### infestations of the plants for planting referred to in point with the pest shall have an unacceptable economic impact on the intended use of those plants as regards one or more of the following points : ### infestations of the plants for planting referred to in point with the pest shall have an unacceptable economic and environmental impact on the intended use of those plants as regards one or more of the following points :


### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , notably human dignity , prohibition of torture and of inhuman or degrading treatment or punishment , right to liberty and security , the rights to the protection of personal data , right to asylum , non - refoulement , non discrimination , the rights of the child and right to an effective remedy . this regulation should be applied by the member states in accordance with these rights and principles . ### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , notably human dignity , prohibition of torture and of inhuman or degrading treatment or punishment , right to liberty and security , the rights to the protection of personal data , right to asylum , non - refoulement , non discrimination , the rights of the child and right to an effective remedy . this regulation endorses the provisions and the aims of council directive 2004 / 83 / ec of 29 april 2004 on minimum standards for the qualification and status of third country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted1 , as well as of directive 2008 / 115 / ec of the european parliament and of the council of 16 december 2008 on common standards and procedures in member states for returning illegally staying third - country nationals2 . this regulation should be applied by the member states in accordance with these rights and principles . ___________________ 1 oj l . . . . . . 2 oj l . . . . . .


### when concluding bilateral agreements with third countries as referred to in article 2 member states shall , where appropriate , include provisions concerning the role and competencies of the agency , in particular regarding the exercise of executive powers by members of the teams deployed by the agency during the activities referred to in article 3 . ### when concluding agreements with third countries on cooperation at an operational level as referred to in article 2 member states shall , where appropriate , include provisions concerning the role and competencies of the agency , in particular regarding the exercise of executive powers by members of the teams deployed by the agency during the activities referred to in article 3 .


### technical standardisation is a cornerstone for the integration of networks , such as the union payments market . the use of standards developed by international or european standardisation bodies should be mandatory as of a given date for all relevant transactions . in the payment context , these would be the iban , bic , and the financial services messaging standard ‘ iso 20022 xml’ . the use of those standards by all payment service providers is therefore a requirement for full interoperability throughout the union . in particular , the mandatory use of iban and bic where necessary should be promoted through comprehensive communication and facilitating measures in member states in order to allow a smooth and easy transition to pan - european credit transfers and direct debits , in particular for consumers . ### technical standardisation is a cornerstone for the integration of networks , such as the union payments market . the use of standards developed by international or european standardisation bodies should be mandatory as of a given date for all relevant transactions . in the payment context , these would be the iban , bic , and the financial services messaging standard ' iso 20022 xml ' . the use of those standards by all payment service providers is therefore a requirement for full interoperability throughout the union . in particular , the mandatory use of iban and bic should be promoted through comprehensive communication and facilitating measures in member states in order to prepare consumers in a timely and adequate manner for the transition to pan - european credit transfers and direct debits . in particular , banks should facilitate that transition by carrying out specific and extensive information campaigns in order to raise public awareness and by having a transparent information policy for their customer business . an adequate and extensive information policy is mandatory in order to gain acceptance , in particular with regard to the wide - ranging changes for consumers .


### it is appropriate to set dates by when all credit transfers and direct debit transactions should comply with those technical requirements , while leaving the market open for further development and innovation . ### in order to allow a concerted transition process in the interests of clarity and simplicity for consumers , it is appropriate to set a single migration deadline by which all credit transfers and direct debit transactions should comply with those technical requirements , while leaving the market open for further development and innovation .


### in some member states , there are certain legacy payment instruments which are credit transfers or direct debits but which have very specific functionalities , often due to historical or legal reasons . the transaction volume of such products is usually marginal ; they could therefore be classified as niche products . a transitional period for such niche products , sufficiently long to minimise the impact of the migration on payment service users , should help both sides of the market to focus first on the migration of the bulk of credit transfers and direct debits , thereby allowing the majority of the potential benefits of an integrated payments market in the union to be reaped earlier . ### in some member states , there are certain legacy payment instruments which are credit transfers or direct debits but which have very specific functionalities , often due to historical or legal reasons . a transitional period for such niche products , sufficiently long to minimise the impact of the migration on payment service users , should help both sides of the market to focus first on the migration of the bulk of credit transfers and direct debits , thereby allowing the majority of the potential benefits of an integrated payments market in the union to be reaped earlier .


### for the practical functioning of the internal market in payments it is essential to ensure that payers such as businesses or public authorities are able to send credit transfers to payment accounts held by the payees with payment service providers which are located in other member states and reachable in accordance with this regulation . ### for the practical functioning of the internal market in payments it is essential to ensure that payers such as consumers , businesses or public authorities are able to send credit transfers to payment accounts held by the payees with payment service providers which are located in other member states and reachable in accordance with this regulation .


### since payment service providers from member states outside the euro area would need to undertake more preparatory work , such payment service providers should be allowed to defer the application of these technical requirements for a certain period . ### since payment service providers from member states outside the euro area would need to undertake more preparatory work , such payment service providers should be allowed to defer the application of these technical requirements for a certain period . member states outside the euro area should however comply with the technical requirements swiftly to create a true european payment area , which will strengthen the internal market .


### requirements for credit transfer and direct debit transactions ### migration deadlines for credit transfer and direct debit transactions


### by [ insert concrete date 12 months after entry into force of this regulation ] at the latest , credit transfers shall be carried out in accordance with the technical requirements set out in points 1 and 2 of the annex . ### by [ insert concrete date 24 months after entry into force of this regulation ] at the latest , credit transfers and direct debit transactions shall be carried out in accordance with the technical requirements set out in article 4a and in of the annex .


### payment service providers located in a member state which does not have the euro as its currency shall comply with the requirements set out in article 4 and in points 1 and 2 of the annex for credit transfers denominated in euros and with the requirements set out in article 4 and in points 1 and 3 of the annex for direct debit transactions denominated in euros by [ insert concrete date month ) 4 years after entry into force of this regulation ] . if , however , the euro is introduced as the currency of any such member state before [ insert concrete date 3 years after entry into force of this regulation ] , the payment service provider located in that member state shall meet those requirements within one year of the date on which the member state concerned joined the euro area . ### payment service providers located in a member state which does not have the euro as its currency shall comply with the requirements set out in article 4 and in points 1 and 2 of the annex for credit transfers denominated in euros and with the requirements set out in article 4 and in points 1 and 3 of the annex for direct debit transactions denominated in euros by [ insert concrete date 36 months after entry into force of this regulation ] . if , however , the euro is introduced as the currency of any such member state , the payment service provider located in that member state shall comply with article 4 within the same time limit as for the member state already within the euro area .


### the following technical requirements shall apply to both credit transfer and direct debit transactions : ### in addition to the essential technical requirements set out in article 4a , the following technical requirements shall apply to both credit transfer and direct debit transactions :


### no decision of the board or the commission shall require member states to provide extraordinary public financial support . ### decisions or actions of the board or of the commission shall neither require member states to provide extraordinary public financial support nor directly impinge on the fiscal responsibilities of the member states .


### when deliberating on an individual entity or a group established only in one participating member state , the board shall take its decisions in its executive sessions by a simple majority of its participating members . in case of a tie the executive director shall have a casting vote . ### the board shall take its decisions in its executive sessions by a simple majority of its voting members . in case of a tie the executive director shall have a casting vote .


### the board may contract for the fund borrowings or other forms of support from financial institutions or other third parties , in the event that the amounts raised in accordance with articles 66 and 67 are not immediately accessible or sufficient to cover the expenses incurred by the use of the fund . ### the board shall seek to contract for the fund borrowings or other forms of support from financial institutions or other third parties , in the event that the amounts raised in accordance with articles 66 and 67 are not immediately accessible or sufficient to cover the expenses incurred by the use of the fund . if the board fails to secure borrowings , it should make use of the loan facility established according to article 64 paragraph 2 a .


### a delegated act adopted pursuant to articles 62 , 65 , 66 , 67 and 70 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 62 , 65 , 66 , 67 and 70 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by three months at the initiative of the european parliament or the council .


### in order to ensure the collection of any necessary additional data about the safety of authorised medicinal products , competent authorities should be empowered to require post - authorisation safety studies at the time of the granting of the marketing authorisation or later , and this requirement should be included as a condition of the marketing authorisation . ### in order to ensure the collection of any necessary additional data about the safety of authorised medicinal products , competent authorities should be empowered to require post - authorisation safety studies at the time of the granting of the marketing authorisation or later , and this requirement should be included as a condition of the marketing authorisation . if the conditions included in the marketing authorisation are not met within the deadline set , the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation .


### risk management system : a set of pharmacovigilance activities and interventions designed to identify , characterise , prevent or minimise risks relating to a medicinal product , including the assessment of the effectiveness of those interventions . ### risk management system : a set of pharmacovigilance activities and interventions designed to identify , characterise , prevent or minimise risks already detected , and risks identified subsequently , relating to a medicinal product , including the assessment of the effectiveness of those interventions .


### 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 statements shall be included : &#8220 ; this newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions . all suspected adverse reactions should be reported to , or reported directly to the pharmacy ' ; an exclamation mark surrounded by a red triangle . this symbol shall also appear on the outer packaging , accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product .


### article 63 of regulation no 726 / 2004 shall apply to the coordination group as regards the transparency and independence of its members . ### article 63 of regulation no 726 / 2004 shall apply to the coordination group as regards the transparency and independence of its members from both the agency and marketing authorisation holders .


### the administrative board shall adopt , in accordance with the procedure provided for in article 110 of the staff regulations , a decision based on article 2 of the staff regulations and on article 6 of the conditions of employment of other servants delegating the relevant appointing authority powers to the executive director and defining the conditions under which this delegation of powers can be suspended . the executive director shall be authorised to sub - delegate these powers . ### the administrative board shall adopt , in accordance with the procedure provided for in article 110 of the staff regulations , a decision based on article 2 of the staff regulations and on article 6 of the conditions of employment of other servants delegating the relevant appointing authority powers to the executive director and defining the conditions under which this delegation of powers can be suspended . the executive director shall report back to the administrative board on these delegated powers . the executive director shall be authorised to sub - delegate these powers .


### the administrative board shall appoint the executive director and may extend or end his term of office pursuant to article 15c . it shall exercise disciplinary authority over the executive director . ### the administrative board shall appoint the executive director and may extend or end his term of office pursuant to article 15c and . it shall exercise disciplinary authority over the executive director .


### he / she shall ensure that the agency , as the operator of the gsmc , is able to respond to instructions provided under joint action 2004 / 552 / cfsp ; ### he / she shall ensure that the agency , as the operator of the gsmc , is able to respond to instructions provided under joint action 2004 / 552 / cfsp and in the role attributed to it in article 6 of decision no 1104 / 2011 / eu ;


### he / she shall draw up an anti - fraud strategy for the agency and submit it to the administrative board for approval . ### he / she shall draw up an anti - fraud strategy and a strategy for preventing and managing conflict of interests for the agency and submit it to the administrative board for approval .


### based on the multiannual work programme , the annual work programme referred to in article 6 lays down the actions that the agency must perform during the coming year , including actions associated with international relations and the communication for which it is responsible . this programme shall determine the human and financial resources assigned to each activity . for information purposes , it shall include the tasks that the commission has delegated , as required , to the agency pursuant to article [ 15 ] of the regulation . ### based on the multiannual work programme , the annual work programme referred to in article 6 lays down the actions that the agency must perform during the coming year , including actions associated with international relations and the communication for which it is responsible . this programme shall determine the human and financial resources assigned to each activity . for information purposes , it shall include the tasks that the commission has delegated , as required , to the agency pursuant to article [ 15 ] of the regulation . the work programme shall include appropriate performance indicators which enable the results achieved to be effectively evaluated . ’


### the security accreditation board and the agency staff under its supervision shall perform their work in a manner ensuring autonomy and independence in relation to the other activities of the agency , particularly operational activities associated with the exploitation of the systems . ### the security accreditation board and the agency staff under its supervision shall perform their work in a manner ensuring autonomy and independence in relation to the other activities of the agency , particularly operational activities associated with the exploitation of the systems . the security accreditation board shall immediately inform the executive director and the administration board of any circumstances that could hamper its autonomy and independence . the security accreditation board shall immediately inform the european parliament and the council if no remedy has been taken .


### the executive director shall be appointed by the administrative board on the grounds of merit and documented administrative and managerial skills , as well as relevant competence and experience , from a list of candidates proposed by the commission , after an open and transparent competition , following publication a call for expressions of interest in the official journal of the european union and elsewhere . ### the executive director shall be appointed by the administrative board on the grounds of merit and documented administrative and managerial skills , as well as relevant competence and experience , from a list of candidates proposed by the commission , after an open and transparent competition , following publication a call for expressions of interest in the official journal of the european union and elsewhere . before being appointed , the candidate selected by the administrative board shall be invited at the earliest opportunity to make a statement before the european parliament and to answer questions from its members .


### 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 . ### 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 . those 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 and observers of the administrative board and the security accreditation board shall also make those declarations which shall be public together with their curricula vitae . the agency shall publish on its website a list of the members of the administrative board and the security accreditation board and a list of external and in - house experts .


