### 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 ;


### the summary shall be drawn up as a short document written in a concise manner and of a maximum of six sides of a4 - sized paper when printed . it shall : ### the introductory summary shall be drawn up as a short document written in a concise manner . it shall :


### an introduction containing warnings ; ### an introduction containing warnings , including the extent to which investors can lose their investment in a worst - case scenario ;


### in as much as measures entail the processing of personal data , those shall be carried out in accordance with union law on the protection of personal data20 . in particular , personal data collected for the purposes of directive 98 / 41 / ec should not be processed and used for any other purpose and should not be retained longer than necessary for the purposes of directive 98 / 41 / ec as specified therein . _______________ 20 in particular regulation no xxx / 2016 of xxx of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data and regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . ### the measures provided for in directive 98 / 41 / ec and directive 2010 / 65 / ec entail the processing of personal data . this processing is governed by union law on the protection of personal data , in particular regulation 2016 / 679 of the european parliament and of the council20a , and regulation no 45 / 2001 of the european parliament and of the council20b , which applies to the processing of personal data recorded in the single window and safeseanet . in particular , personal data collected for the purposes of directive 98 / 41 / ec to facilitate search and rescue operations and the efficient handling of the aftermath of an accident should not be further processed and used for any other purpose and should not be retained longer than necessary for the specific purposes of directive 98 / 41 / ec as specified therein . personal data should therefore be immediately destroyed after the ship ' s voyage has been safely completed or when an investigation or judicial proceedings in the aftermath of an accident or emergency have been concluded . __________________ 20a regulation 2016 / 679 of the european parliament and of the council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . 20b regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data .


### - their year of birth , ### - their date of birth ,


### personal data collected for the purposes of this directive should not be processed and used for any other purpose . ; ### personal data collected for the purposes of this directive shall not be processed and used for any other purpose .


### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . without prejudice to other reporting obligations , once the information is no longer needed for this purpose , it shall be destroyed . ### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . without prejudice to other specific reporting obligations under union or national law , including for statistical purposes , once the information is no longer needed for this purpose , it shall be immediately destroyed .


### without prejudice to other reporting obligations , once the information is no longer needed for these purposes , it shall be destroyed . ; ### without prejudice to other specific reporting obligations under union or national law , including for statistical purposes , once the information is no longer needed for that purpose , it shall be immediately destroyed .


### to reduce the anxiety of relatives in case of an accident and unnecessary delays in the consular assistance and other services , the communicated data should include information on nationality of persons on board . the list of required data entries for voyages beyond 20 nautical miles should be simplified , clarified and aligned as far as possible with reporting requirements into the national single window . ### to provide relatives with timely and reliable information in the case of an accident and to reduce unnecessary delays in the consular assistance and other services , the communicated data should include information on nationality of persons on board . the list of required data entries for voyages beyond 20 nautical miles should be simplified , clarified and aligned as far as possible with reporting requirements into the national single window .


### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . without prejudice to other reporting obligations , once the information is no longer needed for this purpose , it shall be destroyed . ### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive , namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . once recorded , the data shall be destroyed automatically . without prejudice to other specific reporting obligations required by law , including for statistical purposes , once the information is no longer needed for this purpose , it shall be destroyed automatically .


### 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 / 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 classified as high risk class iib implantable devices and class iii devices pursuant to article 51 of regulation 2017 / 745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation and which have already been marketed in at least one member state . _________________ 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 .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 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 the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 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 the member states of the commission ' s exercise of implementing powers .


### 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 or the 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 .


### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent third parties from storing information on the terminal equipment ; this is often presented as ‘ reject third party cookies’ . end - users should be offered a set of privacy setting options , ranging from higher to lower and intermediate . such privacy settings should be presented in a an easily visible and intelligible manner . ### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent by default the cross - domain tracking and storing of information on the terminal equipment by other parties ; this is often presented as ‘ reject third party trackers and cookies’ . users should be offered , by default , a set of privacy setting options , ranging from higher to lower and intermediate . these options may also be more fine - grained . privacy settings should also include options to allow the user to decide for example , whether flash , javascript or similar software can be executed , if a website can collect geo - location data from the user , or if it can access specific hardware such as a webcam or microphone . such privacy settings should be presented in an easily visible , objective and intelligible manner .


### if all end - users concerned have given their consent to the processing of their electronic communications content for one or more specified purposes that cannot be fulfilled by processing information that is made anonymous , and the provider has consulted the supervisory authority . points and of article 36 of regulation 2016 / 679 shall apply to the consultation of the supervisory authority . ### if the service provider ' s end - user has consented to the processing of their electronic communications content pursuant to regulation 2016 / 679 .


