### as part of the multilateral surveillance in accordance with article 121 of the treaty , the council shall discuss and adopt conclusions on the commission report . the euro group shall discuss the report as far as it relates , directly or indirectly , to member states whose currency is the euro . ### as part of the multilateral surveillance in accordance with article 121 of the treaty , the council shall discuss and adopt conclusions on the commission report . the competent committee of the european parliament may organise public debates on the commission report . the euro group shall discuss the report as far as it relates , directly or indirectly , to member states whose currency is the euro .


### as appropriate , whether the member state under review has taken appropriate action in response to council recommendations or invitations adopted in accordance with articles 121 and 126 of the treaty and under articles 6 , 7 , 8 and 10 of this regulation ; ### as appropriate , whether the member state under review has taken appropriate action in response to council recommendations or invitations adopted in accordance with articles 121 and 126 of the treaty and under articles 6 , 7 , 8 and 10 of this regulation , and the economic , social and other important consequences of such recommendations ;


### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public . ### the council , on a recommendation from the commission , after consulting the european parliament and the european social partners may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public .


### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public . ### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and outline the corrective action to be taken and the deadline within which the member state concerned shall take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public .


### ‘ specialised service’ means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ; ### ‘ specialised service’ means an electronic communications service or any other service operated within closed electronic communications networks using the internet protocol with strict admission control that is not marketed or used as a substitute for internet access service ; and that is not functionally identical to services available over the public internet ;


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . ### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 and article 2 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the public , the commission and berec on their monitoring and findings .


### to offer a public regulated service restricted to government - authorised users , for sensitive applications which require a high level of service continuity ; this service uses strong , encrypted signals ; ### to offer a public regulated service restricted to government - authorised users , for sensitive applications which require a high level of service continuity ; this service uses strong , encrypted signals , and must not be used for military purposes , in particular not for missions and operations under the common security and defence policy .


### where requests by railway undertakings concern access to , and supply of services in a service facility managed by an operator of the service facility referred to in paragraph 3 , the operator of the service facility shall justify any decision of refusal and indicate viable alternatives in other facilities . ### where requests by railway undertakings concern access to , and supply of services in a service facility managed by an operator of the service facility referred to in paragraph 3 , the operator of the service facility shall justify any decision of refusal in a written form and address it to the regulatory body in charge to indicate viable alternatives in other facilities to the applicant .


### before…* , the commission shall adopt measures setting out the methodology for the calculation of the cost that is directly incurred as a result of operating the train . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 62 . ________________  oj : please insert date - 36 months after the entry into force of this directive . ### annex vi , point - 1 . a may be amended in the light of experience in accordance with the procedure referred to in article 60 .


### data on the development of prices for union - wide voice , sms and data roaming services since the entry into force of regulation no 717 / 2007 and its amending regulation no 544 / 2009 , including in particular those collected by national regulatory authorities and reported on a quarterly basis through the medium of the berec , do not provide evidence to suggest that competition at the retail or wholesale levels has reasonably developed and is likely to be sustainable from june 2012 onwards in the absence of regulatory measures . such data indicates that retail and wholesale prices continue to cluster at or close to the limits set by regulation no 717 / 2007 as amended by regulation no 544 / 2009 , with only limited competition below those limits . ### data on the development of prices for union - wide voice , sms and data roaming services since the entry into force of regulation no 717 / 2007 and its amending regulation no 544 / 2009 , including in particular those collected by national regulatory authorities and reported on a quarterly basis through the medium of the berec , do not provide evidence to suggest that competition at the retail or wholesale levels has reasonably developed and is likely to be sustainable from june 2012 onwards in the absence of regulatory measures . such data indicates that retail and wholesale prices continue to cluster at or close to the limits set by regulation no 717 / 2007 as amended by regulation no 544 / 2009 , with only limited competition below those limits , which leads to excessive profits for providers , at the expense of european consumers .


### the expiry in june 2012 of the regulatory safeguards which apply to union - wide roaming services at wholesale and retail levels by virtue of regulation no 717 / 2009 , as amended by regulation no 544 / 2009 , would therefore give rise to a significant risk that the underlying lack of competitive pressures in the roaming market and the incentive for mobile operators to maximise their roaming revenues would result in retail and wholesale prices for union - wide roaming that do not constitute a reasonable reflection of the underlying costs involved in the provision of the service , thereby jeopardising the objectives of this regulation . regulatory intervention in the market for mobile roaming services should therefore be extended beyond 30 june 2012 in order to ensure the smooth functioning of the internal market by allowing competition to develop , while at the same time guaranteeing that consumers continue to benefit from the assurance that they will not be charged an excessive price , in comparison with competitive national prices . ### the expiry in june 2012 of the regulatory safeguards which apply to union - wide roaming services at wholesale and retail levels by virtue of regulation no 717 / 2009 , as amended by regulation no 544 / 2009 , would therefore give rise to a significant risk that the underlying lack of competitive pressures in the roaming market and the incentive for mobile operators to maximise their roaming revenues would result in retail and wholesale prices for union - wide roaming that do not constitute a reasonable reflection of the underlying costs involved in the provision of the service , thereby jeopardising the objectives of this regulation . regulatory intervention in the market for mobile roaming services should therefore be extended beyond 30 june 2012 in order to ensure a substantial reduction in charges with the aim of arriving at a situation in 2015 , as indicated in the european digital agenda , in which there are no longer any differences between national and roaming charges .


### data collected by national regulatory authorities indicate that high prices for average wholesale charges for data roaming services levied by visited network operators from roaming customers’ home providers persist , even if these wholesale prices appear to be on a downward trend . ### data collected by national regulatory authorities indicate that average wholesale charges for data roaming services levied by visited network operators from roaming customers’ home providers are still far too high , which is not reflected in the charge structure for roaming services , resulting in excessive profits .


### air carriers currently face unlimited liability for the accommodation of their passengers in the case of extraordinary circumstances of long duration . this uncertainty linked with the absence of any foreseeable limit in time may risk endangering a carrier ' s financial stability . an air carrier should therefore be able to limit the provision of care after a certain duration of time . moreover , contingency planning and speedy rerouting should lessen the risk of passengers being stranded for long periods . ### air carriers currently face unlimited liability for the accommodation of their passengers in the case of extraordinary circumstances of long duration . an air carrier should therefore be able to limit the provision of care after a certain duration of time whilst providing to passengers adequate contingency planning and speedy rerouting in order to lessen the risk of passengers being stranded for long periods .


