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"B "C1 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 3
(OJ L 159, 3.6.1998, p. 4)
Corrected by:
"C1 Corrigendum, OJ L 190 , 4.7.1998, p. 86 (1139/98)
"C2 Corrigendum, OJ L 94 , 9.4.1999, p. 27 (1139/98)1998R1139 — EN — 01.09.1998 — 000.001 — 1
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
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,
(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 environment of genetically modified organisms (2), 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 soyabeans ( 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 theBt-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 modification techniques;
(3) Whereas Directive 90/220/EEC does not cover non-viable products
derived from genetically modified organisms (hereinafter referred to as
‘GMOs’);
(4) Whereas certain Member States have taken measures in respect of the
labelling of foods and food ingredients produced from the productsconcerned; 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; whereasit is therefore necessary to adopt uniform Community labelling rules forthe products concerned;
(5) Whereas Regulation (EC) No 258/97 of the European Parliament and of
the Council of 27 January 1997 concerning novel foods and novel food
ingredients (
5), lays down, in Article 8, additional specific labelling
requirements in order to ensure proper information for the finalconsumer; 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 theentry into force of Regulation (EC) 258/97 and are for that reasonconsidered 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 fromGMOs which were placed on the market before the entry into force of!B
(1) OJ L 33, 8. 2. 1979, p. 1. Directive as last amended by Directive 97/4/EC of the
European Parliament and of the Council (OJ L 43, 14. 2. 1997, p. 21).
(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).
(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.!C1
!B1998R1139 — EN — 01.09.1998 — 000.001 — 2
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 themarket 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 (
1)
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;
(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 finalconsumer 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 longerequivalent to an existing food or food ingredient; whereas, for that
purpose, foods and food ingredients produced from genetically
modified soya beans or from genetically modified maize which arenot equivalent to conventional counterparts should be subject tolabelling requirements;
(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 tosupply 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 thecriterion best complying with the abovementioned requirements;whereas such an approach could be reconsidered in the light of future
developments in scientific knowledge;
(14) Whereas adventitious contamination of foodstuffs with DNA or protein
resulting from genetic modification cannot be excluded; whereaslabelling as a result of such contamination could be avoided by setting athreshold for the detection of DNA and protein;
(15) Whereas urgent consideration must be given, in the light of any relevant
scientific advice, to the question of whether a de minimis threshold forthe presence of DNA or protein resulting from genetic modification canbe set and, if so, at what level;
(16) Whereas f oods 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 besubject to labelling requirements;
(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 should be consideredequivalent for labelling purposes; whereas they should therefore not be
subject to labelling requirements; whereas a list of such products should
be drawn up;
(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 modificationis not present but in which proteins resulting from genetic modificationare present, cannot be considered to be equivalent; whereas therefore,
they should be subject to labelling requirements;!B
(1) OJ L 257, 20. 9. 1997, p. 7.1998R1139 — EN — 01.09.1998 — 000.001 — 3
(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 offoods 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 that such claims are made incompliance with the provisions of Directive 79/112/EEC;
(21) Whereas, having regard to their scope and effects, the Community
measures introduced by this Regulation are not only necessary butessential if the objectives set are to be attained; whereas thoseobjectives cannot be attained by the Member States acting individually;
(22) Whereas this Regulation replaces Commission Regulation (EC) No
1813/97, which should therefore 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, andwhereas in accordance with the same procedure the Commissionaddressed a proposal to the Council, concerning the measures to be
adopted,
HAS ADOPTED THIS REGULATION:
Article 1
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 ‘thespecified 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) No 258/97.
Article 2
1. The specified foodstuffs shall be subject to the additional specific
labelling requirements laid down in paragraph 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 Directive79/112/EEC, taking account of technical developments, the opinion of the
Scientific Committee on Food and any other relevant scientific advice.
3. The additional specific labelling requirements shall 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 forby Article 6 of Directive 79/112/EEC in parentheses immediately afterthe name of the ingredient concerned. Alternatively, these words may
appear in a prominently displayed footnote to the list of ingredients,
related by means of an asterisk (*) to the ingredient concerned. Where aningredient is already listed as being produced from soya or maize thewords ‘produced from genetically modified’ may be abbreviated to
‘genetically modified’; if the abbreviated 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!B1998R1139 — EN — 01.09.1998 — 000.001 — 4
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 nameof 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 derived from the
specified foodstuffs, it shall be mentioned on the labelling of the final
product, with the addition of the wording set out in point (b).
4. This Article shall be without prejudice to the other requirements of
Community law concerning the labelling of foodstuffs.
Article 3
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 manufactured and labelled in the Community, orwhich have been lawfully imported into the Community and put into freecirculation, 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 presence of genetically modified material may be postponed until
six months after the entry into force of this Regulation.
Article 5
This Regulation shall enter into force 90 days after 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.!B
(*) Ingredient(s) to be specified.1998R1139 — EN — 01.09.1998 — 000.001 — 5