There is a lot of confusion when interpreting the EU Regulation 1223/2009. This is a regulation that helps to manage the cosmetic industry as a whole. If you are having problems with understanding it, here are some simple instructions on where to start with its consuming language.
1. A Product information file (PIF) is needed for 10 years after creation of a cosmetic product. If you create a new product, you have to create a PIF, or product information file. This is a formalized file that contains critical information about that product that includes:
a. A description of the product
b. The cosmetic safety report
c. Proof of the marketed claim of the product
d. Data on animal testing, if any, as regulated by company of manufacture
e. A detailed description of the manufacturing method and a statement confirming compliance with all EU rules and regulations
2. The PIF must consistently be updated and amended as the product evolves. Any change to specifications, ingredients, percentage of ingredients or manufacturing process must be documented in the PIF. If your product is ever targeted for review, your file must be current.
3. Though the PIF must contain a general description of said product, article 1 delineates in detail what must be shared. For this to be followed, the following needs to be followed:
a. All raw materials and their individual suppliers must be identified for every product batch. If you change suppliers, this must be noted clearly in your file.
b. Change control must be delineated within the documentation also. If you do make changes to the product, there must be a standardized process for this change to happen. This ensures that all steps are followed to introduce the alteration.
c. Documentation for any change or any reconfiguration of the product must be noted clearly as part of the EU regulation 1223/2009. Dates and reason/s for the change must be clearly documented in the file.
4. If you do opt for a restructure of the product, you must inform your inspector. If the change is small, you may not have to change your PIF much. It may just be a matter of noting the change, date of change and change in percentage of concentration. On the other hand, sometimes products need complete re-formulation. In these cases, the PIF will be more detailed in description. This is where your representative can guide you and let you know what you need to alter. Even if you change a batch, or a series of batches, this must be clearly readable in your file.
5. You are still responsible for your PIF even if you have a Cosmetics Products Safety Report. Yes, your rep will conglomerate and verify information in the report, but your PIF still has to be self-maintained. The safety report is never a substitute for the up-to-date PIF.
EU Regulation 1223/2009 can be difficult to understand, but if you are in the cosmetic market, you need to sort through it. Take time to read up on it, and ask questions if needed. This way you will surely be ready for any regulatory check-ups and pass with ease.
For more info about this topic please visit Ceway.eu, they can help you with the regulations and advise on how to comply with them.