### directive 2009 / 39 / ec of the european parliament and of the council of 6 may 2009 on foodstuffs intended for particular nutritional uses lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended . the majority of the provisions laid down in that directive date back to 1977 and should therefore be reviewed . ### directive 2009 / 39 / ec of the european parliament and of the council of 6 may 2009 on foodstuffs intended for particular nutritional uses lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended . the majority of the provisions laid down in that directive date back to 1977 and fail to address the difficulty experienced by consumers in making an informed choice between dietetic foods , fortified foods , foods bearing claims and foods for normal consumption . the interaction between this legislation and eu provisions adopted more recently , such as directive 2002 / 46 / ec of the european parliament and the council of 10 june on the approximation of the laws of the member states relating to food supplements , regulation no 1924 / 2006 of the european parliament and the council of 20 december 2006 on nutrition and health claims made on foods and regulation no 1925 / 2006 of the european parliament and the council of 20 december 2006 on the addition of vitamins and minerals and other substances to food and regulation no 1169 / 2011 of the european parliament and of the council on the provision of food information to consumers , is a further factor making it necessary to thoroughly overhaul the directive .


### regulation no 178 / 2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law , establishing the european food safety authority and laying down procedures in matters of food safety establishes common principles and definitions for union food law in order to ensure a high level of health protection and the effective functioning of the internal market . it establishes the principles of risk analysis in relation to food and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the european food safety authority . therefore , certain definitions laid down in that regulation must also apply in the context of the present regulation . moreover , for the purpose of this regulation , the authority should be consulted on all matters likely to affect public health . ### regulation no 178 / 2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law , establishing the european food safety authority and laying down procedures in matters of food safety establishes common principles and definitions for union food law in order to ensure a high level of protection of public health and consumer interests , while allowing the effective functioning of the internal market . it establishes the principles of risk analysis in relation to food , sets out the precautionary principle as a provisional risk management measure and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the european food safety authority . therefore , certain definitions laid down in that regulation must also apply in the context of the present regulation . moreover , for the purpose of this regulation , the authority should be consulted on all matters likely to affect public health .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and food intended for use in energy - restricted diets and they are presently covered by provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec respectively . experience has shown that those provisions ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focus on the general compositional and information requirements for , infant formula and follow - on formulae , processed cereal based food and baby food for infants and young children and to food for special medical purposes and food intended for use in energy - restricted diets and that the specific compositional and information requirements for these categories of food should be laid down by the commission in delegated regulations adopted pursuant to this regulation , which take into account and replace directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and directive 96 / 8 / ec . the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of laying down the specific compositional and information requirements for the categories of food covered by this regulation , including additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and the authorisation of nutrition and health claims . 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 .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes . experience has shown that the provisions laid down in directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , regulation no 41 / 2009 , as well as directive 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , milk - based drinks intended for young children , food for special medical purposes , taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , directive 96 / 8 / ec and regulation no 41 / 2009 . in addition , the concept of ‘ specialised nutrition’ should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market using current union acts .


### it is important that ingredients used in the manufacture of the categories of food covered by this regulation are appropriate to satisfy the nutritional requirements of , and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data . such adequacy should be demonstrated through a systematic review of the available scientific data . ### it is important that ingredients used in the manufacture of the categories of food covered by this regulation are appropriate to satisfy the nutritional requirements of , and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data . such adequacy should be demonstrated through a systematic and independent review of the available scientific data .


### in the interests of efficiency and legislative simplification , there should be a medium - term examination of the question whether to extend the scope of the union list to other categories of food governed by other specific union legislation . ### in the interests of legislative simplification and a clear desire to support innovation , there should be a medium - term examination of the question whether to extend the scope of the union list to other categories of food governed by other specific union legislation . this extension may not take place without an evaluation by the authority and the intervention of the european parliament and the council as co - legislator .


### ' meal replacement for weight control ' and ' total diet replacement for weight control ' are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , such statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the health claims referring to the body weight control for food presented as ' total diet replacement for weight control ' and as ' meal replacement for weight control ' and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation . ### ' meal replacement for weight control ' and ' total diet replacement for weight control ' are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . against this background of the growing number of food products containing generic claims and the risk of disorders in dietary habits arising from certain unsupervised diets , the european food safety authority regularly carries out scientific assessments of health claim applications relating to meal replacement . the assessment carried out by the authority does not cover the safety of compositional criteria put forward by the operator applying for the use of a claim or certain labelling methods . it is therefore necessary to maintain specific provisions in this regulation on food for use in energy - restricted diets . this is an important nutrition and health safety tool for people seeking to lose weight .


### adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this regulation . ### the commission should take adequate measures to ensure legal certainty during the transition to the implementation of this regulation and provide the assistance and up - to - date information to the food business operators necessary to enable them to adapt to the requirements of this regulation .


