their inclusion: 2-hydroxypropyl acrylate Suspected of causing cancer and sensitization. Widespread dispersive use and significant occupational exposure. Evaluated by France. Oligomerization products of beta-pinene Potential PBT/vPvB (persistent, bioaccumulative and toxic) properties. Consumer use and potential environmental impact. Assessed by Spain. Oligomerization products of alpha-pinene and beta-pinene Similar PBT/vPvB concerns and wide dispersive use. Also assessed by Spain. Tris(2-ethylhexyl) phosphate Considered a potential endocrine disruptor with significant environmental and occupational risks. Evaluated by France. Triethyl phosphate It poses CMR risks and possible endocrine disruption, as well as a high tonnage of use. Evaluated by France. [3-(2,3-epoxypropoxy)propyl]dimethoxymethylsilane With possible mutagenic effects. Evaluated by Italy. [3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane Similar to the previous substance, with concern for mutagenicity. Also evaluated by Italy. Potassium dicyanoargentate Associated with reproductive toxicity and suspected endocrine disruption. Evaluated by the Netherlands. ECHA: The Evaluation Process These substances will be subject to a thorough review by the responsible Member States, who will analyse additional data to assess the potential risks. This analysis will make it possible to determine whether further regulatory measures are needed, such as restrictions or their classification as substances of very high concern (SVHC). The process not only focuses on gathering sound scientific information, but also considers the impact on industry and consumers. Companies that use these substances in their supply chain could face restrictions that would require significant adjustments, from the replacement of components to innovation in production processes. ECHA: Implications for Industry and Society The assessment of these substances has the potential to impact a range of industries, including chemicals, polymer and adhesive manufacturing, and other sectors dependent on advanced chemicals. Affected companies will need to adapt quickly to comply with the new regulations , while consumers could benefit from greater safety assurances for everyday products. Furthermore, this action reinforces the European Union's commitment to the European Green Deal and its objective of moving towards a sustainable and pollution-free economy. ECHA: A Continuing Commitment to Chemical Safety The publication of this draft underlines the importance of rigorous, evidence-based regulation to protect people and the environment. Collaboration between ECHA, Member States and industry will be crucial to address challenges that may arise during the evaluation process. With this measure, Europe takes a further step towards a safer chemical future, promoting responsible innovation and sustainability at all levels of society. ¡Contácta con nuestro equipo de expertos hoy mismo!

As of January 1, 2025, Royal Decree 1055/2022 will come into force in Spain, a regulation that introduces new obligations regarding the recycling of household packaging. This measure seeks to promote more efficient and sustainable waste management through correct identification of destination containers. Table of contents Obligations established by the Royal Decree Support tools for companies Environmental impact and benefits Reminder for companies Conclusion Real Decreto 1055/2022: Nueva Obligación en el Reciclado de Envases Obligations established by the Royal Decree The main change introduced by this regulation is the obligation to indicate the appropriate container for the final disposal of household packaging waste. This information must be clearly visible and legible, either on the packaging itself or on its label. Temporary application : The regulations apply exclusively to packaging placed on the Spanish market from 1 January 2025. It will not be required for those products that were already in stock or were marketed before this date. Flexibility in format : No specific design is established for this indication. Companies may include informative phrases or symbols that meet the objective, including those used in other countries with similar regulations. Support tools for companies To facilitate the implementation of these measures, organizations such as Ecoembes have developed tools such as the “Recycle Symbol”, a visual guide that allows consumers to easily identify the appropriate container: Yellow container : For plastic, metal and carton containers. Blue container : For paper and cardboard. Green container : For glass containers. Brown container : For compostable waste (if applicable). This symbol is free to use for companies affiliated with Ecoembes and is designed to adapt to various international contexts and regulations. “Símbolo Recicla”, una guía visual que permite a los consumidores identificar fácilmente el contenedor adecuado Environmental impact and benefits The correct identification of recycling containers aims to improve the rate of waste separation and recycling in Spain, reducing pollution and promoting a circular economy. This type of initiative is key to achieving European objectives in terms of sustainability and waste management. Reminder for companies Companies must begin adapting their packaging and labels before the deadline to comply with this regulation. It is crucial that the design includes the required indications to ensure its correct availability in the Spanish market. Conclusion With Royal Decree 1055/2022 , Spain is taking an important step towards more responsible management of packaging waste. Companies and consumers will play a key role in the success of this initiative, contributing together to a more sustainable future.

Last June, the Council of the European Union adopted a key position on the proposal to update the Detergents Regulation, repealing the current Regulation (EC) No 648/2004. This initiative seeks to modernise regulations around detergents, in order to increase transparency, improve sustainability and ensure safety for both consumers and the environment. One of the most significant new features of this update is the harmonization of allergen labeling in detergents with the regulations for cosmetic products, in accordance with the CLP Regulation (Classification, Labeling and Packaging of Substances and Mixtures). Table of contents Allergen labelling on fragrances: greater protection for consumers Main changes in the new Detergents Regulation Detergents Regulation: Monitoring and compliance with the new regulation Detergents Regulation: Key implementation dates Conclusion Allergen labelling on fragrances: greater protection for consumers The proposed new regulation introduces an obligation for detergents to include detailed information on allergens present in the fragrances used in their formulations. This change responds to the need to provide consumers with clear and precise information on the possible components that could trigger allergic reactions, allowing them to make more informed decisions. The measure is especially relevant for people who suffer from sensitivity or allergies to certain ingredients, since until now, this type of labeling was not standardized for cleaning products as it is for cosmetics. Main changes in the new Detergents Regulation The draft new regulation introduces several key changes affecting manufacturers, distributors and importers. The five most important aspects are detailed below: Biodegradability Biodegradability requirements for surfactants used in detergents are being strengthened. This measure aims to minimise the environmental impact of these products, especially with regard to the water cycle. The new regulation seeks to ensure that detergents are more easily degraded, reducing adverse effects on the aquatic environment and promoting more sustainable practices. Labeled In addition to allergen labelling, additional information will be required on detergent packaging, including preservatives. In the case of bulk sales, consumers will receive a physical label with all relevant product information, reinforcing transparency and access to information. Information and contact with authorities Manufacturers must keep detailed information on their products available to competent authorities and medical personnel in the Member States. This ensures rapid and efficient access to information in the event of product safety incidents. Limitations on phosphates In order to reduce water pollution, strict limitations will be placed on the content of phosphates and other phosphorus compounds in laundry detergents and automatic dishwashers. These components, although effective in cleaning, can have harmful effects on the environment, contributing to the eutrophication of water bodies. Restrictions on aerosols Aerosol detergents containing microorganisms will be subject to additional restrictions to avoid risks to public health and the environment. Detergents Regulation: Monitoring and compliance with the new regulation To ensure that detergents and surfactants marketed in the European Union comply with the new regulations, the regulation establishes the obligation to have a designated contact person with the surveillance authorities. Manufacturers outside the EU who wish to sell their products on the European market must appoint an authorised representative. Importers must also ensure that the products comply with all regulatory requirements, including the availability of documentation for review by the competent authorities. An innovative aspect is the introduction of the digital product passport, which will be mandatory for both detergents and surfactants. This digital passport will allow more efficient tracking of products throughout their supply and use chain, facilitating traceability and compliance with regulations. Detergents Regulation: Key implementation dates The new regulation sets specific deadlines for the implementation of the new labelling requirements: July 31, 2026 : Deadline for marketing products that comply with the new allergen labeling. July 31, 2028 : Deadline for withdrawing from the market products that do not comply with the new labeling rules. Conclusion The update to the Detergents Regulation marks an important milestone in the cleaning industry, driving improvements in safety, transparency and sustainability. By aligning fragrance allergen labelling regulations with cosmetics regulations, it is ensured that consumers have access to clear and relevant information for their health and wellbeing. The new restrictions and requirements on biodegradability, phosphates and product formats also represent an effort towards a greener and more responsible industry. With these new measures, the European Union reinforces its commitment to protecting the environment and public health, establishing a robust regulatory framework adapted to the needs of the 21st century.

In the context of product regulation in the United States, especially in relation to products controlled by the Food and Drug Administration (FDA), different key roles have been established to ensure compliance with US regulations by foreign companies. Among these roles, two that may cause confusion due to their similarities, but which have specific and distinct functions, are the "US Responsible Person" and the "US Agent". The differences and similarities between these two positions, as well as their respective responsibilities, are explored below. Table of contents Definition and Responsibilities of the US Responsible Person Definition and Responsibilities of a US Agent Importance of FDA Compliance for Foreign Companies Key Differences Between US Responsible Person and US Agent US Agent and US Responsible Person: Practical Cases and Real Examples Role of the US Responsible Person in the MOCRA Framework for Cosmetics Technology and Tools to Facilitate Compliance Conclusion Definition and Responsibilities of the US Responsible Person The term "US Responsible Person" refers to a person created for the purpose of complying with the requirements of the Food Safety Modernization Act (FSMA) in the food sector, as well as with medical device regulations. Their main objective is to act as a trusted intermediary between the FDA and foreign manufacturers wishing to market products in the US. This role is crucial in the medical device sector, as the FDA requires each foreign device manufacturer to have a US Responsible Person if they are to be granted authorization for sale in the country. Main functions of the US Responsible Person Direct communication with the FDA : The Responsible Person has the obligation to facilitate communications between the FDA and the foreign company, including the receipt of information related to inspections and audits. Facilitation of product recalls : In the event that a medical device or product presents risks to public health, the US Responsible Person plays a crucial role in managing product recalls. Ensure compliance : Ensures that the foreign company follows FDA regulations and compliance procedures required for importing products. Emergency Liaison : This role serves as a key point of contact in emergency situations, where rapid action is required to mitigate health risks to consumers. It is important to note that, unlike the "US Agent", the "US Responsible Person" has a more active role in supervising and ensuring compliance with FDA regulations. Definition and Responsibilities of a US Agent The "US Agent" is a mandatory role for all foreign companies seeking to register products with the FDA, including food, cosmetics, pharmaceuticals, and medical devices. This role was formalized by the Bioterrorism Act of 2002, which requires all foreign facilities wishing to market products in the US market to designate an agent within the US to act as an intermediary with the FDA. Main functions of the US Agent Communications Intermediary : The U.S. Agent is the point of contact for all official communications between the FDA and the foreign company. Although he or she is not required to ensure regulatory compliance, he or she must promptly receive and report to the company any requests or requirements from the FDA. Receiving Documents : The US Agent is responsible for receiving notices, correspondence, and requests from the FDA on behalf of the foreign company. This includes inspections, registrations, and legal documents. Emergency Support : Although the US Agent is