In full compliance with Next Generation Risk Assessment regulations,

The main principles of these ‘next generation’ risk assessments state that the methods used for safety evaluation need to be:

• relevant to assess the effect of cosmetics on human health and
• the overall goal should be the prevention of harm while using cosmetics

Five steps to develop a compliant CPSR

1. Composition: Analyze the quantitative and qualitative ingredients in the cosmetic product.

• As seasoned professionals, we prioritize confidentiality and handle sensitive information with high NDA practices and ultra-secured VPN IT files management. To determine the safety related to each ingredient, we analyze its identification, function, and quantification.

2. Stability: Assess the physical and chemical characteristics, as well as stability over time.

• Stability testing ensures that the functionality and aesthetics of the product are not adversely impacted during its intended shelf-life and consumer use. Testing can be conducted under controlled accelerated or real-time conditions. Packaging clearance is also evaluated. 

3. Microbiological Quality and Impurities: Evaluate the product’s safety.

• Microbiology testing in cosmetics development ensures product safety, quality, and compliance with industry standards. It assesses antimicrobial protection, monitors raw materials, and evaluates the impact on skin microbiota.
• As regards general problems of identification, ingredients requiring a “definition” including any impurities that they contain which are of toxicological significance (e.g., toxic sub-components, residual solvents, heavy metals, etc.) and the ingredients authorized in the annexes to the Cosmetics Directive should be specified using discriminant analytical techniques such as HPLC, GC/MS, NMR, etc.

4. Exposure and Safety Assessment: Consider exposure to the cosmetic product and its ingredients with Toxicological profiles summary.

• In this part, the amount of the substance and the frequency of human exposure to the  substance are determined (including specific groups at potential risk, e.g. children, pregnant women, etc.) based on label specifications. 
• Our toxicologist team will analyze the toxicological profile of each ingredient and determine a specific Margin of Safety (“MoS”) to fully assess the safety related to cosmetic exposure.

5. Final Safety Assessment: Evaluation of the cosmetic product’s safety and conclusions.

• This assessment is crucial because it certifies the safety of a product before it is placed on the EU market. Our ERT toxicologist redacts this CPSR Part B section, which includes labeled warnings, usage instructions, a reasoning, and a safety report conclusion. Based on all the cosmetic safety information, our ERT expert determines whether to approve the product.

Such evaluation takes into consideration different components:

• Hypothesis on the biological mechanisms of the effects of the cosmetic

• Assessments of the mode, duration and frequency of the exposure to the cosmetic substance

Benefits: All available methods and strategies are used with logic, transparency and explicit documentation

• Tiered and iterative approach,
• Appropriate appraisal of all existing information and
• Eobust and relevant methods and strategies.

Our Cosmetics Safety Assessors prepare 

• CPSR Part A: Product Safety Information 

• CPSR Part B: Product Safety Assessment

optimized to be submitted for marketing authorisations within the EU according to EC 1223/2009.

Tox by Design cosmetics safety assessments are certified by a qualified European Registered Toxicologist safety assessor.