Activities of Elisabetta GARDINI related to 2010/0208(COD)
Plenary speeches (1)
Possibility for the Member States to restrict or prohibit the cultivation of GMOs (A8-0038/2014 - Frédérique Ries) IT
Amendments (42)
Amendment 18 #
Proposal for a regulation - amending act
Recital 2
Recital 2
(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. In accordance with the conclusions of the Environment Council of 4 December 2008, this risk assessment should be enhanced, particularly by taking better account of regional and local circumstances in the context of the assessment by the European Food Safety Authority. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. The same high level of protection of health and the environment should be sought and maintained throughout the territory of the Union.
Amendment 25 #
Proposal for a regulation - amending act
Recital 5
Recital 5
(5) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level. Contrary to iIssues related to the placing on the market and the import of GMOs, which should remain regulated at EUnion level to preserve the internal market, c. Cultivation has been acknowledged as an issue with a strong local/regional dimension. In accordance with Article 2(2) TFEUmight require more flexibility in certain instances as it is an issue with a strong local/regional dimension. However, the common authorisation procedure should not be adversely affected by such flexibility. In accordance with Article 2(2) of the Treaty on the Functioning of the European Union, Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EUnion market, provided that those rules do not adversely affect the free movement and marketing of GMO products and seeds.
Amendment 33 #
Proposal for a regulation - amending act
Recital 6
Recital 6
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products. This freedom granted to Member States should not result in any distortion of competition between farmers in the various Member States.
Amendment 34 #
Proposal for a regulation - amending act
Recital 7
Recital 7
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOGMOs on a case-by-case basis in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. Thi, provided that those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months before the beginning of the growing season. These measures should not imperil the objective of harmonising the legislation of Member States as provided for in Directive 2001/18/EC and Regulation (EC) No 1829/2003. The possibility of adopting these measures should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC. Measures should refer to the cultivation of GMOs only and not to the free circulation and import of genetically modified seeds and plant propagating material, as or in products, and of the products of their harvest. Similarly they should not affect the cultivation of non -genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of EU authorised GMOs are found.
Amendment 39 #
Council position
Recital 2
Recital 2
(2) Under that legal framework, GMOs for cultivation are to undergo an individual risk assessment before being authorised to be placed on the Union market in accordance with Annex II to Directive 2001/18/EC, taking into account the direct, indirect, immediate and delayed effects, as well as the cumulative long- term effects, on human health and the environment. The aim of that authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment, biodiversity and consumer interests, whilst ensuring the effective functioning of the internal market. A uniform high level of protection of health and the environment should be achieved and maintained throughout the territory of the Union.
Amendment 40 #
Proposal for a regulation - amending act
Recital 8
Recital 8
(8) According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the EUnion cannot be revised by a Member State and this situation mustshould not be altered. However, Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOGMOs on a case-by-case basis in all or part of their territory on the basis of scientifically substantiated grounds relating to the public interest other thandifferent from those already addrssessed byin accordance with the harmonised set of EUUnion rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment. A prior impact assessment should be performed to demonstrate the necessity and proportionality of these measures. These grounds must depend on factors associated with the management of risks or with other national policies. Those measures should furthermore be in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation. These measures should also respect the principle of proportionality and the freedom of choice of farmers and consumers. In order to attain the latter objective, the period for which the measures adopted by Member States are to remain in force should be limited to three years, and they should be renewable only on condition that a new impact assessment is performed showing that they are necessary and proportionate. The Commission should assess the need for the establishment of thresholds for labelling GMO traces in conventional seeds at the lowest practicable, proportionate and functional levels for all economic operators.
Amendment 63 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – introductory part
Article 26 b – paragraph 1 – introductory part
Member States may adopt measures on a case-by-case basis restricting or prohibiting the cultivation of all or particularindividual GMOs authorised in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, and consisting of genetically modified varieties placed on the market in accordance with relevant EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that:
Amendment 64 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – introductory part
Article 26 b – paragraph 1 – introductory part
Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs authorised in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, and consisting of genetically modified varieties placed on the market in accordance with relevant EU legislation on the marketing of seed and plant propagating material, on a case-by-case basis, in all or part of their territory, provided that:
Amendment 65 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – introductory part
Article 26 b – paragraph 1 – introductory part
Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs authorised in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, and consisting of genetically modified varieties placed on the market in accordance with relevant EU legislation on the marketing of seed and plant propagating material, on a case-by-case basis in all or part of their territory, provided that:
Amendment 73 #
Council position
Recital 7
Recital 7
(7) In accordance with Article 2(2) TFEU, Member States areshould therefore be entitled to have a possibility, during the authorisation procedure and thereafter, to decide to restrict or prohibit the cultivation of a GMO on their territory with the effect of excluding cultivation of a specific GMO in all or part of that Member State's territory. In that context, it appears appropriate to grant Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMO crops on their territory without affecting the risk assessment provided in the system of Union authorisations of GMOs, either in the course of the authorisation procedure or thereafter, and independently of the measures that Member States are entitled to take by application of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products on their territory and in border areas of neighbouring Member States. The grant of that possibility to Member States should facilitate the decision-making process in the GMO field. At the same time, freedom of choice of consumers, farmers and operators should be preserved whilst providing greater clarity to affected stakeholders concerning the cultivation of GMOs in the Union. This Directive should therefore facilitate the smooth functioning of the internal market by revising the rules governing food labelling.
Amendment 81 #
Council position
Recital 7 a (new)
Recital 7 a (new)
(7a) To ensure that the cultivation of GMOs does not result in the unintended presence of GMOs in other products, effective co-existence measures are needed , which must not, however, run counter to other measures authorised or encouraged subject to certain conditions in a Member State. Member States should therefore be required, under Directive 2001/18/EC, to adopt rules applicable to their territories to avoid such unintended presence. Particular attention should be paid to any possible cross-border contamination from a Member State or a region where cultivation is allowed into a neighbouring Member State or region where it is prohibited. The Commission Recommendation of 13 July 2010 provides guidance to Member States for the development of national co-existence measures, including in border areas.1a __________________ 1aCommission Recommendation of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crop (OJ C 200, 22.7.2010, p. 1).
Amendment 83 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a
Article 26 b – paragraph 1 – point a
(a) those measures are scientifically based on grounds other than those related to the assessmentscientific assessment conducted under Part C of Directive 2001/18/EC of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs. These measures shall be justified on the following grounds relating to national and/or regional policy: (i) protecting crop diversity; (ii) the impossibility of establishing coexistence measures on account of specific geographical conditions (for example very small islands, mountain regions and/or areas of high nature value, or where the national territory is small); (iii) the absence of data on the potential negative impacts of the release of GMOs on the territory or biodiversity of a region;
Amendment 85 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a
Article 26 b – paragraph 1 – point a
(a) those measures are based on grounds other than those legitimate and necessary grounds in the public interest that are duly justified, proportionate, non-discriminatory and unrelated to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs;
Amendment 86 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a a (new)
Article 26 b paragraph 1 – point a a (new)
(aa) those measures ensure that the freedom of choice of farmers and consumers is duly respected; and
Amendment 87 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a a (new)
Article 26 b – paragraph 1 – point a a (new)
(aa) those measures ensure that the freedom of choice of farmers and consumers is duly respected;
Amendment 88 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a b (new)
Article 26 b – paragraph 1 – point a b (new)
(ab) those measures do not entail any distortion of competition between farmers in different Member States;
Amendment 93 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
(ab) those measures pursue an objective that cannot be achieved through the implementation of measures relating to coexistence of genetically modified crops with conventional and organic crops; and
Amendment 94 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a a (new)
Article 26 b – paragraph 1 – point a a (new)
(aa) those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months prior to the start of the growing season;
Amendment 99 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a c (new)
Article 26 b – paragraph 1 – point a c (new)
(ac) those measures have been the subject of a prior impact assessment showing them to be necessary and proportionate;
Amendment 100 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a a (new)
Article 26 b – paragraph 1 – point a a (new)
(aa) those measures are preceded by a full impact assessment carried out by the Commission, assessing their potential effects;
Amendment 104 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point ad (new)
Article 26 b – paragraph 1 – point ad (new)
(ad) those measures are adopted for a maximum of three years, and may where appropriate be renewed following the conclusion of a new impact assessment showing that they are necessary and proportionate;
Amendment 105 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point b
Article 26 b – paragraph 1 – point b
(b) that theyose measures are in conformity with the TreatiesUnion’s international obligations and the Treaties, in particular the proportionality principle.
Amendment 107 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point b
Article 26 b – paragraph 1 – point b
(b) that they are in conformity with the Treaties and the Union's international obligations.
Amendment 107 #
Council position
Recital 10
Recital 10
(10) In addition, and only where the notifier/applicant has refused to adjustWithout prejudice to the possibility of a Member State requesting adjustment of the geographical scope of thea notification/application of a GMO as requested by, a Member State, there should balways have the possibility for that Member State toof acting as risk manager and adopting reasoned measures restricting or prohibiting the cultivation of thata GMO once authorised in all or part of its territory, on the basis of grounds distinct from those assessed according to the harmonized set of Union rules, that is Directive 2001/18/EC and Regulation (EC) No 1829/2003r of groups of GMOs defined by crop or trait or of all GMOs, in all or part of its territory, on the basis of grounds relating to the public interest, which are in conformity with Union law. Those grounds may be related to environmental or agricultural policy objectives, or other compellinglegitimate grounds such as town and country planning, land use, socio- economic impacts, co-existence and public policyhe socio- economic consequences, if these factors are not covered under the harmonized procedure set out in Part C of Directive 2001/18/EC, or the persistence of scientific uncertainty. These measures should be duly justified on the basis of scientific reasons or reasons relating to factors of health, economic, social and ethics that might arise from the deliberate release or placing on the market of GMOs. Those grounds may be invoked individually or in combination, depending on the particular circumstances of the Member State, region or area in which those measures will apply.
Amendment 108 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 2
Article 26 b – paragraph 2
Amendment 109 #
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 2
Article 26 b – paragraph 2
Amendment 112 #
Council position
Recital 11
Recital 11
(11) The level of protection of human or animal health and of the environment chosen in the Union allows for a uniform scientific assessment throughout the Unioncannot be diverged from by a Member State, and this Directivprinciple should not alter that situationbe maintained. Therefore, to avoid any interference with the competences which are granted to the risk assessors and risk managers under Directive 2001/18/EC and Regulation (EC) No 1829/2003, a Member State should only use grounds related toin line with environmental policy objectives which do not conflict withcomplement the assessment of risks to health and the environment which are assessed in the context of the authorisation procedures provided in Directive 2001/18/EC and in Regulation (EC) No 1829/2003, such as the maintenance of certain type of natural and landscape features, certain habitats and ecosystems, as well as specific ecosystem functions and services.
Amendment 116 #
Council position
Recital 11 a (new)
Recital 11 a (new)
(11a) Member States should be allowed to base the measures that restrict or prohibit the cultivation of GMOs on duly justified grounds relating to environmental impacts and respect for traditional agricultural methods, or on grounds relating to risk management. Those grounds may include the prevention of the development of pesticide resistance amongst weeds and pests; the invasiveness or persistence of a genetically modified variety, or the possibility of interbreeding with domestically cultivated or wild plants; the prevention of negative impacts on the local environment caused by changes in agricultural practices linked to the cultivation of GMOs; the maintenance and development of agricultural practices which offer a better potential to reconcile production with ecosystem sustainability; the maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features; the absence or lack of adequate data concerning the potential negative impacts of the release of GMOs on the local or regional environment of a Member State, including on biodiversity.
Amendment 118 #
Council position
Recital 11 b (new)
Recital 11 b (new)
(11b) The grounds relating to socio- economic impacts may include the impracticability or the high costs of coexistence measures or the impossibility of implementing coexistence measures due to specific geographical conditions such as those characterising small islands or mountain zones, the need to protect the diversity of agricultural production or the need to ensure seed purity, the availability of plant propagation materials, as well as the preservation of conventional and organic farming methods.
Amendment 120 #
Council position
Recital 11 c (new)
Recital 11 c (new)
(11c) Member States should be allowed to base measures restricting or prohibiting the cultivation of GMOs also on other grounds that may include land use, town and country planning, or other legitimate factors including those relating to cultural traditions.
Amendment 128 #
Council position
Recital 14
Recital 14
(14) Member States' measures adopted pursuant to this Directive should be subject to a procedure of scrutiny and information at Union level. In light of the level of Union scrutiny and information, it is not necessary to provide, in addition, for the application of Directive 98/34/EC of the European Parliament and of the Council1. Member States may restrict or prohibit the cultivation of a GMO in all or part of their territory as fromprior to the date of entry into force of the Union authorisation and no later than two years after the date whenfor the whole duration of the consent/authorisation is granted, provided that an established standstill period, during which the Commission was given the opportunity to comment on the proposed measures, has elapsed. The Member State concerned must therefore communicate to the Commission the measures proposed at least 75 days before consent is given, so as to give the Commission an opportunity to comment, and during this period should refrain from implementing and adopting these measures. Upon expiry of the standstill period, then such Member State should take measures such as originally proposed or as modified to take into account the comments of the Commission. __________________ 1 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37.).
Amendment 135 #
Council position
Recital 15 a (new)
Recital 15 a (new)
(15a) Given the importance of scientific evidence in taking decisions on the prohibition or approval of GMOs, the Authority and the Member States should make use of accredited public and private research institutions so as to guarantee constant information and regular publication of the results of research regarding the risk or evidence of any accidental presence, contamination or danger to the environment or human health of GMOs.
