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  • SCCS opinion and the safety of Methylparaben and Benzophenone-4

    In a recent opinion issued by the Scientific Council on Consumer Safety (SCCS) at the end of January 2024, the safety of methylparaben and benzophenone-4 in cosmetic products was reaffirmed following a thorough evaluation of their potential endocrine-disrupting properties These ingredients, which were already subject to regulation by the European Union (EU), were subject to a safety reassessment due to concerns about their impact on the endocrine system. After carefully reviewing all available data and considering concerns related to endocrine activity, the SCCS reached the following conclusions: - Methylparaben is considered safe as a preservative in cosmetic products, provided its concentration does not exceed 0.4% (expressed as acid). - Benzophenone-4 is also considered safe when used as a UV filter at a maximum concentration of 5% in sunscreens, face and hand creams, lipstick, as well as in propellant aerosol and pump spray products, either individually or in combination with other ingredients. These determinations reinforce existing regulation and provide clarity on the safe use of these ingredients in cosmetic products, offering peace of mind to consumers and the cosmetic industry in general.

  • Advances the Restriction of Cyclotetrasiloxane, Cyclopentasiloxane and Cyclohexasiloxane in Cosmetic Products

    The draft regulation on cyclotetrasiloxane (D4), cyclopentasiloxane (D5) and cyclohexasiloxane (D6), which limits their uses to a maximum of 0.1% w/w in cosmetic products, is on its way to adoption. This measure seeks to regulate the presence of these compounds in cosmetics due to environmental and health concerns. The draft regulation has been submitted to both the European Parliament and the Council of the EU. Unless significant objections are raised, it is expected to be adopted and published in the coming months. This change will amend Annex XVII of the REACH Regulation, thus strengthening the regulations surrounding these compounds in the cosmetics industry. As a result of this measure, the implementation dates for cosmetic products are being adjusted. Implementation is expected to be progressive, with the following deadlines: Until April 2026 for rinse-off products. Until April 2027 for leave-on products. These dates will provide manufacturers and the industry in general with a transition period to adapt to the new regulations and reformulate products as needed. This measure is expected to have a significant impact on the formulation and manufacture of cosmetics in the European Union, with the aim of improving the safety and sustainability of these products for consumers and the environment.

  • Important regulatory change in the European Union for cosmetic products!

    January 5, 2024 marked a significant regulatory development in the European Union with the publication of the 21st Adjustment to Technical Progress, better known as EU Regulation 2024/197. This regulation brings with it key amendments to the annexes of CLP Regulation EU 1272/2008, especially with regard to the classification of certain ingredients used in nail products. Two ingredients in particular have grabbed the attention of the cosmetic and regulatory industry: Dimethyltolylamine (CAS 99-97-8) and TPO (Trimethylbenzoyldiphenylphosphine oxide CAS 75980-60-8). Both have been classified as CMR, i.e. substances that are carcinogenic, mutagenic or toxic to reproduction. This classification means that products containing either of these ingredients will be subject to significant restrictions. Under the new regulation, cosmetic products containing either of these two ingredients will be banned from the European market as of February 1, 2025. This measure, which seeks to protect the health and safety of consumers, will require manufacturers to withdraw affected products from the market before the established deadline. This regulatory update reflects the European Union's continued commitment to consumer protection and the regulation of cosmetic products, ensuring that the highest safety standards are in place at all times. Manufacturers and players in the cosmetics sector are being called upon to take proactive measures to comply with these new regulations and ensure the compliance of their products before the deadline.

