CELEX: 51993PC0631
Language: en
Date: 1993-12-01
Title: Amended Proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) on novel foods and novel food ingredients

No C 16 / 10                         Official Journal of the European Communities                                   19 . 1 . 94
                                                              II
                                                      fPreparatory Acts)
                                                 COMMISSION
              Amended proposal for a European Parliament and Council Regulation (EC) on novel foods and
                                                   novel food ingredients
                                                        (94/C 16/07)
                                              COM(93) 631 final — COD 426
              (Submitted by the Commission in accordance with Article 189a (2) of the EC Treaty on
                                                      1 December 1993)
THE EUROPEAN PARLIAMENT AND THE COUNCIL                           determined at Community level ; whereas such author­
 OF THE EUROPEAN UNION,                                           ization shall be of general application ;
Having regard to the Treaty establishing the European             Whereas this Regulation does not affect food additives,
Community and in particular Article 100a thereof,                 flavourings for use in foodstuffs and extraction solvents
                                                                  falling within the scope of other Community provisions ;
Having regard to the proposal from the Commission f1),
                                                                  Whereas risks to the environment may be associated with
                                                                  food or food ingredients which contain or consist of
Having regard to the opinion of the Economic and                  genetically modified organisms ; whereas Council
Social Committee (2),                                             Directive 90 /220/EEC (3) has specified that, for such
                                                                  products, an environmental risk assessment must always
                                                                  be undertaken to ensure safety for the environment;
                                                                  whereas, in order to provide for a unified Community
Whereas, differences between national laws relating to            system for assessment of a product, provisions must be
novel foods or food ingredients could hinder the free             made under this regulation for a specific environmental
movement of foodstuffs, whereas they may create                   risk assessment, which in accordance with the procedures
conditions of unfair competition, thereby directly                of Article 10 of Directive 90 / 220 / EEC must be similar
affecting the establishment or functioning of the internal        to that laid down in that Directive, together with the
market,                                                           assessment of the suitability of the product to be used as
                                                                  a food or food ingredient.
Whereas the measures aimed at the gradual estab­
lishment of the internal market must be adopted by 31            Whereas the Scientific Committee for Food has to be
December 1992 ; whereas the internal market consists of           consulted on any decision on foods or food ingredients
an area without internal frontiers within which the free          which    have   not    hitherto   been  used  for   human
movement of goods, persons, services and capital is               consumption to a significant degree in the Community
guaranteed ;                                                      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
Whereas, also, the smooth running of the internal                 use likely to have an effect on public health ;
market requires that provisions for notification and auth­
orization of foods or food ingredients which have not
hitherto been used for human consumption to a                    Whereas the provisions of Council Directive
significant degree in the Community and/or which have             89/ 397/EEC on the official control of foodstuffs (4) and
been produced by food production processes that result            of Council Directive 93 /. . ./EC laying down additional
in a significant change in their composition and/or               measures for the official control of foodstuffs apply to
nutritional  value   and / or intended    use   should   be       novel foods or food ingredients ;
O OJ No C 190, 29. 7 . 1992, p. 3 .                               C) OJ No L 117, 8 . 5 . 1990, p. 15 .
O OJ No L 108 , 19. 4. 1993, p. 8 .                               O OJ Np L 186, 30. 6. 1989, p. 23.
 ---pagebreak---  19 . 1 . 94                            Official Journal of the European Communities                              No C 16 / 11
Whereas, in respect of this Regulation, provision should          to technical and scientific progress in accordance with
be made for a procedure instituting close cooperation             the procedure laid down in Article 9 .
between Member States and the Commission within the
Standing Committee on Foodstuffs set up by Council
Decision 69/414/EEC (*),                                          4, Where necessary, it may be decided in accordance
                                                                  with the procedure laid down in Article 9 whether a
                                                                  particular food or food ingredient falls under the scope
HAVE ADOPTED THIS REGULATION :                                    of this Regulation.
                           Article 1                                                            Article 2
 1 . This Regulation lays down provisions for the                 This Régulation shall not apply to ;
placing on the market of novel foods or novel food
ingredients,
                                                                   (a) food additives falling within the scope of Council
                                                                        Directive 88 / 107/EEC (2);
2. This regulation shall apply to the placing on the
market of foods or food ingredients which have not                (b) flavourings for use in foodstuffs, falling within the
hitherto been used for human consumption to a                          scope of Council Directive 8 8 /3 8 8 /EEC (3);
significant degree or which have been produced by
processes which result in a significant change in their
composition, nutritional value or intended use and which          (c) extraction solvents used in the production of food­
fall under the following categories :                                  stuffs, falling within the scope of Council Directive
                                                                        88 /344/EEC (4); '
(a) foods and food ingredients, containing or composed            (d) foods and food ingredients treated with ionizing
      of genetically modified organisms (within the                    radiation, falling within the scope of Council
      meaning of Directive 90/220 /EEC);                               Directive . . . ./ EEC .
