### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component does not exceed 300 km for operations involving a rail , river or sea component . this distance appeared sufficient to link an industrial or commercial site with a freight terminal or a river port . to link a seaport and support the development of motorways of the sea , a longer distance is possible for a short intra - european maritime transport operation . ### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 80 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 80 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport .


### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component does not exceed 300 km for operations involving a rail , river or sea component . this distance appeared sufficient to link an industrial or commercial site with a freight terminal or a river port . to link a seaport and support the development of motorways of the sea , a longer distance is possible for a short intra - european maritime transport operation . ### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 80 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 80 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component does not exceed 300 km for operations involving a rail , river or sea component . this distance appeared sufficient to link an industrial or commercial site with a freight terminal or a river port . to link a seaport and support the development of motorways of the sea , a longer distance is possible for a short intra - european maritime transport operation .


### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component does not exceed 300 km for operations involving a rail , river or sea component . this distance appeared sufficient to link an industrial or commercial site with a freight terminal or a river port . to link a seaport and support the development of motorways of the sea , a longer distance is possible for a short intra - european maritime transport operation . ### the white paper on transport also stresses the need to monitor developments in intermodal transport , particularly in the area of containerisation , where 45 - foot containers are increasingly used . they are transported by rail or inland waterways . but the road components of intermodal journeys can only be undertaken today if both the member states and the transporters follow cumbersome administrative procedures or if these containers have patented chamfered corners , the cost of which is prohibitive . increasing the length of the vehicles transporting them by 15 cm could eliminate these administrative procedures for transporters and facilitate intermodal transport , without risk or prejudice to the infrastructure or other road users . the small increase that this 15 cm represents in relation to the length of an articulated truck does not constitute an additional risk to road safety . this increase should however be authorised only for combined transport , in which the road component does not exceed 150 km at each end for operations involving a rail , river or sea component .


### the improved aerodynamics of the cabs of motor vehicles would also allow significant gains on the energy performance of vehicles , in conjunction with the devices mentioned in recital 3 above . however , this improvement is impossible under the current maximum lengths set by directive 96 / 53 / ec without reducing the vehicle load capacity and threatening the economic equilibrium of the sector . therefore a derogation from this maximum length is required . ### heavy - good vehicles are responsible for about 26 percent of road transport co2 emissions in europe while their fuel efficiency has hardly improved for the last 20 years . the improved aerodynamics of the cabs of motor vehicles would allow significant gains on the energy performance of vehicles , in conjunction with the devices mentioned in recital 3 above and are urgently needed in order for the road freight sector to significantly reduce vehicle emissions . however , this improvement is impossible under the current maximum lengths set by directive 96 / 53 / ec without reducing the vehicle load capacity and threatening the economic equilibrium of the sector . therefore a derogation from this maximum length is required . any derogation should not be used to increase the payload of the vehicle .


### the commission should be empowered to adopt delegated acts , in accordance with article 290 of the treaty on the functioning of the european union , to define the requirements imposed on new aerodynamic devices placed in the rear of the vehicle or the design of new motor vehicles , as well as the technical specifications to ensure full interoperability of onboard weighing devices , and guidelines on the procedures for checking the weight of vehicles in circulation . it is particularly important that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , shall ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### the commission should be empowered to adopt delegated acts , in accordance with article 290 of the treaty on the functioning of the european union , to define the requirements imposed on new aerodynamic devices placed in the rear of the vehicle or the design of new motor vehicles , as well as the technical specifications to ensure full interoperability of onboard weighing devices , and guidelines on the procedures for checking the weight of vehicles in circulation . it is particularly important that the commission carry out appropriate consultations during its preparatory work , including at expert level . the consultations should include the major stakeholders such as truck manufacturers and body and trailer builders . the commission , when preparing and drawing - up delegated acts , shall ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . the stakeholders should be left sufficient time to comply with these requirements .


### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures is to identify vehicles that are likely to have committed an offence and that should be checked manually . these measures may be taken with the aid of automatic systems set up on the infrastructure , or onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states . ### after the expiry of a period of two years from the date of entry into force of this directive , member states shall measure the weight of vehicles or combination of vehicles in circulation . the purpose of these pre - selection measures based on a risk - rating system is to increase the efficiency of the checks and identify vehicles that are likely to have committed an offence and that should be checked manually . these measures may be taken with the aid of automatic systems set up on the infrastructure , such as automatic number plate recognition combined with weight in motion technology , or onboard systems installed in vehicles in line with paragraph 6 below . the automatic systems must enable the identification of the vehicles suspected of exceeding the maximum authorised weights . as these automatic systems are only to be used for pre - selection purposes , and not to define an offence , they do not have to be certified by the member states .


### the commission should be empowered to adopt delegated acts , in accordance with article 290 of the treaty on the functioning of the european union , to define the requirements imposed on new aerodynamic devices placed in the rear of the vehicle or the design of new motor vehicles , as well as the technical specifications to ensure full interoperability of onboard weighing devices , and guidelines on the procedures for checking the weight of vehicles in circulation . it is particularly important that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , shall ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### the commission should be empowered to adopt delegated acts , in accordance with article 290 of the treaty on the functioning of the european union , to define the requirements imposed on new aerodynamic devices placed in the rear of the vehicle or the design of new motor vehicles , with a view of reviewing european type approval procedures as referred to in directive 2007 / 46 / ec within the framework of unece regulations , as well as the technical specifications to ensure full interoperability of onboard weighing devices , and guidelines on the procedures for checking the weight of vehicles in circulation . it is particularly important that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , shall ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### ‘ balanced approach’ means the method under which the range of available measures , namely reduction of aircraft noise at source , land - use planning and management , noise abatement operational procedures and operating restrictions , is considered in a consistent way with the view to addressing the noise problem in the most cost - effective way on an airport by airport basis . ### ‘ balanced approach’ means the process established by the international civil aviation organisation under which the range of available measures , namely reduction of aircraft noise at source , land - use planning and management , noise abatement operational procedures and operating restrictions , is considered in a consistent way with the view to minimising the noise problem in the most overall efficient way on an airport by airport basis .


