Opinion of the European Economic and Social Committee on the ‘Co-existence between genetically modified crops, and conventional and organic crops’
Date: 2004-12-16
Institutions: European Economic and Social Committee, Provisional data
Subjects: EU law, genetically modified organism, organic farming

28.6.2005

EN

Official Journal of the European Union

C 157/155

Opinion of the European Economic and Social Committee on the ‘Co-existence between geneti-
cally modified crops, and conventional and organic crops’

(2005/C 157/29)

On 29 January 2004, the European Economic and Social Committee, acting under Rule 29(2) of its Rules
of Procedure, decided to draw up an opinion on ‘Co-existence between genetically modified crops, and
conventional and organic crops’.

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 21 September 2004. The rapporteur was Mr
Voss.

At its 413th plenary session on 15/16 December 2004 (meeting of 16 December 2004), the European
Economic and Social Committee adopted the following opinion by 47 votes in favour, 13 votes against
and 4 abstentions:

1. Introduction

2. General preliminary remarks and definitions of terms

The EESC considers it necessary to develop and lay
1.1
down rules on coexistence between the cultivation of geneti-
cally modified crops on the one hand, and the conventional
and organic cultivation of crops and environmental protection
on the other. These rules must be sustainable, legally certain,
and practicable, and must apply to the entire food sector and
to agricultural, fishery and forest production including that for
pharmaceutical, non-food and research purposes.

the adventitious or

The Commission a) wants to leave significant aspects of
1.2
coexistence to national legislation, and b) is minded to address
the issue of
technically unavoidable
presence of GMOs in non-GMO seed, which is central to the
future of coexistence, by means of the comitology procedure
under Directive 2000/18 and under the directives on the
marketing of seed. Therefore, the EESC is not being consulted
on these issues. It therefore makes sense to join the debate on
these issues by drawing up an own-initiative opinion, thus
drawing particular attention to the associated economic and
social issues and providing an opinion on these to the Council,
the Commission and the Parliament.

The purpose of this own-initiative opinion is twofold:
1.3
firstly, to shed light on the most important substantive aspects
of coexistence; and secondly, to make proposals as to which of
these aspects should, in the EESC's view, be dealt with by Euro-
pean legislation, which should be dealt with by national legisla-
tion, and what practical objectives and guidance the relevant
businesses, in particular farms, need.

As

the Commission ended

1.4
the moratorium on
marketing GMOs as foodstuffs, which had been in force since
1998, in May this year and intends to take a decision in the
near future on the cultivation of GMOs (1), it is of vital impor-
tance to set up a practical framework for coexistence.

Due to the authorisation of the marketing of genetically

2.1
modified organisms (GMOs):

— for plant and microbe cultivation and stock farming;

— for research purposes;

— as food and animal feed;

— as a raw material for other purposes, including cultivation

for pharmaceutical production;

— for the purpose of managing the natural environment (for

example to break down pollutants), and

— as an aid to agriculture and forestry (for example,

to

control parasites and weeds),

the need arises to lay down practical provisions for the imple-
mentation of such marketing and for the handling of these
products in food, animal feed and the natural environment.

(1) Communication for an orientation debate on Genetically Modified

Organisms and related issues
http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&-
doc=IP/04/118|0|RAPID&lg=EN
GMO authorisations under EU law – Current situation
http://zs-l.de/saveourseeds/downloads/com_stand_g-
vo_28_01_04.pdf
Questions and answers on GMO legislation in the EU
http://zs-l.de/saveourseeds/downloads/com_fragen_antwor-
ten_28_01_04.pdf

The following matters have already been settled at Euro-

2.2
pean level:

— risk assessment and risk management (2);

(2) Directive 2001/18/EEC of 12 March 2001 on the deliberate release

into the environment of genetically modified organisms
OJ L 106, 17.4.2001, p. 1.

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— authorisation;

— labelling requirements for food and animal feed (1)

— traceability (2), and

2.5
GMOs are living organisms that are capable of reprodu-
cing and spreading within the natural environment. The biolo-
gical systems into which they are to be introduced, and from
which they cannot then be easily removed, can neither be
hermetically partitioned nor similarly controlled in the way
that is possible in closed scientific, industrial or craft facilities.
The biosphere is fundamentally a globally interconnected, open
system, of whose laws and behaviour we currently only have
limited knowledge and control.

— transboundary transport outside the European Community
(implementing the International Cartagena Protocol on
Biosecurity) (3).

The following areas have yet to be dealt with at Euro-

2.3
pean level:

For these reasons, the European legislators have taken
2.6
the precautionary principle along with case by case assessment
and regulation as the basis for dealing with GMOs. At the same
time, they have considered transparency and freedom of choice
in respect of the use of GMOs to be of great importance.

— labelling requirements for seed and reproductive material;
the Commission is currently drawing up a proposal on this
matter (4), and

This is taking place against a background where a
2.7
majority of the citizens of the European Union are either scep-
tical or hostile to the use of GMOs in agriculture, forestry, food
and feed.

the use of GMOs (5);

— the practicalities of the economic, social and cultural conse-
the parliaments and
quences of
governments of Member States are currently dealing with
this in the framework of the implementation of Directive
2001/18 and the development of their national legislation
relating to rules on cultivation and civil liability relating to
this.

2.4
Existing EU legislation states that GMOs require particu-
lar risk assessment, risk management and labelling and trace-
ability throughout their life cycle. It is based on the assumption
that it should be possible to refrain from the active and passive
use of GMOs and strictly forbids the use of GMOs in organic
agriculture and organic food (with the exception of a few veter-
inary products). It also provides for the possibility, on a case-
by-case basis, of subjecting the release of GMOs in particular
areas to special conditions or prohibiting it altogether.

(1) Regulation (EC) No 1829/2003 of the European Parliament and the
Council of 22 September 2003 on genetically modified food and
feed
OJ L 268, 18.10.2003, p. 1.

(2) Regulation (EC) No. 1830/2003 of the European Parliament and the
Council of 22 September 2003 on traceability and labelling of
genetically modified organisms
OJ L 268, 18.10.2003, p. 24.
Commission Regulation (EC) No. 65/2004 of 14 January 2004
establishing a system for the development and assignment of unique
identifiers for genetically modified organisms
OJ L 10, 16.1.2004, p. 5.

(3) Regulation (EC) No. 1946/2003 of the European Parliament and the
Council of 15 July 2003 on transboundary movements of geneti-
cally modified organisms
OJ L 287, 5.11.2003, p. 1.

(4) European Commission, September 2003, Questions and Answers

about GMOs in seeds
http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.getfile=gf&-
doc=MEMO/03/186|0|RAPID&lg=EN&type=PDF

(5) Commissioner Fischler, June 2003: Communication to the Commis-
sion on the Co-existence of Genetically Modified, Conventional and
Organic Crops (pdf)
http://zs-l.de/saveourseeds/downloads/Communication_Fis-
chler_02_2003.pdf

The coexistence of agriculture and land use with and

2.8
without genetically modified organisms therefore affects:

— agriculture, forestry, and fisheries, including management of

land ownership;

— the whole of the food sector (processing, trade, catering);

— regional and local land use and economic development;

— consumer protection; and

— environmental protection

within the temporal and spatial framework appropriate to each.

The European Commission,

2.9
in non-binding opinions,
has until now reduced coexistence to the purely economic
factors of various forms of agriculture existing alongside each
other. It suggests that regulating these aspects should be left
largely to individual Member States. However, this position has
caused controversy in the Council of Ministers and has been
criticised by the European Parliament (6).

(6) European Parliament resolution on coexistence between genetically
(2003/

modified crops and conventional and organic
2098(INI))
OJ C 91 E, 15.4.2004, p. 680.

crops

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3. Main aspects of coexistence (structure)

3.1 Current scientific thinking

(rocket), wild radish, annual wall rocket, common dogmustard,
wild mustard, wild cabbage and Mediterranean mustard. The
same also applies to beet, for example.

3.1.1
In order to regulate coexistence effectively, a sound
scientific basis is needed for estimating the speed and breadth
of the spread and interbreeding of GMOs of various plant
species (and, where applicable, the spread of micro-organisms
and animals). Reliable, practical experience and estimates of
possible modes of
transmission during production, storage,
transport and processing are also essential.

3.1.2
The Commission has obtained various reports and
opinions (1) on this subject; however, these do not yet give a
coherent picture. Further studies have been commissioned. At
the first scientific conference on coexistence (2), which was held
in November 2003, the assembled scientists established that
there was a considerable need for research and felt that their
ability to make firm statements on the possibilities of coexis-
tence was limited. An opinion of the EU Scientific Committee
from 2001 (3) points to significant uncertainties and does not
unequivocally commit itself to the limits for food, feed and
seed suggested by the Commission.

3.1.3
The current state of knowledge of cross-breeding
behaviour, propagation, and persistence of genetically modified
plants does not at present allow any reliable predictions to be
made as to the feasibility of coexistence.

3.1.4
This particularly applies to long-term forecasts and to
various ecosystemic surroundings and conditions of cultivation.

3.1.5
The evaluation and estimation of the ability of particu-
lar GMOs to co-exist must be undertaken plant species by plant
species, taking into consideration the regional circumstances
and the various production systems. Such evaluations and esti-
mates also need to take into account the changes to cultivation
methods this involves (for example, the use of total herbicides
made possible as a result of appropriate resistance).

3.1.6
Particular difficulties in forecasting and monitoring
arise where plant species are involved that are genetically
interbreeding with naturally-occurring, non-culti-
capable of
vated related species. Oilseed rape, whose genetic origins are in
Europe, has many direct and indirect wild and cultivated cross-
rape, mustard
breeding partners. These

include cabbage,

(1) Joint Research Centre, 2002, Scenarios for co-existence of geneti-
cally modified, conventional and organic crops in European agri-
culture.
http://www.jrc.cec.eu.int/download/gmcrops_coexistence.pdf
Round Table on research results relating to co-existence of GM and
non-GM crops.
http://europa.eu.int/comm/research/biosociety/news_events/news_-
programme_en.htm

(2) First European Conference on Co-existence of Genetically Modified
Crops with Conventional and Organic Crops 13-14 November,
2003, Helsingør, Denmark
http://www.agrsci.dk/gmcc-03/

(3) Opinion of

the Scientific Committee on Plants concerning the

adventitious presence of GM seeds in conventional seeds
http://europa.eu.int/comm/food/fs/sc/scp/out93_gmo_en.pdf

3.2 Risk management, monitoring and registration of cultivation

3.2.1
The identification and labelling of GMOs is the mate-
rial precondition for the implementation of the registration of
cultivation and the monitoring of GMOs required by Directive
2001/18. It is also a precondition for taking particular GMOs
out of circulation if this becomes necessary due to new scien-
tific information or to the expiry of a time-limited authorisa-
tion. The labelling of GMOs capable of reproducing is of deci-
sive importance for effective risk management, especially in the
event that emergency measures become necessary. It cannot,
therefore, focus solely on the question of whether or not it will
lead to the limit for a labelling requirement in food and feed
being exceeded, particularly since the proposed limits with
respect to consumer information cease to be relevant if an
authorisation is withdrawn.

3.2.2
An assessment of the risks associated with GMOs is
required under Directive 2000/18 and similar provisions in
other Community regulations and directives and is a precondi-
tion of their authorisation. However, the way in which cultiva-
tion is carried out in practice will have a decisive effect on
whether the measures provided for in the directive to limit
cultivation and to control and monitor its effects and to with-
draw authorisation can actually be carried out. Thus, the issue
of coexistence cannot be limited to the economic aspects of
cultivation alone, but is an integral part of the risk management
and prevention laid down by law.

3.3 Traceability and control in the human and animal food chain by

sampling, testing and documentation

for

and

3.3.1 Measures
labelling GMOs
identifying
throughout the food chain are set out in the directive on trace-
ability and labelling of GMOs (part of the general principles
and requirements of food legislation (4)). These extend beyond
the identification of the GMOs in the final product, as products
now need to be labelled even if no trace of the GMOs can be
detected in the end product.

(4) Regulation (EC) No. 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles
and requirements of
food law, establishing the European Food
Safety Authority and laying down procedures in matters of food
safety.

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3.3.2
recorded in a central database and published (1).

The information needed to identify a GMO are

— in the reproduction, preparation, treatment and packaging

of the seed;

3.3.3
The Joint Research Centre of the EU is now working
towards the standardisation and validation of the sample collec-
tion and test procedures that are required in this context.

— in the cultivation, processing, harvesting and transport of

the plant products;

3.3.4
The identification of specific DNA or of a specific
protein of a GMO is technically possible, using currently avail-
able analysis techniques, between 0.001 and 0.05 per cent of
the total of the sample being analysed. The costs for non-
specific, qualitative tests for the presence of GMOs are currently
between 100 and 150 EUR per test. The costs for specific and
quantitative tests vary between 250 and 500 EUR per test.

Considerable differences persist within the Community
3.3.5
as to the reliability and across-the-board availability of detec-
tion procedures and the technical capacity to put them into
practice. As yet, adequate provision for such procedures has
been made in only a few Member States; in some, no such
provision has been made at all.

3.3.6
Currently, there are, in practice, considerable difficul-
ties particularly with quantitative and specific tests for the
presence of GMOs, particularly where the manufacturer has
provided no appropriate detection procedure or insufficient
reference material. This applies especially to those GMOs that
are not permitted in the EU, but whose presence in imported
seed and raw materials cannot be ruled out.

— in selecting and preparing harvested seed for replanting;

— in the buying, processing, storage and transport of agri-

cultural raw materials and products;

— in further processing of food and feed, and

— in packaging, distribution and labelling of

finished

products.

3.4.2
In most areas, good professional practice is in many
ways already established. Complementing them with specific
provisions for handling GMOs is the key condition for the
implementation of the legally defined rules for risk
practical
management, traceability, and labelling of GMOs. The greatest
need for this action is in the areas of seed and agricultural
production, but also with respect to the buying, storage and
transport of agricultural produce.

3.4 Good professional practice in agriculture

3.4.1
throughout the food production chain:

Good professional practice needs to be adhered to

— in research and development, particularly where the release
of GMOs for scientific purposes is involved (2001/18 Part
B);

— in the development of seed, particularly with respect to the
composition of the stock material and of the various stages
of the basic seed;

— in maintenance breeding and reproduction;

3.4.3
Both the success and the requirements of good profes-
sional practice depend substantially on the success with which
good professional practice was adhered to in the prior stages of
the production process.

In order to avoid interbreeding and other spreading of
3.4.4
GMOs on to fields and the environment at large, as well as the
mixing of GMO seed with non-GMO seed, various measures
(appropriate to the crop in question and the regional circum-
stances) need to be taken. The Commission has spelled some of
these out in its guidelines on coexistence (2) and requested
Member States to issue appropriate regulations. These affect
both farmers who plant GMOs and those who want to keep
them out of their produce. They also apply to agricultural
service companies and businesses, including those involved in
storage and transport, as well as the authorities responsible for
agricultural practice and institutions involved in protecting the
countryside and the environment.

(1) Commission Decision of 23 February 2004 laying down detailed
arrangements for the operation of the registers for recording infor-
mation on genetic modifications in GMOs, provided for in Directive
2001/18/EC of the European Parliament and of the Council (notified
under document number C(2004) 540) (2004/204/EC)
OJ L 65, 3.3.2004, p. 20.

(2) Commission Recommendation of 23 July 2003 on guidelines for
the development of national strategies and best practices to ensure
the coexistence of genetically modified crops with conventional and
organic farming (notified under document number C(2003) 2624)
OJ L 189, 29.7.2003, p. 36.

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3.5 Composition, control and labelling of seed

(post-market monitoring) and, in the case of any subsequent
ban, retrieval.

3.5.1
Seed is the first stage in the production chain. It repro-
duces by a factor of between 40 and 1000 depending on type
and may in some cases remain in the soil for long periods.
GMOs in seed fertilise neighbouring crops and any wild rela-
tions growing nearby through external pollenisation. Seed and
pollen can thereby be dispersed across great distances. Scien-
tists agree that these space and time elements mean that the
presence of GMOs in seed is a key factor in coexistence.

Directive 2001/18 provides for the establishment of
3.5.2
limits for certain product groups, below which limits labelling
of GMOs is not required if certain conditions are met. The
regulations on genetically modified food and feed (1) and on
traceability (2) set a limit of 0.9 % for those products.

the Commission withdrew this proposal

3.5.3
The Commission has proposed that the directives on
plants and seed should also contain such limits on GMOs in
seed, which should be between 0.3 and 0.7 per cent. Due to
legal concerns,
in
October 2003 and drew up a new proposal. This contained
only limits of 0.3 % for rape seed and maize seed. However,
in September
the Commission withdrew this proposal, too,
2004. Further risk assessments are now planned in order put
the decision on a sounder scientific basis and, in particular, to
obtain a more accurate picture of the economic effects. It is
clear that setting purity standards for non-genetically modified
seed will have significant effects on whether coexistence of
certain plant species and types of production will even be
possible and, where applicable, on the costs associated with it.

