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Obtaining a compliant and complete PIF (Product Information File) is an essential step in marketing a cosmetic product in Europe. While this document can sometimes seem like an administrative mountain, don't panic: with good organization and a bit of rigor, it is entirely doable. Here are the main steps to follow to successfully complete your DIP.
Product identity
Step one: describe your product. Its name, its purpose, its category… Everything that lets you know what it is and what it’s used for. Be careful, there’s no room for improvisation here: be clear and precise .
Do not hesitate to consult your toxicology expert who will be able to find the right and relevant words for your product. This step is very important, because the presentation of your product must not leave any doubt about the regulations to which it is subject. Some products, due to their presentation or their claims, may find themselves classified in categories such as medical devices or biocides , and therefore subject to other regulatory constraints. This is an essential point of attention.
The composition: transparency above all
Every ingredient counts, from the first to the last. List them all, with their concentration . It's the soul of your product! As a bonus, provide the technical and safety data sheets for each raw material. Real detective work. Don't hesitate to get help from your toxicologist for this investigation: ingredients, additives, impurities, everything must be identified and quantified.
Manufacturing processes and manufacturer documents
Detail each step of manufacturing. This includes good manufacturing practices (GMP) and batch traceability. Remember to write down everything: even the ideal temperature of your emulsion! At this stage, precision is your best friend.
If you are working with a manufacturer to produce your product, ask them for the manufacturing process , the GMP certificate , the declaration of establishment and the method of identifying batch numbers . These are documents that they usually provide and you should not have any difficulty collecting them.
Safety testing and security assessment
Safety tests (compatibility, stability, skin tolerance, etc.) will be requested by your toxicologist to ensure that your product is safe. Add to this the toxicological evaluation carried out by your qualified expert.
During the safety assessment writing stage, your toxicologist will probably ask you for a lot of information and documentation about your finished product and raw materials. Ask him for a checklist of the required elements at the beginning of the project. This will save you time.
Proof of Marketing Claims and Labels
Each claim made on your product must be justified . For example, if you mention that your product is "hydrating", "anti-aging" or "detoxifying", you will need to provide validated tests or studies that attest to its effectiveness . Similarly, to display a label (organic, cruelty-free, etc.), you must provide the corresponding certification issued by a recognized organization.
Information on the label
The label is not just a matter of aesthetics; it must contain all the legal information , such as the list of ingredients, the name of the Responsible Person, the country of origin, and the precautions for use. Think about it: a clear and complete label avoids a lot of hassle.
The CPNP notification
Before you can market your cosmetic product in Europe, it is mandatory to notify it via the CPNP portal (Cosmetic Products Notification Portal). This step allows the competent authorities and poison control centers to have access to all the information on your product.
To do this, you will need to:
Create an account on the CPNP portal.
Submit key information , such as composition and labeling.
Provide an image of the label and, if applicable, data on the nanoparticles used.
Once the notification is validated, your product can officially be placed on the market. Be sure to keep a copy of the confirmation in your PIF.
A living document: keeping the PIF up to date
The PIF is not a simple file to fill out and forget in a drawer. It must be updated regularly , particularly during:
Changes in composition (replacement or modification of a raw material).
Returns related to cosmetovigilance.
Changes to label or marketing claims.
Make sure to keep a record of each modification and verify that all elements of the PIF remain compliant with current regulations.
Document management
Finally, gather all this information into a well-structured and easy-to-access document. A perfect PIF is one that is clear, organized, and ready to be consulted at any time. It’s a bit like a good school binder: everything in its place, and a place for everything.
In conclusion…
Creating a cosmetic PIF may seem complex, but with a rigorous method and good technical support, it is within your reach .
If you need a helping hand or tailor-made support, Galeniform is here to guide you. We transform mountains into hills, and hills into marked paths. So, are you ready to take on the challenge?
It's over here 👇
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