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- Canada's cosmetic ingredient list updated
Se actualiza la lista de ingredientes cosméticos en Canadá In February 2025, Canada updated its Cosmetic Ingredients Hot List, incorporating new restrictions affecting several key ingredients used in cosmetic products. These include: Retinal, retinol, and their esters: The update introduces stricter limits on the concentration and use of these compounds, which are essential in anti-aging and skin-enhancing formulas, due to their potential adverse effects under certain exposure conditions. Thioglycolic acid esters: These compounds, used for their smoothing properties and in hair treatments, must now be evaluated under more rigorous regulations to avoid risks to consumer health. Cresols and their derivatives: Restrictions on the use of these ingredients have been established due to their association with adverse reactions, seeking to reduce exposure to potentially irritating or toxic substances. Peroxides and peroxide-generating compounds, including benzoyl peroxide : These ingredients, primarily used in acne treatments, will need to meet new usage limits to minimize the risk of irritation and other unwanted side effects. These measures require all cosmetics marketers in Canada to review and adapt their products to ensure their safety and compliance with current regulations. For further advice, please contact one of our experts through our contact channels. Contacta con un experto
- Update: EU on plastics in contact with food
Brussels, 27 February 2025. The European Commission has published the new Regulation (EU) 2025/351, which introduces substantial changes to the current legislation on food contact materials. Specifically, key aspects of Regulations (EU) 10/2011 on plastic materials, (EC) 2023/2006 on good manufacturing practices (GMP) and (EU) 2022/1616 on recycled plastic have been revised. Table of contents Main news Repercussions for industry and trade Future prospects Sources consulted Comisión Europea: Actualización Normativa sobre materiales plásticos en contacto con alimentos Main news Labeling requirements and Declaration of Conformity The obligation to indicate specific information on the labelling of plastic products intended to come into contact with food is reinforced, in order to improve transparency and facilitate the identification of materials by consumers and competent authorities. The Declaration of Conformity for plastics is undergoing a review of its content and format. This document, which accompanies the material throughout the supply chain, must contain updated technical data demonstrating compliance with European regulations. New good manufacturing practice guidelines for plastics reprocessing The text incorporates specific GMP guidelines for the reprocessing of plastics falling under the scope of Regulation (EU) 10/2011. These guidelines focus on ensuring the quality and food safety of the final products, as well as promoting more sustainable production processes. Entry into force and transitional measures Regulation (EU) 2025/351 will enter into force on 16 March 2025, 20 days after its official publication. In order to facilitate the adaptation of companies, transitional periods are established. Among the most notable, it is specified that those articles that do not comply with the new requirements, but have been marketed for the first time before September 16, 2026, may remain on the market until stocks run out. Repercussions for industry and trade Industry experts say that the implementation of these changes will have a significant impact on traceability and quality management throughout the production chain. On the one hand, the food industry will be forced to strengthen the control of its manufacturing and labelling processes, which, in turn, could lead to higher operating costs. On the other hand, strengthening food safety standards and promoting sustainability are expected to contribute to improving consumer confidence and the competitiveness of European companies in the long term. Organisations such as the European Plastics Producers Association (EPA) have also highlighted the importance of close collaboration between the private sector and EU authorities. This interaction will be essential to ensure effective implementation of the new rules and to avoid possible imbalances in the supply and demand of plastic materials intended for contact with food. Future prospects The new regulatory framework reinforces the European Union's strategy on the circular economy and sustainability. The implementation of these requirements is expected to lead to a progressive reduction of the industry's environmental footprint, by incorporating more efficient processes and promoting innovation in the design and reprocessing of plastic materials. Sources consulted Official Journal of the European Union (OJEU). Regulation (EU) 2025/351 of the European Commission. Regulation (EU) 10/2011 on plastic materials in contact with food. Regulation (EC) 2023/2006 on good manufacturing practices. Regulation (EU) 2022/1616 on recycled plastics.
