EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10123/2014 
(POOL/E4/2014/10123/10123-EN.doc) 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
on the requirements for the provision of in formation to consumers on the absence or 
reduced presence of gluten in food 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
on the requirements for the provision of in formation to consumers on the absence or 
reduced presence of gluten in food 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 1169/2011 of the European Parliament and of the 
Council of 25 October 2011 on the provisio n of food information to consumers
1, and in 
particular Article 36(3)(d) thereof, 
Whereas: (1) People with coeliac disease suffer from a pe rmanent intolerance to gluten. Wheat (i.e. 
all Triticum species, such as durum wheat, spelt, and khoras an wheat), rye and barley 
have been identified as grains that are sc ientifically reported to contain gluten. The 
gluten present in those grains can cause adve rse health effects to people intolerant to 
gluten and therefore its consumption should be avoided by such people.  
(2) Information on the absence or reduced presen ce of gluten in f ood should help people 
intolerant to gluten to iden tify and choose a varied diet wh en eating inside or outside 
the home.  
(3) Commission Regulatio n (EC) No 41/2009
2 sets out harmonised rules on the 
information provided to consumers on the ab sence ("gluten-free") or reduced presence 
of gluten ("very low gluten") in food. Th e rules of that Regulation are based on 
scientific data and guarantee that consumers are not misled or confused by information 
provided on a divergent basis on the absence or reduced pres ence of gluten in food.  
(4) In the context of the revision of the legi slation on foodstuffs intended for particular 
nutritional uses Regulation (EU) No 609/2013 of  the European Parliament and of the 
Council3 repeals Regulation (EC) No 41/2009 fr om 20 July 2016. It should be ensured 
that, after that date, the provision of information on the absence or reduced presence of 
gluten in food continues to be based on the re levant scientific data  and is not provided 
on a divergent basis which could mislead or confuse the consumers, in accordance with the requirements laid down in Artic le 36(2) of Regulati on (EU) No 1169/2011. It 
                                                
 
1 OJ L 304 , 22.11.2011, p. 18. 
2 Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling 
of foodstuffs suitable for people intolerant to gluten (OJ L 16, 21.1.2009, p. 3). 
3 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food 
intended for infants and young chil dren, food for special medical pur poses, and total diet replacement 
for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of 
the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 
29.6.2013, p. 35).  
EN 3   EN is therefore necessary that uniform conditions  for the application of these requirements 
to food information provided by food business operators on the absence or reduced presence of gluten in food are maintained in the Union and thes e conditions should be 
based on Regulation (EC) No 41/2009.  
(5) Certain foods have been speci ally produced, prepared and/or processed to reduce the 
gluten content of one or more gluten contai ning ingredients or to substitute the gluten 
containing ingredients with ot her ingredients naturally free  of gluten. Other foods are 
made exclusively from ingredients that are naturally free of gluten. 
(6) 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 when using such grains is diffi cult. Consequently, many foods especially 
processed to reduce the gluten content of one  or more gluten cont aining ingredients on 
the market may contain low residual amounts of gluten. 
(7) Most people with intolerance to gluten can include oats in  their diet without adverse 
effect on their health. This is an issu e of ongoing study and investigation by the 
scientific community. However, a major concern 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 rega rd to the relevant information provided on 
those food products by food business operators. 
(8) 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, however,  that the different products are properly 
labelled in order to ensure their correct use by people intolerant to gluten with the 
support of information campaigns fo stered in the Member States. 
(9) It should be possible for a food which is sp ecially produced, prepared and/or processed 
to reduce the gluten content of one or mo re gluten containing ingredients or to 
substitute the gluten containing ingredients with other ingredients naturally free of 
gluten to bear terms indicating either the absence ("gluten-free") or reduced presence 
("very low gluten") of gluten in accord ance with the provisions laid down in this 
Regulation. It should also be possible for this food to bear a statement informing 
consumers that it is specifically formul ated for people intole rant to gluten.  
(10) It should also be possible for a food containi ng ingredients naturally free of gluten to 
bear terms indicating the absence of glute n, provided that the general conditions on 
fair information practices set out in Re gulation (EU) No 1169/2011 are complied with. 
In particular, food information should not be  misleading by sugges ting that the food 
possesses special characteristics when in  fact all similar foods possess such 
characteristics.  
(11) Commission Directive 2006/141/EC
4 prohibits the use of ingredients containing gluten 
in the manufacture of infant formulae and follow-on formulae. Therefore, the use of 
the statements "very low gluten" or "glute n-free" when providing information on such 
products should be prohibited given that pursuant to the present Regulation, these 
                                                 
4 Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae 
and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).   
EN 4   EN statements are used for indicating respectiv ely a content of gluten not exceeding 100 
mg/kg and 20 mg/kg.  
(12) The Codex Standard for Foods for Special Dietary Use for Persons Intolerant to 
Gluten5 should be taken appropriately into consideration for the purposes of this 
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 and subject matter  
This Regulation applies to the provision of information to consumers on the absence or 
reduced presence of gluten in food.  
Article 2 
Definitions  
For the purposes of this Regulation, th e following definitions shall apply: 
(a) "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;   
(b) "wheat" means any Triticum species. 
Article 3 
Information to consumers 
1. Where information is provided to consumer s on the absence or reduced presence of 
gluten in food, such information shall be given only through the statements and in 
accordance with the conditions  set out in the Annex. 
2. The food information referred to in paragraph 1 may be accompanied by the 
statement "suitable for people intolerant to gluten". 
3. The food information referred to in paragraph 1 may be accompanied by the 
statement "specifically formulated for peopl e intolerant to glut en" if the food is 
specially produced, prepared and/or processed to: 
(a) reduce the gluten content of one or more gluten contai ning ingredients or; 
(b) substitute the gluten containing ingredie nts with other ingredients naturally free 
of gluten. 
Article 4 
Infant formulae and follow-on formulae  
The provision of food information on the absence or reduced presence of gluten in infant 
formulae and follow-on formulae as defined in  Directive 2006/141/EC shall be prohibited. 
                                                 
5 http://www.codexalimentarius.net/download/standards/291/cxs_118e.pdf.  
EN 5   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 from 20 July 2016. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO