1. FOODstars Fortified Foods
Guidance to compliance with European Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to food
FOODstars
Dr George Hull
Teagasc
Food Safety Department

2. Overview Introduction to food fortification
Regulation(EC) No. 1925/2006
Aim and scope
Labelling
Maximum and minimum levels
Tolerances
Prohibitions and restrictions
Community register

3. Fortification Malnutrition
Meeting the body’s needs for energy and nutrients is essential for good health
Micronutrient deficiencies
Rickets, scurvy, goiter…
What is fortification?
Restoration and substitution
Why fortify?
Reduce nutrient deficiency disease, value added product …

4. Regulation (EC) 1925/ on the addition of vitamins and minerals and of certain other substances to food
What is the aim of the regulation?
Sets out the EU’s rules concerning voluntary fortification
Harmonises the different rules in force in EU countries
Sets out the list of vitamins and minerals which may be added to foods
Sets out rules for additional food labeling

5. Scope
This Regulation shall apply without prejudice to specific provisions laid down in Community legislation concerning:
foods for particular nutritional uses, new foods and new food ingredients, genetically modified foods ….
It does not apply to food supplements covered by Directive 2002/46/EC
It lists vitamins and minerals which may be added to foods
Only vitamins and/or minerals listed in Annex I, in the form detailed in Annex II, may be added to foods, subject to the rules laid down in the regulation
The lists may be modified taking account of the opinion of the European Food Safety Authority (EFSA)

6. Labelling
Nutritional labelling of products to which vitamins and minerals have been added and which are covered by the regulation is compulsory. It must contain the following information:
The total amounts of vitamins and minerals where they are added to a food
The amount of energy, protein, carbohydrate, sugars, fat, saturates, fibre and sodium (in accordance with Regulation (EU) No 1169/2011 on food labelling)
The labelling, presentation and advertising of foods to which vitamins and minerals have been added:
shall not mislead or deceive the consumer about their nutritional value
shall not include any mention stating or implying that a balanced and varied diet is not an adequate source of nutritional substances

7. Minimum and maximum levels
Adding vitamins and minerals to foods can reduce the risk of deficiencies
Adding a vitamin or a mineral to a food shall result in at least a significant amount (≥15% NRV for solid food per 100g/100mL; ≥7.5 % NRV for beverages per 100 mL) (No 1169/2011)
Excessive intakes of vitamins and minerals may have adverse effect on health.
The maximum amounts take account of:
The upper safe levels for vitamins and minerals
The potential intake of and the reference intakes of the population

10. Prohibitions and restrictions
Vitamins and minerals may not be added to:
Unprocessed foodstuffs, including fruit, vegetables, meat ….
Beverages containing more than 1.2 % by volume of alcohol
The regulation allows for a procedure to prohibit or restrict the use of substances other than vitamins or minerals
EU countries can submit a request to the European Commission, providing scientific evidence allowing it to classify a particular product in the regulation's Annex III
Implementing Regulation (EU) No 307/2012 clarifies the conditions for submitting such a request

11. Enforcement Safeguard measures Responsibility of the member states
Port authorities
Safeguard measures
Member States have the power to temporarily suspend or restrict a product

12. Community Register
The vitamins and minerals which may be added to foods as listed in Annex I
The vitamin formulations and mineral substances which may be added to foods as listed in Annex II
The maximum and minimum amounts of vitamins and minerals which may be added to foods
The information regarding national provisions on the mandatory addition of vitamins
Any restrictions on the addition of vitamins and minerals
Information about the substances referred to in Annex III and the reasons for their inclusion therein
Information about the substances listed in Annex III, Part C, whose use is generally allowed

13. Summary Food fortification Reduce nutrient deficiency disease
Regulation (EC) No.1925/2006
Harmonises the different rules in force in EU countries
Sets out the list of vitamins and minerals which may be voluntary added to foods
Sets out rules for additional food labeling
Defines the maximum and minimum levels allowed
Defines the acceptable tolerances
Prohibitions and restrictions on certain food items
Community register

14. References
Regulation (EC) No 1925/ on the addition of vitamins and minerals and of certain other substances to foods
Regulation (EU) No 1169/ on the provision of food information to consumers
Regulation (EC) No 1924/ on nutrition and health claims made on foods
minerals_en
_nutrition-vitamins_minerals-comm_reg_en.pdf

15. Thank you for your attention