(b) foods and food ingredients produced from gene­
      tically modified organisms, except for those foods                                        Article 3
      produced from genetically modified organisms                In order to place on the market of the Community for
      which, by comparison with conventionally manu­              the first time food or food ingredients falling under the
      factured products, have not undergone any                   scope of this Regulation, the procedure laid down by
      significant change in their composition, nutritional        Article 4 has to be followed and the food or food ingre­
      value or intended use ;
                                                                  dients must meet all of the following three criteria :
(c) food and food ingredients with a new or inten­
      tionally modified primary molecular structure which         1 , they are safe for the consumer when consumed at the
      have not normally been used hitherto as food or                 intended level of use ;
      food ingredients ;
                                                                  2 , they do not mislead the consumer;
(d) single-cell proteins intended for food production ;
                                                                  3 , they do not differ from similar foods or food ingre­
                                                                      dients that they may replace in the diet in such a way
(e) foods and food ingredients to which has been                      that their normal consumption would be nutritionally
      applied a process not currently used in food                    disadvantageous for the consumer.
      production or which, although subjected to such a
      process have not previously been placed on the
      market and where such a process gives rise to                                             Article 4
      significant changes in the composition or structure of
      the end product which affect its nutritional value,         1 . In order to place on the market of the Community
      digestibility, metabolism or level of undesirable           a food or food ingredient falling under the scope of this
      substances in the food .                                    Regulation, the person legally responsible for placing on
                                                                  the market in the Community shall submit a request to
                                                                  the Commission and the Member States comprising the
3. The categories of foods and food ingredients
referred to in subparagraphs 2 a) to 2 e) may be adapted          O OJ No L 40 , 11 . 2 . 1989, p. 27 .
                                                                  (3) OJ No L 184, 15. 7. 1988 , p. 61 .
(') OJ No L 291 , 19. 11 . 1969, p . 9.                           (4) OJ No L 157, 24. 6. 1988 , p. 28 .
 ---pagebreak---   No C 16 / 12                         Official Journal of the European Communities                                 19 . 1 . 94
  necessary information, including a copy of the studies          The person legally responsible for placing the product on
 which have been carried out and all the other evidence           the Community market must submit to the Commission,
 which is available to demonstrate that the food or food          and justify an appropriate proposal for the decision on
 ingredient complies with the criteria laid down in Article       labelling.
  3.
                                                                  8.     The     Commission   shall   communicate    to     the
 2.    The Commission shall arrange for one of the
                                                                  applicant the decision taken with respect to his request
                                                                  for placing on the market.
 competent food assessment bodies mentioned in
 paragraph 9 to carry out an initial assessment and
 prepare a report within a period of two months from the          9. Each Member State shall notify the Commission
 date of transmission of the request for placing on the           the name and address of the competent food assessment
 market.                                                         bodies with responsibility for preparing the initial
                                                                  assessment reports referred to in paragraph 2.
 3. The competent food assessment body shall transmit             10. The Commission shall publish guidelines for the
 the initial assessment report to the Commission, which           assessment of foods or food ingredients falling under the
 shall forthwith circulate it to the Member States. Any          scope of this Regulation, for the conduct of tests and for
 Member State or the Commission may, within a period             the presentation of data.
 of thirty days from the date of transmission of the initial
 assessment report, make comments or present reasoned
 objections to the marketing of the food or food                  11 . Detailed rules for implementing this Article may
 ingredient concerned .                                          be adopted in accordance with the procedure laid down
                                                                 in Article 9 .
4. In the absence of objections to the placing on the
                                                                                            Article 5
market of the food or food ingredient concerned, within
the periods specified in paragraphs 2 and 3, and if the           1 . Where the food ingredient falling under the scope
food or food ingredient is consumed as an organism               of this Regulation contains or consists of a genetically
which is not viable, the Commission shall inform the             modified organism within the meaning of Article 2 ( 1 )
applicant that he may proceed with the placing on the            and (2) of Council Directive 90/220/EEC of 23 April
market.
                                                                 1990 on the deliberate release of genetically modified
                                                                 organisms (*), the information required in the request for
                                                                 placing in the market mentioned in Article 4 shall be
 5 . In the case of objections, the Commission shall             accompanied by :
inform the applicant that a decision on the authorization
for the marketing of the food or food ingredient is              — a copy of the written consent, from the competent
required. The Commission shall also inform the Member                 authority, to the deliberate release of the genetically
States accordingly.                                                   modified organisms for research and development
                                                                      purposes provided for in Article 6 (4) of Directive
                                                                      90 /220/EEC, together with the results of the
6. The decision mentioned in paragraph 5 shall be                     release(s) with respect to any risk to human health
taken in accordance with the procedure laid down in                   and the environment,
Article 9 .
                                                                 — the complete technical dossier supplying the infor­
7.    The decison shall establish, where appropriate, the             mation requested in Annexes I and II of Directive
conditions of use of the food or food ingredient. It may              90 / 220 / EEC and the environmental risk assessment
also establish the name of the food or food ingredient as             resulting form this information ; the results of any
well as whether and to what extent requirements for                   investigations performed for the purposes of research
labelling have to be made .                                           and development.
                                                                 Articles 11 to 18 of Directive 90 / 220 / EEC shall not
The labelling of the food or food ingredient shall satisfy       apply to food or food ingredients which contain or
the requirements of Directive 79 / 112/EEC on the                consist of genetically modified organisms .
approximation of the laws of Member States relating to
the labelling, presentation and advertising of foodstuffs
for sale to the ultimate consumer. In the authorization,         2 . In the case of food or food ingredients falling
additional specific labelling requirements shall be laid         under the scope of this Regulation containing or
down to inform the consumer of any significant                   consisting of genetically modified organisms, the
differences in the characteristics of the novel food or          decision mentioned in Article 4 (5), shall respect the
food ingredient when compared with the equivalent
conventional food or food ingredient.                            O OJ No L 117, 8 . 5 . 1990, p. 15.
 ---pagebreak--- 19 . 1 . 94                           Official Journal of the European Communities                           No C 16/ 13
environmental safety requriements laid down by                  2. The Commission shall examine the grounds given
Directive 90/220/EEC to ensure that all appropriate             by the Member State referred to in paragraph 1 as soon
measures are taken to avoid adverse effects on human            as possible within the Standing Committee for Food­
health and the environment which might arise from the           stuffs, and shall then deliver its opinion forthwith and
deliberate release of genetically modified organisms.           take the appropriate measures following the procedure
During the process of evaluating requests for the placing       laid down in Article 9 .
on the market of products containing or consisting of
genetically modified organisms, necessary consultations         3.     If the Commission considers that the national
will be held by the Commission with the bodies set up by        measures must be dispensed with or modified, it shall
the Community or the Member States in accordance                initiate the procedure laid down in Article 9 for the
with Directive 90 / 220 / EEC .                                 adoptation of the appropriate measures.
3. Detailed rules for implementing this Article may be                                    Article 9
adopted in accordance with the procedure laid down in            1.   Where the procedure laid down in this Article is to
Article 9 .
                                                                be followed, the Commission shall be assisted by the
                                                                Standing Committee on Foodstuffs, set up pursuant to
                           Article 6                            Council Decision 69/414/EEC (*) acting in an advisory
                                                                capacity, hereinafter referred to as 'the Committee'.
Detailed rules for the protection of the information
provided by or on behalf of the person responsible for          2.    The chairman shall submit to the Committee a draft
placing the product on the market in the Community              of measures to be taken . The Committee shall deliver its
shall be laid down in accordance with the procedure laid        opinion on the draft within a time limit which the
down in Article 9 .                                             chairman may lay down according to the urgency of the
                                                                matter, if necessary by taking a vote.
                           Article 7
                                                                3 . The opinion shall be recorded in the minutes ; in
Any decision or provision regarding a food or food              addition, each Member State shall have the right to ask
ingredient falling under the scope of this Regulation           to have its position recorded in the minutes.
likely to have an effect on public health shall be adopted      4.    The Commission shall take the utmost account of
by the Commission after consultation with the Scientific
Committee for Food, either on its own initiative or at the      the opinion delivered by the Committee. It shall inform
request of a Member State.                                      the Committee of the manner in which its opinion has
                                                                been taken into account.
                           Article 8                                                      Article 10
 1 . Where a Member State has detailed grounds for              This Regulation shall enter into force 20 days after its
considering that the use of a food or a food ingredient         publication in the Official Journal of the European
falling under the scope of this Regulation, although it          Communities.
complies with this Regulation, endangers human health,
that Member State may temporarily suspend or restrict           This Regualtion shall be binding in its entirety and
the trade and use of the food or food ingredient in             directly applicable in all Member States .
question in its territory. It shall immediately inform the
other Member States and the Commission thereof and
give reasons for its decision.                                  0) OJ No L 291 , 19. 11 . 1969, p. 9.