Amended Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on novel foods and novel food ingredients
Date: 1996-05-23
Institutions: European Commission
Subjects: consumer protection, foodstuff, genetically modified organism, labelling, new product

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  23.05.1996 
COM(96) 229 final  - COD 426 

OPINION  OF THE  COMMISSION 
pursuant to Article  189 b (2) (d) of the EC Treaty, 
on the European  Parliament's amendments 
to the Council's common  position regarding the 

proposal  for  a 
EUROPEAN PARLIAMENT  AND COUNCIL  REGULATION  (EC) 

on novel foods and novel food ingredients 

AMENDING THE PROPOSAL  OF THE  COMMISSION 
pursuant to Article  189 a (2) of the EC Treaty 

Introduction 

On 7 July  1992 the Commission presented a proposal  for a Council Regulation on novel 

foods and novel food ingredients. (COM(92)295 final - SYN 426). 

Further to  the  opinion  of  the  European  Parliament  delivered  on  27  October  1993,  the 

Commission  prepared  an  amended  proposal  which  was  submitted  to  the  Council  on  1 

December  1993 (COM(93) 631 final - COD 426. 

On 23 October  1995  the Council adopted a common position by qualified  majority. 

On  12  March  1996,  the  European  Parliament  adopted  6  amendments  to  the  common 

position  adopted  by  the  Council  on  23  October  1995  in  respect  of  the  Commission 

proposal  for  a Regulation  of the  European  Parliament  and  of the Council  on  novel  foods 
and novel food  ingredients.1 

Objectives  of the Regulation 

At  present,  within  the European  Union,  foodstuffs  can  generally  be placed  on  the  market 

without any pre-marketing assessment or  authorisation. 

Recently,  a  new  range  of  raw  materials,  processes  and  technologies,  including  but  not 

only  modern  biotechnology  and  genetic  modification  techniques  have  emerged.  These 

innovations  aim  for  example  at  improving  the  nutritional  and  dietary  aspects  of 

foodstuffs,  at  promoting  greater  technical  efficiency 

in  production  processing  or 

distribution, at reducing the risk of microbiological  contamination  or at growing  crops  by 

using  fewer  pesticides.  In  order  to  ensure  consumer  protection  and  to  avoid  the  creation 

of  trade  barriers  in  the  internal  market,  it  was  felt  necessary  to  create  a  Community 

procedure for  the placing on the market  of  "novel  foods"  resulting  from  these  innovations 

and to provide  for  a safety  assessment  and  for  precise  labelling provisions.  The  proposal 

is  therefore  of  major  importance,  from  the  point  of  view  of  consumer  protection  and 

information  as well as for  smooth  functioning  of the  internal  market  and  the diffusion  of 

new  technologies  in  the  agri-food  sector.  The  Commission  believes  that  there  is  general 

agreement  between  the  institutions  about  the  urgent  need  for  Community  legislation  on 

this issue. 

O J n °C  190, 29.7.1992,  p.3 

I 

Opinion of the Commission 

In accordance  with paragraph 2  (d)  of  Article  189b of  the  EC Treaty, the  Commission 

gives the following opinion on  these amendments.. 

The Commission agrees with Parliament that the Regulation should be brought into force 

as  soon  as  possible,  and  it  can  therefore  give  a  favourable  opinion  on  amendment  48 

which  reduces  the  period  for  implementation  of  the Regulation  from  12  months  to  90 

days; 

The Commission understands the concern expressed by the Parliament in amendment  53 

to  ensure  that  food  additives,  flavours  and  extraction  solvents  meet  the  same  level  of 

safety  as  novel  foods,  and  shares  this  principle.  However,  it  cannot  give  a  favourable 

opinion  on  the  wording  of  amendment  53  since  it  implies  that  the  exclusion 

is 

conditional,  requiring  specific  action to  be taken. The Commission  would  point  out  that 
the  framework  Directive  on  food  additives  (89/107/EEC)2  and  the  Common  Position 
agreed  by  the  Council  on  22  December  1995  on  a  proposal  for  a  regulation  of  the 

laying  down  a  Community  procedure  for 
European  Parliament  and  the  Council 
flavouring  substances  intended  for use  in foodstuffs3  already  provide  for  the  same  level 
of  safety  as  for  novel  foods,  including  compulsory  consultation  of  the  scientific 

Committee  for  Food  on  matters  likely  to  affect  public  health.  In  respect  of  extraction 
solvents, Directive  83/344/EEC4  already  provides  for  a similarly  high  level  of  protection 
of public  health. 

