### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation , of the minimum content of the eu declaration of conformity and of the certificates issued by notified bodies , of the minimum requirements to be met by notified bodies , of the classification rules , of the conformity assessment procedures , and of the documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system ; the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation , of the minimum content of the eu declaration of conformity and of the certificates issued by notified bodies , of the requirements to be met by notified bodies , of the classification rules , of the conformity assessment procedures , and of the documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### summary of safety and clinical performance in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### safety and clinical performance report in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation . the manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand . the draft of this report shall be part of the documentation to be submitted to and validated by the national authority or the agency , as relevant , involved in the marketing authorisation procedure . . 1a . the summary referred to in paragraph 1 shall be made available to the public via eudamed in accordance with provisions under article 27 and annex v , part a , point 18 . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


### the commission and the member states shall take all appropriate measures to encourage the establishment of registers for specific types of devices to gather post - market experience related to the use of such devices . such registers shall contribute to the independent evaluation of the long - term safety and performance of devices . ### the commission and the member states shall take all appropriate measures to encourage the establishment of coordinated and harmonized registers for specific types of devices to gather post - market experience related to the use of such devices . such registers shall contribute to the independent evaluation of the long - term safety and performance of devices .


### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . therefore , regulation no 178 / 2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law , establishing the european food safety authority and laying down procedures in matters of food safety should be amended to exclude medical devices from its scope . ### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . since in some cases it is difficult to distinguish between medical devices and cosmetic , medicinal or food products , the strictest legislation should apply in each case .


### for high - risk medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for high - risk medical devices , manufacturers should draft a report of the safety and performance aspects of the device and the outcome of the clinical evaluation . a summary of the safety and performance report should be publicly available .


### to provide advice and assist the commission , at its request , in its assessment of any issue related to the implementation of this regulation ; ### to regularly review norms and standards for medical devices ;


### experts and other third parties invited by the mdcg on a case - by - case basis shall be requested to declare their interests in the issue in question . ### experts and other third parties invited by the mdcg on a case - by - case basis shall declare their interests in the issue in question and their declaration of interest shall be permanently accessible to the public .


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for these patient groups and , if applicable , on appropriate precautionary measures . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . in case the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


### eudamed ' s electronic systems regarding devices on the market , the relevant economic operators and certificates should enable the public to be adequately informed about devices on the union market . the electronic system on clinical investigations should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities . ### eudamed ' s electronic systems should enable the public and healthcare professionals to be adequately informed about devices on the union market . adequate levels of access for the public and healthcare professionals to those parts of eudamed ' s electronic systems which provide key information on medical devices that may pose a risk to public health and safety is essential . where such access is limited , it should be possible , upon a reasoned request , to disclose existing information for medical devices , unless the limitation of access is justified on grounds of confidentiality . the electronic system on clinical investigations should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities .


### 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 device shall provide together with the device information which shall be submitted to the healthcare professional implanting the device who will be responsible for : - submitting this information to the patient ; and - recording this information in the patient ' s medical records .


### patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls . ### patients who are going to be implanted with a device should be given beforehand essential information related to the implanted device allowing it to be identified and containing information about the main characteristic of the device , the potential adverse effects , a warning of the potential health risks , post - operative follow - up care measures and any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls . member states may introduce national provisions requiring that the implant card also includes information on post - operative follow - up care measures and that it is signed by both the patient and the surgeon responsible for the surgery .


### 7 . devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and / or of any waste substances by the user , patient or other person . ### 7 . devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and the substances with which the device has been exposed to and / or of any waste substances by the user , patient or other person and , where possible and appropriate , replace with the use of devices and methods with improved safety features and characteristics to reduce as far as possible the exposure of patients , users and other persons to potentially harmful substances , such as chemical or nuclear material .


### for high - risk medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for high - risk medical devices , manufacturers should provide the national authority or the agency , as relevant , involved in the marketing authorisation procedure , with a full report on the safety and clinical performance of that device . a summary of that report should be publicly available via eudamed .


### experts and other third parties invited by the mdcg on a case - by - case basis shall be requested to declare their interests in the issue in question . ### representative of stakeholder organizations participating in the sub - groups of the mdcg shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . the declaration of interests shall be made publicly available on the european commission web site . this shall not apply to representatives of the medical devices industry .


### labels shall be provided in a human - readable format but may be supplemented by machine - readable forms , such as radio - frequency identification or bar codes . ### labels shall be provided in a human - readable format and shall be supplemented by machine - readable forms , such as radio - frequency identification or bar codes .


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for these patient groups and , if applicable , on appropriate precautionary measures . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . where the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures and the type of devices which the notified body is authorised to assess . ### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures , the risk class and the type of devices which the notified body is authorised to assess .


### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . ### in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report and a summary thereof on the safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this report shall be part of the documentation to be submitted to the national authority or the agency , as relevant , involved in the marketing authorisation procedure .


### member states may notify only conformity assessment bodies which satisfy the requirements set out in annex vi . ### member states shall notify only conformity assessment bodies which satisfy the requirements set out in annex vi .


### to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this regulation , in particular regarding the designation and monitoring of notified bodies , application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies ; ### to assess whether the basic requirements to the safety and performance of medical devices intended by this regulation are sufficient and to identify necessary amendments to annex i .


### provisional duties may be imposed if : proceedings have been initiated in accordance with article 10 ; a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with the second subparagraph of article 10 ; a provisional affirmative determination has been made that the imported product benefits from countervailable subsidies and of consequent injury to the community industry ; and the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### in article 12 , the first and second subparagraph shall be replaced by the following : provisional duties shall be imposed if : proceedings have been initiated in accordance with article 10 ; a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with the second subparagraph of article 10 ; a provisional affirmative determination has been made that the imported product benefits from countervailable subsidies and of consequent injury to the community industry ; and the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings .


### ’’the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### in article 12 , the second sub - paragraph is replaced by the following : ‘ the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings . ’


### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the community industry , and if the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### article 7 shall be replaced by the following : provisional duties shall be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the community industry , and if the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings .


### ' the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ' ### article 12 , subparagraph 2 shall be replaced by the following : ' the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings . '


### proposal for a regulation of the european parliament and of the council establishing for the period 2014 to 2020 the rights and citizenship programme ### proposal for a regulation of the european parliament and of the council establishing for the period 2014 to 2020 the equality , rights and citizenship programme


### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights and the number of complaints . ### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the qualitative and quantitative data collected , at european level , on the respect , exercise and implementation of these rights and the number of complaints .


### to contribute to ensuring a high level of protection of personal data ; ### to ensure the highest level of protection of personal data , both online and offline , in line with european data protection legislation ;


### citizens should be able to exercise fully the rights deriving from the citizenship of the union . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections , their right to consular protection and their right to petition the european parliament . they should feel at ease about living , travelling and working in another member state , trusting that their rights are protected , no matter where in the union they happen to be . ### citizens should be able to exercise fully the rights deriving from the citizenship of the union and from international conventions that the eu has acceded to . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections , their right to consular protection and their right to petition the european parliament . they should feel at ease about living , travelling , working studying and volunteering in another member state , trusting that their rights are protected , no matter where in the union they happen to be , and that access for persons with disabilities on an equal basis with others is ensured .


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how regulation no 510 / 2011 could be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed and for the commission to prepare a report and if appropriate , adopt proposals for targets beyond 2020 . in order to ensure planning certainty for manufacturers however , such a proposal should not be made before 2018 , since the determination of such targets should be based on a new test cycle and relevant test procedures which are due to be adopted in 2014 . this should ensure that sufficient and reliable data is collected in the period from 2014 to 2018 so that any proposal for new targets for the period beyond 2020 is well - founded .


### ‘ by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . ### ‘ from 1 january 2018 at the earliest , the commission shall , where appropriate , review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 based on the new test procedure and test cycle referred to in article 13 or if not available , based on a fully defined and operational test procedure in place at that time . ’


### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . ### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . the aim of this review shall be to set an average emissions target for the fleet of new light vehicles for the period after 2025 which falls within a range of 100 to 115 g co2 / km . on the basis of this review , which shall include an overall assessment of the impact on the car industry and its dependent industries , the commission shall , if appropriate , make a proposal to amend this regulation in a way which is cost - effective and as neutral as possible from the point of view of competition and ensures the achievement of the union ' s long term objectives in combating climate change .


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars .


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . the revised test procedures should be introduced by 1 january 2016 at the latest .


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . end - users shall be free to enter into agreements on data volumes and speeds with providers of internet access services and , in accordance with any such agreements relative to data volumes , to avail of any offers by providers of internet content , applications and services . ### end - users shall be free to access and distribute information and content , run applications and use services and devices of their choice , irrespective of their origin or destination , via their internet access service .


### ‘ specialised service’ means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ; ### ' specialised service ' means an electronic communications service or any other service that provides , over logically distinct capacity and relying on strict admission control , access to specific content , applications or services , or a combination thereof , with a view to securing enhanced quality characteristics which are controlled from end - to - end ; and that is not marketed or used as a substitute for internet access service ;


### implement a legislative provision or a court order , or prevent or impede serious crimes ; ### implement a legislative provision or a court order ;


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or prevent or impede serious crimes ; b ) preserve the integrity and security of the network , services provided via this network , and the end - users ' terminals ; c ) prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures ; d ) minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph . ### providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by discriminating against , restricting , or otherwise interfering with the transmission of internet traffic except in cases where it is necessary to apply reasonable traffic management measures or to implement a court order . such measures shall be set by transparent procedures , not be maintained longer than strictly necessary and provide adequate safeguards ; in particular to ensure that any restrictions are limited to what is necessary , non - discriminatory and proportionate . those safeguards shall be subject to periodic review and include the possibility of judicial redress . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this article .


### ‘ specialised service’ means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ; ### ‘ specialised service’ means an electronic communications service or any other service using the internet protocol that provides to a determined number of parties optimised access to specific content , applications or services , or a combination thereof , and the technical characteristics of which are controlled using traffic management in order to ensure adequate service characteristics ; and that is not marketed or widely used as a substitute for internet access service ;


