Regulation (EC) N° 1223/2009
Product Information File
Notification
While 4-8 months is the typical period, the registration process’ schedule is highly dependent on the Manufacturer.
The PIF is a compilation of technical documents that must accompany each cosmetic product before it may be sold in Europe. The responsible person must keep the file for at least 10 years after the last batch of a specified product was put on the market inside the European Union. It must be always available to European Competent Authorities.
Appointing a Responsible Person early in the process, completing all the necessary testing and having PIF ready will speed up the process.
Safest Assessment: The safety assessment of a cosmetic product largely relies on its method of application. The application route affects the potential ingestion, inhalation, or absorption of the product’s ingredients through the skin and mucous membranes. Additionally, the quantity of each ingredient within the product also plays a significant role in the safety evaluation.
Risk Assessment: Prior to commencing a safety assessment and risk evaluation of a cosmetic product, a comprehensive description of the extent and method of application is essential. This process cannot be generalized but must be conducted on a case-by-case basis, considering the specific composition and intended use of each product. It is crucial to include an assessment of whether the application of a cosmetic product is safe for vulnerable populations, such as children, as a fundamental aspect of the risk evaluation.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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