### before any meeting which they are to attend , external experts participating in ad hoc working groups shall declare the absence of any interest which might place their independence in question in view of the items on the agenda . ### before any meeting which they are to attend , external experts participating in ad hoc working groups shall declare the absence of any interest which might place their independence in question in view of the items on the agenda . the agency shall adopt and implement a policy to evaluate and manage potential conflicts of interest of seconded national experts including prohibiting them from attending working group meetings when their independence and impartiality could be undermined . the executive director shall include the information relating to the implementation of that policy when reporting to the european parliament and the council in accordance with this regulation .


### the commission shall submit the evaluation report and its conclusions with regard to the content of this report to the european parliament , the council , the administrative board and the security accreditation board of the agency . the results of the evaluation shall be made available to the public . ### the commission shall submit the evaluation report and its conclusions with regard to the content of this report to the european parliament , the council , the administrative board and the security accreditation board of the agency . in addition , the commission shall provide the european parliament , the council and the national parliaments with any other information on the evaluation if requested . the results of the evaluation shall be made available to the public .


### this regulation shall enter into force on the [ twentieth ] day following its publication in the official journal of the european union . ### this regulation shall enter into force on the [ twentieth ] day following its publication in the official journal of the european union . it shall be consolidated with the regulation it is amending within three months of its publication .


### council decision 94 / 800 / ec of 22 december 1994 concerning the conclusion on behalf of the european community , as regards matters within its competence , of the agreements reached in the uruguay round multilateral negotiations approved in particular the world trade organisation agreement on government procurement , hereinafter referred to as the ‘ agreement’ . the aim of the agreement is to establish a multilateral framework of balanced rights and obligations relating to public contracts with a view to achieving the liberalisation and expansion of world trade . for contracts covered by the agreement , as well as by other relevant international agreements by which the union is bound , contracting entities fulfil the obligations under those agreements by applying this directive to economic operators of third countries that are signatories to the agreements . ### council decision 94 / 800 / ec of 22 december 1994 concerning the conclusion on behalf of the european community , as regards matters within its competence , of the agreements reached in the uruguay round multilateral negotiations approved in particular the world trade organisation agreement on government procurement , hereinafter referred to as the ‘ agreement’ . the aim of the agreement is to establish a multilateral framework of balanced rights and obligations relating to public contracts with a view to achieving the liberalisation and expansion of world trade . this agreement has been subject to a review which ended in march 2012 ; the main objectives of the review were to increase the degree of openness of markets in the sector , expand its coverage , eliminate discriminatory measures and increase transparency in procedures . for contracts covered by the agreement , as well as by other relevant international agreements by which the union is bound , including commitments entered into under the framework of bilateral trade agreements , contracting entities fulfil the obligations under those agreements by applying this directive to economic operators of third countries that are signatories to the agreements . in this regard , it is necessary for the international commitments entered into by the union with regard to third countries on access to the public procurement market to be transposed into the union’s legal order so as to guarantee their effective and uniform application .


### the agreement applies to contracts above certain thresholds , set in the agreement and expressed as special drawing rights . the thresholds laid down by this directive should be aligned to ensure that they correspond to the euro equivalents of the thresholds of the agreement . provision should also be made for periodic reviews of the thresholds expressed in euros so as to adjust them , by way of a purely mathematical operation , to possible variations in the value of the euro in relation to the special drawing right . to avoid a multiplication of thresholds it is furthermore appropriate , without prejudice to the international commitments of the union , to continue to apply the same thresholds to all contracting entities , regardless of the sector in which they operate . ### the agreement applies to contracts above certain thresholds , set in the agreement and expressed as special drawing rights . the thresholds laid down by this directive should be aligned to ensure that they correspond to the euro equivalents of the thresholds of the agreement . provision should also be made for periodic reviews of the thresholds expressed in euros so as to adjust them , by way of a purely mathematical operation , to possible variations in the value of the euro in relation to the special drawing right . to avoid a multiplication of thresholds it is furthermore appropriate , without prejudice to the international commitments of the union , to continue to apply the same thresholds to all contracting entities , regardless of the sector in which they operate . it is also appropriate for this periodic review of the thresholds to be undertaken not least on the basis of a preliminary assessment of the correct implementation of the principle of substantial reciprocity in the opening up of the market between the union and the other signatories to the agreement . the assessment of substantial reciprocity is also valid for third countries which do not adhere to the agreement on public procurement but which enjoy access to the european public procurement market .


### public contracts should not be awarded to economic operators that have participated in a criminal organisation or have been found guilty of corruption , fraud to the detriment of the union’s financial interests or money laundering . non - payment of taxes or social security contributions should also be sanctioned by mandatory exclusion at the level of the union . given that contracting entities , which are not contracting authorities , might not have access to indisputable proof on the matter , it is appropriate to leave the choice of whether or not to apply the exclusion criteria listed in directive [ 2004 / 18 ] to such contracting entities . the obligation to apply article 55 and of directive [ 2004 / 18 ] should therefore be limited to contracting entities that are contracting authorities . furthermore , contracting entities should be given the possibility to exclude candidates or tenderers for violations of environmental or social obligations , including rules on accessibility for disabled persons or other forms of grave professional misconduct , such as violations of competition rules or of intellectual property rights . ### public contracts should not be awarded to economic operators that have participated in a criminal organisation or have been found guilty of corruption , fraud to the detriment of the union’s financial interests or money laundering . non - payment of taxes or social security contributions and violations of environmental or social obligations , including rules on accessibility for disabled persons , should also be sanctioned by mandatory exclusion at the level of the union . given that contracting entities , which are not contracting authorities , might not have access to indisputable proof on the matter , it is appropriate to leave the choice of whether or not to apply the exclusion criteria listed in directive [ 2004 / 18 ] to such contracting entities . the obligation to apply article 55 and of directive [ 2004 / 18 ] should therefore be limited to contracting entities that are contracting authorities . furthermore , contracting entities should be given the possibility to exclude candidates or tenderers for forms of grave professional misconduct , such as violations of competition rules or of intellectual property rights .


### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . those criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting entities require high - quality works , supplies and services that are optimally suited to their needs . as a result , contracting entities should be allowed to adopt as award criteria either ' the most economically advantageous tender ' or ' the lowest cost ' , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions . ### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . those criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting entities require high - quality works , supplies and services that are optimally suited to their needs . as a result , contracting entities should be allowed to adopt as the award criterion ' the most economically advantageous tender ' .


### where contracting entities choose to award a contract to the most economically advantageous tender , they must determine the award criteria on the basis of which they will assess tenders in order to identify which one offers the best value for money . the determination of those criteria depends on the subject - matter of the contract , since they must allow the level of performance offered by each tender to be assessed in the light of the subject - matter of the contract , as defined in the technical specifications , and the value for money of each tender to be measured . furthermore , the chosen award criteria should not confer an unrestricted freedom of choice on the contracting entity and they should ensure the possibility of effective competition and be accompanied by requirements that allow the information provided by the tenderers to be effectively verified . ### with a view to awarding a contract to the most economically advantageous tender , contracting entities must determine the award criteria on the basis of which they will assess tenders in order to identify which one offers the best value for money . the determination of those criteria depends on the subject - matter of the contract , since they must allow the level of performance offered by each tender to be assessed in the light of the subject - matter of the contract , as defined in the technical specifications , and the value for money of each tender to be measured . furthermore , the chosen award criteria should not confer an unrestricted freedom of choice on the contracting entity and they should ensure the possibility of effective competition and be accompanied by requirements that allow the information provided by the tenderers to be effectively verified .


