Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'Correspondence surrounding the health claim on fructose'.





















Ref. Ares(2014)271780 - 05/02/2014
 
 
 
EUROPEAN 
 COMMISSION 
Brussels, XXX  
SANCO/12712/2012 Rev. 3 
(POOL/E4/2012/12712/12712R3-
EN.doc) 
[…](2013) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Regulation (EU) No 432/2012 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) 
 
EN    EN 

 
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Regulation (EU) No 432/2012 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 foods1, and in 
particular Article 13(3) thereof, 
Whereas: 
(1) 
Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, the Commission adopted 
Regulation (EU) No 432/2012 of 16 May 2012 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 health2. The list as established by Regulation (EU) No 
432/2012 contains 222 permitted health claims, corresponding to 497 entries in the 
consolidated list3 submitted to the European Food Safety Authority ('the Authority') 
for a scientific assessment. 
(2) 
However, at the time of the adoption of the list of permitted health claims, there were a 
number of health claims whose evaluation by the Authority or consideration by the 
Commission was not finalised4.  
(3) 
For health claims on micro-organisms which, in its initial assessment, the Authority 
considered insufficiently characterised and health claims for which it concluded that 
'the evidence provided is insufficient to establish a cause and effect relationship', the 
Commission and Member States agreed that they would not be able to consider their 
inclusion or non-inclusion in the list of permitted claims unless a further assessment 
was carried out by the Authority. The Authority finalised its assessments on these 
health claims and published its opinions on 5 June and 7 August 20125 concluding 
that, on the 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 for two health claims6.  
(4) 
The Commission has finalised its consideration of all health claims submitted for 
evaluation except for three categories of claims made on specific groups of food or 
                                                 

OJ L 404, 30.12.2006, p. 9. 

OJ L 136, 25.5.2012, p. 1. 
3 http://www.efsa.europa.eu/en/topics/topic/article13.htm 

Corresponding to 2232 entries (IDs) in the consolidated list. 
5 http://www.efsa.europa.eu/en/publications.htm 

Corresponding to entries ID 2926 and ID 1164 in the consolidated list.  
EN 
2  
 
EN 

 
one of their constituents. Those categories include claims on plant or herbal 
substances, commonly known as 'botanical substances', claims on specific foodstuffs, 
namely foods for use in very low calorie diets and foods with reduced lactose content, 
and claims on caffeine. 
(5) 
As regards botanical substances, Member States and stakeholders expressed concerns 
as regards the difference in consideration given to the evidence based on 'traditional 
use' on the one hand under Regulation (EC) No 1924/2006 in relation to health claims 
and on the other hand under Directive 2001/83/EC of the European Parliament and of 
the Council of 6 November 2001 on the Community code relating to medicinal 
products for human use7 concerning the use as traditional herbal medicinal products. 
Since the Commission considers that these concerns are relevant and require further 
reflection and consultation, a decision on claims relating to botanical substances8 
should only be taken once those steps have been completed. 
(6) 
As regards the health claims referring to the effects of very low calorie diets9 and 
foods with reduced lactose content10, the current revision of the legislation on 
foodstuffs for particular nutritional uses11 might have an impact on those health 
claims. In order to avoid potential inconsistencies with that legislation, a decision on 
the health claims referring to those foodstuffs should only be taken once that revision 
has been finalised. 
(7) 
As regards the health claims referring to the effects of caffeine12, Member States 
expressed concerns in relation to the safety of caffeine intake within different target 
groups of the population. Since the Commission considers that these concerns are 
relevant and require further scientific advice by the Authority, a decision on claims 
relating to caffeine should only be taken once that step has been completed. 
(8) 
In order to ensure transparency and legal security for all interested parties, claims the 
consideration of which has not yet been completed will remain published on the 
website of the Commission13 and may continue to be used pursuant to paragraphs 5 
and 6 of Article 28 of Regulation (EC) No 1924/2006. 
(9) 
Health claims corresponding to the conclusions of the Authority that a cause and effect 
relationship has been established between a food category, a food or one of its 
constituents and the claimed effect and which comply with the requirements of 
Regulation (EC) No 1924/2006 should be authorised under Article 13(3) of that 
Regulation, and included in the list of permitted claims established by Regulation 
(EU) No 432/201214.  
(10) 
Article 13(3) of Regulation (EC) No 1924/2006 provides that permitted health claims 
must be accompanied with all necessary conditions (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 where applicable, conditions or 
                                                 

OJ L 311, 28.11.2001, p. 67. 

Corresponding to 2078 entries (IDs) in the consolidated list. 