- Poison Centers: EU Mandates Harmonized Format Starting in 2025
Starting January 1, 2025, all Poison Centre Notifications (PCN) for hazardous mixtures marketed in the European Union must be submitted in a harmonized format established in Annex VIII of the Classification, Labeling, and Packaging (CLP) Regulation . This change, set forth in Commission Implementing Regulation (EU) 2017/542, marks the end of the transition period, during which importers and downstream users could comply with non-harmonized national requirements. Table of Contents End of the Transition Period and New Obligations Importance of the UFI and Harmonized Format Steps to Ensure Compliance Consequences of Non-Compliance Resources and Official References Conclusion Poison Centers: EU Mandates Harmonized Format Starting in 2025 1. End of the Transition Period and New Obligations The flexibility granted to industry players to continue using previous notification systems will end on December 31, 2024. From January 1, 2025, any company marketing hazardous mixtures must: Fully comply with the requirements of Annex VIII of the CLP. Update their notifications if they do not meet the harmonized format. Include a Unique Formula Identifier (UFI) on the product label to improve traceability and accuracy in emergency situations. Notifications that do not conform to these new provisions will be considered non-compliant with EU law, potentially resulting in penalties and market restrictions. 2. Importance of the UFI and Harmonized Format The UFI (Unique Formula Identifier) is a 16-character alphanumeric code that enables Toxicology Information Services (Poison Centers) to quickly identify the exact composition of a mixture. This streamlines response times in cases of exposure or poisoning, benefiting both consumer health and worker safety. Advantages of a Harmonized Notification Format Greater clarity for authorities : Reduces errors and data duplication. More effective emergency management : Uniform information enhances cross-border cooperation within the EU. Simplified compliance : A single format for all EU Member States, making it easier for companies operating in multiple markets. 3. Steps to Ensure Compliance To comply with the new PCN requirements, companies should follow these steps: Internal product audit : Review all marketed hazardous mixtures and verify compliance with Annex VIII requirements. Generate or verify the UFI : Each mixture must have a unique UFI. It is advisable to integrate UFI management into internal traceability systems. Prepare documentation : The harmonized format requires details on physicochemical properties, relevant components, and hazard classification. Use the ECHA portal : The European Chemicals Agency (ECHA) provides an electronic portal to facilitate the preparation and submission of PCN notifications. Train personnel : Ensure that teams responsible for notification management understand the regulation, deadlines, and official tools. 4. Consequences of Non-Compliance Companies that fail to transition before 2025 may face: Inability to market their hazardous mixtures in certain EU markets . Fines and penalties imposed by competent national authorities . Reputational damage and loss of trust from customers and business partners. Proper adaptation to the regulation not only prevents legal risks but also enhances safety and strengthens brand reputation. 5. Resources and Official References For detailed information on the Poison Centre Notification (PCN) requirements and UFI creation, consult the following official sources: CLP Regulation (EC) No. 1272/2008 – EUR-Lex (English version) Commission Implementing Regulation (EU) 2017/542 – EUR-Lex (official text) European Chemicals Agency (ECHA): PCN Submission Portal ECHA Guide for UFI Creators – Official ECHA Website 6. Conclusion The January 2025 deadline marks a significant milestone in the EU regulatory framework for chemical products. With the adoption of the harmonized format under Annex VIII of the CLP Regulation, companies will strengthen public health protection and environmental safety while ensuring the legal security of their operations. It is crucial for businesses to review their notification and labeling procedures and to correctly create and implement UFIs. Timely compliance not only mitigates risks and sanctions but also enhances corporate reputation and promotes excellence in hazardous mixture management. Consult an Expert Today
- European Union: New Packaging and PPWR PFAS Restrictions
On January 22, 2025, the long-awaited Packaging and Packaging Waste Regulation (PPWR) was published in the Official Journal of the European Union. This regulation aims to strengthen sustainability throughout the entire life cycle of packaging, with a particular focus on waste reduction, improved recyclability, and stricter limits on potentially hazardous substances, including PFAS (per- and polyfluoroalkyl substances). Table of contents Context and Objectives of the New Regulation Entry into Force and Implementation Deadlines Substance Restrictions and Focus on PFAS Implications for the Industry Future Outlook Official References and Additional Resources Conclusion UE Fortalece Regulación de Envases y Residuos: Nuevas Restricciones PFAS EU Strengthens Packaging and Waste Regulations: New PFAS Restrictions Below, we highlight the key points of this new regulation and its relevance in the context of the transition towards a circular economy in the European Union. 