### over the past decade , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6% modal share of passenger transport for rail in the european union has remained fairly stable . rail passenger services have not kept pace with evolving needs in terms of availability and quality . ### over the past decade , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6% modal share of passenger transport for rail in the european union has remained fairly stable . rail passenger services have not kept pace with the evolution of other modes of transport in terms of availability , price and quality .


### the establishment of an internal market for passenger transport services by rail requires common rules on competitive tendering for public service contracts in this sector to be applied in a harmonised manner in all member states . ### the establishment of an internal market for passenger transport services by rail requires common rules on competitive tendering for public service contracts in this sector which are applicable in a harmonised manner in all member states , but taking into account the specific needs of each country .


### where they concern the annual provision of less than 300 000 kilometres of public passenger transport services or less than 150 000 kilometres in the case of a public service contract including public transport by rail . ### where they concern the annual provision of less than 300 000 kilometres of public passenger transport services or less than 1 500 000 kilometres in the case of a contract including public transport by rail .


### proposal for a regulation of the european parliament and of the council on the access of third - country goods and services to the union’s internal market in public procurement and procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries ### proposal for a regulation of the european parliament and of the council on the access of third - country goods and services to the union’s internal market in public procurement and concessions and procedures supporting negotiations on access of union goods and services to the public procurement markets and to the concessions of third countries


### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade . ### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade . it is stated in the same article 21 that the union ' s action on the international scene shall be guided by the principles which have inspired its own creation , development and enlargement , and which it seeks to advance in the wider world : democracy , the rule of law , the universality and indivisibility of human rights and fundamental freedoms , respect for human dignity , the principles of equality and solidarity , and respect for the principles of the united nations charter and international law .


### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade . ### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to safeguard its values , fundamental interests , security , independence and integrity and to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### within the world trade organisation and within the framework of its bilateral relations , the union supports an ambitious international opening of the public procurement and concessions markets of the union and of its trade partners , in a spirit of reciprocity and mutual benefit .


### many third countries are reluctant to open their public procurement markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement practices in many of the trading partner of the union . those restrictive procurement practices result in the loss of substantial trading opportunities . ### many third countries are reluctant to open their public procurement markets and their concessions to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement and concessions practices in many of the trading partners of the union . those restrictive practices result in the loss of substantial trading opportunities .


### in accordance with article 207 tfeu the common commercial policy in the field of public procurement is to be based on uniform principles . ### in accordance with article 207 tfeu the common commercial policy in the field of public procurement and concessions is to be based on uniform principles .


### in the interest of legal certainty for union and third - country economic operators and contracting authorities / entities , the international market access commitments undertaken by the union vis - à - vis third countries in the field of public procurement should be reflected in the legal order of the eu , thereby ensuring effective application thereof . the commission should issue guidance on the application of the existing international market access commitments of the european union . this guidance should be updated on a regular basis and provide easy to use information . ### in the interest of legal certainty for union and third - country economic operators and contracting authorities / entities , the international market access commitments undertaken by the union vis - à - vis third countries in the field of public procurement and concessions should be reflected in the legal order of the eu , thereby ensuring effective application thereof . the commission should issue guidance on the application of the existing international market access commitments of the european union . this guidance should be updated on a regular basis and provide easy to use information .


### the objectives of improving the access of eu economic operators to the public procurement markets of certain third countries protected by restrictive procurement measures and preserving equal conditions of competition within the european single market require that the treatment of third - country goods and services not covered by the international commitments of the union be harmonised throughout the european union . ### the objectives of improving the access of union economic operators to the public procurement markets and the concessions of certain third countries protected by restrictive procurement measures and preserving equal conditions of competition within the european single market require that the treatment of third - country supplies and services not covered by the international commitments of the union be harmonised throughout the union .


### for this purpose rules of origin should be established so that contracting authorities / entities know whether goods and services are covered by the international commitments of the european union . the origin of a good should be determined in accordance with article 22 to 26 of regulation no 2913 / 1992 of the european parliament and of the council of 12 october 1992 establishing the community customs code2 . according to this regulation goods should be considered to be union goods when they are wholly obtained or produced in the union . goods whose production involved one or more third countries should be deemed to originate in the country where they underwent their last , substantial , economically justified processing or working in an undertaking equipped for that purpose and resulting in the manufacture of a new product or representing an important stage of manufacture . the origin of a service should be determined on the basis of the origin of the natural or legal person providing it . the guidance referred to in recital 9 should cover the application in practice of the rules of origin . ### for this purpose rules of origin should be established so that contracting authorities / entities know whether goods and services are covered by the international commitments of the european union . the origin of a good should be determined in accordance with article 52 to 55 of regulation no xxxx / 2013 of parliament and of the council establishing the union customs code , including the additional provisions to be adopted under article 55 . according to this regulation goods should be considered to be union goods when they are wholly obtained or produced in the union . goods whose production involved one or more third countries should be deemed to originate in the country where they underwent their last , substantial , economically justified processing or working in an undertaking equipped for that purpose and resulting in the manufacture of a new product or representing an important stage of manufacture . the origin of a service should be determined on the basis of the origin of the natural or legal person providing it . the guidance referred to in recital 9 should cover the application in practice of the rules of origin .


### for the sake of transparency , contracting authorities / entities intending to make use of their power in accordance with this regulation to exclude tenders comprising goods and / or services originating outside the european union , in which the value of the non - covered goods or services exceeds 50 % of the total value of these goods or services from procedures for the award of contracts should inform economic operators thereof in the contract notice published in the official journal of the european union . ### for the sake of transparency , contracting authorities / entities intending to make use of their power in accordance with this regulation to exclude tenders comprising goods and / or services originating outside the european union , in which the value of the non - covered goods or services exceeds 50 % of the total value of these goods or services from procedures for the award of contracts or concessions should inform economic operators thereof in the contract notice published in the official journal of the european union .


### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services . ### for contracts and concessions with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement or concessions between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive measures in the field of procurement or the award of concessions leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive measures in the field of procurement or the award of concessions result in serious and recurring discriminations of eu economic operators , goods and services .


### the commission should be able to prevent the possible negative impact of an intended exclusion on on - going trade negotiations with the country concerned . therefore , the commission may , where a country is engaging in substantive negotiations with the union concerning market access in the field of public procurement and the commission considers that there is a reasonable prospect of removing the restrictive procurement practices in the near future , it should be able to adopt a implementing act providing that goods and services from that country should not be excluded from procedures for the award of contracts for a period of one year . ### the commission should be able to prevent the possible negative impact of an intended exclusion on on - going trade negotiations with the country concerned . therefore , the commission may , where a country is engaging in substantive negotiations with the union concerning market access in the field of public procurement or concessions and the commission considers that there is a reasonable prospect of removing the restrictive procurement or concessions practices in the near future , it should be able to adopt an implementing act providing that goods and services from that country should not be excluded from procedures for the award of contracts for a period of one year .