### 2 a description of the environmental sustainability objectives for the airport and the national context . this will include a description of the aircraft noise objectives for the airport . ### 2 a description of the noise abatement objectives for the airport and the national context .


### the competent authorities shall assess the cost - effectiveness of the new measures , as referred ton in paragraph 3 in accordance with annex ii . a minor technical amendment to an existing measure without substantive implications on capacity or operations is not considered as a new operating restriction . ### the competent authorities shall assess the overall efficiency of the new measures , as referred ton in paragraph 3 in accordance with annex ii . a minor technical amendment to an existing measure without substantive implications on capacity or operations is not considered as a new operating restriction .


### any modification of the aircraft which influences its noise performance ; ### any modification of the aircraft which influences its noise performance and is recorded in its noise certificate ;


### the delegation of power referred to in article 11 shall be conferred for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in article 11 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation .


### the available measures may include the withdrawal of marginally compliant aircraft , if so deemed necessary . ### the available measures may include the withdrawal of marginally compliant aircraft , if so deemed necessary . member states may offer economic incentives to encourage aircraft operators to use less noisy aircraft during the transitional period referred to in article 2 .


### member states shall adopt a balanced approach in regard to aircraft noise management . to this end , they shall : ### member states shall implement the balanced approach in regard to aircraft noise management , on an airport - by - airport basis , within the scope of this regulation . to this end , they shall assess the noise situation at an individual airport in accordance with annex ii of directive 2002 / 49 . where a noise problem is identified , they shall :


### ‘ marginally compliant aircraft’ means civil aircraft that meet the chapter 3 certification limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a cumulative margin of less than 10epndb , whereby the cumulative margin is the figure expressed in epndb obtained by adding the individual margins at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 4 of annex 16 to the chicago convention ; ### ‘ marginally compliant aircraft’ means aircraft that is certified in accordance with chapter 3 limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a cumulative margin of less than 8 epndb during a transitional period of four years after the entry into force of this regulation , and by a cumulative margin of less than 10 epndb following the end of that transitional period . the cumulative margin is the figure expressed in epndb obtained by adding the individual margins at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 3 of annex 16 to the chicago convention ;


### ‘ operating restrictions’ means a noise - related action that limits the access to or reduces the optimal capacity use of an airport , including operating restrictions aimed at the withdrawal from operations of marginally compliant aircraft at specific airports as well as operating restrictions of a partial nature , affecting the operation of civil aircraft according to time period . ### ' operating restrictions ' means a noise - related action that limits the access to or reduces the optimal capacity use of an airport , including operating restrictions aimed at the withdrawal from operations of marginally compliant aircraft at specific airports as well as operating restrictions of a partial nature , which for example apply for an identified time period during the day or only for certain runways at the airport .


### ‘ operating restrictions’ means a noise - related action that limits the access to or reduces the optimal capacity use of an airport , including operating restrictions aimed at the withdrawal from operations of marginally compliant aircraft at specific airports as well as operating restrictions of a partial nature , affecting the operation of civil aircraft according to time period . ### ' operating restrictions ' means a noise - related action that limits the access to or reduces the optimal capacity use of an airport , including operating restrictions aimed at the withdrawal from operations of marginally compliant aircraft at specific airports as well as operating restrictions of a partial nature , which for example apply for an identified time period only for certain runways at the airport


### the noise performance certificate or certificates of the aircraft used , together with the associated actual maximum take - off weight ; ### the noise certificate or certificates of the aircraft used , together with the associated actual maximum take - off weight ;


### suspension of noise mitigating measures is important to avoid unwanted consequences on aviation safety , airport capacity and competition . whilst an appeal procedure against noise - related operating restrictions may relate to noise abatement objectives , assessment methods and selection of cost - effective measures , the appeal may not suspend their implementation . therefore , the commission should well before implementation of the measures be able to use the right of scrutiny and to suspend measures deemed to produce unwanted or irreversible consequences . it is recognised that the suspension should be for a limited period . ### the commission should be able to evaluate proposed operating restrictions before their implementation .


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where the noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### 4 forecast noise contours – including an assessment of the number of people likely to be affected by aircraft noise – distinguish between established residential areas and newly constructed residential areas . ### 4 forecast noise contours – including an assessment of the number of people likely to be affected by aircraft noise – distinguish between established residential areas and planned residential areas .


### 1 outline of the additional measures available and an indication of the main reasons for their selection . description of those measures chosen for further analysis and information on the outcome of the cost - efficiency analysis , in particular the cost of introducing these measures ; the number of people expected to benefit and timeframe ; and a ranking of the overall effectiveness of particular measures . ### 1 outline of the additional measures available and an indication of the main reasons for their selection .


### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft type , runway use and / or timeframe covered . ### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft type , runway use , flight path and / or timeframe covered .


### member states shall adopt a balanced approach in regard to aircraft noise management . to this end , they shall : ### member states shall implement the balanced approach in regard to aircraft noise management , on an airport - to - airport basis , within the scope of this regulation . to this end , they shall asses the noise situation at an individual airport in accordance with annex ii of directive 2002 / 49 . where the noise problem is identified , they shall :


### the noise performance certificate or certificates of the aircraft used , together with the associated actual maximum take - off weight ; ### the noise certificate of the aircraft used , including its maximum take - off weight ;


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down the rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where a noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in union , national and local rules , and to assess their interdependence with other environmental objectives , at the level of individual airports ; ### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in union , national and local rules , and to assess their interdependence with the health of citizens and environmental objectives , at the level of individual airports ;


### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body . ### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body in accordance with national laws and practices .


### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body . ### member states in which an airport is located shall designate one or more competent authorities responsible for following the process when adopting operating restrictions , as well as an independent appeal body .


### the member states shall notify the commission of the names and addresses of the designated competent authorities and appeal body referred to in paragraph 1 . ### the member states shall notify the commission of the names and addresses of the designated competent authorities and appeal body referred to in paragraph 1 . the commission shall publish this information .


### when the assessment of the noise situation reveals that new measures are necessary to achieve or maintain the level of noise abatement objectives , the competent authorities shall take due account of the contribution of each type of measure under the balanced approach , in accordance with annex i . ### when the assessment of the noise situation reveals that new measures are necessary to achieve or maintain the level of noise abatement objectives , the competent authorities shall take due account of the contribution of each type of measure under the balanced approach , in accordance with annex i . the competent authorities shall describe additional measures chosen for further analysis and information on the outcome of the overall efficiency analysis , in particular the cost of introducing these measures , the number of people expected to benefit and timeframe , and a ranking of the overall efficiency of particular measures .


### 3 details of noise contours for the current and previous years – including an assessment of the number of people affected by aircraft noise . ### 3 details of noise contours for the current and at least the last two previous years – including an assessment of the number of people affected by aircraft noise , carried out according to the provisions of annex iii of directive 2002 / 49 / ec .


### ‘ marginally compliant aircraft’ means civil aircraft that meet the chapter 3 certification limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a cumulative margin of less than 10epndb , whereby the cumulative margin is the figure expressed in epndb obtained by adding the individual margins at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 4 of annex 16 to the chicago convention ; ### ‘ marginally compliant aircraft’ means aircraft that is certified in accordance with chapter 3 limits laid down in volume 1 , part ii , chapter 3 of annex 16 to the convention on international civil aviation by a cumulative margin of less than 8 epndb during a transitional period of four years after the entry into force of this regulation , and by a cumulative margin of less than 10 epndb following the end of that transitional period . the cumulative margin is the figure expressed in epndb obtained by adding the individual margins at each of the three reference noise measurement points as defined in volume 1 , part ii , chapter 3 of annex 16 to the chicago convention ;


### at the request of the commission , aircraft operators shall communicate the following noise information in respect of their aircraft that use union airports : ### in order to centralise noise information and replace individual databases maintained at airport level , the commission may require aircraft operators to communicate the following noise information in respect of their aircraft that use union airports :


### the cost - effectiveness of envisaged noise - related operating restrictions will be assessed taking due account of following elements , to the extent possible , in quantifiable terms : ### the cost - effectiveness of envisaged noise mitigating measures will be assessed taking due account of following elements , to the extent possible , in quantifiable terms :


### following the assessment carried out in accordance with article 5 , the notification of the decision shall be accompanied by a written report explaining the reasons for introducing the operating restriction , the environmental objective established for the airport , the measures that were considered to meet that objective , and the evaluation of the likely cost - effectiveness of the various measures considered , including , where relevant , their cross - border impact . ### following the assessment carried out in accordance with article 5 , the notification of the decision shall be accompanied by a written report explaining the reasons for introducing the operating restriction , the noise abatement objective established for the airport , the measures that were considered to meet that objective , and the evaluation of the likely cost - effectiveness of the various measures considered , including , where relevant , their cross - border impact .


### the agency shall verify the aircraft noise and performance data for modelling purposes in accordance with article 6 of regulation no 216 / 2008 of the european parliament and the council . ### modelling of airport community noise shall be based on manufacturer provided aircraft noise and performance data recommended for use by the international community and made available through icao . the agency shall verify the aircraft noise and performance data for modelling purposes in accordance with article 6 of regulation no 216 / 2008 of the european parliament and the council . the agency shall refer to the established icao committee on aviation environmental protection modelling and databases group ' s process to determine data validity and best practices and ensure continued harmonization across international airworthiness agencies .


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where the noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft type , runway use and / or timeframe covered . ### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft noise performance , runway use and / or timeframe covered .


### 2 a description of the environmental sustainability objectives for the airport and the national context . this will include a description of the aircraft noise objectives for the airport . ### 2 a description of the noise abatement objectives for the airport and the national context .


### at the request of a member state or on its own initiative , and without prejudice to a pending appeal procedure , the commission may scrutinise the decision on an operating restriction , prior to its implementation . where the commission finds that the decision does not respect the requirements set out in this regulation , or is otherwise contrary to union law , it may suspend the decision . ### at the request of a member state or on its own initiative , and without prejudice to a pending appeal procedure , the commission may within a period of two months after the day on which it receives notice , as referred to in article 7 , evaluate the process for the introduction of a noise - related operating restriction . where the commission finds that the introduction of a noise - related operating restriction does not follow the process set out in this regulation , the commission may notify the relevant competent authorities accordingly . the relevant competent authorities may take the commission ' s opinion into account .


### where the commission has not adopted a decision within a period of six months after it has received the information referred to in paragraph 2 , the competent authority may apply the envisaged decision on an operating restriction . ### where the commission has not notified its opinion within a period of two months after it has received notice , as referred to in article 7 , the competent authority may apply the envisaged decision on an operating restriction .