Corresponding to entry ID 1410 in the consolidated list. 
10 
Corresponding to entries ID 646, ID 1224, ID 1238, ID 1339 in the consolidated list. 
11 
COM (2011)353 final. 
12 
Corresponding to entries ID 737, ID 1486, ID 1488, ID 1490, ID 736, ID 1101, ID 1187, ID 1485, 
ID 1491, ID 2063, ID 2103, ID 2375 in the consolidated list. 
13 
http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm  
14 
Corresponding to 18 entries (IDs) in the consolidated list, as they appear in the Annex to this 
Regulation.  
EN 
3  
 
EN 

 
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.  
(11) 
Pursuant to Article 6(1) and Article 13(1) of Regulation (EC) No 1924/2006 health 
claims need to be based on generally accepted scientific evidence. Accordingly, health 
claims that did not receive a favourable assessment on their scientific substantiation by 
the Authority, during either the initial assessment or during the 'further assessment' 
process, should not be authorised.  
(12) 
Authorisation may also legitimately be withheld if health claims do not comply with 
other general and specific requirements of Regulation (EC) No 1924/2006, even in the 
case of a favourable scientific assessment by the Authority. The Authority concluded 
that for one claim on the effect of L-arginine15 on the maintenance of normal ammonia 
clearance and for another claim on the effect of L-tyrosine16 on the normal synthesis of 
catecholamines a cause and effect relationship has been established. The Commission 
and the Member States have considered whether health claims reflecting those 
conclusions should be authorised. On the basis of the data submitted and of the current 
scientific knowledge, the Authority concluded that no conditions of use can be defined 
which would accompany the health claim on L-arginine17, while for the health claim 
on L-tyrosine, the Authority proposed as appropriate conditions of use that 'a food 
should be at least a source of protein as  per  Annex to Regulation (EC) No 
1924/2006'18.  In the Authority's response of 9 November 2012 to the request of the 
Commission for clarification, the Authority noted that its conclusions for those claims 
were based on the known biochemical role of the two amino acids, as contained in 
protein. It added that it could not provide a quantitative indication of the necessary 
daily intake of L-tyrosine and L-arginine per se to produce the respective beneficial 
physiological effects. Accordingly, it is not possible to establish specific conditions for 
the use of those claims to ensure that the amino acids are contained in the final product 
in a quantity that will produce the respective beneficial physiological effects in 
accordance with point (i) of Article 5(1)(b) of Regulation (EC) No 1924/2006. In the 
absence of such specific conditions of use the beneficial effect of the substance to 
which the claim relates cannot be assured. Therefore, those claims could be misleading 
the consumer and should not be included in the lists of permitted health claims. 
(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 whose consideration by the Commission has 
been completed.  
(14) 
In line with Article 20(1) of Regulation (EC) No 1924/2006, the Register of nutrition 
and health claims containing all authorised health claims and those rejected and the 
reasons for their rejection should be updated in the light of the present Regulation and 
its deferred application. 
                                                 
15 
Corresponding to entry ID 4683 in the consolidated list. 
16 
Corresponding to entry ID 1928 in the consolidated list. 
17 
http://www.efsa.europa.eu/en/efsajournal/doc/2051.pdf  
18 
http://www.efsa.europa.eu/en/efsajournal/doc/2270.pdf 
EN 
4  
 
EN 

 
(15) 
Comments and positions from the members of the public and interested stakeholders, 
received by the Commission have been adequately considered when setting the 
measures provided for in this Regulation. 
(16) 
Regulation (EU) No 432/2012 should therefore be amended accordingly. 
(17) 
The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to 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
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
EN 
5  
 
EN 

 
ANNEX 
Regulation (EU) No 432/2012 is amended as follows: 
In the Annex, the following entries of permitted health claims are inserted in an alphabetical order: 
Conditions and/or 
Relevant entry 
restrictions of use 
Nutrient, 
number in the 
of the food and/or 
EFSA Journal 
substance, food 
Claim 
Conditions of use of the claim 
Consolidated List 
additional 
number 
or food category 
submitted to EFSA 
statement or 
for its assessment 
warning 
The claim may be used for food which 
Consumption of alpha-
contains at least 5 g of alpha-cyclodextrin per 
cyclodextrin as part of a 
50 g of starch in a quantified portion as part 
starch-containing meal 
Alpha-
of the meal. In order to bear the claim 
contributes to the 
 2012;10(6):2713 
2926 
cyclodextrin 
information shall be given to the consumer 
reduction of the blood 
that the beneficial effect is obtained by 
glucose rise after that 
consuming the alpha-cyclodextrin as part of 
meal 
the meal. 
The claim may be used only for food which 
provides a daily intake of 2 g of DHA and 
which contains DHA in combination with 
eicosapentaenoic acid (EPA). In order to 
bear the claim, information shall be given to 
DHA contributes to the 
The claim shall not 
Docosahexaenoic 
the consumer that the beneficial effect is 
maintenance of normal 
be used for foods  2010;8(10):1734 533, 
691, 
3150 
acid (DHA) 
obtained with a daily intake of 2 g of DHA. 
blood triglyceride levels 
targeting children. 
When the claim is used on food supplements 
and/or fortified foods information shall also 
be given to consumers not to exceed a 
supplemental daily intake of 5 g of EPA and 
DHA combined. 
EN 
6  
 EN 