not directly responsible for managing emergencies or product recalls, he or she may be called upon by the FDA to coordinate the delivery of relevant information. The "US Agent" functions primarily as a passive intermediary, without direct responsibility for ensuring regulatory compliance of products. Importance of FDA Compliance for Foreign Companies Complying with FDA regulations is not only a legal requirement, but a fundamental pillar for the success of foreign companies that wish to operate in the United States. This compliance ensures that products meet the safety and quality standards required by the industry, protecting both consumers and companies. Consequences of Non-Compliance Failure to comply with FDA regulations can lead to serious consequences, such as: Fines and legal penalties: Significant penalties that can put company operations at risk. Import prohibitions: Retention of products in customs, preventing their distribution. Reputational impact: Non-compliance can undermine brand trust, affecting business relationships and consumers. Benefits of Compliance Compliance with regulations not only prevents legal problems, but also improves the company's position in the market: Continued Market Access: Compliance ensures products enter and remain in the U.S. Credibility with consumers: FDA-approved products generate trust. Reduction of operational risks: Facilitates processes such as imports and distribution without regulatory complications. Choosing the Right Representative Choosing the right US Responsible Person or US Agent can make a big difference. Make sure you select someone with experience, immediate responsiveness, and the ability to handle critical situations, such as inspections or emergencies. Key Differences Between US Responsible Person and US Agent Although both roles serve as intermediaries between the FDA and foreign companies, there are fundamental differences in their responsibilities, levels of involvement, and the sectors where they are required: Feature US Responsible Person US Agent Application sectors Mainly medical devices, food. All sectors regulated by the FDA (food, cosmetics, medical devices, etc.). Compliance Responsibility Responsible for ensuring that the manufacturer complies with regulations. Has no direct responsibility for regulatory compliance. Participation in recalls Play an active role in coordinating product recalls. It can only help at the intermediation level, but is not responsible for the actions. Emergency Requirements Acts as a point of contact and action in emergencies. Facilitates communication, but is not responsible for actions. Level of involvement High involvement in regulatory compliance and FDA inspections. Low involvement; its main role is communications intermediation. US Agent and US Responsible Person: Practical Cases and Real Examples Compliance with FDA regulations can be challenging for foreign companies, but having a US Responsible Person or US Agent has proven to be key to overcoming regulatory hurdles. Below are examples of how these figures have been instrumental in resolving issues: Example 1: Product retention in customs Problem: A European cosmetics company had its shipment detained in U.S. customs due to discrepancies in ingredient records. Solution: The US Agent quickly intervened to coordinate the correction of documents with the FDA and release the shipment in less than a week. Example 2: Recall of defective products Issue: An Asian medical device manufacturer identified a defect in a batch distributed in the US. Solution: The US Responsible Person coordinated communication with the FDA and facilitated an efficient recall, avoiding further legal and commercial impacts. Example 3: Unexpected inspection Problem: A Latin American food company received a surprise inspection by the FDA. Solution: The US Responsible Person provided complete documentation and acted as liaison, ensuring the inspection was concluded without penalties. Case Problem Key Role Result Customs retention Discrepancy in ingredient records US Agent Shipping release within a week Recall of defective products Defect in medical devices US Responsible Person Efficient coordination of a safe withdrawal Unexpected inspection Request for immediate information US Responsible Person Resolution without regulatory sanctions These case studies highlight how the support of a US Responsible Person or US Agent can make the difference between success and complications when navigating strict FDA regulations. How to Register Products and Establishments with the FDA? The process of registering products and establishments with the FDA is essential to ensure access to the US market and to comply with regulatory standards. Below are the basic steps for this process, highlighting how the US Agent and the US Responsible Person facilitate its execution: Basic Steps of FDA Registration Identify the type of product: Determine whether it is a food, medical device, cosmetic or drug, as each category has specific requirements. Create an account on the FDA portal: Register on the FDA Unified Registration and Listing System (FURLS) or the specific portal, such as Cosmetics Direct for cosmetic products. Designate a US Agent: This is mandatory for foreign companies. This agent will be the intermediary between the FDA and the company for managing communications. Provide establishment information: Include location, contact and manufacturer-specific data. List individual products: Provides a complete description of each product, its ingredients, and where it was manufactured. Pay applicable fees: Depending on the type of product, registration fees may apply. Complete the submission and wait for confirmation: Once approved, you will receive the registration number. Role of the US Agent and the US Responsible Person The US Agent is responsible for receiving notifications and correspondence from the FDA during the registration process. The US Responsible Person, in sectors such as medical devices, ensures that records comply with regulations and that information is accurate. Role of the US Responsible Person in the MOCRA Framework for Cosmetics With the implementation of the Cosmetics Regulation Modernization Act (MOCRA) , the role of the US Responsible Person takes on even greater importance in the cosmetics sector. This regulation establishes new standards of safety and transparency that must be actively monitored. Key Responsibilities under MOCRA Compliance Monitoring: Ensures products meet new FDA safety requirements. Ingredient Review: Verify that ingredients are safe and properly listed. Adverse Event Reporting Management: Facilitates the collection and communication of reports on negative consumer reactions. Recall of unsafe products: Coordinate with the FDA to remove products that may pose a risk. Relationship with MOCRA Compliance: The US Responsible Person is the key link between the foreign company and the FDA, ensuring that FDA cosmetics regulations are applied at all stages of production and marketing. Technology and Tools to Facilitate Compliance Technology plays a vital role in FDA compliance, enabling more efficient and transparent processes. Tools like Cosmetics Direct and FURLS System help companies stay organized and meet regulatory requirements. Main Tools FDA Unified Registration and Listing System (FURLS): Allows establishments to register and products to be listed centrally. Cosmetics Direct Portal: A cosmetics-specific tool that simplifies the registration and listing process. Compliance Management Systems (Compliance Tools): Applications designed to track deadlines, registration updates, and FDA requirements. Benefits of Using Technological Tools Process automation: Reduces human errors and speeds up registration. Real-time notifications: Notify you of regulatory updates or expiration dates. Centralized access: Consolidate all information in one place to facilitate audits or inspections. Conclusion In summary, both the "US Responsible Person" and the "US Agent" play important roles in compliance with FDA regulations for foreign companies seeking to enter the US market. However, the key difference lies in the degree of responsibility. While the US Agent acts as a passive intermediary to facilitate communication between the FDA and the company, the US Responsible Person has a much more proactive role, being responsible for regulatory compliance and the necessary actions in emergency or non-compliance situations. It is critical that foreign companies understand these differences when appointing these figures, to ensure that they comply with all regulations and can act appropriately in the event of inspections, recalls or any other regulatory matter.

