Communication from the Commission to the European Parliament pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on novels foods, amending Commission Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001
Date: 2010-03-24
Institutions: European Commission
Subjects: consumer protection, food safety, food technology, foodstuff, foodstuffs legislation, market approval, public health

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SANCO/10630/2010 Rev. 4 (POOL/E6/2010/10630/10630R4-EN.doc) 

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EUROPEAN COMMISSION 

Brussels, 24.3.2010 
COM(2010)124 final 

2008/0002 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council on novels foods, amending Commission Regulation (EC) No 1331/2008 
and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 
1852/2001 

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2008/0002 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council on novels foods, amending Commission Regulation (EC) No 1331/2008 
and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 
1852/2001 

1. 

BACKGROUND 

Date of transmission of the proposal to the European 
Parliament and to the Council 
(document COM(2007)872 final – 2008/0002COD): 

[14 January 2008] 

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

[29 May 2008] 

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

[25 March 2009] 

Date of transmission of the amended proposal: 

[*…] 

Date of adoption of the position of the Council: 

[15 March 2010] 

* 

Taking into account the developments in Council at the time of the European 
Parliament  first  reading,  the  Commission  did  not  find  necessary  to  prepare  a 
revised proposal but expressed its views on the Parliament amendments within 
the document SP(2009)3060 sent to the European Parliament on 11 September 
2009. 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

1.  Authorisation  and  use  of  novel  foods  are  regulated  at  E.U.  level  since  1997 
when  Council  Regulation  (EC)  n°  258/97  was  adopted.  The  aim  of  the  draft 
Regulation  is  to  update  and  clarify  the  regulatory  framework  for  the 
authorisation  and  placing  on  the  market  of  novel  foods  while  ensuring  food 
safety,  the  protection  of  public  health  and  consumer  interests  and  the 
functioning  of  the  internal  market.  It  repeals  Regulation  (EC)  n°  258/97  and 
Commission regulation (EC) n° 1852/2001. 

2. 

This proposal aims to streamline and centralize at Union level the authorisation 
procedure  in  accordance  with  Regulation  (EC)  n°  1331/2008  establishing  the 

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common  authorisation  procedure.  It  develops  a  specific  authorisation 
procedure for traditional foods from third countries and clarifies the definition 
of novel foods, including new technologies with an impact on food.  

3. 

The current procedure for extensions of use is  abolished and  applicant-linked 
authorisations  are  replaced  by  generic  authorisation  decisions  except  when 
protection of data is granted for innovative food products. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

3.1.  GENERAL REMARKS 

The  position  of  the  Council  reflects  the  result  of  the  examination  of  the 
Commission's  proposal  taking  into  account  the  amendments  voted  by  the 
European Parliament. 

The Commission has accepted all the changes introduced by the Council to its 
proposal  except  the  inclusion  of  the  offspring  (first  generation)  of  cloned 
animals  in  the  scope  of  the  proposal  and  some  modifications  introduced 
following the entry into force of the Treaty on the functioning of the European 
Union. 

3.2.  MAIN AMENDMENTS INTRODUCED BY THE POSITION OF THE COUNCIL  

The  Council  has  included  in  its  position  several  amendments  adopted  at  first 
reading by the European Parliament and also accepted by the Commission. 

a)  Objectives of the Regulation 

The position of the Council (Article 1 and recitals 1 and 2) has extended 
the  objectives  of  the  Regulation,  on  the  basis  of  European  Parliament 
amendments,  to  the  protection  of  the  environment  and  animal  welfare. 
These  objectives  are  in  line  with  other  specific  food  legislations  which 
have been updated and can be supported by the Commission.  

b)  Traditional foods from third countries 

The  Commission  proposal  laid  down  a  simplified  procedure  based  on  a 
notification by any interested party, before the  placing on the European 
Union  market,  of  traditional  foods  from  third  countries  which  can 
demonstrate a history of safe food use. 

The  Council  has  rejected  this  procedure  as  it  would  like  the  European 
Food  Safety  Authority  to  deliver  a  scientific  opinion  and  the  Member 
States  to  be  consulted  on  the  authorisation  for  the  placing  on  the  EU 
market  of  traditional  foods  from  third  countries.  However  a  specific 
procedure  (Article  11(3)  and  11(5))  with  shorter  deadlines  (9  months 
instead of 18 months) has been agreed by the Council. The Commission 
can support this compromise. 

