Commission Press Release (IP/06/626), 16 May 2006
Markos Kyprianou, European Commissioner for Health and Consumer Protection, has welcomed the European Parliament's vote on the Fortified Foods Regulation today. This legislation will lay down common EU rules on the addition of vitamins, minerals and other substances to foods. A positive list of vitamins and minerals that can be added to food is included in the proposed Regulation, as are criteria for setting minimum and maximum levels for such nutrients in food. The Council is expected to formally adopt the Regulation in the coming weeks, and it will enter into force 20 days after its publication in the Official Journal of the European Communities. The new rules on fortification will start to apply 6 months from this date, although for up to 3 years afterwards, products not in compliance with the Regulation will still be allowed to be marketed, provided that they were labelled or placed on the market prior its entry into force.
Commissioner Kyprianou said, “The addition of vitamins, minerals and other fortifying substances to food can offer many benefits to the consumer – but there is also the risk of over-consumption of certain nutrients. The fortification of food must be done in a way that is safe and transparent. I welcome the Parliament's vote on this proposal which will strengthen consumer protection and allow citizens to make more informed choices when it comes to fortified foods. Moreover, food manufacturers throughout the EU will now be able to work under the same, clear, science-based rules.”
Creating a clearer situation
Divergent national legislation on the use of nutrients to fortify food currently poses an obstacle to the free movement of goods within the EU and creates an unclear situation for the consumer. The proposed Regulation aims to tackle these problems by creating harmonised EU rules on the addition of vitamins, minerals and other substances to food. Strict labelling criteria for fortified foods are also set out in the Regulation, which will mean that consumers will be better able to choose products containing certain vitamins and minerals and will have more information about how much of each nutrient they are getting.
Ensuring the safety of added nutrients
An EU list of approved vitamins and minerals is set out in the Regulation, and vitamins and minerals not included on this list will no longer be allowed to be added to food. There is a transitional period of 7 years in which vitamins and minerals not on the EU list may remain on the market, provided that they were added to foods marketed in the EU at the time the Regulation entered into force and that dossiers supporting their use are submitted to the Commission within 3 years of the Regulation entering into force. These dossiers will then be transferred to the European Food Safety Authority (EFSA) for evaluation.
The Regulation also sets out a procedure to scrutinise and, if necessary, restrict or forbid the use of substances other than vitamins and minerals whose addition to foodstuffs would lead to an excessive intake of the substance. An excessive intake is regarded to be consumption greatly exceeding those reasonably expected to be ingested in a normal and varied diet, which could consequently represent a potential risk to consumers. This procedure can be initiated by the Commission on its own initiative or on the basis of information provided by Member States. The substances concerned will be evaluated by EFSA and then a decision on eventual restrictions will be taken by Commission and Member States through Comitology [see note 1 below].
Minimum and maximum levels for the addition of different nutrients to food will also be established through the Comitology procedure based on scientific advice from EFSA. The Commission intends to publish a discussion paper on these levels within the coming months, and within 2 years of the adoption of the Regulation, it plans to put forward proposed levels for agreement by Member States in the Standing Committee on the Food Chain.
Drawing the line for certain products
While most food will be allowed to be fortified, so long as it does not pose a health risk, the Regulation states that fresh food such as fruit, vegetables or meat that should be preserved in their natural state. Adding vitamins or minerals to alcoholic drinks will not be allowed either, except in the case of fortified tonic wine.
For more information, see
 Agreed by the Commission and Member States , within the framework of the Standing Committee on the Food Chain and Animal Health