EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion of certain health claims made on food 
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 food 
and referring to the reduction of disease risk  and to children's development and health  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 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 authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) On 14 November 2008 the Commission and th e Member States received two opinions 
on applications for health claim author isation from the Authority. On 10 December 
2008, the Commission and the Memb er States received five opinions on applications 
for health claim authorisation from the Authority. On 19 December 2008, the Commission and the Member Stat es received nine opinions on  applications for health 
claim authorisation from the Authority. On 15 January 2009, the Commission and the 
Member States received one opinion on an a pplication for health claim authorisation 
from the Authority. Meanwhile one applicat ion for health claim authorisation was 
subject to a previous decision. 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. EN 3   EN (6) One opinion was related to an application for reduction of disease risk claim, as 
referred to in Article 14(1)(a) of Regul ation (EC) No 1924/2006, and fifteen opinions 
were related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006. 
(7) Following an application from LEAF In t and Leaf Holland and Leaf Suomi Oy 
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 
xylitol chewing gum/pastilles on the risk of tooth decay (Question No EFSA-Q-2008-
321)
2. The claim proposed by the applicant wa s worded as follows: "Xylitol chewing 
gum/pastilles reduces th e risk of caries". 
(8) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship was established between the consumption of chew ing gum sweetened 
with 100% xylitol and the claimed effect. Ho wever, it concluded that a cause and 
effect relationship had not been established between the consumption of pastilles sweetened with at least 56% xylitol and th e claimed effect. S ubject to a revised 
wording, the claim should be considered as complying with the requirements of 
Regulation (EC) No 1924/2006 and in particular  Article 14(1)(a) ther eof, and it should 
be included in the Community list of permitted claims.  
(9) Following an application from Danone S.A. submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of da iry fresh cheese with significant amounts of 
calcium, vitamin D, phosphorus  and protein on bone growth (Question No EFSA-Q-
2008-217)
3. The claim proposed by the applicant was worded as follows: "Dairy fresh 
cheese contains calcium, vitamin D, phosphorus and protein, nutrients that contribute 
to healthy bone growth".  
(10) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship was established between th e consumption of calcium, vitamin D, 
phosphorus and protein and the claimed effect. Subject to a revised wording and taken 
into account that health claims for the same claimed effect are authorised for calcium, 
vitamin D and protein, the claim for phosphor us should be considered as complying 
with the requirements of Regulation (E C) No 1924/2006, and it s hould be included in 
the Community list of permitted claims.  
(11) 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 
two authorised claims and include, as th e case may be, the revised wording of the 
claim, specific conditions of use of the cl aim, 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. 
(12) One of the objectives of the Regulation (E C) No 1924/2006 is to ensure that health 
claims are truthful, clear and reliable and useful to the consumer, and that wording and 
presentation have to be take n into account in that respec t; that therefore where the 
wording of claims has the same meaning for c onsumers as that of an authorised health 
                                                 
2 The EFSA Journal (2008) 852, 1-16. 
3 The EFSA Journal (2008) 895, 1-10. EN 4   EN claim as they demonstrate the same relations hip that exists between a food category, a 
food or one of its constituents and hea lth, included in Annex I to the present 
Regulation, they should be subject to the sa me conditions of use indicated therein.  
(13) Following an application from the Inst itute of Biotechnology, Sera and Vaccines 
BIOMED S.A., submitted pursuant to Ar ticle 14(1)(b) of Re gulation (EC) No 
1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of LACTORAL on the normal functioning of the alimentary tract  
(Question No EFSA-Q-2008-269)4. The claim proposed by th e applicant was worded 
as follows: "LACTORAL helps to bring back the normal functioning of the alimentary tract during its microflora di sturbances (for example in case of loose stools, after 
taking antibiotics, in case of intestinal disorders caused by enteric pathogens)".  
(14) On the basis of the data presented, the Authority concluded that the constituents of 
LACTORAL are insufficiently characterised, and that a cause and effect relationship 
had not been established between the c onsumption of LACTORAL and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(15) Following an application from the Inst itute of Biotechnology, Sera and Vaccines 
BIOMED S.A., submitted pursuant to Ar ticle 14(1)(b) of Re gulation (EC) No 
1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of LACTORAL on the im provement of the general immunity (Question 
No EFSA-Q-2008-477)
5. The claim proposed by the applicant was worded as follows: 
"LACTORAL is recommended in order to  improve the general immunity by 
maintaining the microbiological balance".  
(16) On the basis of the data presented, the Authority concluded that the constituents of 
LACTORAL are insufficiently characterised, and that a cause and effect relationship 
had not been established between the c onsumption of LACTORAL and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(17) Following an application from the Inst itute of Biotechnology, Sera and Vaccines 
BIOMED S.A., submitted pursuant to Ar ticle 14(1)(b) of Re gulation (EC) No 
1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of LACTORAL on the building of the natural intestinal barrier (Question No EFSA-Q-2008-478)
6. The claim proposed by th e applicant was worded 
as follows: "LACTORAL helps to protect the alimentary system against enteric 
pathogens because of strong antagonistic properties and helps to build the natural intestinal barrier".  
(18) On the basis of the data presented, the Authority concluded that the constituents of 
LACTORAL are insufficiently characterised, and that a cause and effect relationship 
had not been established between the c onsumption of LACTORAL and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(19) Following an application from the Inst itute of Biotechnology, Sera and Vaccines 
BIOMED S.A., submitted pursuant to Ar ticle 14(1)(b) of Re gulation (EC) No 
                                                
