Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods
Date: 2006-01-13
Institutions: European Commission
Subjects: approximation of laws, consumer information, consumer protection, foodstuff, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.1.2006 
COM(2006) 2 final 

2003/0165 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council on nutrition and health claims made on foods 

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2003/0165 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a Regulation of the European 
Parliament and of the Council on nutrition and health claims made on foods 

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BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(2003) 424 final – 2003/0165 (COD): 

17 July 2003 

Date of the opinion of the European Economic 
and Social Committee: 

26 February 2004 

Date of the opinion of the European Parliament, first reading: 

26 May 2005 

Date of adoption of the common position: 

8 December 2005. 

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OBJECTIVE OF THE COMMISSION PROPOSAL 

This  proposal  covers  nutrition  and  health  claims  used  in  the  labelling,  presentation  and 
advertising  of  foods.  Only  nutrition  and  health  claims  that  are  in  conformity  with  the 
provisions of this Regulation will be allowed on the labelling, presentation and advertising of 
foods  placed  on  the  market  within  the  Community  and  delivered  as  such  to  the  final 
consumer. 

The main objectives of this proposal are the following: 

•  to achieve a high level of consumer protection by providing further voluntary information, 

beyond the mandatory information foreseen by EU legislation; 

•  to improve the free movement of goods within the internal market; 

•  to increase legal security for economic operators;  

•  to ensure fair competition in the area of foods; and 

•  to promote and protect innovation in the area of foods. 

This proposal was foreseen in the White Paper on Food Safety (COM(1999)719 final– Action 
n°  65).  Its  adoption  will  contribute  to  completing  the  regulatory  framework  covering  the 
labelling of food for human consumption.  

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3- 

COMMENTS ON THE COMMON POSITION 

3-1 SUMMARY OF THE POSITION OF THE COMMISSION 

The Commission welcomes the common position adopted unanimously by the Council, as it 
maintains the general principles of the proposal of the Commission, especially regarding the 
requirement  that  foods  meet  a  certain  nutrient  profile  in  order  to  make  claims,  and  the 
requirement  for  certain  health  claim  to  go  through  an  authorisation  procedure.  Numerous 
amendments proposed by the European Parliament are introduced by the Council in the final 
text that can be fully supported by the Commission. 

3-2  Amendments  made  by  the  European  Parliament  at  first  reading  accepted  by  the 

Commission and incorporated in the Common Position 

Scope and definitions 

Amendments  2  and  16  are  partially  taken  into  consideration  into  the  new  recital  4,  which 
precises that non-commercial communications are not covered, and in article 1, paragraph 2, 
which states that the Regulation applies to claims “in commercial communications”. 

Amendment 17 is partially taken into account and it is now stated in article 1 paragraph 4 that 
the  Regulation  shall  apply  without  prejudice  to  Directive  89/398  on  foods  intended  for 
particular nutritional uses and Directives adopted on the basis thereof, Directive 80/777/EEC 
on natural mineral waters, and Directive 98/83/EC on water intended for human consumption. 

In  line  with  amendments  20  and  21,  existing  Community  definitions  are  added,  such  as  the 
definition  of  food  supplements  (Directive  2002/46/EC)  and  the  definition  of  labelling 
(Directive 2000/13/EC), and the definition of “claim” is clarified. 

General principles 

Amendments 26 and 27 are introduced to clarify and complete the general principles for all 
claims, and amendment 28 is also introduced with drafting changes. 

The wording “nutrient and other  substances” is adopted instead of “substance” to be  in  line 
with the definitions of article 2. It refers to the concerns of the accepted part of amendment 
30, and the amendments 31, 32, and 33. 

The first part of amendment 36 stating that claims shall not mask the overall nutritional status 
of  a  food  is  now  integrated  in  the  new  recital  10.  The  reference  to  the  food  supplement 
Directive and its particular nutrition labelling requirement is also included in article 7. 

The  new  recital  10  clarifies  the  way  the  nutrient  profiles  will  be  set  and  used.  It  takes  into 
account parts of amendments 1 and 10, whereas amendment 4 is partially taken into account 
in  recital  11,  which  now  precises  that  the  Authority  should  advise  the  Commission  for  the 
setting of the nutrient profiles. 

Nutrition claims 

Amendment 6 is included in recital 20, which states that the positive list of nutrition claims 
shall be revised “in order to take account scientific and technological developments”. 

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Health Claims 

Amendments  41  and  91  concerning  the  title  of  the  article  are  retained.  Amendment  42 
proposes to allow all the claims that were prohibited in the article 11 of the original proposal, 
provided they are scientifically substantiated. This is partially acceptable for the Commission 
and for the Council:  

Reference  to  general,  non-specific  benefit  for  the  overall  good  health  or  health-
related well being may be made if accompanied by a specific health claim complying 
with the Regulation (new paragraph 3 of article 10) 

Only  the  claims  which  suggest  that  health  could  be  affected  by  not  consuming  the 
food, the claims which make reference to recommendations of individual doctors or 
non-recognised health professionals and other associations, and the claims referring 
to the rate or amount of weight loss remain prohibited. All the others health claims 
that were prohibited under the article 11 of the original proposal are now allowed, if 
scientifically substantiated. 

To take account of this new situation, recital 23 and 24 were redrafted by the Council, in line 
with amendments 7 and 8. 

Amendments 43 and 93 ask for consultation of stakeholders and comitology for the adoption 
of guidelines for the implementation of the article 11 of the original proposal. This is taken 
into account in the new paragraph 4 of article 10. 

Amendment 44 proposes to delete the word “normal” before “functions”, in order to include 
in  these  function  claims  category  normal  and  enhanced  functions  of  the  body.  This  is 
supported by the Commission and retained in the common position.  

Recital 25 was redrafted to take account of part of amendment 9, and the words “long terms 
and non controversial science” are replaced by “generally accepted scientific data”. 

The participation of organisations representing the food industry and consumers to establish 
the  initial  list  of  function  claims  as  proposed  in  amendment  45  was  supported  by  the 
Commission. This amendment is partially retained by the Council in article 13, paragraph 5, 
whereby applications for authorisation can be sent by the interested parties.  

To  take  account  of  amendments  51  and  61,  the  language  requirements  are  considerably 
simplified, as only the language of the dossier is now required. 

The wording precision proposed by amendment 50, accepted by the Commission, is inserted 
in the common position. It adds in paragraph 3b of article 15, “the nutrient or other substance 
or” in front of “the food […] in respect of which the claim is to be made”. 

Amendment 62, accepted by the Commission, is partially maintained in the common position, 
as  the  applicant  may  make  comments  to  the  Commission  on  the  opinion  of  the  Authority 
within 30 days of its publication (article 16, paragraph 6) 

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General and final provisions 

Amendment  12  is  accepted  by  the  Commission  and  inserted  in  the  common  position.  It 
concerns  recital  30  and  clarifies  that  the  Register  should  be  updated  and  available  to  the 
public.  

The Commission supported partially amendment 72, as transitional measures are needed and 
will ensure a smooth transition for the economic operators. The common position adopted by 
the  Council  provides  different  transition  periods  for  various  provisions  of  the  Regulation. 
They are listed in the new article 27. For this reason recital 33 is also slightly amended, taking 
into account the first part of amendment 14, which was totally acceptable for the Commission, 
but only partially for the Council. Nevertheless, the numerous transition periods should allow 
the economic operators, including SMEs, to benefit from a smooth transition. 

3-3  Amendments  made  by  the  European  Parliament  at  first  reading  accepted  by  the 

Commission and not incorporated in the Common Position 

In  the  context  of  overall  compromise,  and  taking  account  of  the  high  degree  of  alignment 
between  those  of  amendments  acceptable  to  the  Commission  and  the  common  position,  the 
Commission was prepared to accept a compromise which did not include several amendments 
that  it  had  accepted  at  least  in  part.  They  are  amendments  13  on  the  need  to  preserve  the 
competitiveness  of  the  food  industry,  15  on  information  campaigns  on  nutrition  to  be 
developed,  37  on  the  involvement  of  a  consumer  panel  to  evaluate  the  claims,  38  on  the 
comparative  claims  between  foods  belonging  to  different  food  categories,  52  on  the 
submission  of  a  food  packaging  sample  to  the  Authority,  54  on  the  substantial  aid  given  to 
SMEs,  59  on  the  Authority  verification  of  the  claims  wording,  67  on  the  time  given  to  the 
Commission  to  examine  the  opinion  of  the  Authority  and  71  on  the  time  given  to  the 
Commission to release a report on the application of the Regulation . 

3-4 New provisions introduced in the Common Position 

The  Council  introduced  new  texts  both  in  recital  4  and  article  1  clarifying  that  Trademarks 
and brand names are covered by the Regulation and providing the applicable conditions. 

The common position now excludes from the scope of the Regulation non-beneficial nutrition 
claims. They are claims, possibly including logos or other schemes, that may imply a negative 
effect  to  health  due  to  the  amounts  of  a  nutrient  present  in  the  product.  The  new  recital  5 
clarifies  that  notification  of  these  schemes  are  required  in  accordance  with  Directive 
98/34/EC. 

The Council amended article 4 to better detail the principles of the nutrient profiles and the 
process  steps  to  set  them.  Furthermore,  the  Council  extended  the  period  to  set  the  nutrient 
profiles from 18 months to 24 months. 

On  claims  made  on  alcoholic  beverages,  in  the  absence  of  Community  rules  on  nutrition 
claims referring to the reduction or absence of alcohol or energy, it is clarified that national 
rules may apply in compliance with the Treaty. New recital 12 excludes food supplements in 
liquid form containing more that 1.2% of alcohol from the scope of these restrictions, as the 
alcohol quantity provided by the consumption as such foodstuffs is negligible. 

The Council, supported by the Commission, made several modifications to the annex taking 
notably account of recent scientific advances, and inserted a new recital 21 stating that claims 
such as “lactose free” or “gluten free” should be dealt with in Directive 89/398/EEC. 

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CONCLUSION 

The  common  position  includes  numerous  amendments  of  the  European  Parliament  and 
introduces  important  clarifications  and  improvements  to  the  original  Commission  text.  The 
Commission  can  support  the  new  text,  although  it  does  not  include  all  the  changes  put 
forward by amendments of the European Parliament, which the Commission could accept as 
such, partially or with drafting changes. 

5- 

DECLARATIONS 

The Commission made a declaration which was attached to the minutes of the Council and is 
also attached in annex to this communication. 

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ANNEX: COMMISSION DECLARATION 

Following the invitation of the Council the Commission agrees, in the context of amendments 
to the Annex, to examine possible clarifications of the claim "source of [name of vitamin/s] 
and or [name of mineral/s]. 

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