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 

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. 
OJn°C 190, 29.7.1992, p.3 
I 
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 OJn°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 
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 
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 regulatory framework for 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. 
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. 
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 
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