CELEX: 52013PC0758
Language: en
Date: 2013-11-06
Title: Proposal for a COUNCIL DECISION concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests

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		52013PC0758
		
			Proposal for a COUNCIL DECISION concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests /* COM/2013/0758 final - 2013/0368 (NLE) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
The attached proposal for a Council
Decision concerns the authorisation of genetically modified 1507 maize, for
which a request for the placing on the market of seeds for cultivation was
submitted by Pioneer Hi-Bred International, Inc. and Mycogen Seeds to the
competent authority of Spain in 2001, under Directive 2001/18/EC on the
deliberate release into the environment of GMOs.
In accordance with the procedure under
Article 14 of Directive 2001/18/EC, the competent authority of Spain prepared
an assessment report, which concluded that there is no scientific evidence to
indicate that the placing on the market of the Zea mays L. line 1507
poses any risk to human and animal health or the environment for the requested
uses.
The assessment report was submitted in
August 2003 to the Commission and the competent authorities of the other Member
States, some of which raised and maintained objections to the placing on the
market of the product.
The opinion of EFSA, adopted on 19 January
2005, concluded that Zea mays L. line 1507 is unlikely to have an
adverse effect on human and animal health or the environment in the context of
its proposed use. 
The Commission convened a technical meeting
with national competent authorities on 19 June 2006, to address the
remaining objections of Member States in view of the EFSA opinion and
subsequently requested EFSA to complement its opinion on 1507 maize by
providing more specific information concerning the lepidopteran species
referred to in the EFSA opinion of 19 January 2005. EFSA was also asked to
recommend whether more precise risk management measures, notably monitoring
plans, should be implemented. EFSA adopted the annex complementing its opinion
on non-target organisms on 7 November 2006 (published 21 November 2006).
After the publication of the above annex, the Commission requested EFSA on 24
July 2008 to review eleven scientific studies, published after the adoption of
the EFSA opinion of 19 January 2005, as well as any other relevant study, and to
confirm its risk assessment of 1507 maize.
On 29 October 2008 EFSA adopted its opinion
which concluded that these publications do not provide new information that
would change previous risk assessments conducted on 1507 maize. Having also
considered other recent scientific publications, EFSA reaffirmed its previous
conclusions on the environmental safety of 1507 maize.
Against this background, a draft Commission
Decision to place the product on the market, in accordance with Article 18
of Directive 2001/18/EC, was presented to the Regulatory Committee for vote on
25 February 2009. The Committee delivered no opinion: 6 Member States (91
votes) voted in favour, 12 Member States (127 votes) voted against, 7 Member
States (95 votes) abstained and 2 Member States (32 votes) were not
represented. 
Following a request of the Commission on 14
June 2010 to consider whether new scientific elements might require a revision
of the conclusions of its scientific opinion adopted on 19 January 2005,
EFSA adopted on 19 October 2011 a Scientific Opinion updating the evaluation of
the environmental risk assessment and risk management recommendations on insect
resistant genetically modified maize 1507 for cultivation. The EFSA GMO Panel
concludes that, subject to appropriate management measures, maize 1507
cultivation is unlikely to raise safety concerns for the environment. In
addition, on 18 October 2012, EFSA adopted a Scientific Opinion supplementing
the 2011 opinion and providing with additional evidence and further clarifications.

Following a further request of the
Commission on 20 June 2012 for a consolidated opinion, EFSA adopted on 18
October 2012 a Scientific Opinion updating the risk assessment conclusions and
risk management recommendations on the genetically modified insect resistant
maize 1507. The GMO EFSA Panel did not identify new scientific publications
reporting new information that would invalidate its previous conclusions on the
safety of maize 1507.
On 26 September 2013, the General Court of
the European Union delivered its Judgement on the case T-164/10, Pioneer
Hi-Bred International v. European Commission, and declared that "the
European Commission has failed to fulfil its obligations under Article 18 of
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/EEC by failing to submit to
the Council a proposal relating to the measures to be taken pursuant to Article
5(4) of Council Decision of 28 June 1999 laying down the procedures for the
exercise of implementing powers conferred on the Commission".
Consequently, pursuant to Article 30(2) of
Directive 2001/18/EC and Article 5 of Council Decision 1999/468/EC, the Commission
is required to submit to the Council a proposal relating to the measures to be
taken, the Council having three months in which to act by a qualified majority,
and inform the Parliament.
2013/0368 (NLE)
Proposal for a
COUNCIL DECISION
concerning the placing on the market for
cultivation, in accordance with Directive 2001/18/EC of the European Parliament
and of the Council, of a maize product (Zea mays L., line 1507)
genetically modified for resistance to certain lepidopteran pests
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union,
Having regard to 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/EEC[1],
and in particular the first subparagraph of Article 18(1) thereof,
Having regard to the proposal from the
Commission,
After consulting the European Food Safety
Authority (hereinafter, EFSA),
Whereas:
(1)       Pursuant to Directive
2001/18/EC, the placing on the market of a product containing or consisting of
a genetically modified organism or a combination of genetically modified
organisms is subject to written consent being granted by the competent
authority of the Member State that received the notification for the placing on
the market of that product, in accordance with the procedure laid down in that
Directive.
(2)       A notification (Reference
C/ES/01/01) concerning the placing on the market of a genetically modified
maize product (Zea mays L., line 1507, hereinafter also "1507
maize") was submitted in 2001 by Pioneer Hi-Bred International, Inc. and
Mycogen Seeds to the competent authority of Spain.
(3)       The notification covers the
placing on the market of seeds of varieties derived from the Zea mays L.,
line 1507 for cultivation in the Union. The scope of the notification, as
confirmed by the consent-holder on 23 February 2007, does not cover the
commercial use of the product as a plant tolerant to glufosinate in the Union, since the pat gene for glufosinate tolerance was only to be used as a marker
gene. In addition, the conditions of approval of the active substance
glufosinate have been restricted to uses as herbicide for band or spot
application by Commission Implementing Regulation (EU) No 365/2013[2] amending Implementing
Regulation (EU) No 540/2011 as regards the conditions of approval of the active
substance glufosinate. Therefore broadcast applications on maize fields cannot
be authorised.
(4)       In accordance with the
procedure under Article 14 of Directive 2001/18/EC, the competent authority of
Spain prepared an assessment report, which concluded that there is no
scientific evidence to indicate that the placing on the market of the Zea
mays L. line 1507 poses any risk to human and animal health or the
environment for the requested uses.
(5)       The assessment report was
submitted in August 2003 to the Commission and the competent authorities of the
other Member States, some of which raised and maintained objections to the
placing on the market of the product.
(6)       The opinion of EFSA,
adopted on 19 January 2005[3],
concluded that Zea mays L. line 1507 is unlikely to have an adverse
effect on human and animal health or the environment in the context of its
proposed use. 
(7)       The Commission convened a
technical meeting with national competent authorities on 19 June 2006, to
address the remaining objections of Member States in view of the EFSA opinion;
certain Member States raised their concerns relating to the risk assessment of
the product and requested a better explanation of the potential effects of the
Bt toxin on non-target organisms and their monitoring. 
(8)       The Commission
subsequently requested EFSA to complement its opinion on Zea mays L.
line 1507 by providing more specific information concerning the lepidopteran
species referred to in the EFSA opinion of 19 January 2005; EFSA was also asked
to recommend whether more precise risk management measures, notably monitoring
plans, including specific scientific research studies on non-target organisms
and taking account of geographical regions, should be implemented. EFSA adopted
the annex complementing its opinion on non-target organisms on 7 November 2006
(published 21 November 2006). After the publication of the above annex,
eleven scientific studies, published after the adoption of the EFSA opinion of
19 January 2005, came to the attention of the Commission. Therefore the
Commission requested EFSA on 24 July 2008 to review these studies, as well
as any other relevant study, and confirm its risk assessment of 1507 maize or
comment on whether these studies would lead EFSA to alter its conclusions or
refine them.
(9)       On 29 October 2008 EFSA
adopted its opinion which concluded that these publications do not provide new
information that would change previous risk assessments conducted on maize
1507. Having also considered other recent scientific publications, EFSA
reaffirmed its previous conclusions on the environmental safety of maize 1507.
(10)     Following a request of the
Commission to consider whether new scientific elements might require a revision
of its scientific opinion of 19 January 2005, EFSA adopted on 19 October 2011[4] a Scientific Opinion updating
the evaluation of the environmental risk assessment and risk management
recommendations on insect resistant genetically modified maize 1507 for
cultivation. The EFSA GMO Panel concludes that, subject to appropriate
management measures, maize 1507 cultivation is unlikely to raise safety concerns
for the environment. In addition, on 18 October 2012, EFSA adopted a Scientific
Opinion[5]
supplementing the 2011 opinion and providing with additional evidence and
further clarifications. 
