Premium international regulatory services
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
Biorius specializes in guiding cosmetic brands through the complexities of the European Union’s Cosmetics Regulation (EC No 1223/2009). Our comprehensive services include:
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Formula Review: Ensuring ingredient compliance and safety -
Cosmetic Product Safety Report (CPSR): Conducting thorough safety assessments -
Product Information File (PIF) Preparation: Compiling essential product documentation -
CPNP Notification: Managing the Cosmetic Products Notification Portal submissions -
Label and Claims Review: Verifying compliance with EU labeling standards -
Legal Representation: Acting as the Responsible Person within the EU
Comprehensive services to ensure your cosmetic products comply with UK regulations. Our expertise includes:
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Formula Review: Assessing ingredient safety and regulatory compliance -
Cosmetic Product Safety Report (CPSR): Providing detailed safety evaluations -
Product Information File (PIF) Preparation: Compiling essential product documentation -
SCPN Notification: Managing the Cosmetic Products Notification Portal submissions -
Label and Claims Review: Ensuring packaging and marketing materials meet UK standards -
Legal Representation: Acting as your UK Responsible Person for regulatory matters
Our team offers specialized guidance to help your cosmetic products achieve full compliance with U.S. federal and state regulations.
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Formula Review: Evaluating your product formulations to meet all federal requirements -
Label and Claims Review: Assessing product labels and marketing communications to ensure compliance and mitigate legal risks -
Safety Substantiation: Conducting analyses to demonstrate product safety, as mandated by the Modernization of Cosmetic Regulation Act (MoCRA) -
Volatile Organic Compounds Management: Assisting with compliance regarding substances regulated due to environmental concerns, such as those overseen by the EPA and California Air Resources Board -
State-Specific Compliance: Ensuring adherence to state-specific regulations, including California's Proposition 65 and the California Safe Cosmetics Program -
Legal Representation: Acting as your adverse event contact in the U.S., fulfilling the role of US Agent as defined by the MoCRA
To enter the Canadian cosmetic market, products must comply with the Food and Drugs Act, Cosmetic Regulations, and Consumer Packaging and Labelling Act, as well as Quebec’s language requirements. Biorius offers a comprehensive solution, including:
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Formula Review: Assessment of ingredients, impurities, and safety -
Label and Claims Review: Ensuring labels meet regulatory standards and claims are substantiated -
Health Canada Notification: Submission of product details for market authorization -
Legal Representation: Acting as the Responsible Person in Canada to ensure ongoing compliance and address regulatory inquiries
To enter the South Korean cosmetic market, products must comply with the Cosmetics Act, relevant K-Beauty standards, and local packaging and labeling requirements, including adherence to the Korean language regulations. Biorius offers a comprehensive solution, including:
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Formula Review: Thorough assessment of ingredients, impurities, and safety to meet South Korea’s stringent regulatory standards -
Label and Claims Review: Ensuring product labels meet Korean regulatory requirements and that marketing claims are accurate and substantiated
To enter the Japanese cosmetic market, products must comply with the Pharmaceutical and Medical Device Act (PMDA), standards set by the Ministry of Health, Labour and Welfare (MHLW), and local packaging and labeling requirements, including adherence to Japanese language regulations. Biorius offers a comprehensive solution, including:
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Formula Review: Detailed assessment of ingredients, impurities, and safety to ensure compliance with Japan's strict regulatory standards -
Label and Claims Review: Verifying that product labels meet Japanese regulatory requirements and that marketing claims are accurate and substantiated
To enter the Chinese cosmetic market, products must comply with the Cosmetic Supervision and Administration Regulation (CSAR) and its subsidiary guidelines, including strict requirements for safety assessments, ingredient compliance, and mandatory local testing. Biorius offers a comprehensive solution, including:
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Formula Review: Ensuring ingredient compliance with China's restricted and banned substance lists, as well as safety requirements -
Cosmetic Product Safety Report (CPSR): Conducting thorough evaluations to meet China's mandatory safety assessment criteria -
Label and Claims Review: Verifying compliance with Chinese labeling regulations and ensuring claims align with legal standards -
NMPA Registration: Managing the National Medical Products Administration (NMPA) registration or filing process for general and special-use cosmetics
Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam.
