COMMISSION REGULATION (EU) No 384/2010  
of 5 May 2010  
on the authorisation and refusal of authorisation 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 health claims 
made on food 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 appli ­
cations 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 Food Safety Authority (EFSA), hereinafter 
referred to as the Authority.  
(3) Following receipt of an application the Authority 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 authorisation 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 France, 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 
Danacol® on blood cholesterol (Question No 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 blood cholesterol is one of the 
main risk factors in the development of (coronary) heart 
disease’.  
(7) On the basis of the data presented, the Authority 
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 Regu ­
lation (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 request of the Commission 
and a similar request from France, following the 
conclusions 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 quantitative effect 
in health claims related to the effects of plant 
sterols/plant stanols esters and 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 expected and that such 
reduction is of biological significance. In addition, the 
Authority indicated that the blood LDL cholesterol 
lowering effect is usually established within the 2-3 
weeks and can be sustained by a continued consumption 
of plant sterols/stanols.  
(9) Accordingly, taking into account the scientific opinion 
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.EN L 113/6 Official Journal of the European Union 6.5.2010  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal  (2009) 1177, 1-12.  
( 3 ) The EFSA Journal  (2009) 1175, 1-9.(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 may be, the revised wording of the 
claim, specific conditions of use of the claim, and, where 
applicable, conditions or restrictions of use of the food 
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. 
Therefore, 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 food or one of 
its constituents and health, 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) (  1 ). 
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 athe ­
rosclerosis’.  
(13) On the basis of the data presented, the Authority 
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 
Lycopene-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 
Bimuno  TM (BGOS) Prebiotic on reduction of the bad 
bacteria that can cause travellers’ diarrhoea (Question 
No EFSA-Q-2008-232) (  2 ). The claim proposed by the 
applicant was worded as follows: ‘Regular consumption 
of Bimuno  TM (BGOS) Prebiotic helps to protect against 
the bad bacteria than can cause the travellers’ diarrhoea’.  
(15) On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
7 July 2009 that a cause and effect relationship had 
not been established between the intake of Bimuno  TM 
(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 au ­
thorised.  
(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 measures provided 
for in this Regulation.  
(17) 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  
The health claim set out in Annex I to this Regulation may be 
made on foods on the European Union market in compliance 
with the conditions set out in that Annex.  
That health claim shall be included in the Community 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.EN 6.5.2010 Official Journal of the European Union L 113/7  
( 1 ) The EFSA Journal  (2009) 1179, 1-10.  (  2 ) The EFSA Journal  (2009) 1105, 1-9.Article 3  
This Regulation shall enter into force on the 20th day following 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, 5 May 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 113/8 Official Journal of the European Union 6.5.2010ANNEX 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-2008-779EN 6.5.2010 Official Journal of the European Union L 113/9ANNEX 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-2009-00232EN L 113/10 Official Journal of the European Union 6.5.2010