### appropriate competences related to the functions of the digital innovation hubs ; ### appropriate competences related to the functions of the digital innovation hubs ; where possible , including experience with managing existing structures ;


### the commission shall adopt a decision on the selection of entities forming the initial network . these entities shall be selected by the commission from candidate entities designated by member states on the basis of the criteria mentioned in paragraph 2 and the following additional criteria : ### the commission , taking utmost account of the recommendation adopted by an advisory group composed of representatives of member states , shall adopt a decision on the selection of entities forming the initial network , where at least one entity per member state shall be represented . these entities shall be selected by the commission from candidate entities designated by member states on the basis of the criteria mentioned in paragraph 2 and the following additional criteria :


### where applicable , a balanced geographical distribution across the union , including the outermost regions ; ### where applicable , a balanced geographical distribution across the union and associated countries , including the union ' s outermost regions ;


### a joint procurement framework for an integrated network of world - class hpc including exascale supercomputing and data infrastructure . it will be accessible on a non - economic basis to public and private users and for publicly funded research purposes . ### a joint procurement framework for an integrated network of world - class hpc including exascale supercomputing and data infrastructure . it will be accessible to all businesses and public administrations , and on a non - economic basis to public and private users and for publicly funded research purposes .


### the programme shall support easy access to advanced digital skills , notably in hpc , ai , distributed ledgers and cybersecurity for the current and future labour force by offering students , recent graduates , and existing workers , wherever they are situated , with the means to acquire and develop these skills . ### the programme shall support easy access to advanced digital skills , notably in hpc , ai , distributed ledgers , data analysis , data science and cybersecurity for the current and future labour force by offering students , recent graduates , and existing workers , wherever they are situated , with the means to acquire and develop these skills .


### transparency on the votes of member state representatives at the appeal committee level should be increased and the individual member state representatives ' votes should be made public . ### transparency on the votes of member state representatives at the appeal committee level should be increased and the individual member state representatives ' votes should be made public in the register .


### where a basic act is adopted under the ordinary legislative procedure , either the european parliament or the council may at any time indicate to the commission that , in its view , a draft implementing act exceeds the implementing powers provided for in the basic act . in such a case , the commission shall review the draft implementing act , taking account of the positions expressed , and shall inform the european parliament and the council whether it intends to maintain , amend or withdraw the draft implementing act . ### in article 11 , paragraph 1 is replaced by the following : ' where a basic act is adopted under the ordinary legislative procedure , and after notification of the draft implementing act simultaneously to the european parliament and the council as soon as it is available , either the european parliament or the council may at any time indicate to the commission that , in its view , that draft implementing act exceeds the implementing powers provided for in the basic act or that it is not compatible with the legislative intent or the content of the basic act . in such a case , the commission shall review the draft implementing act , taking account of the positions expressed , and shall inform the european parliament and the council whether it intends to maintain , amend or withdraw the draft implementing act . '


### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are still significant disparities between member states as regards regulatory practice . moreover , the governance structure of berec and the berec office is cumbersome and gives rise to unnecessary administrative burden . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the role of berec and enhance its governance structure by establishing berec as a union decentralised agency . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum . ### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are significant disparities between member states as regards regulatory practice . moreover , the governance structure of berec and the berec office is cumbersome and gives rise to unnecessary administrative burden . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the role of berec and enhance its governance structure by establishing berec as a union decentralised agency . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum .


### the role of the executive director , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it . the management board should appoint him / her on the basis of a list drawn up by the commission following an open and transparent selection procedure in order to guarantee a rigourous evaluation of the candidates and a high level of independence . moreover , in the past the term of office of the administrative manager of the berec office was three years . it is necessary that the executive director has a sufficiently long mandate in order to ensure stability and delivery of a long - term strategy for the agency . ### the role of the executive director , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it for a term of office of 2 . 5 years . the management board should appoint him / her on the basis of a list drawn up by the commission following an open and transparent selection procedure in order to guarantee a rigorous evaluation of the candidates and a high level of independence . moreover , in the past the term of office of the administrative manager of the berec office was three years .


### experience has shown that most of berec’s tasks are better carried out through working groups , therefore the management board should be in charge of setting up working groups and appointing their members . in order to ensure a balanced approach , the working groups should be coordinated and moderated by members of the berec staff . lists of qualified experts should be prepared in advance to ensure a quick set - up of certain working groups , in particular those related to internal market procedures for draft national measures on market regulation and on assignments of rights of use for radio spectrum , due to the time limits of those procedures . ### experience has shown that most of berec ' s tasks are better carried out through expert working groups , therefore the board of regulators should be in charge of setting up working groups and appointing their co - chairs . lists of qualified experts should be prepared in advance to ensure a quick set - up of certain working groups , in particular those related to procedures with time limits . any conflict of interests of the members of working groups or observers should be avoided .


### as berec is competent for taking decisions with a binding effect , it is necessary to ensure that any natural or legal person subject to , or concerned by , a decision of berec has the right of appeal to a board of appeal , which is part of the agency but independent from its administrative and regulatory structure . as the decisions issued by the board of appeal are intended to produce legal effects towards third parties , an action for review of their legality may be brought to the general court . in order to ensure uniform conditions as regards the rules of procedure of the board of appeal , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council 33 . _________________ 33 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . ### as berec is competent for taking decisions with a binding effect , it is necessary to ensure that any natural or legal person subject to , or concerned by , a decision of berec has the right of appeal to a board of appeal , which is part of the agency and should be independent from its administrative and regulatory structure . as the decisions issued by the board of appeal are intended to produce legal effects towards third parties , an action for review of their legality may be brought to the general court . in order to ensure uniform conditions as regards the rules of procedure of the board of appeal , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council 33 . _________________ 33 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers .


### in order to further extend the consistent implementation of the provisions of the regulatory framework for electronic communications within the scope of berec , the new agency should be open to the participation of regulatory authorities of third countries competent in the field of electronic communications that have entered into agreements with the union to that effect , in particular those of eea efta states and candidate countries . ### in order to further extend the consistent implementation of the provisions of the regulatory framework for electronic communications , berec and the berec office should be open to the participation of nras of third countries competent in the field of electronic communications , in particular those that have entered into agreements with the union to that effect as eea efta states and candidate countries .


### berec should be allowed to engage in communication activities within its field of competence , which should not be detrimental to berec’s core tasks and should be carried out in accordance with relevant communication and dissemination plans adopted by the management board . the content and implementation of berec’s communication strategy should be coherent , relevant and coordinated with the strategies and activities of the commission and the other institutions in order to take into consideration the broader image of the union . ### berec , supported by the berec office , should be allowed to engage in communication activities within its field of competence , which should not be detrimental to berec ' s core tasks . the berec office ' s communication activities should be carried out in accordance with relevant communication and dissemination plans adopted by the management board . the content and implementation of berec office ' s communication strategy should be coherent , relevant and coordinated with the strategies and activities of the commission and the other institutions in order to take into consideration the broader image of the union .


### the management board shall be composed of one representative from each member state and two representatives of the commission , all with voting rights . each nra shall be responsible for nominating its respective representative amongst the head or members of the collegiate body of the nra ### the management board shall be composed of one member from each member state and one representative of the commission , all with voting rights . each nra shall be responsible for nominating its respective representative , who may be either the head or another high - level representative of the nra . third - country regulatory authorities invited by the management board shall have observer status .


### members of the management board , the executive director , seconded national experts and other staff not employed by berec shall each make a declaration indicating their commitment and the absence or presence of any direct or indirect interest which might be considered prejudicial to their independence . ### members , their alternates , and observers of the management board , the board of regulators , the director , seconded national experts and other staff not employed by the berec office shall each make an annual declaration indicating their commitment and the absence or presence of any direct or indirect interest which might be considered prejudicial to their independence .


### medicated feed should be marketed in sealed containers for safety reasons and to protect user ' s interest . ### medicated feed should be marketed in sealed containers for safety reasons and to protect user ' s interest , but appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent excessive burden for the feed business operators .


### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid carry - over . ### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid or minimise carry - over in accordance with the alara principle .


### it is necessary to guarantee legal certainty by clarifying that access to social security benefits for economically inactive mobile citizens in the host member state , may be made conditional upon that citizen holding a legal right of residence in that member state in accordance with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states . 33 for these purposes , an economically inactive citizen should be clearly distinguished from a jobseeker whose right of residence is conferred directly by article 45 of the treaty on the functioning of the european union . __________________ 33 oj l 158 , 30 . 4 . 2004 , p . 77 . ### it is necessary to guarantee legal certainty by clarifying that access to social security benefits for economically inactive mobile citizens in the host member state , may be made conditional upon that citizen holding a legal right of residence in that member state in accordance with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states . 33 for these purposes , an economically inactive citizen should be clearly distinguished from a jobseeker in accordance with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states . __________________ 33 oj l 158 , 30 . 4 . 2004 , p . 77 .


### the commission shall be empowered to adopt implementing acts specifying the procedure to be followed in order to ensure uniform conditions for the application of articles 12 and 13 of this regulation . those acts shall establish a standard procedure including time limits for ### the commission shall adopt implementing acts to specify the procedure , including where appropriate , time limits , to be followed in order to ensure the implementation under uniform conditions of articles 12 and 13 of this regulation . those implementing acts shall establish standard procedures for :


### article 79 funding of activities in the social security field in connection with this regulation and the implementing regulation , the european commission may fund in full or in part : activities aimed at improving exchanges of information between the social security authorities and institutions of the member states , particularly the electronic exchange of data ; any other activity aimed at providing information to the persons covered by this regulation and their representatives about the rights and obligations deriving from this regulation , using the most appropriate means . ### article 79 is replaced by the following : “article 79 funding of activities in the social security field in connection with this regulation and the implementing regulation , the european commission may contribute to the funding of the establishment of an electronic networking system of competent institutions using the crossroads bank for social security* model as an example . ” __________________ * http : / / www . ksz . fgov . be / en / international / page / content / websites / international / aboutcbss . html


### where no agreement is reached between the institutions concerned , the matter may be brought before the administrative commission by the competent authorities no earlier than one month following the date on which the institution that received the document submitted its request . the administrative commission shall endeavour to reconcile the points of view within six months of the date on which the matter was brought before it . ### in article 5 , paragraph 4 is replaced by the following : “4 . where no agreement is reached between the institutions concerned , the matter may be brought before the administrative commission by the competent authorities . the administrative commission shall reconcile the points of view within six months of the date on which the matter was brought before it . ”


### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted within the meaning of the directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services52 or sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation . . __________________ 52 oj l 018 , 21 . 01 . 1997 p . 1 . ### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is sent by that employer to another member state ' shall include a person who is recruited with a view to being sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation .


### for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ### paragraph 2 is replaced by the following : “2 . for the purposes of the application of article 12 of the basic regulation , the words ' which normally carries out its activities there ' shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking into account of all criteria characterising the activities carried out by the undertaking in question , such as the hours worked in the sending state where such hours worked are at least 25% of the total hours worked . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ”


### –the issuance , the format and the contents of a portable document certifying the social security legislation which applies to the holder , ### –the issuance , the electronic format and the contents , with mandatory information of a portable document certifying the social security legislation which applies to the holder ,


### tests , pre - clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product . that investment should be protected in order to stimulate research and innovation , so that it is ensured the necessary veterinary medicinal products are available in the union . for that reason data submitted to a competent authority or the agency should be protected against use by other applicants . that protection should , however , be limited in time in order to allow competition . ### tests , pre - clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product . that investment should be protected in order to stimulate research and innovation , in particular on veterinary medicinal products for minor species and antimicrobials , so that it is ensured the necessary veterinary medicinal products are available in the union . for that reason data submitted to a competent authority or the agency should be protected against use by other applicants . that protection should , however , be limited in time in order to allow competition .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with article 65 extending the marketing authorisation to another species , the periods of the protection provided for in article 34 shall be prolonged by 2 years for each additional target species listed in article 34 , provided that the variation has been submitted at least 3 years before the expiration of the protection periods laid down in article 34 .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to a another species not listed in article 34 , the period of the protection provided for in article 34 shall be prolonged by 4 years . ### where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with article 65 extending the marketing authorisation to another species , the periods of the protection provided for in article 34 shall be prolonged by 4 years for each additional target species not listed in article 34 .


### for veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the union . ### for veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the union or if the application concerns a conversion of a marketing authorisation as referred to in article 57a .


### if a member state raises , within the time period referred to in article 46 or article 48 its objections to the assessment report , proposed summary of product characteristics or proposed labelling and package leaflet , a detailed statement of the reasons shall be provided to the reference member state , the other member states and the applicant . the points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by article 142 by the reference member state . ### if a member state raises , within the time period referred to in article 46 or article 48 its objections to the assessment report , proposed summary of product characteristics or proposed labelling and package leaflet , on grounds of a potential serious risk to human or animal health or to the environment , a detailed statement of the reasons shall be provided to the reference member state , the other member states and the applicant . the points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by article 142 by the reference member state .


### in the event of an opinion in favour of granting a marketing authorisation , the reference member state shall record the agreement of member states , close the procedure and inform member states and the applicant accordingly . ### in the event of an opinion in favour of granting or amending a marketing authorisation , the reference member state shall record the agreement of member states , close the procedure and inform member states and the applicant accordingly .


### an offer of securities addressed to fewer than 150 natural or legal persons per member state , other than qualified investors ; ### addressed to fewer than 500 natural or legal persons per member state , other than qualified investors ; existing shareholders and employees shall not be included when calculating the number of persons to whom the offer is addressed ;


### an offer of securities with a total consideration in the union of less than eur 500 000 , which shall be calculated over a period of 12 months ; ### provided there is a minimum consumer protection standard in place , an offer of securities with a total consideration in the union of less than eur 1 000 000 , which shall be calculated over a period of 12 months ;


### be written in a language and a style that facilitate the understanding of the information , in particular , in language that is clear , non - technical , succinct and comprehensible . ### be written in a language and a style that facilitate the understanding of the information , in particular , in language that is clear , non - technical , succinct and comprehensible for the type of investor concerned .


### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief description of no more than five of the most material risk factors specific to the issuer contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief description of no more than five of the most material risk factors specific to the issuer contained in the category of highest materiality according to article 16 ; the number of risk factors may be increased where necessary .


### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief description of no more than five of the most material risk factors specific to the securities , contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief description of no more than five of the most material risk factors specific to the securities , contained in the category of highest materiality according to article 16 ; the number of risk factors may be increased where necessary .


### the competent authority of each host member state may require that the summary referred to in article 7 be translated into its official language or languages , but it shall not require the translation of any other part of the prospectus . ### the competent authority of each host member state shall require that the introductory summary referred to in article 7 be written in the official languages , or in one of the official languages , used in the part of the member state where the security is offered , or in another 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 those languages . the translation shall faithfully and accurately reflect the content of the original introductory summary . the competent authority of each host member state shall not require the translation of any other part of the prospectus . if a security is offered in a member state through marketing documents written in one or more official languages of that member state , the introductory summary shall be written in at least the corresponding official languages .


### the competent authority of each host member state may require that the summary referred to in article 7 be translated into its official language or languages but it shall not require the translation of any other part of the prospectus . ### the competent authority of each host member state shall require that the introductory summary referred to in article 7 be written in the official languages , or in one of the official languages , used in the part of the member state where the security is offered , or in another 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 those languages . the translation shall faithfully and accurately reflect the content of the original introductory summary . the competent authority of each host member state shall not require the translation of any other part of the prospectus . if a security is offered in a member state through marketing documents written in one or more official languages of that member state , the introductory summary shall be written in at least the corresponding official languages .


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### member states shall notify the commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion . that notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment . the commission shall facilitate the exchange of this information between member states through the it platform referred to in article 27 . ### member states may notify the commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion . that notification may be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment . the commission shall facilitate the exchange of this information between member states through the it platform referred to in article 27 .


### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors . ### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product sector .


### the power to adopt delegated acts referred to in the second subparagraph of article 2 , article 5 , article 8 and in article 14 to shall be conferred on the commission for an indeterminate period of time from [ … ] [ publications office , please insert the exact date of entry into force ] . ### the power to adopt delegated acts referred to in the second subparagraph of article 2 , article 5 , article 8 and in article 14 to shall be conferred on the commission for a period of four years from . . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of four year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament and council opposes such extension not later than three months before the end of each period . ________________ * oj : please insert the date of entry into force of this regulation .


### regulation no 1291 / 2013 of the european parliament and of the council4 established horizon 2020 - the framework programme for research and innovation . horizon 2020 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states . __________________ 4 regulation no 1291 / 2013 of the european parliament and of the council of 11 december 2013 establishing horizon 2020 – the framework programme for research and innovation and repealing decision no 1982 / 2006 / ec . ### regulation no 1291 / 2013 of the european parliament and of the council4 established horizon 2020 - the framework programme for research and innovation . horizon 2020 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states , with a view to the sustainable development of the eu member states . __________________ 4 regulation no 1291 / 2013 of the european parliament and of the council of 11 december 2013 establishing horizon 2020 – the framework programme for research and innovation and repealing decision no 1982 / 2006 / ec .


### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . ### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles - with the aim of strengthening research and innovation in order to obtain sustainable development - in particular those relating to openness and transparency .


### regulation no 1291 / 2013 has identified ' climate action , environment , resource efficiency and raw materials ' and ' food security , sustainable agriculture and forestry , marine , maritime and inland water research , and the bioeconomy ' as two of the priority societal challenges to be addressed by supporting investment in research and innovation . moreover , regulation no 1291 / 2013 recognises that research and innovation activities for these challenges should be carried out at the union level and beyond , given the transnational and global nature of the climate and the environment , their scale and complexity , and the international dimension of the food and agricultural supply chain . ### regulation no 1291 / 2013 has identified ' climate action , environment , resource efficiency and raw materials ' and ' food security , sustainable agriculture and forestry , marine , maritime and inland water research , and the bioeconomy ' as two of the priority societal challenges to be addressed forthwith by supporting investment in research and innovation . moreover , regulation no 1291 / 2013 recognises that research and innovation activities for these challenges should be carried out at the union level and beyond , given the transnational and global nature of the climate and the environment , their scale and complexity , and the international dimension of the food and agricultural supply chain .


### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges . international cooperation in research and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union . ### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges , provided that the third countries concerned are not linked in any way with so - called ‘ islamic state’ and do not trigger a migration crisis to the detriment of the contracting european states . international cooperation in research and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union .


### prima aims at implementing a joint programme for the development and the adoption of innovative and integrated solutions for improving the efficiency , safety , security and sustainability of food production and water provision in the mediterranean area . prima should contribute to the achievement of the recently - agreed sustainable development goals and to the forthcoming european sustainable development strategy . ### prima should aim at implementing a joint programme for the development and the adoption of innovative and integrated solutions for improving the efficiency , safety , security and sustainability of food production and water provision in the mediterranean area . prima should contribute to the achievement of the recently agreed sustainable development goals and to the forthcoming european sustainable development strategy in order to boost employment in the mediterranean countries .


### in line with the objectives of horizon 2020 , any other member state and third country associated to horizon 2020 should be entitled to participate in prima if it commits to contribute to the financing of prima . ### in line with the objectives of horizon 2020 , in order to boost jobs and growth , any other member state and third country associated to horizon 2020 should be entitled to participate in prima if it commits to contribute to the financing of prima .


### the union’s financial contribution should be subject to formal commitments from the participating states to contribute to the financing of prima and to the fulfilment of those commitments in accordance with the terms of this decision . flexibility should be provided to the participating states to optionally contribute financially to the prima - is in view of funding indirect actions , thus achieving a high degree of financial integration . furthermore , participating states should contribute financially or in kind to activities implemented without union contribution . the period during which the participating states have to provide their contribution should be clearly defined . ### the union’s financial contribution should be subject to formal commitments from the participating states to contribute to the financing of prima and to the fulfilment and implementation of those commitments in accordance with the terms of this decision . flexibility should be provided to the participating states to optionally contribute financially to the prima - is in view of funding indirect actions , thus achieving a high degree of financial integration . furthermore , participating states should contribute financially or in kind to activities implemented without union contribution . the period during which the participating states have to provide their contribution should be clearly defined .


