By virtue of Directive 2002/46/EC(1) on food supplements, which entered into force in 2003, it will in practice be prohibited after 1 August 2005 to sell any food supplements not notified in due form to the proper authority in the Member State concerned, in Finland’s case the National Food Agency (Elintarvikevirasto). In Finland, however, there are approximately 3000 food supplements on the market and by the end of 2004 only about 300 of them had been notified to the agency because those working in the industry were not fully informed about the package indications and proof of testing required by the regulation and many wholesalers have failed to act until now. The situation is probably much the same in the other Member States. Food supplements have a long shelf-life (generally three years), and when stocks are high, businesses cannot guarantee that retailers would be able to sell all the products on sale before 1 August 2005. This puts the retailers in a difficult position.
Does the Commission think that it would be possible to bring flexibility to bear on the time limit imposed by the transitional period, so as to enable retailers to clear their remaining stocks of otherwise perfectly saleable products, following the example of foodstuffs and the regulation on food packaging indications, which is so worded as to allow shops to sell off their entire stocks? As far as food supplements are concerned, the industry should accordingly comply with the timetable and provide the necessary package indications and notify supplements to the authorities by 1 August 2005, whereas trading should be made flexible, thus enabling products bearing the old package indications to be sold.
Answer given by Mr Kyprianou on behalf of the Commission
The food supplements Directive(1) establishes harmonized rules for the labelling of food supplements and introduces specific rules on vitamins and minerals in food supplements. Its aim is to ensure that these products are safe and appropriately labelled so that consumers can make informed choices. From 1 August 2005 the marketing of products that do not comply with this legislation will have to be prohibited.
Several Member States are concerned about the proliferation of food supplements on their territory. Therefore, in order to allow an adequate control, Directive 2002/46/EC leaves to them the possibility to require the manufacturer, or the person placing the food supplement on the market, to notify the competent authorities (in the case of Finland, the National Food Agency), of the placing on the market of the product simply by forwarding a model of the label used. However, it is important to note that it is up to Member States to decide whether to impose the notification of food supplements and if so the modalities for such notification.
The Directive does not require any validation or testing of food supplements containing the vitamins and minerals and their sources listed in Annexes I and II. Regarding substances used in the manufacture of food supplements prior to the adoption of the Directive but not appearing in Annex II, the Directive provides that Member States may allow derogations on their territory for use of these sources until 31 December 2009 provided a dossier for their evaluation is submitted by 12 July 2005.
The transitional periods allowed for food supplements to comply with the rules set out in the Directive were carefully considered and debated with all the interested stakeholders and the Member States. The Commission considers they gave sufficient time to the economic operators to adapt.