### tenders that appear abnormally low in relation to the works , supplies or services might be based on technically , economically or legally unsound assumptions or practices . in order to prevent possible disadvantages during contract performance , contracting entities should be obliged to ask for an explanation of the price charged where a tender significantly undercuts the prices demanded by other tenderers . where the tenderer cannot provide a sufficient explanation , the contracting entity should be entitled to reject the tender . rejection should be mandatory in cases where the contracting entity has established that the abnormally low price results from non - compliance with mandatory union legislation in the fields of social , labour or environmental law or international labour law provisions . ### tenders that appear abnormally low in relation to the works , supplies or services might be based on technically , economically or legally unsound assumptions or practices . in order to prevent possible disadvantages during contract performance , contracting entities should have the option of excluding tenders that significantly undercut the prices demanded by other tenderers and should be obliged to ask for an explanation of the price charged where a tender significantly undercuts the prices demanded by other tenderers . where the tenderer cannot provide a sufficient explanation , the contracting entity should be entitled to reject the tender . rejection should be mandatory in cases where the contracting entity has established that the abnormally low price results from non - compliance with mandatory union legislation in the fields of social , labour or environmental law or international labour law provisions .


### it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . when preparing and drawing up delegated acts , the commission should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . when preparing and drawing up delegated acts , the commission should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . the commission should provide full information and documentation on its meetings with national experts within the framework of the preparation and implementation of delegated acts . in this respect , the commission should ensure that the european parliament is duly involved , drawing on best practices from previous experience in other policy areas in order to create the best possible conditions for future scrutiny of delegated acts by the european parliament .


### in accordance with the calculation method set out in the government procurement agreement , the commission shall calculate the value of those thresholds on the basis of the average daily value of the euro in terms of the special drawing rights , over a period of 24 months terminating on the last day of august preceding the revision with effect from 1 january . the value of the thresholds thus revised shall , where necessary , be rounded down to the nearest thousand euros so as to ensure that the thresholds in force provided for by the agreement , expressed in sdr , are observed . ### in accordance with the calculation method set out in the government procurement agreement , the commission shall calculate the value of those thresholds on the basis of the average daily value of the euro in terms of the special drawing rights , over a period of 24 months terminating on the last day of august preceding the revision with effect from 1 january . the value of the thresholds thus revised shall , where necessary , be rounded down to the nearest thousand euros so as to ensure that the thresholds in force provided for by the agreement , expressed in sdr , are observed . the commission may also take into consideration the variations in the thresholds made by the other parties to the agreement .


### as far as covered by annexes&#160 ; iii , iv and v and the general notes to the european union ' s appendix&#160 ; 1 to the government procurement agreement and by the other international agreements by which the union is bound , as listed in annex&#160 ; v to this directive , contracting entities within the meaning of article&#160 ; 4 shall accord to the works , supplies , services and economic operators of the signatories to those agreements treatment no less favourable than the treatment accorded to the works , supplies , services and economic operators of the union . by applying this directive to economic operators of the signatories to those agreements contracting entities shall comply with those agreements . ### as far as covered by annexes&#160 ; iii , iv and v and the general notes to the european union ' s appendix&#160 ; 1 to the government procurement agreement and by the other international agreements by which the union is bound &#8212 ; &#160 ; including the commitments entered into within the framework of bilateral trade agreements , as listed in annex&#160 ; v to this directive , contracting entities within the meaning of article&#160 ; 4 shall accord to the works , supplies , services and economic operators of the signatories to those agreements treatment no less favourable than the treatment accorded to the works , supplies , services and economic operators of the union . by applying this directive to economic operators of the signatories to those agreements contracting entities shall comply with those agreements .


### contracting entities may decide not to award a contract to the tenderer submitting the best tender where they have established that the tender does not comply , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xiv . ### contracting entities shall not award a contract to the tenderer submitting the best tender where they have established that the tender does not comply , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xiv .


### without prejudice to national laws , regulations or administrative provisions on the remuneration of certain services , the criteria on which contracting entities shall base the award of contracts shall be one of the following : ### without prejudice to national laws , regulations or administrative provisions on the remuneration of certain services , the criterion on which contracting entities shall base the award of contracts shall be the most economically advantageous tender .


### the most economically advantageous tender referred to in point of paragraph 1 ) from the point of view of the contracting entity shall be identified on the basis of criteria linked to the subject - matter of the contract in question . ### the most economically advantageous tender from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question .


### those criteria shall include in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the contract in question , such as : ### those criteria shall include in addition to the price or costs – assessed , at the choice of the contracting entity , on the basis of price only or using a cost - effectiveness approach , such as a life - cycle costing approach , under the conditions set out in article 77 - other criteria linked to the subject - matter of the contract in question , such as :


### in the case referred to in point of paragraph 1 , the contracting entity shall specify the relative weighting which it gives to each of the criteria chosen to determine the most economically advantageous tender . ### the contracting entity shall specify the relative weighting which it gives to each of the criteria chosen to determine the most economically advantageous tender .


### where tenders appear to be abnormally low for other reasons , contracting entities may also request such explanations . ### in any case , where tenders appear to be abnormally low for other reasons , contracting entities must also request such explanations .


### the possibility of the tenderer obtaining state aid . ### the possibility of the tenderer obtaining state aid both for the financing of the tender itself , and for the financing of the services , supplies , and works relating to the tender .


### the delegation of power referred to in articles 4 , 35 , 33 , 38 , 25 , 65 , 70 , 77 , 85 and 95 shall be conferred on the commission for an indeterminate period of time from the [ date of entry into force of this directive ] . ### the delegation of power referred to in articles 4 , 35 , 33 , 38 , 25 , 65 , 70 , 77 , 85 and 95 shall be conferred on the commission for a period of five years from . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### a delegated act adopted pursuant to article 98 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of 2 months of notification of the act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 98 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of 2 months of notification of the act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by four months at the initiative of the european parliament or the council .


### 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 and efficiency needed for waste shipment inspections in the member states 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 a systematic approach for regular and consistent planning of inspections . planning should include a number of key elements , including analysis , risk assessments , strategies , objectives , priorities , numbers and types of planned inspections , the facilities for collection , storage and sorting of waste , assignment of tasks , means of cooperation between authorities , as well as provisions on training and qualification of the controlling and inspecting bodies .


### 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 power and 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 therefore provides the possibility for competent authorities in member states to require evidence from suspected illegal waste exporters in order to check the legality of shipments .


### illegal waste shipments frequently stem from uncontrolled collection , storage and sorting facilities . inspection requirements should therefore be introduced for such waste sites . ### the process of waste shipment is related to the operation of collection , storage and sorting facilities and operators , and subject to registration and / or licensing regiment . illegal waste shipments frequently stem from collection , storage and sorting facilities , as well as from omissions in the national legislation of the member states or insufficient control thereof . strict inspection requirements for illegal waste sites and when necessary modifications in the relevant national legislations should therefore be introduced .


### the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission with the objective to adopt technical and organisational requirements for the practical implementation of electronic data interchange . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission with the objective to adopt unified technical and organisational requirements for the introduction and / or practical implementation of electronic data interchange . it is of particular importance that the commission carry out appropriate consultations with member states and stakeholders during its preparatory work , including at expert level .


### “re - use” means any operation by which products or components that are not waste are used again for the same purpose for which they were conceived . ### ' re - use ' means any operation by which products or components that have fulfilled their intended purpose , have preserved their qualities and are not waste , are used again for the same purpose for which they were conceived .


### an assessment of the need for training of inspectors on technical or legal matters relating to waste management and waste shipments and provisions on regular training programmes . ### an assessment of the need for training of inspectors and provisions on regular training programmes .


### specific and technical data on the authentic goods , including images where appropriate ; ### specific and technical data on the authentic goods , including marking , such as bar - coding , and images where appropriate ;


### any information relevant to the customs authorities ' analysis and assessment of the risk of infringement of the intellectual property right concerned ; ### any information relevant to the customs authorities ' analysis and assessment of the risk of infringement of the intellectual property right concerned , such as the authorised distributors ;


### the measures necessary for the implementation of this directive should be adopted in accordance with council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission . ### in order to ensure uniform conditions for the implementation of articles 10 , 11 , 14 and 17 of this directive implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers .


### ‘ railway infrastructure’ means all the items listed in annex i . a to commission regulation no 2598 / 70 of 18 december 1970 specifying the items to be included under the various headings in the forms of accounts shown in annex i to regulation no 1108 / 70 of 4 june 1970 which for reasons of clarity are included in annex i to this directive ; ### ‘ railway infrastructure’ means all the items listed in annex i to this directive ;


### annex iv may be amended in the light of experience in accordance with the procedure referred to in article 60 . ### annex iv may be amended in the light of experience in order to update the information needed for the rail market monitoring in accordance with the procedure referred to in article 60 .


### annex viii , point 5 may be amended in the light of experience in accordance with the procedure referred to in article 60 . ### annex viii , point 5 may be amended in the light of experience in accordance with the procedure referred to in article 60 in order to further promote ertms .


### 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 , and having due regard to articles 93 , 107 and 108 of the treaty , member states shall 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 .


### the commission may adopt implementing measures setting out the details of the procedure to be followed for the application of this paragraph . those measures , designed to ensure the implementation of this directive under uniform conditions shall be adopted as implementing acts in accordance with article 63 . ### the commission may adopt implementing measures specifying the procedural modalities of the cooperation procedure referred to in the previous subparagraph . those implementing measures , designed to ensure the implementation of this directive under uniform conditions shall be adopted as implementing acts in accordance with the advisory procedure referred to in article 64 .


### where the infrastructure manager offers any of the range of services described in annex iii , point 3 as additional services , he shall supply them upon request to railway undertakings in a non - discriminatory manner . ### where the operator of the service offers any of the range of services described in annex iii , point 3 as additional services , he shall supply them upon request to railway undertakings in a non - discriminatory manner .


### the commission may adopt implementing measures setting out the details of the procedure to be followed for the application of this article including the use of a common template for the licence . those measures , designed to ensure the implementation of this directive under uniform conditions shall be adopted as implementing acts in accordance with article 63 . ### the commission may adopt implementing measures specifying the procedural modalities to be followed for the issuing of licences and setting up of a common template for the licence in accordance with the requirements set out in section 2 . those implementing measures , designed to ensure the implementation of this directive under uniform conditions shall be adopted as implementing acts in accordance with the advisory procedure referred to in article 64 .


### for the purposes of the commission ' s market monitoring , member states shall supply on an annual basis the information indicated in annex iv , as well as all other necessary data requested by the commission . ### for the purposes of the commission ' s market monitoring , member states shall supply on an annual basis the following information indicated as annex iv , as well as all other necessary data requested by the commission : the evolution of rail transport performance and compensation for public service obligations ; the modal share of railway undertakings in total transport performance ; the resources and activities of regulatory bodies dedicated to their functioning as appeal bodies ; the relevant developments as regards restructuring of the incumbent railway undertaking and adoption / implementation of national transport strategies over the previous year ; the important training initiatives / measures in the field of railway transport taken in a member state during the previous year ; the employment and the social conditions of railway undertakings , infrastructure managers and of other companies active in the railway sector at the end of the previous year ; the investments in the high - speed rail network during the previous year ; the length of the railway network a the end of the previous year ; the track access charges during the previous year ; the existence of a performance scheme set up according to article 35 of this directive ; the number of active licences issued by the competent national authority ; the status of ertms deployment ; the number of incidents , accidents and serious accidents as defined by directive 2004 / 49 / ec which occurred on the network during the previous year ; other relevant developments .


### the commission shall monitor the use of the networks and the evolution of framework conditions in the rail sector , in particular infrastructure charging , capacity allocation , investments in railway infrastructure , developments as regards prices and the quality of rail transport services , rail transport services covered by public service contracts , licensing and the degree of harmonisation between member states . it shall ensure active cooperation between the appropriate regulatory bodies in the member states . ### the commission shall monitor the use of the networks and the evolution of framework conditions in the rail sector , in particular infrastructure charging , capacity allocation , investments in railway infrastructure , developments as regards prices and the quality of rail transport services , the quality of rail transport services covered by public service contracts , licensing , employment and social conditions and the degree of harmonisation between member states .


### for the purposes of the commission ' s market monitoring , member states shall supply on an annual basis the information indicated in annex iv , as well as all other necessary data requested by the commission . ### for the purposes of the commission ' s market monitoring , member states shall supply on an annual basis the following information as indicated in annex iv , as well as all other necessary data requested by the commission : the evolution of rail transport performance and compensation for public service obligations ; the modal share of railway undertakings in total transport performance ; the resources and activities of regulatory bodies dedicated to their functioning as appeal bodies ; the relevant developments as regards restructuring of the incumbent railway undertaking and adoption / implementation of national transport strategies over the previous year ; the important training initiatives / measures in the field of railway transport taken in a member state during the previous year ; the employment and the social conditions of railway undertakings and infrastructure managers at the end of the previous year ; the investments in the high - speed rail network during the previous year ; the length of the railway network at the end of the previous year ; the track access charges during the previous year ; the existence of a performance scheme set up according to article 35 of this directive ; the number of active licences issued by the competent national authority ; the status of ertms deployment ; the number of incidents , accidents and serious accidents as defined by directive 2004 / 49 / ec which occurred on the network during the previous year ; other relevant developments .


### the requirements relating to financial fitness shall be met when an applicant railway undertaking can demonstrate that it will be able to meet its actual and potential obligations , established under realistic assumptions , for a period of twelve months . ### the requirements relating to financial fitness shall be met when an applicant railway undertaking can demonstrate that it will be able to meet its actual and potential obligations , established under realistic assumptions , for a period of twelve months . licensing authorities shall verify financial fitness by means of a railway undertaking ' s annual accounts or , in the case of applicant undertakings unable to present annual accounts , a balance sheet .


### for these purposes , each applicant shall give at least the particulars listed in annex v . ### for these purposes , each applicant shall provide detailed particulars on the following aspects : available funds , including the bank balance , pledged overdraft provisions and loans ; funds and assets available as security ; working capital ; relevant costs , including purchase costs of payments to account for vehicles , land , buildings , installations and rolling stock ; charges on an undertaking ' s assets ; taxes and social security contributions .


### 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 road freight 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 . such modification of infrastructure charges shall allow for compensation for investments in retrofitting rail vehicles with the most economically viable low - noise braking technology available . member states shall ensure that the introduction of such differentiated charges shall not have any adverse effect on the financial equilibrium of the infrastructure manager .


### the infrastructure manager shall , after consultation with the interested parties , including the regulatory body referred to in article 55 , &#160 ; develop and publish a network statement obtainable against payment of a &#160 ; fee&#160 ; which &#160 ; shall&#160 ; not exceed the cost of &#160 ; publication of&#160 ; that statement . the network statement shall be published in at least two official languages of the union . the content of the network statement shall be made available free of charge in electronic format through the web portal of the european railway agency . &#160 ; ### the infrastructure manager shall , after consultation with the interested parties , including the regulatory body referred to in article 55 , develop and publish a network statement obtainable against payment of a fee which shall not exceed the cost of publication of that statement . the network statement shall be published in at least two official languages of the union , one of which shall be english . the content of the network statement shall be made available free of charge in electronic format through the web portal of the european railway agency .


### the network statement shall set out the nature of the infrastructure which is available to railway undertakings . it shall contain information setting out the conditions for access to the relevant railway infrastructure and to service facilities . the content of the network statement is laid down in annex vi . ### the network statement shall set out the nature of the infrastructure which is available to railway undertakings . it shall contain the following information setting out the conditions for access to the relevant railway infrastructure and to service facilities : a section setting out the nature of the infrastructure which is available to railway undertakings and the conditions of access to it . &#160 ; a section on charging principles and tariffs . a section on the principles and criteria for capacity allocation . operators of service facilities which are not controlled by the infrastructure manager shall supply information on charges for gaining access to the facility and for the provision of services , and information on technical access conditions for inclusion in the network statement . a section on information relating to the application for a licence referred to in article 25 and rail safety certificates issued in accordance with directive 2004 / 49 / ec1 . a section on information about procedures for dispute resolution and appeal relating to matters of access to rail infrastructure and services and to the performance scheme referred to in article 35 . a section on information on access to and charging for service facilities referred to in annex iii . a model agreement for the conclusion of framework agreements between an infrastructure manager and an applicant in accordance with article 42 . the information in the network statement shall be annually updated and consistent with or refer to the rail infrastructure registers to be published in accordance with article 35 of directive 2008 / 57 / ec . infrastructure that is not appropriately maintained and its quality declining shall be reported in a timely manner to users ; the information in points to may be amended and specified by the commission in accordance with annex vi in the light of experience following the procedure referred to in article 60 . 1 oj l 164 , 30 . 4 . 2004 , p . 44 .


### member states shall ensure that representatives of infrastructure managers whose charging decisions have an impact on other infrastructures associate to coordinate the charging or to charge for the use of relevant infrastructure at international level . ### member states shall ensure that representatives of infrastructure managers whose charging decisions have an impact on other infrastructures associate to jointly coordinate the charging or to charge for the use of relevant infrastructure at international level .


### the regulatory body shall also have the power to monitor the competition in the rail services markets and review points to of paragraph 1 on its own initiative and with a view to preventing discrimination between applicants . it shall , in particular , check whether the network statement contains discriminatory clauses or creates discretionary powers for the infrastructure manager that may be used to discriminate between applicants . the regulatory body shall have the necessary organisational capacity to carry out these tasks . ### the regulatory body shall have the power to monitor the competition and to correct undesirable developments in the rail services markets and review points to of paragraph 1 on its own initiative and with a view to preventing discrimination between applicants , including through appropriate corrective measures . it shall , in particular , check whether the network statement contains discriminatory clauses or creates discretionary powers for the infrastructure manager that may be used to discriminate between applicants . to this end , the regulatory body shall also cooperate closely with the national safety authority responsible for assessing the conformity or suitability for use of interoperability constituents or for appraising the ‘ ec’ procedure for verification of subsystems in accordance with directive 2008 / 57 / ec .


### without prejudice to article 258 of the treaty , any member state may refer the commission ' s decision to the council within a time limit of one month from the date of the decision . the council , acting by a qualified majority , may in exceptional circumstances take a different decision within a period of one month from the date of the referral . ### at the request of a member state or on its own initiative the commission shall , in a specific case , examine the application and enforcement of the provisions of this directive , and adopt a decision thereon in accordance with the procedure referred to in article 64 .


### measures designed to ensure the implementation of the directive under uniform conditions shall be adopted by the commission as implementing acts in accordance with the procedure referred to in article 64 . ### measures designed in accordance with articles 10 , 11 , 14 and 17 to ensure the implementation of the directive under uniform conditions shall be adopted by the commission as implementing acts in accordance with the procedure referred to in article 64 .


### the commission shall be assisted by a committee . ### the commission shall be assisted by the committee established by this directive . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### where reference is made to this paragraph , articles 3 and 7 of decision 1999 / 468 / ec shall apply , having regard to the provisions of article 8 thereof . ### where reference is made to this paragraph , articles 4 and 11 of regulation no 182 / 2011 shall apply .


### where reference is made to this paragraph , article 5 , and article 7 of decision 1999 / 468 / ec shall apply , having regard to the provisions of article 8 thereof . ### where reference is made to this paragraph , articles 5 and 11 of regulation no 182 / 2011 shall apply .


