### 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 .


### 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 : ### vitamins , minerals , amino acids and other substances belonging to the categories defined by the implementing acts adopted pursuant to article 11 may be added to food referred to in article 1 , provided that such substances meet the following conditions :


### 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 , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , as well as commission 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 , food for special medical purposes , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec . 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 .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### paragraph 3 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine , nutrition and pharmacy or other professionals responsible for maternal and child health care .


### 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 foods for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , and commission regulation 41 / 2009 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 , food for special medical purposes , and foods for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec commission directive 1999 / 21 / ec , and commission regulation no 41 / 2009 .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , food intended for weight reduction and control , and food intended to meet expenditure of intense muscular effort , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### proposal for a regulation of the european parliament and of the council on food intended for infants and young children and on food for special medical purposes ### proposal for a regulation of the european parliament and of the council on food intended for infants and young children , on food for special medical purposes and on foodstuffs for people intolerant to gluten


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


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


### 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 financial markets or the stability of the whole or part of the financial system in the community , the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law , including the cessation of any practice . ### deleted


### the objective of the authority shall be to contribute to : improving the functioning of the internal market , including in particular a high , effective and consistent level of regulation and supervision , protecting depositors and investors , ensuring the integrity , efficiency and orderly functioning of financial markets , safeguarding the stability of the financial system , and strengthening international supervisory coordination . for this purpose , the authority shall contribute to ensuring the consistent , efficient and effective application of the community law referred to in article 1 above , fostering supervisory convergence and providing opinions to the european parliament , the council , and the commission . ### the objective of the authority shall be to contribute to : improving the functioning of the internal market , including in particular a high , effective and consistent level of regulation and supervision , protecting depositors and investors , ensuring the integrity , efficiency and orderly functioning of financial markets , safeguarding the stability of the financial system , and strengthening international supervisory coordination . for this purpose , the authority shall contribute to ensuring the consistent , efficient and effective application of the community law referred to in article 1 above , fostering supervisory convergence and providing opinions to the european parliament , the council , and the commission and undertaking economic analysis of markets to promote the achievement of the authority ' s objectives . it shall have regard to internationally agreed standards and practices .


### before submitting them to the commission , the authority shall , where appropriate , conduct open public consultations on technical standards and analyse the potential related costs and benefits . ### the authority shall conduct open public consultations on technical standards and analyse the potential related costs and benefits before adopting draft technical standards . the authority shall also request an opinion or advice of the banking stakeholder group referred to in article 22 .


### where the national authority does not comply with the recommendation , the commission should be empowered to address a decision to the national supervisory authority concerned in order to ensure compliance with community law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 226 of the treaty . ### where the national authority does not comply with the recommendation within a deadline fixed by the authority , the authority should address a decision without delay to the national supervisory authority concerned in order to ensure compliance with eu law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 258 of the treaty .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority referred to in paragraph 2 within the period laid down therein , the authority may , where the relevant requirements laid down in the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under that legislation , including the cessation of any practice . ### deleted


### the board of appeal shall be composed of six members and six alternates , who shall be individuals with relevant knowledge and experience , excluding current staff of the competent authorities or other national or community institutions involved in the activities of the authority . ### the board of appeal shall be composed of six members and six alternates . it shall comprise individuals of high repute with a proven record of relevant knowledge and professional expertise , including supervisory experience at a sufficiently high level in the fields of banking insurance and occupational pensions , securities markets or other financial services , and at least two members with sufficient legal expertise to provide expert legal advice on the authority ' s exercise of its powers .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority shall , pursuant to the legislation referred to in article 1 , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice .


### the management board shall be composed of the chairperson , a representative of the commission , and four members elected by the board of supervisors from among its members . ### the management board shall be composed of the chairperson and four members elected by the board of supervisors from among its voting members .


### the authority shall ensure that no decision adopted under articles 10 or 11 impinges in any way on the fiscal responsibilities of member states . ### the authority shall ensure that no decision adopted under articles 10 , 11 or 12a impinges in any way on the fiscal responsibilities of member states .


### the management board shall be composed of the chairperson , a representative of the commission , and four members elected by the board of supervisors from among its members . ### the management board shall be composed of six members : the chairperson , a representative of the commission , and four members elected by the board of supervisors from among its voting members .


### 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 existence of an emergency situation is declared pursuant to paragraph 1 , the authority may adopt decisions addressed to the competent authorities of member states requiring them 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 .


### two members of the board of appeal and two alternates shall be appointed by the management board of the authority from a short - list proposed by the commission , following a public call for expression of interest published in the official journal of the european union , and after consultation of the board of supervisors . ### the members of the board of appeal and their alternates shall be appointed by the european parliament from a short - list proposed by the commission , following a public call for expression of interest published in the official journal of the european union , and after consultation of the board of supervisors . it shall include at least one member representing a consumer organisation , one member representing smes and one member representing the research community . the latter as well as his alternate shall be appointed by the banking stakeholder group .


### given the globalisation of financial services and the increased importance of international standards , the authority should foster the dialogue and cooperation with supervisors outside the community . it shall fully respect the existing roles and competences of the european institutions in relations with authorities outside the community and in international forums . ### given the globalisation of financial services and the increased importance of international standards , the authority should foster the dialogue and cooperation with supervisors outside the union . it shall fully respect the existing roles and competences of the member states and european institutions in relations with authorities outside the community and in international forums .


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


### without prejudice to the competences of the community institutions , the authority may develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries . ### the authority shall develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries .


### where the authority maintains its decision , the council , acting by qualified majority as defined in article 205 of the treaty , shall , within two months , decide whether the authority ' s decision is maintained or revoked . ### where the authority maintains its decision , the council shall take a decision by a majority of the votes cast , at one of its meetings at the latest two months after the authority has informed the member state as set out in the previous subparagraph , as to whether the authority ' s decision is maintained .


### contribute to developing high quality and uniform supervisory standards , including reporting standards ; ### contribute to developing high quality and uniform supervisory standards , including global accounting and reporting standards ;


### serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the community require a swift and concerted response at community level . the authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation . as the determination of an emergency situation involves a significant degree of discretion , this power should be conferred on the commission . to ensure an effective response to the emergency situation , in the event of inaction by the competent national supervisory authorities , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of community law directly applicable to them aimed at mitigating the effects of the crisis and restoring confidence in the markets . ### serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the union require a swift and concerted response at union level . the authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation . the european systemic risk board should establish when there is an emergency situation . to ensure an effective response to the emergency situation , in the event of inaction by the competent national supervisory authorities , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of union law directly applicable to them aimed at mitigating the effects of the crisis and restoring confidence in the markets .


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


### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and , where appropriate , defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported . ### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . based on stakeholder consultation and a duly carried out impact assessment , the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and , where appropriate , defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported . the delegated acts shall : specify the wholesale energy products for which transactions shall be reported ; specify the content of the information to be reported which shall at least include the precise identification of the wholesale energy products bought and sold , the price and quantity agreed , the dates and times of execution , the parties to the transaction and the beneficiaries of the transaction ; lay down the timing and form in which this information shall be reported ; define appropriate thresholds for the reporting of transactions .


### ' inside information ' means precise information which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , could significantly affect the prices of such wholesale energy products ; 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 . ### ' inside information ' means information of a precise nature which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , could significantly affect the prices of such wholesale energy products ; 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 of the european parliament and of the council of 13 july 2009 concerning common rules for the internal market in electricity1 , and directive 2009 / 73 / ec of the european parliament and of the council of 13 july 2009 concerning common rules for the internal market in natural gas2 ; or a reasonable market participant would be likely to use as part of the basis of his decision to enter into transaction relating to a wholesale energy product , and 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 updated estimates of energy reserves , 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 legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ______________ 1 oj l 211 , 14 . 8 . 2009 , p . 55 . 2 oj l 211 , 14 . 8 . 2009 , p . 94 .


### the commission shall seek regular exchanges of information with civil society . ### the commission shall ensure regular exchanges of information with civil society organisations and with local authorities , and ensure that those actors are appropriately involved in the process of designing , implementing , monitoring and evaluating union support .


### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty and hunger , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation . ### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty and hunger , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation . the union ' s policy and international action is also guided by its international commitments and obligations concerning human rights and development , including the universal declaration on human rights , the international covenant on civil and political rights , the international covenant on economic , social and cultural rights , the convention on the elimination of all forms of discrimination against women , the united nations convention on the rights of the child , and the un declaration on the right to development .


