OPINION OF THE COMMISSION  pursuant to Article 294, paragraph 7, point (c) of the Treaty on the Functioning of the European Union, on the European Parliament's amendments  to the Council's position regarding the  proposal for a REGULATION OF THE EUROPEAN PARLIAMENT  AND OF THE COUNCIL  on novel foods, amending Regulation (EC) N° 1331/2008 and repealing Regulation (EC) N° 258/97 and Commission Regulation (EC) N° 1852/2001
Date: 2010-10-11
Institutions: European Commission
Subjects: biotechnology, consumer information, consumer protection, food safety, foodstuffs legislation, genetically modified organism, health policy, human nutrition, marketing, public health

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EUROPEAN COMMISSION 

Brussels, 11.10.2010 
COM(2010) 570 final 

2008/0002 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 294, paragraph 7, point (c) of the Treaty on the Functioning of the 
European Union, 
on the European Parliament's amendments  
to the Council's position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

on novel foods, amending Regulation (EC) N° 1331/2008 and repealing Regulation (EC) 
N° 258/97 and Commission Regulation (EC) N° 1852/2001 

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2008/0002 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 294, paragraph 7, point (c) of the Treaty on the Functioning of the 
European Union, 
on the European Parliament's amendments 
to the Council's position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT  
AND OF THE COUNCIL 

on novel foods, amending Regulation (EC) N° 1331/2008 and repealing Regulation (EC) 
N° 258/97 and Commission Regulation (EC) N° 1852/2001 

1. 

INTRODUCTION 

Article 294 (7) (c) of the Treaty on the Functioning of the European Union provides 
that  the  Commission  is  to  deliver  an  opinion  on  the  amendments  proposed  by  the 
European Parliament at second reading. The Commission sets out its opinion below 
on the 104 amendments proposed by the Parliament.  

2. 

BACKGROUND 

Date on which the proposal was sent to Parliament and Council: 14 January 2008 

Doc COM (2007)872 final -2008/0002 (COD) 

Date of the opinion of the European Economic and social Committee: 29 May 2008 

Date of Parliament's opinion at first reading: 25 March 2009 

Date on which the amended proposal was sent to Parliament and Council: none 

Date of political agreement on the Council position: 22 June 2009  

Date of formal adoption of the Council position: 11 March 2010 

Date of Parliament's opinion at second reading: 7 July 2010 

Date of transmission of Parliament's opinion at second reading: 9 August 2010 

3. 

PURPOSE OF THE PROPOSAL 

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 

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the market of novel foods while ensuring food safety, the protection of public health 
and  of  consumer  interests  and  the  functioning  of  the  internal  market.  It  repeals 
Regulation (EC) n° 258/97 and Commission regulation (EC) n° 1852/2001. 

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

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. 

The proposal also confirms the "status quo" for food derived from animals obtained 
by non conventional breeding techniques (e.g. clones) by explicitly requiring a pre-
market  authorisation  while  food  derived  from  animals  obtained  by  conventional 
breeding techniques (e.g. offspring of clones) is not considered as being novel. 

4. 

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE  EUROPEAN 
PARLIAMENT 

4.1. 

Summary of the Commission's opinion 

The Parliament has adopted 104 amendments to Council's position. The Commission 
can accept 34 amendments, either in full or in part.  

The Commission can accept 16 amendments as they stand (n° 3, 8, 12, 17, 27, 44, 56, 
57,  75  90,  91,  93,  99,  111,  114,  117)  and  can  accept  18  amendments  in  part  or 
subject to rewording (n° 1, 16, 26, 34, 35, 45, 47, 49, 50, 52, 82, 94, 95, 96, 97, 106, 
109, 110). 

The Commission cannot support 70 amendments (n° 2, 4, 5, 6, 9, 10, 11, 13, 14, 15, 
20, 21, 22, 23, 25, 28, 29, 30, 32, 33, 37, 39, 40, 41, 42, 43, 46, 51, 53, 54, 55, 58, 59, 
61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 74, 77, 78, 80, 81, 84, 85, 87, 88, 89, 92, 
98, 100, 101, 102, 103, 104, 105, 107, 108, 113, 115, 116, 118, 120). 

4.2. 

Amendments accepted by the Commission 

4.2.1  Nanotechnologies 

The  Commission  supports  the  principle  of  a  regulatory  definition  of  "engineered 
nanomaterials"  in  order  to  clarify  which  products  would  require  a  pre-market 
approval  under  the  Novel  Food  Regulation  (amendment  16).  This  definition,  based 
on  science,  must  be  enforceable  by  food  business  operators  and  Member  State 
control authorities.  