### a ceiling should be established for the union’s contribution in prima with funding from horizon 2020 . within that ceiling , the union contribution should be equal to the contribution of the participating states to prima in order to achieve a high leverage effect and ensure a stronger integration of the participating states ' programmes . it should be possible to use a limited part of the union contribution to cover administrative costs of the prima - is . ### a ceiling should be established forthwith for the union’s contribution in prima with funding from horizon 2020 . within that ceiling , the union contribution should be equal to the contribution of the participating states to prima in order to achieve a high leverage effect and ensure a stronger integration of the participating states ' programmes . it should be possible to use a limited part of the union contribution to cover administrative costs of the prima - is .


### prima activities should be in line with the objectives and research and innovation priorities of horizon 2020 and with the general principles and conditions laid down in article 26 of regulation no 1291 / 2013 . prima should take into account the oecd definitions regarding technological readiness level in the classification of technological research , product development and demonstration activities . ### prima activities should be in line with the objectives and research and innovation priorities - which operate as key drivers for smart , sustainable and inclusive development - of horizon 2020 and with the general principles and conditions laid down in article 26 of regulation no 1291 / 2013 . prima should take into account the oecd definitions regarding technological readiness level in the classification of technological research , product development and demonstration activities .


### the provisions of this regulation particularise and complement the general rules on the protection of personal data laid down in regulation 2016 / 679 as regards electronic communications data that qualify as personal data . this regulation therefore does not lower the level of protection enjoyed by natural persons under regulation 2016 / 679 . processing of electronic communications data by providers of electronic communications services should only be permitted in accordance with this regulation . ### the provisions of this regulation complement the general rules on the protection of personal data laid down in regulation 2016 / 679 as regards electronic communications data that qualify as personal data and do not go beyond or contradict the high level of protection set down in regulation 2016 / 679 . this regulation therefore does not lower the level of protection enjoyed by natural persons under regulation 2016 / 679 . processing of electronic communications data by providers of electronic communications services should only be permitted in accordance with this regulation .


### while the principles and main provisions of directive 2002 / 58 / ec of the european parliament and of the council22 remain generally sound , that directive has not fully kept pace with the evolution of technological and market reality , resulting in an inconsistent or insufficient effective protection of privacy and confidentiality in relation to electronic communications . those developments include the entrance on the market of electronic communications services that from a consumer perspective are substitutable to traditional services , but do not have to comply with the same set of rules . another development concerns new techniques that allow for tracking of online behaviour of end - users , which are not covered by directive 2002 / 58 / ec . directive 2002 / 58 / ec should therefore be repealed and replaced by this regulation . _________________ 22 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector . ### while the principles and main provisions of directive 2002 / 58 / ec of the european parliament and of the council22 remain generally sound , that directive has not fully kept pace with the evolution of technological and market reality , resulting in insufficient clarity and inconsistent enforcement of the protection of privacy and confidentiality in relation to electronic communications . those developments include the entrance on the market of electronic communications services that from a consumer perspective are substitutable to traditional services , or new techniques that allow for tracking of online behaviour of end - users , both of which are covered by regulation 2016 / 679 . _________________ 22 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector .


### this regulation should apply to electronic communications data processed in connection with the provision and use of electronic communications services in the union , regardless of whether or not the processing takes place in the union . moreover , in order not to deprive end - users in the union of effective protection , this regulation should also apply to electronic communications data processed in connection with the provision of electronic communications services from outside the union to end - users in the union . ### this regulation should apply to electronic communications data processed in connection with the offering and use of electronic communications services in the union , regardless of whether or not the processing takes place in the union . moreover , in order not to deprive end - users in the union of effective protection , this regulation should also apply to electronic communications data processed in connection with the provision of electronic communications services from outside the union to end - users in the union . the mere accessibility of the electronic communication service in the union is not sufficient to ascertain such intention .


### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ‘ hotspots’ situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . the fact that wireless electronic communications services may be ancillary to other services should not stand in the way of ensuring the protection of confidentiality of communications data and application of this regulation . therefore , this regulation should apply to electronic communications data using electronic communications services and public communications networks . in contrast , this regulation should not apply to closed groups of end - users such as corporate networks , access to which is limited to members of the corporation . ### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ‘ hotspots’ situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . this regulation should apply to electronic communications data using publicly available electronic communications services and public communications networks . in this context , publicly available means only services intended for consumers . it should not include services intended for business users , nor should the means of the delivery of the service in question , whether obtained over the public internet or not have any bearing on the interpretation of whether the service is publicly available or not . this regulation should not apply to closed groups of end - users such as corporate networks , access to which is limited to members of the corporation .


### electronic communications data should be defined in a sufficiently broad and technology neutral way so as to encompass any information concerning the content transmitted or exchanged and the information concerning an end - user of electronic communications services processed for the purposes of transmitting , distributing or enabling the exchange of electronic communications content ; including data to trace and identify the source and destination of a communication , geographical location and the date , time , duration and the type of communication . whether such signals and the related data are conveyed by wire , radio , optical or electromagnetic means , including satellite networks , cable networks , fixed and mobile terrestrial networks , electricity cable systems , the data related to such signals should be considered as electronic communications metadata and therefore be subject to the provisions of this regulation . electronic communications metadata may include information that is part of the subscription to the service when such information is processed for the purposes of transmitting , distributing or exchanging electronic communications content . ### electronic communications data should be defined in a sufficiently broad and technology neutral way so as to encompass any information concerning the content transmitted and the information concerning an end - user of electronic communications services processed for the purposes of transmitting of electronic communications content ; including data to trace and identify the source and destination of a communication , geographical location and the date , time , duration and the type of communication . whether such signals and the related data are conveyed by wire , radio , optical or electromagnetic means , including satellite networks , cable networks , fixed and mobile terrestrial networks , electricity cable systems , the data related to such signals should be considered as electronic communications metadata and therefore be subject to the provisions of this regulation . electronic communications metadata may include information that is part of the subscription to the service when such information is processed for the purposes of transmitting electronic communications content .


