Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2006-07-12
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, inorganic chemical product, vitamin

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 12.7.2006 
COM(2006) 369 final 

2003/0262 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

on the addition of vitamins and minerals and of certain other substances to foods 

AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article 250 (2) of the EC Treaty 

EN 

   EN 

 
 
 
  
 
 
2003/0262 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

on the addition of vitamins and minerals and of certain other substances to foods 

1. 

INTRODUCTION 

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is 
to  deliver  an  opinion  on  the  amendments  proposed  by  the  European  Parliament  at  second 
reading.  The  Commission  sets  out  its  opinion  below  on  the  amendments  proposed  by 
Parliament.  

2. 

BACKGROUND 

Date of transmission of the proposal to the EP 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 
qualified majority. 

Date of European Parliament opinion, second reading 

16 May 2006 

3. 

PURPOSE OF THE PROPOSAL 

The proposed Regulation covers the addition of vitamins and minerals and of certain 
other  substances  to  foods.  Different  national  rules  applicable  today  have  led  to 
obstacles  to  intracommunity  trade  that  the  application  of  the  principle  of  mutual 
recognition  did  not  succeed  in  overcoming.  It  is  therefore  necessary  to  adopt 
Community rules regarding these practices. The White Paper on Food Safety adopted 
by the Commission on 14 January 2000 announced the adoption by the Commission 
of this measure (action No 61).  

EN 

2 

   EN 

 
 
 
 
 
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 : 

•  provides for the situations that should be taken into account when considering the 

voluntary addition of vitamins and minerals to foods. 

•  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  

•  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. 

4. 

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE  EUROPEAN 
PARLIAMENT 

4.1. 

Amendments accepted by the Commission 

The Commission can accept all 8 amendments adopted by the European Parliament 
in  full.  They  are  the  result  of  a  compromise  agreement  reached  between  the 
European Parliament, Council and Commission during the second reading.  

EN 

3 

   EN 

 
The main modifications introduced by these amendments are the following: 

– 

– 

– 

– 

– 

– 

– 

introduce  a  definition  of  other  substances  in  line  with  the  one  present 
in the 
claims 
on 
(COM(2003) 424 final – 2003/0165 (COD)) (amendment 14) 

draft  Regulation 

and  health 

nutritional 

provide  that  substances  put  under  scrutiny  in  accordance  with  the 
procedure described in Article 8 and then generally allowed are listed in 
the Community register (amendment 11) 

underline  that  vitamins  and  minerals  added  to  foods  have  to  be  bio-
available to the human body (amendment 5) 

provide  that,  prior  to  making  modification  to  the  Annexes,  the 
Commission  has  to  carry  out  consultations  with  interested  parties 
(amendment 15) 

foresee that the Commission may submit a proposal for the maximum 
amounts of vitamins and minerals added to foods by two years from the 
date of entry into force of the Regulation (amendment 17) 

provide that foods placed on the market or labelled prior to the date of 
application of the Regulation and which do not comply with it, may be 
marketed until thirty-fifth months following the date of entry into force 
of the Regulation (amendment 18) 

give into a recital an example of restrictions regarding the food to which 
vitamins  and  minerals  can  be  added  and  specify  that  such  restrictions 
should concern particular vitamins and minerals (amendments 1 and 16) 

The amendments are in line with the Commission’s objectives for the proposal and 
maintain the balance of interests achieved in the common position. 

5. 

CONCLUSION 

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out 
above. 

EN 

4 

   EN