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Tuesday, December 26, 2017Regulation

Information required in the PIF: Animal testing data

©CosmeticOBS-L'Observatoire des Cosmétiques

Article 11 of the Cosmetic Regulations precisely defines the information that must be held in the DIP. Among them: data relating to animal testing.

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Under Article 11.2.e, the PIF must contain “data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.”

The official text basically remains essentially similar to the former Cosmetics Directive. Thus, the 7th Amendment of the Directive remains the basis for fulfilling this requirement.

The scope of this element of the 7th Amendment should be interpreted taking into account the information that cosmetic companies can be aware of or can reasonably be expected to obtain.
• “Data on animal testing” should be interpreted as a list of tests carried out, including information on the type of test
• “Manufacturer” refers to the manufacturer of the cosmetic product
• “Agent” refers to a person acting on behalf of the cosmetic manufacturer (e.g. third party manufacturer, contracted testing house)
• “Supplier” refers only to the legal entity that supplies the cosmetic ingredient to the cosmetic manufacturer. This will not necessarily be the manufacturer of the ingredient.

The provision applies to any animal tests performed by any of the above on cosmetic …

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