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c)  Nanotechnologies 

With regard to nanotechnologies, the European Parliament called for the 
introduction of a legal definition of nanomaterials and for the mandatory 
labelling of these products. 

Concerning  labelling,  the  Council  considers  that  the  labelling  rules 
should,  as  appropriate,  be  imposed  by  the  authorisation  decision  on  a 
case by case basis. 

The position of the Council (Article 3(2) a) iv) and 3(2) c)) provides for a 
definition of "engineered nanomaterials" and a systematic evaluation and 
pre-marketing  authorisation  of  all  food  ingredients  which  contain  those 
nanomaterials. 

These amendments can be supported by the Commission. 

d)  Animal Cloning 

On cloning, positions between the Council and the European Parliament 
differ  significantly.  The  amendments  of  the  European  Parliament  are  in 
favour  of  the  removal  of  products  from  clones  and  their  offspring  from 
the scope and of a ban of the use of food from clones and their offspring 
or,  as  a  fall  back,  a  moratorium  until  a  specific  legislation  is  in  place. 
Such  exclusion  from  the  scope,  pending  the  adoption  of  a  specific 
legislation  on  cloning,  would  lead  to  situation  where  there  will  be  no 
E.U.  harmonised  legislation  applicable  after  the  repeal  of  current  novel 
food Regulation. 

The  Council  considers  that  a  specific  legislation  on  cloning  would  be 
desirable  to  address  the  various  aspects  of  the  cloning  issue.  However, 
the  Council  agrees  that  the  novel  food  Regulation  should  continue  to 
apply  in  order  to  cover  food  from  cloned  animals  until  a  specific 
legislation is in place. In addition, the Council has agreed by unanimity 
to include food from first generation of clones' offspring in the definition 
of  novel  food  which  implies  that  such  food  would  be  subject  to  a 
marketing authorisation before it is placed on the market. 

The position of the Council (Article 24(2)) also introduces the obligation 
for  the  Commission  to  submit  to  the  European  Parliament  and  the 
Council a report on all aspects of food produced from cloned animals and 
their offspring followed, where appropriate, by any legislative proposal.  

The  Commission  does  not  support  the  inclusion  of  food  from  clones' 
offspring within the scope and therefore can not agree with the position 
of the Council (Article 3(2) b)). The Commission position is to maintain 
the legal status quo for the food produced with new breeding techniques 
such as cloning and to prepare the foreseen report by the end of the year. 

The current and revised novel food definition covers all foods (including 
meat  and  milk)  derived  from  animals  obtained  by  new  reproductive 
techniques  (such  as  cloning),  but  not  the  food  derived  from  animals 

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obtained  by  conventional  reproductive  techniques  (i.e.  techniques  used 
before the entry into force of Regulation (EC) 258/97). 

The Commission considers that there is no justification to include in the 
scope  food  from  clones'  offspring  as  they  are  obtained  through 
conventional  breeding  techniques  and  that  the  submission  of  food  from 
clones' offspring to a pre-market authorisation regime would therefore be 
disproportionate  to  the  objectives  of  the  regulation,  in  particular  food 
safety, and not in line with the Treaty on the Functioning of the European 
Union.  In  addition,  such  provision  would  be  at  variance  with  EU 
international commitments. 

e)  Data protection 

In  order  to  promote  innovation  in  the  food  industry,  the  Commission 
proposal introduced the possibility to protect newly developed scientific 
evidence  and  proprietary  scientific  data.  The  position  of  the  Council 
supports  and  reinforces  these  measures  (Article  16(1)  and  16(4))  by 
defining eligibility criteria for data protection and providing an applicant 
linked  authorisation  for  a  5  year  period.  The  Commission  can  support 
these amendments. 

f) 

Adaptation to the Lisbon Treaty 

Following  the  entry  into  force  of  the  Lisbon  Treaty,  the  position  of  the 
Council was adapted to take into account Articles 290 and 291 of Treaty 
on the Functioning of the European Union. 

