LEGISLATION
As of July 11, 2013, cosmetic products sold in the EU must comply with the European Cosmetics Regulation No. 1223/2009. This new regulation is highly demanding.
The objectives of the European Cosmetics Regulation are formulated in the 3th Recital :
To simplify procedures and streamline terminology, thereby reducing the administrative burden and ambiguities.
To strenghten certain elements of the regulatory framework , such as in-market control, with a view of ensuring a high level of protection of human health.
The key elements for the proof of the human safety are the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF). There is a requirement for maintenance of a complete and current PIF for 10 years following the last sale of a given batch of a cosmetic product. As an integral part of the PIF, a CPSR must be assembled. The cosmetic product safety assessment is reinforced with a more demanding safety report format signed by an appropriately qualified individual (recognized expert). This is to include an evaluation of the toxicological profile of every substance found in the product, an assessment of exposure, and all available data on reported undesirable and seriously undesirable effects. The CPSR must remain current within the PIF.
The PIF has to be kept at one single address in the EU. In short, the PIF has to contain the following information and data, which shall be updated when necessary :
A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product.
A Cosmetic Product Safety Report (CPSR).
A description of the method of manufacturing and a statement on compliance with good manufacturing practice (GMP).
Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.
- Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
The Cosmetic Product Safety Report consists of 2 parts