### funds may be left unallocated . subject to their subsequent allocation or re - allocation as provided for in articles 11 and 13 , the use of these funds shall be decided later in accordance with the common implementing regulation . ### in order to ensure an appropriate union response in the event of unforeseen circumstances , as well as to allow for the synchronisation with partner countries strategy cycles and the modification of indicative allocations as a result of reviews , funds may be left unallocated . in crisis , post - crisis and fragility situations , these funds shall be primarily used in support of a specific strategy to ensure a smooth transition from emergency aid to long - term development . at the level of the instrument , the part of funds left unallocated shall not exceed 5 % . within multiannual indicative programmes , the part of funds left unallocated shall not exceed 5 % , except for the purpose of synchronisation . the subsequent allocation and reallocation shall be decided later in accordance with article 11 , article 13 , and article 14 .


### funds may be left unallocated . subject to their subsequent allocation or re - allocation as provided for in articles 11 and 13 , the use of these funds shall be decided later in accordance with the common implementing regulation . ### in order to ensure an appropriate union response in the event of unforeseen circumstances , as well as to allow for the synchronisation with partner countries strategy cycles and the modification of indicative allocations as a result of reviews , funds may be left unallocated . in crisis , post - crisis and fragility situations , these funds shall be primarily used in support of a specific strategy to ensure a smooth transition from emergency aid to long - term development and targeted at the most vulnerable populations , especially children , the elderly , women and young people .


### 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 . given that specific rules and procedures exist in the area of public procurement , national measures involving public procurement should be excluded from the scope of this directive .


### where appropriate , member states shall simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned , if knowledge of such texts is necessary to assess the implications of the measure proposed . ### where appropriate , member states should simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned , if knowledge of such texts is necessary to assess the implications of the measure proposed .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence and the biosimilarity of medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy , bioequivalence or biosimilarity of the medicinal product .


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


### voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions ; ### agreements concluded at the written request of the holder of a marketing authorisation with public authorities which aim at including a medicinal product in the scope of the public health insurance system whilst monitoring elements agreed upfront with the holder of a marketing authorisation to address evidentiary uncertainties related to the effectiveness and appropriate use of the given medicinal product over time ;


### where member states intend to adopt or amend any measure falling within the scope of this directive , they shall immediately communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based . ### where member states intend to adopt or amend any measure falling within the scope of this directive , they should communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based .


### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures may be taken with the aid of automatic systems set up on the infrastructure , or onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states . ### after the expiry of a period of five years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures shall be taken with onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states .


### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures may be taken with the aid of automatic systems set up on the infrastructure , or onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states . ### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures shall be taken with the aid of automatic systems set up on the infrastructure , or onboard systems , such as intelligent tachographs , installed in vehicles in line with regulation eu 2014 / . . . and with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights .


### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures may be taken with the aid of automatic systems set up on the infrastructure , or onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states . ### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures shall be taken with the aid of automatic systems set up on the infrastructure . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states .


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


### 2 a description of the environmental sustainability objectives for the airport and the national context . this will include a description of the aircraft noise objectives for the airport . ### 2 a description of the noise abatement objectives for the airport and the national context .


### any modification of the aircraft which influences its noise performance ; ### any modification of the aircraft which influences its noise performance and is recorded in its noise certificate ;


### the competent authorities shall ensure that , at the appropriate level , a forum for technical cooperation is established between the airport operator , aircraft operator and air navigation service provider , for actions which these operators are responsible for , and taking due account of the interdependency between measures to mitigate noise and to reduce emissions . the members of this forum for technical cooperation shall regularly consult local residents or their representatives , and provide technical information and advice on noise mitigating measures to the competent authorities . ### the competent authorities shall ensure that , at the appropriate level , a forum for technical cooperation is established between the airport operator , aircraft operator and air navigation service provider , for actions which these operators are responsible for , and taking due account of the interdependency between measures to mitigate noise and to reduce emissions . the members of this forum for technical cooperation shall regularly consult the relevant local authorities and local residents , or their representatives , living in the vicinity of the airport most affected by air traffic noise and shall provide technical information and advice on noise mitigating measures to the competent authorities .


### the competent authorities shall follow up and monitor the implementation of the noise mitigating measures and take action as appropriate . they shall ensure that relevant information is provided on a regular basis to the local residents living in the surroundings of the airports . ### the competent authorities shall follow up and monitor the implementation of the noise mitigating measures and take action as appropriate . they shall ensure that relevant information is made available on - line , thus allowing local residents living in the surroundings of the airports , and other interested parties to access the information freely .


### the competent authorities shall follow up and monitor the implementation of the noise mitigating measures and take action as appropriate . they shall ensure that relevant information is provided on a regular basis to the local residents living in the surroundings of the airports . ### the competent authorities shall follow up and monitor the implementation of the noise mitigating measures and take action as appropriate . they shall ensure that relevant information is made available online and is regularly updated , thus allowing local residents living in the surroundings of the airports and other interested parties to access the information freely .


### when the assessment of the noise situation reveals that new measures are necessary to achieve or maintain the level of noise abatement objectives , the competent authorities shall take due account of the contribution of each type of measure under the balanced approach , in accordance with annex i . ### if this assessment indicates that new operating restriction measures may be required to address a noise problem at an airport , the competent authorities shall ensure that : the method , indicators and information in annex i are applied to take due account of the contribution of each type of measure under the balanced approach , before introducing operating restrictions . at the appropriate level , technical cooperation is established between the airport operators , aircraft operators and air navigation service providers to examine measures to mitigate noise the competent authorities shall also ensure that local residents , or their representatives , and relevant local authorities are consulted , and that technical information on noise mitigating measures is provided to them . the cost - effectiveness of any new operating restriction is assessed , in accordance with annex ii . minor technical amendments to existing measures without substantive implications on capacity or operations are not considered as new operating restrictions . the consultation process with interested parties is organised in a timely and substantive manner , ensuring openness and transparency as regards data and computation methodology . interested parties shall have at least three months prior to the adoption of the new operating restrictions to provide comments . the interested parties shall at least include : local residents , living in the vicinity of the airports , affected by air traffic noise or their representatives and the relevant local authorities ; relevant airport operators ; representatives of aircraft operators which may be affected by noise - related actions ; relevant air navigation service providers ; the network manager , as defined in commission regulation no 677 / 2011 ; where applicable , the designated slots coordinator .


### the noise performance certificate or certificates of the aircraft used , together with the associated actual maximum take - off weight ; ### the noise certificate or certificates of the aircraft used , together with the associated actual maximum take - off weight ;


### while a cost - benefit analysis provides an indication of the total economic welfare effects by comparing all costs and benefits , a cost - effectiveness assessment focuses on achieving a given objective in the most cost - effective way , requiring a comparison of only the costs . ### while a noise abatement objective should be chosen by comparing all costs and all benefits , the tool to reach this objective should be cost - effective , requiring a comparison of only the costs .


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where the noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### 4 forecast noise contours – including an assessment of the number of people likely to be affected by aircraft noise – distinguish between established residential areas and newly constructed residential areas . ### 4 forecast noise contours – including an assessment of the number of people likely to be affected by aircraft noise – distinguish between established residential areas and planned residential areas .


### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft type , runway use and / or timeframe covered . ### the measures may , within the balanced approach , be differentiated according to aircraft type , runway use and / or timeframe covered .


### direct , indirect and catalytic employment effects . ### direct , indirect and catalytic employment and economic effects , including potential effects on regional economies .


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down the rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where a noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body . ### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body in accordance with national laws and practices .


### assess the noise situation at an individual airport ; ### the noise abatement objective for that airport , taking into account , as appropriate , of article 8 and annex v of directive 2002 / 49 is defined ;


### when the assessment of the noise situation reveals that new measures are necessary to achieve or maintain the level of noise abatement objectives , the competent authorities shall take due account of the contribution of each type of measure under the balanced approach , in accordance with annex i . ### if this assessment indicates that new operating restriction measures may be required to address a noise problem at an airport , the competent authorities shall ensure that :


### the competent authorities shall assess the noise situation at airports in their territory on a regular basis , in accordance with the requirements of directive 2002 / 49 / ec and national or local rules . the competent authorities may call on the support of the performance review body referred to in article 3 of commission regulation no 691 / 2010 . ### the competent authorities shall ensure that the noise situation at airports for which they are responsible is assessed on a regular basis , in accordance with directive 2002 / 49 / ec and the legislation applicable within each member state . the competent authorities may call on the support of the performance review body referred to in article 3 of commission regulation no 691 / 2010 . 18


### the cost - effectiveness of envisaged noise - related operating restrictions will be assessed taking due account of following elements , to the extent possible , in quantifiable terms : ### the cost - effectiveness of envisaged noise mitigating measures will be assessed taking due account of following elements , to the extent possible , in quantifiable terms :


### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise nuisance from aircraft at airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects . ### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise from aircraft at airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects .


### environmental sustainability , including interdependencies between noise and emissions ; ### interdependencies between noise and emissions ;


### 2 a description of the environmental sustainability objectives for the airport and the national context . this will include a description of the aircraft noise objectives for the airport . ### 2 a description of the noise abatement objectives for the airport and the national context .


### competent authorities will use noise assessment methods which have been developed in accordance with the ecac report doc 29 ' report on standard method of computing noise contours around civil airports ' , 3rd edition . ### competent authorities will use noise assessment methods which have been developed in accordance with annex ii of directive 2002 / 49


### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators . ### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators and be non - arbitrary .


### ‘ marginally compliant aircraft’ means civil aircraft that meet the chapter 3 certification limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a cumulative margin of less than 10epndb , whereby the cumulative margin is the figure expressed in epndb obtained by adding the individual margins at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 4 of annex 16 to the chicago convention ; ### marginally compliant aircraft means civil aircraft that meet the chapter 3 certification limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a margin of less than 8 epndb , whereby the cumulative margin is the figure expressed in epndb obtained by adding the individual margins ( i . e . the differences between the certificated noise level and the maximum permitted noise level at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 4 3 of annex 16 to the chicago convention ;


### in order to take into account new legislation that may become necessary , the commission shall , by means of a delegated act , amend annex v . ### the commission shall , by means of a delegated act , amend annex v .


### each organisation certified or approved by a member state shall report , where required , to the competent authority member state , as referred to in article 6 , the result of the analysis performed in accordance with paragraph 1 and the actions required in accordance with paragraph 2 within 30 days . ### each organisation established in a member state , which is not covered by paragraph 3 , shall report to the competent authority of the member state , as referred to in article 6 , the initial result of the analysis performed in accordance with paragraph 1 and any action to be taken in accordance with paragraph 2 within 30 days from the day of notification of the occurrence . the final result of the analysis must be reported as soon as it is available and no later than three months from the day of notification of the occurrence .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 . ### each organisation established in a member state which is not covered by paragraph 6 shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 within 72 hours .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 . ### each organisation established in a member state and not covered by paragraph 5 shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 within 72 hours .


### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress , to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements , to update the list of interested parties and the request for european central repository information form , and to ensure that the scope of incidents to be reported under the mandatory scheme remains appropriate . ### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress ; to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements ; to update the list of interested parties and the request for european central repository information form ; to ensure that the list of occurrences to be reported under the mandatory scheme remains appropriate , contains a specific section on operations involving non - complex aircraft , and in particular reflects the emergence of new safety risks ; and to supplement and update the list of mandatory data fields . before making any proposal for a delegated act , the commission shall request the opinion of the network of aviation safety analysts for the review of annexes i and ii of this regulation .


### the power to adopt delegated acts referred to in articles 7 , 8 , 11 and 17 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in articles 7 and 17 shall be conferred on the commission for a period of five years from the entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five year period . the delegation of power shall be tacitly extended for periods of identical duration , unless the european parliament or the council opposes such extension no later than three months before the end of each period .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 the details on occurrences collected in accordance with paragraph 1 . ### any organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details of occurrences collected in accordance with paragraph 1 as soon as practicable , but in any case within 72 hours of the organisation identifying the condition to which the report relates , unless exceptional circumstances prevent this .


### each organisation established in a member state shall designate one or more persons to handle the collection , evaluation , processing , analysis and storage of details on occurrences reported in accordance with articles 4 and 5 . these designated persons shall work separately and independently from other departments of the organisation . ### each organisation established in a member state shall put in place a mechanism to handle the collection , evaluation , processing , analysis and storage of details of occurrences reported in accordance with articles 4 and 5 . the handling of these reports shall be organised so as to appropriately safeguard the confidentiality of the reporter and of the involved personnel with a view to fostering a just culture .


### each organisation certified or approved by easa shall report to the easa the details on occurrences collected in accordance with paragraph 1 . ### each organisation certified or approved by easa shall report to easa the details on occurrences collected in accordance with paragraph 1 . reports shall be made within the timescales required by regulation 216 / 2008 / ec


### each organisation certified or approved by a member state shall report , where required , to the competent authority member state , as referred to in article 6 , the result of the analysis performed in accordance with paragraph 1 and the actions required in accordance with paragraph 2 within 30 days . ### each organisation established in a member state , which is not covered by paragraph 3a , shall report , to the competent authority of the member state , as referred to in article 6 , the initial result of the analysis performed in accordance with paragraph 1 and any action to be taken in accordance with paragraph 2 within 30 days from the day of notification of the occurrence . the final result of the analysis must be reported as soon as it is available .


### it is important to clearly set the line which protects the reporter from prejudice or prosecution by providing a common understanding of the term gross negligence . ### it is important to clearly set the line which protects the person involved in the reported occurrence from prejudice or prosecution by providing a common understanding of the term gross negligence .


### alternate current slow recharging points for electric vehicles shall be equipped , for interoperability purposes , with connectors of type 2 as described in standard en62196 - 2 : 2012 . ### alternate current basic recharging points for electric vehicles shall be equipped , for interoperability purposes , with socket - outlet of type 2 as described in standard en62196 - 2 : 2012 and respective updates .


### electricity is a clean fuel particularly attractive for deployment of electric vehicles and electric two - wheelers in urban agglomerations which can contribute to improving air quality and reducing noise . member states should ensure that recharging points for electric vehicles are built up with sufficient coverage , at least twice the number of vehicles , and 10% of them publicly accessible , focussing in particular on urban agglomerations . private owners of electric vehicles depend to a large extent on access to recharging points in collective parking lots , such as in apartment blocks , office and business locations . regulatory provisions should be set up by public authorities , assisting citizens by ensuring that the appropriate infrastructure with sufficient electric vehicle recharging points is provided by the site developers and managers . ### electricity is a clean fuel particularly attractive for deployment of electric vehicles and electric two - wheelers in urban agglomerations which can contribute to improving air quality and reducing noise . member states should endeavour that recharging points for electric vehicles are built up with sufficient coverage , and part of them publicly accessible , bearing in mind the geographical and socioeconomic aspects and focussing in particular on urban agglomerations . private owners of electric vehicles depend to a large extent on access to recharging points in collective parking lots , such as in apartment blocks , office and business locations . regulatory provisions should be set up by public authorities , assisting citizens by ensuring that the appropriate infrastructure with sufficient electric vehicle recharging points is provided by the site developers and managers .


### ‘ slow recharging point’ means a recharging point that allows for a direct supply of electricity to an electric vehicle with a power of less than or equal to 22 kw . ### ‘ basic recharging point’ means a recharging point that allows for a direct supply of electricity to an electric vehicle with a power of less than or equal to 22 kw .


### minimum number of electric vehicle recharging points in each member state ### indicative number of electric vehicle recharging points in each member state


### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 59 to 73 , the commission shall be empowered to adopt delegated acts in accordance with article 85 as regards the following : ### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 59 to 73 , the commission , having consulted relevant stakeholders , including healthcare professionals’ organisations and manufacturers’ associations , shall be empowered to adopt delegated acts in accordance with article 85 as regards the following :


### member states shall ensure that an accused person or his lawyer is granted access to the case - file once the investigation of the criminal offence is concluded . access to certain documents contained in the case - file may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the documents contained in the case - file . ### member states shall ensure that an accused person or his lawyer is granted access to the evidentiary materials of the case once the investigation of the criminal offence is concluded . access to certain documents may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the evidentiary materials of the case .


### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to those documents contained in the case - file which are relevant for the determination of the lawfulness of the arrest or detention . ### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to the materials of the case , which are relevant for the determination of the lawfulness of the arrest or detention . however , it may be necessary to withhold certain materials which may compromise national security , the safety of persons involved in the investigation , or jeopardise another investigation .


### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . ### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty , unless deemed inappropriate for security reasons or reasons of personal safety .


### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself . cigarettes with a diameter of less than 7 . 5 mm shall be deemed to be misleading . ### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself .


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided36 . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , having a characterising flavour other than tobacco and menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 4 , 4 , 6 , 6 , 9 , 11 , 13 , 13 , 14 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ' natural ' , ' organic ' , ‘ without additives’ , ‘ without flavours’ , ' slim ' , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products could , under certain circumstances , convey the impression to consumers , in particular young people , that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] .


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 4 , 4 , 6 , 6 , 9 , 11 , 13 , 13 , 14 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . ### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the same direction as any other information appearing on the packaging ;


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 40 % of the external area of the front and 50 % of the external area of the back surface of the unit packet and any outside packaging ;


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , names , pictures , and figurative or other signs . likewise , the appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful .


### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy , menthol or vanilla observable before or upon intended use of the tobacco product ; ### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


### for exposure in the range from 100 khz up to 300 ghz , and in any event where exposure above the exposure limit values is detected , a medical examination shall be made available to the worker concerned in accordance with national law and practice . if health damage resulting from such exposure is detected , a reassessment of the risks shall be carried out by the employer in accordance with article 4 . ### for exposure in the range from 100 khz up to 300 ghz , where exposure above the exposure limit values is detected , a medical examination shall be made available to the worker during working hours . the cost shall be met in accordance with national law and practice . if health damage resulting from such exposure is detected , a reassessment of the risks shall be carried out by the employer in accordance with article 4 .


### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations . compliance with the exposure limits values for health effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects . compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects ; ### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations . compliance with the exposure limit values for health effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects . compliance with the exposure limit values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects ;


### on the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1 , if any of the action values referred to in annexes ii or iii is exceeded , the employer shall further assess and , if necessary , calculate whether the exposure limit values for health effects are exceeded . ### on the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1 , if any of the orientation values referred to in annex ii is exceeded , the employer shall further assess and , if necessary calculate whether the exposure limit value for safety effects are exceeded .


### in carrying out the obligations laid down in articles 6 and 9 of directive 89 / 391 / eec , the employer shall assess and , if necessary , measure and / or calculate the levels of electromagnetic fields to which workers are exposed . assessment , measurement and calculation may be carried out using the guidance provided in annexes ii and iii . for specific cases not referred to in these annexes , the employer may use harmonised european standards established by cenelec for relevant assessment , measurement and calculation situations . the employer shall also be entitled to use other scientifically based standards or guidelines if required by the member state concerned . when relevant , the employer shall also take into account the emission levels and other safety - related data provided by the manufacturers of equipment in accordance with relevant union legislation . ### in carrying out the obligations laid down in articles 6 and 9 of directive 89 / 391 / eec , the employer shall assess and , if necessary , measure and / or calculate the levels of electromagnetic fields to which workers are exposed . assessment , measurement and calculation may be carried out using the guidance provided in annexes ii and iii . for specific cases not referred to in these annexes , the employer may use harmonised european standards established by cenelec for relevant assessment , measurement and calculation situations . the employer shall also be entitled to use other scientifically based standards or guidelines . when relevant , the employer shall also take into account the emission levels and other safety - related data provided by the manufacturers of equipment in accordance with relevant union legislation .


### for the purposes of this regulation , a natural or legal person shall be considered to have an uncovered position in a credit default swap relating to an obligation of a member state or the union , to the extent that the credit default swap is not serving to hedge against the risk of default of the issuer where the natural or legal person has a long position in the sovereign debt of that issuer or any long position in the debt of an issuer for which the price of its debt has a high correlation with the price of the obligation of a member state or the union . the party under a credit default swap that is obliged to make the payment or pay the compensation in the event of a default or a credit event relating to the reference entity does not by reason of that obligation have an uncovered position for the purposes of this paragraph . ### for the purposes of this regulation , a natural or legal person shall be considered to have an uncovered position in a credit default swap relating to an obligation of a member state or the union , to the extent that the credit default swap is not serving to hedge against the risk of a decline in the creditworthiness of the issuer where the natural or legal person has another position whose value is likely to be negatively impacted by such a decline . the party under a credit default swap that is obliged to make the payment or pay the compensation in the event of a default or a credit event relating to the reference entity does not by reason of that obligation have an uncovered position for the purposes of this paragraph .


### the natural or legal person has an arrangement with a third party under which that third party has confirmed that the share or sovereign debt instrument has been located and reserved for lending for the natural or legal person so that settlement can be effected when it is due . ### the natural or legal person has entered into an arrangement with a third party under which the third party has confirmed that the share or debt instrument will be available for lending to the person or for settling the short sale on the date that settlement is due .


### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer in excess of eur 5000 for an aid application submitted in respect of calendar year 2013 shall be reduced by 4 . 981759&#160 ; % . ### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer for an aid application submitted in respect of calendar year 2013 shall be reduced by [ xxx ] &#160 ; % .


### efficient alternatives to phosphates - based household laundry detergents require small amounts of other phosphorous compounds , namely phosphonates which if used in increasing quantities might be of concern for the environment . ### efficient alternatives to phosphates - based household laundry detergents require small amounts of other phosphorous compounds , namely phosphonates , which fulfil a very specific function that is different to phosphates and are used in such small quantities that they do not contribute to any measureable extent to eutrophication .