Proposal for a Council Regulation (EC) concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC
Date: 1998-02-25
Institutions: European Commission
Subjects: consumer protection, foodstuff, genetically modified organism, labelling, new product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.02.1998 
COM(1998)99final 

Proposal for a 

COUNCIL REGULATION (EC) 

concerning the compulsory indication on the labelling of certain foodstuffs 
produced from genetically modified organisms of particulars other than those 
provided for in Directive 79/112/EEC 

(presented by the Commission) 

EXPLANATORY MEMORANDUM 

1.  On  19 September  1997, the Commission  adopted  Regulation  n°  1813/97  concerning 
the  compulsory  indication  on  the  labelling  of  certain  foodstuffs  produced  from 
gcnetically  modificd  organisms  of  particulars  other  than  those  provided  for  in 
Directive79/112/EEC. 

2.  This  Commission  Regulation  applics  to  the  labelling  of  foods  and  food  ingrcdients 
produced  from  gcnetically  modificd  soyabcans  and  gcnetically  modificd  maize 
which  were  granted  consent  under  Dircctivc  90/220/EEC  bcforc  the  cnlry  into  force 
of  the  Novel  Foods  Regulation.  It was  publishcd  in  the  Official  Journal  on  20.09.97, 
and  entered  into  force  on  1 November  1997. 

3.  Regulation  (CE)  n°  1813/97  was  adopted  on  the  basis  of  article  4(2)  of  Directive 
79/112/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the 
labelling, presentation  and  advertising  of  foodstuffs 

4. 

5. 

In  the  interest  of  consumer  proteclion,  in  order  to  ensure  fair  conditions  of 
competition  within  the  internal  market,  and  in  view  of  the  need  to  ensure  a  coherent 
Community  policy  for  foods  produced  from  biotechnology,  it  was  considered 
necessary  to  ensure  that  labelling  rulcs  for  the  information  of  the  final  consumer 
based  on  the  samc  principlcs  apply  to  foods  and  food  ingrcdients  produced  from 
OMOs  which  havc  bccn  placcd  on  the  market  bcforc  the  cnlry  into  force  oi' 
Regulation  (EC)  n° 258/97  pursuant  to a consent  given  under  Dircctivc  90/220/EEC, 
and  to  foods  and  food  ingrcdients  which  arc placcd  on  the  market  thercafter. 

In  order  to  achieve  this  goal,  the  first  step,  implcmenlcd  by  the  aforementioned 
Regulation  (CE)  n°  1813/97,  consisted  in  requiring  that  the  same provisions  as  those 
laid  down  in  Article  8  of  Regulation  (CE)  n°  258/97  apply  to  foods  and  food 
ingredients  produced  from  genetically  modificd  soyabeans  covered  by  Decision 
96/281/EC  and  genetically  modified  maize covered  by  Decision  97/98/EC. 

6.  However,  laying  down  general  labelling  rules  for  the  aforementioned  products  is  not 
sufficient  in  order  to  clarify  which  soya  or  maize  products  have  to  be  labelled,  and, 
when  so,  how.  In  order  to  achieve  this  rcsult,  it  is  also  necessary,  as  a  second  step, 
drawing  on  the  approach  taken  in  Article  8  of  Regulation  (EC)  N°  258/97,  to  lay 
down  detailed  uniform  Community  rules. 

As  a matter  of  fact,  Article  3 of  Regulation  (CE)  n°  1813/97  itsclf alrcady  laid  down 
that  "Detailed  uniform  Community  rules  for  the  labelling  of  the  foodstuffs  refcned 
to  in Article  1 shall  be adopted  as soon  as possible." 

7.  The  measures  proposed  in  the  attachcd  proposal  for  a  Regulation  constitutc  the 
detailed  uniform  Community  rules  announccd  in  Article  3  of  Regulation  (CE) 
n°  1813/97. 

oi 

Proposal for 

Council Regulation (EC) N°..../ 97  of.... 

concerning the compulsory indication on the labelling of ccrtain  foodstuffs 
produced from genetically  modified organisms of particulars other than those 
provided for in Directive 79/112/EEC 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Council  Directive  79/112/EEC  of  18  December  1978  on  the 
approximation of the laws of the Member States relating to the labelling, presentation and 
advertising  of  foodstuffs1,  as  last  amended  by  Directive  97/4/EC  of  the  European 
Parliament and of the Council2, and in particular Article 4(2) thereof; 