### for the sole purpose of the provision of a specific service to an end - user , if the end - user or end - users concerned have given their consent to the processing of his or her electronic communications content and the provision of that service cannot be fulfilled without the processing of such content ; or ### for the sole purpose of the provision of a specific service to an end - user , if the service provider ' s end - user concerned has given their consent to the processing of his or her electronic communications content and the provision of that service cannot be fulfilled without the processing of such content ; or


### the processing of electronic communications data can be useful for businesses , consumers and society as a whole . vis - à - vis directive 2002 / 58 / ec , this regulation broadens the possibilities for providers of electronic communications services to process electronic communications metadata , based on end - users consent . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and that they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to obtain end - users’ consent to process electronic communications metadata , which should include data on the location of the device generated for the purposes of granting and maintaining access and connection to the service . location data that is generated other than in the context of providing electronic communications services should not be considered as metadata . examples of commercial usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . to display the traffic movements in certain directions during a certain period of time , an identifier is necessary to link the positions of individuals at certain time intervals . this identifier would be missing if anonymous data were to be used and such movement could not be displayed . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure . where a type of processing of electronic communications metadata , in particular using new technologies , and taking into account the nature , scope , context and purposes of the processing , is likely to result in a high risk to the rights and freedoms of natural persons , a data protection impact assessment and , as the case may be , a consultation of the supervisory authority should take place prior to the processing , in accordance with articles 35 and 36 of regulation 2016 / 679 . ### the processing of electronic communications metadata can be useful for businesses , consumers and society as a whole . vis - à - vis directive 2002 / 58 / ec , this regulation broadens the possibilities for providers of electronic communications services to process electronic communications metadata , in accordance with article 6 and 6 of regulation no 2016 / 679 . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and that they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to comply with regulation no 2016 / 679 when processing electronic communications metadata , which should include data on the location of the device . as an exception from obtaining end - users’ consent , the processing of electronic communications metadata for purposes other than those for which the personal data were initially collected should be allowed in cases where further processing is compatible in accordance with article 6 and article 6 of regulation 2016 / 679 generated for the purposes of granting and maintaining access and connection to the service . location data that is generated other than in the context of providing electronic communications services should not be considered as metadata . examples of commercial usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . to display the traffic movements in certain directions during a certain period of time , an identifier is necessary to link the positions of individuals at certain time intervals . this identifier would be missing if anonymous data were to be used and such movement could not be displayed . therefore , whenever the purpose of further processing cannot be achieved by processing data that is made anonymous , pseudonymisation of data should be allowed . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure . where a type of processing of electronic communications metadata , in particular using new technologies , and taking into account the nature , scope , context and purposes of the processing , is likely to result in a high risk to the rights and freedoms of natural persons , a data protection impact assessment and , as the case may be , a consultation of the supervisory authority should take place prior to the processing , in accordance with articles 35 of regulation 2016 / 679 .


### 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 .


### ‘ electronic communications content’ means the content exchanged by means of electronic communications services , such as text , voice , videos , images , and sound ; ### ' electronic communications content ' means the content transmitted by means of publically available electronic communications services , such as text , voice , videos , images , and sound ;


### end - users may consent to the processing of their metadata to receive specific services such as protection services against fraudulent activities . in the digital economy , services are often supplied against counter - performance other than money , for instance by end - users being exposed to advertisements . for the purposes of this regulation , consent of an end - user , regardless of whether the latter is a natural or a legal person , should have the same meaning and be subject to the same conditions as the data subject’s consent under regulation 2016 / 679 . basic broadband internet access and voice communications services are to be considered as essential services for individuals to be able to communicate and participate to the benefits of the digital economy . consent for processing data from internet or voice communication usage will not be valid if the data subject has no genuine and free choice , or is unable to refuse or withdraw consent without detriment . ### end - users may consent to the processing of their metadata to receive specific services such as protection services against fraudulent activities . in the digital economy , services are often supplied against counter - performance other than money , for instance by end - users being exposed to advertisements . for the purposes of this regulation , consent of an end - user , regardless , should have the same meaning and be subject to the same conditions as the data subject’s consent or another basis for processing under regulation 2016 / 679 . basic broadband internet access and voice communications services are to be considered as essential services for individuals to be able to communicate and participate to the benefits of the digital economy . consent for processing data from internet or voice communication usage will not be valid if the data subject has no genuine and free choice , or is unable to refuse or withdraw consent .


### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent third parties from storing information on the terminal equipment ; this is often presented as ‘ reject third party cookies’ . end - users should be offered a set of privacy setting options , ranging from higher to lower and intermediate . such privacy settings should be presented in an easily visible and intelligible manner . ### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . therefore providers of software enabling publically available electronic communications services and permitting the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers end - users a set of privacy setting options in order that end - users may actively select a preferred option after being given the necessary information to make the choice . such privacy settings should be presented in an easily visible and intelligible manner .


### where a natural or legal person obtains electronic contact details for electronic mail from its customer , in the context of the sale of a product or a service , in accordance with regulation 2016 / 679 , that natural or legal person may use these electronic contact details for direct marketing of its own similar products or services only if customers are clearly and distinctly given the opportunity to object , free of charge and in an easy manner , to such use . the right to object shall be given at the time of collection and each time a message is sent . ### where a natural or legal person obtains electronic contact details for e - mail from its customer , in the context of the sale of a product or a service , in accordance with regulation 2016 / 679 , that natural or legal person may use these electronic contact details for direct marketing of its own products or services only if customers are clearly and distinctly given the opportunity to object , free of charge and in an easy manner , to such use . the customer shall be informed about the right to object and shall be given an easy way to exercise it at the time of collection and each time a message is sent .


### publicly available directories of end - users of electronic communications services are widely distributed . publicly available directories means any directory or service containing end - users information such as phone numbers , email address contact details and includes inquiry services . the right to privacy and to protection of the personal data of a natural person requires that end - users that are natural persons are asked for consent before their personal data are included in a directory . the legitimate interest of legal entities requires that end - users that are legal entities have the right to object to the data related to them being included in a directory . ### publicly available directories of end - users of electronic communications services are widely distributed . publicly available directories means any directory or service containing end - users information such as phone numbers , email address contact details and includes inquiry services . the right to privacy and to protection of the personal data of a natural person acting out of their business capacity requires that end - users that are natural persons are provided , upon request , with transparent information about the data being included in the directory and the means to verify , correct , update , supplement and delete data relating to them free of charge . the legitimate interest of legal entities requires that end - users that are legal entities have the right to object to the data related to them being included in a directory .


