### processing entities within the union shall ensure that their system is technically interoperable with other systems of processing entities within the union through the use of standards developed by international or european standardisation bodies . in addition , processing entities shall not adopt or apply business rules that restrict interoperability with other processing entities within the union . ### by . . . * [ one year after the entry into force of this regulation ] processing entities within the union shall ensure that their system is technically interoperable with other systems of processing entities within the union through the use of standards developed by international or european standardisation bodies . in addition , processing entities shall not adopt or apply business rules that restrict interoperability with other processing entities within the union . eba shall , in close cooperation with the sepa council , establish requirements to be complied with by payment systems , payment schemes and processing entities to ensure a fully open and competitive card processing market . those requirements shall be issued by . . . * [ two years from the date of entry into force of this regulation ] and shall be updated on a regular basis , as appropriate .


### this regulation follows a gradual approach . as a first step , it is necessary to take measures to facilitate cross - border issuing and acquiring of payment card transactions . allowing merchants to choose an acquirer outside their own member state and imposing a maximum level of cross border interchange fees for cross border acquired transactions should provide the necessary legal clarity . in addition , licences for issuing or acquiring of payment instruments should be valid without geographic restrictions within the union . these measures would facilitate the smooth functioning of an internal market for card , internet and mobile payments , to the benefit of consumers and retailers . ### this regulation applies equally to cross - border and to national issuing and acquiring of payment card transactions . if merchants can choose an acquirer outside their own member state , which will be facilitated by the imposition of a maximum level of cross - border interchange fees for acquired transactions and the prohibition of territorial licensing , it should be possible to provide the necessary legal clarity and to prevent distortions of competition between payment - card systems .


### any schemes rules and rules in licensing agreements that hinder or prevent an issuer from co - badging two or more different brands of payment instruments on a card , telecommunication , digital or it device shall be prohibited . ### any schemes rules and rules in licensing agreements or measures of equivalent effect that hinder or prevent an issuer from co - badging two or more different brands of payment instruments on a card , telecommunication , digital or it device shall be prohibited .


### for domestic transactions , a transition period is necessary to provide payment services providers and schemes with time to adapt to the new requirements . therefore , after a two year period following the entry into force of this regulation and in order to provide for a completion of an internal market for card - based payments , the caps on interchange fees for consumer card transactions should be extended to cover all , cross - border and domestic payments . ### for domestic transactions , a transition period is necessary to provide payment services providers and schemes with time to adapt to the new requirements . therefore , after a two year period following the entry into force of this regulation and in order to provide for a completion of an internal market for card - based payments , the rules on interchange fees for consumer card transactions should be extended to cover all , cross - border and domestic payments . in view of the trend in the past ten years , it is likely that the issue and use of consumer debit cards will continue to increase , with the result that , after the transitional period , the aim of encouraging the issue and use of debit cards will no longer justify retaining interchange payments for debit cards .


### four years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market . ### beginning six years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments .


### ‘ three party payment card scheme’ means a payment card scheme in which payments are made from a payment account held by the scheme on behalf of the cardholder to a payment account held by the scheme on behalf of the payee , and card based transactions based on the same structure . when a three party payment card scheme licenses other payment service providers for the issuance and / or the acquiring of payment cards , it is considered as a four party payment card scheme ; ### ' three party payment card scheme ' means a payment card scheme in which payments are made from a payment account held by the scheme on behalf of the payer to a payment account held by the scheme on behalf of the payee , and card based transactions based on the same structure . when a three party payment card scheme licenses other payment service providers for the issuance and / or the acquiring of payment cards , or issues or distributes payment cards with a co - brand partner or through an agent , it is considered as a four party payment card scheme ;


### ‘ cross - border payment transaction’ means a card payment or card - based payment transaction initiated by a payer or by a payee where the payer ' s payment service provider and the payee ' s payment service provider are established in different member states or where the payment card is issued by an issuing payment service provider established in a different member state than that of the point of sale ; ### ‘ cross - border payment transaction’ means a card payment or card - based payment transaction initiated by a payer or by a payee where the payer ' s payment service provider or the point of sale is established in a different member state than the payee ' s payment service provider or where the payment card is issued by an issuing payment service provider established in a different member state than that of the point of sale ;


### ' credit card transaction ' means an card payment transaction where the transaction is settled more than 48 hours after the transaction has been authorised / initiated ; ### ‘ credit card transaction’ means a transaction carried out with a credit card . a credit card is a card enabling its user to carry out payment transactions which are not debited immediately ;


### as a consequence of unilateral undertakings and commitments accepted in the framework of competition proceedings , many cross - border card payment transactions in the union are already carried out respecting the maximum interchanges fees applicable to the first phase of this regulation . therefore , the provisions relating to those transactions should enter into force quickly , creating opportunities for retailers to seek cheaper acquiring services cross - border , and incentivising domestic banking communities or schemes to lower their acquiring fees . ### as a consequence of unilateral undertakings and commitments accepted in the framework of competition proceedings , many cross - border card payment transactions in the union are already carried out respecting the maximum interchanges fees applicable . therefore , all the provisions relating to those transactions and to national transactions should enter into force simultaneously and within a reasonable period of time , taking account of the difficulty and complexity of the migration of payment - card systems , which this regulation necessitates .


### this regulation lays down uniform technical and business requirements for payment card transactions carried out within the union , where both the payer ' s payment service provider and the payee ' s payment service provider are established therein . ### this regulation lays down uniform technical and business requirements for payment card and digital wallet transactions carried out within the union , where the payer ' s payment service provider , the payer , the payee ' s payment service provider and the payee are established therein .


