### scientific advice further indicates that fishing effort limits are an appropriate instrument for fixing fishing opportunities for deep - sea fisheries . in view of the large variety of gears and fishing patterns present in deep - sea fisheries , and the need to develop accompanying measures tackling the environmentally weak points of the fisheries indivdually , fishing effort limits should only replace catch limits when it can be ensured that they are adapted to specific fisheries . ### given the lack of accurate data in most deep sea fisheries and the mixed nature of most of them , fishing effort limits should only be used in combination with catch limits for fixing fishing opportunities for deep - sea fisheries . in view of the large variety of gears and fishing patterns present in deep - sea fisheries , and the need to develop accompanying measures tackling the environmentally weak points of the fisheries individually , fishing effort limits need to be adapted to specific fisheries .


### the council , acting in accordance with the treaty , may decide to switch from the fixing of annual fishing opportunities for deep - sea species in terms of both fishing effort limits and catch limits to the fixing of only fishing effort limits for specific fisheries . ### the switching from the fixing of annual fishing opportunities for deep - sea species in terms of both fishing effort limits and catch limits to the fixing of only fishing effort limits for specific fisheries shall be decided in accordance with the treaty .


### where the best scientific information available does not identify exploitation rates corresponding to the precautionary approach to fisheries management due to lack of sufficient data concerning a certain stock or species , no fishing opportunities may be allocated for the fisheries concerned . ### where the best scientific information available does not identify exploitation rates corresponding to the precautionary approach to fisheries management due to lack of sufficient data concerning a certain stock or species , the fishing opportunities for the relevant fishing management period may not be fixed higher than the rates provided within the ices approach for data limited stocks .


### fishing activities not targeting deep - sea species but catching deep - sea species as a by - catch , carried out by a union fishing vessel , shall be subject to a fishing authorisation , which shall indicate deep - sea species as by - catch . ### fishing activities carried out in union waters not targeting deep - sea species but catching deep - sea species as a by - catch , shall be subject to a fishing authorisation , which shall indicate deep - sea species as by - catch .


### in addition to the requirements set out in article 6 , each application for a fishing authorisation for targeted deep sea fisheries , as referred to in article 4 , that allows the use of bottom gears in union waters as referred to in article 2 , shall be accompanied by a detailed fishing plan specifying : ### in addition to the requirements set out in article 6 , each application for an authorisation for fishing deep - water stocks that allows for the use of bottom gears in union waters as defined in article 2 , or in waters under neafc jurisdiction as referred to in article 2 , shall :


### any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity , as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on scientific advice , that such extension would not have significant adverse impacts on vulnerable marine ecosystems . ### any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the characteristics , type and dimensions of the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity , as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on best available scientific advice , that such extension would not have significant adverse impacts on vulnerable marine ecosystems . this assessment shall be conducted in accordance with annex iia and the 2008 fao international guidelines for the management of deep - sea fisheries in the high seas and shall be made publicly available .


### vessels targeting deep - sea species with other bottom gear should not extend their range of operation according to their authorisation within union waters , unless expansion can be assessed as not carrying a significant risk of negative impact on vulnerable marine ecosystems . ### vessels targeting deep - sea species with other bottom gear should not extend their range of operation according to their authorisation within union waters , unless expansion can be assessed as not carrying a significant risk of negative impact on vulnerable marine ecosystems . impact assessments carried out to that effect must conform to the requirements referred to in paragraph 47 of the 2008 fao guidelines for the management of deep sea fisheries .


### the locations , if any , of activities in the deep - sea métier during the last three full calendar years . those location shall be defined by coordinates in accordance with the world geodetic system of 1984 and they shall circumscribe the fishing activities as closely as possible . ### limit the authorised fishing activities to existing fishing areas ;


### any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity , as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on scientific advice , that such extension would not have significant adverse impacts on vulnerable marine ecosystems . ### without prejudice to article 7 , fishing activities that are to take place in waters defined in paragraph 1 but that are defined as new fishing areas in the meaning of article 3 paragraph 2b shall be subject to a fishing authorisation . applications for such authorisations shall include a detailed project for the exploratory fishing activity that follows the neafc guidelines outlined in annex iia . applications will be accepted if it can be shown that the activity described will have no harmful effects on vulnerable marine ecosystems .


### for the purposes of paragraph 1 , the fishing effort levels for each deep - sea métier that shall be used as a baseline for any adjustmens required in order to follow the principles set out in article 10 shall be the fishing effort levels assessed , based on scientific information , as consistent with the catches made by the relevant deep - sea métiers during the previous two calendar years . ### for the purposes of paragraph 1 , the fishing effort levels for each deep - sea métier that shall be used as a baseline for any adjustments required in order to follow the principles set out in article 10 shall be the fishing effort levels assessed , based on scientific information , as consistent with the rates of exploitation established in accordance with article 10 .


