### member states shall ensure that the limitation period for proceedings concerning a customs infringement referred to in articles 3 to 6 is four years and starts to run on the day on which the customs infringement was committed . ### member states shall ensure that the limitation period for proceedings concerning a customs infringement referred to in articles 3 to 6 is three years and that it starts to run on the day on which the customs infringement was committed .


### that disparity of member states ' legal systems affects not only the optimal management of the customs union , but also prevents that a level playing field is achieved for economic operators in the customs union because it has an impact on their access to customs simplifications and facilitations . ### that disparity of member states ' legal systems not only affects the optimal management of the customs union and the transparency necessary to ensure the proper functioning of the internal market as regards ways in which infringements are handled by the different customs authorities , but also prevents the achievement of a level playing field for economic operators in the customs union because it has an impact on their access to customs simplifications and facilitations .


### four members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members . ### six members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations , one from fisheries and aquaculture organisations , one from the agrochemical industry and one from the food industry . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members .


### take into account risk perceptions ; ### address risk perceptions and misperceptions ;


### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter . ### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant and validated studies including tests that have been carried out in accordance with international standards and good laboratory practices , to demonstrate the safety and in some cases the efficacy of a subject matter .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . the scientific data and studies submitted within the consultation process should be taken into account provided that they are validated , relevant , in line with international standards and good laboratory practices .


### the assessment , update and promotion of existing common specifications and standards and the development , establishment and promotion of new common specifications and standards through the union’s standardisation platforms and in cooperation with european or international standardisation organisations as appropriate ; and ### the assessment , update and promotion of existing common specifications and standards and the development , establishment and promotion of new common specifications and standards through the union’s standardisation platforms and in cooperation with european or international standardisation organisations as appropriate , including with regard to the security of data transmission , processing and storage ; and


### national administrations can be supported in their endeavours through specific instruments under the european structural and investment funds . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif . ### national , regional and local administrations can be supported in their endeavours through specific instruments under the european structural and investment funds . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif .


### interoperability is directly connected with , and dependent on the use of , standards and common specifications . the isa2 programme should promote and , where appropriate , support the partial or full standardisation of existing interoperability solutions . this should be achieved in cooperation with other standardisation activities at union level , european standardisation organisations and other international standardisation organisations . ### the lack of interoperability often undermines the implementation of digital end - to - end services and the development of one - stop shops for businesses and citizens . interoperability is directly connected with , and dependent on the use of , open standards and common specifications . the isa2 programme should promote and , where appropriate , support the partial or full standardisation of existing interoperability solutions . this should be achieved in cooperation with other standardisation activities at union level , european standardisation organisations and other international standardisation organisations .


### interoperability has been a key factor to success in the area of customs , taxation and excise duties , in operating trans - european ict systems spanning all member states supporting interoperable business services funded by the fiscalis 2013 and customs 2013 programmes , implemented and operated by the commission and national administrations . assets created under fiscalis 2013 and customs 2013 programmes are available for sharing and re - use from other policy areas . ### interoperability has been a key factor to success in the area of customs , taxation and excise duties , in operating trans - european ict systems spanning all member states supporting interoperable business services funded by the fiscalis 2013 and customs 2013 programmes , implemented and operated by the commission and national administrations . assets created under fiscalis 2013 and customs 2013 programmes are available for sharing and re - use from other policy areas . in addition , the member states and the commission have committed themselves , in the council conclusions of 26 may 2014 on the governance reform of the eu customs union , to develop a strategy of commonly managed and operated it systems in all customs related areas .


### investments in infrastructure ; ### investments in infrastructure , particularly with european added value as defined in regulation [ new cef regulation ] ;


### member states of group 1 shall allocate at least 85&#160 ; % of their total erdf resources under priorities other than for technical assistance to po&#160 ; 1 and po&#160 ; 2 , and at least 60&#160 ; % to po&#160 ; 1 ; ### member states of group 1 shall allocate at least 70&#160 ; % of their total erdf resources under priorities other than for technical assistance to po&#160 ; 1 and po&#160 ; 2 , and at least 50&#160 ; % to po&#160 ; 1 ;


### member states of group 2 shall allocate at least 35 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ; ### member states of group 2 shall allocate at least 30 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ;


### member states of group 2 shall allocate at least 45 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ; ### member states of group 2 shall allocate at least 40 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ;


### adopt and clearly communicate to suppliers and the public its supply chain policy for the minerals and metals potentially originating from conflict - affected and high - risk areas , ### adopt and clearly and systematically communicate to suppliers and the public its supply chain policy for the minerals and metals potentially originating from conflict - affected and high - risk areas ,


### ' responsible smelters or refiners ' means smelters or refiners in the supply chain of the responsible importer ; ### ‘ smelters or refiners’ means smelters or refiners in the supply chain of the responsible importer ;


### natural mineral resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining national endeavours towards development , good governance and the rule of law . in these areas , breaking the nexus between conflict and illegal exploitation of minerals is critical to peace and stability . ### natural resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining national endeavours towards development , good governance and the rule of law . women and children are disproportionately affected by these conflicts , and are the victims of systematic physical and sexual violence , recognised as an international war crime and used as a weapon of war by armed groups . in these areas , breaking the nexus between conflict and illegal exploitation of natural resources is critical to peace and stability .


### ‘ importer’ means any natural or legal person declaring minerals or metals within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no 2913 / 199213 ; __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code . ### ' importer ' means any natural or legal person placing on the market for the first time minerals or metals within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no 2913 / 199213 __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code .


### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral’s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices . ### importers are an important point in global mineral and metals supply chains as they are typically better placed to collect , disclose and verify information on the mineral’s and metal`s origin and chain of custody . a union list of responsible importers could therefore provide transparency and certainty to downstream undertakings , which themselves must comply , depending on their position in the supply chain , with due diligence practices as defined in this regulation and the oecd due diligence guidance .


### on 7 october 2010 , the european parliament passed a resolution calling for the union to legislate along the lines of the us ' conflict minerals ' law alias section 1502 of the dodd - frank wall street reform and consumer protection act ; and the commission announced in its communications of 20119 and 201210 its intention to explore ways of improving transparency throughout the supply chain , including aspects of due diligence . in the latter communication and in line with the commitment it had made at the may 2011 oecd ministerial council , the commission also advocated greater support for and use of the oecd guidelines for multinational enterprises , and of the oecd due diligence guidance – even outside the oecd membership . __________________ 9 commodity markets and raw materials , com 25 final . 10 trade , growth and development , com 22 final . ### in its resolutions of 7 october 20108a , of 8 march 20118b , of 5 july 20118c and of 26 february 20148d , the european parliament called for the union to legislate along the lines of the us ' conflict minerals ' law alias section 1502 of the dodd - frank wall street reform and consumer protection act ; and the commission announced in its communications of 20119 and 201210 its intention to explore ways of improving transparency throughout the supply chain , including aspects of due diligence . in the latter communication and in line with the commitment it had made at the may 2011 oecd ministerial council , the commission also advocated greater support for and use of the oecd guidelines for multinational enterprises , and of the oecd due diligence guidance – even outside the oecd membership . __________________ 8a european parliament resolution of 7 october 2010 on failures in protection of human rights and justice in the democratic republic of congo . 8b european parliament resolution of 8 march 2011 on tax and development – cooperating with developing countries on promoting good governance in tax matters . 8c european parliament resolution of 5 july 2011 on increasing the impact of eu development policy . 8d european parliament resolution of 26 february 2014 on promoting development through responsible business practices , including the role of extractive industries in developing countries . 9 commodity markets and raw materials , com 25 final . 10 trade , growth and development , com 22 final .


