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Regulatory Consulting Services for EU Cosmetics
(EC) No. 1223/2009

About

We are a specialized consulting firm dedicated to helping cosmetics companies navigate the complex landscape of EU Cosmetics Regulation (EC) No. 1223/2009. With over a decade of experience in both cosmetics development and regulatory affairs, we offer tailored, precise, and effective support – from initial product development to market launch. Our expertise allows us to assist you at every critical stage, ensuring your product’s success in the EU market.

Your challenges, our solutions: Compliance with EU regulations can be challenging, but we specialize in making the process straightforward. Whether you need assistance with formula assessments, ingredient compliance, labeling, or regulatory notifications, we ensure your products meet all requirements and are ready for market entry.

Fast and Reliable Service: Companies frustrated by the slow responses and bureaucratic delays of larger consulting firms value how we deliver quick, thorough solutions. We make sure your products reach the market without setbacks.

Dedicated Expertise: As a specialized firm, we offer direct communication and personalized support. Your project will be managed by a dedicated expert who provides customized solutions and ensures that your needs are addressed promptly.

Long-Term Partnership: We aim to be more than just consultants – we seek to be your long-term partner. Our team stays ahead of regulatory developments, providing proactive and secure solutions throughout your product’s lifecycle.

Contact us today to discover the benefits of personalized regulatory consulting.

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Our Services

As a specialized consulting firm for regulatory affairs in the cosmetics industry, we offer tailored solutions designed to meet the specific needs of your products. Our mission is to guide you through the complex requirements of the EU Cosmetics Regulation and ensure that your products comply with all regulatory standards.

Our services include:
Formula Review: We assess all ingredients to ensure they meet European regulations, making sure your product is legally compliant and ready for market.
Product Information File (PIF): We compile and manage the complete Product Information File required for market access.
Safety Assessment: We conduct thorough evaluations to guarantee the safety of your products for consumers.
Label and Claims Verification: We meticulously review your labels and marketing claims to ensure they meet regulatory requirements and are accurately presented.
CPNP and SCPN Notifications: We handle the necessary notifications to enable the sale of your products in the EU and UK.
Packaging Symbols: We advise on and review the correct symbols and packaging information to ensure all regulations are adhered to.
Regulatory Updates: We keep you informed about the latest developments in cosmetics regulations, so you always stay ahead.

Explore our specific services below, or contact us directly, to learn how we can help bring your products to market in full compliance and with maximum efficiency.

Cosmetic products under development

Formula Review

Ensure your cosmetics comply with all relevant regulations through our comprehensive formula review service. We analyze raw materials, assess ingredient safety, and review test results to guarantee both consumer safety and product compliance.

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Product Information File with cosmetic products

Product Information File (PIF)

The Product Information File (PIF) is a detailed document containing all key information about a cosmetic product, including safety assessments, quality assurance, and regulatory compliance with EU standards. Acting as the product's “passport” for the EU market, the PIF is essential for distribution and ensures that the product meets all safety and quality standards. At Omnirie, our experts assist you in creating and managing your PIF to ensure complete regulatory compliance.

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Cosmetic products with correct labels

Labelling and Claim Review

Cosmetic labels for the EU market must meet strict regulations to ensure consumer safety and transparency. At Omnirie, we help you guarantee that your labels fully comply with all regulatory requirements. We ensure precise and compliant product identification, accurate product claims, responsible party information, net content, and comprehensive ingredient listings. Additionally, we check for necessary warnings, batch numbers, and language requirements. Our expertise in label design protects you from the serious consequences of non-compliance, such as product recalls, fines, or legal actions.

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CPNP and SCPN Notifications

The CPNP (EU) and SCPN (UK) notifications are mandatory steps that provide crucial information about a cosmetic product before it can be sold in the EU or the UK. These details include ingredients, labeling, and safety assessments, ensuring that only safe and compliant products are available to consumers across these markets.
At Omnirie, we handle the entire notification process for you, ensuring all necessary data is submitted accurately and on time. Our team of experts will guide you through the complex requirements, ensuring that your product meets all regulatory standards for both the EU and UK markets.

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A recycling symbol that can be found on packaging labels of cosmetic products

Packaging Symbols

Accurate disclaimers and legally required symbols are essential for cosmetics sold within the EU. They inform consumers about potential risks, proper usage, and product durability, while ensuring compliance with EU regulations. We at Omnirie assists companies in crafting clear disclaimers, selecting the appropriate symbols, and reviewing labels for compliance – all to safeguard consumer safety and reinforce trust in your brand.

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Data Protection

At Omnirie, the security of your data is our top priority. Upon request, we perform regular backups, secured with 256-bit Advanced Encryption Standard (AES) encryption. Your data remains private at all times and will only be shared with third parties with your explicit consent. For secure file transfers, we use SSL/TTS protocols, protected by 128-bit or higher AES encryption.

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Dedicated Project Manager

A dedicated project manager will be your central point of contact throughout the entire project. They will provide regular updates and ensure that all of your questions and concerns are addressed quickly and efficiently.

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Global Support

The world is constantly changing, and Omnirie is here to support you wherever you are. From our office in Sweden, we offer consulting services globally, assisting clients in every time zone.

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Fast Turnaround

At Omnirie customer satisfaction and fast turnaround times are our highest priorities. We respond promptly to your inquiries and keep you informed of your project’s progress every step of the way. This not only gives you peace of mind, but also ensures that your cosmetics are brought to the EU market as quickly as possible.