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 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
Date: 2008-03-11
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, flavouring, food additive, food safety, foodstuffs legislation, public health

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.3.2008 
COM(2008) 145 final 

2006/0143 (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 establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings 

(presented by the Commission) 

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2006/0143 (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 establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM((2006)0423 final – 2006/0143(COD): 

28 July 2006. 

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

25 April 2007. 

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

10 July 2007. 

Date of transmission of the amended proposal: 

24 October 2007. 

Date of political agreement 

Date of adoption of the common position: 

17 December 2007. 

10 March 2008. 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

As part of the efforts undertaken to improve Community legislation on the basis of 
the  “farm  to  table”  concept,  in  the  White  Paper  on  Food  Safety,  the  Commission 
announced  its  intention  to  update  and  complete  existing  legislation  with  regard  to 
food additives and flavourings and to lay down specific provisions in respect of food 
enzymes.  

This proposal aims to ensure the proper functioning of the internal market, while also 
ensuring a high level of protection of human health as regards food additives, food 
enzymes and food flavourings.  

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In  order  to  do  this,  it  aims  to  establish  a  common  authorisation  procedure  that  is 
centralised, effective, expedient and transparent and that is based on risk assessment 
carried out by the European Food Safety Authority (EFSA) and a risk management 
system in which the Commission takes action within the framework of a regulatory 
committee procedure (comitology). It assigns to the Commission, on the basis of the 
EFSA’s  scientific  assessments,  the  task  of  creating,  maintaining  and  updating  a 
general Community list for each category of substances concerned. The inclusion of 
a  substance  on  one  of  these  lists  means  that  its  use  is  authorised  in  general  for  all 
operators in the Community. 

3. 

COMMENTS ON THE COMMON POSITION 

3.1. 

General comment 

The  Commission  supports  the  common  position  as  adopted  by  the  Council  on  10 
March 2008. It is in line with the aims and the approach taken in the Commission's 
original proposal and reflects the principles of several amendments proposed by the 
European Parliament.  

3.2. 

Amendments made by the European Parliament at first reading  

Amendments accepted by the Commission and which are in line with the common 
position:  

With  regard  to  the  scope  of  the  proposed  Regulation  on  the  common  authorisation 
procedure,  the  common  position  (Article  1)  clarifies  that  this  does  not  apply  to 
smoke flavourings falling within the Regulation (EC) No 2065/2003 of the European 
Parliament  and  of  the  Council.  This  covers  amendment  12  made  by  the  European 
Parliament (EP) during its first reading. 

In  relation  to  confidentiality,  the  common  position  clarifies  that  all  information 
related  to  the  safety  of  a  substance,  including toxicological data, safety studies and 
raw  data  as  such,  should  not  be  confidential  (recital  16).  This  change  includes  the 
considerations of amendment 8 by the EP. 

The common position (Article 6(3)) clarifies that the deadline for the EFSA opinion 
may  be  extended  even  when  applicants  submit  additional  information  on  their  own 
initiative, but this should be limited to exceptional circumstances in accordance with 
Article 10. This change is coherent with EP amendment 25.  

Articles  8,  10  and  12(3)  in  the  common  position  have  been  modified  to  strengthen 
transparency and these changes cover EP amendments 27, 28 and 32. 

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Recitals 21, 22, 23 and 24 and Articles 7 and 14 in the common position have been 
modified in order to introduce the regulatory procedure with scrutiny and to align in 
general  the  proposed  Regulation  with  Council  Decision  2006/512/EC  amending 
Decision 1999/468/EC laying down the procedures for the exercise of implementing 
powers  conferred  on  the  Commission.  These  provisions  are  coherent  with  the  EP 
amendments  34,  35,  36  and  37  on  this  subject,  however  the  difference  is  that  the 
common position includes the use of the curtailment of time periods in some cases. 
This aspect was not reflected in the Commission's amended proposal apart from the 
urgency  procedure  which  was  introduced  for  the  cases  of  particular  risk  to  human 
health.  

Amendments  not  incorporated  in  the  common  position,  which  are  nevertheless 
accepted  by  the  Commission  in  the  amended  proposal  as  such  or  subject  to 
rewording:  

The EP clarified in amendment 1 that a high level of protection of the environment 
must also be ensured in the pursuit of Community policies. This principle is already 
included  in  the  General  Food  Law  (Regulation  (EC)  No  178/2002)  and  the 
amendment has been accepted in the Commission amended proposal. 

EP  amendments  3,  9,  10,  19,  and  21  strengthen  the  transparency  and  information 
provisions,  which  were  already  underling  principles  of  the  Commission  proposal; 
they have been therefore endorsed in the amended proposal.  

EP amendment 22 increases the time for EFSA to give its opinion, from six to nine 
months. This has been accepted in the amended proposal. 

Amendments  2  and  6  are  mainly  editorial  and  amendments  4  and  5  clarify 
respectively  that  the  criteria  set  by  each  sectoral  food  law  must  be  fulfilled  for  the 
authorisation of a substance and that the scientific assessment of a substance must be 
independent.  These  amendments  have  been  taken  over  by  the  Commission  in  the 
amended proposal. 

3.3. 

New provisions introduced by the Council 

Contrary  to  the  EP,  the  Council  has  retained  the  9  months  deadline  for  the 
Commission to present a draft measure to update the Community list, after the EFSA 
opinion  has  been  issued.  However,  to  clarify  the  need  for  this  period  of  time,  the 
Council has introduced in the common position the recital 9 which specifies that the 
nine  months  period  is  necessary,  in  some  cases,  for  the  Commission  to  ensure 
adequate  consultation  of  stakeholders.  This  time  of  course  could  be  shorter 
depending  on  the  nature  of  the  draft  measure.  Recital  10  of  the  common  position 
clarifies  further  the  deadlines  of  the  procedure.  These  amendments  are  in  line  with 
the Commission proposal and can be accepted. 

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The common position (recital 12) clarifies further that the other legitimate factors to 
be  considered  during  the  risk  management  decision  for  the  inclusion  or  not  of  a 
substance in the Community list, include societal, economic, traditional, ethical and 
environmental  factors  and  the  feasibility  of  controls.  These  factors  are  already 
mentioned  in  the  General  Food  Law,  therefore  their  reiteration  in  the  proposed 
Regulation reinforces the initial proposal and it can be accepted by the Commission. 

Several  changes  in  Articles  2,  3,  6,  and  9  are  mainly  editorial  and  clarify  practical 
aspects  of  the  authorisation  procedure  and  the  role  of  the  different  actors.  Some 
changes  in  Articles  12  and  15  are  of  technical  nature  and  add  precision  to  the 
proposed Regulation. These changes are consistent with the spirit of the proposal and 
they can be accepted. 

4. 

CONCLUSION 

The  Commission  takes  the  view  that  the  common  position  fully  reflects  the  key 
elements  of  its  initial  proposal  and  the  spirit  of  many  of  the  amendments  of  the 
European Parliament made in the first reading. 

The  Commission  therefore  agrees  with  the  common  position  as  adopted  by  the 
Council by unanimity. 

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