### in order to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject , to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should be audio - visually recorded . this does not include questioning necessary to identify the child . ### bearing in mind that children are particularly vulnerable , questioning may be perceived to be traumatic , therefore it is essential that questioning be carried out by trained professionals taking into consideration the children’s age , maturity , level of understanding and any communication difficulties they may have . questioning should take place in the presence of a lawyer and , where so requested by the child and / or where that is in the best interest of the child , the holder of parental responsibility and , where necessary , specialist professionals . thorough documentation and audio - visual recording of interviews are a vital safeguard serving both to guarantee that interviews will be conducted properly and to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject . in order to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should therefore be audio - visually recorded .


### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . in exceptional cases the court may decide that a hearing should be held publicly after it has taken due account of the best interests of the child . ### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . only in exceptional cases , when in the best interest of the child , should the court be allowed to hold a hearing in public . such a decision should be open for appeal by the child .


### the extent and detail of the individual assessment may vary depending on the circumstances of the case , the seriousness of the alleged offence and the penalty which will be imposed if the child is found guilty of the alleged offence , whether or not the child has previously come to the attention of competent authorities in the context of criminal proceedings . ### whether or not the child has previously come to the attention of competent authorities in the context of criminal proceedings , the extent and detail of the individual assessment may vary . it may depend , in particular on the circumstances of the case , the seriousness of the alleged offence and the penalty which will be imposed if the child is found guilty of the alleged offence , whether or not the child has previously come to the attention of competent authorities in the context of criminal proceedings


### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . ### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . the medical examination shall be as non - invasive as possible and carried out by a qualified physician .


### member states shall ensure that children are deprived of liberty before their conviction only as a measure of last resort and for the shortest appropriate period of time . due account shall be taken of the age and individual situation of the child . ### member states shall ensure that children are deprived of liberty before their conviction only as a measure of last resort , &#160 ; a specific and detailed justification for this being given , and for the shortest appropriate period of time , ensuring in every case respect for the human dignity and the rights of the child in custody . due account shall be taken of the age , individual situation and personality of the child and the particular circumstances under which the offence was committed .


### foster the development of the child and its future integration into society . ### ensure access to programmes that foster the development of the child and his or her future integration into society .


### member states shall ensure that judicial and law enforcement authorities and prison staff who deal with cases involving children are professionals specialising in the field of criminal proceedings involving children . they shall receive particular training with regard to children ' s legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills . ### member states shall ensure that judicial and law enforcement authorities and&#160 ; staff of detention facilities&#160 ; who deal with cases involving children receive appropriate training with regard to children ' s legal rights , interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills .


### member states shall ensure that judicial and law enforcement authorities and prison staff who deal with cases involving children are professionals specialising in the field of criminal proceedings involving children . they shall receive particular training with regard to children ' s legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills . ### member states shall ensure that law enforcement authorities , staff of detention facilities , and other relevant professionals who deal with cases involving children receive adequate training at a level appropriate to their contact with children with regard to children ' s needs and legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills , as well as on rules of confidentiality .


### taking into account the objectives of the union’s agricultural policy , the results of the recent scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species . ### taking into account the objectives of the union’s common agricultural policy , the results of the recent scientific assessments of efsa based on the available scientific studies , and the animal welfare requirement provided in article 13 tfeu , it is prudent to provisionally prohibit the use of cloning in animal production for farming purposes of certain species .


### this directive respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , and notably the freedom to conduct a business and the freedom of the sciences . this directive has to be implemented in accordance with these rights and principles . ### this regulation respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , and in particular the freedom to conduct a business and the freedom of the sciences . this regulation has to be applied in accordance with these rights and principles .


### animals &#8220 ; kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes . it shall not include animals kept and reproduced exclusively for other purposes such as research , the production of medicinal products and medical devices , the preservation of rare breeds or endangered species , sporting and cultural events ; ### &#8220 ; animals kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes . it shall not include animals kept and reproduced exclusively for other purposes such as research , the production of medicinal products and medical devices , or the preservation of rare breeds or endangered species ;


### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ date for transposition of the directive ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ’ ### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are applied . the penalties provided for shall be effective , proportionate , dissuasive and shall ensure a level playing field . member states shall notify those provisions to the commission by [ date : 1 year from the entry into force of the regulation ] and shall notify it without delay of any subsequent amendment thereto .


### entering into force ### entry into force


### reflecting the important contribution that research and innovation should make to address challenges in food , agriculture , rural development and the bioeconomy , and to seize the corresponding research and innovation opportunities in close synergy with common agricultural policy , relevant actions under the specific programme will be supported with eur 10 billion for the cluster ' food and natural resources ' for the period 2021 - 2027 . ### reflecting the important contribution that research and innovation should make to address challenges in food , agriculture , fisheries and aquaculture , rural development and the bioeconomy , and to seize the corresponding research and innovation opportunities in close synergy with common agricultural policy and common fisheries policy , relevant actions under the specific programme will be supported with eur 16 billion for the cluster ‘ food , natural resources , seas and oceans’ for the period 2021 - 2027 .


### reinforcing and spreading excellence ; ### supporting science , research and innovations , reinforcing and spreading excellence ;


### connecting and developing research infrastructures across the european research area ; ### connecting , developing and facilitating wide access to research infrastructures across the european research area and enhancing its involvement in horizon europe’s projects ;


### stimulating the creation and scale - up of innovative companies , in particular smes ; ### stimulating the creation and scale - up of innovative companies , in particular start - ups and smes ;


### cluster food and natural resources ' , as described in annex i , pillar ii , section 5 ; ### cluster food , natural resources , seas and oceans ' , as described in annex i , pillar ii , section 5 ;


### for each mission , a mission board may be established . it shall be composed of around 15 high level individuals including relevant end - users ' representatives . the mission board shall advise upon the following : ### for each mission , a mission board may be established for co - designing and steering implementation . it shall be composed of around 15 high level individuals including relevant end - users ' representatives . the mission board shall include , inter alia , representatives from academia , research and technology organisations , industry of all sizes , and relevant end - users ' representatives and civil society organisations . the members of the mission board shall be appointed by the commission , following an independent and transparent procedure for their selection , including an open call for expressions of interest . they shall advise on the following :