### the power to adopt delegated acts referred to in articles 4 and 6 shall be conferred on the commission for an indeterminate period of time from . . ### the power to adopt delegated acts referred to in article 4 shall be conferred on the commission for a period of five years from . . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the delegation of power referred to in articles 4 and 6 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication in the official journal of the european union or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . ### the delegation of power referred to in article 4 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### following the judgment of the court of justice of 6 september 2011 in case c - 442 / 09 , pollen in honey is to be considered as an ingredient within the meaning of directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the laws of the member states relating to the labelling , presentation and advertising of foodstuffs . the judgment of the court was based on the consideration relying on the facts brought before it that pollen in honey is mainly due to the centrifugation carried out by the beekeeper for the purposes of honey collection . however , pollen only enters into the hive as a result of the activity of the bees and it is naturally present in honey regardless of whether or not the beekeeper extracts the honey through centrifugation . it is necessary therefore to clarify , without prejudice to the application of regulation no 1829 / 2003 of the european parliament and of the council of 22 september 2003 on genetically modified food and feed to genetically modified pollen in honey , that pollen is a constituent of honey , which is a natural substance that has no ingredients , and not an ingredient within the meaning of directive 2000 / 13 / ec . therefore , council directive 2001 / 110 / ec of 20 december 2001 relating to honey should be amended accordingly . ### directive 2001 / 110 / ec defines honey as the natural sweet substance produced by bees . honey consists essentially of different sugars , predominantly fructose and glucose , as well as other substances such as organic acids , enzymes and solid particles derived from honey collection . directive 2001 / 110 / ec preserves the natural character of honey by limiting human intervention that could alter the composition of honey . in particular , that directive prohibits the addition of any food ingredient to honey , including food additives , or to make any other additions other than honey . similarly , that directive prohibits the removal of any constituent particular to honey , including pollen , unless it is unavoidable in the removal of foreign matter . those requirements are in line with the codex alimentarius standard for honey .


### whilst the directive already provides for detailed obligations for member states to exchange information , such obligations should be reinforced . member states should not only react to request for information but also alert other member states in a proactive manner . such alert system should be similar to that of directive 2006 / 123 / ec . a specific alert mechanism is however necessary for health professionals benefiting from automatic recognition under directive 2005 / 36 / ec . this should also apply to veterinary surgeons unless the member states have already triggered the alert mechanism provided for in directive 2006 / 123 / ec . all member states should be alerted if a professional due to a disciplinary action or criminal conviction is no longer entitled to move to another member state . this alert should be activated through the imi regardless of whether the professional has exercised any of the rights under directive 2005 / 36 / ec or of whether he has applied for recognition of his professional qualifications through the issuance of a european professional card or through any other method provided for by that directive . the alert procedure should comply with union law on the protection of personal data and other fundamental rights . ### whilst the directive already provides for detailed obligations for member states to exchange information , such obligations should be reinforced . member states should not only react to request for information but also alert other member states in a proactive manner . such alert system should be similar to that of directive 2006 / 123 / ec . a specific alert mechanism is however necessary for health professionals benefiting from automatic recognition under directive 2005 / 36 / ec and professionals subject to the general system of recognition , under title iii chapters i and ii , that have implications for patient safety . this should also apply to veterinary surgeons unless the member states have already triggered the alert mechanism provided for in directive 2006 / 123 / ec . all member states should be alerted if a professional due to a disciplinary action or criminal conviction is no longer entitled to move to another member state . practise or where restrictions on a professionals ability to practise have been imposed through disciplinary action or if a professional has used or attempted to use false information when applying for recognition of their qualifications . this alert should be activated through the imi regardless of whether the professional has exercised any of the rights under directive 2005 / 36 / ec or of whether he has applied for recognition of his professional qualifications through the issuance of a european professional card or through any other method provided for by that directive . the alert procedure should comply with union law on the protection of personal data and other fundamental rights .


### the competent authorities of a member state shall inform the competent authorities of all other member states and the commission about the identity of a professional who has been prohibited by national authorities or courts from pursuing , even temporarily , on the territory of that member state the following professional activities : ### the competent authorities of a member state shall inform the competent authorities of all other member states and the commission about the identity of a professional who has been prohibited or restricted by national authorities or courts from pursuing , even temporarily , on the territory of that member state the following professional activities :


### “remunerated traineeship” : the pursuit of supervised and remunerated activities , with a view to access to a regulated profession granted on the basis of an examination ; ### “traineeship” : the pursuit of supervised activities , to access a regulated profession pursuant to legislative , regulatory or administrative provisions in a member state ;


### the information referred to in the first subparagraph shall be sent at the latest within three days from the date of adoption of the decision prohibiting the professional concerned from exercising a professional activity . ### the information referred to in the first subparagraph shall be sent at the latest within three days from the date of adoption of the decision prohibiting the professional concerned from exercising a professional activity via the internal market information system .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate representation and consultations during its preparatory work , including experts at both european and national level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely , transparent and appropriate transmission of relevant documents to the european parliament and to the council .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate representation and consultation , including experts at both european and national level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely , transparent and appropriate transmission of relevant documents to the european parliament and to the council .


