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Dec 30, 2025 - Cosmetics

Documents for the preparation of safety reports – what are the most common issues?

For the creation of a safety report in accordance with Annex I of Regulation (EC) No 1223/2009, the following documents are essentially required:

• Composition of the product
• Information on the raw materials used
• Microbiological and chemical-physical properties
• Stability data of the product
• Possible impurities, including those from the packaging material
• Foreseeable use and exposure
• Undesirable side effects that must be included in the safety report

A safety report can only be created if data for all points are completely available. In practice, it is shown that delays can especially occur for the following points:

• Missing documentation on the packaging material concerning its use for cosmetics
• Insufficient documentation on allergenic fragrances
• Missing toxicological data on "exotic" ingredients
• Use of plant-based products from wild collection: missing data on ingredients and possible contaminants 
• Generally insufficient documentation/specification of raw materials

We will inform you as soon as possible in the context of creating a safety report if data is missing. This allows you to submit them subsequently or determine them through analytical measurements.

Source:

https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32009R1223