### are legally binding and apply to and are enforced by every member within the controller ' s or processor ' s group of undertakings , and include their employees ; ### are legally binding and apply to and are enforced by every member within the controller ' s or processor ' s group of undertakings and their external subcontractors , and include their employees ;


### the structure and contact details of the group of undertakings and its members ; ### the structure and contact details of the group of undertakings and its members , and their external subcontractors ;


### in the absence of an adequacy decision pursuant to article 41 or of appropriate safeguards pursuant to article 42 , a transfer or a set of transfers of personal data to a third country or an international organisation may take place only on condition that : ### in the absence of an adequacy decision pursuant to article 41 ; or where the commission decides that a third country , or a territory or a processing sector within that third country , or an international organisation does not ensure an adequate level of protection in accordance with article 41 ; or in the absence of appropriate safeguards pursuant to article 42 , a transfer or a set of transfers of personal data to a third country or an international organisation may take place only on condition that :


### where the processing of personal data takes place in the context of the activities of an establishment of a controller or a processor in the union , and the controller or processor is established in more than one member state , the supervisory authority of the main establishment of the controller or processor shall be competent for the supervision of the processing activities of the controller or the processor in all member states , without prejudice to the provisions of chapter vii of this regulation . ### where the regulation applies by virtue of article 3 , the competent supervisory authority will be the supervisory authority of the member state or territory where the main establishment of the controller or processor subject to the regulation is established . disputes should be decided upon in accordance with the consistency mechanism set out in article 58 , and this without prejudice to the other provisions of chapter vii of this regulation .


### the supervisory authority shall , upon request , advise any data subject in exercising the rights under this regulation and , if appropriate , co - operate with the supervisory authorities in other member states to this end . ### the competent supervisory authority shall , upon request , advise any data subject in exercising the rights under this regulation and , if appropriate , co - operate with the supervisory authorities in other member states to this end .


### each supervisory authority shall have the power : ### the competent supervisory authority shall have the power :


### each supervisory authority shall have the investigative power to obtain from the controller or the processor : ### the competent supervisory authority shall have the investigative power to obtain from the controller or the processor :


### each supervisory authority shall have the power to bring violations of this regulation to the attention of the judicial authorities and to engage in legal proceedings , in particular pursuant to article 74 and article 75 . ### the competent supervisory authority shall have the power to bring violations of this regulation to the attention of the judicial authorities and to engage in legal proceedings , in particular pursuant to article 74 and article 75 .


### each supervisory authority shall have the power to sanction administrative offences , in particular those referred to in article 79 , and . ### the competent supervisory authority shall have the power to sanction administrative offences , in particular those referred to in article 79 , and .


### supervisory authorities shall provide each other relevant information and mutual assistance in order to implement and apply this regulation in a consistent manner , and shall put in place measures for effective co - operation with one another . mutual assistance shall cover , in particular , information requests and supervisory measures , such as requests to carry out prior authorisations and consultations , inspections and prompt information on the opening of cases and ensuing developments where data subjects in several member states are likely to be affected by processing operations . ### supervisory authorities shall provide each other relevant information and mutual assistance in order to implement and apply this regulation in a consistent manner , and shall put in place measures for effective co - operation with one another . mutual assistance shall cover , in particular , information requests and supervisory measures , such as requests to carry out prior authorisations and consultations , inspections and prompt information on the opening of cases and ensuing developments where data subjects in several member states are likely to cause legal effects to the detriment of the data subjects .


### each supervisory authority shall take all appropriate measures required to reply to the request of another supervisory authority without delay and no later than one month after having received the request . such measures may include , in particular , the transmission of relevant information on the course of an investigation or enforcement measures to bring about the cessation or prohibition of processing operations contrary to this regulation . ### each supervisory authority shall take all appropriate measures required to reply to the request of another supervisory authority without delay and no later than one month after having received the request . such measures may include , in particular , the transmission of relevant information on the course of an investigation or enforcement measures to bring about the cessation or prohibition of processing operations that have been proven contrary to this regulation .


### before a supervisory authority adopts a measure referred to in paragraph 2 , this supervisory authority shall communicate the draft measure to the european data protection board and the commission . ### before the competent supervisory authority adopts a measure referred to in paragraph 2 , this competent supervisory authority shall communicate the draft measure to the european data protection board and the commission .


### in order to ensure correct and consistent application of this regulation , the commission may request that any matter shall be dealt with in the consistency mechanism . ### in order to ensure correct and consistent application of this regulation , the commission may , acting on its own behalf , and shall at the request of a stakeholder , request that any matter shall be dealt with in the consistency mechanism .


### the supervisory authority referred to in paragraph 1 and the supervisory authority competent under article 51 shall take account of the opinion of the european data protection board and shall within two weeks after the information on the opinion by the chair of the european data protection board , electronically communicate to the chair of the european data protection board and to the commission whether it maintains or amends its draft measure and , if any , the amended draft measure , using a standardised format . ### the competent supervisory authority referred to in paragraph 1 shall take account of the opinion of the european data protection board and shall within two weeks after the information on the opinion by the chair of the european data protection board , electronically communicate to the chair of the european data protection board and to the commission whether it maintains or amends its draft measure and , if any , the amended draft measure , using a standardised format .


### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects , in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages or for other reasons , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the european data protection board and to the commission . ### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects within their territory , when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages , by clear breach or unjustified inaction of the competent supervisory authority , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the competent supervisory authority , the european data protection board , the commission and the controller or processor .


### where a supervisory authority has taken a measure pursuant to paragraph 1 and considers that final measures need urgently be adopted , it may request an urgent opinion of the european data protection board , giving reasons for requesting such opinion , including for the urgency of final measures . ### where a supervisory authority has taken a measure pursuant to paragraph 1 , it shall request an urgent opinion of the european data protection board , giving reasons for the request , including for the urgency of final measures .