### the possibility for end - users not to be included in a publicly available directory , or to verify , correct and delete any data related to them shall be provided free of charge . ### the possibility for end - users not to be included in a publicly available directory , or to verify , correct , update , supplement and delete any data related to them shall be provided free of charge and in an easily accessible manner .


### the prohibition of storage of communications is not intended to prohibit any automatic , intermediate and transient storage of this information insofar as this takes place for the sole purpose of carrying out the transmission in the electronic communications network . it should not prohibit either the processing of electronic communications data to ensure the security and continuity of the electronic communications services , including checking security threats such as the presence of malware or the processing of metadata to ensure the necessary quality of service requirements , such as latency , jitter etc . ### the prohibition of storage of communications during transmission is not intended to prohibit any automatic , intermediate and transient storage of this information insofar as this takes place for the sole purpose of carrying out the transmission . this regulation also should not prohibit either the processing of electronic communications data to ensure the security , confidentiality , integrity , availability , authenticity and continuity of the electronic communications services and networks , including checking security threats related to the respective service or the processing of metadata of the respective service to ensure the necessary quality of service requirements , such as latency , jitter etc .


### the providers of publicly available directories shall obtain the consent of end - users who are natural persons to include their personal data in the directory and , consequently , shall obtain consent from these end - users for inclusion of data per category of personal data , to the extent that such data are relevant for the purpose of the directory as determined by the provider of the directory . providers shall give end - users who are natural persons the means to verify , correct and delete such data . ### the providers of electronic information , communication and telecommunication services shall collect the data of end - users who are natural persons in order to include their personal data in publicly accessible directories . upon the request of an end - user who is natural person the directory providers shall provide the end - user with transparent information about the data being included in the directory and the means to verify , correct , update , supplement and delete such data .


### the processing of electronic communications data can be useful for businesses , consumers and society as a whole . vis - à - vis directive 2002 / 58 / ec , this regulation broadens the possibilities for providers of electronic communications services to process electronic communications metadata , based on end - users consent . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and that they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to obtain end - users ' consent to process electronic communications metadata , which should include data on the location of the device generated for the purposes of granting and maintaining access and connection to the service . location data that is generated other than in the context of providing electronic communications services should not be considered as metadata . examples of commercial usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . to display the traffic movements in certain directions during a certain period of time , an identifier is necessary to link the positions of individuals at certain time intervals . this identifier would be missing if anonymous data were to be used and such movement could not be displayed . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure . where a type of processing of electronic communications metadata , in particular using new technologies , and taking into account the nature , scope , context and purposes of the processing , is likely to result in a high risk to the rights and freedoms of natural persons , a data protection impact assessment and , as the case may be , a consultation of the supervisory authority should take place prior to the processing , in accordance with articles 35 and 36 of regulation 2016 / 679 . ### the processing of electronic communications metadata can be useful for businesses , consumers and society as a whole . vis - à - vis directive 2002 / 58 / ec , this regulation broadens the possibilities for providers of electronic communications services to further process electronic communications metadata . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and that they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to comply with regulation 2016 / 679 when processing electronic communications metadata , which should include data on the location of the device . the processing of electronic communications metadata for purposes other than those for which the personal data were initially collected should be allowed in cases where consent was obtained for the initial collection and the further processing is compatible in accordance with article 6 of regulation 2016 / 679 . examples of commercial usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . to display the traffic movements in certain directions during a certain period of time , an identifier is necessary to link the positions of individuals at certain time intervals . this identifier would be missing if anonymous data were to be used and such movement could not be displayed . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure .


### the provision of electronic communications services to end - users in the union , irrespective of whether a payment of the end - user is required ; ### the offering of electronic communications services to end - users in the union , irrespective of whether a payment of the end - user is required ;


### 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 .


### where the provider of an electronic communications service is not established in the union it shall designate in writing a representative in the union . ### where the provider of an electronic communications service is not established in the union it shall designate , and prior to the start of its activity within the union , in writing a representative in the union .


### 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 .


### 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 of electronic information , communications and telecommunications services 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 , update , supplement and delete such data . natural persons acting in a professional capacity , such as independent professionals , operators of small businesses or freelancers , shall be equated with legal persons .


### the content of electronic communications may reveal highly sensitive information about the natural persons involved in the communication , from personal experiences and emotions to medical conditions , sexual preferences and political views , the disclosure of which could result in personal and social harm , economic loss or embarrassment . similarly , metadata derived from electronic communications may also reveal very sensitive and personal information . these metadata includes the numbers called , the websites visited , geographical location , the time , date and duration when an individual made a call etc . , allowing precise conclusions to be drawn regarding the private lives of the persons involved in the electronic communication , such as their social relationships , their habits and activities of everyday life , their interests , tastes etc . ### the content of electronic communications may reveal highly sensitive information about the natural persons involved in the communication . similarly , metadata derived from electronic communications may also reveal very sensitive and personal information . these metadata includes the numbers called , the websites visited , geographical location , the time , date and duration when an individual made a call etc . , allowing conclusions to be drawn regarding the private lives of the persons involved in the electronic communication . the protection of confidentiality of communications is an essential condition for the respect of other connected fundamental rights and freedoms , such as the protection of freedom of thought , conscience and religion , freedom of assembly , freedom of expression and information .


### the prohibition of storage of communications is not intended to prohibit any automatic , intermediate and transient storage of this information insofar as this takes place for the sole purpose of carrying out the transmission in the electronic communications network . it should not prohibit either the processing of electronic communications data to ensure the security and continuity of the electronic communications services , including checking security threats such as the presence of malware or the processing of metadata to ensure the necessary quality of service requirements , such as latency , jitter etc . ### the prohibition of storage of communications during transmission is not intended to prohibit any automatic , intermediate and transient storage of this information insofar as this takes place for the sole purpose of carrying out the transmission in the electronic communications network . the processing of pseudonymised data , should be incentivised as the act of psedonymisation dramatically reduces any privacy and security risk associated with processing of data related to transmission . it should not prohibit either the processing of electronic communications data to ensure the security and continuity of the electronic communications services , including checking security threats such as the presence of malware or the processing of metadata to ensure the appropriate quality of service requirements , such as latency , jitter etc .


### 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 their data being included in such directories , they should be able to make an objection on which categories of personal data are included in the directory . in addition , providers of publicly available directories or the providers of electronic communications services should inform the end - users of the purposes of the directory and of the search functions of the directory .


### for the eu compartment , the eligible counterparts shall have expressed their interest and shall be able to cover financing and investment operations in at least three member states . the implementing partners may also cover together financing and investment operations in at least three member states by forming a group . ### for the eu compartment , the eligible counterparts shall have expressed their interest and shall be able to cover financing and investment operations in at least two member states . the implementing partners may also cover together financing and investment operations in at least two member states by forming a group .


### 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


### member states shall include in their accounts for each land accounting category any change in the carbon stock of the carbon pools listed in annex i , section b . member states may choose not to include in their accounts changes in carbon stocks for carbon pools where the carbon pool is not a source , except for above - ground biomass and harvested wood products on managed forest land . ### member states shall include in their accounts for each accounting category any change in the carbon stock of the carbon pools listed in annex i , section b . member states may choose not to include in their accounts changes in carbon stocks for carbon pools where the carbon pool is not a source , except for above - ground biomass and harvested wood products on managed forest land .


### member states shall account for emissions and removals resulting from managed forest land , calculated as emissions and removals in the periods from 2021 to 2025 and from 2026 to 2030 minus the value obtained by multiplying by five its forest reference level . a forest reference level is an estimate of the average annual net emissions or removals resulting from managed forest land within the territory of the member state in the periods from 2021 to 2025 and from 2026 to 2030 . ### member states shall account for emissions and removals resulting from managed forest land , calculated as emissions and removals in the periods from 2021 to 2025 and from 2026 to 2030 minus the value obtained by multiplying by five its forest reference level .


### the commission shall report to the european parliament and to the council by 28 february 2024 and every five years thereafter on the operation of this regulation , its contribution to the eu ' s overall 2030 greenhouse gas emission reduction target and its contribution to the goals of the paris agreement , and may make proposals if appropriate . ### the commission shall report to the european parliament and to the council by 28 february 2024 and every five years thereafter on the operation of this regulation , its contribution to the eu ' s overall 2030 greenhouse gas emission reduction target and its contribution to the goals of the paris agreement , with a view of keeping this regulation in line with relevant decisions adopted by bodies of the unfccc or of the paris agreement , and may make proposals if appropriate .


### each member state shall prepare and maintain accounts that accurately reflect the emissions and removals resulting from the land accounting categories referred to in article 2 . member states shall ensure the accuracy , completeness , consistency , comparability and transparency of their accounts and of other data provided under this regulation . member states shall denote emissions by a positive sign and removals by a negative sign . ### each member state shall prepare and maintain accounts that accurately reflect the emissions and removals resulting from the land accounting categories and other categories referred to in article 2 in accordance with the reporting guidance adopted by bodies of the unfccc or of the paris agreement for the period 2021 - 2030 . member states shall ensure the accuracy , completeness , consistency , comparability and transparency of their accounts and of other data provided under this regulation . member states shall denote emissions by a positive sign and removals by a negative sign .


### member states that have chosen to include managed wetland in the scope of their commitments in accordance with article 2 shall account for emissions and removals resulting from managed wetland , calculated as emissions and removals in the periods from 2021 to 2025 and / or from 2026 to 2030 minus the value obtained by multiplying by five the member state’s average annual emissions and removals resulting from managed wetland in its base period 2005 - 2007 . ### member states shall account for emissions and removals resulting from managed wetland , calculated as emissions and removals in the periods from 2021 to 2025 and / or from 2026 to 2030 minus the value obtained by multiplying by five the member state ' s average annual emissions and removals resulting from managed wetland in its base period 2005 - 2007 .


### member states that have chosen to include managed wetland in the scope of their commitments in accordance with article 2 shall account for emissions and removals resulting from managed wetland , calculated as emissions and removals in the periods from 2021 to 2025 and / or from 2026 to 2030 minus the value obtained by multiplying by five the member state’s average annual emissions and removals resulting from managed wetland in its base period 2005 - 2007 . ### member states that have chosen to include managed wetland in the scope of their commitments in accordance with article 2 shall account for emissions and removals resulting from managed wetland , calculated as emissions and removals in the periods from 2021 to 2025 and / or from 2026 to 2030 minus the value obtained by multiplying by five the member state ' s average annual emissions and removals resulting from managed wetland in its base period 2005 - 2007 or its base year under the unfccc . member states shall communicate their choice of accounting base period or year to the european commission before 31 december 2018 .


