COSMETIC PRODUCT INFORMATION FILE (PIF)

The cosmetic Product Information File (PIF) is a collection of documentation and information relating to a cosmetic product, including information on its safety and regulatory compliance.
Cosmetic products in the European Union (EU) are regulated under Regulation (EC) No 1223/2009, which replaced Directive 76/768/EEC and has applied since 11 July 2013.
The Regulation establishes a comprehensive regulatory framework for cosmetic products, including requirements relating to product safety, the Product Information File (PIF), cosmetic product notification through the CPNP, market surveillance and the responsibilities of the Responsible Person.
Before a cosmetic product is placed on the EU market, the Responsible Person must ensure that a Product Information File (PIF) is available for the product, maintained and compliant with applicable regulatory requirements. The Cosmetic Product Safety Report (CPSR) must be prepared by an appropriately qualified Safety Assessor, who evaluates the safety of the cosmetic product on the basis of the available product information and supporting documentation.

The PIF contains the following information and documentation:

01
Description of the cosmetic product enabling the PIF to be clearly linked to the product (name, identification code, labelling of the primary and secondary packaging, and product photographs)
02
Cosmetic Product Safety Report (CPSR)

Part A: Cosmetic Product Safety Information

  • Qualitative and quantitative composition of the cosmetic product
  • Physical/chemical characteristics and stability of the cosmetic product
  • Microbiological quality
  • Impurities, traces and information on the packaging material
  • Normal and reasonably foreseeable use
  • Data on exposure to the cosmetic product
  • Data on exposure to the substances contained in the cosmetic product
  • Toxicological profile of the substances
  • Undesirable and serious undesirable effects
  • Other information on the cosmetic product

Part B: Cosmetic Product Safety Assessment

  • Assessment conclusion
  • Instructions for use and labelled warnings
  • Reasoning
  • Safety Assessor's credentials and approval
03
A description of the method of manufacturing and a statement of compliance with Good Manufacturing Practice (GMP)
04
Evidence supporting the claimed effects of the cosmetic product
05
Data on any animal testing carried out by the manufacturer, its agents or suppliers in relation to the development or safety assessment of the cosmetic product or its ingredients, including animal testing performed to meet the legislative or regulatory requirements of countries outside the EU

Preparation of Product Information Files (PIF) for Cosmetic Products

Before a cosmetic product is placed on the EU market, the Responsible Person must ensure that the required documentation, including the PIF and CPSR, is in place and that the product has been notified through the Cosmetic Products Notification Portal (CPNP). CPNP notification is a notification requirement and does not constitute approval or authorisation of the cosmetic product.
We provide regulatory support for cosmetic products intended for the EU market and, where applicable, other international markets subject to their respective regulatory requirements.
We provide PIF preparation services for a wide range of cosmetic product categories, including but not limited to:
Skincare products: creams, emulsions, lotions, gels, oils, face masks, anti-wrinkle products, skin-lightening products.
Make-up and decorative cosmetics: tinted bases (liquids, pastes, powders), make-up powders, lip products, nail care and nail make-up.
Bath and body care: toilet soaps, deodorant soaps, bath and shower products (salts, foams, oils, gels), deodorants and antiperspirants, external intimate hygiene products.
Hair care and styling products: shampoos, conditioners, hair colorants, hair-setting products, products for waving, straightening and fixing hair.
Fragrances: perfumes, toilet waters, eau de cologne.
Oral care: toothpaste and other products for teeth and mouth care.
Shaving products: shaving creams, foams, lotions.
Tanning and sun protection: sun protection products and self-tanning products.
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Other services for cosmetic products