The U.S. Food and Drug Administration (FDA) has introduced “Cosmetics Direct,” a digital tool designed to transform the way cosmetics companies register their facilities and products. This platform marks an important step in the implementation of the Cosmetics Regulatory Modernization Act of 2022 (MoCRA) , which sets new standards for safety and transparency in the cosmetics industry. Below, we will explore its features, benefits, and how it relates to key topics such as FDA codes for cosmetics, FDA registration, and cosmetic product ingredient management. Table of contents What is "Cosmetics Direct"? The regulatory framework: MoCRA and the FDA codes for cosmetics Main features of "Cosmetics Direct" Notification of Adverse Events and Product Recalls Registration and Listing Requirements under MoCRA Good Manufacturing Practices (GMP) for Cosmetics Safety Assessment of Cosmetic Ingredients Benefits of the Cosmetics Direct portal Notification of Adverse Events and Product Recalls Labelling and Declaration of Allergens in Cosmetics Why is FDA registration important for cosmetic products? Conclusion: A new standard for the cosmetics industry What is Cosmetics Direct? Cosmetics Direct is an electronic portal created by the FDA to facilitate compliance with MoCRA provisions. This portal not only simplifies the process of facility registration and product listing, but also eliminates the need for more complicated methods such as using the Electronic Submissions Gateway (ESG). Through an intuitive interface, companies can enter critical information about their products and facilities and submit this data directly, improving access to regulatory tools such as the FDA Login . Regulatory Framework: MoCRA and FDA Codes for Cosmetics Cosmetics Direct operates under the reforms driven by MoCRA , a landmark law that has significantly expanded the FDA 's authority in regulating cosmetics. Enacted in 2022, MoCRA has introduced new safety, labeling, and ingredient listing requirements that seek to ensure: Ingredient transparency : Companies must detail each ingredient in their products, a key aspect to comply with the FDA codes for cosmetics . Facility Registration : All facilities involved in the manufacturing or processing of cosmetic products for the U.S. market must obtain an FDA registration number . Cosmetic Product Listings : MoCRA requires companies to submit detailed information about the products they market, including their composition and location of manufacture. Main features of "Cosmetics Direct" The Cosmetics Direct portal is designed to fulfill several key functions within the regulatory framework established by the FDA: Registration of cosmetic facilities Facilities must register with the FDA by providing essential information, such as name and address, in addition to obtaining an FDA registration number . This registration is mandatory for any facility involved in the distribution of cosmetics in the United States. List of cosmetic products Companies must detail each product they sell, including: Product name and category. Complete list of ingredients, in accordance with FDA cosmetics ingredients requirements. Manufacturing location. This listing ensures that all products comply with the FDA codes for cosmetics . Update Management Businesses can update their registration and listing information directly on the portal. Changes must be made within 60 days to maintain regulatory compliance. Presentation in SPL format The platform generates submissions in the Structured Product Labeling (SPL) format, ensuring compatibility with FDA data standards. Notification of Adverse Events and Product Recalls Under MoCRA , companies are required to report any serious adverse events related to their products through the FDA Direct portal. This requirement is part of the FDA 's efforts to improve consumer safety. Mandatory reports Report serious allergic reactions or other adverse events via FDA Login . Document and present information within established deadlines. Product recall procedures If a safety issue is identified, companies must recall the product and notify the FDA. Affected products are also removed from registered listings. Registration and Listing Requirements under MoCRA To comply with the Cosmetics Regulatory Modernization Act of 2022 (MoCRA), companies must complete certain essential steps through platforms such as Cosmetics Direct or the FDA Direct system. These steps ensure that cosmetic products and facilities meet FDA standards. Facility registration Facilities must register by obtaining an FDA registration number , which officially identifies the manufacturing or processing location. Required information: name, address and contact details of the operator. List of cosmetic products Detail each product, its category and the complete list of FDA cosmetics ingredients . This process ensures transparency and compliance with FDA codes for cosmetics . Compliance with these requirements ensures that products can be legally marketed in the United States. Good Manufacturing Practices (GMP) for Cosmetics Good Manufacturing Practice (GMP) compliance is essential under MoCRA regulations and FDA oversight. Tools like FDA Direct allow companies to manage these standards efficiently. GMPs ensure that cosmetic products are safe, effective and consistent in quality. The FDA evaluates facilities' compliance with established quality control requirements. Implementing GMP is key to protecting consumer confidence and avoiding penalties. Using Cosmetics Direct makes it easy for companies to ensure their processes meet these standards. Safety Assessment of Cosmetic Ingredients Ingredient safety is a priority for the FDA and a key aspect of MoCRA. All companies must ensure that FDA cosmetics ingredients are safe and meet regulatory standards. Companies must conduct safety assessments on individual ingredients and combinations. It is crucial to document scientific evidence and maintain up-to-date records in FDA Direct . Ingredients banned by the FDA should not be included in products. Platforms like Cosmetics Direct simplify this process, ensuring that companies comply with ingredient regulations. Benefits of the Cosmetics Direct portal Using "Cosmetics Direct" offers multiple benefits for the industry and the consumer, standing out for its efficiency and ability to comply with FDA standards. Among the main benefits are: Operational efficiency : Process automation reduces errors and management times, allowing companies to focus on their core operations. Enhanced Transparency : Centralizing data allows the FDA to more effectively oversee the industry, protecting consumers and ensuring that only safe products reach the market. Simplified compliance : With tools like FDA Login , companies have direct access to their records and can manage them more effectively. Notification of Adverse Events and Product Recalls Under MoCRA, companies are required to report any serious adverse events related to their products through the FDA Direct portal. This requirement is part of the FDA 's efforts to improve consumer safety. Mandatory reports Report serious allergic reactions or other adverse events via FDA Login . Document and present information within established deadlines. Product recall procedures If a safety issue is identified, companies must recall the product and notify the FDA. Affected products are also removed from registered listings. This proactive approach improves transparency and confidence in FDA products . Labelling and Declaration of Allergens in Cosmetics Accurate labeling and allergen declaration are mandatory requirements under MoCRA and FDA regulation. This process ensures that consumers are fully informed about the products they use. Labeling requirements Products must detail all ingredients on the packaging, including any potential allergens present. Following the FDA codes for cosmetics is essential to avoid sanctions. Examples of compliance Declare specific fragrances and other potentially allergenic components. Use clear and legible labels according to FDA standards. Label management can be easily done using tools like FDA Direct , ensuring correct labeling. Why is FDA registration important for cosmetic products? The implementation of platforms such as Cosmetics Direct highlights the importance of registering products and facilities with the FDA. Having an FDA registration number not only ensures legal compliance, but also improves consumer confidence in products. Furthermore, complying with FDA codes for cosmetics and ensuring that ingredients comply with regulatory standards is essential to operate in an increasingly demanding market. Conclusion: A new standard for the cosmetics industry Cosmetics Direct is much more than a digital tool; it is a comprehensive solution that redefines the way cosmetics companies comply with FDA regulations. In a context where security and transparency are essential, adopting this platform allows companies not only to remain compliant with MoCRA, but also to build a solid foundation of trust with their consumers. If your company has not yet explored the advantages of this tool, now is the time to register, learn about the FDA codes for cosmetics and ensure compliance with the standards established by the FDA. With tools like Cosmetics Direct, companies have access to resources that simplify compliance with complex regulations, including obtaining an FDA registration number, listing products, and declaring ingredients in accordance with FDA codes for cosmetics. Leveraging these platforms not only ensures FDA compliance, but also reinforces consumer confidence in FDA products.

