### this directive shall apply to every trade mark in respect of goods or services which is the subject of registration or of an application in a member state for registration as an individual trade mark , a collective mark or a guarantee or certification mark , or which is the subject of a registration or an application for registration in the benelux office for intellectual property or of an international registration having effect in a member state . ### this directive shall apply to every trade mark in respect of goods or services which is the subject of registration or of an application for registration in a member state as an individual trade mark , a collective mark or a guarantee or certification mark , or which is the subject of a registration or an application for registration in the benelux office for intellectual property or of an international registration having effect in a member state .


### distinguishing the goods or services of one undertaking from those of other undertakings ; ### distinguishing the goods or services of one undertaking from those of other undertakings ; and


### if it is identical with , or similar to , an earlier trade mark irrespective of whether the goods or services for which it is applied or registered are identical with , similar to or not similar to those for which the earlier trade mark is registered , where the earlier trade mark has a reputation in a member state or , in case of a european trade mark , has a reputation in the union and the use of the later trade mark without due cause would take unfair advantage of , or be detrimental to , the distinctive character or the repute of the earlier trade mark ; ### if it is identical with , or similar to , an earlier trade mark irrespective of whether the goods or services for which it is applied or registered are identical with , similar to or not similar to those for which the earlier trade mark is registered , where the earlier trade mark has a reputation in the member state in respect of which registration is applied for or in which the trade mark is registered or , in the case of a european union trade mark , has a reputation in the union and the use of the later trade mark without due cause would take unfair advantage of , or be detrimental to , the distinctive character or the repute of the earlier trade mark ;


### the member states may permit that in appropriate circumstances registration need not be refused or the trade mark need not be declared invalid where the proprietor of the earlier trade mark or other earlier right consents to the registration of the later trade mark . ### the member states shall permit that in appropriate circumstances registration need not be refused or the trade mark need not be declared invalid where the proprietor of the earlier trade mark or other earlier right consents to the registration of the later trade mark .


### where the application for a declaration of invalidity is based on article 5 and the earlier trade mark did not have a reputation within the meaning of article 5 at the filing date or the priority date of the registered trade mark . ### where the application for a declaration of invalidity is based on point of article 5 and the earlier trade mark did not have a reputation within the meaning of point of article 5 at the filing date or the priority date of the registered trade mark .


### where , in a member state , the proprietor of an earlier trade mark as referred to in article 5 and has acquiesced , for a period of five successive years , in the use of a later trade mark registered in that member state while being aware of such use , he shall no longer be entitled on the basis of the earlier trade mark to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used , unless registration of the later trade mark was applied for in bad faith . ### where , in a member state , the proprietor of an earlier trade mark as referred to in article 5 and point of article 5 has acquiesced , for a period of five successive years , in the use of a later trade mark registered in that member state while being aware of such use , he shall no longer be entitled on the basis of the earlier trade mark to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used , unless registration of the later trade mark was applied for in bad faith .


### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from third countries and bear without authorization a trade mark which is identical to the trade mark registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark . ### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from a third country and bear without authorisation a trade mark which is identical to the trade mark validly registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark , on condition that the proprietor proves that the trade mark is also validly registered in the country of destination .


### affixing in the course of trade a sign identical with or similar to the trade mark on get - up , packaging or other means on which the mark may be affixed ; ### affixing in the course of trade a sign identical with or similar to the trade mark on packaging , labels , tags , security features , authenticity devices or any other means on which the mark may be affixed .


### offering or placing on the market , or stocking for those purposes , or importing or exporting get - up , packaging or other means on which the mark is affixed . ### offering or placing on the market , or stocking for those purposes , or importing or exporting , packaging , labels , tags , security features , authenticity devices or any other means on which the mark is affixed .


### on request of one of the parties a transfer shall be entered in the register and published . ### on request of one of the parties a transfer shall be entered in the register and published , if the requesting party has provided documentary evidence of the transfer to the office .


### as long as the transfer has not been entered in the register , the successor in title may not invoke the rights arising from the registration of the trade mark against third parties . ### as long as the application for registration of the transfer has not been received by the office , the successor in title may not invoke the rights arising from the registration of the trade mark against third parties .


### where the applicant requests registration for more than one class , the goods and services shall be grouped according to the classes of the nice classification , each group being preceded by the number of the class to which that group of goods or services belongs and presented in the order of the classes . ### where the applicant requests registration for more than one class , the applicant shall group the goods and services according to the classes of the nice classification , each group being preceded by the number of the class to which that group of goods or services belongs , and shall present them in the order of the classes .


### the administrative procedure referred to in paragraph 1 shall provide that at least the proprietor of an earlier right referred to in article 5 and shall be able to file a notice of opposition . ### the administrative procedure referred to in paragraph 1 shall provide that at least the proprietor of an earlier right referred to in article 5 and point of article 5 shall be able to file a notice of opposition . a notice of opposition may be filed on the basis of one or more earlier rights , provided they all belong to the same proprietor , and on the basis of part or the totality of the goods or services in respect of which the earlier right is registered or applied for , and may be directed against part or the totality of the goods or services in respect of which the contested mark is applied for .


### member states shall provide for an administrative procedure before their offices for revocation or declaration of invalidity of a trade mark . ### member states shall provide for an efficient and expeditious administrative procedure before their offices for revocation or declaration of invalidity of a trade mark .