  • News on Octocrylene

    In a noteworthy shift, the European Union (EU) has implemented updated regulations surrounding Octocrylene, an organic UV filter prevalent in cosmetic products. Designed to safeguard consumers and formulations from harmful UV radiation, the EU Cosmetics Regulation now imposes restrictions on Octocrylene, allowing a maximum concentration of 9% in propellant sprays and up to 10% in other products. These regulations, enforced since January 28, 2023, for new products and July 28, 2023, for existing ones, were instated following a comprehensive evaluation by the SCCS, addressing potential endocrine-disrupting properties. Interestingly, the United Kingdom maintains a slightly different stance, permitting the use of Octocrylene as a UV filter up to 10%, albeit in its acid form. However, France is taking a more proactive approach, signaling a call for additional regulatory measures on Octocrylene due to environmental concerns. A proposal is set to be submitted to Annex XVII of REACH to specifically address the environmental impact associated with the substance. France initiated a call for evidence from November 15, 2023, to January 10, 2024, to gather comprehensive information on Octocrylene's uses, environmental effects, available alternatives, and associated costs. Anses (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail in France) underscores the environmental risks posed by Octocrylene, particularly to aquatic ecosystems, including corals. The concern arises from the release of the substance during bathing and washing by individuals using sunscreens containing Octocrylene. Additionally, groundwater contamination could potentially impact drinking water consumers. While the EU Cosmetics Regulation primarily addresses user safety, REACH encompasses broader environmental considerations. As such, the proposed restriction in Annex XVII to REACH is deemed the most suitable avenue for managing environmental risks tied to cosmetic substances like Octocrylene. This dynamic regulatory landscape reflects a collective effort to balance cosmetic innovation with heightened environmental awareness. If you need more information, please don't hesitate to contact us. References: ECHA. (2023). Call for evidence and information on Octocrilene. Retrieved on 31/01/2024

  • "NON-ANIMAL TESTING" in Canada

    In response to a growing concern for animal welfare, the demand for cruelty-free cosmetics in Canada has seen a marked increase. This trend has led cosmetics manufacturers to become less likely to test on animals, having voluntarily reduced their reliance on animal testing data. Several countries around the world have laws prohibiting or limiting cosmetic testing on animals, including member states of the European Union (EU). Since 2013, the EU has banned the sale of cosmetic products tested on animals. In line with this stance, Canada has joined the ban on the sale of cosmetics tested on animals as of December 22, 2023, joining a large list of countries that have implemented this measure. Anyone is prohibited from testing cosmetics on vertebrate or invertebrate animals in Canada if: - it may cause the animal pain, suffering, or physical or mental injury and. - The purpose of the test is to satisfy cosmetic requirements set out in the Act or cosmetic safety requirements in another country. It is also prohibited: - selling a cosmetic in Canada if safety cannot be established without relying on animal test data. - making a claim on a label or in an advertisement that the cosmetic has not been tested on animals, without prior testing to prove it. The ban and the cosmetics industry To comply with Canadian requirements, the industry must: - Prohibit animal testing in Canada as a means of assessing the safety of cosmetics and comply with cosmetic regulations both domestically and in other countries. - Ensure that the safety of any new cosmetic sold in Canada can be established based strictly on permitted data. - Any "not tested on animals" claims must be supported by evidence. If it is suspected that a cosmetic does not comply with the recent ban, we can file a complaint to ensure that this is not the case. If you need more information don't hesitate contact us

  • FUTURE BAN ON COSMETICS. FLUORINATED GREENHOUSE GASES.

    The new proposal for a Regulation of the European Parliament and of the Council seeks to regulate fluorinated greenhouse gases and their impact on the environment, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No. 517/2014. From January 1, 2025, the marketing of products and equipment containing these gases will be prohibited, including personal care products such as mousse, creams, foams, liquids and aerosols. After one year from the ban deadline, these products or equipment will only be allowed to be supplied or disposed of in the European Union if it can be demonstrated that they were placed on the market before January 1, 2025. It is important to note that the deadlines to comply with this regulation will be tight, so it is recommended to replace fluorinated greenhouse gases as soon as possible in finished products placed on the market. We recommend that, if you own products with these gases, you make the relevant changes as soon as possible, as the deadlines are quite tight. If you need more information, please do not hesitate to contact us.

