### owing to the potential terrorist financing threat posed by anonymous transfers , it is appropriate to require payment service providers to request information on the payer and the payee . in line with the risk based approach developed by fatf , it is appropriate to identify areas of higher and lower risk with a view to better targeting money laundering and terrorist financing risks . accordingly , the payment service provider of the payee and the intermediary service provider should establish effective risk - based procedures for cases where a transfer of funds lacks the required payer and payee information , in order to decide whether to execute , reject or suspend that transfer and what appropriate follow - up action to take . where the payment service provider of the payer is established outside the territory of the union , enhanced customer due diligence should be applied , in accordance with directive [ xxxx / yyyy ] , in respect of cross - border correspondent banking relationships with that payment service provider . ### owing to the potential terrorist financing threat posed by anonymous transfers , it is appropriate to require payment service providers to request information on the payer and the payee . in line with the risk based approach developed by fatf , it is appropriate to identify areas of higher and lower risk with a view to better targeting money laundering and terrorist financing risks . accordingly , the payment service provider of the payee and the intermediary service provider should establish effective risk - based procedures and assess and weigh risks so that resources can be explicitly steered towards high - risk areas of money laundering . such effective risk - based procedures for cases where a transfer of funds lacks the required payer and payee information will help payment service providers to better decide whether to execute , reject or suspend that transfer and what appropriate follow - up action to take . where the payment service provider of the payer is established outside the territory of the union , enhanced customer due diligence should be applied , in accordance with directive [ xxxx / yyyy ] , in respect of cross - border correspondent banking relationships with that payment service provider .


### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector and threaten the internal market . terrorism shakes the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes . ### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector , threaten the internal market and directly or indirectly undermine the confidence of citizens in the rule of law . the funding of terrorism and organised crime remains a significant problem which should be addressed at union level . terrorism and organised crime shake the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes .


### ‘ a person - to - person’ transfer of funds means a transaction between two natural persons . ### ' a person - to - person ' transfer of funds means a transaction between two natural persons , who , as consumers , act for purposes other than their trade , business or profession .


### ‘ payer’ means a natural or legal person who either carries out a transfer of funds from his or her own account or who places an order for a transfer of funds ; ### ' payer ' means a payer as defined in article 4 of directive 2007 / 64 / ec of the european parliament and of the council24a ; _______________ 24a directive 2007 / 64 / ec of the european parliament and of the council of 13 november 2007 on payment services in the internal market amending directives 97 / 7 / ec , 2002 / 65 / ec , 2005 / 60 / ec and 2006 / 48 / ec and repealing directive 97 / 5 / ec .


### the payer ' s address , or national identity number , or customer identification number , or date and place of birth . ### the payer ' s address , or customer identification number , or date and place of birth .


### in order to check whether the required information on the payer and the payee accompanies transfers of funds , and to help to identify suspicious transactions , the payment service provider of the payee and the intermediary payment service provider should have effective procedures in place in order to detect whether information on the payer and the payee is missing . ### in order to check whether the required information on the payer and the payee accompanies transfers of funds , and to help to identify suspicious transactions , the payment service provider of the payee and the intermediary payment service provider should have effective procedures in place in order to detect whether information on the payer and the payee is missing or incomplete . effective checks of the presence and completeness of information , in particular where several payment service providers are involved , can help make investigation procedures less time consuming and more effective , which , in turn , improves the traceability of transfers of funds . competent authorities in the member states should thus ensure that payment service providers include the required transaction information with the wire transfer or related message throughout the payment chain .


### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or it device is used in order to effect a person - to - person transfer of funds . ### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or prepaid or postpaid it device is used in order to effect a person - to - person transfer of funds .


### ‘ payment service provider’ means a natural or legal person who provides the service of transferring funds in his or her professional capacity ; ### ' payment service provider ' means a payment service provider as defined in article 4 of directive 2007 / 64 / ec ;


### the payment service providers shall establish appropriate procedures for their employees to report breaches internally through a specific channel . ### the payment service providers shall establish appropriate procedures for their employees to report breaches internally through a specific , independent and anonymous channel .


### ‘ payee’ means a natural or legal person who is the intended recipient of transferred funds ; ### ' payee ' means a payee as defined in article 4 of directive 2007 / 64 / ec ;


### the payment service provider of the payee shall consider missing or incomplete information on the payer and the payee as a factor in assessing whether the transfer of funds , or any related transaction , is suspicious , and whether it must be reported to the financial intelligence unit . ### the payment service provider of the payee shall consider missing or incomplete information on the payer and the payee as one of the factors in assessing whether the transfer of funds , or any related transaction , is suspicious , and whether it must be reported to the financial intelligence unit . the payment service provider shall , in its effective risk - based procedures , also focus on , and take appropriate measures regarding , other risk factors as identified in the article 16 and in annex iii to directive [ xxxx / yyyy ] .