### the purpose of this regulation is to improve the conditions for the establishment and the functioning of the internal market by making available a uniform set of contract law rules as set out in annex i . these rules can be used for cross - border transactions for the sale of goods , for the supply of digital content and for related services where the parties to a contract agree to do so . ### the purpose of this directive is to establish a voluntary , common european law for the internal market by making available a uniform set of contract law rules as set out in annex i , which shall operate alongside national law and may be used , if so desired , instead of national law , solely in the field of contract law concerning cross - border transactions for the sale of goods , for the supply of digital content and for related services where the parties to a contract explicitly agree to do so .


### in relation to contracts between traders and consumers , this regulation comprises a comprehensive set of consumer protection rules to ensure a high level of consumer protection , to enhance consumer confidence in the internal market and encourage consumers to shop across borders . ### in relation to contracts between traders and consumers in the field of cross - border transactions , this directive comprises a set of consumer protection rules to ensure a high level of consumer protection , to enhance consumer confidence in the internal market and encourage consumers to shop across borders .


### by decision 2012 / 419 / eu3 , the european council amended the status of mayotte with regard to the union with effect from 1 january 2014 . therefore , from that date mayotte will cease to be an overseas territory to become an outermost region within the meaning of articles 349 and 355 tfeu . union law will apply to mayotte from 1 january 2014 . it is appropriate to provide for certain specific measures justified by the particular situation of mayotte in a number of areas . _____________ 3 ol l 201 , 31 . 7 . 2012 , p . 131 ### by decision 2012 / 419 / eu3 , the european council amended the status of mayotte with regard to the union with effect from 1 january 2014 . therefore , from that date mayotte will cease to be an overseas territory and become an outermost region within the meaning of articles 349 and 355 of the treaty on the functioning of the european union . following this change in mayotte ' s legal status , union law will apply to mayotte from 1 january 2014 . it is appropriate to provide for certain specific measures justified by the particular structural , social and economic situation of mayotte which is compounded by its remoteness , insularity , small size , difficult topography and climate . _____________ 3 ol l 204 , 31 . 7 . 2012 , p . 131


### as regards council regulation no 850 / 98 of 30 march 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organism4 , the waters around mayotte should be included within the scope of that regulation and the use of purse - seines on tuna and tuna - like schools of fish inside the area within 24 miles from the baselines of the island should be prohibited in order to preserve the shoals of large migratory fish in the vicinity of the island of mayotte . _______________ 4 oj l 125 , 27 . 4 . 1998 , p . 1 . ### as regards council regulation no 850 / 98 of 30 march 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organism4 , the waters around mayotte , as a new outermost region , should be included within the scope of that regulation and vessels of more than 12 meters should be prohibited from using purse - seines on tuna and tuna - like schools of fish inside the whole marine natural park of mayotte in order to preserve the shoals of large migratory fish in the vicinity of the island of mayotte . ______________ 4 oj l 125 , 27 . 4 . 1998 , p . 1 .


### as regards council regulation no 639 / 2004 of 30 march 2004 on the management of fishing fleets registered in the community outermost regions7 , a particular feature of mayotte is that no objective has been set for its fleet under regulation no 2371 / 2002 which refers to the multiannual guidance programme 1997 - 2002 . from the point of view of conservation of fish resources , it is appropriate to freeze the fishing capacity of the fleets at current levels , especially for the segment of large vessels with a great fishing capacity . however , for smaller vessels , in view of the fact that france presented to the indian ocean tuna commission a development plan indicating the expected evolution of the fleet based in mayotte , to which no iotc contracting party , including the union , has objected , it is appropriate to use the objectives of that plan as reference levels for the capacity of the fleet registered in the ports of mayotte and to allow france to increase its fleet up to the objectives of its development plan . ______________ 7 oj l 102 , 7 . 4 . 2004 , p . 9 . ### as regards council regulation no 639 / 2004 of 30 march 2004 on the management of fishing fleets registered in the community outermost regions7 , a particular feature of mayotte is that no objective has been set for its fleet under regulation no 2371 / 2002 which refers to the multiannual guidance programme 1997 - 2002 . from the point of view of conservation of fish resources , it is appropriate to freeze the fishing capacity of the fleets at current levels , especially for the segment of large vessels with a great fishing capacity . however , for smaller vessels , in view of the fact that france presented to the indian ocean tuna commission a development plan indicating the expected evolution of the fleet based in mayotte , to which no iotc contracting party , including the union , has objected , it is appropriate , due to the current specific social and economic circumstances of mayotte , to use the objectives of that plan as reference levels for the capacity of the fleet registered in the ports of mayotte and to allow france to increase its fleet up to the objectives of its development plan . ______________ 7 oj l 102 , 7 . 4 . 2004 , p . 9 .


### a european state which has applied to join the union can become a member only when it has been confirmed that it meets the membership criteria agreed at the copenhagen european council in june 1993 and provided that the accession does not overstretch the capacity of the union to integrate the new member . these criteria relate to the stability of institutions guaranteeing democracy , the rule of law , respect of human rights and respect for , and protection of , minorities , the development of the economy that must be sufficient to withstand the competitive pressure in the internal market , and the ability to assume not only the rights but also the obligations under the treaties . ### a european state which has applied to join the union can become a member only when it has been confirmed that it meets the membership criteria agreed at the copenhagen european council in june 1993 and provided that the accession does not overstretch the capacity of the union to integrate the new member . these criteria relate to the stability of institutions guaranteeing democracy , the rule of law , respect of human rights and respect for , and protection of , minorities , the development of the economy that must be sufficient to withstand the effects of adapting to new challenges and promoting good governance and social progress , in particular in the fields of employment , decent work , education , environment , the fight against poverty , and the ability to assume not only the rights but also the obligations under the treaties .


### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships . assistance should mainly focus on a limited number of policy areas that will help beneficiary countries strengthen democratic institutions and the rule of law , reform the judiciary and public administration , respect fundamental rights and promote gender equality and non - discrimination . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda in line with the europe 2020 strategy and to align progressively with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened . ### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships . assistance should mainly focus on a limited number of policy areas that will help beneficiary countries strengthen democratic institutions and the rule of law , reform the judiciary and public administration , respect , promote and protect fundamental rights , promote and mainstream gender equality , the effective implementation of the principles of non - discrimination on grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , including equality between women and men and the rights of all persons , including persons with disabilities and the elderly , contribute to ensuring a high level of protection of personal data , enhance respect of the rights of the child , and combat violence and harassment against women , children , minorities and other vulnerable persons . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda , and should in particular increase its support for the fight against social exclusion and poverty in line with the europe 2020 strategy and to align progressively with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened .


### promotion and protection of human rights and fundamental freedoms , enhanced respect for minority rights , promotion of gender equality , non - discrimination and freedom of the press , and promotion of good neighbourly relations ; ### promotion and protection of human rights and fundamental freedoms , enhanced respect for minority rights , promotion and mainstreaming of gender equality , effective implementation of the principles of non - discrimination on grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , including equality between women and men and the rights of all persons , including persons with disabilities and the elderly ; contributing to ensuring a high level of protection of personal data ; enhancing respect of the rights of the child ; combatting violence and harassment against women , children , minorities and other vulnerable persons ; promotion of freedom of the press and good neighbourly relations ;


### the development of civil society and social dialogue ; ### the development of civil society and social dialogue , including core and operational funding for organisations whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations and national , regional and local authorities ;


### support for economic , social and territorial development , with a view to a smart , sustainable and inclusive growth , inter alia through : ### support for economic and social development and territorial cohesion , with a view to a smart , sustainable and inclusive growth , inter alia through :


### economic reforms necessary to cope with competitive pressure and market forces within the union , while pursuing economic , social and environmental goals ; ### support to social partners , non - governmental organisations and local and regional authorities , with a view to facilitating their adaptation to new challenges and the promotion of good governance and social progress , while pursuing economic , social and environmental goals ;


### fostering employment and developing human capital ; ### fostering employment and opportunities , promoting education and life - long learning , developing active inclusion policies and combating poverty and social exclusion in accordance with the commission communication of 16 december 2010 entitled ' the european platform against poverty and social exclusion : a european framework for social and territorial cohesion2010 ' 1 ; __________ 1 com0758 .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a securities and markets stakeholder group should be established for that purpose , representing in balanced proportions community financial market participants , their employees , and consumers and other retail users of financial services , including smes . the securities and markets stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority shall allow interested parties to be consulted on all work undertaken by the authority and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a securities and markets stakeholder group should be established for that purpose , representing in balanced proportions eu financial market participants , their employees , and consumers and other retail users of financial services , including smes . the securities and markets stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or union legislation .


### in particular , the authority shall , in cooperation with the esrb , initiate and coordinate community - wide assessments of the resilience of key financial market participants to adverse market developments to that end , it shall develop the following , for application by the competent authorities : ### in particular , the authority shall , in cooperation with the esrb , initiate and coordinate union - wide assessments of the resilience of key financial market participants to adverse market developments , and of threats arising from financial products’ characteristics and distribution processes . to that end , it shall develop the following , for application by the competent authorities :


### when competent authorities organise their public passenger transport services they need to ensure that public service obligations and the geographical scope of public service contracts are appropriate , necessary and proportionate to achieve the objectives of the public passenger transport policy in their territory . this policy should be set out in public transport plans leaving scope for market based transport solutions . the process of defining public transport plans and public service obligations should be made transparent to relevant stakeholders including potential market entrants . ### when competent authorities organise their public passenger transport services they need to ensure that public service obligations and the geographical scope of public service contracts are appropriate , necessary and proportionate to achieve the objectives of the public passenger transport and cohesion policy in their territory . this policy should be set out in public transport plans where the public service obligations should be made transparent to all relevant stakeholders including potential market entrants .


### to facilitate the preparation of tenders , and hence enhance competition competent authorities need to ensure that all public service operators interested in making such a submission receive certain information on the transport services and infrastructure covered by the public service contract . ### to facilitate the choice of the awarding procedure more consistent with general public service obligations competent authorities need to ensure that all public service operators interested receive certain information on the transport services and infrastructure covered by the public service contract .


### member states shall in compliance with state aid rules take the necessary measures to ensure effective and non - discriminatory access to suitable rolling stock for public passenger transport by rail for operators wishing to provide public passenger transport services by rail under public service contract . ### member states shall in compliance with state aid rules take the necessary measures to ensure effective and non - discriminatory access conditions to suitable rolling stock for public passenger transport by rail with the exceptions of other track - based modes as metro and tramways for operators wishing to provide public passenger transport services by rail with the exception of other track - based modes as metro or tramways services under public service contract .


### restriction measures vary significantly in different member states , meaning that economic operators that use them in the production of various goods must comply , in the case of the same new psychoactive substance , with different requirements , such as pre - export notification , export authorisation , or import and export licences . consequently , the differences between the member states ' laws , regulations and administrative provisions on new psychoactive substances hinder the functioning of the internal market , by causing obstacles to trade , market fragmentation , lack of legal clarity and of an even level playing field for economic operators , making it difficult for companies to operate across the internal market . ### as conditions and circumstances differ in member states with regard to psychoactive substances , restriction measures vary accordingly in different member states , meaning that economic operators that use them in the production of various goods must comply , in the case of the same new psychoactive substance , with different requirements , such as pre - export notification , export authorisation , or import and export licences . consequently , the differences between the member states ' laws , regulations and administrative provisions on new psychoactive substances could potentially hinder to some extent the functioning of the internal market , by causing obstacles to trade , market fragmentation , lack of legal clarity and of an even level playing field for economic operators , making it more difficult for companies to operate across the internal market .


### restriction measures not only cause barriers to trade in the case of new psychoactive substances that already have commercial , industrial or scientific uses , but can also impede the development of such uses , and are likely to cause obstacles to trade for economic operators that seek to develop such uses , by making access to those new psychoactive substances more difficult . ### restriction measures could not only cause barriers to trade in the case of new psychoactive substances that already have commercial , industrial or scientific uses , but could also impede the development of such uses , and are likely to cause obstacles to trade for economic operators that seek to develop such uses , by making access to those new psychoactive substances more difficult .


### 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 , while they are legitimate since they respond to each member state ' s particularities with regard to psychoactive substances , could 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 , if efficient information exchange and coordination among member states is not strengthened .


### such disparities are expected to increase as member states continue to pursue divergent approaches to addressing new psychoactive substances . therefore , the obstacles to trade and market fragmentation , and the lack of legal clarity and of a level playing field are expected to increase , further hindering the functioning of the internal market . ### such disparities are expected to continue as member states adopt divergent approaches to addressing challenges with regard to new psychoactive substances . therefore , the obstacles to trade and market fragmentation , and the lack of legal clarity and of a level playing field are expected to continue , further hindering the functioning of the internal market if member states do not coordinate and cooperate more efficiently .


### those distortions to the functioning of the internal market should be eliminated and , to that end , the rules relating to new psychoactive substances that are of concern at union level should be approximated , while , at the same time , ensuring a high level of health , safety and consumer protection . ### where distortions to the functioning of the internal market are identified they should be addressed and , to that end , the rules relating to new psychoactive substances that are of concern at union level should be approximated , while , at the same time , ensuring a high level of health , safety and consumer protection and a flexibility for member states to respond to local situations .


### this regulation should provide for exceptions in order to ensure the protection of human and animal health , to facilitate scientific research and development , and to allow the use of new psychoactive substances in industry , provided that they cannot be abused or recovered . ### this regulation should provide for exceptions in order to ensure the protection of human and animal health , to facilitate scientific research and development , and to allow the use of new psychoactive substances in industry , provided that they are not liable to have ill effects and that they cannot be abused or recovered .


### 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 delegated 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 .


### 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 . ### if a member state has information relating to what appears to be a new psychoactive substance or mixture , its 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 that 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 , the emcdda and europol shall draw up a joint report on the new psychoactive substance . ### where the emcdda or the commission considers , 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 shall draw up a report on the new psychoactive substance .


### the emcdda and europol shall request the national focal points and the europol national units to provide additional information on the new psychoactive substance . they shall provide that information within four weeks from receipt of the request . ### the emcdda shall request the national focal points , the europol national units and europol to provide information on the new psychoactive substance and in particular on the involvement of criminal groups in the manufacture , distribution or trade in the new psychoactive substance , and any use of the new psychoactive substance in the manufacture of narcotic drugs or psychotropic substances . they shall provide that information within four weeks from receipt of the request .


### the emcdda and europol shall request the european medicines agency to provide information on whether , in the union or in any member state , the new psychoactive substance is : ### the emcdda shall request the european medicines agency and the national competent authorities for medicines of member states to provide information on whether , in the union or in any member state , the new psychoactive substance is :


### the emcdda and europol shall submit the joint report to the commission within eight weeks from the request for additional information referred to in paragraph 3 . ### the emcdda shall submit the report to the commission within eight weeks from the request for additional information referred to in paragraph 3 .


### 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 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 .


### 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 . european parliament , the council , the commission , the emcdda , europol and the european medicines agency shall each have the right to nominate two observers .


### 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 delegated acts . those delegated acts shall be adopted in accordance with the procedure referred to in article 19 .


### on duly justified imperative grounds of urgency 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 , the commission shall adopt immediately applicable implementing acts in accordance with the procedure laid down in article 19 . ### on duly justified imperative grounds of urgency 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 , the commission shall adopt delegated acts in accordance with the urgency procedure laid down in article 19 .


### the social harm caused to individuals and to society , in particular its impact on social functioning , public order and criminal activities , organised crime activity associated with the new psychoactive substance , illicit profits generated by the production , trade and distribution of the new psychoactive substance , and associated economic costs of the social harm ; ### the social harm caused to individuals and to society , based on its impact on public order and criminal activities , organised crime activity associated with the new psychoactive substance , illicit profits generated by the production , trade and distribution of the new psychoactive substance , and associated economic costs of the social harm ;


### 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 safety , based on 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 social harm caused to individuals and to society is moderate , in particular regarding its impact on social functioning and public order , producing public nuisance ; criminal activities and organised crime activity associated with the substance are sporadic , illicit profits and economic costs are moderate ; ### the social harm caused to individuals and to society is moderate , based on its impact on public order , producing public nuisance ; criminal activities and organised crime activity associated with the substance are sporadic , illicit profits and economic costs are moderate ;


### 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 safety are moderate , based on a 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 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 delegated acts . those delegated acts shall be adopted in accordance with the examination procedure referred to in article 19 .


### the social harm caused to individuals and to society is severe , in particular regarding its impact on social functioning and public order , resulting in public order disruption , violent and anti - social behaviour causing damage to the user , to others and to property ; criminal activities and organised crime activity associated with the new psychoactive substance are systematic , illicit profits , and economic costs are high ; ### the social harm caused to individuals and to society is severe , regarding its impact on public order , resulting in public order disruption , violent and anti - social behaviour causing damage to the user , to others and to property ; criminal activities and organised crime activity associated with the new psychoactive substance are systematic , illicit profits , and economic costs are high ;


### 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 safety are severe , based on a 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 .


### for scientific research and development purposes ; ### for scientific research and development purposes , by duly authorised persons in establishments which are directly under the control of member states ' authorities or specifically approved by them ;


### for use in the manufacture of substances and products provided that the new psychoactive substances are transformed in such a condition that they cannot be abused or recovered . ### for use in the manufacture of substances and products provided that the new psychoactive substances are transformed in such a condition that they cannot be abused or recovered , that they are not liable to have ill effects and that the amount of each substance used is included in the information about the substance or the product .


### the emcdda and europol shall report annually on the implementation of this regulation . ### the emcdda shall report annually on the implementation of this regulation .


### 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 . ### personal data shall not be disclosed if such disclosure would harm the privacy or the integrity of the person concerned . such harm shall not be deemed to be caused : - if the data relate solely to the professional activities of the person concerned unless , given the particular circumstances , there is reason to assume that disclosure would adversely affect that person ; - if the data relate solely to a public person unless , given the particular circumstances , there is reason to assume that disclosure would adversely affect that person or other persons connected with him or her ; - if the data have already been published with the consent of the person concerned . personal data shall nevertheless be disclosed if an overriding public interest requires disclosure . in such a case , the institution , body , office or agency concerned shall be required to specify the public interest . it shall give reasons why , in the specific case , the public interest outweighs the interests of the person concerned . where an institution , body , office or agency refuses access to a document on the basis of this paragraph , it shall consider whether it is possible to grant partial access to that document .


