Food Supplements - what are the obligations of a Responsible Food Business Operator?

The Responsible Food Business Operator (RFBO) is the operator under whose name or business name the food is marketed or, if that operator is not established in the EU, the importer into the EU. The RFBO is responsible for the safety and compliance of food products placed on the EU market.

RFBO responsibilities are many and continuous

Legally it is not possible for the RFBO to contract a third party to delegate the responsibilities and legal liability for its food business activities and food supplements it places on the EU market. The RFBO is allowed to appoint a service provider to assist in fulfilling all the obligations.

The responsibilities of the Responsible Food Business Operator are to:

Compile, maintain (keep up-to-date) and securely store a complete and EU compliant Product Information File (PIF). And where needed to include additional information required by local authorities
Perform and where needed update the safety assessment according to EU acceptable methodology as required according to EU Regulation (EC) 852/2004 for the finished product and/or raw materials
Adequately and continuously address the identified potential hazards and risks through prevention, elimination or reduction to acceptable levels
Ensure EU and individual EU member state regulatory compliance of ingredients, formulas, packaging materials and products
Ensure the general EU and individual EU member state regulatory compliance of product labels
Notify products in individual EU member states where notification is required
Update notifications, resulting from relevant changes in formulations, packaging, labelling, etc.
Adequately respond to and handle regulatory requests from the EU and local authorities