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

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

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 …

Regulation (EC) 1925/2006 - 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

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)

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

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

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

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

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

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

References Regulation (EC) No 1925/2006 - on the addition of vitamins and minerals and of certain other substances to foods Regulation (EU) No 1169/2011 - on the provision of food information to consumers Regulation (EC) No 1924/2006 - on nutrition and health claims made on foods https://ec.europa.eu/food/safety/labelling_nutrition/vitamins_ minerals_en https://ec.europa.eu/food/sites/food/files/safety/docs/labelling _nutrition-vitamins_minerals-comm_reg_en.pdf

Thank you for your attention