### for each mission , a mission board may be established . it shall be composed of around 15 high level individuals including relevant end - users ' representatives . the mission board shall advise upon the following : ### for each mission , a mission board may be established . it shall be composed of&#160 ; maximum 15 high level individuals including relevant end - users ' representatives appointed by the commission following a transparent and independent recruitment process with participants of applicants from all member states . the mission board shall advise upon the following :


### selection of expert evaluators , briefing of expert evaluators and evaluation criteria and their weighting ; ### selection of expert evaluators , briefing of expert evaluators and evaluation criteria and their weighting , avoid conflict of interest of expert evaluators ;


### horizon europe will provide dedicated support for open access to scientific publications , to knowledge repositories and other data sources . dissemination and knowledge diffusion actions will be supported , also from cooperation with other eu programmes , including clustering and packaging results and data in languages and formats for target audiences and networks for citizens , industry , public administrations , academia , civil society organisations , and policy makers . for this purpose , horizon europe may make use of advanced technologies and intelligence tools . ### horizon europe will provide dedicated support for open access to scientific publications , to knowledge repositories and other data sources . dissemination and knowledge diffusion actions will be supported , also from cooperation with other eu programmes , including clustering and packaging results and data in languages and formats for target audiences and networks for citizens , industry , public administrations , academia , civil society organisations , and policy makers . for this purpose , horizon europe may make use of advanced technologies and intelligence tools . the commission will implement an instrument to make public in real time , the implementation of the programme , including data about the participants , financing amounts and market uptake .


### the overall aim is to endow europe with world - class sustainable research infrastructures open and accessible to all researchers in europe and beyond , which fully exploit their potential for scientific advance and innovation . key objectives are to reduce the fragmentation of the research and innovation ecosystem , avoiding duplication of effort , and better coordinate the development and use of research infrastructures . it is crucial to support open access to research infrastructures for all european researchers as well as , through the european open science cloud , increased access to digital research resources , specifically tackling the currently sub - optimal embracement of open science and open data practises . equally , the eu needs to tackle the rapid increase of global competition for talent by attracting third country researchers to work with european world - class research infrastructures . increasing the competitiveness of european industry is also a major objective , supporting key technologies and services relevant for research infrastructures and their users , thus improving the conditions for supply of innovative solutions . ### the overall aim is to improve europe ' s endowment with world - class sustainable research infrastructures open and accessible to all researchers in europe and beyond , which fully exploit their potential for scientific advance and innovation . key objectives are to reduce the fragmentation of the research and innovation ecosystem , ensure continuous modernisation avoiding duplication of effort , and better coordinate the development , use and accessibility of research infrastructures as well as its better involvement in horizon europe’s projects , including research infrastructures founded by the eu , particularly from erdf . this will provide clear synergies between horizon europe and conducted national and regional strategies . it is also crucial to support open access to research infrastructures for all european researchers as well as , through the european open science cloud , increased access to digital research resources , specifically tackling the currently sub - optimal embracement of open science and open data practises . equally , the eu needs to tackle the rapid increase of global competition for talent by attracting third country researchers to work with european world - class research infrastructures . increasing the competitiveness of european industry is also a major objective , supporting key technologies and services relevant for research infrastructures and their users , thus improving the conditions for supply and utilisation of innovative solutions .


### 2 . 2 . cultural heritage ### 2 . 2 . cultural heritage and tourism


### cultural heritage is the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial and creative sectors that are drivers of sustainable economic growth , new job creation and external trade . ### cultural heritage the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries and the tourism sector . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial , creative and tourism sectors that are drivers of sustainable economic growth , new job creation and external trade .


### the issues faced by the transport and energy sectors go however beyond the need for emission reduction . there are several challenges to be tackled , including the increasing penetration of digital and space - based technologies , changes in user behaviour and mobility patterns , new market entrants and disruptive business models , globalisation , increasing international competition and an older , more urban and increasingly diverse , population . ### the issues faced by the transport and energy sectors go however beyond the need for emission reduction . there are several challenges to be tackled , including the increasing penetration of digital , automated and space - based technologies , changes in user behaviour and mobility patterns , new market entrants and disruptive business models , globalisation , increasing international competition and an older , more urban and increasingly diverse , population .


### finding new ways to accelerate the deployment of clean technologies and solutions for the decarbonisation of the european economy requires also increased demand for innovation . this can be stimulated through the empowerment of citizens as well as socio - economic and public sector innovation and will lead to approaches broader than technology - driven innovation . socio - economic research covering inter alia user needs and patterns , foresight activities , environmental , economic , social and behavioural aspects , business cases and models and pre - normative research for standard setting , will also facilitate actions fostering regulatory , financing and social innovation , skills , as well as engagement and empowerment of market players and consumers . ### finding new ways to accelerate the deployment of clean technologies and solutions for the decarbonisation of the european economy requires also increased demand for innovation . this can be stimulated through the empowerment of citizens as well as socio - economic and public sector innovation and will lead to approaches broader than technology - driven innovation . socio - economic research covering inter alia user needs and patterns , foresight activities , environmental , economic , social and behavioural aspects , business cases and models and pre - normative research for standard setting , will also facilitate actions fostering regulatory , financing and social innovation , skills , as well as engagement and empowerment of market players and consumers . in the transport sector , the role of applied research and trials aiming at market deployment of innovations is crucial .


### activities under this cluster contribute in particular to the goals of the energy union , as well as to those of the digital single market , the jobs , growth and investment agenda , the strengthening of the eu as a global actor , the new eu industrial policy strategy , the circular economy , the raw materials initiative , the security union and the urban agenda , as well as the common agricultural policy of the eu as well as eu legal provisions to reduce noise and air pollution . ### activities under this cluster contribute in particular to the goals of the energy union , as well as to those of the digital single market , the jobs , growth and investment agenda , the strengthening of the eu as a global actor , the new eu industrial policy strategy , the circular economy , the raw materials initiative , the security union and the urban agenda , the maritime policy as well as the common agricultural policy of the eu as well as eu legal provisions to reduce noise and air pollution .