### ' self - certification ' means the act of declaring one ' s adherence to the obligations relating to management systems , risk management , third - party audits and disclosure as set out in this regulation ; ### ' european responsible importer certificate ' means the document issued by the competent authorities to any importer who complies with the rules set out in this regulation ;


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner . every six months , the commission shall remove from the list the names of the importers that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers .


### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd . ### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . as such , consumers are indirectly linked to conflicts that have severe impacts on human rights , notably the rights of women as armed groups often use mass rape as a deliberate strategy to intimidate and control local populations in order to protect their interests . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd .


### the issue concerns resource - rich regions where the challenge posed by the desire to minimise the financing of armed groups and security forces has been taken up by governments and international organisations together with business operators and civil society organisations . ### the issue concerns resource - rich regions where the challenge posed by the desire to minimise the financing of armed groups and security forces has been taken up by governments and international organisations together with business operators and civil society organisations , including women ' s organisations that are at the forefront of drawing attention to the exploitative conditions imposed by these groups as well as to rape and violence used to control local populations .


### the main infrastructure bottleneck hampering the shift from road freight to other modes of transport is at the transhipment terminal level . the current distribution and coverage of transhipment terminals in the union , at least along the existing ten - t core and comprehensive network , is insufficient yet the capacity of existing transhipment terminals is reaching its limit and will need to develop in order to cope with overall freight traffic growth . investing in transhipment terminal capacity may reduce overall transhipment costs , and hence produce a derived modal shift , as demonstrated in some member states . member states should therefore ensure , in coordination with the neighbouring member states and with the commission , that more combined transport transhipment terminals and transhipment capacity are constructed or made available to transport operators . this would incentivise the use of freight transport alternatives and increase modal shift , thus making combined transport operations more competitive than road transport alone . the increased coverage and capacity of transhipment terminals should , at the very minimum , be established along the existing ten - t core and comprehensive networks . there should be on average at least one suitable transhipment terminal for combined transport located no further than 150 km from any shipment location in the union . ### the main infrastructure bottleneck hampering the shift from road freight to other modes of transport is at the transhipment terminal level . the current distribution and coverage of transhipment terminals in the union , at least along the existing ten - t core and comprehensive network , is in some cases insufficient yet the capacity of existing transhipment terminals is reaching its limit while other terminals are not exploited according to their real capacities that could enable to cope with overall freight traffic growth . investing in transhipment terminal capacity , network optimisation and the development of new transhipment techniques may reduce overall transhipment costs , and hence produce a derived modal shift , as demonstrated in some member states .


### member states should implement additional economic support measures in addition to the existing ones , targeting the various legs of a combined transport operation , in order to reduce the road freight and to encourage the use of other modes of transport such as rail , inland waterways and maritime transport , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion . such measures may include the reduction of certain taxes or transport fees , grants for intermodal load units effectively transport in combined transport operations , or the partial reimbursement of transhipments cost . ### member states should implement additional economic support measures in addition to the existing ones , targeting the various legs of a combined transport operation , in order to reduce the road freight and to encourage the use of other modes of transport such as rail , inland waterways and maritime transport , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion , as well as encouraging action to boost and implement the digitalisation of the sector and the european internal market . such measures may include the reduction of certain taxes or transport fees , grants for intermodal load units effectively transport in combined transport operations , or the partial reimbursement of transhipments cost , among other measures .


### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 18 months after transposition of the directive ] and every two years thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory : ### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 18 months after transposition of the directive ] and every year thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory :


### since the objectives of this directive to further promote the shift from road transport to more environmentally friendly modes of transport , and hence reduce the negative externalities of the union transport system , cannot be sufficiently achieved by the member states but can rather , by reason of the primarily cross - border nature of freight combined transport and interlinked infrastructure , and of the problems this directive is intended to address , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives ### since the objectives of this directive to further promote the shift from road transport to more environmentally friendly modes of transport by developing multimodality , and hence reduce the negative externalities of the union transport system , cannot be sufficiently achieved by the member states but can rather , by reason of the primarily cross - border nature of freight combined transport and interlinked infrastructure , and of the problems this directive is intended to address , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives


### an overview of all national support measures used and envisaged , including their respective uptake and assessed impact . ### an overview of all national support measures used and envisaged , including their respective uptake and assessed impact on the use of combined transport and effect as regards social and environmental sustainability , bottlenecks , congestion , safety and efficiency .


### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 18 months after transposition of the directive ] and every two years thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory : ### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 12 months after transposition of the directive ] and every two years thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory :


### member states shall coordinate with neighbouring member states and with the commission and ensure that , when such measures are implemented , priority is given to ensuring a balanced and sufficient geographical distribution of suitable facilities in the union , and notably on the ten - t core and comprehensive networks , allowing that any location in the union is not situated at a distance farther than 150 km from such terminal . ### member states shall coordinate with neighbouring member states and with the commission and ensure that , when such measures are implemented , priority is given to ensuring a balanced and sufficient geographical distribution of suitable facilities in the union , and notably on the ten - t core and comprehensive networks , allowing that any location in the union is not situated at a distance farther than 150 km as the crow flies from such terminal . in addition , member states shall take due account of the need to : reduce congestion , in particular near urban and sub - urban areas or in areas with natural constraints ; improve cross - border connections ; improve accessibility and connectivity in particular as regards the access infrastructure to transhipment terminals ; and accelerate the shift to digitalisation ;


### the scope of the current economic support measures defined in directive 92 / 106 / eec is very limited , consisting of fiscal measures which concern only combined rail / road transport operations . such measures should be extended to combined transport operations covering inland waterways and maritime transport . other relevant types of measures , such as infrastructure investment support measures or different economic support measures , should also be supported . ### the scope of the current economic support measures defined in directive 92 / 106 / eec is very limited , consisting of fiscal measures which concern only combined rail / road transport operations . such measures should be extended to combined transport operations covering inland waterways and maritime transport . other relevant types of measures , such as infrastructure investment support measures that maintain coherence with the ten - ts or different economic support measures , should also be supported . an analysis should first be made to establish whether existing capacity is being used before creating new infrastructure that could distort the market .