### terminal equipment of end - users of electronic communications networks and any information relating to the usage of such terminal equipment , whether in particular is stored in or emitted by such equipment , requested from or processed in order to enable it to connect to another device and or network equipment , are part of the private sphere of the end - users requiring protection under the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms . given that such equipment contains or processes information that may reveal details of an individual’s emotional , political , social complexities , including the content of communications , pictures , the location of individuals by accessing the device’s gps capabilities , contact lists , and other information already stored in the device , the information related to such equipment requires enhanced privacy protection . furthermore , the so - called spyware , web bugs , hidden identifiers , tracking cookies and other similar unwanted tracking tools can enter end - user’s terminal equipment without their knowledge in order to gain access to information , to store hidden information and to trace the activities . information related to the end - user’s device may also be collected remotely for the purpose of identification and tracking , using techniques such as the so - called ‘ device fingerprinting’ , often without the knowledge of the end - user , and may seriously intrude upon the privacy of these end - users . techniques that surreptitiously monitor the actions of end - users , for example by tracking their activities online or the location of their terminal equipment , or subvert the operation of the end - users’ terminal equipment pose a serious threat to the privacy of end - users . therefore , any such interference with the end - user’s terminal equipment should be allowed only with the end - user’s consent and for specific and transparent purposes . ### terminal equipment of end - users of electronic communications networks and any information relating to the usage of such terminal equipment , whether in particular is stored in or emitted by such equipment , requested from or processed in order to enable it to connect to another device and or network equipment , are part of the private sphere of the end - users requiring protection under the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms . given that such equipment contains or processes information that may reveal details of an individual’s emotional , political , social complexities , including the content of communications , pictures , the location of individuals by accessing the device’s gps capabilities , contact lists , and other information already stored in the device , the information related to such equipment requires enhanced privacy protection . furthermore , the so - called spyware , web bugs , hidden identifiers , and other unwanted tracking tools can enter end - user’s terminal equipment without their knowledge in order to gain access to information , to store hidden information and to trace the activities . information related to the end - user’s device may also be collected remotely for the purpose of identification and tracking , using techniques such as the so - called ‘ device fingerprinting’ , often without the knowledge of the end - user , and may seriously intrude upon the privacy of these end - users . techniques that surreptitiously monitor the actions of end - users , for example by tracking their activities online or the location of their terminal equipment , or subvert the operation of the end - users’ terminal equipment pose a serious threat to the privacy of end - users . therefore , any such interference with the end - user’s terminal equipment should be allowed only with the end - user’s consent and for specific and transparent purposes .


### exceptions to the obligation to obtain consent to make use of the processing and storage capabilities of terminal equipment or to access information stored in terminal equipment should be limited to situations that involve no , or only very limited , intrusion of privacy . for instance , consent should not be requested for authorizing the technical storage or access which is strictly necessary and proportionate for the legitimate purpose of enabling the use of a specific service explicitly requested by the end - user . this may include the storing of cookies for the duration of a single established session on a website to keep track of the end - user’s input when filling in online forms over several pages . cookies can also be a legitimate and useful tool , for example , in measuring web traffic to a website . information society providers that engage in configuration checking to provide the service in compliance with the end - user’s settings and the mere logging of the fact that the end - user’s device is unable to receive content requested by the end - user should not constitute access to such a device or use of the device processing capabilities . ### exceptions to the obligation to obtain consent to make use of the processing and storage capabilities of terminal equipment or to access information stored in terminal equipment should be limited to situations that involve no , or only very limited , intrusion of privacy . for instance , consent should not be requested for authorizing the technical storage or access which is necessary and proportionate for the legitimate purpose of enabling the use of a specific service explicitly requested by the end - user . this may include the storing of cookies for the duration of a single established session on a website to keep track of the end - user’s input when filling in online forms over several pages . this may also cover situations where end - users use a service across devices for the purpose of service personalisation and content recommendation . cookies can also be a legitimate and useful tool , for example , in measuring web traffic to a website . information society providers that engage in configuration checking to provide the service in compliance with the end - user’s settings and the mere logging of the fact that the end - user’s device is unable to receive content requested by the end - user should not constitute access to such a device or use of the device processing capabilities .


### if end - users that are natural persons give their consent to their data being included in such directories , they should be able to determine on a consent basis which categories of personal data are included in the directory . in addition , providers of publicly available directories should inform the end - users of the purposes of the directory and of the search functions of the directory before including them in that directory . end - users should be able to determine by consent on the basis of which categories of personal data their contact details can be searched . the categories of personal data included in the directory and the categories of personal data on the basis of which the end - user’s contact details can be searched should not necessarily be the same . ### if end - users that are natural persons do not object to the inclusion of their data from providers of number - based interpersonal communication services and electronic communication providers in public directories , they should be able to determine which categories of personal data are included in the directory . in addition , providers of publicly available directories should inform the end - users of the purposes of the directory and of the search functions of the directory .


### it is necessary for providing an information society service requested by the end - user ; or ### it is necessary for providing an information society service requested by the end - user ; particularly to preserve or restore the security of the information society service and of the users , or to detect technical faults ; or


### the providers of publicly available directories shall provide end - users that are legal persons with the possibility to object to data related to them being included in the directory . providers shall give such end - users that are legal persons the means to verify , correct and delete such data . ### the providers electronic information , communication and telecommunication services shall provide end - users that are legal persons or natural persons acting in their business capacity with the possibility to object to data related to them being included in the directory . providers shall give such end - users that are legal persons the means to verify , correct , update , supplement and delete such data .


### the investeu portal shall be established by the commission . it shall be an easily accessible and user - friendly project database , providing relevant information for each project . ### the investeu portal shall be established by the commission . it shall be a user - friendly project database , available in all the eu ' s official languages , providing relevant information for each project .


### 4transport : investment mobilised in ten - t of which : ten - t core ### 4 . transport : investment mobilised in ten - t of which : ten - t core and additional network


### the lulucf sector can contribute to climate change mitigation in several ways , in particular by reducing emissions , and maintaining and enhancing sinks and carbon stocks . in order for measures aiming in particular at increasing carbon sequestration to be effective , the long - term stability and adaptability of carbon pools is essential . ### the lulucf sector can contribute to climate change mitigation in several ways , in particular by reducing emissions , and maintaining and enhancing sinks and carbon stocks . in order for measures aiming in particular at increasing carbon sequestration to be effective and in line with the paris agreement , the long - term stability and adaptability of carbon pools is essential .


### the commission shall review the national forestry accounting plans and technical corrections and assess the extent to which the proposed new or corrected forest reference levels have been determined in accordance with the principles and requirements set out in paragraphs and as well as article 5 . to the extent that this is required in order to ensure compliance with the principles and requirements set out in paragraphs and as well as article 5 , the commission may recalculate the proposed new or corrected forest reference levels . ### the commission shall carry out a review of the national forestry accounting plans and technical corrections and conduct a technical analysis of the extent to which the proposed new or corrected forest reference levels have been determined in accordance with the principles and requirements set out in paragraphs and as well as article 5 until corresponding modalities , procedures and guidelines are developed by bodies of the unfccc . to the extent that this is required in order to ensure compliance with the principles and requirements set out in paragraphs and as well as article 5 , the commission may provide technical recommendations to member states in order to facilitate a technical revision of the proposed new or corrected forest reference levels .