### the european professional card shall be valid for as long as its holder maintains the right to practice in the home member state on the basis of the documents and information contained in the imi file . ### the european professional card shall be valid for as long as its holder maintains the right to practice in the home member state on the basis of the documents and information contained in the imi file or unless the holder has been prohibited from practising in any member state .


### the commission shall adopt implementing acts for the application of the alert mechanism . the implementing act shall include provisions on the competent authorities entitled to sending and / or receiving alerts , on complementing the alerts with additional information , on the withdrawal and closure of alerts , on rights of access to data , ways of correcting the information contained in the alerts , and measures to ensure the security of processing and retention periods . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 58 . ### the commission shall adopt implementing acts for the application of the alert mechanism . the implementing act shall include provisions on the competent authorities entitled to sending and / or receiving alerts , on complementing the alerts with additional information , on the withdrawal and closure of alerts , on rights of access to data , ways of correcting the information contained in the alerts , and measures to ensure the security of processing and retention periods . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 58 .


### directive 2005 / 36 / ec already provides for clear obligations for professionals to have the necessary language skills . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients ' safety . language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host member state . ### directive 2005 / 36 / ec already provides for a clear obligation for professionals to have the necessary language skills . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patient ' s safety . where there are patient safety implications , member states may confer the right to undertake or supervise language checks to competent authorities or may choose for employers or other organisations to undertake language checking . language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host member state .


### the decision of the home member state , or the absence of a decision within the period of two weeks referred to in paragraph 1 , shall be subject to appeal under national law . ### the decision of the competent authority of the home member state , or the absence of a decision within the period of one month referred to in paragraph 1 , shall be subject to appeal under national law .


### for the purpose of this article , &#8220 ; common training framework&#8221 ; shall mean a common set of knowledge , skills and competences necessary for the pursuit of a specific profession . for the purpose of access to and pursuit of such profession , a member state shall give evidence of qualifications acquired on the basis of such framework the same effect in its territory as the evidence of formal qualifications which it itself issues , on condition that such framework fulfils the criteria set under paragraph 2 . such criteria shall respect the specifications referred to in paragraph 3 . ### for the purpose of this article , &#8220 ; common training framework&#8221 ; shall mean a common set of knowledge , skills and competences necessary for the pursuit of a specific profession . a common training framework may be set up within the territory of a member state on the conditions and the manner laid down in this article . for the purpose of access to and pursuit of such profession , a member state shall give evidence of qualifications acquired on the basis of such framework the same effect in its territory as the evidence of formal qualifications which it itself issues , on condition that such framework fulfils the criteria set under paragraph 2 . such criteria shall respect the specifications referred to in paragraph 3 .


### the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following two years . ### the competent authority of the home member state shall verify the application , create and validate a european professional card within three weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following year .


### the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following two years . ### the competent authority of the home member state shall verify the application and the supporting documentation and shall issue the european professional card within one month from the date it receives a complete application . it shall transmit the european professional card immediately to the competent authority of the host member state concerned and shall inform the applicant accordingly . the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following years .


### european professional card for establishment and for the temporary provision of services under article 7 ### european professional card for establishment and for the temporary provision of services under article 7 and for the temporary provision of services by health professionals benefiting from automatic recognition under title iii chapter iii


### the member states shall provide that a holder of a professional qualification may apply for a european professional card by any means , including through an on - line tool , with the competent authority of the home member state . ### the member states shall provide that a holder of a professional qualification may apply for a european professional card in writing or in electronic form , including through an on - line tool , with the competent authority of the home member state .


### in the case of evidence of formal qualifications referred to in article 21 and in the case of certificates of acquired rights referred to in articles 23 , 26 , 27 , 30 , 33 , 33a , 37 , 39 , and 43 , evidence attesting knowledge of the language of the host member state ### for professions with patient safety implications , in the case of evidence of formal qualifications referred to in article 21 and in the case of certificates of acquired rights referred to in articles 23 , 26 , 27 , 30 , 33 , 33a , 37 , 39 , and 43 , evidence attesting knowledge of the official language of the language area of the host member state where the professional wishes to work .


### european professional card for the temporary provision of services other than those covered by article 7 ### european professional card for the temporary provision of services other than those covered by article 7 and health professionals benefiting from automatic recognition under directive 2005 / 36 / ec .


### member states shall provide that employers , customers , patients and other interested parties may verify the authenticity and validity of a european professional card presented to them by the card holder without prejudice to paragraphs 2 and 3 . ### host member states shall provide that employers , customers , patients and other interested parties may verify the authenticity and validity of a european professional card presented to them by the card holder without prejudice to paragraphs 2 and 3 .


### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list set out in annex iii to include other products and equipment that contain fluorinated greenhouse gases with a global warming potential of 150 or more , or that rely on them to work , if it has been established that alternatives to the use of fluorinated greenhouse gases or to the use of specific types of fluorinated greenhouse gases are available , and their use would result in lower overall greenhouse gas emissions and to exclude , where appropriate for a specified period of time , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical , economic or safety reasons . ### the commission may , following a request by a competent authority of a member state , by means of implementing acts authorise a time - limited exemption to exclude certain categories of products or equipment listed in annex iii where alternative substances are not available or cannot be used for technical , economic or safety reasons . those implementing acts shall be adopted in accordance with the examination procedure in article 21 .


### the use of fluorinated greenhouse gases , or of mixtures that contain fluorinated greenhouse gases , with a global warming potential of 2500 or more , to service or maintain refrigeration equipment with a charge size equivalent to 5 tonnes of co2 or more , shall be prohibited from 1 january 2020 . ### the use of fluorinated greenhouse gases , or of mixtures that contain fluorinated greenhouse gases , with a global warming potential of 2500 or more , to service or maintain refrigeration equipment designed for an operating temperature of - 50°c or colder and with a charge size equivalent to 40 tonnes of co2 or more , shall be prohibited from 1 january 2025 .


### the maximum co - financing rate under paragraph 3 at the level of a priority axis shall be increased by ten percentage points , where the whole of a priority axis is delivered through financial instruments , or through community - led local development . ### the maximum co - financing rate under paragraph 3 at the level of a priority axis shall be increased by ten percentage points , where the whole of a priority axis is delivered through financial instruments or through territorial instruments supporting local development .


### the part of the union budget allocated to the csf funds shall be implemented within the framework of shared management between the member states and the commission , in accordance with article 53 of the financial regulation , with the exception of the amount of the cf transferred to the connecting europe facility referred to in article 84 and innovative actions at the initiative of the commission under article 9 of the erdf regulation , and technical assistance at the initiative of the commission . ### the part of the union budget allocated to the csf funds shall be implemented within the framework of shared management between the member states and the commission , in accordance with article 53 of the financial regulation , with the exception of innovative actions at the initiative of the commission under article 9 of the erdf regulation , and technical assistance at the initiative of the commission .


### preferential remuneration of investors operating under the market economy investor principle , who provide counterpart resources to the support from the csf funds to the financial instrument or who co - invest at the level of final recipients ; ### preferential remuneration of investors operating under the market economy investor principle , who provide counterpart resources to the support from the csf funds on a co - finance basis to the financial instrument or who co - invest at the level of final recipients ;


### the cooperation network shall bring into permanent communication the commission and the competent authorities . when requested , the european network and information security agency shall assist the cooperation network by providing its expertise and advice . ### the cooperation network shall bring into permanent communication the commission and the single points of contact . when requested , the european network and information security agency shall assist the cooperation network by providing its expertise and advice . where appropriate , market operators and suppliers of cyber security solutions may also be invited to participate in the activities of the cooperation network referred to in points , , of paragraph 3 .


### each member state shall set up a computer emergency response team responsible for handling incidents and risks according to a well - defined process , which shall comply with the requirements set out in point of annex i . a cert may be established within the competent authority . ### each member state shall set up at least one computer emergency response team responsible for handling incidents and risks according to a well - defined process , which shall comply with the requirements set out in point of annex i . a cert may be established within the competent authority .


### the cooperation network shall bring into permanent communication the commission and the competent authorities . when requested , the european network and information security agency shall assist the cooperation network by providing its expertise and advice . ### the cooperation network shall bring into permanent communication the commission and the single points of contact . when requested , the european network and information security agency shall assist the cooperation network by providing its expertise and advice . where appropriate , market operators may also be invited to participate in the activities of the cooperation network referred to in points , and of paragraph 3 .


### in order to enhance the coherence of the mandate , strengthen the focus of the eib external financing activity on supporting eu policies , and for the maximum benefit of beneficiaries , this decision should set out horizontal high - level objectives in the mandate for eib financing operations across all eligible countries , building on the comparative strengths of the eib in areas where it has a well - proven track record . in all regions covered by this decision , the eib should thus finance projects in the areas of climate change mitigation and adaptation , social and economic infrastructure ) , and local private sector development , in particular in support of small and medium - sized enterprises . within these areas , regional integration among partner countries , including economic integration between pre - accession countries , neighbouring countries and the eu , should be an underlying objective for eib financing operations . ### in order to enhance the coherence of the mandate , strengthen the focus of the eib external financing activity on supporting eu policies , and for the maximum benefit of beneficiaries , this decision should set out horizontal high - level objectives in the mandate for eib financing operations across all eligible countries , building on the comparative strengths of the eib in areas where it has a well - proven track record . in all regions covered by this decision , the eib should thus finance projects in the areas of climate change mitigation and adaptation , social and economic infrastructure ) , and local private sector development , in particular in support of small and medium - sized enterprises to boost sustainable economic growth and jobs creation . within these areas , regional integration among partner countries , including economic integration between pre - accession countries , neighbouring countries and the eu , should be an underlying objective for eib financing operations . the eib should contribute to european foreign direct investment in partner countries , including as part of mutually beneficial public - private partnerships , with the objective of promoting innovation and development in the aforementioned project areas .


