EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
SANCO/12826/2011 Rev. 3 (POOL/E4/2011/12826/12826R3-EN.doc) […](2012) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
establishing a list of permitte d 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) No …/.. 
of XXX 
establishing a list of permitted 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 the 
Council of 20 December 2006 on nutrition and health claims made on foods
1, and in 
particular Article 13(3) thereof, 
Whereas: (1) Pursuant to Article 10(1) of 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) Article 13(2) of Regulation (EC) No 1924/ 2006 provides that Member States shall 
submit national lists of health claims made on foods, as referred to in Article 13(1) of 
that Regulation to the Commission, by 31 Janua ry 2008 at the latest. The national lists 
of claims must be accompanied by the condi tions applying to them and by references 
to the relevant scientific justification.  
(3) Article 13(3) of Regulation (EC) No 1924/ 2006 provides that, after consulting the 
European Food Safety Authority (hereinafter  referred to as 'the Authority'), the 
Commission shall adopt a list of permitted heal th claims made on foods, as referred to 
in Article 13(1) of that Regulation, and a ll necessary conditions for the use of those 
claims by 31 January 2010 at the latest . 
(4) On 31 January 2008 the Commission receive d lists with more than 44.000 health 
claims from the Member States. An examination of the national lists showed that due to many duplications and follo wing discussions with Member  States, it was necessary 
to compile the national lists into a consolidated list of the claims for which the Authority should give scientific advice, he reinafter referred to as the 'consolidated 
list'
2.  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 http://www.efsa.europa.eu/en/nd aclaims13/docs/ndaclaims13.zip EN 2   EN (5) On 24 July 2008, the Commission formally transmitted to the Authority the request for 
a scientific opinion pursuant  to Article 13(3) of Re gulation (EC) No 1924/2006, 
together with terms of reference and a first part  of the consolidated list. Subsequent 
parts of the consolidated list were tr ansmitted in November and December 2008. The 
consolidated list was fi nalised by the Commission by an addendum, which was 
forwarded to the Authority on 12 March 2010. Some claims in the consolidated list 
were subsequently withdrawn by Member States before their evaluation by the 
Authority. The scientific evaluation by the Authority concluded in the publication of its opinions between October 2009 and July 2011
3.  
(6) In its evaluation the Authority  found that some submissions  covered different claimed 
effects or brought together the same claimed effect. Th erefore, a health claim 
considered in this Regulation may repres ent one or more of the entries on the 
consolidated list. 
(7) For a number of health claims the Authority  concluded that, on th e basis of the data 
submitted, a cause and effect relationship has been established between a food category, a food or one of its constituents and the claimed effect. Health claims 
corresponding to those conclusions and complying with the requirements of 
Regulation (EC) No 1924/2006 should be aut horised under Article 13(3) of Regulation 
(EC) No 1924/2006, and included in a list of permitted claims.  
(8) Article 13(3) of Regulation (EC) No 1924/ 2006 provides that permitted health claims 
must be accompanied with all necessary c onditions (including restrictions) for their 
use. Accordingly, the list of permitted claims  should include the wording of the claims 
and specific conditions of use of the claims, and wher e applicable, conditions or 
restrictions of use 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. 
(9) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear, reliable a nd useful to the consumer. In that respect, the wording and 
presentation of such claims have to be  taken into account. Where the wording of 
claims has the same meaning for consumers as that of a permitted health claim, because it demonstrates the same relations hip that exists between a food category, a 
food or one of its constituents and health, the claims should be subject to the same 
conditions of use indicated for the permitted health claims. 
(10) The Commission has identified a number of claims submitted for evaluation, referring 
to effects of plant or herbal  substances, commonly known as 'botanical' substances, for 
which the Authority has yet to complete a sc ientific evaluation. In addition, there are a 
number of health claims for which either a further evaluation is required before the 
Commission is able to consider their incl usion or otherwise in the list of permitted 
claims, or which have been evaluated, but due to other legitimate factors consideration 
cannot be completed by the Co mmission at this time.  
                                                
 
3 http://www.efsa.europa.eu/ en/topics/topic/article13.htm EN 3   EN (11) Claims whose evaluation by the Authority or whose considerati on by the Commission 
has not yet been completed will be pub lished on the website of the Commission4 and 
may continue to be used pursuant to Ar ticles 28(5) and (6) of Regulation (EC) 
No 1924/2006. 
(12) Pursuant to Articles 6(1) and 13(1) of Regulation (EC) No 1924/2006 health claims 
need to be based on generally accepted scien tific evidence. Accordingly, health claims 
that did not receive a favourable assessmen t on their scientific substantiation by the 
Authority, as it was not concluded that a cause and effect relationship had been 
established between a food category, a food or  one of its constituents and the claimed 
effect, should not be authorised. Authorisat ion may also legitimately be withheld if 
health claims do not comply with othe r general and specifi c requirements of 
Regulation (EC) No 1924/2006, even in the cas e of a favourable scientific assessment 
by the Authority. Health claims inconsiste nt with generally accepted nutrition and 
health principles should not  be made. The Authority concluded that for one claim5 on 
the effect of fats on the normal absorption of fat soluble vitamins and another claim6 
on the effect of sodium on the maintenanc e of normal muscle function a cause and 
effect relationship has been established. However, the use of these health claims would convey a conflicting and confusing message to  consumers, because it would encourage 
consumption of those nutrients for which, on the basis of generally accepted scientific 
advice, European, national and international authorities inform the consumer that their 
intake should be reduced. Therefore, these tw o claims do not comply with point (a) of 
the second paragraph of Article 3 of Re gulation (EC) No 1924/2006 which foresees 
that the use of claims shall not be ambiguous or misleading.  Furthermore, even if the 
health claims concerned were to be aut horised only under specific conditions of use 
and/or accompanied by additional statements or  warnings, it would not be sufficient to 
alleviate the confusion of th e consumer, and consequently  the claims should not be 
authorised.  
(13) This Regulation should apply six months after the date of its entry into force to enable 
food business operators to adapt to its requirements, including the prohibition 
according to Article 10(1) of Regulation (EC) No 1924/2006 of those health claims 
whose evaluation by the Authority and w hose consideration by the Commission has 
been completed.  
(14) Article 20(1) of Regulation (EC) No  1924/2006 provides for the Commission to 
establish and maintain a Union Register of  nutrition and health claims made on foods, 
hereinafter referred to as 'the Register'. Th e Register will contai n all the authorised 
claims and, inter alia,  the conditions of use applying to them. The Register will also 
contain a list of rejected health clai ms and the reasons for their rejection.  
(15) Health claims that have been withdrawn by the Member States will not be included in 
the list of rejected claims in the Un ion Register. The Register will be updated 
periodically and, as the case may be, follo wing progress on health claims for which the 
evaluation by the Authority and/or consid eration by the Commission has not yet been 
completed. 
                                                
 
4 http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm 
5 Corresponding to entries ID 670 and ID 2902 in the consolidated list. 
6 Corresponding to entry ID 359 in the consolidated list. EN 4   EN (16) Comments and positions from the members of  the public and interested stakeholders, 
received by the Commission have been ad equately considered when setting the 
measures provided for in this Regulation. 
(17) 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 deci sion 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 13(3) 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. 
(18) 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 
Permitted health claims  
1. The list of health claims which may be ma de on foods, as referred to in Article 13(3) 
of Regulation (EC) No 1924/2006, is set out  in the Annex to this Regulation.  
2. Health claims referred to in paragraph 1 may be made on foods in compliance with 
the conditions set out in the Annex.  
Article 2 
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from … [six months after the date of its entry into force] . 
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