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Greetings from
Freyr EU!
Understanding and complying with the regulatory landscape of the European Union (EU) for cosmetics, food and dietary supplements, and chemical substances requires a thorough grasp of complex standards. Businesses must adhere to stringent European Union regulatory services to achieve market approval from Health Authorities (HAs). Freyr, as a global regulatory specialist, assists manufacturers, brand owners, distributors, and private label entities in decoding local regulatory requirements, ensuring comprehensive product classification and managing mandatory European Union regulatory services & submissions.
With Freyr’s end-to-end regulatory affairs consulting, manufacturers, brand owners, distributors, and private label entities can achieve streamlined registrations and approvals, ensuring compliance and successful market entry. Whether dealing with Cosmetics regulation EU, Food supplements regulation, or Chemical substance compliance in EU, Freyr's regulatory expertise helps businesses efficiently secure approvals and maintain compliance across the European Union regulatory services.
Industries We Serve in the European Union
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The European region is considered the second largest market, after the US, for medical devices. At the same time, Europe has a very complex and stringent regulatory compliance. From the implementation of MDR, Brexit to Swixit, Europe has experienced volatility in terms of regulations, especially for medical devices.
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The EU cosmetics registration process is regarded by some to be the most challenging, as far as the global markets go. We do not expect you to have it mastered when you first contact us, our dedicated team will take you through it step by step. We have done so with clients from every part of the world, small and large, across all categories of cosmetic products, such as skin care, hair care, infant care, oral care, nail care, etc.
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The European Union (EU) is a thriving market for food supplements, attracting companies in the industry. However, the EU’s food supplement regulations are implemented at the national level, following Directive 2002/46/EC. Merely classifying a product as a food supplement, dietary supplement, nutraceutical, Natural Health Product (NHP), complementary medicine, health food, or health supplement in other markets is insufficient for EU classification. Compliance with substance usage, maximum levels, and banned substances is crucial. It is essential to adhere to proper food labeling, advertising, and health claims to ensure safety, avoid sanctions, and prevent product withdrawal and recall.
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Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets.
Freyr Offerings
- EU Product Classification
- Formula Review EU/Ingredients Assessment
- Safety assessment of finished products EU
- EU label and claims review
- Packaging Material Requirements
- Dossier Compilation and Submission
- Product Compliance
- Product Notification/Registration
- EU Country-specific Regulatory Support
- EU Legal Representation (LR) and EU Responsible Person (RP)
- EU regulatory intelligence report
- Post-notification/Post-marketing Follow-up
- Management of Alerts and Authorities’ Remarks
- Communication with HAs
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland)
- Prepare Technical Data Files (Specifications, MSDS, etc.) including Chemical Registration in ECHA/Notification Dossiers
- Application Preparation and Submission for Relevant Introductions and Renewals
- Sustainability and Packaging Solutions
- EU REACH Registration Only Representative (OR) Service
- EU CPSR Preparation
- EU PIF Compilation
- EU CPNP Cosmetics Notification
Freyr Advantages
- End-to-end regulatory consultation
- Market-specific regulatory consulting and advice
- Harmonized compliance, local labeling, and local market support
- Qualified team of experts with hands-on experience across all categories of cosmetics, food and dietary supplements, and chemical substances
- Support for region-specific regulatory activities
- Extensive partner network across the globe
- Strong relationship with various HAs