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 enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97
Date: 2008-03-11
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, foodstuff, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.3.2008 
COM(2008) 144 final 

2006/0144 (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 enzymes and amending Council 
Directive 83/417/EEC, 
Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, 
Council Directive 2001/112/EC and Regulation (EC) No 258/97 

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2006/0144 (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 enzymes and amending Council 
Directive 83/417/EEC, 
Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, 
Council Directive 2001/112/EC and Regulation (EC) No 258/97 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM((2006)0425 final – 2006/0144(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 a proposal amending 
the  framework  Directive  89/107/EEC  on  food  additives  to  lay  down  specific 
provisions in respect of food enzymes. In-depth assessment of the situation has led to 
the development of a specific proposal for food enzymes. 

Currently  the  scope  of  Directive  89/107/EEC  only  covers  enzymes  used  as  food 
additives.  The  remaining  enzymes  are  not  regulated  at  all  or  are  regulated  as 
processing  aids  under  the  legislation  of  the  Member  States,  which  is  diverse.  With 
respect to safety, there is neither safety evaluation nor authorisation of food enzymes 
at  European  level,  except  for  those  that  are  considered  as  food  additives.  The 
proposal aims to establish harmonised rules for food enzymes at Community level, in 
order to promote fair trading and effective functioning of the internal market and to 
ensure protection of human health and consumers' interest. 

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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  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:  

Regarding  the  legal  basis  of  the  proposed  Regulation,  the  Common  position  has 
deleted Article 37 of the Treaty and this is in line with amendment 35 made by the 
European Parliament (EP) during its first reading. 

In relation to the criteria for the authorisation of food enzymes the common position 
clarifies what is meant by misleading the consumer (recital 6) which addresses some 
of the considerations of the EP amendments 4 and 16. 

The  common  position  has  introduced  a  definition  of  'food  enzyme  preparation' 
(Article 3) similarly to a request of the EP under amendment 14. 

The new Article 5 of the common position has clarified that a food enzyme or a food 
in which an enzyme is used should not be placed on the market, if the enzyme or its 
use does not comply with the proposed Regulation. This clarification has been also 
requested by the EP in amendment 15.  

Concerning  the  interplay  between  the  proposed  Regulation  on  food  enzymes  and 
Regulation  (EC)  No  1829/2003  on  GM  food  and  feed,  the  EP  had  clarified  in 
amendments 7 and 34 that the evaluation and authorisation procedures under the two 
Regulations  should  run  simultaneously.  The  principle  of  these  amendments  is 
reflected in the common position (recital 11 and Article 8).  

Recitals 20 and 21 and Articles 15 and 17 of the common position were 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 10, 28 and 30.  

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As regards the labelling of food enzymes sold from business to business or directly 
to the final consumer, the EP adopted in first reading a number of amendments 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  enzymes  are  largely  the  same,  with  the  exception  of  the 
provision of amendment 21 of the EP which requires information on the "side effects 
of their use in excessive quantities", which is not endorsed in the common position. 
The scope of the EP provision under amendment 21, that requires food enzymes to 
be added to foods only in a dose strictly necessary to achieve the purpose for which 
they are used, has been taken on  board  in the common position under Article 7(2), 
where the principle of the quantum satis, as defined in the proposed Regulation on 
food additives, has been introduced. The common position has also gone further in 
simplifying  the  labelling  provisions  for  food  enzymes  sold  directly  to  the  final 
consumer, as these enzymes are considered food and hence covered by the labelling 
provisions  of  Directive  2000/13/EC  relating  to  the  labelling,  presentation  and 
advertising of foodstuffs (Article 12). The Commission amended proposal took over 
the main ideas of the EP amendments and reflects the labelling provisions endorsed 
by the Council in the common position. 

EP  amendment  31  amends  Regulation  (EC)  No  258/97  on  novel  foods  in  order  to 
clarify  that  food  enzymes  which  are  covered  by  the  proposed  Regulation  on  food 
enzymes  will  be  excluded  from  the  scope  of  the  novel  food  Regulation.  This 
amendment is endorsed in Article 23 of the common position. 

The  additional  transitional  measures  incorporated  in  Article  18  of  the  common 
position reflect totally the EP amendment 36. 