### in view of the fact that the access of third country goods and services to the public procurement market of the union falls within the scope of the common commercial policy , member states or their contracting authorities / entities should not be able to restrict the access of third country goods or services to their tendering procedures by any other measure than the ones provided for in this regulation . ### in view of the fact that the access of third country goods and services to the public procurement market of the union and to its concessions falls within the scope of the common commercial policy , member states or their contracting authorities / entities should not be able to restrict the access of third country goods or services to their tendering procedures by any other measure than the ones provided for in this regulation .


### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organisation . ### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external investigation into restrictive procurement and concessions practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organisation .


### where the commission has , on the basis of information available to it , reason to believe that a third country has adopted or maintains a restrictive procurement practice , it should be able to start an investigation . if the existence of a restrictive procurement practice in a third country is confirmed the commission should invite the country concerned to enter into consultations with a view to improving the tendering opportunities for economic operators , goods and services in public procurement in that country . ### where the commission has , on the basis of information available to it , reason to believe that a third country has adopted or maintains a restrictive procurement or concessions practice , it should be able to start an investigation . if the existence of a restrictive procurement practice in a third country is confirmed the commission should invite the country concerned to enter into consultations with a view to improving the tendering opportunities for economic operators , goods and services in public procurement in that country .


### such measures may entail the mandatory exclusion of certain third - country goods and services from public procurement procedures in the european union , or may subject tenders made up of goods or services originating in that country to a mandatory price penalty . to avoid circumvention of these measures , it may also be necessary to exclude certain foreign - controlled or owned juridical persons established in the european union , that are not engaged in substantive business operations such that it has a direct and effective link with the economy of a member state concerned . appropriate measures should not be disproportionate to the restrictive procurement practices to which they respond . ### such measures may entail the mandatory exclusion of certain third - country goods and services from public procurement procedures or procedures for the award of concessions in the european union , or may subject tenders made up of goods or services originating in that country to a mandatory price penalty . to avoid circumvention of these measures , it may also be necessary to exclude certain foreign - controlled or owned juridical persons established in the european union , that are not engaged in substantive business operations such that it has a direct and effective link with the economy of a member state concerned . appropriate measures should not be disproportionate to the restrictive procurement practices to which they respond .


### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services . ### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services , in order to provide the necessary economic opportunities for a better integration of their markets in the world economy .


### in order to reflect in the legal order of the european union the international market access commitments undertaken in the field of public procurement after the adoption of this regulation , the commission should be empowered to adopt acts in accordance with article 290 of the treaty on the functioning of the european union amendments to the list of international agreements annexed to this regulation . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### in order to reflect in the legal order of the european union the international market access commitments undertaken in the field of public procurement and concessions after the adoption of this regulation , the commission should be empowered to adopt acts in accordance with article 290 of the treaty on the functioning of the european union amendments to the list of international agreements annexed to this regulation . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### in accordance with the principle of proportionality , it is necessary and appropriate for achievement of the basic objective of establishing a common external policy in the field of public procurement to lay down rules on the treatment of goods and services not covered by the international commitments of the european union . this regulation on the access of third - country economic operators , goods and services does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with the third paragraph of article 5 of the treaty on european union , ### in accordance with the principle of proportionality , it is necessary and appropriate for achievement of the basic objective of establishing a common external policy in the field of public procurement and concessions to lay down rules on the treatment of goods and services not covered by the international commitments of the european union . this regulation on the access of third - country economic operators , goods and services does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with the third paragraph of article 5 of the treaty on european union ,


### this regulation lays down rules on the access of third - country goods and services to the award of contracts for the execution of works or a work , the supply of goods and the provision of services by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries . ### this regulation lays down rules on the access of third - country goods and services to the award of contracts and concessions for the execution of works or a work , the supply of goods and the provision of services , depending on the kind of contract in question , by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets and the concessions of third countries .


### this regulation lays down rules on the access of third - country goods and services to the award of contracts for the execution of works or a work , the supply of goods and the provision of services by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries . ### this regulation lays down rules on the access of third - country goods and services to the award of contracts for the execution of works or a work , the supply of goods and the provision of services by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries , in view of promoting mutual openness of procurement markets between the union and its trading partners .


### this regulation shall apply to the award of contracts where the goods or services are procured for governmental purposes and not with a view to commercial resale or with a view to use in the production of goods or in the provision of services for commercial sale . ### this regulation shall apply to the award of contracts where the goods or services are procured for governmental purposes and to the award of concessions for services provided for governmental purposes and not with a view to commercial resale or with a view to use in the production of goods or in the provision of services for commercial sale .


### ‘ covered goods or services’ means a good or service originating in a country with which the union has concluded an international agreement in the field of public procurement including market access commitments and in respect of which the relevant agreement applies . annex i to this regulation contains a list of relevant agreements ; ### ‘ covered goods or services’ means a good or service originating in a country with which the union has concluded an international agreement in the field of public procurement and concessions including market access commitments and in respect of which the relevant agreement applies . annex i to this regulation contains a list of relevant agreements ; ; adoption of the regulation will entail technical changes throughout the text ) .


### a ‘ mandatory price penalty’ shall refer to an obligation for contracting entities to increase , subject to certain exceptions , the price of services and / or goods originating in certain third countries that have been offered in contract award procedures . ### a ‘ mandatory price penalty’ shall refer to an obligation for contracting entities to increase , subject to certain exceptions , the price of services and / or goods originating in certain third countries that have been offered in contract award procedures or concession award procedures . ; adoption of the regulation will entail technical changes throughout the text ) .


### the origin of a good shall be determined in accordance with article 22 to 26 of regulation no 2913 / 1992 of the european parliament and of the council of 12 october 1992 establishing the community customs code18 . ### the origin of a good shall be determined in accordance with article 52 to 55 , including the delegated acts to be adopted under article 55 , of regulation no xxxx / 2013 of parliament and of the council establishing the union customs code .


### the origin of a service shall be determined on the basis of the origin of the natural or legal person providing it . the origin of the service provider shall be deemed to be : ### the origin of a service shall be determined on the basis of the origin of the natural or legal person providing it . the origin of the economic operator providing the service shall be deemed to be :


### when awarding contracts for the execution of works and / or a work , the supply of goods or the provision of services , contracting authorities / entities shall treat covered goods and services equally to goods and services originating in the european union . ### when awarding contracts for the execution of works and / or a work , the supply of goods or the provision of services , or when awarding concessions for the execution of work or the provision of services , contracting authorities / entities shall treat covered goods and services equally to goods and services originating in the european union .


### where the contracting authority / entity intends , under article 69 of the directive on public procurement or under article 79 of the directive on procurement by entities operating in the water , energy , transport and postal services sectors , after verifying the explanations of the tenderer , to accept an abnormally low tender comprising goods and / or services originating outside the union , in which the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , it shall inform the other tenderers of this in writing , including the reasons for the abnormally low character of the price or costs charged . ### for tenders comprising goods and / or services originating outside the union , in which the value of the non - covered goods and / or services exceeds 50% of the total value of the goods or services constituting the tender , contracting authorities / entities shall require the economic operator concerned to explain the price or costs charged , where : the price or cost charged is at least than 20% lower than the average price or costs of the remaining tenders ; or the price or cost charged is at least 20% lower than the price or costs of the second lowest tender . 2 . the request for explanation under paragraph 1 shall , where applicable , relate in particular to following aspects : economics of the construction method ; manufacturing process or the services provided ; technical arrangements ; originality of the work , supplies or services ; compliance with eu legislation ; state aids received by the tenderer during the last 3 years . 3 . when an abnormally low tender is identified pursuant to paragraph 1 , and without prejudice to the request for explanation , the contracting authority / entity shall inform the other tenderers of this in writing . 4 . the contracting authority / entity shall verify the information provided by consulting the tenderer beforehand . 5 . the contracting authority / entity shall reject the abnormally low tender where the evidence provided does not justify the low level of price or costs charged .