1. Context and Objectives of the New Regulation The PPWR was introduced to address the need to reduce packaging waste and improve its management across EU Member States. The regulation aims to: Minimize the use of unnecessary packaging : Promote efficiency in packaging design by eliminating excessive materials and reducing layers or components that hinder recycling. Encourage sustainable innovation : Incentivize the use of materials with a lower environmental impact and high recycling potential. Strengthen the circular economy : Facilitate the reintegration of raw materials derived from packaging waste into the value chain, closing the resource-use cycle. Protect human health and the environment : Restrict the use of hazardous substances, such as PFAS, to prevent their persistence and accumulation in ecosystems. 2. Entry into Force and Implementation Deadlines Entry into force: The regulation will take effect on February 11, 2025. Mandatory compliance: From August 12, 2026, all EU Member States must enforce its requirements. These deadlines provide a transition period for manufacturers, distributors, and other stakeholders in the packaging industry to adapt their processes and materials to the new regulations. 3. Substance Restrictions and Focus on PFAS One of the most critical aspects of PPWR is the extension of chemical substance restrictions for packaging manufacturing. Among these, PFAS are particularly noteworthy due to their widespread use for water repellency and heat resistance. 3.1. Why Are PFAS a Concern? Environmental Persistence : Often referred to as “forever chemicals,” PFAS degrade extremely slowly, leading to their accumulation in ecosystems and food chains. Health Risks : Scientific studies have linked PFAS exposure to hormonal disruptions and potential long-term carcinogenic effects. Regulatory Scope : The new regulation intensifies PFAS restrictions to limit their presence in packaging, thereby reducing their release into the environment. 4. Implications for the Industry The packaging and packaging waste industry must: Review product formulations : Companies will need to find alternatives to restricted substances (such as PFAS), encouraging the use of safer and more easily recyclable materials. Ensure supply chain traceability : Businesses must enhance material controls to guarantee compliance with the new regulatory limits. Invest in R&D : The sector will be driven to develop innovative solutions that meet the new environmental and public health requirements. 5. Future Outlook The PPWR represents a strong step forward in the EU's goal of consolidating a sustainable production and consumption model. Besides protecting consumer health, this regulation lays the foundation for industry transformation, fostering greater competition in the development of less polluting materials. Furthermore, waste reduction, material reuse, and more efficient packaging designs are expected to create new business opportunities, while strengthening consumer confidence in products that meet sustainability criteria. 6. Official References and Additional Resources For a more detailed review, it is recommended to consult the full text of the regulation in the Official Journal of the European Union. Below are some useful links: Official Journal of the European Union (EUR-Lex): https://eur-lex.europa.eu/ EU Official Chemical Substances Information (ECHA): https://echa.europa.eu/ Conclusion The new Packaging and Packaging Waste Regulation (PPWR) marks a milestone in the European Union’s strategy to reduce pollution, improve recycling quality, and protect public health from potentially harmful substances like PFAS. This regulation not only reinforces the principles of the circular economy but also promotes innovation and competitiveness in the packaging industry, paving the way for a more sustainable and responsible future. Consult an Expert on Cosmetic Regulation
- Update: Vials and Ampoules in the Cosmetics Borderline Products Manual
On 24 January 2025, the European Commission published a key update to the Cosmetics Borderline Products Manual. This document, prepared by the Subgroup on Borderline Products and approved by the Cosmetics Working Group, serves as an essential reference for manufacturers and national authorities, offering detailed guidance on the application of EU legislation in the cosmetics sector. One of the most relevant novelties of this version is the inclusion of a specific section on products in vials or ampoules. Table of contents What is the Cosmetics Borderline Products Manual? Classification of Products in Vials or Ampoules Difference between Cosmetics and Medicines in Vials or Ampoules Recommendations for Manufacturers and Professionals Conclusion Actualización: Viales y Ampollas en el Cosmetics Borderline Products Manual What is the Cosmetics Borderline Products Manual? This manual is a fundamental tool for the interpretation and application of the EU Cosmetics Regulation . It aims to help industry players correctly classify their products and avoid confusion with other categories, such as medicines or medical devices. Classification of Products in Vials or Ampoules The update introduces a detailed analysis of how cosmetic products presented in vials or ampoules should be classified, which represents a category of products on the border between cosmetics and medicine. According to European regulations, a cosmetic product must fulfil at least one of the following functions: Cleaning Perfume Change the appearance Correcting body odor Protect the skin Keeping external parts of the body in good condition In contrast, medicinal products are intended to