### for the purposes of paragraph 1 , the eib shall provide the commission with yearly reports on eib financing operations carried out under this decision at project , sector , country and regional level and on the fulfilment of the external policy and strategic objectives of the eu , including cooperation with the commission , other international financial institutions and bilateral institutions . ### for the purposes of paragraph 1 , the eib shall provide the commission with yearly reports on eib financing operations carried out under this decision at project , sector , country and regional level and on the fulfilment of the external policy and strategic objectives of the eu , including cooperation with the commission , other international financial institutions and bilateral institutions . any agreement between the eib and other ifis or bilateral institutions relating to financial operations under this decision should be notified to the european parliament and the council as part of the commission ' s annual report .


### to contribute to the development of tools that cut across sea or coast - related sectoral policies ; ### to contribute to the development of cross - sectoral tools to support sea or coast - related policies , particularly in the field of economic development , employment , environmental protection , research , maritime safety and energy ;


### to contribute to the development of tools that cut across sea or coast - related sectoral policies ; ### to contribute to the development of cross - sectoral tools to support sea or coast - related policies , particularly in the field of environmental protection and development of green maritime technologies ;


### where the national measure is considered justified and the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , the commission may confirm , modify or revoke the said measure by means of implementing acts in accordance with the advisory procedure referred to in article 38 . the commission shall furthermore be empowered to adopt , by means of delegated acts in accordance with the procedure referred to in article 37 , interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation . ### where the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , and the member state takes a safeguard measure , the commission may confirm , modify or revoke the said measure by means of implementing acts in accordance with the advisory procedure referred to in article 38 . the commission shall furthermore be empowered to adopt , by means of delegated acts in accordance with the procedure referred to in article 37 , interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation .


### without prejudice to law governing the processing of personal data , member states and private sector representatives meeting as the observatory shall : ### without prejudice to law governing the processing of personal data , representatives meeting as the observatory shall :


### activities shall be included in the work plan of the edctp2 programme adopted annually by the edctp2 - is following the positive outcome of their external evaluation by international peer review based on article 14 of regulation no … [ rules for the participation and dissemination in horizon 2020 ] , and with regard to their contribution to the objectives of the edctp2 programme . ### activities shall be included in the work plan of the edctp2 programme adopted annually by the edctp2 - is following the positive outcome of their external evaluation by international peer review to the objectives of the edctp2 programme .


### an increased impact due to effective cooperation with relevant european union initiatives , including its development assistance . ### better coordination , alignment and , where appropriate , integration with relevant european union initiatives , including its development assistance and other key initiatives to enhance research and development for poverty - related diseases , product development partnerships and other government - led programmes in order to better take advantage of synergies , create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of european public investments .


### better coordination , alignment and integration of relevant national programmes to increase the cost - effectiveness of european public investments ; ### better coordination , alignment and , where appropriate , integration of relevant national programmes to increase the cost - effectiveness of european public investments . moreover , the research priorities should be established in an objective - orientated manner in order to accelerate results and contribute to the eradication of poverty - related and neglected diseases .


### target : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in sub - sahara africa for at least one year after their fellowship . ### indicator : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 .


### an increased impact due to effective cooperation with relevant european union initiatives , including its development assistance . ### better coordination , alignment and , where appropriate , integration with relevant european union initiatives , including its development assistance in order to better take advantage of synergies , create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of european public investments ;


### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe and affordable medical interventions for poverty - related diseases , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary for that purpose . ### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe , accessible , appropriate and affordable medical interventions for poverty - related diseases , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary for that purpose .


### supporting clinical trial research and related activities on poverty - related diseases , in particular hiv / aids , malaria , tuberculosis and neglected infectious diseases ; ### supporting clinical trial research and related activities on poverty - related diseases , in particular hiv / aids , malaria , tuberculosis and neglected diseases that are poverty related . special attention should be devoted to diseases that are already affecting sub - saharan africa and europe .


### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with union development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 . ### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the capabilities in developing countries for sound conduct and management of clinical trials should , where necessary , be further developed and strengthened , in particular the role and development of ethical review committees and the corresponding regulatory environment , the coordination , collaboration and where appropriate integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with union development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 .


### target : increase the number of supported clinical trials to at least 150 compared to 88 under edctp1 . ### indicator : increase the number of supported clinical trials that lead to new products , processes , methodologies , diagnostics , treatments or preventions .


### better coordination , alignment and integration of relevant national programmes to increase the cost - effectiveness of european public investments ; ### better coordination , alignment and , where appropriate , integration of relevant national programmes to increase the cost - effectiveness of european public investments ;


### edctp2 shall contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries , in particular in sub - saharan africa , by accelerating the clinical development of effective , safe and affordable medical interventions for poverty - related diseases , in partnership with sub - saharan africa . ### edctp2 shall contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries , in particular in sub - saharan africa , by accelerating the clinical development of effective , safe , accessible , appropriate and affordable medical interventions for poverty - related diseases , in partnership with sub - saharan africa .


### eur 594 million to equal the contributions of participating states listed in article 1 . 1 ; ### eur 594 million to equal the contributions , be they in kind or financial contributions , of participating states listed in article 1 . 1 ;


### target : sustain or increase the number of sub - saharan african countries supported by the edctp2 to at least 30 . ### indicator : aim to sustain or increase the participation of sub - saharan african countries in the edctp2 .


### with regards to calls managed by edctp - is , the annual report shall moreover include information on the number of projects submitted and selected for funding , the detailed use of the union financial contribution , the distribution of national and other contributions , the types of participants , country statistics , brokerage events and dissemination activities . ### with regards to calls managed by edctp - is , the annual report shall moreover include information on the projects submitted and selected for funding , the detailed use of the union financial contribution , the distribution of national and other contributions , the types of participants , country statistics , brokerage events and dissemination activities .


### target : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in sub - sahara africa for at least one year after their fellowship . ### indicator : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in or matters relating to sub - sahara africa for at least one year after their fellowship .


### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20134 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states in accordance with article 185 of the treaty . __________________ 4 oj . . . [ horizon 2020 framework programme ] . ### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20134 aims at achieving a greater impact on research and innovation by developing closer synergies , increasing coordination and avoiding unnecessary duplication with international , national and regional research programmes . public - public partnerships , including union participation in programmes undertaken by several member states in accordance with article 185 of the treaty , should achieve those aims , meet the conditions specified in that regulation , in particular in articles 26 and be in full compliance with the general principles , in particular the conditions relating to the communication and dissemination of information and open access . __________________ 4 oj . . . [ horizon 2020 framework programme ] .


### establishing cooperation and launching joint actions with other public and private funders ; ### establishing cooperation and launching joint actions with other public and private funders , including industry and product development partnerships .


### extended international cooperation with other public and private funders ; ### extended international cooperation with other public and / or private funders to ensure that the impact of all research is maximised and that synergies can be taken into consideration .


### target : increase the number of peer - reviewed scientific articles published to at least 1000 . ### indicator : aim to increase the number of peer - reviewed scientific articles published to three times that of edctp1 .


### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to investment . ### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to foreign direct investment .


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### agreements on foreign direct investment authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to foreign direct investment , in particular common commercial policy .


### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to investment , it shall notify the commission of its intentions in writing . ### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to foreign direct investment , it shall notify the commission of its intentions in writing


### the authorisation to amend or conclude agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation . ### the authorisation to amend or conclude foreign direct investment agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to foreign direct investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation .


### decisions pursuant to paragraphs 4 and 5 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take the decision within 90 days of receipt of the notifications referred to in paragraphs 1 and 2 . where additional information is needed to take the decision , the 90 days shall run from the date of receipt of the additional information . ### decisions pursuant to paragraphs 4 and 5 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take the decision within 60 working days of receipt of the notifications referred to in paragraphs 1 and 2 . where additional information is needed to take the decision , the 60 working days shall run from the date of receipt of the additional information .


### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning investment , or otherwise terminated , bilateral agreements concluded by member states with third countries remain binding on the parties under public international law . ### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends discontinuing the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning investment , or otherwise terminated , bilateral agreements concluded by member states with third countries remain binding on the parties under public international law .


### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to investment , including in particular the common commercial policy , require appropriate management . that relationship will develop further as the union exercises its competence . ### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to foreign direct investment , including in particular the common commercial policy , require appropriate management . that relationship will develop further as the union exercises its competence .


### in the interest of eu investors and their investments in third countries , and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force . ### in the interest of eu investors and their investments in third countries and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of foreign direct investment remain binding under public international law without prejudice to the right of the commission to replace progressively existing direct foreign investment agreements with new agreements offering equal or better conditions to member states .


### at the time of the entry into force of the treaty of lisbon , member states of the union maintained a significant number of bilateral agreements with third countries relating to investment . the treaty does not contain any explicit transitional provisions for such agreements which have now come under exclusive union competence . furthermore , some of those agreements may include provisions affecting the common rules on capital movements laid down in part three chapter 4 of title iv of the treaty . ### at the time of the entry into force of the treaty of lisbon , member states of the union maintained a significant number of bilateral agreements with third countries relating to foreign direct investment . the treaty does not contain any explicit transitional provisions for such agreements which have now come under exclusive union competence . furthermore , some of those agreements may include provisions affecting the common rules on capital movements laid down in part three chapter 4 of title iv of the treaty .


### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning investment , or otherwise terminated , bilateral agreements concluded by member states with third countries remain binding on the parties under public international law . ### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning foreign direct investment , or otherwise terminated , bilateral foreign direct investment agreements concluded by member states with third countries remain binding on the parties under public international law . an indicative timeline should be set that contemplates when the transition from the existing bilateral investment treaties of member states to union international investment treaties might be completed .


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded and / or signed before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . member states shall also notify the commission on future changes to the status of these agreements .


### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to investment . ### this regulation lays down the conditions under which member states are empowered to maintain , amend or conclude international agreements relating to foreign direct investment .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to foreign direct investment . fdi includes any foreign investment which serves to establish lasting and direct links with an undertaking to which capital is made available in order to carry out an economic activity . where fdi takes the form of a shareholding , those lasting and direct links are the ability of the shareholder to participate effectively in the management or control of the undertaking concerned . fdi does not include foreign investments where there is no intention to influence the management or control of an undertaking . such investments which are often of a more short - term , and sometimes of a more speculative , nature , are commonly referred to as portfolio investments .


### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to investment . ### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to foreign direct investment .


### the specific objectives of the union macro - financial assistance should be to strengthen efficiency , transparency and accountability of the public finance management systems in jordan and to promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . these objectives should be regularly monitored by the commission . ### the specific objectives of the union macro - financial assistance should be to strengthen efficiency , transparency and accountability of the public finance management systems in jordan and to promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . the implementation of these objectives should be regularly monitored by the commission .


### the existing exemption for that use should continue to apply until 31 december 2015 in order to enable industry to further adapt the relevant technologies . ### the existing exemption for that use should continue to apply until 31 december 2016 in order to enable producers , the recycling industry and consumers along the whole value chain to further adapt the relevant substitute technologies across all the regions of the union in a uniform manner .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements facilitating the search for documents available for re - use such as asset lists of main documents with relevant metadata , preferably accessible online and in machine - readable format , and portal sites that are linked to decentralised asset lists .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements to facilitate searches for documents available for re - use throughout the union , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists .


### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the independent authority referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article . ### paragraph 1 shall not apply to public sector bodies that generate revenue to cover a substantial part of their costs relating to the performance of their public tasks or any particular activity falling within their public tasks . this exclusion shall be applied without prejudice to paragraph 4 of this article .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for supplying and allowing the re - use of documents , they should in principle be limited to the marginal costs . however , the necessity of not hindering the normal running of public sector bodies that are required to cover a substantial part of their costs relating to the performance of their public task as well as the normal running of libraries , museums and archives should notably be taken into consideration . those public sector bodies should be allowed to charge higher charges for re - use . such charges above marginal costs should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . the burden of proving that charges are cost - oriented and comply with relevant criteria should lie with the public sector body charging for the re - use of documents .


### at the end of paragraph 4 , the following wording is added : ' the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ' ### paragraph 4 is replaced by the following : ' 4 . any decision on re - use shall contain a reference to the means of redress in case the applicant wishes to appeal the decision . the means of redress shall include the possibility of review by an impartial review body , such as the national competition authority , the national access to documents authority or the national judicial authority , that has the authority to investigate complaints regarding the re - use of public sector documents and whose decisions must be considered binding by the public sector body concerned . '


### at the end of paragraph 4 , the following wording is added : ‘ the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ’ ### paragraph 4 is replaced by the following : ‘ 4 . any negative decision shall contain a reference to the means of redress in case the applicant wishes to appeal the decision . the means of redress shall include a reference to the possibility of review by an authority in the member states . ’


### ' however , such arrangements involving cultural establishments and university libraries shall be terminated at the end of the contract or in any case not later than 31 december 20xx [ 6 years after entry into force of the directive ] . ' ### the following sentence is added at the end of paragraph 3 : ' however , such arrangements involving archives , museums and libraries shall be terminated at the end of the contract or in any case not later than 31 december 20xx [ 10 years after entry into force of the directive ] . '


### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . as it constitutes a limitation to the intellectual property rights hold by the authors of the documents , the scope of such a link between the right of access and the right of use should be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights . ### taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should be set according to objective , transparent and verifiable criteria that ensure equal treatment . they should in principle be limited to the marginal costs involved in reproducing documents and making them available . however , the fact that some public bodies may generate revenue to cover a substantial part of their costs relating to the performance of their public tasks from the exploitation of their intellectual property rights should notably be taken into consideration . those bodies and also libraries , museums and archives , should be able to levy charges that exceed the marginal costs involved in reproducing documents and making them available and provide a reasonable return on investment . the charges should be set according to objective , transparent and verifiable criteria that ensure equal treatment . the burden of proving that charges are cost oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents .


### however , such arrangements involving cultural establishments and university libraries shall be terminated at the end of the contract or in any case not later than 31 december 20xx [ 6 years after entry into force of the directive ] . ### existing arrangements involving libraries , museums and archives , shall only be subject to the limitations of duration pursuant to this directive if they were concluded following the entry in force of this directive .


### for the acts listed in annex ii to this regulation , the commission may decide that imi shall be used , taking into account technical feasibility , cost - efficiency , user - friendliness and overall impact on the system . in such cases , the commission shall be empowered to include those acts in annex i following the procedure referred to in article 23 . ### the commission may propose an amendment to the annex to this regulation if it decides that imi is to be used for new legislative acts of the union .


### ' internal market information system ' means the electronic tool provided by the european commission to facilitate administrative cooperation between national administrations and the commission ; ### ' internal market information system ' means the electronic tool provided by the commission to facilitate exchange of information between national administrations and the commission ;


### imi actors shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and unlawfully processed data deleted , in accordance with national legislation . the correction and deletion shall be carried out within 60 days by the imi actor responsible . ### imi actors shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and unlawfully processed data deleted , in accordance with national legislation . the correction and deletion shall be carried out as soon as possible , and at the latest within 60 days , by the imi actor responsible .


### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender . ### in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the 35 most economically advantageous tenders , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or 40 members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender .


### it has been drawn up on the basis of scientific information or is based on other objectively verifiable and non - discriminatory criteria ; ### it has been drawn up in close consultation with stakeholders , including industry , is based on scientific information or is based on other objectively verifiable and non - discriminatory criteria ;


### the transition to stage iii b involves a step change in technology requiring significant implementation costs for redesigning the engines and for developing advanced technical solutions . the transition occurs at the same time when industry faces severe economic difficulties . ### the development of stage iii b engines involves a step change in technology requiring significant implementation costs for redesigning the engines and for developing advanced technical solutions . in addition , the integration of these engines into machines results in substantial modifications of the latter . all this technical work is carried out at the same time when the entire industry still faces severe economic difficulties in the aftermath of an unprecedented downturn


### the cert shall act under the supervision of the competent authority , which shall regularly review the adequacy of its resources , its mandate and the effectiveness of its incident - handling process . ### the cert or certs shall act under the supervision of the competent authority , which shall regularly review the adequacy of their resources , mandates and the effectiveness of their incident - handling process .


### member states shall ensure that public administrations and market operators notify to the competent authority incidents having a significant impact on the security of the core services they provide . ### member states shall ensure mechanisms are in place to enable market operators to notify the competent authority of incidents that have a significant impact on the security of the core services they provide .


### to ensure convergent implementation of article 14 , member states shall encourage the use of standards and / or specifications relevant to networks and information security . ### to ensure convergent implementation of article 14 , member states , without prescribing the use of any particular technology , shall encourage the use of interoperable standards and / or specifications relevant to networks and information security . such standards and / or specifications where appropriate shall take into account international and / or global equivalents .


### the commission shall draw up , by means of implementing acts a list of the standards referred to in paragraph 1 . the list shall be published in the official journal of the european union . ### an industry - led taskforce shall draw up a list of the standards and / or specifications referred to in paragraph 1 with the help of the commission .


### given the transnational and global nature of the climate and the environment , their scale and complexity , and the international dimension of the raw materials supply chain , activities have to be carried out at the union level and beyond . the multi - disciplinary character of the necessary research requires pooling complementary knowledge and resources in order to effectively tackle this challenge . reducing resource use and environmental impacts , whilst increasing competitiveness , will require a decisive societal and technological transition to an economy based on a sustainable relationship between nature and human well - being . coordinated research and innovation activities will improve the understanding and forecasting of climate and environmental change in a systemic and cross - sectoral perspective , reduce uncertainties , identify and assess vulnerabilities , risks , costs and opportunities , as well as expand the range and improve the effectiveness of societal and policy responses and solutions . actions will also seek to empower actors at all levels of society to actively participate in this process . ### given the transnational and global nature of the climate and the environment , their scale and complexity , and the international dimension of the raw materials supply chain , activities have to be carried out at the union level and beyond . the multi - disciplinary character of the necessary research requires pooling complementary knowledge and resources in order to effectively tackle this challenge . reducing resource use and environmental impacts , whilst increasing competitiveness , will require a decisive societal and technological transition to a sustainable economy based on a mutually beneficial relationship between biodiversity and the human population . coordinated research and innovation activities will improve the understanding and forecasting of climate and environmental change in a systemic and cross - sectoral perspective , reduce uncertainties , identify and assess vulnerabilities , risks , costs and opportunities , as well as expand the range and improve the effectiveness of societal and policy responses and solutions . actions will also seek to empower actors at all levels of society to actively participate in this process .


### electronic means of information and communication can greatly simplify the publication of contracts and increase the efficiency and transparency of procurement processes . they should become the standard means of communication and information exchange in procurement procedures . the use of electronic means also leads to time savings . as a result , provision should be made for reducing the minimum periods where electronic means are used , subject , however , to the condition that they are compatible with the specific mode of transmission envisaged at union level . moreover , electronic means of information and communication including adequate functionalities can enable contracting authorities to prevent , detect and correct errors that occur during procurement procedures . ### electronic means of information and communication can greatly simplify the publication of contracts , reduce administrative burdens such as transaction costs particularly for smes , and increase the efficiency and transparency of procurement processes . they should become the standard means of communication and information exchange in procurement procedures . the use of electronic means also leads to time savings . as a result , provision should be made for reducing the minimum periods where electronic means are used , subject , however , to the condition that they are compatible with the specific mode of transmission envisaged at union level . moreover , electronic means of information and communication including adequate functionalities can enable contracting authorities to prevent , detect and correct errors that occur during procurement procedures .


### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ‘ the most economically advantageous tender’ or ‘ the lowest cost’ , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions . ### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of competition , transparency , non - discrimination , cost - effectiveness and equal treatment . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ' the most economically advantageous tender ' or ' the lowest cost ' , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements - applicable during performance of the contract - to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements - applicable during performance of the contract - to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , while respecting the principle of subsidiarity , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements - applicable during performance of the contract - to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are directly linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements - applicable during performance of the contract - to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation