Division 1 INTRODUCTION

Article 11 of Regulation (EC) No 1223/2009 requires that a product information file is drawn up for each product before it is placed on the market. The product information file should be updated when necessary and kept readily accessible, in electronic or other format, at the address of the responsible person given on the label, to the competent authorities for market surveillance purposes for a period of 10 years following the placing on the market of the last batch of the product.

The most important element of the product information file, from a safety point of view, is the cosmetic product safety report referred to in Article 10(1). The other elements are a clear description of the cosmetic product, a description of the method of manufacturing and a statement on compliance with good manufacturing practice, the proof of the effects claimed, and data on animal testing^f1.

Where the responsible person drawing up the cosmetic product safety report is not the manufacturer of the product, they should ensure they have access to all the technical and scientific skills necessary to obtain reliable cosmetic product safety information and an appropriate safety assessment to demonstrate that the product they are responsible for is safe, in accordance with Article 3 of Regulation (EC) No 1223/2009. They may therefore need to involve not only the safety assessor, but also the manufacturer, the suppliers of raw materials, and other technical experts.

In any case, the responsible person is to ensure that the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment; an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market^f2.

The cosmetic product safety assessment, as set out in Part B of Annex I to Regulation (EC) No 1223/2009, is to be carried out by a qualified safety assessor. The responsible person and the safety assessor should work closely together to ensure that the safety of the product is properly assessed and documented and that the assessment is kept up to date. The responsible person and the safety assessor should gather all the necessary information as required by Part A of Annex I to Regulation (EC) No 1223/2009.

The cosmetic product safety report should be drawn up in a transparent way and should be well-argued and easily understood.

The Cosmetic Product Safety Report is an expert piece of work made up of different modules and where the information required under Part A may be stored in different databases. The report, which should contain, as a minimum, all the information indicated in Annex I to Regulation (EC) No 1223/2009, should appear under the same or similar headings for ease of reference of the competent authorities. However, it may be sufficient to provide under each heading a clear reference to a document containing the information and readily available in electronic or printed format.