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Pharmacosmetech show 2022
Tuesday, February 19, 2013Focus

Annex I.A.10 - Information on the cosmetic product

© CosmeticOBS-L'Observatoire des Cosmétiques

The title of Section 10 of Annex I may seem rather strange, since the first nine sections already require nothing more than information on the cosmetic product, and in the most exhaustive way. This is actually about providing… all the others!

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Annex I, in this Sections 10, requires “other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas,” be supplied.

For every cosmetic project, complementary studies may be performed, depending on every type of product and on the already available data.
Here, a sum-up of all these studies shall be presented.

They may include:
• Results of tests performed on healthy volunteers
• Results of in vitro tests
• The experience got with similar products
• Usage tests
• Preliminary studies on tolerance, prior to the tests of final tolerance
• Tests of cutaneous irritation after a lone application, or after repeated applications
• A test of eye irritation
• A photo-toxicity test
• A final clinical safety test of the finished product, in order to confirm the absence of any delayed sensitising potential
• The method to determine the SPF (for sunscreens)
• A test of blackhead genesis (comedogenicity)
• The results of the clinical studies performed to justify a claim
• Etc.

For each data, the report numbers and references of the different formulas evaluated must be clearly indicated.

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