1) What is the PIF for?
The PIF, or Product Information File, is a document listing all the essential elements for determining the safety of cosmetic products. It is mandatory for all cosmetic products in Europe under Regulation 1223/2009. The PIF must be kept by the Responsible Person for a period of 10 years from the date of marketing of the last batch of product.
2) What is the PIF composed of?
The PIF shall consist of all relevant information relating to the cosmetic, including the identity, quality and safety of the product. An essential part of the file is the Cosmetic Product Safety Report. This is divided into two parts:
- Part A: more regulatory, it is intended to contain all the information on the safety of the product. It contains in particular: the quantitative and qualitative composition of the product, its physical/chemical characteristics and stability data, its microbiological quality, impurities, traces, and information concerning the packaging material, normal and reasonably foreseeable use, exposure to the product, exposure to substances, toxicological profile of substances, adverse effects (AEs) and serious adverse effects (SAEs) and information on the cosmetic product.
- Part B: consists of a detailed safety assessment of the cosmetic product. It leads to an essential conclusion on the safety of the cosmetic. The safety assessor takes into account all the information in Part A, verifies its completeness and relevance, and thus assesses the risk and safety of the product. Part B shall contain the conclusion of the safety assessment, the warnings and instructions for use on the label, the scientific reasoning, the reference of the person carrying out the assessment and the approval of Part B.
3) Part B: Why should you be careful in choosing your safety assessor?
Selecting the right safety assessor to draw the conclusion from the assessment is an essential step. Indeed, only training in pharmacy, toxicology, medicine or a similar discipline recognised in Europe enables an individual to carry out the safety assessment.
More than a response to regulatory requirements, it is aimed at consumer safety. This is why choosing the right appraiser is essential. It is this person who will choose which tests are necessary or not and who will ultimately decide on the safety of the product. In the event of an error, the consequences can be extremely serious for consumers, and therefore for companies.
4) Can the PIF be carried out internally?
It is entirely possible to produce your product information package in-house. However, a safety assessor must be available. Without this, it is impossible to finalise the PIF. Many companies choose to subcontract the completion of their PIF to save time and money. The life cycle management of a cosmetic product can also be done through software, such as COSMETIC Factory.
5) What is at risk if the PIF is not compliant?
In case of non-compliance with the European Cosmetic Regulation, it is the Member States that are responsible for applying or not applying sanctions. In France, for example, the ANSM and the DGCCRF are in charge of controls. In case of non-compliance with the regulation, penal sanctions are provided for, which can go, depending on the non-compliance, up to 2 years imprisonment and a fine of �30,000.
Wish to know more about cosmetic Product Information File?
For more information, do not hesitate to contact Sylvain de Backer or one of our experts by phone: +1 (778) 234 1607 for North America or to contact them via our our contact form, typing in the relevant purpose for your inquiry.
1) What is the PIF for?
The PIF, or Product Information File, is a document listing all the essential elements for determining the safety of cosmetic products. It is mandatory for all cosmetic products in Europe under Regulation 1223/2009. The PIF must be kept by the Responsible Person for a period of 10 years from the date of marketing of the last batch of product.
2) What is the PIF composed of?
The PIF shall consist of all relevant information relating to the cosmetic, including the identity, quality and safety of the product. An essential part of the file is the Cosmetic Product Safety Report. This is divided into two parts:
- Part A: more regulatory, it is intended to contain all the information on the safety of the product. It contains in particular: the quantitative and qualitative composition of the product, its physical/chemical characteristics and stability data, its microbiological quality, impurities, traces, and information concerning the packaging material, normal and reasonably foreseeable use, exposure to the product, exposure to substances, toxicological profile of substances, adverse effects (AEs) and serious adverse effects (SAEs) and information on the cosmetic product.
- Part B: consists of a detailed safety assessment of the cosmetic product. It leads to an essential conclusion on the safety of the cosmetic. The safety assessor takes into account all the information in Part A, verifies its completeness and relevance, and thus assesses the risk and safety of the product. Part B shall contain the conclusion of the safety assessment, the warnings and instructions for use on the label, the scientific reasoning, the reference of the person carrying out the assessment and the approval of Part B.
3) Part B: Why should you be careful in choosing your safety assessor?
Selecting the right safety assessor to draw the conclusion from the assessment is an essential step. Indeed, only training in pharmacy, toxicology, medicine or a similar discipline recognised in Europe enables an individual to carry out the safety assessment.
More than a response to regulatory requirements, it is aimed at consumer safety. This is why choosing the right appraiser is essential. It is this person who will choose which tests are necessary or not and who will ultimately decide on the safety of the product. In the event of an error, the consequences can be extremely serious for consumers, and therefore for companies.
4) Can the PIF be carried out internally?
It is entirely possible to produce your product information package in-house. However, a safety assessor must be available. Without this, it is impossible to finalise the PIF. Many companies choose to subcontract the completion of their PIF to save time and money. The life cycle management of a cosmetic product can also be done through software, such as COSMETIC Factory.
5) What is at risk if the PIF is not compliant?
In case of non-compliance with the European Cosmetic Regulation, it is the Member States that are responsible for applying or not applying sanctions. In France, for example, the ANSM and the DGCCRF are in charge of controls. In case of non-compliance with the regulation, penal sanctions are provided for, which can go, depending on the non-compliance, up to 2 years imprisonment and a fine of �30,000.
Wish to know more about cosmetic Product Information File?
For more information, do not hesitate to contact Sylvain de Backer or one of our experts by phone: +1 (778) 234 1607 for North America or to contact them via our our contact form, typing in the relevant purpose for your inquiry.
