### this regulation lays down a framework for verifying that products meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security and other public interests . ### this regulation lays down a framework for verifying that products meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , the protection of workers ' and consumer rights , the environment , public security and other public interests .


### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this regulation seeks to ensure full respect for obligation to ensure a high level of human health protection and consumer protection as well as full respect of the freedom to conduct a business and the right to property , ### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this regulation seeks to ensure full respect for obligation to ensure a high level of human health protection as well as full respect for consumers ' and workers ' rights ,


### ‘ keeper’ means the person or entity that , being the owner of a vehicle or having the right to use it , exploits the vehicle as a means of transport and is registered as such in the national vehicle register referred to in article 43 of directive xx on the interoperability of the rail system ; ### ' owner ' means the person or entity that , being the owner of a vehicle , is registered as such in the national vehicle register referred to in article 43 of directive xx on the interoperability of the rail system ;


### ‘ 17a . trading of medicinal products : ' all activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , or billing or brokering medicinal products , apart from supplying medicinal products to the public , and not falling under the definition of wholesale distribution . ' ### ‘ 17a . trading : ' all activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , active pharmaceutical ingredients or excipients , or billing medicinal products , active pharmaceutical ingredients or excipients , apart from supplying them to the public , and not falling under the definition of wholesale distribution . '


### ‘ the principles of good manufacturing practice for active substances used as starting materials referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’ ### ‘ the principles of good manufacturing and distribution practices for active substances used as starting materials and excipients referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’


### ‘ to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### ‘ to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . excipients shall be subject to the same conditions of good manufacturing and distribution practices . '


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , mandatory safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines and excipients . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . no later than five years after the date of entry into force of this directive , the commission should submit to the european parliament and to the council an assessment report on the application of the safety features referred to in point of article 54 of directive 2001 / 83 / ec and their estimated contribution to the reduction of the number of falsified medicines in the legal supply chain in europe . the report should include an assessment of the safety features of other categories of medicines , including medicinal products not subject to medical prescription as defined in title vi of directive 2001 / 83 / ec .


### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state .


### ‘ they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched or traded at least the following information : – date , – name of the medicinal product , – quantity received , supplied or traded , – name and address of the supplier or consignee , as appropriate ; ### ‘ they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched , traded or brokered at least the following information : – date , – name of the medicinal product , – quantity received , supplied , traded or brokered , – name and address of the supplier or consignee , as appropriate , - batch number , - registration number of the marketing authorisation ;


### importers and manufacturers of active substances used as starting materials established in the community shall notify their address to the competent authority of the member state where they are established . ### importers , manufacturers and distributors of active substances used as starting materials and excipients established in the community shall notify their address to the competent authority of the member state where they are established .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . ### persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply .


### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights . ### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 18 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 18 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 24 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 48 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . 2 ) member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 12 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 12 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 12 months after publication ] , the provisions necessary to comply with article 1 , and from [ insert concrete date 24 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . 2 ) member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive .


### they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the community , and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented . ### they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the community , and that the plant is subject to regular control and efficient enforcement of good manufacturing practices ensuring a protection of public health at least equivalent to that in the community , and that in the event of findings related to non - compliance , this information shall be supplied by the exporting third country to the community without any delay .


### in particular the commission should be empowered to adopt measures regarding safety features that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market . since those measures are of general scope and are designed to amend non - essential elements by supplementing it , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### in particular the commission should be empowered to adopt delegated acts in accordance with article 290 tfeu in respect of safety features that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market .


### any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorisation . in order for the safety features to be effective , the manufacturing authorisation holder should only be permitted to remove , replace or cover these features under strict conditions . ### any actor in the supply chain who packages medicinal products , or makes changes to the labelling or packaging , has to be a holder of a manufacturing authorisation . in order for the safety features to be effective , the manufacturing authorisation holder should only be permitted to remove , replace or cover these features under strict conditions .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### the manufacture of active pharmaceutical ingredients or excipients should be subject to good manufacturing practices irrespective of whether those ingredients or excipients were manufactured in the community or imported . with regard to their manufacture in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients or excipients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation .


### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 . ### the social economy is a cornerstone of europe ' s social models . it can act as a driver of social progress by offering innovative solutions , and therefore make a valuable contribution to promoting inclusive labour markets and social services accessible to all . the programme should improve the social economy organisations ' access to finance .


### the microfinance and social entrepreneurship axis , which shall facilitate access to finance for entrepreneurs , especially those furthest from the labour market , and social enterprises . ### the microfinance and social entrepreneurship axis , which shall facilitate access to , and increase the availability of , finance for potential entrepreneurs , especially unemployed , socially excluded and vulnerable people , as well as existing micro - enterprises and social enterprises .