The  adoption  of  further  criteria  to  clarify  the  definitions  laid  down  in 
Article 3 2) points a) (i) to (iv) related to sub-categories of novel foods, 
in point c) on the definition of "engineered nanomaterials"  and point d) 
and e) related to traditional foods from third countries would be ensured 
through 
the 
implementing  acts.  The  Commission  considers 
determination  of  these  criteria  is  a  measure  aimed  to  supplement  non 
essential  elements  of  the  Regulation  which  should  be  adopted  through 
delegated acts.  

that 

As regards the adaptation of the definition of "engineered nanomaterials" 
to  scientific  and  technical  progress  and  to  definitions  agreed  at 
international  level,  the  Commission  considers  that  the  absence  of  a 
provision  in  the  position  of  the  Council  in  first  reading  allowing  the 
revision  of  the  definition  to  reflect  the  technical  evolution  implies  the 
introduction  of  the  ordinary  legislative  procedure  for  its  revision.  This 
would  prevent  this  definition  to  reflect  the  best  state  of  science  and 
would  have  negative  consequences  for  the  innovation  in  the  food 
industry. Such adaptation is designed to amend non essential elements of 
this regulation and should be adopted through delegated acts.1 

1 

Statement by the Commission at the Council of 15 March 2010. 

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For the above reasons, the Commission opposes to the above mentioned 
provisions of the position of the Council.  

The  Commission  cannot  accept  recital  36  as  it  stands  concerning  the 
consultation  of  experts  in  the  preparation  of  delegated  acts.  The 
Commission has made a political commitment in its Communication of 9 
December 2009 on Art.290 of the TFEU to systematically consult experts 
from the national Authorities of the Member States except in cases where 
this  preparatory  work  does  not  require  any  new  expertise.  However, 
given that the Treaty does not foresee expert groups, they cannot have a 
formal 
the 
involvement of experts in the preparation of delegated acts should not be 
included in the basic acts. 

role.  Therefore,  provisions  as 

institutional 

regards 

Finally,  on  the  duration  of  the  period  to  raise  objections  for  delegated 
acts, the Commission considers that the Council did not provide enough 
reasons to opt for a three-month period.  The  Commission  insists  on  the 
two-month period (which may be extended by one additional month) and 
cannot support this amendment of the Council. 

The Commission can nevertheless support the adaptation of the following 
measures through implementing acts: 

– 

– 

– 

– 

– 

– 

– 

– 

The procedure for determination of the novel food status (Article 4, 
paragraph 4); 

The  decisions  whether  a  type  of  foods  fall  within  the  scope 
(Article 5); 

The  update  of  the  list  of  traditional  foods  from  third  countries  in 
Article 11(5), 

The adoption of detailed rules for implementation of the procedure 
for traditional foods from third countries (Article 11(7)); 

The  update  of  the  Union  list  in  case  of  data  protection  before  the 
expiry of the 5 year- period of data protection in Article 16(5). 

The  adoption  of 
information (Article 17); 

implementing  measures 

to  ensure  public 

The  adoption  of  transitional  measures  for  pending  requests  in 
Article 27(2). 

The update of the Union list of authorised novel foods in Article 28 
(8), 

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4. 

CONCLUSION 

The  Commission  has  accepted  all  the  changes  introduced  by  the  Council  to  its 
proposal except the inclusion of the offspring (first generation) of cloned animals in 
the scope of the proposal and the proposed adaptations of several comitology related 
provisions  to  the  Lisbon  Treaty.  Therefore  the  Commission  can  not  support  the 
position of the Council. 

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ANNEX 

Statement by the Commission 

The  Council's  political  agreement  of  June  2009  considered  that  the  adaptation  of  the 
definition  of  engineered  nanomaterials  to  the  scientific  and  technical  progress  and  to  the 
definitions  subsequently  agreed  at  international  level  should  be  made  in  accordance  to  the 
regulatory  procedure  with  scrutiny.  In  the  current  Council's  position  at  first  reading  the 
adaptation of this definition is limited to the adoption of further criteria to clarify it.  

First,  this  modification  implies  that  any  adaptation  of  the  definition  itself  would  only  be 
possible  through  the  ordinary  legislative  procedure.  The  Commission  opposes  to  this 
limitation as it would prevent this definition to reflect the best state of science and would have 
negative consequences for the innovation in the food industry. 

In  addition,  the  Commission  opposes  the  adoption  of  further  criteria  to  clarify  definitions 
through implementing acts pursuant to Article 291 TFEU. The Commission considers that the 
adoption of these criteria implies supplementing non essential elements of the Regulation and 
thus  they  should  be  adopted  through  delegated  acts  pursuant  to  Article  290  TFEU.  This 
applies to definitions laid down in Article 3(2)(a)(i) to (iv) on sub-categories of novel foods, 
to  Article  3(2)(c)  on  engineered  nanomaterials,  and  to  Article  3(2)(d)  and  (e)  related  to 
traditional foods from third countries. 

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