Since the application of the new European Cosmetics Regulation 1223/2009 article 11 on cosmetic products sold in the European Union, industry professionals have to provide a Product Information File (PIF) for each of the product placed on the market and destined for consumption.
The person responsible placing the cosmetic product on the market have to submit to competent authorities (ANSM, the Directorate General of Health or the DGCCRF) the PIF, as well as the Risk assessment of the product and keep those documents updated for at least 10 years.
What should the PIF include?
The PIF should include all the elements considered to be of primary importance to the consumer and its health: namely the identity of the product, the precaution of use, the list of ingredients and the possible negative effects.
In order to compile the PIF, product information has to be gathered from several stakeholder: suppliers, laboratories, safety assessor, and internal product information system.
Below the list of documents that composed the PIF:
- Product information: the exact name and all names in national language where the product will be placed, identification code and a description of product function.
- Cosmetic product safety report (CPSR): is the scientific review of cosmetic product safety and is divided in two parts:
- Part A – Cosmetic Product Safety Information
- Quantitive and qualitive composition of the product – exact percentage
- Physical/chemical characteristics and stability of the product
- Microbiological quality
- Impurities, traces, information about the packaging
- Normal and reasonably foreseeable use
- Exposure to the product
- Exposure to the substances
- Toxicological profile of the substances
- Undesirable and serious effects
- Information on the product
- Part B – Cosmetic Product Safety Assessment, this report has to be done by a qualified person and is the proof that the product is safe to be use. It should include:
- Statement on the safety of the cosmetic product
- Statement on the need to label any particular warnings and instructions of use
- Explanation of the scientific reasoning of the substances contained in the cosmetic product and on the Safety Information documentation
- Justification of the consideration and non-consideration of the raw materials’ toxicological profiles
- Assessor’s credentials and approval – name, address, proof of qualification, date and signature.
- Part A – Cosmetic Product Safety Information
- Manufacturing method in compliance with Good Manufacturing Practice (GMP): each PIF should include a declaration of compliance with GMP – a set of requirements based on workers safety and health during production process. The cosmetic product’s manufacturing method has to be in alignment with those specific requirements to be compliant and sold in the EU. It can be obtained through an external/internal audit or using self-declaration by manufacturers.
- Evidence of the claimed effect of the cosmetic product: in order to be compliant with regulations, the company has to furnish proofs of effects claimed. Several methods can be used: experimental studies, investigator evaluation, consumer perception tests and past scientific publications. All of them have to reliable and reproducible.
- Data on animal testing: each dossier must include an animal testing report that proofs regulations towards animal testing has been respected. This report should include:
- Identification of the animal testing
- Identification of the ingredients that were used
- Date and place of the test
- Information on entities that performed the test
- Legal objective and justification of the test
If no animal testing has been done, a declaration that says it should still be included.
- Cosmetic product labeling (container and packaging): each cosmetic product labeling has to be stated in the PIF and should include at least the following information:
- Name and address of the responsible person
- The country of origin if the product is imported from countries outside of the EU
- Nominal content of the product, given by weight or volume
- Date of minimum durability or period after opening
- Precautions for use
- Function of the cosmetic product
- List of ingredients
- Identification number
All information contained in product labeling must be indelible, easily legible and written with visible lettering. Language chosen should the country official language(s) where the product is placed.
If it appears that a cosmetic product placed on the market presents a risk to human health, the person responsible for placing it on the market must immediately inform the authorities and specify the preventive and corrective measures to be adopted.
Lascom CPG solution helps you to manage all your product data and information. You will be able to automatically create the product information file and manage all the information related to your cosmetic products: physico-chemical specifications, microbiological, control plans, product formulation, constrained formulation (regulations and customers), nonconformity management, etc.
Click here to learn more about how can Lascom CPG software help you to manage your product development and be compliant with EU regulations.