### the european data protection board shall ensure the consistent application of this regulation . to this effect , the european data protection board shall , on its own initiative or at the request of the commission , in particular : ### the european data protection board shall ensure the consistent application of this regulation . to this effect , the european data protection board shall , on its own initiative , at the request of the commission or other stakeholders , in particular :


### examine , on its own initiative or on request of one of its members or on request of the commission , any question covering the application of this regulation and issue guidelines , recommendations and best practices addressed to the supervisory authorities in order to encourage consistent application of this regulation ; ### examine , on its own initiative or on request of one of its members , the commission or other stakeholders any question covering the application of this regulation and issue guidelines , recommendations and best practices addressed to the supervisory authorities in order to encourage consistent application of this regulation ;


### where more than one controller or processor is involved in the processing , each controller or processor shall be jointly and severally liable for the entire amount of the damage . ### where more than one controller is involved in the processing , each controller shall be jointly and severally liable for the entire amount of the damage to the extent that the joint controllers ' respective liability has not been determined in the legal arrangement referred to in article 24 .


### the controller or the processor may be exempted from this liability , in whole or in part , if the controller or the processor proves that they are not responsible for the event giving rise to the damage . ### the controller may be exempted from this liability , in whole or in part , if the controller proves that it is not responsible for the event giving rise to the damage .


### each supervisory authority shall be empowered to impose administrative sanctions in accordance with this article . ### the competent supervisory authority shall be empowered to impose administrative sanctions in accordance with this article .


### within the limits of this regulation , member states may adopt by law specific rules regulating the processing of employees ' personal data in the employment context , in particular for the purposes of the recruitment , the performance of the contract of employment , including discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship . ### within the limits of this regulation , member states or collective agreement among employers and employees may adopt by law specific rules regulating the processing of employees ' personal data in the employment context , in particular for the purposes of the recruitment , the performance of the contract of employment , including discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , criminal conviction , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship .


### draft legislative resolution ### recalls its resolution of 8 june 2011 on investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe1 ; reiterates that , regardless of realisable savings and reallocations , sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; points out that even with an increase in the level of resources for the next mff of at least 5% compared to the 2013 level only a limited contribution can be made to the achievement of the union ' s agreed objectives and commitments , and to the principle of union solidarity ; challenges the council , if it does not share this approach , to clearly identify which of its political priorities or projects could be dropped altogether , despite their proven european added value ; _______________ 1 texts adopted , p7_ta0266 .


### the commission shall receive annual implementation reports from the international financial institutions referred to in article 5 setting out the supported activities in terms of financial implementation , distribution of funding with regard to sectors and type of beneficiaries , applications submitted , contracts concluded , actions funded , results and , where possible , impact . ### the commission shall receive annual implementation reports from the international financial institutions referred to in article 5 setting out the supported activities in terms of financial implementation , distribution of funding with regard to sectors and type of beneficiaries , applications submitted , contracts concluded , actions funded , results and impact .


### for the first time in 2011 and before 31 december of each year , the commission shall present to the european parliament and to the council a quantitative and qualitative annual report on the activities under this decision in the previous year . the annual report shall be based on the implementation reports referred to in paragraph 1 and focus mainly on the results achieved and shall in particular contain information relating to applications submitted , contracts concluded , actions funded including their complementarity with other community interventions , notably the esf . ### for the first time in 2011 , but no later than 12 months after the entry into force of this decision , and before 31 december of each year , the commission shall present to the european parliament and to the council a quantitative and qualitative annual report on the activities under this decision in the previous year . the annual report shall be based on the implementation reports referred to in paragraph 1 and focus mainly on the results achieved and shall in particular contain information relating to applications submitted , contracts concluded , actions funded including their complementarity with other community interventions , notably the esf .


### to help address such imbalances , a procedure laid down in detail in legislation is necessary . ### to help address such imbalances and vulnerabilities , a procedure laid down in detail in legislation is necessary .


### it is appropriate to supplement the multilateral surveillance referred to in article 121 and of the treaty with specific rules for detection , prevention and correction of macroeconomic imbalances . ### it is appropriate to supplement the multilateral surveillance referred to in article 121 and of the treaty with specific rules for detection , prevention and correction of macroeconomic imbalances . macroeconomic imbalances are defined as situations in which a member state experiences large current account deficits , significant losses of competitiveness , large and unusual increases in asset prices , high levels of or a significant deterioration in external , public sector or private sector indebtedness or a significant risk thereof .


### this procedure should rely on an alert mechanism for early detection of emerging macroeconomic imbalances . it should be based on use of an indicative and transparent scoreboard combined with economic judgment . ### this procedure should rely on an alert mechanism for early detection of emerging macroeconomic imbalances and vulnerabilities . it should be based on use of an indicative and transparent scoreboard combined with economic judgment .


### the scoreboard should consist of a limited set of economic and financial indicators relevant to detection of macroeconomic imbalances , with corresponding indicative thresholds . the composition of the scoreboard may evolve in time , inter alia due to evolving threats to macroeconomic stability or enhanced availability of relevant statistics . ### the scoreboard should consist of a limited set of economic and financial indicators relevant to detection of macroeconomic imbalances and vulnerabilities , with corresponding indicative thresholds . the composition of the scoreboard may evolve in time , inter alia due to evolving threats to macroeconomic stability or enhanced availability of relevant statistics .


### the crossing of one or more indicative thresholds need not necessarily imply that macroeconomic imbalances are emerging , as economic policy - making should take into account inter - linkages between macroeconomic variables . economic judgment should ensure that all pieces of information , whether from the scoreboard or not , are put in perspective and become part of a comprehensive analysis . ### the crossing of one or more indicative thresholds need not necessarily imply that macroeconomic imbalances and vulnerabilities are emerging , as economic policy - making should take into account inter - linkages between macroeconomic variables . economic judgment should ensure that all pieces of information , whether from the scoreboard or not , are put in perspective and become part of a comprehensive analysis .


### a procedure to monitor and correct adverse macroeconomic imbalances , with preventive and corrective elements , will require enhanced surveillance tools based on those used in the multilateral surveillance procedure . this may include enhanced surveillance missions by the commission to member states and additional reporting by the member state in case of severe imbalances , including imbalances that jeopardise the proper functioning of the economic and monetary union . ### a procedure to monitor and correct adverse macroeconomic imbalances and vulnerabilities , with preventive and corrective elements , will require enhanced surveillance tools based on those used in the multilateral surveillance procedure . this may include enhanced surveillance missions by the commission to member states and additional reporting by the member state in case of severe imbalances , including imbalances and vulnerabilities that jeopardise the proper functioning of the economic and monetary union .


### when assessing imbalances , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . the economic adjustment capacity and the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union , should also be considered . ### when assessing imbalances and vulnerabilities , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . given the vulnerabilities and the magnitude of the adjustment required , the need for policy action is particularly pressing in member states showing persistently large current - account deficits and large competitiveness losses . the economic adjustment capacity and the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union , should also be considered .


### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation . ### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities and involve all relevant national stakeholders . it should be tailored to the specific environment and circumstances of the member state concerned , be compatible with medium and long - term convergence and the targets included in a union strategy for growth and jobs , upholding the single market , fostering international trade links , increasing competitiveness , and also cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation .


### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation . ### if macroeconomic imbalances or vulnerabilities are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances and vulnerabilities should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation .


### if severe macroeconomic imbalances are identified , including imbalances that jeopardise the proper functioning of economic and monetary union , an excessive imbalance procedure should be initiated that may include issuing recommendations to the member state , enhanced surveillance and monitoring requirements and in respect of member states whose currency is the euro , the possibility of enforcement in accordance with regulation no [ … / … ] 4 in the event of sustained failure to take corrective action . ### if severe macroeconomic imbalances and vulnerabilities are identified , including imbalances and vulnerabilities that jeopardise the proper functioning of economic and monetary union , an excessive imbalance procedure should be initiated that may include issuing recommendations to the member state , enhanced surveillance and monitoring requirements and in respect of member states whose currency is the euro , the possibility of enforcement in accordance with regulation no [ … / … ] 4 in the event of sustained failure to take corrective action .


### since an effective framework for detection and prevention of macroeconomic imbalances cannot be sufficiently achieved by the member states because of the deep trade and financial inter - linkages between member states and the spillover effect of national economic policies on the union and the euro area as a whole and can be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity , as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in the same article , this regulation does not go beyond what is necessary to achieve those objectives , ### since an effective framework for detection and prevention of macroeconomic imbalances and vulnerabilities cannot be sufficiently achieved by the member states because of the deep trade and financial inter - linkages between member states and the spillover effect of national economic policies on the union and the euro area as a whole and can be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity , as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in the same article , this regulation does not go beyond what is necessary to achieve those objectives ,


### ' excessive imbalances ‘ means severe imbalances , including imbalances that jeopardise the proper functioning of economic and monetary union . ### ‘ excessive imbalances and vulnerabilities’ means imbalances and vulnerabilities that jeopardise the proper functioning of economic and monetary union . ’


### – secure or attempt to secure , by a person or by persons acting in collaboration , the price of one or several wholesale energy products at an abnormal or artificial level , unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for doing so are legitimate and that these transactions or orders to trade conform to accepted market practices on the wholesale energy market concerned ; or ### – secure or attempt to secure , by a person or by persons acting in collaboration , the price of one or several wholesale energy products at an abnormal or artificial level , unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for doing so are legitimate ; or


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . by 31 december 2012 at the latest , the commission shall adopt delegated acts as referred to in article 15 and in accordance with the conditions laid down in articles 16 and 17 laying down minimum standards for penalties , with the aim of bringing about a completely harmonised system of penalties in the european union .


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


### in order to ensure the long - term competitiveness of bio - based industrial sectors , and in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that gives preference to the use of biomass feedstocks that do not have a high economic value for other uses than biofuels . ### in order to ensure the long - term competitiveness and investment security of bio - based industrial sectors , and in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that promotes resource - efficient use of biomass feedstocks and gives preference to second - generation biofuels . the union’s regional policy and the structural funds should play a significant role in promoting new and innovative biofuels .


### the estimated indirect land - use change emissions should be included in the reporting of greenhouse gas emissions from biofuels under directives 98 / 70 / ec and 2009 / 28 / ec . biofuels made from feedstocks that do not lead to additional demand for land , such as those from waste feedstocks , should be assigned a zero emissions factor . ### the estimated indirect land - use change emissions should be included in the reporting of greenhouse gas emissions from biofuels under directives 98 / 70 / ec and 2009 / 28 / ec . biofuels made from feedstocks that do not lead to additional demand for land , such as those from waste and residue feedstocks , should be assigned a zero emissions factor .


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


### renewable liquid and gaseous fuels of non - biological origin shall be considered to be four times their energy content . ### renewable liquid and gaseous fuels of non - biological origin shall be considered to be twice their energy content .


### the commission shall , before 31 december 2017 , submit a report to the european parliament and to the council reviewing , on the basis of the best latest available scientific evidence , the effectiveness of the measures introduced by this directive in limiting indirect land - use change greenhouse gas emissions associated with the production of biofuel and bioliquids . the report shall , if appropriate , be accompanied by a legislative proposal based on the best available scientific evidence , for introducing estimated indirect land use change emissions factors into the appropriate sustainability criteria to be applied from 1st january 2021 and a review of the effectiveness of the incentives provided for biofuels from non - land using feedstocks and non - food crops under article 3d of directive 2009 / 28 / ec . ### the commission shall , before 31 december 2017 , submit a report to the european parliament and to the council reviewing , on the basis of the best latest available scientific evidence , the effectiveness of the measures introduced by this directive in limiting indirect land - use change greenhouse gas emissions associated with the production of biofuel and bioliquids . the report shall also review the impact of the directive on the operation of the existing biofuel industry and the broader socioeconomic impact of the directive on the union’s regions . the report shall , if appropriate , be accompanied by a legislative proposal based on the best available scientific evidence , for introducing estimated indirect land use change emissions factors into the appropriate sustainability criteria to be applied from 1st january 2021 and a review of the effectiveness of the incentives provided for biofuels from non - land using feedstocks and non - food crops under article 3d of directive 2009 / 28 / ec .


### feedstocks whose contribution towards the target referred to in article 3 shall be considered to be twice their energy content ### feedstocks whose contribution towards the target referred to in article 3 shall be considered directly in accordance with their energy content


### on 17 june 2010 the european council19 endorsed the commission proposal for a europe 2020 strategy for jobs and smart , sustainable and inclusive growth20 . the european council advocated full mobilisation of the appropriate eu instruments and policies to support achievement of the common objectives and invited the member states to step up coordinated action . the public employment services have a central role in achieving the europe 2020 target of 75 % employment rate for women and men aged 20 to 64 by 2020 . __________________ 19 nr : euco 13 / 10 dated 17 / 6 / 2010 . 20 communication from the commission europe 2020 – a strategy for smart , sustainable and inclusive growth , com 2020 of 3 march 2010 . ### on 17 june 2010 the european council19 endorsed the commission proposal for a europe 2020 strategy for jobs and smart , sustainable and inclusive growth20 . the european council advocated full mobilisation of the appropriate eu instruments and policies to support achievement of the common objectives and invited the member states to step up coordinated action . the public employment services have a central role in achieving the europe 2020 target of 75 % employment rate for women and men aged 20 to 64 by 2020 , notably by decreasing youth unemployment . __________________ 19 nr : euco 13 / 10 dated 17 / 6 / 2010 . 20 communication from the commission europe 2020 – a strategy for smart , sustainable and inclusive growth , com 2020 of 3 march 2010 .


### the pes network should reinforce co - operation between its members , develop joint initiatives aimed at exchanges of information and best practices in all areas covered by pes , comparative analysis and advice as well as promotion of innovative approaches in the delivery of employment services . by establishing this network an inclusive , evidence - based and performance - oriented comparison of all pes leading to the identification of best practices will be possible . with these results members of the network should be able to shape the design and delivery of employment services within their specific responsibilities . the initiatives carried out by the network should improve pes effectiveness and allow for more efficient public spending . ### the pes network should reinforce co - operation between its members , develop joint initiatives aimed at exchanges of information and best practices in all areas covered by pes , comparative analysis and advice as well as promotion of innovative approaches in the delivery of employment services . by establishing this network an inclusive , evidence - based and performance - oriented comparison of all pes leading to the identification of best practices will be possible . with these results members of the network should be able to shape the design and delivery of employment services within their specific responsibilities . the initiatives carried out by the network should improve pes effectiveness and allow for more efficient public spending . the network should also cooperate with private employment services .


### the programme shall finance actions with european added value . to that effect , the commission shall ensure that the actions selected for funding are intended to produce results with european added value and shall monitor whether european added value was actually achieved through the final results of the actions financed by the programme . ### the programme shall finance actions with european added value and obey the principles of gender budgeting . to that effect , the commission shall ensure that the actions selected for funding are intended to produce results with european added value and shall monitor whether european added value was actually achieved through the final results of the actions financed by the programme . the european added value shall be assessed on the basis of its potential to contribute to achieving the overarching priorities of gender equality and combating violence against women .


### the commission shall monitor the programme regularly in order to follow the implementation of actions carried out under it in the areas of actions referred to in article 6 and the achievement of the specific objectives referred to in article 5 . the monitoring will also provide a means of assessing the way in which gender equality and anti - discrimination issues have been addressed across the programme ' s activities . where relevant , indicators should be disaggregated by sex , age and disability . ### the commission shall monitor the programme regularly in order to follow the implementation of actions carried out under it in the areas of actions referred to in article 6 and the achievement of the specific objectives referred to in article 5 . the monitoring will also provide a means of assessing the way in which gender equality and anti - discrimination issues have been addressed across the programme ' s activities . where relevant , indicators should be disaggregated by sex , age and disability . the european added value in terms of achieving the overarching priority of gender equality and combating violence against women should be a leading benchmark .


### the european union and its more than 50 institutions and agencies should be equipped with a high - quality european public administration , so as to enable it to perform its tasks to the highest possible standard in accordance with the treaties and to meet the challenges , both internal and external , that it will face in the future . ### the european union and its more than 50 institutions and agencies should be equipped with a high - quality european public administration , so as to enable it to perform its tasks , including the new tasks deriving from the treaties , to the highest possible standard in accordance with the treaties and to meet the challenges , both internal and external , that it will face in the future , notably the possible accession of further countries .


### consequently , it is necessary to provide a framework for the recruitment of high calibre staff in terms of productivity and integrity , drawn on the widest possible geographical basis from among citizens of the member states , and to enable such staff to carry out their duties as effectively and efficiently as possible . ### consequently , it is necessary to provide a framework for the recruitment of staff with the highest level of skills and competences , drawn on the widest possible geographical basis from among citizens of the member states , and to enable such staff to carry out their duties as effectively and efficiently as possible , notably through an appropriate career development system that rewards performance , dedication and quality of service .


### the potential advantages for officials and other servants of the european union of the application of the method should be balanced by the continuation of the system of special levy , to be renamed as ' solidarity levy ' . while the rate of the special levy in force during the period from 2004 to 2012 increased gradually over time and averaged at 4 . 23 % , it seems appropriate in the present circumstances to increase the solidarity levy at the uniform rate of 6% , so as to take account of a difficult economic context and its ramifications for public finances throughout the european union . such a solidarity levy should apply to all officials and other servants of the european union for the same period as the ' method ' itself . ### the potential advantages for officials and other servants of the european union of the application of the method should be balanced by the continuation of the system of special levy , to be renamed as ‘ solidarity levy’ . while the rate of the special levy in force during the period from 2004 to 2012 increased gradually over time and averaged at 4 . 23 % , it seems appropriate in the present circumstances to increase the solidarity levy at the uniform rate of 6% , so as to help to finance the union’s growth and employment policies from the union ' s budget and to take account of a difficult economic context and its ramifications for public finances throughout the european union , such a solidarity levy should apply to all officials and other servants of the european union for the same period as the ‘ method’ itself .


### demographic changes and the changing age structure of the population concerned require that the pension age be increased , subject however to transitional measures for officials and other servant of the european union already in service . these transitional measures are necessary to respect acquired rights of officials already in service who have contributed to the notional pension fund for european union officials . ### demographic changes and the changing age structure of the population concerned require that the pension age be increased , subject however to transitional measures for officials and other servant of the european union already in service . these transitional measures are necessary to respect acquired rights of officials already in service who have contributed to the notional pension fund for european union officials . the pension age should also be made more flexible by making it easier for staff to voluntarily continue to work until the age of 67 and making it possible , in exceptional circumstances to work until the age of 70 .


### taking this request into account , it is appropriate that promotion to a higher grade should be made conditional on performing duties whose importance justifies the official ' s appointment to that higher grade . ### taking this request into account , it is appropriate that promotion to a higher grade should be made conditional on personal dedication , improving skills and competences , and performing duties whose importance justifies the official ' s appointment to that higher grade .


### the establishment plan appended to the section of the budget related to each institution shall indicate the number of posts in each grade and function group . each institution’s establishment plan shall reflect the obligations set out in the multi - annual financial framework and the inter - institutional agreement on its implementation . ### the establishment plan appended to the section of the budget related to each institution shall indicate the number of posts in each grade and function group .


### recruitment shall be directed to securing for the institution the services of officials of the highest standard of ability , efficiency and integrity , recruited on the broadest possible geographical basis from among nationals of member states of the european union . no posts shall be reserved for nationals of any specific member state . the principle of the equality of union’s citizens shall allow each institution to adopt corrective measures following the observation of a long lasting and significant imbalance between nationalities among officials which is not justified by objective criteria . these corrective measures shall never result in recruitment criteria other than those based on merit . before such corrective measures are adopted , the appointing authority of the institution concerned shall adopt general provisions for giving effect to this paragraph in accordance with article 110 . ### recruitment shall be directed to securing for the institution the services of officials of the highest standard of skills , competences , ability , efficiency and integrity , recruited on the broadest possible geographical basis from among nationals of member states of the european union . no posts shall be reserved for nationals of any specific member state . the principle of the equality of union’s citizens shall allow each institution to adopt corrective measures following the observation of a long lasting and significant imbalance between nationalities among officials , taking into account the breakdown into each category and into each grade separately , which is not justified by objective criteria . these corrective measures shall never result in recruitment criteria other than those based on merit . before such corrective measures are adopted , the appointing authority of the institution concerned shall adopt general provisions for giving effect to this paragraph in accordance with article 110 .


### recruitment shall be directed to securing for the institution the services of officials of the highest standard of ability , efficiency and integrity , recruited on the broadest possible geographical basis from among nationals of member states of the european union . no posts shall be reserved for nationals of any specific member state . ### recruitment shall be directed to securing for the institution the services of officials of the highest standard of ability , efficiency and integrity , recruited on the broadest possible geographical basis from among nationals of member states of the european union and with due regard to gender balance . no posts shall be reserved for nationals of any specific member state .


### without prejudice to article 29 , officials shall be recruited only at grades sc 1 , ast 1 to ast 4 or ad 5 to ad 8 . ### without prejudice to article 27 and article 29 , officials shall be recruited only at grades sc 1 , ast 1 to ast 4 or ad 5 to ad 8 .


### article 42a shall be amended as follows : in the second sentence of the first paragraph , the word ' institutions ' shall be replaced by ' appointing authority of each institution ' ; in the last sentence of the third paragraph , the word ' adapted ' shall be replaced by ' updated ' ; ### article 42a shall be replaced by the following : ' article 42a an official shall be entitled to up to six months of parental leave without basic salary for every child , to be taken during the first twelve years after the birth or adoption of the child . the duration of the leave may be doubled for single parents recognised under general implementing provisions adopted by the appointing authority of each institution and for parents of dependent children with a disability or a severe illness recognised by the medical officer . the minimum leave taken at any one time shall not be less than one month . during parental leave , the official ' s membership of the social security scheme shall continue ; the acquisition of pension rights , dependent child allowance and education allowance shall be maintained . the official shall retain his post , and continue to be entitled to advancement to a higher step or promotion in grade . the leave may be taken as full - time or half - time leave . where parental leave is taken in the form of half - time leave , the maximum period provided for in the first paragraph shall be doubled . during parental leave , officials shall be entitled to an allowance of 60% of their basic salary per month , subject to a maximum amount of eur 2 552 , 40 , or 50 % of such sum if on half - time leave but may not engage in any other gainful employment . the full contribution to the social security scheme provided for in articles 72 and 73 shall be borne by the institution and calculated on the basis of the basic salary of the official . however , in the case of half - time leave this provision shall apply only to the difference between the full basic salary and the proportionally reduced basic salary . for the part of the basic salary actually received , the official ' s contribution shall be calculated by using the same percentages as if he were in full - time employment . the allowance calculated as referred to in the second paragraph shall not be less than eur 1 592 , 50 per month , or 50 % of such sum if the official is on half - time leave , for the single parents and parents of dependent children with a disability or a severe illness recognised by the medical officer referred to in the first paragraph and during the first three months of parental leave where such leave is taken by the father during maternity leave or by either parent immediately after maternity leave or during or immediately after adoption leave . the parental leave may be extended for a further six months with an allowance limited to 50 % of the amount referred to in the second paragraph . for single parents as referred to in the first paragraph , the parental leave may be extended for a further twelve months with an allowance limited to 50% of the amount referred to in the third paragraph . the amounts mentioned in this article shall be updated in line with remuneration . ' ;


### however , an official may at his own request and where the appointing authority considers it justified in the interest of the service , carry on working until the age of 67 , in which case he shall be retired automatically on the last day of the month in which he reaches that age . ### however , an official may at his own request and where the appointing authority considers it justified in the interest of the service , carry on working until the age of 67 , or on an exceptional base until the age of 70 , in which case he shall be retired automatically on the last day of the month in which he reaches that age .


### ' 4 . the appointing authority of each institution may introduce flexible working - time arrangements . officials to whom the provisions of the second paragraph of article 44 apply shall manage their working - time without resorting to such arrangements . ' ; ### ' 4 . the appointing authority of each institution shall introduce flexible working - time arrangements . ' ;


### the areas for which limitations in total catch of horse mackerel are fixed each year do not coincide with the stock boundaries of atlantic horse mackerel . in the context of fixing the fishing opportunities for 2009 , council and commission have undertaken to rearrange these tac areas which would allow this plan to work properly . ### the areas for which limitations in total catch of horse mackerel are fixed each year do not coincide with the stock boundaries of atlantic horse mackerel . in the context of fixing the fishing opportunities for 2009 , council and commission have undertaken to rearrange these tac areas which would allow this plan to work properly . the new allocation key should be fixed in a fair and equitable manner .


### the establishment and allocation of fishing opportunities and the fixing of the biological references are measures of prime importance in the common fisheries policy and have a direct impact on the socio - economic situation of the fishing fleets of the member states . it is appropriate that the council should reserve to itself the right to exercise directly implementing powers in relation to these specific matters . ### the establishment and allocation of fishing opportunities in the common fisheries policy have a direct impact on the socio - economic situation of the fishing fleets of the member states .


### where the stecf is not able to estimate the level of discards including slipped fish for the year preceding the year in which the latest scientific assessment has been made , the deduction shall be equal to the highest relative amount of discards including slipped fish scientifically estimated as having occurred within the last 15 years , but not lower than 5 % . ### where the stecf is not able to estimate the level of discards including slipped fish for the year preceding the year in which the latest scientific assessment has been made , the deduction shall be equal to the average relative amount of discards including slipped fish scientifically estimated as having occurred within the last 15 years .


### in the event that stecf advises that the egg survey indices as defined in article 3 or their weighting as referred to in article 7 , or the constant factor referred to in article 7 are no longer appropriate in order to maintain a very low risk of stock depletion and a high yield , the council shall decide on new values for those elements . ### in the event that stecf advises that the egg survey indices as defined in article 3 or their weighting as referred to in article 7 , or the constant factor referred to in article 7 are no longer appropriate in order to maintain a very low risk of stock depletion and a high yield , the council shall decide on new values for those elements in accordance with the procedure laid down in article 37 of the ec treaty .


### special fishing permit ### fishing authorisation


### it shall be prohibited for any fishing vessel not holding a fishing permit as referred to in paragraph 1 to fish for , or retain on board , any quantity of horse mackerel while the vessel is engaged on a fishing trip that has included the presence of that vessel in one of the ices divisions mentioned in article 2 . ### it shall be prohibited for any fishing vessel not holding a fishing authorisation as referred to in paragraph 1 to fish for , or retain on board , any quantity of horse mackerel while the vessel is engaged on a fishing trip that has included the presence of that vessel in one of the ices divisions mentioned in article 2 .


### for vessels fitted with a vessel monitoring system , member states shall verify , based on a representative sampling , that the information received at the fisheries monitoring centres corresponds to activities recorded in the logbook by using vms data . such cross - checks shall be recorded in computer - readable form for a period of three years . particular emphasis shall be placed on the coherence of area data concerning activities observed in areas where horse mackerel stock boundaries meet , namely ices divisions viiic and ixa , iva and ivb , viie and viid . ### particular emphasis shall also be placed on the coherence of area data concerning activities observed in areas where horse mackerel stock boundaries meet , namely ices divisions viiic and ixa , iva and ivb , viie and viid .


### in a context of progressive migration to ‘ all ip networks’ , the lack of availability of connectivity products based on the ip protocol for different classes of services with assured service quality that enable communication paths across network domains and across network borders , both within and between member states , hinders the development of applications that rely on access to other networks , thus limiting technological innovation . moreover , this situation prevents the diffusion on a wider scale of efficiencies which are associated with the management and provision of ip - based networks and connectivity products with an assured service quality level , in particular enhanced security , reliability and flexibility , cost - effectiveness and faster provisioning , which benefit network operators , service providers and end users . a harmonised approach to the design and availability of these products is therefore necessary , on reasonable terms including , where requested , the possibility of cross - supply by the electronic communications undertakings concerned . ### in a context of progressive migration to ‘ all ip networks’ , the lack of availability of connectivity products based on the ip protocol for different classes of services with a defined quality of service within closed communications networks using the internet protocol with strict admission control could hinder the development of services that rely on this defined quality in order to function adequately . a harmonised approach to the design and availability of these services is therefore necessary , including safeguards to guarantee that the enhanced quality is not functionally identical or to the detriment of the performance , affordability or quality of internet access services or undermines competition , innovation or net neutrality .


### the internet has developed over the past decades as an open platform for innovation with low access barriers for end - users , content and application providers and internet service providers . the existing regulatory framework aims at promoting the ability of end - users to access and distribute information or run applications and services of their choice . recently , however , the report of the body of european regulators for electronic communications on traffic management practices published in may 2012 and a study , commissioned by the executive agency for consumers and health and published in december 2012 , on the functioning of the market of internet access and provision from a consumer perspective , showed that a significant number of end - users are affected by traffic management practices which block or slow down specific applications . these tendencies require clear rules at the union level to maintain the open internet and to avoid fragmentation of the single market resulting from individual member states ' measures . ### the internet has developed over the past decades as an open platform for innovation with low access barriers for end - users , content and application providers and internet service providers . the key driver of the unprecedented innovation and economic activity in the digital age has been the fact that all internet traffic is treated equally , without discrimination , restriction or interference , independent of its sender , receiver , type , content , device , service or application ; conform the principle of net neutrality . the existing regulatory framework aims at promoting the ability of end - users to access and distribute information or run applications and services of their choice . recently , however , the report of the body of european regulators for electronic communications on traffic management practices published in may 2012 and a study , commissioned by the executive agency for consumers and health and published in december 2012 , on the functioning of the market of internet access and provision from a consumer perspective , showed that a significant number of end - users are affected by traffic management practices which block or slow down specific applications . these tendencies require clear rules to enshrine the principle of net neutrality in law at the union level to maintain the open internet and to avoid fragmentation of the single market resulting from individual member states ' measures .


### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality which are not impaired by specialised services . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with specialised services , and quality as perceived by end - users . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services . ### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality which are not impaired by specialised services . national regulatory authorities should establish clear and comprehensible notification and redress mechanisms for end - users subjected to discrimination , restriction or interference of online content , services or applications . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with specialised services , and quality as perceived by end - users . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services .


### 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 . ### with due account to the principle of net neutrality , end - users shall be free to enter into agreements on data volumes and speeds with providers of internet access services , provided they freely and explicitly give their informed consent , and to avail of any offers by providers of internet content , applications and services .


### end - users shall also be free to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service . ### end - users shall also be free to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service . where such agreements are concluded with the provider of internet access services , that provider shall ensure that the enhanced quality of service is not to the detriment of the performance , affordability or quality of internet access services , in accordance with the principle of net neutrality .


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


### minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . ### minimise the effects of temporary or exceptional network congestion provided all traffic is 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 . ### reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph . therefore all techniques to inspect or analyse data shall be in accordance with privacy and data protection legislation . by default , such techniques should only examine header information .


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . ### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services in accordance with the principle of net neutrality and at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings .


### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . ### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . the annual resolutions on sustainable fisheries issued by united nations general assembly since 2007 , the 2008 iucn ' s global policy against shark finning and the 2010 meeting of the fish stocks agreement review conference have called upon nations to take measures to require that all sharks be landed with their fins naturally attached .


### where fishing vessels flying the flag of a member state catch , retain on board , tranship or land sharks , the flag member state shall send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance of vessels with the regulation , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided : ### where fishing vessels flying the flag of a member state catch , retain on - board , tranship or land sharks , the flag member state shall , in accordance with regulations n&#186 ; 1224 / 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy and n&#186 ; 404 / 2011 laying down detailed rules for the implementation of the above regulation , send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance with the regulation of vessels in the eu and non - eu waters , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided :


### 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 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 . a regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public


### healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents . ### healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats and guaranteeing anonymity , where appropriate . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents .


### 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 .


### where a device , when placed on the market or used in accordance with the manufacturer ' s instructions , incorporates , as an integral part , a substance which , if used separately , would be considered to be a medicinal product as defined in article 1 of directive 2001 / 83 / ec , including a medicinal product derived from human blood or human plasma as defined in article 1 of that directive , with action ancillary to that of the device , that device shall be assessed and authorised in accordance with this regulation . ### where a device , when placed on the market or used in accordance with the manufacturer ' s instructions , incorporates , as an integral part , a substance which , if used separately , would be considered to be a medicinal product as defined in article 1 of directive 2001 / 83 / ec , including a medicinal product derived from human blood or human plasma as defined in article 1 of that directive , with action ancillary to that of the device , that device shall be assessed and authorised in accordance with this regulation following consultation with the national medicine agency or with the european medicines agency .


### ‘ custom - made device’ means any device specifically made in accordance with a written prescription of a doctor of medicine , of a dental practitioner or of any other person authorised by national law by virtue of this person ' s professional qualifications which gives , under his responsibility , specific design characteristics , and is intended for the sole use of a particular patient . ### ‘ custom - made device’ means any device specifically made by an appropriately qualified person exclusively to meet a specific patient’s individual requirements and needs . in particular a ‘ custom - made device’ may be produced on the basis of a written prescription of a doctor of medicine , of a dental practitioner or of any other person authorised by national law by virtue of this person’s professional qualifications which gives , under his responsibility , specific design characteristics . however , mass - produced devices which need to be adapted to meet the specific requirements of a doctor of medicine , a dental practitioner or any other professional user and devices which are mass - produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine , dental practitioners or any other authorised person shall not be considered to be custom - made devices ;


### ‘ making available on the market’ means any supply of a device , other than an investigational device , for distribution , consumption or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ; ### ‘ making available on the market’ means any supply of a device , other than an investigational device , for distribution , consumption or use on the union market , whether in return for payment or free of charge ;


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may , at the request of a member state , and following consultation with the mdcg , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer and his authorised representative and , if appropriate , take the necessary corrective action to bring that device into conformity , withdraw or recall it . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available and , if applicable , the notified body that issued a certificate in accordance with article 45 for the device in question , giving details , in particular , of the non - compliance and of any corrective action taken . ### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer and his authorised representative and , if appropriate , take the necessary corrective action to bring that device into conformity , withdraw or recall it . they shall also immediately inform the competent authorities of all member states and eu notified bodies , specifying the identity of the manufacturer and whether it is part of a group of companies , so that the competent authorities can investigate all the products produced by the manufacturer and the group to which it belongs .


### person responsible for regulatory compliance ### person responsible for compliance


### manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices . the expert knowledge shall be demonstrated by either of the following qualifications : ### manufacturers shall have available within their organisation at least one person responsible for compliance who possesses expertise in the field of medical devices . the expertise shall be demonstrated by a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline necessary to fulfil the tasks laid down in paragraph 2 points and of this article .


