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 the addition of vitamins and minerals and of certain other substances to foods
Date: 2006-01-13
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, inorganic chemical product, vitamin

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.1.2006 
COM(2006) 1 final 

2003/0262 (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 the addition of vitamins and minerals and of certain 
other substances to foods 

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2003/0262 (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 the addition of vitamins and minerals and of certain 
other substances to foods 

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BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
the Council 
(document COM(2003) 671 final – 2003/0262 (COD): 

10 November 2003 

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

31 March 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 

The  proposed  Regulation  covers  the  addition  of  vitamins  and  minerals  and  of  certain  other 
substances to foods.  

The main objectives of the proposal are: 

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

•  to contribute to a high level of protection of human health 

•  to  increase  legal  security  for  operators  and  through  proportionate  measures,  promote 

innovation 

•  to ensure fair competition in the area of foods. 

The proposed Regulation : 

•  lists in Annex I the vitamins and minerals that may be added and in Annex II the vitamin 

preparations and mineral salts that may be used  

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•  provides for certain restrictions regarding the foods to which vitamins and minerals may be 

added 

•  sets the criteria for the establishment of maximum levels of vitamins and minerals in foods 
through the procedure of the Standing Committee on the Food Chain and Animal Health 

•  provides for the setting of minimum levels of vitamins and minerals through the procedure 

of the Standing Committee on the Food Chain and Animal Health. 

•  provides  for  appropriate  specific  rules  on  labelling,  presentation  and  advertising  of 
products to which vitamins and minerals have been added in addition or by derogation to 
other such horizontal rules applicable to all foods 

•  enables  Member  States  to  require  the  notification  of  the  marketing  of  these  products  in 

order to facilitate their monitoring 

•  provides the basis for scrutinising and, where necessary, regulating the addition of certain 

substances, other than vitamins and minerals, to foods. 

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COMMENTS ON THE COMMON POSITION 

3.1 

SUMMARY OF THE POSITION OF THE COMMISSION 

The  Commission  supports  the  common  position  as  adopted  by  the  Council  at  qualified 
majority.  It  is  in  line  with  the  aims  and  the  approach  taken  in  the  Commission’s  original 
proposal and takes into account several amendments proposed by the European Parliament. 

3.2 

AMENDMENTS MADE BY THE EUROPEAN PARLIAMENT AT FIRST READING ACCEPTED BY 
THE COMMISSION AND INCORPORATED IN THE COMMON POSITION 

The common position reflects the spirit of all or part of 17 of the 23 amendments which were 
acceptable by the Commission in full, in part, in principle or subject to drafting changes and 
of 3 amendments which the Commission had originally indicated it was unable to accept. 

Restriction on the addition of vitamins and minerals 

The  common  position  has  included  in  Article  4  Amendments  49/rev  and  54/rev,  thus 
introducing a derogation for the addition of vitamins and minerals to well specified traditional 
beverages containing more than 1.2% by volume of alcohol. 

Other substances 

The common position has merged Articles 10 and 11 of the original Commission proposal on 
the  addition  of  certain  other  substances  to  foods  into  Article  8  simplifying  the  text  and 
specifying  the  procedure  for  evaluation  of  these  substances  in  line  the  requests  of 
Amendments 34, 35 and 55. 

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Annex II 

The common position has added to annex II of the Regulation, as an allowed mineral source, 
calcium  sulphate,  taking  into  account  Amendment  44.  Moreover,  it  has  maintained  in  the 
same  Annex  the  sodium  and  the  potassium  salts  of  ortophosphoric  acid  and  pyridoxine 
dipalmitate  as  a  source  of  vitamin  B6.  These  retentions  have  the  same  effect  than 
Amendments 45 and 46. 

Other 

Amendment 1 (last part) has been considered in the new drafting of recital 8 of the common 
position.  The  Commission,  even  if  it  has  originally  indicated  that  it  could  not  accept 
Amendment 1, is prepared to support this redrafting related to the effort of simplification of 
the  text  of  Articles  2  and  3  (deletion  of  the  concepts  of  “restoration”,  “substitute  food”  and 
“nutritional equivalence”). 