### during the past years , member states have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information which was established by joint action 97 / 396 / jha adopted by the council on the basis of article k . 3 of the treaty on european union concerning the information exchange , risk assessment and the control of new synthetic drugs13 and was further strengthened by council decision 2005 / 387 / jha14 . __________________ 13 council joint action 97 / 396 / jha of 16 june 1997 concerning the information exchange , risk assessment and control of new synthetic drugs . 14 council decision 2005 / 387 / jha of 10 may 2005 on the information exchange , risk assessment and control of new psychoactive substances . ### during the past years , member states have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information which was established by joint action 97 / 396 / jha adopted by the council on the basis of article k . 3 of the treaty on european union concerning the information exchange , risk assessment and the control of new synthetic drugs13 and was further strengthened by council decision 2005 / 387 / jha14 . according to the european medicine centre for drugs and drug addiction , member states notified 101 new psychoactive substances , which had not been reported previously , via that mechanism during the year 2014 . __________________ 13 council joint action 97 / 396 / jha of 16 june 1997 concerning the information exchange , risk assessment and control of new synthetic drugs . 14 council decision 2005 / 387 / jha of 10 may 2005 on the information exchange , risk assessment and control of new psychoactive substances .


### new psychoactive substances can pose serious cross border threats to health which makes necessary to enhance monitoring , early warning and combating of those threats . ### new psychoactive substances can pose serious cross border threats to health , in particular due to their diversity and the speed with which they have been appearing , which makes necessary to enhance monitoring , early warning and combating of those threats .


### “member states shall determine the use of revenues generated by this directive . to enable the transport network to be developed as a whole , revenues generated from infrastructure and external costs charges , or the equivalent in financial value of these revenues , should be used to benefit the transport sector , and optimise the entire transport system . in particular , revenues generated from external cost charges , or the equivalent in financial value of these revenues , should be used to make transport more sustainable , including one or more of the following : facilitating efficient pricing ; reducing road transport pollution at source ; mitigating the effects of road transport pollution at source ; improving the co2 and energy performance of vehicles ; developing alternative infrastructure for transport users and / or expanding current capacity ; supporting the trans - european transport network ; optimising logistics ; improving road safety ; and providing secure parking places . ### in paragraph 2 , the first subparagraph is replaced by the following : “to enable the transport network to be developed as a whole , revenues generated from infrastructure and external costs charges , or the equivalent in financial value of these revenues , shall be used to benefit the transport sector , and optimise the entire transport system . in particular , revenues generated from external cost charges , or the equivalent in financial value of these revenues , shall be used to make transport more sustainable , including one or more of the following : facilitating efficient pricing ; reducing road transport pollution at source ; mitigating the effects of road transport pollution at source ; improving the co2 and energy performance of vehicles ; developing alternative infrastructure for transport users and / or expanding current capacity ; supporting and enhancing the development of electro - mobility including infrastructure to transfer electricity to vehicles ; supporting collective modes of transport . ”


### road charges can mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure . it is therefore appropriate to incentivise member states to use revenues from road charges accordingly and , to this end , to require that they adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of road charging . ### road charges can mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure . therefore member states should use revenues from road charges accordingly and , to this end , adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of road charging .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , and to the extent it intends to rely on the exception , the person responsible for the making , or any person acting on its behalf , should provide certain information to the registered holder of the certificate , at its registered address on a confidentiality basis . the information should be provided before the making is intended to start for the first time . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , would altogether fall within the scope of the exception , provided that the maker has sent this notification to the holder of the certificate . the notification should be without prejudice to any defences otherwise available to the maker and any other persons conducting the related acts referred to in recital 9 against a claim from the holder of the certificate in relation to an alleged infringement or threat of infringement of the certificate , and should not be construed as an acknowledgment by the maker that the certificate or the basic patent is valid and / or that the making or any of the related acts referred to in recital 9 would otherwise infringe the certificate and / or the basic patent .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , to the extent it intends to rely on the exception and in the interest of transparency , the person responsible for the making , or any person acting on its behalf should provide , on a confidentiality basis , a warning letter to the registered holder of the certificate , at its registered address . the maker should also provide to the authority which granted the supplementary protection certificate in the member state , a notification with certain information before the making is intended to start for the first time . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , would altogether fall within the scope of the exception , provided that the maker has sent the warning letter and the notification respectively to the holder of the certificate and to the competent industrial property authority of in the member state of making . the notification should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making .


### the notification sent to an authority as referred to in article 4 shall be published by that authority within 15 days of receipt of the notification . ; ### the authority referred to in article 9 shall keep the notification referred to in article 4 and the information listed in paragraph 3 confidential and shall take appropriate measures to preserve such confidentiality . the authority shall only disclose the notification and the information it contains if such disclosure is ordered by a court having competence under national law to hear an infringement action based on the certificate . a court shall only order such disclose if at least the following conditions are met : the person requesting the disclosure is the holder of the certificate the maker is given the opportunity to attend the proceedings and to be heard before the court ; the holder of the certificate has provided evidence rendering plausible that the maker did not comply with the conditions set out in paragraph 2 ; the holder of the certificate and the court have taken appropriate measures to keep the notification and the information it contains confidential and avoid their disclosure to third parties ;


### the limited use of the autonomous quotas on imports of textiles and clothing originating in the republic of belarus implies that the removal of those quotas will have a limited impact on eu trade . ### the removal of the autonomous quotas on imports of textiles and clothing originating in the republic of belarus implies that the quotas on outward processing traffic are no longer necessary . as a result , recital 5 , article 4 , chapter v on outward processing traffic containing articles 25 , 26 , 27 , 28 and 29 , and annex v should be deleted , which also impacts article 31 . the limited use of the autonomous and outward processing quotas on imports of textiles and clothing originating in the republic of belarus implies that the removal of those quotas will have a limited impact on eu trade .


### this directive should not apply to goods like dvds and cds incorporating digital content in such a way that the goods function only as a carrier of the digital content . however , this directive should apply to digital content integrated in goods such as household appliances or toys where the digital content is embedded in such a way that its functions are subordinate to the main functionalities of the goods and it operates as an integral part of the goods . ### this directive should not apply to digital content integrated in goods such as household appliances , toys , dvds and cds where that digital content is embedded in such a way that it operates as an integral part of the goods and cannot easily be de - installed by the consumer , unless the seller proves that the lack of conformity lies in the hardware of the good .


### this directive should not apply to goods like dvds and cds incorporating digital content in such a way that the goods function only as a carrier of the digital content . however , this directive should apply to digital content integrated in goods such as household appliances or toys where the digital content is embedded in such a way that its functions are subordinate to the main functionalities of the goods and it operates as an integral part of the goods . ### this directive should not apply to goods like dvds and cds incorporating digital content in such a way that the goods function only as a carrier of the digital content . it should equally not apply to goods where digital content is embedded in such a way that it operates as an integral part of the goods , unless the seller proves that the lack of conformity lies in the hardware of the good .


### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . the european defence agency shall be invited as observer . ### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . the european defence agency shall be invited to provide its views and recommendations . the eeas shall also be invited to attend the programme committee .


### viability notably via a demonstration by the beneficiaries that the remaining costs of the eligible action are covered by other means of financing such as member states’ contributions ; and ### viability notably via a demonstration by the beneficiaries that the remaining costs of the eligible action are covered by other means of financing such as member states’ contributions and private sources of funding ; and


### the promotion of innovation and technological development in the union defence industry should take place in a manner coherent with the security interests of the union . accordingly , the action ' s contribution to those interests and to the defence capability priorities commonly agreed by member states should serve as an award criterion . within the union , common defence capability priorities are identified notably through the capability development plan . other union processes such as the coordinated annual review on defence and the permanent structured cooperation will support the implementation of relevant priorities through enhanced cooperation . where appropriate regional or international cooperative initiatives , such as in the nato context , and serving the union security and defence interest , may also be taken into account . ### the promotion of innovation and technological development in the union defence industry should take place in a manner coherent with the security interests of the union . accordingly , the action ' s contribution to those interests and to the defence capability priorities commonly agreed by member states should serve as an award criterion . within the union , common defence capability priorities are identified notably through the capability development plan . other union processes such as the coordinated annual review on defence and the permanent structured cooperation will support the implementation of relevant priorities through enhanced cooperation . where appropriate cooperative capability initiatives , such as in the nato context , and serving the union security and defence interest , may also be taken into account .


### when it relates to actions defined under point to of the first paragraph , the action must be based on common technical specifications . ### for actions described in points to of the first paragraph , consortia shall prove their contribution to the competitiveness of the european defence industry through the demonstration that at least two member states intend to jointly procure the final product or use the technology in a coordinated way , including joint procurement where applicable .


### for actions described in points to of article 6 , the contribution to the competitiveness of the european defence industry through the demonstration by the beneficiaries that member states have committed to jointly produce and procure the final product or technology in a coordinated way , including joint procurement where applicable . ### for actions described in points to of article 6 , the contribution to the further integration of the european defence sector through the demonstration by the beneficiaries that member states intend to jointly use , own or maintain the final product or technology in a coordinated way .


### contribution to the innovation and technological development of defence industries and thus to fostering the industrial autonomy of the union in the field of defence technologies ; and , ### contribution to the industrial autonomy of the european defence industry and to the security and defence interests of the union in line with defence capability priorities commonly agreed by member states within the union and , where appropriate , regional and international cooperative agreements ;


### to foster better exploitation of the results of defence research and contribute to closing the gaps between research and development . ### to foster better exploitation of the results of defence research thus closing the gaps between research and development , by encouraging the production of the researched products and technologies .


### the proposals submitted following the call for proposals shall be evaluated by the commission assisted by independent experts on the basis of the award criteria of article 10 . ### the proposals submitted following the call for proposals shall be evaluated by the commission assisted by independent experts to be validated upon request by member states , on the basis of the eligibility and award criteria set out in articles 6 , 7 , 8and 10 .


### as the programme aims at enhancing the competitiveness of the union ' s defence industry , only entities established in the union and effectively controlled by member states or their nationals should be eligible for support . additionally , in order to ensure the protection of essential security interests of the union and its member states , the infrastructure , facilities , assets and resources used by the beneficiaries and subcontractors in actions funded under the programme , shall not be located on the territory of non - member states . ### as the programme aims at enhancing the competitiveness of the union ' s defence industry , only entities established in the union and effectively controlled by member states or their nationals should be eligible for support , as direct beneficiaries or subcontractors . additionally , in order to ensure the protection of essential security interests of the union and its member states , the infrastructure , facilities , assets and resources used by the beneficiaries and subcontractors in actions funded under the programme , shall not be located on the territory of non - member states .


### the commission should establish a multiannual work programme in line with the objectives of the programme . the commission should be assisted in the establishment of the work programme by a committee of member states . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a proportion of the overall budget will benefit such action . ### the commission should establish a multiannual work programme in line with the objectives of the programme . the commission should be assisted in the establishment of the work programme by a committee of member states . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a fixed proportion of at least 20% of the overall budget will benefit such action .


### in view of the specificities of the sector , in practice no collaborative project between undertakings will be launched if the member states have not first agreed to support such projects . after having defined common defence capability priorities at union - level and also taking into account where appropriate collaborative initiatives on a regional basis , member states identify and consolidate military requirements and define the technical specifications of the project . they may also appoint a project manager in charge of leading the work related to the development of a collaborative project . ### in view of the specificities of the sector , the program will define priority research and development areas previously agreed by the member states depending on common needs in the field of security and defence , in practice no collaborative project between undertakings will be launched if the member states have not first agreed to support such projects . after having defined common defence capability priorities at union - level and also taking into account where appropriate collaborative initiatives on a regional basis , member states identify and consolidate military requirements and define the technical specifications of the projects that adhere to the program .


### the commission should establish a multiannual work programme in line with the objectives of the programme . the commission should be assisted in the establishment of the work programme by a committee of member states . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a proportion of the overall budget will benefit such action . ### the commission should establish a multiannual work programme in line with the objectives of the programme . the commission should be assisted in the establishment of the work programme by a committee within the meaning of regulation 182 / 2011 . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a proportion of the overall budget will benefit such action .


### the financial assistance of the union under the programme should not exceed 20% of the total eligible cost of the action when it relates to prototyping which is often the most costly action in the development phase . the totality of the eligible costs should however be covered for other actions in the development phase . ### the financial assistance of the union under the programme should not exceed 35% of the total eligible cost of the action when it relates to prototyping which is often the most costly action in the development phase . the totality of the eligible costs should however be covered for other actions in the development phase by member states or by private sources .


### the return of third - country nationals who do not fulfil or no longer fulfil the conditions for entry , stay or residence in the member states , in full respect of fundamental rights , in particular of the principle of non - refoulement , and in compliance with the provisions of directive 2008 / 115 / ec9 , is an essential part of the comprehensive efforts to ensure the credibility and proper functioning of the union migration policies and to reduce and deter irregular migration . _________________ 9directive 2008 / 115 / ec of the european parliament and of the council of 16 december 2008 on common standards and procedures in member states for returning illegally staying third - country nationals . ### the return of third - country nationals who do not fulfil or no longer fulfil the conditions for entry , stay or residence in the member states , in full respect of fundamental rights , in particular of the principle of non - refoulement , and in compliance with the provisions of directive 2008 / 115 / ec9 , is an essential part of the comprehensive efforts to ensure the credibility and proper functioning of the union migration policy and to reduce and deter irregular migration . _________________ 9directive 2008 / 115 / ec of the european parliament and of the council of 16 december 2008 on common standards and procedures in member states for returning illegally staying third - country nationals .