### by 1 january 2017 and at least every three years after the entry into force of this regulation , the commission shall submit a report to the european parliament and the council on the application of this regulation and on progress made in international negotiations regarding access for eu economic operators to public contract award procedures in third countries undertaken under this regulation . to this effect , member states shall upon request provide the commission with appropriate information . ### one year after entry into force of this regulation and thereafter at least every three years , the commission shall submit a report to the european parliament and the council on the application of this regulation and on progress made in international negotiations regarding access for eu economic operators to public contract award procedures in third countries undertaken under this regulation . to this effect , member states shall upon request provide the commission with appropriate information .


### member states ' competent public authorities introduce various restriction measures on these new psychoactive substances to address the risks that they pose or may pose when consumed . as new psychoactive substances are often used in the production of various goods or of other substances which are used for manufacturing goods , such as medicines , industrial solvents , cleaning agents , goods in the hi - tech industry , restricting their access for this use can have an important impact on economic operators , potentially disrupting their business activities in the internal market . ### member states ' competent public authorities introduce various restriction measures on these new psychoactive substances to address the risks that they pose or may pose when consumed . as new psychoactive substances are often used for scientific research and development purposes and in the production of various goods or of other substances which are used for manufacturing goods , such as medicines , industrial solvents , cleaning agents , goods in the hi - tech industry , restricting their access for this use can have an important impact on economic operators , potentially disrupting their business activities in the internal market and can also impede sustainable scientific research and development .


### the increasing number of new psychoactive substances available in the internal market , their growing diversity , the speed with which they emerge on the market , the different risks that they may pose when consumed by humans and the growing number of individuals who consume them , challenge the capacity of public authorities to provide effective responses to protect public health and safety without hampering the functioning of the internal market . ### the increasing number of new psychoactive substances available in the internal market , their growing diversity , the speed with which they emerge on the market , the different risks that they may pose when consumed by humans , the growing number of individuals who consume them and the lack of general public knowledge and awareness about the risks associated with their consumption , challenge the capacity of public authorities to provide effective responses to protect public health and safety without hampering the functioning of the internal market .


### the disparities between the various restriction measures applied to new psychoactive substances can also lead to displacement of harmful new psychoactive substances between the member states , hampering efforts to restrict their availability to consumers and undermining consumer protection across the union . ### the disparities between the various restriction measures applied to new psychoactive substances can also lead to displacement of harmful new psychoactive substances between the member states , hampering efforts to restrict their availability to consumers , undermining consumer protection across the union and the efforts to combat potential criminal activities and organised crime activity associated with their distribution .


### no risk assessment should be conducted under this regulation on a new psychoactive substance if it is subject to an assessment under international law , or if it is an active substance in a medicinal product or in a veterinary medicinal product . ### no risk assessment should be conducted under this regulation on a new psychoactive substance if it is an active substance in a medicinal product or in a veterinary medicinal product .


### certain new psychoactive substances pose immediate public health risks , requiring urgent action . therefore , their availability to consumers should be restricted for a limited time , pending their risk assessment . ### certain new psychoactive substances pose immediate public health risks , requiring urgent action . therefore , their availability to consumers should be restricted for a sufficient period of time , pending their risk assessment .


### certain new psychoactive substances pose immediate public health risks , requiring urgent action . therefore , their availability to consumers should be restricted for a limited time , pending their risk assessment . ### certain new psychoactive substances pose immediate public health risks , requiring urgent action . therefore , their availability to consumers should be restricted for a limited time , pending their risk assessment and until the level of risk posed by a new psychoactive substance has been determined and , if justified , a decision introducing permanent measures has come into force .


### those new psychoactive substances which pose moderate health , social and safety risks should not be made available to consumers . ### those new psychoactive substances which pose health , social and safety risks should not be made available to consumers .


### the mechanism for rapid exchange of information on new psychoactive substances has proved to be a useful channel for sharing information on new psychoactive substances , on new trends in the use of controlled psychoactive substances and on related public health warnings . that mechanism should be further strengthened to enable a more effective response to the rapid emergence and spread of new psychoactive substances across the union . ### the mechanism for rapid exchange of information on new psychoactive substances ) has proved to be a useful channel for sharing information on new psychoactive substances , on new trends in the use of controlled psychoactive substances and on related public health warnings . to enable a more effective response to the rapid emergence and spread of new psychoactive substances across the union , the mechanism should be maintained and further developed , in particular as regards to the collection and management of data on the detection and identification of new psychoactive substances , adverse events associated with their use , and the involvement of criminal groups in the market through the union new psychoactive substances database . the media , particularly the scientific and medical literature , can be an important source of information on adverse event case reports . in order to enhance the efficiency of reporting , the emcdda should monitor all new psychoactive substances and enter this information into the european database on new drugs . data sets essential to the functioning of this regulation include data on the detection and identification of new psychoactive substances , adverse events associated with their use , and the involvement of criminal groups in the market . a core data set should be defined . the core data set should be reviewed on a regular basis to ensure it reflects the information required in order for the effective functioning of the regulation . suspected serious adverse events , including fatal adverse events , should be subject to expedited reporting .


### information from member states is crucial for the effective functioning of the procedures leading to decision on market restriction of new psychoactive substances . therefore , member states should collect , on a regular basis , data on the use of new psychoactive substances , related health , safety and social problems and policy responses , in accordance with the emcdda framework for data collection for the key epidemiological indicators and other relevant data . they should share this data . ### information from member states is essential for the effective functioning of this regulation . therefore , member states should collect , on a regular basis , data on the use of new psychoactive substances , related health , safety and social problems and policy responses , in accordance with the emcdda framework for data collection . they should share this data


### information from member states is crucial for the effective functioning of the procedures leading to decision on market restriction of new psychoactive substances . therefore , member states should collect , on a regular basis , data on the use of new psychoactive substances , related health , safety and social problems and policy responses , in accordance with the emcdda framework for data collection for the key epidemiological indicators and other relevant data . they should share this data . ### information from member states is crucial for the effective functioning of the procedures leading to a decision on market restriction of new psychoactive substances . therefore , member states should collect , on a regular basis , data on the emergence and use of new psychoactive substances , related health , safety and social problems and policy responses , in accordance with the emcdda framework for data collection for the key epidemiological indicators and other relevant data . they should share those data .