Amendment 174 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 1
Article 26 b – paragraph 1
1. During the authorisation procedure of a given GMO or during the renewal of consent/authorisation, a Member State may request, viaask the Commission, the notifier/applicant to adjust the geographical scope of its, informing the notificationer/applicantion submitted in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, to the effect that all or part of the territory of that Member State is to be excluded from cultivation. This request shall be motivated by factors such as those indicated in paragraph 3 of this article. This shall be communicated to the Commission at the latest 390 days from the date of the circulation of the assessment report under Article 14(2) of this Directive, or from receiving the opinion of the Authority under Article 6(6) and Article 18(6) of Regulation (EC) No 1829/2003. The Commission shall communicate the request of the Member State to the notifier/applicant and to the other Member States without delay and within no more than 30 days.
Amendment 180 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 2 – subparagraph 1
Article 26 b – paragraph 2 – subparagraph 1
Amendment 196 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 3 – subparagraph 1 – introductory part
Article 26 b – paragraph 3 – subparagraph 1 – introductory part
3. Where the notifier/applicant opposes the adjustment of the geographical scope of its notification/application corresponding to a request made by a Member State in accordance with paragraph 1 of this Article, that Member State may adopt measures restricting or prohibiting the cultivation of that GMO in all oithout prejudice to paragraph 1, a Member State may, further to the risk assessment conducted under this Directive or under Regulation (EC) No 1829/2003, acting as risk manager, adopt measures restricting or prohibiting in all or part of its territory the cultivation of a GMO or a group of GMOs defined by their pvart of its territoryiety or characteristics, or of all GMOs, once authorised in accordance with Part C of this Directive or with Regulation (EC) No 1829/2003, provided that such measures are in conformity with Union law, reasoned, proportional and non- discriminatory and, in addition, are based on compelling grounds such as those related to:
Amendment 207 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 3 – subparagraph 1 – point a
Article 26 b – paragraph 3 – subparagraph 1 – point a
(a) environmental policy objectives distinct from the elements assessed according to this Directive and Regulation (EC) No 1829/2003; relating to environmental impacts which might arise from the cultivation of GMOs and which are complementary to the impacts examined during the scientific risk assessment conducted according to this Directive and Regulation (EC) No 1829/2003; those grounds may include: – the prevention of the development of pesticide resistance amongst weeds and pests; – the invasiveness or persistence of a genetically modified variety, or the possibility of interbreeding with domestically cultivated or wild plants; – the prevention of negative impacts on the local environment caused by changes in agricultural practices linked to the cultivation of GMOs; – the maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features, as well as specific ecosystem functions and services; – the absence or lack of adequate data concerning the potential negative impacts of the release of GMOs on the local or regional environment of a Member State, including on biodiversity; – the protection of bees.
Amendment 213 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 3 – subparagraph 1 – point d
Article 26 b – paragraph 3 – subparagraph 1 – point d
(d) socio-economic impacts such as the impracticability or the high costs of coexistence measures or the impossibility of implementing coexistence measures due to specific geographical conditions such as in the case of small islands or mountain zones;
Amendment 217 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b – paragraph 3 – subparagraph 1 – point e
Article 26 b – paragraph 3 – subparagraph 1 – point e
(e) avoidance of GMO presence in other products without prejudice to Article 26a;
Amendment 221 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
(f) agricultural policy objectives; those grounds may include: – the need to protect the diversity of agricultural production; – the maintenance and development of agricultural practices which offer a better potential to reconcile production with ecosystem sustainability; – the need to ensure seed purity.
Amendment 241 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Those grounds may be invoked individually or in combination, with the exception of the ground set out in point (g) which cannot be used individually, depending on the particular circumstances of the Member State, region or area in which those measures will apply, but shall, in no case, conflict with the environmental risk assessment carried out pursuant to this Directive or to Regulation (EC) No 1829/2003.
Amendment 287 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 b a (new)
Article 26 b a (new)
Article 26ba Liability requirements and financial guarantees Member States shall establish a general mandatory system of financial liability and insurance guarantees which applies to all operators and which ensures that the polluter pays for effects or damage, which may be unintended, that might occur due to the deliberate release or the placing on the market of GMOs
Amendment 294 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
Directive 2001/18/EC
Article 26 c – paragraph 2
Article 26 c – paragraph 2
2. Where the application is pending and the notifier/applicant has explicitly or tacitly agreed to such a request within 30 days from the communication of that request, the geographical scope ofCommission has accepted the request of the Member State, duly communicating it to the notificationer/application shall be adjusted accordingly. The written consent issued under this Directive and, where applicable, the decision issued in accordance with Article 19 as well as the decision of authorisation adopted under Articles 7 and 19 of Regulation (EC) No 1829/2003 shall be issued on the basis of the adjusted geographical scope of the notification/application as explicitly or tacitly agreed by the notifier/applicantnt, to adjust the geographical scope, the effects of that adjustment shall be produced before the entry into force of the written consent issued under this Directive.