### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law . ### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law , a veterinarian where appropriate and only after a veterinary diagnosis . these persons shall , by reason of their initial and continuing training , have the skills necessary to prescribe and issue veterinary medicinal products for all the species they treat .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law , veterinarians where appropriate , shall retail antimicrobial products only for animals which are under their supervision and after diagnosis by a veterinarian , and only in the amount required for the treatment concerned .


### the commission shall , by means of implementing acts , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### the commission shall , by means of implementing acts and taking into consideration the scientific advice of the agency , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . the commission , when establishing these rules , will make decisions on appropriate risk management measures at the class , substance or even the indication level and will consider also the route of administration .


### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report . ### member states shall send to the agency data on the volume of sales of veterinary antimicrobial medicinal products as well as data on how , when , where and why antimicrobials are being used . the agency shall analyse the data and publish an annual report .


### the commission shall be empowered to adopt delegated acts in accordance with article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans . ### the commission shall be empowered to adopt delegated acts in accordance with article 146 and taking into consideration the scientific advice of the agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans . the commission , when establishing these rules , will make decisions on appropriate risk management measures at the class , substance or even the indication level and will consider also the route of administration .


### where a veterinary medicinal product is supplied on prescription , the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned . ### where a veterinary medicinal product is prescribed on prescription , the quantity prescribed shall be restricted to the amount required for the treatment or therapy concerned and take account of the presentations available on the market . prophylactic use of anti - bacterials shall not be authorised except in cases where said use is expressly authorised by the summary of technical characteristics of the veterinary medicinal product , drawn up in accordance with this regulation .


### any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics ; ### any observation of a lack of efficacy of a veterinary medicinal product , including signs of antimicrobial resistance , following administration to an animal in accordance with the summary of product characteristics ;


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


### 10 years for the veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats ; ### 10 years for the veterinary medicinal products for cattle , pigs , chickens , dogs and cats ;


### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency . ### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and consumption of antimicrobials in animals , data on the consumption of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . in particular , better data is needed on how , when , where and why antibiotics are being used . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency .


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


### where offers of securities to the public are addressed only to domestic investors in one member state , and thus have no cross - border effects , and where such offers do not exceed a total consideration of eur 10 000 000 , the passport mechanism under this regulation is not needed and drawing up a prospectus may represent a disproportionate cost . therefore it is appropriate to allow member states to decide to exempt such kinds of offers from the prospectus obligation set out in this regulation , taking into account the level of domestic investor protection they deem to be appropriate . in particular , member states should be free to set out in their national law the threshold between eur 500 000 and eur 10 000 000 , expressed as the total consideration of the offer over a period of 12 months , from which this exemption should apply . ### where offers of securities to the public are addressed only to domestic investors in one member state , and thus have no cross - border effects , and where such offers do not exceed a total consideration of eur 5 000 000 , the passport mechanism under this regulation is not needed and drawing up a prospectus may represent a disproportionate cost . therefore it is appropriate to allow member states to decide to exempt such kinds of offers from the prospectus obligation set out in this regulation , taking into account the level of domestic investor protection they deem to be appropriate . in particular , member states should be free to set out in their national law the threshold between eur 500 000 and eur 5 000 000 , expressed as the total consideration of the offer over a period of 12 months , from which this exemption should apply .


### the total consideration of the offer is less than a monetary amount calculated over a period of 12 months , which shall not exceed eur 10 000 000 . ### the total consideration of the offer is less than a monetary amount calculated over a period of 12 months , which shall not exceed eur 8 000 000 .


### 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 .


### 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 .


### taking into account the availability of electronic means of data recording and the fact that personal data should in any event be collected before the ship ' s departure , the 30 minutes delay currently provided for by directive 98 / 41 / ec should be considered as a maximum and used in exceptional cases only . ### taking into account the availability of electronic means of data recording and the fact that personal data should in any event be collected before the ship ' s departure , on the board of the ship , the 20 minutes delay currently provided for by directive 98 / 41 / ec should be considered as a maximum and used in exceptional cases only .


### 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 .


### the commission shall evaluate the implementation of this directive and submit the results of the evaluation to the european parliament and the council no later than [ seven years after the date referred to in the second subparagraph of article 3 ] . . ### the commission shall evaluate the implementation of this directive and submit the results of the evaluation to the european parliament and the council no later than [ three years after the date referred to in the second subparagraph of article 3 ] .


### 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 .


### 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 . as soon as it is no longer needed for this purpose , it shall be destroyed .


### cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices . ### cooperation between the european medicines agency and the coordination group on the preparation and update of joint clinical assessments of medicinal products . this cooperation shall take into account that the coordination group , due to its competences in clinical aspects , is the competent body to detect and prioritize the emerging technologies based on impact on health .


### 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 , the commission should establish , by means of implementing acts , a common procedural framework for joint clinical assessments and joint scientific consultations , while the coordination group should establish a common methodological framework . where appropriate , and in justified cases , distinct rules must be developed for medicinal products and medical devices . in the development of such rules , the results of the work already undertaken in the eunethta joint actions , 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 may be taken into account . those powers should be exercised in accordance with regulation no 182 / 2011of the european parliament and of the council13 . the methodology should guarantee high quality and high clinical evidence . any flexibility in the methodology should be exceptional and adapted to very specific circumstances , but never to the detriment of the quality of health technologies or clinical evidence . clinical trials are the studies par excellence in the biomedical field , so the use of another type of study , for example , epidemiological studies , should be exceptional and fully justified . the rules to be developed in tertiary legislation should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed . _________________ 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 establishment of a time - frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment . as the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time , it should be possible for assessments of such devices to take place following market launch of medical devices . ### the establishment of a time - frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment . as the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time , it should be possible for assessments of such devices to take place following market launch of medical devices and , if possible , in the presence of producers .


### 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 . 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 .


### the coordination group shall approve the final joint scientific consultation report , wherever possible by consensus or , where necessary , by a simple majority of member states , at the latest 100 days following the start of the preparation of the report referred to in paragraph 4 . ### the coordination group shall approve the final joint scientific consultation report , wherever possible by consensus or , where necessary , by a two - thirds majority of member states , at the latest 100 days following the start of the preparation of the report referred to in paragraph 4 .


### the coordination group shall act by consensus , or , where necessary , vote by simple majority . there shall be one vote per member state . ### the coordination group shall act by consensus , or , where necessary , vote by a two - thirds majority . there shall be one vote per member state .


### joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and hta authorities and bodies . in order to ensure the protection of such information , information provided to the coordination group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded . in addition , it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature . ### joint clinical assessments and joint scientific consultations necessitate the sharing of all available clinical data and publically available scientific evidence from health technology developers . the clinical data employed , the studies , the methodology and the clinical results used should be made public . the highest possible level of public openness in scientific data and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system .


### the coordination group shall approve the final joint clinical assessment report and summary report , wherever possible by consensus or , where necessary , by a simple majority of member states . ### the coordination group shall approve the final joint clinical assessment report and summary report , wherever possible by consensus or , where necessary , by a two - thirds majority of member states .


### joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and hta authorities and bodies . in order to ensure the protection of such information , information provided to the coordination group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded . in addition , it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature . ### joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and hta authorities and bodies . in order to ensure the protection of such information , information provided to the coordination group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded with the notification of the technology developer that has provided the information . in addition , it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature .


### the designated sub - group shall request relevant health technology developers to submit documentation containing the information , data and evidence necessary for the joint clinical assessment . ### the designated sub - group shall request relevant health technology developers to submit documentation containing the information , data and evidence necessary for the joint clinical assessment . the relationship between evaluators and health technology developers must be independent and impartial . developers of health technologies can be consulted but never participate actively in the evaluation process .


### in order to achieve eu air quality objectives and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to achieve union air quality objectives , as set out by the air quality standards and by the directive no 2008 / 50 of the european parliament and of the council1a , and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . __________________ 1a directive 2008 / 50 / ec of the european parliament and of the council of 21 may 2008 on ambient air quality and cleaner air for europe .


### in order to achieve eu air quality objectives and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to achieve union air quality objectives and to ensure a continuous effort to reduce vehicle emissions , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 7 500 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , including remote diagnostic support , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates , including nano - particulates , and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### activities may only be funded under prima if they are set out in the prima annual work plan . the prima annual work plan shall distinguish between the activities referred to in point of paragraph 1 , the activities referred to in point of that paragraph , as well as the administrative costs of the prima - is . it shall provide for their corresponding expenditure estimates as well as for the budget allocation to activities funded with union contribution and to activities funded by the participating states through their national funding bodies without union contribution . the prima annual work plan shall also include the estimated value of the participating states ' in kind contributions referred to in article 5 . ### activities may only be funded under prima if they are set out in the prima annual work plan . the prima annual work plan shall distinguish between the activities referred to in point of paragraph 1 , the activities referred to in point of that paragraph , as well as the administrative costs of the prima - is . it shall provide for their corresponding expenditure estimates as well as for the budget allocation to activities funded with union ' s financial contribution referred to in article 3 and to activities funded by the participating states without union ' s financial contribution referred to in article 3 . the prima annual work plan shall also include the estimated value of the participating states ' in kind contributions referred to in article 5 .


