Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX (common procedure) COM(2007) 872 final — 2008/0002 (COD)
Date: 2008-05-29
Institutions: European Economic and Social Committee
Subjects: consumer protection, food inspection, food safety, food standard, foodstuff, human nutrition

30.8.2008

EN

Official Journal of the European Union

C 224/81

Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the
foods and amending Regulation (EC)
European Parliament and of

the Council on novel

No XXX/XXXX (common procedure)

COM(2007) 872 final — 2008/0002 (COD)

(2008/C 224/18)

On 30 January 2008, the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation
(EC) No XXX/XXXX (common procedure).

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 29 April 2008. The rapporteur was Mr Espuny
Moyano.

At its 445th plenary session, held on 28 and 29 May 2008 (meeting of 29 May), the European Economic
and Social Committee adopted the following opinion by 71 votes to one with two abstentions.

The EESC considers an update of

legislation on novel
1.1
foods to be necessary and appropriate, as this would achieve
greater food safety and legal certainty, and thus endorses the
Commission proposal, although a number of suggestions should
be taken into account.

The Committee supports the creation of a web page
1.2
containing the ‘whitelist’ of authorised foods
that can be
consulted by consumers and businesses but wishes to draw the
Commission's attention to the importance of this page being
easy to find amongst the mass of Commission pages and of it
giving clear explanations, to ensure that it is genuinely useful.

1.3
Because the regulation makes a distinction between two
categories of novel foods (according to whether or not they
originate in an EU Member State), the EESC suggests that the
whitelist of authorised foods be divided into two parts, so that it
is easier to access and understand by consumers and operators
alike.

The EESC considers that businesses' efforts in the field of
1.4
R+D+I should be safeguarded by the authorities through the
adequate protection of the data they provide and respect for the
intellectual property of these data.

In the Committee's view,

1.5
(before 1 January 2015) lies too far in the future.

the deadline for evaluation

The EESC considers that the phrase ‘that has not been
1.6
used for human consumption to a significant degree …’ is too
ambiguous and could lead to error, confusion and dubious prac-
tices.

1.7
The EESC notes that there is no system or deadline for
the revision of the list. It therefore proposes that the regulation
establish a procedure for its revision as and when necessary.

2. Gist of the Commission proposal

2.1
The original European regulations on novel foods date
back to 1997. With the passing of time, it has become clear
that some aspects of these regulations need to be updated and
amended.

2.2
The aim is to improve the efficiency, transparency and
application of an authorisation system that should ensure the
safety of novel
foods and include a procedure for scientific
assessment by the EFSA (the European Food Safety Authority),
thus reducing the administrative burden on businesses and
enabling them to be more competitive.

2.3
The Commission proposal lays down harmonised rules
for the placing of novel foods on the market in the EU with a
view to ensuring a high level of human health and consumers'
the
protection, whilst ensuring the effective functioning of
internal market.

The regulation will not apply to food additives, flavour-
2.4
ings, extraction solvents, enzymes, vitamins and minerals or
genetically modified food and feed, because specific procedures
already exist for these products.

2.5

The proposal considers ‘novel food’ to mean:

— food that has not been used for human consumption to a
significant degree within the Community before 15 May
1997;

The Committee wonders whether the deadline set by the

1.8
EFSA for evaluation, where necessary, will be adequate.

— food of plant or animal origin, when a non-traditional
breeding technique not used before 15 May 1997 is applied
to the plant or animal; and

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30.8.2008

— food to which a new production process not used before
15 May 1997 is applied, where that production process
gives rise to significant changes in the composition of the
food which affect its nutritional value, metabolism or level
of undesirable substances.

by the EFSA (Article 10), should help to standardise the safety
of novel foods in the EU, simplify the procedures to be followed
by businesses and speed up the pace of authorisations for novel
indirectly stimulates
In short, the proposal
foods in Europe.
businesses' investment and interest in developing novel foods.

2.6
The proposal also contains definitions of basic concepts
such as ‘traditional food from a third country’ and ‘history of
safe food use’.

2.7
It lays down that only novel foods included in the Com-
munity list of novel foods may be placed on the market and
only if they meet the following conditions:

— they do not, on the basis of the scientific evidence available,

pose a safety concern;

— they do not mislead the consumer;

— they are not nutritionally disadvantageous for the consumer
in cases where it is intended to replace a traditional food.

2.8
These conditions will also apply to the inclusion in the
Community list of both novel foods produced by new breeding
methods or new production processes and to traditional foods
In both
from third countries considered to be novel
cases, novel foods must observe the applicable rules and adhere
to the established procedure (which involves the Commission,
the EFSA and the Member States).

foods.

2.9
The Commission will, where appropriate (in cooperation
with the EFSA), provide tools and technical guidance to opera-
tors — and especially to SMEs — in the process of applying for
authorisation.

Again where appropriate, the Commission may,

2.9.1
for
food safety reasons and following the opinion of the EFSA,
impose a requirement for post-market monitoring (Article 11).

The proposal aims to ensure that the right to data
2.10
protection is respected (Article 12) and establishes that
the
national authorities will lay down the corresponding framework
for penalties applicable to infringements of Community provi-
sions (Article 13).

The Commission will be assisted by the Standing
2.11
Committee on the Food Chain and Animal Health (SCFCAH)
and, lastly, a deadline is set for submitting the assessment of this
Regulation's implementation (2015) with a view to making any
changes that might be needed.

3. General comments

3.1 Centralising evaluation and authorisation procedures

The proposal puts forward a centralised framework for
3.1.1
assessing and authorising novel foods, which would be carried
out by the EFSA (scientific assessment) and the European
involving assessment
Commission (authorisation). This model,

3.2 The need for a centralised procedure for authorising novel foods
that ensures their safety and simplifies authorisation procedures
for novel foods

3.2.1 With the publication of the Regulation on novel foods
and novel food ingredients in 1997, Community law acquired
the new instrument it needed to ensure the free movement of
safe food products.

3.2.2
The passing of time and the regulation's implementa-
tion have highlighted a number of aspects that need to be
improved in order to ensure a high level of public health protec-
tion and wellbeing and the free movement of goods and to
establish efficient authorisation mechanisms that help businesses
to innovate.

3.2.3
The proposal sets out two authorisation procedures, to
be selected according to the type of novel food in question: a
procedure for traditional foods from third countries that produ-
cers wish to place for the first time on the EU market and a
procedure for novel foods produced by non-traditional breeding
techniques or by new production processes.

3.2.4 With regard to the former (Article 8), there is a need to
simplify the existing authorisation procedure, which validates
the safety of such products on the basis of a history of safe food
use over a period of time (one generation) in third countries
and on the basis of proof that such food has not been used for
human consumption to a significant degree within the European
Union before 15 May 1997. This notification procedure to a
large extent simplifies the requirements that traditional foods
from third countries have until now had to meet to in order to
be placed on the market in the European Union.

3.2.5 With regard to foods in the latter category (novel foods
produced by non-traditional breeding techniques or by new
production processes), which are the focus of the R&D carried
out by the EU's food industry, the requirement is for a single
safety assessment by the EFSA and a procedure (Article 19) that
is clear, straightforward and effective and which helps to speed
up the hitherto lengthy authorisation procedures. Nevertheless,
despite the importance of this aspect, the proposal does not
fully develop the procedure to be followed in such cases, in that
it refers to the common authorisation procedure for additives,
enzymes and flavourings. Referring to this authorisation proce-
dure (which has not yet been adopted in the EU) looks to be an
interesting proposal, but its scope does not appear to have been
considered in sufficient detail.

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3.2.6
Centralising the assessment and authorisation of novel
foods (involving the EFSA and the European Commission) is
essential, but a simple, clear, effective, detailed procedure with
deadlines also needs to be established (along the lines of the
notification procedure for traditional foods from third countries)
to authorise novel foods produced by non-traditional breeding
techniques or by new production processes, which lie at the
heart of innovation in the food industry.

3.2.7
This procedure could be included in the proposal or
could refer to another regulation. In both cases, however, the
proposal should contain all of the details needed to ensure that
the operator is familiar with the procedures to follow in order
to obtain the appropriate authorisations.

3.2.8
The proposal should be sufficiently clear and compre-
hensive as to enable operators to apply it, although this does
prevent the Commission from drawing up relevant guidelines at
a later date (Article 9).

3.3 Community lists

3.3.1
The initiative to draw up lists of novel foods (Articles
5, 6 and 7) will help to improve consumer information and
provide operators with greater legal certainty. The list-based
model
is by no means new, since the use of such lists has
become increasingly common (for example, the Regulation on
nutrition and health claims and the Regulation on the addition

Brussels, 29 May 2008.

of vitamins and minerals to foods, amongst others). Where
traditional foods from third countries are concerned, the model
appears to be quite thoroughly developed in the proposal, in
the list content and publication on DG SANCO's
terms of
website, but the same cannot be said of other novel foods (it is
not known whether the list will be published on DG SANCO's
website, …). It would be useful for this to be clarified.

3.4 Protection of intellectual property

3.4.1
Developing novel foods requires considerable commit-
ment to and investment in R&D on the part of businesses and
swift and
they therefore require not only straightforward,
economically feasible procedures; knowledge and developments
must also be protected to ensure that competitiveness does not
suffer. No clear definition is provided for the scope of the data
protection to which, according to the proposal, businesses will
be entitled (it refers only to authorisations, what becomes of
applications that are ultimately rejected, etc.).

3.4.2
Providing the future regulation with a tool such as data
protection will help to give businesses some security as regards
into new
the economic and human resources they channel
projects. They will see data protection as a tool that affords
them the protection they need to continue innovating and to
become
ever-more
competitive,
demanding nature of both the market and consumers.

increasingly

given

the

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS