### the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . ### the commission shall , after consultation with the applicant , adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . within three months of receiving the notification , the commission shall make a proposal for a decision . should the commission ask the agency for an opinion under the procedure set out in article 30 , the three - month period shall be suspended until the agency has forwarded its opinion .


### a risk assessment on the active substance present in the biocidal product shall always be carried out . if there are , in addition , any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these . the risk assessment shall cover the proposed normal use of the biocidal product together with a realistic worst - case scenario including any relevant production and disposal issue either of the biocidal product itself or any material treated with it . ### a risk assessment on the active substance present in the biocidal product shall always be carried out . if there are , in addition , any substances of concern present in the biocidal product then all available data shall be included in the dossier for authorisation of a biocidal product for each of these . the data shall cover the proposed normal use of the biocidal product together with a realistic worst - case scenario including any relevant production and disposal issue either of the biocidal product itself or any material treated with it .


### a biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met : ### a biocidal product shall be considered as substantially identical to the reference product if all of the following conditions are met :


### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . ### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation , within the meaning of this regulation , of an application for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . the comparative assessment must be carried out for all biocidal products having the same purpose , when sufficient experience has been gained in their use and they have been in use for at least five years .


### application for authorisation shall be made by , or on behalf of , the person who shall be responsible for the placing on the market of a biocidal product in a particular member state or in the community . ### application for authorisation shall be made by , or on behalf of , the person who will be the holder of the authorisation . this person may be , but is not necessarily , the person responsible for the placing on the market of a biocidal product in a particular member state or in the community .


### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . ### the receiving competent authority or , in the case of evaluation of an application for renewal of a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 .


### a competent authority of a member state may grant a parallel trade permit for a biocidal product that is authorised in another member state to be placed on the market and used in the member state of introduction , if it determines that the biocidal product is substantially identical in composition to a biocidal product already authorised in that member state . ### a competent authority of a member state may grant a parallel trade permit for a biocidal product that is authorised in another member state to be placed on the market and used in the member state of introduction , if it determines that the biocidal product is identical in composition to a biocidal product already authorised in that member state .


### data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering in its effect on target vertebrates . this shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates ; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated . ### data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering and pain in its effect on target vertebrates . this shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates ; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated . those findings shall for each authorised biocidal product be made publicly available on the agency website .


### unless otherwise specified in the decision to renew the inclusion of an active substance in annex i , the renewal shall be for an unlimited period of time . ### unless stricter specified in the decision to renew the inclusion of an active substance in annex i , the renewal may be renewed for a period not exceeding 10 years .


### the labelling shall be clearly visible , easily legible and appropriately durable . where this is necessary because of the size or the function of the treated article or material , the labelling shall be printed on the packaging , on the instructions for use or on the warranty of the treated article or material . ### the labelling shall be clearly visible , easily legible , appropriately durable and printed on the article or material , on the packaging , on the instructions for use or on the warranty of the treated article or material in the national language or languages of the member state on whose market the treated article or material is to be placed .


### it is either the same or similar with regard to the non - active substances present and the type of formulation ; ### it is identical with regard to the specification and content of the active substances and in the type of formulation ;


### an active substance shall be included in annex i for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point of article 16 . ### an active substance shall be included in annex i for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point of article 16 .


### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products that are authorised in different member states . ### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trading of identical biocidal products which are authorised in different member states .


### the purpose of this regulation is to increase the free movement of biocidal products within the community . in order to remove as far as possible obstacles to trade in biocidal products stemming from the different levels of protection in the member states , harmonised rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products , including the rules on the mutual recognition of authorisations and on parallel trade . ### the purpose of this regulation is to increase the free movement of biocidal products within the community and to ensure a high level of protection of both human and animal health and the environment . particular attention should be paid to the protection of vulnerable groups of the population , including pregnant women , infants and children . the precautionary principle should be applied to this regulation in order to ensure that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment . in order to remove as far as possible obstacles to trade in biocidal products rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products , including the rules on the mutual recognition of authorisations and on parallel trade .


### it meets two of the criteria to be considered as a persistent , bio - accumulative and toxic substance as set out in annex xiii of regulation no 1907 / 2006 ; ### it meets one of the criteria to be considered as a persistent , bio - accumulative and toxic substance as set out in annex xiii of regulation no 1907 / 2006 ;


### dossiers on active substances shall contain the information needed to establish , where relevant , acceptable daily intake , acceptable operator exposure level , predicted environmental concentration and predicted no - effect concentration . ### dossiers on active substances shall contain the information needed to establish that exposure is below the threshold of toxicological concern , or where relevant , to establish the acceptable daily intake , acceptable operator exposure level , predicted environmental concentration and predicted no - effect concentration .


### by way of derogation from articles 25 and 28 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , animals or plants , the protection of national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof . ### by way of derogation from articles 25 - 29 , competent authorities of member states may refuse mutual recognition of national authorisations granted for product types 15 , 17 and 23 of annex v provided that such a refusal can be justified on grounds of the protection of health of humans , particularly of vulnerable groups , the protection of health of animals or plants , the protection of environment national treasures possessing artistic , historic or archaeological value , or the protection of industrial and commercial property . competent authorities of member states shall without delay inform each other and the commission of any decision taken in this respect and shall indicate the reasons thereof .


### by way of derogation from articles 15 and 16 , a competent authority may authorise for a period not exceeding nine months , the placing on the market of a biocidal product not complying with the provisions of this regulation for a limited and controlled use if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means . ### by way of derogation from articles 15 and 16 , a competent authority may authorise for a period not exceeding four months , the placing on the market of a biocidal product not complying with the provisions of this regulation for a limited and controlled use if all of the following conditions are met : such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means and the active substances concerned are approved for inclusion into annex i or evaluated according to article 4 of this regulation and a full dossier is provided if the relevant active substances are classified as cut - off substances or candidates for substitution , a mandatory substitution plan is established and implemented by the applicant or competent authority in order to replace the relevant substances with non - hazardous chemical or non - chemical alternatives within 2 years after approval and the application of the product is restricted to professional users who are certified pursuant to the requirements for an integrated pest management and the use is appropriately monitored .