### in addition to the participants eligible for funding under article 10 of regulation no 1290 / 2013 , any legal entity established in a participating state shall be eligible for funding . ### by way of derogation from article 10 and of regulation no 1290 / 2013 , the following participants shall be eligible for funding by the prima - is : any legal entity created under union law and established in a participating state ; any international european interest organisation . 4a . in the case of an international organisation which is not eligible for funding by the prima - is , funding may be granted provided that at least one of the following conditions is fulfilled : participation is deemed to be essential by the prima - is for carrying out the action ; such funding is provided for under a bilateral scientific and technological agreement or any other arrangement between the union and the international organisation . 4b . in the case of a legal entity created under union law and established in a country which is not a participating state , funding by the prima - is may be granted provided that at least one of the following conditions is fulfilled : participation is deemed to be essential by the prima - is for carrying out the action ; an ad hoc funding arrangement is found between prima - is and the third country in which the legal entity is established .


### the general assembly shall approve the participation in prima of any third country not associated to horizon 2020 other than those listed in article 1 after examining the relevance of its participation for achieving the objectives of prima . ### the board of trustees shall approve the participation in prima of any third country not associated to horizon 2020 other than those listed in article 1 after examining the relevance of its participation for achieving the objectives of prima .


### the general assembly shall determine the number of management board members , which shall not be less than five , and shall appoint them . the management board shall supervise the secretariat of the prima - is . ### the board of trustees shall determine the number of steering committee members , which shall not be less than five , and shall appoint them . the steering committee shall supervise the secretariat of the prima - is .


### activities funded by the participating states through their national funding bodies without union contribution , addressing increasingly also the higher technology readiness levels and consisting in : ### activities funded by the participating states without union contribution , addressing a wide range of research and innovation activities and ensuring a balance between small and large projects consisting in :


### activities funded by the participating states through their national funding bodies without union contribution , addressing increasingly also the higher technology readiness levels and consisting in : ### activities funded by the participating states without union contribution , consisting in :


### the union shall participate in the partnership for research and innovation in the mediterranean area jointly undertaken by [ cyprus , czech republic , france , greece , israel , italy , luxembourg , malta , portugal , spain and tunisia ] , in accordance with the conditions laid down in this decision . ### the union shall participate in the partnership for research and innovation in the mediterranean area jointly undertaken by [ cyprus , france , germany , greece , israel , italy , luxembourg , malta , portugal , spain and tunisia ] , in accordance with the conditions laid down in this decision .


### in addition to the participants eligible for funding under article 10 of regulation no 1290 / 2013 , any legal entity established in a participating state shall be eligible for funding . ### by way of derogation from article 10 and of regulation no 1290 / 2013 , the following participants shall be eligible for funding by the prima - is : any legal entity established in a participating state or created under union law ; any international european interest organisation . in the case of a participating international organisation , which is not eligible for funding by the prima - is according to the first subparagraph , funding may be granted provided that its participation is deemed essential by the prima - is for carrying out the action . in the case of a participating legal entity established in a country which is not a participating state , which is not eligible for funding by the prima - is according to the first subparagraph , funding may be granted provided that an ad hoc funding arrangement is found between the prima - is and the country in which that legal entity is established .


### proposals shall be ranked according to the evaluation results . the selection shall be made by the prima - is on the basis of this ranking . the participating states shall agree on an adequate funding mode that allows maximising the number of proposals to be funded on the basis of this ranking , in particular by providing reserve amounts to the national contributions for calls for proposals . ### proposals shall be ranked according to the evaluation results . the selection shall be made by the prima - is and shall follow this ranking . the participating states shall agree on an adequate funding mode that allows maximising the number of proposals to be funded on the basis of this ranking , in particular by providing reserve amounts to the national contributions for calls for proposals . in case one or more projects cannot be funded , the projects following directly in the ranking list may be selected .


### the proposals shall be selected following transnational calls for proposals and through a two - step procedure . step 1 shall consist of a review at national or transnational level of proposals submitted by legal entities eligible for funding under the relevant national programmes . step 2 shall consist of a single independent international peer review organised by the prima - is . under step 2 , the proposals shall be evaluated with the assistance of at least three independent experts , on the basis of the following award criteria : excellence , impact , quality and efficiency of the implementation . ### the proposals shall be selected following transnational calls for proposals and shall be evaluated with the assistance of at least three independent experts , on the basis of the following award criteria : excellence , impact , quality and efficiency of the implementation .


### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision and food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream . ### the general objective of prima is to build research and innovation capacities and to develop knowledge and the fully piloted and demonstrated common innovative solutions for water management and provision and agro - food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving water scarcity , food security , nutrition , health , well - being and migration problems upstream .


### the proposals shall be for transnational projects , with minimum participation of at least three independent legal entities established in three different participating states , of which : ### the proposals shall be for transnational projects , with minimum participation of at least three independent legal entities established in three different countries considered as participating states in accordance with this decision by the submission deadline under the relevant call for proposals , of which :


### the prima - is shall be governed by the general assembly , in which all participating states are represented . the general assembly shall be the decision - making body of prima - is . ### the prima - is shall be governed by the board of trustees , in which all participating states are represented . the board of trustees shall be the decision - making body of prima - is .


### prima activities should be in line with the objectives and research and innovation priorities of horizon 2020 and with the general principles and conditions laid down in article 26 of regulation no 1291 / 2013 . prima should take into account the oecd definitions regarding technological readiness level in the classification of technological research , product development and demonstration activities . ### prima activities should be in line with the objectives and research and innovation priorities of horizon 2020 and with the general principles and conditions laid down in article 26 of regulation no 1291 / 2013 . prima should take into account the oecd definitions regarding technological readiness level in the classification of technological research , product development and demonstration activities , as well as addressing low to high technology readiness levels , including forms of ' curiosity - driven ' and ' practice - based ' research .


### the formulation of a stable , long - term , common strategic agenda in the area of water provision and food systems ; ### the formulation of a stable , long - term , common strategic agenda in the area of water provision and agro - food systems ;


### prima shall be implemented on the basis of annual work plans , to be adopted by the prima - is , after obtaining approval by the commission , by the end of the previous year . as an exception , the prima annual work plan for 2018 may be adopted by 31 march 2018 . the prima - is shall make the annual work plan publicly available . ### prima shall be implemented on the basis of annual work plans , covering activities to be launched in the period from 1 january to 31 december of a given year . the annual plan shall to be adopted by the prima - is by 31 march of the reference year , after obtaining approval by the commission without undue delay . if the commission does not respond to the request for approval work plan proposal in one month , it shall be deemed approved , the prima - is shall make the annual work plan publicly available .


### the orientation of all national r&i programmes towards the implementation of the strategic agenda ; ### the orientation of all relevant national research and innovation programmes towards the implementation of the strategic agenda ;


### activities to be funded by the participating states through their national funding bodies without union contribution may only be included in the prima annual work plan following the positive outcome of their external independent evaluation by international peer review with regard to the objectives of prima , as organised by the prima - is . ### activities to be funded by the participating states without union ' s financial contribution referred to in article 3 may only be included in the prima annual work plan following the positive outcome of their external independent evaluation by international peer review with regard to the objectives of prima , as organised by the prima - is .


### research and innovation actions , as well as innovation actions , including demonstrators , pilot plants , testing , pre - commercial deployment , addressing in particular the higher technology readiness levels ; ### research and innovation actions , as well as innovation actions ;


### one established in a third country considered as a participating state in accordance with this decision by the submission deadline under the relevant call for proposals . ### one established in a third country listed in article 1 or bordering the mediterranean sea .


### by way of derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants shall be three legal entities established in three different participating states of which : ### by way of derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants shall be three legal entities established in three different countries considered as participating states in accordance with this decision by the submission deadline under the relevant call for proposals , of which :


### contributions referred to in points and of paragraph 2 counting as contributions from participating states shall be made after the entry into force of this decision for the activities included in the first prima annual work plan , and after adoption of the subsequent annual work plans by the prima - is . ### contributions referred to in points , and of paragraph 2 counting as contributions from participating states shall be made after the adoption of the annual work plan . if the annual work plan is adopted during the reference year referred to in article 6 , the contributions referred to in point of paragraph 2 counting as contributions from participating states included in the annual work plan may comprise contributions made as from 1 january of that year . by way of derogation from the first subparagraph , the contributions referred to in point of paragraph 2 counting as contributions from participating states included in the first annual work plan may comprise contributions made after the entry into force of this decision .


### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision and food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream . ### in line with the priorities of horizon 2020 , the general objective of prima is to build research and innovation capacities and to develop knowledge and common innovative solutions for water management and agro - food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream .


### egypt , lebanon and morocco shall become participating states subject to the conclusion of international agreements with the union setting out the terms and conditions of their participation in prima . ### egypt , jordan , lebanon and morocco shall become participating states subject to the conclusion of science and technology international agreements with the union setting out the terms and conditions of their participation in prima .


### the commitment by each participating state to contribute to the financing of prima ; ### the commitment by each participating state to contribute to the financing of prima with an adequate percentage of the total effort ;


### the management board ; ### the steering committee


### in line with the objectives of horizon 2020 , any other member state and third country associated to horizon 2020 should be entitled to participate in prima if it commits to contribute to the financing of prima . ### in line with the objectives of horizon 2020 , any other member state and third country associated to horizon 2020 should be entitled to participate in prima if it commits to contribute to the financing of prima with an adequate percentage of the total effort .


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


### without prejudice to paragraph 1 , where technically possible and feasible , for the purposes of point of article 8 , consent may be expressed by using the appropriate technical settings of a software application enabling access to the internet . ### where technically possible and feasible for the purposes of point of article 8 consent may be expressed by using the appropriate technical setting of software application enabling access to the internet or by the continued use of the information society service after having been provided with accessible and comprehensive information about this action of the end - user .


### 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 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 . 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 , spam or distributed denial - of - service attacks , or the processing of metadata 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 publicly available directories or the electronic communication services providers shall obtain the consent of users to include their personal data in the directory and , consequently , shall obtain consent from these users for inclusion of data per category of personal data , to the extent that such data are relevant for the purpose of the directory . electronic communication service providers shall give users the means to verify , correct , update , complete and delete such data . when electronic communication service providers obtain consent of users , they shall make users ' data available for public directory providers in an immediate , non - discriminatory and fair manner .


### when the processing of electronic communications data by providers of electronic communications services falls within its scope , this regulation should provide for the possibility for the union or member states under specific conditions to restrict by law certain obligations and rights when such a restriction constitutes a necessary and proportionate measure in a democratic society to safeguard specific public interests , including national security , defence , public security and the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , including the safeguarding against and the prevention of threats to public security and other important objectives of general public interest of the union or of a member state , in particular an important economic or financial interest of the union or of a member state , or a monitoring , inspection or regulatory function connected to the exercise of official authority for such interests . therefore , this regulation should not affect the ability of member states to carry out lawful interception of electronic communications or take other measures , if necessary and proportionate to safeguard the public interests mentioned above , in accordance with the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms , as interpreted by the court of justice of the european union and of the european court of human rights . providers of electronic communications services should provide for appropriate procedures to facilitate legitimate requests of competent authorities , where relevant also taking into account the role of the representative designated pursuant to article 3 . ### when the processing of electronic communications data by providers of electronic communications services falls within its scope , this regulation is without prejudice to the possibility for the union or member states under specific conditions to restrict by law certain obligations and rights set out in this regulation when such a restriction is targeted at persons suspected of having committed a criminal offence and constitutes a necessary and proportionate measure in a democratic society to safeguard specific public interests , including national security , defence , public security and the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , including the safeguarding against and the prevention of threats to public security . therefore , this regulation should not affect the ability of member states to carry out lawful interception of electronic communications or take other measures , if necessary and proportionate to safeguard the public interests mentioned above , in accordance with the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms , as interpreted by the court of justice of the european union and of the european court of human rights .


### in order to fulfil the objectives of this regulation , namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data and to ensure the free movement of personal data within the union , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to supplement this regulation . in particular , delegated acts should be adopted in respect of the information to be presented , including by means of standardised icons in order to give an easily visible and intelligible overview of the collection of information emitted by terminal equipment , its purpose , the person responsible for it and of any measure the end - user of the terminal equipment can take to minimise the collection . delegated acts are also necessary to specify a code to identify direct marketing calls including those made through automated calling and communication systems . it is of particular importance that the commission carries out appropriate consultations and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201625 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . furthermore , in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission when provided for by this regulation . those powers should be exercised in accordance with regulation no 182 / 2011 . __________________ 25 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 . ### in order to fulfil the objectives of this regulation , namely to protect the fundamental rights and freedoms of natural persons in the provision and use of electronic communications services and in particular their right to respect of their private life and communications with regard to the processing of personal data and to ensure the free movement of personal data within the union , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to supplement this regulation . in particular , delegated acts should be adopted in respect of the information to be presented , including by means of standardised icons in order to give an easily visible and intelligible overview of the collection of information emitted by terminal equipment , its purpose , the person responsible for it and of any measure the user of the terminal equipment can take to minimise the collection . it is of particular importance that the commission carries out appropriate consultations and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201625 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . furthermore , in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission when provided for by this regulation . for instance , implementing measures are necessary to specify a code to identify direct marketing calls including those made through automated calling and communication systems . those powers should be exercised in accordance with regulation no 182 / 2011 . __________________ 25 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 .


### it is necessary for providing an information society service requested by the end - user ; or ### it is strictly technically necessary for providing an information society service requested by the user ; or


### natural or legal persons may use electronic communications services for the purposes of sending direct marketing communications to end - users who are natural persons that have given their consent . ### the use by natural or legal persons of electronic communications services , including automated calling , communications systems , semi - automated systems that connect the call person to an individual , faxes , e - mail or other use of electronic communications services for the purposes of presenting unsolicited or direct marketing communications to end - users , shall be allowed only in respect of end - users who have given their prior 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 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 .


### electronic communications data shall be confidential . any interference with electronic communications data , such as by listening , tapping , storing , monitoring , scanning or other kinds of interception , surveillance or processing of electronic communications data , by persons other than the end - users , shall be prohibited , except when permitted by this regulation . ### electronic communications shall be confidential . any interference , with electronic communications at rest or in transit , such as by listening , tapping , storing , monitoring , scanning or other kinds of interception , surveillance or any processing of electronic communications , by persons other than the users , shall be prohibited , except when permitted by this regulation .


### 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 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 . it should not prohibit the processing of electronic communications data by public authorities , computer emergency response teams , computer security incident response teams , providers of electronic communications networks and services and by certified providers of security technologies and services , in compliance with regulation 2016 / 679 and to the extent strictly necessary and proportionate for the sole purposes of ensuring network and information security , i . e . preservation of availability , integrity and confidentiality of information , and ensuring the security of the related services offered by , or accessible via , those networks and systems . this could , for example , include preventing unauthorised access to electronic communications networks and malicious code distribution and stopping ‘ denial of service’ attacks and damage to computer and electronic communication systems , checking security threats such as the presence of malware , spam or to check against ddos attacks , or the processing of metadata to ensure the necessary quality of service requirements such as latency , jitter etc .


### the content of electronic communications pertains to the essence of the fundamental right to respect for private and family life , home and communications protected under article 7 of the charter . any interference with the content of electronic communications should be allowed only under very clear defined conditions , for specific purposes and be subject to adequate safeguards against abuse . this regulation provides for the possibility of providers of electronic communications services to process electronic communications data in transit , with the informed consent of all the end - users concerned . for example , providers may offer services that entail the scanning of emails to remove certain pre - defined material . given the sensitivity of the content of communications , this regulation sets forth a presumption that the processing of such content data will result in high risks to the rights and freedoms of natural persons . when processing such type of data , the provider of the electronic communications service should always consult the supervisory authority prior to the processing . such consultation should be in accordance with article 36 and of regulation 2016 / 679 . the presumption does not encompass the processing of content data to provide a service requested by the end - user where the end - user has consented to such processing and it is carried out for the purposes and duration strictly necessary and proportionate for such service . after electronic communications content has been sent by the end - user and received by the intended end - user or end - users , it may be recorded or stored by the end - user , end - users or by a third party entrusted by them to record or store such data . any processing of such data must comply with regulation 2016 / 679 . ### the content of electronic communications pertains to the essence of the fundamental right to respect for private and family life , home and communications protected under article 7 of the charter . this regulation provides for the possibility of providers of electronic communications services to process electronic communications data at rest or in transit , with the informed consent of all the users concerned . for example , providers may offer services that entail the scanning of e - mails to remove certain pre - defined material . given the sensitivity of the content of communications , this regulation sets forth a presumption that the processing of such content data will result in high risks to the rights and freedoms of natural persons . when processing such type of data , the provider of the electronic communications service should always consult the supervisory authority prior to the processing . such consultation should be in accordance with article 36 and of regulation 2016 / 679 . the presumption does not encompass the processing of content data to provide a service requested by the user where the user has consented to such processing and it is carried out for the purposes and duration strictly necessary and proportionate for such service . after electronic communications content has been sent by the user and received by the intended user or users , it may be recorded or stored by the user , users or by another party entrusted by them to record or store such data . any processing of such data must comply with regulation 2016 / 679 .


### 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 requires that users are asked for consent before their personal data are included in a directory . the legitimate interest of legal entities requires that end - users have the right to object to the data related to them being included in a directory . natural persons who act with commercial intent , such as freelancers , small traders or self - employed persons , should be equated to legal persons .


### 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 strictly necessary and proportionate for the legitimate purpose of enabling the use of a specific service explicitly requested by the user . this may include the storing of information for the duration of a single established session on a website to keep track of the user’s input when filling in online forms over several pages . tracking techniques , if implemented with appropriate privacy safeguards , can also be a legitimate and useful tool , for example , in measuring web traffic to a website . information society providers could engage in configuration checking in order to provide the service in compliance with the user ' s settings and the mere logging revealing the fact that the user’s device is unable to receive content requested by the user , should not constitute illegitimate access .


### permitted processing of electronic communications data ### lawful processing of electronic communications data


### pursuant to article 8 of the charter and article 16 of the treaty on the functioning of the european union , everyone has the right to the protection of personal data concerning him or her . regulation 2016 / 679 lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data . electronic communications data may include personal data as defined in regulation 2016 / 679 . ### pursuant to article 8 of the charter and article 16 of the treaty on the functioning of the european union , everyone has the right to the protection of personal data concerning him or her . regulation 2016 / 679 lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data . electronic communications data are generally personal data as defined in regulation 2016 / 679 .


### natural or legal persons may use electronic communications services for the purposes of sending direct marketing communications to end - users who are natural persons that have given their consent . ### the use by natural or legal persons of electronic communications services , including voice - to - voice calls , automated calling and communications systems , including semi - automated systems that connect the call person to an individual , faxes , e - mail or other use of electronic communications services for the purposes of presenting unsolicited or direct marketing communications to end - users , shall be allowed only in respect of end - users who have given their prior consent .


### providers of electronic communications services may process electronic communications metadata if : ### providers of electronic communications services may process electronic communications metadata only if :


### 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 users 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 or electronic communications service providers 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 . 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 user ' s contact details can be searched should not necessarily be the same .


### software placed on the market permitting electronic communications , including the retrieval and presentation of information on the internet , shall offer the option to prevent third parties from storing information on the terminal equipment of an end - user or processing information already stored on that equipment . ### software placed on the market permitting electronic communications , including the retrieval and presentation of information on the internet , shall :


### if it is necessary for web audience measuring , provided that such measurement is carried out by the provider of the information society service requested by the end - user . ### if it is technically necessary for web audience measuring of the information society service requested by the user , provided that such measurement is carried out by the provider , or on behalf of the provider , or by an independent web analytics agency acting in the public interest or for scientific purpose ; and further provided that no personal data is made accessible to any other party and that such web audience measurement does not adversely affect the fundamental rights of the user ;


### 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 publicly available directories or the electronic communication services providers shall obtain the consent of users to include their personal data in the directory and , consequently , shall obtain consent from these users for inclusion of data per category of personal data , to the extent that such data are relevant for the purpose of the directory . electronic communication service providers shall give users the means to verify , correct , update , complete and delete such data . when electronic communication service providers obtain consent of users , they shall make users ' data available for public directory providers in an immediate , non - discriminatory and fair manner .


### the end - user concerned has given his or her consent to the processing of his or her communications metadata for one or more specified purposes , including for the provision of specific services to such end - users , provided that the purpose or purposes concerned could not be fulfilled by processing information that is made anonymous . ### after receiving all relevant information about the intended processing in clear and easily understandable language , provided separately from the terms and conditions of the provider , the user or users concerned have given their specific consent to the processing of their communications metadata for one or more specified purposes , including for the provision of specific services to such users , provided that the purpose or purposes concerned could not be fulfilled without the processing of such metadata .


### ‘ direct marketing voice - to - voice calls’ means live calls , which do not entail the use of automated calling systems and communication systems ; ### ‘ direct marketing voice - to - voice calls’ means live calls , which do not entail the use of automated calling systems and communication systems ; this shall not include calls and text messages linked to amber alert ;


### the definitions of ‘ electronic communications network’ , ‘ electronic communications service’ , ‘ interpersonal communications service’ , ‘ number - based interpersonal communications service’ , ‘ number - independent interpersonal communications service’ , ‘ end - user’ and ‘ call’ in points , , , , , and respectively of article 2 of [ directive establishing the european electronic communications code ] ; ### the definition of ‘ call’ in point of article 2 of [ directive establishing the european electronic communications code ] ;


### 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 all 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 .


### the protection of information related to the terminal equipment of end - users located in the union . ### the protection of information related to or processed by the terminal equipment of end - users in the union .