### this regulation establishes compositional and information requirements for the following categories of food : ### this regulation , complementing eu legislation on foodstuffs , establishes compositional and information requirements for the following categories of food :


### this regulation provides the rules for the establishment and update of a union list of vitamins , minerals and other substances that can be added to the categories of food referred to in paragraph 1 . ### this regulation provides the rules for the establishment and update of a clearly defined union list of vitamins , minerals and other substances that can be added to the categories of food referred to in paragraph 1 for a specific nutritional purpose .


### the composition of food referred to in article 1 shall be such that it is appropriate to satisfy the nutritional needs of , and it is suitable for the persons to whom it is intended , in accordance with generally accepted scientific data . ### the composition of food referred to in article 1 shall be such that it is appropriate to satisfy the nutritional needs of , and it is suitable for the persons to whom it is intended , in accordance with generally accepted and independently evaluated scientific data and medical opinion .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , in particular the results of risk evaluations and the precautionary principle , the commission shall be empowered to adopt delegated regulations for foods covered under article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### 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 6a 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 , 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 , the results of new risk assessments and the precautionary principle , the commission shall update the delegated regulations mentioned in paragraph 2 of this article in accordance with article 15 .


### vitamins , minerals , amino acids and other substances may be added to food referred to in article 1 , provided that such substances meet the following conditions : they do not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer ; and b ) they are available for use by the human body . 2 . no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of implementing regulations . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified grounds of extreme urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14 . ### taking account of the provisions of directives 2006 / 141 / ec and 2006 / 125 / ec and regulation no 953 / 2009 , no later than [ 2 years after the date of entry into force of this regulation ] the commission shall establish a union list of vitamins , minerals and other substances which may be added to the types of food referred to in article 1 . that list shall be different for each category of food referred to in article 1 . 2 . only the substances included in the union list may be added to the types of food referred to in article 1 . 3 . vitamins , minerals , amino acids and other substances may be added to food referred to in article 1 , provided that such substances meet the following conditions : they do not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer ; and b ) they are available for use by the human body . 4 . the commission shall establish the union list by means of implementing regulations . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 .


### the entry of a substance in the union list referred to in paragraph 2 may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 4 . 4 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 5 . when a substance is already included in the union list and there is a significant change in the production methods , or there is a change in particle size , for example through nanotechnology , the substance prepared by those new methods shall be considered as different substance and the union list shall be modified accordingly before it can be placed on the union market . ### article 11a updating of the union list the entry of a substance in the union list may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 2 . 2 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 3 . where a substance is already included in the union list and there is a significant change in the production methods , the substance prepared by those new methods shall be considered as a different substance and shall be removed from the union list unless the union list is modified accordingly before it can be placed on the union market . 4 . if a substance that is on the union list no longer meets the conditions referred to in article 11 , the commission shall decide to remove that substance from the union list . 5 . the entry for a substance in the union list shall include : - a specification of the substance - where appropriate , a specification of the conditions of use , and - where appropriate , a specification of the applicable purity criteria . 6 . the commission shall update the union list by means of implementing regulations . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified imperative grounds of urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14


### general confidentiality clause 13 . the commission , the authority and the member states shall , in accordance with regulation no 1049 / 2001 , take the necessary measures to ensure appropriate confidentiality of the information received by them under this regulation , except for information which must be made public if circumstances so require in order to protect human health , animal health or the environment . ### general transparency and confidentiality clause 13 . the commission , the authority and the member states shall , in accordance with regulation no 1049 / 2001 , guarantee the broadest possible access to documents and , in particular , shall assist members of the public with and inform them about the procedures for submitting applications for access to documents . they shall also take the necessary measures to ensure appropriate confidentiality of the information received by them under this regulation , except for information which must be made public if circumstances so require in order to protect human health , animal health or the environment .


### the delegation of power referred to in articles 2 and 10 of this regulation shall be conferred for an indeterminate period of time from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ] ### the delegation of power referred to in articles 10 and 18a shall be conferred for a period of 5 years from the 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 .


### the delegation of power referred to in articles 2 and 10 of this regulation shall be conferred for an indeterminate period of time from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ] ### the power to adopt delegated acts referred to in articles 2 and 10 shall be conferred on the commission for a period of five years starting from the date of entry into force of this regulation . the commission shall submit a report on the delegation of power no later than six 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 .


### – maintaining the agricultural area in a state which makes it suitable for grazing or cultivation without any particular preparatory action going beyond traditional agricultural methods and machineries , or ### – maintaining the agricultural area in a state which makes it suitable for grazing or cultivation without any particular preparatory action going beyond traditional agricultural methods and machineries , as long as this refraining from the activities stated in the first indent of article 4 is based on the ground of resource efficiency or environmental objectives established by the member states , or


### – maintaining the agricultural area in a state which makes it suitable for grazing or cultivation without any particular preparatory action going beyond traditional agricultural methods and machineries , or ### – maintaining the agricultural area in a state which makes it suitable for grazing or cultivation without any particular preparatory action going beyond traditional annual agricultural methods and machineries , or