### ' 1 . member states shall ensure that all end - users of the service referred to in paragraph 2 , including users of public pay telephones , are able to call the emergency services free of charge and without having to use any means of payment , by using the single european emergency call number ' 112 ' and any national emergency call number specified by member states . 2 . member states , in consultation with national regulatory authorities , emergency services and providers , shall ensure that undertakings providing end - users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services . 3 . member states shall ensure that calls to the single european emergency call number ' 112 ' are appropriately answered and handled in the manner best suited to the national organisation of emergency systems . such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers , where these continue to be in use . 4 . member states shall ensure that access for disabled end - users to emergency services is equivalent to that enjoyed by other end - users . measures taken to ensure that disabled end - users are able to access emergency services whilst travelling in other member states shall be based to the greatest extent possible on european standards or specifications published in accordance with the provisions of article 17 of directive 2002 / 21 / ec , and they shall not prevent member states from adopting additional requirements in order to pursue the objectives set out in this article . 5 . member states shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority . this shall apply to all calls to the single european emergency call number ' 112 ' . member states may extend this obligation to cover calls to national emergency numbers . competent regulatory authorities shall lay down criteria for the accuracy and reliability of the location information provided . 6 . member states shall ensure that citizens are adequately informed about the existence and use of the single european emergency call number ' 112 ' , in particular through initiatives specifically targeting persons travelling between member states . 7 . in order to ensure the effective access to ' 112 ' services in the member states , the commission , having consulted berec , may adopt technical implementing measures . however , these technical implementing measures shall be adopted without prejudice to , and shall have no impact on , the organisation of emergency services , which remains of the exclusive competence of member states . ' ### article 26 is amended as follows : ' 1 . member states shall ensure that all end - users of the service referred to in paragraph 2 , including users of public pay telephones and users of private telecommunications networks , are able to call the emergency services free of charge and without having to use any means of payment , by using the single european emergency call number ' 112 ' and any national emergency call number specified by member states . 2 . member states , in consultation with national regulatory authorities , emergency services and providers , shall ensure that undertakings providing end - users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services . end - users shall also be able to access ' 112 ' directly when calling from a private telecommunications network . 3 . member states shall ensure that calls to the single european emergency call number ' 112 ' are appropriately answered and handled in the manner best suited to the national organisation of emergency systems . such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers , where these continue to be in use . the commission , in consultation with national regulatory authorities and emergency services , shall adopt a recommendation on performance indicators for member states . the commission shall bi - annually publish a report on the effectiveness of the implementation of ' 112 ' and on the functioning of the performance indicators . the first such report shall be provided to the european parliament and the council by the end of 2015 . 4 . member states shall ensure that access for disabled end - users to emergency services is equivalent to that enjoyed by other end - users . measures taken to ensure that disabled end - users are able to access emergency services whilst travelling in other member states shall be based to the greatest extent possible on european standards or specifications published in accordance with the provisions of article 17 of directive 2002 / 21 / ec , and they shall not prevent member states from adopting additional requirements in order to pursue the objectives set out in this article . 5 . member states shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority . this shall apply to all calls to the single european emergency call number ' 112 ' , including calls from private telecommunications networks and roaming calls . member states may extend this obligation to cover calls to national emergency numbers . the commission may adopt by means of an implementing act criteria for the accuracy and reliability of the location information provided to emergency services by the end of 2015 . 6 . member states and the commission shall ensure that citizens are adequately informed about the existence and use of the single european emergency call number ' 112 ' , in particular through initiatives specifically targeting persons travelling between member states . the commission shall support and complement member states ' action . 7 . in order to ensure the effective access to ' 112 ' services in the member states , the commission , having consulted berec , may adopt technical implementing measures . however , these technical implementing measures shall be adopted without prejudice to , and shall have no impact on , the organisation of emergency services , which remains of the exclusive competence of member states . '


### ‘ internet access service’ means a publicly available electronic communications service that provides connectivity to the internet , and thereby connectivity between virtually all end points connected to the internet , irrespective of the network technology used ; ### ' internet access service ' means a publicly available electronic communications service that provides connectivity to the internet , and thereby connectivity between virtually all end points connected to the internet , irrespective of the network technology or devices used ;


### member states shall take the necessary measures to ensure that additional leave is granted in the case of premature childbirth , children hospitalised at birth , children with disabilities and multiple births . the duration of the additional leave should be proportionate and allow the special needs of the mother and the child / children to be accommodated . ### member states shall take the necessary measures to ensure that fully paid additional maternity leave is granted in specific situations such as in the case of premature childbirth , stillbirth , caesarean section , children hospitalised at birth , children with disabilities , mothers with disabilities , teenage mothers , multiple births or births occurring within 18 months of the previous birth . the duration of the additional maternity leave after confinement should be proportionate and allow the special needs of the mother and the child / children to be accommodated .


### member states shall take the necessary measures to ensure that additional leave is granted in the case of premature childbirth , children hospitalised at birth , children with disabilities and multiple births . the duration of the additional leave should be proportionate and allow the special needs of the mother and the child / children to be accommodated . ### member states shall take the necessary measures to ensure that fully paid additional maternity leave is granted in specific situations justified on medical grounds , such as in the case of premature childbirth , children with disabilities , mothers with disabilities , teenage mothers , multiple births or births occurring within 18 months of the previous birth . the duration of the additional maternity leave after confinement should be proportionate and allow the special needs of the mother and the child / children to be accommodated . where national legislation and / or practice provide for maternity leave or parental leave in excess of 20 weeks this can be counted towards any additional periods of maternity leave provided for under paragraphs 3 and 4 .


### the maternity leave stipulated in paragraph 1 shall include compulsory leave of at least six weeks after childbirth . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . ### the maternity leave stipulated in paragraph 1 shall include compulsory fully paid maternity leave of at least six weeks after childbirth . member states may extend the compulsory period of maternity leave to a maximum of six weeks before confinement . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . the six week period of compulsory maternity leave shall apply to all working women regardless of the number of days worked prior to confinement .


### the maternity leave stipulated in paragraph 1 shall include compulsory leave of at least six weeks after childbirth . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . ### the maternity leave stipulated in paragraph 1 shall include compulsory fully paid maternity leave of at least six weeks after childbirth , without prejudice to existing national laws which provide for a period of compulsory maternity leave before childbirth . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . the six week period of compulsory maternity leave shall apply to all working women regardless of the number of days worked prior to confinement .


