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On August 1, 2024, the Scientific Committee on Consumer Safety (SCCS) released its opinion on the safety of Biphenyl-2-ol and Sodium 2-biphenylolate in cosmetic products. These ingredients, also known as o-Phenylphenol and Sodium o-Phenylphenate, are commonly used as preservatives. The evaluation was prompted by concerns over their potential classification as Category 2 carcinogens. Biphenyl-2-ol and Sodium 2-biphenylolate: Background Biphenyl-2-ol and Sodium 2-biphenylolate: Regulatory Framework SCCS Conclusions Impact on the Cosmetics Industry Conclusion Biphenyl-2-ol and Sodium 2-biphenylolate: Background o-Phenylphenol and its sodium salt have been approved for use in cosmetics at concentrations up to 0.15% in leave-on products and 0.2% in rinse-off products under Annex V of the Cosmetics Regulation (EC) No. 1223/2009. However, recent scientific evaluations, including opinions from the Risk Assessment Committee (RAC) of ECHA, raised concerns about their safety due to the potential carcinogenicity of o-Phenylphenol. Biphenyl-2-ol and Sodium 2-biphenylolate: Regulatory Framework The European Commission requested the SCCS to assess the safety of o-Phenylphenol and its sodium salt following the RAC's recommendation to classify o-Phenylphenol as a Category 2 carcinogen. According to the Cosmetics Regulation (EC) No. 1223/2009, CMR Category 2 substances are prohibited in cosmetics unless proven safe by the SCCS. SCCS Conclusions The SCCS concluded that o-Phenylphenol and Sodium o-Phenylphenate are safe as preservatives in cosmetic products at concentrations up to 0.2% in rinse-off products and 0.15% in leave-on products. No additional scientific concerns were identified, provided these concentration limits are adhered to. Impact on the Cosmetics Industry This favorable opinion allows the continued use of o-Phenylphenol and its sodium salt as preservatives in cosmetics, within the specified concentration limits. Cosmetics manufacturers should review their product formulations to ensure compliance with the SCCS's recommendations and be prepared for potential regulatory updates following the public comment period ending on September 27, 2024. Conclusion The SCCS's assessment underscores the importance of adhering to established concentration limits to ensure consumer safety. The cosmetics industry must remain vigilant for regulatory changes and ensure that products comply with current and future regulations.

The Scientific Committee on Consumer Safety (SCCS) has issued an opinion on the safety of Citral (CAS No. 5392-40-5, EC No. 226-394-6), a commonly used fragrance ingredient in cosmetic products. Citral is widely used due to its pleasant lemon scent, but it has been under scrutiny due to its potential as a fragrance allergen. About the Background and Use of Citral SCCS: Assessment of Citral Implications for the Cosmetics Industry Conclusion and Recommendations About the Background and Use of Citral Citral is a natural compound found in the oils of various plants, including lemongrass and lemon myrtle. It is used extensively in the cosmetic industry as a fragrance component due to its strong citrus scent. The safety of Citral in cosmetic products is crucial, given its widespread use in formulations such as perfumes, lotions, and creams. SCCS: Assessment of Citral The SCCS assessment of Citral focused on its potential to cause allergic reactions when used in cosmetics. The evaluation was conducted using the Quantitative Risk Assessment (QRA) methodology, specifically the QRA2 approach, which is designed to assess the safety of fragrance allergens in consumer products. According to the SCCS, the QRA2 methodology, while useful, requires further refinement to improve its predictive accuracy for allergens like Citral. Conclusion and Recommendations The SCCS concluded that Citral is generally safe for use in cosmetics at the concentrations currently proposed, based on the available data and the QRA2 assessment. However, the SCCS recommended further research and refinement of the QRA2 methodology to ensure more reliable safety assessments in the future. The committee also suggested conducting additional case studies to confirm Citral's safety, particularly for consumers with sensitive skin or known allergies. Implications for the Cosmetics Industry This opinion from the SCCS has important implications for the cosmetics industry. Manufacturers using Citral in their products should ensure that concentrations are within the recommended limits and be aware of the potential for allergic reactions among consumers. The industry may also need to adapt to any future changes in safety assessment methodologies that could result from ongoing research. In summary, while Citral remains a valuable ingredient in cosmetic formulations, its use must be carefully managed to ensure consumer safety. The SCCS's findings highlight the need for continued vigilance and adaptation in the regulatory landscape to protect public health. If you need more detailed information, do not hesitate to consult the official link

The European Commission has put into force a new regulation affecting cosmetic products marketed in the EU . This regulation lowers the threshold for including the warning ‘releases formaldehyde’ on the labels of products containing formaldehyde releasing preservatives. Details of the new requirement Impact on the Cosmetics Industry Next Steps for Companies Details of the new requirement Immediate application for new products From 31 July 2024 , all new products placed on the EU market containing formaldehyde-releasing preservatives must carry the warning ‘releases formaldehyde’ on their labelling. Transitional period for existing products Companies that already have products on the market have until 31 July 2026 to comply with this new labelling requirement. This gives manufacturers and distributors sufficient time to update their labels and comply with the new regulation. Impact on the Cosmetics Industry This regulatory change aims to increase transparency and safety for consumers by alerting them to the presence of formaldehyde, a substance that can have adverse health effects. Companies will have to review their formulations and labelling to ensure compliance with the new regulation. In addition, this may involve adjustments to production and distribution processes to align with the new requirements. Next Steps for Companies Ingredient Review : Identify products containing preservatives that release formaldehyde. Label Update : Include the warning ‘releases formaldehyde’ on affected products. Deadline Compliance: Ensure that all new products are compliant by 31 July 2024 and that existing products are updated by 31 July 2026. For more information on how to comply with this regulation that is about to come into force and for assistance in the labelling update process, Belab Services can offer you the help you need.

The Scientific Committee on Consumer Safety (SCCS) has evaluated the safety of silver and Triphenyl Phosphate used in cosmetic products. SCCS's final opinion on Silver Background and Context Safety of Silver Particles Maximum Safe Concentration Additional Scientific Concerns SCCS's final opinion on Triphenyl Phosphate Background and Context Safety Concerns Maximum Safe Concentration Additional Scientific Concerns Next Steps SCCS's final opinion on Silver Background and Context: The Scientific Committee on Consumer Safety (SCCS) has evaluated the safety of silver (CAS/EC No. 7440-22-4/231-131-3) used in cosmetic products. This opinion is crucial for manufacturers and consumers as it ensures the safety of cosmetic products containing silver particles, ensuring compliance with current regulations and protecting user health. Safety of Silver Particles: Not Safe:  Silver particles of micrometer size are not safe at concentrations up to 0.2% in rinse-off products and 0.3% in leave-on products. Safe in Specific Use:  They are safe in eye shadows and oral exposure products (lip balm, toothpaste, and mouthwash) at specified concentrations. Maximum Safe Concentration: No alternative maximum safe concentration was specified in the opinion. Additional Scientific Concerns: No additional scientific concerns were mentioned. This opinion is crucial for manufacturers and consumers as it ensures the safety of cosmetic products containing silver particles, ensuring compliance with current regulations and protecting user health. SCCS's final opinion on Triphenyl Phosphate Background and Context: The Scientific Committee on Consumer Safety (SCCS) was tasked with evaluating the safety of triphenyl phosphate due to its suspected endocrine-disrupting properties. The evaluation focused on determining a safe concentration limit for its use in cosmetic formulations, specifically nail products. Safety Concerns: Based on the available data and concerns about the potential endocrine-disrupting properties of triphenyl phosphate, the SCCS cannot conclude its safety when used as a plasticizer in nail products at concentrations up to 5%. The potential for genotoxicity cannot be excluded. Maximum Safe Concentration: The SCCS did not determine an alternative maximum safe concentration for triphenyl phosphate in nail products. Additional Scientific Concerns: The SCCS mandate does not cover environmental aspects, so this evaluation did not include the safety of triphenyl phosphate for the environment. Next Steps: Additional Research: Further studies are needed to conclusively determine the genotoxic potential of triphenyl phosphate. Regulatory Actions: Until a clear safety profile is established, regulatory bodies may need to reconsider the use of triphenyl phosphate in nail products. To stay updated on all the latest cosmetic regulations in Europe , feel free to contact us. We provide comprehensive and timely information to ensure your compliance with the newest industry standards and changes.

New Enhancements: Cosmetic Product Registration and Listing On 29 July 2024, the US Food and Drug Administration (FDA) announced new enhancements to make it easier for industry to update registration and listing submissions: Cosmetics Direct, an electronic submission portal created under the Cosmetics Regulatory Modernization Act of 2022 (MoCRA) , introduces two new functions for registering and listing cosmetic facilities and products. The new functionality for direct sales of cosmetics allows you to stop and restart such sales of your cosmetic products. FDA Announce: Features of the update Suspend Cosmetics Listing This feature allows the manager to suspend the use of cosmetics that were previously listed in Cosmetics Direct but are no longer available on the market. Re-listing cosmetics This feature allows responsible parties to re-list cosmetics that were previously discontinued on Cosmetics Direct and reintroduced. Please note that discontinuing a product is not the same as removing it from Cosmetics Direct. When the product is discontinued, it remains in the Structured Product Label (SPL) profile and can be reintroduced for sale. However, once a product is removed, it is permanently deleted from the SPL file and cannot be restored for re-publication.