### the establishment of an internal market for passenger transport services by rail requires common rules on competitive tendering for public service contracts in this sector to be applied in a harmonised manner in all member states . ### the establishment of an internal market for passenger transport services by rail requires common rules on competitive tendering for public service contracts in this sector to be applied in a harmonised manner in all member states to ensure a level - playing field between all potential bidders .


### in view of creating framework conditions for enabling society to fully reap the benefits of effective opening of the market for domestic passenger transport services by rail it is important that member states ensure an adequate level of social protection for the staff of public service operators . ### in view of creating framework conditions for enabling society to fully reap the benefits of effective opening of the market for domestic passenger transport services by rail it is important that member states ensure an adequate level of social protection for the staff of public service operators . 2 ) a minimum service level during public transport strikes .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 . ### each organisation established in a member state which is not covered by paragraph 6 shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 within 72 hours .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 . ### each organisation established in a member state and not covered by paragraph 5 shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 within 72 hours .


### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress , to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements , to update the list of interested parties and the request for european central repository information form , and to ensure that the scope of incidents to be reported under the mandatory scheme remains appropriate . ### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress ; to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements ; to update the list of interested parties and the request for european central repository information form ; to ensure that the list of occurrences to be reported under the mandatory scheme remains appropriate , contains a specific section on operations involving non - complex aircraft , and in particular reflects the emergence of new safety risks ; and to supplement and update the list of mandatory data fields . before making any proposal for a delegated act , the commission shall request the opinion of the network of aviation safety analysts for the review of annexes i and ii of this regulation .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 . ### each organisation established in a member state and not covered by paragraph 5 shall report to the competent authority of that member state , as referred to in article 6 , the details on occurrences collected in accordance with paragraph 1 as soon as possible .


### ‘ gross negligence’ means a manifest and wilful violation of the duty of care directly causing foreseeable damage to a person or to a property , or which seriously lowers the level of aviation safety ; ### ' gross negligence ' means a manifest and severe serious disregard to the duty of care , or to an obvious risk and profound failure to take such care that is evidently required in the circumstances , causing foreseeable damage to a person or to a property , or which seriously lowers the level of aviation safety ;


### each organisation established in a member state shall designate one or more persons to handle the collection , evaluation , processing , analysis and storage of details on occurrences reported in accordance with articles 4 and 5 . these designated persons shall work separately and independently from other departments of the organisation . ### each organisation established in a member state shall designate one or more persons and put in place a mechanism to handle the collection , evaluation , processing , analysis and storage of details on occurrences reported in accordance with articles 4 and 5 . these designated persons shall ensure that the handling of the reports shall be organized separately and independently from other departments of the organisation so as to appropriately safeguard the confidentiality of the reporter and of the involved personnel with a view to fostering a just culture . .


### each organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 the details on occurrences collected in accordance with paragraph 1 . ### any organisation certified or approved by a member state shall report to the competent authority of that member state , as referred to in article 6 , the details of occurrences collected in accordance with paragraph 1 as soon as practicable , but in any case within 72 hours of the organisation identifying the condition to which the report relates , unless exceptional circumstances prevent this .


### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress , to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements , to update the list of interested parties and the request for european central repository information form , and to ensure that the scope of incidents to be reported under the mandatory scheme remains appropriate . ### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning the annexes to this regulation in order to adapt the annexes to technical progress , to align the annexes with the international agreed taxonomy adrep , with other legislations adopted by the union and with international agreements , to update the list of interested parties and the request for european central repository information form , and to ensure that the list of occurrences to be reported under the mandatory scheme remains appropriate , contains a specific section on operations involving non - complex aircraft , and in particular reflects the emergence of new safety risks ; and to supplement and update the list of mandatory data fields . before making any proposal for a delegated act , the commission shall request the opinion of the network of aviation safety analysts for the review of annexes i and ii of this regulation . at this stage , the commission shall involve easa according to its competencies .


### each organisation certified or approved by easa shall report to the easa the details on occurrences collected in accordance with paragraph 1 . ### each organisation certified or approved by easa shall report to easa the details on occurrences collected in accordance with paragraph 1 . reports shall be made within the timescales required by regulation 216 / 2008 / ec


### each organisation certified or approved by easa shall report to the easa the details on occurrences collected in accordance with paragraph 1 . ### each organisation certified or approved by easa shall report to the easa the details on occurrences collected in accordance with paragraph 1 . reports shall be made within the timescales required by regulation 216 / 2008ec .


### ‘ recharging point’ means a slow recharging point or a fast recharging point or an installation for the physical exchange of a battery of an electric vehicle . ### ‘ recharging point’ means a slow recharging point , a fast recharging point , a wireless recharging point , or an installation for the physical exchange of a battery of an electric vehicle .


### member states shall not prohibit electric vehicle users from buying electricity from any electricity supplier regardless of the member state in which the supplier is registered . member states shall ensure that consumers have the right to contract electricity simultaneously with several suppliers so that electricity supply for an electric vehicle can be contracted separately . ### member states shall not prohibit electric vehicle users from buying electricity from any electricity supplier regardless of the member state in which the supplier is registered . member states shall ensure that consumers have the right to contract electricity simultaneously with several suppliers so that electricity supply for an electric vehicle can be contracted separately . member states shall ensure that the above does not result in separate connection fees or a separate physical electricity connection required .


### all publicly accessible recharging points for electric vehicles shall be equipped with intelligent metering systems as defined in article 2 of directive 2012 / 27 / eu and respect the requirements laid down in article 9 of that directive . ### all publicly accessible recharging points for electric vehicles shall be equipped , either individually or in aggregate , with intelligent metering systems as defined in article 2 of directive 2012 / 27 / eu and respect the requirements laid down in article 9 of that directive .


