Tuesday, January 29, 2013Focus

Annex I.A.5 - Normal and reasonably foreseeable use

© CosmeticOBS-L'Observatoire des Cosmétiques

This section, which is fairly simple to formalise, is intended to describe the expected use of the product, but is an essential element to enable the exposure assessment required by Section 6 of Annex I.

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As per the text of Annex I, the normal and reasonably foreseeable use is based on a reasoning, which shall be justified, in particular in the light of warnings and other explanations in the product labelling.
This section deals with the overall presentation of the product as well as with its instructions for use or its labelling. Hence, it is recommended to think about it from the very beginning of the project, before to formulate, from the first marketing brief.

Three elements shall be considered to support the reasoning:
• The normal conditions of use
• The reasonably foreseeable use
• The potential misuses

For instance, for a shampoo:
• Normal conditions: application on the scalp and hair
• Reasonably foreseeable use: contact with eyes and body
• Misuse: ingestion

To be complete, the file shall contain:
• The description of the product presentation
• The Pass for Press of the packaging or of the texts that are on it, including the instructions for use and the potential warnings and precautions for use
• The instructions manual

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