(11)     Following a further request
of the Commission for a consolidated opinion, EFSA adopted on 18 October 2012[6] a Scientific Opinion updating
the risk assessment conclusions and risk management recommendations on the
genetically modified insect resistant maize 1507. The GMO EFSA Panel did not
identify new scientific publications reporting new information that would
invalidate its previous conclusions on the safety of maize 1507. 
(12)     An examination of each of
the Member State objections in the light of (i) Directive 2001/18/EC, (ii) the
information submitted in the notification and (iii) the opinions of EFSA,
discloses no evidence to indicate that the placing on the market of Zea mays
L. line 1507 is likely to cause adverse effects on human and animal health or
the environment in the context of its proposed use.
(13)     Zea mays L., line
1507 has been approved for feed use under Directive 2001/18/EC in accordance
with Commission Decision 2005/772/EC[7]
and for food use under Regulation (EC) No 1829/2003 in accordance with
Commission Decision 2006/197/EC[8].
(14)     A unique identifier has
been assigned to the Zea mays L., line 1507 for the purposes of
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of
22 September 2003 concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed products produced from
genetically modified organisms and amending Directive 2001/18/EC[9] and 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[10].
(15)     Prior to the placing on the
market of the Zea mays L., line 1507, the necessary measures to ensure
its labelling and traceability at all stages of its placing on the market,
including verification by appropriate validated detection methodology, should
be applied. A detection method for the Zea mays L., line 1507 has been
validated by the European Union Reference Laboratory as referred to in the
Annex of Regulation (EC) No 1829/2003, in accordance with Commission Regulation
(EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No
1829/2003[11].

(16)     For the purpose of
appropriate information for operators and consumers, and to facilitate better
management practices, the label, or an accompanying document, should also
indicate that the product protects itself against the European corn borer (Ostrinia
nubilalis), pink borers (Sesamia spp.), fall armyworms (Spodoptera
frugiperda), black cutworms (Agrotis ipsilon) and south-western corn
borers (Diatraea grandiosella). 
(17)     As EFSA indicated in its
opinion of 19 January 2005, "the only adverse effect identified was the
possibility that resistance to Bt toxin might evolve in corn borers exposed to
1507 maize following cultivation for some years. The Panel accepts the
monitoring plan developed by the applicant to monitor specifically for
resistance in corn borers and recommends that cultivation should be accompanied
by appropriate risk management strategies to minimise exposure of both target
and non-target insects to Bt toxins". Therefore the consent holder should
carry out monitoring and provide instruction to farmers in order to ensure the
implementation by them of required measures, such as the planting of refuge
maize and monitoring, to minimise development of resistance in target pests and
to assist farmers in cultivating Zea mays L., line 1507. 
(18)     In accordance with the EFSA
Opinion of 19 January 2005, "(..) management recommendations for the
cultivation of 1507-maize, as given by the applicant to users of 1507 maize,
considers measures to reduce exposure of non-target lepidoptera (as well as the
target pest), such as the use of non-transgenic border rows as refugia for the
target that would also reduce exposure of field margin weeds (and hence non-target
lepidoptera) to pollen from Bt maize". 
(19)     The refugia strategy should
take into account further recommendations of EFSA in its opinions of 19 October
2011 and 18 October 2012. In particular, EFSA advises in its opinion of 2011
that "In the case of a cluster of fields with an aggregate area greater
than 5 ha of Bt-maize, there shall be refugia equivalent to 20% of this
aggregate area, irrespective of individual field and farm size". In its
updating opinion of 2012, EFSA recommends that "in regions where maize
1507 and Cry1Ab-expressing maize events would be cultivated together, refuge
areas equivalent to 20% of the total Lepidoptera-active Bt-maize area are
established due to the potential for cross-resistance between Cry1Ab and
Cry1F". EFSA further recommends in its Supplementing opinion of 2012 that
"If a maize 1507 field has margins, then sown strips of non-Bt-maize,
placed between the edges of the Bt-maize crop and each margin, are considerably
more effective as a mitigation measure at reducing expected mortality than a
single block of non-Bt-maize of comparable area, wherever the latter is
planted". 
(20)     For the purpose of best
possible handling and use of the product, the consent holder should distribute
with each bag of seeds to the operators a leaflet detailing information about
the product and practices for its use.
(21)     Monitoring should be
conducted in accordance with Article 20(1) of Directive 2001/18/EC, the
monitoring plan and revisions submitted by the notifier including commitments made
in response to requests from competent authorities, and the opinions of EFSA. 