 
Conditions and/or 
Relevant entry 
restrictions of use 
Nutrient, 
number in the 
of the food and/or 
EFSA Journal 
substance, food 
Claim 
Conditions of use of the claim 
Consolidated List 
additional 
number 
or food category 
submitted to EFSA 
statement or 
for its assessment 
warning 
The claim may be used only for food which 
provides a daily intake of 3 g of EPA and 
DHA. In order to bear the claim, information 
shall be given to the consumer that the 
Docosahexaenoic 
DHA and EPA 
beneficial effect is obtained with a daily  The claim shall not 
acid and 
contribute to the 
2009; 7(9):1263 
502, 506, 516, 703, 
intake of 3 g of EPA and DHA. When the  be used for foods 
Eicosapentaenoic 
maintenance of normal 
2010;8(10):1796 
1317, 1324 
claim is used on food supplements and/or  targeting children. 
acid (DHA/EPA) 
blood pressure 
fortified foods information shall also be given 
to consumers not to exceed a supplemental 
daily intake of 5 
g of EPA and DHA 
combined. 
The claim may be used only for food which 
provides a daily intake of 2 g of EPA and 
DHA. In order to bear the claim, information 
shall be given to the consumer that the 
Docosahexaenoic 
DHA and EPA 
beneficial effect is obtained with a daily  The claim shall not 
acid and 
contribute to the 
2009; 7(9):1263 
506, 517, 527, 538, 
intake of 2 g of EPA and DHA. When the  be used for foods 
Eicosapentaenoic 
maintenance of normal 
2010;8(10):1796 
1317, 1324, 1325 
claim is used on food supplements and/or  targeting children. 
acid (DHA/EPA) 
blood triglyceride levels 
fortified foods information shall also be given 
to consumers not to exceed a supplemental 
daily intake of 5 
g of EPA and DHA 
combined. 
EN 
7  
 EN 

 
Conditions and/or 
Relevant entry 
restrictions of use 
Nutrient, 
number in the 
of the food and/or 
EFSA Journal 
substance, food 
Claim 
Conditions of use of the claim 
Consolidated List 
additional 
number 
or food category 
submitted to EFSA 
statement or 
for its assessment 
warning 
The claim may be used only for food which 
Dried plums of 
provides a daily intake of 100 g of dried 
Dried plums/prunes 
'prune' cultivars 
plums (prunes). In order to bear the claim, 
contribute to normal 
 2012;10(6):2712 
1164 
(Prunus 
information shall be given to the consumer 
bowel function 
domestica L.) 
that the beneficial effect is obtained with a 
daily intake of 100 g of dried plums (prunes). 
Consumption of foods 
In order to bear the claim, glucose and/or 
containing fructose 
sucrose should be replaced by fructose in 
leads to a lower blood 
sugar-sweetened foods or drinks so that the 
Fructose 
 2011;9(6):2223 
558 
glucose rise compared 
reduction in content of glucose and/or 
to foods containing 
sucrose, in these foods or drinks, is at least 
sucrose or glucose  
30%. 
EN 
8  
 EN 

 
Conditions and/or 
Relevant entry 
restrictions of use 
Nutrient, 
number in the 
of the food and/or 
EFSA Journal 
substance, food 
Claim 
Conditions of use of the claim 
Consolidated List 
additional 
number 
or food category 
submitted to EFSA 
statement or 
for its assessment 
warning 
In order to bear the claim, information shall 
be given to the consumer that the beneficial 
effect is obtained with a daily intake of 130 g 
of carbohydrates from all sources.  
The claim may be used for food which 
contains at least 20 g carbohydrates which are 
Carbohydrates 
metabolised by humans, excluding polyols, 
contribute to the 
per quantified portion and complies with the 
Carbohydrates 
 2011;9(6):2226 
603, 
653 
maintenance of normal 
nutrition claim LOW SUGARS as listed in 
brain function 
the Annex of Regulation (EC) No 1924/2006.  
The claim may also be used for dextrose 
tablets. When the claim is used on dextrose 
tablets, information shall also be given to the 
consumer that intake of added sugars from all 
sources shall not exceed 10% of the total 
daily energy intake (=50g/day). 
 
EN 
9  
 EN 

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