Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC
Date: 1998-05-26
Institutions: Council of the European Union
Subjects: foodstuff, genetically modified organism, labelling

L 159/4

EN

Official Journal of the European Communities

3. 6. 98

COUNCIL REGULATION (EC) No 1139/98

of 26 May 1998

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

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 foodstuffs (1), and in particular Article 4(2)
thereof,

Having regard to the proposal from the Commission,

of

genetically modified

(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 the environ-
organisms (2),
ment
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 geneti-
cally modified soya beans (Glycine max L.) with
increased tolerance to the herbicide glyphosate,
pursuant to Council Directive 90/220/EEC (3), 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/EEC (4);

(2) Whereas in accordance with Directive 90/220/EEC
there were no safety grounds for mentioning on the
label of genetically modified soya beans (Glycine
max L.) or of genetically modified maize (Zea
mays L). that they were obtained by genetic modi-
fication techniques;

(3) Whereas Directive 90/220/EEC does not cover
non-viable products derived from genetically modi-
fied organisms (hereinafter referred to as ‘GMOs');

(1) OJ L 33, 8. 2. 1979, p. 1. Directive as last amended by Dir-
the

the European Parliament

ective 97/4/EC of
Council (OJ L 43, 14. 2. 1997, p. 21).

and of

(2) OJ L 117, 8. 5. 1990, p. 15. Directive as last amended by

Directive 97/35/EC (OJ L 169, 27. 6. 1997, p. 72).

(4) Whereas certain Member States have taken meas-
ures 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 Regulation (EC) No 258/97 of the Euro-
pean Parliament and of the Council of 27 January
1997 concerning novel foods and novel food ingre-
dients (5), lays down, in Article 8, additional specific
labelling requirements in order to ensure proper
information for the final consumer; whereas those
additional specific labelling requirements do not
apply to foods or food ingredients which were used
for human consumption to a significant degree
within the Community before the entry into force
of Regulation (EC) 258/97 and are for that reason
considered not to be novel;

(6) Whereas,

in order

to prevent distortions of
competition, labelling rules for the information of
the final consumer based on the same principles
should apply to foods
and food ingredients
consisting of or derived from GMOs which were
placed on the market before the entry into force of
Regulation (EC) No 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)
No 1813/97 of 19 September 1997 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 (6) laid down general
labelling rules for the abovementioned products;

(8) Whereas it is now urgent to lay down detailed
uniform Community rules for the labelling of the
foodstuffs covered by Regulation (EC) No 1813/97;

(3) OJ L 107, 30. 4. 1996, p. 10.
(4) OJ L 31, 1. 2. 1997, p. 69.

(5) OJ L 43, 14. 2. 1997, p. 1.
(6) OJ L 257, 20. 9. 1997, p. 7.

3. 6. 98

EN

Official Journal of the European Communities

L 159/5

(9) Whereas, in particular, drawing on the approach
taken in Article 8 of Regulation (EC) No 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 nutri-
tional effects or the intended use of the food, which
renders a food or food ingredient no longer equiva-
lent to an existing food or food ingredient; whereas,
for
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;

that purpose,

(10) Whereas, drawing on the approach taken in Article
8 of Regulation (EC) No 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 abovementioned products, allowing
official control on a reliable, readily repeatable and
practicable basis; whereas common scientifically
validated testing methods should be developed;

(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 protein or DNA resulting from
genetic modification constitutes the criterion best
complying with the abovementioned requirements;
whereas such an approach could be reconsidered in
the light of
in scientific
future developments
knowledge;

(17) Whereas

it

is possible that protein or DNA
resulting from genetic modification has been
destroyed by successive
stages of processing;
whereas, in that case, foods and food ingredients
labelling
should be considered equivalent
purposes; whereas they should therefore not be
subject to labelling requirements; whereas a list of
such products should be drawn up;

for

(18) Whereas, nevertheless, some processing methods
may eliminate DNA but not proteins; whereas the
possibility cannot be excluded that such methods
may be capable of being applied to food uses;
whereas foods and food ingredients in which DNA
resulting from genetic modification is not present
but in which proteins resulting from genetic modi-
fication are present, cannot be considered to be
they should be
equivalent; whereas
subject to labelling requirements;

therefore,

(19) 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;