### the intermediary payment service provider shall establish effective risk - based procedures for determining when to execute , reject or suspend a transfer of funds lacking the required payer and payee information and the appropriate follow up action . ### the intermediary payment service provider shall establish effective risk - based procedures for determining whether the received information on the payer and the payee is missing or incomplete and shall put in place an appropriate follow up action .


### if the payment service provider of the payee becomes aware , when receiving transfers of funds , that information on the payer and the payee required under articles 4 and , 5 and 6 is missing or incomplete , it shall either reject the transfer or ask for complete information on the payer and the payee . ### if the payment service provider becomes aware , when receiving transfers of funds , that information on the payer and the payee required under articles 4 and , 5 and 6 is missing or incomplete or has not been completed using the characters or inputs admissible within the conventions of the messaging or payment and settlement system , it shall either reject the transfer or suspend it and ask for complete information on the payer and the payee before executing the payment transaction .


### since in criminal investigations it may not be possible to identify the data required or the individuals involved until many months , or even years , after the original transfer of funds and in order to be able to have access to essential evidence in the context of investigations , it is appropriate to require payment service providers to keep records of information on the payer and the payee for the purposes of preventing , investigating and detecting money laundering or terrorist financing . this period should be limited . ### since in criminal investigations it may not be possible to identify the data required or the individuals involved until many months , or even years , after the original transfer of funds and in order to be able to have access to essential evidence in the context of investigations , it is appropriate to require payment service providers to keep records of information on the payer and the payee for the purposes of preventing , investigating and detecting money laundering or terrorist financing . this period should be limited to five years , after which all personal data should be deleted , unless otherwise provided for by national law . further retention should be granted only if necessary for the prevention , detection or investigation of money laundering and terrorist financing and should not exceed ten years . payment service providers should ensure that data retained under this regulation is used only for the purposes described herein .


### repeated non - inclusion of required information on the payer and payee , in breach of articles 4 , 5 and 6 ; ### repeated non - inclusion of required information on the payer and payee by a payment service provider , in breach of articles 4 , 5 and 6 ;


### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data19 . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent e with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . the fight against money laundering and terrorist financing is recognised as an important public interest ground by all member states . hence , in the application of this regulation , the transfer of personal data to a third country which does not ensure an adequate level of protection in the meaning of article 25 of directive 95 / 46 / ec should be permitted according to article 26 of the same directive . __________________ 19 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council19 . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent e with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . the fight against money laundering and terrorist financing is recognised as an important public interest ground by all member states . hence , in the application of this regulation , the transfer of personal data to a third country which does not ensure an adequate level of protection in the meaning of article 25 of directive 95 / 46 / ec should be permitted according to article 26 of the same directive . it is important that payment service providers operating in multiple jurisdictions with branches or subsidiaries located outside the union are not unreasonably prevented from sharing information on suspicious transactions within the same organisation . this is without prejudice to international agreements concluded between the union and third countries on combating money laundering including appropriate safeguards for citizens ensuring an equivalent or adequate level of protection . __________________ 19 directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data .


### administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 shall be published without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets . ### the competent authorities shall publish administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 without undue delay including information on the type and nature of the breach and the identity of persons responsible for it .


### payment service providers shall respond fully and without delay , in accordance with the procedural requirements established in the national law of the member state in which they are established , to enquiries from the authorities responsible for combating money laundering or terrorist financing of that member state concerning the information required under this regulation . ### payment service providers shall respond fully and without delay , in accordance with the procedural requirements established in the national law of the member state in which they are established , to enquiries exclusively from the authorities responsible for combating money laundering or terrorist financing of that member state concerning the information required under this regulation . specific safeguards shall be put in place in order to ensure that such exchanges of information respect data protection requirements .


### in order not to impair the efficiency of payment systems , the verification requirements for transfers of funds made from an account should be separate from those for transfers of funds not made from an account . in order to balance the risk of driving transactions underground by imposing overly strict identification requirements against the potential terrorist threat posed by small transfers of funds , the obligation to check whether the information on the payer is accurate should , in the case of transfers of funds not made from an account , be imposed only in respect of individual transfers of funds that exceed eur 1 000 , . for transfers of funds made from an account , payment service providers should not be required to verify information on the payer accompanying each transfer of funds , where the obligations under directive [ xxxx / yyyy ] have been met . ### payment service providers should ensure that the information on the payer and the payee is not missing or incomplete . in order not to impair the efficiency of payment systems , the verification requirements for transfers of funds made from an account should be separate from those for transfers of funds not made from an account . in order to balance the risk of driving transactions underground by imposing overly strict identification requirements against the potential terrorist threat posed by small transfers of funds , the obligation to check whether the information on the payer is accurate should , in the case of transfers of funds not made from an account , be restricted only to the name of the payer for individual transfers of funds of up to eur 1 000 . for transfers of funds made from an account , payment service providers should not be required to verify information on the payer accompanying each transfer of funds , where the obligations under directive [ xxxx / yyyy ] have been met .


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


### ‘ vehicle type’ means a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . ### ‘ vehicle type’ means : for vehicles , tested according to annex ii , paragraph 4 . 1 . 2 . 1 a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . for vehicles , tested according to annex ii , paragraph 4 . 1 . 2 . 2 a set of vehicles which do not essentially differ in such respects as : the shape or materials of the bodywork ; the type of engine , number and capacity of cylinders , type of injection system , arrangement of valves , rated engine speed , or the type of electric motor . vehicles having the same type of engine and / or different overall gear ratios , may be regarded as vehicles of the same type . however , if the above differences provide for a different test method , these differences are to be considered as a change of type .


### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states . ### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic or biosimilar medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january and 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : ### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information :


### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products and the similarity of biosimilar products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy , bioequivalence or biosimilarity of the medicinal product . the marketing authorisation of an orphan medicinal product is also based on the evaluation of several criteria , including the significant benefit of the product over any available existing alternatives in the union , in accordance with regulation no 141 / 2000 , which should not be re - assessed in the framework of pricing and reimbursement procedures .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### that they are in conformity with the treaties . ### that those measures are in conformity with the treaties and the union ' s international obligations .


### member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , in all or part of their territory , provided that : ### member states may adopt measures restricting or prohibiting the cultivation of a gmo or a particular group of gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , in all or part of their territory , provided that :


### this regulation establishes rules prohibiting abusive practices on wholesale energy markets coherent with those applying in financial markets . it provides for the monitoring of wholesale energy markets by the agency . ### this regulation establishes rules prohibiting abusive practices on wholesale energy markets coherent with those applying in financial markets . it provides for the monitoring of wholesale energy markets by the agency , in close collaboration with national regulatory authorities .


### the agency may decide to make publicly available parts of the information which it holds provided that commercially sensitive information on individual market participants or individual transactions is not released . ### the agency should make publicly available the information which it holds provided that commercially sensitive information on individual market participants or individual transactions is not released .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### trust services provided by trust service providers established in a third country shall be recognised as legally equivalent to qualified trust services provided by qualified trust service providers established in the union if the trust services originating from the third country comply with the relevant requirements of this regulation as determined by a supervisory body established in a member state .


### member states which notify an electronic identification scheme shall forward to the commission the following information and without undue delay , any subsequent changes thereof : a description of the notified electronic identification scheme ; the authorities responsible for the notified electronic identification scheme ; information on by whom the registration of the unambiguous person identifiers is managed ; ### the notifying member state shall forward to the commission the following information and without undue delay , any subsequent changes thereof : a description of the notified electronic identification scheme , including its identity assurance levels ; the authority or authorities responsible for the notified electronic identification scheme ; information on the entity or entities which manages the verification of the person identification data ;


### the notifying member state ensures the availability of an authentication possibility online , at any time and free of charge so that any relying party can validate the person identification data received in electronic form . member states shall not impose any specific technical requirements on relying parties established outside of their territory intending to carry out such authentication . when either the notified identification scheme or authentication possibility is breached or partly compromised , member states shall suspend or revoke without delay the notified identification scheme or authentication possibility or the compromised parts concerned and inform the other member states and the commission pursuant to article 7 ; ### the notifying member state ensures the availability of authentication online , so that any relying party established outside of the territory of that member state can validate the person identification data received in electronic form . such authentication shall be provided free of charge when accessing a service online provided by a public sector body . member states shall not unduly impose any specific technical requirements on relying parties intending to carry out such authentication ;


### the commission shall be empowered to adopt delegated acts in accordance with article 38 concerning the facilitation of cross border interoperability of electronic identification means by setting of minimum technical requirements . ### the implementing acts referred to in paragraphs 1b and 2 of this article shall be adopted in accordance with the examination procedure referred to in article 39 .


### qualified trust service providers shall be audited by a recognised independent body once a year to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and shall submit the resulting security audit report to the supervisory body . ### qualified trust service providers shall be audited , annually , at their own expense by a conformity assessment body in order to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and they shall submit the resulting conformity assessment report to the supervisory body .


### monitoring trust service providers established in the territory of the designating member state to ensure that they fulfil the requirements laid down in article 15 ; ### trust service providers established in the territory of the designating member state fulfil the requirements laid down in this regulation ;


### without prejudice to paragraph 1 , the supervisory body may at any time audit the qualified trust service providers to confirm that they and the qualified trust services provided by them still meet the conditions set out in this regulation , either on its own initiative or in response to a request from the commission . the supervisory body shall inform the data protection authorities of the results of its audits , in case personal data protection rules appear to have been breached . ### without prejudice to paragraph 1 , the supervisory body may at any time audit the qualified trust service providers to confirm that they and the qualified trust services provided by them meet the conditions set out in this regulation . where personal data protection rules as set out in directive 95 / 46 / ec appear to have been breached , the supervisory body shall inform the data protection authorities of the results of its audits .


### trust service providers shall , without undue delay and where feasible not later than 24 hours after having become aware of it , notify the competent supervisory body , the competent national body for information security and other relevant third parties such as data protection authorities of any breach of security or loss of integrity that has a significant impact on the trust service provided and on the personal data maintained therein . ### trust service providers shall , without undue delay after having become aware of it , notify the supervisory body and , where appropriate , other relevant bodies , such as the competent national body for information security or the data protection authority , of any breach of security or loss of integrity that has a significant impact on the trust service provided and on the personal data maintained therein .


### the commission shall be empowered to adopt delegated acts , in accordance with article 38 , concerning the further specification of the measures referred to in paragraph 1 . ### the commission may , by means of implementing acts , define further specification of the measures referred to in paragraph 1 and the formats and procedures , including deadlines , applicable for the purpose of paragraph 2 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### where appropriate , in particular if a breach of security or loss of integrity concerns two or more member states , the supervisory body concerned shall inform supervisory bodies in other member states and the european network and information security agency . ### where appropriate , in particular if a breach of security or loss of integrity concerns two or more member states , the notified supervisory body shall inform the supervisory bodies in the other member states and the european network and information security agency .


### member states shall designate an appropriate body established in their territory or , upon mutual agreement , in another member state under the responsibility of the designating member state . supervisory bodies shall be given all supervisory and investigatory powers that are necessary for the exercise of their tasks . ### member states shall designate a supervisory body established in their territory or , upon mutual agreement , in another member state under the responsibility of the designating member state . the designated supervisory body , its addresses and the names of responsible persons shall be communicated to the commission . supervisory bodies shall be given adequate resources necessary for the exercise of their tasks .


### a supervisory body to which a request for assistance is addressed may not refuse to comply with it unless : ### a supervisory body to which a request for assistance is addressed may refuse that request under any of the following conditions :


### bear the risk of liability for damages by maintaining sufficient financial resources or by an appropriate liability insurance scheme ; ### with regard to the risk of liability for damages as referred to in article 8 , maintain sufficient financial resources or obtain appropriate liability insurance ;


### the electronic identification means are issued by , on behalf of or under the responsibility of the notifying member state ; ### the electronic identification means are issued : by the notifying member state , under a mandate from the notifying member state , or independently of the notifying member state and are recognised by that member state ;


### record for an appropriate period of time all relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings . such recording may be done electronically ; ### record and keep accessible for an appropriate period of time , including after the activities of the qualified trust service provider have ceased , all relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings . such recording may be done electronically ;


### undertaking supervision of qualified trust service providers established in the territory of the designating member state and of the qualified trust services they provide in order to ensure that they and the qualified trust services provided by them meet the applicable requirements laid down in this regulation ; ### qualified trust services provided by qualified trust service providers meet the requirements laid down in this regulation ; and


### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a service online , any electronic identification means issued in another member state falling under a scheme included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised and accepted for the purposes of accessing this service . ### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a public service online in one member state , the electronic identification means issued in another member state under a scheme , which is included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised in the first member states for the purposes of accessing that service online , provided that those electronic identification means correspond to an identity assurance level equal to or higher than the identity assurance level required for access to that service online in the first member state .


### use trustworthy systems to store data provided to them , in a verifiable form so that : – they are publicly available for retrieval only where the consent of the person to whom the data has been issued has been obtained , – only authorised persons can make entries and changes , – information can be checked for authenticity ; ### use trustworthy systems to store data provided to them , in a verifiable form so that : - they are publicly available for retrieval only where the consent of the person to whom the data relates has been obtained , - only authorised persons can make entries and changes to the stored data , - the data can be checked for authenticity ;


### supervisory bodies shall cooperate with a view to exchange good practice and provide each other , within the shortest possible time , with relevant information and mutual assistance so that activities can be carried out in a consistent manner . mutual assistance shall cover , in particular , information requests and supervisory measures , such as requests to carry out inspections related to the security audits as referred to in articles 15 , 16 and 17 . ### supervisory bodies shall cooperate with a view to exchanging good practice . they shall , upon justified requests , provide each other assistance so that activities can be carried out in a consistent manner . requests for assistance may cover , in particular , information requests and supervisory measures , such as requests to carry out inspections related to the compliance audits as referred to in articles 15 , 16 and 17 .


### supervisory bodies shall cooperate with a view to exchange good practice and provide each other , within the shortest possible time , with relevant information and mutual assistance so that activities can be carried out in a consistent manner . mutual assistance shall cover , in particular , information requests and supervisory measures , such as requests to carry out inspections related to the security audits as referred to in articles 15 , 16 and 17 . ### supervisory bodies shall cooperate with a view to exchanging good practice . a supervisory body shall , upon a receiving a request from another supervisory body , provide that body with assistance so that their activities can be carried out in a consistent manner . supervisory bodies shall also cooperate where a request is made under the regulation no 765 / 2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products1 . in addition , mutual assistance may also cover information requests and supervisory measures related to the conformity assessment reports as referred to in articles 15 , 16 and 17 of this regulation . ______________ 1 oj l 218 , 13 . 8 . 2008 , p . 30 .


### coordination ### coordination and interoperability


### trust service providers who are established in the territory of the union shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust services they provide . having regard to state of the art , these measures shall ensure that the level of security is appropriate to the degree of risk . in particular , measures shall be taken to prevent and minimise the impact of security incidents and inform stakeholders of adverse effects of any incidents . ### trust service providers who are established in the territory of the union shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust services they provide . having regard to the latest technological developments , any such measures shall ensure that the level of security is appropriate to the degree of risk . in particular , measures shall be taken to prevent and minimise the impact of security incidents and inform stakeholders of the adverse effects of any incidents .


### the electronic identification means can be used to access at least public services requiring electronic identification in the notifying member state ; ### the electronic identification means under that scheme can be used to access at least one service provided by a public sector body requiring electronic identification in the notifying member state ;


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### trust services provided by trust service providers established in a third country shall be recognised as legally equivalent to qualified trust services provided by qualified trust service providers established in the union if the trust services originating from the third country comply with the relevant requirements of this regulation as determined by a supervisory body established in a member state .


### draft by the court of justice ### to enable the general court to operate more efficiently and ensure that proceedings can be dealt with and adjudicated on within a reasonable time , the general court may set up specialised chambers where this is warranted by the number of proceedings in a given field .


### draft by the court of justice ### as regards the internal organisation of the general court , the office of vice - president should , following the approach adopted for the court of justice , be established for the purpose of assisting the president .


### draft by the court of justice 7 . in article 48 , the figure ‘ 27’ shall be replaced by the figure ‘ 39’ . ### article 48 shall be replaced by the following : ' the general court shall consist of 39 judges . when , every three years , the judges are partially replaced , 20 and 19 judges shall be replaced alternately . '


### draft by the court of justice ### in order to avoid any doubts as to the authority of the temporary judges , it is of the utmost importance that they be elected in a way which does not compromise the authority of the court and which ensures their total independence .


### in a multiannual plan established pursuant to articles 9 , 10 and 11 member states may be authorised to adopt measures , in accordance with that multiannual plan , which specify the conservation measures applicable to vessels flying their flag in relation to stocks in union waters for which they have been allocated fishing opportunities . ### in a multiannual plan established pursuant to articles 9 , 10 and 11 member states shall be authorised , after consulting the regional fisheries management bodies , to adopt measures , in accordance with that multiannual plan , which specify the conservation measures applicable to vessels flying their flag in relation to stocks in union waters for which they have been allocated fishing opportunities .


### in a technical measures framework established pursuant to article 14 member states may be authorised to adopt measures , in accordance with that framework , which specify the technical measures applicable to vessels flying their flag in relation to stocks in their waters for which they have been allocated fishing opportunities . member states shall ensure that such technical measures : ### in a technical measures framework established pursuant to article 14 member states shall be authorised , after consulting the relevant regional fisheries management bodies , to adopt measures , in accordance with that framework , which specify the technical measures applicable to vessels flying their flag in relation to stocks in their waters for which they have been allocated fishing opportunities . member states shall ensure that such technical measures :


### if the commission concludes that the measures do not comply with the conditions laid down in paragraph 1 it shall adopt an implementing decision requiring the member state to withdraw or modify the measures . ### if the commission concludes that the measures do not comply with the conditions laid down in paragraph 1 it shall adopt an implementing act requiring the member state to withdraw or modify the measures .


### any question with respect to proprietary aspects in relation to financial instruments held by a csd shall be governed by the law of the country where the account is maintained . ### without prejudice to the law under which the securities are constituted , any question with respect to proprietary aspects in relation to financial instruments held by a csd , as set out in points to , shall be governed by the law of the country where the account is maintained , namely : the legal nature and effects against the csd and third parties of the rights arising from a credit of financial instruments onto the account and of the disposition of financial instruments credited to the account ; the requirements for perfecting a disposition of financial instruments credited to the account , and more generally the completion of the steps necessary to render a disposition effective against the csd and third parties ; whether a person ' s title to or interest in financial instruments credited to the account is overridden by or subordinated to a competing title or interest , or a good faith acquisition has occurred . the steps required for the realisation of an interest in financial instruments credited to the account which were created by way of collateral following the occurrence of an enforcement event .


### a csd shall account separately for costs and revenues of the services provided and shall disclose that information to the competent authority . ### a csd shall account separately for costs and revenues of the services provided and shall disclose that information to the competent authority as well as to its users .


### for each securities settlement system it operates , a csd shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 that are not settled on the intended settlement date . these procedures shall provide for a sufficiently deterrent penalty mechanism for participants that cause the settlement fails . ### for each securities settlement system it operates , a csd shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 excluding repurchase agreements that are not settled on the intended settlement date . these procedures shall provide for a penalty mechanism which will serve as a suitable deterrent for participants that cause the settlement fails and be reviewed regularly to ensure that they are not designed to be revenue - generating , or creating improper incentives .


