EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels,  
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion of certain health claims made on foods 
and 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 
on the authorisation and refusal of authorisat ion of certain health claims made on foods 
and 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 17(3) 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 of the application, 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) All the opinions referred to in this Regulation are related to applications for reduction 
of disease risk claims, as referred to in  Article 14(1)(a) of Regulation (EC) No 
1924/2006.  
(6) Following an application from Danone Fran ce, 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 effect s of Danacol® on blood cholesterol ( Question No 
                                                
 
1 OJ L 404, 30.12.2006, p. 9.  
EN 3   EN EFSA-Q-2008-779)2. The claim proposed by the applicant was worded as follows: 
"Danacol® reduces LDL-cholesterol by 10%  in 3 weeks, and the reduction is 
maintained with daily consumption. High bl ood cholesterol is one of the main risk 
factors in the development of  (coronary) heart disease". 
(7) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission on 3 August 2009 that a cause and effect relationship had been established between the daily  consumption of 1.6 g of phytosterols and the claimed 
effect. Accordingly, a health claim reflecting this conclusion should be considered as 
complying with the requirements of Re gulation (EC) No 1924/ 2006, and it should be 
included in the Community list of permitted claims.  
(8) On 3 August 2009, the Commission and the Member  States received also the scientific 
opinion from the Authority, based on the re quest of the Commission and a similar 
request from France, following the conclu sions of the Standing Committee of the Food 
Chain and Animal Health and in accordance with Article 19(2) of  Regulation (EC) No 
1924/2006, regarding the possibility  to indicate a qua ntitative effect in  health claims 
related to the effects of plant sterols/pl ant stanols esters a nd lowering of blood 
cholesterol (Question No EFSA-Q-2009-00530 and Q-2009-00718)
3. The Authority 
concluded that for a daily intake of 1.5 – 2.4 g plant sterols/stanols added to foods 
such as yellow fat spreads, dairy products, mayonnaise and salad dressings an average reduction of between 7 and 10.5% can be ex pected and that such reduction is of 
biological significance. In addition, the Authority indicated that the blood LDL 
cholesterol lowering effect is usually esta blished within the 2-3 weeks and can be 
sustained by a continued consump tion of plant sterols/stanols. 
(9) Accordingly, taking into account  the scientific op inion from the Authority and in order 
to ensure that such health claims referring to the magnitude of the claimed effect are 
authorised in a way that would not mislead the consumer, and that their conditions of 
use are set in a coherent way, it is necessary  to set different conditions of use than 
those proposed by the applicant.  
(10) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of 
authorising a health claim should include certain particulars.  Accordingly, those 
particulars should be set out in the Annex I to the present Regulation as regards the 
authorised claim and include, as the case ma y be, the revised wording of the claim, 
specific conditions of use of the claim,  and, where applicable, conditions or 
restrictions of use of the f ood 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. 
(11) 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 that respect. Ther efore, where the wording of 
claims has the same meaning for consumers as  that of an authorised health claim, 
because they demonstrate the same relationship that exists between a food category, a 
                                                
 
2 The EFSA Journal (2009) 1177, 1-12. 
3 The EFSA Journal, (2009) 1175, 1-9.  
EN 4   EN food or one of its constituents and healt h, they should be subject to the same 
conditions of use, as indicated in Annex I.  
(12) Following an application from Cambridge Theranostics Ltd., 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 Lycopene-whey complex 
on risk of athero sclerotic plaques (Question No EFSA-Q-2008-703)4. The claim 
proposed by the applicant was worded as follows: "Lycopene-whey complex prevents 
oxidative damage of plasma lipoproteins, which reduces the build up of arterial 
plaques and reduces the risk of heart disease,  stroke and other clinical complications of 
atherosclerosis". 
(13) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission on 3 August 2009 that a cause and effect relationship had not been 
established between the intake of Lycope ne-whey complex 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.  
(14) Following an application from Clasado Ltd., 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 BimunoTM (BGOS) Prebiotic on reduction of the 
bad bacteria that can cause travellers' diarrhoea (Question No EFSA-Q-2008-232)5. 
The claim proposed by the applicant was word ed as follows: "Regular consumption of 
BimunoTM (BGOS) Prebiotic helps to protect against the bad bacteria than can cause 
the travellers' diarrhoea". 
(15) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission 7 July 2009 that a cause and effect relations hip had not been 
established between the intake of BimunoTM (BGOS) Prebiotic 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.  
(16) 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. 
(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 
The health claim set out in Annex I to this Regulation may be made on foods on the European 
Union market in compliance with th e conditions set out in that Annex. 
                                                 
4 The EFSA Journal (2009) 1179, 1-10. 
5 The EFSA Journal (2009) 1105, 1-9.  
EN 5   EN That health claim shall be included in the Co mmunity list of permitted claims referred to in 
Article 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
The health claims set out in the Annex II to this Regulation shall not be included in the 
Community list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 
1924/2006. 
Article 3 
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 6   EN ANNEX I  
Permitted health claim 
Application 
– Relevant 
provisions of 
Regulation 
(EC) No 
1924/2006 Applicant – 
Address Nutrient, 
substance, food 
or food 
category Claim Conditions of use of the claim Conditions 
and/or 
restrictions 
of use of the 
food and/or 
additional 
statement or 
warning EFSA 
opinion 
reference 
Article 
14(1)(a) health claim referring to a reduction of a 
disease risk Danone France, 
150 Bd Victor Hugo, 93589 Saint-Ouen 
Cedex, France Plant sterols/ 
Plant stanol 
esters Plant sterols and plant 
stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of 
coronary heart disease. Information to the consumer that the 
beneficial effect is obtained with a daily intake of 1,5-2,4 g plant sterols/stanols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the entire range '7 to 10%' and the duration to obtain the effect 'in 2 to 3 weeks' must 
be communicated to the consumer.   Q-2008-779 
  
EN 7   EN ANNEX II  
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 Lycopene-whey complex Lycopene-whey complex prevents 
oxidative damage of plasma 
lipoproteins, which reduces the build up of arterial plaques and reduces the risk of heart disease, stroke and other clinical 
complications of atherosclerosis Q-2008-703 
Article 14(1)(a) health claim 
referring to a reduction of a disease 
risk BimunoTM (BGOS) Prebiotic Regular consumption of BimunoTM 
(BGOS) Prebiotic helps to protect 
against the bad bacteria than can 
cause the travellers' diarrhoea Q-2009-00232