Cosmetics Product Information File (PIF) is compiled documentation with information about the cosmetic product.
The requirements for cosmetic products are set by the Regulation (EC) N° 1223/2009 on cosmetic products which replaced the Cosmetic Directive 76/768/EC. The Regulation (EC) N° 1223/2009 on cosmetic products is implemented in full from July 2013.
According to the Regulation (EC) N° 1223/2009 on cosmetic products, prior placing a cosmetic product on the market of the European Union it is necessary to prepare supporting documentation for cosmetic product - Product Information File (PIF). PIF consists of the following sections:
- 1. A detailed description of the cosmetic product (the necessary information for connecting cosmetic products with documentation)
- 2. Cosmetic Product Safety Report
Part A: Cosmetic Product Safety Information:
- Qualitative and quantitative composition of 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
- Data on the exposure to the cosmetic product
- Data on exposure to the substances
- Toxicological profile of the substances
- Undesirable effects and serious undesirable effects
Part B: Cosmetic Product Safety Assessment:
- Assessment conclusion
- Instructions for use and labelled warnings
- Safety Assessor’s credentials and approval
- 3. A detailed description of the production process
- 4. Evidence (a signed statement) on compliance with good manufacturing practices - GMP
- 5. A proof of the effects claimed for the cosmetic product
- 6. A statement on testing cosmetic products on animals (or data on animal testing, if conducted, for the purpose of placing on the market outside the European Union)
- 7. Product labelling, which includes primary and secondary packaging
EU market includes the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom and EFTA countries: Norway, Switzerland, Iceland, Lichtenstein.
We can prepare the PIF for any category of cosmetic products.
Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, bath and shower preparations (salts, foams, oils, gels), toilet waters and eau de cologne, depilatories, deodorants and anti-perspirants, hair colorants, hair-setting products, products for waving, straightening and fixing hair, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products, anti-wrinkle products.
All about the prices you can found on this