Amendments 2 (first part) has been incorporated in the common position in recital 10. 

Amendment 4 has been taken in part and in principle in Recital 2 and in Article 11 paragraph 
2, second part. 

Amendment 5 and Amendment 25 have been incorporated in principle with the rewording of 
Article 6 paragraph 6. The Commission recognizes that the Annex of Directive 90/496/EEC 
on nutritional labelling is not complete therefore can support this redrafting and engages itself 
in  a  Declaration  to  reflect  modifications  that  may  be  adopted  in  the  future  revision  of  the 
abovementioned Directive in the Regulation on the addition of  vitamins and mineral  and of 
certain other substances to foods. 

Amendment 13 and 41 have been partially reflected in Article 3 paragraph 3 which indicates 
that modification to the Annexes I and II will be adopted taking into account the opinion of 
the Authority.  

Amendment 16 is partially reflected in Articles 17 paragraph 1(b) and in Article 9 paragraph 
2(d)  according  to  which  during  the  initial  transitional  period  Member  States  could  allow  in 
their  territory  vitamins  and  minerals  not  listed  in  the  annexes  of  the  Regulation  provided  a 
dossier is submitted to the Commission. The list of these substances will then be published in 
the Community register which will be available to the public. 

Amendment  17  (first  part)  has  been  incorporated  in  the  common  position  in  Article  17 
paragraph 2. 

Amendment  31  is  addressed  by  Article  9  paragraph  2(d)  concerning  the  publication  in  the 
Community  Register  of  information  on  national  provisions  on  the  mandatory  addition  of 
vitamins and minerals. 

Amendment 38 (first part) has been partially taken into consideration in Article 9 paragraph 
2(d) of the common position. In fact information concerning mandatory addition of vitamins 
and minerals will be included in the Community Register. 

Amendment  39  has  been  partially  considered  in  Article  11  paragraph  2(b)  of  the  common 
position  concerning  the  notification  of  national  prohibitions  or  restrictions  on  the  use  of 
certain other substances. 

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3.3 

AMENDMENTS MADE BY THE EUROPEAN PARLIAMENT AT FIRST READING ACCEPTED BY 
THE COMMISSION AND NOT INCORPORATED IN THE COMMON POSITION 

In  light  of  the  significant  degree  of  alignment  between  the  Amendments  of  the  Parliament 
acceptable  to  the  Commission  and  the  common  position,  the  Commission  has  accepted  a 
compromise which does not include a small number of amendments which it could have, at 
least  in  part,  accepted  (Amendments  11  on  the  bio-availability  of  added  vitamins  and 
minerals, Amendments 12 and 28 on the necessity that labelling, presentation and advertising 
should  not  mislead  consumers,  Amendment  22  proposing  to  take  into  consideration  the 
intakes  of  vitamins  and  minerals  from  food  supplements  when  setting  maximum  levels  , 
Amendment 40 making compulsory the consultation of the Standing Committee on the Food 
Chain  and  Animal  Health  when  Member  States  notify  the  Commission  on  the  adoption  of 
new provisions and Amendment 42 proposing the communication to the Commission and the 
publication  of  the  notifications  of  the  placing  on  the  market  of  foods  covered  by  the 
Regulation).  The  Commission  would  like  to  remark  that  the  concerns  expressed  in  some  of 
these Amendments are implicitly addressed by the common position and specifically in recital 
10 for Amendment 11, in article 7 paragraph 2 for Amendments 12 and 28 and in recital 15 
and in Article 6 paragraph 3(b) for Amendment 22. 