### specific actions shall be undertaken within the specific objective ‘ leadership in enabling and industrial technologies’ set out in point 1 of part ii of annex i and each of the specific objectives under the priority ‘ societal challenges’ set out in points 1 to 6 of part iii of annex i . these specific actions shall take the form of a dedicated sme instrument that is targeted at all types of smes with an innovation potential and shall be implemented in a consistent manner and tailored to the needs of smes as set out under the specific objective ‘ innovation in smes’ in point 3 . 3 . of part ii of annex i . ### specific actions shall be undertaken within the specific objective ‘ leadership in enabling and industrial technologies’ set out in point 1 of part ii of annex i and each of the specific objectives under the priority ‘ societal challenges’ set out in points 1 to 6 of part iii of annex i . these specific actions shall take the form of a dedicated sme instrument that is targeted at all types of smes with an innovation potential and shall be implemented in a consistent manner through a single management and tailored to the needs of smes as set out under the specific objective ‘ innovation in smes’ in point 3 . 3 . of part ii of annex i .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to climate change and sustainable development , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including a gender perspective , to sme involvement in research and innovation and the broader private sector participation , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers .


### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . ### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both more resource - efficient and resilient , enhancing the quality and value of agricultural products , while at the same time developing services , concepts and policies for thriving rural livelihoods and rural innovative smes . knowledge development capacity and innovation transfers in agriculture shall aim at reversing the continuous decrease of the yield growth potential in europe , and create a virtuous cycle towards achieving a sustainable intensification of union agriculture production . with a view to reducing agriculture ' s carbon footprint , the importance of short supply chains should be underlined .


### the european parliament has called for a radical simplification of union research and innovation funding in its resolution of 11 november 2010 , has highlighted the importance of the innovation union to transform europe for post - crisis world , in its resolution of 12 may 2011 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 2011 and has supported the concept of a common strategic framework for research and innovation funding in its resolution of 27 september 2011 . ### the european parliament has called for a radical simplification of union research and innovation funding in its resolutions of 11 november 2010 and 8 june 20111 , that emphasised that any increase of funds should be coupled with a radical simplification of funding procedures , has highlighted the importance of the innovation union to transform europe for post - crisis world in its resolution of 12 may 2011 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 2011 , has supported the concept of a common strategic framework for research and innovation funding , and has called for doubling of the budget for research and innovation in the next mff compared to the seventh framework programme in its resolution of 27 september 2011 . ______________ 1 texts adopted , p7_ta0266 .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding the basis of disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing new and better preventive vaccines and drugs ; using in - silico medicine for improving disease management and prediction ; developing adapted treatments and treating disease ; transferring knowledge to clinical practice and scalable innovation actions including psychosocial aspects ; improving regulatory procedures and support of access related activities ; better collection and use of health data ; standardised data analysis techniques ; healthy and active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing health disparities and inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . all of these activities shall properly account for gender and sex analysis . the activities shall take full advantage of the opportunities presented for a true interdisciplinary approach , combining knowledge from all six challenges and the other pillars to ensure sustainable solutions within the domain . active involvement of health care providers must be encouraged in order to secure rapid take - up and implementation of results .


### the european commission does not explicitly solicit the use of human embryonic stem cells . the use of human stem cells , be they adult or embryonic , if any , depends on the judgement of the scientists in view of the objectives they want to achieve and is subject to stringent ethics review . no project involving the use of human embryonic stem cells should be funded that does not obtain the necessary approvals from the member states . no activity should be funded that is forbidden in all member states . no activity should be funded in a member state where such activity is forbidden . ### stem cell therapies have shown their strong added value by leading to breakthroughs in disease treatment . therefore , the union should continue to support research in this area . the european commission does not explicitly solicit the use of human embryonic stem cells . the use of human stem cells , be they adult or embryonic if any , depends on the judgement of the scientists in view of the objectives they want to achieve and is subject to stringent ethics review . projects involving the use of human embryonic stem cells may be funded provided that they have been duly approved by the member states concerned . where allowed by national legislation , the creation and maintenance of public human embryonic stem cell banks should be considered .


### clear financial commitments of the participating countries , including prior commitments to pool national and / or regional investments for transnational research and innovation ; ### clear financial commitments of the participating countries and / or regions , in cash or in - kind , including prior commitments to pool national and / or regional investments for transnational research and innovation ;


### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats . ### the focus of activities shall be to reduce congestion , improve accessibility and interoperability and match user needs chiefly by removing bottlenecks and promoting users’ transport by promoting integrated door - to - door transport and logistics ; to develop intelligent transport applications and systems for traffic management , integrated ticketing , travel information and payment and to accelerate the uptake of intermodal solutions for passengers ; to adapt road infrastructure to unprotected road users and the needs of an ageing society ; to identify benefits that its and cooperative systems can bring for infrastructure safety management ; and to drastically reduce the occurrence of accidents and the impact of security threats .


### the transport sector is a major contributor to greenhouse gases and generates up to a quarter of all emissions . transport is 96 % dependent on fossil fuels . meanwhile , congestion is an increasing problem ; systems are not yet sufficiently smart ; alternatives for shifting between different modes of transport are not always attractive ; road fatalities remain dramatically high at 34 000 per year in the union ; citizens and businesses expect a transport system that is safe and secure . the urban context poses specific challenges to the sustainability of transport . ### the transport sector is a major contributor to greenhouse gases and generates up to a quarter of all emissions . transport is 96 % dependent on fossil fuels . meanwhile , congestion is an increasing problem ; systems are not yet sufficiently smart ; alternatives for shifting towards more sustainable modes of transport are not always attractive ; road fatalities remain dramatically high at 34 000 per year in the union ; citizens and businesses expect a transport system that is accessible to all , safe and secure . the urban context poses specific challenges to a better balance of quality of life and the sustainability of transport and mobility .


