What is a cosmetics PIF?
According to the European regulation for cosmetics (Reg. UE n° 1223/2009) the responsible person who places a cosmetic product on the European market must be able to demonstrate that the product is safe for human health under normal conditions of use or reasonably foreseeable, in order to always guarantee maximum consumer protection.
In order for the responsible person to fulfill this obligation he must draw up – or have drawn up on his behalf – the cosmetic PIF (Product Information File), that is the information documentation on the cosmetic product placed on the market. Cosmetic PIF must be kept by the responsible person for 10 years after the last batch of cosmetic placed on the European Union market and must be immediately available to the competent authorities if they request. According to the regulation, the PIF for cosmetics must not be physically present at the address indicated on the product label, but can be made available in any format, including digital.
The cosmetic safety assessment report template
The cosmetic PIF report must be drawn up in the language of the country where the product is sold or, in the case of international sales, in a language that can be understood by the Authorities of the country where it is placed on the market, generally in English.
The cosmetic PIF file may be drawn up in paper or in digital format and must be kept up to date with changes in the formulation, any regulatory changes or in case of undesirable events following the cosmetic product use, which must be registered in the dossier.
The cosmetic PIF report consists of:
- Description of the product that allows to uniquely link the documentation to the product;
- Product safety report (part A and part B);
- Description of the manufacturing method and declaration of compliance with GMPs;
- Any evidence of efficacy of the effects claimed by the product;
- Any data concerning animal testing.
The information contained in PIF dossier is confidential. Consumers and the public can only access PIF elements as regulated by art. 21 of EU Reg. 1223/2009 for health and safety protection of consumer in balance with manufacturer’s intellectual property protection.
The cosmetic product safety assessment
The most important and substantial part that makes up PIF documentation is certainly the product safety report, which is made up of two parts: Part A, relating to information on cosmetic products safety; Part B, relating to safety cosmetic products assessment.
The information required by part A concerns the qualitative and quantitative products composition, the chemical-physical characteristics and the relative stability studies.
In addition to this, microbiological safety is assessed, supporting tests, any traces and impurities, information on packaging, normal and reasonably foreseeable use.
It’s also necessary to consider the application site of product, the area extent, the product amount to apply, in addition to instructions on how and how often to use.
The toxicological profile of the contained substances is then evaluated, paying particular attention to local toxicity phenomena such as skin and eye irritation, photo-induced toxicity in the case of UV radiation absorption, and finally the undesirable effects.
Based on the available information, the cosmetic product safety assessment that makes up part B of safety report is carried out, underlining, where necessary, the indication of warnings and instructions of use on the label. It may also be added an explanation of scientific rationale behind the evaluation performed.
Cosmetic safety assessment cost: how much does it cost to draw up cosmetic PIF?
The cost of a cosmetic PIF can vary greatly depending on product formulation complexity as well as the safety assessor fees in charge of this task: costs range from a few hundred euros to a few thousand euros.
The work quality carried out is not proportional to cost for PIF drafting, it’s advisable to rely on qualified and trusted specialists.
PIF editorial staff: who deals with the cosmetic safety assessment
The Responsible Person has the responsibility for producing the cosmetic product safety assessment or for having it produced on their behalf by a suitable cosmetic safety assessor.
The requirements of the Security Assessor
The cosmetic products safety assessment is performed by persons in possession of diplomas or other documents certifying formal qualifications obtained following the theoretical and practical completion by university courses in the pharmaceutical, toxicological, medical or similar fields, or courses recognized as equivalent by a European Member State.