### member states should ensure that publicly accessible infrastructure for the supply of hydrogen to motor vehicles is built up , with distances between refuelling points for motor vehicles allowing area covering circulation of hydrogen vehicles within the national territory , as well as a certain number of refuelling points located in urban agglomerations . this would allow hydrogen vehicles to circulate union - wide . ### member states should ensure that publicly accessible infrastructure for the supply of hydrogen to motor vehicles is built up as the technology matures , with distances between refuelling points for motor vehicles allowing area covering circulation of hydrogen vehicles within the national territory , as well as a certain number of refuelling points located in urban agglomerations . this would allow hydrogen vehicles to circulate union - wide .


### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to those documents contained in the case - file which are relevant for the determination of the lawfulness of the arrest or detention . ### where a person is arrested and detained at any stage of the criminal proceedings , member states shall ensure that all information which relates to the specific case in the possession of the competent authorities and which is essential to effectively challenge the lawfulness of the arrest or detention under national law , is made available to the arrested person or his lawyer .


### member states shall ensure that an accused person or his lawyer is granted access to the case - file once the investigation of the criminal offence is concluded . access to certain documents contained in the case - file may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the documents contained in the case - file . ### member states shall ensure that access is granted at least to all material evidence in the possession of the competent authorities for or against the suspected or accused person to that person or his lawyer to safeguard the fairness of the proceedings and to prepare the defence . this shall include access to any new evidence or material facts which emerge during the proceedings .


### tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a commission report . ### tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5 .


### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity . filters and capsules shall not contain tobacco . ### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity where these increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . . filters and capsules shall not contain tobacco .


### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself . cigarettes with a diameter of less than 7 . 5 mm shall be deemed to be misleading . ### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself .


### in case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the commission shall be empowered to adopt delegated acts in accordance with article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavour . ### in case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration and where these increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . the commission shall be empowered to adopt delegated acts in accordance with article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavour .


### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . ### member states shall prohibit the placing on the market of tobacco products with a characterising flavour where this increases in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product .


### tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a commission report . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the prohibitions laid down in paragraphs 1 and 5 .


### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy , menthol or vanilla observable before or upon intended use of the tobacco product ; ### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco and menthol , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the same direction as any other information appearing on the packaging ;


### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy , menthol or vanilla observable before or upon intended use of the tobacco product ; ### ' characterising flavour ' means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , with the exception of menthol , including fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of article 25 . ### the application of paragraph 1 to 8 shall for cigarettes and roll - your - own tobacco shall begin 3 years and for all other tobacco products 7 years following the date referred to in paragraph 1of article 25 .


### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of article 25 . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 10 years following the date referred to in paragraph 1 of article 25 .


### the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . ### the general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed or affixed on the other most visible surface of the unit packet and any outside packaging .


### tobacco products ; ### cigarettes and roll - your - own tobacco ;


### on the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1 , if any of the action values referred to in annexes ii or iii is exceeded , the employer shall further assess and , if necessary , calculate whether the exposure limit values for health effects are exceeded . ### on the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1 , if any of the orientation values referred to in annex ii is exceeded , the employer shall further assess and , if necessary calculate whether the exposure limit value for safety effects are exceeded .


### for exposure in the range from 100 khz up to 300 ghz , and in any event where exposure above the exposure limit values is detected , a medical examination shall be made available to the worker concerned in accordance with national law and practice . if health damage resulting from such exposure is detected , a reassessment of the risks shall be carried out by the employer in accordance with article 4 . ### for exposure in the range from 100 khz up to 300 ghz , where exposure above the exposure limit values is detected , a medical examination shall be made available to the worker during working hours . the cost shall be met in accordance with national law and practice . if health damage resulting from such exposure is detected , a reassessment of the risks shall be carried out by the employer in accordance with article 4 .


### for exposure levels above the action value , appropriate verifications shall demonstrate that the exposure level is not exceeding the relevant exposure limit value for health effects . for exposure levels above the orientation value , appropriate verifications shall demonstrate that the exposure is not exceeding the relevant exposure limit values for safety and health effects or by demonstrating that the exposure level is below the action value . in the latter case , preventive measures and information to workers shall be adapted . ### for exposure levels above the action value , appropriate verifications shall demonstrate that the exposure level is not exceeding the relevant exposure limit value for health effects . for exposure levels above the orientation value , procedures and training for workers shall be put in place to prevent safety consequences of any occurrence of adverse safety effects , unless appropriate verifications demonstrate that the exposure does not exceed the relevant exposure limit values for safety effects .


### in any event , workers shall not be exposed above the exposure limit values for health effects unless the conditions under article 3 are fulfilled . if , despite the measures taken by the employer to comply with this directive , the exposure limit values for health effects are exceeded , the employer shall take immediate action to reduce exposure below these exposure limit values . the employer shall identify the reasons why the exposure limit values for health effects have been exceeded , and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again . ### in situations where workers are exposed above the exposure limit values for safety effects , procedures need to be in place and workers trained to ensure that any consequences of adverse safety effects are prevented . in any event , workers shall not be exposed above the exposure limit values for health effects unless the conditions under article 3 are fulfilled . if , despite the measures taken by the employer to comply with this directive , the exposure limit values for health effects are exceeded , the employer shall take immediate action to reduce exposure below these exposure limit values . the employer shall identify the reasons why the exposure limit values for health effects have been exceeded , and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again .


### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer in excess of eur 5000 for an aid application submitted in respect of calendar year 2013 shall be reduced by 4 . 981759&#160 ; % . ### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer for an aid application submitted in respect of calendar year 2013 shall be reduced by [ xxx ] &#160 ; % .


### the competent authority shall ensure that conditions for supplies to protected customers are established without prejudice to the proper functioning of the internal gas market and at a price respecting the market value of the commodity . ### the competent authority shall ensure that conditions for supplies to protected customers and vulnerable customers are established without prejudice to the proper functioning of the internal gas market and at a price respecting the market value of the commodity .


### efficient alternatives to phosphates - based household laundry detergents require small amounts of other phosphorous compounds , namely phosphonates which if used in increasing quantities might be of concern for the environment . ### efficient alternatives to phosphates - based household laundry detergents require small amounts of other phosphorous compounds , namely phosphonates , which fulfil a very specific function that is different to phosphates and are used in such small quantities that they do not contribute to any measureable extent to eutrophication .


### article 16 is replaced by the following : ' article 16 report by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorus compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### article 16 is replaced by the following : ' article 16 report by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorus compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### the following articles 13a , 13b and 13c are inserted : ' article 13a exercise of the delegation the powers to adopt the delegated acts referred to in article 13 shall be conferred on the commission for an indeterminate period of time . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 13b and 13c . article 13b revocation of the delegation the delegation of power referred to in article 13 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and possible reasons for a revocation . 3 . the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union . article 13c objections to delegated acts the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act it shall be published in the official journal of the european union and shall enter into force at the date stated therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . 3 . if the european parliament or the council objects to a delegated act , it shall not enter into force . the institution which objects shall state the reasons for objecting to the delegated act . ' ### the following article is inserted : ' article 13a exercise of the delegation the power to adopt the delegated acts referred to in article 13 is conferred on the commission subject to the conditions laid down in this article . 1a . the power to adopt delegated acts referred to in article 13 shall be conferred on the commission for an indeterminate period of time from . . . * . 1b . the power to adopt delegated acts referred to in article 13 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 . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . a delegated act adopted pursuant to article 13 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . * oj : please insert the date of entry into force of this regulation . '


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to this regulation . ### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to regulation no 648 / 2004 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### it is not appropriate to extend limitations of the use of phosphates and other phosphorus compounds in household laundry detergents to household automatic dishwasher detergents or to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available . ### efficient household automatic dishwasher detergents with a limited concentration of phosphorus are currently available on the market . it is thus appropriate to extend limitations of the use of phosphates and other phosphorus compounds in household laundry detergents to household automatic dishwasher detergents . it is not appropriate , however , to extend these limitations to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available .


### it is appropriate to provide for deferred application of the restriction established in this regulation so as to allow operators , in particular small and medium–sized enterprises , to reformulate their phosphate–based household laundry detergents using alternatives during their usual reformulation cycle in order to minimise the costs . ### it is appropriate to provide for deferred application of the restrictions established in this regulation so as to allow operators , in particular small and medium–sized enterprises , to reformulate their phosphate–based household laundry detergents and household automatic dishwasher detergents using alternatives during their usual reformulation cycle in order to minimise the costs .


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### by 31 december 2013 , the commission shall evaluate and submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents , based on a life - cycle analysis of those detergents and taking into account the non - toxicity and effectiveness of alternative products . if justified , it shall present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### fostering the sustainable development and growth of the fisheries and aquaculture sector , including employment in fisheries and connected sectors ; ### fostering the sustainable development of the fisheries sector and sustainable growth of the aquaculture sector , including employment in fisheries and connected sectors ;


### each member state shall establish and implement a maritime spatial plan or plans and an integrated coastal management strategy or strategies . they may be prepared in separate documents . ### each member state shall establish and implement maritime spatial plans and integrated coastal management strategies . member states may decide whether to follow an integrated approach or to establish maritime spatial plans and integrated coastal management strategies separately .


### the main purpose of maritime spatial planning is to identify and manage spatial uses and conflicts in maritime areas . in order to achieve that purpose , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change . ### the main purposes of maritime spatial planning are to identify and manage spatial uses , to minimise cross - sectoral conflicts in maritime areas and to enhance sustainable growth in the maritime sector . in order to achieve those purposes , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change .


### maritime spatial plans and integrated coastal management strategies shall establish operational steps to achieve the objectives as set out in article 5 taking into account all relevant activities and measures applicable to them . ### each member state shall establish operational steps to achieve the objectives set out in article 5 , taking into account all relevant activities and measures applicable to them .


### this directive establishes a framework for maritime spatial planning and integrated coastal management aiming at promoting the sustainable growth of maritime and coastal economies and the sustainable use of marine and coastal resources . ### this directive establishes a framework for maritime spatial planning and integrated coastal management aiming at promoting the sustainable development and growth of maritime and coastal economies and the sustainable use of marine and coastal resources .


### within the integrated maritime policy of the union , this framework provides for the establishment and implementation by member states of maritime spatial plans and of integrated coastal management strategies with the aim of meeting the objectives specified in article 5 . ### within the integrated maritime policy of the union , this directive provides a framework for the establishment and implementation by member states of maritime spatial plans and of integrated coastal management strategies with the aim of meeting the objectives specified in article 5 .


### maritime spatial plans shall contain at least a mapping of marine waters which identifies the actual and potential spatial and temporal distribution of all relevant maritime activities in order to achieve the objectives as set out in article 5 . ### maritime spatial plans shall contain at least a mapping of marine waters which identifies the actual , intended and potential spatial and temporal distribution of all relevant maritime uses and activities in order to achieve the objectives set out in article 5 .


### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones , and shall aim to contribute to : ### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate sustainable development , growth in the maritime sector and the co - existence of different sector activities and to minimise conflicts between those activities in marine waters and coastal zones , and shall aim to contribute to :


### the maritime spatial plans and integrated coastal management strategies referred to in article 4 shall be established within a period of 36 months after the entry into force of this directive . ### the maritime spatial plans and integrated coastal management strategies referred to in article 4 shall be established within a period of 48 months after the entry into force of this directive .


### member states shall establish means for the public participation of all interested parties at an early stage in the development of maritime spatial plans and integrated coastal management strategies . ### member states shall establish means for public participation by informing and consulting the relevant stakeholders and authorities and the public concerned at an early stage in the development of maritime spatial plans and integrated coastal management strategies . member states shall also ensure that those stakeholders and authorities and the public concerned have access to the results once they are finalised .


### integrated coastal management strategies shall contain at least , an inventory of existing measures applied in coastal zones and an analysis of the need for additional actions in order to achieve the objectives set out in article 5 . the strategies shall provide for integrated and cross - sectoral policy implementation and consider interactions between terrestrial and maritime activities . ### integrated coastal management shall be established either in the form of a set of practices or by establishing one or more strategies . member states shall identify existing measures applied in coastal zones and draw up an analysis of the need for additional actions in order to achieve the objectives set out in article 5 . integrated coastal management shall enhance integrated and cross - sectoral policy implementation and consider interactions between terrestrial and maritime activities to ensure land - sea connectivity .


### when establishing maritime spatial plans and integrated coastal management strategies , member states shall give due regard to the particularities of the regions and the sub - regions , the respective sector activities , the marine waters and coastal zones concerned and potential climate change impacts . ### when establishing maritime spatial plans and integrated coastal management strategies , member states shall have due regard to the particularities of the marine and coastal regions and sub - regions , the respective existing and future sector activities , the marine waters and coastal zones concerned and potential climate change impacts .


### when establishing maritime spatial plans member states shall take into consideration , at least , the following activities : ### when establishing maritime spatial plans member states shall take into consideration , inter alia , the following uses and activities :


### ensure effective trans - boundary cooperation between member states , and between national authorities and stakeholders of the relevant sector policies ; ### ensure effective participation of the stakeholders of the relevant sector policies in accordance with article 9 ;


### while it is appropriate for the union to lay down rules on maritime spatial plans and integrated coastal management strategies , member states and their competent authorities remain responsible for designing and determining , within their marine waters and coastal zones , the content of such plans and strategies , including the apportionment of maritime space to the different sector activities . ### while it is appropriate for the union to lay down a framework for maritime spatial plans and integrated coastal management strategies , member states and their competent authorities remain responsible for designing and determining , within their marine waters and coastal zones , the content of such plans and strategies , including the apportionment of maritime space to the different sector activities and maritime uses .


### member states bordering a coastal zone or maritime area of a third country shall make every effort to coordinate their maritime spatial plans and integrated coastal management strategies with that third country in the marine region or sub - region and the related coastal zone concerned . ### member states bordering a coastal zone or maritime area of a third country shall consult that country and make every effort to cooperate and coordinate their maritime spatial plans and integrated coastal management strategies with that third country in the marine region or sub - region and the related coastal zone concerned .


### the management of maritime and coastal areas is complex and involves different levels of authorities , economic operators and other stakeholders . in order to guarantee sustainable development in an effective manner , it is essential that stakeholders , authorities and the public are consulted at an appropriate stage in the preparation of maritime spatial plans and integrated coastal management strategies under this directive , in accordance with relevant eu legislation . a good example for public consultation provisions can be found in article 2 of directive 2003 / 35 . ### the management of maritime and coastal areas is complex and involves different levels of authorities , economic operators and other stakeholders . in order to guarantee sustainable development in an effective manner , it is essential that stakeholders , the authorities at the various levels and the public are consulted at every stage of the development of maritime spatial plans and integrated coastal management strategies under this directive , in accordance with relevant eu legislation . good examples for public consultation provisions can be found in article 2 of directive 2003 / 35 / ec and article 6 of directive 2001 / 42 / ec .


### in order to ensure consistency and legal clarity , the geographical scope for maritime spatial planning and integrated coastal management strategies should be defined in conformity with existing legislative instruments of the union and international maritime law . ### in order to ensure consistency and legal clarity , the geographical scope for maritime spatial planning and integrated coastal management should be defined in conformity with existing legislative instruments of the union and international maritime law .


### ‘ integrated maritime policy’ means the union policy with the aim to foster coordinated and coherent decision - making to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union , as well as maritime sectors , through coherent maritime - related policies and relevant international cooperation . ### ' integrated maritime policy ' means the union policy established to foster a coordinated and coherent cross - sectoral and trans - boundary maritime governance designed to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union .


### the reports referred to in article 15 shall be provided , at the latest , 42 months following the entry into force of the directive , and every six years thereafter . ### the reports referred to in article 15 shall be provided , at the latest , 54 months following the entry into force of this directive , and every six years thereafter .


### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , maritime shipping and fishing activities , ecosystem conservation and tourism and aquaculture installations , as well as the multiple pressures on coastal resources require an integrated planning and management approach . ### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , maritime shipping and fishing activities , ecosystem conservation , the extraction of raw materials , tourism and aquaculture installations , as well as the multiple pressures on coastal resources , require an integrated planning and management approach .