### no direct payments shall be granted to natural or legal persons , or to groups of natural or legal persons , where one of the following applies : the annual amount of direct payments is less than 5 % of the total receipts they obtained from non - agricultural activities in the most recent fiscal year ; or their agricultural areas are mainly areas naturally kept in a state suitable for grazing or cultivation and they do not carry out on those areas the minimum activity established by member states in accordance with article 4 . ### no direct payments shall be granted to natural or legal persons which are placed onto a ' negative list ' decided at eu level , identifying non - active farmers . the commission will establish objective and non - discriminatory criteria to ensure that no payment entitlement is allocated to a natural or legal person : - whose agricultural activities form only an insignificant part of its overall economic activities ; or - whose principal business or company objects do not consist of exercising an agricultural activity ; or - who does not bear the economic risk of the agricultural activity carried out on the land declared for the benefit of the direct payments . in addition , member states may define additional non - discriminative criteria at their discretion to exclude applicants who are economically marginally engaged in agricultural activities , which will be approved by the commission .


### as of claim year 2019 at the latest , all payment entitlements in a member state or , in case of application of article 20 , in a region , shall have a uniform unit value . ### as of claim year 2017 at the latest , all payment entitlements in a member state or , in case of application of article 20 , in a region , shall have a uniform unit value .


### any agricultural area of the holding that is used for an agricultural activity or , where the area is used as well for non - agricultural activities , predominantly used for agricultural activities ; or ### any agricultural area of the holding that is used for an agricultural activity or , where the area is used as well for non - agricultural activities , predominantly used for agricultural activities on the condition that the non - agricultural activities do not exceed a period 4 weeks in one calendar year and are not harmful for the environment ; or


### the european banking authority should act with a view to improving the functioning of the internal market , including in particular by ensuring a high , effective and consistent level of regulation and supervision taking account of the varying interests of all member states , to protect depositors and investors , to ensure the integrity , efficiency and orderly functioning of financial markets , to safeguard the stability of the financial system , and to strengthen international supervisory coordination , for the benefit of the economy at large , including financial institutions and other stakeholders , consumers and employees . in order to be able to fulfil its objectives , it is necessary and appropriate that the authority should be a community body having legal personality and it should have legal , administrative and financial autonomy . ### the european banking authority should act with a view to improving the functioning of the internal market , including in particular by ensuring a high , effective and consistent level of regulation and supervision taking account of the varying interests of all member states to prevent regulatory arbitrage and guarantee a level playing field , to protect depositors and investors , to ensure the integrity , efficiency and orderly functioning of financial markets , to safeguard the stability of the financial system , and to strengthen international supervisory coordination , for the benefit of the economy at large , while taking account of the need to enhance competition and innovation within the internal market and to ensure global competitiveness , including financial institutions and other stakeholders , consumers and employees . its tasks also include promoting supervisory convergence and providing advice to the eu institutions in the areas of banking , payments , e - money regulation and supervision , and related corporate governance , auditing and financial reporting issues . in order to be able to fulfil its objectives , it is necessary and appropriate that the authority should be a community body having legal personality and it should have legal , administrative and financial autonomy .


### ensuring the correct and full application of community law is a core prerequisite for the integrity , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the community . a mechanism should therefore be established whereby the authority addresses instances of incorrect or insufficient application of community law . this mechanism should apply in areas where community legislation defines clear and unconditional obligations . ### ensuring the correct and full application of european union law is a core prerequisite for the integrity , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the community . a mechanism should therefore be established whereby the authority addresses instances of non - application or incorrect application , which constitute a breach of european union law . this mechanism should apply in areas where european union legislation defines clear and unconditional obligations . it should in general not be used for cases concerning only the incorrect transposition of european union law .


### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant community legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned . ### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of the authority or in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant community legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned .


### close cooperation between the authority and the european systemic risk board is essential to give full effectiveness to the functioning of the european systemic risk board and the follow - up to its warnings and recommendations . the authority should share any relevant information with the european systemic risk board . data related to individual undertakings should be provided only upon reasoned request . upon receipt of warnings or recommendations addressed by the european systemic risk board to the authority or a national supervisory authority , the authority should ensure follow - up . ### close cooperation between the authority and the european systemic risk board is essential to give full effectiveness to the functioning of the european systemic risk board and the follow - up to its warnings and recommendations . the authority and the european systemic risk board should share any relevant information with the european systemic risk board . data related to individual undertakings should be provided only upon reasoned request . upon receipt of warnings or recommendations addressed by the european systemic risk board to the authority or a national supervisory authority , the authority should ensure follow - up as appropriate .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , trade unions , academics and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or by eu legislation .


### a full time chairperson , selected by the board of supervisors through an open competition , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote . ### a full time chairperson , selected by the european parliament following an open competition managed by the commission and the subsequent drawing up of a short list by the commission , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote .


### a full time chairperson , selected by the board of supervisors through an open competition , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote . ### a full time chairperson , appointed by the european parliament following an open selection procedure managed by the board of supervisors , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote .


### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely in a joint committee of european supervisory authorities and reach common positions where appropriate . the joint committee of european supervisory authorities should assume all of the functions of the joint committee on financial conglomerates . where relevant , acts also falling within the area of competence of the european insurance and occupational pensions authority or the european securities and markets authority should be adopted in parallel by the european supervisory authorities concerned . ### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely through the european supervisory authorities and reach common positions where appropriate . the joint committee should coordinate the functions of the three european supervisory authorities in relation to financial conglomerates . where relevant , acts also falling within the area of competence of the european supervisory authority or the european supervisory authority should be adopted in parallel by the european supervisory authorities concerned . the joint committee will be chaired on a yearly revolving basis by the chairpersons of the three european supervisory authorities . the chairperson of the joint committee should be a vice - chair of the european systemic risk board . the joint committee will have a permanent secretariat , staffed on secondment from the three european supervisory authorities , to allow for informal information sharing and the development of a common cultural approach across the three european supervisory authorities .


### it is essential that business secrets and other confidential information are protected . the confidentiality of information exchanged in the network should likewise be safeguarded . ### it is essential that commercially sensitive and other confidential information are protected . the confidentiality of information made available to the authority and exchanged in the network should be subject to rigorous and effective confidentiality rules .


### 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 the draft standards . the commission may extend that period by one month . in exceptional circumstances , the commission may endorse the draft standards only in part or with amendments where the european union interest so requires .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of the of financial markets or the stability of the whole or part of the financial system in the european union , the authority shall actively facilitate and , where deemed necessary , coordinate any actions undertaken by the relevant national competent supervisory authorities .


### . ### where the addressee of the decision refuses to comply with union law or a specific decision taken by the authority , the authority may issue proceedings in the national courts , including applications for interim relief .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation . ### where the esrb has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with this regulation and the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation .


### contribute to developing high quality and uniform supervisory standards , including reporting standards ; ### contribute to developing high quality and uniform supervisory standards , including reporting standards and taking into account the principle of proportionality ;


### the authority shall monitor and assess market developments in the area of its competence and , where necessary , inform the european insurance and occupational pensions authority , the european securities and markets authority , the esrb and the european parliament , the council and the commission about the relevant micro - prudential trends , potential risks and vulnerabilities . ### the authority shall monitor and assess market developments in the area of its competence and , where necessary , inform the european supervisory authority , the european supervisory authority , the esrb and the european parliament , the council and the commission about the relevant micro - prudential trends , potential risks and vulnerabilities .


### for the purpose of consultation with stakeholders in areas relevant to the tasks of the authority , a banking stakeholder group shall be established . ### for the purpose of consultation with stakeholders in areas relevant to the tasks of the authority , a banking stakeholder group shall be established . the stakeholder group shall be consulted on all relevant decisions and actions of the authority . if case of urgency immediate consultation is impossible , the stakeholder group has to be informed about the decision as quick as possible .


### the chairperson shall be appointed by the board of supervisors on the basis of merit , skills , knowledge of financial institutions and markets , and experience relevant to financial supervision and regulation , following an open selection procedure . ### the chairperson shall be appointed by the european parliament on the basis of merit , skills , knowledge of financial institutions and markets , and experience relevant to financial supervision and regulation , following an open selection procedure managed by the board of supervisors who shall select the three strongest candidates for consideration by the european parliament .


### the authority shall contribute adequate resources to the administrative support of the joint committee of european supervisory authorities . this includes staff , administrative , infrastructure , and operational expenses . ### the joint committee shall have a permanent secretariat , staffed on secondment from the three european supervisory authorities . the authority shall contribute adequate resources to administrative , infrastructure and operational expenses .


### the joint committee shall be composed of the chairperson and the chairpersons of the european insurance and occupational pensions authority and the european securities and markets authority , and , where applicable , the chairperson of a sub - committee established under article 43 . ### the joint committee shall have a board composed of the chairpersons of the european supervisory authorities , and , where applicable , the chairperson of a sub - committee established under article 43 .


### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets , which are dynamic and subject to change . the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . ### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets , which are dynamic and subject to change . the main elements of the definitions should be set out in this regulation . however , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . expertise could in particular be provided inter alia by experts from the agency for the cooperation of energy regulators , the committee of european securities regulators , the european networks of transmission system operators for gas and for electricity , the european securities and markets authority national regulatory authorities , national competition authorities , competent financial authorities in the member states and market participants . 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 and ensure that the european parliament and the council are closely involved in the preparatory phase and regularly invited to take part at the expert meetings .


### 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 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 may develop and maintain a methodology setting out how it will make this information available .


### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . ### it is important that the penalties for breaches of this regulation are proportionate , dissuasive and are harmonised across all member states to avoid a situation where those who breach this regulation move to the least severe member state , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . taking account of the consultation on the commission communication of . . . entitled ' reinforcing sanctioning regimes in the financial services sector ' the commission should bring forward proposals to further harmonise the penalties system of member states .


