### member states shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time . member states may also provide the possibility for marketing authorisation holders to submit such requests once the committee for medicinal products for human use established by regulation no 726 / 2004 or the national competent authority has issued a positive opinion . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed . ### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to increase the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### for the purposes of the remedies procedure member states shall designate a body and entrust it with the powers to : take , at the earliest opportunity and by way of interlocutory procedures , interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned ; award damages to the applicant in case of non - compliance with time limits set in article 7 where damages are claimed , unless the competent authority may prove that the delay is not imputable to it ; impose a penalty payment , calculated by day of delay . for the purposes of point , the penalty payment shall be calculated depending on the seriousness of the infringement , its duration , the need to ensure that the penalty itself is a deterrent to further infringements . ### for the purposes of the remedies procedure member states shall designate a body and entrust it with the powers to : take , at the earliest opportunity and by way of interlocutory procedures , interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned ; award damages to the applicant in case of non - compliance with time limits set in article 7 where damages are claimed , unless the competent authority may prove that the delay is not imputable to it ;


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or , where appropriate , the bioequivalence or biosimilarity of the medicinal product or the criteria for orphan designation . however , this directive shall not prevent member states from using the data generated in the marketing authorisation process for health technology assessment or pharmaco - economic evaluation purposes .


### the commission shall submit a report to the european parliament and the council on the implementation of this regulation not later than 5 years after the date of application of this regulation . the report shall in particular assess any significant impact on the quality of groundhandling services , employment and working conditions . the report shall include the following set of indicators and criteria for a sample of airports : ### the commission shall submit a report to the european parliament and the council on the implementation of this regulation not later than 3 years after the date of application of this regulation . the report shall in particular assess the impact on the quality of groundhandling services , employment and working conditions . the report shall examine the following indicators and criteria :


### in a labour - intensive sector such as groundhandling , continuous staff development and training have a strong impact on service quality . minimum training requirements should therefore be set to ensure the quality of operations in terms of reliability , resilience , safety and security , and to create a level playing field among operators . ### in a labour - intensive sector such as groundhandling , continuous staff development and training have a strong impact on service quality . the current highest standards in the union should therefore be set as minimum standards for the training and further training of all employees in the groundhandling sector to ensure the quality of operations in terms of reliability , resilience , safety and security , and to create a level playing field among operators . if competent authorities in the member state find that minimum standards are not being complied with , no further service providers should be approved until the required standard has been attained again . this procedure should help to maintain safety in european aviation .


### where relevant for the activity of groundhandling services in question , training shall cover at least : ### the specific content of the tests and courses and their proper conduct shall be regulated by national provisions in the member states . where relevant for the activity of the groundhandling services in question , training and tests shall cover at least :


### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore appropriate to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment and working conditions . ### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore essential to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings , in consultation with the social partners , enabling member states to ensure adequate employment and working conditions .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec . ### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services or where a service provider ceases to provide groundhandling services to an airport user or where a self - handling airport user decides to cease self - handling , member states must require supplier of groundhandling services or self - handling airport users which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec . article 4 , second sentence , of directive 2001 / 23 / ec shall not apply to the cases referred to in the first sentence of this paragraph . dismissal on economic , technical or organisational grounds shall not be permitted .


### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore appropriate to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment and working conditions . ### the legislature should establish without ambiguity and ensure that member states require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore urgently necessary to clarify and , if necessary , amend the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment and working conditions .


### member states should retain the power to ensure an adequate level of social protection for the staff of undertaking providing groundhandling services . ### member states must ensure an adequate level of social protection for the staff of undertaking providing groundhandling services . in the absence of adequate social protection , accreditation may be suspended , withdrawn or withheld .


### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore appropriate to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment and working conditions . ### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore appropriate to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment , safety and working conditions .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 . ### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states shall require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 .


### without prejudice to the application of this regulation , and subject to the other provisions of union law , member states may take the necessary measures to ensure protection of rights of workers . ### member states shall ensure that the staff of undertakings providing groundhandling services enjoy an adequate level of social security . if competent authorities in the member state find that gaps in protection exist or that rules are being breached , no further service providers should be approved until the appropriate standard has been attained again .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 . ### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , and when the supplier of groundhandling services ceases the performance of groundhandling services for an airport user or when a self - handling airport user decides to cease self - handling , member states may recommend that supplier of groundhandling services which subsequently provide these services grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 .