### promote workers’ geographical mobility and boost employment opportunities by developing union labour markets that are open and accessible to all ; ### consolidate the single market by promoting workers’ geographical mobility and boost employment opportunities by developing union labour markets that are open and accessible to all , by respecting and guaranteeing freedom of movement and workers’ rights throughout the union ;


### promote employment and social inclusion by increasing the availability and accessibility of microfinance for vulnerable groups and micro - enterprises , and by increasing access to finance for social enterprises . ### promote employment and social inclusion by increasing the availability and accessibility of microfinance for vulnerable groups and micro - enterprises and by increasing access to finance for social enterprises , as a means of improving their liquidity and independence .


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to articles 8 and 10 of the treaty on the functioning of the european union , the commission and the member states should ensure that the mainstreaming of gender equality and anti - discrimination objectives help to promote equality between men and women in all the programme’s axes and activities , and that the european pact for gender equality is also taken into consideration . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . effective application of the principle of gender equality should include gender - aggregated data and indicator , s and objectives and criteria focused on gender equality .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . it is also important for the credit that is offered to be made more flexible through non - bank institutions and for it to be adequate to cover the technological modernisation and improvements needed to safeguard the liquidity and independence of micro , small and medium - sized enterprises .


### promote workers ' geographical mobility and boost employment opportunities by developing union labour markets that are open and accessible to all ; ### facilitate workers ' voluntary geographical mobility , especially in border regions by supporting cross - border partnerships , cross - border social dialogue and also counselling and information for jobseekers , mobile workers and employers , and boost employment opportunities by developing high - quality inclusive labour markets that are open and accessible to all ;


### strengthen ownership of the union objectives in the employment , social and working conditions fields among key union and national policy - makers , as well as other interested parties in order to bring about concrete and coordinated actions at both union and member state level ; ### promote strategies , among key union and national policy - makers , as well as other interested parties , to increase employment and safeguard social and labour rights , while always keeping sight of the objective of gender equality and gender mainstreaming , in order to bring about concrete and coordinated actions at both union and member state level ;


### in accordance with article 148 of the treaty on the functioning of the european union , the council adopted guidelines for employment policies on 21 october 2010 , which , together with the broad guidelines for the economic policies of the member states and of the union adopted in accordance with article 121 of the treaty , comprise the europe 2020 integrated guidelines . the programme should contribute to applying the europe 2020 integrated guidelines , and in particular guidelines 7 , 8 and 10 , while supporting implementation of the flagship initiatives , with special regard to the european platform against poverty and social exclusion , an agenda for new skills and jobs , and youth on the move . ### in accordance with article 148 of the treaty on the functioning of the european union , the council adopted guidelines for employment policies on 21 october 2010 , which , together with the broad guidelines for the economic policies of the member states and of the union adopted in accordance with article 121 of the treaty , comprise the europe 2020 integrated guidelines . the programme should contribute to achieving the europe 2020 targets with special regard to poverty reduction and employment objectives .


### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 . ### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social progress by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 .


### the progress axis , which shall support the development , implementation , monitoring and evaluation of union employment and social policy and legislation on working conditions and shall promote evidence - based policy - making and innovation , in partnership with the social partners , civil society organisations and other interested parties ; ### the progress axis , which shall support the development , implementation , monitoring and evaluation of union employment and social policy and legislation on working conditions and shall promote evidence - based policy - making and innovation , in partnership with the social partners , civil society organisations and other interested parties . it shall focus on developing common european strategies that produce real improvements in employment and social policy and in working conditions in europe ;


### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities . ### the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty , while keeping sight of the objective of gender equality and in gender mainstreaming . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities .


### 15% to the eures axis ; ### 15% to the eures axis , of which at least 10% shall be allocated to targeted mobility schemes , at least 40% to cross - border partnerships , and at least 20% to the training and qualification of eures personnel ;


### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from international financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . ### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and the social economy should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social economy organisations . the union contribution thus assists in the development of the social economy and the microfinance market in the union and encourages cross - border activities . the union ' s actions should be complementary to the member states ' use of financial instruments for microfinance and the social economy . the entities entrusted with the implementation of the actions should ensure added value and avoid duplication of financing through union resources .


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up annual monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . the report shall be published and made available to the public in the interests of greater transparency .