### for the purposes of applying the first subparagraph , information a reasonable market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas , as well as information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ### for the purposes of applying the first subparagraph , inside information means information : which is required to be made public in accordance with the provisions of regulation no 714 / 2009 , regulation no 715 / 2009 or this regulation , including guidelines , network codes or delegated acts adopted pursuant to those regulations , or in accordance with other legislative or regulatory provisions at european union level , in particular directive 2009 / 72 / ec and directive 2009 / 73 / ec ; or where no disclosure requirements exist under sub - paragraph a ) , which has not been made public and which , if it were made public , could significantly affect the prices of such wholesale energy products . such inside information only constitutes the following : information a reasonable professional market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products ; or information which is price - sensitive and precise information related to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas or lng - facility , as well as information which is routinely made available to the relevant wholesale energy market , or required to be disclosed in accordance with national legal or regulatory provisions , market rules , contracts or accepted market practices on the relevant wholesale energy market . for the purposes of applying the first subparagraph , information shall be deemed to be of a precise nature if it indicates a set of circumstances which exists or may reasonably be expected to come into existence or an event which has occurred or may reasonably be expected to do so and if it is specific enough to enable a conclusion to be drawn as to the possible effect of that set of circumstances or event on the prices of wholesale energy products .


### national regulatory authorities shall ensure that the prohibitions set out in articles 3 and 4 are applied . ### national regulatory authorities or designated authorities shall ensure that the prohibitions set out in articles 3 and 4 are applied .


### each member state shall ensure that national regulatory authorities have the investigatory powers necessary for the exercise of this function . these powers shall be exercised in a proportionate manner . these powers may be exercised : ### each member state shall ensure that national regulatory authorities or designated authorities have the investigatory powers necessary for the exercise of this function . these powers shall be exercised in a proportionate manner . these powers may be exercised :


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . minimum standards for penalties shall be laid down by 31 december 2012 with the aim of striving towards a fully harmonised penalties system . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them .


### this regulation should provide an enabling framework for programming , allowing enhanced consistency between union policies by using a joint framework document as a basis for programming . it should enable full alignment with partner countries and regions by relying , where appropriate , on national development plans or similar comprehensive development documents ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . ### this regulation should allow for enhanced consistency between union policies while respecting the overall requirement of policy coherence for development . it should enable full alignment with partner countries and regions by using , where possible , national development plans or similar comprehensive development documents as the basis for the programming of the union ' s action ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . it should enable structured annual meetings between representatives of national parliaments of member states and the european parliament to ensure consistency in the spending of development aid .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , empowerment of women , non - discrimination , democracy , good governance , the promotion of peace and the prevention of violent conflict , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , decent work , environmental sustainability including addressing climate change and combating hiv / aids .


### due to diversity of national measures managing the consumption of medicines , regulating their prices or establishing the conditions of their public funding it is necessary to clarify directive 89 / 105 / eec . in particular this directive should cover all types of measures devised by member states and susceptible to impact the internal market . since the adoption of directive 89 / 105 / eec , the pricing and reimbursement procedures have evolved and have become more complex . while some member states have interpreted the scope of directive 89 / 105 / eec restrictively , the court of justice ruled that those pricing and reimbursement procedures fall within the scope of directive 89 / 105 / eec given the objectives of that directive and the need to ensure its effectiveness . therefore , this directive should reflect the developments in national pricing and reimbursement policies . given that specific rules and procedures exist in the area of public procurement and voluntary contractual agreements , national measures involving public procurement and voluntary contractual agreements should be excluded from the scope of this directive . ### due to diversity of national measures managing the consumption of medicines , regulating their prices or establishing the conditions of their public funding it is necessary to clarify directive 89 / 105 / eec . in particular this directive should cover all types of measures devised by member states and susceptible to impact the internal market . since the adoption of directive 89 / 105 / eec , the pricing and reimbursement procedures have evolved and have become more complex . while some member states have interpreted the scope of directive 89 / 105 / eec restrictively , the court of justice ruled that those pricing and reimbursement procedures fall within the scope of directive 89 / 105 / eec given the objectives of that directive and the need to ensure its effectiveness . therefore , this directive should reflect the developments in national pricing and reimbursement policies . in addition to measures of direct and indirect pricing policies in accordance with objective criteria subject to evaluation , price transparency should be ensured . a distortion of competition can only be avoided through price transparency . distorting effects in the perception of prices created by different decision making procedures in the member states for pricing and reimbursement between manufacturer and insurance carrier can be averted by more transparency of pricing methods . improved transparency on prices leads to cost - effectiveness and cost - efficiency , as intended by this directive . that again means cost savings for health systems .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 . ### where , following the selection procedure laid down in articles 7 to 10 , any supplier of groundhandling services , including self - handling airport users , mentioned in paragraph 1 is replaced by one or more supplier , member states may require suppliers of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 . ### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services or a supplier ceases to provide an airport user with groundhandling services that represent a significant part of its groundhandling service , or an airport user that provides its own groundhandling services decides to cease such services , member states shall require supplier of groundhandling services or airport users that provide their own groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec . a significant part as referred to in the first sentence of subparagraph 1 above always applies if more than 5 % of its groundhandling services are affected . article 4 , second sentence , of directive 2001 / 23 / ec shall not apply to the cases outlined in the first sentence of subparagraph 1 of this paragraph . dismissal on economic , technical or organisational grounds shall not be permitted .


### member states shall limit the requirement in paragraph to the employees of the previous supplier who are involved in the provision of services for which the previous supplier lost authorisation , and who voluntarily accept to be taken on by the new supplier . ### member states shall limit the requirement in paragraph to the employees of the previous supplier , including self handling airport users , who are involved in the provision of groundhandling services that the previous supplier stops providing , and who voluntarily accept to be taken on by the new supplier or self - handling airport user .


### an undertaking applying for an approval shall demonstrate that its employees have the qualification , professional experience and length of service necessary for the performance of the activity it applies for . ### an undertaking applying for an approval shall demonstrate that its employees have the qualification , professional experience and length of service necessary for the performance of the activity for which it has applied .


### suppliers of groundhandling services and self - handling airport users shall ensure that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , regularly attend specific and recurrent training to enable them to perform the tasks assigned to them . ### suppliers of groundhandling services and self - handling airport users shall ensure that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , attend at least two days of initial training when taking up a new job , and subsequent specific and recurrent training to enable them to perform the tasks assigned to them . this training must meet minimum european standards and be relevant to the specific tasks to which the employee is assigned .


### technological developments include the possibility of attaching retractable or foldable aerodynamic devices to the rear of vehicles , mainly trailers or semi - trailers , but which then exceed the maximum lengths allowed under directive 96 / 53 / ec . this equipment may be installed as soon as this directive enters into force , as the products are available on the market and already used in other continents . ### technological developments include the possibility of attaching retractable or foldable aerodynamic devices to the rear of vehicles , mainly trailers or semi - trailers , but which then exceed the maximum lengths allowed under directive 96 / 53 / ec . this equipment may be installed as soon as the appropriate requirements are laid down at the european level , as the products are available on the market and already used in other continents .


### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the driver’s vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . __________________ 7 com 389 8 com 258 ### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the driver’s vision , including under the windscreen and to the side of the vehicle , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile should also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . __________________ 7 com 389 8 com 258


### in its policy orientations on road safety 2011 - 2020 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers’ vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . ### in its policy orientations on road safety 2011 - 2020 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers’ vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . the new cab profile should therefore , after an appropriate transitional period , become mandatory . this new profile should also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety .


### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission ' s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers ' vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver ' s comfort and safety . __________________ 7 com 389 8 com 258 ### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission ' s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers ' vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . the new cab profile should therefore , after appropriate transitional period , become mandatory . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver ' s comfort and safety . __________________ 7 com 389 8 com 258


### aerodynamic devices and their installation in vehicles must be tested before being put on the market . to this end , member states are to issue certificates that will be recognised by other member states . ### aerodynamic devices and their installation in vehicles must be tested , in accordance with the test procedure for measurement of aerodynamic performance being developed by the european commission , before being put on the market . to this end , member states are to issue certificates that will be recognised by other member states . the commission should develop detailed technical guidelines on the application and requirements for certificates .


### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component does not exceed 300 km for operations involving a rail , river or sea component . this distance appeared sufficient to link an industrial or commercial site with a freight terminal or a river port . to link a seaport and support the development of motorways of the sea , a longer distance is possible for a short intra - european maritime transport operation . ### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate combined transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . this increase should however be authorised only for combined transport in which the road component does not exceed the distance to or from the nearest transshipment station for operations involving a rail component or 150 km from the river port or seaport of transshipment for operations involving a river or sea component .


### the authorities responsible for enforcing road transport - related requirements note a high number of infringements , sometimes serious , particularly in relation to the weight of transport vehicles . this situation stems from the insufficient number of checks conducted under directive 96 / 53 / ec , or from their inefficiency . furthermore , the procedures and rules for checks differ between member states , creating legal uncertainty for drivers of vehicles operating in several member states of the union . furthermore , transporters that do not comply with the relevant rules enjoy a significant competitive advantage over competitors that do comply with the rules , and over other modes of transport . this situation constitutes an obstacle to the proper functioning of the internal market . it is therefore important that member states increase the pace of checks carried out , both the manual checks and the pre - selections for manual checks . ### the authorities responsible for enforcing road transport - related requirements note a high number of infringements , sometimes serious , particularly in relation to the weight of transport vehicles . this situation stems from the insufficient number of checks conducted under directive 96 / 53 / ec , or from their inefficiency . furthermore , the procedures and rules for checks differ between member states , creating legal uncertainty for drivers of vehicles operating in several member states of the union . furthermore , transporters that do not comply with the relevant rules enjoy a significant competitive advantage over competitors that do comply with the rules , and over other modes of transport . this situation constitutes an obstacle to the proper functioning of the internal market and a risk to road safety . it is therefore important that member states increase the pace and efficiency of checks carried out , both the manual checks and the pre - selections for manual checks , based on a risk - rating system .


### the observation of a high number of infringements of the provisions of directive 96 / 53 / ec is to a large extent due to the non - deterrent level of penalties prescribed by member states’ legislation for violations of these rules , or even the absence of any such penalties . this weak point is further compounded by the wide variety in the levels of administrative penalties applicable in the different member states . to remedy these weak points , the levels and categories of administrative penalties for infringements of directive 96 / 53 / ec should be approximated at union level . these administrative penalties should be effective , proportionate and dissuasive . ### the observation of a high number of infringements of the provisions of directive 96 / 53 / ec is to a large extent due to the non - deterrent level of penalties prescribed by member states’ legislation for violations of these rules , or even the absence of any such penalties . this weak point is further compounded by the wide variety in the levels of administrative penalties applicable in the different member states . to remedy these weak points , the levels and categories of administrative penalties for infringements of directive 96 / 53 / ec should be approximated at union level . these administrative penalties should be effective , proportionate , dissuasive and non - discriminatory .


### the exceedances of maximum lengths do not increase the capacity of vehicles or combinations of vehicles . ### the exceedances of maximum lengths do not increase the load capacity of vehicles or combinations of vehicles .


### before they are put on the market , the aerodynamic performance of new motor vehicle designs shall be tested by member states , who will issue a certificate to this end . this will certify compliance with the requirements of paragraph 2 above . the test certificates issued in one member state shall be recognised by the other member states . ### before they are put on the market , the aerodynamic and safety performance of new motor vehicle designs shall be tested within the framework of directive 2007 / 46 / ec by member states , who will issue a certificate to this end . this will certify compliance with the requirements of paragraph 2 above . the test certificates issued in one member state shall be recognised by the other member states .


### the maximum weights of vehicles with hybrid propulsion or fully electric propulsion shall be those set out in annex i , point 2 . 3 . 1 . ### the maximum weights of alternatively fuelled vehicles shall be those set out in point 2 . 3 . 4 of annex i .


### the vehicles with hybrid or electric propulsion must however comply with the limits set out in annex i point 3 : maximum authorized axle weight . ### alternatively fuelled vehicles must however comply with the limits set out in point 3 of annex i : maximum authorised axle weight .


### 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 risk - rating system for pre - selecting and targeting checks on vehicles or combinations of vehicles in circulation , in order to ensure compliance with the requirements , in particular requirements laid down under article 4a , of this directive .


### an overload of less than 5 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for this type of penalty ; ### an overload of less than 2 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for this type of penalty .


### an overload of between 5 and 10 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered as a minor offence within the meaning of this directive , and shall give rise to a financial penalty . the inspection authorities may also immobilise the vehicle for unloading until it reaches the maximum authorised weight ; ### an overload of between 2 % and 10 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered as a minor offence within the meaning of this directive , and shall give rise to a financial penalty . the inspection authorities may also immobilise the vehicle for unloading until it reaches the maximum authorised weight .


### an overload of between 10 and 20 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a serious infringement within the meaning of this directive . it shall give rise to a financial penalty and the immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight , ### an overload of between 10 and 15 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a serious infringement within the meaning of this directive . it shall give rise to a financial penalty and the immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight ,


### an overload of more than 20 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . this shall give rise to an immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight , and to a financial penalty . the procedure leading to the loss of good repute of the transport company shall be implemented in accordance with article 6 of regulation no 1071 / 200914 , __________________ 14 oj l300 , 14 . 11 . 2009 , p . 51 . ### an overload of more than 15 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . this shall give rise to an immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight , and to a financial penalty . the procedure leading to the loss of good repute of the transport company shall be implemented in accordance with article 6 of regulation no 1071 / 200914 , __________________ 14 oj l300 , 14 . 11 . 2009 , p . 51 .


### an excess length or excess width of less than 2% of the maximum dimensions indicated in point 1of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for such a penalty . ### an excess length or excess width of less than 1 % of the maximum dimensions indicated in point 1of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for such a penalty .


### an excess length or excess width of between 2 and 20% of the maximum dimensions indicated in point 1 of annex 1 , either of the load on board or of the vehicle itself , shall give rise a financial penalty . the inspection authorities shall immobilise the vehicle until its unloading if the excess length or excess width comes from the load or until the transport company obtains a special permit in accordance with article 4 ; ### an excess length or excess width of between 1 and 10% of the maximum dimensions indicated in point 1 of annex 1 , either of the load on board or of the vehicle itself , shall give rise a financial penalty for the haulier . the inspection authorities shall immobilise the vehicle until its unloading if the excess length or excess width comes from the load or until the transport company obtains a special permit in accordance with article 4 ;


### an excess length or excess width of between 2 and 20% of the maximum dimensions indicated in point 1 of annex 1 , either of the load on board or of the vehicle itself , shall give rise a financial penalty . the inspection authorities shall immobilise the vehicle until its unloading if the excess length or excess width comes from the load or until the transport company obtains a special permit in accordance with article 4 ; ### an excess length or excess width of between 1 % and 10 % of the maximum dimensions indicated in point 1 of annex 1 , either of the load on board or of the vehicle itself , shall give rise a financial penalty . the inspection authorities shall immobilise the vehicle until its unloading if the excess length or excess width comes from the load or until the transport company obtains a special permit in accordance with article 4 .


### an excess length or excess width of the load or of the vehicle of more than 20% of the maximum dimensions indicated in point 1 of annex 1 shall be considered as a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . it shall give rise to a financial penalty and to the immediate immobilisation of the vehicle by the inspection authorities , until its unloading or until the transport company obtains a special permit in accordance with article 4 , if the excess length or excess width comes from the load . the procedure leading to the loss of good repute of the transport company shall be implemented in accordance with article 6 of regulation no 1071 / 2009 . ### an excess length or excess width of the load or of the vehicle of more than 10% of the maximum dimensions indicated in point 1 of annex 1 shall be considered as a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . it shall give rise to a financial penalty for the haulier and to the immediate immobilisation of the vehicle by the inspection authorities , until its unloading or until the transport company obtains a special permit in accordance with article 4 , if the excess length or excess width comes from the load . the procedure leading to the loss of good repute of the transport company shall be implemented in accordance with article 6 of regulation no 1071 / 2009 .


### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container a statement indicating the weight of the container moved . if this information is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . ### for the transport of freight , including containers , swap bodies or any other loads , the shipper shall give the road haulier to whom it entrusts the transport of a container , in advance of loading , a written statement indicating the gross weight of the load moved . that statement can also be submitted by electronic means . irrespective of its form , the document declaring the gross weight of the load shall be signed by a person duly authorised by the shipper . if the information on the gross weight of the load is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . in intermodal transport operations , the information on the gross weight of a packed intermodal loading unit , including container and / or swap body , shall be provided to the next party taking custody of the intermodal loading unit .


### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container a statement indicating the weight of the container moved . if this information is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . ### for the transport of freight , including containers , swap bodies or any other loads , the shipper shall give the road haulier to whom it entrusts the transport of a container a written statement indicating the gross weight of the container moved . that statement can also be submitted by electronic means . irrespective of its form , the document declaring the gross weight of the load shall be signed by a person duly authorised by the shipper . if the information on the gross weight of the load is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . in intermodal transport operations , the information on the gross weight of a packed intermodal loading unit , including container and / or swap body , shall be provided to the next party taking custody of the intermodal loading unit .


### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container a statement indicating the weight of the container moved . if this information is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . ### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container , in advance of loading , a written statement indicating the gross weight of the container moved . that statement can also be submitted by electronic means . irrespective of its form , the document declaring the gross weight of the container shall be signed by a person duly authorised by the shipper . if the information on the gross weight of the container is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . in combined transport operations , the information on the gross weight of a packed container shall be provided to the next party taking custody of the container .


### 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 , article 9 and article 12 shall be conferred on the commission for a period of five years from [ the date of entry into force of this directive ] . 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 .


### in order to reflect the continuous technological progress in engine and airframe technologies and the methods used to map noise contours , 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 with respect to regularly updating the noise standards for aircraft referred to in this regulation and the reference to the associated certification methods ; amending the definitions of marginally compliant aircraft and of civil aircraft accordingly , and updating the reference to the method to computing noise contours . it is particularly important 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 council . ### in order to reflect the continuous technological progress and the methods used to map noise contours , 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 with respect to regularly updating the method and technical report relating to the assessment of the noise situation at an airport . it is particularly important 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 council .


### the member states shall notify the commission of the names and addresses of the designated competent authorities and appeal body referred to in paragraph 1 . ### the member states shall notify the commission in a timely manner of the names and addresses of the designated competent authorities and appeal body referred to in paragraph 1 .


### member states shall adopt a balanced approach in regard to aircraft noise management . to this end , they shall : ### member states shall implement the balanced approach in regard to aircraft noise management , on an airport - to - airport basis , within the scope of this regulation . to this end , they shall asses the noise situation at an individual airport in accordance with annex ii of directive 2002 / 49 . where the noise problem is identified , they shall :


### evaluate the likely cost - effectiveness of the available measures ; ### carry - out a formal and comprehensive assessment of the likely cost - effectiveness of the available measures ;


### before introducing an operating restriction , the competent authorities shall give notice of six months , ending at least two months prior to the determination of the slot coordination parameters as defined in article 2 , point m ) of council regulation eec n&#176 ; 95 / 93 for the airport concerned for the relevant scheduling period , to the member states , the commission and the relevant interested parties . ### the competent authorities shall give notice to the member states , the commission and the relevant interested parties six months before introducing any operating restriction .


### following the assessment carried out in accordance with article 5 , the notification of the decision shall be accompanied by a written report explaining the reasons for introducing the operating restriction , the environmental objective established for the airport , the measures that were considered to meet that objective , and the evaluation of the likely cost - effectiveness of the various measures considered , including , where relevant , their cross - border impact . ### following the assessment carried out in accordance with article 5 , the notification of the decision shall be accompanied by a written report explaining the reasons for introducing the operating restriction , the environmental objective established for the airport , the measures that were considered to meet that objective , and the evaluation of the likely overall efficiency of the various measures considered , including , where relevant , their cross - border impact .