Should science provide new information about the elements to be considered in the 
draft  definition  before  the  final  adoption  of  the  text,  the  Commission  will  submit 
appropriate changes to that definition to the co-legislators. 

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The  Commission  agrees  with  the  need  to  adapt  the  regulatory  definition  of 
"engineered nanomaterials" to the scientific progress and international developments 
through delegated acts (amendments 34 and 49). 

As regards, the labelling of nanomaterials in foodstuffs, the Commission can accept 
the  principle  of  a  mandatory  and  systematic  labelling  of  all  foods  and  food 
ingredients  containing  nanomaterials  (amendment  75).  This  labelling  requirement 
would  apply  at  the  level  of  the  list  of  ingredients  and  to  all  food  ingredients 
containing engineered nanomaterials covered by the above mentioned definition. 

The Commission considers that the labelling requirement should preferably be done 
within  the  framework  of  the  proposal  for  a  Regulation  of  the  European  Parliament 
and  the  Council  on  the  provision  of  food  information  to  consumers  in  order  to 
provide a coherent approach to the labelling of engineered nanomaterials in all foods. 

4.2.2 

Precautionary  principle,  protection  of  animal  welfare  and  environmental  and 
ethical aspects 

The  primary  objective  of  the  Novel  Food  Regulation  is  to  ensure  the  food  safety 
through a systematic EU risk assessment and authorisation procedure prior to getting 
market access and the free circulation of goods within the EU.  

However the Commission supports the inclusion, where applicable, of the objectives 
related  to  the  protection  of  animal  health,  animal  welfare,  the  environment  and 
consumer protection (amendments 1, 3 and 35).  

4.2.3  Traditional foods from third countries 

The Commission can agree with the requirement for a 25 year period of consumption 
in third countries to demonstrate the history of safe food use of traditional foods from 
third  countries  (amendment  47).  This  comes  in  addition  to  the  necessity  to  submit 
relevant data required to establish the safety of these foods. 

4.2.4  Animal testing 

The Commission agrees that repetition of tests on vertebrates should be avoided as 
much as possible. Therefore, the possibility for an applicant to refer to the results of 
animal test studies made by a prior applicant against financial compensation can be 
provided,  including  when  data  protection  has  been  granted.  However,  such 
possibility does not mean that the prior applicant has the obligation to grant access to 
its data in all cases. Therefore amendment 99 can be accepted provided rewriting to 
clarify this aspect. 

4.2.5  Adaptation to the Lisbon Treaty 

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 recourse to the "ordinary legislative procedure" for its 
revision  would  prevent  this  definition  to  reflect  the  best  state  of  science  and  can 
agree with its revision through delegated acts (amendment 49). 

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As  regards  the  modalities  for  the  delegation  and  revocation  of  power  to  the 
Commission  for  adopting  delegated  acts  and  for  objections  to  delegated  acts,  the 
Commission  can  support  the  EP  amendments  (amendment  109  as  regards  the 
duration  of  the  delegation,  amendment  110  as  regards  the  modalities  for  the 
revocation of the delegation and amendment 111 as regards the modalities for raising 
objections to delegated acts). 

4.3. 

Amendments rejected by the Commission 

4.3.1.  Cloning 

The  EP  requests  a  legislative  proposal  to  prohibit  food  from  clones  and  their 
offspring  of  all  generations  within  6  months  after  the  entry  into  force  of  the 
Regulation  (amendment  5).  The  EP  also  requests  a  moratorium  on  the  placing  of 
such  products  on  the  market  until  the  proposal  is  adopted  (amendment  14)  and  a 
report dealing with all aspects of cloning within 3.5 years after the entry into force of 
the  Novel  Food  Regulation,  accompanied  if  necessary  by  any  legislative  proposal 
(amendment 113). 

Following  extensive  discussions  at  both  EP  and  Council  levels,  the  Commission 
considers  that  the  Novel  Food  Regulation  is  not  the  appropriate  legal  frame  for 
addressing  globally  the  cloning  issue  for  food  production.  In  particular,  the 
production  and  marketing  of  products  other  than  food  (reproductive  materials) 
cannot  be  covered  by  the  Novel  Food  Regulation  which  deals  exclusively  with  the 
pre-market authorisation of food products. 

The  Commission  will  also  adopt  by  mid  November  at  the  latest  a  report  on  all 
aspects of the use of the cloning technique for food production. This report will serve 
as  a  basis  for  further  discussions  on  this  issue  between  the  EU  Institutions.  The 
Commission is open to find a consensus and is considering the options for a future 
legal frame. 