On 13 November 2024, the Court of Justice of the European Union (CJEU) issued a landmark ruling in case T-274/21, brought by the Syndicat national des compléments alimentaires (SYNADIET). The decision invalidates several key sections of Regulation (EU) 2021/468, which restricted the use of herbal preparations containing compounds such as aloe-emodin, emodin and aloe leaves, as well as certain plants including senna, rhubarb, buckthorn and cascara. Table of contents The regulatory context Impact on the food supplements industry Regulatory implications Conclusion The regulatory context: Regulation (EU) 2021/468 Regulation (EU) 2021/468, based on Article 8 of Regulation No 1925/2006, established restrictions on plant-derived products containing hydroxyanthracenes (HAD), arguing potential health risks. However, the CJEU found that the interpretation of this article was inappropriate when applied to herbal “preparations”, a term whose scope is broader than that provided for in the original text. The Court also noted that no clear toxicity thresholds associated with HAD compounds were identified, which invalidates the scientific basis for the ban and makes it incompatible with the legal principles set out in Article 8 of Regulation No 1925/2006. Impact on the food supplements industry This resolution represents a significant step forward for the food supplements sector. From now on, manufacturers can market products containing hydroxyanthracene derivatives, provided they can scientifically justify their safety for human consumption, in compliance with general food safety regulations. Regulatory implications The CJEU decision obliges the European Commission and Member States to review and adapt current regulations on the use of plant compounds in food supplements . This underlines the need to establish clear, evidence-based thresholds before implementing restrictions that impact both industry and consumers. Conclusion The annulment of Regulation (EU) 2021/468 not only strengthens the European regulatory framework by requiring more precise and transparent criteria, but also provides an opportunity for innovation in the food supplements sector. This ruling highlights the importance of balancing consumer safety with market freedom, supporting operators that meet safety and quality standards in their products.

The European Union has implemented a significant change in the regulation of classification, labelling and packaging of chemical substances and mixtures with the publication of Regulation (EU) 2024/2865. This regulatory framework, approved by the European Parliament and the Council, modifies the pre-existing regulation (EC Regulation No. 1272/2008), with the aim of aligning practices with scientific advances and sustainability priorities. Table of contents A Modernized Approach to Chemical Management Impact on Industry and Market A Commitment to Public Health and the Environment Conclusion Sources of interest A Modernized Approach to Chemical Management The update regulates critical aspects of chemical substance management to ensure clear labelling and accurate classification. This amendment responds to the need to address new risks arising from advanced compounds, reflecting a commitment to protecting human and environmental health. Key points include: Revision of Classification Criteria : Stricter definitions have been introduced for highly hazardous substances, including endocrine disruptors and environmentally persistent mixtures. Transparent Labeling : Labels will now include more detailed information about potential associated risks, improving communication with consumers and workers. Compatibility with the Global Approach : The changes harmonize European standards with the criteria of the Globally Harmonized System (GHS), promoting international coherence. Impact on Industry and Market The European chemical industry will have to adapt to these demands with a phased transition that includes specific deadlines for implementation. These regulations are expected to boost innovation in safer and more sustainable alternatives, creating incentives to reduce the use of toxic compounds in everyday products. Requirements for Manufacturers : Producers must subject their substances to more rigorous testing, ensuring the scientific validity of the data provided. Extended Responsibility : Obligations of importers and distributors in the supply chain are reinforced to ensure regulatory compliance. Facilitating the Circular Economy : Regulation encourages recycling and safe reuse of chemical materials. A Commitment to Public Health and the Environment Regulation (EU) 2024/2865 also reflects the EU’s commitment to the European Green Deal , seeking to reduce the impact of hazardous chemicals on the environment. These changes are anticipated to significantly reduce exposure to harmful pollutants, protecting both biodiversity and future generations. Conclusion The update of Regulation (EU) 2024/2865 is a momentous step towards safer and more responsible handling of chemicals in Europe . This effort not only strengthens the protection of public health and the environment, but also positions the EU as a global leader in sustainability and innovative regulation. Sources of interest: Regulation - EU - 2024/2865 - EN - EUR-Lex

On 7 November 2024, the Member State Committee (MSC) of the European Chemicals Agency (ECHA) officially added triphenyl phosphate to the List of Substances of Very High Concern (SVHC). This update brings the total number of entries on the list to 242, considering that some of these entries cover groups of chemicals. Table of contents Properties and Uses of Triphenyl Phosphate Obligations Arising from Inclusion on the List of Candidates Requirements related to the Waste Directive Future Implications: Regulation and Transparency Possibility of Inclusion in the Authorization List Properties and Uses of Triphenyl Phosphate Triphenyl phosphate is widely known for its endocrine disrupting properties. It is used in a variety of industrial applications, including as a flame retardant and plasticizer in polymer formulations, adhesives and sealants. Its inclusion on this list implies that it could be more tightly regulated in the future, affecting its availability and use. Obligations Arising from Inclusion on the List of Candidates Companies that market products containing this substance must comply with strict obligations: Provision of information: Suppliers must include a safety data sheet (SDS ) and provide detailed instructions on the safe use of the products. Notifications to ECHA : Manufacturers and importers are required to inform the agency if their products contain more than 0.1% of this substance, within six months of their inclusion on the list. Requirements related to the Waste Directive Under the Waste Framework Directive, companies must submit notifications to the ECHA's SCIP (Substances of Concern In articles, as such or in complex objects (Products)) database. In addition, products containing this substance will not be eligible for the EU Ecolabel. Future Implications: Regulation and Transparency The increasing regulation around substances such as triphenyl phosphate not only poses challenges, but also opens doors for innovation. Companies are driven to develop more sustainable products, promote research into chemical alternatives and adopt clean technologies. This regulatory framework also stimulates global competitiveness, as European industries that lead these changes will be better positioned in a market increasingly oriented towards sustainability and transparency. Possibility of Inclusion in the Authorization List The inclusion of triphenyl phosphate in the Candidate List is a preliminary step towards its possible incorporation into the Authorization List . If this happens, companies will have to request specific permits to continue using this substance in their production processes. The inclusion of substances such as triphenyl phosphate reflects the EU's proactive approach to managing hazardous chemicals , marking a significant step towards sustainability and safety in the chemical sector.

As the cosmetic industry continues to evolve, regulatory bodies like Health Canada are implementing new standards to enhance consumer safety and transparency. The latest updates to Canada's cosmetic regulations aim to strengthen oversight, improve labeling clarity, and ensure that cosmetic products on the market are safe and clearly labeled. These regulations are crucial for manufacturers, distributors, and retailers who need to adapt their processes to maintain compliance. In this article, we break down the key updates, compliance requirements, and important dates to help industry stakeholders navigate these changes effectively. Overview of Health Canada's Cosmetic Regulations Updates to Terms and Definitions: Clarity and Consistency Major Updates to Cosmetic Regulations: Ingredient Disclosure and Safety Labeling Requirements: Ensuring Transparency and Safety Updated Documentation and Resources Key Compliance Dates to Remember How to Navigate the Notification Process Conclusion: Preparing for Compliance Overview of Health Canada's Cosmetic Regulations Health Canada’s new cosmetic regulations, effective from October 9, 2024 , mark a significant shift towards greater transparency and consumer protection. With new rules on ingredient disclosure, labeling requirements, and revised definitions, the goal is to enhance consumer confidence and safety in cosmetic products. This article details the regulatory changes, updated definitions, key compliance dates, and guidance for adherence to these regulations. Key Regulatory Changes: An Overview The recent regulations introduce comprehensive updates that affect various aspects of cosmetic production, including: Labeling Flexibility for Small Containers : Small containers now have alternative labeling options to include essential information without compromising legibility. Ingredient Disclosure Requirements : Manufacturers are now required to disclose full ingredient lists, concentrations, and the functions of each component. Mandatory Updates in Contact Information : Updated and accessible contact information is now a requirement on all labels. Enhanced Safety and Testing Protocols : Emphasis is placed on manufacturers to conduct safety testing, especially when using ingredients that might be allergenic or otherwise potentially hazardous. These regulatory changes aim to bring about a standardized approach to labeling and transparency across the cosmetic industry. Updates to Terms and Definitions: Clarity and Consistency To facilitate consistency, Health Canada has revised core definitions within the cosmetics industry: Clarified Definitions of Key Terms Manufacturer : The term “manufacturer” now specifically refers to entities that formulate, produce, or label cosmetics, thereby eliminating ambiguity about who holds responsibility for compliance. Product Classifications : Cosmetic products are now classified as either “rinse-off” or “leave-on” within notification forms, impacting product testing and labeling. Mandatory Use of INCI Names INCI (International Nomenclature Cosmetic Ingredient) : It is now mandatory for manufacturers to use INCI names for ingredients on labels. This standardized ingredient identification ensures uniformity across products and helps consumers easily identify ingredients. Revised Concentration Ranges Health Canada has updated concentration ranges for ingredient disclosure. This change promotes transparency by allowing consumers to see how much of each ingredient is in the product, enhancing clarity and promoting safer choices. These updates to terms and definitions streamline communication, ensure uniform compliance, and support Health Canada's broader goal of transparency. Major Updates to Cosmetic Regulations: Ingredient Disclosure and Safety One of the most significant updates revolves around ingredient disclosure and safety standards: Ingredient Disclosure Standards As of April 24, 2024 , all manufacturers must notify Health Canada within 10 days  of launching a new cosmetic product. This notification should include a comprehensive list of ingredients, the function of the product, and up-to-date contact information on the label. Manufacturers are also required to disclose ingredient concentrations, allowing consumers to understand product composition better. Enhanced Safety Testing Requirements Health Canada’s updated guidelines mandate that products undergo rigorous safety testing, especially if they contain ingredients known to cause allergies or other reactions. Manufacturers must maintain records of these safety tests, as they may be requested during inspections or compliance checks. These measures ensure that every cosmetic product meets a basic safety standard before reaching consumers, reducing the risk of adverse effects. Labeling Requirements: Ensuring Transparency and Safety To uphold transparency, Health Canada has introduced stringent labeling requirements. These include: Comprehensive Labeling Information Labels must provide all essential details about the product, including ingredients, concentrations, safety warnings, and contact information. Products must display ingredient lists using INCI names to standardize labeling, which aids consumers in identifying potential allergens or unwanted substances. Alternative Labeling Options for Small Containers Recognizing the limitations of small packaging, Health Canada allows alternative labeling methods to fit essential information without sacrificing clarity. Small containers can use fold-out labels, adhesive tabs, or even QR codes to direct consumers to full ingredient lists and safety information online. These labeling requirements ensure that consumers have access to crucial product information, regardless of the container size. Updated Documentation and Resources In addition to regulatory changes, Health Canada has published updated documentation to guide manufacturers and importers in implementing these changes: Labeling Guide The Labeling Guide  provides detailed instructions on how to display information on product labels, including the proper formatting of INCI names, safety warnings, and contact details. Notification Form Manufacturers must use the updated notification form  to inform Health Canada about new products. This form requires comprehensive details about the product's function, ingredient composition, and manufacturer information. Compliance Guide The Compliance Guide  offers step-by-step instructions on how to meet regulatory standards, including guidelines for safety testing, record-keeping, and reporting requirements. These resources are designed to ease the transition to the new regulations, providing manufacturers and importers with a clear framework for compliance. Key Compliance Dates to Remember Health Canada has outlined specific compliance dates to ensure a smooth transition to the new regulations. Here are the critical dates to keep in mind: October 9, 2024 : Initial changes to labeling, ingredient disclosure, and updated definitions come into effect. April 12, 2026 : Manufacturers must ensure that all products comply with the new concentration range requirements and safety testing protocols. August 1, 2028 : Full compliance with all updated regulations, including those specific to small container labeling and contact information requirements, is expected. These staggered compliance dates provide the industry with ample time to adapt processes and packaging to meet the new standards. How to Navigate the Notification Process The notification process is critical for manufacturers planning to launch new cosmetic products. Here’s a step-by-step guide to ensure a smooth notification process: Complete the Notification Form : Ensure all fields are completed accurately, including the product's function, list of ingredients with INCI names, and concentration ranges. Submit within 10 Days : Submit the notification to Health Canada within 10 days of the product’s launch. Maintain Records : Keep a record of the submission and any related documentation, including safety testing results and compliance guides. Label and Package According to Requirements : Ensure the product label complies with all updated standards, including ingredient lists and contact information. Prepare for Compliance Checks : Health Canada may conduct inspections or request additional information to verify compliance. By following these steps, manufacturers can avoid delays and penalties, ensuring a successful product launch. Conclusion: Preparing for Compliance The new Health Canada cosmetic regulations underscore the importance of transparency and safety in the cosmetics industry. With clear guidelines on ingredient disclosure, labeling requirements, and safety standards, these changes aim to empower consumers and uphold product quality. Manufacturers, importers, and distributors should prioritize these updates to ensure compliance and enhance consumer trust. Final Tips for Compliance Stay Informed : Regularly check Health Canada’s website for updates and additional guidance. Train Your Team : Ensure all team members understand the new requirements and their roles in maintaining compliance. Consult Compliance Experts : If needed, work with compliance consultants to navigate more complex regulatory changes. Monitor Industry Trends : Keep an eye on global cosmetic regulations, as they may influence future updates to Canadian regulations. For more information on the new regulations, refer to Health Canada’s official guides and resources. By staying proactive, the cosmetic industry can effectively adapt to these new standards and continue providing safe, high-quality products to consumers. References and Resources Health Canada Cosmetic Regulations Update Health Canada Labeling Guide for Cosmetics INCI Ingredient Standards Adapting to these regulations may seem challenging, but with a clear plan and adherence to Health Canada's guidelines, manufacturers can ensure both compliance and consumer satisfaction.

The Free Sale Certificate (FSC) in Dubai is an essential document for companies wishing to export products to the region , ensuring that the goods sold meet safety standards and are authorized for sale in their country of origin. This certificate is issued by the competent authorities of the exporting country and confirms that the products are freely sold in the local market, facilitating their entry into international markets, including Dubai. It serves as a guarantee for Dubai customs authorities and other regulatory bodies, ensuring that the products are already legally available for sale in their home market and that they meet international quality and safety standards. Obtaining Process and Requirements Issuance by national authorities: The Free Sale Certificate must be issued by an official body in the country of origin of the product, such as a health ministry or a chamber of commerce. This document confirms that the product is approved for sale in the exporting country without legal restrictions. Legalization and apostille: In most cases, the FSC must be legalized by the UAE consulate in the exporter's country of origin, or apostilled in accordance with the Hague Convention regulations, to ensure its authenticity. Submission to local authorities: Once the product arrives in Dubai, the importer must submit the Free Sale Certificate to local authorities, such as the Dubai Municipality, the Ministry of Health, or the Emirates Authority for Standardization and Metrology (ESMA), depending on the type of product, to proceed with its registration and approval for sale in the Emirati market. Conclusion The Free Sale Certificate is a key requirement for entering the Dubai market , and is an essential step in consumer product regulation that ensures the safety, quality, and conformity of goods being marketed in the region. For businesses looking to export to Dubai, ensuring this document is in order is a crucial component of their export and regulatory compliance strategy.