### within nine months from the receipt of the conclusions of the evaluation , the agency shall prepare and submit to the commission an opinion on the authorisation of the biocidal product . ### within three months from the receipt of the conclusions of the evaluation , the agency shall prepare and submit to the commission an opinion on the authorisation of the biocidal product .


### the exposure of humans to that active substance in a biocidal product , under normal conditions of use , is negligible , in particular where the product is used in closed systems or strictly controlled conditions ; ### the exposure of humans to that active substance in a biocidal product , under prescribed conditions of use , is negligible or adequately controlled , taking account of the intrinsic hazards presented by the substance , in particular where the product is used in closed systems or strictly controlled conditions ;


### information protected under directive 98 / 8 / ec or under this article or for which the protection period expired under directive 98 / 8 / ec or under this article shall not be protected again . ### an individual date of submission shall be assigned to each document , as identified by the unique code under article 48 .


### esma shall develop draft implementing technical standards to determine the format of the reports mentioned in point of paragraph 1 , and the content of the information to be provided in accordance with paragraph 2 . ### esma shall develop draft implementing technical standards to determine the format of the reports mentioned in paragraph 1 and in paragraph 1a and the content of the information to be provided in accordance with paragraph 2 .


### regulated markets , mtf and otfs shall inform their competent authority of the details of the limits or arrangements . the competent authority shall communicate the same information to esma which shall publish and maintain on its website a database with summaries of the limits or arrangements in force . ### regulated markets , mtf and otfs shall inform their competent authority of the details of the limits . the competent authority shall communicate the same information to esma which shall publish and maintain on its website a database with summaries of the limits in force .


### there is a need to pursue studies and work , in particular on issues related to gdp and beyond and europe 2020 with the aim of developing a more comprehensive measurement approach for wellbeing and progress in order to support the promotion of a smart , sustainable and inclusive economy . these studies and work will help to further improve data availability , transmission and quality , to enhance methodologies , so as to prepare for future developments . ### there is a need to conduct studies and work , in particular on issues related to gdp and beyond and europe 2020 with the aim of developing a more comprehensive measurement approach for wellbeing and progress in order to support the promotion of a smart , sustainable and inclusive economy , taking into account environmental considerations . such studies and work will help to further improve data availability , transmission and quality , to enhance methodologies , so as to prepare for future developments . data on national and regional accounts should be seen as one element in the pursuit of those aims .


### since the implementation of this regulation might require major adaptations in the national statistical systems , derogations may be granted by the commission to member states . ### since the implementation of this regulation might require major adaptations in the national statistical systems , the commission should provide the necessary resources and expertise to assist member states who have insufficient available resources or have major methodological obstacles to overcome . derogations may be granted by the commission to member states . however , such derogations should be temporary and subject to regular review .


### it is important that gas supply is maintained , particularly as regards household customers , as well as other protected customers such as schools and hospitals , in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis . ### it is important that gas supply is maintained particularly as regards household customers , as well as a limited amount of additional customers , especially customers delivering important public services , which can be defined by the member states concerned , in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis .


### period , expressed in days , during which it is possible to ensure gas supply to the protected customers ### period , expressed in days , during which it is expected that gas supply to the protected customers can be ensured .


### following the recommendation of the commission referred to in article 4 or in situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by demand side measures . ### following the recommendation of the commission referred to in article 4 or in the situation referred to in article 4 , the calculation set out in paragraph 1 may be carried out at the regional level . in its calculation of the n - 1 indicator , the competent authority shall be allowed to demonstrate in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by specific measures , including demand side measures .


### the competent authority shall take the measures to ensure the gas supply to the protected customers of the member state in the case of : extremely cold temperatures during a seven days peak period statistically occurring once every twenty years ; and b ) any period of sixty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years . ### in carrying out the risk and impact assessment defined in article 8 , the competent authority shall use a common methodology , which shall include the following indicators for the supply of gas to the protected customers of the member state : supplies in case of extremely cold average temperatures during a seven days period statistically occurring once every twenty years ; and b ) supplies in case of any period of thirty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years .


### since gas supplies from third countries are central to the security of gas supply of the community , the commission should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the community . the commission should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the community and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role . ### since gas supplies from third countries are central to the security of gas supply of the union , in the event of a union emergency , the commission , after consultation of the gas coordination group , should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the union . the commission , after consultation of the gas coordination group , should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the union and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role .


### by [ 31 march 2014 ; 3 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the largest gas supply infrastructure , the remaining infrastructure has the capacity to deliver the necessary volume of gas to satisfy total gas demand of the calculated area during a period of sixty days of exceptionally high gas demand during the coldest period statistically occurring every twenty years . ### by [ 31 march 2016 ; 5 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the single largest gas infrastructure , the remaining infrastructure has the technical capacity to satisfy total daily gas demand of the calculated area during a day of exceptionally high demand statistically occurring once every twenty years .


### any period of sixty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years . ### any period of thirty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years .


### the commission may declare a community emergency at the request of one competent authority or when the community loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a community emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a community emergency for specifically affected geographical regions comprising more than one member state . ### the commission may declare a union emergency at the request of one competent authority or where the union is losing more than 10% of its daily gas import from third countries &#8211 ; which amounts to the daily consumption of certain member states &#8211 ; as calculated by entso - g . it shall declare a union emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a union emergency for specifically affected geographical regions comprising more than one member state .


### in a community emergency , the commission shall coordinate the actions of the competent authorities . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the community level , and shall coordinate the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency . ### in a union emergency , the commission shall ensure coordination of the emergency actions of the competent authorities . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the union level , and may ensure coordination of the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient gas infrastructure within a member state and across the union is essential for tackling supply interruptions . risk and impact assessments based on a common methodology should ensure effective and efficient implementation of minimum criteria on security of gas supply and a level playing field for security of gas supply while taking into account national or regional specificities and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce gas demand appreciably to react to a supply disruption .