### the network statement referred to in article 27 shall contain the following information : ### the sections of the network statement referred to in article 27 shall contain the following information :


### a section on charging principles and tariffs . this shall contain appropriate details of the charging scheme as well as sufficient information on charges as well as other relevant information on access applying to the services listed in annex iii which are provided by only one supplier . it shall detail the methodology , rules and , where applicable , scales used for the application of articles 31 to 36 , as regards both costs and charges . it shall contain information on changes in charges already decided upon or foreseen in the next five years . ### the section on charging principles and tariffs shall contain appropriate details of the charging scheme as well as sufficient information on charges as well as other relevant information on access applying to the services listed in annex iii which are provided by only one supplier . it shall detail the methodology , rules and , where applicable , scales used for the application of articles 31 and to 36 , as regards both costs and charges . it shall contain information on changes in charges already decided upon or foreseen in the next five years .


### a section on the principles and criteria for capacity allocation . this shall set out the general capacity characteristics of the infrastructure which is available to railway undertakings and any restrictions relating to its use , including likely capacity requirements for maintenance . it shall also specify the procedures and deadlines which relate to the capacity allocation process . it shall contain specific criteria which are employed during that process , in particular : ### the section on the principles and criteria for capacity allocation shall set out the general capacity characteristics of the infrastructure which is available to railway undertakings and any restrictions relating to its use , including likely capacity requirements for maintenance . it shall also specify the procedures and deadlines which relate to the capacity allocation process . it shall contain specific criteria which are employed during that process , in particular :


### the scope of the agreement as regards infrastructure and service facilities , structured according to annex iii . it shall cover all aspects of infrastructure development , including maintenance and renewal of the infrastructure already in operation . construction of new infrastructure may be included as a separate item ; ### the scope of the agreement as regards infrastructure and service facilities , structured according to annex iii . it shall cover all aspects of maintenance and renewal of the infrastructure already in operation . construction of new infrastructure may be included as a separate item ;


### the structure of agreed payments apportioned to the infrastructure services listed in annex iii , to maintenance , to construction of new infrastructure and to dealing with existing maintenance backlogs ; ### the structure of agreed payments apportioned to the infrastructure services listed in annex iii , to maintenance , including renewal and upgrading , and to dealing with existing maintenance backlogs ; payments to new infrastructure may be included as a separate item ;


### network capacity , ### network capacity and the availability of infrastructure ,


### a mechanism that ensures that a significant share of cost reductions is passed on to users in the form of a reduced level of charges ; ### a mechanism that ensures that a significant share of cost reductions is passed on to users in the form of a reduced level of charges , in accordance with the requirements of article 30 , without compromising the balancing of the infrastructure manager ' s accounts as required under article 8 ;


### for freight transport ### for freight transport :


### for passenger transport ### for passenger transport :


### article 8a of the directive 2002 / 21 / ec of the european parliament and of the council of 7 march 2002 on a common regulatory framework for electronic communications networks and services provides that the commission may submit a legislative proposal to the european parliament and council for establishing multiannual radio spectrum policy programmes setting out policy orientations and objectives for the strategic planning and harmonisation of the use of spectrum in accordance with the directives applicable to electronic communications networks and services . these policy orientations and objectives should refer to the availability and efficient use of spectrum necessary for the establishment and functioning of the internal market . this decision is without prejudice to existing eu law , in particular directives 1999 / 5 / ec and directives 2002 / 20 / ec and 2002 / 21 / ec , as well as decision no 676 / 2002 / ec . it is also without prejudice to measures taken at national level , in compliance with eu law , to pursue general interest objectives , in particular relating to content regulation and audio - visual policy and to the right of member states to organise and use their spectrum for public order and public security purposes and defence . ### article 8a of directive 2002 / 21 / ec of the european parliament and of the council of 7 march 2002 on a common regulatory framework for electronic communications networks and services as amended by directive 2009 / 140 / ec of the european parliament and of the council of 25 november 20091 provides that the commission may submit a legislative proposal to the european parliament and council for establishing multiannual radio spectrum policy programmes setting out policy orientations and objectives for the strategic planning and harmonisation of the use of spectrum in accordance with the directives applicable to electronic communications networks and services . these policy orientations and objectives should refer to the availability and efficient use of spectrum necessary for the establishment and functioning of the internal market . furthermore , having realised that there is a real risk of interference in the general reception of audiovisual broadcasting , be it analogue or not , such policies and the market it refers to must ensure a strong consumer rights protection and proper public information on the forthcoming change . 1 oj l 337 , 18 . 12 . 2009 , p . 37 .


### spectrum is a key resource for essential sectors and services , including mobile , wireless broadband and satellite communications , television and radio broadcasting , transport , radiolocation , and applications such as alarm , remote controls , hearing aids , microphones , and medical equipment . it supports public services such as security and safety services , including civil protection , and scientific activities , such as meteorology , earth observation , radio astronomy and space research . regulatory measures on spectrum therefore have economic , safety , health , public interest , cultural , scientific , social , environmental and technical implications . ### spectrum is a public good of major societal , cultural , social and economic value . it is a key resource for essential sectors and services , including mobile , wireless broadband and satellite communications , television and radio broadcasting , transport , radiolocation , and applications such as alarm , remote controls , hearing aids , wireless microphones , and medical equipment . it supports public services such as security and safety services , including civil protection , the facilitation of relations between the citizen and the state by means of electronic governance and scientific activities , such as meteorology , earth observation , radio astronomy and space research . regulatory measures on spectrum therefore have economic , safety , health , public interest , cultural , scientific , social , environmental and technical implications .


### 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 . 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 , culture 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 . 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 , employment creation and this will simultaneously contribute 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 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 specify guiding principles and objectives up to 2015 for member states and union institutions , and set out specific implementation initiatives . spectrum management is a national competence and must be exercised in compliance with existing eu law and allow for measures to be adopted to pursue an union spectrum policy . pursuant to article 8a of the framework directive , member states are required to cooperate with one another and with the commission in connection with the strategic planning , coordination and harmonisation of spectrum use .


### 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 , 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 as amended by directive 2009 / 140 / ec of 25 november 2009 and article 1 of directive 87 / 372 / eec as amended by directive 2009 / 114 / ec of 16 september 2009 .


### 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 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 private and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs .


### harmonised standards under directive 1999 / 5 / ec of the european parliament and of the council of 9 march 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity are essential to achieve efficient spectrum use and should take account of legally defined sharing conditions . european standards for non - radio electric and electronic equipment and networks should also avoid disturbance to spectrum use . the cumulative impact of the increasing volume and density of wireless devices and applications combined with the diversity of spectrum use challenges current approaches to interference management . these should be examined and reassessed together with receiver characteristics and more sophisticated interference avoidance mechanisms . ### harmonised standards under directive 1999 / 5 / ec of the european parliament and of the council of 9 march 1999 on radio equipment and telecommunications terminal equipment , the mutual recognition of their conformity and future harmonisations in respect of electronic networks and wireless devices are essential to achieve efficient spectrum use and should ensure the coexistence of existing and new applications . european standards for non - radio electric and electronic equipment and networks should also avoid disturbance to spectrum use . the cumulative impact of the increasing volume and density of wireless devices and applications combined with the diversity of spectrum use challenges current approaches to interference management . these should be examined and reassessed together with receiver characteristics - such as increasing reliability of receivers and appropriate output levels for emitting devices - and more sophisticated interference avoidance mechanisms .