### in the interests of a correct recognition of those persons in need of protection as refugees within the meaning of article 1 of the geneva convention or as persons eligible for subsidiary protection , every applicant should have an effective access to procedures , the opportunity to cooperate and properly communicate with the competent authorities so as to present the relevant facts of his / her case and sufficient procedural guarantees to pursue his / her case throughout all stages of the procedure . moreover , the procedure in which an application for international protection is examined should normally provide an applicant at least with the right to stay pending a decision by the determining authority , access to the services of an interpreter for submitting his / her case if interviewed by the authorities , the opportunity to communicate with a representative of the united nations high commissioner for refugees and with organizations providing advice or counselling to applicants for international protection , the right to appropriate notification of a decision , a motivation of that decision in fact and in law , the opportunity to consult a legal adviser or other counsellor , and the right to be informed of his / her legal position at decisive moments in the course of the procedure , in a language he / she can reasonably be supposed to understand and , in the case of a negative decision , the right to an effective remedy before a court or tribunal . ### in the interests of a correct recognition of those persons in need of protection as refugees within the meaning of article 1 of the geneva convention or as persons eligible for subsidiary protection , every applicant should have an effective access to procedures , the opportunity to cooperate and properly communicate with the competent authorities so as to present the relevant facts of his / her case and sufficient procedural guarantees to pursue his / her case throughout all stages of the procedure . moreover , the procedure in which an application for international protection is examined should normally provide an applicant at least with the right to stay pending a final decision by the determining authority , including in cases where an applicant lodges an appeal , and for so long as a competent court or tribunal so authorises , access to the services of an interpreter for submitting his / her case if interviewed by the authorities , the opportunity to communicate with a representative of the united nations high commissioner for refugees and with organizations providing advice or counselling to applicants for international protection , the right to appropriate notification of a decision , a motivation of that decision in fact and in law , the opportunity to consult a legal adviser or other counsellor , and the right to be informed of his / her legal position at decisive moments in the course of the procedure , in a language he / she can reasonably be supposed to understand and , in the case of a negative decision , the right to an effective remedy before a court or tribunal .


### member states shall ensure that organizations providing advice and counseling to applicants for international protection have access to the border crossing points , including transit zones , and detention facilities subject to an agreement with the competent authorities of the member state . ### member states shall ensure that organizations providing legal advice and representation and counselling to applicants for international protection have access to the border crossing points , including transit zones , and detention facilities subject to an agreement with the competent authorities of the member state .


### member states shall also ensure that , where an application is rejected with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing . ### member states shall also ensure that , where an application is rejected with regard to refugee status and / or subsidiary protection status , the reasons in fact and in law are clearly stated in the decision and information on how to challenge a negative decision is given in writing at the time of issuing the decision .


### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned . ### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender , sexual orientation , gender identity , and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned .


### member states shall allow the applicant to bring to the personal interview a legal adviser or other counsellor admitted or permitted as such under national law . ### member states shall allow the applicant to bring to the personal interview a legal adviser or other counsellor admitted or permitted as such under national law , or a qualified expert .


### ensure that the representative is given the opportunity to inform the unaccompanied minor about the meaning and possible consequences of the personal interview and , where appropriate , how to prepare himself / herself for the personal interview . member states shall ensure that a representative and / or a legal advisor or other counsellor admitted as such under national law are present at that interview and have an opportunity to ask questions or make comments , within the framework set by the person who conducts the interview . ### ensure that the representative is given the opportunity to inform the unaccompanied minor about the meaning and possible consequences of the personal interview and , where appropriate , how to prepare himself / herself for the personal interview . member states shall ensure that a representative and / or a legal advisor or other counsellor admitted as such under national law or other qualified professional are present at that interview and have an opportunity to ask questions or make comments , within the framework set by the person who conducts the interview .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with article 27 by [ 3 years from the date of the transposition ] . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with article 27 by [ 2 years from the date of the transposition ] . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive .


### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health ; ### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health , with the exclusion of laboratories providing commercial clinical services ;


### ‘ sponsor’ means any individual , company , institution or organisation which takes responsibility for the initiation and management of a clinical performance study ; ### ‘ sponsor’ means any individual , company , institution or organisation which takes responsibility for the initiation , management or financing of a clinical performance study ;


### for devices for self - testing or near - patient - testing , the information supplied in accordance with section 17 of annex i shall be provided in the language of the member state where the device reaches its intended user . ### for devices for self - testing or near - patient - testing , the information supplied in accordance with section 17 of annex i shall be easily understandable and provided in the language of the member state where the device reaches its intended user .


### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the distributors and , where applicable , the authorised representative accordingly . ### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the responsible national competent authority , the distributors and , where applicable , the authorised representative accordingly .


### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body . ### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be made publicly available and written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body .


### a serious adverse event that has a causal relationship with the device for performance evaluation , the comparator or the study procedure or where such causal relationship is reasonably possible ; ### any adverse event that has a causal relationship with the device for performance evaluation , the comparator or the study procedure or where such causal relationship is reasonably possible ;


### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for shall be effective , proportionate , and dissuasive . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented and sufficiently dissuasive . the penalties provided for shall be effective , proportionate , and dissuasive . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them .


### promoting business r&i investment , product and service development , technology transfer , social innovation and public service applications , demand stimulation , networking , clusters and open innovation through smart specialisation ; ### promoting business r&i investment , product and service development , technology transfer , social and organizational innovation and public service applications , demand stimulation , networking , clusters and open innovation through smart specialisation ;


### promoting entrepreneurship , in particular by facilitating the economic exploitation of new ideas and fostering the creation of new firms ; ### promoting entrepreneurship among women and men , in particular by facilitating the economic exploitation of new ideas and fostering the creation of new firms ;


### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . ### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . special attention shall be given and , where relevant , resources be allocated for areas in which other union funds explicitly provide for an integrated approach , such as joint funding for integrated projects in the field of environment and climate .


### operations financed by the csf funds shall comply with applicable union and national law . ### operations financed by the csf funds shall comply with applicable union and national law and should not , through their support for strategic long - lasting investments , undermine the strategic long - term coherent application of this legislation .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change and environmental objectives , including biodiversity and resource efficiency , using the methodology adopted by the commission . the methodology shall also , to the extent possible , assess the negative impacts of csf - fund expenditure on climate change and environmental objectives . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments and with the eib ; ### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . ### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . with regards to the implementation of plans or strategies under the thematic objectives 4 , 5 and 6 , member states shall consider integrated projects in the field of climate and environment as a potential model for an efficient , coherent and well coordinated implementation .


### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change objectives ; ### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change and environmental , including biodiversity and resource efficiency , objectives ;


### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change objectives ; ### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change objectives and biodiversity objectives including natura 2000 as requested by national prioritized action frameworks ;


### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , and with the eib ; ### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall submit an opinion of the national equality bodies on the measures set out in points and with the proposal for an operational programme under the investment for growth and jobs goal . ### member states shall submit an opinion of the national or , dependent on the level where the operational programme is prepared , regional environmental bodies on the measures set out in point , and an opinion of the national or regional equality bodies on the measures set out in points and with the proposal for an operational programme under the investment for growth and jobs goal .


### an analysis of the environmental impact , taking into account climate change adaptation and mitigation needs , and disaster resilience ; ### an analysis of the environmental impact , taking into account climate change adaptation and mitigation needs , biodiversity protection , resource efficiency and disaster resilience ;


### during a clinical trial , a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial . this should be reported to the member states concerned in order for action to be taken by those member states , where necessary . ### during a clinical trial , a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial . this should be reported to all member states without delay in order for action to be taken by those member states , where necessary .


### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land . ### when pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied . that demand may be satisfied either through intensification of current production , achieved by raising agricultural productivity , which can have negative environmental impacts including a loss of biodiversity , water scarcity , soil erosion and water and soil pollution , or by bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions , as well as a loss of biodiversity in cases where the land is of high biodiversity value . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels will become increasingly important in the transport sector in order to reduce its greenhouse gas emissions . greenhouse gas savings from many biofuels are still substantial in comparison with fossil fuels , including if the impact of indirect land - use changes is taken into account . advanced biofuels , such as those made from wastes , wood residues and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . however , this directive should not result in the genuine greenhouse gas savings in transport fall short of forecasts . in order for member states to be able as flexibly as possible to develop innovative and new feedstocks and to promote their use in biofuel production , it is important to lay down in this directive general principles and provisions with regard to second generation and advanced biofuel feedstocks . this would give member states and hence also the regions the opportunity to decide on the treatment of feedstocks on the basis of their own strengths . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework .


### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact , which could include the introduction of estimated indirect land - use change emission factors in the sustainability scheme as of 1st january 2021 . ### the commission should review the effectiveness of the measures introduced by this directive and their impact at all levels , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact , which could include the introduction of estimated indirect land - use change emission factors in the sustainability scheme as of 1st january 2021 . the commission should also review the wider economic and social impact of the proposal on the union’s regions , the countryside and also the operations of existing biofuel producers .


### ' p ) ‘ waste’ shall be defined as in article 3 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives . substances that have been intentionally modified or contaminated to meet that definition are not covered by this category . ### ‘ p ) ‘ waste’ means any substance or object which the holder discards or intends or is required to discard , as defined in article 3 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives , and whose status is subject to independent verification and certification as to its compliance with the waste hierarchy established in article 4 of that directive or with a comparable waste prevention and management programme . substances that have been intentionally modified or contaminated to meet that definition are not covered by this category .


### having regard to the treaty on the functioning of the european union , and in particular article 114 [ … ] thereof , ### having regard to the treaty on the functioning of the european union , and in particular article 192 thereof ,


### under this set of legislation , gmos for cultivation shall undergo an individual risk assessment before being authorised to be placed on the union market . 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 . ### under this set of legislation , gmos for cultivation shall undergo an individual risk assessment before being authorised to be placed on the union market , taking into account , in accordance with annex ii of directive 2001 / 18 / ec , the direct , indirect , immediate and delayed effects , as well as the cumulative long - term effects , on human health and the environment . 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 .


### under this set of legislation , gmos for cultivation shall undergo an individual risk assessment before being authorised to be placed on the union market . 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 . ### under this set of legislation , gmos for cultivation shall undergo an individual assessment of direct and indirect short - term and long - term risks before being authorised to be placed on the union market . 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 .


### 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 issues related to the placing on the market and the import of gmos , which should remain regulated at eu level to preserve the internal market , cultivation has been acknowledged as an issue with a strong local / regional dimension . in accordance with article 2 tfeu 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 eu market . ### 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 issues related to the placing on the market and the import of gmos , which should remain regulated at eu level to preserve the internal market , cultivation has been acknowledged as an issue with a strong local / regional / territorial dimension , and as one of particular importance for the self - determination of member states . in accordance with article 2 tfeu member states should therefore be entitled to have a possibility to adopt binding legislative provisions concerning the effective cultivation of gmos in their territory after the gmo has been legally authorised to be placed on the eu market .


### 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 . ### in this context , it appears appropriate to grant to 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 changing the system of union authorisations of gmos and in parallel with the measures that member states must take by application of article 26a of directive 2001 / 18 / ec , as amended by this regulation , to avoid the unintended presence of gmos in other products .


### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular gmos 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 . this 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 . ### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of particular gmos , a group of gmos defined by the crop variety , or all gmos in all or part of their territory , provided those measures have been subject to prior impact assessment and public consultation , and as long as those measures are adopted and made publicly available to all operators concerned , including growers , at least twelve months prior to the start of sowing . this choice left to member states is directly linked to their sovereignty on territorial management and development , land use and the need to preserve the diversity of ecosystems . this 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 .


### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular gmos 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 . this 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 . ### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular gmos 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 . cultivation is in fact closely linked to land use and the conservation of fauna and flora , areas in which the member states retain significant powers . 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 .


### 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 eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . 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 . ### 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 union cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of particular gmos , a group of gmos defined by the crop variety , or all gmos in all or part of their territory on the basis of duly justified grounds relating to the public interest other than those already addressed by the harmonised set of union rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . the distinct notion of ' risk management ' , as established in regulation ec no 178 / 2002 could be used , however , as a basis to justify those measures . such measures may be justified on the basis of general policy objectives such as : - the need to preserve specific types of agriculture such as organic or high nature value farming , as well as traditional types of farming , - grounds related to the protection of the diversity of agricultural production , - the protection of gmo - free areas provided that co - existence measures in place are not sufficient to protect , - the impossibility to implement co - existence due to specific geographical conditions , - socio - economic grounds such as the protection of specific mountain products , product quality policy or labels , - wider environmental policy objectives such as specific habitats , ecosystems , biodiversity , emergence of resistance and landscape features preservation , - territorial management or land use planning , - other legitimate grounds in the public interest or addressing public concerns , duly justified , proportionate and non - discriminatory , 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 , the principle of proportionality 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 . those measures should also ensure that the freedom of choice of farmers and consumers is duly respected .


### 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 eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . 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 . ### 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 union cannot be revised by a member state and this situation should not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest complementary to , or differing from , those already assessed by the harmonised set of union rules . the grounds given by the member states may include consideration of environmental impacts complementary to those already covered by the risk assessment provided for in part c of directive 2001 / 18 / ec , and may thus , at least partially , include the consideration of scientific data relating to the central , local or regional environmental impact on receiving environments . these grounds may also depend on factors that are not directly connected with the risk assessment , but are linked to risk management or other national policies . the grounds given by the member states may also include , inter alia , the risk of resistance development in weeds or in the target organisms , or the invasive potential of the plant . they may also include socio - economic considerations such as the practicality and cost of the measures laid down in article 26a of directive 2001 / 18 / ec for avoiding the unintended presence of gmos in other products , fragmentation of the territory , changes in agricultural practices linked to intellectual property regimes , or social policy objectives such as the conservation of diversity or distinctive agricultural practices . 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 .


### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of gmos on their territory . in addition one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes . ### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant flexibility to member states to invoke duly justified grounds in the public interest which are different from those related to the scientific assessment of health and environmental risks carried out pursuant to part c of directive 2001 / 18 / ec , such as those grounds listed under recital 8 of this regulation , in order to restrict or prohibit the cultivation of gmos on all or part of their territory in order to ease the decision - making process on gmos in the union . in addition one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations1 which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify per se the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes .


### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of gmos on their territory . in addition , one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes . ### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to invoke grounds complementary to , or differing from , the scientific assessment of health and environmental risks to ban cultivation of gmos on their territory . in addition , one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the commission to consider the adoption of binding acts at union level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes .


### 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 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 : ### member states may adopt measures restricting or prohibiting the cultivation of particular gmos , a group of gmos defined by the crop variety , or all gmos authorised in accordance with part c of this directive or regulation 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 :


### those measures are based on grounds other than those related 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 ; ### those measures : are based on different grounds from those covered by the harmonised scientific assessment of health and environmental risks carried out pursuant to part c of directive 2001 / 18 / ec which might arise from the deliberate release or the placing on the market of gmos , while the distinct notion of ' risk management ' , as established by regulation ec no&#160 ; 178 / 2002 , could be used as a basis to justify national / regional restrictive measures ; may be justified on the basis of general policy objectives such as : - the need to preserve specific types of agriculture such as organic or high nature value farming , as well as traditional types of farming , - grounds related to the protection of the diversity of agricultural production , - the protection of gmo - free areas provided that co - existence measures in place are not sufficient to protect , - the impossibility to implement co - existence due to specific geographical conditions - socio - economic grounds such as the protection of specific mountain products , product quality policy or labels , - wider environmental policy objectives such as specific habitats , ecosystems , biodiversity and landscape features preservation , - territorial management or land use planning , - other legitimate grounds in the public interest or addressing public concerns , duly justified , proportionate and non - discriminatory .


### this regulation shall enter into force on the [ … ] day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union .


### where the results of an assessment show that a union quarantine pest fulfils the conditions referred to in paragraph 1 , or a pest no longer fulfils one or more of those conditions , the commission shall amend the implementing act referred to in the first subparagraph by adding the pest concerned to , or removing it from , that list . ### at annual intervals or at the request of an eu member state , union quarantine pests shall be reassessed on the basis of a risk analysis . where the results of an assessment show that a union quarantine pest fulfils the conditions referred to in paragraph 1 , or a pest no longer fulfils one or more of those conditions , the commission shall , within three months , amend the implementing act referred to in the first subparagraph by adding the pest concerned to , or removing it from , that list .


### a single bank resolution fund is an essential element without which a single resolution mechanism could not work properly . different systems of national funding would distort the application of uniform bank resolution rules in the internal market . the fund should help to ensure a uniform administrative practice in the financing of resolution and to avoid the creation of obstacles for the exercise of fundamental freedoms or the distortion of competition in the internal market due to divergent national practices . the fund should be financed directly by banks and should be pooled at union level so that the resolution resources can be objectively allocated across member states thus increasing financial stability and limiting the link between the perceived fiscal position of individual member states and the funding costs of banks and undertakings operating in those member states . ### a network of national bank resolution funds is an essential element without which a single resolution mechanism could not work properly . different systems of national funding would distort the application of uniform bank resolution rules in the internal market . the fund should help to ensure a uniform administrative practice in the financing of resolution and to avoid the creation of obstacles for the exercise of fundamental freedoms or the distortion of competition in the internal market due to divergent national practices . the national funds should be financed directly by banks and should be pooled at union level so that the resolution resources can be objectively allocated across member states . only the national resolution funds of the member states where the bank under resolution operates would participate in the funding , according to the share of financial activity , thus increasing financial stability and limiting the link between the perceived fiscal position of individual member states and the funding costs of banks and undertakings operating in those member states .