### the european travel document for return shall be established in the official language or languages of the member state that issues the return decision and , where appropriate , it shall be translated into english and french . ### the european travel document for return shall be established in the official language or languages of the member state that issues the return decision and it shall be translated into english and french .


### in order to amend or supplement certain non - essential elements of the model for a european travel document for return , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to amend or supplement certain non - essential elements of the model for a european travel document for return , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level among the staff of the competent authorities of the member states and the eu agencies with responsibility for migration .


### for as long as the only contributors to the efsi are the union and the eib , the number of members and votes within the steering board shall be allocated based on the respective size of contributions in the form of cash or guarantees . ### the number of members of the steering board shall be allocated between the eib and the commission .


### in order to allow for further increase in its resources , participation in the efsi should be open to third parties , including member states , national promotional banks or public agencies owned or controlled by member states , private sector entities and entities outside the union subject to the consent of existing contributors . third parties may contribute directly to the efsi and take part in the efsi governance structure . ### in order to allow for further increase in its resources , participation in the efsi should be open to third parties , including member states , national promotional banks or public agencies owned or controlled by member states , private sector entities and entities outside the union subject to the consent of existing contributors .


### the efsi should support strategic investments with high economic value added contributing to achieving union policy objectives . ### the efsi should support strategic investments with high economic , social and environmental value added contributing to achieving union policy objectives in an objective manner .


### the commission and the eib , with support from the member states , shall promote the creation of a transparent pipeline of current and potential future investment projects in the union . the pipeline is without prejudice to the final projects selected for support according to article 3 . ### the commission and the eib shall create a transparent pipeline of current and potential investment projects in the union . member states may contribute to its establishment and management .


### the managing director and the deputy managing director shall be appointed by the steering board on a joint proposal of the commission and the eib for a renewable fixed term of three years . ### the managing director and the deputy managing director shall be appointed by the steering board on a joint proposal of the commission and the eib for a renewable fixed term of three years and not exceeding 6 years in total . the managing director and the deputy managing director shall be appointed following an open and transparent selection procedure .


### to partially finance the contribution from the union budget , the available envelopes of the horizon 2020 – the framework programme for research and innovation 2014 - 2020 , provided by regulation no 1291 / 2013 of the european parliament and of the council2 , and the connecting europe facility , provided by regulation no 1316 / 2013 of the european parliament and of the council3 , should be reduced . those programmes serve purposes that are not replicated by the efsi . however , the reduction of both programmes to finance the guarantee fund is expected to ensure a greater investment in certain areas of their respective mandates than is possible through the existing programmes . the efsi should be able to leverage the eu guarantee to multiply the financial effect within those areas of research , development and innovation and transport , telecommunications and energy infrastructure compared to if the resources had been spent via grants within the planned horizon 2020 and connecting europe facility programmes . it is , therefore , appropriate to redirect part of the funding presently envisaged for those programmes to the benefit of efsi . __________________ 3 regulation no 1316 / 2013 of the european parliament and of the council of 11 december 2013 establishing the connecting europe facility , amending regulation no 913 / 2010 and repealing regulations no 680 / 2007 and no 67 / 2010 . ### the contribution from the union budget will be progressively authorised by a decision of the european parliament and the council in the framework of the annual budgetary procedures up to 2020 , using in priority all provisions under council regulation n°1311 / 2013 laying down the multiannual financial framework for the years 2014 - 2020 , in particular its articles 5 , 11 , 13 and 14 , as well as any budgetary surplus entered into the general budget of the european union , and avoiding to affect programmes that already serve an investment purpose , are operational and contain a possibility to use innovative financial instruments . therefore , envelops of programmes under the sub - heading 1a of the multiannual financial framework could be reduced only if proved necessary and as a last resort solution . __________________ 3 regulation no 1316 / 2013 of the european parliament and of the council of 11 december 2013 establishing the connecting europe facility , amending regulation no 913 / 2010 and repealing regulations no 680 / 2007 and no 67 / 2010 .


### documents access to which is excluded or restricted by virtue of the access regimes on the grounds of protection of personal data , and parts of documents accessible by virtue of those regimes which contain personal data the re - use of which has been defined by law as being incompatible with the law concerning the protection of individuals with regard to the processing of personal data ; ### documents or parts of documents access to which is excluded or restricted by access regimes on the grounds of protection of personal data , or which contain personal data the re - use of which could undermine the protection of privacy and integrity of the individual , in particular in accordance with union legislation regarding the protection of personal data ;


### for the reasons explained above , it is appropriate to set an obligation on member states to adopt open access policies with respect to publicly - funded research results and ensure that such policies are implemented by all research performing organisations and research funding organisations . open access policies typically allow for a range of exceptions from making scientific research results openly available . on 17 july 2012 , the commission adopted a recommendation on access to and preservation of scientific information , updated on 25 april 201834 , and describing , among other things , relevant elements of open access policies . additionally , the conditions , under which certain research results can be re - used , should be improved . for this reason , certain obligations stemming from this directive should be extended to research data resulting from scientific research activities subsidised by public funding or co - funded by public and private - sector entities . however , in this context , concerns in relation to privacy , protection of personal data , trade secrets , national security , legitimate commercial interests and to intellectual property rights of third parties should be duly taken into account . in order to avoid any administrative burden , such obligations should only apply to such research data that have already been made publicly available by researchers . other types of documents held by research performing organisations and research funding organisations should continue to be exempt from the scope of application of this directive . _________________ 34 c2375 ### for the reasons explained above , it is appropriate to set an obligation on member states to adopt open access policies with respect to publicly - funded research results and ensure that such policies are implemented by all research performing organisations and research funding organisations . open access policies typically allow for a range of exceptions from making scientific research results openly available . on 17 july 2012 , the commission adopted a recommendation on access to and preservation of scientific information , updated on 25 april 201834 , and describing , among other things , relevant elements of open access policies . additionally , the conditions , under which certain research results can be re - used , should be improved . for this reason , certain obligations stemming from this directive should be extended to research data resulting from scientific research activities subsidised by public funding or co - funded by public and private - sector entities . however , in this context , concerns in relation to privacy , confidentiality , protection of personal data , trade secrets , national security , legitimate commercial interests and to intellectual property rights of third parties should be duly taken into account . in order to avoid any administrative burden , such obligations should only apply to such research data that have already been made publicly available by researchers . other types of documents held by research performing organisations and research funding organisations should continue to be exempt from the scope of application of this directive . _________________ 34 c2375


### europol shall be responsible for providing an opinion following a consultation request pursuant to article 26 . ### europol shall be responsible for providing an opinion following a consultation request pursuant to article 25 .


### for the purpose of paragraph 1 , eu - lisa shall establish , implement and host a central repository containing the data referred to in paragraph 1 which would not allow for the identification of individuals and would allow the authorities listed in paragraph 1 to obtain customisable reports and statistics to improve the assessment of the irregular migration , security and health risks , to enhance the efficiency of border checks , to help the etias central unit processing the travel authorisation applications and to support evidence - based union migration policymaking . the repository shall also contain daily statistics on the data referred to in paragraph 4 . access to the central repository shall be granted by means of secured access through s - testa with control of access and specific user profiles solely for the purpose of reporting and statistics . ### for the purpose of paragraph 1 , eu - lisa shall establish , implement and host a central repository containing the data referred to in paragraph 1 which would not allow for the identification of individuals and would allow the authorities listed in paragraph 1 to obtain customisable reports and statistics to improve the assessment of the security risks , to enhance the efficiency of border checks , to help the etias central unit processing the travel authorisation applications . the repository shall also contain daily statistics on the data referred to in paragraph 4 . access to the central repository shall be granted by means of secured access through s - testa with control of access and specific user profiles solely for the purpose of reporting and statistics .


### verifying travel authorisations ' applications rejected from the automated process in order to determine whether the applicant personal data corresponds to the personal data of the person having triggered a hit in one of the consulted information systems / databases or the specific risk indicators referred to in article 28 ; ### verifying travel authorisations ' applications that have triggered one or more hits during the automated process in order to determine whether the applicant personal data corresponds to the personal data of the person having triggered a hit in the etias central system , one of the consulted information systems / databases or the specific risk indicators referred to in article 28 or the etias watchlist referred to in article 29 ;


### whether he or she has ever been convicted of any criminal offence in any country ; ### whether he or she has ever been convicted of any serious criminal offence in any country ;


### a travel authorisation fee of eur 5 shall be paid by the applicant for each application . ### a travel authorisation fee of eur 10 shall be paid by the applicant for each application .


### [ whether the applicant was subject to a return decision or a removal order issued following the withdrawal or rejection of the application for internal protection in the eurodac ; ] ### [ whether the applicant was subject to a return decision or a removal order recorded in the eurodac ; ]


### prior to boarding , air and sea carriers , as well as carriers transporting groups overland by coach should have the obligation to verify if travellers have all the travel documents required for entering the territory of the member states pursuant to the schengen convention25 . this should include verifying that travellers are in possession of a valid travel authorisation . the etias file itself should not be accessible to carriers . a secure internet access , including the possibility using mobile technical solutions , should allow carriers to proceed with this consultation using travel document data . _________________ 25 convention implementing the schengen agreement of 14 june 1985 between the governments of the states of the benelux economic union , the federal republic of germany and the french republic on the gradual abolition of checks at their common borders . ### prior to boarding , air and sea carriers , as well as carriers transporting groups overland by coach should have the obligation to verify if travellers have all the travel documents required for entering the territory of the member states pursuant to the schengen convention25 . this should include verifying that travellers are in possession of a valid travel authorisation and in the case of a travel authorisation with limited territorial validity , verify the territory or territories to which the applicant is authorised to travel . the etias file itself should not be accessible to carriers . secure access , including the possibility using mobile technical solutions , should allow carriers to send a request to the etias central system using travel document data . _________________ 25 convention implementing the schengen agreement of 14 june 1985 between the governments of the states of the benelux economic union , the federal republic of germany and the french republic on the gradual abolition of checks at their common borders .


### the costs incurred in connection with the development of the etias information system , the integration of the existing national border infrastructure and the connection to the national uniform interface as well as by hosting the national uniform interface , the set - up of the etias central and national units and the operation of the etias shall be borne by the general budget of the union . ### the costs incurred in connection with the development of the etias information system , the integration of the existing national border infrastructure and the connection to the national uniform interface as well as by hosting the national uniform interface , the set - up of the etias central and national units and the operation of the etias shall be proportionate to the individual administrative needs of each member state and borne by the general budget of the union . before starting any procurement procedure , the commission shall undertake a precise analysis of the technical requirements for the integration of existing national systems , of the technical standards of the etias , and of the requirements concerning the content and accessibility of the etias .


### five years from the last decision to refuse , revoke or annul the travel authorisation in accordance with articles 31 , 34 and 35 . ### two years from the last decision to refuse , revoke or annul the travel authorisation in accordance with articles 31 , 34 and 35 .


### for the purpose of carrying out the assessment referred to in article 22 the etias national unit of the responsible member state shall consult the authorities of the member state responsible for the data having triggered a hit pursuant to article 18 , , , , or . ### for the purpose of carrying out the assessment referred to in article 22 the etias national unit of the responsible member state shall consult the authorities of the member state responsible for the data having triggered a hit pursuant to article 18 , , , , , or .


### the etias central unit shall verify whether the data recorded in the application file corresponds to the data present in one of the consulted information systems / databases , the etias watchlist referred to in article 29 or the specific risk indicators referred to in article 28 . ### the etias central unit shall verify whether the data recorded in the application file corresponds to the data present in the etias central system or one of the consulted information systems / databases , the etias watchlist referred to in article 29 or the specific risk indicators referred to in article 28 .


### where a travel authorisation is amended by the etias central unit or an etias national unit during its validity period , the etias central system shall carry out the automated processing laid down in article 18 to determine whether the amended application file triggers a hit pursuant to article 18 to . where the automated processing does not report any hit , the etias central system shall issue an amended travel authorisation with the same validity of the original and notify the applicant . where the automated processing reports one or several hit , the etias national unit of the member state of first entry as declared by the applicant in accordance with article 15 shall assess the irregular migration , security or public health risk and shall decide whether to issue an amended travel authorisation or , where it concludes that the conditions for granting the travel authorisation are no longer met , revoke the travel authorisation . ### where a travel authorisation is amended by the etias central unit or an etias national unit during its validity period , the etias central system shall carry out the automated processing laid down in article 18 to determine whether the amended application file triggers a hit pursuant to article 18 to . where the automated processing does not report any hit , the etias central system shall issue an amended travel authorisation with the same validity of the original and notify the applicant . where the automated processing reports one or several hit , the etias national unit of the member state of first entry as declared by the applicant in accordance with article 15 shall assess the security risk and shall decide whether to issue an amended travel authorisation or , where it concludes that the conditions for granting the travel authorisation are no longer met , revoke the travel authorisation .


### regarding any decision requiring him or her to leave the territory of a member state or of any other country or whether he or she was subject to any return decision issued over the last ten years . ### regarding any decision requiring him or her to leave the territory of a member state or of any other country or whether he or she was subject to any return decision issued over the last five years .


### the date of expiry of the validity of the travel document ; ### the date of issue and date of expiry of the travel document ;


### ' travel authorisation ' means a decision issued in accordance with this regulation indicating that there are no factual indications or reasonable grounds to conclude that the presence of the person on the territory of the member states poses an irregular migration , security or public health risk and which is a requirement for third country nationals referred to in article 2 to fulfil the entry condition laid down in article 6 of regulation 2016 / 399 . ### ' travel authorisation ' means a decision issued in accordance with this regulation indicating that there are no factual indications or reasonable grounds to conclude that the presence of the person on the territory of the member states poses an irregular migration or a security risk and which is a requirement for third country nationals referred to in article 2 to fulfil the entry condition laid down in article 6 of regulation 2016 / 399 .