(22)     It is appropriate to
provide for post-marketing surveillance measures to address unanticipated
effects of maize lines expressing Bt proteins on non-target organisms in
particular.
(23)     As indicated in the
notification, the consent holder should undertake a monitoring study of
unanticipated potential adverse effects on non-target organisms from
cultivation of 1507 maize and report the outcome of this study to the rapporteur
competent authority and the European Commission; the consent holder should also
report to the competent authorities of the other Member States.
(24)     The Committee established
under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within
the time-limit laid down by its Chairman;
HAS ADOPTED THIS DECISION: 
Article 1
Consent
1.           Without prejudice to other Union
legislation, in particular Directive 2002/53/EC, written consent shall be
granted by the competent authority of Spain to the placing on the market for
cultivation, in accordance with this Decision, of the product identified in
Article 2, as notified (Reference C/ES/01/01) by Pioneer Hi-Bred International,
Inc. and Mycogen Seeds.
2.           The consent shall, in accordance
with Article 19(3) of Directive 2001/18/EC, explicitly specify the conditions
to which the consent is subject, including any specific condition of use,
handling and packaging of the GMO(s) as or in products, and conditions for the
protection of particular ecosystems/environments and/or geographical areas,
which are set out in Articles 3 (conditions for placing on the market) and 4
(monitoring). 
Article 2
Product
1.           The genetically modified
organisms to be placed on the market as or in products, hereinafter ‘the
product’, are seeds of maize (Zea mays L., line 1507), with resistance
to the European corn borer (Ostrinia nubilalis) and certain other
lepidopteran pests and with tolerance to the herbicide glufosinate-ammonium,
derived from Zea mays L., line 1507, which has been transformed
using particle acceleration technology with the linear DNA fragment PHI8999A
containing the following DNA in two expression cassettes:
(a)     Cassette 1:
A synthetic version of the truncated cry1F
gene derived from Bacillus thuringiensis subsp. aizawai, which
confers resistance to the European corn borer (Ostrinia nubilalis) and
certain other lepidopteran pests such as the pink borer (Sesamia spp.),
fall armyworm (Spodoptera frugiperda), black cutworm (Agrotis ipsilon)
and south-western corn borer (Diatraea grandiosella), under the
regulation of the ubiquitin promoter ubiZM1(2) derived from Zea mays
and the ORF25PolyA terminator from Agrobacterium tumefaciens pTi15995;
(b)     Cassette 2:
A synthetic version of the pat gene
derived from Streptomyces viridochromogenes strain Tü494, which confers
tolerance to the herbicide glufosinate-ammonium, under the regulation of the
CaMV 35S promoter and terminator sequences.
2.           The consent shall cover seeds
from genetically modified progeny derived from crosses of Zea mays L.,
line 1507 with any traditionally bred maize as or in products. 
Article 3
Conditions for placing on the market
The product
may be placed on the market subject to the following conditions:
(a)          In
accordance with Article 15(4) of Directive 2001/18/EC, the period of validity
of the consent shall be 10 years starting from the date at which the consent
for Zea mays L., line 1507 is issued;
(b)          the unique identifier of the
product shall be DAS-Ø15Ø7-1;
(c)          without prejudice to Article 25
of Directive 2001/18/EC, the consent holder shall make available positive and
negative control samples of the product and its genetic materials to the
competent authorities of Member States as well as to the National Reference Laboratories
in charge of official controls on request; the consent holder shall announce
where the reference material[12]
can be accessed; 
(d)          the detection method specific to Zea
mays L., line 1507, as validated by the European Union reference laboratory
as referred to in the Annex of Regulation (EC) No 1829/2003 shall be used for
the purpose of inspection and control;
(e)          the words ‘This product contains
genetically modified organisms’ or ‘This product contains genetically modified
1507 maize’ shall appear either on a label or in a document accompanying the
product, except where other Union legislation sets a threshold below which such
information is not required; 
(f)           it shall also be indicated on
the label, or in an accompanying document for non-pre-packaged products, that the
product protects itself against the European corn borer (Ostrinia nubilalis),
pink borers (Sesamia spp.), fall armyworm (Spodoptera frugiperda),
black cutworm (Agrotis ipsilon) and south-western corn borer (Diatraea
grandiosella); 
(g)          the practices of the insect
resistance management plan as contained in the notification shall be applied to
minimise development of resistance in target pests and exposure of non-target
insects to Bt-toxins and shall be modified to comply with the following
provisions: 
–              
the 20% refuge area shall be calculated in
proportion to the total Lepidoptera-active Bt-maize area;
–              
the 20% refuge area shall also be applied in the
case of a cluster of fields of Lepidoptera-active Bt-maize with an aggregate
area greater than 5 ha, irrespective of individual field and farm size.
