EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10121/2014 Rev. 1 CIS 
(POOL/E4/2014/10121/10121R1-EN 
CIS.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
authorising and refusing to authorise certain health claims made on foods and referring 
to the reduction of disease risk 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
authorising and refusing to authorise certain health claims made on foods and referring 
to the reduction of disease risk 
(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 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 (EFS A), 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 deli ver an opinion on the 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) Following an application from Abtei Phar ma Vertriebs GmbH., 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 rela ted to Calcium and vitamin D3 chewing 
tablets and bone loss.  (Question No EFSA-Q-2008-721)
2. The claim proposed by the 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal (2009) 1180, 1-13.  
EN 3   EN applicant was worded as follows: "Chewing tablets with calcium and vitamin D 
improve bone density in women 50 years a nd older. Thus chewing tablets may reduce 
the risk of osteoporotic fractures".  
(6) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 7 August 2009 that a cause and effect 
relationship had been established between the intake of calcium, either alone or in 
combination with vitamin D, and reducing the loss of bone minera l density (BMD) in 
postmenopausal women. Reducing the loss of  BMD may contribute  to a reduction in 
the risk of bone fractures.  Accordingly, two health claims  reflecting this conclusion 
should be considered as complying with the requirements of Regulation (EC) No 
1924/2006, and should be included in the Union list of permitted claims. However, the 
Authority concluded that the informati on provided was insufficient to establish 
conditions of use for the claims. Subseque ntly, the Commission went back to the 
Authority to seek further advice to enable the regulators to set appropriate conditions 
of use for the relevant health claims. The Authority concluded in its opinion received 
by the Commission and the Member States on 17 May 2010 (Question No EFSA-Q-
2009-00940)3 that at least 1200 mg of calcium from  all sources or at least 1200 mg of 
calcium and 800 I.U. (20 μg) of vitamin D from all sour ces should be consumed daily 
in order to obtain the claimed effect. 
(7) When the health claim is made only on calcium , in order to ensure  that a food provides 
a significant quantity of calcium, it is appropriate to set conditions of use which allow the claim to be made only on foods which provide at least 400 mg of calcium per 
quantified portion. 
(8) Taking into account the high level of vitamin D intake required to achieve the claimed 
effect (20 μg), when the health claim is made on the combination of calcium and 
vitamin D, it is appropriate to limit the use of the claim to food supplements. In order to ensure that a food suppl ement would provide a signifi cant quantity of calcium and 
vitamin D in the context of this claim, it is  appropriate to set c onditions of use which 
allow the claim to be made only on food suppl ements which provide at least 400 mg of 
calcium and 15 μg of vitamin D per daily portion. 
(9) Following an application from DSM Nutr itional Products Europe AG, submitted 
pursuant to Article 14(1)(a) of Regulat ion (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of vitamin D and 
risk of falling for men and women 60 years of age and older (Question No EFSA-Q-
2010-01233)
4. The claim proposed by the applican t was worded as follows: “Vitamin 
D reduces the risk of falling. Falling is a risk factor for fractures”.  
(10) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 30 September 2011 that a cause and effect 
relationship had been established between th e intake of vitamin D and a reduction in 
the risk of falling, which is positevely asso ciated with postural instability and muscle 
weakness. A reduction in the risk of fa lling among men and women 60 years of age 
                                                 
3 EFSA Journal (2010); 8(5):1609. 
4 EFSA Journal (2011); 9(9):2382.  
EN 4   EN and older is beneficial to human health by reducing the risk of bone fractures. 
Accordingly, a health claim reflecting th is conclusion should be considered as 
complying with the requirements of Regulation (EC) No 1924/2006, and should be 
included in the Union list of permitted claims. 
(11) In its opinion, the Au thority also conclude d that 800 I.U. (20 μg) of vitamin D, from 
all sources, should be consumed daily in order to obtain the claimed effect. Taking 
into account the high level of vitamin D inta ke required to achieve the claimed effect 
(20 μg), it is appropriate to lim it the use of the claim to f ood supplements. In order to 
ensure that a food supplement would provide a significant quantity of vitamin D in the 
context of this claim, it is appropriate to set conditions of use which allow the claim to be made only on food supplements which provide at least 15 μg of vitamin D per daily 
portion. 
(12) 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 to this Regulatio n as regards the authorised 
claims and include, as the case may be, th e revised wording of the claim, specific 
conditions of use of the claim, and, where a pplicable, 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.  
(13) 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 healt h, they should be subject to the same 
conditions of use indicated in the Annex to this Regulation.  
(14) Following an application from GP International Holding B.V., 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 relate d to glucosamine hydrochloride and reduced 
rate of cartilage degeneration (Question No EFSA-Q-2009-00412)
5. The claim 
proposed by the applicant was worded as follows: "Slowing down/reduce the destruction process of cartilage of the musculoskeletal system and consequently 
reduce the risk of osteoarthritis". 
(15) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 29  October 2009 that a cause and effect 
relationship had not been established between the c onsumption of glucosamine 
hydrochloride and the claimed effect. Accord ingly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(16) Following an application from the Eu ropean Natural Soyfood Manufacturers 
Association (ENSA), the European Vegeta ble Protein Federation (EUVEPRO) and the 
Soya Protein Association (SPA), submitted pursuant to Article 14(1)(a) of Regulation 
                                                