### no decision of the board or the commission shall require member states to provide extraordinary public financial support . ### no decision of the board or the commission shall require member states collectively or individually to provide public financial support or distort loss allocation as between participating and non - participating member states .


### the commission shall be empowered to adopt delegated acts in accordance with article 82 to specify the following : ### the eba shall develop draft regulatory technical standards in accordance with article 82 to specify the following :


### suspected adverse reaction : an adverse reaction in respect of which a causal relationship between the event and the medicinal product cannot be excluded . ### suspected adverse drug reaction : an unintended event in respect of which a causal relationship between the event and the medicinal product cannot be excluded .


### the information referred to in point of the first subparagraph shall be presented in a box surrounded by a black border . any new or amended text shall for a period of 1 - year be presented in bold text and preceded by the following symbol and text ' new information ' . for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the following additional statement shall be included “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to ' . ### for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the following additional statement shall be included “this medicinal product is subject to post - authorisation safety monitoring . all suspected adverse reactions should be reported to ' .


### through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of an adverse reaction report is identifiable ; ### ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of a suspected adverse reaction report is identifiable by , as far as available , the name of the marketing authorisation holder , the international non - proprietary name , the name of the medicinal product and the batch number , using the standard forms and procedures developed in accordance with article 25 of regulation no 726 / 2004 and taking due account of the developments within the eudravigilance system ;


### the member states shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database and to any authorities responsible for patient safety within that member state . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state . ### the member states shall ensure that reports of medication errors , or of the unintended effects of medicinal products used contrary to the indications covered by the authorisation , brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database and to any authorities responsible for patient safety within that member state . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state .


### the executive director , as well as officials seconded by member states and the commission on a temporary basis shall make a declaration of commitments and a declaration of interests indicating the absence of any direct or indirect interests , which might be considered prejudicial to their independence . these declarations shall be made in writing on their entry into service and shall be renewed in the event of a change in their personal circumstances . ### members of the administrative board and of the security accreditation board , the executive director , as well as officials seconded by member states and the commission on a temporary basis shall make a declaration of commitments and a declaration of interests indicating the absence or presence of any direct or indirect interests , which might be considered prejudicial to their independence . these declarations shall be accurate and complete . these declarations shall be made in writing on their entry into service and shall be renewed and updated promptly in the event of a change in their personal circumstances .


### public procurement plays a key role in the europe 2020 strategy as one of the market - based instruments to be used to achieve a smart , sustainable and inclusive growth while ensuring the most efficient use of public funds . for that purpose , the current public procurement rules adopted pursuant to directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts have to be revised and modernised in order to increase the efficiency of public spending , facilitating in particular the participation of small and medium - sized enterprises in public procurement and to enable procurers to make better use of public procurement in support of common societal goals . there is also a need to clarify basic notions and concepts to ensure better legal certainty and to incorporate certain aspects of related well - established case - law of the court of justice of the european union . ### public procurement plays a key role in the europe 2020 strategy as one of the market - based instruments to be used to achieve a smart , sustainable and inclusive growth while ensuring the most efficient use of public funds . public procurement is a key tool in the process of reframing european industrial policy . for that purpose , the current public procurement rules adopted pursuant to directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts have to be revised and modernised in order to increase the efficiency of public spending , facilitating in particular the participation of small and medium - sized enterprises in public procurement and to enable procurers to make better use of public procurement in support of common societal goals . there is also a need to clarify basic notions and concepts to ensure better legal certainty and to incorporate certain aspects of related well - established case - law of the court of justice of the european union .


### it may only reject the tender where the evidence does not justify the low level of price or costs charged , taking into account the elements referred to in paragraph 3 . ### it shall reject the tender where the evidence does not justify the low level of price or costs charged , taking into account the elements referred to in paragraph 3 .


### regulation no 1013 / 2006 of the european parliament and of the council of 14 june 2006 on shipments of waste13 lays down requirements for shipments of waste both within the union and between the member states and third countries , in order to protect the environment . however , gaps have been identified in the enforcement and inspections carried out by the competent authorities in member states due to , inter alia , a lack of clear provisions in the regulation on these matters . __________________ 13 oj l 190 , 12 . 7 . 2006 , p . 1 . ### regulation no 1013 / 2006 of the european parliament and of the council13 lays down requirements for shipments of waste both within the union and between the member states and third countries , in order to protect the environment . however , gaps and divergences have been identified in the enforcement and inspections carried out by the competent authorities in member states due to , inter alia , a lack of clear provisions in the regulation on these matters . the number of contraventions of legislation on shipments of waste is therefore thought to be considerable . __________________ 13 regulation no 1013 / 2006 of the european parliament and of the council of 14 june 2006 on shipments of waste .


### adequate planning of waste shipment inspections is necessary to establish the capacity needed for waste shipment inspections and effectively prevent illegal shipments . the provisions on enforcement and inspections in article 50 of regulation no 1013 / 2006 should therefore be strengthened with a view to ensuring regular and consistent planning of inspections . planning should include a number of key elements , including risk assessments , strategies , objectives , priorities , numbers and types of planned inspections , assignment of tasks , means of cooperation between authorities and provisions on training of inspectors . ### adequate planning of waste shipment inspections is necessary to establish the capacity needed for waste shipment inspections and effectively prevent illegal shipments . the provisions on enforcement and inspections in article 50 of regulation no 1013 / 2006 should therefore be strengthened with a view to ensuring regular and consistent planning and implementation of inspections . planning should include a number of key elements , including risk assessments , strategies , objectives , priorities , numbers and types of planned inspections , assignment of tasks , means of cooperation between authorities and provisions on training of inspectors .