treat, prevent diseases or modify physiological functions of the body. Difference between Cosmetics and Medicines in Vials or Ampoules The classification of a product may be influenced by its mode of application and presentation. According to Article 2(2) of the EU Cosmetics Regulation, any substance intended to be injected or implanted into the human body is not considered a cosmetic product. Therefore: If a product in vial or ampoule is designed for injection, it cannot be classified as a cosmetic. If its use is exclusively external and meets the established cosmetic criteria, it can be considered a cosmetic. In addition, labelling, instructions for use and the way it is marketed are key factors in determining its classification. Recommendations for Manufacturers and Professionals We stress the importance of companies and professionals in the cosmetics sector closely following these regulatory updates. To avoid confusion and possible sanctions, we recommend: Check the application mode of the products : Avoid any presentation that could lead to misclassification. Ensure clear and accurate labelling : Explicitly indicate the external use of the product. Consult with cosmetic regulatory experts : Ensure regulatory compliance before launching a product on the market. Monitoring the evolution of legislation : Stay up to date with changes in European regulations. Conclusion The update of the Cosmetics Borderline Products Manual reflects the need to precisely define which products belong to the cosmetics category and which should be considered medicines or medical devices. At Belab Services , we are committed to providing up-to-date information and advice to enable the cosmetics industry to adapt to these changes and ensure regulatory compliance. If you want to know more about this update and its impact on the sector, we invite you to follow our blog and consult with our experts in cosmetic regulation. Contact a cosmetic regulatory expert
- ANSES: On Glycoxylic Acid in Straightening Products
The cosmetics world has recently been shaken by a major health alert. The French Agency for Food, Environmental and Occupational Health Safety (ANSES) has confirmed the risks associated with the use of Glycoxylic Acid in hair straightening products, particularly in treatments known as Brazilian straightening. This warning marks the beginning of a process that could lead to restrictions or even a ban on this ingredient in the cosmetics industry. Table of contents Glycooxylic Acid Toxicity: A Real Health Risk Towards stricter regulation Conclusion ANSES: On Glycoxylic Acid in Straightening Products Glycooxylic Acid Toxicity: A Real Health Risk Glycolic acid is a common chemical component in hair straightening products, as it allows the hair structure to be modified without the use of formaldehyde. However, after an independent evaluation of the available scientific data, ANSES has determined that this substance is strongly linked to cases of acute kidney failure. The health alert was first issued in October 2024, following reports of patients who experienced kidney damage without an apparent cause after undergoing hair straightening treatments. Since then, at least four new cases have been recorded in France, leading ANSES to confirm that there is a direct link between the use of this ingredient and the development of serious kidney problems. Towards stricter regulation Despite scientific evidence, there are currently no specific restrictions in the European Union on the use of Glycoxylic Acid in cosmetics. However, in view of the growing concern of experts and health authorities, the European Commission and the Scientific Committee on Consumer Safety (SCCS) are expected to assess the need to establish regulatory measures. Meanwhile, ANSES strongly recommends avoiding the use of straightening products containing this substance. It also calls on manufacturers to re-evaluate the safety of their products and to extend their studies to the different derivatives of this acid that are also used in hair treatments. Conclusion The confirmation of the alert by ANSES is a clear indication that the use of Glycoxylic Acid in hair straightening products should be re-evaluated. At Belab Services , we are committed to transparency and safety in the world of cosmetics. If you have questions about the ingredients in your hair products or are looking for safer alternatives, please do not hesitate to contact us. Contact a cosmetic regulatory expert
- New Regulations for Cosmetic Products in Europe and the United Kingdom
As of February, important amendments have come into force that will impact the cosmetics industry. Below is a summary of the most relevant changes. Table of contents Regulatory Updates in Europe Restricted Substances Banned Nanomaterials New Regulations in the UK Key Differences in BHT Limits Permitted Use of BHT in the UK New Regulations for Cosmetic Products in Europe and the United Kingdom Regulatory Updates in Europe As of 1 February 2025, new cosmetic products containing these substances that do not comply with the established conditions may not be marketed in the European Union. For those products already on the market, the formulas must be adapted before 1 November 2025, when non-compliant products must be withdrawn from the market. Restricted Substances Genistein: Up to 0.007%. Daidzein: Up to 0.02%. Kojic Acid: Up to 1% in face and hand products. Alpha-Arbutin: Up to 2% in facial creams and 0.5% in body lotions. In addition, Hydroquinone levels should be kept as low as possible and not exceed the unavoidable trace level. Arbutin: Up to 7% in facial creams, keeping Hydroquinone at trace levels only. Hydroxyapatite (nano): Up to 10% in toothpastes and up to 0.465% in mouthwashes. Exposure by inhalation and surface modifications are not permitted. Banned Nanomaterials The following nanomaterials have been banned in the EU and cannot be used in new cosmetic products from 1 February 2025 : Styrene/Acrylates copolymer (nano) Sodium Styrene/Acrylates copolymer (nano) Copper (nano) and colloidal copper (nano) Colloidal silver (nano) Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) Acetylheptapeptide-9 Colloidal Gold (nano) Platinum (nano), Colloidal platinum (nano) Acetyltetrapeptide-17 Colloidal Platinum (nano) Products already on the market must be sold and removed from shelves by 1 November 2025. After this date, they may no longer be marketed in the EU. New Regulations in the UK In 2022, the European Commission introduced restrictions for BHT (Butylated Hydroxytoluene) through Regulation (EU) 2022/2195. In parallel, the United Kingdom has established its own regulation with different limits than those of the EU, which impacts the compliance of products sold in both markets. Key Differences in BHT Limits In the EU, BHT is limited to 0.8% on leave-on oral care products . In the UK, the maximum permitted limit is 0.001% in leave-on oral care products . Permitted Use of BHT in the UK Toothpaste: Up to 0.1%. Mouthwashes and leave-on products for oral care: Up to 0.001%. Other leave-on and rinse-off products: Up to 0.8%. From 24 February 2025, no new cosmetic products can be launched in the UK containing BHT outside the permitted limits. Products already on the market will have a transition period until 24 June 2025, after which they must comply with the new restrictions or be withdrawn from the market. At Belab Services , we recommend reviewing product formulations as soon as possible to align them with the latest regulations and ensure continued availability in the market. If you need assistance with adapting your products to these new requirements, our team of experts is ready to help. Do you have questions or need more information? Contact us for personalized advice on regulatory compliance in the EU and the UK. Contact an expert in cosmetic regulation
- The Omnibus Act VII: New Restrictions for CMR Substances in Cosmetic Products
On June 24, 2024, the European Commission notified the World Trade Organization (WTO) of a draft regulation amending the use of certain carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetic products. This draft, known as the Omnibus Act VII, aims to implement Commission Regulation (EU) No 2024/197 into the EU Cosmetics Regulation , introducing newly classified CMR substances according to the EU CLP Regulation. Implementation and Compliance Prohibited Substances Impact on the Cosmetic Industry Official Sources Summary The Omnibus Act VII: New Restrictions for CMR Substances in Cosmetic Products The Omnibus Act VII: Implementation and Compliance The Omnibus Act VII will come into effect on September 1, 2025, eliminating any distinction between marketing and placing products on the market. From this date, cosmetics that do not comply with these new standards must be withdrawn from the EU market. Annex II: Aggregated Prohibited Substances The following substances will be added to Annex II of the EU Cosmetics Regulation, prohibiting their use in cosmetic products: diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide: it is currently restricted under Annex III to the EU Cosmetics Regulation. 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5- ylmethyl)-3-methyl-2-nitroguanidine benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1) reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate (1:1) reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1) dimethyl propylphosphonate dibutyltin maleate dibutyltin oxide reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3- epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2- hydroxymethyl butane 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol; bisphenol AF benfluralin (ISO); N-butyl-N-ethyl-α,α,αtrifluoro-2,6-dinitro-p-toluidin N,N-dimethyl-p-toluidine 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs 4-nitrosomorpholine difenoconazole (ISO); 1-({2-[2-chloro-4-(4- chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2- yl}methyl)-1H-1,2,4-triazole; 3-chloro-4- [(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4- triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4- chlorophenyl ether 4-methylimidazole 3,3′-dimethylbiphenyl-4,4′-diyl diisocyanate foramsulfuron (ISO); 2-{[(4,6- dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}- 4-formamido-N,N-dimethylbenzamide; 1-(4,6- dimethoxypyrimidin-2-yl)-3-(2- dimethylcarbamoyl-5- formamidophenylsulfonyl)urea (2E)-2-cyano-N-[(ethylamino)carbonyl]-2- (methoxyimino)acetamide Impact on the Cosmetic Industry Although these substances are not widely known and their use in cosmetics is limited, implementing these new restrictions underscores the EU's commitment to consumer safety. Official Sources and Summary For more information, you can consult the following official links: WTO Regulation (EU) No 2024/197 The Omnibus Act VII, effective from September 1, 2025, will ban the use of CMR substances in cosmetic products according to Regulation (EU) No 2024/197. This measure is crucial to align cosmetic regulations with the latest classifications of hazardous substances, ensuring the safety of products available in the EU market.
- Methyl Salicylate: New Regulation in the United Kingdom
Methyl salicylate, a compound widely used in cosmetic products for its aromatic and analgesic properties, has been subject to new regulatory restrictions in the UK. The recent update to the Restriction of Chemicals in Cosmetic Products Regulations 2025, announced by the Department of Business and Trade, introduces stricter limits on its use in various formulations, with the aim of strengthening consumer protection. Table of contents The regulatory framework and its impact on the cosmetics industry Main restrictions and permitted gatherings Transition and compliance period A necessary adjustment for consumer safety More information Salicilato de Metilo en Cosméticos: Cambios Regulatorios 2025 The regulatory framework and its impact on the cosmetics industry On 30 April 2025, the United Kingdom brought into force the amendments to Regulation (EC) No 1223/2009 , inherited from the European regulations after Brexit. The main reason behind this adjustment is the classification of methyl salicylate as a CMR Category 2 substance (Carcinogenic, Mutagenic or Toxic for Reproduction), which has led to a re-evaluation of its safety in cosmetic products. The decision is based on studies by the UK Scientific Advisory Group on Chemical Safety, which considers it safe to use within certain concentration limits. Main restrictions and permitted gatherings The new restrictions affect a wide range of cosmetic products. Below are the main changes in terms of maximum permitted concentrations: Rinse aids (except hand soaps) 0.02% on products intended for children aged 0.5 to 1 year . 0.06% on products for children over 1 year old and adults. Hand soaps 0.02% for children from 0.5 to 1 year old . 0.6% for children over 1 year old and adults. Leave-in skin products (except facial makeup, aerosol deodorants and hydroalcoholic fragrances): 0.02% on products for children from 0.5 to 1 year old . 0.06% on products for people over 1 year of age and adults. Lipsticks and lip balms 0.02% for children from 0.5 to 1 year old . 0.03% for children over 1 year of age and adults. Face makeup 0.05% . Spray deodorants and spray hair products 0.009% . Toothpaste 2.5% . Mouthwashes 0.1% on products for children aged 6 to 10 . 0.4% for those over 10 years old and adults. Mouth sprays 0.65% . Body lotions in spray 0.04% . Transition and compliance period To avoid a drastic impact on the industry, a transition period has been established that will allow the sale of products with the current formulation until March 31, 2026, provided that they have been marketed before September 30, 2025. A necessary adjustment for consumer safety New restrictions on methyl salicylate in cosmetics reinforce the UK’s commitment to consumer safety. While these regulations can be a challenge for manufacturers, they also represent an opportunity to reformulate products and adapt to an increasingly regulated market. Since the European Union is also considering similar changes , it is possible that both regulations will converge in the future, thus avoiding regulatory discrepancies between the British and European markets. Contacta con un Experto en Regulación Cosmética More information: The Cosmetic Products (Restriction of Chemical Substances) Regulations 2025 Regulation - 1223/2009 - EN - Cosmetic Products Regulation - EUR-Lex
- Health Canada's Role in Cosmetics Regulation
Health Canada plays a critical role in ensuring the safety and efficacy of cosmetic products available in the Canadian market. As the federal agency responsible for public health, it sets and enforces regulations to protect the well-being of the public. This article takes an in-depth look at Health Canada's involvement in cosmetics regulation, covering its legislative framework, regulatory processes, and the measures taken to ensure consumer safety. Table of contents Health Canada: Legislative Framework Health Canada: Regulatory Processes Health Canada: Consumer Safety Measures Conclusion El Papel de Health Canada en la Regulación de Cosméticos Health Canada: Legislative Framework Health Canada's authority to regulate cosmetics is derived from the Food and Drugs Act (FDA) and the associated Cosmetic Regulations . These statutory instruments provide the legal basis for monitoring the safety, efficacy and quality of cosmetic products, ensuring that they do not pose health risks. Food and Drugs Act (FDA): This law governs the safety of food, drugs and cosmetics in Canada. It requires that all cosmetics marketed are safe for use and properly labelled. It also prohibits the sale of products that contain harmful ingredients or are advertised in a misleading manner. Cosmetic Regulations: These regulations detail specific requirements regarding ingredients, labelling and safety of cosmetics. They define the information that must be included on product labels, permitted ingredients and the application of good manufacturing practices. Health Canada: Regulatory Processes Health Canada implements a number of regulatory processes to ensure the safety and compliance of cosmetics on the market: Ingredient Assessment: Health Canada reviews the safety of cosmetic ingredients by analyzing scientific data