Composition and labelling of foodstuffs suitable for people intolerant to gluten
Commission Regulation (EC) No 41/2009 (OJ L16, p3, 21/01/2009 ) of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten
This Regulation enters into force on the 10th February 2009. It shall apply from 1 January 2012. However, foodstuffs which at the date of entry into force of the Regulation which comply with the provisions of the Regulation can be marketed in the European Community as from the date of entry into force the Regulation.
Commission Regulation (EC) No 41/2009 defines ‘foodstuffs for people intolerant to gluten’ as
"foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten"
The Regulation applies to foodstuffs other than infant formulae and follow-on formulae covered by Directive 2006/141/EC.
Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children requires the indication of the presence or the absence of gluten when the product is intended for infants below six months of age. The absence of gluten in those products should be indicated in accordance with the requirements laid down in Regulation (EC) No 41/2009.
Composition and labelling of foodstuffs for people intolerant to gluten
Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, must not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer. The labelling, advertising and presentation of such products shall bear the term ‘very low gluten’.
Such products may bear the term ‘gluten-free’ if the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer.
Oats contained in foodstuffs for people intolerant to gluten must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats must not exceed 20 mg/kg.
Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients which substitute wheat, rye, barley, oats or their crossbred varieties shall not contain a level of gluten exceeding 20 mg/kg in the food as sold to the final consumer. The labelling, presentation and advertising of those products shall bear the term ‘gluten-free'.
The terms ‘very low gluten’ or ‘gluten-free’ must appear in proximity to the name under which the food is sold.
Composition and labelling of other foodstuffs suitable for people intolerant to 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, 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 may bear terms indicating the absence of gluten. Article 2(1)(a)(iii)of Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs, requires that such a statement does not mislead the consumer by suggesting that the food possesses special characteristics when in fact all similar foodstuffs possess such characteristics.
Without prejudice to Article 2(1)(a)(iii) of Directive 2000/13/EC on the labelling, advertising and presentation of the following foodstuffs may bear the term ‘gluten-free’ provided that the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer:
- foodstuffs for normal consumption;
- foodstuffs for particular nutritional uses which are specially formulated, processed or prepared to meet special dietary needs other than those of people intolerant to gluten but which are nevertheless suitable, by virtue of their composition, to meet the special dietary needs of people intolerant to gluten.
The labelling, advertising and presentation of foodstuffs referred to in (a) and (b) above may not bear the term ‘very low gluten’.
Last reviewed: 12/3/2009