EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) 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 hea lth claims made on food are prohibited 
unless they are authorised by the Commissi on 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 Commission and to  deliver an opinion on a 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 The Na tural Push-Up Company, submitted on 
28 November 2008 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 
Natural Push-Up® Tablets and Natural Push-Up® Capsules on female breast 
enhancement (Question No EFSA-Q-2008-784)
2. The claim proposed by the 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal (2009) 1100, 1-9.  
EN 3   EN applicant was worded as follows: "NPU Ta blets imitate female breasts enhancement 
process by 8-PN (8-Prenylnaringenin)".  
(6) On 5 June 2009, the Commission and the Memb er 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 
Natural Push-Up® Tablets and Natural Push-Up® Capsules  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 Clasado Ltd., submitted on 29 December 2008 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 BimunoBT (BGOS) 
Prebiotic on maintaining a healthy gastro-intestinal function (Question No EFSA-Q-
2009-00231)3. The claim proposed by the applicant was worded as follows: "Helps 
maintain a healthy gastro-intestinal (GI) function". 
(8) On 7 July 2009, the Commission and the Memb er 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 
BimunoBT (BGOS) Prebiotic and the claimed eff ect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(9) Following an application from Clasado Ltd., submitted on 15 July 2008 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 BimunoBT (BGOS) Prebiotic on 
support of the immune system (Question No EFSA-Q-2008-230)4. The claim 
proposed by the applicant was worded as follows: "Supports your natural defences". 
(10) On 7 July 2009, the Commission and the Memb er States received the scientific 
opinion from the Authority which concluded th at on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
BimunoBT (BGOS) Prebiotic and the claimed eff ect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(11) Following an application from Sunstar Su isse S.A., submitted on 4 February 2009 
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 Gum 
PeriobalanceTM tablets and chewing gum on oral health (Question No EFSA-Q-2009-
00373)5. The claim proposed by the applicant was worded as follows: "Gum 
PeriobalanceTM, combined with a correct oral hygi ene, helps re-balancing the oral 
microflora and improving oral health". 
(12) On 20 July 2009, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
                                                 
3 The EFSA Journal (2009)1107, 1-10. 
4 The EFSA Journal (2009) 1106, 1-8. 
5 The EFSA Journal (2009) 1178, 1-8.  
EN 4   EN cause and effect relationship had not been  established between the consumption of 
Gum PeriobalanceTM tablets and chewing gum  and the claimed effect. Accordingly, as 
the claim does not comply with the re quirements of Regulat ion (EC) No 1924/2006, it 
should not be authorised. 
(13) The comments from the applicants and the 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. 
(14) Health claims referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006 are 
subject to the transition measur es laid down in Article 28(5 ) of that Regulation only if 
they comply with the conditions therein mentioned, among which that they have to comply with the Regulation. As for the four claims subject to the present Regulation, 
the Authority concluded that a cause and e ffect relationship had not been established 
between the consumption of the foods and the claimed effects and thus they do not 
comply with the Regulation (EC) No 1924/2006, they could not benefit from the 
transition period foreseen in Article 28(5) of  that Regulation. A transition period of six 
months is provided for to enable food busin ess operators to adapt to the requirements 
laid down in this Regulation.  
(15) 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 
Health claims set out in the Annex to this Re gulation shall not be included in the Community 
list of permitted claims as provided for in  Article 13(3) of Regulation (EC) No 1924/2006. 
However, they may continue to be used for si x 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 
 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 Natural Push-Up® 
Tablets and Natural 
Push-Up® 
Capsules NPU Tablets imitate female 
breasts enhancement process by 
8-PN (8-Prenylnaringenin) Q-2008-
784 
Article 13(5) health 
claim based on 
newly developed scientific evidence and/or including a request for the protection of 
proprietary data Bimuno
BT (BGOS) 
Prebiotic  Helps maintain a healthy gastro-
intestinal (GI) function Q-2009-
00231 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Bimuno
BT (BGOS) 
Prebiotic  Supports your natural defences Q-2009-
00230 
Article 13(5) health 
claim based on newly developed scientific evidence 
and/or including a 
request for the protection of 
proprietary data Gum 
Periobalance
TM 
tablets and chewing 
gum Gum PeriobalanceTM, combined 
with a correct oral hygiene, helps re-balancing the oral microflora and improving oral health Q-2009-
00373