Amendment  54  provides  that  the  labelling  rules  of  Article  8 apply  to  novel  foods  and 

novel  food  ingredients  which  are  the  subject  of  the  simplified  notification  procedure.  In 

isolation, this  amendment  presents  no  difficulty,  since  it simply  clarifies  the  intention  of 

the  Common  Position  which  is  to  apply  a  single  coherent  set  of  labelling  rules  to  all 

categories  of  novel  foods.  However,  this  amendment  must  also  be  seen  in  conjunction 

with  amendment  55  which  deletes  the  word  "significant"  in  Article  8  (1)  (a)  of  the 

Common  Position  so  that  labelling  of  novel  foods  will  be  required  in  all  cases  where  a 

novel  food  is different  from  the  conventionally  produced  food.  It should  be recalled  that 

labelling  of  significant  differences 

is  the  mirror-image  of  the  application  of  the 

internationally  recognised  scientific  principle  of  "substantial  equivalence"  on  which  the 

Regulation  is based.  Under  the  common  position,  an  operator  would  therefore  know  that 

if  he  can  provide  evidence  that  the  food  or  food  ingredient  is  clearly  substantially 

equivalent,  then  the  notification  procedure  could  be  used  and  the  product  would  not 

2 
3 
'1 

O J n °L  40,  11.2.1989, p.  27 
OJ  n<  C 59, 28.2. Î 996, p. 37 
().l.n°l.  157,24.6.1988,  p.28 

5 

require  any  specific  labelling.  With  the  new  formulation  of Amendment  55, the  operator 

cannot  be  certain  that  his  substantially  equivalent  product  does  not  present  negligible 

differences.  Therefore, the notification  procedure may become unusable in practice. 

The  Commission  understands  the  concern  of  Parliament  to  ensure  that  consumers  are 

informed  of  all  differences  between  novel  foods  and  conventionally  produced  foods. 

Nevertheless,  the  application  of  a  criterion  that  would  lead  to  special 

labelling 

requirements even for novel foods which are substantially  equivalent is likely to give  rise 

to  practical  difficulties.  Particularly  in  the  case  of  fruit  and  vegetables,  climatic  and 

geographical  factors  such  as  soil  types  may  have  noticeable  effects  on the  properties  of 

the final product.  For example, climatic  variations  from  year to year result in  differences 

in the final crop. In  such circumstances  it may  be difficult  to decide what are the  precise 

parameters  to  be used  in determining  whether  a novel  food  differs  from  its  conventional 

counterpart.  In  order 

to  provide  meaningful 

information 

for  the  consumer, 

the 

Commission  considers  that  a  product  should  only  be  labelled  when 

it  presents 

characteristics  which  fall  outside  of the range  of natural  variations and which  may  affect 

the  composition,  the  nutritional  value  or  effects  or the  intended  use of the products.  The 

Commission  is  therefore  unable  to  accept  these  2  amendments  and  considers  that  all 

possibilities  should  be  explored  in  order  to  outline  the  concept  of  difference  so  that  it 

provides more legal certainty  for economic  operators. 

The  current  text  of  the  common  position  provides  that  the  presence  of  a  genetically 

modified  organism  does  not  need  to  be  indicated  on  the  labelling  when  this  presence  is 

solely  due  to  agricultural  characteristics  and  does  not  modify  the  characteristics  of  the 

foodstuff  itself.  This  exemption  would  cover,  for  example,  corn  which  is  genetically 

modified  to  increase  insect  resistance.  Amendments  51  and  52  have  the  effect  of 

deleting  this exemption.  The  Commission  does  not  share  the point  of view of  Parliament 

that  the  presence  of  genetically  modified  organisms  should  be  indicated  on  the  labelling 

of  the  foodstuff  concerned  in  all  cases,  even  when  this  presence  has  no  effect  on  the 

properties  of  the  foodstuff.  The  purpose  of  food  labelling  is  to  inform  consumers  about 

the  characteristics  of  the  food.  Information  about  methods  of  production  and  agronomic 

properties  is required  only  where these have  an effect  on the finished  product.  Moreover, 

the  introduction  of  such  a provision  would  make  it necessary  either  to establish  separate 

distribution  systems  for  foods  containing  GMOs  -which  would  be extremely  difficult  to 

implement  from  practical  point of view- or to provide  for systematic  labelling  in all  cases 

that  the  produce  may  contain  GMOs.  Particular  problems  arise  in  respect  of  imports, 

since none of the Community's  major  trading partners provide for  labelling in such  cases, 

and  GMO  produce  will  usually  be  mixed  with  conventional  produce  before  shipment  to 

the EU. 

K 

In addition, amendment 51 requires the labelling of "an organism genetically modified  by 
genetic engineering methods". The Commission considers that this formulation, implies 
legal  uncertainty,  because  the  concept  used  is  not  sufficiently  precise  and  does  not 
correspond to an already existing definition. A clear defimtion for GMO's is provided by 
Directive 90/220/EC and this is why  it  is proposed  to use it also for  labelling of novel 
foods. 

On the basis of this analysis, the Commission has incorporated one amendment (n° 48) in 
its modified proposal. The Commission would, however, emphasise that there is general 
agreement on the urgent need to establish a satisfactory regulatory framework for novel 
foods at Community level. To this end the Commission will participate constructively 
with the institutions in the remaining stages of the institutional decision-making 
procedure using all available possibilities with a  view to resolving the outstanding 
problems identified above. 

Amended Proposal for a 

Regulation of the European Parliament and of the Council 

on novel foods and novel food ingredients 

(presented by the Commission pursuant to Article 189 A (2) of the EC Treaty) 

Current Proposal 

Amended proposal 

Article 15,1st paragraph 

This regulation shall enter into force  12 
months following the day of its 
publication in the Official  Journal of the 
European Communities. 

This regulation shall enter into force 90 
days following its publ'cation in the 
Official  Journal of the European 
Communities. 

ISSN 0254-147.S 

COM(96) 229  final 

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