### promote workers ' geographical mobility and boost employment opportunities by developing union labour markets that are open and accessible to all ; ### promote workers ' voluntary geographical mobility on a fair basis and boost employment opportunities by developing high - quality union labour markets that are open and accessible to all ;


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which the principles of gender equality and gender mainstreaming have been respected and anti - discrimination considerations , including accessibility issues , have been addressed in all the programme’s axes and activities . wherever possible , data shall be gender - aggregated .


### modernise union law in line with the smart regulation principles and ensure that union law on matters relating to working conditions is effectively applied ; ### improve union law in line with the ' good work ' principles and ensure that union law on matters relating to working conditions is effectively applied ;


### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 . ### the social economy is a cornerstone of europe ' s social models . it can act as a driver of social progress by offering innovative solutions , and therefore make a valuable contribution to promoting inclusive labour markets and social services accessible to all . the programme should improve the social economy organisations ' access to finance .


### the microfinance and social entrepreneurship axis , which shall facilitate access to finance for entrepreneurs , especially those furthest from the labour market , and social enterprises . ### the microfinance and social economy axis , which shall facilitate access to finance for entrepreneurs , especially those furthest from the labour market , and social enterprises .


### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material by making it more difficult for offenders to upload such content onto the publicly accessible web . action is therefore necessary to remove the content at source and apprehend those guilty of making distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal by third country authorities of websites containing child pornography , which are hosted in their territory . however as , despite such efforts , the removal of child pornography content at its source proves to be difficult where the original materials are not located within the eu , mechanisms should also be put in place to block access from the union ' s territory to internet pages identified as containing or disseminating child pornography . for that purpose , different mechanisms can be used as appropriate , including facilitating the competent judicial or police authorities to order such blocking , or supporting and stimulating internet service providers on a voluntary basis to develop codes of conduct and guidelines for blocking access to such internet pages . both with a view to the removal and the blocking of child abuse content , cooperation between public authorities should be established and strengthened , particularly in the interest of ensuring that national lists of websites containing child pornography material are as complete as possible and of avoiding duplication of work . any such developments must take account of the rights of the end users , adhere to existing legal and judicial procedures and comply with the european convention on human rights and the charter of fundamental rights of the european union . the safer internet programme has set up a network of hotlines whose goal is to collect information and to ensure coverage and exchange of reports on the major types of illegal content online . ### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material . action is therefore necessary to remove the content at source and apprehend those guilty of making distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal by third country authorities of websites containing child pornography , which are hosted in their territory . for that purpose , mechanisms should be put in place to strengthen international cooperation between states , judicial and police authorities , and reporting points for child pornography in order to ensure the safe and fast removal such websites .


### the proposal , by means of information and communication technology , by an adult to meet a child who has not reached the age of sexual consent under national law , for the purpose of committing any of the offences referred to in articles 3 and article 5 , where this proposal has been followed by material acts leading to such a meeting , shall be punishable by a maximum term of imprisonment of at least two years . ### to influence , as an adult , a child who has not reached the age of sexual consent under national law , by means of written or spoken word or by the showing of pornographic material , in order to commit any of the offences referred to in article 3 , article 4 , and article 5 , shall be punishable by a maximum term of imprisonment of at least two years .


### the provisions of article 3 , with regard to witnessing sexual activities , and ; article 4 and and article 5 do not govern consensual sexual activities between children or involving persons who are close in age and degree of psychological and physical development or maturity , insofar as the acts did not involve any abuse . ### at the discretion of the courts on a case by case basis and in accordance with national provisions for the implementation of the law concerning the age of sexual consent , the provisions of article 3 , with regard to witnessing sexual activities , and , article 4 and and article 5 may be waived for consensual sexual activities between children or involving persons who are close in age and degree of psychological and physical development or maturity , insofar as the acts did not involve any abuse , including that defined in article 3 and .


### interviews with the child victim take place , where necessary , in premises designed or adapted for this purpose ; ### interviews with the child victim take place in premises designed or adapted for this purpose , and where the child feels safe ;


### member states shall take the necessary measures to enable investigative units or services to attempt to identify the victims of the offences referred to in articles 3 to 7 , in particular by analysing child pornography material , such as photographs and audiovisual recordings transmitted or made available by means of information and communication technology . ### member states shall take the necessary measures to enable investigative units or services to attempt to identify the victims of the offences referred to in articles 3 to 7 , in particular by analysing child pornography material , such as photographs and audiovisual recordings transmitted or made available by means of information and communication technology . for that purpose , mechanisms shall be put in place to ensure the efficient cooperation and knowledge transfer between law enforcement authorities , judicial authorities , social welfare authorities , the information and communication technology industry and civil society organisations . police forces and social services should work together on these cases so that children receive an adequate response and treatment when they are identified .


