Cosmetics

In the cosmetic industry, ensuring Regulatory compliance for products is vital. A key step is meticulously compiling documentation required by Health Authorities (HAs), often in the form of a product dossier or a Product Information File (PIF). This comprehensive dossier and robust documentation requirements may cover product formulation, raw materials, ingredient data, labeling, testing results, and safety assessments.

Cosmetic product classification, compliance, and registration rules vary in countries. Some mandate registration or notification, while others focus on compliance without formal registration. Terminology differs; some use simple notification or approval.

A thorough product dossier includes administrative, manufacturing, quality, control, and testing data. Freyr aids in understanding and compiling the technical documents needed for product registration in compliance with the HA regulations.

We streamline the process and offer assistance in gap analysis, document review, and compilation for successful Regulatory submissions.

For personal care products’ registration and notification, numerous countries require local support to facilitate effective communication regarding product status and safety for consumers. Addressing this need, companies seek a Legal Representative (LR) or Responsible Person (RP) to oversee continuous product compliance, handle queries, and manage post-market obligations. The representative acts as a vital intermediary between the manufacturer or brand owner and the Health Agencies (Has).

Freyr, with regional offices worldwide and an extensive partner network in 120+ countries, provides LR services for cosmetic products. Operating in Europe, North America, the Middle East, India, Asia Pacific (APAC), and beyond, we ensure seamless communication between customers and Has. Our services guarantee compliance with country-specific regulations, oversee product registration, and maintain product data validity throughout the specified period.

1. Safety Assessment

Many countries require cosmetic products to undergo a rigorous safety assessment, including formula evaluation, exposure calculation, toxicological analysis of ingredients, and decision-making regarding safety compliance. Post-market monitoring ensures ongoing compliance and product safety. The process aims to safeguard public health by ensuring that personal care products and their ingredients meet safety standards before being introduced into the market and during the lifetime of the product.

Freyr supports the preparation of a Cosmetic Product Safety Report (CPSR) according to the guidelines of the respective HA, ensuring compliance. Upon completion, the reports are stored on behalf of the customer, with ongoing monitoring of legislative changes and, when required, Freyr follow-ups with the HA to address any inquiries or requests for additional information, facilitating a smooth market entry process.

1. Product Testing

Testing represents an important part of a cosmetic product manufacturing process. Cosmetic products must undergo specific testing in order to be compliant, and more importantly, to prove they are safe and effective under reasonably foreseeable use conditions. A notable challenge is achieving consumer safety without animal testing, aligning with international Regulatory standards.

To uphold strict Regulatory standards and protect consumers, Freyr supports a range of cosmetic testing services, covering microbiological purity, challenge tests, stability, dermatological testing, efficacy, applicational testing, claims support, and sun protection testing. Our expert team assists manufacturers in navigating testing requirements and assisting with testing services with our partner laboratory network in Europe.

For a seamless entry into global markets, manufacturers need to comply with cosmetic label and claims requirements. Labels of personal care products are essential factors for the sales and marketing of cosmetics and should be carefully weighed to balance business objectives and Regulatory compliance.

With an expert Regulatory team, Freyr provides cosmetic label and claims review, label compliance, harmonization for multiple markets, translations, and substantiation support to achieve compliance and optimize market presence. Our comprehensive approach guarantees obtaining Regulatory excellence, distinguishing therapeutic claims from cosmetic claims, verifying claims support, ensuring global compliance, and boosting market success.