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 the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC
Date: 2008-03-11
Institutions: European Commission
Subjects: consumer information, enzyme, flavouring, food additive, foodstuffs legislation, labelling

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.3.2008 
COM(2008) 142 final 

2006/0147 (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 the Council on flavourings 
and certain food ingredients with flavouring properties for use in and on foods and 
amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, 
Regulation (EC) No 2232/96 and Directive 2000/13/EC 

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2006/0147 (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 the Council on flavourings 
and certain food ingredients with flavouring properties for use in and on foods and 
amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, 
Regulation (EC) No 2232/96 and Directive 2000/13/EC 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(2006) 427 final – 2006/0147 COD): 

28 July 2006. 

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 by the Council 

17 December 2007 

Date of formal adoption of the common position by the Council 

10 March 2008 

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

25 April 2007 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

The  proposed  Regulation  aims  at  replacing 
the  current  Council  Directive 
88/388/EEC in order to take into account technological and scientific developments 
in  the  area  of  flavourings  and  the  developments  of  the  food  legislation  in  the 
European Community. 

The main objectives are: 

• 

• 

• 

to clarify the scope of legislation on flavourings; 

to modernise and adapt the existing legislation on flavourings to technological 
and scientific developments;  

to establish clear rules for evaluation and authorisation; 

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• 

• 

to better inform the consumer about the use of natural flavourings; 

to  adapt  to  the  requirements  of  Regulation  (EC)  N°  882/2004  on  official 
controls for food and feed. 

3. 

COMMENTS ON THE COMMON POSITION 

3.1. 

General comment 

The  Commission  supports  the  common  position  as  adopted  by  the  Council  at 
unanimity.  It  is  in  line  with  the  objectives  and  the  approach  taken  in  the 
Commission's  original  proposal  and  reflects  the  principles  of  several  amendments 
proposed by the European Parliament. 

3.2. 

Outcome of Parliament's amendments at first reading 

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

The  common  position  reflects  the  spirit  of  17  of  the  21  amendments  which  were 
acceptable  by  the  Commission  in  full,  in  part,  in  principle  or  subject  to  drafting 
changes. Most of these amendments bring further clarification to the text.  

In  relation  to  the  criteria  for  the  authorisation  of  flavourings,  the  common  position 
clarifies what is meant by misleading the consumer (recital 6) which addresses some 
of the considerations of the EP amendment 1. 

Amendment  29  concerns  the  labelling  of  natural  flavourings.  At  least  95  %  of  the 
flavouring  component  must  be  obtained  from  the  source  referred  to.  This  change 
corresponds better to consumer expectations and will have limited impact on current 
practices.  

Amendments 12, 24, 34 and 35 introduce the regulatory procedure with scrutiny on 
measures  to  amend  non-essential  elements  of  the  regulation  by  supplementing  it. 
There  is  agreement  between  the  European  Parliament,  the  Council  and  the 
Commission  on  these  amendments;  however  the  Council  and  the  Commission 
introduced the option for an urgency procedure.  

Amendments  made  by  the  European  Parliament  accepted  by  the  Commission 
and not incorporated in the common position.  

4  amendments  that  were  accepted  by  the  Commission  have  not  been  incorporated 
into the Common position.  

Amendments 27 and 28 concern further clarification of the labelling of flavourings 
falling within the scope of Regulation (EC) No 1829/2003.  

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Amendment  7  concerns  rewording  of  Article  1  on  the  subject  matter.  In  the 
amendment  the  Parliament  proposes  to  place  the  high  level  of  health  protection 
before the effective functioning of the internal market, as otherwise this may give the 
impression  that  protection  of  human  health  is  secondary  to  the  functioning  of  the 
internal market.  

Amendment 15 concerns the definition of an "appropriate physical process" for the 
production  of  natural  flavouring  substances  or  flavouring  preparations.  In  the 
amendment the Parliament want to avoid that traditional preparation processes can be 
considered as physical processes that are not appropriate. Commission accepted this 
amendment, as it clarifies the situation and in case of doubt, a comitology decision 
can be adopted.  

Points  of  diversion  between  the  Commission's  modified  proposal  and  the 
Council common position.  

With  exception  of  the  Commission  position  on  amendments  7,  15,  27  and  28  (see 
above), there are no divergences between the Commission and the Council. 

3.3. 

Commission's position on new provisions introduced by the Council 

Several  new  provisions  have  been  introduced  by  the  Council.  Most  of  them  aim  at 
further  clarifying  the  text  or  are  in  line  with  the  general  objective  of  the  original 
Commission proposal. The Commission can therefore accept these changes. 

Recital 5a (new) clarifies the meaning of "raw foods" and "non-compound food" to 
which the proposed Regulation does not apply.  

Recital 8a (new) justifies the risk based approach for the establishment of maximum 
levels  for  substances  of  toxicological  concern,  referred  to  in  Article  5,  that  may  be 
present in flavourings. It furthermore emphasizes the responsibilities of the producers 
in relation to those substances.  

Article  1  clarifies  the  principle  already  included  in  the  General  Food  Law 
(Regulation (EC) No 178/2002) that the rules on flavourings take into account, where 
appropriate,  the  protection  of  the  environment.  This  change  keeps  also  consistency 
with the proposed Regulation on food additives and food enzymes and relevant EP 
amendments on the proposal on food additives.  

Art 3 (2) c, adds to the definition of natural flavouring substance that they correspond 
to substances that are naturally present and have been identified in nature. This is to 
avoid that some flavouring substances that are not present in materials of vegetable 
or  animal  origin,  but  that  are  obtained  by  artificial  enzymatic  processes,  would  be 
considered as natural. 

In  Art  3  (3)  the  Common  Position  completes  the  definition  of  source  materials 
considered  as  food  for  the  production  of  flavourings,  as  proposed  by  the 
Commission,  by  adding  that  the  definition  is  valid  only  for  the  purpose  of  this 
Regulation. 

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Art  4a  (new)  clarifies  that  flavourings  and/or  foodstuffs  in  which  flavourings  are 
used should not be placed on the market, if the flavouring or its use does not comply 
with the proposed Regulation.  

Article  7  (2),  Article  18  (4)  and  Article  19  introduce  the  option  for  an  urgency 
procedure into the regulatory procedure with scrutiny. 

For reasons of clarity the interpretation decisions have been moved from Articles 2 
and 3 to a separate new Article 11. 

Article 12, 13 and 15 (new), bring further clarification of labelling requirements and 
alignment with the proposals on food additives and food enzymes.  

Article 14 (4) concerns the labelling of natural flavourings. The maximum of 5 % of 
the flavouring component derived from other source materials shall not reproduce the 
flavour of the source material referred to.  

In Annex III Part A, aloin and coumarin remain included in the list of substances that 
shall not be added as such to food, as already established in the current legislation. 
Scientific  consideration  on  potential  carcinogenicity  of  aloin  is  still  ongoing  and 
there are concerns that the exposure to coumarin via the use of food ingredients with 
flavouring properties (cinnamon) could be already too high.  

Annex III Part B: 

– 

For  reasons  of  proportionality,  it  has  been  clarified  in  the  title  that  the 
maximum  levels  shall  not  apply  to  compound  foods  which  are  prepared  and 
consumed  on  the  same  site  (restaurants),  contain  no  added  flavourings  and 
contain only herbs and spices as food ingredients with flavouring properties.  

–  Maximum levels for coumarin have been introduced in certain food categories.  

– 

The maximum level for teucrine A in alcoholic beverages has been increased 
from 2 to 5 mg/kg in bitter tasting spirit drinks and liqueurs with bitter taste. 
This  change  was  introduced  at  the  request  of  Italy  which  had  concern  about 
some  local  traditional  drinks  in  Italy  that  otherwise  could  no  longer  be 
maintained on the market. The Commission can accept this increase, as these 
spirit drinks will have a limited impact on the total exposure to teucrine A. 

3.4.  Major problems encountered in adoption of the Common Position 

Directive  88/388/EEC  lays  down  maximum  levels  for  coumarin  in  foodstuffs.  The 
Commission  did  not  maintain  maximum  levels  for  coumarin  in  the  proposed  new 
Regulation,  because  in  its  opinion  on  coumarin  of  6  October  2004,  the  European 
Food Safety Authority (EFSA) concluded that the intake of the substance was not of 
concern compared to the Tolerable Daily Intake. New analytical data from Germany 
demonstrated that the actual levels in certain foodstuffs to which cinnamon is added, 
are much higher than the current maximum levels and that the Tolerable Daily Intake 
(TDI)  was  likely  to  be  exceeded.  Germany  therefore  requested  to  reintroduce 
maximum levels. 

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The  Member  States  agreed  with  this  reintroduction.  However  there  was  major 
concern about traditional cinnamon containing products that could be affected by too 
strict levels. The Commission organised two technical meetings with Member State 
experts  and  stakeholders  and,  following  these  consultations,  possible  maximum 
levels were identified.  

Furthermore,  since  the  opinion  of  EFSA  was  adopted  in  October  2004,  additional 
scientific information has been made available, that suggests that the TDI should be 
reviewed.  The  Commission  asked  therefore  EFSA  to  assess  this  information.  The 
conclusions  of  EFSA's  additional  assessment  are  expected  to  be  available  in  May 
2008.  The  Council  has  in  the  mean  time  adopted  maximum  levels  that  will  be 
reconsidered  in  the  light  of  these  conclusions  and  a  joint  statement  of  Council  and 
Commission has therefore been prepared.  

4. 

CONCLUSIONS 
POSITION 

/  GENERAL  OBESERVATIONS  ON  THE  COMMON 

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 supports the common position as adopted by the Council 
by unanimity. 

5. 

STATEMENT 

Following  the  discussion  on  coumarin  (see  3.4)  the  following  joint  statement  has 
been annexed to the Common Position:  

The  Council  and  the  Commission  undertake  to  reconsider  the  maximum  levels  for 
coumarin set out in Annex III B as soon as the advice (expected in the first half of 
2008) of the European Food Safety Authority becomes available. 

To  this  end,  the  Council  invites  the  Commission  to  convene  a  meeting  of  experts 
without  delay  after  the  advice  of  the  Authority  is  issued  in  order  to  examine  the 
technical aspects. 

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