### within three months following the reception of the application for registration , the european parliament shall adopt a decision , which it shall publish in the official journal of the european union , together with the party or foundation statutes or , where an application has not been approved , the grounds for rejection . ### if the documents submitted with an application by a political alliance and / or the foundation affiliated to it for registration as a european political party or european political foundation fulfil the criteria in articles 3 , 4 and 5 of this regulation , it shall be formally registered . if the documents do not meet these requirements , the application for registration shall be deemed to have been rejected . the applicant shall be informed accordingly by the european parliament . the applicant may resubmit its application for registration in an appropriately corrected form .


### the european political parties and the european political foundations should be governed by the substantive rules set out in this regulation , and by national law in the member states , in particular that of the member state where they have their respective seat and for the purposes of which they should identify the appropriate legal form , which must correspond to a form of legal entity recognised in the legal order of that member state . ### the european political parties and the european political foundations should be governed by the substantive rules set out in this regulation , and , in matters not , or only partly , regulated by this regulation or their respective statutes , by national law in the member states , in particular that of the member state where they have their respective seat .


### the admission , resignation and exclusion of the party ' s members , with the list of members annexed to it , ### the admission , resignation and exclusion of the party ' s members , with the list of member parties cooperating in the european political party annexed to it ,


### the european parliament shall verify annually that the conditions and requirements set out in articles 3 , 4 and 5 continue to be met by the european political parties and the european political foundations . ### the european parliament shall verify immediately after the submission of changes to the documents or to the statutes of a european political party or european political foundation whether the european political party or european political foundation concerned continues to meet the conditions and requirements set out in articles 3 , 4 and 5 .


### the dissolution of the entity as a recognised european political party . ### the procedure for terminating the structured cooperation between the political parties and / or natural persons in a political alliance as referred to in article 2 .


### european political parties should not fund , directly or indirectly , other political parties and in particular national parties or candidates . european political foundations should not fund , directly or indirectly , european or national political parties or candidates . moreover , european political parties and their affiliated european political foundations should not finance national referenda campaigns . these principles reflect declaration no 11 on article 191 of the treaty establishing the european community annexed to the final act of the treaty of nice . ### european political parties may not fund , directly or indirectly , political parties and in particular national parties or candidates . european political foundations may not fund , directly or indirectly , european or national political parties or candidates . moreover , european political parties and their affiliated european political foundations may not finance national or regional referendum campaigns on purely national or regional topics . these principles reflect declaration no 11 on article 191 of the treaty establishing the european community annexed to the final act of the treaty of nice .


### the delegation of power referred to in articles 2 , 7 , 10 , 16 , 20 , 23 , 25 , 31 , 33 , 43 , 55 , 57 , 64 , 76 , 87 , 94 , 102 , 109 , 113 , 118 , 129 , 133 , 136 , 139 , 142 , 145 , 151 , 155 , 157 , 166 , 171 , 173 , 177 , 179 , 182 , 184 , 186 , 190 , 192 , 195 , 198 , 202 , 217 , 219 , 230 , 232 , 234 , 238 , 241 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in articles 2 , 7 , 10 , 16 , 20 , 23 , 25 , 31 , 33 , 43 , 55 , 57 , 64 , 76 , 87 , 94 , 102 , 109 , 113 , 118 , 129 , 133 , 136 , 139 , 142 , 145 , 151 , 155 , 157 , 166 , 171 , 173 , 177 , 179 , 182 , 184 , 186 , 190 , 192 , 195 , 198 , 202 , 217 , 219 , 230 , 232 , 234 , 238 , 241 shall be conferred on the commission until 31 december 2014 .


### the rules for the granting of the authorisation referred to in article 196 ; ### the rules for granting of the authorisation for authorised consignor , authorised consignee , the use of special seals and the rules for simplified transit procedures for movements by air and sea referred to in article 196 .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard shall be made up of an array of macroeconomic , macrofinancial and social indicators for member states . these will allow to detect serious misalignments between aggregate demand and supply and between an economy’s income and consumption and reflect short - term , structural and medium - long term trends . the commission shall set indicative and symmetric lower or upper thresholds for these indicators to serve as alert levels .


