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 food additives
Date: 2008-03-11
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, food safety, foodstuff, foodstuffs legislation, labelling

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.3.2008 
COM(2008) 143 final 

2006/0145 (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 food additives 

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2006/0145 (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 food additives 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(2006)428 final – 2006/0145 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 

The  Commission  announced  in  the  White  Paper  on  food  Safety  (COM  (1999)719 
final)  that  it  would  up-date  and  simplify  existing  legislation  with  regard  to  food 
additives (Action 11 in the White Paper). The objectives of this proposal are: 

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To  simplify  food  additive  legislation  by  creating  a  single  instrument  for 
principles, procedures and approvals; 

To  confer  the  implementing  powers  on  the  Commission  to  update  the 
Community list of authorised food additives; 

To  consult  the  European  Food  Safety  Authority  (EFSA)  for  the  safety 
evaluation of food additives; 

To set up a re-evaluation programme for existing food additives; 

To  require  the  authorisation  of  additives  that  consist  of,  contain  or  are 
produced  from  genetically  modified  organism  under  Regulation  (EC)  No 
1829/2003  of  the  European  Parliament  and  of  the  Council  of  22  September 
2003 on genetically modified food and feed. 

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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  also  reflects  the  principles  of  several 
amendments proposed by the European Parliament.  

3.2. 

Amendments made by the European Parliament at first reading accepted by the 
Commission and which are in line with the common position  

The common position reflects the spirit of the majority of the 39 amendments which 
were accepted by the Commission in full, in part, in principle or subject to drafting 
changes. 

In  relation  to  the  criteria  for  the  authorisation  of  food  additives,  and  in  particular 
what  is  meant  by  misleading  the  consumer,  the  common  position  includes  changes 
which address some of the considerations in European Parliament (EP) amendments 
3 and 30.  

The common position also includes amendments (in recital 7 and Articles 1 and 6) to 
reflect that, although the environmental impact is not among the general conditions 
for authorisation of food additives, it is of course a legitimate factor which should be 
considered. For instance when adverse environmental effects are identified, they can 
be  taken  account  of  during  the  authorisation  or  revision  of  the  conditions  of  use. 
These changes contain references to the other principles contained within the General 
Food Law, i.e., that the rules on food additives used in foods will ensure the effective 
functioning of the internal market and a high level of protection of human health and 
protection of consumers' interests, including fair practices in food trade, taking into 
account the environment. These changes reflect the environmental aspects contained 
in  amendments  1,  7  and  25  of  the  EP.  Recital  7  has  also  been  amended  in  the 
common  position  regarding  the  use  of  potentially  allergenic  food  additives;  this 
change reflects to some extent the principle in EP amendment 1. 

The  Council  has  proposed  to  amend  the proposal  so  that the  definition  of  quantum 
satis is included in Article 3 and has made consequential changes to Article 11. The 
EP proposed similar changes in amendments 21 and 36. The Commission can accept 
these proposals subject to linguistic changes as included in Articles 3 and 12 of the 
Commission's amended proposal.  

The new Article 5 of the common position clarifies that no person shall place on the 
market a food additive or a food in which a food additive is used if its use does not 
comply  with  the  Regulation.  This  clarification  was  also  requested  by  the  EP  in 
amendments 9 and 22.  

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Regarding  the  interplay  between  the  proposed  Regulation  and  Regulation  (EC)  No 
1829/2003 on GM food and feed, the EP clarified in amendments 4, 38 and 63 that 
the  evaluation  and  authorisation  procedures  under  these  two  Regulations  can  run 
simultaneously.  This  important  principle  has  also  been  reflected  in  the  common 
position. 

Recitals  20  and  21  and  the  various  articles  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  64rev,  47,  48,  67rev,  79,  68rev,  80,  51  and  69rev  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.  

The  common  position  includes  a  provision  in  Article  28  to  clarify  that  during  the 
transfer of current authorisations for food additives into the new annexes, those food 
additives  or  uses  thereof  which  are  no  longer  necessary  should  not  be  transferred. 
This  reflects  the  principle  of  amendment  55  of  the  EP.  Similarly  the  common 
position reflects a change necessary in Article 28 as a result of the decision to include 
additives  in  flavourings  in  Annex  III  of  the  Regulation  and  not  in  Annex  II.  This 
principle is also proposed by the EP in amendments 58 and 59.  

3.3. 

Amendments  made  by  the  European  Parliament  at  first  reading  which  were 
accepted  by  the  Commission  and  have  not  been  included  in  the  Common 
position 

Amendment 28 of the EP proposed that the approval of food additives should refer to 
the  consideration  given  to  the  criteria  for  authorisation  and  the  reason  for  the 
decision.  In  its  amended  proposal  the  Commission  accepted  the  principle  of  the 
amendment  in  that  any  decision  to  authorise  a  food  additive  should  explain  its 
motivation and therefore included new recital 8 in the amended proposal.  

3.4. 

New  provisions  introduced  by  the  Council  which  are  accepted  by  the 
Commission 

As with all food additives, sweeteners used in table top sweeteners are assessed for 
their  safety  before  they  are  permitted.  The  information  provided  to  consumers  on 
food labels should be clear and easy to understand. If there is evidence available that 
particular  groups  of  consumers  are  exceeding  the  acceptable  daily  intake  as  a 
consequence  of  using  table  top  sweeteners,  other  non  legislative  methods  could  be 
used locally to provide the necessary information to consumers. It is noted that some 
manufacturers  already  provide  'off  label'  information.  The  amendment  included  in 
the  common  position  (Recital  18  and  Article  22),  whereby  manufactures  would  be 
obliged  to  make  the  necessary  information  available  by  any  appropriate  means, 
would  provide  useful  information  for  the  consumer  and  also  to  Member  States  to 
assist with consumer education campaigns where they are necessary. 

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The  Council  has  removed  the  requirement  that  food  additives  should  at  all  times 
comply with the specific purity criteria (specifications) which have been set and have 
simply  stated  that  they  should  comply  with  the  specifications.  This  change,  whilst 
ensuring  that  food  additives  meet  the  requirements  with  regard  to  levels  of 
contaminants, clarifies that additives when mixed together or made up in solution do 
not at all times have to meet other quality criteria such as moisture content or acidity. 
A similar amendment was originally proposed in the EP but was not supported in the 
first reading vote.  

A  new  recital  16  has  been  introduced  into  the  common  position  in  order  to  further 
describe the principle of carryover set out in Article 17. 

As regards the labelling of food additives sold from business to business or directly 
to the final consumer, the EP adopted in first reading a number of amendments in the 
proposal  on  food  enzymes  with  a  view  to  simplifying  the  labelling  provisions.  The 
common  position  incorporated  a  similar  simplification.  Despite  the  differences  in 
structure  and  wording,  the  labelling  requirements  for  food  additives  are  largely  in 
line with those proposed by the EP on enzymes. The common position also contains 
similar provisions to those proposed by EP amendments 42 and 44 with regard to the 
date of minimum durability/shelf life and derogations for food additives delivered by 
bulk transport e.g. tanker. The common position has also gone further in simplifying 
the labelling provisions for food additives sold directly to the final consumer which 
are  considered  food  and  hence  covered  by  the  labelling  provisions  of  Directive 
2000/13/EC relating to the labelling, presentation and advertising of foodstuffs. The 
Commission's amended proposal took over the main ideas of the EP amendments and 
reflects the labelling provisions endorsed by the Council in the common position. 

In  its  common  position  the  Council  has  made  some  adjustments  to  recital  13  and 
Article 24 to clarify that a new nanoscale form of a food additive could be considered 
to be a significantly different production method and therefore would require a new 
safety assessment. EP amendment 35 also proposed to introduce separate limit values 
for  nanoscale  food  additives.  The  Commission  considered  that  the  EP  amendment 
was  not  necessary,  as  specific  restrictions  could  already  be  allocated  under  the 
conditions  if  these  are  necessary  following  a  safety  assessment.  The  Commission 
agrees however with the spirit of the amendments proposed in the common position. 
However it is considered that this principle would be better addressed in a separate 
article as contained in Article 11 of the Commission's amended proposal. 

During the period in which the current food additive authorisations are reviewed and 
transferred  into  the  new  Annex,  there  is  a  potential  that  pending  requests  for  new 
additives or new uses  of food  additives would be put on hold. Such a move would 
stifle innovation and have a detrimental effect on the food industry. The Council has 
therefore proposed an amendment to allow the current Directives to be amended by 
comitology  during  this  interim  period  so  that  those  food  additives  in  the  pipeline 
which  have  already  received  a  positive  opinion  from  the  European  Food  Safety 
Authority  can  be  authorised.  The  common  position  therefore  includes  a  new 
Article 29 and consequential changes to Article 33.  

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The common position includes a modification to clarify what is meant by 'extending 
shelf life through the replacement of sugars' so that this concept is better explained 
(Article 7 (b). On the contrary the European Parliament proposed to delete this text 
(amendment  73).  The  Commission  can  accept  the  new  wording  proposed  in  the 
common position. The common position also includes additional clarification on the 
specific  conditions  for  colours  (Article  8  b)  in  that  they  are  used  to  help  identify 
flavours which are normally associated with certain foods.  

The  Commission  proposal  originally  proposed  that  as  a  general  rule  the  levels  of 
food additives should apply to the foods as ready to eat, as this could be of relevance 
for  exposure  calculations.  The  Council  however  considers  that  for  ease  of 
enforcement it would be clearer to establish the levels in food as marketed, although 
for  clarity  the  common  position  includes  an  amendment  specifying  that,  for  foods 
which  have  to  be  reconstituted  or  diluted,  the  levels  should  be  established  for  the 
reconstituted or diluted food. EP amendment 37 also included reference to the diluted 
state. With the additional clarification proposed by the Council, the Commission can 
accept the change to 'as marketed'. 

The  common  position  has  modified  Article  18  to  include  all  the  interpretation 
decisions,  including  the  one  originally  included  in  Article  2,  as  to  whether  a  given 
substance meets the definition of food additive. The application of the provisions in 
Article  18  is  an  implementation  of  the  rules  contained  in  the  basic  act  (e.g.  the 
definition  of  food  additive).  Therefore  it  does  not  fall  within  the  new  regulatory 
procedure  with  scrutiny  and  this  has  been  reflected  in  the  common  position.  EP 
amendments  12,  40  and  47  propose  regulatory  procedure  with  scrutiny  for  such 
decisions. 

The  common  position  includes  a  new  provision  in  Article  29  to  reflect  the  need 
created  by  the  changes  to  the  labelling  provisions  that  a  transitional  period  is 
provided for products which no longer comply with the new rules. The Commission 
included  a  similar  provision  in  Article  32  of  its  amended  proposal  which  may  be 
better placed.  

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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