### applications for access to a document shall be made in any written form , including electronic form , in one of the languages referred to in article 314 of the ec treaty and in a sufficiently precise manner to enable the institution to identify the document . the applicant is not obliged to state reasons for the application . ### applications for access to a document shall be made in any written form , including electronic form , in one of the languages referred to in article 314 of the ec treaty . the applicant is not obliged to state reasons for the application .


### if an application is not sufficiently precise or if the requested documents cannot be identified , the institution shall ask the applicant to clarify the application and shall assist the applicant in doing so , for example , by providing information on the use of the public registers of documents . the time limits provided for under articles 7 and 8 shall start to run when the institution has received the requested clarifications . ### if an application is not sufficiently precise or if the requested documents cannot be identified , the institution , body , office or agency shall within 15 working days ask the applicant to clarify the application and shall assist the applicant in doing so , for example , by providing information on the use of the public registers of documents . the time limits provided for under articles 7 and 8 shall start to run when the institution has received the requested clarifications .


### the cost of producing and sending copies may be charged to the applicant . this charge shall not exceed the real cost of producing and sending the copies . consultation on the spot , copies of less than 20 a4 pages and direct access in electronic form or through the register shall be free of charge . ### the cost of producing and sending copies may be charged to the applicant . this charge shall not exceed the real cost of producing and sending the copies . consultation on the spot , copies of less than 200 a4 pages and direct access in electronic form or through the register shall be free of charge .


### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction . ### the mandatory equipping of vehicles with the emergency 112 ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction .


### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union ' s information technology industry on the global market , the ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable and open - access platform for possible future in - vehicle applications or services . ### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union ' s information technology industry on the global market , the emergency 112 ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators ;


### 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 emergency 112 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 .


### a member state shall require any large undertaking or any public interest entity active in the extractive industry or the logging of primary forests and governed by its national law to draw up a consolidated report on payments to governments in accordance with articles 37 and 38 if that parent undertaking is under the obligation to prepare consolidated financial statements as laid down in article 23 to 23 of this directive . ### a member state shall require any large undertaking or any public interest entity governed by its national law to draw up a consolidated report on payments to governments in accordance with articles 37 and 38 if that parent undertaking is under the obligation to prepare consolidated financial statements as laid down in article 23 to 23 of this directive .


### the internal market is a reality for consumers in their daily lives , when they travel , buy and make payments . consumers are key players in the internal market and should therefore be at its heart . the digital dimension of the internal market is becoming vital for both consumers and traders . consumers increasingly make purchases over the internet and an increasing number of traders sell online . consumers and traders should feel confident in carrying out transactions in a digital environment . ### the internal market is a reality for consumers in their daily lives , when they travel , buy and make payments and the effectiveness of the consumer protection policy depends on the extent to which legislation prevents practices and measures that harm consumers ' interests . consumers are key players in the internal market and should therefore be at its heart . the digital dimension of the internal market is becoming vital for both consumers and traders . consumers increasingly make purchases over the internet and an increasing number of traders sell online . consumers and traders should feel confident in carrying out transactions in a digital environment .


### data subjects should be informed about the processing of their personal data in the odr platform , and their rights with regard to that processing , by means of a comprehensive privacy notice to be made publicly available by the commission and explaining , in a clear and simple language , the processing operations performed under the responsibility of the various actors of the platform , in accordance with articles 11 and 12 of regulation no 45 / 2001 and with national legislation adopted pursuant to articles 10 and 11 of directive 95 / 46 / ec . ### data subjects should be informed about , and give their assent to , the processing of their personal data in the odr platform , and their rights with regard to that processing , by means of a comprehensive privacy notice to be made publicly available by the commission and explaining , in a clear and simple language , the processing operations performed under the responsibility of the various actors of the platform , in accordance with articles 11 and 12 of regulation no 45 / 2001 and with national legislation adopted pursuant to articles 10 and 11 of directive 95 / 46 / ec .


### it is essential to ensure that effective and efficient criminal law measures protect the euro and any other currency whose circulation is legally authorised in an appropriate way in all member states . ### it is essential to ensure that member states take all necessary measures to protect the euro and any other currency whose circulation is legally authorised . such measures shall include preventive as well as enforcement measures .


### the protection of the euro and other currencies calls for a common definition of the offences related to the currency counterfeiting as well as for common sanction types both for natural and legal persons . in order to ensure coherence with the geneva convention , this directive should provide for the same offences to be punishable as in the convention . therefore , the production of counterfeit notes and coins and their distribution should be a criminal offence . important preparatory work to those offences , for example the production of counterfeiting instruments and components , should be punished independently . the common aim of those definitions of offences should be to act as a deterrent from any handling with counterfeit notes and coins , instruments and tools for counterfeiting . ### the protection of the euro and other currencies calls for a common definition of the offences related to the currency counterfeiting as well as for effective , proportionate and dissuasive penalties both for natural and legal persons . in order to ensure coherence with the geneva convention , this directive should provide for the same offences to be punishable as in the convention . therefore , the production of counterfeit notes and coins and their distribution should be a criminal offence . important preparatory work to those offences , for example the production of counterfeiting instruments and components , should be punished independently . the common aim of those definitions of offences should be to act as a deterrent from any handling with counterfeit notes and coins , instruments and tools for counterfeiting .


### member states should establish their jurisdiction in coherence with the geneva convention and the provisions on jurisdiction in other union criminal law legislation , that is to say , for offences committed on their territory and for offences committed by their nationals . the pre - eminent role of the euro for the economy and society of the european union as well as the specific threat to the euro as a currency of world - wide importance calls for an additional measure to protect it . therefore , each member state whose currency is the euro should exercise universal jurisdiction , for offences related to the euro committed outside the european union , if either the offender is in its territory or counterfeit euros related to the offence are detected in that member state . when exercising universal jurisdiction , member states should respect the principle of proportionality , in particular with regard to convictions by a third country for the same conduct . ### member states should establish their jurisdiction in coherence with the geneva convention and the provisions on jurisdiction in other union criminal law legislation , that is to say , for offences committed on their territory and for offences committed by their nationals , noting that offences are best dealt with by the criminal justice system of the state where they occur . the principle of ne bis in idem has to be respected , which means that no prosecution measures will be taken against those who have been finally convicted or acquitted in a previous trial .


### instruments , articles , computer programs and any other means peculiarly adapted for the counterfeiting or altering of currency ; or ### instruments , articles , computer programs and any other means specifically adapted for the counterfeiting or altering of currency ; or


### in order to prevent , reduce and as far as possible eliminate pollution arising from industrial activities in compliance with the ' polluter pays ' principle and the principle of pollution prevention , it is necessary to establish a general framework for the control of the main industrial activities , giving priority to intervention at source and ensuring prudent management of natural resources . ### in order to prevent , reduce and as far as possible eliminate pollution arising from industrial activities , it is necessary to establish a general framework for the control of the main industrial activities , ensuring that responsibility lies with operators in the light of the specific characteristics of both industries and operators , giving priority to intervention at source and ensuring prudent management of natural resources .


### in order to prevent , reduce and , as far as possible , eliminate pollution arising from industrial activities in the most cost effective way while ensuring a high level of protection of the environment as a whole , in particular through the implementation of best available techniques , the possibilities for market based instruments such as trading in nitrogen oxides and sulphur dioxide emissions could be explored . ### in order to prevent , reduce and , as far as possible , eliminate pollution arising from industrial activities in the most cost effective , fair and efficient way while ensuring a high level of protection of the environment as a whole , in particular through the implementation of best available techniques , the possibilities of ensuring full access and financing for microbusinesses and smes in respect of its implantation and updating could be explored .


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


### it is therefore necessary to ensure a more level playing field for undertakings operating in the internal market and to improve the conditions for consumers to exercise the rights they derive from the internal market . it is also appropriate to increase legal certainty and to reduce the differences between the member states as to the national rules governing actions for damages for infringements of european competition law and , when applied in parallel to the latter , national competition law . an approximation of these rules will also help to prevent the emergence of wider differences between the member states ' rules governing actions for damages in competition cases . ### it is therefore necessary to ensure a more level playing field for undertakings operating in the internal market and to improve the conditions for consumers to exercise the rights they derive from the internal market . it is also appropriate to increase legal certainty and to reduce the differences between the member states as to the national rules governing actions for damages for infringements of european competition law and , when applied in parallel to the latter , national competition law . an approximation of these rules and an obligation for the member states to introduce collective redress mechanisms based on defined common principles will also help to prevent the emergence of wider differences between the member states ' rules governing actions for damages in competition cases .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , an insurance , reinsurance and occupational pension funds stakeholder group should be established for that purpose , representing in balanced proportions community insurance and reinsurance firms as well as occupational pension funds , their employees and consumers and other retail users of the insurance , reinsurance and occupational pension services , including smes . the insurance , reinsurance and occupational pension funds stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should allow interested parties to be consulted on all work undertaken by the authority and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , an insurance , reinsurance and occupational pension funds stakeholder group should be established for that purpose , representing in balanced proportions union insurance and reinsurance firms as well as occupational pension funds , their employees and consumers and other retail users of the insurance , reinsurance and occupational pension services , including smes . the insurance , reinsurance and occupational pension funds stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or union legislation .


### contribute to developing high quality and uniform supervisory standards , including reporting standards ; ### contribute to developing high quality uniform supervisory standards , including reporting and accounting standards ;


### on the basis of the peer review the authority may issue recommendations to the national supervisory authorities concerned . ### on the basis of the peer review the authority may issue guidelines and recommendations pursuant to article 8 to the competent authorities concerned , or adopt a decision addressed to competent authorities or adopt draft technical standards in accordance with articles 7 to 7d .


### in particular , the authority shall , in cooperation with the esrb , initiate and coordinate community - wide assessments of the resilience of financial institutions to adverse market developments . to that end , it shall develop the following , for application by the national supervisory authorities : ### in particular , the authority shall , in cooperation with the esrb , initiate and coordinate community - wide assessments of the resilience of financial institutions to adverse market developments , and of threats arising from financial products’ characteristics and distribution processes . to that end , it shall develop the following , for application by the competent authority :


### to prevent and minimise recidivism , offenders should be subject to an assessment of the danger posed by the offenders and the possible risks of repetition of sexual offences against children , and should have access to effective intervention programmes or measures on a voluntary basis . ### to prevent and minimise recidivism , offenders should have access to support programmes or treatment on a voluntary basis .


### this directive respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and notably human dignity , the prohibition of torture and inhuman or degrading treatment or punishment , the rights of the child , the right to liberty and security , freedom of expression and information , protection of personal data , the right to an effective remedy and to a fair trial and the principles of legality and proportionality of criminal offences and penalties . in particular , this directive seeks to ensure full respect for those rights and has to be implemented accordingly . ### this directive respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and notably human dignity , the prohibition of torture and inhuman or degrading treatment or punishment , the rights of the child , the right to liberty and security , freedom of expression and information , protection of personal data , the right to an effective remedy and to a fair trial and the principles of legality and proportionality of criminal offences and penalties . in particular , this directive ensures full respect for those rights and has to be implemented accordingly .


### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries which take into account their economic , social and political contexts and also the union ' s specific interests , policy priorities and strategies , whilst maintaining the ability to intervene all over the world wherever needed . ### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries which take into account their economic , social and political contexts and also the union ' s specific policy priorities and strategies .


### in order to adapt the scope of this regulation to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission in respect of the detailed areas of cooperation defined in the annex . 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 to the council . ### in order to adapt the scope of this regulation to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission in respect of the financial allocation of funds by regions and priority areas of cooperation defined in the annex . 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 to the council .


### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional or multilateral relationships with third countries and address challenges of global concern . ### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional , interregional or multilateral relationships with partner countries and regions and address challenges of global concern .