### the commission shall adopt delegated acts in accordance with article 14 to amend annex ii in the light of the review carried out pursuant to paragraph to update member state forest reference levels based on the national forestry accounting plans or the technical corrections submitted , and any recalculations made in the context of the review . until the entry into force of the delegated act , member state forest reference levels as specified in annex ii shall continue to apply for the period 2021 - 2025 and / or 2026 - 2030 . ### the commission shall adopt implementing acts in accordance with article 14a in the light of the review carried out pursuant to paragraph to establish member state forest reference levels based on assumptions provided in the national forestry accounting plans or the technical corrections submitted , and any recalculations made in the context of the review , by 31 december 2019 for the period 2021 - 25 and by 30 june 2024 for the period 2026 - 30 .


### in order to secure competition and the supply of electricity at the most competitive price , member states and national regulatory authorities should facilitate cross - border access for new suppliers of electricity from different energy sources as well as for new providers of power generation , storage and demand response . ### in order to secure competition and the supply of electricity at the most competitive price , member states and national regulatory authorities should facilitate cross - border access for new suppliers of electricity from different energy sources as well as for new providers of power generation , storage and demand response . however , member states should cooperate in scheduling electricity flows and should take necessary action to prevent unscheduled loop - flows of electricity .


### when it comes to deciding at national level on the smart metering deployment , it should be possible to base this on an economic assessment . should that assessment conclude that the introduction of such metering systems is economically reasonable and cost - effective only for consumers with a certain amount of electricity consumption , member states should be able to take that into account when proceeding with implementation . ### when it comes to deciding at national level on the smart metering deployment , it should be possible to base this on an economic assessment , but also taking into account technical feasibility and proportionality of assumed savings compared to necessary costs . should that assessment conclude that the introduction of such metering systems is economically reasonable and cost - effective only for consumers with a certain amount of electricity consumption , member states should be able to take that into account when proceeding with implementation .


### the development of digital technologies and internet has transformed the distribution of and access to television and radio programmes . users increasingly expect to have access to television and radio programmes both live and on - demand , using traditional channels such as satellite or cable and also through online services . broadcasting organisations are therefore increasingly offering , in addition to their own broadcasts of television and radio programmes , online services ancillary to their broadcast , such as simulcasting and catch - up services . retransmission services operators , which aggregate broadcasts of television and radio programmes into packages and provide them to users simultaneously to the initial transmission of the broadcast , unaltered and unabridged , use various techniques of retransmission such as cable , satellite , digital terrestrial , closed circuit ip - based or mobile networks as well as the open internet . on the part of users , there is a growing demand for access to broadcasts of television and radio programmes not only originating in their member state but also in other member states of the union , including from members of linguistic minorities of the union as well as from persons who live in another member state than their member state of origin . ### the development of digital technologies , the internet and online marketplace is transforming the distribution of , and access to , television and radio programmes . users increasingly expect to have access to television and radio programmes both live and on - demand , using traditional channels such as satellite or cable and also through online services . broadcasting organisations are therefore increasingly offering , in addition to their own broadcasts of television and radio programmes , online services ancillary to their broadcast that are complementary to their traditional linear output , such as simulcasting and catch - up services . retransmission services operators , which aggregate broadcasts of television and radio programmes into packages and provide them to users simultaneously to the initial transmission of the broadcast , unaltered and unabridged , use various techniques of retransmission such as cable , satellite , digital terrestrial , closed circuit ip - based or mobile networks as well as the open internet . on the part of users , there is a growing demand for access to broadcasts of television and radio programmes not only originating in their member state but also in other member states of the union , including from members of linguistic minorities of the union as well as from persons who live in another member state than their member state of origin . such demand needs to be weighed against the success of the current territorial funding model for european content , which is vital to current and future investment in high quality european content and the success of the audiovisual media sector .


### through the principle of contractual freedom it will be possible to continue limiting the exploitation of the rights affected by the principle of country of origin laid down in this regulation , especially as far as certain technical means of transmission or certain language versions are concerned , provided that any such limitations of the exploitation of those rights are in compliance with union law . ### through the principle of contractual freedom it remains possible to limit the exploitation of the rights , especially as far as certain technical means of transmission or certain language versions and the necessarily territorial nature of certain contracts are concerned .


### operators of retransmission services offered on satellite , digital terrestrial , closed circuit ip - based , mobile and similar networks , provide services which are equivalent to those provided by operators of cable retransmission services when they retransmit simultaneously , in an unaltered and unabridged manner , for reception by the public , an initial transmission from another member state of television or radio programmes , where this initial transmission is by wire or over the air , including by satellite but excluding online transmissions , and intended for reception by the public . they should therefore be within the scope of this regulation and benefit from the mechanism introducing mandatory collective management of rights . retransmission services which are offered on the open internet should be excluded from the scope of this regulation as those services have different characteristics . they are not linked to any particular infrastructure and their ability to ensure a controlled environment is limited when compared for example to cable or closed circuit ip - based networks . ### operators of retransmission services offered on satellite , digital terrestrial , closed circuit ip - based , mobile and similar networks , provide services that are equivalent to those provided by operators of cable retransmission services when they retransmit simultaneously , in an unaltered and unabridged manner , for reception by the public , an initial transmission from another member state of television or radio programmes , where this initial transmission is by wire or over the air , including by satellite but excluding online transmissions , and intended for reception by the public . they should therefore be within the scope of this regulation and benefit from the mechanism introducing mandatory collective management of rights . retransmission services that are offered on the open internet should , however , be excluded from the scope of this regulation as such services have different characteristics . they are not linked to any particular infrastructure and their ability to ensure a controlled environment is limited when compared for example to cable or closed circuit ip - based networks .


### in order to ensure legal certainty , it is necessary to clarify that rules on union market surveillance and control of products entering the union market provided for in regulation no 765 / 2008 of the european parliament and of the council21 apply to energy - related products . given the principle of free movement of goods , it is imperative that the market surveillance authorities of the member states cooperate with each other effectively . such cooperation on energy labelling should be reinforced through support by the commission . __________________ 21 oj l 218 , 13 . 8 . 2008 , p . 30 . ### in order to ensure legal certainty , it is necessary to clarify that rules on union market surveillance and control of products entering the union market provided for in regulation no 765 / 2008 of the european parliament and of the council apply to energy - related products . given the principle of free movement of goods , it is imperative that the market surveillance authorities of the member states cooperate with each other effectively . such cooperation on energy labelling should be reinforced through support by the commission to the group of experts on ecodesign and energy labelling administrative co - operation working group . __________________ 21 null


### ‘ label’ means a graphic diagram including a classification using letters from a to g in seven different colours from dark green to red in order to show consumption of energy ; ### ‘ label’ means a graphic diagram , either in printed or electronic form , including a classification using letters from a to g in seven different colours from dark green to red in order to show energy efficiency and consumption of energy . it includes rescaled labels and labels with fewer classes and colours in accordance with article 7 and ;


### ' product information sheet ' means a standard table of information relating to a product ; ### ' product information sheet ' means a standard table of information relating to a product , either in printed or electronic form ;


### suppliers shall comply with the following : ### suppliers shall :


### they shall ensure that products placed on the market are provided , free of charge , with accurate labels and product information sheets in accordance with this regulation and the relevant delegated acts ; ### ensure that products placed on the market are supplied , free of charge , with accurate labels and product information sheets for each unit in accordance with this regulation and the relevant implementing acts adopted under article 12 of this regulation . as an alternative to supplying the product information sheet with the product , implementing acts may provide that entering the parameters of such product information sheets into the product database established under article 8 is sufficient .


