EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10158/2022 
(POOL/E1/2022/10158/10158 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods and referring to children’s 
development and health  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the C ommission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods and referring 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 foods1, 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 the Union  list of permitted claims.  
(2) Regulation (EC) No 1924/2006 also provides that applications for authorisation 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 A uthority (‘the Authority ’). 
(3) Following the receipt of an application , the Authority is to inform without delay the 
other M ember States and the Commission,  and to deliver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisa tion of the health claim taking into 
account the opinion delivered by the Authority.  
(5) Following an application from the Cyprus International Institute for Environmental 
and Public Health, Cyprus University of Technology, submitted pursuant to Article 
14(1), point (b), of Regulation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on the scientific substantiation of a  health claim related to organic 
foods and their contribution to the protection of body cells and molecules (lipids and 
DNA) from oxidative damage , and whose target population are healthy children 3 to 
15 years old  (Question No EFSA -Q-2021 -00055). The claim proposed by the 
applicant was worded as follows: ‘Organic food (lower  levels  of pesticide residues 
than those in convention al food)  contributes  to the protection of body cells and 
molecules (lipids and DNA) from oxidative damage’ .  
(6) On 20 October 2021 , the Commission and  the Member States received the Authority’s 
scientific opinion2 on that claim . In that opinion, the Authority noted that the level of 
pesticide residues required to characterise foods as ‘organic’ has not been specified 
either in the application or in the human studies submitted for the substantiation of the 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2021;19 (10):6847 .  
EN 2  EN health claim, and  conclud ed that , on the basis of the data presented, the 
food/constituent  ‘organic foods ’, which is the subject of the health  claim, is  not 
sufficiently characterised and therefore a cause and effect relationship cannot be 
established between the consumption of organic foods and the protection of body cells 
and molecules (lipids and DNA) from oxidative damage . Accordingly, as the health 
claim does not comply with the requirements of Regulation (EC) No 1924/2006  for 
the inclusion in the Union list of permitted health claims , it should not be authorised.  
(7) Upon the publication of that Opinion, the Commission did not receive any comments 
pursuant to Article 16(6) of Regulation (EC) No 1924/2006.  
(8) The measures provided for in this Regulation are in accordance with the  opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
The health claim set out  in the Annex to this Regulation shall not be included in the Union list 
of permitted health claims as provided for in Arti cle 14(1) of Regulation (EC) No  1924/2006.  
Article 2  
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  
 Ursula VON DER L EYEN