### member states shall limit the requirement in paragraph to the employees of the previous supplier who are involved in the provision of services for which the previous supplier lost authorisation , and who voluntarily accept to be taken on by the new supplier . ### member states shall limit the requirement in paragraph to the employees of the previous supplier who are involved in the provision of services for which the previous supplier lost authorisation , and who voluntarily accept to be taken on by the new supplier . the costs of a redundancy plan for departing staff shall be borne by airport users in proportion to their traffic shares .


### suppliers of groundhandling services and self - handling airport users shall ensure that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , regularly attend specific and recurrent training to enable them to perform the tasks assigned to them . ### suppliers of groundhandling services and self - handling airport users shall ensure that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , regularly attend specific and recurrent training to enable them to perform the tasks assigned to them . by means of appropriate measures , supervisory authorities in the member states shall check compliance with training standards . if the relevant authorities in a member state find that training standards have not been complied with , the continued provision of services by suppliers of groundhandling services and self - handling airport users shall be blocked until the required standards are achieved .


### minimum quality standards for groundhandling undertakings ; ### minimum quality standards for groundhandling undertakings at each airport in the european union for the 11 categories of services ; examination of the connection between delays caused by groundhandling services and minimum quality standards ;


### where a member state imposes a requirement as referred to in paragraph , tender documents for the selection procedure laid down in articles 7 to 10 shall list the staff concerned and give the relevant details of employees ' contractual rights and the conditions under which employees are deemed to be linked to the services in question . ### tender documents for the selection procedure laid down in articles 7 to 10 shall list the staff concerned and give the relevant details of employees ' contractual rights and the conditions under which employees are deemed to be linked to the services in question .


### facilitating diversification , creation of new small enterprises and job creation ; ### facilitating diversification , creation of new small enterprises and job creation in particular for young people ;


### agri - environment - climate payments shall be granted to farmers , groups of farmers or groups of farmers and other land - managers who undertake , on a voluntary basis , to carry out operations consisting of one or more agri - environment - climate commitments on agricultural land . where duly justified to achieve environmental objectives , agri - environment - climate payments may be granted to other land - managers or groups of other land - managers . ### agri - environment - climate payments shall be granted to farmers , groups of farmers or groups of farmers and other land - managers who undertake , on a voluntary basis , to carry out operations consisting of one or more agri - environment - climate commitments on agricultural land or land suitable for agriculture or who have invested in measures to adapt to climate change . where duly justified to achieve environmental objectives , agri - environment - climate payments may be granted to groups of farmers .


### in the aim of improving the aerodynamic performance and road safety of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the main purpose of these exceedances is to allow the construction of tractor cabs improving the aerodynamic characteristics of vehicles or combinations of vehicles , and improving road safety . ### in the aim of improving the fuel efficiency of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i could be extended within the limits set by the european type approval legislation and by the requirements set by this directive , which will be need to be further developed , according to the procedures as stated in article 16 . the main purpose of these exceedances is to allow improvements of vehicles or vehicle combinations design in order to improve road safety . regulation n 661 / 2009 should be amended correspondingly .


### for the purposes of this article , and of point 2 . 2 . 2 of annex i , an intermodal transport operation shall include at least rail , river or sea transport at least . it shall also include a road section for its initial and / or terminal journey . each of these road sections shall be less than 300 km in the territory of the european union or just as far as the closest terminals between which there is a regular service . a transport operation shall also be regarded as intermodal transport if it uses intra - european short sea shipping , regardless of the lengths of the initial and terminal road journeys . the initial road journey and the terminal road journey for an operation using intra - european short sea shipping takes place from the point where the goods are loaded to the nearest appropriate seaport for the initial leg , and / or where appropriate between the nearest appropriate seaport and the point where the goods are unloaded for the final leg . ### for the purposes of this article , and of point 2 . 2 . 2 of annex i , an intermodal transport operation shall include at least rail , river or sea transport at least . it shall also include a road section for its initial and / or terminal journey . each of these road sections shall be established by the member states in accordance with existing infrastructural and geographical factors or just as far as the closest terminals between which there is a regular service . a transport operation shall also be regarded as intermodal transport if it uses intra - european short sea shipping , regardless of the lengths of the initial and terminal road journeys . the initial road journey and the terminal road journey for an operation using intra - european short sea shipping takes place from the point where the goods are loaded to the nearest appropriate seaport for the initial leg , and / or where appropriate between the nearest appropriate seaport and the point where the goods are unloaded for the final leg .


### for the purposes of this article , and of point 2 . 2 . 2 of annex i , an intermodal transport operation shall include at least rail , river or sea transport at least . it shall also include a road section for its initial and / or terminal journey . each of these road sections shall be less than 300 km in the territory of the european union or just as far as the closest terminals between which there is a regular service . a transport operation shall also be regarded as intermodal transport if it uses intra - european short sea shipping , regardless of the lengths of the initial and terminal road journeys . the initial road journey and the terminal road journey for an operation using intra - european short sea shipping takes place from the point where the goods are loaded to the nearest appropriate seaport for the initial leg , and / or where appropriate between the nearest appropriate seaport and the point where the goods are unloaded for the final leg . ### for the purposes of this article , and of point 2 . 2 . 2 of annex i , an intermodal transport operation shall include at least rail , river or sea transport at least . it shall also include a road section for its initial and / or terminal journey . a transport operation shall also be regarded as intermodal transport if it uses short sea shipping .


### in the aim of improving the aerodynamic performance and road safety of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the main purpose of these exceedances is to allow the construction of tractor cabs improving the aerodynamic characteristics of vehicles or combinations of vehicles , and improving road safety . ### in the aim of improving the energy efficiency performance and road safety of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the main purpose of these exceedances is to allow improvements in the energy performance of vehicles or combinations of vehicles , and to enhance road safety . regulation no 661 / 2009 should be amended accordingly .


### two - axle buses : 19 tonnes ### two - axle buses : 19 . 5 tonnes


### the maximum dimensions laid down in annex i points 1 . 1 and 1 . 6 may be exceeded by 15 cm for vehicles or combinations of vehicles engaged in the transport of 45 - foot containers or swap bodies , if the road transport of the container or swap body is part of an intermodal transport operation . ### to enhance intermodal / combined transport performance and increase energy efficiency , the dimensions of vehicles / vehicle combinations shall be adapted to intermodal transport unit specifications in compliance with the maximum admissible dimensions specified in annex i .


### – ‘ intermodal transport unit’ means a unit belonging to one of the following categories : container , swap body , semi - trailer ; ### – ‘ intermodal loading unit’ means a unit belonging to one of the following categories : container , swap body , semi - trailer ;


### with the aim of improving the aerodynamic performance of vehicles or combinations of vehicles , vehicles or combinations of vehicles equipped with devices that meet the criteria set out below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the only purpose of these exceedances is to allow the addition to the rear of vehicles or vehicle combinations of devices increasing their aerodynamic characteristics . ### with the aim of improving the aerodynamic performance of vehicles or combinations of vehicles and optimising other parts or elements of vehicles , vehicles or combinations of vehicles equipped with devices that meet the criteria set out below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the only purpose of these exceedances is to allow the addition to the rear of vehicles or vehicle combinations of devices increasing their aerodynamic characteristics .


### using alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , such as electric or hybrid engines for heavy - duty vehicles or buses generates extra weight which should not be counted at the expense of the effective load of the vehicle so that the road transport sector is not penalised in economic terms . ### using alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , such as electric or hybrid engines for heavy - duty vehicles or buses generates extra weight which should not be counted at the expense of the effective load of the vehicle so that the road transport sector is not penalised in economic terms . the solutions should also maintain the principle of technological neutrality .


### in the aim of improving the aerodynamic performance and road safety of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the main purpose of these exceedances is to allow the construction of tractor cabs improving the aerodynamic characteristics of vehicles or combinations of vehicles , and improving road safety . ### in the aim of improving the aerodynamic performance and road safety of vehicles or combinations of vehicles , vehicles or combinations of vehicles that meet the criteria set out in paragraph 2 below may exceed the maximum lengths provided for in point 1 . 1 of annex i . the main purpose of these exceedances is to allow the construction of tractor cabs improving the aerodynamic characteristics of vehicles or combinations of vehicles , and improving road safety for vulnerable road users and vehicles involved in rear - end collisions .


### 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 . in the policy orientation of the white paper on transport , this increase is however authorised only for intermodal transport , for which the road component for operations involving a rail , river or sea component should be evaluated differently from region to region and should be set by the individual member states in order 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 .


### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers ' vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver ' s comfort and safety . __________________ 7 com 389 8 com 258 ### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . however , safety improvements will not come automatically after the re - design and the extension of the cab . safety has to be addressed by the general safety regulation and under the corresponding unece legislation . in these legislations , additional safety measures may be introduced to reduce the blind spot in the driver’s vision , including under the windscreen and to avoid potential collisions so as to help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . __________________ 7 com 389 8 com 258


### 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 .


### using alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , such as electric or hybrid engines for heavy - duty vehicles or buses generates extra weight which should not be counted at the expense of the effective load of the vehicle so that the road transport sector is not penalised in economic terms . ### in line with the principle of technological neutrality and to encourage hauliers to use alternative engines that no longer rely only on fossil fuels and are therefore non - polluting or less polluting , it seems essential that the extra weight of these alternative engines is not counted at the expense of the effective load of the vehicle so that the road transport sector is not penalised in economic terms .


### 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 and underrun protective devices placed at the sides and 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 .


### technological developments include the possibility of attaching retractable or foldable aerodynamic devices to the rear of vehicles , mainly trailers or semi - trailers , but which then exceed the maximum lengths allowed under directive 96 / 53 / ec . this equipment may be installed as soon as this directive enters into force , as the products are available on the market and already used in other continents . ### technological developments include the possibility of attaching retractable or foldable aerodynamic devices to the rear of vehicles , mainly trailers or semi - trailers , but which then exceed the maximum lengths allowed under directive 96 / 53 / ec . this equipment may be installed as soon as this directive enters into force , as the products are available on the market and already used in other continents . the same applies to energy absorbing aerodynamic cowls and underrun protective devices affixed in the area of the wheels on the sides and at the rear under the trailers , semi - trailers and vehicles . these can significantly improve the energy efficiency of the vehicle while also significantly reducing the risk of injury to other road users .


### an excess length or excess width of less than 2% of the maximum dimensions indicated in point 1of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for such a penalty . ### an excess length , height or width of less than 2% of the maximum dimensions indicated in point 1of annex 1 shall give rise to a written warning to the transport company , which could give rise to a penalty , if the national legislation provides for such a penalty .


### ‘ 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 .


### to enable selection of the most cost - effective noise mitigation measures in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective . ### to enable selection of the most effective noise mitigation measures , taking account of both the health and the economic aspects , in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective .


### 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 ensure that , at the appropriate level , a forum for technical cooperation is established between the airport operator , aircraft operator and air navigation service provider , for actions which these operators are responsible for , and taking due account of the interdependency between measures to mitigate noise and to reduce emissions . the members of this forum for technical cooperation shall regularly consult local residents or their representatives , and provide technical information and advice on noise mitigating measures to the competent authorities . ### the competent authorities shall ensure that , at the appropriate level , a forum for technical cooperation is established between the airport operator , aircraft operator and air navigation service provider , for actions which these operators are responsible for , and taking due account of the interdependency between measures to mitigate noise and to reduce emissions . the members of this forum for technical cooperation shall regularly engage with local residents or their representatives , and provide technical information and advice on noise mitigating measures to the competent authorities . the competent authorities may decide not to assess new measures against annex i and annex ii , if they are in line with the recommendations of the technical forum .


### 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 ;


### ‘ 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 ;


### evaluate the likely cost - effectiveness of the available measures ; ### evaluate the likely effectiveness of the available measures in the light of the environmental objective set ;


### noise assessments should build on existing information available and ensure that such information is reliable and accessible to competent authorities and stakeholders . competent authorities should put in place the necessary monitoring and enforcement tools . ### in accordance with directive 2002 / 49 / ec , noise assessments should be based on objective and measurable criteria common to all the member states . this information must be reliable , obtained in a transparent manner , comparable and accessible to all stakeholders . assessments should include monitoring of the latest technological developments and exchanges of the latest findings concerning the procedures to be employed . competent authorities should put in place the necessary monitoring and enforcement tools . noise assessments should be carried out or supervised by outside agencies independent of the airport operator .


### ‘ 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 ;


### while a cost - benefit analysis provides an indication of the total economic welfare effects by comparing all costs and benefits , a cost - effectiveness assessment focuses on achieving a given objective in the most cost - effective way , requiring a comparison of only the costs . ### while a noise abatement objective should be chosen by comparing all costs and all benefits , the tool to reach this objective should be cost - effective , requiring a comparison of only the costs .