### with the aim to achieve the greatest possible impact of union funding , horizon 2020 is to develop closer synergies , which may also take the form of public - public partnerships , with national and regional programmes that support research and innovation . ### with the aim to achieve the greatest possible impact of union funding , horizon 2020 is to develop closer synergies , which may also take the form of public - public partnerships , with international , national and regional programmes that support research and innovation .


### the aim is to develop and assess innovative , cost - effective and sustainable adaptation and mitigation measures , targeting both co2 and non - co2 greenhouse gases , and underlining both technological and non - technological green solutions , through the generation of evidence for informed , early and effective action and the networking of the required competences . activities shall focus on : improving the understanding of climate change and the provision of reliable climate projections ; assessing impacts , vulnerabilities and developing innovative cost - effective adaptation and risk prevention measures ; supporting mitigation policies . ### the aim is to develop and assess innovative , cost - effective and sustainable adaptation and mitigation measures , targeting both co2 and non - co2 greenhouse gases , and underlining both technological and non - technological green solutions , through the generation of evidence for informed , early and effective action and the networking of the required competences . activities shall focus on : improving the understanding of climate change and the provision of reliable climate projections ; assessing impacts , vulnerabilities and developing innovative cost - effective adaptation and risk prevention measures ; supporting mitigation policies . a gender dimension should be integrated in the activities described above and should be preceded by a gender analysis .


### the aim shall be to support partnerships between relevant policymakers and funding bodies , mapping and monitoring tools for decision - making and also international cooperation activities . ### the aim shall be to support partnerships between relevant policymakers and funding bodies , mapping and monitoring tools for decision - making and also international cooperation activities . european research infrastructures shall be supported in their international relations activities and consulted in the process of shaping the european strategy for international cooperation in research .


### the integrated approach set out in paragraphs 1 and 2 is expected to lead to around 15% of the total combined budget for the specific objective on ‘ leadership in enabling and industrial technologies’ and the priority ‘ societal challenges’ going to smes . ### the integrated approach set out in paragraphs 1 and 2 is expected to lead to around 30% of the total budget of the specific objective on ‘ leadership in enabling and industrial technologies’ and 15% of the budget of the priority ‘ societal challenges’ going to smes .


### for all the enabling and industrial technologies , including the kets , a major aim will be to foster interactions between the technologies , and with the applications under the societal challenges . this shall be fully taken into account in developing and implementing the agendas and priorities . it requires that stakeholders representing the different perspectives are fully involved in priority setting and implementation . in certain cases , it will also require actions that are jointly funded by the enabling and industrial technologies , and by the relevant societal challenges . this will include joint funding for public - private partnerships that aim to develop technologies and apply them to address societal challenges . ### for all the enabling and industrial technologies , including the kets , a major aim will be to foster interactions between the technologies , and with the applications under the societal challenges . this shall be fully taken into account in developing and implementing the agendas and priorities . it requires that stakeholders representing the different perspectives are fully involved in priority setting and implementation . in certain cases , it will also require actions that are jointly funded by the enabling and industrial technologies , and by the relevant societal challenges . this will include joint funding for public - private partnerships and for partnerships with civil society organisations that aim to develop technologies and methods and apply them to address societal challenges .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , broad collaboration between research , public authorities , civil society and business to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to achieving gender balance , enhancing the attractiveness of the research profession , especially amongst young women and facilitating cross - border and cross - sector mobility of researchers , with particular attention to female researchers . each work programme shall contain a dedicated section describing the action planned to address gender imbalances and to integrate a gender dimension . this shall be reflected also at a project level within the provisions of grant agreements .


### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur 3194 million as set out in annex ii . a first allocation of eur 1542 million shall be provided to the european institute of innovation and technology for activities under title xvii of the treaty on the functioning of the european union . a second allocation of up to eur 1652 million shall be provided , subject to the review set out in article 26 . this additional amount shall be provided on a pro - rata basis , as indicated in annex ii , from the amount for the specific objective ‘ leadership in enabling and industrial technologies’ within the priority on industrial leadership set out in paragraph 2 and from the amount for the priority on societal challenges set out in 2 . ### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur xxx million as set out in annex ii . in view of the need to identify and select the strongest kics with the greatest chance of quickly reaching critical mass , the kic selection process in 2014 will be open to kic applications within the following pre - defined themes : - innovation for healthy living and active ageing , - raw materials , - food4future , - urban mobility , - added - value manufacturing , and - smart secure societies from the themes in the kic selection proposal , a number of kics will be selected . the number of kics selected will depend on the maturity and readiness of european consortia to form credible kics , the potential societal and economic impact , and opportunities for synergies with other initiatives , as well as the absorption capacity of the eit and the budget available .


### activities shall focus on multi - disciplinary research for energy technologies and joint implementation of pan - european research programmes and world - class facilities . ### activities shall focus on multi - disciplinary research for energy technologies and the impact of devices , facilities and new technological developments on the marine environment and joint implementation of pan - european research programmes and world - class facilities .


### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . ### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources including biodiversity , in a european and world - wide perspective and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture , livestock and forestry systems which are resource - efficient , protect natural resources , are diverse and can adapt to a changing environment and are resilient , while at the same time developing services , concepts and policies for diverse food systems and thriving rural livelihoods .


