CELEX: 51992PC0295
Language: en
Date: 1992-07-07
Title: Proposal for a COUNCIL REGULATION (EEC) on novel foods and novel food ingredients

29 . 7 . 92                           Official Journal of the European Communities                              No C 190 / 3
                                                              II
                                                      (Preparatory Acts)
                                                COMMISSION
                   Proposal for a Council Regulation (EEC) on novel foods and novel food ingredients
                                                       (92 / C 190/04)
                                              COM(92) 295 final — SYN 426
                                       (Presented by the Commission on 7 July 1992)
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                         Whereas this Regulation does not affect food additives ,
                                                                  flavourings for use in foodstuffs and extraction solvents
                                                                  falling within the scope of other Community provisions ;
Having regard to the Treaty establishing the European
Economic Community and in particular Article 100a
thereof,
                                                                  Whereas risks to the environment may be associated with
                                                                  food or food ingredients which contain or consist of
Having regard to the proposal from the Commission,                genetically modified organisms ; whereas Directive
                                                                  90/220 /EEC has specified that, for such products , an
                                                                  environmental risk assessment must always be
                                                                  undertaken to ensure safety for the environment ;
In cooperation with the European Parliament,
                                                                  whereas, in order to provide for a unified Community
                                                                  system for assessment of a product, provisions must be
                                                                  made under this regulation for a specific environmental
Having regard to the opinion of the Economic and                  risk assessment, which in accordance with the procedures
Social Committee,                                                 of Article 10 of Directive 90 / 220 / EEC must be similar
                                                                  to that laid down in that Directive , together with the
                                                                  assessment of the suitability of the product to be used as
Whereas differences between national laws relating to             a food or food ingredient ;
novel foods or food ingredients could hinder the free
movement of foodstuffs ; whereas they may create
conditions of unfair competition, thereby directly
affecting the establishment or functioning of the internal        Whereas the Scientific Committee for Food has to be
market ;                                                          consulted on any decision on foods or food ingredients
                                                                  which    have   not   hitherto    been  used  for  human
                                                                  consumption to a significant degree in the Community
Whereas the measures aimed at the gradual estab­                  and/or which have been produced by food production
lishment of the internal market must be adopted by 31             processes that result in a significant change in their
December 1992 ; whereas the internal market consists of           composition and/ or nutritional value and /or intended
an area without internal frontiers within which the free          use likely to have an effect on public health ;
movement of goods, persons, services and capital is
guaranteed ;
                                                                  Whereas, in respect of this Regulation, provision should
Whereas, also, the smooth running of the internal                 be made for a procedure instituting close cooperation
market requires that provisions for notification and auth­        between Member States and the Commission within the
orization of foods or food ingredients which have not             Standing Committee on Foodstuffs set up by Council
hitherto been used for human consumption to a                     Decision 69/414 /EEC ('),
significant degree in the Community and/or which have
been produced by food production processes that result
in a significant change in their composition and/or
nutritional   value   and / or intended   use   should   be
determined at Community level ; whereas such author­
ization shall be of general application ;                         O OJ No L 291 , 19 . 11 . 1969, p. 9 .
 ---pagebreak--- No C 190 / 4                                Official Journal of the European Communities                                29 . 7 . 92
HAS ADOPTED THIS REGULATION :                                         first time in accordance with the procedure stipulated in
                                                                      Article 5 ; however, where the food is consumed as a
                                                                      viable organism or where generally accepted scientific
                             Article 1                                data are not available to demonstrate its safety it is
                                                                      submitted to the procedure of Article 6 .
This Regulation lays down provisions for the placing on
the market of foods or food ingredients which have not
hitherto been used for human consumption to a                                                     Article 5
significant degree and/or which have been produced by
processes that result in a significant change in their                 1 . Where on the basis of generally accepted scientific
composition and/or nutritional value and/or intended                  data, in the opinion of one or more of the qualified
use. The categories of products falling within the scope              experts from the list mentioned in Article 3, there is
of this Regulation are listed in Annex I.                             evidence that the product to be used as a food or food
                                                                       ingredient complies with the general criteria mentioned
                                                                       in Annex II, the person legally responsible shall notify
                             Article 2                                the Commission with a summary of the evidence
                                                                      together with the opinion of the expert.