### 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 .


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


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


### 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 .


### evaluate the likely cost - effectiveness of the available measures ; ### the likely cost - effectiveness of the noise mitigation measures is evaluated ;


### this regulation shall apply to aircraft engaged in civil aviation . ### this regulation shall apply to aircraft flights engaged in civil aviation .


### the data shall be provided free of charge , in electronic form and using the format specified , where applicable . ### the data shall be provided in electronic form and using the format specified , where applicable . the commission shall bear the costs for providing these data .


### the competent authorities shall assess the noise situation at airports in their territory on a regular basis , in accordance with the requirements of directive 2002 / 49 / ec and national or local rules . the competent authorities may call on the support of the performance review body referred to in article 3 of commission regulation no 691 / 2010 . ### the competent authorities shall assess the noise situation at airports in their territory on a regular basis , but not more than once every two years , in accordance with the requirements of directive 2002 / 49 / ec and national or local rules . the competent authorities may call on the support of the performance review body referred to in article 3 of commission regulation no 691 / 2010 .


### 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 .


### ‘ 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 ;


### 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 . ### forecast noise contours – including an assessment of the number of people likely to be affected by aircraft noise – distinguish between established residential areas , newly constructed residential areas and planned future residential areas that have already been granted authorisation by the competent authorities .


### 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 .


### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body . ### member states shall designate a competent authority responsible for assessment of airport noise situation and for adopting measures including on operating restrictions , as well as an independent appeal body .


### 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 . ### if this assessment indicates that new operating restriction measures may be required to address a noise problem at an airport , the competent authorities shall ensure that :


### 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 :


### to enable selection of the most cost - effective noise mitigation measures in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective . ### to enable selection of the most effective noise mitigation measures , taking account of both the health and the economic aspects , in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective .


### 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 .


### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise nuisance from aircraft at airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects . ### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise from aircraft at airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects .


### 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 .


### member states may , within the balanced approach , differentiate noise mitigating measures according to aircraft type , runway use and / or timeframe covered . ### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . in case the measures or a combination of measures will not determine the achievement of the environmental noise abatement objectives set for that airport the member state shall determine a new combination of measures including operational restrictions .


### it shall not apply to aircraft engaged in military , customs , police , or similar services . ### it shall not apply to aircraft flights engaged in military customs , police , or similar services .


### 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 data shall be provided free of charge , in electronic form and using the format specified , where applicable . ### the data shall be provided in electronic form and using the format specified , where applicable . the commission shall bear the costs for providing these data .


### 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 .


### in order to take into account new legislation that may become necessary , the commission shall , by means of a delegated act , amend annex v . ### the commission shall , by means of a delegated act , amend annex v .


### where competent authorities , in accordance with national law , require public service operators to comply with certain quality and social standards or establish social and qualitative criteria , these standards and criteria shall be included in the tender documents and in the public service contracts . ### where competent authorities , in accordance with the law of the member state , require public service operators to comply with certain quality and social standards or establish social and qualitative criteria , these standards and criteria shall be included in the tender documents and in the public service contracts .


### where competent authorities , in accordance with national law , require public service operators to comply with certain quality and social standards or establish social and qualitative criteria , these standards and criteria shall be included in the tender documents and in the public service contracts . ### without prejudice to national and community law , including collective agreements between the social partners , the competent authorities shall lay down the quality and social standards applicable and shall include them in the tender documents and in the public service contracts .


### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies . ### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education , training and social policies .


### enhancing access to lifelong learning , upgrading the skills and competences of the workforce and increasing the labour market relevance of education and training systems ; ### enhancing the access to lifelong learning and the learning mobility of young people , upgrading the skills and competences of the workforce and increasing the labour market relevance of education and training systems ;


### enhancing access to lifelong learning , upgrading the skills and competences of the workforce and increasing the labour market relevance of education and training systems ; ### access to lifelong learning , upgrading the skills , knowledge , qualifications and competences of workers ;


### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and other vulnerable groups , such as migrants . the esf should aim to promote employment and support labour mobility , invest in education , skills and life - long learning , promote social inclusion and combat poverty . in promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers , the esf should , in particular , support european employment services in relation to recruitment and the related information , advice and guidance services at national and cross - border level . ### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and vulnerable social groups . the esf should aim to promote employment and support labour mobility , invest in education , skills and life - long learning , support and encourage entrepreneurship , especially among young people , promote social inclusion and combat poverty . in promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers , the esf should , in particular , support european employment services in relation to recruitment and the related information , advice and guidance services at national and cross - border level .


### each organisation certified or approved by a member state shall report , where required , to the competent authority member state , as referred to in article 6 , the result of the analysis performed in accordance with paragraph 1 and the actions required in accordance with paragraph 2 within 30 days . ### each organisation established in a member state , which is not covered by paragraph 3 , shall report to the competent authority of the member state , as referred to in article 6 , the initial result of the analysis performed in accordance with paragraph 1 and any action to be taken in accordance with paragraph 2 within 30 days from the day of notification of the occurrence . the final result of the analysis must be reported as soon as it is available and no later than three months from the day of notification of the occurrence .


### 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 member state shall ensure all personal data such as that names or addresses of individual persons are never recorded in the national database mentioned in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec . ### each member state shall ensure that all personal data such as names or addresses of individual persons are only made available to the staff of the competent authorities designated in accordance with article 6 and are never recorded in the national database referred to in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec .


### each organisation certified or approved by easa shall report to 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 within 72 hours of the actual or potential danger to aviation safety being identified .


### 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 .


### ‘ 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 member state shall ensure all personal data such as that names or addresses of individual persons are never recorded in the national database mentioned in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec . ### each member state shall ensure that all personal data such as names or addresses of individual persons are only made available , when they are forwarded , to the staff of the competent authorities designated in accordance with article 6 and are never recorded in the national database referred to in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec .


### member states shall refrain from instituting proceedings in respect of unpremeditated or inadvertent infringements of the law which come to their attention only because they have been reported in application of articles 4 and 5 . this rule shall not apply in cases of gross negligence . ### member states and easa shall refrain from instituting proceedings in respect of unpremeditated or inadvertent infringements of the law which come to their attention only because they have been reported in application of articles 4 and 5 . member states may choose not to apply this rule in cases of gross negligence . where a member state or easa institutes proceedings , the information contained in the occurrence report shall not be used by the member state or easa against the person reporting or persons involved in the occurrence .


### each member state shall designate one or more competent authorities to put in place a mechanism to collect , evaluate , process , analyse and store details on occurrences reported in accordance with articles 4 and 5 . the designated competent authorities shall work separately and independently from other departments when handling the information reported . ### each member state shall designate one or more competent authorities to put in place a mechanism to collect , evaluate , process , analyse and store details on occurrences reported in accordance with articles 4 and 5 . the designated competent authorities shall work separately and independently from other departments of the organisation when handling the information reported in order to ensure the confidentiality of the information and the anonymity of the person reporting the occurrence .


### every person listed in paragraph 3 shall report occurrences within the time - limit and in accordance with the requirements specified in annex ii point 1 . ### every person listed in paragraph 3 shall report occurrences within a time limit not exceeding 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 . ### 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 .


### each organisation established in a member state shall ensure that all personal data such as names or addresses of individual persons are only available to the persons referred to in article 6 . disidentified information shall be disseminated within the organisation as appropriate . each organisation established in a member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec . ### each organisation established in a member state shall ensure that all personal data such as names or addresses of individual persons are only made available to the staff of the organisations designated in accordance with article 6 and are never recorded in the database of the organisation referred to in article 6 . disidentified information shall be disseminated within the organisation as appropriate . each organisation established in a member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec .


### employees should have the possibility to report breaches to the principles delimiting their protection as established by this legislation . member states should define the consequences for those having infringed the principles of protection of reporter and should adopt penalties when relevant . ### employees should have the possibility to report breaches of the principles delimiting their protection as established by this legislation and should not be penalised for reporting such breaches . member states should define the consequences for those having infringed the principles of protection of persons involved in the reporting and should adopt penalties when relevant .


### a ' just culture ' environment should encourage individuals to report safety related information . it should however not absolve individuals from their normal responsibilities . in this context , employees should not be punished on the basis of information they have provided in application of this regulation , expect in case of gross negligence . ### a ' just culture ' environment should encourage individuals to report safety related information . it should however not absolve individuals from their normal responsibilities . in this context , employees should not be punished on the basis of information provided in application of this regulation , expect in case of gross negligence .