### implementing the international dimension of the ' europe 2020 ' strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change and environment . this objective shall be measured by the uptake of the ' europe 2020 ' policies and objectives by key partner countries ; ### supporting the union ' s bilateral , regional , inter - regional and multilateral cooperation partnership strategies in accordance with the principles guiding the union ' s external action , as laid down in the treaties . this objective includes the promotion of democracy , the respect for human rights and fundamental freedoms and the rule of law , as well as the promotion of decent work and good governance , the preservation of the environment , the promotion of policy dialogues and the development of collective approaches and responses to challenges of global concern such as renewable energies supply and climate change in order to contribute to progress and sustainable development processes in partner countries and regions and the union . regarding partner countries specifically targeted by actions , programmes and measures under this regulation , this objective shall be measured by the degree of reductions of human rights violations , by improvement in their human development index , improvement in their international labour organisation decent work indicators , by the increase of the share of renewable energies in their energy supply mix , and by the reduction of their climate relevant emissions ;


### improving market access and developing trade , investment and business opportunities for european companies by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union ' s share in foreign trade with key partner countries and by trade and investments flows to partner countries specifically targeted by actions , programmes and measures under this regulation ; ### supporting the establishment and expansion of fair bilateral economic , trade and investment relations , with a focus on promoting business opportunities for small and medium - sized enterprises by means of creating mutual market access support and information centres and by supporting regulatory cooperation through research , analysis and workshop schemes . this objective shall be measured by the market share of smes and fair trade , by trade and investments flows to and from partner countries specifically targeted by actions , programmes and measures under this regulation ;


### the union seeks to promote , develop and consolidate the principles of liberty , democracy , respect for human rights and fundamental freedoms and the rule of law on which it is founded by means of dialogue and cooperation with third countries . ### the union seeks to promote , develop and consolidate the values of respect for human dignity , freedom , democracy , equality , the rule of law and respect for human rights , including the rights of persons belonging to minorities , on which it is founded by means of dialogue and cooperation with third countries . these values are common to member states of the union in a society in which pluralism , non - discrimination , tolerance , justice , solidarity and equality between women and men prevail .


### to enhance the impact of the union ' s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries to take account of their economic , social and political contexts as and also of the union ' s specific interests , policy priorities and strategies . ### to enhance the impact of the union ' s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries and regions to take account of their economic , social and political contexts as and also mutual policy priorities and strategies .


### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and shall also relate to areas linked to the union ' s specific interests , policy priorities and strategies . ### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the partner countries and regions concerned , and shall also relate to areas linked to the union ' s policy priorities and strategies .


### since the objective of this directive , namely to ensure the availability of criminal sanctions for the most serious market abuse offences across the union , cannot be sufficiently achieved by the member states and can therefore , by reason of the scale and effects of this directive , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve that objective . ### although at the moment no reliable statistics are available about the cross - border dimension of insider dealing and market manipulation , considering the integration of financial markets inside the union , it can be safely assumed that many of these offences are not limited to transactions in one member state only . against that background , the objective of this directive , namely to ensure the availability of criminal sanctions for the most serious market abuse offences across the union , is likely not to be sufficiently achieved by the member states and can therefore , by reason of the scale and effects of this directive , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve that objective .


### the commission should assess the implementation of this directive in the member states , also with a view to assessing a possible future need for introducing minimum harmonisation of the types and levels of criminal sanctions . ### the commission should assess the implementation of this directive in the member states , also with a view to assessing a possible future need for introducing minimum harmonisation of the types and levels of criminal sanctions . in particular , the commission should seek to obtain information on the cross - border nature of many of the transactions constituting an offence according to this directive , thus strengthening the implementation of the subsidiarity principle .


### to facilitate enforcement , relevant designated third parties such as trade unions or other associations should be able to lodge complaints in order to ensure effective application of the directive . this is considered necessary to address situations where seasonal workers are unaware of the existence of enforcement mechanisms or hesitant to use these in their own name , out of fear of possible consequences . ### to facilitate enforcement of the directive , effective mechanisms should be established for the lodging of complaints directly or via designated third parties , such as trade union organisations or other associations . this is considered necessary to address situations where seasonal workers are unaware of the existence of enforcement mechanisms or hesitant to use these in their own name , out of fear of possible consequences . there should also be adequate judicial protection for seasonal workers following the lodging of a complaint .


### ‘ seasonal worker’ means a third - country national who retains a legal domicile in a third country but resides temporarily for the purposes of employment in the territory of a member state in a sector of activity dependent on the passing of the seasons , under one or more fixed - term work contracts concluded directly between the third - country national and the employer established in a member state ; ### ‘ seasonal worker’ means a third - country national who retains a legal domicile in a third country but resides temporarily for the purposes of employment in the territory of a member state in a sector of activity dependent on the passing of the seasons or on collective living arrangements , under one or more fixed - term work contracts concluded directly between the third - country national and the employer established in a member state .


### member states shall ensure that third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , may engage either on behalf of or in support of a seasonal worker , with his / her approval , in any administrative or civil proceedings provided for with the objective of implementing this directive . ### member states shall ensure that there are effective mechanisms through which seasonal workers may lodge complaints against their employers , directly or through third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , or through a competent authority of the member state if there is appropriate provision under national legislation . before a complaint is lodged , member states shall ensure that third parties which have a legitimate interest in ensuring compliance with this directive may engage , either on behalf of or in support of a seasonal worker , in any form of mediation between the employer and the seasonal worker and any administrative or civil proceedings provided for with the objective of implementing this directive .


### the provisions of the common market organisation should be implemented in compliance with the union international commitments , in particular with regard to the provisions of the world trade organisation . ### the provisions of the common market organisation should be implemented in compliance with the union international commitments , in particular with regard to the provisions of the world trade organisation . it must be stressed , however , that fish and shellfish are a common good and that fishing is therefore not like other industries . it should , in particular , be regulated by measures that satisfy environmental and ecosystemic criteria , irrespective of market requirements .


### producer organisations are the key actors for the appropriate application of the common fisheries policy and the common market organisation . it is therefore necessary to strengthen their objectives to ensure that their members carry out fishing and aquaculture activities in a sustainable manner , improve the placing on the market of products , and collect economic information on aquaculture . when realising these objectives , producer organisations should take account the different conditions of the fishery and aquaculture sectors prevailing in the union , in particular the specificities of small - scale fisheries . ### producer organisations are the key actors for the appropriate application of the common fisheries policy and the common market organisation . it is therefore necessary to strengthen their objectives in order to ensure that their members carry out fishing and aquaculture activities in a sustainable manner , improve the placing on the market of products and collect environmental and economic information on aquaculture , whilst experiencing an improvement in their incomes . when realising these objectives , producer organisations should take into account the different conditions of the fishery and aquaculture sectors prevailing in the union , in particular the specificities of small - scale fisheries , and especially their greater environmental sustainability , which warrants support and positive discrimination in favour of this fleet segment within the cmo .