This Regulation shall not apply to :
                                                                      The Commission shall immediately send the notification
(a) food additives falling within the scope of Council                 to the Member States .
     Directive 89 / 107 / EEC (');
(b) flavourings for use in foodstuffs, falling within the              2 . The food or food ingredient concerned may be
     scope of Council Directive 88/388 /EEC (2);                       placed on the market only three months after the notifi­
                                                                       cation received by the Commission and provided the
                                                                       Commission has not delivered a negative opinion within
(c) extraction solvents used in the production of food­                the period of three months at its own initiative or at the
     stuffs, falling within the scope of Council Directive             duly motivated request from a Member State.
     88 / 344/EEC (3)
 (d) foods and food ingredients treated with ionizing                  In the event of a negative opinion, the procedure in
                                                                       Article 6 is to be followed .
     radiation, falling within the scope of Council
     Directive . ./. . ./ EEC .
                                                                       3 . For the purposes of control, where necessary, the
                             Article 3                                 competent authority shall be empowered to require the
                                                                       person legally responsible for placing the product on the
 1.    Member States shall establish a list of independent             market to produce the scientific work and the data
experts with scientific experience qualified to carry out              establishing the product's compliance with the general
 the examinations referred to in Article 5                             criteria mentioned in Annex II and with the procedure
                                                                       laid down in paragraph 2 . If such work is contained in a
                                                                       readily available publication, a mere reference to this
 2.    The list and subsequent modifications shall be                  publication shall suffice .
 notified to the Commission . The Commission shall
 compile the consolidated list of experts from the notifi­
 cations and shall ensure its publication .                            4. Detailed rules for implementing paragraphs 1 and 2
                                                                       may be adopted in accordance with the procedure laid
                                                                       down in Article 10 .
 3.    Criteria for the selection of the experts mentioned
 in paragraph 1 may be adopted in accordance with the
 procedure laid down in Article 10 .                                                               Article 6
                                                                        1 . When the procedure laid down in this Article is to
                             Article 4                                 be followed , the person legally responsible for placing
                                                                       the product on the market in the Community shall
  1.   A food or food ingredient falling within the scope               submit a request for authorization to the Commission
 of this Regulation shall be placed on the market for the               comprising the necessary information to assure the
                                                                       compliance with the criteria mentioned in Annex II . The
 O OJ No L 40 , 11 . 2 . 1989, p . 27 .                                 Commission shall inform the Member States accordingly.
 C) OJ No L 184 , 15 . 7 . 1988 , p. 61 .                              The Member States may send to the Commission obser­
 (3) OJ No L 157 , 24 . 6 . 1988 , p . 28 .                            vations including pertinent scientific information .
 ---pagebreak--- 29. 7 . 92                                 Official Journal of the European Communities                               No C 190 / 5
2.     A decision shall be taken on the authorization for            2. In the case of food or food ingredients falling
the marketing of the food or food ingredient according               within the scope of this Regulation containing or
to the procedure laid down in Article 10 .                           consisting of a genetically modified organism , the
                                                                     decision mentioned in Article 6 (2) shall take account of
                                                                     the environmental safety requirements laid down by
3.     The decision mentioned in paragraph 2 may                     Directive 90 / 220 / EEC .
establish the conditions of use of the food or food
ingredient when appropriate . It may also establish the
name of the food or food ingredient and any indications              3 . Detailed rules for implementing this Article may be
concerning the labelling, as the case may be, as laid                adopted in accordance with the procedure laid down in
down in Article 5 of Council Directive 79 / 112 / EEC on             Article 10 .
the approximation of the laws of the Member States
relating to the labelling, presentation and advertising of
foodstuffs for sale to the ultimate consumer (1 ).                                              Article 8
                                                                     Any decision or provision regarding a food or food
4.     The    Commission        shall    communicate    to   the     ingredient falling within the scope of Article 1 likely to
applicant the decision taken with respect to his request.            have an effect on public health shall be adopted by the
                                                                     Commission      after  consultation     with  the   Scientific
                                                                     Committee for Food , either on its own initiative or at the
5.     The Commission shall inform Member States of                  request of a Member State .
any decision adopted pursuant to paragraph 2 .
                                                                                                Article 9
6 . Detailed rules for implementing this article may be
adopted in accordance with the procedure laid down in                 1 . Where a Member State has detailed grounds for
Article 10 .
