### the commission may adopt delegated acts in accordance with article 5 for the purpose of amending the annexes in order to introduce amendments and technical adjustments necessary following amendments to the combined nomenclature codes and to the taric subdivisions . ### the commission shall present by 31 october 2011 a report to the european parliament and the council on the evolution of imports between 1 january and 30 june 2011 of products covered by this regulation . 2 . where the commission concludes , in its report , that the volume of imports of one of the products included in annex i originating from pakistan exceeds the volume of such imports in the corresponding period of 2010 by twenty percentage points , the commission may adopt a delegated act , in accordance with article 9 , to subject the imports of that product to tariff rate quotas for imports of that product in the year 2012 by amending annex ii . 3 . the tariff rate quota provided for under paragraph 2 shall take the form of a duty free quota limited to the level of imports of that product in 2010 increased by 20% . by way of derogation from article 1 , upon the entry into force of the delegated act , imports in excess of that tariff rate quota shall be subject to most - favoured nation or other applicable duties .


### it shall apply from 1 january 2011 provided that the tariff preferences provided for in this regulation are permitted by a waiver granted by the world trade organisation . in case the world trade organisation grants such a waiver after 1 january 2011 , it shall apply from such later date on which the waiver takes effect . ### it shall apply from 1 january 2011 provided that the conditions set out in points ca and cb of article 2 have been fulfilled and provided that the tariff preferences provided for in this regulation are permitted by a waiver granted by the world trade organisation . in case the world trade organisation grants such a waiver after 1 january 2011 , it shall apply from such later date on which the waiver takes effect .


### in its resolution on the enforcement of intellectual property rights in the internal market of 1 march 2010 , the council invited the commission , the member states and industry to provide the observatory with available reliable and comparable data on counterfeiting and piracy and to jointly develop and agree , in the context of the observatory , on plans to collect further information . the council also invited the observatory to publish each year a comprehensive annual report covering the scope , scale and principal characteristics of counterfeiting and piracy as well as its impact on the internal market . that annual report should be prepared with the information provided by the authorities of the member states , the commission and the private sector , within the limits of data protection law , on the scope , scale and principal characteristics of counterfeiting and piracy as well as its impact on the internal market . ### in its resolution on the enforcement of intellectual property rights in the internal market of 1 march 2010 , the council invited the commission , the member states and industry to provide the observatory with available reliable and comparable data on infringements of intellectual property rights and to jointly develop and agree , in the context of the observatory , on plans to collect further information . the council also invited the observatory to publish each year a comprehensive annual report covering the scope , scale and principal characteristics of infringements of intellectual property rights as well as its impact on the internal market . that annual report should be prepared with the information provided by the authorities of the member states , the commission and the private sector , within the limits of data protection law , on the scope , scale and principal characteristics of infringements of intellectual property rights as well as its impact on the internal market .


### recommendations on the future policies in the area of the protection of intellectual property rights , including on how to enhance an effective cooperation between member states . ### observations on the protection of intellectual property rights and potential future policies and strategies , including on how to enhance cooperation with and between member states , drawing on their own experiences .


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a non - tobacco dominant flavour other than tobacco or traditional flavours such as menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns . .


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states and consistent with wto international obligations . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive .


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : ### if nicotine containing products are presented as having properties for treating or preventing disease they may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec :


### all emissions from flights to and from countries outside the european economic area in 2013 ; ### all emissions from flights to or from countries outside the european economic area in each calendar year from and including 2013 to and including 2020 ;


### the council shall examine this regulation on the basis of a report from the commission three years after its entry into force and shall determine whether the missions and organisation of the esrb need to be reviewed after having received an opinion from the ecb . ### the council shall examine this regulation on the basis of a report from the commission two years after its entry into force and shall determine whether the missions and organisation of the esrb need to be reviewed after having received an opinion from the ecb .


### increasingly , as investors also pursue social goals and are not only seeking financial returns , a social investment market has been emerging in the union , comprised in part by investment funds targeting social undertakings . such investment funds provide funding to social undertakings which are acting as drivers of social change by offering innovative solutions to social problems and making a valuable contribution to meeting the objectives of the europe 2020 strategy . ### increasingly , as investors also pursue social goals and are not only seeking financial returns , a social investment market has been emerging in the union , comprised in part by investment funds targeting social undertakings . such investment funds provide funding to social undertakings which are acting as drivers of social change by offering innovative solutions to social problems and making a valuable contribution to meeting the objectives of the europe 2020 strategy , while taking into account the long - term challenges facing member states of the union , such as those identified in the european strategy and policy analysis system ' s report , global trends 2030 .


### member states shall ensure that the rightholder gives express consent specifically for each right or category of rights or type of works and other subject matter which that rightholder authorises the collecting society to manage and that any such consent is evidenced in documentary form . ### member states shall ensure that the rightholder gives consent for each right or category of rights or type of works and other subject matter which that rightholder authorises the collecting society to manage and that any such consent is evidenced in documentary form .


### the general meeting shall control the activities of the collecting society by , at least , deciding on the appointment and removal of the auditor and approving the annual transparency report and the auditor ' s report . ### the general meeting shall control the activities of the collective management organisation by at least deciding on the appointment and removal of the auditor and having placed before them , together with the company ' s accounts , the annual transparency report .


### member states shall ensure that collecting societies make available to their members and rightholders effective and timely procedures for dealing with complaints and for resolving disputes in particular in relation to authorisation to manage rights and termination or withdrawal of rights , membership terms , the collection of amounts due to rightholders , deductions and distributions . ### member states shall ensure that collecting societies make available to their members and rightholders effective and timely procedures for dealing with complaints and for resolving disputes , including where appropriate recourse to an independent and impartial dispute resolution body , in particular in relation to authorisation to manage rights and termination or withdrawal of rights , membership terms , the collection of amounts due to rightholders , deductions and distributions .


### this regulation applies to protection measures taken in civil matters whatever the nature of the authority . it does not apply to protection measures covered by regulation no 2201 / 2003 . ### this regulation applies to protection measures taken in civil matters whatever the nature of the authority issuing the protection measure . it does not apply to protection measures covered by regulation no 2201 / 2003 or to the protection measures covered by directive [ . . . ] of the european parliament and of the council on the european protection order , in order to prevent overlapping between the civil law and criminal law systems .


