Tuesday, December 11, 2018Congress reports

Safety assessment, Brexit, International regulations: the FEBEA's answers

Questions/Réponses de la FEBEA

The last part of the report of the traditional Q&A session, which closes the Cosmetic Valley Perfumes and Cosmetics Congress every year. The FEBEA’s scientific, regulatory, environmental and international affairs experts answered the congress participants’ questions regarding the cosmetic product safety assessment, but also concerns raised by Brexit and international issues such as the Nagoya Protocol or export blockages.

Reading time
~ 13 minutes

They answered questions from delegates on November 15, 2018:
• Anne Dux, Director of Scientific and Regulatory Affairs, European Relations Officer
• Virginie d’Enfert, Director of Economic, Environmental and International Affairs
• Françoise Audebert, Scientific and Regulatory Advisor
• Raffaella Berioli, Scientific and Regulatory Advisor
• Catherine Bramaud, Scientific and Regulatory Advisor

Safety assessment

It has been requested by the ANSM that toxicological experts extrapolate tolerance tests to the target population if the test has not been done on the right population. However, some experts consider that it is not up to them to do so. What then to do?

Françoise Audebert’s answer
It depends on the target population in question and the tests performed. Ideally, if you really have a very special target population (we can take the example of babies), it is better to ask the safety assessor what type of test he needs and on what type of population to validate the target.
There are many products for target populations, for example a face cream for a baby, for which extrapolation does not seem very complicated if the test was done on sensitive skin.

What is the profile required for security assessors in France? Are …

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