 
4 The EFSA Journal (2008) 861, 1-9. 
5 The EFSA Journal (2008) 860, 1-8. 
6 The EFSA Journal (2008) 859, 1-9. EN 5   EN 1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of LACTORAL on the mainte nance of natural intestinal microflora 
during travel (Question No EFSA-Q-2008-479)7. The claim proposed by the 
applicant was worded as follows: "LACTORA L helps to maintain natural intestinal 
microflora during travel, changing the clim atic zone or a diet, especially in poor 
hygiene conditions".  
(20) On the basis of the data presented, the Authority concluded that the constituents of 
LACTORAL are insufficiently characterised, and that a cause and effect relationship 
had not been established between the c onsumption of LACTORAL and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(21) Following an application from the Inst itute of Biotechnology, Sera and Vaccines 
BIOMED S.A., submitted pursuant to Ar ticle 14(1)(b) of Re gulation (EC) No 
1924/2006, the Authority was required to deliv er an opinion on a he alth claim related 
to the effects of LACTORAL on the living probiotic bacteria (Question No EFSA-Q-
2008-480)8. The claim proposed by the applicant was worded as follows: 
"LACTORAL contains living probiotic bacteria with strong ability to intestinal tract 
colonisation, isolated from h ealthy, naturally fed infants".  
(22) On the basis of the data presented, the Authority concluded that the constituents of 
LACTORAL are insufficiently characterised, an d that the claimed effect had not been 
shown. Accordingly, as the claim does no t comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(23) Following an application from Potters Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Mumomega® on the central nervous system 
development (Question No EFSA-Q-2008-328 )9. The claim proposed by the 
applicant was worded as follows: "Mumomega® provides the nourishments that 
support healthy central ner vous system development". 
(24) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of the food and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(25) Following an application from Efamol Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the e ffects of Efalex® on coordination (Question No EFSA-Q-
2008-121)10. The claim proposed by the applican t was worded as follows: "Efalex® 
may help maintain coordination". 
(26) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of Efalex® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
                                                 
7 The EFSA Journal (2008) 863, 1-8. 
8 The EFSA Journal (2008) 862, 1-2. 
9 The EFSA Journal (2008) 902, 1-9. 
10 The EFSA Journal (2008) 896, 1-9. EN 6   EN (27) Following an application from Efamol Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Efalex® on concentration  (Question No EFSA-
Q-2008-317 )11. The claim proposed by the applicant was worded as follows: "Efalex® 
may help maintain concentration". 
(28) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of Efalex® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(29) Following an application from Efamol Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Efalex® on brain development and function 
(Question No EFSA-Q-2008-318)12. The claim proposed by the applicant was 
worded as follows: "Efalex® may help ma intain and support brain development and 
function". 
(30) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of Efalex® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(31) Following an application from Efamol Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Efalex® on the learning ability (Question No 
EFSA-Q-2008-319)13. The claim proposed by the applicant was worded as follows: 
"Efalex® may help maintain learning ability". 
(32) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of Efalex® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(33) Following an application from Efamol Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of  Efalex® on eye development and function 
(Question No EFSA-Q-2008-320)14. The claim proposed by the applicant was 
worded as follows: "Efalex® may help maintain and support eye development and function". 
(34) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the consumption of Efalex® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(35) Following an application from Potters Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Eye q baby® on the central nervous system 
                                                
 
11 The EFSA Journal (2008) 897, 1-10. 
12 The EFSA Journal (2008) 898, 1-2. 
13 The EFSA Journal (2008) 899, 1-10. 
14 The EFSA Journal (2008) 900, 1-2. EN 7   EN development (Question No EFSA-Q-2008-119)15. The claim proposed by the 
applicant was worded as follows: "Eye q baby® provides the nourishments that support healthy central ner vous system development". 
(36) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established betw een the intake of Eye q baby® and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(37) Following an application from Potters Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effect s of Eye q® on brain functions (Question No EFSA-
Q-2008-329)
16. The claim proposed by the applicant was worded as follows: "Eye q® 
provides the nourishments that help childre n to maintain healthy brain functions". 
(38) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established between  the intake of Eye q® and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(39) Following an application from Potters Ltd., submitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Eye q® on concentration (Question No EFSA-Q-
2008-330)17. The claim proposed by the applicant was worded as follows: "Eye q® 
provides the nourishments that help childre n to maintain concentration levels ". 
(40) On the basis of the data presented, the Au thority concluded that  a cause and effect 
relationship had not been established between  the intake of Eye q® and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(41) 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 measur es provided for in this Regulation. 
(42) In accordance with Article 28(6) of Re gulation (EC) No 1924/2006 health claims 
referred to in Article 14(1)(b) of Regulat ion (EC) No 1924/2006 and not authorised by 
this Regulation may continue to be used for six months after the adoption of a decision 
pursuant to Article 17(3) of Regulation (E C) No 1924/2006. However, for applications 
which were not made before 19 Janua ry 2008 the requirement provided for in 
Article 28(6)(b) is not fulfilled, and the transition period laid down in that Article is not applicable. Accord ingly, a transition period of six months should be provided for, 
to enable food business opera tors to adapt to the requirements la id down in this 
Regulation. 
(43) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
                                                