### since gas supplies from third countries are central to the security of gas supply of the community , the commission should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the community . the commission should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the community and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role . ### since gas supplies from third countries are central to the security of gas supply of the union , in the event of a union emergency the commission , after consultation of the gas coordination group , should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the union . the commission , after consultation of the gas coordination group , should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the union and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role .


### the natural gas undertakings , the relevant organisations representing the interests of household and industrial customers and the regulatory authority , where it is not the competent authority , shall cooperate and provide all necessary information for the risk assessment . ### the natural gas undertakings , the relevant organisations representing the interests of household and industrial customers and the regulatory authority , where it is not the competent authority , shall cooperate and provide all necessary information for the risk and impact assessment .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authorities shall be allowed to calculate these indicators on a regional or union level and they shall not be required to calculate these indicators only within their territory .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall take into account efficiently incurred costs related to measures imposed as a result of this regulation . in the case of investments that affect more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation of efficiently incurred costs in one or more member states . article 8 of regulation no 715 / 2009 shall apply .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall duly take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in a transparent and detailed manner , reflecting costs incurred in a clear and identifiable manner and in line with article 41 of directive 2009 / 73 / ec . in the case of costs incurred in more than one member state , the agency for the cooperation of energy regulators with the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no 715 / 2009 shall apply .


### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , the competent authority , after consultation of the natural gas undertakings , of the relevant organisations representing the interests of household and industrial customers and of the regulatory authority , where it is not the competent authority , shall establish : ### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , on the basis of the risk and impact assessment carried out according to article 8 , the competent authority , after consultation of the natural gas undertakings , of gas - powered generators , of the relevant organisations representing the interests of household and industrial customers and of the regulatory authority , where it is not the competent authority , shall establish :


### following the recommendation of the commission referred to in article 4 or in situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by demand side measures . ### following the recommendation of the commission referred to in article 4 or in the situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by market based demand side measures .


### the risk assessment shall be repeated every two years before 30 september of that year . ### the risk and impact assessment shall be repeated every two years before 30 september of that year .


### since gas supplies from third countries are central to the security of gas supply of the community , the commission should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the community . the commission should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the community and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role . ### since gas supplies from third countries are central to the security of gas supply of the union , particularly in the event of a union emergency , the commission , after consultation with the gas coordination group should coordinate the actions with regard to third countries , working with producer and transit countries on arrangements to handle crisis situations and to ensure a stable gas flow to the union . the commission , after consultation with the gas coordination group , should be entitled to deploy a task force to monitor gas flows in crisis situations within and , in consultation with the third countries involved , outside the union and , where a crisis arises due to difficulties in a third country , to assume a mediation and facilitation role .


### each competent authority shall report to the commission without delay any non - compliance with the n - 1 standard . ### each competent authority shall , after consultation of the relevant natural gas undertakings , report to the commission the results of its calculation of the n - 1 indicator in accordance with article 13 .


### the commission may declare a community emergency at the request of one competent authority or when the community loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a community emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a community emergency for specifically affected geographical regions comprising more than one member state . ### the commission , after consulting the gas coordination group , may declare a union emergency at the request of at least two competent authorities in the affected region or when the union loses more than 20% of its daily gas import from third countries as compared to planned import volumes as estimated by entso - g . after consulting the gas coordination group , it shall declare a union emergency where more than two competent authorities have declared emergency following the verification in accordance with article 9 . it may declare a union emergency for specifically affected geographical regions comprising more than one member state .


### the competent authority shall take the measures to ensure the gas supply to the protected customers for the period of sixty days also in the event of an emergency as defined in article 9 . the competent authority shall endeavour to maintain the supply for the protected customers as long as necessary . ### in the event of an emergency as defined in article 9 , the competent authority shall work with natural gas undertakings to prioritise the gas supply to the protected customers . supply to the protected customers shall be maintained as long as possible .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient and diversified gas infrastructure in the member states , particularly in regions that are isolated from sources of energy supply , is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption .


### hourly flow of gas at all cross - border entry and exit points as well as all points connecting a production facility to the network , storage , lng in mcm / d ; ### hourly flow of gas at all cross - border entry and exit points as well as all points connecting the transmission network to a production facility , storage facility or lng terminal ;


### the competent authority shall take the measures to ensure the gas supply to the protected customers of the member state in the case of : extremely cold temperatures during a seven days peak period statistically occurring once every twenty years ; and b ) any period of sixty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years . ### in carrying out the risk and impact assessment defined in article 8 , the competent authority shall use a common methodology , which shall include the following indicators for the supply of gas to the protected customers of the member state : supplies in case of extremely cold average temperatures during a seven days period statistically occurring once every twenty years ; and b ) supplies in case of any period of thirty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years .


### natural gas undertakings shall notify the commission of the following details of the contracts concluded with suppliers from third countries : ### the competent authorities shall notify the commission of the following details of the contracts concluded by the natural gas undertakings of their respective member states with suppliers from third countries on an aggregated basis :


### by [ 31 march 2014 ; 3 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the largest gas supply infrastructure , the remaining infrastructure has the capacity to deliver the necessary volume of gas to satisfy total gas demand of the calculated area during a period of sixty days of exceptionally high gas demand during the coldest period statistically occurring every twenty years . ### by [ 31 march 2016 ; five years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of largest gas supply infrastructure , the remaining infrastructure has the technical capacity to satisfy total daily gas demand of the calculated area during a day of exceptionally high demand statistically occurring once every twenty years .


### in a community emergency , the commission shall coordinate the actions of the competent authorities . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the community level , and shall coordinate the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency . ### in a union emergency , the commission shall ensure coordination of the emergency actions of the competent authorities . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the union level , and may ensure coordination of the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency .


### the transmission system operators shall enable permanent physical capacity to transport gas in both directions on all interconnections within two years from the entry into force of this regulation , except in cases where at the request of a competent authority , the commission decides that the addition of a bi - directional flow capacity would not enhance the security of supply of any member state . such decision may be reviewed if circumstances change . the level of the bi - directional flow capacity shall be reached in a cost efficient way and at least take into account the capacity required to meet the supply standard set in article 7 . within that two year period , the gas transmission system operator shall adapt the functioning of the transmission system as a whole so as to enable bi - directional gas flows . ### if necessary according to the risk and impact assessment carried out according to article 8 , taking into account technical feasibility and an economic assessment of the costs and benefits to the market , the transmission system operators shall , within three years from the entry into force of this regulation , enable necessary physical capacity to transport gas in both directions on those interconnections where the addition of a bi - directional flow capacity would enhance security of supply , in particular during an emergency . within that three year period , the gas transmission system operator shall , in accordance with the risk and impact assessment carried out according to article 8 , taking into account technical feasibility and an economic assessment of the costs and benefits to the market , adapt the functioning of the transmission system as a whole so as to enable bi - directional gas flows .


### different sources of community funding are available to support member states to finance the necessary investment in indigenous production and infrastructure , notably loans and guarantees from the european investment bank or funding from regional , structural or cohesion funds . the european investment bank as well as the community external instruments such as enpi , ipa and dci can also finance actions in third countries in order to improve security of energy supply . ### different sources of community funding are available to support member states to finance the necessary investment in production , infrastructure and energy efficiency measures at regional and local level , notably loans and guarantees from the european investment bank or funding from regional , structural or cohesion funds .


### the failure of the largest single gas infrastructure or gas supply source , the so - called n - 1 principle , is a realistic scenario . using the failure of such infrastructure or supply source as a benchmark of what member states should be able to compensate is a valid starting point for ensuring their security of gas supply . ### the failure of the largest single gas infrastructure or gas supply source , the so - called n - 1 principle , is a realistic scenario . using the failure of such infrastructure or supply source as a benchmark of what the eu as a whole and the member states individually should be able to compensate is a good yardstick for an initial assessment of the security of gas supply , both for the eu as a whole and for each member state .


### period , expressed in days , during which it is possible to ensure gas supply to the protected customers ### period , expressed in days , during which it is expected that gas supply to the protected customers can be ensured .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authorities shall be allowed to calculate these indicators on a regional or union level and they shall not be required to calculate these standards indicators only within their territory .


### the competent authority shall immediately inform the commission and provide it with all the necessary information when it declares any of the crisis levels . in the event of an emergency which may result in a call for assistance from the eu and its member states the competent authority of the member state concerned shall without delay notify the commission’s civil protection monitoring and information centre . ### the competent authority shall immediately inform the commission and the gas coordination group and provide them with all the necessary information when it declares any of the crisis levels . in the event of an emergency which may result in a call for assistance from the eu and its member states the competent authority of the member state concerned shall without delay notify the commission’s civil protection monitoring and information centre .


### the methodology for calculating the n - 1 standard as provided in annex i shall be used . it should take into consideration the network configuration and actual gas flows as well as the presence of production and storage capacities . the calculated area as referred to in annex i shall be extended to the appropriate regional level , where necessary . ### the methodology for calculating the n - 1 indicator as provided in annex i shall be used . the calculated area as referred to in annex i shall be defined by the competent authority after consultation with the relevant natural gas undertakings and shall be extended to the appropriate regional level , where necessary .


### following the recommendation of the commission referred to in article 4 or in situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by demand side measures . ### following the recommendation of the commission referred to in article 4 or in the situation referred to in article 4 , the calculation set out in paragraph 1 may be carried out at the regional level . in its calculation of the n - 1 indicator , the competent authority shall be allowed to demonstrate in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by specific measures , including demand side measures .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall introduce appropriate incentives and include all the costs of efficiently fulfilling the infrastructure standard and the costs of enabling the economic permanent physical capacity to transport gas in both directions in their approval of tariffs or methodologies , and exempt these costs from efficiency benchmarks , in line with article 41 of directive 2009 / 73 / ec . in the case of costs incurred in more than one member state , or in one member state for the exclusive benefit of other member states the national regulatory authorities of all member states concerned shall jointly decide on the cost allocation . article 8 of regulation no 715 / 2009 shall apply .


### in a community emergency , the commission shall coordinate the actions of the competent authorities . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the community level , and shall coordinate the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency . ### in a union emergency , the commission shall coordinate the actions of the competent authorities after consultation with the gas coordination group . in particular the commission shall ensure the exchange of information , ensure the consistency and effectiveness of the actions at member state and regional level in relation to the union level , and shall coordinate the actions with regard to third countries . the commission may convene a crisis management group composed in particular of representatives of the industry and the member states concerned by the emergency .


### the competent authority shall take the measures to ensure the gas supply to the protected customers for the period of sixty days also in the event of an emergency as defined in article 9 . the competent authority shall endeavour to maintain the supply for the protected customers as long as necessary . ### in the event of an emergency as defined in article 9 , the competent authority shall work with natural gas undertakings to prioritise the gas supply to the protected customers . supply to the protected customers shall be maintained as long as possible .


### by [ 31 march 2014 ; 3 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the largest gas supply infrastructure , the remaining infrastructure has the capacity to deliver the necessary volume of gas to satisfy total gas demand of the calculated area during a period of sixty days of exceptionally high gas demand during the coldest period statistically occurring every twenty years . ### by . . . * , the competent authority shall ensure that in the event of a disruption of flows at the largest gas transmission entry point the available infrastructure has the capacity to deliver the necessary volume of gas to satisfy gas demand of the protected customers in the calculated area during a day of exceptionally high gas demand during the coldest period statistically occurring every twenty years . * oj please insert date : 6 years after the entry into force of this regulation .


### hourly flow of gas at all cross - border entry and exit points as well as all points connecting a production facility to the network , storage , lng in mcm / d ; ### hourly flow of gas at all cross - border entry and exit points as well as all points connecting the transmission network to a production facility , storage facility or lng terminal ;


### each competent authority shall report to the commission without delay any non - compliance with the n - 1 standard . ### each competent authority shall , after consultation of the relevant natural gas undertakings , report to the commission the results of its calculation of the n - 1 indicator in accordance with article 13 .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall introduce appropriate incentives and take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs or their methodologies in line with article 41 of directive 2009 / 73ec . in the case of costs incurred in more than one member state or in one member state for the benefit of other member states , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation before any investment decision is taken . any such investment decision shall be subject to approval by the national regulatory authority in relation to its costs and the allocation of such costs among all of the national regulatory authorities concerned . the proportion to which each member state benefits from the investment with regard to security of supply shall be taken into consideration in relation to the allocation of costs among those member states . article 8 of regulation no 715 / 2009 / shall apply .


### by [ 31 march 2014 ; 3 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the largest gas supply infrastructure , the remaining infrastructure has the capacity to deliver the necessary volume of gas to satisfy total gas demand of the calculated area during a period of sixty days of exceptionally high gas demand during the coldest period statistically occurring every twenty years . ### by [ 31 march 2016 ; 5 years after entry into force ] at the latest , the competent authority shall ensure that in the event of a disruption of the single largest gas infrastructure , the remaining infrastructure has the technical capacity to satisfy total daily gas demand of the calculated area during a day of exceptionally high demand statistically occurring once every twenty years .


### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for a more coordinated response to supply crises , both concerning preventive action and the reaction to concrete disruptions of supply . ### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market and the security of protected , including vulnerable , customers . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for solidarity and coordination in the response to supply crisis , both concerning preventive action and the reaction to concrete disruptions of supply .


### the competent authority shall take the measures to ensure the gas supply to the protected customers of the member state in the case of : extremely cold temperatures during a seven days peak period statistically occurring once every twenty years ; and b ) any period of sixty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years . ### in carrying out the risk and impact assessment defined in article 8 , the competent authority shall use a common methodology , which shall include the following indicators for the supply of gas to the protected customers of the member state : supplies in case of extremely cold average temperatures during a seven days period statistically occurring once every twenty years ; and b ) supplies in case of any period of thirty days of exceptionally high gas demand during the coldest weather periods statistically occurring every twenty years .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authorities shall be allowed to calculate these indicators on a regional or union level and they shall not be required to calculate these indicators only within their territory .


### gas routes and sources for the community should support the security of supply of the community as a whole and its member states individually . security of supply will depend in the future on the evolution of the fuel mix , the development of production in the community and in third countries supplying the community , investments in storage facilities and in routes within and outside the community including liquefied natural gas facilities . ### the diversification of gas routes and sources for the community is essential to improve the security of supply of the community as a whole and its member states individually . security of supply will depend in the future on the evolution of the fuel mix , the development of production in the community and in third countries supplying the community , investments in storage facilities and in the diversification of routes and sources of supply within and outside the community including liquefied natural gas facilities . for these reasons it is necessary to adopt measures that promote such diversification in the long term .


### the commission shall verify within one week whether the declaration of an emergency is justified and whether it does not impose an undue burden on the natural gas undertakings and on the functioning of the internal market . the commission may , in particular , ask the competent authority to modify measures imposing an undue burden on natural gas undertakings and to lift its declaration of emergency if the commission considers it not or no longer justified . ### the commission shall verify within one week whether the declaration of an emergency is justified and whether it does not impose an undue burden on the natural gas undertakings and on the functioning of the internal market . the commission may , in particular , ask the competent authority to modify measures imposing an undue burden on natural gas undertakings .


### national regulatory authorities shall take into account the costs of fulfilling the n - 1 standard and the costs of enabling the permanent physical capacity to transport gas in both directions in their approval of tariffs in line with article 41 of directive [ … / …ec ] . in the case of costs incurred in more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation . article 8 of regulation no … / … shall apply . ### national regulatory authorities shall take into account efficiently incurred costs related to measures imposed as a result of this regulation . in the case of investments that affect more than one member state , the national regulatory authorities of all member states concerned shall jointly decide on cost allocation of efficiently incurred costs in one or more member states . article 8 of regulation no 715 / 2009 shall apply .


### the failure of the largest single gas infrastructure or gas supply source , the so - called n - 1 principle , is a realistic scenario . using the failure of such infrastructure or supply source as a benchmark of what member states should be able to compensate is a valid starting point for ensuring their security of gas supply . ### the failure of the largest single gas infrastructure or gas supply source , the so - called n - 1 principle , is a realistic scenario . using the failure of such infrastructure or supply source as a benchmark of what the eu as a whole and the member states individually should be able to compensate is a good yardstick for an initial assessment of the security of gas supply , both for the eu as a whole and for each member state .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authorities shall be allowed to calculate these indicators on a regional or union level and they shall not be required to calculate these standards indicators only within their territory .


### the natural gas undertakings , the relevant organisations representing the interests of household and industrial customers and the regulatory authority , where it is not the competent authority , shall cooperate and provide all necessary information for the risk assessment . ### the natural gas undertakings , the relevant organisations representing the interests of household , industrial customers and other stakeholders and the regulatory authority , where it is not the competent authority , shall cooperate and provide all necessary information for the risk assessment .


### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , the competent authority , after consultation of the natural gas undertakings , of the relevant organisations representing the interests of household and industrial customers and of the regulatory authority , where it is not the competent authority , shall establish : ### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , on the basis of the risk and impact assessment carried out according to article 8 , the competent authority , after consultation of the natural gas undertakings , of gas - powered generators , of the relevant organisations representing the interests of household and industrial customers and of the regulatory authority , where it is not the competent authority , shall establish :


### following the recommendation of the commission referred to in article 4 or in situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by demand side measures . ### following the recommendation of the commission referred to in article 4 or in the situation referred to in article 4 , the calculation set out in paragraph 1 may be carried out at the regional level . in its calculation of the n - 1 indicator , the competent authority shall be allowed to demonstrate in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by specific measures , including demand side measures .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient gas infrastructure within a member state and across the union is essential for tackling supply interruptions . risk and impact assessments based on a common methodology should ensure effective and efficient implementation of minimum criteria on security of gas supply and a level playing field for security of gas supply while taking into account national or regional specificities and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce gas demand appreciably to react to a supply disruption .


### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , the competent authority , after consultation of the natural gas undertakings , of the relevant organisations representing the interests of household and industrial customers and of the regulatory authority , where it is not the competent authority , shall establish : ### by [ 31 march 2011 ; 12 months from entry into force ] at the latest , the competent authority , after consultation of the natural gas undertakings , of the relevant organisations representing the interests of household and industrial customers , shall establish :


### different sources of community funding are available to support member states to finance the necessary investment in indigenous production and infrastructure , notably loans and guarantees from the european investment bank or funding from regional , structural or cohesion funds . the european investment bank as well as the community external instruments such as enpi , ipa and dci can also finance actions in third countries in order to improve security of energy supply . ### different sources of community funding are available to support member states to finance the necessary investment in production , infrastructure and energy efficiency measures at regional and local level , notably loans and guarantees from the european investment bank or funding from regional , structural or cohesion funds .


### natural gas undertakings shall notify the commission of the following details of the contracts concluded with suppliers from third countries : ### the competent authorities shall notify the commission of the following details of the contracts concluded by the natural gas undertakings of their respective member states with suppliers from third countries on an aggregated basis , but in a form which delivers the necessary information for the commission to act :


### when a retail investor demonstrates a loss resulting from the use of the information contained in the key information document , the investment product manufacturer has to prove that the key information document has been drawn up in compliance with articles 6 , 7 and 8 of this regulation . ### when a retail investor demonstrates a loss and that the information contained in the key information document was wrong or misleading , the investment product manufacturer has to prove that the key information document has been drawn up in compliance with articles 6 , 7 and 8 of this regulation .


### to meet the needs of retail investors , it is necessary to ensure that information on investment products is accurate , fair , clear and not misleading for those investors . this regulation should therefore lay down common standards for the drafting of the key information document , in order to ensure that it is comprehensible for retail investors . given the difficulties many retail investors have in understanding specialist financial terminology , particular attention should be paid to the vocabulary and style of writing used in the document . rules should also be laid down on the language in which it should be drawn up . furthermore , retail investors should be able to understand the key information document on its own without referring to other information . ### to meet the needs of retail investors , it is necessary to ensure that information on investment products is accurate , fair , clear and not misleading for those investors . this regulation should therefore lay down common standards for the drafting of the key information document , in order to ensure that it is comprehensible for retail investors . given the difficulties many retail investors have in understanding specialist financial terminology , particular attention should be paid to the vocabulary and style of writing used in the document . rules should also be laid down on the language in which it should be drawn up . furthermore , retail investors should be able to understand the key information document on its own without referring to other information . the importance of the key information document should also be stressed to retail investors , so that regulation has an effect .


### under a section titled ' how has it done in the past ? ' , the past performance of the investment product , if this is relevant having regard to the nature of the product and the length of its track record ; ### under a section titled ' how has it done in the past ? ' , the past performance of the investment product , if this is relevant having regard to the nature of the product and the length of its track record . past performance will not be disclosed without due warning that it is not a reliable indication of future performance . when the investment strategy is referring to a benchmark , the benchmark performance will be published together with the investment product performance ;


### the commission shall be empowered to adopt delegated acts in accordance with article 23 specifying the details of the presentation and the content of each of the elements of information referred to in paragraph 2 , the presentation and details of the other information the product manufacturer may include within the key information document as referred to in paragraph 3 , and the details of the common format and the common symbol referred to in paragraph 4 . the commission shall take into account the differences between investment products and the capabilities of retail investors as well as the features of investment products that allow the retail investor to select between different underlying investments or other options provided for by the product , including where this selection can be undertaken at different points in time , or changed in the future . ### the commission shall be empowered to adopt delegated acts in accordance with article 23 specifying the details of the presentation and the content of each of the elements of information referred to in paragraph 2 , the presentation and details of the other information the product manufacturer may include within the key information document as referred to in paragraph 3 , and the details of the common format and the common symbol referred to in paragraph 4 . the commission shall take into account the differences between investment products and the capabilities of retail investors as well as the features of investment products that allow the retail investor to select between different underlying investments or other options provided for by the product , including where this selection can be undertaken at different points in time , or changed in the future . before adopting delegated acts , the commission shall conduct due consumer testing in order to select the most appropriate measures for consumers .


### the key information document shall be written in the official language , or one of the official languages of the member state where the investment product is sold , or in a language accepted by the competent authorities of that member state , or where it has been written in a different language , it shall be translated into one of these languages . ### the key information document shall be written in the official languages , or the official language used in the part of the member state where the investment product is distributed , or in another language accepted by the competent authorities of that member state if used in the part of the member state where the investment product is distributed , or where it has been written in a different language , it shall be translated into one of these languages .


### where a retail investor initiates a procedure for alternative dispute resolution laid down in national law against an investment product manufacturer or a person selling investment products with regard to a dispute concerning rights and obligations established under this regulation , the investment product manufacturer or the person selling investment products shall participate in that procedure , provided that it fulfils the following requirements : ### member states shall ensure that where a retail investor initiates a procedure for alternative dispute resolution laid down in national law against an investment product manufacturer or a person selling investment products with regard to a dispute concerning rights and obligations established under this regulation , the investment product manufacturer or the person selling investment products shall participate in that procedure , provided that it fulfils the following requirements :


### the procedure results in decisions which are not binding ; ### the procedure results in decisions which may be binding for the manufacturer and the person selling investment products ;


### where a retail investor initiates a procedure for alternative dispute resolution laid down in national law against an investment product manufacturer or a person selling investment products with regard to a dispute concerning rights and obligations established under this regulation , the investment product manufacturer or the person selling investment products shall participate in that procedure , provided that it fulfils the following requirements : ### member states shall ensure that where a retail investor initiates a procedure for alternative dispute resolution laid down in national law against an investment product manufacturer or a person selling investment products with regard to a dispute concerning the key information document and the underlying investment products the investment product manufacturer or the person selling investment products shall participate in that procedure , provided that it fulfils the following requirements :


### however , where the key information document is provided using a durable medium other than paper or by means of a website , a paper copy shall be provided to retail investors upon request and free of charge . ### however , where the key information document is provided using a durable medium other than paper or by means of a website , a paper copy shall be provided to retail investors upon request and free of charge . a paper copy shall also be provided free of charge when the investment recommendation or the intermediation service is provided in person .