To enter the ASEAN cosmetics market, products must comply with the ASEAN Cosmetic Directive (ACD) and individual country-specific requirements, including safety assessments, ingredient compliance, and proper labeling standards. Biorius offers a comprehensive solution, including:
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Formula Review: Ensuring ingredient compliance with the ASEAN Cosmetic Ingredient Listings, including restricted and prohibited substances -
Cosmetic Product Safety Report (CPSR): Conducting thorough safety assessments to ensure the product meets ASEAN safety standards -
Label and Claims Review: Verifying that product labels adhere to ASEAN labeling standards and that marketing claims are substantiated
To enter the Australian cosmetic market, products must comply with the requirements set by the Australian Industrial Chemicals Introduction Scheme (AICIS), the Therapeutic Goods Administration (TGA) for specific products, and local packaging and labeling standards, including adherence to Australian Consumer Law. Biorius offers a comprehensive solution, including:
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Formula Review: Detailed assessment of ingredients and impurities to ensure compliance with Australian regulations, including restricted and prohibited substances under AICIS -
Label and Claims Review: Verifying that product labels meet Australian labeling requirements and that marketing claims are accurate, substantiated, and align with local advertising standards
Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates, Yemen.
To enter the GSO (Gulf Standards Organization) countries’ cosmetic markets, products must comply with the Gulf Technical Regulation for Cosmetic and Personal Care Products, including ingredient safety, proper labeling, and packaging requirements. Biorius offers a comprehensive solution, including:
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Formula Review: Detailed assessment of ingredients and impurities to ensure compliance with the Gulf Technical Regulation and adherence to the list of restricted and prohibited substances -
Label and Claims Review: Verifying that product labels meet GSO countries' specific requirements, including Arabic language labeling, and ensuring marketing claims are accurate and substantiated
To enter the South African cosmetic market, products must comply with the South African Department of Health regulations, including the Cosmetic, Toiletry, and Fragrance Association (CTFA) guidelines and applicable labeling and safety requirements. Biorius offers a comprehensive solution, including:
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Formula Review: Detailed assessment of ingredients and impurities to ensure compliance with South African regulatory standards, including alignment with international best practices -
Label and Claims Review: Verifying that product labels meet South African requirements, including language considerations, and ensuring marketing claims are accurate and substantiated
Bolivia, Colombia, Ecuador, Peru.
To enter the Andean Community (CAN) cosmetic markets, products must comply with the Harmonized Regulation for Cosmetic Products and additional local requirements. Biorius offers a comprehensive solution, including:
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Formula Review: Detailed assessment of ingredients and impurities to ensure compliance with the Andean Community's regulations, including restricted and prohibited substances -
Label and Claims Review: Verifying that product labels meet the Andean Community's harmonized labeling requirements and ensuring marketing claims are accurate and substantiated
To enter the Brazilian cosmetic market, products must comply with the regulations established by the National Health Surveillance Agency (ANVISA), including safety assessments, ingredient compliance, and proper labeling standards. BIORIUS offers a comprehensive solution, including:
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Formula Review: Thorough assessment of ingredients, impurities, and safety to ensure compliance with Brazil's regulatory requirements, including restricted and prohibited substances -
Label and Claims Review: Verifying that product labels meet ANVISA standards, including Portuguese language requirements, and ensuring marketing claims are accurate and substantiated
Navigate International Regulations with MyApps
Simplify global compliance with Biorius’ international services and MyApps, our exclusive online platform. Effortlessly manage your portfolio, from compliance documents to formulas and reports, all in one place.
Paired with personalized expert support, MyApps streamlines your workflow and ensures seamless regulatory oversight. Partner with Biorius for tailored guidance and cutting-edge tools to drive your global success.
Expanding Horizons: New Regions Coming Soon
At Biorius, we are constantly evolving and expanding our expertise to meet the ever-changing demands of the global cosmetics industry. If the region you’re looking for isn’t available yet, it might already be in development or coming soon.
Contact us today to discover how we can tailor our ever-growing range of services to support your goals and ensure your success in the global cosmetics market. Stay ahead with Biorius!
Looking for a Responsible Person ?
Discover how Biorius simplifies regulatory compliance as your Responsible Person in the EU, UK, and Canada, and as your US Agent in the United States.
Need a quick compliance overview?
Explore Biorius’ Formula Check and Formula Review services to gain a clear understanding of your formula’s regulatory status early in the development process. We help you identify potential issues and streamline your path to market readiness.
Get in Touch
Need a piece of advice, a quotation or answers to your questions?
Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmeticproducts in various markets:
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First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries -
50 regulatory experts, toxicologists, pharmacists, and chemists to serve you. -
A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more! -
A best-in-class IT tool, free of charge, and saving a lot of your time. -
More than 1,500 international clients have already chosen Biorius! -
We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence
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