### diverging rules exist throughout the union as regards the possibility for competent authorities in member states to require evidence from waste exporters in order to check the legality of shipments . such evidence may concern whether the substance or object is ' waste ' within the meaning of regulation no 1013 / 2006 or whether the waste will be shipped to environmentally sound facilities according to article 49 of the regulation . article 50 of the regulation should therefore provide the possibility for competent authorities in member states to require evidence from suspected illegal waste exporters in order to check the legality of shipments . ### diverging rules exist throughout the union as regards the possibility for competent authorities in member states to require evidence from waste exporters in order to check the legality of shipments . such evidence may concern whether the substance or object is ' waste ' within the meaning of regulation no 1013 / 2006 or whether the waste will be shipped to environmentally sound facilities according to article 49 of the regulation . article 50 of the regulation should therefore provide the possibility for competent authorities in member states to require evidence from suspected illegal waste exporters in order to check the legality of shipments . where the exporter is unable to provide evidence , the shipment should be deemed to be illegal .


### in accordance with article 3 of the treaty on the functioning of the european union , the union has the exclusive competence for the conservation of marine biological resources . since salmon is an anadromous species , conservation of the marine baltic salmon stocks cannot be achieved in the absence of measures being taken to protect such stocks during their river life . therefore , such measures are also covered by the exclusive competence of the union to ensure effective conservation of marine species throughout their whole migratory cycle and should be addressed in the multiannual plan . ### in accordance with article 3 of the treaty on the functioning of the european union , the union has the exclusive competence for the conservation of marine biological resources . since salmon is an anadromous species , conservation of the baltic salmon stocks cannot be achieved without phasing out mixed - stock salmon fishing , nor can it be achieved in the absence of measures being taken to protect such stocks during their river life . therefore , such measures are also covered by the exclusive competence of the union to ensure effective conservation of marine species throughout their whole migratory cycle and should be addressed in the multiannual plan .


### directive 92 / 43 / eec on the conservation of natural habitats and of wild fauna and flora , lists salmon as a species of european union interest and measures taken pursuant to this directive should be designed to ensure that their exploitation is compatible with a favourable conservation status . there is hence a need to ensure that measures to protect salmon taken under this regulation are consistent and coordinated with those taken under the mentioned directive . ### directive 92 / 43 / eec on the conservation of natural habitats and of wild fauna and flora , lists salmon as a species of european union interest and measures taken pursuant to this directive should be designed to ensure that their exploitation is compatible with a favourable conservation status . there is hence a need to ensure that measures to protect salmon taken under this regulation are consistent and coordinated with those taken under the mentioned directive . in order for sustainable growth of salmon stocks to be achieved , mixed - stock fishing must be phased out and replaced with separate fishing of each stock . prohibiting fishing with drift long - liners is also an important way of improving salmon stocks , as this would reduce discards of under - sized salmon .


### ' baltic salmon stock ' means all salmon stocks in the baltic sea and in baltic rivers , both wild and reared ; ### ' baltic salmon stocks ' means all salmon stocks in the baltic sea and in baltic rivers , both wild and reared ;


### use of the national quota by service vessels ### use of the national quota by service vessels and recreational fishing


### salmon caught at sea from service vessels shall be counted against the national quota . ### salmon caught at sea from service vessels and at coast and river recreational fishing shall be counted against the national quota .


### stocking of salmon may only be conducted in wild salmon river . the number of released smolts in each river shall not exceed the estimated potential smolt production capacity of the river . ### stocking of salmon may be conducted in wild salmon rivers and , during a transition period , also in estuaries . the number of fry released in each river shall not exceed the estimated potential smolt production capacity of the river .


### the river has free migratory waterways , appropriate water quality and habitat suitable for reproduction and growth of salmon ; ### it is possible for salmon to migrate and the river has appropriate water quality and habitat suitable for reproduction and growth of salmon ;


### where goods suspected of infringing intellectual property rights are not counterfeit or pirated goods , it may be difficult to determine upon mere visual examination by customs authorities whether an intellectual property right might be infringed . it is therefore appropriate to provide that proceedings should be initiated , unless the parties concerned , namely the holder of the goods and the right - holder , agree to abandon the goods for destruction . it should be for the competent authorities dealing with such proceedings to determine whether an intellectual property right has been infringed and to take appropriate decisions concerning the infringements of intellectual property rights concerned . ### it may be difficult to determine upon mere visual examination by customs authorities whether an intellectual property right might be infringed . it is therefore appropriate to provide that proceedings should be initiated , unless the parties concerned , namely the holder of the goods and the right - holder , agree to abandon the goods for destruction . it should be for the competent authorities dealing with such proceedings to determine whether an intellectual property right has been infringed and to take appropriate decisions concerning the infringements of intellectual property rights concerned .


### goods which are subject of an action infringing an intellectual property right under the law of the union or of that member state ; ### counterfeit goods and pirated goods according to the law of the union or of that member state ;


### having due regard to articles 93 , 107 and 108 of the treaty , member states may also provide the infrastructure manager with financing consistent with its tasks , the size of the infrastructure and financial requirements , in particular in order to cover new investments . ### whenever revenues are not sufficient to cover the financing needs of the infrastructure manager , without prejudice to the charging framework of articles 31 and 32 , having due regard to articles 93 , 107 and 108 of the treaty , member states shall provide the infrastructure manager with financing consistent with its tasks , the size of the infrastructure and financial requirements , in particular in order to cover new investments .


### when charging for the cost of noise effects is allowed by union legislation for road freight transport , the infrastructure charges shall be modified to take account of the cost of noise effects caused by the operation of the train in accordance with annex viii , point 2 . ### when a member state applies charging for other modes of transport for the cost of noise effects , in accordance with union legislation , the infrastructure charges in that member state shall be modified to take account of the cost of noise effects caused by the operation of the train in accordance with annex viii , point 2 .


### the strategic planning and harmonisation of spectrum use at union level should enhance the single market for wireless electronic communications services and equipment as well as other union policies requiring spectrum use , thus creating new opportunities for innovation and contributing to economic recovery and social integration across the union , while at the same time respecting the important social , cultural and economic value of spectrum . to this end , the union therefore needs a policy programme that covers the internal market in all union policy areas involving the use of spectrum such as electronic communications , research and development , transport and energy . ### the strategic planning and harmonisation of spectrum use at union level should enhance the single market for wireless electronic communications services and equipment as well as other union policies requiring spectrum use , thus creating new opportunities for innovation and contributing to economic recovery and social integration across the union , while at the same time respecting the important social , cultural and economic value of spectrum . the harmonisation of spectrum use is also essential to ensure the quality of the services provided by electronic communications and to create economies of scale lowering both the cost of deploying wireless networks and the cost of wireless devices for consumers . to this end , the union therefore needs a policy programme that covers the internal market in all union policy areas involving the use of spectrum such as electronic communications , research and development , transport and energy .


### the first programme should specify guiding principles and objectives up to 2015 for member states and union institutions , and set out specific implementation initiatives . while spectrum management is still largely a national competence , it should be exercised in compliance with existing union law and allow for action to pursue union policies . ### the first programme should set the principles and objectives up to 2015 for member states and union institutions , and set out specific implementation initiatives . while spectrum management is still largely a national competence , it should be exercised in compliance with existing union law and allow for action to pursue union policies .


### as underlined in the digital agenda for europe , wireless broadband is an important means to boost competition , consumer choice and access in rural and other areas where deployment of wired broadband is difficult or economically unviable . however , spectrum management may affect competition by changing the role and power of market players , for example if existing users receive undue competitive advantages . limited spectrum access , in particular when appropriate spectrum becomes scarcer , can create a barrier to entry for new services or applications and hamper innovation and competition . acquisition of new usage rights , including through spectrum trading or other transactions between users , and the introduction of new flexible criteria for spectrum use can have an impact on the existing competitive situation . member states should therefore take appropriate ex ante or ex post regulatory measures to avoid distortions of competition in line with the principles underpinning article 5 of directive 2002 / 20 / ec and article 1 of directive 87 / 372 / eec . ### as underlined in the digital agenda for europe , wireless broadband is an important means to boost competition and a pan - european level playing field , consumer choice and access in rural and other areas where deployment of wired broadband is difficult or economically unviable . however , spectrum management may affect competition by changing the role and power of market players , for example if existing users receive undue competitive advantages . limited spectrum access , in particular when appropriate spectrum becomes scarcer , can create a barrier to entry for new services or applications and hamper innovation and competition . acquisition of new usage rights , including through spectrum trading or other transactions between users , and the introduction of new flexible criteria for spectrum use can have an impact on the existing competitive situation . member states should therefore conduct a thorough analysis of competition effects prior to new spectrum allocations as well as take appropriate ex ante or ex post regulatory measures to avoid distortions of competition in line with the principles underpinning article 5 of directive 2002 / 20 / ec and article 1 of directive 87 / 372 / eec .


### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use together with an effective review and assessment methodology are necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 3 ghz . this would help to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs . ### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use and the efficiency thereof , following a common review and assessment methodology , is necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 3 ghz . the inventory should be sufficiently detailed to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs .


### since a common approach and economies of scale are key to developing broadband communications throughout the union and preventing competition distortion and market fragmentation among member states , certain authorisation and procedural conditions could be defined in concerted action among member states and with the commission . conditions could include coverage obligations , spectrum block size , the timing of granting rights , access to mobile virtual network operators and the duration of rights of use . reflecting the importance of spectrum trading for increasing efficient use of spectrum and developing the internal market for wireless equipment and services , these conditions should apply to spectrum bands that are allocated to wireless communications , and for which rights of use may be transferred or leased . ### since a common approach and economies of scale are key to developing broadband communications throughout the union and preventing competition distortion and market fragmentation among member states , certain authorisation and procedural conditions should be defined in concerted action among member states and with the commission . conditions should primarily ensure new entrants ' access to lower bands through auctions or other competition procedures ; conditions could also include coverage obligations , spectrum block size , the timing of granting rights , access to mobile virtual network operators and the duration of rights of use . reflecting the importance of spectrum trading for increasing efficient use of spectrum , facilitating the emergence of new pan - european services and developing the internal market for wireless equipment and services , these conditions should apply to spectrum bands that are allocated to wireless communications , and for which rights of use may be transferred or leased .


### additional spectrum may be needed by other sectors such as transport , r&d , public protection and disaster relief , e - health and e - inclusion . optimising synergies between spectrum policy and r&d activities and carrying out studies of radio compatibility between different spectrum users should help innovation . the commission ' s joint research centre should help in developing the technical aspects of spectrum regulation , notably by providing testing facilities to verify interference models relevant to union legislation . moreover , results of research under the seventh framework programme require the examination of the spectrum needs of projects that may have a large economic or investment potential , in particular for smes , e . g . cognitive radio or e - health . adequate protection against harmful interference should also be ensured to sustain r&d and scientific activities . ### additional spectrum may be needed by other sectors such as transport , r&d , e - health , e - inclusion and public protection and disaster relief , the latter in view of its increased use of video and data transmission for quick and more efficient service . optimising synergies between spectrum policy and r&d activities and carrying out studies of radio compatibility between different spectrum users should help innovation . the commission ' s joint research centre should help in developing the technical aspects of spectrum regulation , notably by providing testing facilities to verify interference models relevant to union legislation . moreover , results of research under the seventh framework programme require the examination of the spectrum needs of projects that may have a large economic or investment potential , in particular for smes , e . g . cognitive radio or e - health . adequate protection against harmful interference should also be ensured to sustain r&d and scientific activities .


### essential public interest objectives such as safety of life call for coordinated technical solutions for the interworking of safety and emergency services between member states . sufficient spectrum should be made available on a coherent basis for the development and free circulation of safety services and devices and innovative pan - european or interoperable safety and emergency solutions . studies have already shown the need for additional harmonised spectrum below 1 ghz to deliver mobile broadband services for public protection and disaster relief , across the union in the next 5 to 10 years . ### essential public interest objectives such as safety of life call for coordinated technical solutions for the interworking of safety and emergency services between member states . sufficient spectrum should be made available in a coordinated pan - european block of radio spectrum for the development and free circulation of safety services and devices and innovative pan - european or interoperable safety and emergency solutions . studies have already shown the need for additional harmonised spectrum below 1 ghz to deliver mobile broadband services for public protection and disaster relief , across the union in the next 5 to 10 years . any additional harmonised allocation of spectrum for public protection and disaster relief below 1ghz should also include a review of potential to free up or share other ppdr - held spectrum .


### guaranteeing the functioning of the internal market , in particular by ensuring effective competition . ### guaranteeing the development and functioning of the internal digital market , in particular by ensuring effective competition and a pan - european level playing field .


### member states shall foster , in cooperation with the commission , the collective use of spectrum as well as shared use of spectrum . ### member states shall foster , where appropriate , in cooperation with the commission , the collective use of spectrum as well as shared use of spectrum by enabling new technologies , such as cognitive radio , to develop .


### member states shall ensure that selection conditions and procedures promote investment and efficient use of spectrum . ### member states shall ensure that selection conditions and procedures promote competition and a pan - european level playing field , investment and efficient use of spectrum .


### member states may amend the existing rights in accordance with article 14 of directive 2002 / 20 / ec when this is necessary to remedy ex - post excessive accumulation of spectrum frequencies within certain economic operators which significantly harms competition . ### member states may amend the existing rights in accordance with article 14 of directive 2002 / 20 / ec when this is necessary to remedy ex - post excessive accumulation of spectrum frequencies within certain economic operators which is likely to distort competition .


### without prejudice to the principles of service and technology neutrality , member states , in cooperation with the commission , shall take all steps necessary to ensure that sufficient spectrum for coverage and capacity purposes is allocated within the union , in order to ensure that wireless applications contribute effectively to achieving the target for all citizens to have access to broadband of a speed of at least 30 mbps by 2020 . ### without prejudice to the principles of service and technology neutrality , member states , in cooperation with the commission , shall take all steps necessary to ensure that sufficient harmonised spectrum for coverage and capacity purposes is available within the union , enabling the union to have the fastest broadband speed in the world in order to ensure that wireless applications and european leadership in new services contribute effectively to economic growth achieving the target for all citizens to have access to broadband of speeds of not less than 30 mbps by 2020 .


### member states shall , by 1 january 2012 , authorise the use of all the spectrum designated by commission decisions 2008 / 477 / ec , 2008 / 411 / ec and 2009 / 766 / ec , under conditions that provide consumers with easy access to wireless broadband services . ### member states shall , by 1 january 2012 , make the bands designated by commission decisions 2008 / 477 / ec , 2008 / 411 / ec and 2009 / 766 / ec , available , in order to promote wider availability of wireless broadband services for the benefit of eu citizens and consumers , without prejudice to the existing and future deployment of other services that have equal access to this spectrum under the conditions specified in those commission decisions .


### member states shall , by 1 january 2013 make the 800 mhz band available for electronic communications services in line with the harmonised technical conditions laid down pursuant to the decision no 676 / 2002 / ec . in member states where exceptional national or local circumstances would prevent the availability of the band , the commission may authorise specific derogations until 2015 . in accordance with article 9 of directive 2002 / 21 / ec , the commission , in cooperation with the member states , shall keep under review the use of the spectrum below 1ghz and assess whether additional spectrum could be freed and made available for new applications . ### member states shall , by 1 january 2013 make the 800 mhz band available for spectrum assignments for electronic communications services in line with the harmonised technical conditions laid down pursuant to the decision no 676 / 2002 / ec . only in exceptional cases and where duly justifiable historical reasons prevent the availability of the band , the commission may authorise specific derogations until 2015


### the commission is invited to adopt , as a priority , appropriate measures , pursuant to article 9b of the directive 2002 / 21 / ec , to ensure that member states allow trading within the union of spectrum usage rights in the harmonised bands 790–862 mhz , 880–915 mhz , 925–960 mhz , 1710–1785 mhz , 1805–1880 mhz , 1900–1980 mhz , 2010–2025 mhz , 2110–2170 mhz , 2 . 5–2 . 69 ghz , and 3 . 4–3 . 8 ghz . ### the commission in close cooperation with member states , is invited to adopt , as a priority , appropriate measures , pursuant to article 9b of the directive 2002 / 21 / ec , to ensure that member states allow transferring or leasing within the union of spectrum usage rights in one or more of the harmonised bands 790–862 mhz , 880–915 mhz , 925–960 mhz , 1710–1785 mhz , 1805–1880 mhz , 1900–1980 mhz , 2010–2025 mhz , 2110–2170 mhz , 2 . 5–2 . 69 ghz , and 3 . 4–3 . 8 ghz .


### if necessary , the commission shall ensure the availability of additional spectrum bands for the provision of harmonised satellite services for broadband access that will cover the whole territory of the union including the most remote areas with a broadband offering enabling internet access at a comparable price to terrestrial offerings . ### in order to ensure that all citizens have access to advanced digital services including broadband , in particular in remote and sparsely populated areas , member states and the commission may explore the availability of sufficient spectrum for the provision of broadband satellite services enabling internet access .