The cosmetic Product Information File (PIF) is essential so as to sell your cosmetic products on the European market. To build this regulatory dossier required by the European Cosmetics Regulation n°1223/2009, you will need to gather a certain amount of documents and tests on the cosmetic product as a whole as well as on its raw material.
In order to create your PIF, you will need the following information and documents:
The complete formula of your product (qualitative and quantitative) must be specified with the following elements:
The product manufacturing method and Good Manufacturing Practices (GMP) will also have to be present. They include:
When the nature or the effect of the cosmetic product justifies it, you will have to prove your claims. They can be of several types but must comply with regulation 655/2013/EC: clinical studies, perception studies, experimental studies, etc. More information on claims, here.
You must ensure the manufacturer and/or brand does not conduct animal testing for its raw materials and that they do not have suppliers of raw materials who have tested ingredients, a combination of ingredients or the finished product itself on animals, after 2013.
You must indicate if your product contains nanomaterials. If so, you will have to notify on the CPNP 6 months before the product is placed on the market; in the situation where the nanomaterial is not listed in the regulation.
The PIF must contain all available and verified data on Undesirable Effects (UEs) and Serious Undesirable Effects (SUEs), their accountability as well as statistical data and the number of units sold.
For the CPNP notification, you must specify the first European country in which your product will be marketed.
You are required to provide documents on the finished product, namely:
On top of that, in order for the assessor to be able to evaluate exposure, you must also provide the finished product’s exposure data. In other words:
There are specific labelling and packaging rules to place your product on the market: primary and secondary labelling must comply with Article 19 of the cosmetics regulation. For more information on this matter, you can visit the dedicated page by clicking here.
It will be necessary to establish the characteristics of every raw material. Careful, the information required depends on the origin and nature of the raw material.
For all raw materials, you will at least need:
For raw materials of natural origin:
For all perfumes and essential oils:
For all perfumes and essential oils:
Note that other documents may be asked, depending on other origins.