Fortified Food consists of food with added vitamins and minerals, that aim to fulfil the nutritional requirements. Examples of Fortified Food include folate fortified foods, zinc fortified foods, vitamin D fortified foods, fortified cereals, iron fortified bread, iron fortified orange juice, fortified milk powder and vitamin B12 fortified cereals.  Article 8 of the EU Regulation (EC) No 1925/2006 on fortifying vitamins and minerals and certain other substances to foods sets out the procedures that must be followed for the authorisation of fortified foods. 

 Steps for Article 8 submission: 

1. The producer is required to submit an application to the member state’s competent authorities before marketing a fortified food on the market. The application must include the following: 

• A description of the product and the proposed use. 
• The nature and source of the added vitamins and minerals and their chemical form. 
• The levels of added vitamins and minerals. 
• Scientific data justifying the need for adding vitamins and minerals and demonstrating the product’s safety. 
• A proposal for labelling and instructions for use. 
• Information on the intended target groups. 

2. The competent authority must evaluate the application, considering the safety, nutritional value, and bioavailability of the added vitamins and minerals.

3. If the competent authority approves the application, the fortified food can be placed on the market in that Member State. 

4. If the fortified food is to be marketed in other Member States, the manufacturer must inform the competent authority in each of those Member States and provide them with the information contained in the original application. 

5.The relevant agencies of the Member States must cooperate with each other to assess and authorise fortified foods. The European Commission may guide the interpretation of the regulation and the procedures to be followed [1].