### for domestic transactions , a transition period is necessary to provide payment services providers and schemes with time to adapt to the new requirements . therefore , after a two year period following the entry into force of this regulation and in order to provide for a completion of an internal market for card - based payments , the caps on interchange fees for consumer card transactions should be extended to cover all , cross - border and domestic payments . ### for domestic transactions , a transition period is necessary to provide payment services providers and schemes with time to adapt to the new requirements and to take account of the significant differences in payment habits in member states . therefore , after a five year period following the entry into force of this regulation and in order to provide for a completion of an internal market for card - based payments , the caps on interchange fees for consumer card transactions should be extended to cover all , cross - border and domestic payments . the transitional period of five years should allow the interchange fees on domestic payments to converge from the current average in a member state to the maximum cap .


### four years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market . ### three years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market .


### as a consequence of unilateral undertakings and commitments accepted in the framework of competition proceedings , many cross - border card payment transactions in the union are already carried out respecting the maximum interchanges fees applicable to the first phase of this regulation . therefore , the provisions relating to those transactions should enter into force quickly , creating opportunities for retailers to seek cheaper acquiring services cross - border , and incentivising domestic banking communities or schemes to lower their acquiring fees . ### as a consequence of unilateral undertakings and commitments accepted in the framework of competition proceedings , many cross - border card payment transactions in the union are already carried out respecting the maximum interchanges fees . they should be further developed by new provisions in order to create opportunities for retailers to use cheaper acquiring services . a transition period is necessary to provide payment services providers and schemes with time to adapt to the new requirements . therefore , after a six months period following the entry into force of this regulation and in order to provide for a completion of an internal market for card - based payments , the caps on interchange fees for consumer card transactions should be extended to cover all cross - border and domestic payments .


### payment card transactions are generally carried out on the basis of two main business models , so - called three party payment card schemes and four party payment card schemes . many four payment card party schemes are using an explicit interchange fee , mostly multilateral . interchange fees are implicit in three party payment card schemes . to acknowledge the existence of implicit interchange fees and contribute to the creation of a level playing field , three party payment card schemes using payment service providers as issuers or acquirers should be considered as four party payment card schemes and should follow the same rules , whilst transparency and other measures related to business rules should apply to all providers . ### payment card transactions are generally carried out on the basis of two main business models , so - called three party payment card schemes and four party payment card schemes . many four payment card party schemes are using an explicit interchange fee , mostly multilateral . interchange fees are implicit in three party payment card schemes . to acknowledge the existence of implicit interchange fees and contribute to the creation of a level playing field , three party payment card schemes using payment service providers as issuers or acquirers should be considered as four party payment card schemes and should follow the same rules , whilst transparency and other measures related to business rules should apply to all providers . three party schemes should accept transactions made using their cards from any acquirer based on general card transaction standards and acquiring rules comparable to the merchant rules for the specific three party schemes and with interchange caps in accordance with this regulation .


### for the effective functioning of the limitations to the honour all cards rule certain information is indispensable . first , payees should have the means to identify the different categories of cards . therefore , the various categories should be identifiable visibly and electronically on the device . secondly , also the payer should be informed about the acceptance of his payment instrument at a given point of sale . it is necessary that any limitation on the use of a given brand to be announced by the payee to the payer at the same time and under the same conditions as the information that a given brand is accepted . ### payees should have the means to identify the different categories of cards . therefore , the various categories should be identifiable electronically on the device . also the payer should be informed about the acceptance of his payment instrument at a given point of sale .


### interchange fees for cross - border consumer debit or credit card transactions ### interchange fees for cross - border consumer debit or credit card based payment transactions


### for the purposes of the application of the caps referred to in article 3 and article 4 , any net compensation received by an issuing bank from a payment card scheme in relation to payment transactions or related activities shall be treated as part of the interchange fee . ### for the purposes of the application of the caps referred to in article 3 and article 4 , compensation received by an issuing bank from a payment card scheme in relation to payment transactions or related activities shall be lower than previous year fees paid to this scheme from the same issuer . this request can be temporally waived for new emerging schemes or initiatives aiming to access to the european card payment market .


### four years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market . ### three years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . this report shall include a comprehensive assessment on the impact of the application of this regulation . the commission ' s assessment and report shall look in particular at - the appropriateness of the levels of interchange fees and steering mechanisms such as charges ; - the application of the transitional period for domestic debit card and credit card transactions ; - the use and cost of the various means of payments ; - the development of cardholder fees ; - the level of entry of new players ; - the emergence of new technology on the market ; - the specificities of internet - based transactions .


### this regulation follows a gradual approach . as a first step , it is necessary to take measures to facilitate cross - border issuing and acquiring of payment card transactions . allowing merchants to choose an acquirer outside their own member state and imposing a maximum level of cross border interchange fees for cross border acquired transactions should provide the necessary legal clarity . in addition , licences for issuing or acquiring of payment instruments should be valid without geographic restrictions within the union . these measures would facilitate the smooth functioning of an internal market for card , internet and mobile payments , to the benefit of consumers and retailers . ### in order to facilitate the smooth functioning of an internal market for card , internet and mobile payments , to the benefit of consumers and retailers , it is necessary to take measures to facilitate cross - border issuing and acquiring of payment card transactions . allowing merchants to choose an acquirer outside their own member state and imposing the same maximum level of interchange fees for both domestically and cross border acquired transactions should provide the necessary legal clarity . in addition , licences for issuing or acquiring of payment instruments should be valid without geographic restrictions within the union .


### for the effective functioning of the limitations to the honour all cards rule certain information is indispensable . first , payees should have the means to identify the different categories of cards . therefore , the various categories should be identifiable visibly and electronically on the device . secondly , also the payer should be informed about the acceptance of his payment instrument at a given point of sale . it is necessary that any limitation on the use of a given brand to be announced by the payee to the payer at the same time and under the same conditions as the information that a given brand is accepted . ### for the effective functioning of the limitations to the honour all cards rule certain information is indispensable . first , payees and payers should have the means to identify the different categories of cards . therefore , the various categories should be identifiable visibly and electronically on the device or the terminal as appropriate . secondly , also the payer should be clearly and comprehensively informed in an understandable manner about the acceptance of his payment instrument at a given point of sale . it is necessary that any limitation on the use of a given brand to be announced by the payee to the payer at the same time and under the same conditions as the information that a given brand is accepted .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , large undertakings should include in their annual report a non - financial statement containing information relating to at least respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed undertakings . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 20 of directive 2013 / 34 / eu .


### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 500 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million . ### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to large companies whose average number of employees exceeds 1000 , and exceed either a balance sheet total of eur 40 million or a net turnover of eur 80 million .


### draft legislative resolution ### underlines that the proposal is expected to be budget - neutral and therefore compatible with the ceiling of heading 5 of the multiannual financial framework ; recalls however that any unforeseen appropriations necessary for implementing the regulation should be decided in the annual budgetary procedure ;


### they may be engaged for a maximum period of four years . contracts may be renewed more than once for a maximum period of four years for each renewal . a renewal shall be granted on condition that the secondment from the national diplomatic service is extended for the period of renewal . ### they may be engaged for a maximum period of four years . contracts may be renewed more than once for a maximum period of four years . in total , engagement should not exceed eight years . however , in exceptional circumstances and in the interest of the service , at the end of the eighth year , the contract may be extended for a maximum period of two years . a renewal shall be granted on condition that the secondment from the national diplomatic service is extended for the period of renewal .


### the results of the pilot studies shall be evaluated and published by the commission , taking into account the benefits of the availability of the data in relation to the cost of collection and the response burden . on the basis of the conclusions of the pilot studies , the commission shall adopt the necessary delegated acts in accordance with article 9 . ### the results of the pilot studies shall be evaluated and published by the commission , taking into account the benefits of the availability of the data in relation to the cost of collection and the response burden . in carrying out the evaluation it shall ensure that no additional administrative or financial burdens are placed on respondents . on the basis of the conclusions of the pilot studies , the commission shall adopt the necessary delegated acts in accordance with article 9 .


### ' authorisation ' means authorisation , accreditation , designation or licensing , depending of the concepts used in each member state ; ### ' authorisation ' means accreditation , authorisation , licensing or certification , depending on the regulatory approaches used in each member state ;


### - recommended transport conditions , including instructions for keeping the container at a certain temperature and in a certain position ### - recommended transport conditions , including instructions for keeping the container at an appropriate temperature and in an appropriate position


### member states shall report to the commission before &#8230 ; &#8230 ; &#8230 ; &#8230 ; . and every three years thereafter on the activities undertaken in relation to the provisions of this directive , and on the experience gained in implementing it . 2 . before …… . and every three years thereafter , the commission shall transmit to the european parliament , the council , the european economic and social committee and the committee of the regions , a report on the implementation of this directive . ### member states shall report to the commission before . . . * and every three years thereafter on the activities undertaken in relation to the provisions of this directive , and on the experience gained in implementing it . 2 . before . . . ** and every three years thereafter , the commission shall transmit to the european parliament , the council , the european economic and social committee and the committee of the regions , a report on the implementation of this directive . * 2 years after the entry into force of this directive . ** 3 years after the entry into force of this directive .


### this directive should respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union . in line with that charter and to take account of , as appropriate the convention on human rights and biomedicine , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation , altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient . ### this directive should respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union . in line with that charter and to take account of , as appropriate the convention on human rights and biomedicine , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation , altruism of the donor and solidarity between donor and recipient while ensuring that strict confidentiality rules and security measures are in place for the protection of the donors ' and the recipients ' personal data .


### member states shall ensure that all exchanges of organs from or to third countries , are authorised by the competent authority . ### member states shall ensure that exchanges of organs from or to third countries , are authorised by the competent authority .


### member states shall ensure that medical activities in procurement organisations , such as donor selection , are performed under the advice and the supervision of a medical doctor as defined in directive 2005 / 36 / ec . ### member states shall ensure that medical activities in procurement organisations , such as donor selection and evaluation , are performed under the advice and the supervision of a medical doctor as defined in directive 2005 / 36 / ec .


### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall communicate to the commission the text of the provisions of national law which they adopt in the field covered by this directive .


### designation and tasks of competent authorities ### designation and tasks of the competent authorities / organisations / institutions


### the organisations , bodies or companies involved in the transportation of organs have appropriate standard operating procedures in place to ensure the integrity of the organ during transport and that transport time is minimised . ### the organisation involved in the transportation of organs ensure that the organ is transported with due care ;


### member states shall ensure that the procurement takes place in procurement organisations that comply with the rules laid down in this directive . ### member states shall ensure that the procurement and making available of organs take place through one or more public or private non - profit making body or bodies / organisation / institution that comply with the rules laid down in this directive .


### “procurement organisation” means a health care establishment , a team or a unit of a hospital or another body which is authorised by the competent authority to undertake procurement of human organs ### “procurement organisation” means a health care establishment , a team or a unit of a hospital or another body which is authorised by the competent authority / organisation / institution to undertake procurement of human organs


### every year organs are exchanged between member states . the exchange of organs is an important way of expanding the pool of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplant . this is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatments , hypersensitised patients or paediatric patients . available organs should be able to cross borders without unnecessary problems and delays . ### every year organs are exchanged between member states . the exchange of organs is an important way of ensuring a better match between donor and recipient and therefore improving the quality of the transplant . this is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatments , hypersensitised patients or paediatric patients . available organs should be able to cross borders without unnecessary problems and delays .


### the measures needed to implement 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 . ### the measures needed to implement 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 . with regard to article 25 , in all cases where implementing measures affecting data protection and security are considered , all relevant stakeholders should be consulted , including the european data protection supervisor .


### – the responsibilities of procurement organisations and transplantation centres in the process of reporting . ### – the responsibilities of procurement organisations and transplantation centres in the process of reporting and management .