### a travel authorisation with limited territorial validity shall be valid for the territory of the issuing member state and for a maximum of 15 days . ### a travel authorisation with limited territorial validity shall be valid for the territory of member states concerned and for a maximum of 30 days .


### each applicant shall submit a completed application form including a declaration of authenticity , completeness and reliability of the data submitted and a declaration of veracity and reliability of the statements made . minors shall submit an application form electronically signed by a person exercising permanent or temporary parental authority or legal guardianship . ### each applicant shall submit a completed application form including a declaration of authenticity , completeness and reliability of the data submitted and a declaration of veracity and reliability of the statements made . minors shall submit an application form duly completed by a person exercising permanent or temporary parental authority or legal guardianship .


### for minors , surname and first name of the applicant ' s parental authority or legal guardian ; ### for minors , surname and first name , home address , email address and telephone number of the applicant ' s parental authority or legal guardian ;


### the travel authorisation fee shall be waived for children under 18 years . ### the travel authorisation fee shall be waived for applicants belonging to one of the following categories : children under 12 years of age ; family members of eu citizens or of third - country nationals enjoying right of free movement under union law ; school pupils , students , postgraduate students and accompanying teachers travelling for study or educational purposes ; researchers travelling for the purpose of carrying out scientific research who are third - country nationals ; representatives of non - profit organisations aged 25 or less participating in seminars , conferences or sports , cultural or educational events organised by non - profit organisations .


### whether he or she has ever been convicted of any criminal offence in any country ; ### whether he or she has ever been convicted of any serious criminal offence as defined in article 3 , points and of this regulation ;


### the etias watchlist shall consist of data related to persons who are suspected of having committed or taken part in a criminal offence or persons regarding whom there are factual indications or reasonable grounds to believe that they will commit criminal offences . ### the etias watchlist shall consist of data related to persons who are suspected by one or several member states of having committed or taken part in a serious criminal offence or persons regarding whom there are factual indications or reasonable grounds to believe that they will commit criminal offences .


### information provided by member states concerning abnormal rates of overstayers and refusals of entry for a specific group of travellers for that member state ; ### information provided by member states concerning abnormal rates of overstayers and refusals of entry for that member state ;


### a secure internet access to the carrier gateway , including the possibility to use mobile technical solutions , referred to in article 6 shall allow carriers to proceed with the consultation referred to in paragraph 1 prior to the boarding of a passenger . for this purpose , the carrier shall be permitted to consult the etias central system using the data contained in the machine readable zone of the travel document . ### a secure access to the carrier gateway , including the possibility to use mobile technical solutions , referred to in article 6 shall allow air carriers , sea carriers and carriers carrying groups operating international road links by coach to proceed with the query referred to in paragraph 1 prior to the boarding of a passenger . for this purpose , the carrier shall send a query to the etias central system using the data contained in the machine readable zone of the travel document .


### the delegation of power referred to in article 15 and , article 16 , article 28 and article 72 and may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in article 15 and , article 16 , and article 72 and may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### the personal data recorded in the etias should be kept for no longer than is necessary for its purposes . in order for the etias to function , it is necessary to keep the data related to applicants for the period of validity of the travel authorisation . in order to assess the security , irregular migration and public health risks posed by the applicants it is necessary to keep the personal data for five years from the last entry record of the applicant stored in the ees . in fact , the etias should rely on accurate preliminary assessments of the security , public health and irregular migration risks , notably through the use of the screening rules . in order to constitute a reliable basis for the manual risk assessment by the member states , and reduce to the minimum the occurrence of hits not corresponding to real risks , the hits resulting from screening rules based on statistics generated by etias data itself need to be representative of a sufficiently broad population . this cannot be achieved exclusively on the basis of the data of the travel authorisations in their validity period . the retention period should start from the last entry record of the applicant stored in the ees , since that constitutes the last actual use of the travel authorisation . a retention period of five years corresponds to the retention period of an ees record with an entry authorisation granted on the basis of an etias travel authorisation or a refusal of entry . this synchronisation of retention periods ensures that both the entry record and the related travel authorisation are kept for the same duration and is an additional element ensuring the future interoperability between etias and ees . this synchronisation of data retention periods is necessary to allow the competent authorities to perform the risk analysis requested by the schengen borders code . a decision to refuse , revoke or annul a travel authorisation could indicate a higher security or irregular migration risk posed by the applicant . where such a decision has been issued , the 5 years retention period for the related data should start from its date of issuance , in order for etias to be able to take accurately into account the higher risk possibly posed by the applicant concerned . after the expiry of such period , the personal data should be deleted . ### the personal data recorded in the etias should be kept for no longer than is necessary for its purposes . in order for the etias to function , it is necessary to keep the data related to applicants for the period of validity of the travel authorisation .


### statistics generated by the etias in accordance with article 73 indicating abnormal rates of refusals of travel authorisations due to an irregular migration , security or public health risk associated with a specific group of travellers ; ### statistics generated by the etias in accordance with article 73 indicating abnormal rates of refusals of travel authorisations due to security risk ;


### ' hit ' means the existence of a correspondence established by comparing the personal data recorded in an application file of the etias central system with the personal data stored in a record , file or alert registered in an information system queried by the etias central system , in the etias watchlist or with the specific risk indicators referred to in article 28 ; ### ' hit ' means the existence of a correspondence established by comparing the personal data recorded in an application file of the etias central system with the personal data stored in a record , file or alert registered in the etias central system , in a database or in an information system queried by the etias central system , in the etias watchlist referred to in article 29 or with the specific risk indicators referred to in article 28 ;


### in accordance with article 26 of the convention implementing the schengen agreement carriers shall consult the etias central system in order to verify whether or not third country nationals subject to the travel authorisation requirement are in possession of a valid travel authorisation . ### for the purposes of article 26 of the convention implementing the schengen agreement , carriers shall ensure that third - country nationals subject to the travel authorisation requirement are in possession of a valid travel authorisation and , in the case of a travel authorisation with limited territorial validity , shall verify the territory or territories to which the applicant is authorised to travel . air carriers , sea carriers and group carriers operating international routes by coach shall send a query to the etias central system in order to verify whether or not third country nationals subject to the travel authorisation requirement are in possession of a valid travel authorisation .


### the etias watchlist shall consist of data related to persons who are suspected of having committed or taken part in a criminal offence or persons regarding whom there are factual indications or reasonable grounds to believe that they will commit criminal offences . ### the etias watchlist shall consist of data related to persons who are suspected of having committed or taken part in a serious criminal offence or persons regarding whom it has been assessed that there are factual indications or&#160 ; grounds to&#160 ; suppose that they will commit criminal offences .