### they shall display in a visible manner the label provided by the supplier or otherwise made available for a product covered by a delegated act ; ### they shall display in a visible manner , on the appliance or in its immediate proximity , the label provided by the supplier or otherwise made available for a product covered by an implementing act ;


### member states shall not prohibit , restrict or impede the placing on the market or putting into service , within their territories , of energy - related products which comply with this regulation and its relevant delegated acts . ### member states shall not impede , in relation to matters covered by this regulation , the placing on the market or putting into service , within their territories , of products which comply with this regulation and the relevant implementing acts under this regulation .


### the agency should contribute towards raising the awareness of the public about risks related to cybersecurity and provide guidance on good practices for individual users aimed at citizens and organisations . the agency should also contribute to promote best practices and solutions at the level of individuals and organisations by collecting and analysing publicly available information regarding significant incidents , and by compiling reports with a view to providing guidance to businesses and citizens and improving the overall level of preparedness and resilience . the agency should furthermore organise , in cooperation with the member states and the union institutions , bodies , offices and agencies regular outreach and public education campaigns directed to end - users , aiming at promoting safer individual online behaviour and raising awareness of potential threats in cyberspace , including cybercrimes such as phishing attacks , botnets , financial and banking fraud , as well as promoting basic authentication and data protection advice . the agency should play a central role in accelerating end - user awareness on security of devices . ### the agency should contribute towards raising the awareness of the public about risks related to cybersecurity and provide guidance on good practices for individual users aimed at citizens and organisations . the agency should also contribute to promote best practices and solutions at the level of individuals and organisations by collecting and analysing publicly available information regarding significant incidents , and by compiling reports with a view to providing guidance to businesses and citizens and improving the overall level of preparedness and resilience . the agency should furthermore organise , in cooperation with the member states and the union institutions , bodies , offices and agencies regular outreach and public education campaigns directed to end - users , aiming at promoting safer individual online behaviour and raising awareness of measures that can be taken to guard against potential threats in cyberspace , including cybercrimes such as phishing attacks , botnets , financial and banking fraud , as well as promoting basic authentication and data protection advice . the agency should play a central role in accelerating end - user awareness on security of devices and secure use of services .


### conformity assessment is the process demonstrating whether specified requirements relating to a product , process , service , system , person or body have been fulfilled . for the purposes of this regulation , certification should be considered as a type of conformity assessment regarding the cybersecurity features of a product , process , service , system , or a combination of those by an independent third party , other than the product manufacturer or service provider . certification cannot guarantee per se that certified ict products and services are cyber secure . it is rather a procedure and technical methodology to attest that ict products and services have been tested and that they comply with certain cybersecurity requirements laid down elsewhere , for example as specified in technical standards . ### conformity assessment is the process demonstrating whether specified requirements relating to a product , process , service , system , person or body have been fulfilled . for the purposes of this regulation , certification should be considered as a type of conformity assessment regarding the cybersecurity features and practices comprised in a product , process , service , system , or a combination of those by an independent third party , other than the product manufacturer or service provider . certification cannot guarantee per se that certified ict products and services are cyber secure . it is rather a procedure and technical methodology to attest that ict products and services as well as the underlying processes and systems have been tested and that they comply with certain cybersecurity requirements laid down elsewhere , for example as specified in technical standards .


### facilitate the establishment and take - up of european and international standards for risk management and for the security of ict products and services , as well as draw up , in collaboration with member states , advice and guidelines regarding the technical areas related to the security requirements for operators of essential services and digital service providers , as well as regarding already existing standards , including member states’ national standards , pursuant to article 19 of directive 2016 / 1148 ; ### consult international and european standardisation organisations on the development of standards for risk management and for the security of ict products and services and facilitate the establishment and take - up of relevant international and european standards ;


### when preparing candidate schemes referred to in paragraph 1 of this article , enisa shall consult all relevant stakeholders and closely cooperate with the group . the group shall provide enisa with the assistance and expert advice required by enisa in relation to the preparation of the candidate scheme , including by providing opinions where necessary . ### throughout the preparation of candidate schemes referred to in paragraph 1 of this article , enisa shall consult all relevant stakeholders and closely cooperate with the group . relevant stakeholders and the group shall provide enisa with the assistance and expert advice required by enisa in relation to the preparation of the candidate scheme , including by providing opinions where necessary . where relevant , enisa may also set up a stakeholder expert group , composed of members of the permanent stakeholders’ group and any other relevant stakeholders with specific expertise in the field of a given candidate scheme , in order to provide further assistance and advice .


### a european cybersecurity certification scheme shall be so designed to take into account , as applicable , the following security objectives : ### a european cybersecurity certification scheme shall be so designed to take into account at least the following security objectives , insofar as they are relevant :


### a european cybersecurity certificate pursuant to this article shall be issued by the conformity assessment bodies referred to in article 51 on the basis of criteria included in the european cybersecurity certification scheme , adopted pursuant to article 44 . ### a european cybersecurity certificate pursuant to this article shall be either subject to a declaration of conformity by a manufacturer or service provider or issued by the conformity assessment bodies referred to in article 51 on the basis of criteria included in the european cybersecurity certification scheme , adopted pursuant to article 44 . where a scheme offers more than one level of assurance , it may choose a combination of methods to determine compliance with the scheme .


### certificates shall be issued for a maximum period of three years and may be renewed , under the same conditions , provided that the relevant requirements continue to be met . ### certificates shall be issued for a maximum period as deemed appropriate for each scheme , which shall not be less than 24 months where those are issued by a conformity assessment body . certificates may be renewed , under the same conditions , provided that the relevant requirements continue to be met . certificates shall not become invalid following the provision of updates or other changes in hardware or software versions where the requirements of article 47 are complied with .


### an operation may receive support from one or more esi funds or from one or more programmes and from other union instruments , provided that the expenditure declared in a payment application for one of the esi funds does not receive support from another fund or union instrument , or support from the same fund under another programme . the amount of expenditure to be entered into a payment application of an esi fund may be calculated for each esi fund on a pro rata basis in accordance with the document setting out the conditions for support . ### without prejudice to art . 65 , an operation may receive support from one or more esi funds or from one or more programmes and from other union instruments , provided that the expenditure declared in a payment application for one of the esi funds does not receive support from another fund or union instrument , or support from the same fund under another programme . the amount of expenditure to be entered into a payment application of an esi fund may be calculated for each esi fund on a pro rata basis in accordance with the document setting out the conditions for support .