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

EP amendments 2, 8 and 17 improve the proposal from a technical (e.g. introduction 
of  definition  of  enzyme)  and  editorial  point  of  view  and  are  incorporated  in  the 
Commission amended proposal. 

The  EP  clarified  that  the  proposed  Regulation  does  not  apply  to  food  enzymes 
intended for direct human consumption, such as enzymes for nutritional purposes or 
enzymes  used  as  digestive  aids.  This  clarification  is  in  line  with  the  Commission 
proposal  and  it  has  therefore  been  endorsed  in  the  amended  proposal.  The  Council 
has not introduced similar clarification in the common position. 

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Regarding food enzymes which are already on the market, the EP proposed them to 
be  transferred  directly  to  the  Community  list  ('fast  track  authorisation'),  if  the 
European  Food  Safety  Authority  (EFSA)  is  satisfied  with  the  previous  safety 
assessment carried out at Community or national level. The Commission considered 
that  an  automatic  transfer  of  food  enzymes  into  the  Community  list,  without  a 
previous  evaluation  by  EFSA,  is  not  appropriate.  However,  it  is  usual  practice  that 
when  EFSA  evaluates  substances  they  consider  any  relevant  scientific  assessments 
undertaken  by  other  bodies.  The  Commission  has  therefore  introduced  in  the 
amended proposal wording to clarify that EFSA could consider existing opinions as 
part of their evaluation.  

3.3. 

New provisions introduced by the Council 

The  common  position  (Article  2)  excludes  from  the  scope  of  the  proposed 
Regulation,  food  enzymes  used  exclusively  in  the  production  of  processing  aids, 
while on the other hand it includes within the scope enzymes used in the production 
of novel foods and in the production of flavourings. The Council considered that the 
initial  proposed  exclusion  of  enzymes  for  flavourings  is  not  justified  because  some 
flavourings, such as flavouring preparations from food sources, are not evaluated for 
their  safety.  The  Commission  raised  concerns  that  such  a  measure  would  be 
disproportionate  taking  into  account  the  small  quantity  of  enzymes  used  in  the 
production  of  flavourings  which  themselves  are  added  in  small  amounts  into  the 
food. However, as most of the enzymes used in the production of flavourings seem to 
be the same as the enzymes used in other foods, this amendment would not have a 
major practical impact, considering the small number of enzymes concerned and can 
be accepted by the Commission.  

The  common  position  strengthened  the  requirement  set  already  in  the  Commission 
proposal  that  enzymes  produced  from  different  production  methods  should  be 
evaluated for their safety before they can be used. The common position strengthens 
the  proposal  by  reiterating  the  text  of  a  recital  in  an  article  (Article  14(2)).  The 
amended Commission proposal has included a new Article to this effect. 

The  Council  clarified  in  the  common  position  the  principle  already  included  in  the 
General  Food  Law  (Regulation  (EC)  No  178/2002)  that  the  rules  on  food  enzymes 
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  account  of,  where  appropriate,  the  protection  of  the 
environment.  This  change  keeps  also  consistency  with  the  proposed  Regulation  on 
food additives and relevant EP amendments on that proposal. The Commission can 
accept this change. 

Concerning  the  interplay  between  the  proposed  Regulation  on  food  enzymes  and 
Regulation  (EC)  No  1830/2003  with  regard  to  the  unique  identifier  attributed  to  a 
GMO, the EP clarified the relevant provision of the proposal. The Commission has 
accepted  this  clarification  in  the  amended  proposal.  The  Council  has  deleted  the 
provisions  relevant  to  the  unique  identifier  from  recital  8  and  Article  7(2)  of  the 
common position. This deletion is technically correct and it can be supported by the 
Commission. 

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The  Council  has  also  included  in  the  common  position  a  new  Article  9  to  provide, 
where  necessary,  for  interpretation  decisions  under  the  regulatory  procedure  as  to 
whether a given substance is a food enzyme or if a particular food belongs to a food 
category in the Community list. 

Finally the common position modified further Directive 2000/13/EC to exclude from 
labelling  in  the  final  food  of  substances  used  in  quantities  strictly  necessary  as 
solvents  or  media  for  enzymes,  as  it  is  the  case  currently  for  additives  and 
flavourings. This change is technically correct. 

4. 

CONCLUSION 

The  Commission  takes  the  view  that  the  common  position  fully  reflects  the  key 
elements  of  its  initial  proposal  and  of  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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