Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms
Date: 2000-01-10
Institutions: European Commission
Subjects: flavouring, food additive, foodstuff, genetically modified organism, labelling

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COMMISSION REGULATION (EC) No 50/2000

of 10 January 2000

on the labelling of foodstuffs and food ingredients containing additives and flavourings that have
been genetically modified or have been produced from genetically modified organisms

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 99/112/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 the Council (2), and in
particular Article 4(2) thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 258/97 of the European Parliament
and of the Council concerning novel foods and novel
food ingredients (3) does not apply to additives and
flavourings intended to be used in foodstuffs as, for the
purpose of testing these substances for their safety evalu-
ation, they come under other Community provisions,
namely Council Directive 89/107/EEC of 21 December
1988 on the approximation of the laws of the Member
States concerning food additives authorised for use in
intended for human consumption (4), as
foodstuffs
amended by Directive 94/34/EEC of the European Parlia-
ment and of the Council (5), and Council Directive 88/
388/EEC of 22 June 1988 on the approximation of the
laws of the Member States relating to flavourings for use
in foodstuffs and to source materials for their produc-
tion (6), as amended by Commission Directive 91/
71/EEC (7);

these additives and flavourings are also excluded from
the scope of Council Regulation (EC) No 1139/98 of 26
May 1998 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 (8);

a consequence of this exclusion is that additives and
flavourings that have been genetically modified or have
been produced from genetically modified organisms and
are used as ingredients in foodstuffs are not subject to
the specific labelling provisions laid down in Article 8 of
Regulation (EC) No 258/97 and the labelling provisions
laid down in Article 2 of Regulation (EC) No 1139/98;

(1) OJ L 33, 8.2.1979, p. 1.
(2) OJ L 43, 14.2.1997, p. 21.
(3) OJ L 43, 14.2.1997, p. 1.
(4) OJ L 40, 11.2.1989, p. 27.
(5) OJ L 237, 10.9.1994, p. 1.
(6) OJ L 184, 15.7.1988, p. 61.
(7) OJ L 42, 15.2.1991, p. 25.
(8) OJ L 159, 3.6.1998, p. 4.

(5)

(6)

(7)

(8)

(9)

(10)

it is important that consumers should also be informed
of the use of additives or flavourings that have been
genetically modified or have been produced through
genetic engineering as they are already informed of the
presence of other ingredients containing or produced
from genetically modified organisms;

some Member States have served notice of their inten-
tion to impose at national level indications on labelling
informing consumers of
the use of additives and/or
flavourings produced from genetically modified organ-
isms;

such provisions are likely to create new obstacles to
infra-Community trade;

the Commission,
in its Decision 98/613/EC of 21
October 1998 concerning a draft decree of the Republic
of Austria concerning the identification of genetically
modified additives and flavourings (9), took the view,
with the agreement of the Member States, that the most
satisfactory solution would be to draw up Community
provisions an labelling;

accordingly, it would be useful to make it obligatory to
indicate on the labelling of the foodstuffs concerned that
the additives or flavourings used are or contain geneti-
cally modified organisms or have been produced from
such organisms, in accordance with the same principles
as those laid down for the labelling of ingredients that
are, contain, or are produced from genetically modified
organisms;

the provisions of this Regulation do not apply to addi-
tives and flavourings sold as such to the final consumer.
Separate measures imposing similar obligatory labelling
for additives and flavourings should be introduced;

in particular, in accordance with the approach adopted
in Article 8 of Regulation (EC) No 258197, it is neces-
sary 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 this food or food ingre-
dient no longer equivalent to an existing food or food
ingredient. To this end additives and flavourings that
have been genetically modified or have been produced
from genetically modified organisms that are not equiva-
lent to their traditional counterparts must be subject to
labelling requirements;

(9) OJ L 291, 30.10.1998, p. 35.

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in accordance with the approach adopted in Article 8 of
Regulation (EC) No 258/97, labelling requirements must
be based on scientific assessment;

which are, contain or are produced from genetically modified
organisms within the meaning of Council Directive 90/
220/EEC (1).

(11)

(12)

(13)

(14)

(15)

(16)

(17)

clear labelling rules should be formulated for the above-
mentioned products so as to ensure that official inspec-
tions can be carried out on the basis of reliable, reprodu-
cible and practicable data;

care should also be taken to ensure that the labelling
requirements are not excessively complex but neverthe-
less sufficiently detailed to provide consumers with the
information they need;

Regulation (EC) No 1139!98 specifies the criterion
according to which the labelling obligations become
operative for food produced from genetically modified
maize or soya;

the presence in additives and, flavourings used as ingre-
dients in a foodstuff of protein or DNA resulting from
genetic modification is, as matters
stand, also the
criterion that best meets the abovementioned require-
ments. Such an approach could be re-examined in the
light of new scientific evidence;

in view of the scope and consequences of the proposed
action,
the Community measures introduced by this
Regulation are not only necessary but indeed essential to
achieve the objectives;

adventitious contamination of additives and flavourings
with DNA or protein resulting from genetic modifica-
tion cannot be excluded;
it is useful to examine the
possibility of setting up a threshold in order to avoid
labelling as a result of such contamination;

(18)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.
This Regulation provides for specific additional labelling
requirements for food and food ingredients intended for final
consumers and mass caterers hereinafter referred to as ‘speci-
fied foodstuffs’) containing additives and/or flavourings as
described in paragraph 2 (hereinafter referred to as ‘specified
additives and flavourings’).

2.

The following are specified additives and flavourings:

— additives falling within the scope of Directive 89/107/EEC

and/or

Article 2

Without prejudice to the other requirements of Community
legislation on food labelling, the labelling of the specified food-
stuffs must inform final consumers and mass caterers of:

(a) in accordance with Article 4(1), any characteristic or food

property such as:
— composition
— nutritional value or nutritional effects
— intended use of the additives, or flavourings

as a result of which the specified additives or flavourings are
no longer equivalent to existing additives or flavourings;

(b) the presence in the specified additives or flavourings of
material which is not present in existing equivalent addi-
tives or flavourings and which may affect the health of
certain sections of the population;

(c) the presence in the specified additives or flavourings of
material which is not present in existing equivalent addi-
tives or
rise to ethical
concerns;

flavourings and which gives

(d) in accordance with Article 4(2), the presence of an additive
or flavouring that is or contains an organism genetically
modified by techniques of genetic modification, the non-
exhaustive list of which is laid down in Annex I A, Part 1,
of Directive 90/220/EEC.

Article 3

The specified additives or flavourings shall be deemed to be no
longer equivalent within the meaning of Article 2(a) if scientific
assessment, based upon an appropriate analysis of existing
data, can demonstrate that
the characteristics assessed are
different in comparison with traditional additives or flavour-
ings, having regard to the accepted limits of natural variations
of such characteristics. This is the case where the specified
additives or flavourings contain protein and/or DNA resulting
from genetic modification.

Article 4

The additional specific labelling requirements with regard
1.
to the information referred to in Article 2(a) are as follows:

The words ‘produced from genetically modified …’ shall appear
in the list of ingredients provided for in Article 6 of Directive
791/112/EEC, in parentheses, immediately after the indication
of the additive or flavouring in question.

this wording may appear

in a prominently
Alternatively,
linked to the
displayed footnote to the list of
additive or the flavouring concerned by an asterisk (*). It shall
be printed in a font that is at least of the same size as that used
for the list of ingredients itself.

ingredients,

— flavourings for use in foodstuffs falling within the scope of

Directive 88/388/EEC

(1) OJ L 117, 8.5.1990, p. 15.

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For specified foodstuffs for which there is no list of ingredients,
this wording shall appear clearly on the product's label.

For specified foodstuffs for which there is no list of ingredients,
this wording shall appear clearly on the product's label.

2.
The additional specific labelling requirements with regard
to the information referred to in Article 2(d) are as follows:

The words ‘genetically modified’ shall appear in the list of
ingredients immediately after the indication of the additive or
flavouring in question.

this wording may appear

Alternatively,
in a prominently
linked to the
displayed footnote to the list of
additive or the flavouring concerned by an asterisk (*). It shall
be printed in a font that is at least of the same size as that used
for the list of ingredients itself.

ingredients,

Article 5

This Regulation shall not apply to specified foodstuffs lawfully
manufactured and labelled in the Community or lawfully
imported into the Community and put into free circulation
before the entry into force of this Regulation.

Article 6

This Regulation shall enter into force 90 days following 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