### a lack of capacity to identify and anticipate the emergence and spread of new psychoactive substances and a lack of evidence about their health , social and safety risks hamper the provision of an effective response . therefore , support should be provided , including at union level , to facilitate cooperation between the emcdda , research institutes and forensic laboratories with relevant expertise , in order to increase the capacity to assess and address effectively new psychoactive substances . ### a lack of capacity to identify and anticipate the emergence and spread of new psychoactive substances and a lack of evidence about their health , social and safety risks hamper the provision of an effective response . therefore , support should be provided , including at union level , in order for the emcdda to lead a network of forensic laboratories and to facilitate cooperation between the emcdda , research institutes and forensic laboratories with relevant expertise , in order to increase the capacity to assess and address effectively new psychoactive substances .


### a lack of capacity to identify and anticipate the emergence and spread of new psychoactive substances and a lack of evidence about their health , social and safety risks hamper the provision of an effective response . therefore , support should be provided , including at union level , to facilitate cooperation between the emcdda , research institutes and forensic laboratories with relevant expertise , in order to increase the capacity to assess and address effectively new psychoactive substances . ### a lack of capacity to identify and anticipate the emergence and spread of new psychoactive substances and a lack of evidence about their health , social and safety risks hamper the provision of an effective response . therefore , support and necessary resources should be provided , at union and national level , to facilitate regular and systematic cooperation between the emcdda , national focal points , health - care and law enforcement representatives at national and regional level , research institutes and forensic laboratories with relevant expertise , in order to increase the capacity to assess and address effectively new psychoactive substances .


### prevention , treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . the internet , which is one of the important distribution channels through which new psychoactive substances are sold , should be used for disseminating information on the health , social and safety risks that they pose . ### prevention , early detection and intervention , treatment , risk and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . member states should improve the availability and effectiveness of prevention programmes and raise awareness about the risk of the use of the new psychoactive substances and related consequences . to this end , prevention measures should include early detection and intervention , promotion of healthy lifestyles and targeted prevention directed also at families and communities . the internet , which is one of the important distribution channels through which new psychoactive substances are advertised and sold , should be used for disseminating information on the health , social and safety risks that they pose , and for the prevention of misuse and abuse .


### prevention , treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . the internet , which is one of the important distribution channels through which new psychoactive substances are sold , should be used for disseminating information on the health , social and safety risks that they pose . ### prevention , treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . the internet , which is one of the important distribution channels through which new psychoactive substances are sold , should be used for disseminating information on the health , social and safety risks that they pose . it is essential for children , adolescents and young adults to be made aware of those risks , including by means of information campaigns in schools and other educational environments .


### prevention , treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . the internet , which is one of the important distribution channels through which new psychoactive substances are sold , should be used for disseminating information on the health , social and safety risks that they pose . ### prevention , treatment and harm reduction measures are important for addressing the growing use of new psychoactive substances and their potential risks . the internet , which is one of the important and rapidly developing distribution channels through which new psychoactive substances are sold , should be used for disseminating information on the health , social and safety risks that they pose .


### the commission should adopt immediately applicable implementing acts where , in duly justified cases relating to a rapid increase in the number of reported fatalities in several member states associated with the consumption of the new psychoactive substance concerned , imperative grounds of urgency so require . ### the commission should adopt immediately applicable implementing acts where , in duly justified cases relating to a rapid increase in the number of reported fatalities and severe health consequences or incidents posing a grave threat to health in several member states associated with the consumption of the new psychoactive substance concerned , imperative grounds of urgency so require .


### in the application of this regulation , the commission should consult member states ' experts , relevant union agencies , civil society and economic operators . ### in the application of this regulation , the commission should consult member states ' experts , relevant union agencies , in particular the emcdda , civil society and economic operators .


### ' new psychoactive substance ' means a natural or synthetic substance that , when consumed by a human , has the capacity to produce central nervous system stimulation or depression , resulting in hallucinations , alterations in motor function , thinking , behaviour , perception , awareness or mood , which is intended for human consumption or is likely to be consumed by humans even if not intended for them with the purpose of inducing one or more of the effects mentioned above , which is neither controlled under the 1961 united nations single convention on narcotic drugs , as amended by the 1972 protocol , nor the 1971 united nations convention on psychotropic substances ; it excludes alcohol , caffeine and tobacco , as well as tobacco products within the meaning of council directive 2001 / 37 / ec of 5 june 2001 on the approximation of the laws , regulations and administrative provisions of the member states concerning the manufacture , presentation and sale of tobacco products24 ; _____________ 24oj l 194 , 18 . 7 . 2001 , p . 26 . ### ' new psychoactive substance ' means a natural or synthetic substance that , when consumed by a human , has the capacity to produce central nervous system stimulation or depression , resulting in hallucinations , alterations in motor function , thinking , behaviour , perception , awareness or mood , whether it is intended or not for human consumption , with the purpose of inducing one or more of the effects mentioned above , which is intended for human consumption or is likely to be consumed by humans even if not intended for them with the purpose of inducing one or more of the effects mentioned above , which is neither controlled under the 1961 united nations single convention on narcotic drugs , as amended by the 1972 protocol , nor the 1971 united nations convention on psychotropic substances ; it excludes alcohol , caffeine and tobacco , as well as tobacco products within the meaning of council directive 2001 / 37 / ec of 5 june 2001 on the approximation of the laws , regulations and administrative provisions of the member states concerning the manufacture , presentation and sale of tobacco products24 ; ____________ 24oj l 194 , 18 . 7 . 2001 , p . 26 .


### ' new psychoactive substance ' means a natural or synthetic substance that , when consumed by a human , has the capacity to produce central nervous system stimulation or depression , resulting in hallucinations , alterations in motor function , thinking , behaviour , perception , awareness or mood , which is intended for human consumption or is likely to be consumed by humans even if not intended for them with the purpose of inducing one or more of the effects mentioned above , which is neither controlled under the 1961 united nations single convention on narcotic drugs , as amended by the 1972 protocol , nor the 1971 united nations convention on psychotropic substances ; it excludes alcohol , caffeine and tobacco , as well as tobacco products within the meaning of council directive 2001 / 37 / ec of 5 june 2001 on the approximation of the laws , regulations and administrative provisions of the member states concerning the manufacture , presentation and sale of tobacco products24 ; _________________________ 24 oj l 194 , 18 . 7 . 2001 , p . 26 . ### a ' new psychoactive substance ' means a natural or synthetic substance that , when consumed by a human , has the capacity to produce central nervous system stimulation or depression , resulting in hallucinations , alterations in motor function , thinking , behaviour , perception , awareness or mood , whether or not it is intended for human consumption with the purpose of inducing one or more of the effects mentioned above , which is neither controlled under the 1961 united nations single convention on narcotic drugs , as amended by the 1972 protocol , nor the 1971 united nations convention on psychotropic substances ; it excludes alcohol , caffeine and tobacco , as well as tobacco products within the meaning of council directive 2001 / 37 / ec24 ; __________________________ 24 council directive 2001 / 37 / ec of 5 june 2001 on the approximation of the laws , regulations and administrative provisions of the member states concerning the manufacture , presentation and sale of tobacco products .