### activities under this cluster contribute in particular to the goals of the energy union , as well as to those of the digital single market , the jobs , growth and investment agenda , the strengthening of the eu as a global actor , the new eu industrial policy strategy , the circular economy , the raw materials initiative , the security union and the urban agenda , as well as the common agricultural policy of the eu as well as eu legal provisions to reduce noise and air pollution . ### activities under this cluster contribute in particular to the goals of the energy union , as well as to those of the digital single market , the jobs , growth and investment agenda , the strengthening of the eu as a global actor , the new eu industrial policy strategy , the circular economy , the raw materials initiative , the security union and the urban agenda , as well as the common agricultural policy of the eu as well as eu legal provisions to reduce noise and air pollution and help member states to achieve the national emission reduction targets .


### the eu aims to be world leader in affordable , secure and sustainable energy technologies improving its competitiveness in global value chains and its position in growth markets . diverse climatic , geographical , environmental and socio - economic conditions in the eu as well as the need to ensure energy security and access to raw materials , dictate a broad portfolio of energy solutions , including of non - technical nature . as regards renewable energy technologies , costs need to decrease further , performance must improve , integration into the energy system must be improved and breakthrough technologies need to be developed . as regards fossil fuels , decarbonising their usage will be essential to meet the climate objectives . ### the eu aims to be world leader in affordable , secure and sustainable energy technologies improving its competitiveness in global value chains and its position in growth markets . diverse climatic , geographical , environmental and socio - economic conditions in the eu as well as the need to ensure energy security and access to raw materials , dictate a broad portfolio of energy solutions , including of non - technical nature . as regards renewable energy technologies , costs need to decrease further , performance must improve , integration into the energy system must be improved and breakthrough technologies need to be developed . as regards fossil fuels , decarbonising their usage will be essential to meet the climate objectives . also gas infrastructure plays an important role in integrating renewable and low carbon gases .


### –renewable energy technologies and solutions for power generation , heating and cooling , sustainable transport fuels and intermediate carriers , at various scales and development stages , adapted to geographic conditions and markets , both within the eu and worldwide ; ### –renewable energy technologies and solutions for power generation , hydrogen production , heating and cooling , sustainable transport fuels and intermediate carriers , at various scales and development stages , adapted to geographic conditions and markets , both within the eu and worldwide ;


### the expected growth of variable electricity production and shift towards more electric heating , cooling and transport dictates the need for new approaches to manage energy grids . next to decarbonisation , the goal is to ensure energy affordability , security and stability of supply , achieved through investments in innovative network infrastructure technologies and innovative system management . energy storage in different forms will play a key role in providing services to the grid , also improving and reinforcing network capacities . exploiting synergies between different networks and actors will be crucial for enabling the smart , integrated operation of the relevant infrastructures . ### the expected growth of variable electricity production and shift towards more decentralised production , electric heating , cooling and transport dictates the need for new approaches to manage energy grids . next to decarbonisation , the goal is to ensure energy affordability , security and stability of supply , achieved through investments in innovative network infrastructure technologies and innovative system management . energy storage in different forms will play a key role in providing services to the grid , also improving and reinforcing network capacities . exploiting synergies between different networks and actors will be crucial for enabling the smart , integrated operation of the relevant infrastructures .


### –technologies and tools for electricity networks to integrate renewables and new loads such as electro - mobility and heat pumps ; ### –technologies and tools for networks to integrate renewables and new loads such as electro - mobility and heat pumps ;


### –electrification of all transport modes including new technologies for vehicle / vessel / aircraft powertrains , fast charging / refuelling , energy harvesting and user - friendly and accessible interfaces with the charging infrastructure , ensuring interoperability and seamless services provision ; development and deployment of competitive , safe , high - performing and sustainable batteries for low and zero - emission vehicles ; ### –decarbonisation of transport modes including new technologies for vehicle / vessel / aircraft powertrains , fast charging / refuelling , energy harvesting and user - friendly and accessible interfaces with the charging infrastructure , ensuring interoperability and seamless services provision ; development and deployment of competitive , safe , high - performing and sustainable batteries for low and zero - emission vehicles ;


### –sustainable new fuels and new smart vehicles / vessels / aircraft for existing and future mobility patterns and supporting infrastructure ; technologies and user - based solutions for interoperability and seamless services provision ; ### –sustainable new fuels and new smart vehicles / vessels / aircraft for existing and future mobility patterns and supporting infrastructure ; technologies and user - based solutions for interoperability and seamless services provision ; quieter and more environmentally friendly aircraft ;


### cluster ' food and natural resources ' ### cluster ' food , natural resources , seas and oceans '


### food and natural resources ### food , natural resources , seas and oceans


### 2 . 4 . sea and oceans ### 2 . 4 . seas and oceans


### –digitisation in individual sectors , such as energy , transport , construction , health and government ; ### –digitisation in individual sectors , such as energy , transport , construction , health , government and tourism ;


### bringing together activities on digital , key enabling and space technologies , as well as a sustainable supply of raw materials , will allow for a more systemic approach , and a faster and more profound digital and industrial transformation . it will ensure that research and innovation in these areas feed into , and contribute to the implementation of , the eu’s policies for industry , digitisation , environment , energy and climate , circular economy , raw and advanced materials and space . ### bringing together activities on digital , key enabling and space technologies , as well as a sustainable supply of raw materials , will allow for a more systemic approach , and a faster and more profound digital and industrial transformation . it will ensure that research and innovation in these areas feed into , and contribute to the implementation of , the eu’s policies for industry , digitisation , environment , energy and climate , mobility , circular economy , raw and advanced materials and space .


