EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11587/2011 Rev. 2 (POOL/E4/2011/11587/11587R2-
EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
refusin
g to authorise certain health claims made on foods and referrin g to the reduction 
of disease risk and to children's development and health 
(Text with EEA relevance) 
  
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
refusing to authorise certain he alth claims made on foods and referring to the reduction 
of disease risk and to child ren's development and health 
(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 Eu ropean Food Safety Authority (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 Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from SVUS Pharma a.s, submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of Prot eQuine®, a mixture of 
free amino acids, oligopeptides and nuc leotides on increase of suppressed 
concentrations of secretory immunoglobulin  A (ScIgA) and reduction of the risk of 
influenza and common cold (Question No EFSA-Q-2008-397)
2. The claim proposed 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(4):2128.   
EN 2   EN by the applicant was worded as follows: "ProteQuine® elevates/maintains the level of 
ScIgA on mucous membranes. Decreased or insu fficient level of ScIgA is a risk factor 
in the development of common cold or influenza". 
(6) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 13 April 2011 that a cause and effect 
relationship had not been established betw een the consumption of ProteQuine® and 
increasing suppressed concentrations of Sc IgA and reducing the ri sk of common cold 
and influenza. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(7) Following an application from SVUS Pharma a.s, submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of Prot eQuine®, a mixture of 
free amino acids, oligopeptides and nucleotides , and bovine lactoferrin on increase of 
suppressed concentrations of secretory immunoglobulin A (ScIgA) and reduction of 
the risk of common cold with sore throat (Question No EFSA-Q-2008-398)3. The 
claim proposed by the applicant was worded as follows: "ProteQuine® in combination 
with bovine lactoferrin elevat es/maintains the level of ScIgA on mucous membranes. 
Decreased or insufficient level of ScIgA is a risk factor in the development of common 
cold with sore throat and combination of ProteQuine® with bovine lactoferrin reduces 
the risk of the development of sore throat". 
(8) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 13 April 2011 that a cause and effect 
relationship had not been established betw een the consumption of ProteQuine® and 
bovine lactoferrin  and increasing suppressed concentra tions of ScIgA and reduction of 
the risk of common cold with sore throat . Accordingly, as the claim does not comply 
with the requirements of Regulation (EC)  No 1924/2006, it should not be authorised.  
(9) Following an application from CSL - Centro Sperimentale del Latte S.p.A., submitted 
pursuant to Article 14(1)(b ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of a combination 
of Lactobacillus delbrueckii subsp. bulgaricus strain  AY/CSL (LMG P-17224) and 
Streptococcus thermophilus strain  9Y/CSL (LMG P-17225) on beneficial modulation 
of intestinal microflora (Question No EFSA-Q-2008-273)4. The claim proposed by 
the applicant was worded as follows: "Maintaining the gut health by normalizing the intestinal flora".  
(10) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 20 July 2011 that a cause and effect 
relationship had not been established between  the consumption of the combination of 
L. delbrueckii subsp. bulgaricus strain AY/CSL (LMG P-17224) and S. thermophilus 
strain 9Y/CSL (LMG P-17225) and a beneficial physiological effect related to the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
                                                
 
3 The EFSA Journal 2011; 9(4):2129.  
4 The EFSA Journal 2011; 9(7):2288.  
EN 3   EN (11) Following an application from the Europ ean Dietetic Food Industry Association 
(IDACE), submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, 
the Authority was required to deliver an opi nion on a health claim re lated to the effects 
of beta-palmitate on increased calcium absorption (Question No EFSA-Q-2008-
172)5. The claim proposed by the applicant was worded, inter alia,  as follows: "Beta 
palmitate enrichment contributes to increase calcium absorption". 
(12) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 28 July 2011 that the evidence provided was insufficient to establish a cause and e ffect relationship between the consumption 
of beta-palmitate and the claimed effect. A ccordingly, as the claim does not comply 
with the requirements of Regulation (EC)  No 1924/2006, it should not be authorised.  
(13) In accordance with Article 28(6) of Regulation (EC) No 1924/2006, health claims 
referred to in its Article 14(1)(b) and not  authorised by a decision pursuant to 
Article 17(3) of Regulation (EC) No 1924/ 2006 may continue to be used for six 
months after the adoption of this Regulation, provided an a pplication was made before 
19 January 2008. Accordingly, th e transition period laid down in that Article is 
applicable to the health claim relevant to beta-palmitate listed in the Annex of this 
Regulation.  
(14) As the health claim application relevant to Lactobacillus delbrueckii subsp. bulgaricus 
strain  AY/CSL (LMG P-17224) and Streptococcus thermophilus strain  9Y/CSL (LMG 
P-17225) was not made before 19 January  2008, the requirement provided for in 
Article 28(6)(b) is not fulfilled, and the tran sition period laid down in that Article is 
not applicable.  
(15) However, in order to ensure that this Regulation is fully complied with, both food 
business operators and the national competen t authorities should take the necessary 
actions to ensure that, at the latest six months following the entry into force of this Regulation, the health claims listed in its Annex that have been submitted pursuant to Article 14(1)(b) of Regulation (E C) No 1924/2006 are no longer used.  
(16) 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. 
(17) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims listed in the Annex to this Regulation shall not  be included in the 
Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006. 
                                                
 
5 The EFSA Journal 2011; 9(7):2289.   
EN 4   EN 2. However, health claims as referred to  in Article 14(1)(b)  of Regulation (EC) 
No 1924/2006 and referred to in paragraph 1 used  prior to the entry into force of this 
Regulation, may continue to be used for a maximum period of six months after the 
entry into force of this Regulation. 
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  
EN 5   EN ANNEX  
Rejected health claims  
Application – Relevant provisions 
of Regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(a) health claim 
referring to a reduction of a disease 
risk ProteQuine®  ProteQuine® el evates/maintains the level 
of ScIgA on mucous membranes. 
Decreased or insufficient level of ScIgA is a risk factor in the development of 
common cold or influenza Q-2008-397 
Article 14(1)(a) health claim 
referring to a reduction of a disease 
risk ProteQuine® in combination with 
bovine lactoferrin  ProteQuine® in combination with bovine 
lactoferrin elevates/maintains the level of ScIgA on mucous membranes. Decreased or insufficient level of ScIgA is a risk factor in the development of common cold with sore throat and combination of ProteQuine® with bovine lactoferrin reduces the risk of the development of 
sore throat Q-2008-398 
Article 14(1)(b) health claim 
referring to children's development 
and health Lactobacillus delbrueckii subsp. 
bulgaricus strain  AY/CSL (LMG 
P-17224) and Streptococcus 
thermophilus strain  9Y/CSL (LMG 
P-17225)  Maintaining the gut health by 
normalizing the intestinal flora Q-2008-273 
Article 14(1)(b) health claim 
referring to children's development 
and health Beta palmitate  Beta palmitate enrichment contributes to 
increase calcium absorption Q-2008-172