on their potential health effects. Ingredients that pose risks are restricted or banned and are reflected in the Cosmetic Ingredient Hotlist , a list of substances restricted or banned in cosmetics. Product Notification: Prior to marketing, manufacturers and importers must file a Cosmetic Notification Form (CNF) with Health Canada. This form provides details about the product's composition, ingredient concentrations, and intended use. Labeling Requirements: Cosmetic labels are required to contain key information such as the name of the product, the full list of ingredients, warnings, safe use instructions, and contact information for the manufacturer or distributor. This transparency allows consumers to make informed choices and avoid ingredients to which they may be allergic. Post-Marketing Surveillance: Health Canada conducts ongoing surveillance of products available on the market, through inspections, review of consumer complaints and monitoring of adverse reaction reports. If a health risk is detected, the agency may issue warnings, recall products and apply enforcement measures. Enforcement Actions: In the event of non-compliance with regulations, Health Canada has the authority to take action such as issuing warnings, seizing products and prosecuting responsible entities. Health Canada: Consumer Safety Measures To ensure consumer safety, Health Canada implements several strategies, including: Cosmetic Ingredient Hotlist: This list is regularly updated based on new scientific findings on ingredient safety, ensuring that hazardous substances are restricted or removed from the market. Adverse Reaction Reporting: Through the Canada Surveillance Program , consumers and health professionals can report adverse reactions to cosmetics, allowing Health Canada to take appropriate measures to mitigate risks. Public Education: Health Canada provides informational resources to educate consumers about cosmetic safety, including guides on how to interpret labels, understand ingredient lists and report adverse incidents. Conclusion Health Canada's regulatory framework ensures that cosmetic products available in Canada are safe for consumers. By assessing ingredients, imposing labelling requirements, conducting market surveillance and applying enforcement measures, Health Canada protects public health. As new scientific data emerges, the agency continues to update its regulations to address emerging risks in the cosmetics industry. Contact a Canadian Cosmetic Regulatory Expert
- Cosmetics Notification and Labeling Compliance in Canada
The cosmetics industry in Canada is subject to strict regulations aimed at ensuring the safety and transparency of products available on the market. These regulations, established by Health Canada, range from mandatory product notification to specific labelling requirements. This document provides detailed guidance on the procedures and obligations that cosmetics manufacturers and importers in Canada must comply with, incorporating the most recent updates to current legislation. Table of contents Definition of Cosmetic under Canadian Law Cosmetics Notification Requirements Recent Updates in Cosmetics Legislation Cosmetic Labeling Requirements Compliance and Consequences of Non-Compliance Conclusion Notificación de Cosméticos y Cumplimiento de Etiquetado en Canadá Definition of Cosmetic under Canadian Law According to Section 2 of the Food and Drugs Act (FDA) , a "cosmetic" is defined as: "Any substance or mixture of substances manufactured, sold or presented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes." This definition covers products used in professional cosmetic services, institutional bulk products such as hand soaps in public facilities, and "handmade" cosmetics sold in artisan markets or home-based businesses. Cosmetics Notification Requirements Under section 30 of the Cosmetic Regulations (CR) , all manufacturers and importers must notify Health Canada within 10 days of the first sale of a cosmetic in Canada. This notification is done using the Cosmetic Notification Form (CNF), which requires detailed product information, including: Brand and product name. Name and address of the server. Manufacturing and import information. Contact details for labeling. Product type (e.g. rinse-off or after-treatment). Area of application. Function of the cosmetic. Physical form of the cosmetic (cream, gel, powder, etc.). Ingredients and their concentrations. It is important to note that the submission of the CNF does not constitute approval for sale by Health Canada, nor does it imply that the product complies with all legislative requirements. The responsibility for ensuring compliance lies with manufacturers and importers. Recent Updates in Cosmetics Legislation A significant change to Canadian regulation is the ban on animal testing of cosmetics , effective December 22, 2023. This ban applies to both imported and Canadian-made cosmetics and covers: Conducting animal testing to comply with cosmetic requirements under the Food and Drugs Act or to meet cosmetic safety regulations in other countries. The sale of cosmetics in Canada whose safety cannot be established without recourse to data obtained from tests on animals that