Product Information Files (PIF) EU 1223/2009

Product Information Files

All cosmetic products sold in the EU and the UK must conform to the Cosmetics Regulations ((EU) 1223/2009). As part of these regulations manufacturers or own brand labellers (private labellers) are required to produce a Product Information File (PIF) for each cosmetic product they place onto the market.

What is a Product Information File?

The PIF is a dossier that contains all the information relating to the cosmetic product such as its listed ingredients, material safety data sheets, manufacturing process, testing data, labelling information and packaging information. The PIF also contains a safety assessment and information relating to any claims made about the product.

The Responsible Person must keep a PIF for each cosmetic product placed on the EU/UK market, at the address specified on the product label, readily accessible for the competent authority of the EU member state (or UK) where the Responsible Person is established.

The PIF must be available in a language easily understood by the local competent authority of the country where the Responsible Person is keeping the cosmetics Product Information File.

The Product Information File content is described in article 11 of EU Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The content of the cosmetics Product Information File is standardized and does not change, irrespective of the type of cosmetic product in question.

According to article 11, the Product Information File must contain the following information and data.

  • A description of the cosmetic product
  • Cosmetic Product Safety Report (CPSR), the contents of which are described in annex I, consisting of the following.
    • Part A: Cosmetic product safety information
      • Quantitative and qualitative composition of the cosmetic product
      • Physical/chemical characteristics and stability of the cosmetic product
      • Microbiological quality
      • Impurities, traces, information about the packaging material
      • Normal and reasonably foreseeable use
      • Exposure to the cosmetic product
      • Exposure to the substances
      • Toxicological profile of the substances
      • Undesirable effects and serious undesirable effects
      • Information on the cosmetic product
    • Part B: Cosmetic product safety assessment
      • Assessment conclusion
      • Labelled warnings and instructions for use
      • Reasoning
      • Assessor’s credentials and approval
      • A description of the method of manufacturing and either a Good Manufacturing Practice (GMP) certificate or a statement on compliance with Good Manufacturing Practice (the GMP standard which must be followed in the EU is standard ISO 22716)
      • Where justified, a proof of the effect claimed for the cosmetic product
      • Any data on animal testing
      • The Product Information File should also contain product labelling

The most important and most extensive part of the cosmetics Product Information File is the Cosmetic Product Safety Report (CPSR), which contains all the information, specifications and tests relating to the raw materials, finished product, packaging, etc. Based on these, the safety and the compliance of the cosmetic product with the EU/UK cosmetics regulation can be proven.

A complete cosmetics Product Information File (PIF) is the basis for the notification to the EU CPNP (Cosmetic Product Notification Portal) or the UK CPNS (Cosmetic Product Notification System), which must be performed before the cosmetic products can be placed on the EU/UK market.

Here at Patient Guard our experts can assist you in producing a fully compliant PIF for each of your cosmetic products. Enquire today at Cosmetics@patientguard.com for a free consultation.