### without prejudice to national provisions regarding professional qualifications , manufacturers of custom - made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture . ### without prejudice to national provisions regarding professional qualifications , manufacturers of custom - made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture . gaining a qualification to run a business and to train apprentices shall , in particular , be deemed to constitute proof of professional experience .


### the qualified person shall at least be responsible for ensuring the following matters : ### the person responsible for compliance shall at least be responsible for ensuring the following matters :


### the qualified person shall suffer no disadvantage within the manufacturer ' s organisation in relation to the proper fulfilment of his duties . ### the person responsible for compliance shall suffer no disadvantage within the manufacturer ' s organisation in relation to the proper fulfilment of his duties .


### authorised representatives shall have available within their organisation at least one qualified person who possesses expert knowledge regarding the regulatory requirements for medical devices in the union . the expert knowledge shall be demonstrated by either of the following qualifications : ### authorised representatives shall have available within their organisation at least one person responsible for compliance who possesses expertise regarding the requirements for medical devices in the union . the expertise shall be demonstrated by a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline necessary to fulfil the tasks laid down in paragraph 2 points and of this article .


### this card shall contain the following : ### this information shall contain the following :


### the information shall be written in a way that is readily understood by a lay person . ### the information shall be written in a way that is readily understood by a lay person . this information shall be supplied to the patient at the time of consent , before the device is implanted . the patients need to know that implants are not permanent and may need to be replaced or removed ; patients also need to be informed about the quality of implants and the potential risks associated with them .


### to operate its system for the assignment of udis for the period to be determined in the designation which shall at least be three years after its designation ; ### to operate its system for the assignment of udis for the period to be determined in the designation which shall at least be five years after its designation ;


### to enable the public to be adequately informed about devices placed on the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators ; ### to enable the public to be adequately informed about devices placed on the market as well as devices removed from the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators ;


### to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to be conducted in more than one member state to comply with information obligations under articles 50 to 60 ; ### to enable the public to be adequately informed about clinical investigations , for healthcare professionals to have adequate access to the results of clinical investigations , and to enable sponsors of clinical investigations to be conducted in more than one member state to comply with information obligations under articles 50 to 60 ;


### the commission shall assign an identification number to each notified body for which the notification is accepted in accordance with article 33 . it shall assign a single identification number even when the body is notified under several union acts . ### the commission shall assign an identification number to each notified body for which the notification is accepted in accordance with article 33 . it shall assign a single identification number even when the body is notified under several union acts . if they are successfully renotified , bodies notified pursuant to directives 90 / 385 / eec and 93 / 42 / eec shall retain the identification number assigned to them .


### at least once a year , the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in annex vi . this assessment shall include an on - site visit to each notified body . ### at least once a year , the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in annex vi . this assessment shall include an unannounced on - site visit to each notified body .


### where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in annex vi , or that it is failing to fulfil its obligations , the authority shall suspend , restrict , or fully or partially withdraw the notification , depending on the seriousness of the failure to meet those requirements or fulfil those obligations . a suspension shall not exceed a period of one year , renewable once for the same period . where the notified body has ceased its activity , the national authority responsible for notified bodies shall withdraw the notification . ### where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in annex vi , or that it is failing to fulfil its obligations , the authority shall suspend , restrict , or fully or partially withdraw the notification , depending on the seriousness of the failure to meet those requirements or fulfil those obligations . suspension shall apply until a decision to annul the suspension has been reached by the mdcg , which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in article 30 and . where the notified body has ceased its activity , the national authority responsible for notified bodies shall withdraw the notification .


### in the case of suspension of a notification : on condition that , within three months of the suspension , either the competent authority for medical devices of the member state in which the manufacturer of the device covered by the certificate is established , or another notified body confirm in writing that it is assuming the functions of the notified body during the period of suspension ; ### in the case of suspension of a notification : on condition that , within three months of the suspension another notified body confirm in writing that it is assuming the functions of the notified body during the period of suspension ;


### where the commission ascertains that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification if necessary . ### where the commission , in consultation with the medical devices coordination group , decides that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification , in line with article 36 .


### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices , including in vitro diagnostic medical devices . ### the commission , in consultation with the medical devices coordination group , shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices , including in vitro diagnostic medical devices .


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . before adopting implementing acts , the commission shall consult with relevant stakeholders and take into account their suggestions .


### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation . ### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation .


### 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 .


### to assist the competent authorities of the member states in their coordination activities in the fields of clinical investigations , vigilance and market surveillance ; ### to develop guidelines for clinical studies on medical devices


### 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 .


### 2 . 1 . the notified body shall be a third - party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities . the notified body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer . ### 2 . 1 . the notified body , including its personnel shall be a third - party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities . the notified body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer . this does not preclude any conformity assessment activities for economic operators or competitors , mentioned above .


### 2 . 4 . the impartiality of the notified bodies , of their top level management and of the assessment personnel shall be guaranteed . the remuneration of the top level management and assessment personnel of a notified body shall not depend on the results of the assessments . ### 2 . 4 . the impartiality of the notified bodies , of their top level management , of the assessment personnel and subcontractors shall be guaranteed . the remuneration of the top level management , assessment personnel and subcontractors of a notified body shall not depend on the results of the assessments .


### the notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations . it shall document and provide evidence of its financial capacity and its sustainable economic viability , taking into account specific circumstances during an initial start - up phase . ### the notified body , including its subsidiaries , shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations . it shall document and provide evidence of its financial capacity and its sustainable economic viability , taking into account specific circumstances during an initial start - up phase .


### 6 . 1 . the notified body shall participate in , or ensure that its assessment personnel is informed of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation , guidance and best practice documents adopted in the framework of this regulation . ### 6 . 1 . the notified body shall participate in , or ensure that its assessment personnel , including subcontractors , is informed and trained on of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation , standards , guidance and best practice documents adopted in the framework of this regulation .


### 2 . the quality management system of the notified body shall at least address the following : ### 2 . the quality management system of the notified body and its subcontractors shall at least address the following :