### . member states shall take appropriate measures to protect customers and shall , in particular , ensure that there are adequate safeguards to protect vulnerable customers . in this context , each member state shall define the concept of vulnerable customers which may refer to energy poverty and , inter alia , to the prohibition of disconnection of electricity to such customers in critical times . member states shall ensure that rights and obligations linked to vulnerable customers are applied . in particular , they shall take measures to protect customers in remote areas . they shall ensure high levels of consumer protection , particularly with respect to transparency regarding contractual terms and conditions , general information and dispute settlement mechanisms . ### . member states shall take appropriate measures to protect customers and shall , in particular , ensure that there are adequate safeguards to protect vulnerable customers . in this context , each member state shall define the concept of vulnerable customers , taking into account specific circumstances of a particular member state , which may refer to energy poverty and , inter alia , to the prohibition of disconnection of electricity to such customers in critical times . member states shall ensure that rights and obligations linked to vulnerable customers are applied . in particular , they shall take measures to protect customers in remote areas . they shall ensure high levels of consumer protection , particularly with respect to transparency regarding contractual terms and conditions , general information and dispute settlement mechanisms .


### 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 is still possible to limit 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 and national law .


### 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 .


### 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 and internet has transformed the distribution of , and access to , television and radio programmes , pitting traditional audiovisual media services against increasingly fierce international competition , including from on - line platforms . to meet user demand for 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 have managed to adapt and offer innovative solutions such as online services ancillary to their broadcasts , like 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 . these new techniques have made it possible to offer users a broad choice and increasingly easy access to high - quality content .


### 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 .


### 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 .


### where member states provide any incentives for an energy - related product covered by this regulation and specified in a delegated act , these shall aim at the highest class of energy efficiency laid down in the applicable delegated act . ### where member states provide any incentive for an energy - related product covered by this regulation and specified in a delegated act , that incentive shall aim at the highest classes of energy efficiency , where products are available , laid down in the applicable delegated act .


### 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 ;


### the commission shall , having consulted the consultation forum referred to in article 10 , establish a working plan which shall be made publicly available . the working plan shall set out an indicative list of product groups which are considered as priorities for the adoption of delegated acts . the working plan shall also set out plans for the revision and rescaling of labels of products or product groups . the working plan may be amended periodically by the commission after consultation with the consultation forum . the working plan may be combined with the working plan required by article 16 of directive 2009 / 125 / ec . ### the commission shall , by means of delegated acts adopted pursuant to article 13 , and having consulted the consultation forum referred to in article 10 , establish a working plan . the working plan shall set out an indicative list of product groups which are considered as priorities for the adoption of implementing acts . the working plan shall be amended periodically by the commission after consultation with the consultation forum . the working plan shall be combined with the working plan required by article 16 of directive 2009 / 125 / ec .


### where member states provide any incentives for an energy - related product covered by this regulation and specified in a delegated act , these shall aim at the highest class of energy efficiency laid down in the applicable delegated act . ### where member states provide any incentives for a product covered by this regulation and specified in an implementing act , these shall aim at the highest classes of energy efficiency , in which products are available , laid down in the applicable implementing act .


### suppliers shall provide both the current and the rescaled labels to dealers for a period of six months before the date specified in paragraph . ### suppliers shall provide the rescaled labels to dealers .


### they shall make reference to the energy efficiency class of the product in any advertisement or technical promotional material for a specific model of products in accordance with the relevant delegated act ; ### make reference to the energy efficiency class of the product and the range of the efficiency classes available on the label in any technical promotional material for a specific model in accordance with the relevant implementing act and to the energy consumption , unless this is stipulated otherwise by the relevant implementing act ;


### ‘ 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 , 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 ;


### dealers shall replace the existing labels on products on display including on the internet with the rescaled labels within one week following the date specified for that purpose in the relevant delegated act . dealers shall not display the rescaled labels before that date . ### dealers may sell goods already delivered with the existing label .


### suppliers shall provide both the current and the rescaled labels to dealers for a period of six months before the date specified in paragraph . ### suppliers shall provide the current labels .


### ‘ energy - related product’ means any good or system or service with an impact on energy consumption during use , which is placed on the market and put into service in the union , including parts to be incorporated into energy - related products which are placed on the market and put into service ; ### ‘ energy - related product’ means any good or system with an impact on energy consumption during use , which is placed on the market and put into service in the union ;


### ‘ energy - related product’ means any good or system or service with an impact on energy consumption during use , which is placed on the market and put into service in the union , including parts to be incorporated into energy - related products which are placed on the market and put into service ; ### ‘ energy - related product’ means any good , system or service with an impact on energy consumption during use , which is placed on the market or put into service in the union , including parts intended to be incorporated into energy - related products which are placed on the market or put into service in the union as individual parts for customers , and the environmental performance of which can be assessed independently ;


### ‘ energy - related product’ means any good or system or service with an impact on energy consumption during use , which is placed on the market and put into service in the union , including parts to be incorporated into energy - related products which are placed on the market and put into service ; ### ‘ energy - related product’ means any good with an impact on energy consumption during use , which is placed on the market and put into service in the union , including parts to be incorporated into energy - related products which are placed on the market and put into service ;


### member states shall ensure that the introduction of labels including rescaled labels and product information sheets is accompanied by educational and promotional information campaigns aimed at promoting energy efficiency and more responsible use of energy by customers , if appropriate in cooperation with dealers . ### member states shall ensure that the introduction of labels including rescaled labels and product information sheets is accompanied by educational and promotional information campaigns on energy labelling , if appropriate in cooperation with dealers and suppliers . the commission shall support cooperation and the exchange of best practices in relation to these campaigns , including through the provision of a core script .


### 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


### advances in digital technology allow for alternative ways of delivering and displaying labels electronically , such as on the internet , but also on electronic displays in shops . in order to take advantage of such advances , this regulation should allow the use of electronic labels as replacement of or complementary to the physical energy label . in cases where it is not feasible to display the energy label , such as certain forms of distance selling and in advertisements and technical promotional material , potential customers should be provided at least with the energy class of the product . ### advances in digital technology allow for alternative ways of delivering and displaying labels electronically , such as on the internet , but also on electronic displays in shops . in order to take advantage of such advances , this regulation should allow the use of electronic labels as replacement of or complementary to the physical energy label . in cases where it is not feasible to display the energy label , such as certain forms of distance selling and in advertisements and technical promotional material , potential customers should be provided at least with the energy class of the product . technical promotional material does not include advertisements in billboards , newspapers , magazines , radio broadcasting , television and similar online formats .


### the commission may , by means of delegated acts adopted pursuant to articles 12 and 13 , introduce labels or rescale existing labels . ### the commission may , by means of implementing acts adopted pursuant to articles 12 and 13 , introduce labels or rescale existing labels for those products listed in annex ia .


### the permanent stakeholders’ group shall advise the agency in respect of the performance of its activities . it shall in particular advise the executive director on drawing up a proposal for the agency’s work programme , and on ensuring communication with the relevant stakeholders on all issues related to the work programme . ### the permanent stakeholders’ group shall advise the agency in respect of the performance of its activities . it shall in particular advise the executive director on drawing up a proposal for the agency’s work programme , and on ensuring communication with the relevant stakeholders on all issues related to the work programme . it may also propose that the commission request the agency to prepare candidate european cybersecurity certification schemes in accordance with article 44 , either on its own initiative or following submission of proposals from relevant stakeholders .


### the certification shall be voluntary , unless otherwise specified in union law . ### the certification shall be voluntary .


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


### 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 . ### when preparing candidate schemes referred to in paragraph 1 of this article , enisa shall consult the permanent stakeholders’ group , in particular the european standardisation organisations , and all other 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 . 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 .


### the qualified entity shall provide sufficient information as required under national law to support the action , including a description of the consumers concerned by the action and the questions of fact and law to be resolved . ### the qualified entity must provide sufficient information as required under national law to support the action , including a description of the consumers concerned by the action and the questions of fact and law to be resolved and a demonstration that the claim procedure has been exhausted where consumers rights are protected by pre - defined claim - based regulations .


### in order to seek injunction orders , qualified entities shall not have to obtain the mandate of the individual consumers concerned or provide proof of actual loss or damage on the part of the consumers concerned or of intention or negligence on the part of the trader . ### in order to seek injunction orders , qualified entities shall have to obtain the mandate of the individual consumers concerned or provide proof of actual loss or damage on the part of the consumers concerned or of intention or negligence on the part of the trader .


### member states that do not maintain screening mechanisms shall provide the commission with an annual report covering foreign directs investments that took place in their territory , on the basis of information available to them . ### member states that do not maintain screening mechanisms shall provide the commission with a report covering foreign directs investments that took place in their territory on a case - by - case basis if they consider the investments liable to prejudice public order or security in other member states , on the basis of information available to them .


### 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 :


### 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 .


### member states shall inform the commission and the other member states of any foreign direct investments that are undergoing screening within the framework of their screening mechanisms , within 5 working days from the start of the screening . as part of the information , and when applicable , the screening member states shall endeavour to indicate whether it considers that the foreign direct investment undergoing screening is likely to fall within the scope of regulation no 139 / 2004 . ### member states shall inform the commission of any foreign direct investments that are undergoing screening within the framework of their screening mechanisms which it considers likely to affect public order or security in another member state or in the union , within 20 working days from the start of the screening . as part of the information , and when applicable , the screening member states shall endeavour to indicate whether it considers that the foreign direct investment undergoing screening is likely to fall within the scope of regulation no 139 / 2004 .


### notification by member states of screening mechanisms and annual reporting ### notification by member states of screening mechanisms and reporting


### the reclamation plant operator shall draw - up a water reuse risk management plan based on the key risk management tasks set out in annex ii . the water reuse risk management plan shall propose any additional requirements to those specified in annex i necessary to further mitigate any risks , and shall , inter alia , identify hazards , risks and appropriate preventive measures . ### the reclamation plant operator shall draw - up a water reuse risk management plan based on the key risk management tasks set out in annex ii for which he is responsible . the water reuse risk management plan shall propose any additional requirements to those specified in annex i necessary to further mitigate any risks , and shall , inter alia , identify hazards , risks and appropriate preventive measures .


### the competent authority shall verify compliance of the reclaimed water with the conditions set out in the permit , at the point of compliance . the compliance check shall be performed using the following means : ### before issuing a permit , the competent authority shall verify compliance of the reclaimed water with the conditions set out in the permit , at the point of compliance . the compliance check shall be performed using the following means :


### in the event of non - compliance , the competent authority shall require the reclamation plant operator to take any necessary measures to restore compliance without delay . ### in the event of non - compliance detected after issue of a permit , the competent authority shall require the reclamation plant operator to halt the supply of reclaimed water until the necessary measures to restore compliance have been taken .


### if an incident affecting compliance with the permit ' s conditions occurs , the reclamation plant operator shall immediately inform the competent authority and the end - user which may be potentially affected , and communicate to the competent authority the information necessary for assessing the impacts of such an incident . ### if an incident affecting compliance with the permit ' s conditions occurs , the reclamation plant operator shall immediately inform the competent authority and all end - user and communicate to the competent authority the information necessary for assessing the impacts of such an incident .


### a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . ### undeclared work has negative effects also on the functioning of the single market . a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . the main responsibility for tackling undeclared work will remain with the member states .


### the platform and its tasks should be funded through the progress axis of the programme for employment and social innovation within the appropriations set by the budgetary authority . ### the platform and its tasks should be funded through the progress axis of the programme for employment and social innovation within the appropriations set by the budgetary authority . the commission will make sure that the financial resources are used in a transparent and efficient way for the work of the platform .


### the global resources for the implementation of this decision shall be established within the framework of the programme for employment and social innovation , the annual appropriations of which shall be authorised by the budgetary authority within the limits of the financial framework . ### the global resources for the implementation of this decision shall be established within the framework of the programme for employment and social innovation , the annual appropriations of which shall be authorised by the budgetary authority within the limits of the financial framework . the commission shall make sure that all financial resources are used in a transparent and efficient way .


### member states should conduct their economic policies and should coordinate them in such a way as to attain the objective of strengthening economic , social , and territorial cohesion . ### member states should , with regards to their fiscal limits as set out in the treaties , conduct their economic policies and should optimize them for their own country , but always try to learn from others .


### this directive shall apply without prejudice to the decisions taken by member states to levy fees on particular types of vehicles , to determine the level of those fees and the purpose for which such fees are levied . ### in order to respect the principle of subsidiarity , this directive shall apply without prejudice to the decisions taken by member states to levy fees on particular types of vehicles , and to determine the level of those fees and the purpose for which such fees are levied .


### article 8 data protection the provisions of regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 shall apply to personal data processed under this directive . 2 . member states shall ensure that personal data processed under this directive are , within an appropriate time period , rectified if inaccurate , or erased or restricted , and that a time limit for the storage of data is established in accordance with regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 . member states shall ensure that all personal data processed under this directive are only used for the purpose of facilitating the cross - border exchange of information on failures to pay road fees , and that the data subjects have the same rights to information , access , rectification , erasure and blocking , compensation and judicial redress as provided for in regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 . 3 . any person concerned shall have the right to obtain information on which personal data recorded in the member state of registration were transmitted to the member state in which there was a failure to pay a road fee , including the date of the request and the competent authority of the member state in whose territory there was a failure to pay a road fee . ### article 8 data protection regulation 2016 / 679 and directive 2002 / 58 / ec shall apply to personal data processed under this directive . directive 2016 / 680 shall only apply to personal data processed under this directive when the failure to pay a road fee is a criminal offence in the member state where the payment is due . 2 . member states shall ensure that the processing of personal data for the purposes of article 5 is limited to the types of data listed in annex ii . member states shall also ensure that data subjects have the right to update , rectify or erase personal data processed without undue delay if inaccurate . member states shall establish a time limit for the storage of personal data in accordance with regulation 2016 / 679 and , where applicable , directive 2016 / 680 . ) member states shall ensure that personal data processed under this directive are processed for the sole purpose of facilitating the cross - border exchange of information on failures to pay road fees and shall not be further processed for any other purpose . member states shall also ensure that the data subjects have the same rights of information , access , rectification , erasure and restriction of processing , to lodge a complaint with a data protection supervisory authority , compensation and an effective judicial remedy as provided for in regulation 2016 / 679 and , where applicable , directive 2016 / 680 . member states shall ensure that access to personal data is only granted to the designated competent authorities for the exchange of vehicle registration . 3 . any person concerned shall have the right to obtain , without undue delay , information on which personal data recorded in the member state of registration were transmitted to the member state in which there was a failure to pay a road fee , including the date of the request and the competent authority of the member state in whose territory there was a failure to pay a road fee .


### the overall aim of the ' digital single market strategy ' , is to deliver sustainable economic and social benefits from a connected digital single market . union consumers still do not enjoy the full benefits of prices and choice that the single market can offer , because cross - border online transactions are still very limited . fragmentation also limits demand for cross - border e - commerce transactions . there is also a need for concerted action to make sure that new electronic content is also fully available to persons with disabilities . it is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all union citizens regardless of their abilities can enjoy its benefits . ### the overall aim of the ‘ digital single market strategy’ , is to deliver sustainable economic and social benefits from a connected digital single market , facilitating trade and promoting employment within the union . union consumers still do not enjoy the full benefits of prices and choice that the single market can offer , because cross - border online transactions are still very limited . fragmentation also limits demand for cross - border e - commerce transactions . there is also a need for concerted action to make sure that new electronic content is also fully available to persons with disabilities . it is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all union citizens regardless of their abilities can enjoy its benefits .