### –electrification and use of unconventional energy sources within industrial plants , and energy and resource exchanges between industrial plants ; ### –electrification and use of unconventional or renewables - based energy sources within industrial plants , and energy and resource exchanges between industrial plants ;


### to meet the objectives of the paris agreement the eu will need to transition to low - carbon , resource - efficient and resilient economies and societies . this will be based on profound changes in technology and services , to the ways in which businesses and consumers behave , as well as involving new forms of governance . limiting the increase of global average temperature to well below 2°c , and pursuing efforts to limit the temperature increase to 1 . 5°c , requires rapid progress in decarbonising the energy system and substantially reducing greenhouse - gas emissions from the transport sector17 . it will also need new impetus to accelerate the pace of developing next - generation breakthroughs as well as demonstrating and deploying innovative technologies and solutions , using also the opportunities provided by digital and space technologies . this will be pursued through an integrated approach encompassing decarbonisation , resource efficiency , reduction of air pollution , access to raw materials and circular economy . __________________ 17 substantial decarbonisation of other sectors is addressed in other areas of the horizon europe global challenges and industrial competitiveness pillar . ### to meet the objectives of the paris agreement the eu will need to transition to low - carbon , resource - efficient and resilient economies and societies . this will be based on profound changes in technology and services , to the ways in which businesses and consumers behave , as well as involving new forms of governance . limiting the increase of global average temperature to well below 2°c , and pursuing efforts to limit the temperature increase to 1 . 5°c , requires rapid progress in decarbonising the energy system and substantially reducing greenhouse - gas emissions from the transport sector17 . currently , the transport sector represents almost a quarter of union ' s ghg emissions . transport sector is of key importance for reducing ghg emissions and decarbonising the union economy . it will also need new impetus to accelerate the pace of developing next - generation breakthroughs as well as demonstrating and deploying innovative technologies and solutions , using also the opportunities provided by digital , automatisation and space technologies . this will be pursued through an integrated approach encompassing decarbonisation , resource efficiency , reduction of air pollution , access to raw materials and circular economy . __________________ 17 substantial decarbonisation of other sectors is addressed in other areas of the horizon europe global challenges and industrial competitiveness pillar .


### massive , concentrated and decentralised storage solutions for the energy system will increase efficiency , flexibility , technology independence and accessibility as well as the security of supply . low - emission , decarbonised transport will require a growing share of electrical and / or other alternatively fuelled vehicles , with better - performing and cheaper , recyclable and reusable batteries , as well as local provision of synthetic / renewable fuels such as hydrogen and innovative solutions for on - site storage . ### massive , concentrated and decentralised storage solutions for the energy system will increase efficiency , flexibility , technology independence and accessibility as well as the security of supply . low - emission , decarbonised transport will require a growing share of electrical and / or other alternatively fuelled vehicles , with better - performing and cheaper , sustainably manufactured , recyclable and reusable batteries , as well as local provision of synthetic / renewable fuels such as hydrogen and innovative solutions for on - site storage .


### –low zero - carbon hydrogen including fuel cells , and the eu value chain from design to end use across various applications . ### –storage and related infrastructure of low carbon hydrogen and other substances and materials enabling the storage of energy including but limited to to the technology of fuel cells , and the eu value chain from design to end use across various applications .


### in its resolution of 8 february 2018 , the european parliament called on the commission to conduct an assessment of the summer - time arrangements provided by directive 2000 / 84 / ec and , if necessary , to come up with a proposal for its revision . that resolution also confirmed that it is essential to maintain a harmonised approach to time arrangements throughout the union . ### against the background of several petitions from citizens , parliamentary questions and a public hearing on the matter , the european parliament , in its resolution of 8 february 2018 , the european parliament called on the commission to conduct an assessment of the summer - time arrangements provided by directive 2000 / 84 / ec and , if necessary , to come up with a proposal for its revision . that resolution also confirmed that it is essential to maintain a harmonised approach to time arrangements throughout the union .


### a lively public debate is taking place on summer - time arrangements and some member states have already expressed their preference to discontinue the application of such arrangements . in the light of these developments , it is necessary to continue safeguarding the proper functioning of the internal market and to avoid any significant disruptions thereto caused by divergences between member states in this area . therefore , it is appropriate to put an end in a coordinated way to summer - time arrangements . ### a lively public debate is taking place on summer - time arrangements and some member states have already expressed their preference to discontinue the application of such arrangements . in the light of these developments , it is necessary to continue safeguarding the proper functioning of the internal market as well as cross - border transport and to avoid any significant disruptions thereto caused by divergences between member states in this area . therefore , it is appropriate to put an end in a coordinated and harmonised way to summer - time arrangements .


### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information . ### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors such as gas pipeline networks , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information .


### this directive should apply from 1 april 2019 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2019 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2019 in a concerted manner . ### this directive should apply from 1 april 2020 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 29 march 2020 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 , so that similar and lasting changes occurring in different member states take place simultaneously . it is a prerequisite for the implementation of this scheme that member states take the decisions on the standard time that each of them will apply as from 2020 in a concerted and consensual manner , taking account of their need to remain in their current time zone .


### implementation of this directive should be monitored . the results of this monitoring should be presented by the commission in a report to the european parliament and to the council . that report should be based on the information that is made available to the commission by the member states in a timely fashion to allow for the report to be presented at the specified time . ### implementation of this directive must be monitored and shall be covered by the coordination mechanism agreed in advance among the member states as part of this codecision procedure . the results of this monitoring should be presented by the commission in a report to the european parliament and to the council . that report should be based on the information that is made available to the commission by the member states in a timely fashion to allow for the report to be presented at the specified time .


### without prejudice to article 1 , if a member state decides to change its standard time or times in any territory under its jurisdiction , it shall notify the commission at least 6 months before the change takes effect . where a member state has made such a notification and has not withdrawn it at least 6 months before the date of the envisaged change , the member state shall apply this change . ### if a member state&#160 ; intends to change its standard time or times in any territory under its jurisdiction , it shall&#160 ; inform the commission .


### member states shall adopt and publish , by 1 april 2019 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions . ### if the impact assessment referred to in article 1 determines that discontinuing seasonal time changes would have no negative impact on the economy and the transport sector , the member states shall , by 1 april 2024 at the latest , adopt and publish the laws , regulations and administrative provisions necessary to comply with this directive . they shall immediately communicate the text of those provisions to the commission .


### vehicles designed and constructed for use by the armed services , civil defence , fire services and forces responsible for maintaining public order ; ### vehicles designed and constructed for use by the armed services , civil defence , fire services , disaster management bodies and forces responsible for maintaining public order ;


### ‘ market surveillance authority’ means the national authority or authorities responsible for carrying out market surveillance on the territory of the member state ; ### ‘ market surveillance authority’ means the national authority or authorities , independent of any type - approval authority , which are responsible for carrying out market surveillance on the territory of the member state ;


### ‘ registration’ means the permanent or temporary administrative authorisation for the entry into service in road traffic of a vehicle , including the identification of the vehicle and the issuing of a serial number ; ### ‘ registration’ means the administrative authorisation for the entry into service in road traffic of a vehicle , involving the identification of the latter and the issuing to it of a serial number , to be known as the registration number , be it permanently , temporarily or for a short period of time ;


### ‘ vehicle repair and maintenance information’ means all information required for diagnosing , servicing , inspecting , periodic monitoring , repairing , re - programming or re - initialising of a vehicle as well as for the fitting on vehicles of parts and equipment , and that is provided by the manufacturer to his authorised dealers and repairers , including all subsequent amendments and supplements to that information ; ### ‘ vehicle repair and maintenance information’ means all information that is required for diagnosing , servicing , inspecting , periodic monitoring , repairing , re - programming or re - initialising of a vehicle as well as for the fitting on vehicles of parts and equipment and for remote diagnostic support for vehicles , including all subsequent amendments and supplements to that information ;


### member states shall establish or appoint the approval authorities and the market surveillance authorities . member states shall notify the commission of the establishment and appointment of such authorities . ### member states shall establish or appoint the approval authorities and the market surveillance authorities . member states shall notify the commission of the establishment and appointment of such authorities . member states shall ensure that approval authorities and surveillance authorities function independently from each other .


### member states shall organise and carry out market surveillance and controls of vehicles , systems , components or separate technical units entering the market , in accordance with chapter iii of regulation no 765 / 2008 . ### member states shall organise and carry out market surveillance and controls of vehicles , systems , components or separate technical units entering the market , in accordance with chapter iii of regulation no 765 / 2008 and shall make the results of those actions available to the public free of charge , on the commission’s website , within one month of conclusion of the tests .


### member states shall organise and carry out market surveillance and controls of vehicles , systems , components or separate technical units entering the market , in accordance with chapter iii of regulation no 765 / 2008 . ### member states shall organise and carry out market surveillance and controls of vehicles , systems , components or separate technical units entering the market , in accordance with chapter iii of regulation no 765 / 2008 . they may decide to carry out joint market surveillance activities for the purposes of article 8 .


### the member states shall periodically review and assess the functioning of their type - approval activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public , in particular the number of type - approval granted and the identity of the corresponding manufacturers . ### the member states shall periodically review and assess the functioning of their type - approval activities and the quality of the type - approvals issued . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . third parties will have access to the results upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of type - approvals granted or rejected and the identity of the corresponding manufacturers and vehicle types .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . third parties shall have access to the results upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of those vehicles , systems , components or separate technical units that are not in compliance with this regulation together with the identity of the corresponding manufacturers .


### where an approval authority is informed in accordance with articles 8 , 9 , 52 or 54 , it shall take all necessary measures to review the approval granted and , where appropriate , correct or withdraw the approval depending on the reasons and the seriousness of the deviations demonstrated . ### where an approval authority is informed in accordance with articles 8 , 9 , 52 or 54 , it shall take all necessary measures to review the approval granted , correct or withdraw the approval , where appropriate , depending on the reasons and the seriousness of the deviations demonstrated , and notify the commission without delay about the action taken .


### market surveillance authorities shall carry out their duties independently and impartially . they shall observe confidentiality where necessary in order to protect commercial secrets , subject to the obligation of information laid down in article 9 to the fullest extent necessary in order to protect the interests of users in the european union . ### market surveillance authorities shall carry out their duties independently and impartially . that means that , as regards administrative , technical and financial arrangements , market surveillance authorities shall act fully independently , and there shall be strict separation between them and type - approval authorities , technical services and manufacturers . they shall observe confidentiality where necessary in order to protect commercial secrets , subject to the obligation of information laid down in article 9 to the fullest extent necessary in order to protect the interests of users in the european union .


### the market surveillance authorities of different member states shall coordinate their market surveillance activities , cooperate with each other and share with each other and with the commission the results thereof . where appropriate , the market surveillance authorities shall agree on work - sharing and specialisation . ### the market surveillance authorities of different member states shall coordinate their market surveillance activities , cooperate with each other and share with each other and with the commission the results thereof . to this end the member states’ market surveillance authorities may share with each other , by means of the internal market information system , the test results and associated reports . where appropriate , the market surveillance authorities shall agree on work - sharing and specialisation .


### its advisory tasks shall comprise inter alia the promotion of good practices , the exchange of information on enforcement problems , cooperation , development of working methods and tools , development of an electronic information exchange procedure , evaluation of harmonised enforcement projects , penalties and joint inspections . ### its coordination tasks shall comprise inter alia the promotion of good practices , the exchange of information on enforcement problems , cooperation , development of working methods and tools , development of an electronic information exchange procedure , evaluation of harmonised enforcement projects , penalties and joint inspections .