### national focal points within the european information network on drugs and drug addiction and europol national units shall provide to the emcdda and europol the available information on the consumption , possible risks , manufacture , extraction , importation , trade , distribution , trafficking , commercial and scientific use of substances that appear to be new psychoactive substances or mixtures . ### national focal points within the european information network on drugs and drug addiction and europol national units shall provide to the emcdda and europol the information on the consumption , possible risks , manufacture , extraction , importation , trade , distribution , trafficking , commercial and scientific use of substances that appear to be new psychoactive substances or mixtures .


### national focal points within the european information network on drugs and drug addiction and europol national units shall provide to the emcdda and europol the available information on the consumption , possible risks , manufacture , extraction , importation , trade , distribution , trafficking , commercial and scientific use of substances that appear to be new psychoactive substances or mixtures . ### national focal points within the european information network on drugs and drug addiction and europol national units shall collect and provide to the emcdda and europol the available information on the toxicity level , including oral cumulative toxicity , mutagenicity , reproductive toxicity or neurotoxicity , and on the consumption , possible risks , manufacture , extraction , importation , trade , distribution channels , trafficking , commercial and scientific use of substances that appear to be new psychoactive substances or mixtures .


### the chemical and physical identity of the new psychoactive substance , the methods and , if known , the chemical precursors used for its manufacture or extraction , and other new psychoactive substances with a similar chemical structure that have emerged ; ### the chemical and physical identity of the new psychoactive substance , the methods and , if known , the chemical precursors used for its manufacture or extraction , and any other new psychoactive substance or groups of substances with a similar chemical structure that have emerged ;


### an active substance in a medicinal product or a veterinary medicinal product that has obtained a marketing authorisation , but the marketing authorisation has been suspended by the competent authority ; ### an active substance in a medicinal product or a veterinary medicinal product that has obtained a marketing authorisation , but the marketing authorisation has been suspended , revoked or withdrawn by the competent authority ;


### the emcdda shall request the european chemicals agency and the european food safety authority to provide the information and data at their disposal on the new psychoactive substance . the emcdda shall respect the conditions on use of the information , which are communicated to the emcdda by the european chemicals agency and the european food safety authority , including conditions on information and data security and protection of confidential business information . the european chemicals agency and the european food safety authority shall provide the information and data at their disposal within four weeks from receipt of the request . ### the emcdda shall request the european chemicals agency , the european centre for disease prevention and control and the european food safety authority to provide the information and data at their disposal on the new psychoactive substance . the emcdda shall respect the conditions on use of the information , which are communicated to the emcdda by the european chemicals agency , the european centre for disease prevention and control and the european food safety authority , including conditions on information and data security and protection of confidential business information . the european chemicals agency , the european centre for disease prevention and control and the european food safety authority shall provide the information and data at their disposal within four weeks from receipt of the request .


### where the emcdda and europol , or the commission , consider that the information shared on a new psychoactive substance notified by several member states gives rise to concerns across the union because of the health , social and safety risks that the new psychoactive substance may pose , the emcdda and europol shall draw up a joint report on the new psychoactive substance . ### where the emcdda and europol , or the commission , consider that the information shared on a new psychoactive substance notified by several member states gives rise to concerns across the union because of the health , social and safety risks that the new psychoactive substance may pose , or in response to a reasoned request from more than one member state , the emcdda and europol shall draw up a joint report on the new psychoactive substance .


### the nature of the risks that the new psychoactive substance poses when consumed by humans and the scale of the risk to public health , as referred to in article 9 ; ### the nature of the risks that the new psychoactive substance poses when consumed by humans , including when consumed in combination with other substances , and the scale of the risk to public health , as referred to in article 9 ;


### the chemical and physical identity of the new psychoactive substance , the methods and , if known , the chemical precursors used for its manufacture or extraction , and other new psychoactive substances with a similar chemical structure that have emerged ; ### the chemical and physical identity of the new psychoactive substance , the methods and , if known , the chemical precursors used for its manufacture or extraction , and other new psychoactive substances with a similar chemical structure that have emerged or which may reasonably be expected to emerge , based on scientific assessment ;


### member states shall provide the european medicines agency with the above information , if so requested by it . ### member states shall provide the european medicines agency with the above information without any undue delay , if so requested by it .


### the emcdda shall request the european chemicals agency and the european food safety authority to provide the information and data at their disposal on the new psychoactive substance . the emcdda shall respect the conditions on use of the information , which are communicated to the emcdda by the european chemicals agency and the european food safety authority , including conditions on information and data security and protection of confidential business information . ### the emcdda shall request the european chemicals agency and the european food safety authority to provide the information and data at their disposal on the new psychoactive substance . the emcdda shall respect the conditions on use of the information , which are communicated to the emcdda by the european chemicals agency and the european food safety authority , including conditions on information and data security and protection of confidential data , including sensitive data or business information .


### the scientific committee of the emcdda shall carry out the risk assessment on the basis of information on the risks of the substance and on its uses , including commercial and industrial uses , provided by the member states , the commission , the emcdda , europol , the european medicines agency , the european chemicals agency , the european food safety authority and on the basis of any other relevant scientific evidence . it shall take into consideration all opinions held by its members . the emcdda shall support the risk assessment and shall identify information needs , including targeted studies or tests . ### the scientific committee of the emcdda shall carry out the risk assessment on the basis of information on the risks of the substance and on its uses , including commercial and industrial uses , provided by the member states , the commission , the emcdda , europol , the european medicines agency , the european chemicals agency , the european centre for disease prevention and control , the european food safety authority and on the basis of any other relevant scientific evidence . it shall take into consideration all opinions held by its members . the emcdda shall support the risk assessment and shall identify information needs , including targeted studies or tests .


### within four weeks from the receipt of the joint report referred to in article 6 , the commission may request the emcdda to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report . the risk assessment shall be conducted by the scientific committee of the emcdda . ### within four weeks from the receipt of the joint report referred to in article 6 , or in response to a reasoned request from more than one member state , the commission may request the emcdda to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report . the risk assessment shall be conducted by the scientific committee of the emcdda .


### the scientific committee of the emcdda shall assess the risks during a special meeting . the committee may be extended by not more than five experts , representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance . the director of the emcdda shall designate them from a list of experts . the management board of the emcdda shall approve the list of experts every three years . the commission , the emcdda , europol and the european medicines agency shall each have the right to nominate two observers . ### the scientific committee of the emcdda shall assess the risks during a special meeting . the committee may be extended by not more than five experts , including a psychologist specialising in addiction and psychological disorders in children and adolescents , representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance . the director of the emcdda shall designate them from a list of experts . the management board of the emcdda shall approve the list of experts every three years . the commission , the emcdda , europol and the european medicines agency shall each have the right to nominate two observers .


### the scientific committee of the emcdda shall assess the risks during a special meeting . the committee may be extended by not more than five experts , representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance . the director of the emcdda shall designate them from a list of experts . the management board of the emcdda shall approve the list of experts every three years . the commission , the emcdda , europol and the european medicines agency shall each have the right to nominate two observers . ### the scientific committee of the emcdda shall assess the risks during a special meeting . the committee may be extended by not more than five experts , representing the scientific fields relevant for ensuring a balanced assessment of the risks of the new psychoactive substance . the director of the emcdda shall designate them from a list of experts . the management board of the emcdda shall approve the list of experts every three years . the european parliament , the council , the commission , the emcdda , europol and the european medicines agency shall each have the right to nominate two observers .


### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several member states , related to the serious acute toxicity of the new psychoactive substance ; ### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several member states , related to the toxicity of the new psychoactive substance ;


### the prevalence and patterns of use of the new psychoactive substance in the general population and in specific groups , in particular frequency , quantities and modality of use , its availability to consumers and the potential for diffusion , which indicate that the scale of the risk is considerable . ### the prevalence and patterns of use of the new psychoactive substance in the general population and in specific groups , in particular frequency , quantities and modality of use , its availability to consumers and the potential for diffusion , which indicate that the scale of the risk is moderate or considerable .


### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several member states , related to the serious acute toxicity of the new psychoactive substance ; ### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance , including when it is consumed in combination with other substances , in member states , related to the serious acute toxicity of the new psychoactive substance ;


### the market restriction contained in the decision referred to in paragraph 1 shall not exceed a period of twelve months . ### the market restriction contained in the decision referred to in paragraph 1 shall not exceed a period of twelve months . if the level of health , social and safety risks posed by the new psychoactive substance justifies the introduction of permanent restriction measures , the duration of the temporary market restriction may be prolonged by a further 12 months , in the absence of permanent market restrictions .


### the commission shall determine the level of the health , social and safety risks posed by the new psychoactive substance on which a risk assessment report was drafted . it shall do so on the basis of all available evidence , in particular the risk assessment report . ### the commission shall determine without undue delay the level of the health , social and safety risks posed by the new psychoactive substance on which a risk assessment report was drafted . it shall do so on the basis of all available evidence , in particular the risk assessment report .


### the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity , abuse liability and dependence - producing potential , in particular injury , disease , and physical and mental impairment ; ### the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity , contraindications with other substances , abuse liability and dependence - producing potential , in particular injury , disease , aggression , and physical and mental impairment ;


### the risks to safety , in particular the spread of diseases , including transmission of blood borne viruses , the consequences of physical and mental impairment on the ability to drive , the impact of the manufacture , transport and disposal of the new psychoactive substance and associated waste materials on the environment . ### the risks to public safety , in particular the spread of diseases , including transmission of blood borne viruses , the consequences of physical and mental impairment on the ability to drive , the impact of the manufacture , transport and disposal of the new psychoactive substance and associated waste materials on the environment .


### the risks to safety are limited , in particular low risk of spread of diseases , including transmission of blood borne viruses , non - existent or low consequences of physical and mental impairment on the ability to drive , and the impact of the manufacture , transport and disposal of the new psychoactive substance and associated waste materials on the environment is low . ### the risks to public safety are limited , in particular low risk of spread of diseases , including transmission of blood borne viruses , non - existent or low consequences of physical and mental impairment on the ability to drive , and the impact of the manufacture , transport and disposal of the new psychoactive substance and associated waste materials on the environment is low .


### low risks ### active monitoring


### the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity , abuse liability and dependence - producing potential , is limited , as it provokes minor injury and disease , and minor physical or mental impairment ; ### does not represent imminent harm to health ;


### the social harm caused to individuals and to society is limited , in particular regarding its impact on social functioning and public order , criminal activities associated with the new psychoactive substance is low , illicit profits generated by the production , trade and distribution of the new psychoactive substance and associated economic costs are non - existent or negligible ; ### or social harm ;


### the risks to safety are limited , in particular low risk of spread of diseases , including transmission of blood borne viruses , non - existent or low consequences of physical and mental impairment on the ability to drive , and the impact of the manufacture , transport and disposal of the new psychoactive substance and associated waste materials on the environment is low . ### or risks to safety .


### the risks to safety are moderate , in particular sporadic spread of diseases , including transmission of blood borne viruses , moderate consequences of physical and mental impairment on the ability to drive , and the manufacture , transport and disposal of the new psychoactive substance and associated waste materials results in environmental nuisance . ### the risks to public safety are moderate , in particular sporadic spread of diseases , including transmission of blood borne viruses , moderate consequences of physical and mental impairment on the ability to drive , and the manufacture , transport and disposal of the new psychoactive substance and associated waste materials results in environmental nuisance .


### the commission shall , by means of a decision , without undue delay , prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of the new psychoactive substance if , based on existing evidence , it poses , overall , severe health , social and safety risks , in particular : ### the commission shall , by means of a decision , without undue delay , prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of the new psychoactive substance if , based on existing evidence , it poses , overall , severe health , social or safety risks , in particular :


### the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity , abuse liability and dependence - producing potential , is life threatening , as it generally provokes death or lethal injury , severe disease , and severe physical or mental impairment ; ### the harm to health caused by the consumption of the new psychoactive substance associated with its acute and chronic toxicity , abuse liability and dependence - producing potential , is severe and significant , as it generally provokes death or lethal injury , severe disease , and severe physical or mental impairment ;


### the risks to safety are severe , in particular significant spread of diseases , including transmission of blood borne viruses , severe consequences of physical and mental impairment on the ability to drive , and the manufacture , transport and disposal of the new psychoactive substance and associated waste materials result in environmental harm . ### the risks to public safety are severe , in particular significant spread of diseases , including transmission of blood borne viruses , severe consequences of physical and mental impairment on the ability to drive , and the manufacture , transport and disposal of the new psychoactive substance and associated waste materials result in environmental harm .


### the commission shall adopt the decision referred to in paragraph 1 by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 19 . ### the commission shall adopt the decision referred to in paragraph 1 by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 19 . the commission shall notify the union and member state judicial authorities , so that proceedings may be brought against anyone selling or using such substances illegally .


### the decisions referred to in article 13 may set requirements and conditions for the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks for the uses listed in paragraph 2 . ### the decisions referred to in article 13 may set requirements and conditions for the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks for the uses listed in paragraph 2 . member states shall take any appropriate measures to prevent the diversion to the illicit market of new psychoactive substances used for research and development purposes or for any other authorised uses .


### the commission and the member states shall support the development , sharing and dissemination of information and knowledge on new psychoactive substances . they shall do so by facilitating cooperation between the emcdda , other union agencies , and scientific and research centres . ### the commission and the member states shall support the development , sharing and dissemination of information and knowledge on new psychoactive substances . they shall do so by facilitating cooperation between the emcdda , other union agencies and scientific and research centres , and by regularly providing these bodies with up to date information on such substances wherever possible . the commission and the member states shall also promote and support the research , including applied research into new psychoactive substances and ensure cooperation and coordination between networks at national and eu level in order to strenghten the understanding of the phenomenon . they shall do so by facilitating cooperation between the emcdda , other union agencies and scientific and research centres . in particular , emphasis should be placed on developing forensic and toxicological capacity as well as on improving the availability of epidemiological information .


### the commission and the member states shall support the development , sharing and dissemination of information and knowledge on new psychoactive substances . they shall do so by facilitating cooperation between the emcdda , other union agencies , and scientific and research centres . ### support shall be provided , including financial at union level , in order for the emcdda to lead a network of forensic laboratories and to facilitate cooperation between the emcdda , research institutes and other bodies with relevant expertise , in order to increase the capacity to assess and address effectively new psychoactive substances .


