21.1.2009 Official Journal of the European Union L 16/3 COMMISSION REGULATION (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (*), and in particular Article 2(3) and Article 4a thereof, Whereas: Directive 89/398/EEC concerns foodstuffs intended for particular nutritional uses which owing to their special composition or manufacturing process are intended to satisfy the particular nutritional requirements of specific categories of the population. People with coeliac disease are such a specific group of the population suffering from a permanent intolerance to gluten. The food industry has developed a range of products presented as ‘gluten-free’ or similar equivalent terms. Differences between national provisions concerning the conditions for the use of such product descriptions may impede the free movement of the concerned products and may fail to ensure the same high level of protection for consumers. For the sake of clarity and in order to avoid confusing consumers with different types of product descriptions at national level, the conditions for the use of the terms related to the absence of gluten should be laid down at Community level. Wheat (i.e. all Triticum species, such as durum wheat, spelt, and kamut), rye and barley, have been identified as grains that are scientifically reported to contain gluten. The gluten present in those grains can cause adverse health effects to persons intolerant to gluten and therefore should be avoided by them. The removal of gluten from gluten-containing grains presents considerable technical difficulties and economic constraints and therefore the manufacture of totally () O] L 186, 30.6.1989, p. 27. gluten-free food is difficult. Consequently, many food- stuffs for this particular nutritional use on the market may contain low residual amounts of gluten. Most but not all people with intolerance to gluten can include oats in their diet without adverse effect on their health. This is an issue of ongoing study and investi- gation by the scientific community. However, a major concern is the contamination of oats with wheat, rye or barley that can occur during grain harvesting, transport, storage and processing. Therefore, the risk of gluten contamination in products containing oats should be taken into consideration with regard to labelling of those products. Different people with intolerance to gluten may tolerate variable small amounts of gluten within a restricted range. In order to enable individuals to find on the market a variety of foodstuffs appropriate for their needs and for their level of sensitivity, a choice of products should be possible with different low levels of gluten within such a restricted range. It is important, however, that the different products should be properly labelled in order to ensure the correct use of those products by people intolerant to gluten with the support of information campaigns fostered in the Member States. Foodstuffs for particular nutritional uses which have been specially formulated, processed or prepared to meet the dietary needs of people intolerant to gluten and marketed as such should be labelled either as ‘very low gluten’ or ‘gluten-free’ in accordance with the provisions laid down in this Regulation. These provisions can be achieved by the use of foodstuffs which have been specially processed to reduce the gluten content of one or more gluten containing ingredients andf/or foodstuffs where the gluten containing ingredients have been substituted by other ingredients naturally free of gluten. Article 2(3) of Directive 89/398/EEC provides for the possibility for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability. Therefore, it should be possible for a normal food which is suitable as part of a gluten- free diet because it does not contain ingredients derived from gluten containing grains or oats to bear terms indi- cating the absence of gluten. Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member