### the overall aim of the ‘ digital single market strategy’ , is to deliver sustainable economic and social benefits from a connected digital single market . union consumers still do not enjoy the full benefits of prices and choice that the single market can offer , because cross - border online transactions are still very limited . fragmentation also limits demand for cross - border e - commerce transactions . there is also a need for concerted action to make sure that new electronic content is also fully available to persons with disabilities . it is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all union citizens regardless of their abilities can enjoy its benefits . ### the overall aim of the ‘ digital single market strategy’ , is to deliver sustainable economic and social benefits from a connected digital single market , facilitating trade and promoting employment within the union . union consumers still do not enjoy the full benefits of prices and choice that the single market can offer , because cross - border online transactions are still very limited . fragmentation also limits demand for cross - border e - commerce transactions . there is also a need for concerted action to make sure that new electronic content is also fully available to persons with disabilities and persons with age related or any other impairments . it is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all union citizens regardless of their abilities can enjoy its benefits .


### the european disability strategy 2010 - 2020 – a renewed commitment to a barrier - free europe33 – in line with the convention , establishes accessibility as one of the eight areas of action , and aims at ensuring accessibility of products and services . __________________ 33 com 636 . ### the european disability strategy 2010 - 2020 – a renewed commitment to a barrier - free europe – in line with the convention , establishes accessibility as one of the eight areas of action , which is a basic precondition for participation in society and aims at ensuring accessibility of products and services . __________________ 33 com636 .


### each product and service has to comply with the accessibility requirements identified in article 3 and listed in annex i to be accessible for persons with disabilities and older persons . the e - commerce accessibility obligations also apply to the online sale of services under article 1 to of this directive . ### for each product and service within the scope of this directive an accessibility report should be available , outlining which of the accessibility requirements identified in article 3 and listed in annex i have been implemented to make the product or service accessible for persons with disabilities and older persons . the accessibility report is a list or statement of accessibility features that form part of the general description of the product as required in annex ii and of the services as required in annex iii . the e - commerce accessibility obligations also apply to the online sale of services under article 1 to of this directive .


### in order to facilitate conformity assessment with applicable requirements it is necessary to provide for a presumption of conformity for products and services which are in conformity with voluntary harmonised standards that are adopted in accordance with regulation no 1025 / 2012 of the european parliament and of the council39 for the purpose of expressing detailed technical specifications of those requirements . the commission has already issued a number of standardisation requests to the european standardisation organisations on accessibility which would be relevant for the preparation of harmonised standards . __________________ 39 regulation no 1025 / 2012 of 25 october 2012 of the european parliament and of the council on european standardisation , amending council directives 89 / 686 / eec and 93 / 15 / eec and directives 94 / 9 / ec , 94 / 25 / ec , 95 / 16 / ec , 97 / 23 / ec , 98 / 34 / ec , 2004 / 22 / ec , 2007 / 23 / ec , 2009 / 23 / ec and 2009 / 105 / ec of the european parliament and of the council and repealing council decision 87 / 95 / eec and decision no 1673 / 2006 / ec of the european parliament and of the council . ### in order to facilitate conformity assessment with applicable requirements regarding accessibility , it is necessary to provide for a presumption of conformity for products and services which are in conformity with voluntary harmonised standards that are adopted in accordance with regulation no 1025 / 2012 of the european parliament and of the council39 for the purpose of expressing detailed technical specifications of those requirements . the commission has already issued a number of standardisation requests to the european standardisation organisations on accessibility which would be relevant for the preparation of harmonised standards . __________________ 39 regulation no 1025 / 2012 of 25 october 2012 of the european parliament and of the council on european standardisation , amending council directives 89 / 686 / eec and 93 / 15 / eec and directives 94 / 9 / ec , 94 / 25 / ec , 95 / 16 / ec , 97 / 23 / ec , 98 / 34 / ec , 2004 / 22 / ec , 2007 / 23 / ec , 2009 / 23 / ec and 2009 / 105 / ec of the european parliament and of the council and repealing council decision 87 / 95 / eec and decision no 1673 / 2006 / ec of the european parliament and of the council .


### public contracts and concessions which are subject to directive 2014 / 23 / eu42 directive 2014 / 24 / eu and directive 2014 / 25 / eu . __________________ 42 directive 2014 / 23 / eu of the european parliament and of the council of 26 february 2014 on the award of concession contracts ### subject to paragraph 3a of this article , public contracts , including mixed contracts , the object of which is intended for use by natural persons , whether general public or staff of the contracting authority or contracting entity , and that are subject to directive 2014 / 24 / eu and directive 2014 / 25 / eu , where technical specifications are drawn up in accordance with those directives so as to take into account , except in duly justified cases , accessibility criteria for persons with disabilities or design for all users .


### when placing their products on the market , manufacturers shall ensure that the products have been designed and manufactured in accordance with the applicable accessibility requirements set out in article 3 . ### when placing their products on the market , manufacturers shall ensure that the products have been designed and manufactured in accordance with the applicable accessibility requirements set out in article 3 unless the functional requirements are not achievable as the adaptation of product would need a fundamental alteration or would impose a disproportionate burden for the manufacturer .


### distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this directive shall make sure that the necessary corrective measures are taken to bring that product into conformity , to withdraw it or recall it , if appropriate . furthermore , where the product presents a risk , distributors shall immediately inform the competent national authorities of the member states in which they made the product available to that effect giving details , in particular , of the non - compliance and of any corrective measures taken . ### distributors who consider or have reason to believe that a product which they have made available on the market does not meet the requirements of this directive shall make sure that the necessary corrective measures are taken to bring that product into accordance , to withdraw it or recall it , if appropriate . furthermore , where the product presents a risk , distributors shall immediately inform the competent national authorities of the member states in which they made the product available to that effect giving details , in particular , of the non - compliance and of any corrective measures taken .