### ' protection measure ' means any decision , whatever it may be called , of a preventive and temporary nature taken by an authority in a member state in accordance with its national law with a view to protecting a person when serious reasons exist to consider the person ' s physical and / or psychological integrity or liberty to be at risk . it shall include measures ordered without the person causing the risk being summoned to appear . the following are notably protection measures : an obligation not to enter certain localities , places or defined areas where the protected person resides , works or that he visits ; or an obligation not to enter into contact , in any form , with the protected person , including by phone , electronic or ordinary mail , fax or any other means ; or an obligation not to approach the protected person closer than a prescribed distance ; or a decision attributing the exclusive use of the common housing of two persons to the protected person . ### ' protection measure ' means any decision , whatever it may be called , of a preventive and temporary nature taken by an authority in a member state in accordance with its national law with a view to protecting an individual person when serious reasons exist to consider the person ' s life , physical and / or psychological integrity , dignity , personal liberty or sexual integrity to be at risk . it shall include measures ordered without the person causing the risk being summoned to appear . protection measures may include one or more of the following obligations or prohibitions : a prohibition from entering and / or remaining in certain localities , places or defined areas where the protected person resides , works or that he visits ; or a prohibition or regulation of contact , in any form , with the protected person , including by phone , electronic or ordinary mail , fax or any other means ; or a prohibition or regulation on approaching the protected person closer than a prescribed distance ; or a decision attributing the exclusive use of the common housing of two persons to the protected person ; or any other prohibitions or regulations imposed in order to guarantee the protection of the protected person .


### in addition to the general measures to be taken at member states’ level in directive [ pls insert number of nis directive after adoption ] , the security risks related to payment transactions should also be addressed at the level of the payment service providers . the security measures to be taken by the payment service providers need to be proportionate to the security risks concerned . a regular reporting mechanism should be established , so as to ensure payment services should provide the competent authorities on an annual basis with updated information on the assessment of their security risks and the measures that they have taken in response to these risks . furthermore , in order to ensure that damages to other payment service providers and payment systems , such as a substantial disruption of a payment system and to users is kept to a minimum , it is essential that payment service providers have the obligation to report within undue delay major security incidents to the european banking authority . ### the security measures to be taken by the payment service providers need to be proportionate to the security risks concerned . a regular reporting mechanism should be established , so as to ensure payment services should provide the competent authorities on a regular basis with updated information on the assessment of their security risks and the measures that they have taken in response to these risks . furthermore , in order to ensure that damages to other payment service providers and payment systems , such as a substantial disruption of a payment system and to users is kept to a minimum , it is essential that payment service providers have the obligation to report without undue delay major security incidents to the european banking authority .


### service providers seeking to benefit from an exemption under directive 2007 / 64 / ec often do not consult authorities on whether their activities are covered or exempted under that directive but rely on their own assessments . it appears that some exemptions may have been used by payment service providers to redesign business models so that the payment activities offered would be outside the scope of that directive . this may result in increased risks for payment service users and diverging conditions for payment service providers in the internal market . service providers should therefore be obliged to notify certain activities to the competent authorities , to ensure a homogenous interpretation of the rules throughout the internal market . ### service providers seeking to benefit from an exemption under directive 2007 / 64 / ec often do not consult authorities on whether their activities are covered or exempted under that directive but rely on their own assessments . it appears that some exemptions may have been used by payment service providers to redesign business models so that the payment activities offered would be outside the scope of that directive . this may result in increased risks for payment service users and diverging conditions for payment service providers in the internal market . service providers should therefore be obliged to notify certain activities to the competent authorities in particular in relation to the limited networks exemption in article 3 , to ensure a homogenous interpretation of the rules throughout the internal market .


### since the adoption of directive 2007 / 64 / ec new types of payment services have emerged , especially in the area of internet payments . in particular , third party providers have evolved , offering so - called payment initiation services to consumers and merchants , often without entering into the possession of the funds to be transferred . those services facilitate the e - commerce payments by establishing a software bridge between the website of the merchant and the online banking platform of the consumer in order to initiate internet payments on the basis of credit transfers or direct debits . the tpps offer a low - cost alternative to card payments for both merchants and consumers and provide consumers a possibility to shop online even if they do not possess credit cards . however , as tpps are currently not subject to directive 2007 / 64 / ec , they are not necessarily supervised by a competent authority and do not follow the requirements of directive 2007 / 64 / ec . this raises a series of legal issues , such as consumer protection , security and liability as well as competition and data protection issues . the new rules should therefore respond to those issues . ### since the adoption of directive 2007 / 64 / ec new types of payment services have emerged , especially in the area of internet payments . in particular , third party payment service providers have evolved , offering online payment initiation services to consumers and merchants , often without entering into the possession of the funds to be transferred . the tpps offer an alternative to card payments for both merchants and consumers and provide consumers a possibility to shop online even if they do not possess payment cards . tpps also represent important security challenges to the safeguarding of the integrity of payments and personal data made available to them by payers . however , as tpps are currently not subject to directive 2007 / 64 / ec , they are not necessarily supervised by a competent authority and do not follow the requirements of directive 2007 / 64 / ec . this raises a series of legal issues , such as consumer protection , security and liability as well as competition and data protection issues . the new rules should therefore address all those challenges appropriately and ensure that tpps operating in the union are authorised or registered and supervised as payment institutions .


### while this directive specifies the minimum set of powers competent authorities should have when supervising the compliance of payment institutions , these powers are to be exercised with respect to fundamental rights , including the right to privacy . for the exercise of those powers which may amount to serious interferences with the right to respect private and family life , home and communications , member states should have in place adequate and effective safeguards against any abuse or arbitrariness , for instance , where appropriate through prior authorisation from the judicial authority of the member state concerned . ### while this directive specifies the minimum set of powers competent authorities should have when supervising the compliance of payment institutions , these powers are to be exercised with respect to fundamental rights , including the right to privacy . for the exercise of those powers which may amount to serious interferences with the right to respect private and family life , home and communications , member states should have in place adequate and effective safeguards against any abuse or arbitrariness .


### in the case of unauthorized payment transactions the payer should be refunded immediately the amount of the respective transaction . in order to prevent the payer from any disadvantages , the credit value date of the refund should not be later than the date when the respective amount has been debited . in order to provide an incentive for the payment service user to notify , without undue delay , the provider of any theft or loss of a payment instrument and thus to reduce the risk of unauthorised payment transactions , the user should be liable only for a very limited amount , unless the payment service user has acted fraudulently or with gross negligence . in this context an amount of eur 50 seems to be adequate in order to ensure a harmonized and a high level user protection within the union . moreover , once users have notified a payment service provider that their payment instrument may have been compromised , the users should not be required to cover any further losses stemming from unauthorised use of that instrument . this directive should be without prejudice to the payment service providers’ responsibility for technical security of their own products . ### in the case of unauthorized payment transactions the payer should be refunded immediately the amount of the respective transaction . in order to prevent the payer from any disadvantages , the credit value date of the refund should not be later than the date when the respective amount has been debited . in order to provide an incentive for the payment service user to notify , without undue delay , the provider of any theft or loss of a payment instrument and thus to reduce the risk of unauthorised payment transactions , the user should be liable only for a very limited amount , unless the payment service user has acted fraudulently or with gross negligence . in this context an amount of eur 100 , or national currency equivalent as determined by non - euro member states , seems to be adequate in order to ensure a harmonized and a high level user protection within the union . moreover , once users have notified a payment service provider that their payment instrument may have been compromised , the users should not be required to cover any further losses stemming from unauthorised use of that instrument . this directive should be without prejudice to the payment service providers’ responsibility for technical security of their own products .


