EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/11619/2013 CIS 
(POOL/E4/2013/11619/11619-EN 
CIS.doc) […](2013) XXX  draft 
  
COMMISSION DELEGATED REGULATION (EU) No …/.. 
of XXX  
amending Annexes II and III to Regulati on (EU) No 1169/2011 of the European 
Parliament and of the Council on the provision  of food information to consumers, as 
regards certain cereals causing allergies or intolerances and foods with added 
phytosterols, phytosterol esters, phytostanols or phytostanol esters 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Regulation (EU) No 1169/2011 of the Europe an Parliament and of the Council of 
25 October 2011 on the provision of food information to consumers1 establishes the 
general principles, requirements and res ponsibilities governing food information, and 
in particular food labelling.  
Annex II to Regulation (EU) No 1169/2011 establishes a list of substances or 
products causing allergies or  intolerances. Point 1 of that Annex lists, amongst 
others, 'kamut' and 'spelt'. However,  'kamut' is a trademark, which has been 
registered in over 40 countries throughout the world. This trademark is used for selling a special type of wheat, commonly refe rred to as 'khorasan'. In addition, spelt 
is also a type of wheat. Therefore, this  Delegated Regulation amends Annex II to 
Regulation (EU) No 1169/2011 to properly reflect the nature of 'kamut' and 'spelt' as 
types of wheat.  
Commission Regulation (EC) No 608/ 2004 of 31 March 2004 concerning the 
labelling of foods and food ingredients w ith added phytosterols, phytosterol esters, 
phytostanols and/or phytostanol esters
2 will be repealed by Regulation (EU) No 
1169/2011. The content of Article 2 of Regul ation (EC) No 608/2004 is provided for 
in Annex III to Regulation (EU) No 1169/2011.  
In order to ensure consiste ncy of the information provide d on the labelling of foods 
and food ingredients with added phytostero ls, phytosterol esters , phytostanols and/or 
phytostanol esters, one of the mandatory stat ements laid down in Regulation (EC) No 
608/2004 has been amended by Commission Regulation (EU) No 718/2013.3 This 
Delegated Regulation amends Annex III to Regulation (EU) No 1169/2011 to align it 
to the current wording of Regulation (EC) No 608/2004. 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT 
The Expert Group on Regulation (EU) No  1169/2011 on the provision of food 
information to consumers was consulted durin g the preparation of this delegated act 
on the basis of a Working Document prep ared by the Commission services in two 
meetings that took place on 6 March 2013 and 12 April 2013.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
The legal bases for this Delegated Regul ation are Article 10 (2) and 21(2) of 
Regulation (EU) No 1169/2011, on the basis of which Annexes II and III to that 
Regulation may be amended by delegated acts. 
                                                 
1 OJ L 304, 22.11.2011, p. 18. 
2  Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and 
food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (OJ 
L 97, 1.4.2004, p. 44). 
3 Commission Regulation (EU) No 718/2013 of 25 July 2013 amending Regulation (EC) No 608/2004 
concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, 
phytostanols and/or phytostanol esters (OJ L 201, 26.7.2013, p. 49).  
EN 3   EN COMMISSION DELEGATED REGU LATION (EU) No …/.. 
of XXX  
amending Annexes II and III to Regulati on (EU) No 1169/2011 of the European 
Parliament and of the Council on the provision  of food information to consumers, as 
regards certain cereals caus ing allergies or intoleran ces and foods with added 
phytosterols, phytosterol esters, phytostanols or phytostanol esters 
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 on the provision of food information to consumers
4, and in particular Articles 10(2) 
and 21(2) thereof, 
Whereas: (1) Annex II to Regulation (EU) No 1169/2011 estab lishes a list of substances or products 
causing allergies or intolerances. Point 1 of  Annex II lists, amongst others, 'kamut' and 
'spelt'. However, 'kamut' is a registered trademark of a type of wheat, known as 
'khorasan wheat' and spelt is also a type of  wheat. 'Khorasan wheat' and 'spelt' should 
therefore be indicated as types of  wheat in point 1 of that Annex. 
(2) Annex III to Regulation (EU) No 1169/2011 esta blishes the list of foods for which the 
labelling must include one or  more additional particulars.   Point 5.1 of that Annex 
provides that the labelling of  of foods or food ingredie nts with added phytosterols, 
phytosterol esters, phytostanols or phytostano l esters must cont ain, inter alia, a 
statement that the food is intended exclus ively for people who want to lower their 
blood cholesterol level.  
(3) That statement, in combination with the he alth claims authorised for those foods or 
food ingredients, could potentially lead c onsumers who do not need to control their 
blood cholesterol level to use the product and should therefore be amended. Such 
amendment should reflect the wording of the statement currently provided for in 
Commission Regulation (EC) No 608/2004.
5 That Regulation will  be repealed and 
replaced by Regulation (EU) No  1169/2011 as from 13 December 2014. 
(4) Regulation (EU) No 1169/2011 should th erefore be amended accordingly,   
HAS ADOPTED THIS REGULATION: 
Article 1 
The introductory sentence in point 1 of Annex II to Regulation (EU) No 1169/2011 is 
replaced by the following: 
                                                 
4 OJ L 304, 22.11.2011, p. 18.  
5 Commission Regulation (EC) No 608/2004 of 31 March 2004 concerning the labelling of foods and 
food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (OJ 
L 97, 1.4.2004, p. 44).  
EN 4   EN '1. Cereals containing gluten, namely: wheat (such as spelt and khorasan wheat), rye, 
barley, oats or their hybridised stra ins, and products thereof, except:' 
Article 2 
In the second column of point 5.1 of Annex III to Regulation (EU) No 1169/2011, point (3) is 
replaced by the following: 
'(3) a statement that the product is not in tended for people who do not need to control 
their blood cholesterol level;' 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
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