The practices of the insect resistance
management plan shall include the recommendation to plant refuge maize in
border rows along field margins where present.
(h)          the consent holder shall provide
instruction to farmers in order to ensure the implementation by them of
required measures including, where appropriate, the planting of refuge maize in
border rows, and monitoring, to minimise development of resistance in target
pests and exposure of non-target insects to Bt-toxins, and to assist farmers in
cultivating Zea mays L., line 1507; 
(i)           for the purpose of best possible
handling and use of the product, the consent holder shall distribute with each
bag of seeds to the operators a leaflet detailing information about the product
and practices for its use, including the requirements indicated in
paragraph (h). The content of this leaflet is listed in Annex II.
Article 4
Monitoring by the consent holder
1.           The consent holder shall ensure
that the monitoring plan with regard to cultivation contained in the
notification is modified in accordance with Annex I and that through the period
of validity of the consent it is put in place and implemented. The consent
shall be granted only after the monitoring plan is modified and consolidated in
accordance with the provisions of this Decision. The consolidated monitoring
plan shall be made available on the website of the European Commission after
consultation with the Member States (web link to the consolidated monitoring
plan to be added). 
2.           The consent holder shall directly
inform the operators and users of the introduction of Zea mays L., line
1507 into the Union as well as of the safety and general characteristics of the
product and of the conditions for monitoring.
3.           The following obligations are laid
down for the consent holder:
(a)     The consent-holder shall undertake
case-specific monitoring of the possible development of resistance in target
species through exposure to the CRY1F protein in accordance with the insect
resistance management plan contained in the monitoring plan, and taking account
of Annex I in order to:
(i)      Measure the baseline susceptibility
of target pests to CRY1F protein;
(ii)      Detect changes relative to baseline
susceptibility that cause inadequate field protection against target pests.
(b)     The consent holder shall undertake
general surveillance and establish a general surveillance network through use
of farmer questionnaires and taking account of the additional measures referred
to in Annex I. The consent holder shall continue to develop the content and
format of the questionnaire. 
(c)     In addition, the consent holder shall
undertake a case-specific study on potential adverse effects on non-target
organisms from cultivation of 1507 maize and report the outcome of this study
to the rapporteur Competent Authority, the competent authorities of the other Member States and the European Commission. 
(d)     Without prejudice to Article 20 of
Directive 2001/18/EC, the monitoring plan shall, where appropriate and subject
to the agreement of the Commission and the competent authority of the Member
State which received the original notification, be revised in line with the
results of the monitoring activities by the consent holder, and/or by the
competent authority of the Member State which received the original
notification. Revised monitoring plans shall be submitted by the competent
authority to the Commission and the competent authorities of the other Member
States. 
4.           The
consent holder shall be in the position to give evidence to the Commission and
the competent authorities of the Member States:
(a)     that
the networks for monitoring of resistance and general surveillance will gather
the information necessary for the monitoring and surveillance of the products;
and
(b)     on the time schedule for receipt of
the above information by the consent holder and its transmission to the
Commission and the competent authorities of the Member States.
5.           The consent holder shall submit
to the Commission and to the competent authorities of the Member States annual
reports on the results of all monitoring activities, including general
surveillance. The presentation of these reports shall be made in accordance
with the Standard Reporting Format established by Commission Decision 2009/770/EC[13] of 13 October 2009 establishing
standard reporting formats for presenting the monitoring results of the
deliberate release into the environment of genetically modified organisms, as
or in products, for the purpose of placing on the market, pursuant to Directive
2001/18/EC of the European Parliament and of the Council.
Article 5
Addressee
This
Decision is addressed to the Kingdom of Spain.
Done at Brussels,
                                                                       For
the Council
                                                                       The
President
ANNEX I
Monitoring
by the consent holder
1.           In the context of Article 4(3)(a)
on case-specific monitoring, the consent holder shall increase the frequency of
monitoring activities as appropriate, taking account of the rate at which
potential resistance to the CRY1F protein is likely to evolve the resistance
management strategy as well as the scale and the geographical dispersal of Zea
mays L., line 1507, and shall revise the sampling protocol to detect
resistance alleles frequency between 1% to 3%.