### “1a . operations concerning the provision of services to citizens or businesses which cover the whole territory of a member state shall be considered as being located in all programme areas within a member state . in such cases , expenditure shall be allocated to the concerned programme areas on a pro - rata basis , based on objective criteria other than the budget allocation to the programme areas . ### “1a . operations concerning the provision of services to citizens or businesses which cover the whole territory of a member state shall be considered as being located in all programme areas within a member state . in such cases , expenditure shall be allocated to the concerned programme areas on a pro - rata basis , based on objective criteria .


### “2a . for the funds and the emff where operations implemented outside the programme area in accordance with paragraph 2 have benefits both outside and within the programme area expenditure shall be allocated to these areas on a pro rata basis based on objective criteria other than the budget allocation to the programme areas . ; ” ### “2a . for the funds and the emff where operations implemented outside the programme area in accordance with paragraph 2 have benefits both outside and within the programme area expenditure shall be allocated to these areas on a pro rata basis based on objective criteria ; ”


### where the independent quality review has not been notified to the commission within 6 month of the submission of that information to the independent experts or where the relevant appraisal is negative , the corresponding expenditure shall be withdrawn and the declaration of expenditure shall be rectified accordingly . ; ### an independent quality review shall be delivered within 9 months of the submission of that information to the independent experts . where the independent quality review has not been notified to the commission within 3 months after its completion or where the relevant appraisal is negative , the corresponding expenditure shall be withdrawn and the declaration of expenditure shall be rectified accordingly . ;


### the impact assessment carried out underlines the benefits of changing the overall governance approach to clean vehicle procurement at union level . setting minimum procurement targets can effectively reach the objective of impacting market uptake of clean vehicles in comparison to relying on the internalisation of external cost into overall procurement decisions , while noting the relevance to consider environmental aspects in all procurement decisions . the medium and long - term benefits for european citizens and enterprises fully justify this approach insofar as it does not prescribe a specific technology to use for contracting authorities , entities and operators . ### the impact assessment carried out underlines the benefits of changing the overall governance approach to clean vehicle procurement at union level . setting minimum procurement targets can effectively reach the objective of impacting market uptake of clean vehicles in comparison to relying on the internalisation of external cost into overall procurement decisions , while noting the relevance to consider environmental aspects in all procurement decisions . the medium and long - term benefits for european citizens and enterprises fully justify this approach insofar as it does not prescribe a specific technology to use for contracting authorities , entities and operators . the eu nonetheless appreciates the often very difficult financial situation of many municipalities and their financial capacity when it comes to implementing the directive .


### further support to market uptake of clean vehicles can be achieved by providing targeted public support measures at national and union level . this includes better exchange of knowledge and alignment of procurement to enable actions at a scale great enough for cost reductions and market impact . the possibility of public support in favour of promoting development of infrastructures necessary for the distribution of alternative fuels is recognised in the guidelines on state aid for environmental protection and energy 2014 - 202027 . however , the rules of the treaty , and in particular articles 107 and 108 thereof , will continue to apply to such public support . _________________ 27 oj c 200 , 28 . 6 . 2014 , p . 1 . ### further support to market uptake of clean vehicles can be achieved by providing targeted public support measures at national and union level . this includes better exchange of knowledge and alignment of procurement to enable actions at a scale great enough for cost reductions and market impact . regional pilot projects should also be encouraged , particularly in places where rural and urban areas interconnect . the possibility of public support in favour of promoting development of infrastructures necessary for the distribution of alternative fuels is recognised in the guidelines on state aid for environmental protection and energy 2014 - 202027 . however , the rules of the treaty , and in particular articles 107 and 108 thereof , will continue to apply to such public support . _________________ 27 oj c 200 , 28 . 6 . 2014 , p . 1 .


### this directive shall apply to representative actions brought against infringements by traders of provisions of the union law listed in annex i that harm or may harm the collective interests of consumers . it shall apply to domestic and cross - border infringements , including where those infringements have ceased before the representative action has started or before the representative action has been concluded . ### this directive shall apply to representative actions brought against infringements by traders of provisions of the union law listed in annex i that does or is likely to do mass harm to the collective interests of consumers . &#160 ; it&#160 ; shall apply to infringements with a union dimension , &#160 ; including where those&#160 ; infringements have ceased before the representative action&#160 ; has started&#160 ; or&#160 ; before the representative action has been concluded .


### the framework for the screening of foreign direct investment should provide the member states and the commission with the means to address risks to security or public order in a comprehensive manner , and to adapt to changing circumstances , whilst maintaining the necessary flexibility for member states to screen foreign direct investments on grounds of security and public order taking into account their individual situations and national circumstances . ### the framework for the screening of foreign direct investment should first and foremost provide the member states and the commission with the means to address risks to security or public order in a comprehensive manner , and to adapt to changing circumstances , whilst maintaining the necessary flexibility for member states to screen foreign direct investments on grounds of security and public order taking into account their individual situations and national circumstances .


### in order to facilitate the cooperation with other member states and the screening of foreign direct investment by the commission , member states should notify their screening mechanisms and any amendment thereto to the commission , and should report on the application of their screening mechanisms on a regular basis . for the same reason , member states that do not have a screening mechanism should also report on the foreign direct investments that took place in their territory , on the basis of the information available to them . ### in order to facilitate the cooperation with other member states and the screening of foreign direct investment by the commission , member states may report on the application of their screening mechanisms on a regular basis . member states that do not maintain a screening mechanism should report on the foreign direct investments that took place in their territory , on the basis of the information available to them .


### to that end , it is also important to ensure a minimum level of information and coordination with regard to foreign direct investments falling under the scope of this regulation in all member states . this information should be made available by the member states in which the foreign direct investment is planned or has been completed upon request of the member states or of the commission . relevant information includes aspects such as the ownership structure of the foreign investor and the financing of the planned or completed investment , including , when available , information about subsides granted by third countries . ### to that end , it is also important to ensure a minimum level of information and coordination with regard to foreign direct investments falling under the scope of this regulation in all member states . this information should be made available by the member states in which the foreign direct investment is planned or has been completed upon request of the member states or of the commission . relevant information includes aspects such as the ownership structure of the foreign investor and the financing of the planned or completed investment , including information about subsides granted by third countries .


### the communication and cooperation at member state and union level should be enhanced through the establishment of contact points for the screening of foreign direct investments in each member state . ### the communication and cooperation at member state and union level should be enhanced through the establishment of contact points for screening and monitoring the course of foreign direct investments in each member state .


### member states that maintain screening mechanisms shall provide the commission with an annual report on the application of their screening mechanisms . for each reporting period , the report shall include in particular information on : ### by . . . [ 3 years after the entry into force of this regulation ] , and every five years thereafter , member states that maintain screening mechanisms shall provide the commission with a report on the application of their screening mechanisms . for each reporting period , the report shall include in particular information on :