MINISTERIO
DE AGRICULTURA, PESCA
Y ALIMENTACIÓN
DIRECCIÓN GENERAL DE
AGRICULTURA
DRAFT OF ROYAL DECREE ....../2004, OF ....... APPROVING THE
REGULATION FOR COEXISTENCE BETWEEN GENETICALLY
MODIFIED CROPS AND CONVENTIONAL OR ORGANIC CROPS
(28 October 2004)
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22
September 2003, on genetically modified food and feed, amends, in article 43 of Chapter
IV, the Directive 2001/18/EC of the European Parliament and of the Council of 12 March
2001 on the deliberate release into the environment of genetically modified organisms
and repealing Council Directive 90/220/ECC. The amendment inserted an article in
Directive 2001/18/EC whereby the Member States may adopt appropriate measures to
prevent the adventitious or technically unavoidable presence of GMO in other products.
Furthermore, it establishes that the Commission will gather and coordinate the
information based on studies, will observe the development of crop coexistence in the
Member States and the grounds of such information and observation, and elaborate
guidelines on coexistence of genetically modified crops with conventional and organic
crops.
Law 9/2003, of 25 April, establishing the juridical regime of confined use, deliberate
release and placing on the market of genetically modified organisms, incorporated to the
Spanish juridical order the rules of Directive 98/81/EC of the Council, of 26 October
1998, amending Directive 90/219/EC on the confined use of genetically modified
organisms, and of Directive 2001/18/EC.
Then, on 23 July 2003, the European Commission approved recommendations on the
Guidelines concerning the elaboration of strategies and best national practices in order to
guarantee the coexistence of genetically modified crops with conventional and organic
agriculture (2003/556/EC). These guidelines offer a list of principles and general aspects
for the elaboration of strategies and best national practices applicable to coexistence,
recommending the Member States to follow these guidelines when elaborating their
coexistence strategies and best national practices. Coexistence refers to the possible
economic effects and repercussions resulting from the mixture of transgenic and nontransgenic crops as well as to the most appropriate management measures that can be
adopted in order to minimize the mixture and at the cost of these measures.
Founded on these provisions, this Royal Decree establishes coexistence rules,
whose non-compliance is subject to the regime of infringements and penalties established
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in Law 9/2003 and to the one established for traceability and labeling in accordance with
Regulation (EC) 1830/2003.
The rules gathered in this Royal Decree are based on the general principles
established in the European Commission Guidelines on coexistence and particularly on
the transparency in information transmission, cooperation of all the actors involved in the
production process and equitable balance between the interests of the farmers of all types
of production.
Moreover, the approval of this Royal Decree plays a significant role in fixing
concrete measures that farmers should apply to prevent the adventitious presence of
GMO in other products, in establishing a clear inspection and follow-up process as well
as supplying and exchanging information and elaborating a register of plots where
genetically modified organisms are cultivated.
Therefore, by proposal of the Ministry of Agriculture, Fisheries and Food, the
prior approval of the Ministry of Public Administrations, in accordance with the State
Council, and the prior deliberation of the Ministers’ Council in the meeting held on
……….
I DECIDE TO:
CHAPTER 1
General provisions
Article 1. Object
The object of this Royal Decree is to regulate the coexistence of genetically
modified crops with conventional and organic crops.
Article 2. Scope of application
The scope of this Royal Decree extends to varieties of all plant species, for which
the European Union has authorized a genetic modification for its cultivation, provided
that its production is conducted though different cultivation types, transgenic,
conventional and organic, and they should coexist.
Article 3. Coexistence
Coexistence refers to the ability of farmers to make a choice in producing
conventional, organic and genetically modified crops, complying with the legal
requirements applicable to the chosen production system.
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CHAPTER II
Coexistence measures and requirements for the farmers
Article 4. Measures to apply in the productive process.
1. The measures that should be applied to allow the coexistence of transgenic crops with
conventional and organic crops possible, could include the following aspects:
a) Preparation for sowing, planting and cultivating the soil
- isolation distances
- buffer zones
- pollen barriers
- appropriate rotation cultivation systems
- control of naturally regenerating plants
- programming the crop production cycle
- reduction of the seed bank by sufficiently working the soil
- use of the varieties with reduced pollen production or with male sterility
- cleaning of the planters before and after its use to avoid seed transfer from
previous operations
- careful seed handling to avoid mixtures, using different packaging and labels and
storing them separately
b) Looking after the plots during harvest and post-harvest
- cleaning of the machinery before and after the harvest
- sharing use of the harvest machinery only with farmers that use the same
production type
- minimize production loss, as it would be for maize grains, during the harvest
c) Transport and storage
- physical separation of crops with genetically modified grains from those not
genetically modified both in transport and storage
d) Cooperation measures between neighboring fields
- information concerning sowing plans
- signing of voluntary agreements between farmers to separate the genetically
modified crop and the non genetically modified crop
- application of coordinated management measures: voluntary gathering of plots of
different fields for the cultivation of similar varieties in a production area, use of
varieties with different flowering periods, program of sowing dates to avoid crosspollination during flowering, coordination of crop rotations.
2. The specific measures for each species or groups of species are provided in Annex II of
this Royal Decree.
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Article 5. Labeling thresholds
This Royal Decree adopts the labeling thresholds, under which it is not necessary to label
as GMO unless this presence is adventitious or technically unavoidable, which are
established in paragraph 2 of article 12, paragraph 2 of article 24 and paragraph 1 of
article 47 of Regulation 1829/2003 of the European Parliament and of the Council, of
September 22, on genetically modified food and feed, unless specific thresholds for other
types of production are established.
Article 6. General obligations of the farmers
In order to allow coexistence between transgenic, conventional and organic crops, the
following general requirements are established:
a) The farmers who introduce a new production type should be responsible for
putting into practice the necessary agricultural management measures in order to
limit the pollen flux and which will be the ones described in Annex II of this
Royal Decree.
b) The farmers who wish to cultivate genetically modified crops in their fields,
should notify their intention to the neighboring farmers and to those that are
located within the isolation distance established in Annex II of this Royal Decree
concerning each one of the crop species for which genetically modified varieties
have been authorized.
c) The farmers should notify the competent body of the corresponding Autonomous
Region, of any problem or difficulty that they find when applying the measures
established in the Royal Decree or any conflict in relation with coexistence.
d) The farmer should keep the labels that appear on the seed packaging, which
indicate that these seeds are genetically modified, and also notify this fact and the
unique identifier allocated to the GMO to the buyer of the product of the harvest,
transmitting him that information in writing.
e) The farmer who has the intention to plant genetically modified crops should
notify the competent body of the corresponding Autonomous Region. This
notification should be made before the farmer plants the plot. This notification
should include the following aspects:
-
Species and variety to use
Plot location and surface where planting will be conducted
Coexistence measures for favoring the coexistence that will be applied
An example of this notification is provided in Annex I.
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f) In any case, the farmers should apply the usual good agricultural practices.
g) The farmer who cultivates genetically modified varieties should use certified
seeds in order to guarantee the purity and the quality of the harvest.
h) The farmer who cultivates genetically modified varieties must fully collaborate in
conducting inspections, controls, sampling and collecting the necessary
information for complying with the Monitoring Plans of these varieties.
Article 7. Requirements for the Companies producing genetically modified seeds
The companies producing genetically modified seeds should supply all the
necessary information in writing to the farmers in order to facilitate the compliance with
the coexistence measures and the rules of traceability and labeling.
Article 8. Training measures
In order to inform the farmers about GM crops, coexistence practices and
traceability and labeling measures, the Public Administrations will promote training and
advice courses for the farmers.
Article 9. Measures established by pact or agreement
1. The voluntary agreements on coexistence conducted between the farmers of a same
geographical area will be preferred to the specific measures established in Annex II of
this Royal Decree, provided that they have previously been notified to the competent
body of the Autonomous Region.
2. Without prejudice to the validity of the agreements, the rules provided in Article 6 of
this Royal Decree shall be complied with.
CHAPTER III
Application system
Article 10. General requirements
Without prejudice to the compliance of the general measures provided in Article
6, the specific measures established in Annex II of this Royal Decree will not apply
when:
a) the plots adjacent to genetically modified, conventional or organic crops are from
different species
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b) when all the crops in the same area are genetically modified
CHAPTER IV
Surveillance and control
Article 11. National Surveillance Plan
1. The competent authority of the Autonomous Regions, within the frame of a National
Surveillance Plan, yearly elaborated by the Ministry of Agriculture, Fisheries and Food,
should inspect at least 5% of the declared plots with genetically modified crops, in line
with the data shown in the model of Annex I. These inspections should be conducted at
least once during the following periods:
a) during the cultivation in order to verify the application of the coexistence rules:
isolation distances, buffer zones, use of certified seed, notification to the
neighbors, good agricultural practices and others.
b) at harvest time in order to verify the appropriate use of the combines (in line
with the coexistence rules of Annex II) and the physical separation of the harvests
with different purposes by using different production systems, from the harvest to
the first point of sale, therefore checking that storage and process are conducted
separately, also avoiding adventitious spillage during transport.
2. The National Surveillance Plan will also include all the controls and analysis that are
considered convenient for the vigilance and assessment of the coexistence rules, both in
crop as well as when the products are placed on the market, paying special attention to
the organic production.
3. The competent authority should verify how the traceability and labeling system works,
as it is established in Regulation (EC) 1830/2003 of the European Parliament and of the
Council, of September 22, 2003, concerning the traceability and labeling of genetically
modified organisms and the traceability of food and feed produced from GMO as well as
in Royal Decree 323/2003, of March 3, amending the general technical Regulation of
control and seed certification, ensuring that farmers keep the labels that appear on the
seed packaging indicating that they are genetically modified, as well as the transmission
of that information and the unique identifier assigned to the GMO to the person to whom
the harvest is being sold.
Within the National Surveillance Plan, a follow-up of the adventitious presence of
genetically modified organisms will be conducted in the crops of neighboring plots
cultivated with genetically modified crops, aiming at verifying the working of the
coexistence measures.
Article 12. Register and Communications
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1.The competent authority will register the data supplied by the farmers in accordance
with the data provided in the example of Annex I and will notify this information to the
Ministry of Agriculture, Fisheries and Food within one month from the reception of the
notifications of the farmers.
2. The competent authority must send to the Ministry of Agriculture, Fisheries and Food,
before December 31 of each year, a copy with all the information collected by the
conducted follow-ups and inspections, as well as the information supplied by the farmers
concerning problems or difficulties in applying coexistence rules or any other related
conflict.
Article 13. Information and reports by the General State Administration.
Corresponds to the General State Administration, through the Ministry of
Agriculture, Fisheries and Food:
1. Elaborate an annual report on the results of the follow-up and assessment works. This
report should gather, among other aspects, the problems that could have occurred
between neighboring farmers, the data that they have obtained on levels of adventitious
or technically unavoidable presence of GMO in non-GMO crops and observations on the
compliance degree of the rules by farmers. This report will be delivered to the European
Commission in accordance with the Recommendation of the Commission concerning the
guidelines for the elaboration of the strategy and best national practices in order to
guarantee the coexistence of genetically modified crops with conventional and organic
agriculture and in Regulation (CE) 1829/2003 modifying Directive 2001/18/CE.
2. Notify the National Biovigilance Commission the relevant information received from
the Autonomous Regions for the compliance of its functions.
Additional unique regulation. Infringements in the commercialization of Genetically
Modified Organisms.
The infringements to the provisions provided in this Royal Decree concerning the
placing on the market, traceability and labeling of genetically modified organisms or
products that contain GMO, referred to by Regulation (EC) 1830/2003 of the European
Parliament and of the Council of September 22 2003 relative to the traceability and the
labeling of genetically modified organisms and the traceability of genetically modified
food and feed, amending Directive (EC) 2001/18 and Law 9/2003 of 25 April,
establishing the judicial regime of the confined use, deliberate release and the placing on
the market of genetically modified organisms, will be penalized in accordance with these
rules as well as their corresponding regulatory development rules.
First final provision. Constitutional basis
MINISTERIO
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This Royal Decree falls, concerning plant varieties, under the scope of article 149.1.9º of
the Constitution, giving the State the exclusive competence concerning legislation on
Intellectual and Industrial Property and of article 149.1.13º, which confers to the State the
basis and coordination of the general planning of the economic activity, and regarding
genetically modified organisms, under the scope of article 149.1.16º and 23º of the
Constitution, conferring to the State the competence on basis and general coordination of
health and basic legislation regarding the protection of the environment, respectively.
Second final provision. Legal entitlements
The Ministry of Agriculture, Fisheries and Food is entitled to modify and approve the
Annexes of the Royal Decree and to establish the National Surveillance Plan referred to
in article 11 of this Royal Decree.
MINISTERIO
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ANNEX 1
NOTIFICATION ON THE CULTIVATION OF GENETICALLY MODIFIED
SPECIES
Owner of the plot Mr/Mrs…………………………………Farmer of the plot. Mr/Mrs………………..
SPECIES
VARIETY
GENETIC
PLOT
PLANTED
APPLIED
MODIFICATION
(LOCATION)
AREA
COEXISTENCE
CONTAINED (1)
(2)
(ha.)
MEASURES (3)
Day/Month/Year …….……………………………, 200…..
NOTES
(1)- Indicate the unique identifier of the genetic modification
(2)- Reference to the SIG PAC number
(3)- Note (indicating A, B, C…) the measures taken to prevent the adventitious or technically
unavoidable presence of genetically modified crops in non-genetically modified crops:
A) Isolation distances
B) Buffer zones
C) Different flowering periods
D) Separation during the sowing
E) Treatment and separation during the harvest
F) Separation during the transport and the storage
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ANNEX II
PART A : MAIZE
SPECIFIC COEXISTENCE
CULTIVATION
RULES
APPLICABLE
TO
MAIZE
Isolation distances
To ensure that the adventitious presence of genetically modified crops in nongenetically modified crops is maintained below the thresholds established by the
community legislation, a 25-meter isolation distance must be established between plots of
maize cultivated with different production systems.
When maize plots cultivated with different production systems are located at a
distance exceeding the established isolation distance, it is not necessary to take additional
measures. If this is not the case, other measures should be applied such as: buffer zones
or different flowering periods.
Buffer zones
When, for any reason, these isolation distances cannot be maintained, buffer
zones should be established, which consist in planting, at least, four lines of conventional
corn to be harvested and mixed with the genetically modified maize and labeled as GMO.
In the case of farmers growing genetically modified crops with resistance to corn
borerrs, to avoid the appearance of resistant insects, a generally recommended practice is
to leave a “refuge”, which consists in an area planted with conventional maize. The size
of the refuge should be at least 20% of the total maize area planted in the plot. This row
of conventional maize can be used as a buffer zone to avoid pollen exchange with
neighboring plots and would be labelled as genetically modified.
Different flowering periods
The competent bodies of the Autonomous Regions may authorize, as an
alternative measure to isolation distances, the programming of the planting dates as to
avoid coincidence of flowering dates.
Sowing
A careful separation of seeds destined to different production systems should be
maintained in order to avoid adventitious mixtures. Planters and other work tools should
be cleaned before and after use, to avoid the spreading of seeds that were used in previous
operations. The planters should only be shared by farmers who use the same production
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system, avoiding, in any case, the adventitious spillage of seeds when traveling from and
to the plot and the field edges.
Harvest
Combine harvesters and other work tools should be cleaned before and after use
in order to avoid the spreading of seeds that were used in previous operations. The
combines can be shared, exclusively, with farmers who use the same production system,
except when, at the end of the harvest of the transgenic varieties, they harvest at least
2.000 m2 of conventional maize and label it as GMO.
Transport and storage
A physical separation of the grains for different purposes, that were produced
using different production systems must be guaranteed from the harvest to the first point
of sale. Therefore, they should be stored and processed separately and avoiding their
adventitious spillage during the transport.