  • UNITED KINGDOM - FUTURE RESTRICTION AND THE UPDATE OF ITS LIST OF SUBSTANCES

    On October 27, the United Kingdom informed the World Trade Organization (WTO) of draft regulations limiting the use of BHT (Butylated hydroxytoluene; CAS: 128-37-0). UNITED KINGDOM AND ITS PROPOSAL TO RESTRICT THE USE OF BHT COSMETICS UPDATE OF ITS LIST OF SUBSTANCES CLASSIFIED UNDER THE CLP THE UNITED KINGDOM AND ITS PROPOSAL TO RESTRICT THE USE OF BHT COSMETICS The proposed restriction is in line with the EU Cosmetic Regulation for BHT. In addition, an additional restriction is proposed for leave on oral care products, setting a limit of 0.001% compared to the EU regulation. This measure complies with established standards and aims to ensure the safety and quality of rinse-free oral care products on the market. On October 27, the United Kingdom informed the World Trade Organization (WTO) of draft regulations limiting the use of BHT (Butylated hydroxytoluene; CAS: 128-37-0). The maximum concentrations established by this draft are as follows: Toothpastes: 0.1%. Mouthwashes: 0.001%. Leave on" oral care products: 0.001%. Other leave on and rinse off products: 0.8%. Cosmetic products that do not comply with this restriction in the UK: May not be placed on the market as of October 6, 2024. May not be placed on the market as of February 6, 2025. UPDATE OF ITS LIST OF SUBSTANCES CLASSIFIED UNDER THE CLP At the end of October, the United Kingdom updated its CLP Regulation and GB MCL (Great Britain Mandatory Classification and Labelling). The CLP Regulation and the GB MCL play a crucial role in identifying and communicating the hazards associated with the use of chemicals. By providing appropriate classification and labeling, valuable information is provided to workers, consumers and the general public, enabling them to make informed decisions and take appropriate safety measures. This update consists of a total of 98 substances, including some with INCI designations, which are intended to align with the latest Adaptation to Technical Progress (ATP) in Europe. These are substances with cosmetic interest: Azadirachta Indica Seed Extract Benzophenone Benzyl Salicylate Citric Acid Cumene p-Cymene Dibromocyanoacetamide Isobornyl Acrylate Isophorone Diamine Limonene Melamine Methyl Salicylate Methylene Di-T-Butylcresol MIBK Phenoxyethanol Piperonyl Butoxide Theophylline Trimethylolpropane Triacrylate Xylene Diisocyanat If you need more information, please do not hesitate to contact us.

  • FDA - Delays MoCRA Compliance

    In a recent release, the Food and Drug Administration (FDA) has announced a delay in the launch of the facility registration and product listing platform, providing additional leeway for compliance with established requirements. Compliance Policy Shift for Cosmetic Product Facilities Changes in Cosmetic Product Regulations and Deadlines In summary FDA's Grace Period: Compliance Policy Shift for Cosmetic Product Facilities This move comes in the wake of the FDA's recent publication of the "Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing." Under this guidance, the agency will not impose penalties for noncompliance with cosmetic product facility registration and listing requirements until six months after the statutory deadline, which was originally set for December 29, 2023, or until July 1, 2024. The main purpose of this extension is to provide the regulated industry with additional time to comply with such requirements. FDA's Comprehensive Approach: Changes in Cosmetic Product Regulations and Deadlines In addition, FDA has also decided not to require facility registration for those owners or operators who began manufacturing or processing cosmetic products after December 29, 2022, or the listing of cosmetic products that are first marketed after this same date, until July 1, 2024. This measure seeks to facilitate the adaptation of industry players to the new requirements without imposing additional burdens in the transition. However, FDA has not officially communicated whether it intends to delay the implementation of the professional product labeling requirements as set forth in MoCRA, whose effective date is December 29, 2023. Also, it has not been reported whether the delay in implementation will alter the December 29, 2023 deadline for companies to maintain adverse event records, report serious adverse events to FDA, or retain adequate safety justification records. In summary FDA has decided to extend the deadlines for compliance with facility registration and listing requirements for cosmetic products, granting an additional six months to the regulated industry. This measure is intended to promote a smooth and effective transition to the new regulatory framework, allowing industry operators to adjust to the new regulations in an appropriate manner and without undue pressure. If you want to know more about MoCRA, you can click on the following link: Learn about MoCRA: Ensuring Safer Cosmetics with BELAB (belabservices.com) For more information, please contact us Contact | BeLab Services Consultants

  • The ban of Glitter in Cosmetic Products according to the European Commission

    The European Commission, in a new press release, informed that the first measures, such as the ban on loose glitter and microbeads, will be implemented when the restriction comes into force on October 15. This has created alarm in the sector, as it was considered that the mentioned products were ipso facto banned as of the indicated date. The European Commission has made this clarification The Glitter Ban: What It Means for Consumers Cosmetic Industry's Transition to Sustainable Sparkles A Global Effort to Curb Microplastic Pollution On September 27, the European Union published in its official journal Regulation (EU) 2023/2055, which introduces amendments to Annex XVII of Regulation (EC) No 1907/2006 (REACH) regarding microparticles of synthetic polymers. This regulation prohibits, among others, microplastics intentionally added to cosmetic products. Among the products affected are exfoliants and products with glitter or glitter, many of them in the area of make-up. However, the European Commission has made this clarification: It is ratified that the marketing of plastic glitter in products subject to a transitional period as set out in section 6 of the Annex to Regulation (EU) 2023/2055 will not be subject to a ban until the completion of that transitional period. Cosmetic products containing synthetic polymer microparticles (excluding microbeads) and glitter may be placed on the market during specific transitional periods as set out in section 6 of the restriction until the following cut-off date: As of Oct 16, 2027, rinse off cosmetics must comply with the regulations set forth in section 6b. As of Oct 16, 2029, leave on cosmetics must comply with the regulations set forth in section 6d. As of Oct 16, 2030, makeup, lip and nail products must comply with the regulations set forth in paragraph 6c. As of October 17, 2031, makeup, lip and nail products must carry a label indicating the presence of microplastics in order to continue to be sold until October 16, 2035. The Glitter Ban: What It Means for Consumers The glitter ban introduced by the European Commission has brought significant changes to the market. As of October 17, the sale of non-biodegradable, insoluble plastic glitter, including decorative, craft, and glitter used in toys and textiles, is no longer permitted. However, consumers need not despair, as there are alternatives available. Biodegradable, soluble, natural, or inorganic glitter is still allowed and can be found in various products. We'll dive deeper into these eco-friendly glitter options and discuss their benefits. Cosmetic Industry's Transition to Sustainable Sparkles The cosmetic industry, which often relies on glitter for its products, has been at the forefront of finding sustainable solutions. Cosmetic companies have made significant strides in creating biodegradable glitter products that maintain the sparkle without the environmental drawbacks. Some cosmetic products with traditional glitter have been granted a moratorium, allowing them to be sold during a transitional period. We'll explore the advancements in the glitter field within the cosmetics industry and what consumers can expect from glitter-infused cosmetic products in the coming years. A Global Effort to Curb Microplastic Pollution The European Commission's decision to restrict microplastics is driven by a pressing need to combat the release of microplastics into the environment. An estimated 42,000 tonnes of microplastics intentionally added to products are released in the EU each year, leading to widespread contamination of the seas and oceans. We'll discuss the environmental implications of this decision and how it aligns with global efforts to reduce microplastic pollution. The Commission's goal to prevent the release of approximately half a million tonnes of microplastics into the environment and protect our ecosystems and food chains will be explored in detail. In conclusion, the European Commission's ban on non-biodegradable plastic glitter is a significant step toward a more sustainable future. It is driving innovation and promoting the use of eco-friendly alternatives, ensuring that sparkle doesn't come at the cost of our environment. This change not only affects the glitter industry but also aligns with the broader mission to protect our planet from the detrimental effects of microplastic pollution. However, all of the above-mentioned products subject to the immediate ban, if introduced to the market before October 17, 2023, need not be withdrawn from the market. If you need more information do not hesitate to contact us.

  • Latest developments in the UK Cosmetics (Restriction of Chemicals substances) Regulations 2023

    Stay informed about the latest advancements in the UK Cosmetics (Restriction of Chemicals Substances) Regulations 2023. These new regulations are designed to enhance the safety and quality of cosmetic products in the UK. Discover the key updates and their implications for the cosmetics industry. Amendment to Annex 3 (comes into force on July 6, 2024). Amendment to Annex 6 (comes into force on August 10, 2024) BELAB, Your source for staying compliant and ensuring product safety. On July 20, 2023, legislation is known as the Cosmetic Products (Restriction of Chemicals) Regulations 2023 (No. 836 of 2023) was enacted in the United Kingdom to revise the requirements relating to the use of methyl-N-methyl anthranilate (CAS No. 85-91-6), HAA (CAS No. 919803-06-8) and HAA (nano). This regulation applies in all regions of the United Kingdom, including England, Wales and Scotland. UK Cosmetics: Amendment to Annex 3 (comes into force on July 6, 2024). Until July 6, 2026, any cosmetic product that has been introduced on the market before July 6, 2024, may be available until that date. UK Cosmetics: Amendment to Annex 6 (comes into force on August 10, 2024) If you need more information, please do not hesitate to contact us.