### 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 , public protection and disaster relief , e - health and e - inclusion . optimising synergies and direct links 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 .


### spectrum regulation has strong cross - border or international dimensions , due to propagation characteristics , the international nature of markets dependent on radio - based services , and the need to avoid harmful interference between countries . moreover , the references to international agreements in directives 2002 / 21 / ec and 2002 / 20 / ec as amended means that member states shall not enter into international obligations that prevent or constrain the fulfilment of their union obligations . member states should , in accordance with the case - law , undertake all necessary efforts to enable appropriate representation of the union in matters under its competence in international bodies in charge of spectrum coordination . moreover , where union policy or competence is at stake , the union should politically drive the preparation of negotiations and play a role in multilateral negotiations , including in the international telecommunications union that corresponds to its level of responsibility for spectrum matters under union law . ### spectrum regulation has strong cross - border or international dimensions , due to propagation characteristics , the international nature of markets dependent on radio - based services , and the need to avoid harmful interference between countries . moreover , the references to international agreements in directives 2002 / 21 / ec and 2002 / 20 / ec as amended means that member states shall not enter into international obligations that prevent or constrain the fulfilment of their union obligations . member states should , in accordance with the case - law and in cooperation with the commission , examine what arrangements are needed to ensure appropriate representation of the union’s common interests in international bodies in charge of spectrum coordination and put the findings into practice without delay .


### the 2012 wrc includes specific issues of union relevance such as the digital dividend , scientific and meteorological services , sustainable development and climate change , satellite communications and the use of spectrum for galileo no 876 / 20029 setting up the galileo joint undertaking and council regulation no 1321 / 200410 on the establishment of structures for the management of the european satellite radio - navigation programmes ) , as well as the global monitoring for environment and security european programme11 for the improved use of earth observation data . ### to avoid the growing pressure on frequency band reserved for satellite navigation and satellite communication their bandwidth must be secured in the new planning of spectrum use ; the 2012 wrc includes specific issues of union relevance such as the digital dividend , scientific and meteorological services , sustainable development and climate change , satellite communications and the use of spectrum for galileo no 876 / 20029 setting up the galileo joint undertaking and council regulation no 1321 / 200410 on the establishment of structures for the management of the european satellite radio - navigation programmes ) , as well as the global monitoring for environment and security european programme11 for the improved use of earth observation data .


### the commission should report to the european parliament and the council on the results achieved under this decision , as well as on planned future actions . ### the commission will report to the european parliament and the council on the results achieved under this decision , as well as on planned future actions .


### this decision establishes a radio spectrum policy programme for the strategic planning and harmonisation of the use of spectrum to ensure the functioning of the internal market . ### this decision establishes a radio spectrum policy programme for the strategic planning , harmonisation and rationalisation of the use of spectrum to ensure the functioning of the internal market .


### applying the least onerous authorisation system possible in such a way as to maximise flexibility and efficiency in spectrum usage ; ### applying the most appropriate , transparent and flexible authorisation system possible in such a way as to maximise accessibility , flexibility and efficiency in spectrum usage ;


### in order to avoid possible fragmentation of the internal market due to divergent selection conditions and procedures for harmonised spectrum bands allocated to electronic communication services and made tradable in all member states pursuant to article 9b of directive 2002 / 21 / ec , the commission , in cooperation with member states , shall develop guidelines on authorisation conditions and procedures for such bands , in particular on infrastructure sharing and coverage conditions . ### in order to avoid possible fragmentation of the internal market due to divergent selection conditions and procedures for harmonised spectrum bands allocated to electronic communication services and made tradable in all member states pursuant to article 9b of directive 2002 / 21 / ec , the commission , in cooperation with member states and in accordance with the principle of subsidiarity , shall develop guidelines on authorisation conditions and procedures for such bands , in particular on infrastructure sharing and coverage conditions .


### competition ### regulatory principles for competition in the field of electronic communications


### member states may refuse to grant new rights of use or to allow new spectrum usages in certain bands , or may attach conditions to the grant of new rights of use or to the authorisation of new spectrum usages , when this would lead to an accumulation of spectrum frequencies by certain economic operators which is likely to result in significant harm to competition ; ### member states may refuse to grant new rights of use or to allow new spectrum usages in certain bands , or may attach conditions to the grant of new rights of use or to the authorisation of new spectrum usages , when this would lead to an accumulation of spectrum frequencies by certain economic operators , in cases where such accumulation is likely to result in significant harm to 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 significantly harms competition . ### member states may amend the existing rights in accordance with article 14 of the authorisation directive when this is necessary to remedy ex - post excessive accumulation of spectrum frequencies within certain economic operators which significantly harms competition .


### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition . ### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition . to that extent and to avoid lengthy discussions impeding roll - out , to the detriment of the customers , member states should consider the opportunity to set - up deadlines to the negotiations with landlords in relation to passive infrastructure deployment . after this time , it should be considered that no agreement has been made and give the possibility to start a new negotiation .


### member states shall ensure that authorisation and selection procedures avoid delays and promote effective competition . ### member states shall ensure that authorisation and selection procedures avoid delays , ensure predictable outcomes and promote investment and effective competition .


### member states , in cooperation with the commission , shall ensure that the provision of access to broadband content and services using the 790 - 862 mhz band is encouraged in sparsely populated areas , in particular through coverage obligations ; in doing so , they shall examine ways and , where necessary , take appropriate measures to ensure that the freeing of the 800 mhz band does not adversely affect programme making and special events users . ### member states , in cooperation with the commission , shall ensure that the provision of access to broadband content and services , for example using the 790 - 862 mhz bands , is guaranteed in sparsely populated areas , in particular through coverage obligations ; in doing so , they shall examine ways and , where necessary , take appropriate measures to ensure that the freeing of the 800 mhz band does not adversely affect programme making and special events users .


### 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 is invited to adopt , as a priority , appropriate measures , pursuant to article 9b of the framework directive , 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 .


### 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 . ### if necessary , the commission shall ensure the continued availability of spectrum 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 .


### 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 rural , remote and sparsely populated areas , member states and the commission shall ensure the availability of sufficient spectrum for the provision of satellite services enabling internet access and the delivery of audiovisual content . taking into account the appropriate compatibility studies , technical harmonisation of additional frequency bands may be considered in accordance with decision 676 / 2002 / ec .