EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12053/2016 CIS 
(POOL/E1/2016/12053/12053 -EN 
CIS.doc)  
[…](2017) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
authorising a health claim made on foods and referring to the reduction of disease risk  
(Text with EEA relevance)   EN 1  EN  COMMISSION REGULATION (EU) …/…  
of XXX  
authorising a health claim 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 foods1, and in 
particular Article 17(3) thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 health claim s 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 also 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 European Food Safety Authority (EFSA), hereinafter referred to as 
'the Authority'.  
(3) Follo wing receipt of an application the Authority is to inform without delay the other 
Member States and the Commission thereof, and to deliver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisation of health claims taking i nto account 
the opinion delivered by the Authority.  
(5) Following an application from Laboratoire Lescuyer, submitted pursuant to Article 
14(1)(a) of Regulation (EC) No 1924/2006 and including a request for protection of 
proprietary data, the Authority was required to deliver an opinion on a health claim 
related to the combination of artichoke leaf dry extract standardised in caffeoylquinic 
acids, monacolin K in red yeast rice, sugar -cane derived policosanols, procyanidolic 
oligomers  (OPC ) from French maritime pine bark, garlic dry extract standardised in 
allicin, d -α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate and 
the reduction of blood LDL -cholesterol concentrations (Question No EFSA -Q-2012 -
009682). The claim proposed by the applicant was worded as follows “Limicol® has 
been shown to  lower/reduce blood cholesterol. High cholesterol is a risk factor in the 
development of coronary heart disease” . 
(6) On 26 July 2013, the Commission and the Member States received the scientific 
opinion from the Authority which concluded that a cause and effe ct relationship has 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2013;11(7):3327  EN 2  EN  been established between the consumption of the combination of artichoke leaf dry 
extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar -cane 
derived policosanols, OPC from French maritime pine bark, garlic d ry extract 
standardised in allicin, d -α-tocopheryl hydrogen succinate, riboflavin and inositol 
hexanicotinate in the food subject to the claim and a reduction in blood LDL -
cholesterol concentrations. Accordingly, a health claim 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 . 
(7) The Authority indicated in its opinion that it could not have reached its conclusions 
without three human i ntervention studies , which are  claimed by the applicant  as 
proprietary .3  
(8) Following the receipt of the Authority's opinion, the Commission requested  the 
Applicant to further clarify  the justification s provided with regard to their proprietory 
claim over th e human interve ntion studies , and  their claim to  an exclusive right of 
reference  to those studies , as referred to in Article 21(1) of Regulation (EC) No 
1924/2006.  
(9) The Applicant has also declared that, at the time the application was submitted , it held 
proprietary  right as well as  an exclusive  right  of reference  to the studies and that 
therefore third parties could not lawfully  access or  use those studies. The Commission 
assessed all t he information provided by the A pplicant and considered that the 
Applica nt has sufficiently substantiated the fulfillment of the requirements laid down 
in Article 21(1) of Regulation (EC) No 1924/2006.  
(10) Accordingly, the scientific data and other information included in those three studies 
should  not be used by the Authority  for the benefit of a subsequent applicant for a 
period of five years from the date of entry into force of this Regulation. As a 
consequence, the use of the health claim authorised by this Regulation should be 
restricted to the applicant for a period of five  years.  
(11) However, restricting the authorisation of this claim  and of the reference to the studies 
contained in the applicant's file for the sole use of the applicant does not prevent other  
applicants from applying for an authorisation to use the same clai m provided that their 
                                                 
3  Barrat E, Zaïr Y, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M 
and Peltier SL, 2012, unpublished -a. Effect on LDL -cholesterol of a large dose of a dietary portfolio 
supple ment in subjects with untreated moderate hypercholesterolaemia: a double -blind, placebo -
controlled study, published as : Barrat E, Zaïr Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord 
E, Lescuyer JF, Bard JM, Cazaubiel M and Peltier SL, 2012, Effect o n LDL -cholesterol of a large dose 
of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: 
a randomised, double -blind, placebo -controlled study,  European Journal of Nutrition, Dec 25. [Epub 
ahead of print]; Ba rrat E, Zaïr Y, Ogier N, Housez B, Vergara C, Maudet C, Lescuyer JF, Bard JM, 
Carpentier YA, Cazaubiel M and Peltier SL, 2012, unpublished -b. A dietary portfolio supplement 
substantially lowers LDL -cholesterol in subjects with moderate untreated hyperchol esterolaemia: a 
randomised controlled study, published as : Barrat E, Zaïr Y, Ogier N, Housez B, Vergara C, Maudet C, 
Lescuyer JF, Bard JM, Carpentier YA, Cazaubiel M and Peltier SL, 2013,  A combined natural 
supplement lowers LDL cholesterol in subjects wi th moderate untreated hypercholesterolemia: a 
randomized placebo -controlled trial. International Journal of Food Sciences and Nutrition, Jul 2. [Epub 
ahead of print]; Ogier N, Amiot MJ, Georgé S, Maillot M, Mallmann C, Maraninchi M, Morange S, 
Lescuyer JF, Peltier SL and Cardinault N, 2013, LDL -cholesterol -lowering effect of a dietary 
supplement with plant extracts in subjects with moderate hypercholesterolemia, European Journal of 
Nutrition, 52, 547 -557. EN 3  EN  application is based on legally obtained information supporting the authorisation under 
this Regulation.   
(12) One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims 
are truthful, clear and reliable and usefu l to the consumer, and that the wording and the 
presentation are taken into account in that respect. Therefore, where the wording of a 
claim used by an applicant has the same meaning for consumers as that of this 
authorised health claim, because it demonst rates that the same relationship exists 
between a food category, a food or one of its constituents and health, that claim should 
be subject to the same conditions of use as those listed in the Annex to this Regulation.  
(13) In accordance with Article 20 of Regu lation (EC) No 1924/2006, the Register of 
nutrition and health claims containing all authorised health claims should be updated 
in order to take account of this Regulation.  
(14) The comments from the Applicant 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.  
(15) The addition of substances to or the use of substances in foodstuffs is governed by 
specific Union and national legislation, as is the classif ication of products as 
foodstuffs or medicinal products. Any decision on a health claim in accordance with 
Regulation (EC) No 1924/2006 such as inclusion in the list of permitted claims 
referred to in Article 14(1) thereof does not constitute an authorisat ion to the 
marketing of the substance on which the claim is made, a decision on whether the 
substance can be used in foodstuffs, or a classification of a certain product as a 
foodstuff.  
(16) The measures provided for in this Regulation are in accordance with th e opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
1. The health claim listed in the Annex to this Regulation  shall be included in the Union 
list of permitted claims as provided for in Article 14(1) o f Regulation (EC) No 
1924/2006.  
2. For a period of five years from the date of entry into force of this Regulation only the 
Applicant:  
Laboratoire Lescuyer , 
ZAC de Belle Aire Nord,  
15 rue le Corbusier,  
17440 Aytré, France  
is authorised to make the health clai m listed in the Annex to this Regulation, unless a 
subsequent applicant obtains an authorisation to use the same claim without 
reference to the data protected pursuant to Article 2  or with the agreement of 
Laboratoire Lescuyer . 
Article 2  
The studies  includ ed in the application  file on the basis of which the health claim referred to 
in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the EN 4  EN  requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 , shall  not be used 
for the benefit of a subsequent applicant for a period of five years from the date of entry into 
force of this Regulation  without the  prior  agreement of Laboratoire Lescuyer . 
Article 3  
This Regulation shall enter into force on the twentieth day follow ing 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  
 Jean -Claude JUNCKER