may cause pain or suffering. Claims on labels or advertising that the cosmetic has not been tested on animals, unless evidence supporting such a claim can be provided upon request by the Minister of Health. This initiative brings Canada into line with other countries that have implemented similar bans , reflecting growing concerns about animal welfare and a consumer preference for cruelty-free products. Cosmetic Labeling Requirements All cosmetics sold in Canada must comply with labelling requirements set out in the Food and Drugs Act and the Cosmetic Regulations . Labels must include: Product name. Full list of ingredients in descending order of predominance. Manufacturer or distributor information, including name and address. Instructions for use where necessary to ensure safe use. Warnings about possible adverse reactions or specific precautions. In addition, labels must be written in English and French, the two official languages of Canada, to ensure understanding by all consumers. Compliance and Consequences of Non-Compliance Health Canada actively monitors the market to identify cosmetic products that may pose health risks or that do not comply with current regulations. Enforcement actions may include: Working with companies to correct non-conforming products. Take additional measures to protect the health and safety of Canadians, including through the issuance of public communications. Seize products or prosecute companies that fail to comply with regulatory requirements. It is imperative that manufacturers and importers maintain accurate and up-to-date records and respond in a timely manner to any concerns raised by Health Canada to avoid penalties and ensure consumer confidence in their products. Conclusion Compliance with Canadian cosmetics notification and labelling regulations is essential to legally operating in the market and to ensure consumer confidence and safety. Staying informed about legislative updates and strictly adhering to the guidelines set by Health Canada is not only a legal obligation, but also an ethical practice that reflects the industry's commitment to quality. Contact a Canadian Cosmetic Regulatory Expert
- ECHA: Addition of 5 new hazardous chemicals
On 21 January 2025, the European Chemicals Agency (ECHA) announced the addition of five new substances to the Candidate List of Substances of Very High Concern (SVHC), bringing the total to 247 entries. This increase reinforces ECHA's commitment to regulating chemicals that may pose significant risks to human health and the environment. Table of contents New substances added and their impact Implications for industry Challenges and measures to be taken ECHA: Addition of 5 new hazardous chemicals ECHA: New substances added and their impact The substances recently added to the list include compounds used in key industrial sectors such as cosmetics, automotive and electronics manufacturing. These include: 6-[(C10-C13)-Alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid : Known for its reproductive toxicity, this substance is found in lubricants, greases, and metalworking fluids. O,O,O-Triphenyl phosphorothioate : Classified as Persistent, Bioaccumulative and Toxic (PBT), it is commonly used in industrial lubricants. Octamethyltrisiloxane : Considered Very Persistent and Very Bioaccumulative (vPvB), present in cosmetics and personal care products. Perfluamine : Also classified as vPvB, it is found in electrical and electronic equipment. Reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives : Marked as PBT, no declared uses at present. Additionally, the entry for Tris(4-nonylphenyl, branched and linear) phosphite has been updated to reflect its classification as an endocrine disruptor, implying increased regulatory attention on its use in polymers, adhesives and coatings. ECHA: Implications for industry The inclusion of these substances in the SVHC list entails various obligations for companies, including: Transparency in the supply chain : Suppliers must provide detailed information on the presence of these substances in products with concentrations greater than 0.1%, ensuring access to safety data. Notification to ECHA : Manufacturers and importers are required to report the presence of these substances if they exceed the annual tonne or 0.1% limit by weight. Registration in the SCIP database : Since January 2021, it is mandatory to report the presence of SVHCs in products to the Substances of Concern in Products (SCIP) database. Impact on eco-certifications : Products containing these substances may not qualify for the EU Ecolabel, affecting their viability in markets with high environmental standards. ECHA: Challenges and measures to be taken Companies must be proactive in reviewing their formulations, evaluating safer alternatives and ensuring compliance with REACH regulations. Constant assessment of the supply chain and communication with suppliers are essential to avoid business interruptions and ensure legal compliance. With this update, ECHA continues its efforts to mitigate the risks associated with hazardous chemicals and promote a safer environment for both consumers and the environment. Contacta con un experto en regulación cosmética












