EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) 
Draft 
COMMISSION REGULATION (EU) 
of 
refusing to authorise a health claim made on  foods, other than th ose referring to the 
reduction of disease risk and to ch ildren's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION (EU) 
of 
refusing to authorise a health claim made on  foods, other than th ose referring to the 
reduction of disease risk and to ch ildren'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 foods
1, and in 
particular Article 18(5) 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 and to  deliver an opinion on a health claim 
concerned.  
(4) The Commission is to decide on the authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from PROBI AB , submitted on 22 December 2008 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 the effects of Lactobacillus plantarum 
299v on improved iron absorption (Question No EFSA-Q-2008-785)
2. The claim 
proposed by the applicant was worded as follows: " Lactobacillus plantarum 299v 
(DSM 9843) improves iron absorption". 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal (2009) 999, 1-9.  
EN 3   EN (6) On 6 April 2009, the Commission and the Me mber States received the scientific 
opinion from the Authority which concluded th at on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Lactobacillus plantarum 299v (DSM 9843)  and the claimed effect. Accordingly, as the 
claim does not comply with the requirem ents of Regulation (EC) No 1924/2006, it 
should not be authorised. 
(7) The comments from the applicants and the 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. 
(8) Health claims referred to in Article 13(1)(a) of Regulation (EC) No 1924/2006 are 
subject to the transition measur es laid down in Article 28(5 ) of that Regulation only if 
they comply with the conditions therein mentioned, among which that they have to comply with the Regulation. As the Author ity concluded that a cause and effect 
relationship had not been establis hed between the consumption of Lactobacillus 
plantarum 299v (DSM 9843) and the claimed effect , the claim does not comply with 
the Regulation (EC) No 1924/2006, and therefore the transition period foreseen in Article 28(5) of that Regulation is not appl icable. A transition period of six months is 
provided for, to enable food business operato rs to adapt to the requirements laid down 
in this Regulation.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them,   
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claim set out in the Annex to th is Regulation shall no t be included in the 
Community list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 
1924/2006. 
However, it may continue to be used for si x months after the entry into force of this 
Regulation. 
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 .  
EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX  
Rejected health claims  
Application – Relevant 
provisions of Regulation 
(EC) No 1924/2006 Nutrient, 
substance, food 
or food category Claim EFSA 
opinion 
reference 
Article 13(5) health claim 
based on newly developed 
scientific evidence and/or including a request for the 
protection of proprietary data Lactobacillus 
plantarum 299v 
(DSM 9843)  Lactobacillus plantarum 
299v (DSM 9843) 
improves iron absorption Q-2008-785