Division 3 PART A — COSMETIC PRODUCT SAFETY INFORMATION

Part A of the cosmetic product safety report is intended to gather the data necessary to prove that the cosmetic product is safe. The information should enable the safety assessor to clearly identify and quantify, based on the identified hazards, the risks a cosmetic product may present to human health. A hazard may arise, for example, from the raw materials, the manufacturing process, the packaging, the conditions of use of the product, the microbiological specifications, the quantities used, the toxicological profile of the substances, etc.

As Part A of Annex I to Regulation (EC) No 1223/2009 requires that the data listed under its headings are provided as a minimum, any discrepancy with regards to the requirements of Part A should be justified.

Part A of Annex I to Regulation (EC) No 1223/2009 lists the data that is to be available, ‘as a minimum’, for the safety assessor to be able to carry out the safety assessment.

In addition to the minimum data listed in Part A of Annex I to Regulation (EC) No 1223/2009, the safety assessor can use any additional data, where relevant. On the other hand, they, or the responsible person, may consider that, depending on the type of product, some of the required data are not relevant or necessary to assess the safety of the product (e.g. preservation challenge test). In this case, the absence of specific data is to be clearly justified in Part A and the justification is to be repeated and validated by the safety assessor in their reasoning in Part B. The responsible person should check the presence of the required data or the justification for their absence.

The data required by Part A can be drawn from any reliable source. Examples include: data from suppliers, scientific literature, experience gained with similar or other product categories, results of studies on the product itself or on the substances it contains, available data on similar formulations, or computer models. The safety report should highlight the relevance of the data in relation to the product.

The guidance published by the EU scientific committees concerned with risk assessment^f1, as well as the recommendations of national competent authorities or professional organisations, may provide further helpful support.