                                                                     considering that the use of a food or a food ingredient
                                                                     falling within the scope of Article 1 , although it complies
                                                                     with this Regulation , endangers human health , that
                             Article 7                               Member State may temporarily suspend or restrict the
                                                                     trade and use of the food or food ingredient in question
1.     Where the food or food ingredient falling within              in its territory. It shall immediately inform the other
the scope of this Regulation contains or consists of                 Member States and the Commission thereof and give
a genetically modified organism within the meaning                   reasons for its decision .
of Article     2   (1)    and      ( 2)  of Council    Directive
90/ 220/ EEC (2) on the deliberate release of genetically
modified organisms, the information required in the                  2. The Commission shall examine the grounds given
request for authorization mentioned in Article 6 shall be            by the Member State referred to in paragraph 1 as soon
accompanied by :                                                     as possible within the Standing Committee for Food­
                                                                     stuffs, and shall then deliver its opinion fort with and
                                                                     take the appropriate measures following the procedure
— a copy of the written consent, from the competent                  laid down in Article 10 .
    authority, to the deliberate release of the genetically
    modified organisms for research and development
    purposes provided for in Article 6 (4) of Directive              3.     If the Commission considers that the national
    90/220/EEC, together with the results of the                     measure must be dispensed with or modified , it shall
    release(s) with respect to any risk to human health              initiate the procedure laid down in Article 10 for the
    and the environment,                                             adoption of the appropriate measures .
— the complete technical dossier supplying the infor­
                                                                                                Article 10
    mation requested in Annexes II and III of Directive
    90 /220 / EEC and the environmental risk assessment
    resulting from this information .                                1.     Where the procedure laid down in this Article is to
                                                                     be followed, the Commission shall be assisted by the
                                                                     Standing Committee on Foodstuffs , set up pursuant to
Articles 11 to 18 of Directive 90 / 220 / EEC shall not              Decision 69/414 / EEC (5) acting in an advisory capacity ,
apply to food or food ingredients falling within the scope           hereinafter referred to as ' the Committee '.
of Article 6 which contain or consist of a genetically
modified organism .
                                                                     2.     The Chairman shall submit to the Committee a
                                                                     draft of measures to be taken . The Committee shall
                                                                     deliver its opinion on the draft within a time limit which
(') OJ No L 33 , 8 . 2 . 1979 , p . 1 .
(2) OJ No L 117, 8 . 5 . 1990 , p . 15 .                             O OJ No L 291 , 19 . 11 . 1969 , p. 9 .
 ---pagebreak--- No C 190 / 6                               Official Journal of the European Communities                                       29 . 7 . 92
the Chairman may lay down according to the urgency of                       the Committee of the manner in which its opinion has
the matter, if necessary by taking a vote .                                 been taken into account.
                                                                                                      Article 11
3 . The opinion shall be recorded in the minutes ; in
addition, each Member State shall have the right to ask
to have its position recorded in the minutes.                               This Regulation shall enter into force on 1 . January
                                                                            1993 .
4.   The Commission shall take the utmost account of                        This Regulation shall be binding in its entirety and
the opinion delivered by the Committee. It shall inform                     directly applicable in all Member States .
                                                                   ANNEX I
             Categories of products falling within the scope of this Regulation :
             — a product consisting of or containing a modified food molecular entity, or a molecular entity with no
                  established history of food use,
             — a product produced from, or consisting of, or containing an organism, or part of an organism, with no
                  established history of food use,
             — a product produced from, or consisting of, or containing an organism, or part of an organism ,
                  currently used in food production which has been modified by gene technology,
             — a product to which has been applied a process not currently used for food manufacture or which ,
                  although subjected to such a process, has not previously been placed on the market and where such a
                  process gives rise to significant changes in the composition or structure of the end product which affect
                  its nutritional value and/or its digestibility and/or its metabolism and/or level of undesirable substances
                  in the food .
                                                                  ANNEX II
             General criteria for the placing on the market of foods and food ingredients falling within the scope of
                                                                   Article 1
             Foods and food ingredients falling under the scope of Article 1 may be placed on the market provided that :
             1 . they are safe for the consumer when consumed as food at the intended levels of use ;
             2. they do not mislead the consumer;
             3 . they do not differ from similar foods or food ingredients that they may replace in the diet in such a way
                 that their normal consumption would be nutritionally disadvantageous for the consumer.