Spain has approved Royal Decree 1055/2022, which establishes an innovative regulation in response to global concern about the environmental impact of consumer products, emphasising transparency and environmental responsibility by modifying packaging labelling standards. This decree, aligned with the circular economy policies promoted by the European Union, aims to close the life cycle of products through a labelling system that facilitates recycling and reuse. Labelling Standards in Spain: The purpose of the new law 1. Transparency 2. Promote recycling Additional Considerations Labelling Standards in Spain: The purpose of the new law 1. Transparency Consumers can make better choices with clear labelling. it also forces manufacturers to consider the design of their products towards a greener/environmental side. 2. Promote recycling In order to increase recycling rates in the country and decrease the amount of waste sent to landfills, more stringent targets have been set. Manufacturers must now ensure that their packaging is easily recyclable, which could mean significant changes in materials and manufacturing processes. On the other hand, consumers, thanks to more thorough labelling, will be able to distinguish and choose products that meet sustainability standards , thus driving the market towards greener options. Several industries, in particular those using complex packaging, have faced difficulties due to the implementation of the decree. Significant investments in technology and design may be required to meet these requirements. In addition, the implementation of effective collection and recycling systems at the local level will determine the effectiveness of these actions. Additional Considerations It is crucial that household containers are clearly identified to indicate in which section or container the waste should be stored. In addition, single-use plastics must comply with the labelling requirements established by Regulation 2020/2151. With Royal Decree 1055/2022, Spain reaffirms its commitment to environmental sustainability. This regulation not only benefits the environment, but also lays the foundations for future waste management policies, promoting practices that extend the useful life of products and reduce waste generation. It is recommended that you consult the official text of Royal Decree 1055/2022 in the Spanish Government Gazette: Real Decreto 1055/2022.

FDA Unified Agenda Update The Office of Information and Regulatory Affairs (OIRA) recently published the Spring 2024 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions. The FDA Agenda includes three proposed rules specific to cosmetic products, including two directed by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA and MoCRA: Key Observations Although two of these proposed rules appeared on the Fall 2023 Unified Agenda, this marks the first time the Fragrance Allergen Disclosure Rule has appeared on a unified agenda. The anticipated NPRM publication dates are aspirational. The FDA often misses these targets, and this is even more likely this year given that rulemaking tends to slow down leading up to a federal election. It would be out of the ordinary for any of these proposed rules to actually be issued until after this year’s election, but we will continue to monitor their status closely.

The UKCA (UK Conformity Assessed) marking is essential for products marketed in Great Britain (England, Scotland and Wales). As of January 1, 2021, this marking applies to most products for which the CE marking can also be used. Here we explain how to use the UKCA marking and the implications for your business. Continued Recognition of CE Marking Fast-Track Provision Long-Term Flexibility and Certainty Exceptions Details of the New Measures Use of UKCA Marking Accompanying Documentation Rules for Using the UKCA Image Conclusion Continued Recognition of CE Marking The government has legislated to continue to recognize current EU requirements, including CE marking. This gives companies the flexibility to use both UKCA and CE marking to sell products in Great Britain . This legislation is detailed in the Product Safety and Metrology (Amendment) Regulations 2024. Fast-Track Provision As part of this legislation, a new fast-track provision is introduced that allows manufacturers to place products on the GB market if they comply with essential EU requirements and, where necessary, have been assessed by an EU-recognized conformity assessment body. To benefit from this provision, manufacturers must: Affix the UKCA marking in a permitted manner. Produce the UK declaration of conformity, listing compliance with relevant EU legislation. Long-Term Flexibility and Certainty This system is designed to provide long-term certainty and flexibility for companies, should the UK require UKCA marking for certain regulations in the future. CE marking and reverse epsilon marking will continue to be recognized for 21 product regulations. Exceptions This legislation does not apply to regulations for medical devices , construction products, marine equipment, railway products, cableways, transportable pressure equipment, and unmanned aircraft systems, which have specific arrangements. Details of the New Measures As of January 5, 2021, companies must notify ECHA's Substances of Concern in Products (SCIP) database if products contain more than 0.1% SVHC. Use of UKCA Marking The UKCA marking must be clear, visible, legible and indelible. There are specific rules on the size and dimensions of the marking. It must be affixed by the manufacturer, its authorized representative or if the product is marketed under the manufacturer's name or trademark. Accompanying Documentation The documentation accompanying the product must be in English and include: The UKCA marking. The UK Declaration of Conformity. The EU declaration of conformity (if applicable). Relevant instructions and safety information. Rules for Using the UKCA Image Make sure that: The letters forming the UKCA marking are in proportion. The UKCA marking is at least 5 mm high, unless a different minimum dimension is specified. The UKCA marking is easily visible, legible and indelible. Conclusion The UKCA marking offers flexibility and long-term security for companies marketing products in Great Britain. Complying with these standards is essential to ensure continued access to the UK market and avoid penalties. For more details, please refer to the specific guides on how to use UKCA marking and CE marking on products destined for the UK and European markets. If you need more information, please do not hesitate to contact BELAB Services.