### the emcdda and europol shall report annually on the implementation of this regulation . ### the emcdda and europol shall report annually to the commission and member states on the implementation of this regulation , and such reports will be published on a website and made public .


### the emcdda and europol shall report annually on the implementation of this regulation . ### the emcdda and europol shall report annually on the implementation of this regulation . the implementation reports shall be made publicly available .


### by [ five years after the entry into force of this regulation ] at the latest and every five years thereafter , the commission shall assess the implementation , application and effectiveness of this regulation and publish a report . ### by [ three years after the entry into force of this regulation ] at the latest and every five years thereafter , the commission shall assess the implementation , application and effectiveness of this regulation and publish a report .


### implementing powers should be conferred on the commission in respect of the adoption of annual work programmes . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 , laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . given the annual amounts concerned , the budgetary implications can be considered as non - substantial . therefore , the advisory procedure should apply . ### in order to operate the programme , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the adoption of annual work programmes . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights and the number of complaints . ### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the number and percentage of citizens reached by awareness - raising activities funded by the programme , qualitative data collected at national and european level on the degree of awareness of citizens of their rights under union law , and the european perception of the respect , exercise and implementation of these rights and the number of complaints .


### mutual learning , cooperation , awareness raising and dissemination activities , such as identification of , and exchanges on , good practices , innovative approaches and experiences , organisation of peer review and mutual learning ; organisation of conferences and seminars ; organisation of awareness - raising and information campaigns , media campaigns and events , including corporate communication of the political priorities of the european union ; compilation and publication of materials to disseminate information as well as results of the programme ; development , operation and maintenance of systems and tools using information and communication technologies ; ### mutual learning , cooperation , coordination mechanisms for cross - border cooperation , awareness raising and dissemination activities , such as identification of , and exchanges on , good practices , innovative approaches and experiences , organisation of peer review and mutual learning ; organisation of conferences and seminars ; organisation of awareness - raising and information campaigns , media campaigns and events , including corporate communication of the legislation and political priorities of the european union ; compilation and publication of materials to disseminate information as well as results of the programme ; development , operation and maintenance of systems and tools using information and communication technologies , including the cross - border interoperability of the existing systems and applications in the member states ;


### support for main actors , such as support for member states when implementing union law and policies ; support for key european level networks whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations , national , regional and local authorities at european level ; funding of experts ' networks ; funding of european level observatories . ### support for main actors , such as support for member states when implementing and applying union law and policies ; support for key european level networks , whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations , national , regional and local authorities at european level ; improving the coordination of existing networks ; funding of experts ' networks ; funding of european level observatories .


### public and / or private bodies and entities legally established in other third countries , notably countries where the european neighbourhood policy applies , may be associated to actions of the programme , if this serves the purpose of these actions . ### public and / or private bodies and entities legally established in other third countries , notably countries where the european neighbourhood policy applies , may be associated to actions of the programme , if this serves the purpose of those actions and if those actions are co - financed by the third country concerned .


### implementing measures ### article delegating power


### the commission shall implement the union financial support in accordance with the regulation no xx / xx of xx on the financial rules applicable to the annual budget of the european union . ### the commission shall be empowered to adopt delegated acts in accordance with article 9 concerning the adoption of annual work programmes .


### committee procedure ### exercise of the delegation


### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article .


### where reference is made to this paragraph , article 4 of regulation no 182 / 2011 shall apply . ### the delegation of power referred to in article 8 shall be conferred on the commission from [ the date of entry into force of this regulation ] until 31 december 2020 .


### wider access should be granted to documents in cases where the institutions are acting in their legislative capacity , including under delegated powers , while at the same time preserving the effectiveness of the institutions ' decision - making process . such documents should be made directly accessible to the greatest possible extent . ### the right of access to documents should be granted in cases where the institutions are acting in their legislative capacity , including under delegated powers , while at the same time preserving the effectiveness of the institutions ' decision - making process . such documents should be made directly accessible to the greatest possible extent .


### in principle , all documents of the institutions should be accessible to the public . however , certain public and private interests should be protected by way of exceptions . the institutions should be entitled to protect their internal consultations and deliberations where necessary to safeguard their ability to carry out their tasks . in assessing the exceptions , the institutions should take account of the principles in community legislation concerning the protection of personal data , in all areas of union activities . ### in principle , all documents of the institutions that relate to their activities should be registered and accessible to the public . however , without prejudice to the european parliament ' s scrutiny , access to the entire document or to part of it may be denied for reasons of protection of public or private interests , in order to enable the institutions to protect their internal consultations and deliberations where necessary to safeguard their ability to carry out their tasks . in assessing the exceptions , the institutions should take account of the principles in community legislation concerning the protection of personal data in accordance with regulation no 45 / 2001 , in all areas of union activities .


### all rules concerning access to documents of the institutions should be in conformity with this regulation . ### all rules concerning access to documents of the institutions should be in conformity with this regulation , as it implements article 15 tfeu .


### to define the principles , conditions and limits on grounds of public or private interest governing the right of access to european parliament , council and commission documents provided for in article 255 of the ec treaty in such a way as to grant the public&#160 ; the widest possible access to such&#160 ; documents ; ### to define the principles , conditions and limits on grounds of public or private interest , pursuant to regulation no 45 / 2001 , governing the right of access to european parliament , council and commission documents provided for in article 15 tfeu in such a way as to grant the public&#160 ; the widest possible access to such&#160 ; documents ;


### to promote good administrative practice on access to documents . ### to promote good administrative practice on access to documents , and in particular the overall goals of greater transparency , accountability , and democracy .


### the financial , monetary or economic policy of the community or a member state ; ### the financial , monetary or economic policy of the european union or a member state ;


### the institutions shall refuse access to a document where disclosure would undermine the protection of : ### the institutions shall refuse access to a document or collection of documents where disclosure would undermine the protection of :


### legal advice and court , arbitration and dispute settlement proceedings ; ### court proceedings and legal advice ;


### names , titles and functions of public office holders , civil servants and interest representatives in relation with their professional activities shall be disclosed unless , given the particular circumstances , disclosure would adversely affect the persons concerned . other personal data shall be disclosed in accordance with the conditions regarding lawful processing of such data laid down in ec legislation on the protection of individuals with regard to the processing of personal data . ### names , titles and functions of public office holders , civil servants and interest representatives in relation with their professional activities shall be disclosed solely with the consent of the originator , unless , given the particular circumstances , disclosure would adversely affect the privacy and integrity of the persons concerned . other personal data shall be disclosed in accordance with the conditions regarding lawful processing of such data laid down in union legislation on the protection of individuals with regard to the processing of personal data . consent shall be requested from public office holders , civil servants and interest representatives prior to having their names , titles and functions included in a document . where an institution , body , office or agency refuses access to a document on the basis of paragraph 1 , it shall consider whether partial access to that document is possible .


