CELEX: 51996PC0229
Language: en
Date: 1996-05-23
Title: Amended Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on novel foods and novel food ingredients

COMMISSION OF THE EUROPEAN COMMUNITIES
                                        Brussels, 23.05.1996
                                        COM(96) 229 final - COD 426
              OPINION OF THE COMMISSION
      pursuant to Article 189 b (2) (d) of the EC Treaty,
           on the European Parliament's amendments
       to the Council's common position regarding the
                         proposal for a
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC)
          on novel foods and novel food ingredients
    AMENDING THE PROPOSAL OF THE COMMISSION
        pursuant to Article 189 a (2) of the EC Treaty
 ---pagebreak---  ---pagebreak---  Introduction
 On 7 July 1992 the Commission presented a proposal for a Council Regulation on novel
 foods and novel food ingredients. (COM(92)295 final - SYN 426).
 Further to the opinion of the European Parliament delivered on 27 October 1993, the
 Commission prepared an amended proposal which was submitted to the Council on 1
December 1993 (COM(93) 631 final - COD 426.
On 23 October 1995 the Council adopted a common position by qualified majority.
On 12 March 1996, the European Parliament adopted 6 amendments to the common
position adopted by the Council on 23 October 1995 in respect of the Commission
proposal for a Regulation of the European Parliament and of the Council on novel foods
and novel food ingredients.1
Objectives of the Regulation
At present, within the European Union, foodstuffs can generally be placed on the market
without any pre-marketing assessment or authorisation.
Recently, a new range of raw materials, processes and technologies, including but not
only modern biotechnology and genetic modification techniques have emerged. These
innovations aim for example at improving the nutritional and dietary aspects of
foodstuffs, at promoting greater technical efficiency in production processing or
distribution, at reducing the risk of microbiological contamination or at growing crops by
using fewer pesticides. In order to ensure consumer protection and to avoid the creation
of trade barriers in the internal market, it was felt necessary to create a Community
procedure for the placing on the market of "novel foods" resulting from these innovations
and to provide for a safety assessment and for precise labelling provisions. The proposal
is therefore of major importance, from the point of view of consumer protection and
information as well as for smooth functioning of the internal market and the diffusion of
new technologies in the agri-food sector. The Commission believes that there is general
agreement between the institutions about the urgent need for Community legislation on
this issue.
        O J n ° C 190, 29.7.1992, p.3
                                             I
 ---pagebreak--- Opinion of the Commission
In accordance with paragraph 2 (d) of Article 189b of the EC Treaty, the Commission
gives the following opinion on these amendments..
The Commission agrees with Parliament that the Regulation should be brought into force
as soon as possible, and it can therefore give a favourable opinion on amendment 48
which reduces the period for implementation of the Regulation from 12 months to 90
days;
The Commission understands the concern expressed by the Parliament in amendment 53
to ensure that food additives, flavours and extraction solvents meet the same level of
safety as novel foods, and shares this principle. However, it cannot give a favourable
opinion on the wording of amendment 53 since it implies that the exclusion is
conditional, requiring specific action to be taken. The Commission would point out that
the framework Directive on food additives (89/107/EEC)2 and the Common Position
agreed by the Council on 22 December 1995 on a proposal for a regulation of the
European Parliament and the Council laying down a Community procedure for
flavouring substances intended for use in foodstuffs3 already provide for the same level
of safety as for novel foods, including compulsory consultation of the scientific
Committee for Food on matters likely to affect public health. In respect of extraction
solvents, Directive 83/344/EEC4 already provides for a similarly high level of protection
of public health.
Amendment 54 provides that the labelling rules of Article 8 apply to novel foods and
novel food ingredients which are the subject of the simplified notification procedure. In
isolation, this amendment presents no difficulty, since it simply clarifies the intention of
the Common Position which is to apply a single coherent set of labelling rules to all
categories of novel foods. However, this amendment must also be seen in conjunction
with amendment 55 which deletes the word "significant" in Article 8 (1) (a) of the
Common Position so that labelling of novel foods will be required in all cases where a
novel food is different from the conventionally produced food. It should be recalled that
labelling of significant differences is the mirror-image of the application of the
internationally recognised scientific principle of "substantial equivalence" on which the
Regulation is based. Under the common position, an operator would therefore know that
if he can provide evidence that the food or food ingredient is clearly substantially
equivalent, then the notification procedure could be used and the product would not
2
        O J n ° L 40, 11.2.1989, p. 27
3
        OJ n< C 59, 28.2. Î 996, p. 37
'1      ().l.n°l. 157,24.6.1988, p.28
                                               5
 ---pagebreak--- require any specific labelling. With the new formulation of Amendment 55, the operator
cannot be certain that his substantially equivalent product does not present negligible
differences. Therefore, the notification procedure may become unusable in practice.
The Commission understands the concern of Parliament to ensure that consumers are
informed of all differences between novel foods and conventionally produced foods.
Nevertheless, the application of a criterion that would lead to special labelling
requirements even for novel foods which are substantially equivalent is likely to give rise
to practical difficulties. Particularly in the case of fruit and vegetables, climatic and
geographical factors such as soil types may have noticeable effects on the properties of
the final product. For example, climatic variations from year to year result in differences
in the final crop. In such circumstances it may be difficult to decide what are the precise
parameters to be used in determining whether a novel food differs from its conventional
counterpart. In order to provide meaningful information for the consumer, the
Commission considers that a product should only be labelled when it presents
characteristics which fall outside of the range of natural variations and which may affect
the composition, the nutritional value or effects or the intended use of the products. The
Commission is therefore unable to accept these 2 amendments and considers that all
possibilities should be explored in order to outline the concept of difference so that it
provides more legal certainty for economic operators.
The current text of the common position provides that the presence of a genetically
modified organism does not need to be indicated on the labelling when this presence is
solely due to agricultural characteristics and does not modify the characteristics of the
foodstuff itself. This exemption would cover, for example, corn which is genetically
modified to increase insect resistance. Amendments 51 and 52 have the effect of
deleting this exemption. The Commission does not share the point of view of Parliament
that the presence of genetically modified organisms should be indicated on the labelling
of the foodstuff concerned in all cases, even when this presence has no effect on the
properties of the foodstuff. The purpose of food labelling is to inform consumers about
the characteristics of the food. Information about methods of production and agronomic
properties is required only where these have an effect on the finished product. Moreover,
the introduction of such a provision would make it necessary either to establish separate
distribution systems for foods containing GMOs -which would be extremely difficult to
implement from practical point of view- or to provide for systematic labelling in all cases
that the produce may contain GMOs. Particular problems arise in respect of imports,
since none of the Community's major trading partners provide for labelling in such cases,
and GMO produce will usually be mixed with conventional produce before shipment to
the EU.
                                             K
 ---pagebreak--- In addition, amendment 51 requires the labelling of "an organism genetically modified by
genetic engineering methods". The Commission considers that this formulation, implies
legal uncertainty, because the concept used is not sufficiently precise and does not
correspond to an already existing definition. A clear defimtion for GMO's is provided by
Directive 90/220/EC and this is why it is proposed to use it also for labelling of novel
foods.
On the basis of this analysis, the Commission has incorporated one amendment (n° 48) in
its modified proposal. The Commission would, however, emphasise that there is general
agreement on the urgent need to establish a satisfactory regulatoryframeworkfor novel
foods at Community level. To this end the Commission will participate constructively
 with the institutions in the remaining stages of the institutional decision-making
procedure using all available possibilities with a view to resolving the outstanding
problems identified above.
 ---pagebreak---                                   Amended Proposal for a
              Regulation of the European Parliament and of the Council
                        on novel foods and novel food ingredients
      (presented by the Commission pursuant to Article 189 A (2) of the EC Treaty)
            Current Proposal                              Amended proposal
                                Article 15,1st paragraph
This regulation shall enter into force 12     This regulation shall enter into force 90
months following the day of its               days following its publ'cation in the
publication in the Official Journal of the    Official Journal of the European
European Communities.                         Communities.
 ---pagebreak---                                                                  ISSN 0254-147.S
                                                           COM(96) 229 final
                                             DOCUMENTS
EN                                                                      10 15
                                    Catalogue number : CB-CO-96-240-EN-C
                                                            ISBN 92-78-04462-8
Qffke for Official Publications of the European Communities
L-2985 Luxembourg
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