Having regard to the proposal  from  the Commission, 

1.  Whereas,  in  accordance  with  the  provisions  of  Part  C  of  Council  Directive 
90/220/EEC  of  23  April  1990  on  the  deliberate  release  into  Ihe  environment  of 
genetically  modified  organisms3,  consents  have  been  given  for  the  placing  on  the 
market of certain  genetically  modified  products by Commission  Decision  96/281/EC 
of  3 April  1996 concerning  the placing  on the  market  of  genetically  modified  soya 
beans (Glycine max L.) with increased tolerance to the herbicide glyphosate pursuant 
to  Council  Directive  90/220/EEC4,  and  by  Commission  Decision  97/98/EC  of  23 
January  1997  concerning  the  placing  on  the  market  of  genetically  modified  maize 
(Zea  mays  L.)  with  the  combined  modification  for  insecticidal  properties  conferred 
by  the  Bt-endotoxin  gene  and  increased  tolerance  to  the  herbicide  glufosinate 
ammonium  pursuant to Council Directive 90/220/EEC5; 

2.  Whereas  in  accordance  with  Directive  90/220/EEC  there  have  been  no  safely 
grounds  for  mentioning  on  the  label  of  genetically  modified  soya  beans  ((ilycine 
max  L) or of genetically  modified  maize (Zea mays L.) that they  have been obtained 
by genetic modification  techniques; 

3.  Whereas  Directive  90/220/EEC  does  not  cover  non-viable  products  derived  from 

genetically modified  organisms (hereinafter  referred  to as "GMOs"); 

OJn°L33,  8.2.1979, p.  I..  ^ 

OJn°L43,  14.2.1997, p. 21 

OJn°L  117, 8.5.1990, p. 15 

OJn"L  107, 30.4.1996, p. 10 
OJnr  L3I,  1.2.1997, p. 69 

3 

4.  Whereas  certain  Member  States  have  taken  measures  in  respect  of  the  labelling  of 
foods  and  food 
ingredients  produced  from  the  products  concerned;  whereas 
differences  between those measures are liable to impede the free  movement  of those 
foods  and  food  ingredients  and  thereby  adversely  affect  the  functioning  of  the 
internal  market;  whereas  it  is  therefore  necessary  to  adopt  uniform  Community 
labelling rules for the products concerned; 

5.  Whereas  European  Parliament  and  Council  Regulation  (EC)  N°  258/97  of  27 
January  1997  concerning  novel  foods  and  novel  food  ingredients6,  lays  down,  in 
Article  8,  additional  specific  labelling  requirements  in  order  to  ensure  proper 
information  for  the  final  consumer;  whereas  these  additional  specific  labelling 
requirements  do  not  apply  to  foods  and  food  ihgredients which  have  been  used  for 
human  consumption  to  a significant  degree  within  the  Community  before  the  entry 
into force  of Regulation  (EC) N° 258/97 and are not for  this reason considered  to be 
novel; 

6.  Whereas,  in  order  to  prevent  distortions  of  competition,  labelling  rules  for  the 
inlbrmation of the final consumer based on the same principles should  apply  to  foods 
and  food  ingredients consisting of or derived  from  GMOs which have been placed on 
the  market  before  the  entry  into  force  of  Regulation  (EC)  N°  258/97  pursuant  to  a 
consent  given  under  Directive 90/220/EEC, and to foods  and  food  ingredients  which 
are placed on the market  thereafter; 

7.  Whereas,  therefore,  Commission  Regulation  (EC)  N°  1813/97  concerning  the 
indication  on  the  labelling  of  certain  foodstuffs  produced  from 
compulsory 
genetically  modified  organisms  of  particulars  other  than  those  provided  for  in 
Directive  79/112/EEC7  has  laid  down  general  labelling  rules  for  the  above-
mentioned products; 

8.  Whereas  it  is  now  urgent  to  lay  down  detailed  uniform  Community  rules  for  the 

labelling of the foodstuffs  covered by Regulation (EC) N°  1813/97; 