### the commencement and expiry dates of the validity period of the travel authorisation ; ### the commencement and expiry dates of the validity period of the travel authorisation where the period in question is shorter than provided for in article 30 ;


### three years after the start of operations of the etias and every four years thereafter , the commission shall evaluate etias and shall make any necessary recommendations to the european parliament and the council . this evaluation shall include : ### one year after the start of operations of the etias and every two years thereafter , the commission shall evaluate etias and shall make any necessary recommendations to the european parliament and the council , including a detailed assessment of their budgetary implications . this evaluation shall include :


### the etias should also support the objectives of the schengen information system related to the alerts in respect of persons wanted for arrest or for surrender or extradition purposes , on missing persons , on persons sought to assist with a judicial procedure and on persons for discreet checks or specific checks . for this purpose the etias should carry out an automated processing of the application files against the relevant alerts in the sis . this processing will be carried for the purpose of supporting the sis . accordingly , any hit resulting from this comparison should be stored in the sis . ### the etias should also support the objectives of the schengen information system related to the alerts for the purpose of refusing entry , the alerts in respect of persons wanted for arrest or for surrender or extradition purposes , on missing persons , on persons sought to assist with a judicial procedure and on persons for discreet checks , inquiry checks or specific checks . for this purpose the etias should carry out an automated processing of the application files against the relevant alerts in the sis . this processing will be carried for the purpose of supporting the sis . accordingly , any hit resulting from this comparison should be stored in the sis .


### the etias central system shall respond by indicating whether or not the person has a valid travel authorisation . ### the etias central system shall respond by indicating whether or not the person has a valid travel authorisation and , where applicable , the territory or territories in which a travel authorisation with limited territorial validity is valid .


### l - category vehicles , with the exception of l1e , l2e and l6e vehicles , shall be equipped with an obd system which complies with the functional requirements and test procedures laid down in the delegated acts adopted pursuant to paragraph 8 and as from the application dates set out in annex iv . ### l - category vehicles , with the exception of l1e , l2e and l6e vehicles , shall be equipped with an obd system which complies with the functional requirements and test procedures laid down in the delegated acts adopted pursuant to paragraph 8 and as from the application dates set out in annex iv . manufacturers shall design and connect to the obd system in such a way that does not allow for tampering or deliberate manipulation by economic operators , users , or any other party .


### respect for the rule of law is not only important for citizens of the union , but also for business initiatives , innovation , investment and the proper functioning of the internal market , which will flourish most where a solid legal and institutional framework is in place . ### respect for democracy , the rule of law and fundamental rights is not only important for citizens of the union , but also for business initiatives , innovation , investment and the proper functioning of the internal market , which will flourish most where a solid legal and institutional framework is in place .


### generalised deficiencies in the member states as regards the rule of law which affect in particular the proper functioning of public authorities and effective judicial review , can seriously harm the financial interests of the union . ### generalised deficiencies in the member states as regards democracy , the rule of law and fundamental rights which affect in particular the proper functioning of public authorities and effective judicial review , can seriously harm the financial interests of the union .


### the rule of law is a prerequisite for the protection of the other fundamental values on which the union is founded , such as freedom , democracy , equality and respect for human rights . respect for the rule of law is intrinsically linked to respect for democracy and for fundamental rights : there can be no democracy and respect for fundamental rights without respect for the rule of law and vice versa . ### democracy , the rule of law and fundamental rights are in a triangular relationship , reinforcing each other and together safeguarding the constitutional core of the union and its member states . there can be no democracy and respect for fundamental rights without respect for the rule of law and vice versa .


### ' generalised deficiency as regards the rule of law ' means a widespread or recurrent practice or omission , or measure by public authorities which affects the rule of law ; ### ' generalised deficiency as regards democracy , the rule of law and fundamental rights ' means a widespread or recurrent practice or omission , or measure by public authorities which affects the democracy , the rule of law and fundamental rights ;


### ' the rule of law ' refers to the union value enshrined in article 2 of the treaty on european union which includes the principles of legality , implying a transparent , accountable , democratic and pluralistic process for enacting laws ; legal certainty ; prohibition of arbitrariness of the executive powers ; effective judicial protection by independent courts , including of fundamental rights ; separation of powers and equality before the law ; ### ' democracy , the rule of law and fundamental rights ' are enshrined in article 2 of the treaty on european union and include the principles of legality , implying a transparent , accountable , democratic and pluralistic process for enacting laws ; free and fair elections , legal certainty ; prohibition of arbitrariness of the executive powers ; effective judicial protection by independent courts ; separation of powers and equality before the law ; and the fundamental rights as stipulated in the charter of fundamental rights of the eu and in the european convention for the protection of human rights and fundamental freedoms ;


### proposal for a regulation of the european parliament and of the council on the protection of the union ' s budget in case of generalised deficiencies as regards the rule of law in the member states ### proposal for a regulation of the european parliament and of the council on the protection of the union ' s budget in case of generalised deficiencies as regards democracy , the rule of law and fundamental rights in the member states


### article 19 teu , which gives concrete expression to the value of the rule of law stated in article 2 teu , requires the member states to provide effective judicial protection in the fields covered by union law , including those relating to the implementation of the union’s budget . the very existence of effective judicial review designed to ensure compliance with union law is the essence of the rule of law and requires independent courts13 . maintaining the independence of the courts is essential , as confirmed by the second subparagraph of article 47 of the charter of fundamental rights of the european union14 . this is true , in particular , for the judicial review of the validity of the measures , contracts or other instruments giving rise to public expenditure or debts , inter alia in the context of public procurement procedures which may also be brought before the courts . __________________ 13 case c - 64 / 16 , para 32 - 36 . 14 case c - 64 / 16 , para 40 - 41 . ### article 19 teu , which gives concrete expression to the value of the rule of law stated in article 2 teu , requires the member states to provide effective judicial protection in the fields covered by union law , including those relating to the implementation of the union’s budget . the very existence of effective judicial review designed to ensure compliance with union law is the essence of the rule of law and requires independent courts13 . ensuring the right to an effective remedy and to a fair trial and maintaining the independence of the courts is essential , as confirmed by article 47 of the charter of fundamental rights of the european union14 . this is true , in particular , for the judicial review of the validity of the measures , contracts or other instruments giving rise to public expenditure or debts , inter alia in the context of public procurement procedures which may also be brought before the courts . __________________ 13 case c - 64 / 16 , para 32 - 36 . 14 case c - 64 / 16 , para 40 - 41 .


### appropriate measures shall be taken where a generalised deficiency as regards the rule of law in a member state affects or risks affecting the principles of sound financial management or the protection of the financial interests of the union , in particular : ### appropriate measures shall be taken where a generalised deficiency as regards democracy , the rule of law and fundamental rights in a member state affects or risks affecting the principles of sound financial management or the protection of the financial interests of the union , in particular :