Cosmetic Regulatory
Our Cosmetic Regulatory and Cosmetovigilance Services are designed to provide comprehensive support to cosmetic manufacturers, importers, and distributors in navigating the complex landscape of cosmetic regulations and ensuring the safety of their products for consumers. We offer a range of specialized solutions tailored to meet the diverse needs of the cosmetics industry.
Notification CPNP
Product Information File (PIF)
Cosmetovigilance
Verification of the conformity of ingredients
Surveillance Regulatory Monitoring
Safety and Efficacy Testing Management
Regulatory Verification of Formulas
From the moment a formula is validated, it is essential to verify its compliance with European cosmetic regulations, while also considering the criteria defined in the product specifications.
Depending on the type of product, its intended use, and the target population (pregnant women, children, babies, etc.), certain restrictions may apply.
Our role is to take these into account from the very beginning to ensure a smooth development process and avoid any unpleasant surprises later on.
Verification and Management of Regulatory Data for Raw Materials
There are numerous suppliers of raw materials for cosmetic products, and choosing the right ones is a key responsibility of the Responsible Person.
That’s why we can provide you with a list of reliable and transparent suppliers.
We verify the regulatory documentation of raw materials, and—if you prefer—we can directly contact the suppliers on your behalf to collect the necessary documents and follow up on any missing information.
Verification and Management of Regulatory Data
We list, collect, and verify all regulatory data related to the cosmetic product (including information on packaging, labeling, and more).
All regulatory data associated with the finished product are used both for the toxicological assessment and for the final preparation of the Product Information File (PIF).
Management of Safety and Efficacy Testing
Product safety and proof of efficacy are also key pillars of regulatory compliance.
We support you in selecting and conducting the necessary tests, including both safety tests (skin and eye tolerance, microbiological analysis, SPF testing, stability and compatibility studies, etc.) and efficacy tests to substantiate your product claims (moisturizing, anti-aging, mattifying, and more).
We collaborate with various specialized laboratories to meet your specific needs and challenges. Our team provides expert guidance on which tests to perform and handles all aspects of test planning and communication with the laboratories.
CPNP Notification
In accordance with Article 13 of the Cosmetic Regulation (EC) No. 1223/2009, cosmetic products must be notified on the European CPNP (Cosmetic Products Notification Portal) before being placed on the market.
This notification involves submitting certain product-related information to the European Commission — such as the product category, the name and address of the Responsible Person, and the country of origin in the case of imported products.
These data are used by the authorities for market surveillance purposes and are also made available to poison control centers, when necessary.
Preparation of Your Product Information Files (PIF)
In accordance with Article 13 of the Cosmetic Regulation (EC) No. 1223/2009, when a cosmetic product is placed on the market, the Responsible Person must keep a Product Information File (PIF) for it.
We prepare the complete PIF for each of your products, ensuring full compliance with European regulatory requirements.
The PIF includes:
Description of the Cosmetic Product
Safety Report:
Part A: Information on the safety of the cosmetic product
Part B: Safety assessment of the cosmetic product — prepared in collaboration with a qualified toxicologist
Description of the Manufacturing Methods and Declaration of Compliance with Good Manufacturing Practices (GMP)
Evidence Supporting the Claimed Effects
Data on Animal Testing
Cosmetovigilance
Placing a compliant and safe cosmetic product on the market is not the only responsibility of the Responsible Person.
They must also ensure ongoing monitoring of their cosmetic products once they are commercialized.
For this purpose, it is essential to have a system for monitoring and recording undesirable effects, known as Cosmetovigilance.
Discover our "Private labeling" service
After product development, we accompany you through the production process.
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