EN    EN EN 
SANCO/13182/2010 Rev. 1 (POOL/E4/2010/13182/13182R1-EN.doc)  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2011) final 
Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth 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)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth 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 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 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 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 deliver  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 Synbiotec S.r.l.,
 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 Synbio  on maintenance and improvement of 
intestinal well-being (Question No EFSA-Q-2009-00889)2. The claim proposed by the 
applicant was worded as follows: " Synbio persists in the intestin al tract an d favours the 
natural regularity contributing to maintain and improve human inte stinal well-being".  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2010; 8(9):1773.  
EN 3   EN (6) On 27 September 2010, the Commi ssion and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Synbio and the claimed effect. Accordingly, as  the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(7) Following an application from MILTE ITALIA S.p.a., 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 Silymarin BIO-C® on increase in 
production of breast milk (Question No EFSA-Q-2009-00957)3. The claim proposed 
by the applicant was worded, inter alia,  as follows: "Suggested for improving the 
physiological production of breast m ilk during breast feeding".  
(8) On 28 September 2010, the Commi ssion and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Silymarin BIO-C®  and the claimed effect. Accordingl y, as the claim does not comply 
with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(9) All the health claims subject to this Regulati on are health claims as referred to in point 
(a) of Article 13(1) of Regulation (EC)  No 1924/2006 and may benefit from the 
transition period laid down in Article 28( 5) of that Regulation. As the Authority 
concluded that cause and effect relationshi ps have not been established between the 
foods and the respective claimed effects,  the two claims do not comply with 
Regulation (EC) No 1924/2006, and therefore they may not benefit from the transition 
period provided for in that Article. 
(10) In order to ensure that this Regulation is fully complied with, both food business 
operators and the national competent authorit ies should take the necessary actions to 
ensure that, at the latest six months follo wing the entry into force of this Regulation, 
products bearing the health claims listed in its Annex are no longer present on the 
market.  
(11) 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 measures  provided for in this Regulation.  
(12) 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 fo r in Article 13(3) of Regulation (EC) No 
1924/2006. 
                                                 
3 The EFSA Journal 2010; 8(9):1774.  
EN 4   EN 2. However, products bearing these health cl aims placed on the market or labelled prior 
to the date of entry into force of this  Regulation may remain on the market for a 
maximum period of six months after that date.  
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 
 José Manuel BARROSO  The President 
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 13(5) health 
claim based on 
newly developed scientific evidence and/or including a request for the protection of 
proprietary data Synbio  Synbio persists in the intestinal 
tract and favours the natural 
regularity contributing to maintain and improve human 
intestinal well-being Q-2009-
00889 
Article 13(5) health 
claim based on 
newly developed scientific evidence and/or including a request for the protection of 
proprietary data Silymarin BIO-C® Suggested for improving the 
physiological production of 
breast milk during breast feeding Q-2009-
00957