EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION REGULATION 
of 
concerning the composition and labelling of food stuffs suitable for people intolerant to 
gluten 
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION REGULATION 
of 
concerning the composition and labelling of food stuffs suitable for people intolerant to 
gluten 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 for particul ar nutritional uses1, and in 
particular Article 2(3) and Article 4a thereof, 
Whereas: (1) Directive 89/398/EEC concerns foodstuffs in tended for particular nutritional uses 
which owing to their special composition or  manufacturing process are intended to 
satisfy the particular nutritional requiremen ts of specific categor ies of the population. 
People with coeliac disease are such a specific group of the population suffering from 
a permanent intolerance to gluten. 
(2) The food industry has developed a range of products presented as "gluten-free" or 
similar equivalent terms. Differences be tween national provisions concerning the 
conditions for the use of such product descri ptions may impede the free movement of 
the concerned products and may fail to ensu re 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. 
(3) Wheat (i.e. all Triticum species, such as durum wheat, spelt, and kamut), rye and 
barley, have been identified as grains that are scientifically repor ted to contain gluten. 
The gluten present in those grains can cause adverse health effects to persons 
intolerant to gluten and theref ore should be avoided by them. 
(4) The removal of gluten from gluten-containing grains presents considerable technical 
difficulties and economic constraints and ther efore the manufacture of totally gluten-
free food is difficult. Consequently, many foods tuffs for this partic ular nutritional use 
on the market may contain low residual amounts of gluten. 
                                                
 
1 OJ L 186, 30.6.1989 p. 27. EN 3   EN (5) Most but not all people with intolerance to gl uten can include oats in their diet without 
adverse effect on their health. This is an  issue of ongoing study and investigation by 
the scientific community. However, a major c oncern is the contamination of oats with 
wheat, rye or barley that can occur duri ng 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. 
(6) Different people with intolerance to gluten  may tolerate variable small amounts of 
gluten within a restricted ra nge. In order to enable indivi duals to find on the market a 
variety of foodstuffs appropriate for their needs and for their le vel of sensitivity, a 
choice of products should be possible with diffe rent low levels of gluten within such a 
restricted range. It is important, howeve r, that the different products should be 
properly labelled in order to  ensure the correct use of  those products by people 
intolerant to gluten with th e support of information campaigns fostered in the Member 
States.  
(7) Foodstuffs for particular nut ritional 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 cont aining ingredients a nd/or foodstuffs where 
the gluten containing ingredients have been substituted by other ingredients naturally free of gluten. 
(8) Article 2(3) of Dir ective 89/398/EEC provides for the possibility for foodstuffs for 
normal consumption which are suitable for a pa rticular nutritional us e 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 indicating the ab sence 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 St ates relating to the labelling, presentation 
and advertising of foodstuffs
2, requires that such a statement does not mislead the 
consumer by suggesting that the food possesse s special characteristics when in fact all 
similar foodstuffs possess such characteristics. 
(9) Commission Directive 2006/141/ EC of 22 December 2006 on infant formulae and 
follow-on formulae and amending Directive 1999/21/EC3, prohibits the use of 
ingredients containing gluten in  the manufacture of such fo odstuffs. Therefore, the use 
of the terms "very low gluten" or "glute n-free" on the labelling of such products 
should be prohibited given that pursuant to the present Regulation, this labelling is 
used for indicating respectively a conten t of gluten not exceeding 100 mg/kg and 
20 mg/kg. 
                                                 
2 OJ L 109, 6.5.2000, p. 29. 
3 OJ L 401, 30.12.2006, p. 1. EN 4   EN (10) Commission Directive 2006/125/EC of 5 D ecember 2006 on proces sed cereal-based 
foods and baby foods for infants and young children4 requires the indication of the 
presence or the absence of gluten when th e 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 this Regulation. 
(11) The Codex Standard for Foods for Special Dietary Use for Persons Intolerant to 
Gluten was adopted by the 31st session of  the Codex Alimenta rius Commission in 
July 20085, with a view to enabling those persons to find on the market a variety of 
food suitable to their needs and to their leve l of sensitivity to gluten. That standard 
should be taken appropriately into consider ation for the purposes of this Regulation. 
(12) In order to allow the economic operators to adapt their production process, the date of 
application of the present Regulation should allow the ne cessary transitional period. 
However products which at the date of entr y into force of this regulation already 
comply with it can be marketed in the Community as from the date of entry into force of the present Regulation. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Scope 
This Regulation shall apply to foodstuffs ot her than the infant formulae and follow-on 
formulae covered by Directive 2006/141/EC. 
Article 2 
Definitions  
For the purposes of this Regulation, th e following definitions shall apply: 
(a) "foodstuffs for people intolerant to glut en" 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 wh eat, 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. 
                                                
 
4 OJ L 339, 6.12.2006, p. 16. 
5 http://www.codexalimentarius.net/download/standards/291/cxs_118e.pdf EN 5   EN Article 3 
Composition and labell ing of foodstuffs for  people intolerant to gluten  
1. Foodstuffs for people intolerant to glute n, consisting of or c ontaining one or more 
ingredients made from wheat, rye, barley, oats or their crossb red varieties which 
have been especially proce ssed to reduce gluten, shall no t contain a leve l 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 intole rant to gluten must have been specially 
produced, prepared and/or processed in a way to avoid contamination by wheat, rye, 
barley, or their crossbred va rieties and the gluten content of such oats must not 
exceed 20 mg/kg. 
4. Foodstuffs for people intolerant to glute n, consisting of or c ontaining one or more 
ingredients which substitute wheat, rye, barl ey, 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 a dvertising 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 thei r crossbred varieties and ingredients made 
from wheat, rye, barley, oats or their cro ssbred varieties which ha ve 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-fr ee' referred 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 foodstuff s 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 followi ng 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 neve rtheless suitable, by virtue of their 
composition, to meet the special dietary needs of people intolerant to gluten. 
2. The labelling, advertising a nd presentation of foodstuffs referred in paragraph 1 shall 
not bear the term 'very low gluten'. EN 6   EN Article 5 
Entry into force and application 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union.  
It shall apply as from the 1st January 2012. However, foodstuffs which at the date of entr y into force of the pr esent 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, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission