EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10700/2018 
(POOL/E1/2018/10700/10700 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise certain health claims made on foods, other than those referring to 
the reduction of disease risk and to children's development and health  
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise certain health claims made on foods, other than those 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 t he 
Council of 20 December 2006 on nutrition and health claims made on foods1, and in 
particular Article 18(5) 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 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', for a scientific assessment, as well as to the Commission and the 
Member States for information.  
(3) The Authority is to deliver an opinion on the 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) Following an application from Lonza Ltd, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to L-carnitine and normal lipid metabolism (Question No EFSA - 
Q-2017- 00564).  The claim proposed by the applic ant was worded as follows: ‘ L-
carnitine contributes to normal lipid metabolism’ . 
(6) On 16 January 2018, the Commission and the Member States received the scientific 
opinion2 from the Authority, which concluded that , on the basis of the data presented,  
a cause and effect relationship has not been established between the consumption of  L-
carnitine and contribution to normal lipid metabolism  in the target population. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/ 2006, it should not be authorised.  
(7) Following an application from Unilever N .V., submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to black tea and maintenance of normal endothelium -dependent 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2018 ;16(1):5137 . EN 2  EN vasodilation (Question No EFSA -Q-2017- 00419). The claim proposed by the 
applicant was worded as follows: ‘ improves endothelium -dependent vasodilation 
which contributes to healthy blood flow ’. 
(8) On 16 January 2018, the Commission and the Member States received the scientific 
opinion3 from the Authority, which concluded that , on the basis of the data presented,  
a cause and effect relationship has not been established between the consumption of 
black  tea and  maintenance of normal endothelium -dependent  vasodilation. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised.  
(9) Following an application from Newtricious R&D B.V ., submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an 
opinion on a health claim related to NWT -02, a fixed combination of lutein, 
zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the  loss of vision 
(Question No EFSA -Q-2017- 00539). The claim proposed by the applicant was worded 
as follows: ‘ Consumption of NWT -02 reduces loss of vision’ . 
(10) On 18 January 2018, the Commission and the Member States received the scientific 
opinion4 from th e Authority, which concluded that , on the basis of the data presented,  
a cause and effect relationship has not been established between the consumption of 
NWT -02, a fixed combination of lutein, zeaxanthin and DHA in egg yolk and a 
reduction of the loss of vision. Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(11) Following an application from  TA-XAN AG, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authorit y was required to deliver an opinion on a 
health claim related to xanthohumol in XERME®, a xanthohumol -enriched  roasted 
malt extract, and protection of DNA from oxidative damage (Question No EFSA -Q-
2017- 00663). The claim proposed by the applicant was worde d as follows: ‘ helps to 
maintain the integrity of DNA and protects against oxidative damage in the cells of the 
body ’. 
(12) On 13 March 2018, the Commission and the Member States received the scientific 
opinion5 from the Authority which concluded that , on the basis of the data presented,  a 
cause and effect relationship has not been established between the consumption of 
xanthohumol in XERME®, a xanthohumol -enriched roasted malt extract, and 
protection of DNA  from oxidative damage . Accordingly, as the claim does  not comply 
with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(13) Following an application from Essential Sterolin Products (Pty) Ltd., submitted 
pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health claim related to a combination of beta‐
sitosterol and beta‐sitosterol glucoside and normal function of the immune system 
(Question No EFSA -Q-2018- 00701). The claim proposed by the applicant was worded 
as follows: ‘ contribut es to the normal function of the immune system by restoring 
balance between T H1‐ and T H2- mediated immunity ’. 
(14) On 24 July 2019, the Commission and the Member States received the scientif ic 
opinion6 from the Authority, which concluded that, on the basis of the data presented, 
                                                 
3 EFSA Journal 2018 ;16(1):5138 . 
4 EFSA Journal 2018 ;16(1):5139 . 
5 EFSA Journal 2018 ;16(3):5192 . 
6 EFSA Journal 2019;17( 7):5776 . EN 3  EN a cause and effect relationship cannot be established between the consumption of a 
combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1 and a 
beneficial physiological effect . Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, F ood and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The health claim s listed in the Annex to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Article 13(3) of Regulation (EC) No  1924/2006. 
Article 2  
This Regu lation 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 C ommission  
 The President  
 Ursula von der Leyen