4.3.2.  Nanotechnologies 

The  Commission  does  not  agree  with  the  EP  assumption  that  the  general 
methodology used for the risk assessment of foodstuffs would not be applicable for 
that of nanomaterials in food (amendment 6) and that, until specific test methods are 
developed, no food with nanomaterials should be put on the EU market (amendment 
120). 

In line with the EFSA opinion of 10 February 2010, the Commission acknowledges 
that  additional  safety  tests  and  control  tools  need  to  be  developed  but  that  the 
methodology used for the risk assessment of foodstuffs remains valid (amendments 
6, 10, 13 and 23). Therefore amendments 6, 10, 13, 23 and 120 cannot be accepted. 

The  Commission  is  committed  to  only  approve  the  marketing  of  food  containing 
nanomaterials for which the food safety has been established. 

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4.3.3.  Traditional foods from third countries 

The  Commission  considers  that  traditional  foods  from  third  countries  should  cover 
foods  derived  from  primary  production,  including  some  processed  foods  provided 
they have not undergone extensive or innovative food processes and is not in favour 
of  a  restriction  to  "natural  non  engineered  novel  foods  "  (amendment  47–  partial 
rejection). 

The Commission has agreed with a systematic risk assessment by EFSA followed by 
an authorisation at EU level with shorter deadlines as laid down in the position of the 
Council.  

However,  as  amendment  81  refers  to  the  notification  procedure  provided  by  the 
original Commission proposal and would facilitate the trade of traditional foodstuffs 
from third countries without undermining the food safety, the Commission considers 
it would be appropriate to reintroduce the concept of the notification procedure. 

4.3.4.  Data protection 

The  Commission  considers  that,  in  dully  justified  cases  concerning  genuine 
innovative  products  for  which  data  protection  has  been  granted,  these  novel  foods 
could benefit from an individual authorisation and 5-year period of exclusivity on the 
EU market.  

As only generic authorisations are granted through Article 7 of Regulation (EC) No 
1331/2008  of  the  European  Parliament  and  of  the  Council  establishing  a  common 
authorisation  procedure  for  food  additives,  food  enzymes  and  food  flavourings,  the 
authorisation  procedure  with  data  protection  clearly  derogates  from  the  common 
authorisation  procedure  and  shall  therefore  be  kept  separate  in  the  Novel  Food 
Regulation and therefore amendments 100, 101 and 102 cannot be accepted.  

The synchronisation of the data protection periods which may be granted both under 
Novel  Food  Regulation  and  under  Regulation  (EC)  No  1924/2006  of  the  European 
Parliament and of the Council on nutrition and health claims made on foods would 
provide an improved benefit for the placing of the market of such products. 

However,  as  the  data  to  be  assessed  are  under  both  Regulations  are  of  totally 
different nature and have to be examined by different EFSA panels, the matching of 
the  periods  of  data  protection  cannot  be  ensured  in  practice  and  therefore 
amendments 28 and 103 cannot be accepted.  

4.3.5.  Adaptation to the Lisbon Treaty 

The possibility to adopt further criteria to clarify the definitions laid down in Article 
3 2) points a) (i) to (iv) related to sub-categories of novel foods, and point d) and e) 
related to traditional foods from third countries should be kept. Its removal implies 
that it could be done only through the "ordinary legislative procedure" (amendment 
33). The Commission considers that the determination of these criteria is a measure 
aimed  at  supplementing  non  essential  elements  of  the  Regulation,  which  should  be 
adopted through delegated acts.  

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The Commission also considers that the adaptation of the following measures should 
be done through implementing acts: 

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

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

The update of the list of traditional foods from third countries and the adoption 
of detailed rules for implementation of the procedure for traditional foods from 
third countries in Article 11(5) and (7); -  

The adoption of implementing measures to ensure public information in Article 
17; 

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 transitional measures for pending requests in Article 27(2); 

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

Therefore amendments 32, 34, 54, 55, 70, 81 100, 101 102, 104, 108, 115 and 118 
cannot be accepted. 

4.3.5.  Other issues 

Several  amendments  on  other  issues  (such  as  the  procedures  applicable  for 
determining the status of a food, the setting up of EU lists of authorised novel foods, 
the rules for the transitional period or the update of Regulation n° 1331/2008 on the 
common  authorisation  procedure)  do  not  provide  further  improvements  to  the  text 
and thus should be rejected. 

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