 
15 The EFSA Journal (2008) 901, 1-8. 
16 The EFSA Journal (2008) 903, 1-8. 
17 The EFSA Journal (2008) 904, 1-2. EN 8   EN HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims set out in Annex I to this Regulation may be made on food on the 
Community market in compliance with th e conditions set out in that Annex. 
Those health claims shall be included in a list of permitted claims referred to in Article 14(1) 
of Regulation (EC) No 1924/2006.  
Article 2 
The health claims set out in Annex II to this Regulation shall not be in cluded in the 
Community list of permitted claims as provided for in Article 14(1) 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 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 
 Androulla VASSILIOU  Member of the Commission  
EN 9   EN ANNEX I  
Permitted health claims 
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 LEAF Int and Leaf 
Holland, Hoevestein 
26,4903 SC Oosterhout NB, The Netherlands, and Leaf Suomi Oy, PO Box 25, FI-21381 Aura, 
Finland Chewing gum 
sweetened with 
100% xylitol Chewing gum 
sweetened with 100% 
xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries 
in children Information to the 
consumer that the 
beneficial effect is obtained with a consumption of 2-3g of chewing gum sweetened with 100% xylitol at least 3 times per day after the 
meals  Q-2008-321 
Article 
14(1)(b) health claim referring to children’s development 
and health DANONE S.A., 
C/Buenos Aires, 21, 08029 Barcelona, 
Spain Phosphorus  Phosphorus is needed 
for the normal growth and development of 
bone in children The claim can be used 
only for food which is at least a source of phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 1924/2006  Q-2008-217 
  
EN 10   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)(b) health claim 
referring to children’s development 
and health  LACTORAL LACTORAL helps to bring back 
the normal functioning of the 
alimentary tract during its microflora disturbances (for example in case of loose stools, after taking antibiotics, in case of intestinal disorders caused by 
enteric pathogens) EFSA-Q-2008-269 
Article 14(1)(b) health claim 
referring to children’s development 
and health  LACTORAL LACTORAL is recommended in 
order to improve the general immunity by maintaining the 
microbiological balance EFSA-Q-2008-477 
Article 14(1)(b) health claim 
referring to children’s development 
and health  LACTORAL LACTORAL helps to protect the 
alimentary system against enteric pathogens because of strong antagonistic properties and helps to 
build the natural intestinal barrier EFSA-Q-2008-478  
EN 11   EN Application - Relevant provisions 
of regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(b) health claim 
referring to children’s development 
and health  LACTORAL LACTORAL helps to maintain 
natural intestinal microflora during 
travel, changing the climatic zone or a diet, especially in poor hygiene 
conditions EFSA-Q-2008-479 
Article 14(1)(b) health claim 
referring to children’s development 
and health  LACTORAL LACTORAL contains living 
probiotic bacteria with strong 
ability to intestinal tract colonisation, isolated from healthy, 
naturally fed infant EFSA-Q-2008-480 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Mumomega® Mumomega® provides the 
nourishments that support healthy central nervous system 
development EFSA-Q-2008-328 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Efalex® Efalex® may help maintain 
coordination EFSA-Q-2008-121 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Efalex® Efalex® may help maintain 
concentration EFSA-Q-2008-317  
EN 12   EN Application - Relevant provisions 
of Regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Efalex® Efalex® may help maintain and 
support brain development and 
function EFSA-Q-2008-318 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Efalex® Efalex® may help maintain 
learning ability EFSA-Q-2008-319 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Efalex® Efalex® may help maintain and 
support eye development and 
function EFSA-Q-2008-320 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Eye q baby® Eye q baby® provides the 
nourishments that support healthy central nervous system 
development EFSA-Q-2008-119 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Eye q® Eye q® provides the nourishments 
that help children to maintain 
healthy brain functions EFSA-Q-2008-329 
Article 14(1)(b) health claim 
referring to children’s development 
and health  Eye q® Eye q® provides the nourishments 
that help children to maintain 
concentration levels EFSA-Q-2008-330