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Assess the causality of an undesirable effect in cosmetics

A decision-support tool that follows the cosmetovigilance method (Regulation (EC) No 1223/2009): chronology, semiology, seriousness, then a PDF report ready to file. In a few minutes.

  • Regulation (EC) No 1223/2009
  • PDF report
  • No data stored
The tool

Your assessment, step by step

References: ANSES causality assessment method (2023) · Regulation (EC) No 1223/2009

STEP 1: Product information

Enter the information on the cosmetic product concerned

Customer information (optional)

Methodology & responsibility

Methodology and limitations

This tool is provided for purely indicative and methodological purposes. It is in no way a substitute for a medical consultation, for an assessment by a qualified safety assessor, or for the official guidelines of the regulatory authorities. Final validation of causality and seriousness, as well as the decision to report to the competent authorities, rests with the professional using the tool.

Frequently asked questions

What you need to know

Does the tool replace the opinion of a safety assessor?

No. It is a decision-support tool, for indicative and methodological purposes. It is not a substitute for a medical consultation, for an assessment by a qualified assessor, or for the guidelines of the regulatory authorities. The final decision on causality, seriousness and reporting remains the responsibility of the professional.

What is cosmetovigilance?

It is the monitoring of undesirable effects linked to the use of cosmetic products, governed by Regulation (EC) No 1223/2009. Its purpose is to ensure the safety of products placed on the market and to protect consumers.

How is causality calculated?

The tool follows a structured method that cross-references chronology (time to onset), semiology (clinical picture), additional tests, re-exposure and the search for another aetiology, to arrive at a causality level.

Is my data stored?

The assessment takes place in your browser. You generate a PDF report that you keep. Costomise does not archive your assessments.

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