### service providers who offer electronic communications services should inform end - users of measures they can take to protect the security of their communications for instance by using specific types of software or encryption technologies . the requirement to inform end - users of particular security risks does not discharge a service provider from the obligation to take , at its own costs , appropriate and immediate measures to remedy any new , unforeseen security risks and restore the normal security level of the service . the provision of information about security risks to the subscriber should be free of charge . security is appraised in the light of article 32 of regulation 2016 / 679 . ### service providers who offer electronic communications services should process electronic communications data in such a way as to prevent unauthorised access , disclosure or alteration , ensure that such unauthorised access , disclosure or alteration is capable of being ascertained , and also ensure that such electronic communications data are protected by using specific types of software and encryption technologies . the requirement to inform end - users of particular security risks does not discharge a service provider from the obligation to take , at its own costs , appropriate and immediate measures to remedy any new , unforeseen security risks and restore the normal security level of the service . the provision of information about security risks to the subscriber should be free of charge . security is appraised in the light of article 32 of regulation 2016 / 679 . the obligations of article 40 of the [ european electronic communications code ] should apply to all services within the scope of this regulation as regards the security of networks and services and related security obligations thereto .


### electronic communications data should be treated as confidential . this means that any interference with the transmission of electronic communications data , whether directly by human intervention or through the intermediation of automated processing by machines , without the consent of all the communicating parties should be prohibited . the prohibition of interception of communications data should apply during their conveyance , i . e . until receipt of the content of the electronic communication by the intended addressee . interception of electronic communications data may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . interception also occurs when third parties monitor websites visited , timing of the visits , interaction with others , etc . , without the consent of the end - user concerned . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating end - user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , including browsing habits without the end - users ' consent . ### electronic communications should be treated as confidential . this means that any interference with the transmission of electronic communications , whether directly by human intervention or through the intermediation of automated processing by machines , without the consent of all the communicating parties should be prohibited . when the processing is allowed under any exception to the prohibitions under this regulation , any other processing on the basis of article 6 of regulation 2016 / 679 should be considered as prohibited , including processing for another purpose on the basis of article 6 of that regulation . this should not prevent requesting additional consent for new processing operations . the prohibition of interception of communications should apply also during their conveyance , i . e . until receipt of the content of the electronic communication by the intended addressee , and to any temporary files in the network after receipt . interception of electronic communications may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . interception also occurs when other parties monitor websites visited , timing of the visits , interaction with others , etc . , without the consent of the user concerned . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , and analysis of customers ' traffic data , including browsing habits without the users ' consent .


### without prejudice to point of article 6 and points and of article 6 , the provider of the electronic communications service shall erase electronic communications content or make that data anonymous after receipt of electronic communication content by the intended recipient or recipients . such data may be recorded or stored by the end - users or by a third party entrusted by them to record , store or otherwise process such data , in accordance with regulation 2016 / 679 . ### without prejudice to point of article 6 and points and of article 6 , the provider of the electronic communications service shall erase electronic communications content after receipt of electronic communication content by the intended recipient or recipients . such data may be recorded or stored by the users or by a specific other party entrusted by them to record , store or otherwise process such data .


### 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 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 users . 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 .


### notwithstanding paragraph 1 , member states may provide by law that the placing of direct marketing voice - to - voice calls to end - users who are natural persons shall only be allowed in respect of end - users who are natural persons who have not expressed their objection to receiving those communications . ### notwithstanding paragraph 1 , member states may provide by law that the placing of direct marketing voice - to - voice calls to end - users who are natural persons shall only be allowed in respect of end - users who are natural persons who have not expressed their objection to receiving those communications . member states shall provide that users can object to receiving the direct marketing voice - to - voice calls via a national do not call register , thereby also ensuring that the user needs to opt - out only once .


### the providers of a publicly available directory shall inform end - users who are natural persons whose personal data are in the directory of the available search functions of the directory and obtain end - users’ consent before enabling such search functions related to their own data . ### the providers of a publicly available directories shall inform users whose personal data are in the directory of the available search functions of the directory . the electronic communication service providers shall inform users if new search functions are enabled .


### it is necessary for providing an information society service requested by the end - user ; or ### it is necessary for providing an information society service requested by the end - user which shall include inter alia maintaining , operating and managing the integrity , access or security of the information society service , enhancing user experience or measures for preventing unauthorized access to or use information society service according to the terms of use for making available the service to the end - user ; or