Product information file (Dossier)
The person responsible for placing an imported cosmetic product on the EU market must for control purposes keep specific detailed information readily accessible to the competent authorities of the Member State concerned at the address specified on the label (Article 7a of the EU Cosmetics Directive).
Data required in the product information file (PIF) include:
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the assessment of the safety for human health of the finished product; as well as the name and address of the qualified person responsible for the assessment
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the qualitative and quantitative composition of the product
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the physico-chemical and microbiological specifications
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the method of manufacture complying with the good manufacturing practice (GMP)
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existing data on undesirable effects on human health
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proof of the effect claimed for the cosmetic product
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data on any animal testing
The product information file is neither automatically inspected nor approved. It must be available to national inspection authorities at the address printed on the product's label; inspectors have to be able to track a product on sale in shops to the company or individual responsible for placing it on the market.
BIORIUS services include compilation of the PIF; secure storage and availability in case of inspection by the national competent authority.