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►B 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
(OJ L 6, 11.1.2000, p. 15)
Corrected by:
►C1Corrigendum, OJ L 47, 19.2.2000, p. 34 (50/2000)
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COMMISSION REGULATION (EC) No 50/2000
of 10 January 2000
onthelabellingoffoodstuffsandfoodingredientscontainingaddi-
tives and flavourings that have been genetically modified or have
been produced from genetically modified organisms
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
►C1Having regard to Council Directive 79/112/EEC ◄of 18
December 1978 on the approximation of the laws of the Member Statesrelating to the labelling, presentation and advertising of foodstuffs(
1), as
last amended by Directive 97/4/EC of the European Parliament and theCouncil (
2), and in particular Article 4(2) thereof,
Whereas:
(1)Regulation (EC) No 258/97 of the European Parliament and of
the Council concerning novel foods and novel food ingredi-ents(
3) does not apply to additives and flavourings intended to be
used in foodstuffs as, for the purpose of testing these substancesfor their safety evaluation, they come under other Communityprovisions, namely Council Directive 89/107/EEC of 21December 1988 on the approximation of the laws of the MemberStates concerning food additives authorised for use in foodstuffsintended for human consumption (
4), as amended by Directive
94/34/EEC of the European Parliament and of the Council (5),
and Council Directive 88/388/EEC of 22 June 1988 on theapproximation of the laws of the Member States relating toflavourings for use in foodstuffs and to source materials for theirproduction (
6), as amended by Commission Directive 91/
71/EEC (7);
(2)these additives and flavourings are also excluded from the scopeof Council Regulation (EC) No 1139/98 of 26 May 1998concerning the compulsory indication, on the labelling of certainfoodstuffs produced from genetically modified organisms, ofparticulars other than those provided for in Directive 79/112/EEC (
8);
(3)a consequence of this exclusion is that additives and flavouringsthat have been genetically modified or have been produced fromgenetically modified organisms and are used as ingredients infoodstuffs are not subject to the specific labelling provisions laiddown in Article 8 of Regulation (EC) No 258/97 and the label-ling provisions laid down in Article 2 of Regulation (EC) No1139/98;
(4)it is important that consumers should also be informed of the useof additives or flavourings that have been genetically modified orhave been produced through genetic engineering as they arealready informed of the presence of other ingredients containingor produced from genetically modified organisms;
(5)some Member States have served notice of their intention toimpose at national level indications on labelling informingconsumers of the use of additives and/or flavourings producedfrom genetically modified organisms;
(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.
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(6)such provisions are likely to create new obstacles to
►C1intra-Community trade; ◄
(7)the Commission, in its Decision 98/613/EC of 21 October 1998
concerning a draft decree of the Republic of Austria concerningthe identification of genetically modified additives and flavour-ings (
1), took the view, with the agreement of the Member States,
that the most satisfactory solution would be to draw up►
C1Community provisions on labelling; ◄
(8)accordingly, it would be useful to make it obligatory to indicate
on the labelling of the foodstuffs concerned that the additives orflavourings used are or contain genetically modified organisms orhave been produced from such organisms, in accordance with thesame principles as those laid down for the labelling of ingredientsthat are, contain, or are produced from genetically modifiedorganisms;
(9)the provisions of this Regulation do not apply to additives andflavourings sold as such to the final consumer. Separate measuresimposing similar obligatory labelling for additives and flavour-ings should be introduced;
(10)in particular, in accordance with the approach adopted in Article8o f►
C1Regulation (EC) No 258/97, ◄it is necessary to
ensure that the final consumer is informed of any characteristic orfood property such as composition, nutritional value or nutritionaleffects or the intended use of the food, which renders this food orfood ingredient no longer equivalent to an existing food or foodingredient. To this end additives and flavourings that have beengenetically modified or have been produced from geneticallymodified organisms that are not equivalent to their traditionalcounterparts must be subject to labelling requirements;
(11)in accordance with the approach adopted in Article 8 of Regula-tion (EC) No 258/97, labelling requirements must be based onscientific assessment;
(12)clear labelling rules should be formulated for the abovementionedproducts so as to ensure that official inspections can be carriedout on the basis of reliable, reproducible and practicable data;
(13)care should also be taken to ensure that the labelling require-ments are not excessively complex but nevertheless sufficientlydetailed to provide consumers with the information they need;
(14)►C1Regulation (EC) No 1139/98 ◄specifies the criterion
according to which the labelling obligations become operative forfood produced from genetically modified maize or soya;
(15)the presence in ►C1additives and flavourings ◄used as ingre-
dients in a foodstuff of protein or DNA resulting from geneticmodification is, as matters stand, also the criterion that best meetsthe abovementioned requirements. Such an approach could bere-examined in the light of new scientific evidence;
(16)in view of the scope and consequences of the proposed action,the Community measures introduced by this Regulation are notonly necessary but indeed essential to achieve the objectives;
(17)adventitious contamination of additives and flavourings withDNA or protein resulting from genetic modification cannot beexcluded; it is useful to examine the possibility of setting up athreshold in order to avoid labelling as a result of such contami-nation;
(18)the measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee on Foodstuffs,
(1) OJ L 291, 30.10.1998, p. 35.
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HAS ADOPTED THIS REGULATION:
Article 1
1. This Regulation provides for specific additional labelling require-
ments for food and food ingredients intended for final consumers andmass caterers ►
C1(hereinafter referred to as ‘specified 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— flavourings for use in foodstuffs falling within the scope of
Directive 88/388/EEC
which are, contain or are produced from genetically modified organisms
within the meaning of Council Directive 90/220/EEC (
1).
Article 2
Without prejudice to the other requirements of Community legislation
on food labelling, the labelling of the specified foodstuffs must informfinal 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 ►
C1additives 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 additives or flavouringsand which may affect the health of certain sections of the popula-tion;
(c) the presence in the specified additives or flavourings of material
which is not present in existing equivalent additives or flavouringsand which gives rise to ethical concerns;
(d) in accordance with Article 4(2), the presence of an additive or
flavouring that is or contains an organism genetically modified bytechniques of genetic modification, the non-exhaustive list of whichis 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 demonstratethat the characteristics assessed are different in comparison with tradi-tional additives or flavourings, having regard to the accepted limits ofnatural variations of such characteristics. This is the case where thespecified additives or flavourings contain protein and/or DNA resultingfrom genetic modification.
Article 4
1. The additional specific labelling requirements with regard 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 ►
C1Directive 79/
112/EEC, ◄in parentheses, immediately after the indication of the
additive or flavouring in question.
(1) OJ L 117, 8.5.1990, p. 15.
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Alternatively, this wording may appear in a prominently displayedfootnote to the list of ingredients, linked to the additive or theflavouring concerned by an asterisk (*). It shall be printed in a font thatis at least of the same size as that used for the list of ingredients itself.
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 ques-tion.
Alternatively, this wording may appear in a prominently displayed
footnote to the list of ingredients, linked to the additive or theflavouring concerned by an asterisk (*). It shall be printed in a font thatis at least of the same size as that used for the list of ingredients itself.
For specified foodstuffs for which there is no list of ingredients, this
wording shall appear clearly on the product’s label.
Article 5
This Regulation shall not apply to specified foodstuffs lawfully manu-
factured and labelled in the Community or lawfully imported into theCommunity and put into free circulation before the entry into force ofthis 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.