Food Supplements - what kind of data and documents do I need to have available as RFBO?

The Responsible Food Business Operator (RFBO) needs to have all required information available to demonstrate that the products are compliant and safe. In addition, the product information provided to the consumer, by means of product labels, brochures and websites must be evidence based.

Data and documents need to be up to date for inspection

Most of the required data and documents are used as input for the safety and compliance assessment including the Food Safety & Compliance Report (FSCR), for local member state notifications and/or needed to be presented during authority inspections. The FSCR will become part of the Product Information File (PIF).

As a minimum the PIF contains the following:
1)   Product label/artwork as presented to consumers in the relevant EU member states
2)   Image of the product as presented to consumers
3)   Product presentation, marketing (claims) information and product brochures
4)   Product formulation (exact qualitative and quantitative composition)
5)   Individual ingredients information (Composition declaration, MSDS, CoA, TDS, purity and/or declarations of absence of specific frequent contaminants or allergens when relevant; e.g. quantification of PA’s in certain botanical raw materials)
6)   Finished product specification (SPEC) and Certificate of Analysis (CoA)
7)   Manufacturing method/production process flow
8)   Stability test report and minimum durability conclusions (to justify best before end date)
9)   If applicable: scientific claim substantiation for each specific EFSA-approved nutritional and health claim (and botanical claims with “on hold” status)
10)  Impurities, traces, and information about the packaging material compliance and compliance with Food Contact Materials Regulation requirements (e.g. results of migration tests)
11)  Proof of traceability
12)  FSCR of all individual ingredients and of the finished product
13)  Nutrivigilance records and periodic safety update reports