(20) 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 soya beans 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 that such claims are made in compliance
with the provisions of Directive 79/112/EEC;

(14) Whereas adventitious contamination of foodstuffs
with DNA or protein resulting from genetic modi-
fication cannot be excluded; whereas labelling as a
result of such contamination could be avoided by
setting a threshold for the detection of DNA and
protein;

(21) Whereas, having regard to their scope and effects,
the Community measures introduced by this Regu-
lation 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;

(15) Whereas urgent consideration must be given, in the
light of any relevant scientific advice, to the ques-
tion of whether a de minimis threshold for the
presence of DNA or protein resulting from genetic
modification can be set and, if so, at what level;

(16) 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 should therefore be
subject to labelling requirements;

(22) Whereas

this Regulation replaces Commission
Regulation (EC) No 1813/97, which should there-
fore be repealed;

(23) Whereas in pursuance of the procedure laid down
in Article 17 of Directive 79/112/EEC, a draft of
this text was submitted to the Standing Committee
on Foodstuffs, which was unable to deliver an
opinion, and whereas in accordance with the same
procedure the Commission addressed a proposal to
the Council, concerning the measures
to be
adopted,

L 159/6

EN

Official Journal of the European Communities

3. 6. 98

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation shall apply to foods and food ingre-
1.
dients which are to be delivered as such to the final
consumer (hereinafter referred to as ‘the specified food-
stuffs') produced, in whole or in part, from:

(cid:190) genetically modified soya beans covered by Decision

96/281/EC,

(cid:190) 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) No 258/97.

Article 2

is
the ingredient concerned. Where an ingredient
already listed as being produced from soya or maize
the words ‘produced from genetically modified' may
be abbreviated to ‘genetically modified'; if the abbre-
viated form of words is used as a footnote, the asterisk
shall be directly attached to the word ‘soya' or ‘maize'.
Where either form of words is used as a footnote, it
shall have 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 accordance with the provisions of the first
indent of Article 6(5)(b) of Directive 79/112/EEC an
ingredient is designated by the name of a category,
that designation shall be completed by the words
‘contains . . . (*) produced from genetically modified
soya/genetically modified maize', as appropriate;

(d) where an ingredient of a compound ingredient

is
it shall be
derived from the specified foodstuffs,
mentioned on the labelling of the final product, with
the addition of the wording set out in point (b).

This Article shall be without prejudice to the other
4.
requirements of Community law concerning the labelling
of foodstuffs.

The specified foodstuffs shall be subject to the addi-
1.
tional specific labelling requirements laid down in para-
graph 3.

Article 3

2. However, the specified foodstuffs in which neither
protein nor DNA resulting from genetic modification is
present shall not be subject to the said additional specific
labelling requirements.

A list of products not subject to the additional specific
labelling requirements shall be drawn up under
the
procedure laid down in Article 17 of Directive 79/
112/EEC, taking account of technical developments, the
opinion of the Scientific Committee on Food and any
other relevant scientific advice.

The additional specific labelling requirements shall

3.
be 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 ingre-
dient concerned. Alternatively,
these words may
appear in a prominently displayed footnote to the list
of ingredients, related by means of an asterisk (*) to

Commission Regulation (EC) No 1813/97 is hereby
repealed.

Article 4

1.
The labelling requirements of this Regulation shall
not apply to products which have been lawfully manufac-
tured 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.

2.
The application of Article 2 to products placed on
the market with labelling complying with Commission
Regulation (EC) No 1813/97 so as to indicate the pres-
ence of genetically modified material may be postponed
until six months after the entry into force of this Regula-
tion.

Article 5

This Regulation shall enter into force 90 days after its
publication in the Official Journal of the European
Communities.

(*) Ingredient(s) to be specified.

3. 6. 98

EN

Official Journal of the European Communities

L 159/7

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

Done at Brussels, 26 May 1998.

For the Council

The President

J. CUNNINGHAM