EN EN
EUROPEAN
COMMISSION
Brussels, XXX
SANCO/10389/2013 
(POOL /E4/2013/10389/10389 -EN.doc)
[…](2013) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
refusing to authorise certain health claims made on foods, other than those referring to 
the reduction of dis ease risk and to children's development and health 
(Text with EEA relevance)EN 2 ENCOMMISSION REGULATION (EU) No …/..
of XXX
refusing to authorise certain health claims made on foods, other than those referring to 
the reduction of disease risk and to children's development and health 
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
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 foods1, and in 
particular Article 18(5) 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 also 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 Fo od Safety Authority (EFSA), hereinafter referred to as 
the Authority , for a scientific assessment, as well as to the Commission and the 
Member States for information. 
(3) The Authority is 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 b y the Authority .
(5) Following an application from PiLeJe,submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of acombination of B. longum LA 101, L. helveticus 
LA 102, L. lactis LA 103 and S. thermophilus LA 104 and intestinal discomfort 
(Question No EFSA -Q-2012 -00588)2. The claim proposed by the applicant was 
worded, inter alia ,as follows: “Improves intestinal comfort” .
  
1OJ L 404, 30.12.2006, p. 9.
2The EFSA Journal 2013; 11( 2):30 85.EN 3 EN(6) On 12 February  2013, the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relations hip could not been established between the consumption of a 
combination of B. longum LA 101, L. helveticus LA102, L. lactis LA 103 and S. 
thermophilus LA 104 and the claimed effect. Accordingl y, as the claim does not 
comply with the requirements of Regula tion (EC) No 1924/2006, it should not be 
authorised.
(7) Following an application from PiLeJe, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of a combination of B. longum LA 101, L. helveticus 
LA 102, L. lactis LA 103 and S. thermophilus LA 104 and stool frequency  (Question 
No EFSA -Q-2012 -0058 9)3. The claim proposed by the applicant was worded , inter 
alia,as follows: “Regulates your (intestinal) tra nsit”.
(8) On 12 February 2013, the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relationship could not been established between the consumption of a 
combination of B. longum LA 101, L. helveticus LA102, L. lactis LA 103 and S. 
thermophilus LA 104 and the claimed effect. Accordingl y, 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 Nutrilinks Sarl ,submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of EFAX™ and reduction of menstrual discomfort 
(Question No EFSA -Q-2012 -00591 )4. The claim proposed b y the applicant was 
worded ,inter alia ,as follows: “EFAX™ contributes to maintain a normal 
menstruation cy cle”.
(10) On 12 February 2013 , the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relationship had not been established between the consumption of 
EFAX™ and the claimed effect. Accordingl y, as t he claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(11) Following an application from Kemin Foods L C,submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authority was required to de liver an opinion on 
a health claim related to the effects of Slendesta® Potato Extract and reduction of 
body weight (Question No EFSA -Q-2012 -00704)5. The claim proposed b y the 
applicant was worded as follows: “Slendesta® contributes to the reduction of bod y 
weight in overweight individuals ”.
(12) On 12 February 2013 , the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relationship had not been establi shed between the consumption of 
  
3The EFSA Journal 2013; 11(2):3086.
4The EFSA Journal 2013; 11( 2):30 81.
5The EFSA Journal 2013; 11 (2):3083 .EN 4 ENSlendesta® Potato Extract and the claimed effect. Accordingl y, as the claim does not 
comply with the requirements of Regulation (EC) No 1924/2006, it should not be 
authorised.
(13) Following an application from Zambon B.V. ,submi tted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Monurelle® and reduction of bacterial 
colonisation of the urinary tract (Question No EFSA -Q-2012 -00737)6. The claim 
proposed b y the applicant was worded, inter alia , as follows: “ Proanthocy anidins from 
Monurelle® may help to support defence against bacterial pathogens in the lower 
urinary tract”.
(14) On 12 February 2013 , the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relationship had not been established between the consumption of 
Monurelle® and the claimed effect. Accordingl y,as the claim d oes not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(15) Following an application from S.A. Vich y Catalan ,submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on 
a health claim related to the effects of Vichy Catalan carbonated natural mineral water 
and reduction of post -prandial lipaemic response (Question No EFSA -Q-2012 -
00872)7. The claim proposed by the applicant was worded as follows: “Vichy Catal an, 
a bicarbonated natural mineral water rich in mineral salts, contributes to reduce blood 
triglycerides rise during digestion ”.
(16) On 12 February 2013 , the Commission and the Member States received the scientific 
opinion from the Authority , which concluded that on the basis of the data presented, a 
cause and effect relationship had not been established between the consumption of 
Vichy Catalan carbonated natural mineral water and the claimed effect. Accordingl y, 
as the claim does not comply with the requireme nts of Regulation (EC) No 1924/2006, 
it should not be authorised.
(17) The health claim related to Slendesta® Potato Extract is ahealth claim as referred to in 
point (c) of Article 13(1) of Regulation (EC) No 1924/2006 and istherefore subject to 
the transitio nal period laid down in Article 28(6) of that Regulati on. However, as the 
application wasnot made before 19 January 2008, the requirement provided for in 
point (b) of Article 28(6) of that Regulation is not fulfilled, and therefore th isclaim 
maynot bene fit from the transitional period provided for in that Article.
(18) The other health claims subject to this Regulation are health claims as referred to in 
point (a) of Article 13(1) of Regulation (EC) No 1924/2006, which are subject to the 
transitional period l aid down in Article 28(5) of that Regulation until the adoption of 
the list of permitted health claims provided that they comply with that Regul ation.
  
6The EFSA Journal 2013; 11( 2):3082 .
7The EFSA Journal 2013; 11 (2):30 87.EN 5 EN(19) The list of permitted health claims has been established by Commission Regulation
(EU) No 432/20128and i s applicable since 14 December 2012. As regards claims 
referred to in Article 13(5) of Regulation (EC) No 1924/2006 for which the evaluation 
bythe Authorit y or consideration b y the Commission has not been completed by  
14December 2012 and which by virtue of this Regulation are not included in the list 
of permitted health claims, it is appropriate to provide for a transitional period during 
which they maystill be used, in order to allow both food business operators and the 
competent national authorities to adapt to the prohibition of such claims.
(20) The comments from the applicants and the members of the public received b y the 
Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been 
considered when setting the measures provided for in thi s Regulation.
(21) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health and neither the European 
Parliament nor the Council have opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
1. The health claim slisted in the Annex to this Regulation shall not be included in the 
Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 
1924/2006.
2. However, thehealth claim sreferred to in paragraph 1 used prior to the entry into 
force of this Regulation, maycontinue 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 publi cation 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
  
8OJ L 136, 25.5.2012, p. 1.EN 6 ENANNEX 
Rejected health claims
Application –
Relevant provisions 
of Regulation (EC) 
No 1924/2006Nutrient, 
substance, food 
or food categoryClaimEFSA 
opinion 
reference
Article 13(5) health 
claim based on newly 
developed scientific 
evidence and/or 
including a request for 
the protection of 
proprietary dataAcombination of 
B. longum LA 
101, L. helveticus 
LA 102, L. lactis 
LA 103 and S. 
thermophilus LA 
104Improves intestinal comfort Q-2012 -
00588
Article 13(5) health 
claim based on newly 
developed scientific 
evidence and/or 
including a r equest for 
the protection of 
proprietary dataAcombination of 
B. longum LA 
101, L. helveticus 
LA 102, L. lactis 
LA 103 and S. 
thermophilus LA 
104Regulates your (intestinal) 
transitQ-2012 -
00589
Article 13(5) health 
claim based on newly 
developed scienti fic 
evidence and/or 
including a request for 
the protection of 
proprietary dataEFAX™ “EFAX™ contributes to 
maintain a normal menstruation 
cycleQ-2012 -
00591
Article 13(5) health 
claim based on newly 
developed scientific 
evidence and/or 
including a request for 
the protection of 
proprietary dataSlendesta® Potato 
ExtractSlendesta® contributes to the 
reduction of bod y w eight in 
overweight individualsQ-2012 -
00704
Article 13(5) health 
claim based on newly 
developed scientific 
evidence and/or 
including a request for 
the protection of 
proprietary dataMonurelle® Proanthocy anidins from 
Monurelle® may help to support 
defence against bacterial 
pathogens in the lower urinary 
tractQ-2012 -
00737EN 7 ENArticle 13(5) health 
claim based on newly 
developed scientific 
evidence and/or 
including a request for 
the protection of 
proprietary dataVichy Catalan 
carbonated natural 
mineral waterVichy Catalan, a bicarbonated 
natural mineral water rich in 
mineral salts, contributes to 
reduce blood trigly cerides rise 
during digestionQ-2012 -
00872