3.5.4
On the question of whether limits should be set on
the adventitious and technically unavoidable presence of GMOs
in seed, and if so what limits. There are differing opinions, not
only among the governments of Member States, but also
among the businesses and organisations affected.

3.5.5
Unlike food and feed, seed labelling is not designed as
information to help final consumers make a free choice.
Rather, it provides key information for those releasing GMOs
into the environment in line with the legal provisions and for
the authorities responsible for implementing the deliberate
release directive. Lack of information about the presence of
GMOs in certain seed makes it all but impossible to comply
with the legal requirements for their registration, monitoring

(1) Regulation (EC) No 1829/2003 of the European Parliament and the
Council of 22 September 2003 on genetically modified food and
feed
OJ L 268, 18.10.2003, p. 1.

(2) Regulation (EC) No. 1830/2003 of the European Parliament and the
Council of 22 September 2003 on traceability and labelling of
genetically modified organisms
OJ L 268, 18.10.2003, p. 24

3.5.6
If, for instance, a GMO should subsequently prove to
be allergenic, or where the transfer of its properties to wild
relations generates a competitive advantage and thus produces
undesired shifts in the ecological balance, the GMO in question
would have to be banned and withdrawn from circulation. For
this purpose,
limits in the area proposed by the European
Commission would be wholly unacceptable. Assuming that all
the seed of the affected plant species is contaminated with up
to 0.5 % of this GMO, then retrieval and emergency measures
would have to cover the entire yield and the entire seed of the
species concerned.

Practical experiences with a product recall in the USA
3.5.7
illustrate both the difficulties and the possible costs. In 2000,
after the US Environmental Protection Agency banned the use
of
the genetically modified maize variety Starlink due to
possible allergenic effects, the total costs across the product
chain were around US$1 billion. Contaminated seed and crops
were bought up on a large scale and withdrawn from the
market. To this day, however, it has been impossible to elimi-
nate the contamination completely. In 2003, more than 1 % of
samples tested showed traces of Starlink.

3.5.8 Moreover, the presence of GMOs in non-genetically-
modified seed has a critical impact on the costs incurred in the
downstream farming and processing sectors. A huge amount of
expensive testing and monitoring is involved in cases where,
under legal provisions permitting a certain degree of contami-
nation, all non-genetically-modified products still have to be
their contamination with
routinely checked to ensure that
labelling limit of 0.9 % for
GMOs does not exceed the legal
food and feed, or correspondingly lower levels for upstream
products.

The contamination of conventional and organic seed
3.5.9
with GMOs will also be a key factor in determining the party
liable for any financial damage incurred by exceeding the label-
ling limits for food and feed, as well as the lower limits derived
from this that commercial and processing businesses are
demanding. Naturally, any potentially liable parties will first of
all demand proof that the damage involved has not been the
result, at least in part, of the condition of the seed rather than
the transfer of GMOs in the field.

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3.5.10
Also, the presence of GMOs in conventional and
organic seed adversely affects farmers' scope for breeding and
planting their own seed. The original seed contamination can
accumulate in subsequent generations, especially, of course,
when combined with further contamination from neighbouring
fields. That might not only generate substantial financial losses
for the farmers concerned, but could also harm seed diversity
and the suitability of seed for local conditions.

3.6 Product and environmental liability

Under Directive 85/374/EEC concerning liability for
3.6.1
defective products, manufacturers and suppliers of GMOs are
liable only for defective products in the case of culpable or
negligent damage to life, limb or property (1). This liability is,
restricted to final products for private use and
however,
consumption and therefore does not cover either the seed or
any financial damage incurred by a reduction in the value of
the yield or its derivative products.

This

3.6.2
on
comprehensive Community
product liability makes it difficult for national rules to place
direct liability on GMO suppliers for any damage falling within
the scope of civil law as well. It puts the entire civil liability on
the users (i.e. the farmers) as the direct manufacturers of the
final product.

restriction

3.6.3
The scope of the new environmental liability directive
(2004/35/EC) covers ‘any deliberate release into the environ-
ment, transport and placing on the market of genetically modi-
fied organisms as defined by Directive 2001/18/EC’. This direc-
tive authorises Member States (but not individual citizens) to
require those responsible to remove and remedy environmental
damage if they are at fault or negligent and a causal link can be
established between the damage and the activities of individual
operators (2). Member States are required to implement this
Directive by 30 April 2007. The fact that a GMO is authorised
for release within the Community will, generally speaking, rule
out
the conditions for negligence or intent, unless specific
conditions for release were breached. In its opinion on the
environmental liability directive (3), the EESC had already stated
that ‘the definition of biodiversity should include the effect of
GMOs, in both the short and long term’.

(1) Council Directive 85/374/EEC of 25 July 1985 on the approxima-
tion of the laws, regulations and administrative provisions of the
Member States concerning liability for defective products
http://europa.eu.int/eur-lex/en/consleg/main/1985/
en_1985L0374_index.html
(2) Directive 2004/35/CE of

the
Council of 21 April 2004 on environmental liability with regard to
the prevention and remedying of environmental damage, OJ L 143 ,
30/04/2004 P. 56 – 75 , see Article 3 and 4 and Annex III.
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CE-
LEXnumdoc&lg=DE&numdoc=32004L0035&model=guicheti

the European Parliament and of

(3) Opinion of the Economic and Social Committee on the Proposal for
a Directive of the European Parliament and the Council on environ-
mental
liability with regard to the prevention and remedying of
environmental damage, COM(2002)17 final – 2001/0021 (COD)),
CES 868/2002, OJ C 241 of 7.10.2002, pp. 37-45

3.7 Civil liability

The unwelcome presence of GMOs

3.7.1
in products,
production facilities and production areas can cause financial
damage to farmers, processors and traders of food and feed if
this hampers or prevents the production and sale of products
without genetic modification or makes special measures for
inspection and removal necessary. It can also make measures to
return areas to their original state necessary if the release of
GMOs is not permitted in those places (for example environ-
mentally sensitive areas). Such measures cost money.

3.7.2
ance against such civil claims.

The insurance industry is at present ruling out insur-

The European Commission feels that

3.7.3
the Member
States should determine the civil liability for these costs. This
will obviously have an effect on competition within the Com-
munity. Differing national rules in this area may significantly
distort competition in the internal market and create legal
uncertainty in cases where cause and effect cross the Communi-
ty's internal borders.

Individual

3.7.4
liability for the costs incurred by third
parties in avoiding damage (testing, monitoring and other
measures to prevent cross-breeding and contamination with
GMOs) is hardly legally practicable. In contrast to compensa-
these very considerable
tion for damages actually incurred,
costs, which will arise in all regions where GMOs are culti-
vated, cannot be dealt with by civil
liability provisions. The
affected farmers, businesses and authorities could, however, be
compensated by special funds financed by the companies and
farmers who bring the costs about.

3.8 Macroeconomic and microeconomic costs

3.8.1
The cultivation of GMOs will make measures for
control and prevention of the unwelcome presence of GMOs
necessary right across the food and feed production sector.
There may also be an impact on markets in certain regions and
for certain kinds of production and product types (for example,
regional quality labels and organic farming and production). In
addition to the market players, this affects various authorities
and institutions of the Member States and of the Community.

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3.8.2
The monitoring and prevention measures required for
coexistence to some extent involve radical changes in farming,
craft and industrial practice and tradition. The economic, social
and cultural impact, especially on farmers and the craft-based
food industry, has not so far been consistently examined and
presented. This is, however, essential so as not to adversely
affect either their ability to survive and compete, or the market
and price structure.

3.8.3
A comprehensive picture of these costs is needed in
order to evaluate what measures and regulations on coexistence
will be most appropriate. To date, however, only limited, piece-
meal information and estimates exist on this subject (1)

3.8.4
The EESC considers a comprehensive overview and
estimate of costs that will arise out of coexistence measures for
a) individual market players in various types of production and
regions and b) the public purse to be an essential requirement
for a forward-looking and sustainable solution for coexistence.
Clear, binding and reliable arrangements are needed as to who
should bear or indeed avoid these costs.

3.8.5
The Commission is right when it writes in its guide-
lines on coexistence: ‘As a general principle, during the phase
of introduction of a new production type in a region, operators
(farmers) who introduce the new production type should bear
the responsibility of
implementing the farm management
measures necessary to limit gene flow. Farmers should be able
to choose the production type they prefer, without imposing
the necessity to change already established production patterns
in the neighbourhood.’

The increased production costs resulting from the
3.8.6
requisite coexistence measures must not be passed on in higher
consumer prices. That would curb freedom of choice, not least
for more socially disadvantaged consumers. Agricultural and
craft-based food production not involving genetic engineering
must not be threatened by cost and price increases and forced
into niche production.

4. EESC Recommendations

4.1 Principles of coexistence

4.1.1
Rules on coexistence should be driven by the princi-
ples of caution, maintaining natural and agricultural biodiver-

sity, minimum cost, maximising economic and social opportu-
nities, promoting regional diversity and economic autonomy,
and the polluter pays principle. They should be sustainable in
the long term, robust, realistic and forgiving of mistakes.

The necessary measures and the resulting costs should,
4.1.2
as a matter of principle, be borne by those economic players
who make them necessary by supplying and using GMOs. The
burden on those who wish to produce and consume without
GMOs should be kept to a minimum, and such measures must
not push up their production costs and prices. Nor should they
be borne by the taxpayer.

4.1.3 Measures to prevent the appearance and spread of
GMOs should, as a matter of principle, take place at the stage
where they are least costly and most effective.

4.1.4
GMO cultivation must not be allowed wherever this
would make production of plants of the same or similar types
without genetic manipulation no longer possible or dispropor-
tionately difficult.

4.2 Elaboration of scientific principles and dealing with the current

state of scientific knowledge

4.2.1
Until an adequate scientific basis is established, the
conditions for coexistence must be developed using the precau-
tionary principle, the aim being to prevent changes that are
difficult or impossible to reverse and whose consequences for
coexistence cannot adequately be assessed. Such preventive
action should also include the economic, social and agricultural
aspects of coexistence.

4.2.2
The Commission is called upon to launch a coherent,
interdisciplinary, scientific and practical research programme to
bridge the huge gaps in knowledge about coexistence.

The opinion of the Scientific Committee on Plants (2)
4.2.3
referred to by the Commission in the discussion on GMO
limits in seed is not satisfactory. It fails to answer the question
of what limits are required for labelling to meet the provisions
of Directive 2001/18. Nor does it adequately answer the ques-
tion of which kinds of seed contamination will,
in practice,
lead to which kinds of contamination in the yield and final
product. The Commission should therefore again submit
specific questions to the EFSA Scientific Committee.

(1) DG Agriculture,

‘Economic Impacts of Genetically Modified Crops

on the Agri-Food Sector’ (2000)
http://europa.eu.int/comm/agriculture/publi/gmo/fullrep/index.htm

(2) Opinion of

the Scientific Committee on Plants concerning the

adventitious presence of GM seeds in conventional seeds
http://europa.eu.int/comm/food/fs/sc/scp/out93_gmo_en.pdf

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Furthermore, the scientific and practical studies by the
4.2.4
European Food Safety Agency,
the European Environment
Agency and the Joint Research Centre available at national and
regional level should be summarised and made accessible to the
Member States.

The Committee recommends that

the Commission
4.2.5
join forces with a number of European regions to undertake
practical, large-scale coexistence trials under various conditions.
By cultivating species of maize, rape, potatoes, beet and toma-
toes that are not genetically modified but are quite distinct
from other species, all those involved should test and study the
practical implications of cross-breeding prevention, various safe
distances, the cleaning of machinery, separation during trans-
port, storage and processing and other coexistence measures.

4.3 Precautions and use of the best available technologies in risk

management

Labelling and good professional practice must be
4.3.1
aimed at making it possible to monitor the spread and effects
of GMOs as accurately as possible. It should also facilitate the
fullest possible elimination of a GMO from the environment,
seed and produce.

4.3.2
Under no circumstances should the setting of thresh-
olds for labelling or provisions for good professional practice
impede or render impossible the aims and objectives of Direc-
tive 2001/18 and Regulations 1830/2003 and 1829/2003.

It should therefore be a fundamental requirement that
4.3.3
the best available technology and practice is used in cultivation,
transport, processing, import and export of GMOs.

In this

4.3.4
requirements of
protecting nature and the diversity of Europe's ecosystems
must also be taken into consideration.

the particular

context,

4.4 Obtaining and keeping the information necessary for identifica-

tion and labelling

4.4.1
It should be a fundamental requirement that the iden-
tification of GMOs and their labelling at various stages of
production is carried out as accurately as possible at the begin-
ning of the chain of production and is passed on to subsequent
stages in the chain in as complete a form as possible.

passed on, regardless of any threshold values that may be in
place.

4.4.3
The provision and validation of test procedures and
reference material is the responsibility of the companies and
institutions that want to supply a particular GMO or release it
for the purpose of scientific tests. They also have a duty to
keep these up to date and to make them available to all inter-
ested parties at minimum cost.

Sampling procedures should, especially at the begin-
4.4.4
ning of
they
the production chain, be selected such that
provide the highest possible level of certainty and secure the
maximum possible information. They should therefore be
based on the most reliable technology available, and not on
any threshold limits for labelling that may apply.

4.5 Binding, practicable, verifiable and robust standards for good
professional practice at all stages of production are a key criterion
for coexistence.

They should be set out

4.5.1
they
achieve the goals of coexistence and precaution in the long
term and can be adapted to ongoing developments in science
and technology.

in such a way that

In order to avoid a) damaging the single market in
4.5.2
food and feed and the agricultural order within the Community
and b) distortions in competition, the rules on good profes-
sional practice should, whilst remaining flexible enough to take
account of the various conditions of cultivation and processing,
be set or harmonised at a high (i.e. Community) level.

4.6 The regulations on labelling and purity of seed are crucial

in

guaranteeing coexistence.

4.6.1
Therefore, when setting limits for labelling of GMOs
in seed, the highest technically and practically achievable level
of precision and transparency should be sought. Although the
technically reliable detection threshold in a sample is currently
as low as 0.01 %, in practice the size and number of samples to
be taken mean that a level of 0.1 % of the entire batch of seed
is more realistic.

4.6.2
fied seed must be set at the virtual detection threshold.

The limit for labelling GMOs in non-genetically-modi-

4.4.2
information must be prevented. Once
information has been obtained, this should be documented and

The loss of

The respective seed directives should,

4.6.3
in addition,
contain strict rules (maximum limits) concerning the market-
ability of non-genetically modified seed.

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4.7 Civil liability provisions must fully cover compensation for finan-

cial damages

4.8.3
The Commission is also asked to set out how the extra
costs of coexistence are to be shared out and compensated for
according to the polluter pays principle, and what measures are
necessary in order to reliably prevent any negative impact on
the prices of non-GMO foodstuffs across the single market.

4.7.1
The reproductive capability of GMOs and the fact that
their unwelcome presence can cause financial damage to those
affected makes it necessary to adapt the civil liability provisions
in Member States to ensure that such damages are covered.

4.8.4 When establishing the proportionality of particular
measures, the effects on the whole production chain should be
taken into consideration.

4.7.2
The civil liability provisions should ensure that those
involved are liable only to the extent that they are able to
prevent possible damages. Liability for keeping to good profes-
sional practice and any further expenses of the supplier of a
GMO should rest with the users of that GMO. Conversely, the
liability for damage occurring despite good professional prac-
tice being observed should rest with the supplier. If appro-
priate, the Community rules on legal liability should be adapted
accordingly.

4.9 Recommendations for Community and national legislation

4.9.1
at European level:

The following aspects of coexistence must be regulated

— labelling requirements for the presence of GMOs in non-

genetically-modified seed;

— purity requirements for non-genetically-modified seed with
regard to the adventitious presence of GMOs under the
existing seed directives;

4.7.3
Suppliers or users of GMOs should be able to prove
their ability to cover, whether through insurance or by similar
means, any liability for damages that arise from their activities.

— the requisite targets, results, legal provisions and minimum
standards of good practice in GMO cultivation and the
financing of the costs that arise from complying with them;

4.8 The total costs of coexistence need to be established, kept to a
minimum, and shared in line with the polluter-pays principle.

The Commission is asked to submit a comprehensive
4.8.1
and systematic assessment of the costs involved in coexistence,
the changes to market conditions and the impact on the
various sectors and production patterns in the farming and
food industry, especially on small and medium-sized enter-
prises,
the
traditional craft-based food industry, the organic farming and
food industry and seed production and reproduction busi-
nesses. In particular, this should include the effects on employ-
ment.

including part-time farmers,

traditional

farming,

— and civil liability both for users and suppliers of GMOs for

potential damage connected with co-existence.

4.9.2
at national and regional level:

The following aspects of coexistence must be regulated

— specific measures to prevent undesired cross-breeding and
the transfer of GMOs in line with the conditions obtaining
in each region;

— regional provisions for the cultivation of certain GMOs
where this makes economic sense and is commensurate
with the regional cost-benefit ratio between cultivation and
the precautionary measures required; these provisions may
also include banning the cultivation of certain GMOs;

— measures to protect nature conservation areas in line with
the Directive 92/43 on habitats, flora and fauna (1), Direc-
tive 79/409 on the protection of birds (2), and other ecolo-
gically sensitive areas; and

— measures to safeguard regional economic and cultural inter-

ests.

4.8.2
Beyond that, the Commission should set out what
effects the necessary coexistence measures and the separation
of means of productions and goods flows will have on
achieving the aims of the Common Agricultural Policy and the
reform thereof. Particular attention should be given to the
effects on business structures and on local and regional cultiva-
tion, processing, origin and quality control programmes and
their labelling.

(1) Council Directive 92/43/EEC of 21 May 1992 on the conservation
of natural habitats and of wild fauna and flora, OJ L 206,
22.7.1992, pp. 7-50
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CE-
LEXnumdoc&lg=en&numdoc=31992L0043&model=guicheti

(2) Council Directive 79/409/EEC of 2 April 1979 on the conservation

of wild birds, OJ L 103, 25.4.1979, pp. 1-18.
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CE-
LEXnumdoc&lg=en&numdoc=31979L0409&model=guicheti

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5. Practical and topical aspects of coexistence

stage, must likewise be complied with, and external inspections
carried out.

5.1
In July 2004 the European Economic and Social
Committee invited players from the entire production chain to
a hearing in order to obtain a detailed picture of the current
and likely future situation. The following conclusions, amongst
others, were reached:

5.8
That purity has to be guaranteed up to the 0.1 % detect-
ability threshold in the USA too, where GMOs are grown in
large quantities, and by firms which prepare GMO and non-
GMO seed in the same installations, was convincingly demon-
strated by a leading international seed producer.

5.2
The testing and tracing of GMOs along the whole
production chain will certainly lead to considerable additional
costs. Simple, qualitative tests currently cost between EUR 100
and 150, while the cost of more sophisticated and quantitative
In the process a
tests varies between EUR 250 and 400.
sample is tested for one specific gene sequence only. The
possible presence of a number of different GMOs will mean a
corresponding increase in the cost of testing.

5.9
There are at present no binding practical limit values or
standards for GMO contamination in seed production either
within the EU or internationally. The monitoring of seed in the
Member States is at present subject to different regulations. The
official approach in dealing with contamination (tolerance of
between 0.1 % and 0.5 %) also differs.

5.3
The first case in which a GMO had to be taken out of
circulation on health grounds (Starlink maize in the USA) has
so far cost more than US$ 1 bn. Nevertheless, more than two
years after the start of retrieval operations,
it has still not
proved possible to withdraw the GMO completely from circula-
tion.

5.10
Although seed producers at present categorically refuse
to give a complete guarantee of the GMO-free status of their
in Italy between the Italian
products, direct negotiations
farmers' union Coldiretti and leading seed producers have
resulted in guarantees supervised by third parties. In Austria,
supplying seed that contains GMOs (more than 0.1 % in a test
sample) has been forbidden by a regulation since 2002. Despite
intensive monitoring, no violations of this regulation have been
detected since then.

5.4
The amount and distribution of testing and tracing costs
essentially depend on whether the GMO-free status of certain
products is the generally accepted and maintained standard on
the market, which may be departed from only in exceptional
cases, or whether proof of GMO-free status has to be provided
by producers, processors and traders in every single case.

5.11
The additional costs for seed production and propaga-
tion vary, according to industry estimates, between 10 and
50 %.

5.5
Once a GMO has been placed on the market it is, in
principle, no longer possible to guarantee its complete absence
from other varieties. It is, however, possible to keep the level of
fortuitous and technically unavoidable contamination with the
GMO in question below 0.1 %, which is effectively the
threshold for reliable detection.

5.12
If GMOs are commercially used in a region where
GMO-free seed is propagated, large areas need to be designated
as protected zones for cultivation as is already done in some
countries
crops. Particularly long separation
distances are required for rape cultivation.

for various

5.6
Keeping non-GMO seed free of unintentional mixing
with GMO seed imposes considerable additional demands on
seed production. The lower the threshold,
the higher the
prevention and monitoring costs for seed production and
propagation.

5.13
All market players, with the exception of the seed
producers, see compliance with strict purity rules for seed
(labelling if above the 0.1 % detection threshold) as the decisive
pre-condition for guaranteeing GMO-free products in future.

5.7
Depending on the method of propagation used for the
plant species in question, ensuring GMO-free status will be
possible only by maintaining a considerable physical distance
during cultivation and a complete separation during the proces-
sing, packing and sales processes. ISO standards and HACCP
protocols, which are in some cases still at the development

5.14
Guaranteeing GMO-free status below 0.1 %, as required
by manufacturers of foodstuffs, starch and pet food, already
adds EUR 3 per tonne to the cost of buying up and processing
maize. These costs would rise considerably if there were exten-
sive use of GMOs in agriculture. In addition, the potential cost
of
failure to prevent contamination above the tolerance
threshold varies between EUR 150,000 and 7.5 m, depending
on batch size.

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5.15
The parallel purchase of GMO and GMO-free
commodities at one location appears impracticable. What is
required is complete separation for the purposes of buying,
storage, drying and transport.

5.20
Consumer caution has meant whole areas where GMO
cultivation gives rise to an increased risk of contamination
being effectively boycotted whether or not contamination has
actually occurred. The mere fact that GM wheat was on an
experimental basis in a particular German federal state caused
the largest German milling group to stop buying wheat from
that area.

5.16
Purchasing companies and cooperatives already guar-
antee that their products are GMO-free by contractual agree-
ments with the farmers supplying them. Inter alia, a positive
list of accepted and tested seed varieties is drawn up, and a
continuous monitoring system established from cultivation to
supply and delivery checks.

From the standpoint of

5.17
the purchasing companies,
systems which guarantee GMO-free status below the threshold
currently applied by their customers will work only if there is a
regional separation of GM and non-GM cultivation. The costs
of such management are estimated at EUR 150 to 250 per
hectare. The additional cost of separate transport and storage is
estimated at EUR 10 to 20 per tonne.

5.21
The policy of most of the large retailers and branded
good manufacturers in the EU of guaranteeing that they do not
use GMOs has in the past few years led to the emergence of
extensive quality assurance systems in which individual compa-
nies invest tens of millions of euros annually. These consist of a
comprehensive documentation and audit
the
suppliers, as well as regular spot checks on goods on offer.
These additional costs have usually not been passed on to
customers. No systematic quantification has so far taken place
in relation to individual products and product groups.

system for

5.18
IP (Identity Preservation) and quality assurance systems
also exist at processing plants, such as mills. Their customers at
present
expect purity guarantees between 0.1 % and a
maximum of 0.5 %. Standard PCR (Polymerase chain reaction)
tests and traces are carried out on all deliveries. In addition,
suppliers are audited and proof required that they buy and
process exclusively GMO-free goods. During transport, points
where mingling or contamination could occur, such as road
haulage and port warehouses where GMO goods are handled,
are, wherever possible, avoided.

5.22
From a regional point of view, the requirements for
coexistence of GMO and non-GMO cultivation vary widely.
Particularly in regions with small-scale agriculture, parallel
cultivation within a region appears to be impracticable. For
example, according to Italy's register of farm land, 90 % of
cultivated land in Tuscany is unsuitable for coexistence. The
same applies to many more of Europe's regions. Moreover,
technically demanding separation, monitoring and planning
measures would often be beyond the scope of small and part-
time farmers. This is also true of the small-scale processing of
regional speciality products.

In the case of mills processing maize,

5.19
the cost of
keeping equipment clean is currently estimated at EUR 2.50,
in addition to the extra charges demanded by suppliers (see
above). As these costs can be passed on only in relation to
goods for which a guarantee is required, but are nevertheless
incurred for the entire volume processed they are in some
cases considerably higher for GMO-free end products. For
example, maize meal constitutes only 50 % of the processed
product, i.e. the additional costs (EUR 2.50 plus EUR 3.00 =
EUR 5.50) make a significant difference, at EUR 11 per tonne.
The cost of failing to prevent contamination and of supplying
goods to customers with a GMO content above the guaranteed
threshold could, depending on the batch size and processing,
run into tens of millions of euros. It is not at present possible
to insure against this risk.

5.23
Regional quality marks and guarantees of origin, which
play an ever more important role in the marketing of premium
high-quality products, have up to now not used GMOs. The
introduction of GMOs in the regions in question would have a
massive impact on the actual production costs and image of
these products. This is one reason why may regions of Europe
have declared themselves GMO-free zones, although the legal
basis for this is controversial and requires clarification by Euro-
pean and domestic legislation. The possibility that individual
farmers, as a result of the freedom to cultivate GMOs guaran-
teed by European law, could impose enormous additional costs
and problems on many neighbouring farms and enterprises is
considered extremely regrettable by those affected and a threat
to social stability.

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5.24
A particular source of concern to regional authorities,
farmers' associations and processors is the possibility that
future GMO varieties (for example pharmaceutical varieties)
unlike the existing ones, will have to be hermetically separated
from food and animal feed production for health reasons. This
has already led to massive additional problems and uncertainty
in the USA .

In some Member States legislation regulating coexis-
5.25
tence has been passed, or else the legislative procedure is
almost complete. Legal and procedural systems already differ
widely from country to country. These differences cannot be

explained by regional peculiarities. It is already clear that the
approach adopted to ensuring coexistence will need to be
harmonised.

Coexistence of methods of

5.26
cultivation with and
without GMOs and the possibility of GMO-free food is the EU's
stated political objective. If it appears that this goal cannot be
attained within the existing legal framework, it will be in the
interest of consumers, farmers and the other economic players
involved to amend the relevant regulations and directives in
good time.

Brussels, 16 December 2004

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND

APPENDIX

to the opinion of the European Economic and Social Committee

The following amendments were defeated but obtained at least a quarter of the votes cast:

Point 3.5.10

Delete.

Reason

Given that, in setting thresholds for source material, consideration is given to cross-breeding in adjacent plots and that
the coexistence provisions do take account of unintentional contamination, the fear expressed in this point is unwar-
ranted.

Result of vote

For: 25

Against: 55

Abstentions: 10

Point 4.2.1

Delete.

Reason

When authorising market access for GMOs, consideration is given to all factors that may have an adverse effect on
human and animal heath and to environmental impact. There is no reason at all to bring the precautionary principle
back into play at this juncture. After all, 100 % safety can never be guaranteed and is hardly realistic.

Result of vote

For: 22

Against: 60

Abstentions: 5