9.  Whereas,  in  particular,  drawing  on  the  approach  taken  in  Article  8  of  Regulation 
(EC) N° 258/97, it is necessary  to ensure  that the final consumer  is informed  of any 
characteristic  or  food  property,  such  as composition,  nutritional  value or  nutritional 
effects  or  the  intended  use  of the  food,  which  renders  a food  or  food  ingredient  no 
longer  equivalent  to  an  existing  food  or  food  ingredient;  whereas,  for  this  purpose, 
foods  and  food  ingredients  produced  from  genetically  modified  soya  beans  or  from 
genetically  modified  maize  which  are  not  equivalent  to  conventional  counterparts 
should be subject to labelling requirements; 

10.  Whereas, drawing on the approach taken  in Article  8 of Regulation (EC) N° 258/97, 

it is necessary that labelling requirements are based on scientific  evaluation; 

11.  Whereas  it  is  necessary  to  establish  clear  labelling  rules  for  the  above-mentioned 
products,  allowing  official  contrql  on  a  reliable,  readily  repeatable  and  practicable 
basis; whereas common scientifically  validated testing methods should be developed. 

O J n ° L 4 3,  14.2.1997, p.  1 

OJ n° L 257, 20.9.97 p.7 

4 

12.  Whereas  it  is  also  necessary  to  ensure  that  the  labelling  requirements  are  no  more 
burdensome  than  necessary  but  sufficiently  detailed  to  supply  consumers  with  the 
information  they require. 

13.  Whereas  at  this  stage  the  presence  in  foods  and  food  ingredients  of  DNA  resulting 
from  genetic  modification  constitutes  the  criterion  best  complying  with  the  above-
mentioned  requirements  ;  whereas  such  an  approach  could  be  reconsidered  in  the 
light of future  developments in scientific knowledge; 

14.  Whereas foods  and food  ingredients  produced  from  genetically  modified  soya beans 
(Glycine  max  L) or  from  genetically  modified  maize (Zea  mays  L.),  in which  DNA 
resulting  from  genetic  modification  is  present,  are  not  equivalent  and  therefore  are 
subject to labelling requirements ; 

15.  Whereas  it  is  possible  that  DNA  resulting  from  genetic  modification  has  been 
destroyed  by successive  stages of processing  ; whereas,  in that case,  foods  and  food 
ingredients  should be considered equivalent  for  labelling purposes; whereas they  are 
therefore  not subject to labelling requirements; 

16.  Whereas  nevertheless  some  processing  methods  may  eliminate  DNA  but  not 
proteins;  whereas  it  cannot  be  excluded  that  such  methods  can  be  applied  to  food 
uses  ;  whereas  foods  and  food  ingredients  in  which  DNA  resulting  from  genetic 
modification  is  not  present  but  in  which  there  are  proteins  resulting  from  genetic 
modification  present, cannot be considered  to be equivalent; whereas therefore,  they 
are subject to labelling requirements. 

17.  Whereas  the  necessary  information  should  be  provided  in  the  list  of  ingredients 
except  in the  case of  products for  which  no such  list  exists,  in  which  case  it  should 
appear clearly on the labelling of the product; 

18.  Whereas, with  regard  to foods  and food  ingredients  which  are intended to be placed 
on  the  market  to  be  supplied  to  the  final  consumer,  and  which  may  contain  both 
genetically  modified  and  conventional  produce,  and  without  prejudice  to  the  other 
labelling  requirements  of  this  Regulation,  information  for  the  consumer  on  the 
possibility  that  genetically  modified  produce  may  be present  in  the  foods  and  food 
ingredients  concerned  is deemed -by way of exception,  in particular  as regards bulk 
consignments- to fulfil  the requirements of this Regulation. 

19.  Whereas  this  Regulation  is  without  prejudice  to  the  operators'  right  to  include 
voluntary  claims in the labels of their products as to particulars other than those laid 
down in this Regulation (such as the absence of foods and food  ingredients produced 
from  genetically  modified  soyabeans  and  maize, or  the  presence  of  such  foods  and 
food  ingredients  in cases where it is not scientifically  verifiable  but evidence of  it is 
available  through  other  means),  provided  such  claims  are  made  in compliance  with 
the provisions of Directive 79/112/EEC. 

20.  Whereas,  having  regard  to  the  scope  and  effects  of  the  proposed  action,  the 
Community  measures  introduced  by  this  Regulation  are  not  only  necessary  but 
essential  if the objectives  set are to  be attained;  whereas  those  objectives  cannot  be 
attained  by the Member States acting  individually; 

21.  Whereas  this  Regulation  replaces  Regulation  (EC)  N°  1813/97  which  should 

therefore  be repealed; 

22.  Whereas  in  pursuance  of  the  procedure  laid  down  in  Article  17  of  directive 
79/112/EEC,  this  text  was  submitted  to  the  Standing  Committee  for  Foodstuffs, 
which  was  unable  to deliver  an  opinion,  and  whereas  in  accordance  with  that  same 
procedure the Commission is required to address a proposal to the Council, 

HAS ADOPTED THIS REGULATION 

Arlicle l 

1.  This  Regulation  shall  apply to foods  and  food  ingredients  which  are to be  delivered 
as  such  to  the  final  consumer  (hereinafter  referred  to  as  "the  specified  foodstuffs") 
produced, in whole or in part, from: 

genetically modified  soya beans covered by Decision 96/281/EC; 

genetically modified  maize covered by Decision 97/98/EC. 

2.  This Regulation  shall not apply to food  additives, flavourings  for use in foodstuffs  or 
extraction solvents used  in the production  of foodstuffs  as referred  to in Article  2(1) 
of Regulation  (EC) N° 258/97. 

Article 2 

1.  The  specified  foodstuffs  shall  be  subject  to  the  additional  specific 

labelling 

requirements laid down in paragraph 3 of this article. 

2.  However, foods and food  ingredients referred  to in the first paragraph  in which DNA 
resulting  from  genetic modification  is not present shall  not be subject  to the  specific 
Iabelling requirements, unless there are proteins resulting  from  genetic  modification 
present. 

3.  The specific  labelling requirements referred  to in paragraph  1  are the  following: 

(a)  Where the food  consists of more than one ingredient, the words "produced  from 
genetically  modified  soya"  or  "produced  from  genetically  modified  maize",  as 
appropriate,  shall  appear  in  the  list  of  ingredients  provided  for  by  Article  6 of 
Directive  79/112/EEC  in  parentheses  immediately  after  the  name  of  the 
ingredient  concerned.  Alternatively,  these  words  may  appear  in  a  prominently 
displayed  footnote  to the  list of  ingredients  which  has a typeface  of  at  least  the 
same size as the list of ingredients itself. 

(b)  In  the  case  of  products  for  which  no  list  of  ingredients  exists,  the  words 
"produced  from  genetically  modified  soya"  or  "produced  from  genetically 
modified  maize",  as  appropriate,  shall  appear  clearly  on  the  labelling  of  the 
food. 

£ 

(c)  Where  in accordancc with  the provisions of the first  indent of sub paragraph  (b) 
of paragraph  5 of Article 6 of  Directive  79/112/EEC an  ingredient  is designated 
by  the  name  of  a  category,  that  designation  shall  be  completed  by  the  words 
"contains"  or  "  may  contain  [ingredients]  produced  from  genetically  modified 
soya/genetically modified  maize", as appropriate. 

(d)  Where  an  ingredient  of  a  compound  ingredient  is  derived  from  the  specified 
foodstuffs,  it  shall  be  mentioned  on  the  labelling  of  the  final  product,  with  the 
addition of the wording shown in point (b). 

(e)  By  way  of  exception,  where  the  presence  in  foods  and  food  ingredients,  of 
genetically  modified  produce  subject  to the  labelling  provisions  of points  (a) to 
(d),  cannot  be excluded  but  where  no evidence  of  it  is available, the  use  of  the 
terms "may  contain" or "may  have  been produced  from"  shall  be considered  to 
fulfil  the requirements of those points. 

4.  The  first,  second  and  third  paragraphs  shall  be  without  prejudice  to  the  other 

requirements of Community  law concerning the labelling of  foodstuffs. 

Regulation (EC)  1813/97 is hereby repealed. 

Article 3 

Article 4 

The  labelling  requirements  of  this  Regulation  shall  not  apply  to  products  which  have 
been lawfully  manufactured  and labelled in the Community, or which have been  lawfully 
imported  into the Community  and put into free  circulation, before  the entry  into force  of 
this Regulation. 

Article 5 

This Regulation  shall enter into force  20 days after  its publication  in the Official  Journal 
of the European  Community. 

This  Regulation  shall  be  binding  in  its  entirety  and  directly  applicable  in  all  Member 
States. 

Done at, 

For the Council 

^ 

ISSN 0254-1475 

COM(98) 99 final 

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03  10  15 

Catalogue  number  :  CB-CO-98-104-EN-C 

ISBN  92-78-31295-9 

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