### in order to reduce the risks and maximise the benefits of the transplantation process . member states need to operate an effective national quality programme . this programme should be implemented and maintained throughout the entire chain from donation to transplantation or disposal , and should cover the personnel and organisation , premises , equipment , materials , documentation and record - keeping involved . the national quality programme should include auditing where necessary . member states should be able to delegate , through written agreements , the responsibility for parts of this programme to european organ exchange organisations . ### does not apply to the english version .


### the scope of the eit contribution to the knowledge and innovation communities should be defined and the origins of kics ' financial resources clarified . ### the scope of the eit contribution to the knowledge and innovation communities should be defined and the origins of kics ' financial resources clarified . eit should act as an investor , following an entrepreneurial logic , and its investments should be acting as leverage for other sources of private or public funding .


### the eit triennial work programme should take into account the commission ' s opinion concerning the eit ' s specific objectives , as defined in horizon 2020 , and its complementarities with european union policies and instruments . ### the eit triennial work programme should take into account the opinions of the commission , the european parliament and the councilconcerning the eit ' s specific objectives , as defined in horizon 2020 , and its complementarities with european union policies and instruments . these eu institutions should be adequately involved when this programme is established .


### the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at eur 3 . 182 , 230 million the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope . ### the financial envelope for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 shall be laid down by article 6 of regulation no [ xxx / xxxx ] establishing horizon 2020 - the framework programme for research and innovation . annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope .


### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources . it shall also contain appropriate indicators for monitoring the kics and eit activities . the preliminary rolling triennial work programme shall be submitted by the eit to the commission by 31 december each n - 2 . the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of the commission opinion , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ; ### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources taking into account the financial viability of each kic . it shall also contain appropriate indicators for monitoring the kics and eit activities . the preliminary rolling triennial work programme shall be submitted by the eit to the european parliament , the council and the commission by 31 december each n - 2 . the european parliament , the council and the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of these opinions , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ;


### decide on eit’s language regime , taking into account the existing principles on multilingualism and the practical requirements of its operations ; ### ensure the eit complies with the existing principles on multilingualism ;


### the commission should strengthen its role in monitoring the implementation of specific aspects of eit activities . ### the commission and the eit should strengthen their roles in monitoring the implementation of specific aspects of eit and kics activities .


### the eit ' s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' . ### the eit ' s mission is to contribute to sustainable european economic and social development and competitiveness by reinforcing the innovation and entrepreneurship capacity of the member states and the union . it shall do this by promoting and integrating higher education , research , innovation and entrepreneurship of the highest standards the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' .


### in order to assure broader participation of organizations from different members states in the kics , the partner organizations should be established in at least three different member states . ### in order to assure broader participation of organizations from different members states in the kics , the partner organizations should be established in at least three different member states . excellence should be the main driver for eit as a whole while promoting the widening of participation in order to stimulate excellence across europe , including the concept of ' stairway to excellence ' , something that will further encourage the participation of strong units of embryonic excellence , such as small research groups and highly innovative start - ups , who will be able to act as innovation catalysts at regional and local level and diffuse the innovation culture from the eit to the whole of the eu .


### the eit’s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards . ### the eit’s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research , innovation and entrepreneurial activities of the highest standards .


### stakeholder forum means a meeting open to representatives of national and regional authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle . ### stakeholder forum means a platform , involving physical and virtual conferences and events , open to representatives of national and regional authorities , organized interests and individual entities from business , education , and research , associations , civil society and cluster organisations , as well as other interested parties from across the knowledge triangle .


### the kics should broaden their educational activities , by providing professional training courses . ### the kics should broaden their educational activities , by providing professional and summer training courses , distance learning courses and internships . the eit should invest in cultivating a world - class eit brand - name in the area of innovative entrepreneurial education .


### new kics , including their priority fields and the organisation and timing of the selection process , should be launched on the basis of modalities defined in the strategic innovation agenda . ### new kics , including their priority fields and the organisation and timing of the selection process , should be launched on the basis of modalities defined in the strategic innovation agenda , through a rigorous , transparent and competitive process that takes into consideration bottom - up approaches and the evolving societal challenges landscape in the eu , yet provides clarity and predictability for potential participants .


### the payout delay of at maximum six weeks from 31 december 2010 , runs counter to the need to maintain depositor confidence and does not meet their needs . the payout delay should therefore be reduced to a period of one week . ### the payout delay of at maximum six weeks from 31 december 2010 , runs counter to the need to maintain depositor confidence and does not meet their needs . the payout delay should therefore be reduced to a period of four weeks .


### the commission may , at the request of a member state , on its own initiative , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . ### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . such decision should in particular be taken in order to resolve diverging decisions between member states .


### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who is implanted with the device . ### the manufacturer of an implantable device shall make available in advance to the healthcare professional or where relevant , to the particular patient who is going to be implanted with the device , the information to be included in an implant passport or in an implant card .


### an article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device . ### an article that is intended specifically to replace a part or component of a device and that changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this regulation .


### the implantable or other invasive products , intended to be used for human beings , which are listed in annex xv shall be considered medical devices , regardless of whether or not they are intended by the manufacturer to be used for a medical purpose . ### the implantable or other invasive products , as well as products using external physical agents , intended to be used for human beings , which are listed in annex xv shall be considered medical devices , regardless of whether or not they are intended by the manufacturer to be used for a medical purpose .


### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device . ### the manufacturer of an implantable , sterile - packaged device shall make available in advance to the healthcare professional or where relevant , to the particular patient who is going to be implanted with the device , the information to be included in an implant passport or in an implant card .


### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . ### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . the final decision shall be made publically available in the eudamed .


### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission and to the notified bodies . ### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission , to the notified bodies and to manufacturers relating to information about their own devices .


### devices that are composed of substances or combination of substances intended to be ingested , inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class iii . ### devices that are composed of substances or combination of substances primarily intended to be ingested , inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are classified as class iii .


### – are intended specifically to control , diagnose , monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body , in which case they are in class iii , ### – are active or implantable devices intended specifically to control , diagnose , monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body , in which case they are in class iii ,


### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without significantly changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states . ### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states .