New York State has taken a decisive step in environmental protection by implementing updated regulations resulting from amendments to Sections 35 and 37 of the Environmental Conservation Law (ECL). The regulations, originally adopted in 2019, set strict limits on the presence of the chemical compound 1,4-dioxane in household cleaning products, cosmetics and personal care items sold in the state. These measures aim to mitigate the environmental and public health risks associated with this compound, which is considered a possible human carcinogen and an emerging contaminant in bodies of water. Relevant Aspects of Regulation Technical and Scientific Criteria for Compliance Environmental and Public Health Implications Conclusion Relevant Aspects of Regulation The new regulations impose specific limits on the concentration of 1,4-dioxane in products commonly found in the home . These products include, among others, detergents, shampoos, soaps and creams. The regulations establish maximum permitted thresholds for this chemical compound, in accordance with international standards on chemical safety and human exposure. One of the central pillars of the regulation is the implementation of procedures for manufacturers to request exemptions from these limits, provided they demonstrate that they have adopted reasonable and effective measures to minimise the presence of 1,4-dioxane in their products. This provision allows the industry the possibility of adjusting to the new rules without an immediate interruption in the supply chain, while maintaining the commitment to reduce environmental impact. Technical and Scientific Criteria for Compliance The regulation not only defines the quantitative limits of 1,4-dioxane permitted in products, but also sets out the technical procedures that manufacturers must follow to ensure compliance with these limits. In this regard, companies are required to use scientifically validated analytical methods to detect and measure the concentration of 1,4-dioxane. Approved methods include advanced chromatography and spectrometry techniques, which guarantee accurate and reproducible quantification of the compound. For those companies seeking to apply for a temporary exemption, they are required to submit detailed information about the efforts made to reduce the presence of this contaminant in their production processes. In addition, during the exemption period, companies must provide technical information related to the methods used to detect 1,4-dioxane, including details of the laboratory carrying out the testing and a comprehensive description of the ingredients that contribute to the formation of the compound in question. Environmental and Public Health Implications 1,4-Dioxane is an unintended byproduct formed in certain manufacturing processes, particularly those involving the ethoxylation of chemicals. Its persistence in the environment, as well as its solubility in water, raises significant concerns regarding the contamination of water resources. Long-term exposure to 1,4-dioxane has been linked to health risks, including liver and kidney damage, and a potential risk of cancer, reinforcing the need for more stringent controls on its industrial use. With these measures, New York State seeks to balance the protection of the environment and public health with the continuity of industrial operations. The implementation of these regulations is an example of how environmental legislation can adapt to scientific and technological advances, promoting both sustainability and innovation in the manufacturing sector. Conclusion The introduction of strict limits on 1,4-dioxane in consumer products in New York represents a major step forward in environmental protection and public health. By regulating this chemical compound, a precedent is set for greater responsibility in industry regarding the control of pollutants, with a view to more sustainable development and less exposure to hazardous substances in everyday life. The success of these measures will depend, in large part, on effective collaboration between regulators, scientists and industry to ensure a safer environment for all citizens.

On October 8, 2024, EPA announced a proposal to add 16 per- and polyfluoroalkyl substances (PFAS )—along with 15 additional categories of these compounds—to the Toxics Release Inventory (TRI). This action is part of an effort to strengthen monitoring and management of pollution from these chemicals, which have received growing attention due to the potential negative effects they can have on both human health and the environment. Nature of PFAS Substances and Their Relevance in Regulation Compounds Proposed for Inclusion in TRI Implications of Facility Regulation and Liability Environmental and Public Health Impact Public Participation and Next Steps Conclusion Nature of PFAS Substances and Their Relevance in Regulation PFAS compounds, known for their chemical durability and resistance to degradation in the environment, have been widely used in a variety of industries, from consumer product manufacturing to advanced industrial processes. However, recent research has revealed that certain PFAS may be linked to adverse effects on human health, such as endocrine and immunological disruptions, and certain types of cancer. Furthermore, their persistence in the environment has raised concerns about their cumulative potential in water bodies and ecosystems. The EPA proposal seeks to expand regulatory control over these chemicals by establishing a 100-pound reporting threshold for their manufacture, processing, and other uses under the provisions of the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). This is expected to increase accountability for facilities that handle these compounds by fostering greater transparency about emissions and associated waste. Compounds Proposed for Inclusion in TRI The proposal includes the addition of 16 specific PFAS substances, including widely used compounds such as broflanilide (CASRN 1207727-04-5) and perfluorotridecanoic acid (PFTrDA, CASRN 72629-94-8), which have been used in agrochemical, industrial and pharmaceutical applications. In addition, 15 categories of PFAS substances are proposed, representing more than 100 individual compounds, such as perfluorooctanoic acid (PFOA, CASRN 335-67-1) and perfluorooctanesulfonic acid (PFOS, CASRN 1763-23-1), both widely studied due to their toxic effects and persistence in the environment. These chemicals are listed by TRI based on their toxicity, either through their direct impact on human health, the environment, or both. Accumulating data suggest that even at relatively low concentrations, PFAS can pose significant long-term risks, justifying the need for stricter regulation. Implications of Facility Regulation and Liability Establishing a 100-pound threshold for reporting these chemicals is aligned with EPA’s efforts to ensure that industrial facilities, regardless of size or capacity, adequately report any significant releases or uses of PFAS. This rule proposes that facilities that manufacture, process, or use these chemicals in quantities exceeding this threshold provide detailed reports on their annual emissions, waste management, and pollution prevention strategies, as required by Section 313 of EPCRA and Section 6607 of PPA. The legislation also provides for the reclassification of certain PFAS that are already part of the TRI. Some of these compounds, which were previously aggregated individually, will be grouped into one of the 15 proposed categories, facilitating a more coherent management of these chemicals due to their structural and functional similarity. Environmental and Public Health Impact The EPA proposal is a response to growing public and scientific concern about exposure to PFAS, which has been the subject of multiple investigations due to its persistence and bioaccumulation in the environment. The impact of these compounds on human health includes possible alterations in fetal development, effects on the immune system, and potential carcinogenic risks. From an ecological perspective, PFAS have also been identified as emerging contaminants in bodies of water, affecting various aquatic and terrestrial species. By enhancing oversight of these compounds and requiring detailed reporting on their use and release, EPA aims to not only mitigate their impact, but also encourage more sustainable and responsible practices within industries that rely on these chemicals. Public Participation and Next Steps The EPA has opened a public consultation period until December 9, 2024, during which interested parties will be able to submit comments and suggestions on the proposal. This process of citizen participation is essential to ensure that the regulations reflect the concerns of civil society, as well as the most recent scientific evidence on the management of PFAS. Ultimately, if approved, the new regulations will strengthen the capacity of regulatory agencies to monitor and control emissions of these compounds, contributing to a safer and healthier environment for both the population and natural ecosystems. Conclusion EPA’s proposal to include 16 specific PFAS and 15 additional categories in the Toxics Release Inventory represents a significant step forward in regulating chemically persistent and potentially harmful compounds. Through a more rigorous reporting threshold and consistent reclassification of substances, the agency seeks to strengthen the existing regulatory framework, promoting environmental protection and public health. This effort is another step in the growing awareness of the need to manage the risks associated with PFAS and ensure greater transparency in the chemical industry.