### where an application concerns a document originating from a member state , other than documents transmitted in the framework of procedures leading to a legislative act or a non - legislative act of general application , the authorities of that member state shall be consulted . the institution holding the document shall disclose it unless the member state gives reasons for withholding it , based on the exceptions referred to in article 4 or on specific provisions in its own legislation preventing disclosure of the document concerned . the institution shall appreciate the adequacy of reasons given by the member state insofar as they are based on exceptions laid down in this regulation . ### where an application concerns a document originating from a member state , other than documents transmitted in the framework of procedures leading to a legislative act or a non - legislative act of general application , or information submitted to the commission concerning the implementation of union legislation , until such time as any court proceedings relating to it have begun , the authorities of that member state shall be consulted . the institution , body , office or agency holding the document shall disclose it unless the member state gives reasons for withholding it , based on the exceptions referred to in article 4 . the institution shall appreciate the adequacy of such reasons given by the member state .


### in the event of a total or partial refusal , the applicant may , within 15 working days of receiving the institution’s reply , make a confirmatory application asking the institution to reconsider its position . ### the institution shall notify the applicant whether , and if so when , partial or full access to the document is likely to be possible at a later point in time . the applicant may , within 15 working days of receiving the institution’s reply , make a confirmatory application asking the institution to reconsider its position .


### the institutions shall immediately take the measures necessary to establish a register which shall be operational by 3 june 2002 . ### the institutions shall immediately take the measures necessary to establish a common interface for the institutional registers in order to ensure coordination between the registers .


### some of the species that are invasive in the union may be native in some of the union’s outermost regions and vice versa . in the communication from the commission on “the outermost regions : an asset for europe”18 it was recognised that the remarkable biodiversity of the outermost regions calls for the development and implementation of measures to prevent and manage invasive alien species in those regions as defined by the treaty on the functioning of the european union taking into account european council decisions 2010 / 718 / eu of 29 october 2010 amending the status with regard to the european union of the island of saint - barthélemy19 and 2012 / 419 / eu of 11 july 2012 amending the status of mayotte with regard to the european union20 . therefore all the provisions of these new rules should apply to the union’s outermost regions except for provisions relating to invasive alien species of union concern which are native to those regions . in addition , to allow for the necessary protection of the biodiversity in such regions , it is necessary that the concerned member states draw up , as a complement to the list of invasive alien species of union concern , specific lists of invasive alien species for their outermost regions to which these new rules should also apply . __________________ 18 com 642 final . 19 oj l 325 , 9 . 12 . 2010 , p . 4 . 20 oj l 204 , 31 . 7 . 2012 , p . 131 . ### some of the species that are invasive in the union may be native in some of the union’s outermost regions and vice versa . in the communication from the commission on “the outermost regions : an asset for europe”18 it was recognised that the remarkable biodiversity of the outermost regions calls for the development and implementation of measures to prevent and manage invasive alien species in those regions as defined by the treaty on the functioning of the european union taking into account european council decisions 2010 / 718 / eu of 29 october 2010 amending the status with regard to the european union of the island of saint - barthélemy19 and 2012 / 419 / eu of 11 july 2012 amending the status of mayotte with regard to the european union20 . therefore all the provisions of these new rules should apply to the union’s outermost regions except for provisions relating to invasive alien species of union concern which are native to those regions . in addition , to allow for the necessary protection of the biodiversity in such regions , it is necessary that in all appropriate cases the member states concerned draw up and update , as a complement to the list of invasive alien species of union concern , specific lists of invasive alien species for their outermost regions to which these new rules should also apply . __________________ 18 com 642 final . 19 oj l 325 , 9 . 12 . 2010 , p . 4 . 20 oj l 204 , 31 . 7 . 2012 , p . 131 .


### they are , having regard to scientific evidence available , found to be alien to the territory of the union excluding the outermost regions ; ### they are , having regard to the best and most recent scientific evidence available , found to be alien to the territory of the union excluding the outermost regions ;


### they are , having regard to scientific evidence available , found to be capable of establishing a viable population and spreading in the environment under current or foreseeable climate change conditions anywhere in the union excluding the outermost regions ; ### they are , having regard to the best and most recent scientific evidence available , found to be capable of establishing a viable population and spreading in the environment under current or foreseeable climate change conditions anywhere in the union excluding the outermost regions ;


### according to the recommendations made by the article 29 data protection working party and contained in the ' working document on data protection and privacy implications in ecall initiative ' , adopted on 26 september 20069 , any processing of personal data through the ecall in - vehicle system should comply with the personal data protection rules provided for in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector 11 in particular to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the appropriate handling of emergency calls . ________________ 9 1609 / 06 / en – wp 125 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37 . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector 11 , govern the processing of personal data carried out in the context of this regulation through the ecall in - vehicle system , and under the supervision of the member states ' competent authorities , in particular the independent public authorities designated by the member states pursuant to those directives , to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the appropriate handling of emergency calls . ________________ 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37


### in order to ensure the application of common technical requirements regarding the ecall in - vehicle system , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of the relevant standards , on testing , on personal data and privacy protection and on exemptions for certain vehicles or classes of vehicles of categories m1 and n1 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council ### in order to ensure the application of common technical requirements regarding the ecall in - vehicle system , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules on the application of the relevant standards , on testing , on personal data and privacy protection and on exemptions for certain vehicles or classes of vehicles of categories m1 and n1 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , in particular the european data protection supervisor and the article 29 working party established by directive 95 / 46 / ec . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council


### the minimum set of data sent by the ecall in - vehicle system shall include only the minimum information required for the appropriate handling of emergency calls . ### the minimum set of data sent by the 112 - based ecall in - vehicle system shall include only the minimum information required for the specific purpose of ensuring appropriate handling of emergency calls .


### the fact that the ecall in - vehicle system is activated by default ; ### whether the ecall in - vehicle system is activated by default and the way of deactivating it manually ;


### the purpose of the ecall processing ; ### the specific purpose of the ecall processing ;


### the time limit for the retention of data in the in - vehicle system ; ### the period for which the data will be stored in the in - vehicle system , or if that period is not known , the criteria used to determine that period ;


### the fact that there is no constant tracking of the vehicle ; ### the fact that there is a constant tracking of the vehicle or not in the case of private and / or added - value ecall services ;


### the modalities for exercising data subjects ' rights ; ### the modalities for exercising data subjects ' rights , the contact information of the controller as well as information on the data subject’s right of access to the data and the rights to rectification or erasure of the data ;


### the forecasts for the direct payments and market related expenditure determined in the preparation of the 2014 draft budget show that the annual ceiling for the european agricultural guarantee fund in respect of financial year 2014 is likely to be exceeded taking into account the need to establish the reserve for crises referred to in the conclusions of the european council on the multiannual financial framework . an adjustment rate to the direct payments listed in annex i to regulation no 73 / 2009 should therefore be determined . ### pending the adoption of a regulation laying down the multiannual financial framework on the basis of article 312 of the treaty on the functioning of the european union , the level of the applicable ceiling for the year 2014 remains uncertain . until there is clarity on the level of the applicable ceiling , it is not possible to determine whether an adjustment of the direct payments for 2013 is necessary and , if so , what the rate should be .