### the payer’s payment service provider should assume liability for correct payment execution , including , in particular the full amount of the payment transaction and execution time , and full responsibility for any failure by other parties in the payment chain up to the account of the payee . as a result of that liability the payment service provider of the payer should , where the full amount is not or only late credited to the payee’s payment service provider , correct the payment transaction or without undue delay refund to the payer the relevant amount of that transaction , without prejudice to any other claims which may be made in accordance with national law . due to the payment service provider’s liability , the payer or payee should not be burdened with any costs related to the incorrect payment . in case of non - execution , defective or late execution of payment transactions , member states should ensure that the value date of corrective payments of payment service providers is always the same as the value date in case of correct execution . ### the payer’s payment service provider , being the account servicing payment service provider or , where involved , the tpp , should assume liability for correct payment execution , including , in particular the full amount of the payment transaction and execution time , and full responsibility for any failure by other parties in the payment chain up to the account of the payee . as a result of that liability the payment service provider of the payer should , where the full amount is not or only late credited to the payee’s payment service provider , correct the payment transaction or without undue delay refund to the payer the relevant amount of that transaction , without prejudice to any other claims which may be made in accordance with national law . due to the payment service provider’s liability , the payer or payee should not be burdened with any costs related to the incorrect payment . in case of non - execution , defective or late execution of payment transactions , member states should ensure that the value date of corrective payments of payment service providers is always the same as the value date in case of correct execution .


### payment transactions consisting of the non - professional cash collection and delivery within the framework of a non - profit or charitable activity ; ### payment transactions consisting of cash collection and delivery or its virtual equivalent within the framework of a non - profit or charitable activity ;


### services provided by technical service providers , which support the provision of payment services , without them entering at any time into possession of the funds to be transferred , including processing and storage of data , trust and privacy protection services , data and entity authentication , information technology and communication network provision , provision and maintenance of terminals and devices used for payment services , with the exclusion of payment initiation services and account information services ; ### services provided by technical service providers , which support the provision of payment services , without them entering at any time into possession of the funds to be transferred , including processing and storage of data , trust and privacy protection services , data and entity authentication , information technology and communication network and secure channels provision , provision and maintenance of terminals , devices and applications used for payment services , except where they also involve payment initiation services and account information services ;


### ‘ payment order’ means any instruction by a payer or payee to his payment service provider requesting the execution of a payment transaction ; ### ‘ payment order’ means any instruction by a payer or payee to the account servicing payment service provider whether initiated directly or via a third party payment provider requesting the execution of a payment transaction ;


### a description of the process in place to monitor , track and restrict access to sensitive payment data , and logical and physical critical resources ; ### a description of the process in place to monitor , track and restrict access to sensitive payment data ;


### a description of the internal control mechanisms which the applicant has established in order to comply with obligations in relation to money laundering and terrorist financing under directive 2005 / 60 / ec of the european parliament and of the council45 and regulation no 1781 / 2006 of the european parliament and of the council46 ; __________________ 45 directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing 46 regulation no 1781 / 2006 of the european parliament and of the council of 15 november 2006 on information on the payer accompanying transfers of funds . ### for payment institutions subject to the obligations in relation to money laundering and terrorist financing under directive 2005 / 60 / ec of the european parliament and of the council45 and regulation no 1781 / 2006 of the european parliament and of the council a description of the internal control mechanisms which the applicant has established in order to comply with those obligations46 ; __________________ 45 directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing 46 regulation no 1781 / 2006 of the european parliament and of the council of 15 november 2006 on information on the payer accompanying transfers of funds .


### the competent authorities may withdraw an authorisation issued to a payment institution only where the institution falls within the following cases : ### the competent authorities may withdraw an authorisation issued to a payment institution only where the institution falls within the following case :


### would constitute a threat to the stability of or the trust in the payment system by continuing its payment services business ; ### would constitute a threat to the stability of or the trust in the payment system by continuing its payment services business ; or


### when payment institutions engage in the provision of one or more of the payment services , they may hold only payment accounts used exclusively for payment transactions . member states shall ensure that access to those payment accounts is proportionate . ### when payment institutions engage in the provision of one or more of the payment services , they may hold only payment accounts and safeguarding accounts used exclusively for payment transactions . for payment institutions and their agents to be able to provide payment services , they require access to payment accounts . member states shall ensure that the rules on access of payment institutions to payment and safeguarding accounts shall be objective , non - discriminatory and proportionate and that those rules do not inhibit access more than is necessary to protect against specific risks such as the risk of the conditions established by chapter ii of directive 2005 / 60 not being satisfied .


### a confirmation of the successful initiation of the payment order with the payer ' s account servicing payment service provider ; ### a confirmation of the initiation of the payment order with the payer ' s account servicing payment service provider ;


### where applicable , the amount of any charges for the payment transaction and , where applicable , a breakdown thereof . ### where applicable , the amount of any charges payable to the third party payment provider for the payment transaction , such charges to be individually itemised .


### if agreed , information that the payment service user will be deemed to have accepted changes in the conditions in accordance with article 47 , unless he notifies the payment service provider that he does not accept them before the date of their proposed date of entry into force ; ### if agreed , information that the payment service user will be deemed to have accepted changes in the conditions in accordance with article 47 , unless he notifies the payment service provider that he does not accept them before the date of their proposed date of entry into force , such notification being ineffective where the change is clearly and unambiguously more favourable to payment service users ;


### account servicing payment service providers shall treat payment orders transmitted through the services of a third party payment service provider without any discrimination for other than objective reasons in terms of timing and priority vis - à - vis payment orders transmitted directly by the payer himself . ### account servicing payment service providers shall treat payment orders transmitted through the services of a third party payment service provider without any discrimination for other than objective reasons , in particular in terms of timing and priority vis - à - vis payment orders transmitted directly by the payer himself . this is without prejudice to controls to be performed by account servicing payment service providers objectively justified by the particularities of these transactions .


### where a third party payment service provider is involved , the account servicing payment service provider shall refund the amount of the unauthorised payment transaction and , where applicable , restore the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place . financial compensation to the account servicing payment service provider by the third party payment service provider may be applicable . ### where the unauthorised payment transaction is originated by a payment order transmitted by a third party payment service provider , the account servicing payment service provider shall inform the payer accordingly and the third party payment provider shall without undue delay refund the amount of the unauthorised payment transaction and , where applicable , restore the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place .


