Cosmetics Regulation (EC) No. 1223/2009 is the main regulatory framework for finished products placed on the EU market (see overview from July). The regulation indicates that for the purpose of effective market surveillance, a Product Information File (PIF) should be made readily accessible, the requirements for which are specified in Article 11.
According to the regulation, the PIF shall contain information and data organized into five sections (per Article 11.2), as shown in Table 1.
In short, the PIF should include:
- A description of the cosmetic product
- The cosmetic product safety report, consisting of:
Part A: Cosmetic Product Safety Information and
Part B: Cosmetic Product Safety Assessment.
- A description of the method of manufacturing and statement of GMP compliance,
- Proof of the effect claimed for the cosmetic product and
- Data on animal testing.
One key section is the Cosmetic Product Safety Report (11.2.a). Its two parts, the cosmetic product safety information and cosmetic product safety assessment, are critical in planning to market a cosmetic product in the EU. They will be the focus of the next column.
Requirements for the PIF
The Responsible Person (see overview from August) is charged with keeping a PIF for each cosmetic product placed on the EU market and must ensure that the PIF is complete and updated as necessary. The PIF should be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market (Art. 11.1). The RP should also ensure that the PIF is readily available to the competent authority (Art. 11.3).
Now that you know about PIFs, stay tuned for the next column on the required cosmetic product safety assessment and report.
European Commission web site
COLIPA guidelines on the Product Information File requirement – Dec. 2011