### each organisation established in a member state shall ensure that all personal data such as names or addresses of individual persons are only available to the persons referred to in article 6 . disidentified information shall be disseminated within the organisation as appropriate . each organisation established in a member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec . ### each organisation established in a member state shall ensure that all personal data such as names or addresses of individual persons are only made available to the staff of the competent authorities designated in accordance with article 6 and are never recorded in the database of the organisation referred to in article 6 . disidentified information shall be disseminated within the organisation as appropriate . each organisation established in a member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec .


### the pilot - in - command of an aircraft registered in a member state or an aircraft registered outside the union but used by an operator for which a member state ensures oversight of operations or an operator established in the union ; ### the pilot - in - command or , where appropriate , any other crew member of an aircraft registered in a member state or an aircraft registered outside the union but used by an operator for which a member state ensures oversight of operations or an operator established in the union ;


### member states and easa shall participate in an exchange of information by making all safety related information stored in their respective reporting databases available to the competent authorities of the other member states , easa and the commission , through the means of the european central repository . occurrence reports shall be transferred to the european central repository within 30 days after the initial collection of details on the occurrence . occurrence reports shall be updated whenever necessary with additional safety related information . ### member states and easa shall participate in an exchange of information by making all safety related information stored in their respective reporting databases available to the competent authorities of the other member states , easa and the commission , through the means of the european central repository . occurrence reports shall be transferred to the european central repository within 15 days after the initial collection of details on the occurrence . occurrence reports shall be updated whenever necessary with additional safety related information .


### 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 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 . the independence requirement does not apply to small organisations , upon agreement with the competent authority .


### each member state shall ensure all personal data such as that names or addresses of individual persons are never recorded in the national database mentioned in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec . ### each member state shall ensure that all personal data such as names or addresses of individual persons are only made available to the staff of the competent authorities designated in accordance with article 6 and are never recorded in the national database referred to in article 6 . disidentified information shall be made available to all relevant parties notably to allow them to discharge their obligations in terms of aviation safety improvement . each member state shall processes personal data only to such an extent as necessary for the purpose of this regulation and without prejudice to the national legislations implementing directive 95 / 46 / ec .


### each organisation certified or approved by a member state shall report , where required , to the competent authority member state , as referred to in article 6 , the result of the analysis performed in accordance with paragraph 1 and the actions required in accordance with paragraph 2 within 30 days . ### each organisation established in a member state , which is not covered by paragraph 3 , shall report to the competent authority of the member state , as referred to in article 6 , the initial result of the analysis performed in accordance with paragraph 1 and any action to be taken in accordance with paragraph 2 within 30 days from the day of notification of the occurrence . the final result of the analysis must be reported as soon as it is available and no later than three months from the day of notification of the occurrence .


### it is important to clearly set the line which protects the reporter from prejudice or prosecution by providing a common understanding of the term gross negligence . ### it is important to clearly set the line which protects the person involved in the reported occurrence from prejudice or prosecution by providing a common understanding of the term gross negligence .


### a point of contact which receives a request shall check that it is made by an interested party and that the point of contact is competent to deal with such request . ### a point of contact which receives a request shall check that it is made by an interested party and that the point of contact is competent to deal with such request . should the point of contact not be competent to deal with the request , it shall transfer it to the competent authority as established in article 10 .


### member states shall refrain from instituting proceedings in respect of unpremeditated or inadvertent infringements of the law which come to their attention only because they have been reported in application of articles 4 and 5 . this rule shall not apply in cases of gross negligence ### member states and easa shall refrain from instituting proceedings in respect of unpremeditated or inadvertent infringements of the law which have been reported in application of articles 4 and 5 . member states may choose not to apply this rule in cases of gross negligence . where a member state or easa institutes proceedings , the information contained in the occurrence report shall not be used by the member state or easa against the person reporting or persons involved in the occurrence .


### investments in new gas infrastructure should be strongly promoted . they should enhance the security of gas supply while ensuring the proper functioning of the internal market in natural gas . where an infrastructure investment is of cross - border nature the agency for the cooperation of energy regulators established by regulation no . . . / … of the european parliament and of the council and the european network of transmission system operators for gas should be closely involved in order to take better account of the cross - border implications . ### investments in new gas infrastructure should be strongly promoted . they should enhance the security of gas supply while ensuring the proper functioning of the internal market in natural gas . investments should as a matter of fundamental principle be made by undertakings and be based on economic incentives . where an infrastructure investment is of cross - border nature the agency for the cooperation of energy regulators established by regulation no . . . / … of the european parliament and of the council and the european network of transmission system operators for gas should be closely involved in order to take better account of the cross - border implications .


### the transmission system operators shall enable permanent physical capacity to transport gas in both directions on all interconnections within two years from the entry into force of this regulation , except in cases where at the request of a competent authority , the commission decides that the addition of a bi - directional flow capacity would not enhance the security of supply of any member state . such decision may be reviewed if circumstances change . the level of the bi - directional flow capacity shall be reached in a cost efficient way and at least take into account the capacity required to meet the supply standard set in article 7 . within that two year period , the gas transmission system operator shall adapt the functioning of the transmission system as a whole so as to enable bi - directional gas flows . ### the transmission system operators shall enable permanent physical capacity to transport gas in both directions on all interconnections within four years from the entry into force of this regulation , except in cases where at the request of a competent authority , the commission decides that the addition of a bi - directional flow capacity would not enhance the security of supply of any member state . such decision may be reviewed if circumstances change . the level of the bi - directional flow capacity shall be reached in a cost efficient way and at least take into account the capacity required to meet the supply standard set in article 7 . within that four - year period , the gas transmission system operator shall adapt the functioning of the transmission system to enable bi - directional gas flows .


### in a community emergency , the member states shall ensure that cross - border access to the storage facilities is maintained and shall not introduce any legal provisions which unduly restrict the flows of gas to the affected markets . ### in a community emergency the member states shall ensure that cross - border access to the storage facilities is maintained and shall not introduce any legal provisions which unduly restrict the flows of gas to the affected markets . the commission shall facilitate the application of those measures in order to maintain the good functioning of the internal market , particularly in supply disruptions and in crisis situations .


### ' protected customers ' means all household customers already connected to a gas distribution network , and , if the member state concerned so decides , can also include small and medium - sized enterprises , schools and hospitals provided that they are already connected to a gas distribution network ; ### ' protected customers ' means all household customers already connected to a gas distribution network ;


### ' protected customers ' means all household customers already connected to a gas distribution network , and , if the member state concerned so decides , can also include small and medium - sized enterprises , schools and hospitals provided that they are already connected to a gas distribution network ; ### ' protected customers ' means all household customers already connected to a gas distribution network , and , if the member state concerned so decides , can also include other customers , such as small and medium - sized enterprises , schools and hospitals provided that they are already connected to a gas distribution network ;


### when the competent authority declares an emergency it shall follow the pre - defined actions as defined in its emergency plan and shall immediately inform the commission in particular of the actions it intends to take according to article 9 . the commission may convene the gas coordination group . ### when the competent authority declares an emergency it shall follow the pre - defined actions as defined in its emergency plan and shall immediately inform the commission in particular of the actions it intends to take according to article 9 . the commission shall convene the gas coordination group .


### member states on the territory of which exist already at the day of the entry into force of this directive hydrogen refuelling points shall ensure that a sufficient number of publicly accessible refuelling points are available , with distances not exceeding 300 km , to allow the circulation of hydrogen vehicles within the entire national territory by 31 december 2020 at the latest . ### member states opting for the deployment of hydrogen refuelling points in their national policy framework as defined in article 3 shall ensure that a sufficient number of publicly accessible refuelling points are available , preferably with distances not exceeding 300 km , to facilitate the circulation of hydrogen vehicles within the entire national territory by 31 december 2020 at the latest .


### the delegation of power referred to in articles 3 , 4 , 5 , and 6 shall be conferred on the commission for an indeterminate period of time . ### the delegation of power referred to in articles 4 , 5 , and 6 shall be conferred on the commission for an indeterminate period of time .


### alternate current slow recharging points for electric vehicles shall be equipped , for interoperability purposes , with connectors of type 2 as described in standard en62196 - 2 : 2012 . ### alternate current basic recharging points for electric vehicles shall be equipped , for interoperability purposes , with socket - outlet of type 2 as described in standard en62196 - 2 : 2012 and respective updates .


### alternate current fast recharging points for electric vehicles shall be equipped , for interoperability purposes , with connectors of type 2 as described in standard en62196 - 2 : 2012 . ### alternate current fast recharging points for vehicles shall be equipped , for interoperability purposes , with attached cables with connector of type 2 as described in standard en62196 - 2 : 2012 and respective updates . '