HOW TO COMPLY WITH EU AND FDA IN THE SAME LABELLING?

When we are referring to the labelling of a cosmetic product, we enter into the controversy between two departments, Marketing and Regulatory; that is, we open a debate between what we want and what we can sell following the regulations.

For this reason, we would like to make a visual review of the needs that the labelling of a cosmetic product must meet in order to comply with two of the most powerful global regulations in the field.

eu-fda-labelling

* Manufacturer or importer of the product in USA.
✓Mandatory information.

× Not aplicable information.

×** Not mandatory information but recommended.

≈ Comments about each specific point as follow:

  • List of ingredients: In primary packaging shall only be indicated if there is space for it and the company responsible of the product in each market wants it to be so.
  • Precautions: They are only mandatory to be indicated in case of any mandatory restriction due to ingredients, type of product, target population, etc. 
  • Mode of use: No será obligatorio para aquellos productos en los que se puedan sobreentender las instrucciones de uso por el tipo de producto o su función.

On the other hand, we could see differences in the layout of the information on the labelling:

  • Cosmetic product name and function:For the FDA, this is reduced to “product
    identification” and must appear on what they call the Principal Display Panel (PDP), that is, on the front of the secondary packaging. Meanwhile, in the EU it is not specified where this information must appear, the obligation is that it must be indicated on the packaging
  • Nominal content: For FDA compliance, this information must appear within the
    bottom 30% of the PDP, whereas in the EU it is not specified where.

Finally, we find the world of claims, where the clearest example of difference between both markets is found in claims such as “Cruelty-Free” or “Not tested on animals”, which would be allowed in the USA, but not in the EU, as not doing animal tests would simply be complying with the Regulation.

Don’t forget that from Sigillum KS we are at your disposal to help you to have all the regulatory requirements of your product ready for both Regulations and other important ones worldwide, such as China (CSAR).