### the aim is to meet the requirements of citizens for safe , healthy and affordable food , and to make food and feed processing and distribution more sustainable and the food sector more competitive . the activities shall focus on healthy and safe foods for all , informed consumer choices , and competitive food processing methods that use less resources and produce less by - products , waste and green - house gases . ### the aim is to meet the requirements of citizens for good quality , safe , healthy and affordable food , and to make food and feed processing and distribution as well as food consumption more sustainable and the food sector more competitive while preserving european biodiversity . . the activities shall focus on good quality , a broad diversity of healthy , authentic , high quality and safe foods for all , better food information to consumers , and competitive food processing methods that use less resources and additives and produce less by products , waste and green - house gases .


### the specific objective is to achieve a resource efficient and climate change resilient economy and a sustainable supply of raw materials , in order to meet the needs of a growing global population within the sustainable limits of the planet ' s natural resources . activities will contribute to increasing european competitiveness and improving well being , whilst assuring environmental integrity and sustainability , keeping average global warming below 2 °c and enabling ecosystems and society to adapt to climate change . ### the specific objective is to achieve a resource efficient and climate change resilient economy and society and a sustainable supply of raw materials , in order to meet the needs of a growing global population within the sustainable limits of the planet ' s natural resources . activities will contribute to increasing european competitiveness and improving well being , whilst assuring environmental integrity and sustainability , with the aim of keeping average global warming below 2 °c and enabling ecosystems and society to adapt to climate change .


### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness . ### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for funding excellent research and innovation , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness .


### the right mix of openness and varying degrees of structuring of topics , communities and funding shall be defined for each activity in order to address optimally the objectives pursued . ### the right mix of openness and varying degrees of structuring of topics , communities and funding shall be defined for each activity in order to address optimally the objectives pursued . fet activities shall be open to collaboration with third parties , based on common interest and mutual benefit , while protecting european interests .


### the specific objective is to secure sufficient supplies of safe and high quality food and other bio - based products , by developing productive and resource - efficient primary production systems , fostering related ecosystem services , along side competitive and low carbon supply chains . this will accelerate the transition to a sustainable european bio - economy . ### the specific objective is to secure sufficient supplies of safe and high quality healthy food and other bio - based products , avoiding the current over - exploitation of ecosystems , by developing productive and resource - efficient primary production and food processing systems which respect biodiversity , bringing together quantitative et qualitative approaches , alongside competitive and low carbon supply chains .


### an increasing disease and disability burden in the context of an aging population places further demands on health and care sectors . if effective health and care is to be maintained for all ages , efforts are required to improve decision making in prevention and treatment provision , to identify and support the dissemination of best practice in the health and care sectors , and to support integrated care and the wide uptake of technological , organisational and social innovations empowering in particular older persons as well as disabled persons to remain active and independent . doing so will contribute to increasing , and lengthening the duration of their physical , social , and mental well - being . ### an increasing disease and disability burden in the context of an aging population places further demands on health and care sectors . if effective health and care is to be maintained for all individuals , irrespective of their age or gender and economic means , efforts are required to improve decision making in prevention and treatment provision , and diagnosis , to identify and support the dissemination of best practice in the health and care sectors , to empower citizens and patients through health literacy , and to support integrated care , and the wide uptake of technological , organisational and social innovations empowering in particular older persons , persons with chronic diseases as well as disabled persons and patients to remain active and independent . doing so will contribute to increasing , and lengthening the duration of their physical , social , and mental well - being and quality of life .


### by fostering novel ideas , fet shall support embryonic science and technology research exploring new foundations for radically new future technologies by challenging current paradigms and venturing into unknown areas . a bottom - up selection process widely open to any research ideas shall build up a diverse portfolio of targeted projects . early detection of promising new areas , developments and trends , along with attracting new and high - potential research and innovation players , will be key . ### by fostering novel ideas , fet shall support early stage science and technology research exploring new foundations for radically new future technologies by challenging current paradigms and venturing into unknown areas . a bottom - up selection process widely open to any research ideas shall build up a diverse portfolio of targeted projects . early detection of promising new areas , developments and trends , along with attracting new and high - potential research and innovation players , will be key .


### ** around eur 1131 million of this amount may go towards the implementation of strategic energy technology plan projects . around one third of this may go to smes . ### ** around eur 1131 million of this amount shall go towards the implementation of strategic energy technology plan projects . around one third of this may go to smes .


### food security , sustainable agriculture , marine and maritime research , and the bio - economy ; ### food security , sustainable agriculture and forestry , marine and maritime research , and the bio - economy ;


### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources and enhancing ecosystems services , including coping with and mitigating climate change . the activities shall focus on more sustainable and productive agriculture and forestry systems which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies for thriving rural livelihoods . ### the aim is to supply sufficient food , feed , biomass and other raw - materials , while safeguarding natural resources at the global level and enhancing ecosystems services , including protecting biodiversity and natural habitats , and coping with and mitigating climate change . the activities shall favour systemic approaches and focus on more sustainable and productive agriculture and forestry systems , including organic farming , which are both resource - efficient and resilient , while at the same time developing of services , concepts and policies aimed at ensuring a diversity of food production systems and thriving rural livelihoods .


### ** around eur 1131 million of this amount may go towards the implementation of strategic energy technology plan projects . around one third of this may go to smes . ### ** around eur 1131 million of this amount may go towards the implementation of strategic energy technology plan projects . at least one third of this shall go to smes .


