Commission Regulation (EC) No 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/98 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: 2000-01-10
Institutions: European Commission
Subjects: foodstuff, genetically modified organism, labelling

11. 1. 2000

EN

Official Journal of the European Communities

L 6/13

COMMISSION REGULATION (EC) No 49/2000

of 10 January 2000

amending Council Regulation (EC) No 1139/98 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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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), as last amended by Directive 97/4/
EC of the European Parliament and of the Council (2), and in
particular Article 4(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Council Regulation (EC) No 1139/98 (3) laid down the
compulsory indication on the labelling of foods and
food ingredients produced from genetically modified
soya (Glycine max L.) covered by Commission Decision
96/281/EC (4) and genetically modified maize (Zea mays
L.) covered by Commission Decision 97/98/EC (5), of
particulars other than those provided for in Directive
79/112/EEC;

Council Regulation (EC) No 1139/98 acknowledged that
adventitious contamination of foodstuffs with DNA or
protein resulting from genetic modification cannot be
excluded;

consequently, the Council, at the moment of adopting
Council Regulation (EC) No 1139/98,
invited the
Commission to study the practicality of setting up de
minimis thresholds for the presence of DNA or protein
resulting from genetic modification in order to take
account of the problem of adventitious contamination;

despite the fact that some operators avoid using geneti-
cally modified soya beans (Glycine max L.) or maize (Zea
mays L.) or produce thereof as a source for their food
ingredients, material derived from the said genetically
modified organisms may be present in them as a result
of adventitious contamination during e.g., cultivation,
harvest, transport, storage and processing;

in the cases in which the presence of such material is
adventitious and represents only a small proportion of a
food ingredient considered, this food ingredient should
not be subject to the labelling requirements of Regula-
tion (EC) No 1139/98;

(6)

in order to achieve this objective,
it is necessary to
establish a de minimis threshold for the adventitious pres-

(1) OJ L 33, 8.2.1979, p. 1.
(2) OJ L 43, 14.2.1997, p. 21.
(3) OJ L 159, 3.6.1998, p. 4.
(4) OJ L 107, 30.4.1996, p. 10.
(5) OJ L 31, 1.2.1997, p. 69.

(7)

(8)

(9)

(10)

(11)

(12)

(13)

ence in food ingredients of material derived from the
abovementioned genetically modified soya and maize;

for the purpose of clarity,
threshold in terms of a single percentage value;

it is appropriate to fix a

the value of 1 % best serves the purpose of establishing a
tolerance level which simultaneously remains low and
takes into account the necessary feasibility along the
production chain. Detection methods already provide or
shortly will, the necessary tools to implement this value.
Nonetheless the 1 % value is to be seen as a maximum,
and operators should therefore aim at achieving the
lowest possible level of adventitious presence of the said
material

in practice;

it is appropriate to clarify that the 1 % value should be
the tolerance level not only for the adventitious presence
of material derived from the abovementioned genetically
modified organisms, but for the combined adventitious
presence of such material and any other material placed
on the market pursuant to Regulation (EC) No 258/
97 (6) derived from other genetically modified organ-
isms;

the notion of material derived from the genetically
modified organisms should be understood as referring to
the part of each ingredient that is derived from the
genetically modified organisms;

in order to establish that the presence of this material is
adventitious, operators must be in a position to supply
evidence to satisfy competent authorities that they have
taken appropriate steps to avoid using as a source genet-
ically modified soya beans (Glycine max L.) or maize (Zea
mays L.), or any other additional genetically modified
organisms whose derived material has been placed on
the market pursuant to Regulation (EC) No 258/97, or
produce thereof;

for the purposes of consistency with Directive 79/
112/EEC, it is appropriate to apply the threshold at the
level of food ingredients individually considered;

it should be clarified that the same approach is to be
followed for the purpose of establishing a list of food
ingredients not subject to the labelling requirements of
Regulation (EC) No 1139/98 because of the absence of
protein and DNA resulting from the genetic modifica-
tion as specified in its Article 1(1);

(6) OJ L 43, 14.2.1997, p. 1.

L 6/14

EN

Official Journal of the European Communities

11. 1. 2000

(14)

(15)

in any case, food ingredients are not subject to the
labelling requirements of Regulation (EC) No 1139/98
when neither protein nor DNA resulting from the
genetic modification as specified in Article 1(1)
is
present. In this light, it is appropriate to clarify that such
list is not exhaustive;

in some cases foods comprise a single ingredient. It is
therefore necessary to bring clarity as to how these
foods should be considered for the purposes of estab-
lishing the abovementioned list and for the application
of the threshold;

(16) Directive 79/112/EEC applies to products which are
delivered as such not only to the ultimate consumer, but
also to mass caterers;

(17)

the measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for foodstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1139/98 is modified as follows:
1. In Article 1(1), ‘to the final consumer’ is replaced by ‘to the

final consumer or mass caterers’.
2. Article 2 is modified as follows:

(a) Paragraph 2 is replaced by the following:

The specified foodstuffs shall not be subject to the

‘2.
additional specific labelling requirements where:
(a) neither protein nor DNA resulting from genetic
modification as specified in Article 1(1) is present in
their food ingredients individually considered or the
food comprising a single ingredient;
or

Regulation (EC) No 258/97 derived from other
genetically modified organisms,
is present in their
food ingredients or the food comprising a single
ingredient in a proportion no higher than 1 % of the
food ingredients individually considered or food
comprising a single ingredient, provided this pres-
ence is adventitious;

the presence of

In order to establish that
this
material is adventitious, operators must be in a posi-
tion to supply evidence to satisfy the competent
authorities that they have taken appropriate steps to
avoid using the genetically modified organisms (or
produce thereof) referred to in the previous para-
graph as a source.’

(b) The following paragraph 2a is inserted:

‘2a.
In order to facilitate the application of paragraph
2(a), a non-exhaustive list of food ingredients or foods
comprising a single ingredient in which neither protein
nor DNA resulting from the genetic modification as
specified in Article 1(1) is present, 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 for food and
any other relevant scientific advice.’

Article 2

The labelling requirements of Regulation (EC) No 1139/98
shall not apply to specified foodstuffs which are to be delivered
as such to mass caterers which have been lawfully manufac-
tured and labelled in the Community, or which have been
lawfully imported into the Community and put into free circu-
lation, before the entry into force of this Regulation.

Article 3

(b) material derived from the genetically modified
organisms referred to in Article 1(1), together with
to
any material placed on the market pursuant

This Regulation shall enter into force on the ninetieth day
following that of its publication in the Official Journal of the
European Communities.

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

Done at Brussels, 10 January 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission