### the financial crisis has revealed important shortcomings in the financial supervision , which has failed to prevent the accumulation of excessive risks in the financial sector and has in particular highlighted the weaknesses of the existing macro - prudential oversight . ### financial stability is a precondition for the real economy to provide jobs , credit and growth . the financial crisis has revealed important shortcomings in financial supervision , which has failed to prevent the accumulation of excessive risks within the financial system . the crisis has huge consequences for the tax payers , for many union citizens who are now unemployed and for many small and medium size enterprises . the members states cannot afford to bail out financial institutions , in the event of a new crisis on the same scale , without breaching the rules of the stability and growth pact .


### in its communication entitled “european financial supervision” of 27 may 2009 , the commission set out a series of reforms to the current arrangements for safeguarding financial stability at the eu level , notably including the creation of a european systemic risk board responsible for macro - prudential oversight . the council on 9 june 2009 and the european council at its meeting of 18 and 19 june supported the view of the commission and welcomed the commission’s intention to bring forward legislative proposals so that the new framework is in place in the course of 2010 . in line with the views of the commission , it concluded inter alia that the ecb “should provide analytical , statistical , administrative and logistical support to the esrb , also drawing on technical advice from national central banks and supervisors” . ### in its communication entitled “european financial supervision” of 27 may 2009 , the commission set out a series of reforms to the current arrangements for safeguarding financial stability at the eu level , notably including the creation of a european systemic risk board responsible for macro - prudential oversight . the council on 9 june 2009 and the european council at its meeting of 18 and 19 june supported the view of the commission and welcomed the commission’s intention to bring forward legislative proposals so that the new framework is in place in the course of 2010 . in line with the views of the commission , it concluded inter alia that the ecb “should provide analytical , statistical , administrative and logistical support to the esrb , also drawing on technical advice from national central banks and supervisors” . the support provided to the esrb by the ecb as well as the tasks conferred upon the esrb should be without prejudice to the principle of the independence of the ecb in the performance of its tasks pursuant to the treaty on the functioning of the european union .


### the esrb should , where appropriate , issue warnings and recommendations of a general nature concerning the community as a whole , individual member states or groups of member states , with a specified timeline for the relevant policy response . ### the esrb should , where appropriate , issue and make public warnings and recommendations of a general nature concerning the community as a whole , individual member states or groups of member states , with a specified timeline for the relevant policy response .


### the ecb and national central banks should have a leading role in macro - prudential oversight because of their expertise and existing responsibilities in the area of financial stability . the participation of micro - prudential supervisors in the work of the esrb is essential to ensure that assessment of macro - prudential risk is based on complete and accurate information about developments in the financial system . accordingly , the chairpersons of the european supervisory authorities should be members with voting rights , while one national supervisor per member state should attend as member without voting rights . ### the ecb and national central banks should have a leading role in macro - prudential oversight because of their expertise and existing responsibilities in the area of financial stability . the participation of micro - prudential supervisors in the work of the esrb is essential to ensure that assessment of macro - prudential risk is based on complete and accurate information about developments in the financial system . accordingly , the chairpersons of the european supervisory authorities should be members with voting rights . in a spirit of openness , six independent persons , who should not be members of the esa , chosen on the basis of their general competence and commitment to the union , and for their diverse backgrounds in academic fields or in the private sector , in particular in smes , trade - unions or as providers or consumers of financial services and offering all guarantees in terms of independence and confidentiality , should be part of the general board . one representative of the national competent authorities per member state should attend as member without voting rights .


### the participation of a member of the commission will help to establish a link with the macro - economic and financial surveillance of the community , while the presence of the chairman of the economic and financial committee reflects the role of finance ministries in safeguarding financial stability . ### the participation of a member of the commission will help to establish a link with the macro - economic and financial surveillance of the community , while the presence of one representative of the economic and financial committee at the advisory scientific committee reflects the role of finance ministries in safeguarding financial stability .


### it is essential that the members of the esrb perform their duties impartially and only consider the financial stability of the european union as a whole . voting on warnings and recommendations within the esrb should not be weighted and decisions should as a rule be taken by a simple majority . ### it is essential that the members of the esrb perform their duties impartially and only consider the financial stability of the european union as a whole . unless a consensus cannot be reached , voting on warnings and recommendations within the esrb should not be weighted and decisions should as a rule be taken by a simple majority .


### the interconnectedness of financial institutions and markets implies that the monitoring and assessment of potential systemic risks should be based on a broad set of relevant macro - economic and micro - financial data and indicators . the esrb should therefore have access to all the information necessary to perform its duties while preserving the confidentiality of these data as required . ### the interconnectedness of financial institutions and markets implies that the monitoring and assessment of potential systemic risks should be based on a broad set of relevant macro - economic and micro - financial data and indicators . the esrb should therefore have access to all the information necessary to perform its duties while preserving the confidentiality of these data as required . as a rule , that information should be in summary or aggregate form , unless there might be a sustained and severe risk to market dislocation , supported by objectively verifiable data . where the esrb requests data that are not in summary or aggregate form , the financial institutions concerned shall have the right to express their views on the merits of such a request .


### market participants can provide valuable input to the understanding of the evolutions affecting the financial system . where appropriate , the esrb should therefore consult private sector stakeholders and give them a fair opportunity to provide their comments . ### market participants can provide valuable input to the understanding of the evolutions affecting the financial system . where appropriate , the esrb should therefore consult private sector stakeholders and give them a fair opportunity to provide their comments through a formal consultative panel .


### market participants can provide valuable input to the understanding of the evolutions affecting the financial system . where appropriate , the esrb should therefore consult private sector stakeholders and give them a fair opportunity to provide their comments . ### market participants can provide valuable input to the understanding of the evolutions affecting the financial system . where appropriate , the esrb should therefore consult private sector stakeholders and give them a fair opportunity to provide their comments . furthermore , given that there is no rigid definition of systemic risk and that the assessment of systemic risk may be time - varying depending on the economic environment , the esrb should ensure a wide range of experiences and skills within its staff and advisors .


### a european systemic risk board , hereinafter referred to as ' esrb ' , is established . ### a european systemic risk board , hereinafter referred to as ' esrb ' , is established . it shall have its seat in frankfurt . it shall be part of the european system of financial supervision , the purpose of which is to ensure the supervision of the eu financial system .


### the esrb shall be responsible for the macro - prudential oversight of the financial system within the community in order to prevent or mitigate systemic risks within the financial system , so as to avoid episodes of widespread financial distress , contribute to a smooth functioning of the internal market and ensure a sustainable contribution of the financial sector to economic growth . ### the esrb shall be responsible for the macro - prudential oversight of the financial system within the community in order to prevent or mitigate systemic risks within the financial system , particularly the generation of future credit bubbles in the union , so as to avoid episodes of widespread financial distress , contribute to a smooth functioning of the internal market and ensure a sustainable contribution of the financial sector to economic growth .


### determine and / or collect , as appropriate , and analyse all the information relevant for the mission described in paragraph 1 ; ### determine and / or collect , as appropriate , and analyse all the information relevant , including legislation with a potential impact on financial stability such as accounting , bankruptcy and bail - out rules , for the mission described in paragraph 1 ;


### issue recommendations for remedial action where appropriate ; ### issue recommendations for remedial action and make them public where appropriate ;


### the steering committee shall assist in the decision - making process of the esrb by supporting the preparation of the meetings of the general board , reviewing the documents to be discussed and monitoring the progress of the esrb’s ongoing work . ### the steering committee shall assist in the decision - making process of the esrb by identifying and prioritising risks , supporting the preparation of the meetings of the general board , fulfilling the tasks referred to in points to of article 3 , reviewing the documents to be discussed and monitoring the progress of the esrb’s ongoing work .


### the steering committee shall assist in the decision - making process of the esrb by supporting the preparation of the meetings of the general board , reviewing the documents to be discussed and monitoring the progress of the esrb ' s ongoing work . ### the steering committee shall assist in the decision - making process of the esrb by preparing the meetings of the general board , reviewing the documents to be discussed , monitoring the progress of the esrb ' s ongoing work and maintaining a strong link with all the parties to the esfs .


### the secretariat shall provide analytical , statistical , administrative and logistical support to the esrb under the direction of the chair of the general board in accordance with council decision xxxx / ec / 2009 . ### the secretariat shall be responsible for the day - to - day business of the esrb and all staff matters . it shall provide high - quality analytical , statistical , administrative and logistical support to the esrb under the direction of the chair of the general board in accordance with council decision xxxx / ec / 2009 . it shall also draw on technical advice from esas , national central banks and national supervisors .


### the esrb shall be supported by the advisory technical committee referred to in article 12 , which shall provide advice and assistance on issues relevant to the work of the esrb , when requested . ### the advisory scientific committee referred to in article 12 shall provide advice and assistance on substance issues relevant to the work of the esrb .


### the vice - chair shall preside at the general board and / or the steering committee when the chair cannot participate in a meeting . ### the vice - chairs , in order of precedence , shall preside at the general board and / or the steering committee when the chair cannot participate in a meeting .


### if the term of office of the members of the general council of the ecb elected as chair or vice - chair ends before the completion of the 5 year term or if for any reason the chair or vice chair are unable to discharge their duties , a new chair or vice chair shall be elected in accordance with paragraph 1 . ### if for any reason the vice - chairs are unable to discharge their duties , new vice - chairs shall be elected in accordance with paragraphs 1a and 1b and 1c .


### the chair of the advisory technical committee shall be appointed by the general board following a proposal from the chair of the general board . ### the chair of the advisory scientific committee shall be appointed by the general board following a proposal from the chair of the general board .


### the esrb secretariat shall support the work of the advisory technical committee and the head of the secretariat shall participate in the meetings . ### the esrb secretariat shall support the work of the advisory scientific committee and the head of the secretariat shall participate in the meetings .


### in performing its tasks , the esrb shall seek , where appropriate , the advice of relevant private sector stakeholders . ### in performing its tasks , the esrb shall seek , where appropriate , the advice of relevant private sector stakeholders . for this purpose , a consultative panel shall be formed to allow the esrb to benefit from input to the understanding of the evolution of the financial system .


### in performing its tasks , the esrb shall seek , where appropriate , the advice of relevant private sector stakeholders . ### in performing its tasks , the esrb shall seek , where appropriate , the views of relevant private or public sector stakeholders , particularly , but not exclusively , the stakeholder groups of the esas .


### the esrb shall provide the european supervisory authorities with the information on systemic risks necessary for the achievement of their tasks . ### the esrb shall provide each european supervisory authority with the information on systemic risks necessary for the achievement of their tasks .


### the european supervisory authorities , the national central banks and member states shall cooperate closely with the esrb and provide all the information necessary for the fulfilment of its tasks in accordance with community legislation . ### the european supervisory authorities , the national central banks and all relevant authorities in the member states shall cooperate closely , in compliance with article 1 , with the esrb and provide all the information necessary for the fulfilment of its tasks in accordance with community legislation . this should be done without prejudice to regulation no 223 / 2009 of the european parliament and of the council of 11 march 2009 on european statistics and to council regulation no 2533 / 98 of 23 november 1998 concerning the collection of statistical information by the european central bank .


### when significant risks to the achievement of the objective in article 3 are identified , the esrb shall provide warnings and , where appropriate , issue recommendations for remedial action . ### when significant risks to the achievement of the objective in article&#160 ; 3 are identified , the esrb shall provide warnings and , where appropriate , issue recommendations for remedial action . the warnings and recommendations shall be made public when needed .


### any member of the board may request a vote on a draft warning or a draft recommendation at any time . ### in order to enhance the awareness of risks in the european economy and to prioritise such risks , the ersb , in close cooperation with the esfs , shall elaborate a colour - coded system corresponding to situations of different risk levels . once the criteria of such classification have been elaborated , its warnings and recommendations will indicate , on a case - by - case basis , and where appropriate , to which category the risk belongs .


### the general board of the esrb shall decide whether a warning or a recommendation should be made public on a case - by - case basis . by derogation to article 10 , a qualified majority of two - thirds of the votes is needed to make a warning or recommendation public . ### in accordance article 10 , the general board of the esrb shall decide whether a warning or a recommendation should be made public on a case - by - case basis . by derogation to article 10 , a qualified majority of two - thirds of the votes is needed to make a warning or recommendation public .


### reporting obligations ### accountability and reporting obligations


### the esrb shall report at least annually to the european parliament and to the council . ### the esrb shall report at least bi - annually to the council and the european parliament marking the publication of the biannual report , more frequently in the event of widespread financial distress , and in a different context from the monetary dialogue between the european parliament and the president of the european central bank .


### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject . ### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject . however , imbalance between the controller and the data subject is not a problem where union or member state law has made the data subject ' s consent a specific condition for a specific type of processing of the personal data or set of processing operations .


### the monitoring of their behaviour . ### monitoring the behaviour of such data subjects with a view to offering goods or services to them .


### processing is necessary for compliance with a legal obligation to which the controller is subject ; ### processing is necessary for compliance with or to avoid breach of an eu or national legal obligation or legal right to which a controller is subject including the performance of a task carried out for assessing creditworthiness or for fraud prevention and detection purposes .


### processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller ; ### processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller or for the performance of a task carried out for assessing creditworthiness or for fraud prevention and detection purposes ;


### the law of the member state must meet an objective of public interest or must be necessary to protect the rights and freedoms of others , respect the essence of the right to the protection of personal data and be proportionate to the legitimate aim pursued . ### the law of the member state must meet an objective of public interest or must be necessary to protect the rights and freedoms of others . the law of the member state must also respect this regulation and international treatises that the member state has decided to follow . finally the member state is obliged to evaluate and decide if national legislation is proportionate to the legitimate aim pursued or if a legitimate aim could be achieved using less privacy invasive solutions .


### the data subject shall have the right to withdraw his or her consent at any time . the withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal . ### the data subject shall have the right to withdraw his or her consent . the withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal or in cases where a minimum mandatory term of storage is provided by a european or national law , or data are processed according to european and national regulatory provisions , or for anti - fraud or legal purposes . the data subject has to communicate his willingness to withdraw his or her consent to the processor . the withdrawal of the consent is effective 30 days after the receipt of the declaration .


### the processing of personal data , revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , and the processing of genetic data or data concerning health or sex life or criminal convictions or related security measures shall be prohibited . ### the processing of personal data , revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , significant social problems , private information and the processing of genetic data or data concerning health or sex life or criminal convictions or related security measures shall be prohibited .


### processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller in the field of employment law in so far as it is authorised by union law or member state law providing for adequate safeguards ; or ### processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller in the field of employment law in so far as it is authorised by union law , member state law , or collective agreements on the labour market providing for adequate safeguards ; or


### processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation , association or any other non - profit - seeking body with a political , philosophical , religious or trade - union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed outside that body without the consent of the data subjects ; or ### processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation , association , organizations on the labour market or any other non - profit - seeking body with a political , philosophical , religious or trade - union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed outside that body without the consent of the data subjects ; or


### processing of data relating to criminal convictions or related security measures is carried out either under the control of official authority or when the processing is necessary for compliance with a legal or regulatory obligation to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority . ### processing of data relating to criminal convictions or related security measures is carried out either under the supervision of the competent supervisory authority or when the processing is necessary for compliance with or to avoid a breach of an eu or a national legal or regulatory obligation or collective agreements on the labour market to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority .


### in the case of a personal data breach , the controller shall without undue delay and , where feasible , not later than 24 hours after having become aware of it , notify the personal data breach to the supervisory authority . the notification to the supervisory authority shall be accompanied by a reasoned justification in cases where it is not made within 24 hours . ### in the case of a personal data breach which will have significant risk of harm to citizens , the controller shall without undue delay , notify the personal data breach to the supervisory authority . the notification to the supervisory authority shall be accompanied by a reasoned justification in cases where it is not made within 24 hours .


### when the personal data breach is likely to adversely affect the protection of the personal data or privacy of the data subject , the controller shall , after the notification referred to in article 31 , communicate the personal data breach to the data subject without undue delay . ### in the case of any significantly harmful personal data breach , when the personal data breach is likely to adversely affect the protection of the personal data or privacy of the data subject , the controller shall , after the notification referred to in article 31 , communicate the personal data breach to the data subject without undue delay .


### the communication of a personal data breach to the data subject shall not be required if the controller demonstrates to the satisfaction of the supervisory authority that it has implemented appropriate technological protection measures , and that those measures were applied to the data concerned by the personal data breach . such technological protection measures shall render the data unintelligible to any person who is not authorised to access it . ### the communication of a personal data breach to the data subject shall not be required if the data breach does not have significant risk of harm to citizens and the controller demonstrates to the satisfaction of the supervisory authority that it has implemented appropriate technological protection measures , and that those measures were applied to the data concerned by the personal data breach . such technological protection measures shall render the data unintelligible to any person who is not authorised to access it .


### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data . ### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , or where processing takes place as a public sector infrastructure project the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data .


### information on sex life , health , race and ethnic origin or for the provision of health care , epidemiological researches , or surveys of mental or infectious diseases , where the data are processed for taking measures or decisions regarding specific individuals on a large scale ; ### information on sex life , health , political opinions , religious beliefs , criminal convictions , race and ethnic origin or for the provision of health care , epidemiological researches , or surveys of mental or infectious diseases , where the data are processed for taking measures or decisions regarding specific individuals on a large scale ;


### the assessment shall contain at least a general description of the envisaged processing operations , an assessment of the risks to the rights and freedoms of data subjects , the measures envisaged to address the risks , safeguards , security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this regulation , taking into account the rights and legitimate interests of data subjects and other persons concerned . ### the assessment shall contain at least a general description of the envisaged processing operations , an assessment of the risks to the rights and freedoms of data subjects , the measures envisaged to address the risks , safeguards , security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this regulation , taking into account the rights and legitimate interests of data subjects and other persons concerned and also taking into account modern technologies and methods that can improve citizens ' privacy .


### the transfer is necessary for the purposes of the legitimate interests pursued by the controller or the processor , which cannot be qualified as frequent or massive , and where the controller or processor has assessed all the circumstances surrounding the data transfer operation or the set of data transfer operations and based on this assessment adduced appropriate safeguards with respect to the protection of personal data , where necessary . ### the transfer is necessary for the purposes of the legitimate interests pursued by the controller or the processor , which cannot be qualified as frequent or massive or where , prior to such transfer , the personal data is already made public in the third country , and where the controller or processor has assessed all the circumstances surrounding the data transfer operation or the set of data transfer operations and based on this assessment adduced appropriate safeguards with respect to the protection of personal data , where necessary .


### the supervisory authority shall impose a fine up to 500 000 eur , or in case of an enterprise up to 1 % of its annual worldwide turnover , to anyone who , intentionally or negligently : ### the supervisory authority shall impose a fine up to 500 000 eur , to anyone who , intentionally or negligently :


### the supervisory authority shall impose a fine up to 1 000 000 eur or , in case of an enterprise up to 2 % of its annual worldwide turnover , to anyone who , intentionally or negligently : ### the supervisory authority shall impose a fine up to 1 000 000 eur or , to anyone who , intentionally or negligently :


### 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 may adopt by law or collective agreement among employers and employees 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 , criminal conviction 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 .


### the programme activities , i . e . the european information systems , the joint actions for customs officials and the common training initiatives , are expected to contribute to the realisation of the europe 2020 strategy for smart , sustainable and inclusive growth . in providing a framework for activities which strive for more efficient customs authorities , strengthen the competitiveness of businesses , promote employment and contribute to the protection of the union ' s financial and economic interests , the programme will actively strengthen the functioning of the customs union . ### the programme activities , i . e . the european information systems , the joint actions for customs officials and the common training initiatives , are expected to contribute to the realisation of the europe 2020 strategy for smart , sustainable and inclusive growth . in providing a framework for activities which strive for more efficient and modernised customs authorities , strengthen the competitiveness of businesses , promote employment and contribute to the protection of the union ' s financial and economic interests , the programme will actively strengthen the functioning of the customs union .


### the programme objectives take into account the problems and challenges identified for customs in the next decade . the programme should continue to play a role in vital areas like the coherent implementation of union customs and related law . moreover , the focus of the programme will be on protecting the financial and economic interests of the union , safeguarding safety and security , trade facilitation , among others through collaborative efforts to fight fraud and increasing the administrative capacity of customs authorities . ### the programme objectives take into account the problems and challenges identified for customs in the next decade . the programme should continue to play a role in vital areas like the coherent implementation of the modernised union customs and related law . moreover , the focus of the programme will be on protecting the financial and economic interests of the union , safeguarding safety and security , trade facilitation through simplifications for compliant business , among others through collaborative efforts to fight fraud and increasing the administrative capacity of customs authorities .


### human competency building in the form of common training should also be realised through the programme . customs officials need to build up and update their knowledge and skills required to serve the needs of the union . the programme should be essential to strengthen the human capacities through enhanced training support that targets customs officials as well as economic operators . to this end , the current common training approach of the union which was mainly based on central elearning development should develop into a multi - facetted training support programme for the union . ### human competency building is vital and should be carried out in the form of common training should also be realised through the programme . customs officials need to build up and update their knowledge and skills required to serve the needs of the union . the programme should be essential to strengthen the human capacities through enhanced training support that targets customs officials as well as economic operators . to this end , the current common training approach of the union which was mainly based on central elearning development should develop into a multi - facetted training support programme for the union .


### to fight fraud and to enhance competitiveness , safety and security by enhancing cooperation with international organisations , third countries , other governmental authorities , economic operators and their organisations . ### to fight fraud and to enhance competitiveness , safety and security by enhancing cooperation with union authorities such as olaf , international organisations , third countries , other governmental authorities , economic operators and their organisations .


### roadworthiness testing is a part of a wider regime ensuring that vehicles are kept in a safe and environmental acceptable condition during their use . this regime should cover periodic roadworthiness tests for all vehicles and roadside technical inspection for vehicles used for commercial road transport activities as well as provisions on a vehicle registration procedure to ensure that vehicles which constitute an immediate risk to road safety are not used on roads . ### roadworthiness testing is a part of a wider regime ensuring that vehicles are kept in a safe and environmental acceptable condition during their use . this regime should cover periodic roadworthiness tests for all vehicles and roadside technical inspection for vehicles used for commercial road transport activities as well as provisions on a vehicle registration procedure . periodic testing should be the main tool to ensure roadworthiness . roadside inspections of commercial vehicles should only be complementary to periodic tests and target vehicles which constitute an immediate risk to road safety .


### vehicles of historic interest are supposed to conserve heritage of the époque they have been built and considered to be hardly used on public roads , it should be left to member states to extend the period of periodic roadworthiness testing for such vehicles . it should also be for member states to regulate roadworthiness testing of other types of specialised vehicles . ### vehicles of historic interest conserve heritage of the époque in which they were built , are preserved and maintained in a historically correct condition and are rarely used as everyday vehicles . it should be left to member states to extend the period of periodic roadworthiness testing for such vehicles or to otherwise regulate their roadworthiness testing regime .


### roadworthiness testing is part of a wider regulatory scheme , governing vehicles throughout their lifetime from approval via registrations , inspections until scrapping . the development and interconnection of national and manufacturers ' electronic vehicle databases should in principle contribute to improve the efficiency of the whole vehicle administrative chain and reduce costs and administrative burdens . the commission should therefore carry out a study on the feasibility , costs and benefits of setting - up a european electronic vehicle information platform for this purpose . ### roadworthiness testing is part of a wider regulatory scheme , governing vehicles throughout their lifetime from approval via registrations , inspections until scrapping . the development and interconnection of national and manufacturers’ electronic vehicle databases would contribute to improve the efficiency of the whole vehicle administrative chain and reduce costs and administrative burdens .


### – vehicles belonging to armed forces , fire services , civil protection , emergency or rescue services , ### – vehicles used by armed forces , fire services , civil protection , emergency or rescue services ,


### ‘ vehicle of historic interest’ means any vehicle which fulfils all the following conditions : ### ' vehicle of historic interest ' means any vehicle which was manufactured at least 30 years ago and is preserved and maintained in a historically correct condition .


### the holder of the registration certificate may request the testing centre , or the competent authority if relevant , to carry out the roadworthiness test during a period extending from the beginning of the month preceding the month of the anniversary date referred to in paragraph 1 until the end of the second month following this date , without affecting the date for the next roadworthiness test . ### the holder of the registration certificate may request the testing centre , or the competent authority or the bodies or establishments certified and supervised by the state if relevant , to carry out the roadworthiness test during a period starting from the beginning of the month preceding the month of the anniversary date referred to in paragraph 1 , without affecting the date for the next roadworthiness test .


### for the purposes of checking the odometer reading , and where this information was not communicated electronically following the previous roadworthiness test , the inspector shall require the person presenting the vehicle to the test to show the certificate issued following the previous roadworthiness test . ### for the purposes of checking the odometer reading , and where this information was not communicated electronically following the previous roadworthiness test , the inspector shall require the person presenting the vehicle to the test to show the certificate issued following the previous roadworthiness test , if the certificate has not been issued electronically .


### the results of the roadworthiness test shall be notified to the registration authority of the vehicle . this notification shall contain the information mentioned in the roadworthiness certificate . ### the results of the roadworthiness test shall be notified by electronic means to the registration authority of the vehicle . this notification shall contain the information mentioned in the roadworthiness certificate .


### the testing centre or , if relevant , the competent authority of the member state that has carried out a roadworthiness test on a vehicle registered in its territory shall issue a proof to each vehicle having successfully passed such a test . the proof shall indicate the date of the next roadworthiness test . ### the testing centre or , if relevant , the competent authority of the member state that has carried out a roadworthiness test on a vehicle registered in its territory shall issue a proof to each vehicle having successfully passed such a test . the proof shall indicate the date of the next roadworthiness test . no proof of roadworthiness need be issued if it is possible to indicate in the vehicle registration document that the roadworthiness test has been conducted and the date of the next such test .


### inspectors employed by competent authorities of the member states or a testing centre at the date of application of this regulation shall be exempted from the requirements laid down in annex vi , point 1 . the member states shall deliver a certificate of equivalence to these inspectors . ### inspectors employed or authorised by competent authorities of the member states or a testing centre at the date of application of this regulation shall be exempted from the requirements laid down in annex vi , point 1 . the member states shall deliver a certificate of equivalence to these inspectors .


### testing centres directly operated by a competent authority shall be exempted from the requirements regarding authorisation and supervision . ### testing centres directly operated by a member state ' s competent authority shall be exempted from the requirements regarding authorisation and supervision .


### the diversity and evolution of the conditions under which professional activities are pursued make it necessary to take into account the situation of highly mobile workers . new labour supply structures have become evident amongst others in the air transport sector . linking the applicable legislation for aircrew members to the member state where the registered office or place of business of the undertaking or employer employing him / her is situated only is effective if there is a sufficiently close connection to the registered office or place of business . for aircrew members it is considered appropriate to refer to ‘ home base’ as specification of the notion of ‘ registered office or place of business’ for the application of regulation no 883 / 2004 . ### annex iii to council regulation 3922 / 91 on the harmonisation of technical requirements and administrative procedures for the field of civil aviation1 defines the concept ' home base ' for aircrew members under union law . in order to facilitate the application of title ii of the regulation no 883 / 2004 for this group of persons , it is justified to create a special rule by using this notion of ' home base ' as the criterion for determining the applicable legislation for aircrew members . on the other hand , the applicable legislation for aircrew members should remain stable and the ' home base ' principle should not result in frequent changes of applicable legislation due to the industry’s work patterns or seasonal demands . _________________ 1 oj l 373 , 31 . 12 . 1991 , p . 4 .


### article 65 of regulation no 883 / 2004 should be amended to ensure that self - employed persons receive benefits in accordance with the legislation of the competent member state to offer them the best prospects of re - integrating into the labour market in their member state of residence when returning to that state . ### a new article 65a should be inserted into regulation no 883 / 2004 in order to ensure that a self - employed frontier worker who becomes wholly unemployed receives benefits , if he / she has completed periods of insurance as a self - employed person or periods of self - employment recognised for the purposes of granting unemployment benefits in the competent member state and if no unemployment benefits system covering self - employed persons exists in the member state of residence . such a new provision should be reviewed in the light of the experience after two years of implementation and , if necessary , adjusted .


### in article 9 , the first sentence is replaced by the following : ' 1 . the member states shall notify the european commission in writing of the declarations made in accordance with article 1 , the legislation and schemes referred to in article 3 , the conventions entered into as referred to in article 8 and the minimum benefits referred to in article 58 , as well as substantive amendments made subsequently . ' ### in article 9 paragraph 1 is replaced by the following : ' 1 . the member states shall notify the european commission in writing of the declarations made in accordance with article 1 letter , the legislation and schemes referred to in article 3 , the conventions entered into as referred to in article 8 , the minimum benefits referred to in article 58 and the lack of an insurance system as referred to in article 65a , as well as substantive amendments made subsequently . such notifications shall indicate the date [ . . . ] from which this regulation will apply to the schemes specified in the declarations by the member states . '


### the competent institution may not refuse to grant the authorisation provided for in article 20 to an insured person who has sustained an accident at work or has contracted an occupational disease and who is entitled to benefits chargeable to that institution , where the treatment appropriate to his / her condition cannot be given in the member state in which the person resides within a time limit which is medically justifiable , taking into account his / her current state of health and the probable course of his / her illness . ### the competent institution may not refuse to grant the authorisation provided for in article 20 to a person who has sustained an accident at work or has contracted an occupational disease and who is entitled to benefits chargeable to that institution , where the treatment appropriate to his / her condition cannot be given in the member state in which the person resides within a time limit which is medically justifiable , taking into account his / her current state of health and the probable course of his / her illness . '


### for the purposes of the application of article 13 of the basic regulation a person who “normally pursues an activity as an employed person in two or more member states” shall refer to a person who simultaneously , or in alternation , for the same undertaking or employer or for various undertakings or employers , exercises one or more separate activities in two or more member states , with the exception of marginal activities . ### for the purposes of the application of article 13 of the basic regulation , a person who ' normally pursues an activity as an employed person in two or more member states ' shall refer to a person who simultaneously , or in alternation , for the same undertaking or employer or for various undertakings or employers , exercises one or more separate activities in two or more member states .


### in the situation of aircrew members performing air passenger or freight services the “registered office or place of business” as defined in title ii of the basic regulation shall deemed to be the “home base” , as defined in annex iii to council regulation no 3922 / 91 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation . ' ### for the purposes of article 13 of the basic regulation , an employed aircrew member normally pursuing air passenger or freight services in two or more members states shall be subject to the legislation of the member state where the home base as defined in annex iii to council regulation no 3922 / 91 is located . '


### paragraphs 1 to 6 shall apply mutatis mutandis to the persons referred to in article 65 of the basic regulation , except for paragraph 1 of this article . ### paragraphs 2 to 6 shall apply mutatis mutandis to the situation covered by article 65a referred to in the basic regulation .


### over the period 2001 - 11 , barely 30 % of the budget earmarked for information provision and promotion measures under regulation no 3 / 2008 was spent on measures targeting third - country markets , even though these markets offer major growth potential . with the aim of reaching 75 % of estimated expenditure , specific arrangements are therefore required to encourage a larger number of information provision and promotion measures for union agricultural products in third countries , in particular through increased financial support ### over the period 2001 - 11 , barely 30 % of the budget earmarked for information provision and promotion measures under regulation no 3 / 2008 was spent on measures targeting third - country markets , even though these markets offer major growth potential . specific arrangements are therefore required to encourage a larger number of information provision and promotion measures for union agricultural products in third countries , in particular through increased financial support


### over the period 2001 - 11 , barely 30 % of the budget earmarked for information provision and promotion measures under regulation no 3 / 2008 was spent on measures targeting third - country markets , even though these markets offer major growth potential . with the aim of reaching 75 % of estimated expenditure , specific arrangements are therefore required to encourage a larger number of information provision and promotion measures for union agricultural products in third countries , in particular through increased financial support ### over the period 2001 - 11 , barely 30 % of the budget earmarked for information provision and promotion measures under regulation no 3 / 2008 was spent on measures targeting third - country markets , even though these markets offer major growth potential . therefore , in order to encourage a larger number of information provision and promotion measures for union agricultural products in third countries , at least 75% of the budget earmarked for information and promotion measures will be allocated to measures taking place in third countries .


### information measures on the themes referred to in article 5 ; ### information measures aimed at stressing the characteristics of agricultural and food products and on the themes referred to in article 5 ;


### the percentage referred to in paragraph 1 shall be increased to 60 % for : ### the percentage referred to in paragraph 1 shall be increased to 60% for a simple programme targeting one or more third country ;


### in order to facilitate cross border acquiring all ‘ consumer’ debit card transactions and card based payment transaction should have a maximum interchange fee of 0 , 20% and all consumer credit card transactions and card based payment transactions based on those should have a maximum interchange fee of 0 . 30% . ### in order to facilitate cross border acquiring all ‘ consumer’ debit transactions by card and card based payment transaction should have a maximum interchange fee of 0 , 20% and all consumer credit card transactions and card based payment transactions based on those should have a maximum interchange fee of 0 . 30% .


### payment card schemes shall allow for the possibility that authorisation and clearing messages of single card transactions be separated and processed by different processing entities . ### payment card schemes and issuers shall allow for the possibility that authorisation and clearing messages of single card transactions be separated and processed by different processing entities . any scheme rules and rules in licensing agreements or other contracts leading to a restriction on the freedom to choose a processor shall be prohibited .


### four years after the entry into force of this regulation , the commission shall present to the european parliament and to the council a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market . ### by . . . 1 and every three years thereafter , the commission shall publish a report on the application of this regulation . the commission ' s report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges , taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market . the report shall also assess whether it would be appropriate to make mandatory the co - badging and choice of application referred to in article 8 . the assessment should in particular consider : the level of competition among payment card providers and schemes , b ) the effects on costs for the payer and the payee , c ) the technical requirements and its implications for all the parties involved , d ) the effects of co - badging on user - friendliness , notably for the elderly and the most vulnerable users . the report and any accompanying proposals , as appropriate , shall be forwarded to the european parliament and to the council __________________ 1 four years after the entry into force of this regulation


### proposal for a directive of the european parliament and of the council amending council directives 78 / 660 / eec and 83 / 349 / eec as regards disclosure of non - financial and diversity information by certain large companies and groups ### proposal for a directive of the european parliament and of the council amending directive 2013 / 34 / eu as regards disclosure of non - financial and diversity information by certain large undertakings and groups


### in its communication to the european parliament , the council , the economic and social committee and the committee of the regions entitled ' single market act twelve levers to boost growth and strengthen confidence ' working together to create new growth ' ' , 9 adopted on 13 april 2011 , the commission identifies the need to improve the transparency of the social and environmental information provided by companies in all sectors , in order to ensure a level playing field . __________________ 9 com 206 final of 13 april 2011 . ### in its communication to the european parliament , the council , the economic and social committee and the committee of the regions entitled ' single market act twelve levers to boost growth and strengthen confidence ' working together to create new growth ' , 9 adopted on 13 april 2011 , the commission identifies the need to improve the transparency of the social and environmental information provided by undertakings in all sectors , in order to ensure a level playing field . __________________ 9 com 206 final of 13 april 2011 .


### the necessity to improve company disclosure of social and environmental information , by presenting a legislative proposal in this field , was reiterated in the communication from the commission to the european parliament , the council , the economic and social committee and the committee of the regions entitled ‘ a renewed eu strategy 2011 - 14 for corporate social responsibility’10 adopted on 25 october 2011 . __________________ 10 com 681 final of 25 october 2011 . ### the necessity to improve undertakings ' disclosure of social and environmental information , by presenting a legislative proposal in this field , was reiterated in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions entitled ' a renewed eu strategy 2011 - 14 for corporate social responsibility ' 10 adopted on 25 october 2011 . __________________ 10 com 681 final of 25 october 2011 .


### the coordination of national provisions concerning the disclosure of non - financial information in respect of large undertakings with limited liability is of importance for the interests of companies , shareholders and other stakeholders alike . coordination is necessary in those fields because most of these undertakings operate in more than one member state . ### the coordination of national provisions concerning the disclosure of non - financial information in respect of large undertakings with limited liability is of importance for the interests of undertakings , shareholders and other stakeholders alike . coordination is necessary in those fields because most of these undertakings operate in more than one member state .


### it is also necessary to establish a certain minimum legal requirement as regards the extent of the information that should be made available to the public by undertakings across the union . annual reports should give a fair and comprehensive view of an undertaking ' s policies , results , and risks . ### it is also necessary to establish a certain minimum legal requirement as regards the extent of the information that should be made available to the public and other authorities by undertakings across the union . management reports should give a fair and comprehensive view of an undertaking ' s policies , results , and risks .


### paragraph 47 of the final declaration of the united nations rio + 20 conference , ‘ the future we want’13 , recognises the importance of corporate sustainability reporting and encourages companies , where appropriate , to consider integrating sustainability information into their reporting cycle . it also encourages industry , interested governments and relevant stakeholders with the support of the united nations system , as appropriate , to develop models for best practice and facilitate action for the integration of financial and non - financial information , taking into account experiences from already existing frameworks . __________________ 13 united nations , ‘ the future we want’ , outcome document of the united nations conference on sustainable development rio + 20 , a / conf . 216 / l . 1 ### paragraph 47 of the final declaration of the united nations rio + 20 conference , ' the future we want ' 13 , recognises the importance of corporate sustainability reporting and encourages undertakings , where appropriate , to consider integrating sustainability information into their reporting cycle . it also encourages industry , interested governments and relevant stakeholders with the support of the united nations system , as appropriate , to develop models for best practice and facilitate action for the integration of financial and non - financial information , taking into account experiences from already existing frameworks . __________________ 13 united nations , ‘ the future we want’ , outcome document of the united nations conference on sustainable development rio + 20 , a / conf . 216 / l . 1


### some of the companies and groups falling under the scope of directive 78 / 660 / eec and directive 83 / 349 / eec already prepare non - financial reports on a voluntary basis . those companies should not be subject to the obligation to provide a non - financial statement in the annual report , provided that the report corresponds to the same financial year , covers at least the same content required by this directive , and is annexed to the annual report . ### some of the undertakings and groups falling under the scope of directive 2013 / 34 / eu already prepare non - financial reports on a voluntary basis . those undertakings should not be subject to the obligation to provide a non - financial statement in the management report , provided that the report corresponds to the same financial year , covers at least the same content required by this directive , and is annexed to the management report .


### as required by article 51a of directive 78 / 660 / eec , the report of the statutory auditors should also contain an opinion concerning the consistency or otherwise of the annual report , including non - financial information contained in the annual report , with the annual accounts for the same financial year . ### as required by article 28 of directive 2006 / 43 / ec , the audit report should also contain an opinion and a statement concerning the management report , including any non - financial information contained within it .


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


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


### directives 78 / 660 / eec and 83 / 349 / eec should therefore be amended accordingly , ### directive 2013 / 34 / eu should therefore be amended accordingly ,


### amendments to directive 78 / 660 / eec ### amendments to directive 2013 / 34 / eu


### directive 78 / 660 / eec is amended as follows : ### directive 2013 / 34 / eu is amended as follows :


### 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 europe ' 1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil the 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 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 establishment of a european border surveillance system is necessary in order to strengthen the information exchange and operational cooperation between national authorities of member states as well as with the european agency for the management of operational cooperation at the external borders of the member states of the european union established by council regulation no 2007 / 2004 of 26 october 2004 , hereinafter referred to as ' the agency ' . eurosur should provide these authorities and the agency with the infrastructure and tools needed to improve their situational awareness and reaction capability when detecting and preventing irregular migration and cross - border crime as well as protecting and saving lives of migrants at the external borders of the member states of the union . ### the establishment of a european border surveillance system is necessary in order to strengthen the information exchange and operational cooperation between national authorities of member states as well as with the european agency for the management of operational cooperation at the external borders of the member states of the european union established by council regulation no 2007 / 2004 of 26 october 2004 , hereinafter referred to as ' the agency ' . eurosur should provide these authorities and the agency with the infrastructure and tools needed to improve their situational awareness and reaction capability when detecting and preventing irregular migration and cross - border crime , therefore contributing to better protecting and saving lives of migrants at the external borders of the member states of the union .


### this regulation establishes a common framework for the exchange of information and cooperation between member states and the agency in order to improve the situational awareness and reaction capability at the external borders of the member states and of the european union , hereinafter referred to as the european border surveillance system . ### this regulation establishes a common framework for the exchange of information and cooperation between member states and the agency in order to improve the situational awareness and reaction capability at the external borders of the member states and of the european union , therefore contributing to better protecting and saving lives of migrants at the external borders of the member states of the union , hereinafter referred to as the european border surveillance system .


### communication network ; ### data exchange and communication network ;


### principles of coherent management and of using existing structures : the agency shall ensure the coherence between the different components of the eurosur framework , including providing guidance and support to the national coordination centres and promoting the interoperability of information and technology . to the extent possible , the eurosur framework shall make use of existing systems and capabilities . in this context , eurosur shall be established in full compatibility with the initiative for a common information sharing environment for the surveillance of the eu maritime domain , thereby contributing to and benefit from a coordinated and cost - efficient approach for cross - sectoral information exchange in the union . ### principles of coherent management and of using existing structures : the agency shall ensure the coherence between the different components of the eurosur framework , including providing guidance and support to the national coordination centres and promoting the interoperability of information and technology . to the extent possible , the eurosur framework shall make use of existing systems and capabilities , in order to optimise the use of the eu budget and to avoid the creation of redundancies . in this context , eurosur shall be established in full compatibility with the initiative for a common information sharing environment for the surveillance of the eu maritime domain , thereby contributing to and benefit from a coordinated and cost - efficient approach for cross - sectoral information exchange in the union .


### member states shall collect the necessary data for the observation of the modules ' characteristics referred to in article 3 . ### member states shall collect the necessary data for the observation of the modules ' characteristics referred to in article 3 , at national and regional level when relevant .


### the data shall be transmitted in an appropriate technical format , which shall be laid down in accordance with the regulatory procedure referred to in article 12 . ### the data shall be transmitted in an appropriate technical format , which shall be laid down by the commission by delegated acts in accordance with article 9 .


### in applying the quality criteria referred to in paragraph 1 to the data covered by this regulation , the modalities , structure and periodicity of the quality reports shall be defined in accordance with the regulatory procedure referred to in article 12 . ### in applying the quality criteria referred to in paragraph 1 to the data covered by this regulation , the modalities , structure and periodicity of the quality reports shall be defined by the commission by delegated acts in accordance with article 9 .


### the commission may grant derogations to member states during the transitional periods referred to in the annexes in accordance with the regulatory procedure referred to in article 12 insofar as the national statistical systems require major adaptations . ### the commission may grant derogations to member states during the transitional periods referred to in the annexes , by delegated acts in accordance with article 9 , insofar as the national statistical systems require major adaptations .


### over the past 50 years organ transplantation has become an established worldwide practice , bringing immense benefits to hundreds of thousands of patients . the use of human organs for transplantation has steadily increased during the last two decades . organ transplantation is now the most cost - effective treatment for end - stage renal failure , while for end - stage failure of organs such as the liver , lung and heart it is the only available treatment . ### over the past 50 years organ transplantation has become an established worldwide practice , bringing immense benefits to hundreds of thousands of patients . the use of human organs for transplantation has steadily increased during the last two decades . organ transplantation is now the treatment with the best risk / benefit ratio for end - stage renal and pancreatic failure , while for end - stage failure of organs such as the liver , lung , intestines and heart it is the only available treatment .


### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases . ### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to improve the risk / benefit ratio while minimising any risks inherent in the logistics by which organs are obtained .


### in particular , power should be conferred on the commission to lay down , where the organs concerned are to be exchanged between member states , the procedures for the transmission to transplantation centres of the information on the characteristics of the organs , the procedures needed to ensure the traceability of the organs , including labelling requirements , and the procedures for the reporting of serious adverse events or reactions . since these measures are of general scope and are designed to amend non - essential elements of this directive , or to supplement this directive with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### in particular , power should be conferred on the commission to lay down , where the organs concerned are to be exchanged between member states , the procedures for the transmission to transplantation centres of the information on the characteristics of the donor and the organs , the procedures needed to ensure the traceability of the organs , including labelling requirements , and the procedures for the reporting of serious adverse events or reactions . since these measures are of general scope and are designed to amend non - essential elements of this directive , or to supplement this directive with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec .


### ' organ ' means a differentiated and vital part of the human body , formed by different tissues , that maintains its structure , vascularisation , and capacity to develop physiological functions with an important level of autonomy ; ### ' organ ' means both a differentiated and vital part of the human body , formed by different tissues , that maintains its structure , vascularisation , and capacity to develop physiological functions with an important level of autonomy ; and parts of organs , if it is their function to be used for the same purpose as the entire organ in the human body , maintaining the requirements of structure and vascularisation ;


### standard operating procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules ; ### standard operating procedures for the verification of the details of the absence of any objection by the donor or donor family in accordance with national rules ;


### member states shall ensure that procurement takes place in dedicated facilities , which are designed , constructed , maintained and operated so as to comply with the requirements laid down in this directive and which allow minimising bacterial or other contamination of procured human organs in accordance with best medical practices . ### member states shall ensure that procurement takes place in dedicated facilities which comply with normal standards for operating theatres .


### the competent authority shall indicate in the accreditation , designation , authorisation or licence which activities the transplantation centre concerned may undertake . ### the competent authority shall indicate in the accreditation , designation , authorisation or licence which programmes the transplantation centre concerned may undertake .


### procurement shall only be carried out only after compliance with all mandatory consent or authorisation requirements in force in the member state concerned . ### procurement shall only be carried out only after compliance with all requirements relating to the absence of any objection to organ donation in force in the member state concerned .


### ensure that procurement organisations and transplantations centres are controlled and audited on a regular basis to ascertain compliance with the requirements of this directive ; ### ensure that procurement organisations and transplantations centres are subject to public controls and audited on a regular basis to ascertain compliance with the requirements of this directive ;


### the kics should seek synergies with relevant european union initiatives . ### the kics should seek synergies with relevant european union initiatives . these synergies should not compromise the principle of research , innovation and education excellence that the eit should pursue .


### the criteria and procedures for the financing , monitoring and evaluation of the activities of the kics should be adopted by the eit prior to launching the kic selection process . ### the criteria and procedures for the financing , monitoring and evaluation of the activities of the kics should be adopted by the eit prior to launching the kic selection process , being of utmost importance the implementation of simplification measures .


### the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at eur 3 . 182 , 230 million the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope . ### within the meaning of point [ 17 ] of the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management , the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at a maximum of eur 3 . 182 , 230 million . this amount shall constitute the prime reference for the budgetary authority during the annual budgetary procedure . the annual appropriations shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and to the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management . the eit financial contribution to the kics shall be provided under this financial envelope .


### patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls . ### patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing information about the main characteristic of the device , the potential adverse effects , a warning of the potential health risks , post - operative follow - up care measures and any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls .


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


### ‘ clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and performance of the device when used as intended by the manufacturer ; ### ‘ clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety , performance and efficacy of the device when used as intended by the manufacturer ;


### ‘ sponsor’ means an individual , company , institution or organisation which takes responsibility for the initiation and management of a clinical investigation ; ### ‘ sponsor’ means an individual , company , institution or organisation which takes responsibility for the initiation , management or funding of a clinical investigation ;


### the commission shall ensure the sharing of expertise between member states in the fields of medical devices , in vitro diagnostic medical devices , medicinal products , human tissues and cells , cosmetics , biocides , food and , if necessary , other products in order to determine the appropriate regulatory status of a product , or category or group of products . ### the commission shall , by means of implementing act determine the regulatory status of border line products on the basis of the opinion of the eu multidisciplinary experts group composed of experts in the fields of medical devices , in vitro diagnostic medical devices , medicinal products , human tissues and cells , cosmetics , biocides and food . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg . ### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . the declaration of interests shall be made publicly available on the european commission web site .


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


### the union seeks to promote , develop and consolidate the values of liberty , democracy , respect for human rights and fundamental freedoms , principles of equality and the rule of law on which it is founded through dialogue and cooperation with third countries . ### the union seeks to promote , develop and consolidate the values of liberty , democracy , respect for human rights and fundamental freedoms , principles of equality , the rule of law and good governance on which it is founded through dialogue and cooperation with third countries .


### they shall communicate to the commission as soon as possible , either on their own initiative or in response to a reasoned request from the commission , any relevant information , be it in the form of documents or copies or extracts thereof , needed to determine the facts so that the commission may coordinate the steps taken by the member states . ### article 18 . 1 . 2 is replaced by the following : they shall communicate to the commission as soon as possible , but no later than three weeks , either on their own initiative or in response to a reasoned request from the commission , any relevant information , be it in the form of documents or copies or extracts thereof , needed to determine the facts so that the commission may coordinate the steps taken by the member states .


### where the commission considers that irregularities have taken place in one or more member states , it shall inform the member state or states concerned thereof and that state or those states shall at the earliest opportunity carry out an enquiry , at which commission officials may be present under the conditions laid down in articles 9 and 11 of this regulation . ### article 18 . 4 . 1 is replaced by the following : 4 . where the commission considers that irregularities have taken place in one or more member states , it shall inform the member state or states concerned thereof and that state or those states shall at the earliest opportunity but no later than three weeks after the information was received carry out an enquiry , at which commission officials may be present under the conditions laid down in articles 9 and 11 of this regulation .


### the required csms shall be reported in either of the following situations : ### the required csms shall be reported for containers destined to be brought by vessel into the customs territory of the union from a third country ;


### without prejudice to regulation no 45 / 2001 , the commission may transfer , subject to the agreement of the supplying member state , selected data obtained in accordance with the procedure specified in paragraph 1 to international organisations and / or eu institutions / agencies which contribute to the protection of the financial interests of the union and correct application of customs legislation with which the commission concluded a relevant arrangement or memorandum of understanding . ### the commission may transfer , subject to the agreement of the supplying member state , selected data obtained in accordance with the procedure specified in paragraph 1 to the international organisations world customs organisation , international maritime organization , international civil aviation organization and international air transport association , and europol which contribute to the protection of the financial interests of the union and correct application of customs legislation with which the commission concluded a relevant arrangement or memorandum of understanding .


### the power to adopt delegated acts referred to in articles 18f and 23 shall be conferred on the commission for an indeterminate period of time from [ dd / mm / yyyy ] [ insert date of entry into force of this regulation ] . ### the power to adopt delegated acts referred to in articles 18a , 18g and 23 shall be conferred on the commission for an indeterminate period of time from [ dd / mm / yyyy ] [ insert date of entry into force of this regulation ] .


### the power to adopt delegated acts referred to in articles 18f and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect on the day following publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the power to adopt delegated acts referred to in articles 18a , 18g and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect on the day following publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act adopted pursuant to articles 18f and 23 shall enter into force only if no objection has been expressed by either the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to articles 18a , 18g and 23 shall enter into force only if no objection has been expressed by either the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### information , in particular the assemble , analysis and dissemination of best practices , techniques and innovations , such as instruments for monitoring ships ' tank - emptying and for monitoring of offshore platforms for operational releases and accidental spills ; ### information , in particular the assemble , analysis and dissemination of best practices , the techniques used in each action , together with an analysis of the outcome , and innovations , such as instruments for monitoring ships ' tank - emptying and for monitoring of offshore platforms for operational releases and accidental spills ;


### operational assistance and supporting , on request , with additional means , such as stand - by anti - pollution ships , satellite images and equipment , pollution response actions by the affected states in the event of accidental or deliberate pollution caused by ships or marine pollution caused by offshore oil and gas installations . ### operational assistance and supporting , on request , with additional means , such as stand - by anti - pollution ships , satellite images and equipment , proposed actions and details of techniques and responsibilities in actions , as well as pollution response actions by the affected states in the event of accidental or deliberate pollution caused by ships or marine pollution caused by offshore oil and gas installations .


### in order to define the requirements for the provision of operational assistance by the agency , such as additional anti - pollution vessels , the agency shall set up on a regular basis a list of the public and , where available , private pollution response mechanisms and associated response capabilities in the various regions of the union . ### in order to define the requirements for the provision of operational assistance by the agency , such as additional anti - pollution vessels , the agency shall set up on a regular basis a list of the public and , where available , private pollution response mechanisms and associated response capabilities in the various regions of the union . it shall also draw up a list of requirements that have not been met , and the implications thereof .


### the community financial assistance shall be implemented in accordance with the provisions of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities6 and its implementing rules7 . in particular , the memorandum of understanding and the loan agreement to be agreed with the authorities of ukraine shall provide for appropriate measures by ukraine in relation to the prevention of , and the fight against , fraud , corruption and other irregularities affecting the assistance . they shall also provide for controls by the commission , including the european anti - fraud office , with the right to perform on - the - spot checks and inspections , and for audits by the court of auditors , where appropriate , to be carried out on the spot . ### the union financial assistance shall be implemented in accordance with the provisions of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities6 and its implementing rules7 . in particular , the memorandum of understanding and the loan agreement to be agreed with the authorities of ukraine shall provide for appropriate measures by ukraine in relation to the prevention of , and the fight against , fraud , corruption and other irregularities affecting the assistance . they shall also provide for controls by then commission , including the european anti - fraud office , with the right to perform on - the - spot checks and inspections , and for audits by the court of auditors , where appropriate , to be carried out on the spot . the commission shall conduct an operational assessment of the financial circuits and administrative procedures in ukraine no later than three months after the first instalment is made available .


### 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 as well as electricity from renewable energy , energy savings and an increase in energy efficiency are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels potentially 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 only encourage greater production of such advanced biofuels that will not contribute to indirect land use change or any other adverse effects to the environment . on the basis of a thorough impact assessment on the positive and negative impacts of advanced biofuels on indirect land use change , further incentives should be provided by increasing the weighting of advanced biofuels towards the 10% target for transport set in directive 2009 / 28 / ec . in this context , only advanced biofuels with low risks in relation to indirect land use change , high overall greenhouse gas savings and without any risk to directly or indirectly endangering the right to food will be supported as part of the post 2020 renewable energy policy framework .


### 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 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 , notably through an appropriate career development system that rewards performance , dedication and quality of service .


### 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 .


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