### the investment product manufacturer shall establish appropriate procedures and arrangements which ensure that retail investors who have submitted a complaint in relation to the key information document receive a substantive reply in a timely and proper manner . ### the investment product manufacturer and seller shall establish appropriate procedures and arrangements which ensure that retail investors who have submitted a complaint in relation to the key information document and the underlying investment products receive a substantive reply in a timely and proper manner .


### the investment product manufacturer shall draw up a key information document in accordance with the requirements laid down in this regulation for each investment product it produces and shall publish the document on a website of its choice before the investment product can be sold to retail investors . ### the investment product manufacturer shall draw up a key information document in accordance with the requirements laid down in this regulation for each investment product it produces and shall publish the document together with the prospectus where a prospectus is published and at least on its website before the investment product can be sold to retail investors . the key information document shall be completed by the distributor where relevant .


### whether the investment product is covered by a compensation or guarantee scheme ; ### whether the investment product is covered by a compensation or guarantee scheme , detailing which risks are covered by the scheme and which are not ;


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive not later than 12 months after the date of entry into force of this directive . they shall forthwith communicate to the commission the text of those provisions . when member states adopt those provisions , they shall contain a reference to this directive or shall be accompanied by such reference on the occasion of their official publication . the methods of making such reference shall be laid down by member states . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive not later than one month after the date of entry into force of this directive . they shall forthwith communicate to the commission the text of those provisions . when member states adopt those provisions , they shall contain a reference to this directive or shall be accompanied by such reference on the occasion of their official publication . the methods of making such reference shall be laid down by member states .


### article 6 of regulation no 247 / 2006 provides for a transitional period during which the canary islands may continue to receive supplies of determined quantities of milk - based preparations falling within cn codes 1901 90 99 and 2106 90 92 intended for industrial processing . this transitional period expires on 31 december 2009 . the product falling within cn code 1901 90 99 – skimmed milk powder with vegetable fat – is a traditional product for the local consumers , including the most deprived , and has been sold in the canary islands during the last 40 years . the supply of this product has generated a specific local industry ensuring employment and added value . in the current situation of economic crisis it is appropriate to maintain the supply of this specific product and to extend the transitional period set by article 6 of that regulation to 31 december 2013 . ### article 6 of regulation no 247 / 2006 provides for a transitional period during which the canary islands may continue to receive supplies of determined quantities of milk - based preparations falling within cn codes 1901 90 99 and 2106 90 92 intended for industrial processing . this transitional period expires on 31 december 2009 . however , the product falling within cn code 1901 90 99 – skimmed milk powder with vegetable fat – has become a traditional product for the local consumers , including the most deprived . its supply has generated a specific local industry ensuring employment and added value . therefore , it is appropriate to maintain the supply of this specific product , which is used for local consumption only .


### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and accessible manner on their website . ### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and easily accessible manner in the annual report and on their website .


### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executives directors . only an eu - level measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life . ### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of a transparent and clearly defined selection procedure and an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executives directors . only an eu - level binding measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life .


### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex . ### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a vacancy announcement opening up for applications and a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex .


### companies listed on stock exchanges enjoy a particular economic importance , visibility and impact on the market as a whole . the measures provided for in this directive should therefore apply to listed companies , which are defined as companies incorporated in a member state whose securities are admitted to trading on a regulated market within the meaning of article 4 of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , in one or more member states . these companies set standards for the economy in its entirety and their practices can be expected to be followed by other types of companies . the public nature of listed companies justifies that they be regulated to a greater extent in the public interest . ### companies listed on stock exchanges enjoy a particular economic importance , visibility and impact on the market as a whole . the measures provided for in this directive should therefore apply to listed companies , which are defined as companies incorporated in a member state whose securities are admitted to trading on a regulated market within the meaning of article 4 of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , in one or more member states . these companies set standards for the economy in its entirety and their practices can be expected to be followed by other types of companies . the public nature of listed companies justifies that they be adequately regulated in the public interest .


### the commission shall review the application of this directive and report to the european parliament and the council by 31 december 2021 at the latest and every two years thereafter . the commission shall evaluate in particular whether the objectives of this directive have been achieved . ### the commission shall review the application of this directive and report to the european parliament and the council by 1 july 2018 at the latest and every two years thereafter . the commission shall evaluate in particular whether the objectives of this directive have been achieved .


### existing evidence also shows that labour market equality can improve economic growth substantially . enhancing female presence in the boardrooms of listed companies in the union not only affects the women appointed to boards , but also contributes to attracting female talent to the company and ensuring a greater presence of women at all levels of management and in the workforce . therefore , a higher share of women on company boards has a positive impact on closing both the gender employment gap and the gender pay gap . making full use of the existing female talent pool would constitute a marked improvement in terms of return on education for both individuals and the public sector . female under - representation in the board rooms of publicly listed companies in the eu is a missed opportunity in terms of achieving long - term sustainable growth for member states ' economies at large . ### existing evidence also shows that labour market equality can improve economic growth substantially . enhancing female presence in the boardrooms of listed companies in the union not only affects the women appointed to boards , but also contributes to attracting female talent to the company and ensuring a greater presence of women at all levels of management and in the workforce . therefore , a higher share of women on company boards has a positive impact on closing both the gender employment gap and the gender pay gap . making full use of the existing female talent pool would constitute a marked improvement in terms of return on education for both individuals and the public sector . female under - representation in the board rooms of publicly listed companies in the eu is a missed opportunity in terms of achieving long - term sustainable growth for member states ' economies at large . member states should therefore introduce measures to encourage career progression of women at all levels through positive actions such as networking and mentoring programmes .


### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published and , where the company in question has not met the objective , it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objective . ### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published in an appropriate and easily accessible manner in the annual report and on the website and , where the company in question has not met the objective , it should include a comprehensive description of the measures that it has taken so far and intends to take in the future in order to meet the objective .


### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises , even if they are listed companies . ### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . this sme exemption should be applicable to listed , and at a later stage non - listed , companies .


### the international commission for the conservation of atlantic tunas has adopted a recommendation 10 - 04 amending the multiannual recovery plan for bluefin tuna . in order to rebuild the stock , the recommendation provides for a further reduction of the total allowable catch , for strengthening measures to reduce the fishing capacity and for reinforcing the control measures , in particular as regards the transfer and the caging operations . ### the international commission for the conservation of atlantic tunas has adopted a recommendation 10 - 04 amending the multiannual recovery plan for bluefin tuna . in order to rebuild the stock , the recommendation provides for a further reduction of the total allowable catch , for strengthening measures to reduce the fishing capacity and for reinforcing the control measures , in particular as regards the transfer and the caging operations , and foresees additional advice on the identification of spawning grounds and creation of sanctuaries to be developed by 2012 .


### the programme aims to contribute to the objectives of the europe 2020 strategy and of the education and training strategic framework 2020 , including the corresponding benchmarks established in those instruments , to renewed framework for european cooperation in the youth field , to the sustainable development of third countries in the field of higher education and to developing the european dimension in sport . ### the programme aims to contribute to the objectives of the europe 2020 strategy and of the education and training strategic framework 2020 , including the corresponding benchmarks established in those instruments , to renewed framework for european cooperation in the youth field , to the eradication of poverty and the sustainable development of third countries , particularly in the field of higher education , training and skills development , and to developing the european dimension in sport .


### the amount of the advance shall not exceed 10 % of the amount of the contribution anticipated and shall in no case exceed eur 30 000 000 . once the definitive amount of the contribution has been determined , the commission shall take into account the sum of the advance prior to the balance of the contribution being paid . the commission shall recover unduly paid advances . ### the amount of the advance shall not exceed 15 % of the amount of the contribution anticipated and shall in no case exceed eur 40 000 000 . once the definitive amount of the contribution has been determined , the commission shall take into account the sum of the advance prior to the balance of the contribution being paid . the commission shall recover unduly paid advances


### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should , therefore , be covered by the union criminal law provisions on illicit drug trafficking . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ‘ drug’ in the framework decision 2004 / 757 / jha should , therefore , be amended . ### new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no . . . / . . . on new psychoactive substances ] should , once they have been added to the annex to the framework decision 2004 / 757 / jha , therefore be covered by the union criminal law on illicit drug trafficking . in order to add such substances in the annex , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of amending the annex and thereby the definition of drug in the framework decision 2004 / 757 / jha . 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 to the council .


### the chairperson of the european banking authority ; ### the chairperson of the european supervisory authority ;


### where a recommendation referred to in letter of article 3 is addressed to one or more member states , one or more european supervisory authorities , or one or more national supervisory authorities , the addressees shall communicate the actions undertaken in response to the recommendations to the esrb or explain why they have not acted . the council and , where relevant , the european supervisory authorities shall be informed . ### where a recommendation referred to in point of article 3 is addressed to the commission , one or more member states , one or more european supervisory authorities , or one or more national supervisory authorities , the addressees shall communicate the actions undertaken in response to the recommendations to the esrb or explain why they have not acted . the council and , where relevant , the european supervisory authorities shall be informed .


### the chairperson of the european insurance and occupational pensions authority ; ### the chairperson of the european supervisory authority ;


### the steering committee shall assist in the decision - making process of the esrb by supporting the preparation of the meetings of the general board , reviewing the documents to be discussed and monitoring the progress of the esrb’s ongoing work . ### the steering committee shall assist in the decision - making process of the esrb by supporting the preparation of the meetings of the general board , reviewing the documents to be discussed and monitoring the progress of the esrb’s ongoing work . where the general board is called upon to take decisions on sector - specific matters , the steering committee shall work in close collaboration with the competent european authority and its appropriate stakeholder group for the purpose of compiling the papers for meetings .


### in order to increase their weight and legitimacy , such warnings and recommendations should be transmitted through the council and , where appropriate , the european banking authority established by regulation no … / … the european parliament and of the council , the european securities and markets authority established by regulation no … / … of the european parliament and of the council , and the european insurance or the occupational pension authority established by regulation no … / …of the european parliament and of the council . ### in order to increase their weight and legitimacy , such warnings and recommendations should be transmitted directly to the addressees , and in copy to the european parliament , the council and , where appropriate , the european banking authority established by regulation no … / … the european parliament and of the council , the european securities and markets authority established by regulation no … / … of the european parliament and of the council , and the european insurance or the occupational pension authority established by regulation no … / …of the european parliament and of the council .


### the vice - chair of the esrb ; ### the first and second vice - chairs of the esrb ;


### the esrb may request information from the european supervisory authorities in summary or collective form , such that individual financial institutions cannot be identified . if the requested data are not available to those authorities or are not made available in a timely manner , the esrb may request the data from national supervisory authorities , national central banks or other authorities of member states . ### on request by the esrb , the european supervisory authorities shall provide information in summary or collective form , such that individual financial institutions cannot be identified . if the requested data are not available to those authorities or are not made available in a timely manner , and in any event within 60 days of the request , national supervisory authorities , national central banks or other authorities of member states shall provide the data pursuant to a request by the esrb .