Safety Assessment
for Cosmetics
Acc. to EU Regulations

Regulation (EC) No. 1223/2009 governs the safety of cosmetic products in the EU. The aim of this regulation is to ensure that cosmetic products do not pose a risk to human health when used under normal or reasonably foreseeable conditions. A key tool in achieving this goal is the comprehensive safety report. This report must be prepared for every cosmetic product before it is placed on the market and is part of the product information file that must be maintained for each cosmetic product. The safety assessment is seen as a crucial part of the product documentation. Packaging and the contact with cosmetic products are also taken into consideration.

The safety assessment for cosmetics includes the analysis of all ingredients, physical and chemical properties, and potential risks. This is essential to ensure that the products pose no health risks to consumers.

The safety assessment for cosmetics is a key part of product safety

The safety assessment for cosmetics is a critical process to ensure that cosmetic products are safe for consumers. According to Regulation (EC) No. 1223/2009, all cosmetic products must undergo a thorough safety assessment before being placed on the market. This report describes how the safety assessment for cosmetic products is conducted and what factors must be considered.

Content of a safety report for cosmetics

The safety report under Regulation (EC) No. 1223/2009 is divided into two main parts:

Part A: Cosmetic Product Safety Information

This part gathers all relevant data about the product necessary for the safety assessment, including:

• Product composition: A detailed list of all ingredients and their concentrations in the final product.
• Physical-chemical properties: Information about the physical and chemical properties of the product, including its stability under different conditions.
• Microbiological quality: Information about the microbiological purity and stability of the product. Special requirements apply for sensitive application areas such as eyes, mucous membranes, or baby products.
• Impurities and trace materials: Evaluation of possible contaminants in the ingredients, as well as information about the packaging material that comes into contact with the product.
• Toxicological profiles: Assessment of the safety of individual ingredients based on available toxicological data.
• Exposure: Calculation of how much of the ingredients can be absorbed by the body, depending on the type and frequency of use.
• Side effects: Documentation of known side effects and potential risks for consumers.

Part B: Cosmetic Product Safety Assessment

This section summarizes the actual safety assessment and includes:

• Safety conclusion: A clear determination of whether the product is considered safe based on the information gathered in Part A.
• Warnings and instructions: Any warnings that must be included on the product packaging to ensure safe use of the product.
• Justification: A detailed explanation of the safety conclusions, often requiring scientific analysis and evaluation of the collected data.
• Information about the evaluator: Details about the qualified person who conducted the safety assessment, including their qualifications and expertise.

A precise safety assessment of these factors ensures that the cosmetic product poses no threat to consumers. Residues that cosmetic products may come into contact with are also considered in the evaluation.

Why are safety reports important?

Safety reports are essential for several reasons:

• Consumer protection: They ensure that cosmetic products available on the market are safe and pose no health risks.
• Legal compliance: Manufacturers and importers must ensure their products comply with regulations to avoid legal consequences and product liability cases.
• Consumer confidence: A comprehensive and well-documented safety report strengthens consumer trust in the safety and quality of products.
• Scientific basis: The safety assessment is based on scientific data and methods, enabling an objective and transparent risk assessment.

Safety reports in accordance with Regulation (EC) No. 1223/2009 are a key element of product safety in the cosmetics industry. They ensure that cosmetic products are safe for consumers and comply with legal requirements. In addition, the suitability of the packaging material is also assessed. If there are changes in the formulation or packaging during marketing, these must be re-evaluated by the safety assessor, requiring an update of the safety report. These changes must also be documented in the product information file to meet the legal requirements of the cosmetics regulation.

Through the systematic collection and evaluation of all relevant information, these reports ensure that potential risks are identified and minimized before a product is launched. Notifying products in the appropriate regulatory databases is also essential. Manufacturers who meet these requirements not only contribute to consumer health protection but also enhance their reputation and trust in the market.

The experts at the BAV Institute support and advise you in all aspects of placing cosmetic products on the market in Germany or other EU Member State as well as in Great Britain and Switzerland. We make your product fit for the EU Cosmetics Regulation (EC) No. 1223/2009.