### in the case of implantable devices and devices falling within class iii , clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone . demonstration of equivalence in accordance with section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph . ### in the case of implantable devices and devices falling within class iii , clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone . for novel products , demonstration of equivalence in accordance with section 4 shall not be considered as sufficient justification within the meaning of the first sentence of this paragraph . however , for iteration of devices already on the market and for which clinical data are available and for which the data from the post - market surveillance are not indicating any safety concerns , demonstration of equivalence may be considered as a sufficient justification . for devices submitted to the scientific assessment foreseen in this regulation , demonstration of equivalence shall be assessed by the mdcg .


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user ' s body when the device is used within its intended purpose . ### all devices incorporating or consisting of nanomaterial intended to be intentionally released in the human body are classified as class iii .


### ‘ active device’ means any device , the operation of which depends on a source of electrical energy or any source of power other than that directly generated by gravity and which acts by changing the density of or converting this energy . devices intended to transmit energy , substances or other elements between an active device and the patient , without any significant change , shall not be considered to be active devices . stand alone software shall be considered an active device ; ### ‘ active device’ means any device , the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy . devices intended to transmit energy , substances or other elements between an active device and the patient , without any significant change , shall not be considered to be active devices . stand alone software shall be considered an active device ;


### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation including through legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in interconnections ; ### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation including through the opening - up of markets in goods and services , legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in energy and transport interconnections ;


### under the european neighbourhood policy , the union offers neighbourhood countries a privileged relationship , building upon a mutual commitment to and promotion of the values of democracy and human rights , the rule of law , good governance and the principles of market economy and sustainable development . ### under the european neighbourhood policy , the union offers neighbourhood countries a privileged relationship , building upon a mutual commitment to and promotion of the values of democracy and human rights , the rule of law , good governance , the principles of market economy and the transition to well - functioning market economies , and sustainable development .


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### sustainable and inclusive development in all aspects , poverty reduction by means of strengthening social security networks , improving worker employability and developing the private sector , particularly by fostering smes and entrepreneurship ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ;


### the union is committed to promote in relations with its partners worldwide decent work as well as ratification and effective implementation of the internationally recognised labour standards and multilateral environment agreements , in relations with its partners worldwide . ### the union is committed to promote in relations with its partners worldwide decent work as well as ratification and effective implementation of the internationally recognised labour standards and multilateral environment agreements , in relations with its partners worldwide , as well as good governance and the fight against corruption , tax fraud and money laundering .


### promoting human rights and fundamental freedoms , the rule of law , principles of equality , establishing deep and sustainable democracy , promoting good governance and developing a thriving civil society including social partners ; ### promoting human rights and fundamental freedoms , the rule of law , principles of equality , establishing deep and sustainable democracy , market economy principles , promoting good governance , combating corruption , tax fraud and money laundering , and developing a thriving civil society including social partners ;


### creating conditions for well managed mobility of people and promotion of people - to - people contacts ; ### creating conditions for well managed mobility of people and promotion of people - to - people contacts as well as business cooperation ;


### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation including through legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in interconnections ; ### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation including through mutual opening up of goods and services markets and legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in energy and transport interconnections ;


### the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , a directory containing data on import , export and transit of goods including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export . ### given the increase in the scale of customs fraud , it is crucial to improve detection and prevention simultaneously at national and european level . the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , the most complete possible directory containing data on import , export and transit of goods by land , sea or air , including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export without delay . the commission should each year submit the results obtained from this directory to the european parliament and to the council .


### with a view to increasing clarity , consistency and transparency , it is necessary to define in more concrete terms the authorities which should have access to the directories established on the basis of this regulation ; for that purpose a uniform reference to competent authorities will be established . ### with a view to increasing clarity , consistency , coherence and transparency , it is necessary to define in concrete terms the authorities which should have access to the directories established on the basis of this regulation ; for that purpose a uniform reference to competent authorities will be established .


### – ' service providers active in the international supply chain ' means owners , shippers , consignees , freight forwarders , carriers and other intermediaries or persons involved in the international supply chain . ### – ' public or private service providers active in the international supply chain ' means owners , shippers , consignees , freight forwarders , carriers and other intermediaries or persons involved in the international supply chain .


### the commission shall establish and manage a directory containing data on import , export and transit of goods , including transit within a member state , as detailed in annexes 37 and 38 of commission regulation no 2454 / 93 , the &#8220 ; import , export , transit directory&#8221 ; . the member states shall authorise the commission to systematically replicate data relating to import , export and transit from the sources operated by the commission on the basis of regulation no 2913 / 92 establishing the community customs code . the member states shall supply to the commission data concerning the transit of goods within a member state and direct export . ### the commission shall establish and manage a directory containing data on import , export and transit of goods , including transit within a member state , as detailed in annexes 37 and 38 of commission regulation no 2454 / 93 , the ' import , export , transit directory ' . the member states shall authorise the commission to systematically replicate data relating to import , export and transit from the sources operated by the commission on the basis of regulation no 2913 / 92 establishing the community customs code . the member states shall , at the earliest possible date , supply to the commission data concerning the transit of goods within a member state and direct export . to ensure that the information regarding the interests of member states ' service providers contained in this directory shall not be used in an improper way .


### the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , a directory containing data on import , export and transit of goods including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export . ### given the increase in the scale of customs fraud , it is crucial to increase detection and prevention simultaneously at national and european level . the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , the fullest possible directory containing data on import , export and transit of goods by land , sea or air , including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export without delay . the commission should each year submit the results obtained from this directory to the european parliament and to the council .