### the commission shall , after consultation with member states , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances . ### the commission shall , after a broad consultation with all member states and european parliament , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard shall be made up of an array of macroeconomic , social and macrofinancial indicators for member states . the commission shall set indicative symmetric lower and upper thresholds for these indicators to serve as alert levels , taking into account the starting performance of member states as well as the average position of the union and the euro area and its evolution over time . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard shall be made up of an array of macroeconomic , macrofinancial and social indicators for member states . these will allow to detect serious misalignments between aggregate demand and supply and between an economy’s income and consumption . social indicators will , amongst others , include indicators on inequalities , the incidence of low pay , the working poor , the share of labour income in overall gdp and unit profit rates .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : ### providers of internet access services shall not restrict the rights provided for in paragraph 1 by blocking , slowing down , degrading , altering or discriminating against specific content , applications or services , or specific classes thereof , except in certain special cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , and strictly proportionate and necessary to


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public could foster the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such defined levels of quality are technically necessary for the functionality of the service and these agreements do not impair the quality of internet access services , in accordance with the principle of net neutrality .


### in an open internet , providers of electronic communications to the public should , within contractually agreed limits on data volumes and speeds for internet access services , not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . reasonable traffic management encompasses prevention or impediment of serious crimes , including voluntary actions of providers to prevent access to and distribution of child pornography . minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances . ### in an open internet , providers of electronic communications to the public should not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . legally mandated interferences in traffic flows does not constitute traffic management . minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances .


### ‘ 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 , operated within closed electronic communications networks using the internet protocol with strict admission control ; and that is not marketed or used as a substitute for internet access service or functionally identical to services available over the public internet access service ;


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : ### providers of internet access services shall not restrict the rights provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , strictly proportionate and necessary to :


### end - users shall be free to enter into agreements on data volumes and speeds with providers of internet access services and , in accordance with any such agreements relative to data volumes , to avail of any offers by providers of internet content , applications and services . ### providers of internet access services may however offer agreements that differentiate according to data volumes and speeds provided that they do not discriminate based on the content , application or service themselves , or specific classes .


### the commission may adopt implementing acts defining uniform conditions for the implementation of the obligations of national competent authorities under this article . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 33 . ### the commission may adopt , after consultations with berec and other stakeholders , implementing acts defining uniform conditions for the implementation of the obligations of national competent authorities under this article . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 33 .


### ‘ 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 ;


### minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . ### mitigate the effects of temporary and exceptional network congestion , primarily by means of application - agnostic measures , provided that equivalent types of traffic are treated equally .


### in order to enable the provision of specialised services to end - users , providers of content , applications and services and providers of electronic communications to the public shall be free to enter into agreements with each other to transmit the related data volumes or traffic as specialised services with a defined quality of service or dedicated capacity . the provision of specialised services shall not impair in a recurring or continuous manner the general quality of internet access services . ### in order to enable the provision of specialised services to end - users , providers of content , applications and services and providers of electronic communications to the public may enter into agreements with each other to transmit the related data volumes or traffic as specialised services with a defined quality of service or dedicated capacity . the provision of specialised services shall not impair the quality of internet access services .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : ### providers of internet access services shall not restrict the rights provided for in paragraph 1 by blocking , slowing down , degrading , altering or discriminating against specific content , applications or services , or specific classes thereof , except in certain special cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , strictly proportionate and necessary to :


### in an open internet , providers of electronic communications to the public should , within contractually agreed limits on data volumes and speeds for internet access services , not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . reasonable traffic management encompasses prevention or impediment of serious crimes , including voluntary actions of providers to prevent access to and distribution of child pornography . minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances . ### in an open internet , providers of electronic communications to the public should not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances .


### end - users shall also be free to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service . ### end - users shall also have the right to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service .


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public could serve to provide specialised services and is expected to play a role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . this should however not impair the development of the general purpose internet . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such quality characteristics are technically necessary for the functionality of the service and agreements do not impair the quality of internet access services .


### 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 .


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . ### end - users shall have the right to access and distribute information and content , run applications , connect hardware and use services and software of their choice via their internet access service .


### having due regard to articles 93 , 107 and 108 of the treaty , member states may also provide the infrastructure manager with financing consistent with its functions as referred to in point of article 3 , the size of the infrastructure and financial requirements , in particular in order to cover new investments . member states may decide to finance those investments through means other than direct state funding . ### whenever revenues are not sufficient to cover the financing needs of the infrastructure manager , without prejudice to the charging framework of articles 31 and 32 of this directive , and having due regard to articles 93 , 107 and 108 of the treaty , member states shall also provide the infrastructure manager with financing consistent with its tasks , the size of the infrastructure and financial requirements , in particular in order to cover new investments .


### maintenance facilities , with the exception of heavy maintenance services supplied in maintenance facilities exclusively dedicated to specific types of rolling stock , and other technical facilities , including cleaning and washing facilities ; ### maintenance facilities as referred in the concerned definitions in article 3 , with the exception of heavy maintenance services supplied in maintenance facilities dedicated to specific types of rolling stock and other technical facilities , including cleaning and washing facilities ;


### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall not exceed eur 0 , 10 . without prejudice to articles 13 and 19 , the regulated maximum retail charge for the euro - sms tariff shall remain at eur 0 , 10 until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - sms tariff which a home provider may levy from its roaming customer for a regulated roaming sms message sent by that roaming customer may vary for any roaming sms message but shall fall from eur 0 , 07 on 1 july 2012 to eur 0 , 03 on 1 july 2014 , after which the sms roaming charge shall be aligned with the domestic rate by 1 july 2015 .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 50 per megabyte . the price ceiling for data used shall decrease to eur 0 , 30 and eur 0 , 10 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively , after which data roaming charges will be aligned with domestic rates , which must not exceed the eurotariff set here , by 1 july 2015 .


### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 32 per minute for any call made or eur 0 , 11 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 28 and eur 0 , 24 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 10 on 1 july 2013 . without prejudice to articles 13 and 19 these regulated maximum retail charges for the eurotariff shall remain valid until 30 june 2016 . ### the retail charge of a eurotariff which a home provider may levy from its roaming customer for the provision of a regulated roaming call may vary for any roaming call but shall not exceed eur 0 , 15 per minute for any call made or eur 0 , 07 per minute for any call received as of 1 july 2012 . the price ceiling for calls made shall decrease to eur 0 , 13 and eur 0 , 10 on 1 july 2013 and on 1 july 2014 respectively , and for calls received to eur 0 , 05 and eur 0 , 03 on 1 july 2013 and 1 july 2014 respectively , after which roaming charges shall be aligned with domestic rates , which must not exceed the amount set here , by 1 july 2015 .


### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 90 per megabyte . the price ceiling for data used shall decrease to eur 0 , 70 and eur 0 , 50 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 50 , per megabyte used until 30 june 2016 . ### with effect from 1 july 2012 , the retail charge of a euro - data tariff which a home provider may levy from its roaming customer for the provision of a regulated roaming data shall not exceed eur 0 , 45 per megabyte . the price ceiling for data used shall decrease to eur 0 , 30 and eur 0 , 20 , per megabyte used on 1 july 2013 and on 1 july 2014 respectively . without prejudice to articles 13 and 19 , the regulated maximum retail charge shall remain at eur 0 , 20 , per megabyte used until 30 june 2016 .


### 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 .


### where the passenger , or an intermediary acting on behalf of the passenger , reports a spelling mistake in the name of one or several passengers included in the same contract of carriage that may lead to a denial of boarding , the air carrier shall correct this at least once up until 48 hours before departure without any additional charge to the passenger or the intermediary , except where it is prevented from doing so by national or international law . ### where the passenger , or an intermediary acting on behalf of the passenger , reports a spelling mistake in the name of one or several passengers included in the same contract of carriage that may lead to a denial of boarding , the air carrier shall correct this at least once up until 24 hours before departure without any additional charge to the passenger or the intermediary , except where it is prevented from doing so by national or international law .


### regulation no 261 / 2004 should explicitly include the right to compensation for passengers suffering long delays , in line with the judgement of the european court of justice in the joined cases c - 402 / 07 and c - 432 / 07 . at the same time , the thresholds above which delays give rise to a right to compensation should be increased to take account of the financial impact on the sector and to avoid any increase in the frequency of cancellations as a consequence . to ensure that citizens travelling within the eu face homogenous conditions for compensation , the threshold should be the same for all travel within the union , but it should depend upon the journey distance for travel to and from third countries to take into account the operational difficulties encountered by air carriers to deal with delays on remote airports . ### regulation no 261 / 2004 should explicitly include the right to compensation for passengers suffering long delays , in line with the judgement of the european court of justice in the joined cases c - 402 / 07 and c - 432 / 07 . at the same time , the thresholds above which delays give rise to a right to compensation should be increased to take account of the financial impact on the sector and to avoid any increase in the frequency of cancellations as a consequence . to ensure that citizens travelling within the eu face homogenous conditions for compensation , the threshold should be the same for all travel within the union .


### at airports whose annual traffic has been not less than three million passengers for at least three consecutive years , the airport managing body shall ensure that the operations of the airport and of airport users , in particular the air carriers and the suppliers of ground handling services , are coordinated through a proper contingency plan in view of possible situations of multiple cancellations and / or delays of flights leading to a considerable number of passengers stranded at the airport , including in cases of airline insolvency or revocation of the operating licence . the contingency plan shall be set up to ensure adequate information and assistance to the stranded passengers . the managing body of the airport shall communicate the contingency plan and any amendments to it to the national enforcement body designated pursuant to article 16 . at airports below the above - mentioned threshold , the airport management body shall make all reasonable efforts to coordinate airport users and to assist and inform stranded passengers in such situations . ### at airports whose annual traffic has been not less than one and a half million passengers for at least three consecutive years , the airport managing body shall ensure that the operations of the airport and of airport users , in particular the air carriers and the suppliers of ground handling services , are coordinated through a proper contingency plan in view of possible situations of multiple cancellations and / or delays of flights leading to a considerable number of passengers stranded at the airport , including in cases of airline insolvency or revocation of the operating licence . the contingency plan shall be set up to ensure adequate information and assistance to the stranded passengers . the managing body of the airport shall communicate the contingency plan and any amendments to it to the national enforcement body designated pursuant to article 16 . at airports below the above - mentioned threshold , the airport management body shall make all reasonable efforts to coordinate airport users and to assist and inform stranded passengers in such situations .


### 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 .


### member states shall take all necessary measures to check by sampling that the sulphur content of fuels used complies with articles 3 , 3a , 4 , 4a and 4b . the sampling shall commence on the date on which the relevant limit for maximum sulphur content in the fuel comes into force . it shall be carried out with sufficient frequency and in such a way that the samples are representative of the fuel examined , and in the case of marine fuel , of the fuel being used by vessels while in relevant sea areas and ports . ### member states shall take all necessary measures to check by sampling that the sulphur content of fuels used complies with articles 3 , 3a , 4 , 4a and 4b . the sampling shall commence on the date on which the relevant limit for maximum sulphur content in the fuel comes into force . it shall be carried out with sufficient frequency , in sufficient quantities and in such a way that the samples are representative of the fuel examined , and in the case of marine fuel , of the fuel being used by vessels while in relevant sea areas and ports .


### 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


### having regard to the treaty on the functioning of the european union , and in particular article 43 and article 168 thereof , ### having regard to the treaty on the functioning of the european union , and in particular article 43 , article 168 and article 349 thereof ,


### candidate countries and potential candidates need to be better prepared to withstand global challenges , such as sustainable development and climate change , and align with the union ' s efforts to address these issues . union assistance under this regulation should also contribute to the goal of raising the climate - related proportion of the union budget to at least 20 % . ### candidate countries and potential candidates need to be better prepared to withstand global challenges , such as sustainable development and climate change , and align with the union ' s efforts to address these issues . union assistance under this regulation should also contribute to mainstreaming achievement of the europe 2020 goals , democracy , the rule of law , entrepreneurship , human rights , workers ' rights , social progress , environmental protection and the goal of raising the climate - related proportion of the union budget to at least 20 % .


### in its notification , the member state shall justify why and clearly demonstrate how the decision impinges on its fiscal responsibilities . ### in its notification , the member state shall justify why and provide an impact assessment on how much the decision impinges on its fiscal responsibilities .


### 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 :


### 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 should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a securities and markets stakeholder group should be established for that purpose , representing in balanced proportions union financial market participants , their employees , academia 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 by eu legislation .


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


### the securities and markets stakeholder group may submit opinions and advice to the authority on any issue related to the tasks of the authority specified in articles 7 and 8 . ### the securities and markets stakeholder group may submit opinions and advice to the authority on any issue related to the tasks of the authority specified in articles 7 to 19 .


### where competent authorities , in accordance with national law , require public service operators to comply with certain quality and social standards or establish social and qualitative criteria , these standards and criteria shall be included in the tender documents and in the public service contracts . ### the competent authorities shall , in accordance with national law , set the quality and social standards , determine appropriate social and qualitative criteria , such as the obligation to retain workers employed by the previous operator on at least the same terms , and include these in the tender documents and in the public service contracts , regardless of the type of award procedure involved . when the award criteria are set , social and qualitative criteria must each be given a weighting of 20 % .


### where competent authorities , in accordance with national law , require public service operators to comply with certain quality and social standards or establish social and qualitative criteria , these standards and criteria shall be included in the tender documents and in the public service contracts . ### the competent authorities shall , without prejudice to national law and union law , including collective agreements concluded between social partners , lay down the quality , social and environmental standards applicable , determine appropriate social and qualitative criteria and include these standards and criteria in the tender documents and in the public service contracts , regardless of the award procedure , unless at a national , regional or local level a law , a regulation or a binding sector - wide collective agreement , including binding social standards and compulsory transfer of staff in case of change of operator , exists for the staff concerned .


### the specifications of public service obligations and the related compensation of the net financial effect of public service obligations shall : achieve the objectives of the public transport plan in the most cost - effective manner ; financially sustain the provision of public passenger transport in accordance to the requirements laid down in the public transport plan in the long term . ### the specifications of public service obligations and the related compensation of the net financial effect of public service obligations shall be designed to achieve the objectives of the public transport plan in a cost - effective manner and financially sustain the provision of public passenger transport in the long term .


### the establishment of an internal market for passenger transport services by rail requires common rules on competitive tendering for public service contracts in this sector to be applied in a harmonised manner in all member states . ### the establishment of an internal market for passenger transport services by rail requires common rules on adequate social protection and on competitive tendering for public service contracts in this sector to be applied in a harmonised manner in all member states preventing any economic and social dumping .


### 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 .


### in the cases referred to in points and , the competent authority shall have the right to require the public service operator to transfer the rolling stock after the expiry of the public service contract to the new operator to whom a contract is awarded . the competent authority may oblige the new public transport operator to take the rolling stock over . the transfer shall be done at market rates . ### the competent authority may ask the public service operator by means of a prior written consent before the commitment is enforced to transfer the rolling stock after the expiry of the public service contract to the new operator to whom a contract is awarded . the competent authority may oblige the new public transport operator to make use of the taken rolling stock . the transfer shall be done at market value .


### 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 .


### no risk assessment should be conducted under this regulation on a new psychoactive substance if it is subject to an assessment under international law , or if it is an active substance in a medicinal product or in a veterinary medicinal product . ### no risk assessment should be conducted under this regulation on a new psychoactive substance if it is subject to an assessment under international law , or if it is an active substance in a medicinal product or in a veterinary medicinal product , provided that the substance used is not liable to have ill effects and is transformed in such a condition that it cannot be abused or recovered .


### no risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the united nations system , namely once the world health organisation expert committee on drug dependence has published its critical review together with a written recommendation , except where there is significant information that is new or of particular relevance for the union and that has not been taken into account by the united nations system . ### no risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the united nations system , namely once the world health organisation expert committee on drug dependence has published its critical review together with a written recommendation , except where there is significant and concrete information that is new or of particular relevance for the union and that has not been taken into account by the united nations system , which is to be mentioned in the assessment report .


### 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 .


### 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 .


### no risk assessment shall be carried out where the new psychoactive substance has been assessed within the united nations system , but it has been decided not to schedule it under the 1961 single convention on narcotic drugs , as amended by the 1972 protocol , or the 1971 convention on psychotropic substances , except where there is significant information that is new or of particular relevance for the union . ### no risk assessment shall be carried out where the new psychoactive substance has been assessed within the united nations system , but it has been decided not to schedule it under the 1961 single convention on narcotic drugs , as amended by the 1972 protocol , or the 1971 convention on psychotropic substances , except where there is significant and concrete information that is new or of particular relevance for the union , the reasons for which shall be indicated in the assessment report .


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


### 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 .


### new psychoactive substances and mixtures should be able to move freely in the union when intended for commercial and industrial use , as well as for scientific research and development . this regulation should establish rules for introducing restrictions to this free movement . ### new psychoactive substances and mixtures should be able to move freely in the union when intended for commercial and industrial use , as well as for scientific research and development , by duly authorised persons in establishments which are directly under the control of member states ' authorities or specifically approved by them .


### joint report ### report


### no restriction measures should be introduced at union level on new psychoactive substances which pose low health , social and safety risks . ### no restriction measures should be introduced at union level on new psychoactive substances which pose low health , social and safety risks , but member states may introduce further measures that are deemed appropriate or necessary depending on the specific risks that the substance poses in their territories taking into account national circumstances and any social , economic , legal , administrative or other factor they may consider relevant .


### the exceptions as laid down in this article shall only apply for the period during which protection is justified on the basis of the content of the document . the exceptions may apply for a maximum period of 30 years . in the case of documents covered by the exceptions relating to the protection of personal data or commercial interests and in the case of sensitive documents , the exceptions may , if necessary , continue to apply after this period . ### the exceptions as laid down in this article shall in principle not apply to documents transmitted in the framework of procedures leading to a legislative act or delegated or implementing act of general application . the exceptions shall only apply for the period during which protection is justified on the basis of the content of the document . the exceptions may apply for a maximum period of 30 years .


### 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 .