2.           The consent holder shall carry
out general surveillance of unanticipated potential effects on non-target
insects in particular (including parasitoids), taking into account the
possibility of both direct and indirect effects on those and other non-target
organisms including other arthropods. 
3.           The consent holder shall also:
(a)     assist in insect collections for
relevant analyses in the context of general surveillance;
(b)     encourage growers to report any
observed adverse effects (including on non-target insects or derived from
changes in conventional agricultural practices);
(c)     participate in monitoring programmes
developed by the EU Competent Authorities or other relevant national
authorities appropriate to 1507 maize.
4.           The farmer questionnaire referred
to in Article 4, paragraph 3(b) shall include the following elements in line
with EFSA opinions: 
(a)     a request to the farmer to provide
factual information as opposed to only comments as to possible observed
differences; 
(b)     a request to the farmer to provide
data on fertilizer usage, soil fertility, crop rotations, crop performance,
crop yield, pests and diseases, pesticide use, weed abundance and on regionally
occurring lepidopteran pests other than corn borers; 
(c)     a particular focus on sites where Zea
mays L., line 1507 is a significant proportion of the maize being grown and
on years following cultivation. The selection of farms shall be done
independently of the size of Bt-maize cultivation. In addition, the sampling
strategy shall ensure that 2500 farmer questionnaires are collected over the
period of cultivation to achieve an acceptable statistical power;
(d)     a structure designed to elicit
detailed information. The questions should be presented in a way that the
respondent can choose from a selection of answers;
(e)     an additional field for free answers
or comments following the pre-formulated answers to allow comments on other
factors not covered specifically in the questionnaire;
(f)      the standard procedures of univariate
or multivariate and cumulative analysis of the questionnaire’s key variables to
be analysed by the consent-holder should be described precisely;
(g)     questions regarding the occurrence of
beneficial insects and other wildlife.
5.           The consent holder shall ensure
that the general surveillance network involves all necessary existing
surveillance systems and any new surveillance systems required in addition to
that established through the farmer questionnaire. The consent holder shall
consult networks involved in relevant biodiversity surveys at local, national
and Union level.
6.           The monitoring plan shall
include: observation parameters; survey methods, location and frequency;
timetable for inspections; description and details of representativeness of the
receiving environment; reference areas; relevant agreements with third parties;
adaptation of the plan to regional conditions. 
ANNEX II
Content
of the leaflet for operators
Throughout the period of validity of the
consent, the consent holder, when placing seeds from varieties derived from the
Zea mays L., line 1507 on the market in a Member State, shall, based on
the conditions for placing on the market set out in Article 3, distribute
a leaflet with each bag of seeds of the Zea mays L., line 1507
indicating the following:
(a)          General description of the
product, including general characteristics of and safety requirements for
varieties derived from the Zea mays L., line 1507, and the unique
identifier assigned to the GMO;
(b)          Mention of the requirement that
the transmission of seed from varieties derived from the Zea mays L.,
line 1507, between operators be recorded by the operators, and that written
information regarding the product must be provided as established by
Article 4 of Regulation (EC) No 1830/2003; 
(c)          Design and management of the
planting, including guidance to the operators to design refuges;
(d)          An indication of the applicable
national legislation on the cultivation of GMOs, including legislation on
co-existence between GM maize crops and non-GM maize crops where applicable and
its detailed provisions as regards treatment of equipment and product material,
notification requirements if applicable, and distances or buffer zones where
relevant, among others, and reminder of the basic obligations for the
cultivation and use of the product at national and Union level;
(e)          Monitoring requirements according
to the insect resistance management plan, and reference to the farmer
questionnaire.
[1]               OJ L 106, 17.4.2001, p.
1.
[2]               OJ L 111, 23.4.2013, p.27.
[3]               The EFSA Journal (2005) 181, 1-33.
[4]               The EFSA Journal (2011),
9(11):2429.
[5]               The EFSA Journal (2012),
10(11):2934.
[6]               The EFSA Journal (2012),
10(10):2933.
[7]               OJ L 291, 5.11.2005, p. 42.
[8]               OJ L 70, 9.3.2006, p. 82.
[9]               OJ L 268, 18.10.2003, p. 24.
[10]             OJ L 10, 16.1.2004, p. 5.
[11]             OJ L 102, 7.4.2004, p. 14.
[12]             Reference Material: ERM®-BF418 accessible via the Joint
Research Centre (JRC) of the European Commission, the Institute for Reference
Materials and Measurements (IRMM) at      
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
[13]             OJ L 275, 21.10.2009, p. 9.