 
5 EFSA Journal 2009; 7(10):1358.   
EN 5   EN (EC) No 1924/2006, the Authority was require d to deliver an opinion on a health 
claim related to the effects of isolat ed soy protein on reduction of blood LDL-
cholesterol concentrations (Question No EFSA-Q-2011-00784)6. The claim proposed 
by the applicant was worded as follows: "Protein-rich soybean component has been 
shown to lower/reduce blood cholesterol; bl ood cholesterol lowe ring may reduce the 
risk of (coronary) heart disease". 
(17) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 2 February 2012 that a cause and effect 
relationship had not been established between  the consumption of isolated soy protein 
(as defined by the applicant) and the clai med effect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(18) Following an application from Health  Concern B.V., 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 rela ted to a combination of plant sterols and 
Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations  
(Question No EFSA-Q-2009-00237, EFSA-Q-2011-01114)7. The claim proposed by 
the applicant was worded as follows: “Actively lowers cholesterol”.  
(19) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 17 July 2012 that a cause and effect 
relationship had not been established betw een the consumption of a combination of 
plant sterols and Cholesternorm®mix a nd the claimed effect at the proposed 
conditions of use. Accordingly, as the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(20) Following an application from Minami Nu trition Health BVBA, 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 relate d to the effects of eicosapentaenoic acid 
(EPA) on a reduction of the Arachidonic Acid  (AA)/EPA ratio in  blood in children 
with attention deficit hype ractivity disorder (ADHD) (Question No EFSA-Q-2012-
00573)8. The claim proposed by the applicant was worded as follows: “EPA has been 
shown to reduce the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in 
the development of attention difficult ies in children with ADHD-like symptoms. 
These children are also characterise d by less hyperactivity and/or coexisting 
oppositional behaviour”. 
(21) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 8 April 2013 that the target population for 
the claim is a diseased population (i.e. ch ildren with ADHD) and that the claimed 
effect relates to the tr eatment of a disease.  
                                                 
6 EFSA Journal 2012; 10(2):2555.  
7 EFSA Journal 2012; 10(7):2810.  
8 EFSA Journal 2013; 11(4):3161.  
EN 6   EN (22) Regulation (EC) No 1924/2006 complements th e general principles of Directive 
2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the 
approximation of the laws of the Member St ates relating to the labelling, presentation 
and advertising of foodstuffs9. Article 2(1)(b) of Direct ive 2000/13/EC provides that 
the labelling shall not attri bute to any foodstuff the propert y of preventing, treating or 
curing a human disease, or refer to such pr operties. Accordingly, as the attribution of 
medicinal properties to foods is prohibite d, the claim related to the effects of 
eicosapentaenoic acid (EPA) on a reduction of  the AA/EPA ratio in blood in children 
with ADHD should not be authorised. 
(23) Following an application from McNeil Nu tritionals and Raisio Nutrition Ltd., 
submitted pursuant to Article 14(1)(a ) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opi nion on a health claim related to the 
consumption of 2g/day of plant stanols (as plan t stanol esters) as part of a diet low in 
saturated fat and a two-fold greater reducti on in blood LDL-choleste rol concentrations 
compared to the consumption of a diet low in saturated fat alone  (Question No EFSA-
Q-2012-00915)10. The claim proposed by the applicant was worded as follows: 
“Consuming 2 g/day plant stanols (as plant st anol esters) as part of a diet low in 
saturated fat results in a 2-fold greater re duction in LDL-choleste rol than consuming a 
low saturated fat diet alone. High cholesterol is a risk factor in the development of 
coronary heart disease”. 
(24) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 8 April 2013 that the evidence provided by 
the applicant does not establish that the cons umption of 2 g/day plant stanols (as plant 
stanol esters) as part of a diet low in saturated fat results in a two-fold greater reduction in LDL-cholesterol concentrations compared with consuming a diet low in 
saturated fat alone. Accordingly, as the cl aim does not comply with the requirements 
of Regulation (EC) No 1924/2006, it should not be authorised. 
(25) 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. 
(26) The addition of substances to or the use of  substances in foodstuffs is governed by 
specific Union and national legislation, as  is the classification of products as 
foodstuffs or medicinal products. Any decisi on on a health claim in accordance with 
Regulation (EC) No 1924/2006 such as incl usion in the list of permitted claims 
referred to in Article 14(1) thereof does not constitute an authorisation to the 
marketing of the substance on which the cl aim is made, a decision on whether the 
substance can be used in foodstuffs, or a classification of a certain product as a 
foodstuff. 
(27) 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, 
                                                
 
9 OJ L 109, 6.5.2000, p. 29. 
10 EFSA Journal 2013; 11(4):3160.   
EN 7   EN HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims listed in Annex I to this Regulation may be made on foods placed 
on the Union market in compliance with the conditions laid down in that Annex. 
2. The health claims referred to in paragrap h 1 shall be included in the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
The health claims listed in Annex II to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Ar ticle 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 
 The President  José Manuel BARROSO