The  Commission  would  also  like  to  remark  that,  concerning  the  modification  to  the 
compulsory elements of nutritional labelling, the common position makes implicit reference 
in  Article  6  paragraph  6  to  the  incompleteness  of  the  Annex  of  Directive  90/496/EEC. 
Moreover,  it  includes  a  statement  by  the  Commission  indicating  its  intention  to  revise  the 
Annex  of  Directive  90/496/EEC  on  nutritional  labelling  and  consequently  reflect  these 
modifications in the Regulation on the addition of vitamins and minerals and of certain other 
substances  to  foods.  The  Commission  also  engages  itself  to  present  within  two  years 
following 
the  establishment  of 
the  Regulation  a  proposal 
maximum/minimum  amounts  of  vitamins  and  minerals  and  of  any  related  condition.  In  the 
view of the Commission this responds in principle to the aim of Amendments 21, 26 and 30. 

the  adoption  of 

for 

3.4 

NEW PROVISIONS INTRODUCED IN THE COUNCIL’S COMMON POSITION 

The  common  position  has  deleted  the  concepts  of  “restoration”,  “substitute  food”  and 
“nutritional equivalence” as purposes for the addition of vitamins and minerals to foodstuffs 
in Article 2 and consequently the requirements and the conditions for addition of vitamins and 
minerals to foods in Article 3 and 6. The Commission can accept these changes in the context 
of a simplification effort. 

For  the  sake  of  clarity  the  Commission  is  ready  to  accept  the  grouping  of  all  transitional 
measures  into  the  new  Article  17,  with  the  consequent  deletion  of  Article  4  of  the  original 
proposal concerning transitional measures for the addition of vitamins and minerals to foods. 

In order to facilitate the monitoring of their market the Commission can accept that Member 
States can require notification for both the placing and the withdrawal of products to which 
vitamins and minerals have been added from their market (Article 15). 

Finally,  the  Commission  supports  the  deletion  of  sodium  chloride  from  Annex  II  together 
with the clarification in recital 10 that this substance can continue to be used as an ingredient 
in the preparation of foods. 

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4- 

CONCLUSION 

In the light of the above comments, the Commission agrees with the common position by the 
Council with a view of the adoption of a Regulation of the European Parliament and of the 
Council on the addition of vitamins and minerals and of certain other substances to foods. 

5- 

DECLARATIONS 

The  Commission  declarations  to  the  minutes  of  the  Council  are  attached  in  annex  to  this 
communication. 

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COMMISSION DECLARATIONS 

ANNEX 

STATEMENT BY THE COMMISSION AND THE COUNCIL 

"The Council and the Commission declare that any claim (message or representation, which is 
not  mandatory  under  Community  or  national  legislation,  including  pictorial,  graphic  or 
symbolic representation) related to the addition of vitamins and minerals such as: “with…”, 
"restored  in…",“added…”,  enriched….”  should  be  considered  as  having  the  same  meaning 
for  consumers  as  the  claim  “source  of…”  as  defined  in  the  Annex  of  the  Regulation  on 
nutrition and health claims made on foods." 

STATEMENT BY THE COMMISSION 

"In  the  framework  of  Article  4  on  Restrictions  on  the  addition  of  vitamins  and  minerals 
(second indent) the Commission will examine the possible addition of food categories such as 
confectionery." 

STATEMENT BY THE COMMISSION 

"In  the  framework  of  its  reflection  on  the  revision  of  Directive  90/496/EEC  on  nutrition 
labelling of foodstuff, the Commission has the intention to consider the following elements in 
relation to vitamins and minerals: 

–  revising/updating reference values included in the Annex of Directive 90/496/EEC and the 

levels that may be considered as significant amounts. 

–  establishing  tolerance  levels  for  acceptable  variation  from  the  declared  value  of  added 

vitamins and minerals on the nutrition label. 

Any modification to the compulsory elements of nutritional labelling that may be adapted in 
the future revision of nutrition labelling Directive will be consequently reflected in Article 7 
paragraph 3 of the Regulation on the addition of vitamins and minerals and of certain other 
substances to foods. 

The Commission has the intention to present as soon as possible and in any case within two 
years following the adoption of the Regulation a proposal for the establishment of maximum/ 
minimum amounts of vitamins and minerals and any conditions for their addition to food as 
referred to in Article 6 paragraph 2." 

STATEMENT BY THE COMMISSION 

"The  Commission  confirms  that  additional  wording  for  the  labelling,  designed  to  draw  the 
attention  of  particular  categories  of  consumer  to  the  specific  risks  which  certain  substances 
may present for them, can be envisaged as a condition when the maximum content for certain 
substances listed in Annex I is fixed, if such wording is justified by public-health protection 
considerations." 

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