Commission Regulation (EC) No 41/2009 (repealed)Show full title

Article 1 Scope

This Regulation shall apply to foodstuffs other than the infant formulae and follow-on formulae covered by Directive 2006/141/EC.

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)

‘foodstuffs for people intolerant to gluten’ means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten;

(b)

‘gluten’ means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof, to which some persons are intolerant and which is insoluble in water and 0,5 M sodium chloride solution;

(c)

‘wheat’ means any Triticum species.

Article 3 Composition and labelling of foodstuffs for people intolerant to gluten

1. 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, shall not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer.

2. The labelling, advertising and presentation of the products referred to in paragraph 1 shall bear the term ‘very low gluten’. They 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.

3. 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.

4. 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’.

5. Where foodstuffs for people intolerant to gluten contain both ingredients which substitute wheat, rye, barley, oats or their crossbred varieties and ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, paragraphs 1, 2, and 3 shall apply and paragraph 4 shall not apply.

6. The terms ‘very low gluten’ or ‘gluten-free’ referred to in paragraphs 2 and 4 shall appear in proximity to the name under which the food is sold.

Article 4 Composition and labelling of other foodstuffs suitable for people intolerant to gluten

1. Without prejudice to Article 2(1)(a)(iii) of Directive 2000/13/EC, 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:

(a) foodstuffs for normal consumption;

(b) 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.

2. The labelling, advertising and presentation of foodstuffs referred to in paragraph 1 shall not bear the term ‘very low gluten’.

Article 5 Entry into force and application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2012.

However, foodstuffs which at the date of entry into force of the present Regulation already comply with the provisions of the Regulation may be placed on the market in the Community.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 January 2009.

For the Commission

Androulla Vassiliou

Member of the Commission