To create your Product Information File, you will have to gather:
- information / documents on the finished product
- information / documents on the labelling and packaging (in direct contact with the formula) of the product information / documents on the raw materials of your product.
Below is the detailed list of the information and documents.
Information on the finished product
Information on the formula of your product
- Quantitative and qualitative formula of the cosmetic product. The complete formula of the product must be specified with the following elements:
- the trade name of the raw material in the finished product and/or the internal reference of the raw materials and /or the supplier of the raw materials
- the concentration of the raw material in the finished product
- the INCI name and CAS, EINECS/ELINCS number of the ingredients in the raw materials
- the function of each ingredient
- the final concentration of ingredients in the finished product
Information on Good Manufacturing Practices
Product manufacturing method and Good Manufacturing Practices, which include:
- the manufacturing method of the product: “cooking recipe” of the product
- the SOP (Standard Operating Procedures): every analytical measure/method must be subject to a documented quality process (PH measure, viscosity, impurity rate, etc.) to prove the tests are reliable, complete and reproducible.
- the ISO 22716 standard: being certified ISO 22716 (Good Manufacturing Practices) is mandatory to comply with the cosmetics regulation. You have the choice for this standard: you can conduct an external audit by another company (recommended even in the absence of an official certifying organisation) or conduct one internally. The ISO standard is available on the ISO website.
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 natures as long as they comply with regulation 655/2013/EC: clinical studies, perception studies, experimental studies, etc.
Absence of animal testing
You must ensure the manufacturer and/or brand does not conduct animal testing for its raw materials and that he does not have suppliers of raw materials who have tested ingredients, a combination of ingredients or the finished product itself on animals.
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.
Available data on Undesirable Effects and Serious Undesirable Effects
The PIF must contain all available data on Undesirable Effects (UE) and Serious Undesirable Effects (SUE), their imputability as well as statistical data. The SUE will also have to be declared by the RP and/or by the distributor to the competent authorities of the country where the effects took place. If the product has already been marketed in another country, the existing effects will have to be listed.
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 will then have to provide documents on the finished product, ie:
- the certificate of analysis, which presents the physico-chemical characteristics of the finished product (organoleptic characteristics, density, pH, viscosity, peroxide value, etc.)
- the microbiological specifications of the finished product
- the manufacturing process of the finished product
- the challenge test. If the product is considered to have a low microbiological risk according to ISO 29621, the microbiological specifications and the challenge test do not have to be provided! Different challenge tests exist and are approved by the cosmetic regulation: ISO 11930, European Pharmacopoeia.
- the stability test enables to establish the date of minimum durability (DOMD) of a product. There is no established standard protocol. It is up to the manufacturer to establish one. Two types of tests exist: in accelerated aging conditions and normal conditions. The test protocol as well as the findings on the DOMD must be provided for the PIF. If the DOMD is more than 30 months, a PAO will have to be calculated. The method for establishing the PAO must also be provided for the PIF.
Exposure data of the product must also be provided. These are:
- instructions of use, special precautions for use, warnings
- targeted population
- site and surface area of application
- types of skin
- application mode
- the amount of product applied
- frequency of use
- duration of use
- normal and reasonably foreseeable exposure route
Non-clinical and clinical tests if available: tests in vitro (HET-CAM, BCOP), tolerance tests on volunteers, tests to determine SPF (UVB), UVA and critical wavelength (mandatory for sunscreens), product efficacy tests: if there are specific claims with the supporting test protocols (in vitro, experimental, clinical).
Labelling and packaging of the product
Information required for the product’s label
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, ie. have the 8 mandatory pieces of information in indelible, easily legible and visible lettering”:
- 1) Name and address of the Responsible Person:
- 2) Country of origin: Add the words: “Made in XXXXX” unless the product is made in Europe in which case this is not mandatory. Note: the “Made in” expression does not need any translation.
- 3) Nominal content: The nominal content must appear in grams (g) or milliliter (ml) and in first position. You can add additional measurement units but they must appear after the international system (IS).
- 4) Date of minimum durability (DOMD) & Period after opening (PAO): If the DOMD (defined by the stability test) is inferior or equal to 30 months, you need to indicate it using the “hour glass” symbol and print date (MMYYYY or MMYY or DDMMYYYY or DDMMYY). If the DOMD is superior to 30 months then you must indicate the PAO, defined by the challenge test. You’ll need to print the “open jar” symbol with the number of months (M) or year (Y) inside or next to the open jar.
- 5) Particular precautions of use and warnings: Depending on the type of cosmetic product, some particular precautions of use and warnings might be useful to consumers or even mandatory in certain cases.
- 6) Batch number: is mandatory, and no particular format is required.
- 7) Product function: The function of the product must be clearly indicated so as to prevent any misuse.
- 8) List of ingredients: In decreasing order of weight, except for ingredients below 1%.
/!\ Translation: You must translate the function of the product, the precautions of use and warnings but also the nominal content in the language of the country you export to. Note that Austria, Bulgaria, France, Poland, Portugal and Slovakia, request full translation of the label.
Documents on the packaging of the product
Documents on the primary packaging (= part of the packaging in direct contact with the cosmetic formula) are also required for the PIF: the different components of the primary packaging must be assessed to ensure that unexpected substances of concern do not migrate within concerning exposure conditions in the cosmetic product.
- Identification of the suppliers of the primary packaging components in direct contact with the SDS formula
- Indication of the presence of additives in the components (colorants, antioxydants, lubricants)
- Indication of all prohibited substances: CMR, SVHC, technically unavoidable impurities, nitrates or nitrating agents
- Heavy metal levels
- Regulatory framework (Food, Toys, European pharmacopoeia, etc.)
- Content/container compatibility tests if available : in accelerated aging conditions or normal conditions
- Data on migration
Data on Raw Materials
It will be required to establish the characteristics of every raw material. You must be careful because the information required depends on the origin and nature of the raw material and there is no general document provided by the supplier. You will have to indicate:
- the qualitative / quantitative composition of the raw material
- the name and codification of the ingredients composing it (INCI name, ENEICS number, CAS number)
- the origin of the raw material (synthetic, mineral, vegetal, animal, biotechnological)
- physico-chemical specifications (pH, viscosity, purity, etc.), certificate of analysis
- microbiological specifications
- the manufacturing process of the raw material
- the regulatory framework of the raw material
- various certificates depending on origin : the ESB certificate, GMO certificate, animal testing declarations, CITES certificate, organic origin certificate, etc. (This list is non-exhaustive).
- the Safety Data Sheets (SDS)
- the nature and percentage of impurities potentially in the raw material, according to the origin and/or manufacturing process of the raw material, such as CMR (carcinogenic, mutagenic and toxic for reproduction), residual solvents, traces of prohibited substances, heavy metals, dioxins, secondary amines, acrylamides, nitrosamines, VOC (volatile organic compounds), etc.
- the granulometric distribution curve for substances of mineral origin
- the UV absorption spectrum for UV filters
- the up-to-date IFRA certificate and the allergen certificate for perfumes and essential oils
- allergen certificates for any plant extract
- food certificates for flavourings
- toxicological data if available
Please do not hesitate to contact us: [email protected], if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
Contact us via phone: for North America please use + 1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54