### have access to the information folder referred to in article 22 and the certificate of conformity referred to in article 34 in one of the official union languages . such documentation shall be made available to the approval authorities for a period of ten years after the placing on the market of a vehicle and for a period of five years after the placing on the market for a system , component or separate technical unit ; ### have access to the information folder referred to in article 22 and the certificate of conformity referred to in article 34 in one of the official union languages . such documentation shall be made available to the approval authorities and the market surveillance authorities for a period of ten years after the placing on the market of a vehicle and for a period of five years after the placing on the market for a system , component or separate technical unit ;


### following a reasoned request from an approval authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of production of a vehicle , system , component or separate technical unit ; ### following a reasoned request from an approval authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of production of a vehicle , system , component or separate technical unit ; this shall include any technical specifications at type approval and access to software and algorithms as requested ;


### the eu type - approval for the final stage of completion shall be granted only after the approval authority has verified that the type of vehicle approved at the final stage meets at the time of the approval all applicable technical requirements . verification shall include a documentary check of all requirements covered by an eu type - approval for an incomplete type of vehicle granted in the course of a multi - stage procedure , even where granted for a different category of vehicle . ### the eu type - approval for the final stage of completion shall be granted only after the approval authority has verified that the type of vehicle approved at the final stage meets at the time of the approval all applicable technical requirements . verification shall include a documentary check of all requirements covered by an eu type - approval for an incomplete type of vehicle granted in the course of a multi - stage procedure , even where granted for a different category of vehicle . it shall also include verification that performance of the systems that were granted type approval separately are still in conformity with said type approvals when incorporated into a whole vehicle .


### the approval authority shall , within one month of issuing or amending the eu type - approval certificate , send to the approval authorities of the other member states and the commission a copy of the eu type - approval certificate , together with the attachments , including the test reports referred to in article 23 , for each type of vehicle , system , component and technical unit that it has approved . that copy shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file . ### the approval authority shall , within one month of issuing or amending the eu type - approval certificate , send to the approval authorities of the other member states and the commission a copy of the eu type - approval certificate , together with the attachments described in annexes i and iii , including the test reports referred to in article 23 , for each type of vehicle , system , component and technical unit that it has approved . the attachments will at least include data on : - test vehicle mass / weighs - test temperature - road load coefficients - non - essential equipment in use during testing - tyre details - vehicle specific gear shift points - driver mode enabled during testing - aero dynamic drags - test vehicle rolling resistance - technical services used at each stage that copy shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file .


### where requested by an approval authority of another member state or the commission , the approval authority that has issued an eu type - approval shall , within one month of receiving that request , send to the requesting approval authority a copy of the eu type - approval certificate , together with the attachments , by means of a common secure electronic exchange system or in the form of a secure electronic file . ### where requested by an approval authority of another member state or the commission , the approval authority that has issued an eu type - approval shall , within one month of receiving that request , send to the requesting approval authority a copy of the eu type - approval certificate , together with the attachments described in annexes i and iii . the attachments will at least include data on : - test vehicle mass / weighs - test temperature - road load coefficients - non - essential equipment in use during testing - tyre details - vehicle specific gear shift points - driver mode enabled during testing - aero dynamic drags - test vehicle rolling resistance - technical services used at each stage that copy shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file .


### the approval authority shall without delay inform the approval authorities of the other member states and the commission of its refusal or withdrawal of any eu type - approval , stating the reasons for its decision . ### the approval authority shall without delay inform the approval authorities of the other member states and the commission of its refusal or withdrawal of any eu type - approval , stating the reasons for its decision . the approval authority shall include all test results including at least data on : - test vehicle mass / weighs - test temperature - road load coefficients - non - essential equipment in use during testing - tyre details - vehicle specific gear shift points - driver mode enabled during testing - aero dynamic drags - test vehicle rolling resistance - technical services used at each stage its reasoned decision shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file .


### national fee structure for type - approvals and market surveillance costs ### national fee structure for market surveillance costs


### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type . ### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of eight years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it shall be reissued unchecked , upon application by the manufacturer , only where the approval authority has verified that there have been no changes to the type of vehicle , system , component and separate technical unit concerned and that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type .


### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type . ### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of eight years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it shall be reissued unchecked , upon application by the manufacturer , only where the approval authority has verified that there has been no change to the type of vehicle , system , component and separate technical unit concerned and that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type .


### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type . ### type - approvals for vehicles , shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type .


### the person authorised to sign certificates of conformity shall be employed by the manufacturer and shall be duly authorised to fully engage the legal responsibility of the manufacturer with respect to the design and the construction of the vehicle or to the conformity of its production . ### the person authorised to sign certificates of conformity shall be employed by the manufacturer and shall be duly authorised to engage the legal responsibility of the manufacturer with respect to the design and the construction of the vehicle or to the conformity of its production .


### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a serious risk to the health or safety of persons or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings . ### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a serious risk to the safety of persons , the environment or persons ' health or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings .


### within two months after finalising this assessment of the technical service , the member states shall report to the commission and to the other member states on those monitoring activities . the reports shall contain a summary of the assessment which shall be made publicly available . ### within two months after finalising this assessment of the technical service , the member states shall report to the commission and to the other member states on those monitoring activities without this resulting in an increased load in administrative or human resources terms . the reports shall contain a summary of the assessment which shall be made publicly available .


### the commission shall consult the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the commission , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned . ### the commission shall cooperate with the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the commission , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned .


### the member states shall levy fees on technical services applying to be designated established in their territory to cover wholly or partly , the costs relating to the activities exercised by the national authorities responsible for technical services in accordance with this regulation . ### the member states shall levy fees on technical services applying to be designated established in their territory to cover the costs relating to the activities exercised by the national authorities responsible for technical services in accordance with this regulation .


### falsifying test results for type - approval ; ### falsifying test results for type - approval meaning that the results can ' t be reproduced empirically in a new testing environment where the conditions and values can be verified by the relevant authority ;


### the administrative fines imposed by the commission shall not be in addition to the penalties imposed by the member states in accordance with article 89 for the same infringement and shall not exceed eur 30 000 per non - compliant vehicle , system , component or separate technical unit . ### the administrative fines imposed by the commission can be in addition to the penalties imposed by the member states in accordance with article 89 for the same infringement but shall not exceed eur 30 000 per non - compliant vehicle , system , component or separate technical unit .


