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July 1, 2006
By: Sean Moloughney
Editor, Nutraceuticals World
European Parliament Votes on Health Claims and Fortified Foods Markos Kyprianou, European Commissioner for Health and Consumer Protection, welcomed the European Parliament’s 2nd Reading vote on the Health and Nutrition Claims Regulation in May, which paves the way for the adoption of this piece of legislation. The proposed regulation will ensure that consumers can rely on the truth and accuracy of information on food labels and will create a level playing field for food manufacturers wishing to use health or nutrition claims. Formal adoption of the regulation is expected by the Fall, and it will enter into force within 20 days of its publication in the Official Journal. The first provisions of the regulation will begin to apply six months from entry into force. As a transitional measure, existing nutrition claims will be able to remain on the market for two years, and existing health claims for three years. Nutrient profiles will be drawn up by the Commission based on an opinion by the European Food Safety Authority (EFSA) within two years. The proposed Health and Nutrition Claims Regulation lays down strict conditions for the use of nutrition claims such as “low fat,” “high fiber” or “reduced sugar.” Set thresholds will have to be met before such claims can be made. For example, there will have to be 6 grams of fiber per 100 grams for the claim “high fiber” to be used and no more than 0.12 grams of sodium per 100g/100ml for the claim “low sodium/salt.” In line with the commission’s proposal, the European Parliament agreed to a ban on nutrition claims on alcohol products, except if these claims refer to a reduction in alcohol or calories. With regard to health claims, the commission will draw up a positive list of well-established claims, such as “calcium is good for your bones,” which may be used on a label so long as they are proven to apply to the food in question. Member States will submit a list of claims already approved at national level and, within three years of the regulation entering into force, the commission will produce an EU positive list of health claims. Any claims submitted for the EU list after this period will have to be examined by EFSA and approved by the commission and member states through the Comitology procedure. The use of new health claims or disease reduction claims, such as “[name of product] lowers cholesterol” or “calcium helps reduce the risk of osteoporosis,” will require specific authorization by the commission through the Comitology procedure, following scientific assessment and verification of the claim by EFSA. The regulation will also apply to trademarks. Within 15 years of the entry into force of the regulation, existing brand names suggesting health benefits (such as promises of weight loss) that do not meet the requirements of the regulation must be phased out and removed from the market. However, certain generic descriptors, e.g. digestives, may apply for derogation from this rule. In other developments, the European Parliament has also welcomed the vote on legislation pertaining to fortified foods regulation. 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 need for this legislation stems from divergent national legislation on the use of nutrients to fortify food, which poses an obstacle to the free movement of goods within the EU and creates an unclear situation. The proposed regulation aims to tackle these problems by creating harmonized EU rules. The EU list of approved vitamins and minerals is set to be part of the new regulation, which means unapproved nutrients will no longer be allowed to be added to food. However, there is a transitional period of seven years in which vitamins and minerals not on the list may remain on the market, provided 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 three years of the regulation coming into force. While most foods 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, be preserved in their natural state. Adding vitamins and minerals to alcoholic drinks will also be prohibited, with the exception of fortified tonic wine. (For more information on the state of harmonization in the EU, see this month’s Europe feature (page 50), which is part of Nutraceuticals World’s International Markets Report.)
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