### in the case of chemicals listed in parts 2 or 3 of annex i , the designated national authority of the exporter may , in consultation with the commission assisted by the agency and on a case - by - case basis , decide that the export may proceed if , after all reasonable efforts , no response to a request for explicit consent pursuant to paragraph 6 has been received within 60 days and there is evidence from official sources in the importing party or other country that the chemical has been licensed , registered or authorised or that it has in the last 5 years been used in , or imported into the importing party or importing other country and no regulatory action has been taken to prohibit its use . ### in the case of chemicals listed in parts 2 or 3 of annex i , the designated national authority of the exporter may , in consultation with the commission assisted by the agency and on a case - by - case basis , decide that the export may proceed if , after all reasonable efforts , no response to a request for explicit consent pursuant to paragraph 6 has been received within 60 days and the following conditions have been met : there is evidence from official sources in the importing party or other country that the chemical has been licensed , registered or authorised ; and the designated national authority of the exporter ' s member state is satisfied with regard to the intended use of the chemical and that the intended use is not prohibited within the union ; and the use of the chemical is permitted inside the union for a specific purpose and its export is intended for that same specific purpose .


### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . ### any professionals in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training , for example concerning victims of sexual offences , families bereaved by murder , young victims of crime or victims of cross - border crime .


### member states shall take measures to ensure that those providing victim support and restorative justice services receive adequate training to a level appropriate to their contact with victims and observe professional standards to ensure such services are provided in an impartial , respectful and professional manner . ### member states shall take measures to ensure that those providing victim support and restorative justice services receive adequate training to a level commensurate with their contact with victims and observe professional standards to ensure such services are provided in an impartial , respectful and professional manner .


### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . ### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level commensurate with their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner .


### member states shall ensure that victims are offered the opportunity to be notified when the person prosecuted or sentenced for offences concerning them is released from detention . victims shall receive this information where they have expressed such a wish . ### member states shall ensure that victims are offered the opportunity to be notified when the person prosecuted or sentenced for offences concerning them is released from detention . victims shall receive this information in every case .


### the amounts to be committed for the funding of pollution response should cover the period from 1 january 2014 to 31 december 2020 , in line with the new multiannual financial framework . a financial envelope covering the same period should therefore be provided . ### the amounts to be committed for the funding of pollution response should cover the period from 1 january 2014 to 31 december 2020 , in line with the new multiannual financial framework . it is therefore necessary to allocate more resources to the agency to take account of its new tasks , but this must be done with due heed to the current economic context , in which the new multiannual financial framework is to be approved , an in a manner consistent with it


### the choice of the method used to calculate the estimated value of a concession shall not be made with the intention of excluding it from the scope of this directive . a works project or an entirety of services shall not be subdivided with the effect of preventing it from falling within the scope of this directive , unless justified by objective reasons . ### the estimation of the value of a concession shall not be made with the intention of excluding it from the scope of this directive . a works project or an entirety of services shall not be subdivided with the effect of preventing it from falling within the scope of this directive , unless justified by objective reasons .


### the duration of the concession shall be limited to the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a reasonable return on invested capital . ### for concessions lasting for more than five years , the maximum duration of the concession shall not exceed the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works , or services , including preliminary costs , together with a reasonable return on invested capital corresponding to a return expected under normal market conditions .


### a ‘ public works concession’ means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works , where the consideration for the works to be carried out consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment . ### a ‘ works concession’ means a contract for pecuniary interest concluded in writing whereby one or more contracting authorities or contracting entities entrusts the execution of works for which they are responsible to one or more economic operators , where the consideration therefore consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment . a ' services concession ' means a contract for pecuniary interest concluded in writing whereby one or more contracting authorities or contracting entities entrusts the provision of services for which they are responsible to one or more economic operators , where the consideration therefore consists either solely in the right to exploit the service which is the subject - matter of the contract or in that right together with payment . the right to exploit the works or services referred in points a ) and b ) shall imply the transfer to the concessionaire of the substantial operating risk . the concessionaire shall be deemed to assume the substantial operating risk where it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject - matter of the contract . the operational risk shall be understood as : the risk of exposure to the vagaries of the market ; or the risk related to the availability of the infrastructure provided by the concessionaire or used for the provision of services to users .


### the award criteria shall be linked to the subject matter of the concession , and shall not confer an unrestricted freedom of choice on the contracting authority or the contracting entity . those criteria shall ensure effective competition and shall be accompanied by requirements which allow the information provided by the tenderers to be effectively verified . contracting authorities and contracting entities shall verify effectively on the basis of the information and proof provided by the tenderers , whether the tenders meet the award criteria . ### the award criteria shall be linked to the subject matter of the concession , and may include environmental , social or innovation - related aspects , and , where appropriate , public policy grounds for the promotion of sustainable economic growth and social cohesion . those criteria shall ensure effective competition and shall be accompanied by requirements which allow the information provided by the tenderers to be effectively verified .


### ' concessions ' means public works concessions , works concessions or services concessions . ### ' concessions ' means works or services concessions .


### difficulties related to the interpretation of the concepts of concession and public contract have been source of continued legal uncertainty among stakeholders and have given rise to numerous judgments of the court of justice of the european union on this subject . therefore , the definition of concession should be clarified , in particular by referring to the concept of substantial operating risk . the main feature of a concession , the right to exploit the works or services , always implies the transfer to the concessionaire of an economic risk involving the possibility that it will not recoup the investments made and the costs incurred in operating the works or services awarded . the application of specific rules governing the award of concessions would not be justified if the contracting authority or entity relieved the contractor of any potential loss , by guaranteeing a minimal revenue , equal or higher to the costs that the contractor has to incur in relation with the performance of the contract . at the same time it should be made clear that certain arrangements which are fully paid by a contracting authority or a contracting entity should qualify as concessions where the recoupement of the investements and costs incurred by the operator for execution the work or provididng the service depends on the actual demand for or the availability of the service or asset . ### difficulties related to the interpretation of the concepts of concession and public contract have been source of continued legal uncertainty and have given rise to numerous judgments of the court of justice of the european union on this subject . in view of the fact that the right to exploit the works or services always implies the transfer to the concessionaire of an economic risk , involving the possibility that it will not recoup the investments made and the costs incurred in operating the works or services awarded , the definition of concession should be related to the concept of substantial operating risk . the application of specific rules governing the award of concessions would not be justified if the contracting authority or entity relieved the contractor of any potential loss , by guaranteeing a minimal revenue , equal or higher to the costs that the contractor has to incur in relation with the performance of the contract .


### the calculation of the estimated value of a concession shall be based on the total amount payable , net of vat , as estimated by the contracting authority or the contracting entity , including any form of option and any extension of the duration of the concession . ### the calculation of the estimated value of a concession shall be based on the estimated turnover of the concessionaire , net of vat , throughout the duration of the concession .


### at least 90% of the activities of that legal person are carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity ### all the activities of that legal person are carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity


### the estimated value of a concession shall be calculated as the value of an entirety of works or services , even if purchased through different contracts , where the contracts are part of one single project . indications for the existence of one single project consist in overall prior planning and conception by the contracting authority or contracting entity , the fact that the different elements purchased fulfil a single economic and technical function or that they are otherwise logically interlinked . where the contracting authority or the contracting entity provides for prizes or payments to candidates or tenderers it shall take them into account when calculating the estimated value of the concession . ### the method for calculating the estimated value of a concession shall be specified in the concession documents .


### the european political party shall , in accordance with the conditions and time limits laid down in the call for contributions , submit to the authorising officer for approval a final report on the use of the contribution and its accounts . ### the european political party shall , in accordance with the conditions and time limits laid down in the call for contributions , submit annually to the authorising officer for approval a final report on the use of the contribution and its accounts .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels by introducing a separate target for advanced biofuels of at least 2% for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only biofuels with high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework .


### part a . feedstocks whose contribution towards the target referred to in article 3 shall be considered to be four times their energy content algae . biomass fraction of mixed municipal waste , but not separated household waste subject to recycling targets under article 11 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives . biomass fraction of industrial waste . straw . animal manure and sewage sludge . palm oil mill effluent and empty palm fruit bunches . tall oil pitch . crude glycerine . bagasse . grape marcs and wine lees . nut shells . husks . cobs bark , branches , leaves , saw dust and cutter shavings . part b . feedstocks whose contribution towards the target referred to in article 3 shall be considered to be twice their energy content used cooking oil . animal fats classified as category i and ii in accordance with ec / 1774 / 2002 laying down health rules concerning animal by - products not intended for human consumption . non - food cellulosic material . ligno - cellulosic material except saw logs and veneer logs . ### feedstocks contributing towards the 2% target referred to in article 3 d are as followed . algae . biomass fraction of mixed municipal waste , but not separated household waste subject to recycling targets under article 11 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives . biomass fraction of industrial waste . straw . animal manure and sewage sludge . palm oil mill effluent and empty palm fruit bunches . tall oil pitch . crude glycerine . bagasse . grape marcs and wine lees . nut shells . husks . cobs bark , branches , leaves , saw dust and cutter shavings . used cooking oil . animal fats classified as category i and ii in accordance with ec / 1774 / 2002 laying down health rules concerning animal by - products not intended for human consumption . non - food cellulosic material . ligno - cellulosic material except saw logs and veneer logs .


### in estimating net greenhouse gas emission saving from the use of biofuels , the member state may , for the purpose of the reports referred to in paragraph 1 , use the typical values given in part a and part b of annex v , and shall add the estimates for indirect land - use change emissions set out in annex viii . ### in estimating net greenhouse gas emission saving from the use of biofuels , the member state may , for the purpose of the reports referred to in paragraph 1 , use the typical values given in part a and part b of annex v .


### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars and oil crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 . ### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from feedstock listed in annex ix shall be at least 2% of the final consumption of energy in transport in 2020 and the share of energy from biofuels produced from food crops shall be at least 8% [ 10% ] of the final consumption of energy


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels by introducing a separate target for advanced biofuels of at least 2% for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only biofuels with high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework


### the name , address and signature of the owner ; ### the name , address and signature of the owner and of up to two previous owners if applicable ;


### member states shall lay down rules on the minimum qualifications required for the persons carrying out the implantation of transponders in pet animals . ### the implantation of a transponder shall be carried out by an approved veterinarian .


### from a third country or territory listed in the implementing acts adopted pursuant to article 13 after transit through third countries or territories other than those listed in the implementing acts adopted pursuant to article 13 , provided that the owner or a natural person acting on behalf of and in agreement with the owner provides proof that during such transit , the pet animals have had no contact with species susceptible to rabies and remain secured within a means of transport or within the perimeter of an international airport . ### after transit through other third countries or territories , provided that the owner or authorised person provides proof by means of a written declaration that during such transit the pet animals have had no contact with animals of species susceptible to rabies and remain secured within a means of transport or within the perimeter of an international airport .


### return the pet animal to its country or territory of dispatch , or ### return the pet animal , at the expense of the owner , to its country or territory of dispatch , or


### member states shall lay down rules on the minimum qualifications required for the persons carrying out the implantation of transponders in pet animals . ### the implantation of a transponder shall be carried out by an approved veterinarian . by way of derogation from paragraph 1 , member states may lay down rules on the minimum qualifications required for the persons carrying out the implantation of transponders in pet animals under the supervision of an authorised veterinarian .


### they are accompanied by a duly completed identification document issued : in accordance with article 28 ; in the format provided for in article 33 . ### they are accompanied by a duly completed identification document issued : in accordance with article 33a , in the format provided for in article 31a .


### identification documents accompanying pet animals of the species listed in part a of annex i which are moved for non - commercial purposes into member states are necessary to attest compliance with the conditions of this regulation . the regulation should therefore establish the conditions for issuing the identification documents and the requirements for their content , validity and format . ### identification documents accompanying pet animals of the species listed in part a of annex i which are moved for non - commercial purposes into member states are necessary to attest compliance with the conditions of this regulation . the regulation should therefore establish the conditions for issuing the identification documents and the requirements for their content , validity , safety features and format .


### this regulation should also give the member states the possibility to authorise , where the need for an urgent departure arises , the direct entry onto their territory of pet animals of the species listed in annex i which do not comply with the conditions provided for in this regulation provided that a permit is applied for in advance and granted by the member state of destination , and a time - limited quarantine under official supervision is carried out to meet those conditions . despite the need for such urgent departure , such permit should be indispensable due to the animal health risks arising from the introduction into the union of a pet animal not complying with the conditions provided for in this regulation . ### this regulation should also give the member states the possibility to authorise , where the need for an urgent departure of the owner arises – for example , in the event of a sudden natural disaster , political unrest or particularly serious personal emergencies – , the direct entry onto their territory of pet animals of the species listed in annex i which do not comply with the conditions provided for in this regulation provided that a permit is applied for in advance and granted by the member state of destination , and a time - limited quarantine under official supervision is carried out to meet those conditions . despite the need for such urgent departure , such permit should be indispensable due to the animal health risks arising from the introduction into the union of a pet animal not complying with the conditions provided for in this regulation .


### support cooperation among competent public bodies in europe , in particular supporting their efforts to develop and exchange good practices and standards ; ### support cooperation among the competent public bodies and between public and private stakeholders in the union , inter alia , facilitate dialogue and efforts to develop and exchange good practices , promote information sharing and awareness raising , facilitate the establishment and take up of european and international standards for risk management and for the security of electronic products , networks and services ;


### regularly assess , in cooperation with the member states and the european institutions , the state of network and information security in europe ; ### on the basis of information provided by the member states , and by the union ' s institutions in accordance with the union provisions and national provisions in compliance with union law , maintain awareness of the latest state of network and information security in the union for the benefit of the member states and the union ' s institutions ;


### assist the member states and the european institutions and bodies , at their request , in their efforts to develop network and information security detection , analysis and response capability ; ### assist the union ' s institutions and bodies set up by union law in their efforts to develop network and information security prevention , detection , analysis and response capability ;


### facilitate the cooperation among the member states and between the member states and the commission in their efforts with a cross - border dimension to prevent , detect and respond to network and information security incidents ; ### facilitate the cooperation among the member states and between the member states and the union ' s institutions in their efforts to prevent , detect and respond to network and information security incidents where this has an impact across borders ;


### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission may , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . ### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission shall , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . only reasons of force majeure shall prevent the suspension from being imposed .


### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission may , in accordance with the examination procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . ### a separate annual trigger import volume is set for imports from central american country for products mentioned in paragraph 1 as indicated in the table in the annex to this regulation . the importation of the products mentioned in paragraph 1 at the preferential customs duty rate shall , in addition to the proof of origin established under annex iii of the agreement with central america , be subject to the presentation of an export certificate issued by the competent authority of the republic of the central american country from which the products are exported . once the trigger volume is met during the corresponding calendar year , the commission shall , in accordance with the advisory procedure referred to in article 12 , temporarily suspend the preferential customs duty during that same year for a period of time not exceeding three months , and not going beyond the end of the calendar year . only reasons of force majeure shall justify the suspension not being imposed .


### an investigation shall be initiated upon request by a member state , by any legal person or any association not having legal personality , acting on behalf of the union industry , or on the commission ' s own initiative if it is apparent to the commission that there is sufficient prima facie evidence , as determined on the basis of factors referred to in article 4 , to justify such initiation . ### an investigation shall be initiated upon request by a member state , by any legal person or any association not having legal personality , acting on behalf of the union industry , by the european parliament , or on the commission ' s own initiative if it is apparent to the commission that there is sufficient prima facie evidence , as determined on the basis of factors referred to in article 4 , to justify such initiation .


### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20135 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states in accordance with article 185 of the treaty . __________________ 5 oj … [ h2020 fp ] ### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20135 aims at achieving a greater impact on research and innovation by developing closer synergies , increasing coordination and avoiding unnecessary duplication with international , national and regional research programmes . public - public partnerships , including union participation in programmes undertaken by several member states in accordance with article 185 of the treaty should achieve these goals , meet the conditions specified in that regulation in particular those in article 20 and fully respect the general principles in particular on open access and transparency . __________________ 5 oj … [ h2020 fp ]


### without prejudice to article 5 , a european patent with unitary effect may only be limited , licensed , transferred , revoked or lapse in respect of all the participating member states . ### without prejudice to article 5 , a european patent with unitary effect may only be limited , transferred or revoked , or lapse , in respect of all the participating member states .


### the part of the collected renewal fees to be distributed to the participating member states referred to in article 12 shall be 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect minus the costs associated with the administration of the unitary patent protection referred to in article 12 . ### the european patent office shall retain 50 percent of the renewal fees referred to in article 14 paid for european patents with unitary effect . the remaining amount shall be distributed to the participating member states in accordance with the share of distribution of the renewal fees set in accordance with article 12 .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for the enforcement of this regulation and for other patent and innovation - related purposes , including for the provision of advice and support to small and medium - sized enterprises . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently .


### renewal fees should be paid to the european patent organisation . 50 percent thereof minus expenses incurred by the european patent office in carrying out tasks in relation to the unitary patent protection shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity and having acquired membership of the european patent organisation relatively recently . ### renewal fees should be paid to the european patent organisation . the european patent office should retain an amount to cover the expenses generated at the european patent office in carrying out tasks in relation to the unitary patent protection in accordance with article 146 of the epc . the remaining amount shall be distributed among the participating member states , which should be used for patent - related purposes . the share of distribution should be set on the basis of fair , equitable and relevant criteria namely the level of patent activity and the size of the market and should guarantee a minimum amount to be redistributed to each participating member state in order to maintain a balanced and sustainable functioning of the system . the distribution should provide compensation for having an official language other than one of the official languages of the european patent office , having a disproportionately low level of patenting activity established on the basis of the european innovation scoreboard and having acquired membership of the european patent organisation relatively recently .