EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12574/2013 CIS 
(POOL/E4/2013/12574/12574-EN 
CIS.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made  on foods and referring to the reduction of 
disease risk 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made  on foods and referring to the reduction of 
disease risk 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods
1, and in 
particular Article 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/ 2006 health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that 
Regulation and included in a list of permitted claims. 
(2) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid 
applications to the European Food Safety Au thority (EFSA), hereinafter referred to as 
'the Authority'. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Commission thereof, and to deliver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on  the authorisation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Lactalis B&C, submitted pursuant to Article 14(1)(a) of 
Regulation (EC) No 1924/2006, the Authority was asked to deliver an opinion on a 
health claim related to “Low fat and low tr ans spreadable fat rich in unsaturated and 
omega-3 fatty acids” and reduction of  LDL-cholesterol concentrations.  (Question No 
EFSA-Q-2009-00458)
2. The claim proposed by the applicant was worded as follows: 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2011; 9(5):2168.  EN 3   EN “Replacing a fat rich in saturated/trans fa tty acids by a fat rich in unsaturated fatty 
acids helps to reduce LDL cholesterol. LD L cholesterol is a cardiovascular risk 
factor”. 
(6) On the basis of the data presented, the Authority concluded in its opinion received by 
the Commission and the Member States on 25 May 2011 that a cause and effect 
relationship had been estab lished between the consumpti on of mixtures of dietary 
saturated fatty acids (SFAs) and an increas e in blood LDL-cholesterol concentrations, 
and that replacement of a mixture of SFAs w ith cis-monounsaturated fatty acids and/or 
cis-polyunsaturated fatty acids in foods or diets on a gram-per-gram basis reduces 
LDL-cholesterol concentrations.  Accordingly, a health claim reflecting this conclusion 
should be considered as complying with the requirements of Regulation (EC) No 
1924/2006, and should be included in the Union list of permitted claims. The clinical 
intervention study claimed by the applican t as proprietary, was not considered 
necessary by the Authority for reaching its co nclusion. It is therefore considered that 
the requirement laid down in Article 21(1 )(c) of Regulation (EC) No 1924/2006 is not 
fulfilled and accordingly, protection of propr ietary data should not be granted.  
(7) In its opinion, the Authority concludes that in order to bear the claim, significant 
amounts of saturated fatty acids should be replaced by monounsaturated and/or 
polyunsaturated fatty acids in foods or diet s on a gram-per-gram basis. Therefore, in 
order to ensure that a food provides si gnificant amounts of m onounsaturated and/or 
polyunsaturated fatty acids, it is appropriate to limit the us e of the claim to fats and 
oils and to propose conditions of use in  accordance with the nutrition claim "HIGH 
UNSATURATED FAT" as laid down in th e Annex to Regulation (EC) No 1924/2006.  
(8) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of 
authorising a health claim is to include  certain particulars.  Accordingly, those 
particulars should be set out in  the Annex to this Regulatio n as regards the authorised 
claim and include, as the case may be, the revised wording of the claim, specific 
conditions of use of the claim, and, where a pplicable, conditions or restrictions of use 
of the food and/or an additional statement or  warning, in accordance with the rules laid 
down in Regulation (EC) No 1924/2006 and in line  with the opinions of the Authority.  
(9) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear and reliable and useful  to the consumer, and that wording and 
presentation are taken into account in th at respect. Therefore where the wording of 
claims has the same meaning for consumers as  that of an authorised health claim, 
because they demonstrate the same relations hip that exists between a food category, a 
food or one of its constituents and healt h, they should be subject to the same 
conditions of use indicated in the Annex to this Regulation.  
(10) The comments from the applicants and th e members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No 1924/2006 have been 
considered when setting the measur es provided for in this Regulation. 
(11) 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, EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claim listed in the Annex to th is Regulation may be made on foods placed 
on the Union market in compliance with th e conditions laid down in that Annex.  
2. The health claim referred to paragraph 1 shall be included in  the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
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