### the main purpose of maritime spatial planning is to identify and manage spatial uses and conflicts in maritime areas . in order to achieve that purpose , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change . ### the main purposes of maritime spatial planning are to identify and manage spatial uses , to minimise cross - sectoral conflicts in maritime areas and to enhance sustainable growth in the maritime sector . in order to achieve those purposes , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change .


### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones , and shall aim to contribute to : ### maritime spatial plans and integrated coastal management strategies shall foster the sustainable development of maritime and coastal activities in the long - term applying an ecosystem - based approach to facilitate co - existence and cooperation between competing sector activities in marine waters and coastal zones , by preventing conflicts between them , with the full participation of public stakeholders , and having regard to the principle of subsidiarity shall aim in particular to contribute to :


### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , maritime shipping and fishing activities , ecosystem conservation and tourism and aquaculture installations , as well as the multiple pressures on coastal resources require an integrated planning and management approach . ### the high and rapidly increasing demand for maritime space for different purposes , such as renewable energy installations , oil and gas exploration and exploitation , maritime shipping and fishing activities , ecosystem and biodiversity conservation and tourism and aquaculture installations as well as multiple pressures on coastal resources require an integrated planning and management approach .


### securing the energy supply of the union by promoting the development of marine energy sources , the development of new and renewable forms of energy , the interconnection of energy networks , and energy efficiency ; ### meeting the union ' s objectives as regards the development of renewable forms of energy , securing the energy supply of the union , improving the integration of the internal energy market and contributing to sustainable development and environmental protection by promoting the development of renewable marine energy and through the development of new and renewable forms of energy , the interconnection of energy networks , and energy efficiency ;


### the pharmacovigilance risk assessment advisory committee shall be composed of the following : ten members and ten alternates appointed by the management board , on the basis of proposals by the national competent authorities ; five members and five alternates appointed by the commission , on the basis of a public call for expressions of interest , after consulting the european parliament . the alternates shall represent and vote for the members in their absence . the commission may adapt the number of members and alternates in the light of technical and scientific needs . those measures , designed to amend non - essential elements of this regulation , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 87 . ### the pharmacovigilance risk assessment committee shall be composed of the following : one member and one alternate per member state , appointed by the national competent authority in consultation with the management board ; seven additional members and five alternates appointed by the commission , including at least one healthcare professional representative , and at least one patient representative , on the basis of a public call for expressions of interest , after consulting the european parliament . a member state may request another member state to take its place in the committee . the alternates shall represent and vote for the members in their absence .


### the opinions and decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 . ### the final opinions and final decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 .


### the agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products for human use containing certain active substances . it shall publish the list of active substances being monitored and the publications subject to this monitoring . ### the agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products for human use containing certain active substances . it shall publish the list of active substances being monitored and the publications subject to this monitoring . the agency shall monitor all medical literature for reports of suspected adverse reactions to medicinal products for human use containing well - established active substances .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders make available only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be made available should be defined . it is appropriate to allow marketing authorisation holders to make available the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders make only high - quality non - promotional information accessible , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to make accessible the most recent summaries of product characteristics and package leaflet , approved by the competent authorities .


### the prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the member states . ### the prohibition referred to in paragraph 1 shall not apply to vaccination campaigns in the interest of public health approved by the competent authorities of the member states .


### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the dissemination of information from the marketing authorisation holder to the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated . ### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the making available of information from the marketing authorisation holder to patients and the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be made available .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its supply . only such information that has been approved in advance by the competent authorities should be provided , and it should be provided in the approved form only .


### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria . ### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription is accessible . the information should take into account patients needs and expectations in order to empower patients allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria .


### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to prescription - only medicinal products , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . ### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to the supply of information on prescription - only medicinal products that has been approved by the competent authorities by the marketing authorisation holder , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall require the marketing authorisation holder to make available , either directly or indirectly through a third party acting on behalf of the marketing authorisation holder , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that such information and the manner in which it is made available is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . when such information is made available , the marketing authorisation holder and any third party shall be identified , and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such .


### - information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription , which is subject to the provisions of title viiia . ### - information on medicinal products that has been approved by the competent authorities in the member states and that has been made available to the general public in approved form by the marketing authorisation holder and that is subject to medical prescription , which is subject to the provisions of title viiia .


### medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . ### measures to prevention and medical treatment . such information shall be vetted by the agency prior to its being made available in accordance with article 20 b of regulation ec 726 / 2004 .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders make available only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be made available should be defined . it is appropriate to clarify that marketing authorisation holders can disseminate the contents of the approved summaries of product characteristics , package leaflet , and public assessment report .


### national competent authorities and health care professionals should remain important sources of information on medicinal products for the general public . member states should facilitate the access of citizens to high - quality information through appropriate channels . marketing authorisation holders may be a valuable source of non promotional information on their medicinal products . this directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public . the ban on advertising to the general public for prescription - only medicinal products should be maintained . ### national competent authorities and health care professionals should remain the main source of information on medicinal products for the general public . while there is already a lot of independent information on pharmaceuticals , for example by national authorities or health care professionals , the situation differs very much between member states and among the different products available . member states and commission should take much more efforts to facilitate the access of citizens to high - quality information through appropriate channels .


### member states shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof . ### member states shall ensure that misuse is avoided by securing that only the marketing authorisation holder supplies information , and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription , and in the form which has been approved for the dissemination to the general public or members thereof . by way of derogation member states may continue those types of control mechanism which they have been implemented before 31 . 12 . 2008 . the commission verifies and approves these systems .


### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products . ### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products by placing emphasis on the interests of patients . they should have the right to easily access certain information such as a summary of product characteristics , and the package leaflet in electronic and printed form .