### where the csd has seriously and systematically infringed the requirements set out in this regulation . ### where the csd has seriously or systematically infringed the requirements set out in this regulation .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament , the council and the member states shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent , at the same time as the members of the committees and on the same terms , all information referred to in paragraph 1 .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament , the council and the member states shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent , at the same time as the members of the committees and on the same terms , all the information referred to in paragraph 1 .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament and the council shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent all information referred to in paragraph 1 at the same time and on the same terms as it is sent to the committee members .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the agreement and types of irregularities referred to in points and of paragraph 3 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards regarding the agreement and types of irregularities referred to in points and of paragraph 3 of this article . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] .


### the identification of areas for technical standards should strike an appropriate balance between building a single set of harmonised rules , without unduly complicating regulation . only those areas should be selected where consistent technical rules will contribute significantly to financial stability , depositor , policy holder and investor protection , market efficiency and integrity , and eliminate distortions of competition and risks of regulatory arbitrage . ### the identification of areas for technical standards should strike an appropriate balance between building a single set of harmonised rules , without unduly complicating regulation . only those areas should be selected where consistent technical rules will contribute significantly to financial stability , depositor , policy holder and investor protection , market efficiency and integrity , and eliminate distortions of competition and risks of regulatory arbitrage , while ensuring that policy decisions are taken , in accordance with the usual procedures , by the european parliament , the council and the commission .


### in order to ensure uniform application of this article and of articles 7 , 9 - , 10 - , and 12 , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the requirements and procedures for such authorisation as laid down in this article and in articles 7 , 9 - , 10 - and 12 . ### in order to ensure uniform application of this article and of articles 7 , 9 - , 10 - , and 12 , the european securities and markets authority may develop draft technical standards to specify the information , formats , templates , criteria , and procedures for such authorisation as laid down in this article and in articles 7 , 9 - , 10 - and 12 .


### if , at the end of the six month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the six month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six month period or after a joint decision has been reached ### if , at the end of the six - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation on its decision , and shall take its decision in conformity with the european banking authority ' s decision . the six - month period shall be deemed to be the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the consolidating supervisor pursuant to this directive .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards for endorsement by the commission to determine the conditions of application of the implementing measures adopted by the commission regarding the information referred to in paragraph 3 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards regarding the information referred to in paragraph 3 of this article . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] .


### if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached . ### if , at the end of the initial two - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall defer their decision and await the decision that the european banking authority may take in accordance with article 11 of that regulation , and shall take their decision in conformity with the authority’s decision . the two - month period shall be deemed to be the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the initial two - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the host member state pursuant to this directive .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the criteria , principles and steps referred to in points , , and of the first subparagraph of this article . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the criteria , principles and steps referred to in points , , and of paragraph 2 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure for delegated acts pursuant article 290 of the treaty .


### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ' ### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer their decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall not replace the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . '


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the agreement , measures and procedures referred to in points , and of paragraph 6 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the delegated acts adopted by the commission regarding the agreement , measures and procedures referred to in points , and of paragraph 6 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure for delegated acts in accordance with article 290 of the treaty on the functioning of the european union .


### in order to ensure uniform application of this article , the european banking authority shall develop draft technical standards to determine the conditions of application of the joint decision process referred to in this paragraph , with regard to the application of articles 123 , 124 and 132 and with a view to facilitating joint decisions . the authority shall submit those draft technical standards to the commission by 1 january 2014 . the commission may adopt thse draft technical standards referred to in the tenth subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards to determine the conditions of application of the joint decision process referred to in this paragraph , with regard to the application of articles 123 , 124 and 132 and with a view to facilitating joint decisions . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the tenth subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards for endorsement by the commission to determine the conditions of application of the implementing measures adopted by the commission regarding the information referred to in paragraph 3 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the delegated acts adopted by the commission according to paragraph 7 regarding the information referred to in paragraph 3 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure for implementing acts pursuant article 290 of the treaty


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the procedures , arrangements , structures and organisational requirements referred to in paragraph 3 of this article . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards regarding the procedures , arrangements , structures and organisational requirements referred to in paragraph 3 of this article . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the information and procedure referred to in points and of paragraph 4 . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards regarding the information and procedure referred to in points and of paragraph 4 of this article . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] .


### member states shall provide that reporting shall be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ### member states shall provide that reporting is to be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards to introduce , within the european union , uniform formats , frequencies , language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] .


### in order to ensure uniform application of this article , the european securities and markets authority may develop draft technical standards to determine the conditions of application of the implementing measures adopted by the commission regarding the content , format and method by which the information referred to in paragraphs 1 and 3 of this article should be provided . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] . ### the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards regarding the content , format and method by which the information referred to in paragraphs 1 and 3 of this article should be provided . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers referred to in the first subparagraph at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ esma ] .


### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation on its decision , and shall take its decision in conformity with the european banking authority ' s decision . the four - month period shall be deemed to be the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the consolidating supervisor pursuant to this directive .


### for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , languages and dates of reporting before 1january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] . ### for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards to introduce , within the european union , uniform formats , frequencies , languages and dates of reporting before 1january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the second subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] .


### member states shall ensure that organisers and retailers facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency . ### member states shall ensure that organisers of packages and retailers facilitating the procurement of linked travel arrangements obtain security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of the insolvency of the organiser , of the retailer or of any of the linked travel arrangement service providers .


### ‘ assisted travel arrangement’ means a combination of at least two different types of travel services for the purpose of the same trip or holiday , not constituting a package , resulting in the conclusion of separate contracts with the individual travel service providers , if a retailer facilitates the combination : ### ‘ linked travel arrangement’ means a combination of carriage of passengers and at least one different type of travel service for the purpose of the same trip or holiday , not constituting a package , resulting in the conclusion of separate contracts with the individual travel service providers , if a retailer facilitates the combination :


### member states shall ensure that organisers and retailers facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency . ### member states shall ensure that organisers of packages and retailers facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and for the continuation , where possible , of the package in the event of their insolvency or that of any of the service providers . insofar as carriage of passengers is included , member states shall ensure that passenger carriers established in their territory obtain a security for the travellers ' refunding or effective and prompt repatriation in the event of their insolvency .


### on the basis of separate bookings on the occasion of a single visit or contact with the point of sale ; or ### on the basis of separate bookings where the traveller individually selects and individually pays for the services ; or


### member states shall ensure that the organiser gives prompt assistance to the traveller in difficulty , in particular by : ### member states shall ensure that the organiser has adequate insurance or means to give appropriate assistance to the traveller in difficulty , in particular by :


### assisting the traveller in making distance communications and alternative travel arrangements . ### assisting the traveller to make distance communications and helping the traveller to source alternative travel arrangements .


### through the procurement of additional travel services from another trader in a targeted manner through linked online booking processes at the latest when the booking of the first service is confirmed ; ### through the procurement of additional travel services offered by another trader in a targeted manner through linked online booking processes commencing at the latest when the booking of the first service is confirmed and concluded not more than one day after that confirmation ;


### the price increase referred to in paragraph 1 shall be valid only if the organiser notifies the traveller of it with a justification and calculation on a durable medium at the latest 20 days prior to the start of the package . ### the price increase referred to in paragraph 1 shall be valid only if the organiser , without undue delay , notifies the traveller clearly and comprehensibly on a durable medium at the latest 20 days prior to the start of the package : of the price increase with a justification and calculation , and ; b ) of the fact that the traveller may terminate the contract without penalty within a specified reasonable time - limit and that otherwise the price increase will be considered as accepted .


### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea to protect rockall haddock , cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks . ### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea , to protect cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks .


### devices classified as class d in accordance with the rules set out in annex vii , even if manufactured and used within a single health institution , shall comply with the requirements of this regulation . however , the provisions regarding ce marking set out in article 16 and the obligations referred to in articles 21 to 25 shall not apply to those devices . ### devices classified as class d in accordance with the rules set out in annex vii , if manufactured and used within a single health institution , shall be exempt from the requirements of this regulation , with the exception of article 59 and general safety performance requirements set out in annex 1 where the following conditions are met : the recipient patient or patient group ' s specific needs can not be met by an available ce - marked device ; the health institution is accredited to iso standard 15189 quality management system , or any other equivalent recognised standard ; the health institution provides the competent authority referred to in article 26 with a list of such devices , which shall include a justification of their manufacturing , modification or use , in particular , where similar devices have been made available on the market . this information shall be made public . member states shall retain the right to restrict the in - house manufacture and use of any specific type of in - vitro diagnostic device in relation to aspects that are not covered by this regulation , and may also make the manufacture and use of the devices concerned subject to further safety requirements .


### devices classified as class d in accordance with the rules set out in annex vii , even if manufactured and used within a single health institution , shall comply with the requirements of this regulation . however , the provisions regarding ce marking set out in article 16 and the obligations referred to in articles 21 to 25 shall not apply to those devices . ### devices classified as class d in accordance with the rules set out in annex vii , if manufactured and used within a single health institution , shall be exempt from the requirements of this regulation , with the exception of article 59 , where the following conditions are met ; the recipient patient or patient group ' s specific needs can not be met by an available ce - marked device ; the health institution is accredited to en iso standard 15189 quality management system , or any other equivalent recognised standard ; the health institution provides their competent authority referred to in article 26 with a list of such devices , which shall include a justification of their manufacturing or modification , in particular , where similar devices have been made available on the market . this information shall be updated yearly , and shall be made public .


### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline , and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices ; ### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level , in natural sciences , medicine , pharmacy , engineering or another relevant discipline , and at least five years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices ;


### five years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices . ### ten years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices as well as a proven in - depth knowledge of both the therapeutic area and the product concerned . .


### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified as class a , b and c , in accordance with the rules set out in annex vii , and manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution’s single quality management system , and the health institution is compliant with standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements . ### with the exception of article 59 , the requirements of this regulation shall not apply to laboratory - developed tests manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution’s single quality management system , and the health institution is accredited to standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements .


### this regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription . ### this regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription . direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal . the following devices may only be supplied on a medical prescription : class d devices 2 ) class c devices in the following categories : devices for genetic testing ; companion diagnostics . the commission shall be empowered to adopt delegated acts in accordance with article 85 to decide on other category c tests after consultation with stakeholders .


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


### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact , which could include the introduction of estimated indirect land - use change emission factors in the sustainability scheme as of 1st january 2021 . ### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact .


### member states may not maintain or introduce , in their national law , provisions diverging from those laid down in this directive , including more or less stringent provisions to ensure a different level of consumer protection . ### unless indicated differently in this directive , member states may adopt or maintain in force more stringent provisions , compatible with the treaty in the field covered by this directive , to ensure a higher level of consumer protection . 2 . where member states maintain or introduce more stringent provisions to ensure a higher level of consumer protection in the field harmonised by this directive , these provisions must be compatible with the treaty and must be notified to the commission . the commission shall make that information public on a website or in another easily accessible way . 3 . the rights resulting from this directive shall be exercised without prejudice to other rights which the consumer may invoke under the national rules governing contractual or non - contractual liability .


### when the trader has remedied the lack of conformity by replacement , he shall be held liable under article 25 where the lack of conformity becomes apparent within two years as from the time the consumer or a third party indicated by the consumer has acquired the material possession of the replaced goods . ### when the trader has remedied the lack of conformity by repair or replacement , the period specified in paragraph 1 shall be suspended from the moment the consumer informs the trader of the lack of conformity until the moment the consumer has reacquired the material possession of the replaced goods .


### this directive shall only apply to financial services as regards certain off - premises contracts as provided for by articles 8 to 20 , unfair contract terms as provided for by articles 30 to 39 and general provisions as provided for by articles 40 to 46 , read in conjunction with article 4 on full harmonisation . ### this directive shall only apply to financial services as regards certain unfair contract terms as provided for by articles 30 to 39 and general provisions as provided for by articles 40 to 46 , read in conjunction with article 4 on full harmonisation .


### in october 2009 , in light of this difficult market situation for milk , a high level expert group on milk was set up with the purpose of discussing mid - term and long - term arrangements for the milk and milk products sector , given the expiry of dairy quotas in 2015 . while respecting the outcome of the health check , the hlg was to work on a regulatory framework to be put in place , to contribute to stabilising the market and producers ' income and enhance its transparency . ### in response to this difficult market situation for milk , a high level expert group on milk was set up , in october 2009 , with the purpose of discussing mid - and long - term arrangements for the milk and milk products sector which , in the context of the expiration of dairy quotas in 2015 , would contribute to stabilising the market and producers ' income and of enhancing transparency in the sector .


### the hlg obtained oral and written input from major european stakeholder groups in the dairy supply chain representing farmers , dairy processors , dairy traders , retailers and consumers . further , the hlg received contributions from invited academic experts , third country representatives , national competition authorities and the commission ' s services . a dairy stakeholder conference was also held on 26 march 2010 allowing a wider range of actors in the supply chain to express their views . the hlg delivered its report on 15 june 2010 , which contained an analysis of the current situation of the dairy sector and number of recommendations . ### the hlg obtained oral and written input from major european stakeholder groups in the dairy supply chain and delivered its report on 15 june 2010 . the report contained an analysis of the current situation of the dairy sector and a number of recommendations which focused on contractual relations , the bargaining power of producers , interprofessional / interbranch organisations , transparency , market measures and futures , marketing standards and origin labelling and innovation and research .


### in 2007 - 2009 , exceptional developments took place in milk and milk products sector markets . initially , extreme weather conditions in oceania brought about a significant decline in supplies , leading to a rapid and significant increase in prices . yet while world supplies had started their recovery , and prices had started to return to more normal levels , the subsequent financial and economic crisis negatively affected eu dairy producers , aggravating price volatility . initially feed and other input costs including energy increased significantly as a result of higher commodity prices . subsequently , a drop in worldwide , as well as eu , demand , including for milk and milk products , whilst eu production was stable led to a collapse in eu prices , down to the lower safety net level . this sharp decline in dairy commodity prices failed to fully translate into lower dairy prices at consumer levels , generating a widening in the gross margin of the downstream sectors for most milk and milk sector products and countries , and preventing demand for them to adjust to low commodity prices , slowing down price recovery and exacerbating the impact of low prices on milk producers . ### in the period from 2007 to2009 , exceptional events impacted on the milk and milk products sector causing extreme price volatility , ultimately resulting in a price crash in 2009 which forced many dairy farmers in europe out of business and put the viability of many other dairy producers at serious risk .