Mandatory documents

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 finished product
  • The labelling and packaging (in direct contact with the formula) of the product
  • The raw materials of your product
 

Data on the finished product

Formula of the product

The complete formula of your product (qualitative and quantitative) must be specified with the following elements:

  • the trade name of the raw material in the finished product
  • the concentration of the raw material in the finished product, as well as that of each ingredient present in the raw material itself
  • the INCI name and CAS, EINECS/ELINCS numbers of the ingredients in the raw materials
  • the function of each ingredient
  • the final concentration of ingredients in the finished product
 

Good Manufacturing Practices & Manufacturing method

The product manufacturing method and Good Manufacturing Practices (GMP) will also have to be present. They include:

  • the manufacturing method of the product
  • the Standard Operating Procedures (SOPs)
  • the ISO 22716 norm (GMP). It is compulsory to comply with the GMPs and a certification according to the norm ensures a recognised compliance to the GMPs.
 

Proof of claims

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.

 

Absence of animal testing

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.

 

Nanomaterials

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.

 

Undesirable Effects and Serious Undesirable Effects

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.

 

First European country of marketing

For the CPNP notification, you must specify the first European country in which your product will be marketed.

 

Technical documents on the finished product

You are required to provide documents on the finished product, namely:

  • the certificate of analysis presenting its physicochemical characteristics
  • its microbiological specifications
  • the challenge test, or a justification for exemption
  • the stability test, which establishes the Date Of Minimum Durability (DOMD) on 3 months
  • calculation methodology of the Period After Opening (PAO) if the stability test requires a mention of it
  • reports on clinical or vitro tests (if carried out)

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:

  • the instructions of use, special precautions for use, warnings
  • the targeted population
  • site and surface area application
  • types of skin
  • application mode
  • the amount of product applied (optional)
  • frequency of use
  • duration of use
  • normal and reasonably foreseeable exposure routes (optional)
 

Labelling and packaging of the product

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.

 

Raw Materials

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:

  • physicochemical characteristics
  • microbiological specifications
  • a Safety Data Sheet (SDS)
  • an impurity profile
  • the exact decomposition if it is not mentioned in any other document

For raw materials of natural origin:

  • allergen certificate (detailing all the cosmetic allergens present in the products)

For all perfumes and essential oils:

  • a certificate proving your compliance to the latest IFRA amendment
  • a certificate testifying of your compliance to the cosmetic regulation
  • a Fragrance Safety Evaluation (FSE)
  • allergen certificate (detailing all the cosmetic allergens present in the products)

Note that other documents may be asked, depending on other origins.