### member states shall ensure that the payer can request the refund referred to in article 67 of an authorised payment transaction initiated by or through a payee for a period of eight weeks from the date on which the funds were debited . ### member states shall ensure that the payer can request the refund referred to in article 67 of an authorised payment transaction initiated by or through a payee for a period of at least eight weeks from the date on which the funds were debited .


### this section shall apply to other payment transactions , unless otherwise agreed between the payment service user and the payment service provider , with the exception of article 78 , which is not at the disposal of the parties . however , when the payment service user and the payment service provider agree on a longer period than those laid down in article 74 , for intra - union payment transactions such period shall not exceed 4 business days following the point in time of receipt in accordance with article 69 . ### this section shall apply to other payment transactions , unless otherwise agreed between the payment service user and the payment service provider , with the exception of article 78 , which is not at the disposal of the parties . however , when the payment service user and the payment service provider agree on a longer period than those laid down in article 74 , for intra - union payment transactions such period shall not exceed 4 business days , or such time as permitted by other legal obligations covered by national and union law , following the point in time of receipt in accordance with article 69 .


### any processing of personal data for the purposes of this directive shall be carried out in accordance with directive 95 / 46 / ec , the national rules which transpose directive 95 / 46 / ec and regulation no 45 / 2001 . ### member states shall permit the processing of personal data by payment systems and payment service providers when this is necessary to safeguard the prevention , investigation and detection of payment fraud . the processing of such personal data shall be carried out in accordance with directive 95 / 46 / ec , the national rules which transpose directive 95 / 46 / ec and regulation no 45 / 2001 .


### the authority designated under article 6 of directive [ nis directive ] [ op please insert number of directive once adopted ] shall without undue delay inform the competent authority in the home member state and eba of the notifications of nis incidents received from payment services providers . ### payment service providers shall without undue delay notify any major operational incident , including security incidents , to the competent authority in the home member state of the payment service provider .


### without prejudice to articles 14 and 15 of directive [ nis directive ] [ op please insert number of directive once adopted ] , eba shall , in close cooperation with the ecb , develop guidelines with regard to the establishment , implementation and monitoring of the security measures , including certification processes when relevant . it shall , inter alia , take into account the standards and / or specifications published by the commission under article 16 of directive [ nis directive ] [ op please insert number of directive once adopted ] . ### eba shall , in close cooperation with the ecb , develop guidelines with regard to the establishment , implementation and monitoring of the security measures , including certification processes when relevant . it shall , inter alia , take into account the standards and / or specifications published by the commission under article 16 of directive [ nis directive ] [ op please insert number of directive once adopted ] as well as the ecb eurosystem ' s recommendations for the security of internet payments under the ' securepay ' forum .


### member states shall ensure that procedures are set up which allow payment service users and other interested parties , including consumer associations , to submit complaints to the competent authorities with regard to payment service providers ' alleged infringements of this directive . ### member states shall ensure that procedures are set up which allow payment service users and other interested parties , including consumer associations , to submit complaints to the competent authorities or adr authorities with regard to payment service providers ' alleged infringements of this directive .


### regulation of the european parliament and of the council laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers ### regulation of the european parliament and of the council laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers in accordance with article 291 of the treaty on the functioning of the european union


### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act requires that the adoption of binding implementing acts by the commission be subject to the control of member states . ### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act requires uniform conditions of implementation and provides that the adoption of such implementing acts by the commission be subject to the control of member states .


### if the draft measures are not in accordance with the opinion of the committee , the commission shall not adopt those measures . the chairperson may submit to the committee the draft measures for further deliberation or submit an amended version of the draft measures . ### if the draft measures are not in accordance with the opinion of the committee , or if the committee does not deliver an opinion , the commission shall not adopt those measures . the chairperson may submit to the committee the draft measures for further deliberation or submit an amended version of the draft measures .


### the chairperson shall without delay submit the measures referred to in paragraph 2 to the relevant committee in order to obtain its opinion in accordance with the procedure provided for in the basic act . ### the chairperson shall immediately submit the measures referred to in paragraph 2 to the relevant committee in order to obtain its opinion , within one month , in accordance with the procedure provided for in the basic act .


### the summary records , together with the lists of the authorities and organisations to which the persons designated by the member states to represent them belong , ### the records , together with the lists of the authorities and organisations to which the persons designated by the member states to represent them belong ,


### 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 . they shall receive all information referred to in paragraph 1 at the same time and on the same terms as the committees .


### the protection to be ensured under the union civil protection mechanism should cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including acts of terrorism and technological , radiological and environmental accidents , marine pollution and acute health emergencies , occurring inside or outside the union . civil protection and other emergency assistance may be required in all of these disasters to complement the response capabilities of the affected country . ### the protection to be ensured under the union civil protection mechanism should cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including acts of terrorism and technological , radiological and environmental accidents , marine pollution and acute health emergencies , occurring inside or outside the union . civil protection and other emergency assistance may be required in all of these disasters to complement the response capabilities of the affected country and of its competent public authorities , including regional and local authorities , which are closest to dealing with the problems .


### other preparatory measures include pooling of information related to necessary medical resources and stimulating the use of new technologies . in accordance with article 346 of the treaty , no member state should be obliged to supply information the disclosure of which it considers contrary to the essential interests of its security . ### other preparatory measures include pooling of information related to necessary medical resources and stimulating the use of new technologies . in accordance with article 346 of the treaty on the functioning of the european union , no member state should be obliged to supply information the disclosure of which it considers contrary to the essential interests of its security .


### in order to improve the planning of disaster response operations and to ensure the availability of key capacities , it is necessary to develop reference scenarios for the main types of disasters , map key existing capacities available in member states , develop contingency plans for the deployment of the capacities and develop a european emergency response capacity in the form of a voluntary pool of pre - committed capacities of member states . the contingency planning exercise could also be used to determine whether there are gaps in the emergency response capacities available in the member states that may be filled with capacities to be developed with union support , which would be shared across the union . ### in order to improve the planning of disaster response operations and to ensure the availability of key capacities , it is necessary to develop reference scenarios for the main types of disasters , map key existing capacities available in member states and identify risks and define the measures needed to address them . the registration of risks can also be used to determine whether there are gaps in the emergency response capacities available in the member states .


### this decision shall not apply to the actions carried out under [ regulation no 1717 / 2006 ; regulation no 1257 / 96 ; regulation no 1406 / 2002 [ and union legislation concerning action programmes in the fields of health , home affairs , justice ] ### this decision shall not apply to the actions carried out under [ regulation no 1717 / 2006 ; regulation no 1257 / 96 ; regulation no 1406 / 2002 [ and union legislation concerning action programmes in the fields of health , home affairs , justice ] and other unrelated union legislation .


### promote and support the development and implementation of members states ' risk management plans including guidelines on their content and provide for adequate incentives , where needed ; ### support the development of member states ' risk lists and response measures including guidelines on their content ;


### in order to ensure an effective cooperation within the mechanism , members states shall communicate to the commission their risk management plans . ### in order to ensure an effective and coherent approach to disaster prevention and preparedness by sharing information and best practices within the union mechanism , members states shall make available to the commission the relevant non - sensitive elements of their risk assessments and their risk management plans no later than 2016 .


### risk management plans ### risk lists and response measures


### in the event of deployment , the capacities shall remain under member states’ command and direction . the coordination among the different capacities shall be ensured by the commission through the erc . the capacities shall remain available for the national purposes of member states when not deployed in operations under the mechanism . ### response capacities that member states make available for the european emergency response capacity shall remain available for national purposes of member states at all times .


### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . ### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . in case emergency measures require eradication , control or containment , the welfare of targeted and non - targeted animals should be taken into account . the competent authorities should take the necessary measures to avoid pain , distress and suffering of animals during the process , based insofar as possible on best practices in the field .


### in order to enable commercial operators , who may have legitimate expectations , for instance those who have received an authorisation in accordance with regulation no . 708 / 2007 , to exhaust their stock of invasive alien species of union concern when these new rules enter into force , it is justified to allow them two years to slaughter , sell or hand over the specimens to research or ex - situ conservation establishments . ### in order to enable commercial operators , who may have legitimate expectations , for instance those who have received an authorisation in accordance with regulation no . 708 / 2007 , to exhaust their stock of invasive alien species of union concern when these new rules enter into force , it is justified to allow them two years to humanely cull , sell or , where relevant , hand over the specimens to research or ex - situ conservation establishments .


### ‘ eradication’ means the complete and permanent removal of a population of invasive alien species by physical , chemical or biological means ; ### ‘ eradication’ means the complete and permanent removal of a population of invasive alien species by lethal or non - lethal physical , chemical or biological means ;


### ‘ management’ means any physical , chemical or biological action aimed at the eradication , population control or containment of a population of an invasive alien species ; ### ‘ management’ means any lethal or non - lethal physical , chemical or biological action aimed at the eradication , population control or containment of a population of an invasive alien species , while also avoiding impact on non - targeted species and their habitats ;


### ‘ population control’ means physical , chemical or biological actions applied to a population of invasive alien species with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised . ### ‘ population control’ means lethal or non - lethal physical , chemical or biological actions applied to a population of invasive alien species , while also avoiding impact on non - targeted species and their habitats , with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised .


### they are , having regard to scientific evidence available , found to be alien to the territory of the union excluding the outermost regions ; ### they are found , based on available scientific evidence , to be alien to the territory of the union excluding the outermost regions , or alien to one biogeographical region of the union but native to another ;


### a description of the current distribution of the species including whether the species is already present in the union or in neighbouring countries ; ### a description of the current distribution of the species including whether the species is already present in the union as a native or alien species or in neighbouring countries and a projection of its likely future distribution ;


### a description of the negative impact on biodiversity and ecosystem services , including on native species , protected sites , endangered habitats , on human health and the economy including an assessment of the magnitude of future impact ; ### a description , or estimation based on the best available scientific knowledge , of the negative impact on biodiversity and ecosystem services , including on native species , protected sites , endangered habitats , on human health and the economy including an assessment of the magnitude of future impact ;


### the activity is to be carried out by personnel possessing the scientific and technical qualifications prescribed by the competent authorities ; ### the activity is to be carried out by personnel possessing the scientific or technical qualifications prescribed by the competent authorities ;


### regulatory measures to ensure appropriate checks at the union borders , other than the official controls pursuant to article 13 ; ### ensure appropriate checks at the union borders , other than the official controls pursuant to article 13 ;


### member states shall develop guidelines and training programmes to facilitate the identification and detection of invasive alien species of union concern through cooperation between all authorities involved in the verifications referred to in paragraph 2 . the training programmes for custom authorities shall include information on filling the single administrative document on which the customs declaration is made . ### member states shall develop guidelines and training programmes to facilitate the identification and detection of invasive alien species of union concern and , to the extent possible , those of member state concern , through cooperation between all authorities involved in the verifications referred to in paragraph 2 . the training programmes for custom authorities shall include information on filling the single administrative document on which the customs declaration is made .


### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted animals are spared any avoidable pain , distress or suffering . ### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that both targeted and non - targeted animals are spared any avoidable pain , distress or suffering .


### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted animals are spared any avoidable pain , distress or suffering . ### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted and non - targeted animals are spared any avoidable pain , distress or suffering .


### applications for derogations shall be based on sound scientific evidence and only be submitted if the following conditions are met : ### applications for derogations shall be based on sound scientific evidence and only be submitted if at least one of the following conditions are met :


### by 12 months of an invasive alien species being included on the list referred to in article 4 at the latest , member states shall have in place management measures for those invasive alien species of union concern which the member states have found to be widely spread on their territory , so that their impacts on biodiversity and ecosystem services , human health and the economy are minimised . those management measures shall be based on an analysis of costs and benefits and also include the restoration measures referred to in article 18 . ### by 12 months of an invasive alien species being included on the list referred to in article 4 at the latest , member states shall have in place management measures for those invasive alien species of union concern which the member states have found to be widely spread on their territory , so that their impacts on biodiversity and ecosystem services , human health and the economy are minimised . those management measures shall include an analysis of costs and benefits and also the restoration measures referred to in article 18 .


### the management measures shall consist of physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species . where appropriate , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions . ### the management measures shall consist of lethal and non - lethal physical , chemical or biological actions aimed at the eradication , population control or containment of a population of an invasive alien species . where necessary , management measures shall include actions applied to the receiving ecosystem aimed at increasing its resilience to current and future invasions .


### the surveillance system provided for in article 12 shall be designed and used to monitor how effective eradication , population control or containment measures are in minimising the impacts on biodiversity and ecosystems services , human health or the economy . ### the surveillance system provided for in article 12 shall be designed and used to monitor how effective eradication , population control or containment measures are in minimising the impacts on biodiversity and ecosystems services , human health or the economy . monitoring should also assess the impact on non - targeted species and the welfare impact on targeted species .


### where there is a significant risk that an invasive alien species of union concern will spread to a neighbouring member state , the member states in which the species is widely spread shall immediately notify the neighbouring member states and the commission . where appropriate , the member states concerned shall establish jointly agreed management measures . in the cases where third countries may also be affected by the spread , the member state affected shall consider the need to inform the concerned third countries . ### where there is a significant risk that an invasive alien species of union concern will spread to a neighbouring member state , the member states in which the species is widely spread shall immediately notify the neighbouring member states and the commission . where appropriate , the member states concerned shall establish jointly agreed management measures . in the cases where third countries may also be affected by the spread , the member state affected shall inform the concerned third countries .


### the delegation of power referred to in article 5 shall be conferred on the commission for an undetermined period of time from the entry into force of this regulation . ### the delegation of power referred to in article 5 shall be conferred on the commission for a period of five years from [ the date of entry into force of this regulation ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### for non - commercial owners who cannot ensure that the conditions set out in paragraph 1 are met , member states shall offer to them the possibility of having their specimens taken over from them and shall give due regard to animal welfare when handling them . ### for non - commercial owners who cannot comply with the requirements in paragraph 1 , member states must remove the animals , ensuring that they are spared any avoidable pain , distress or suffering .


### developing smart distribution systems at low voltage levels ; ### developing smart distribution systems at low voltage levels including smart grids and intelligent buildings ;


### developing comprehensive , high quality and interoperable railway systems ; ### developing and reconstruction of comprehensive , high quality and interoperable public transport systems ;


### the internal market comprises an area without internal frontiers in which the free movement of goods , persons , services and capital must be ensured . to that end a comprehensive union type - approval system for motor vehicles is in place . the technical requirements for the type - approval of motor vehicles and their exhaust systems with regard to permissible sound levels should be harmonised to avoid the adoption of requirements that differ from one member state to another and to ensure the proper functioning of the internal market while , at the same time , providing for a high level of environmental protection and public safety . ### the internal market comprises an area without internal frontiers in which the free movement of goods , persons , services and capital must be ensured . to that end a comprehensive union type - approval system for motor vehicles is in place . the technical requirements for the type - approval of motor vehicles and their exhaust systems with regard to permissible sound levels should be harmonised to avoid the adoption of requirements that differ from one member state to another and to ensure the proper functioning of the internal market while , at the same time , providing for a high level of environmental protection and public safety . the commission should also undertake an impact assessment regarding the labelling conditions applicable to air and noise pollution levels . this impact assessment should take into consideration the different types of vehicles covered by this regulation as well as the effect that such labelling could have on the car industry . in fact , while such labelling could be considered a useful tool for raising awareness among consumers and protecting their rights as regards transparency prior to the purchase of a vehicle , it could seriously and adversely affect the car industry on cost grounds . the impact assessment should therefore evaluate the cost - effectiveness of this tool .


### this regulation should therefore introduce a different method in relation to the compulsory one of directive 70 / 157 / eec . that method should be based on the method published by the unece working party on noise in 2007 which incorporated a 2007 version of the standard iso 362 . the results of monitoring of both the old and the new test methods were submitted to the commission . ### this regulation should therefore introduce a different method in relation to the compulsory one of directive 70 / 157 / eec . that method should be based on the method published by the unece working party on noise in 2007 which incorporated a 2007 version of the standard iso 362 . the results of monitoring of both the old and the new test methods were submitted to the commission . furthermore , in order to overcome the shortcomings inherent in the previous test method , the commission should , within 24 months of the entry into force of this regulation , submit an impact assessment to the european parliament and to the council on the effective contribution of tyre rolling equipment in reducing the noise level of vehicles , focussing on the road surface impact , and the research needs in this specific field , in view of adopting a new european test method which also takes into account road surface behaviour .


### in order to enable the commission to replace the technical requirements of this regulation with a direct reference to unece regulations no 51 and no 59 once the limit values relating to the new test method are laid down in those regulations , or to adapt those requirements to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the amendment of the provisions in annexes to this regulation related to the test methods and sound levels . it is of particular importance that the commission carry out appropriate consultations during its preparatory work . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to enable the commission to adapt the technical requirements of this regulation to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend the annexes to this regulation related to eu type - approval procedures in respect of sound level of vehicle types and of exhaust systems , methods and instruments for measuring the noise made by motor vehicles , silencing systems , compressed air noise , checks on conformity of production , specifications for test sites , measuring methods for additional sound emission provisions , and measures ensuring the audibility of hybrid and electric vehicles . it is of particular importance that the commission carry out appropriate consultations during its preparatory work including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### ‘ 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 in accordance with 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 in accordance with 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 .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall complete a review of the noise limits in annex iii . the review shall include an impact assessment which includes an overall assessment of the impact on the car industry and its in particular its dependent industries , taking into account the influence of other regulations - such as those in the field of co2 emissions reductions and safety - on the sound level of motor vehicles . on the basis of such a review and its impact assessment , the commission shall , if appropriate , make a proposal to amend this regulation in a way that is as neutral as possible from the point of view of competition . the limit values referred to in annex iii , column 4 phase 2 , shall enter into force six years after confirmation of the impact assessment and completion of the review process of the commission .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### the commission shall carry out and publish a detailed study as soon as possible after the date referred to in annex iii , fourth column , phase 2 , to ascertain whether the noise limits for phase 3 prove to be appropriate . on the basis of the conclusions of the study , the commission shall , where appropriate , present proposals for amendment to this regulation . in the event of such amendment to this regulation , phase 3 shall apply as from four years after publication of the detailed study referred to in this subparagraph . the commission shall carry out and publish a detailed study as soon as possible after the date referred to in annex iii , fourth column , phase 3 , to ascertain whether the noise limits for phase 4 prove to be appropriate . on the basis of the conclusions of that study , the commission shall , where appropriate , present proposals for amendment to this regulation . in the event of such amendment to this regulation , phase 4 shall apply as from four years after publication of the detailed study referred to in this subparagraph .


### the commission shall be empowered to adopt delegated acts to amend annexes i to xi . ### the commission shall , in order to adapt the technical requirements of this regulation to technical and scientific developments , be empowered to adopt delegated acts in accordance with article 11 to amend annexes i to ii and iv to xii .


### the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in this article . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article .


### the delegation of power referred to in article 10 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal or at a later date specified therein . it shall not effect the validity of any delegated acts already in force . ### the delegation of power referred to in article 10 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not effect the validity of any delegated acts already in force .


### 2 . 2 . tyre rolling sound emissions are laid down in regulation no 661 / 2009 on the general safety of motor vehicles . the tyres to be used for the test shall be representative for the vehicle and shall be selected by the vehicle manufacturer and recorded in appendix 3 to annex i of this regulation . they shall correspond to one of the tyre sizes designated for the vehicle as original equipment . the tyre is or will be commercially available on the market at the same time as the vehicle . 2 / the tyres shall be inflated to the pressure recommended by the vehicle manufacturer for the test mass of the vehicle . the tyres shall have at least legal tread depth . ### 2 . 2 . tyre rolling sound emissions are laid down in regulation no 661 / 2009 on the general safety of motor vehicles . the tyres to be used for the test shall be representative for the vehicle and shall be selected by the vehicle manufacturer and recorded in appendix 3 to annex i of this regulation . they shall correspond to one of the tyre sizes designated for the vehicle as original equipment . the tyre is or will be commercially available on the market at the same time as the vehicle . 2 / the tyres shall be inflated to the pressure recommended by the vehicle manufacturer for the test mass of the vehicle . the tyres shall have a tread depth of at least 80 per cent of the full tread depth .


### 1 . 2 . 1 . 4 . 1 . vehicles with manual transmissions , automatic transmissions , adaptive transmissions or cvts tested with locked gear ratios the following conditions for selection of gear ratios are possible : if one specific gear ratio gives an acceleration in a tolerance band of &#61472 ; &#61617 ; 5 % of the reference acceleration awot ref , not exceeding 3 , 0 m / s2 , test with that gear ratio . if none of the gear ratios give the required acceleration , then choose a gear ratio i , with an acceleration higher and a gear ratio i + 1 , with an acceleration lower than the reference acceleration . if the acceleration value in gear ratio i does not exceed 3 , 0 m / s2 , use both gear ratios for the test . the weighting ratio in relation to the reference acceleration awot ref is calculated by : k = ) / - a wot ) if the acceleration value of gear ratio i exceeds 3 . 0 m / s2 , the first gear ratio shall be used that gives an acceleration below 3 . 0 m / s2 unless gear ratio i + 1 provides acceleration less than aurban . in this case , two gears , i and i + 1 shall be used , including the gear i with acceleration exceeding 3 . 0 m / s2 . in other cases , no other gear shall be used . the achieved acceleration awot test during the test shall be used for the calculation of the part power factor kp instead of awot ref . ### 1 . 2 . 1 . 4 . 1 . vehicles with manual transmissions , automatic transmissions , adaptive transmissions or cvts tested with locked gear ratios the following conditions for selection of gear ratios are possible : if one specific gear ratio gives an acceleration in a tolerance band of &#61472 ; &#61617 ; 5 % of the reference acceleration awot ref , not exceeding 2 , 0 m / s2 , test with that gear ratio . if none of the gear ratios give the required acceleration , then choose a gear ratio i , with an acceleration higher and a gear ratio i + 1 , with an acceleration lower than the reference acceleration . if the acceleration value in gear ratio i does not exceed 2 , 0 m / s2 , use both gear ratios for the test . the weighting ratio in relation to the reference acceleration awot ref is calculated by : k = ) / - a wot ) if the acceleration value of gear ratio i exceeds 2 . 0 m / s2 , the first gear ratio shall be used that gives an acceleration below 2 . 0 m / s2unless gear ratio i + 1 provides an acceleration less than aurban . in this case , two gears , i and i + 1 shall be used , including the gear i with the acceleration exceeding 2 . 0 m / s2 . in other cases , no other gear shall be used . the achieved acceleration awot test during the test shall be used for the calculation of the part power factor kp instead of awot ref .


### sampling and evaluation of the results one vehicle has to be chosen and subjected to the tests set out in point 2 . if the test results fulfil the cop requirements of annex x of directive 2007 / 46 / ec , the vehicle shall be considered to be in compliance with the cop provisions . ### sampling and evaluation of the results one vehicle has to be chosen and subjected to the tests set out in point 2 . if the test results fulfil the cop requirements of annex x of directive 2007 / 46 / ec , the vehicle shall be considered to be in compliance with the cop provisions . the applicable cop requirements are the limit values laid down in annex iii with an additional margin of 1 db .


### it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories and provided it is considered admissible , each member state should be responsible for the verification and certification of statements of support collected from citizens coming from that state . taking account of the need to limit the administrative burden for member states , they should , within a period of three months , carry out such verifications on the basis of appropriate checks and should issue a document certifying the number of valid statements of support received . ### it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories and provided it is considered admissible , each member state should be responsible for the verification and certification of statements of support collected from citizens coming from that state . taking account of the need to limit the administrative burden for member states , they should , within a period of five months , carry out such verifications on the basis of appropriate checks and should issue a document certifying the number of valid statements of support received .


### proposed citizens ' initiatives which can be reasonably regarded as improper because they are abusive or devoid of seriousness will not be registered . ### proposed citizens ' initiatives which can be reasonably regarded as improper because they are abusive or frivolous will not be registered .


### proposed citizens ' initiatives which can be reasonably regarded as improper because they are abusive or devoid of seriousness will not be registered . ### the commission shall register a proposed initiative within two months from its receipt when the following conditions are fulfilled : the citizens ' committee has been formed and the contact persons have been designated ; there are no manifest , significant inconsistencies between the different language versions of the title , subject - matter and objectives of the proposed initiative ; the initiative does not manifestly fall outside the scope of the commission’s power under the treaties to submit a proposal for the requested legal act ; the proposed initiative is not manifestly abusive , frivolous or vexatious ; the proposed initiative is in line with article 2 of the treaty on european union .


### the competent authorities shall , within a period that shall not exceed three months , verify the statements of support provided on the basis of appropriate checks , and deliver to the organiser a certificate in accordance with the model set out in annex vii , certifying the number of valid statements of support for that member state . ### the competent authorities shall , within a period that shall not exceed five months , verify the statements of support provided on the basis of appropriate checks , and deliver to the organiser a certificate in accordance with the model set out in annex vii , certifying the number of valid statements of support for that member state .


### in recognition of the disproportionate impacts on the smallest manufacturers resulting from the compliance with the specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of co2 reduction of the vehicles sold by these manufacturers , producers responsible annually for less than 500 new light commercial vehicles are excluded from the scope of the specific emissions target and the excess emissions premium . ### in recognition of the disproportionate impacts on the smallest manufacturers resulting from the compliance with the specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of co2 reduction of the vehicles sold by these manufacturers , producers responsible annually for less than 1000 new light commercial vehicles are excluded from the scope of the specific emissions target and the excess emissions premium .


### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ‘ food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' . with regard to this category , no successful conclusion could be reached on the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation . however , the undertaking made by the commission in directive 2009 / 39 / ec to meet the specific requirements of sportspeople should still apply , as supported by the publication of efsa scientific opinions on claims relevant to active individuals which justifies the review of general food law . ' food for persons suffering from carbohydrate metabolism disorders ' . in this regard , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , and foods for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , and foods for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### food for special medical purposes . ### food for special medical purposes , including formula intended for low birth - weight and pre - term infants .


### subject to the requirements of articles 7 and 9 and taking into account relevant technical and scientific progress , the commission shall update the delegated regulations mentioned in paragraph 2 in accordance with article 15 . ### subject to the requirements of articles 7 and 9 and taking into account relevant technical and scientific progress , which may be based on data provided by interested parties , the commission shall update the delegated regulations mentioned in paragraph 2 in accordance with article 15 .


### within three months of receipt of the draft standards , the commission shall decide whether to endorse the draft standards . the commission may extend that period by one month . the commission may endorse the draft standards only in part or with amendments where the community interest so requires . ### within three months of receipt of the draft standards , the commission shall decide whether to endorse , partially endorse , or reject the draft standards . the commission may extend that period by one month . the commission shall inform the european parliament and the council of its decision , stating the reason .


### consistent application of community rules where a competent authority has not correctly applied the legislation referred to in article 1 , in particular by failing to ensure that a financial institution satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article . ### breach of european union law where a competent authority has not correctly applied the legislation referred to in article 1 in a way which appears to be a breach of european union law , in particular by failing to ensure that a financial institution satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article .


### where the competent authority has not complied with community law within one month from receipt of the authority ' s recommendation , the commission may , after having been informed by the authority or on its own initiative , take a decision requiring the competent authority to take the action necessary to comply with community law . ### where the competent authority has not complied with community law within twenty working days from receipt of the authority ' s recommendation , the commission may , after having been informed by the authority or on its own initiative , issue a formal opinion requiring the competent authority to take the action necessary to comply with european union law . the commission ' s formal opinion shall take into account the authority ' s recommendation .


### the commission shall take such a decision no later than three months from the adoption of the recommendation . the commission may extend this period by one month . ### the commission shall issue such a formal opinion no later than one month from the adoption of the recommendation . the commission may extend this period by one month .


### decisions adopted under paragraph 3 shall prevail over any previous decision adopted by the competent authorities on the same matter . any action by the competent authorities in relation to facts which are subject to a decision pursuant to paragraph 2 or 3 shall be compatible with those decisions . ### deleted


### the authority shall participate as an observer in colleges of supervisors as it deems appropriate . for the purpose of that participation , it shall be considered a ' competent authority ' within the meaning of the relevant legislation and , at its request , shall receive all relevant information shared with any member of the college . ### the authority shall participate as an observer in colleges of supervisors as it deems appropriate for the european interest . for the purpose of that participation , it shall be considered a ' competent authority ' within the meaning of the relevant legislation and , at its request , shall receive all relevant information shared with any member of the college .


### without prejudice to the competences of the community institutions , the authority may develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries . ### the authority may develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries . these arrangements will not prevent member states and their competent authorities from concluding bilateral or multilateral arrangements with third countries .


### at the request of the authority , competent authorities and other public authorities of the member states shall provide the authority with all the necessary information to carry out the duties assigned to it by this regulation . ### at the request of the authority , competent authorities and other public authorities of the member states shall provide the authority with all the necessary information to carry out the duties assigned to it by this regulation , provided that the addressee has legal access to the relevant data , and provided that the request for information is proportionate in relation to the nature of the duty in question .


### for the purpose of consultation with stakeholders in areas relevant to the tasks of the authority , a banking stakeholder group shall be established . ### to help faciliate consultation with stakeholders in areas relevant to the tasks of the authority , a banking stakeholder group shall be established .


### for the purposes of article 11 , the board of supervisors shall convoke a panel to facilitate the settlement of the disagreement , consisting of the chairperson and two of its members , who are not representatives of the competent authorities which are parties to the disagreement . ### for the purposes of article 11 , the board of supervisors shall convoke a panel to facilitate the settlement of the disagreement , consisting of the chairperson , two members of the board of supervisors and two people drawn from an expert list that the chairperson shall maintain . no member of the panel from the board of supervisors shall be drawn from a national supervisory authority party to the disagreement , nor shall they have any interest in the conflict . the panel shall reach a decision by simple majority .


### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . ### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public provided such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets and will not have and adverse impact upon market liquidity or the commercial interests of market participants .


### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . ### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . the agency and national regulatory agencies should not publish contemporaneous market sensitive information .


### 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 .


### when the member state concerned definitively adopts the draft measure , it shall communicate the final text to the commission without delay . if observations have been made by the commission in accordance with paragraph 4 , this communication shall be accompanied by a report on the actions taken in response to the observations of the commission . ### when the member state concerned definitively adopts the draft measure , it should communicate the final text to the commission without delay .


### using alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , such as electric or hybrid engines for heavy - duty vehicles or buses generates extra weight which should not be counted at the expense of the effective load of the vehicle so that the road transport sector is not penalised in economic terms . ### using alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , such as electric or hybrid engines for heavy - duty vehicles or buses , helps the european union to attain energy independence and to achieve the objectives of the ' roadmap to a single european transport area – towards a competitive and resource efficient transport system ' white paper .


### before being put on the market , the additional aerodynamic devices and their installation on vehicles shall be authorised by the member states , which shall issue a certificate to this effect , attesting compliance with the requirements mentioned in paragraph 2 above and indicating that the device contributes significantly to improving aerodynamic performance . the certificates of authorisation issued in one member state shall be recognised by the other member states . ### before being put on the market , the additional aerodynamic devices and their installation on vehicles shall be authorised by the member states , which shall issue a certificate to this effect , attesting compliance with the requirements mentioned in paragraph 2 above and indicating that the device contributes significantly to improving aerodynamic performance . the certificates of authorisation issued in one member state shall be recognised by the other member states , subject to the limitations in paragraph 5 .


### the member states shall establish a system for pre - selecting and targeting checks on vehicles or combinations of vehicles in circulation , in order to ensure compliance with the requirements of this directive . ### the member states shall establish a system for pre - selecting and targeting checks on vehicles or combinations of vehicles in circulation , without discriminating on the basis of the nationality of drivers or transport entrepreneurs , in order to ensure compliance with the requirements of this directive .


### the power to adopt delegated acts referred to in article 8 , article 9 and article 12 shall be conferred on the commission for an indeterminate period of time from the [ date of entry into force of this directive ] ### the power to adopt delegated acts referred to in article 8 and article 9 shall be conferred on the commission for a maximum period of 5 years from the [ date of entry into force of this directive ]


### two - axle motor vehicles other than buses , and with hybrid or electric propulsion : 19 tonnes ### two - axle motor vehicles other than buses , and with hybrid or electric propulsion : 18 tonnes


### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in union , national and local rules , and to assess their interdependence with other environmental objectives , at the level of individual airports ; ### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in , national or local rules , and to assess their interdependence with other environmental objectives , at the level of individual airports ;