EU Regulation 1223/2009 replaces Directive 76/768/EC as the governing regulation for cosmetic products in the EU. It requires companies to maintain a Product Information File for each cosmetic product containing information such as a product description, safety report, manufacturing details, proof of claims, and animal testing data. The responsible person must keep the file for 10 years and make it available in electronic or other format to competent authorities in the Member State where the file is kept. The regulation took effect in July 2013.

1. EU REGULATION 1223/2009
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2. LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
directive 76/768/EC)
• Applicable: July 2013 onwards
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3. PRODUCT INFORMATION FILE
• “When a cosmetic product is placed on the
market, the responsible person shall keep a
product information file for it. The product
information file shall be kept for a period of
ten years following the date on which the last
batch of the cosmetic product was placed on
the market.” (Regulation 1223/2009, Article 11.1)
• PIF has to be kept by the responsible person
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4. PRODUCT INFORMATION FILE
• Responsible person has to make PIF:
 Readily accessible in electronic or other format to
the competent authorities of the Member State in
which PIF is kept
 At his address indicated on the product label*
 Available in a language which can be easily
understood by the competent authorities of the
Member State where the responsible person is
established
• *PIF should be made readily accessible at one
single address within the EU  one
responsible person per product
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5. PRODUCT INFORMATION FILE
• PIF has to be fully compliant with the
provisions set out in the regulation before
the notification can be performed
• Find out more on our website
(www.ceway.eu)
• PIF must always be kept updated and
compliant with the regulation!
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6. PRODUCT INFORMATION FILE CONTENT
• PIF has to contain the following information
and data
 A description of the cosmetic product
 Cosmetic product safety report
 A description of the method of manufacturing
and a statement on GMP compliance
 Proof of the effect claimed for the product
 Any data on animal testing
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7. PRODUCT INFORMATION FILE CONTENT
• Cosmetic product safety report:
 Part A: Safety information
 Part B: Safety assessment
• Safety assessor performing the safety assessment
has to be qualified
 University degree in pharmacy, toxicology, medicine
or a similar discipline, or a course recognized as
equivalent by a Member State
• Also cosmetic products notified under the
directive 76/768/EEC have to undergo a safety
assessment according to 1223/2009
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8. www.ceway.eu
info@ceway.eu
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