Technical documentations?

The EU Technical Documentation for CE Marking is a comprehensive set of documents that manufacturers must compile to demonstrate that their products comply with the applicable EU directives or regulations. Essentially
compliance against the FPR almost entirely revolves around this documentation.

For FPR there are specific requirements for the contents of a technical file. 

At a minimum your technical documentation must contain at least the following the information listed in the FPR under annex IV, where applicable to your situtaition. Having said that this list is quite generic (i.e. the FPR speaks of calculations, but if you do not have specific calculations for your product then it is not explicitly required). Thus we want to highlight a few of the most important documents that Notified Bodies, and market surveillaince authorities will assess to ensure you are compliant with the requirements from FPR's first three annexes. 

Some of the most crucial documents are:

- A test report from an accredited laboratory 

- Information for each ingredient proving compliance against the CMC requirements, for example for a virgin material this will be a confirmation of reach and of 

- Ingredient list

- An example of the label

- In case of Biostimulants the dossier proving the claims you have placed on the label

- A declaration confirming that you do not intentionally add phosphonates to the product, or other evidence in this regard. 

It is required to keep a copy of your technical documentation for each product you have sold for 5 years after you have sold that product. Even if you cease production the documentation must remain available. 

See FPR for the full legal list of required documents. 

Please note that if you repackage a product under the FPR you will be required to have access to the technical documentation, if your supplier cannot provide this access then it will be required to sign a letter of access to ensure that legally you can fulfill your obligations under the FPR. Contact us if you have any questions in this regard, and please see here: Repackaging and the Letter of Access under article 10