Scientific Committee on Consumer Safety (SCCS) and the Hexyl Salicylate Assessment Recently, on May 31, 2024, the Scientific Committee on Consumer Safety (SCCS) issued a new mandate to review the safety of hexyl salicylate in cosmetic products, focusing specifically on childhood exposure, including children under 3 years of age. This mandate complements and expands on the European Commission's previous request, highlighting the continued safety concern of this ingredient. Background and Context New SCCS Mandate Relationship between the Assessments Deadline and Next steps Conclusion Hexyl Salicylate: Background and Context Hexyl salicylate is an ingredient used in fragrances and cosmetic products, known for its sweet and floral aroma. Although it is currently not restricted by the Cosmetics Regulation (EC) No 1223/2009, ECHA recommended in March 2022 to classify it as "toxic for reproduction category 2" and "skin sensitizer category 1". This recommendation was based on toxicity and skin sensitization studies. In December 2022, a dossier was submitted to support the safe use of hexyl salicylate in cosmetics, with specific concentration limits. However, the SCCS noted that no specific scenarios for childhood exposure had been provided. In response, industry submitted additional information in May 2024 to address these concerns. Hexyl Salicylate: New SCCS Mandate In this new mandate, the SCCS is requested to Assess the Safety of Hexyl Salicylate for Children Under 3: Based on the data provided and considering the proposed classification as CMR2 (reprotox) under the CLP Regulation, the SCCS should determine whether hexyl salicylate is safe for children under 3 years of age when used at the maximum concentrations indicated in the dossier. Identify Additional Safety Concerns: The SCCS should also identify any additional scientific concerns related to the use of hexyl salicylate in cosmetic products and exposure of children. Hexyl Salicylate: Relationship between the Assessments This new SCCS mandate is directly related to the previous request made by the European Commission on June 24, 2024, which also requested an assessment of the safety of hexyl salicylate in cosmetic products, specifically for children under 3 years of age. Both requests underline the need to ensure that cosmetic products are safe for all age groups, especially the most vulnerable. Deadline and Next Steps The SCCS has 2 months to issue its opinion on this issue. This detailed assessment will help establish safe use limits and protect the health of younger consumers. Hexyl Salicylate, Conclusion The evaluation of hexyl salicylate by the SCCS, both in the initial application and in the new mandate, is crucial to ensure the safety of cosmetic products. These ongoing and detailed reviews reflect the EU's commitment to consumer protection and the safety of cosmetic ingredients. If you need more information on this subject, please do not hesitate to contact us.

Recently, the Member State Committee (MSC) of the European Chemicals Agency (ECHA) confirmed the addition of a new hazardous chemical to the List of Substances of Very High Concern (SVHC). With this addition, the candidate list now contains 241 entries, including several groups of chemicals, increasing the total number of affected substances. Recently added substance Substance details Implications of being listed as a candidate substance Implications for companies ECHA: Recently Added Substance The newly added substance is bis(α,α-dimethylbenzyl) peroxide , with CAS number 80-43-3 and EC number 201-279-3. This substance has been identified as toxic for reproduction (Article 57c) and is commonly used as a flame retardant in various industrial applications. Substance Details Substance Name EC No. CAS No. Reason for Inclusion Example of Use Bis(α,α-dimethylbenzyl) peroxide 201-279-3 80-43-3 Toxic for reproduction Flame retardant Implications of Being Listed as a Candidate Substance The inclusion of a substance on the Candidate List implies several obligations for companies handling these chemicals: Providing Safety Information Suppliers of articles containing SVHCs in concentrations above 0.1% must provide a Safety Data Sheet (SDS) to downstream users. They must also provide safe use instructions to downstream recipients if the concentration of SVHCs exceeds 0.1%. This information must be made available to consumers within 45 days upon request. Notification to ECHA Manufacturers, importers, or EU-exclusive representatives must notify ECHA if the substance is present in total quantities exceeding one tonne per year per producer or importer. They must also notify if the substance is present in articles above a concentration of 0.1% weight by weight (w/w). SCIP Database Since January 5, 2021, companies must submit notifications to the ECHA's SCIP (Substances of Concern In articles, as such or in complex objects (Products)) database for any article containing more than 0.1% SVHC. ECHA: Implications for Companies The inclusion of new substances on the Candidate List underscores the importance of continuous monitoring and proactive management of chemicals in supply chains. Companies must ensure compliance with all regulations and provide the necessary information to ensure consumer safety and environmental protection. For more information on regulations and how to comply with them, visit the ECHA website or consult with regulatory compliance experts.

Understanding the requirements for coloring agents in cosmetics in the US is crucial for compliance. This article provides a comprehensive overview of the additives permitted for use in cosmetics based on FDA guidelines. The Significance of Color Additives in Cosmetics Types of Color Additives Conclusion The Significance of Color Additives in Cosmetics According to the FDA, a color additive is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body. They are essential for creating appealing products such as lipsticks, eyeshadows, blushes, and nail polishes, making them more attractive to consumers. The United States Food and Drug Administration (FDA) is the primary body responsible for overseeing the safety and approval of color additives in cosmetics. They are required to be pre-approved by the FDA and listed in the specific regulations before they may be used and intended for sale in the United States. Types of Color Additives Color additives approved for use in cosmetics are classified into two main categories: certified colors and colors exempt from certification. Certified Colors: also known as color additives from Petroleum and coal sources. These are synthetic additives that undergo a batch certification process by the FDA to ensure they meet strict safety standards. Each batch is tested for purity and safety before it can be used in products. Certified color additives get a special name, which consists of a prefix, such as FD&C, D&C, or Ext. D&C, a color, and a number. Some examples are: FD&C Blue No. 1 and D&C Red No. 7. Certified colors are known for their vibrant and consistent coloring capabilities. Colors exempt from certification: these coloring agents are generally derived from mineral, botanical, or animal sources. Despite this, they must still meet FDA safety requirements. Some examples are caramel color and mica. If you have a new colorant that is not identified and listed by the FDA you must submit a petition to the FDA. The data typically cover toxicological studies, manufacturing processes, and proposed usage levels. The FDA reviews the submitted data to assess the safety of the coloring additive. This includes evaluating potential health risks such as toxicity, carcinogenicity, and allergic reactions. If the FDA determines that the color additive is safe for its intended use, it publishes a regulation listing the approved uses and restrictions of the additive in the Federal Register. Conclusion In conclusion, the regulation of color additives permitted for use in cosmetics by the FDA is essential for ensuring the safety and quality of cosmetic products. They specifically restrict the use of color additives in eye contour areas and externally applied cosmetics. If you’re looking to ensure the safety of your products, we’re here to provide you with answers and specialized guidance. Email us at info@belabservices.com

On May 27, 2024, Switzerland communicated to the World Trade Organization (WTO) its plan to amend Annexes 2 and 3 of its Chemicals Ordinance (ChemO). These amendments are aimed at improving environmental protection and human health, as well as reducing trade barriers and facilitating trade. The new regulations are expected to be adopted on August 2, 2024 and enter into force on September 1, 2024. Regulatory Context in Switzerland Modifications to the Chemical Ordinance Switzerlands New Regulation: Impact Conclusion Regulatory Context in Switzerland Switzerland aligns its chemical regulations with the EU to ensure access to the single market. Switzerland bases its chemical regulatory system on the Federal Chemicals Act and the Ordinance on Protection against Dangerous Substances and Preparations. To ensure access to the EU single market, Switzerland has adopted regulations similar to the EU REACH and CLP Regulations, including regulations on classification, labeling and packaging of chemicals, as well as a system to identify and control substances of very high concern (SVHC). Modifications to the Chemical Ordinance 28 new substances or groups of substances are added to the List of Harmonized Classification and Labeling of Hazardous Substances. Additionally, 24 existing entries are updated to align with the 21st Adaptation to Technical Progress (ATP) of the EU CLP Regulation. Details of the modifications Switzerlands New Regulation: Impact New regulations boost Swiss environmental protection and trade with the EU. These amendments will enable Switzerland to improve environmental and public health protection, as well as facilitate trade with the EU by minimizing regulatory differences. Companies will need to adapt to the new regulations to maintain access to the European market and avoid possible sanctions. Conclusion The update of the Swiss Chemicals Ordinance to align it with EU regulations represents a key step in harmonizing chemical safety standards and promoting international trade. The amendments that will come into force in September 2024 reflect Switzerland's commitment to environmental protection and human health, and to staying aligned with advanced European regulations. If you need more information, please do not hesitate to contact us.