### powered by the expansion of the knowledge of living systems , biotechnology is set to deliver a stream of new applications and to strengthen the union ' s industrial base and its innovation capacity . examples of the rising importance of biotechnology are in industrial applications including bio - chemicals , of which the market share is estimated to increase by up to 12 % - 20 % of chemical production by 2015 . a number of the so - called twelve rules of green chemistry are also addressed by biotechnology , due to the selectivity and efficiency of bio - systems . the possible economic burdens for union enterprises can be reduced by harnessing the potential of biotechnology processes and bio - based products to reduce co2 emissions , estimated to range from between 1 to 2 . 5 billion tons co2 equivalent per year by 2030 . in europe ' s biopharmaceutical sector , already some 20 % of the current medicines are derived from biotechnology , with up to 50 % of new medicines . biotechnology also opens new avenues for exploiting the huge potential of marine resources for producing innovative industrial , health and environmental applications . the emerging sector of marine biotechnology has been predicted to grow by 10 % a year . ### powered by the expansion of the knowledge of living systems , biotechnology is set to deliver a stream of new applications and to strengthen the union ' s industrial base and its innovation capacity . examples of the rising importance of biotechnology are in industrial applications including bio - chemicals , of which the market share is estimated to increase by up to 12 % - 20 % of chemical production by 2015 . a number of the so - called twelve rules of green chemistry are also addressed by biotechnology , due to the selectivity and efficiency of bio - systems . the possible economic burdens for union enterprises can be reduced by harnessing the potential of biotechnology processes and bio - based products to reduce co2 emissions , estimated to range from between 1 to 2 . 5 billion tons co2 equivalent per year by 2030 . in europe ' s biopharmaceutical sector , already some 20 % of the current medicines are derived from biotechnology , with up to 50 % of new medicines . with biotechnology , agricultural and food production will be more sustainable through increased efficiency and reduced environmental impact . biotechnology also opens new avenues for exploiting the huge potential of marine resources for producing innovative industrial , health , energy , energy efficiency and environmental applications . the emerging sector of marine biotechnology has been predicted to grow by 10 % a year .


### horizon 2020 shall be implemented in a manner ensuring that the priorities and actions supported are relevant to changing needs and take account of the evolving nature of science , technology , innovation , markets and society , where innovation includes business , organisational and social aspects . ### horizon 2020 shall be implemented in a manner ensuring that the priorities and actions supported are relevant to changing needs and take account of the evolving nature of science , technology , innovation , economies and society , where innovation includes business , organisational , social and environmental aspects .


### these activities will contribute to the objectives of the europe 2020 flagship initiatives on innovation union , resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe as well as union space policy objectives . ### these activities will contribute to the objectives of the europe 2020 flagship initiatives on innovation union , resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . they will also contribute to union policy objectives and international commitments in the fields of space , health , environment , energy and food security .


### the european commission shall implement information and communication actions concerning horizon 2020 , including communication measures concerning supported projects and results . budget allocated to communication under horizon 2020 shall also contribute to covering the corporate communication of the union ' s political priorities as far as they are related to the general objective of this regulation . ### the european commission shall implement information and communication actions concerning horizon 2020 , including communication measures concerning supported projects and results . in order to increase the circulation and exploitation of knowledge and maximize the efficiency of research efforts , free open online access to scientific publications , already embraced in the seventh framework programme , shall be the general principle for scientific publications of research receiving public funding from horizon 2020 . free open access to scientific data produced or collected through research funded by horizon 2020 shall be promoted and tested . budget allocated to communication under horizon 2020 shall also contribute to covering the corporate communication of the union ' s political priorities as far as they are related to the general objective of this regulation .


### increasing the competitiveness of process industries , by drastically improving resource and energy efficiencies and reducing the environmental impact of such industrial activities through the whole value chain , promoting the adoption of low - carbon technologies . ### increasing the competitiveness of process industries , by drastically improving resource and energy efficiencies and reducing the environmental impact of such industrial activities through the whole value chain , promoting the adoption of low - carbon technologies , e . g . developing new catalysts for more ecofriendly and efficient processes .


### addressing the availability of raw materials calls for co - ordinated research and innovation efforts across many disciplines and sectors to help provide safe , economically feasible , environmentally sound and socially acceptable solutions along the entire value chain . innovation in these fields will provide opportunities for growth and jobs , as well as innovative options involving science , technology , the economy , policy and governance . for this reason , a european innovation partnership on raw materials is being prepared . ### addressing the availability of raw materials calls for co - ordinated research and innovation efforts across many disciplines and sectors to help provide safe , economically feasible , environmentally sound and socially acceptable solutions along the entire value chain . call for water use in rural , urban and industrial areas should be included as well as call in the field of water ecosystem protection . innovation in these fields will provide opportunities for growth and jobs , as well as innovative options involving science , technology , the economy , policy and governance . for this reason , a european innovation partnership on raw materials is being prepared .


### by 2020 , nanotechnologies will be mainstreamed , that is seamlessly integrated with most technologies and applications , driven by consumer benefits , quality of life , sustainable development and the strong industrial potential for achieving previously unavailable solutions for productivity and resource efficiency . ### by 2015 , the commission will review all relevant legislation to ensure safety for all applications of nanomaterials in products with potential health , environmental or safety impacts over their life cycle . by 2020 , nanotechnologies will be mainstreamed , that is seamlessly integrated with most technologies and applications , driven by consumer benefits , quality of life , sustainable development and the strong industrial potential for achieving previously unavailable solutions for productivity and resource efficiency .


### the aim is to meet the requirements of citizens for safe , healthy and affordable food , and to make food and feed processing and distribution more sustainable and the food sector more competitive . the activities shall focus on healthy and safe foods for all , informed consumer choices , and competitive food processing methods that use less resources and produce less by - products , waste and green - house gases . ### the aim is to meet the requirements of citizens for safe , healthy and affordable food , and to make food and feed processing and distribution as well as food consumption more sustainable and the food sector more competitive . the activities shall focus on a broad diversity of healthy , authentic , high quality and safe foods for all , informed consumer choices , and competitive food processing methods that use less resources and additives and produce less by - products , waste and green - house gases . consumers have to make conscious choices and be not only informed about safe foods , but also made aware of the environmental , socio - economic , and nutritional consequences entailed in their choices and in the fact of wasting food . these innovations should also aim to reduce food waste in production , the distribution chain and by consumers .


### particular attention shall be paid to ensuring the adequate participation of , and innovation impact on , small and medium - sized enterprises in horizon 2020 . quantitative and qualitative assessments of sme participation shall be undertaken as part of the evaluation and monitoring arrangements . ### particular attention shall be paid to ensuring the adequate participation of , and innovation impact on , small and medium - sized enterprises in horizon 2020 , in particular in the closer - to - market phases of projects . quantitative and qualitative assessments of sme participation shall be undertaken as part of the evaluation and monitoring arrangements .


### entities established in third countries and international organisations shall be eligible to participate in indirect actions of horizon 2020 under the conditions set out in regulation xx / xx [ rules for participation ] . international cooperation with third countries and international organisations shall be promoted across and within horizon 2020 to achieve , in particular , the following objectives : ### entities established in third countries and international organisations shall be eligible to participate in indirect actions of horizon 2020 under the conditions set out in regulation xx / xx [ rules for participation ] . international cooperation with third countries and international organisations shall be promoted and integrated in horizon 2020 to achieve , in particular , the following objectives :


### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur 3194 million as set out in annex ii . a first allocation of eur 1542 million shall be provided to the european institute of innovation and technology for activities under title xvii of the treaty on the functioning of the european union . a second allocation of up to eur 1652 million shall be provided , subject to the review set out in article 26 . this additional amount shall be provided on a pro - rata basis , as indicated in annex ii , from the amount for the specific objective ‘ leadership in enabling and industrial technologies’ within the priority on industrial leadership set out in paragraph 2 and from the amount for the priority on societal challenges set out in 2 . ### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur xxx million as set out in annex ii . in view of the need to identify and select the strongest kics with the greatest chance of quickly reaching critical mass , the kic selection process in 2014 will be open to kic applications within the following pre - defined themes : - innovation for healthy living and active ageing , - raw materials , - food4future , - urban mobility , - added - value manufacturing , and - smart secure societies from the themes in the kic selection proposal , a number of kics will be selected . the number of kics selected will depend on the maturity and readiness of european consortia to form credible kics , the potential societal and economic impact , and opportunities for synergies with other initiatives , as well as the absorption capacity of the eit and the budget available .


### the aim is the promotion of low carbon , resource efficient , sustainable and competitive european bio - based industries . the activities shall focus on fostering the bio - economy by transforming conventional industrial processes and products into bio - based resource and energy efficient ones , the development of integrated biorefineries , utilising biomass from primary production , biowaste and bio - based industry by - products , and opening new markets through supporting standardisation , regulatory and demonstration / field trial activities and others , while taking into account the implication of the bio - economy on land use and land use changes . ### the aim is the promotion of low carbon , more resource efficient , sustainable and competitive european bio - based industries , while making bio - waste an asset used at its full potential . it is vital to create a closed circuit between urban and rural areas . the activities shall focus on fostering the bio - economy by transforming conventional industrial processes and products into bio - based resource and energy efficient ones , the development of integrated second and third generation biorefineries , producing and utilising biomass and other residues from primary agricultural and forestry production , biowaste and bio - based industry by - products , and through efficient transformation of bio - waste in urban areas into agricultural inputs . this will foster new markets and create potential new revenue streams for primary producers through supporting standardisation , certification schemes , regulatory and demonstration / field trial activities and others , while taking into account the implication of the bio - economy on land use and land use changes .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , broad collaboration between research , public authorities , civil society and business to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to achieving gender balance , enhancing the attractiveness of the research profession , especially amongst young women and facilitating cross - border and cross - sector mobility of researchers , with particular attention to female researchers . each work programme shall contain a dedicated section describing the action planned to address gender imbalances and to integrate a gender dimension . this shall be reflected also at a project level within the provisions of grant agreements .


### research and innovation activities supported by horizon 2020 should respect fundamental ethical principles . the opinions of the european group on ethics in science and new technologies should be taken into account . research activities should also take into account article 13 tfeu and reduce the use of animals in research and testing , with a view ultimately to replacing animal use . all activities should be carried out ensuring a high level of human health protection in accordance with article 168 tfeu . ### research and innovation activities supported by horizon 2020 should respect fundamental ethical principles . the reasoned , regularly updated opinions of the european group on ethics in science and new technologies should be taken into account , which entails , as a prerequisite , a transparent method of selection underpinned by the independence and scientific expertise of the members of the european group on ethics in science and new technologies . research activities should also take into account article 13 tfeu and reduce the use of animals in research and testing , with a view ultimately to replacing animal use , including through strategic development , integration and use of innovative , non - animal tools and technologies . all activities should be carried out ensuring a high level of human health protection in accordance with article 168 tfeu .


### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies in the context of globalisation . particular support will be provided for the development of the era and the development of framework conditions for innovation . ### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies that engage third countries . particular support will be provided for the development of the era and the development of framework conditions for innovation .


### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness . ### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for funding excellent research and innovation , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness .


### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated door - to - door transport and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats . ### the focus of activities shall be to reduce congestion , improve accessibility and match user needs by promoting integrated and completely intermodal door - to - door transport , infrastructure and logistics ; to enhance inter - modality and the deployment of smart planning and management solutions ; and to drastically reduce the occurrence of accidents and the impact of security threats .