### use of protected content by information society service providers storing and giving access to large amounts of works and other subject - matter uploaded by their users ### use of protected content by information society service providers storing and giving access to large amounts of works and other subject - matter


### the objective of the energy union strategy , as adopted by the commission on 25 february 20153 , is to give consumers secure , sustainable , competitive and affordable energy . more precisely , the energy union strategy emphasizes that full compliance of agreements related to the buying of energy from third countries with union law is an important element in ensuring energy security , building on the analysis already carried out in the european energy security strategy of may 20144 . in the same spirit , the european council in its conclusions of 19 march 2015 called for full compliance with union law of all agreements related to the buying of gas from external suppliers , notably by reinforcing transparency of such agreements and compatibility with union energy security provisions . ____________________ 3 com80 . 4 com 330 . ### the objective of the energy union strategy , as adopted by the commission on 25 february 20153 , is to give consumers secure , sustainable , competitive and affordable energy . this can be achieved when energy , trade and external policies go hand in hand in a coherent and consistent manner . more precisely , the energy union strategy emphasizes that full compliance of agreements related to the buying of energy from third countries with union law is an important element in ensuring energy security , building on the analysis already carried out in the european energy security strategy of may 20144 . in the same spirit , the european council in its conclusions of 19 march 2015 called for full compliance with union law of all agreements related to the buying of gas from external suppliers , notably by reinforcing transparency of such agreements and compatibility with union energy security provisions . ____________________ 3 com0080 . 4 com 0330 .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission should develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives including energy security objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified . ### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . where the commission finds that draft international agreement does not comply with union law , the member state concerned should find a suitable solution to eliminate the incompatibility identified .


### member states establish relations to third countries not only by concluding intergovernmental agreements , but also in the form of non - binding instruments . even if legally non - binding , such instruments can be used to set out a detailed framework for energy infrastructure and energy supply . in this respect non - binding instruments can have similar impacts on the internal energy market as intergovernmental agreements as their implementation might result in a violation of union law . in order to ensure greater transparency regarding all measures applied by member states that can have an impact on the internal energy market and energy security , member states should therefore submit to the commission , ex post , also the respective non - binding instruments . the commission should assess the submitted non - binding instruments and , if appropriate , inform the member state accordingly . ### member states establish relations to third countries not only by concluding intergovernmental agreements , but also in the form of non - binding instruments . even if legally non - binding , such instruments can be used to set out a detailed framework for energy infrastructure and energy supply . in this respect non - binding instruments can have similar impacts on the internal energy market as intergovernmental agreements as their implementation might result in a violation of union law . in order to ensure greater transparency regarding all measures applied by member states that can have an impact on the internal energy market and energy security , member states should therefore submit to the commission , also the respective non - binding instruments . the commission should assess the submitted non - binding instruments and , if appropriate , inform the member state accordingly .


### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , where appropriate in cooperation with the european external action service as regards the union’s external policies , should develop optional model clauses to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . their use should be optional , and it should be possible to adapt their content to any particular circumstance . ### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , in cooperation with member states and where appropriate in cooperation with the european external action service as regards the union’s external policies , should develop optional model clauses and guidance to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . their use should be optional , and it should be possible to adapt their content to any particular circumstance .


### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , where appropriate in cooperation with the european external action service as regards the union’s external policies , should develop optional model clauses to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . their use should be optional , and it should be possible to adapt their content to any particular circumstance . ### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , where appropriate in cooperation with the european external action service as regards the union ' s external policies , should develop optional model clauses to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . the commission should also provide guidelines to avoid incompatibility of intergovernmental agreements with union ' s energy security objectives . their use should be optional , and it should be possible to adapt their content to any particular circumstance .


### this decision establishes a mechanism for the exchange of information between member states and the commission with regard to intergovernmental agreements and non - binding instruments in the field of energy as defined in article 2 , in order to optimise the functioning of the internal energy market . ### this decision establishes a mechanism for the exchange of information between member states and the commission with regard to intergovernmental agreements and non - binding instruments in the field of energy as defined in article 2 , in order to optimise the functioning of the internal energy market and ensure security of energy supplies to the union .


### ‘ non - binding instrument’ means a legally non - binding arrangement between one or more member states and one or more third countries , such as a memorandum of understanding , joint declaration , ministerial joint declaration , joint action or joint code of conduct , which contains interpretation of union law , sets the conditions for energy supply or the development of energy infrastructures ; ### ‘ non - binding instrument’ means a legally non - binding arrangement between one or more member states and one or more third countries , such as a memorandum of understanding , joint declaration , ministerial joint declaration , joint action or joint code of conduct , which contains interpretation of union law , sets the conditions for energy supply or the development or operation of energy infrastructures ;


### where the commission participates in the negotiations as an observer , it may provide the member state concerned with advice on how to avoid the incompatibility of the intergovernmental agreement or amendment under negotiation with union law . ### where the commission participates in the negotiations as an observer , it may provide the member state concerned with advice on how to avoid the incompatibility of the intergovernmental agreement or amendment under negotiation with union law and union ' s energy security objectives .


### when signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall take utmost account of the commission ' s opinion referred to in paragraph 2 . ### before signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall take utmost account of the commission ' s opinion referred to in paragraph 2 .


### upon adopting a non - binding instrument or an amendment to a non - binding instrument , the member state concerned shall notify the non - binding instrument or the amendment , including any annexes thereto , to the commission . ### before adopting a non - binding instrument or an amendment to a non - binding instrument , the member state concerned shall notify the non - binding instrument or the amendment , including any annexes thereto , to the commission .


### identifying common problems in relation to intergovernmental agreements and non - binding instruments and considering appropriate action to address those problems and , where appropriate , proposing solutions ; ### identifying common problems in relation to intergovernmental agreements and non - binding instruments and considering appropriate action to address those problems and , where appropriate , proposing guidance and solutions ;


### the commission shall be empowered to adopt delegated acts in accordance with article 210 concerning detailed rules on external action procurement . ### the commission shall be empowered to adopt delegated acts in accordance with article 210 concerning detailed rules on external action procurement . these rules shall include specific provisions on procurement related to missions under the common security and defence policy in order to guarantee the rapid and flexible conduct of operations , establishing , in particular , adapted fast - track procedures to be applied to all csdp missions .


### since the adoption in 1992 of the predecessor to regulation no 469 / 2009 , markets have evolved significantly and there has been huge growth in the manufacture of generics and especially of biosimilars , in particular in third countries where protection does not exist or has expired . ### since the adoption in 1992 of the predecessor to regulation no 469 / 2009 , markets have evolved significantly and there has been huge growth in the manufacture of generics and especially of biosimilars , in particular in countries outside the eu where protection does not exist or has expired . assuming a sustained growth in global demand for medical products , by 2020 generics and biosimilars will represent 80 % of all medicines by volume , and about 28 % by value .


### without any intervention , the viability of the manufacture of generics and biosimilars in the union could be under threat , with consequences for the union’s pharmaceutical industrial base as a whole . ### without any intervention , the viability of manufactures of generics and biosimilars in the union could be under threat , with consequences for the union’s pharmaceutical industrial base as a whole .


### without any intervention , the viability of the manufacture of generics and biosimilars in the union could be under threat , with consequences for the union’s pharmaceutical industrial base as a whole . ### without any intervention , the viability of the manufacture of generics and biosimilars in the union could be under threat , with consequences for the union’s pharmaceutical industrial base as a whole , which may affect the very functioning of the internal market through the loss of potential new business opportunities as well as diminishing investment at eu level , possibly hampering the creation of new jobs .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### keeping in mind that the spc regulation in the eu provides for uniform solution of the protection and for the free movement of medicinal products , the aim of this regulation is to enhance further balance between the interests of the originators , generic and biosimilar makers and public health by following the principle of proportionality . the regulation will promote the competitiveness of makers of generics and biosimilar producers established in the union , enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions . this will help these makers to compete effectively in markets where intellectual property protection does not exist or has expired . it should also complement the efforts of the union’s trade policy to ensure open markets for union - based makers of medicinal products or active ingredients , and it will ensure that neither member states’ health systems nor the patients are forced to bear excessive pharmacotherapy costs which would be in direct conflict with the public interest .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export or day - 1 entry on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting , i . e . their re - export from third countries to the union .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export or for the entry on the union ' s market on the first day after patent expiration in the member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . __________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . ### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . furthermore , this regulation does not affect the rules on the unique identifier provided for in commission delegated regulation 2016 / 161 . __________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . 42 a commission delegated regulation 2016 / 161 of 2 october 2015 supplementing directive 2001 / 83 / ec of the european parliament and of the council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use .


### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . _________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . ### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . furthermore , this regulation does not affect the rules on the unique identifier provided for in commission delegated regulation 2016 / 1611a . . _________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . 1a commission delegated regulation 2016 / 161 of 2 october 2015 supplementing directive 2001 / 83 / ec of the european parliament and of the council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use .


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted on or after a specified date after entry into force of this regulation and by imposing certain conditions on the application of the exception , ### the cjeu has confirmed on numerous occasions that the objective pursued by regulation no 469 / 2009 is not to compensate the holder fully for the delay to the marketing of his invention . moreover , the protection granted by the spc relates to exclusivity on the eu market which does not fall within the scope of the waiver introduced by this regulation in respect of the fundamental rights and principles recognized by the charter of fundamental rights of the european union . in particular , this regulation aims at ensuring full respect for the right to property guaranteed by article 17 of the charter by maintaining the core rights of the supplementary protection certificate holder . by the introduction of this exception , the union adopts a solution in the pharmaceutical sector which is essential to promote public interest . the exception should be considered in the light of the principle of proportionality , measuring it up with the protection of values such as health protection , which is a special emanation of the general concept of public interest . facilitating the wide - ranging availability of medicinal products constitutes an important goal of health policy , including the one pursued at the eu level in accordance with article 35 of the charter of fundamental rights of the european union . any unjustified delay of lawful price competition in the pharmaceutical sector means that both state budgets and patients are forced to bear excessive pharmacotherapy costs , which is in conflict with the public interest . the provisions establishing supplementary protection certificate aim at compensating the holder of the basic patent for the period prior to the granting of a marketing authorization when they cannot enjoy the market exclusivity conferred by the basic patent . this compensation consists of a specific extension of patent protection for the purpose of ensuring market exclusivity lasting 15 years from the first marketing authorization of the medicinal product . such an extension , however , does not grant an absolute right to the holder of the certificate and therefore may be subject to certain restrictions , as long as the essential compensation function of the extension is safeguarded , notably that adequate market exclusivity is ensured for the duration of the certificate . in order to reap the full benefits of the exception introduced by this regulation with due regard to the protection of legitimate expectations and without unduly curtailing acquired rights , the exception should be operational in the case of certificates that enter into effect two years after the entry into force of this regulation , irrespective of when these certificates were granted . this solution ensures an appropriate transitional period but also makes the exception apply across the board from the specified date , allowing for a timely and transparent introduction of the new regime . from the point of view of public interest , it is most beneficial to introduce the waiver as soon as possible . however , postponing its application guarantees predictability to applicants and other stakeholders . in addition , it is ensured that legal continuity is maintained to the extent that it is necessary for the planned systemic change . it needs to be underlined that it is not possible to achieve the desired goal by other means . the legitimate expectations of holders of certificates granted before the specified date remains fully respected , as the exception does not alter their factual status on the markets on which they enjoy the extension of patent protection in any economically relevant manner . they will continue to enjoy market exclusivity for the same amount of time , as their competitors will only be able to lawfully enter the market in territories where no such exclusivity exists .


### that the placing on the market , import or re - import of the product might infringe the certificate referred to in that paragraph where , and as long as , that certificate applies . ### that the placing on the market , import or re - import of the product referred to in point of paragraph 2might infringe the certificate referred to in paragraph 2 where , and as long as , that certificate applies .


### article 4 is replaced by the following : ### article 5 is replaced by the following :