  • Publication of the MoCRA register of products and facilities

    The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetics law in recent U.S. history. MoCRA: New regulation for cosmetics products in the USA Remember that MoCRA gave new responsibilities to the FDA In addition to the information mentioned, the new guide establishes On August 7, the FDA published the Draft Registration of Cosmetic Facilities and Products in the United States, complying with the new requirements approved in December 2022 through the Modernization of the Cosmetic Act (MoCRA). MoCRA: New regulation for cosmetics products in the USA The new regulations on cosmetic products in the USA require that any person who owns or operates a facility dedicated to the manufacturing or processing of a cosmetic product for distribution in the United States, register said facility with the FDA. In addition, MoCRA establishes the obligation to register all cosmetic products through a Responsible Person in the US. The former (and voluntary) VCRP registration program has been rescinded, invalidating all registrations submitted to date. The FDA intends to launch the new e-filing portal in October 2023. As described, the FDA Establishment Identifier (FEI) will be used as the registration number for the draft guidance. installation required. Therefore, facility owners or operators will need to obtain an FEI number before submitting facility registration. Remember that MoCRA gave new responsibilities to the FDA: • Facility Registration: All existing facilities subject to the new FDA MoCRA regulations must register within one year (December 2023); this includes contract manufacturers. New facilities must also register within 60 days and must be renewed every two years as required by the FDA. • Product Listing: The responsible person must list each cosmetic product marketed with the FDA, including the product ingredients, and provide updates annually. Each product created now requires the submission of a cosmetic product list detailing everything from ingredients, including fragrance or flavor, and the party responsible for the manufacturing facility and its location. In addition to the information mentioned, the new guide establishes: The legal requirement to submit cosmetic product facility records and product listings; Who is responsible for making the presentations What information to include in presentations How to make presentations When to make presentations BELAB SERVICES LLC, located in Miami (Florida) lends all its knowledge to the service of companies to register their facilities and products in strict compliance with the new regulations, acting as Contact Agents (US Agent) and Responsible Person in the US (US Responsible Person) for its products and facilities. For more information, please contact us consult@belabservices.com / info@belabservices.com

  • New Decree No. 2023-837 and its list of products that may not be sold in bulk

    Decree No. 2023-837, published in the Official Journal of the French Republic last August 31, aims to protect public health by establishing a list of products that cannot be sold in bulk. However, in the specific case of cosmetic products requiring a Challenge Test, exceptions are provided for in accordance with the Implementing Decision of November 25, 2013, which establishes guidelines for the application of Annex I of Regulation (EC) No. 1223/2009 on cosmetic products. The term "bulk sale" in this context refers to the marketing of products without packaging to the final consumer. Under this modality, consumers have the possibility to purchase the desired quantity of products, which are delivered in reusable containers. For the bulk sale of these cosmetic products, the use of two specific modalities will be required. The first modality is through an assisted service, in which an operator at the point-of-sale packages and delivers the product immediately to the consumer. The second modality is through a distribution system suitable for self-service bulk sales. To be considered adequate, this distribution system must guarantee the preservation of the integrity of the product, comply with safety, hygiene, and conservation requirements, as well as comply with all safety requirements at the points of sale. It should be noted that this decree has a broader scope that covers various products, such as toilet paper, kitchen paper towels, paper napkins, tissues, absorbent cotton, and other single-use articles made of cotton or vegetable fibers for personal hygiene or cleaning purposes. This decree came into force on September 1, 2023 More information about Decree No. 2023-837 can be found here: Decreto Nº 2023-837 de 30 de agosto de 2023 por el que se establece la lista de productos que no pueden venderse a granel por razones de salud pública - Légifrance (legifrance.gouv.fr)

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