### improving producer’s profitability . ### improving producers’ profitability and improving the income of fishing operators ;


### improving producer’s profitability . ### improving producers’ profitability and the income of workers in the sector while improving their working conditions ;


### promotion of responsible and sustainable aquaculture , notably in terms of environment protection , animal health and animal welfare ; ### promotion of responsible and sustainable aquaculture , notably in terms of environment protection , animal health and animal welfare , including through the provision of training to memberundertakings ;


### collecting information on the marketed products including economic information on first sales , and on production forecasts . ### collecting environmental information and information on the marketed products including economic information on first sales , and on production forecasts .


### for the purposes of paragraph 1 a fishery producer organisation is deemed representative where it accounts for at least 65 % of the quantities marketed of the relevant product during the previous year in the area where it is proposed to extend the rules ### for the purposes of paragraph 1 a fishery producer organisation is deemed representative where it accounts for at least 65% of the producers and 65% of the quantities landed of the relevant product during the previous year in the area where it is proposed to extend the rules .


### producer organisations may finance the storage of fishery products listed in annex ii to this regulation , provided that : ### storage aid may be granted to producer organisations with a view to the storage of fishery products listed in annex ii to this regulation , provided that :


### fishery and aquaculture products referred to in points , , and of annex i which are marketed within the union , irrespective of their origin , may only be offered for retail to the final consumer where appropriate marking or labelling indicates : ### fishery and aquaculture products referred to in points , , and of annex i which are marketed within the union , irrespective of their geographical origin , may only be offered for retail to the final consumer where appropriate marking or labelling indicates :


### in the case of fishery products caught at sea , the name of one of the areas , subareas or divisions listed in the fao fishing areas ; ### in the case of fishery products caught at sea , both the name and the distinctive number of one of the areas , subareas or divisions listed in the fao fishing areas ;


### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset disposal activities . ### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset disposal activities , whilst respecting the principle of proportionality .


### this directive respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , and notably the right to property , the right to respect for private and family life , the right to protection of personal data , the right to an effective remedy and to a fair trial , the presumption of innocence and the right of defence , the right not to be tried or punished twice in criminal proceedings for the same criminal offence and the principles of legality and proportionality of criminal offences . this directive has to be implemented in accordance with these rights and principles . ### this directive respects the fundamental rights and observes the principles recognised by the european convention on human rights and the jurisprudence of the european court of human rights , the charter of fundamental rights of the european union , and notably the right to property , the right to respect for private and family life , the right to protection of personal data , the right to an effective remedy and to a fair trial , the presumption of innocence and the right of defence , the right not to be tried or punished twice in criminal proceedings for the same criminal offence and the principles of legality and proportionality of criminal offences . this directive has to be implemented in accordance with these rights and principles .


### other property of the convicted person , which was transferred to third parties in order to avoid confiscation of property the value of which corresponds to the proceeds . ### other property of the convicted person , which was transferred to third parties for the sole reason of avoiding confiscation of property the value of which corresponds to the assets .


### strengthening social inclusion with cooperation on equitable access to basic services , employment for all , empowerment and respect of rights of specific groups , notably youth , persons with disabilities , women and minority groups to let all population participate and benefit from wealth creation and cultural diversity . ### strengthening social inclusion and gender equality with cooperation on equitable access to basic services , employment for all , empowerment and respect of rights of specific groups , notably youth , persons with disabilities , women and minority groups to let all population participate and benefit from wealth creation and cultural diversity .


### supporting country level programmes to promote women ' s economic and social empowerment and political participation ; ### supporting local , regional and country level programmes to promote women ' s economic and social empowerment and political participation ;


### supporting national , regional and global initiatives to promote the integration of this issue in the aid effectiveness agenda . ### supporting local , regional , national and global programmes and initiatives , to promote and implement gender equality , women and girls ' empowerment , namely through micro - credit assistance , and the aid effectiveness agenda .


### improving the health and well - being of people in developing countries through increasing access to , and equitable provision of , good quality essential public health services and more specifically : ### in line with the priorities set out in the european consensus for development , supporting the health and well - being of people in developing countries through increasing access to , and equitable provision of , good quality essential public health services and more specifically :


### supporting and shaping the policy agenda of global initiatives of direct significant benefit to partner countries , considering result orientation , aid effectiveness and effects on health systems , including supporting partner countries to better engage with these initiatives ; ### supporting and shaping the policy agenda of global initiatives of direct significant benefit to partner countries , in the context of poverty eradication and in the areas of health and basic education , considering result orientation , aid effectiveness and effects on health systems , including supporting partner countries to better engage with these initiatives ;


### supporting specific initiatives especially at regional and global level , which strengthen health systems and help countries develop and implement sound , evidence - based national health policies , and in priority areas . ### supporting specific initiatives at local , regional and global levels , which strengthen health systems and help countries develop and implement sound , evidence - based national health policies , and in priority areas .


### improving equal access and quality of education , including for vulnerable groups , women and girls , and countries furthest from achieving global targets . ### enhancing equal access and quality of education , with particular emphasis on women , girls and other vulnerable groups , and countries furthest from achieving global targets .


### since the objective of this regulation , namely to ensure that , throughout the union , clinical trial data are reliable and robust while ensuring the safety and rights of subjects , cannot sufficiently be achieved by the member states and can , by reason of the scale of the measure , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective , ### since the objective of this regulation , namely to ensure that , throughout the union , clinical trial data are reliable and robust while ensuring the safety , well - being and rights of subjects , cannot sufficiently be achieved by the member states and can , by reason of the scale of the measure , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective ,


### – the rights , safety and well - being of subjects are protected ; and ### – the rights , safety , dignity and well - being of subjects are protected ; and


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within 14 days , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### compliance with the requirements for informed consent as set out in chapter v ; ### compliance with the requirements for the protection of the subjects and informed consent as set out in chapter v ;


### where the member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . ### where the member state concerned disagrees with the conclusion of the reporting member state , it shall communicate its disagreement through the eu portal to the commission , to all member states , and to the sponsor .


### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ; ### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with a medical doctor who is the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ;


### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . ### any subject may , without any resulting liability or detriment , withdraw from the clinical trial at any time by revoking without any justification his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal .