### in order to provide for enhanced transparency of payments made to governments , issuers whose securities are admitted to trading on a regulated market and which have activities in the extractive or logging of primary forest industries should disclose in a separate report on an annual basis payments made to governments in the countries in which they operate . the report should include types of payments comparable to those disclosed under the extractive industries transparency initiative and provide civil society with information to hold governments of resource - rich countries to account for their receipts from the exploitation of natural resources . the initiative is also complementary to the eu flegt action plan and the timber regulation which require traders of timber products to exercise due diligence in order to prevent illegal wood from entering into the eu market . the detailed requirements are defined in chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council . ### in order to provide for enhanced transparency of financial activities in third countries , in particular payments made to governments , issuers whose securities are admitted to trading on a regulated market should disclose as part of the annual report of financial statements , payments made to governments in the countries in which they operate on a per - country basis . the disclosure of such data is intended to enable investors to make better - informed decisions , thereby improving corporate governance and accountability and contributing to the containment of tax evasion . the report should incorporate disclosures on a country basis . for issuers active in the extractive industry or the logging of primary forests , the report should also specify the specific project or projects to which those payments have been attributed , building on the disclosure requirements of the extractive industries transparency initiative to provide civil society with information whereby governments of resource - rich countries can be held to account for their receipts from the exploitation of natural resources . the initiative is also complementary to the eu flegt action plan and the timber regulation which require traders of timber products to exercise due diligence in order to prevent illegal wood from entering into the union market . the detailed requirements are defined in chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council .


### article 6 report on payments to governments member states shall require issuers active in the extractive or logging of primary forest industries , as defined in [ … ] to prepare , in accordance with chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council , a report on payments made to governments on an annual basis . the report shall be made public at the latest six months after the end of each financial year and shall remain publicly available for at least five years . payments to governments shall be reported at consolidated level . ### article 6 report on payments to governments member states shall require all issuers to prepare , in accordance with chapter 9 of directive 2011 / . . . / eu of the european parliament and of the council , a report on payments made to governments and additional information on their financial activities in third countries on an annual basis as part of the annual financial statements . the report shall be made public at the latest six months after the end of each financial year and shall remain publicly available . payments to governments shall be reported at consolidated level .


### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators . ### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport and the development of the region it serves . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators .


### direct , indirect and catalytic employment effects . ### direct , indirect and catalytic employment effects , especially in the sectors affected by air traffic .


### eib activity in neighbourhood countries should take place in the framework of the european neighbourhood policy , under which the eu aims to develop a special relationship with neighbouring countries with a view to establishing an area of prosperity and good neighbourliness , founded on the values of the eu and characterised by close and peaceful relations based on co - operation . to achieve these objectives the eu and its partners implement jointly agreed bilateral action plans defining a set of priorities including on political and security issues , trade and economic matters , environmental concerns and integration of transport and energy networks . the union for the mediterranean , the eastern partnership , and the black sea synergy are multilateral and regional initiatives complementary to the european neighbourhood policy aimed at fostering co - operation between the eu and the respective group of neighbouring partner countries facing common challenges and / or sharing a common geographical environment . the union for the mediterranean supports improved socio - economic , solidarity , regional integration , sustainable development and knowledge building , underlining the need to increase financial co - operation to support regional and trans - national projects . the eastern partnership aims to create the necessary conditions to accelerate political association and further economic integration between the eu and eastern partner countries . the russian federation and the eu have a wide - ranging strategic partnership , distinct from the european neighbourhood policy and expressed through the common spaces and roadmaps . this is complemented at multilateral level by the northern dimension which provides a framework for co - operation between the eu , russia , norway and iceland . ### eib activity in neighbourhood countries should take place in the framework of the european neighbourhood policy , under which the eu aims to develop a special relationship with neighbouring countries with a view to establishing an area of prosperity and good neighbourliness , founded on the values of the eu and characterised by close and peaceful relations based on co - operation . to achieve these objectives the eu and its partners implement jointly agreed bilateral action plans defining a set of priorities including on political and security issues , trade and economic matters , environmental and social concerns and integration of transport and energy networks . the union for the mediterranean , the eastern partnership , and the black sea synergy are multilateral and regional initiatives complementary to the european neighbourhood policy aimed at fostering co - operation between the eu and the respective group of neighbouring partner countries facing common challenges and / or sharing a common geographical environment . the union for the mediterranean supports improved socio - economic development , solidarity , regional integration , sustainable development and knowledge building , underlining the need to increase financial co - operation to support regional and trans - national projects and support smes . the eastern partnership aims to create the necessary conditions to accelerate political association and further economic integration between the eu and eastern partner countries . the russian federation and the eu have a wide - ranging strategic partnership , distinct from the european neighbourhood policy and expressed through the common spaces and roadmaps . this is complemented at multilateral level by the northern dimension which provides a framework for co - operation between the eu , russia , norway and iceland .


### regulation no 1060 / 2009 of the european parliament and of the council of 16&#160 ; september 2009 on credit rating agencies requires credit rating agencies to comply with rules of conduct in order to mitigate possible conflicts of interest , ensure high quality and sufficient transparency of ratings and the rating process . following the amendments introduced by regulation no 513 / 2011 of the european parliament and of the council , the european securities and markets authority has been empowered to register and supervise credit rating agencies . this amendment complements the current regulatory framework for credit rating agencies . some of the issues addressed had been identified , but not fully resolved by the existing rules . the need to review transparency and procedural requirements specifically for sovereign ratings was highlighted by the current sovereign debt crisis . ### regulation no 1060 / 2009 of the european parliament and of the council of 16&#160 ; september 2009 on credit rating agencies requires credit rating agencies to comply with rules of conduct in order to mitigate possible conflicts of interest , ensure high quality and sufficient transparency of ratings and the rating process . following the amendments introduced by regulation no 513 / 2011 of the european parliament and of the council , the european securities and markets authority has been empowered to register and supervise credit rating agencies . this amendment complements the current regulatory framework for credit rating agencies . some of the issues addressed had been identified , but not fully resolved by the existing rules . the need to review transparency , procedural requirements and the timing of the publication specifically for sovereign ratings was highlighted by the current sovereign debt crisis .


### the perception of independence of credit rating agencies would be particularly affected should the same shareholders or members be investing in different credit rating agencies not belonging to the same group of credit rating agencies , at least if this investment reaches a certain size that could allow these shareholders or members to exercise a certain influence on the agency ' s business . therefore , in order to ensure the independence of credit rating agencies , it is appropriate to provide for stricter rules regarding the relations between the credit rating agencies and their shareholders . for this reason , no person should simultaneously hold a participation of 5% or more in more than one credit rating agency , unless the agencies concerned belong to the same group . ### the perception of independence of credit rating agencies would be particularly affected should the same shareholders or members be investing in different credit rating agencies not belonging to the same group of credit rating agencies . therefore , in order to ensure the independence of credit rating agencies , it is appropriate to provide for stricter rules regarding the relations between the credit rating agencies and their shareholders . for this reason , a shareholder or member holding a participation of 5% or more in one credit rating agency should not be allowed to hold any participation in another credit rating agency , unless the agencies concerned belong to the same group .


### it is important to ensure that modifications to the rating methodologies do not result in less rigorous methodologies . for that purpose , issuers , investors and other interested parties should have the opportunity to comment on any intended change of rating methodologies . this will help them to understand the reasons behind new methodologies and for the change in question . comments provided by issuers and investors on the draft methodologies may provide valuable input for the credit rating agencies in defining the methodologies . moreover , esma should verify and confirm the compliance of new rating methodologies with article 8 of regulation no 1060 / 2009 and the relevant regulatory technical standard before methodologies are applied in practice . esma should verify that the proposed methodologies are rigorous , systematic , continuous and subject to validation based on historical experience , including back - testing . however , this verification process should not grant esma any power to judge the appropriateness of the proposed methodology or the content of the credit ratings issued following the application of the methodologies . ### it is important to ensure that modifications to the rating methodologies do not result in less rigorous methodologies . for that purpose , issuers , investors and other interested parties should have the opportunity to comment on any intended change of rating methodologies . this will help them to understand the reasons behind new methodologies and for the change in question . comments provided by issuers and investors on the draft methodologies may provide valuable input for the credit rating agencies in defining the methodologies . moreover , esma should have the possibility to check and confirm the compliance of new rating methodologies with article 8 of regulation no 1060 / 2009 and the relevant regulatory technical standard before methodologies are applied in practice within one month . esma should only check that the proposed methodologies are rigorous , systematic , continuous and subject to validation based on historical experience , including back - testing . however , this verification process should not grant esma any power to judge the appropriateness of the proposed methodology or the content of the credit ratings issued following the application of the methodologies . esma should under no circumstances interfere with the content of methodologies or the resulting credit rating , but simply perform a check that the relevant procedures have been followed . this ex - ante check shall be without prejudice to esma ' s ongoing supervisory duties .


### regarding matters concerning the civil liability of a credit rating agency and which are not covered by this regulation , such matters should be governed by the applicable national law determined by the relevant rules of international private law . the competent court to decide on a claim for civil liability brought by an investor should be determined by the relevant rules on international jurisdiction . ### in view of the national differences in member states ' civil law , particular care should be taken with regard to the definition of the applicable jurisdiction . regarding matters concerning the civil liability of a credit rating agency and which are not covered by this regulation , such matters should be governed by the applicable national law determined by the relevant rules of international private law . the competent court to decide on a claim for civil liability brought by an investor should be determined by the relevant rules on international jurisdiction .


### in order to contribute to the issuance of up to date and credible sovereign ratings and to facilitate users ' understanding , it is important to regularly review ratings . it is also important to increase the transparency about the research work carried out , the staff allocated to the preparation of ratings and the underlying assumptions behind the credit ratings made by credit rating agencies in relation to sovereign debt . ### in order to contribute to the issuance of up to date and credible sovereign ratings and to facilitate users ' understanding , it is important to regularly review ratings . it is also important to increase the transparency about the research work carried out , the staff allocated to the preparation of ratings , its territorial presence , and the underlying assumptions behind the credit ratings made by credit rating agencies in relation to sovereign and sub - sovereign debt .


### in view of the specificities of sovereign ratings and in order to reduce the risk of volatility , it is appropriate to require credit rating agencies to only publish these ratings after the close of business of the trading venues established in the union and at least one hour before their opening . ### in view of the specificities of sovereign ratings and in order to reduce the risk of volatility , it is appropriate to require credit rating agencies to only publish these ratings according to a pre - defined calendar at the choice of the credit rating agency and to require the publication only on fridays after the close of business of the trading venues established in the union . only in exceptional circumstances may a credit rating agency deviate from its self - prescribed sovereign rating calendar , in such cases it shall only publish these ratings after the close of business of the trading venues established in the union and at least one hour before their opening .


### the commission should adopt the draft regulatory technical standards developed by esma regarding the content of the handover file when a credit rating agency is replaced by another credit rating agency , the content , frequency and presentation of the information to be provided by issuers on structured finance instruments , harmonisation of the standard rating scale to be used by credit rating agencies , the presentation of the information , including structure , format , method and timing of reporting , that credit rating agencies should disclose to esma in relation to eurix and the content and format of the periodic reporting on fees charged by credit rating agencies for the purposes of ongoing supervision by esma . the commission should adopt those standards by means of delegated acts pursuant to article 290 of the treaty and in accordance with articles 10 to 14 of regulation no 1095 / 2010 . ### the commission should adopt the draft regulatory technical standards developed by esma , the content , frequency and presentation of the information to be provided by issuers on structured finance instruments , the presentation of the information , including structure , format , method and timing of reporting , that credit rating agencies , eba and central banks of the members states should disclose to esma in relation to eurix and the content and format of the periodic reporting on fees charged by credit rating agencies for the purposes of ongoing supervision by esma . the commission should adopt those standards by means of delegated acts pursuant to article 290 of the treaty and in accordance with articles 10 to 14 of regulation no 1095 / 2010 .


### the commission should adopt the draft regulatory technical standards developed by esma regarding the content of the handover file when a credit rating agency is replaced by another credit rating agency , the content , frequency and presentation of the information to be provided by issuers on structured finance instruments , harmonisation of the standard rating scale to be used by credit rating agencies , the presentation of the information , including structure , format , method and timing of reporting , that credit rating agencies should disclose to esma in relation to eurix and the content and format of the periodic reporting on fees charged by credit rating agencies for the purposes of ongoing supervision by esma . the commission should adopt those standards by means of delegated acts pursuant to article 290 of the treaty and in accordance with articles 10 to 14 of regulation no 1095 / 2010 . ### the commission should adopt the draft regulatory technical standards developed by esma regarding the content , frequency and presentation of the information to be provided by issuers on structured finance instruments , harmonisation of the standard rating scale to be used by credit rating agencies , the presentation of the information , including structure , format , method and timing of reporting , that credit rating agencies should disclose to esma in relation to eurix and the content and format of the periodic reporting on fees charged by credit rating agencies for the purposes of ongoing supervision by esma . the commission should adopt those standards by means of delegated acts pursuant to article 290 of the treaty and in accordance with articles 10 to 14 of regulation no 1095 / 2010 .


### where a credit rating agency has entered into a contract with an issuer or its related third party for the issuing of credit ratings on that issuer , it shall not issue credit ratings on that issuer for a period exceeding three years . ### where a credit rating agency has entered into an exclusive contract with an issuer or its related third party for the issuing of credit ratings on that issuer , it shall not issue credit ratings on that issuer for a period exceeding five years .


### where an issuer has entered into a contract regarding the same matter with more than one credit rating agency , the limitations set out in paragraphs 1 and 2 shall only apply to one of these agencies . however , none of these agencies shall have a contractual relationship with the issuer exceeding a period of six years . ### where an issuer has entered into a contract regarding the same matter with more than one credit rating agency , the rotation periods shall be extended to seven years provided they are staggered by at least three years .


### paragraphs 1 to 4shall not apply to sovereign ratings . ### paragraphs 1 to 4 shall not apply to unsolicited sovereign ratings .


### a credit rating agency that intends to change or use any new rating methodologies , models or key rating assumptions shall publish the proposed changes or proposed new methodologies on its website inviting stakeholders to submit comments for a period not shorter than one month , together with a detailed explanation of the reasons for and the implications of the proposed changes or proposed new methodologies . ### a credit rating agency that intends to change or use any new rating methodologies shall inform esma and publish relevant information about changes to the methodologies on its website inviting stakeholders to submit comments together with a explanation of the reasons for and the implications of the proposed changes or proposed new methodologies .


### a credit rating agency that intends to change or use any new rating methodologies , models or key rating assumptions shall publish the proposed changes or proposed new methodologies on its website inviting stakeholders to submit comments for a period not shorter than one month , together with a detailed explanation of the reasons for and the implications of the proposed changes or proposed new methodologies . ### a credit rating agency that intends to materially change or use any new rating methodologies , models or key rating assumptions shall publish the proposed changes or proposed new methodologies on its website inviting stakeholders to submit comments for a period of one month , together with a detailed explanation of the reasons for and the implications of the proposed material changes or proposed new methodologies .


### esma shall also verify that any intended changes to rating methodologies notified by a credit rating agency in accordance with article 8 comply with the criteria laid down in article 8 as specified in the regulatory technical standard referred to in point of article 21 . the credit rating agency may only apply the new rating methodology after esma has confirmed the methodology ' s compliance with article 8 . ### without prejudice to article 23 , within one month after notification by a credit rating agency in accordance with article 8 esma shall raise issues with any new rating methodologies or intended material changes to existing rating methodologies if they do not comply with the criteria laid down in article 8 . esma may require the credit rating agency to revise any new rating methodologies or material changes to existing rating methodologies that are not in accordance with the regulatory technical standard referred to in point of article 21 . this power shall be notwithstanding esma ' s ongoing supervisory tasks .


### where a credit rating agency has committed intentionally or with gross negligence any of the infringements listed in annex&#160 ; iii having an impact on a credit rating on which an investor has relied when purchasing a rated instrument , such an investor may bring an action against that credit rating agency for any damage caused to that investor . ### where a credit rating agency has been deemed by esma ' s board of supervisors to have committed , intentionally or with gross negligence , any of the infringements listed in annex&#160 ; iii in accordance with article 24 and where this has resulted in an impact on a credit rating on which an investor / issuer has relied when purchasing or selling a rated instrument , such an investor / issuer may bring an action against that credit rating agency for any damage caused to that investor / issuer .


### a credit rating agency shall ensure that fees charged to its clients for the provision of rating and ancillary services are not discriminatory and are based on actual costs . fees charged for rating services shall not depend on the level of the credit rating issued by the credit rating agency or on any other result or outcome of the work performed . ### a credit rating agency shall ensure that fees charged to its clients for the provision of rating and ancillary services are not discriminatory and commensurate to the actual costs incurred . fees charged for rating services shall not depend on the level of the credit rating issued by the credit rating agency or on any other result or outcome of the work performed .


### a credit rating agency shall disclose on its website , on an ongoing basis , information about all entities or debt instruments submitted to it for their initial review or for preliminary rating . such disclosure shall be made whether or not issuers contract with the credit rating agency for a final rating . ### a credit rating agency shall report to esma , on an ongoing basis , information about all entities or debt instruments submitted to it for their initial review or for preliminary rating , indifferent with regard to whether or not the issuers contract with the credit rating agency for a final rating .


### where a credit rating agency issues sovereign ratings or related rating outlooks , it shall publish these ratings or outlooks only after the close of business of trading venues established in the union and at least one hour before their opening . point 3 of section d . i . remains unaffected . ### where a credit rating agency issues sovereign ratings or related rating outlooks , it shall publish these ratings or outlooks only in accordance with the calendar referred to under article 10 , on a friday after the close of business of trading venues established in the union . publication of sovereign ratings or related rating outlooks at times other than those referred to in the first subparagraph shall take place only in exceptional circumstances and only after close of business of trading venues established in the union and at least one hour before their opening . point 3 of section d . i . remains unaffected .


### the credit rating agency infringes the first subparagraph of article 8 by not publishing on its website the proposed changes to the methodologies , models or key rating assumptions or the proposed new methodologies , models or key rating assumptions together with a detailed explanation of the reasons for and the implications of the proposed changes . ### the credit rating agency infringes the first subparagraph of article 8 by not informing esma or not publishing on its website the proposed new methodologies or changes of the methodologies together with a explanation of the reasons for and the implications of the changes .


### the entry into force of the lisbon treaty strengthened the status of union citizenship and complemented the rights attached to it , including by introducing a new right , the citizens ' initiative , which enables one million citizens , from a significant number of member states , to ask the commission to present a proposal in any of the eu ' s areas of responsibility . ### the entry into force of the lisbon treaty has significantly strengthened the citizenship of the union not only by consolidating the currently existing rights attached to it but also by promoting new rights and instruments in particular the citizens ' initiative , which enables one million citizens , from a significant number of member states , to ask the commission to present a proposal in any of the eu ' s areas of responsibility .


### in particular , free movement and workers ' mobility help addressing the consequences of demographic change on the labour market , while also increasing the employability of people and improving the competitiveness of european industries . at the same time , free movement either enables , as an essential condition , or stimulates the exercise by citizens of a broad range of rights available to them under union law , such as their rights as consumers to access goods and services or their rights as passengers and tourists . facilitating free movement has therefore the potential to enhance citizens ' possibilities to fully benefit from the single market , whilst being a key driver for growth . ### in particular , free movement and workers ' mobility help addressing the consequences of demographic change on the labour market , while also increasing the employability of people and improving the competitiveness of european industries . the right to work in each member state is linked to the right of movement and residence and should not be restricted in any way other than through the treaties ; should any restricting measures apply they could only be acceptable if a member state experiences serious disturbances in its labour market and only for a limited period of time . at the same time , free movement either enables , as an essential condition , or stimulates the exercise by citizens of a broad range of rights available to them under union law , such as their rights as consumers to access goods and services or their rights as passengers and tourists . facilitating free movement has therefore the potential to enhance citizens ' possibilities to fully benefit from the single market , whilst being a key driver for growth .


### a european year of citizens in 2013 will provide a very timely opportunity to raise the awareness of the general public about the rights attached to union citizenship and thus to contribute to the objective of facilitating the exercise of the right to free movement . ### a european year of citizens in 2013 will provide a very timely opportunity to seek to restore citizens’ confidence in the activities of the european union and to raise the awareness of the general public about the rights attached to union citizenship and thus to contribute to the objective of facilitating the exercise of the right to free movement .


### the general purpose of the european year shall be to enhance awareness of the rights attached to union citizenship , in order to help citizens make full use of their right to move and reside freely within the territory of the member states . in this context , the european year shall focus , among others , on the opportunities for civic participation and access to rights by union citizens residing in another member state than their own , by students , workers , consumers , and providers of goods and services across the union . ### the general purpose of the european year shall be to enhance awareness of the rights attached to union citizenship , in order to help citizens make full use of their right to move and reside freely within the territory of the member states . in this context , the european year shall promote , among others , the opportunities for civic participation , access to rights and their exercise by union citizens by focusing precisely on those eu citizens residing in another member state than their own like students , workers , consumers , and providers of goods and services across the union .


### the general purpose of the european year shall be to enhance awareness of the rights attached to union citizenship , in order to help citizens make full use of their right to move and reside freely within the territory of the member states . in this context , the european year shall focus , among others , on the opportunities for civic participation and access to rights by union citizens residing in another member state than their own , by students , workers , consumers , and providers of goods and services across the union . ### the general purpose of the european year shall be to enhance awareness of the rights attached to union citizenship , in order to help citizens make full use of their right to move and reside freely within the territory of the member states . in this context , the european year shall focus , among others , on the opportunities for civic participation and access to rights by union citizens residing in another member state than their own , by students , workers , consumers , and providers of goods and services across the union . any cross - border debates within the eu shall be in any way encouraged and especially through and in reference to the european citizen ' s initiative


### the financial assistance measures to be adopted under this programme should aim at supporting the adaptation and / or restructuring of areas dependent upon banana exports through sector - specific budget support or project - specific interventions . the measures should aim to provide for social resilience policies , economic diversification or investment to improve competitiveness , where this is a viable strategy , taking into account the results of and experiences gained through the special system of assistance to traditional acp suppliers of bananas7 and the special framework of assistance to traditional acp suppliers of bananas8 . ### the financial assistance measures to be adopted under this programme should aim at improving the living standards and living conditions of people in banana growing areas and banana value chains , as well as complying with labour and occupational health and safety standards by supporting the adaptation and / or restructuring of areas dependent upon banana exports through sector - specific budget support or project - specific interventions . the measures should aim to provide for social resilience policies , economic diversification or investment to improve competitiveness , where this is a viable strategy , taking into account the results of and experiences gained through the special system of assistance to traditional acp suppliers of bananas7 and the special framework of assistance to traditional acp suppliers of bananas8 .


### the financial assistance measures to be adopted under this programme should aim at supporting the adaptation and / or restructuring of areas dependent upon banana exports through sector - specific budget support or project - specific interventions . the measures should aim to provide for social resilience policies , economic diversification or investment to improve competitiveness , where this is a viable strategy , taking into account the results of and experiences gained through the special system of assistance to traditional acp suppliers of bananas7 and the special framework of assistance to traditional acp suppliers of bananas8 . ### the financial assistance measures to be adopted under this programme should aim at supporting the adaptation and / or restructuring of areas dependent upon banana exports through sector - specific budget support or project - specific interventions . the measures should aim to provide for social resilience policies , economic diversification , income support for growers or investment to improve competitiveness , where this is a viable strategy , taking into account the results of and experiences gained through the special system of assistance to traditional acp suppliers of bananas7 and the special framework of assistance to traditional acp suppliers of bananas8 .


### the programme should accompany the adaptation process in acp countries which have exported significant volumes of bananas to the ec in recent years and which will be affected by liberalisation in the framework of the wto9 . the programme builds on the special framework of assistance for traditional acp suppliers of bananas . it is in conformity with the eu’s international obligations in the framework of the wto and has a clear restructuring and hence temporary nature , with a maximum duration of four years , ### the programme should accompany the adaptation process in acp countries which have exported significant volumes of bananas to the ec in recent years and which will be affected by liberalisation in the framework of the wto9 and by the bilateral and regional agreements concluded , or in the process of being concluded , between the eu and latin american countries , which are the leading exporters of bananas . the programme builds on the special framework of assistance for traditional acp suppliers of bananas . it is in conformity with the eu’s international obligations in the framework of the wto , focuses on restructuring and boosting competitiveness , and is consequently temporary in nature , with a duration of four years . depending on the situation of acp banana exporters at the end of the current programme , another programme may be launched in 2013 to continue addressing the impact of further cuts in customs duties ,


### ‘ 1 . acp banana supplying countries listed in annex iiia shall benefit from banana accompanying measures . union assistance to these countries shall aim at supporting their adjustment process following from liberalisation of the eu market for bananas in the framework of the world trade organisation . union assistance shall take into account the countries’ policies and adaptation strategies and shall pay specific attention to the following areas of cooperation : ’ ### ‘ 1 . acp banana supplying countries listed in annex iiia shall benefit from banana accompanying measures . union assistance to these countries shall aim to combat poverty by effectively improving the standard of living of the people concerned and compliance with labour and safety standards , and by ensuring that assistance is allocated so as to support farmers , who are at the beginning of the production chain , and to support their adjustment process following from liberalisation of the eu market for bananas in the framework of the world trade organisation . union assistance shall take into account the countries’ policies and adaptation strategies and shall pay specific attention to the following areas of cooperation : ’


### within the amount referred to in annex iv , the commission shall fix the maximum amount available to each eligible acp banana - supplying country for financing the actions referred to in paragraph 1 on the basis of a set of objective indicators . the indicators shall include trade in bananas with the eu ; the importance of banana exports to the economy in the acp country concerned ; and country’s level of development . the measurement of the allocation criteria shall be based on data from years preceding 2009 . ### within the amount referred to in annex iv , the commission shall fix the maximum amount available to each eligible acp banana - supplying country for financing the actions referred to in paragraph 1 according to the needs of each country , placing particular emphasis on ‘ most favoured nation’ status within the wto , and on the basis of the following objective , weighted indicators : firstly , trade in bananas with the eu ; secondly , the importance of banana exports to the economy in the acp country concerned , along with the country’s level of development . the measurement of the allocation criteria shall be based on representative data preceding 2010 and covering a period not longer than five years .


### the commission shall adopt multi - annual support strategies by analogy to article 19 , and in accordance with article 21 . it shall ensure that such strategies complement the geographic strategy papers of the countries concerned , and the temporary nature of these banana accompanying measures . the support strategies may be reviewed ad hoc , if necessary , but shall not be submitted to a mid - term review . ### the commission shall adopt multi - annual support strategies by analogy to article 19 , and in accordance with article 21 . it shall ensure that such strategies complement the geographic strategy papers of the countries concerned , and the temporary nature of these banana accompanying measures . the multi - annual support strategies for banana accompanying measures shall include : an environmental profile of the country with regard to the banana industry ; b ) a set of specifications stating when the banana accompanying measures were first implemented and the terms of reference for their review ; c ) indicators to assess progress in relation to disbursement conditions , when budget support will be chosen as the form of financing ; d ) the expected results of the assistance ; e ) a time schedule of support activities and of expected disbursements for each recipient country ; f ) the ways in which progress will be achieved and monitored in meeting internationally - agreed ilo core labour standards and appropriate occupational safety and health conventions ; g ) the support strategies shall be subject to an independent ex ante review and , if necessary , an ad hoc review . ’


### ‘ strategy papers and multi - annual indicative programmes referred to in articles 19 and 20 , and any reviews thereof referred to in article 19 and article 20 , as well as accompanying measures referred to in articles 17 and 17a respectively , shall be adopted by the commission in accordance with the procedure referred to in article 35 . ’ ### ‘ strategy papers and multi - annual indicative programmes referred to in articles 19 and 20 , and any reviews thereof referred to in article 19 and article 20 , as well as accompanying measures referred to in articles 17 and 17a respectively , shall be adopted by the commission by means of delegated acts adopted in accordance with articles 35 , 35a and 35b . ’


### the constant rise of infringements of intellectual property rights constitutes a genuine threat not only to the union economy , but also to the health and safety of union consumers . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon . ### the high level of infringements of intellectual property rights constitutes a genuine threat not only to the union economy , but also in many cases to the health and safety of union consumers . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon .


### in the context of the overall intellectual property rights strategy foreseen by the council resolution of 25 september 2008 on a comprehensive european anti - counterfeiting and anti - piracy plan , the council called on the commission to launch a european observatory on counterfeiting and piracy . the commission therefore formed a network of experts from the public and the private sectors and described its tasks in the communication ‘ enhancing the enforcement of intellectual property rights in the internal market’ . ### in the context of the overall intellectual property rights strategy foreseen by the council resolution of 25 september 2008 on a comprehensive european anti - counterfeiting and anti - piracy plan , the council called on the commission to launch a european observatory on counterfeiting and piracy . the commission therefore formed a network of experts from the public and the private sectors and described its tasks in the communication ‘ enhancing the enforcement of intellectual property rights in the internal market’ . this regulation changes the name of the observatory on counterfeiting and piracy to the observatory on intellectual property rights .


### the office should offer a forum that brings together public authorities and the private sector , ensuring the collection , analysis and dissemination of relevant objective , comparable and reliable data regarding the value of intellectual property rights and the infringements of those rights , the development of best practices and strategies to protect intellectual property rights , and raising public awareness of the impacts of intellectual property rights infringements . furthermore , the office should fulfil additional tasks , such as to improve the understanding of the value of intellectual property rights , enhance the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures , increase knowledge on techniques to prevent counterfeiting , and improve cooperation with third countries and international organisations . ### the office should offer a forum that brings together public authorities and the private sector , ensuring the collection , analysis and dissemination of relevant objective , comparable and reliable data regarding the value of intellectual property rights and the infringements of those rights , the development of best practices and strategies to protect intellectual property rights which will raise public awareness of the impacts of intellectual property rights infringements . furthermore , the office should fulfil additional tasks , such as to evaluate measures to improve the understanding of the value of intellectual property rights , enhance the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures , increase knowledge on techniques to prevent counterfeiting , and improve cooperation with third countries and international organisations .


### this regulation entrusts the office for harmonization in the internal market with certain tasks related to the protection of intellectual property rights . in carrying out these tasks the office shall regularly invite experts , authorities and stakeholders which will assemble under the name ‘ european observatory on counterfeiting and piracy’ . ### this regulation entrusts the office for harmonisation in the internal market with certain tasks related to the protection of intellectual property rights . in carrying out these tasks the office shall regularly invite experts , authorities and stakeholders which will assemble under the name ‘ european observatory on intellectual property rights’ .


### drawing up reports and publications to raise awareness of the union ' s citizens of the impact of infringements of intellectual property rights , and organising conferences , on - line and off - line campaigns , events and meetings at european and international levels ; ### drawing up reports and publications to raise awareness of the union ' s citizens of the value of intellectual property rights and the impact of infringements of those rights , and organising conferences at european and international levels ;


### building strategies in cooperation with the central industrial property offices of the member states , including the benelux office for intellectual property , and developing techniques , skills and tools related to the protection of intellectual property rights , including training programmes and awareness campaigns ; ### building strategies in cooperation with the central industrial property offices of the member states , including the benelux office for intellectual property , and developing techniques , skills and tools related to the protection of intellectual property rights , including training programmes ;


### making recommendations to the commission on issues falling within the scope of this regulation , including on the basis of a request from the commission ; ### making recommendations to the commission on issues falling within the scope of this regulation , on the basis of a request from one or more of the union institutions ;


### recommendations on the future policies in the area of the protection of intellectual property rights , including on how to enhance an effective cooperation between member states . ### assessments of policy options in the area of the protection and valorisation of intellectual property rights , including on how to enhance an effective cooperation between member states .


### draft legislative resolution ### recalls the council declaration of 10 july 2009 on payment appropriations and invites the commission to submit an amending budget to cover the needs for additional payment appropriations for 2010 ;


### draft legislative resolution ### supports the proposed frontloading of payments but underlines that the overall financial programming should be respected ; recalls that the final amounts for payments during the remaining programming period should be decided in the annual budgetary procedure ;


### draft legislative resolution ### stresses that a possible derogation from the n + 2 rule should remain exceptional and should apply only to the 2007 payment appropriations ;


### radio equipment interworks with accessories , and / or it interworks via networks with other radio equipment , and / or it can be connected to interfaces of the appropriate type throughout the union ; ### radio equipment interworks with accessories , in particular chargers , and / or it interworks via networks with other radio equipment , and / or it can be connected to interfaces of the appropriate type throughout the union ;


### long - stay visas should be replaced by residence permits after the entry of third - country nationals into the territory of a member state in due time in order to enable third - country nationals legally residing in one member state on the basis of a long - stay visa to travel to the other member states during their stay or transit through the territories of the other member states when returning to their home country . however , long - stay visas are not replaced with residence permits by more and more member states or are replaced only with considerable delays after the entry of third - country nationals into their territory . this legal and practical situation has important negative consequences on third - country nationals legally staying in a member state on the basis of a long - stay visa regarding their circulation in the schengen area . ### long - stay visas should be replaced by residence permits after the entry of third - country nationals into the territory of a member state in due time in order to enable third - country nationals legally residing in one member state on the basis of a long - stay visa to travel to the other member states during their stay or transit through the territories of the other member states when returning to their home country . however , long - stay visas are not replaced with residence permits by an increasing number of member states or are replaced only with considerable delays after the entry of third - country nationals into their territory . this legal and practical situation has important negative consequences for the circulation in the schengen area of third - country nationals legally staying in a member state on the basis of a long - stay visa .


### this regulation does not aim at encouraging member states not to issue residence permits and it should not affect the obligation of member states to issue residence permits for certain categories of third - country nationals set out by other community instruments . ### this regulation does not aim to discourage member states from issuing residence permits and it should not affect the obligation on member states to issue residence permits for certain categories of third - country nationals set out by other community instruments .


### this regulation shall not affect the obligation for member states to issue residence permits to third - country nationals as provided by other instruments of community law . ### this regulation shall not affect the obligation for member states to issue residence permits to third - country nationals in compliance with time - limits and as provided by other instruments of community law , in particular – council directive 2005 / 71 / ec , – council directive 2004 / 114 / ec , – council directive 2003 / 86 / ec , – council directive 2004 / 38 / ec , and – council directive 2003 / 109 / ec .


### directive 2009 / 110 / ec of the european parliament and of the council of 16 september 2009 on the taking up , pursuit and prudential supervision of the business of electronic money institutions amending directives 2005 / 60 / ec and 2006 / 48 / ec and repealing directive 2000 / 46 / ec article 14 ### directive 2009 / 110 / ec of the european parliament and of the council of 16 september 2009 on the taking up , pursuit and prudential supervision of the business of electronic money institutions amending directives 2005 / 60 / ec and 2006 / 48 / ec and repealing directive 2000 / 46 / ec article 14 article 14


### persons who have been subject to discrimination based on sex should have adequate means of legal protection . to provide more effective protection , associations , organisations and other legal entities should be empowered to engage in proceedings , as member states so determine , either on behalf or in support of any victim , without prejudice to national rules of procedure concerning representation and defence before the courts . ### persons who have been subject to discrimination based on sex should have suitable means of legal protection . to provide more effective protection , associations , organisations and other legal entities should be empowered to engage in proceedings , as member states so determine , either on behalf or in support of any victim , without prejudice to national rules of procedure concerning representation and defence before the courts .


### member states may maintain or adopt measures within the meaning of article 157 of the treaty on the functioning of the european union with a view to ensuring full equality in practice between men and women in working life , for instance aimed at promoting entrepreneurship among women . ### member states may maintain or adopt measures within the meaning of article 157 of the treaty on the functioning of the european union with a view to ensuring full equality in practice between men and women in working life , for instance aimed at promoting entrepreneurship initiatives among women .


### the member states shall take the necessary measures to ensure that female self - employed workers and female spouses and life partners referred to in article 2 may , in accordance with national law , be granted an adequate maternity allowance enabling interruptions in their occupational activity owing to pregnancy or motherhood for at least 14 weeks . ### the member states shall take the necessary measures to ensure that female self - employed workers and female spouses and life partners referred to in article 2 may , in accordance with national law , be granted a sufficient maternity allowance enabling interruptions in their occupational activity owing to pregnancy or motherhood for at least 14 weeks .


### the allowance referred to in paragraph 1 shall be deemed adequate if it guarantees an income at least equivalent to : ### the allowance referred to in paragraph 1 shall be deemed sufficient if it guarantees an income at least equivalent to :


### the intensity of the economic and fiscal surveillance should be commensurate to the severity of the financial difficulties encountered and should take due account of the nature of the financial assistance received , which may range from a mere precautionary support based on eligibility conditions up to a full macro - economic adjustment programme involving strict policy conditionality . ### the intensity of the economic and fiscal surveillance should be commensurate to the severity of the financial difficulties encountered and should take due account of the nature of the financial assistance received , which may range from a mere precautionary support based on eligibility conditions up to a full macro - economic adjustment programme involving strict policy conditionality . any macro - economic adjustment programme shall , where possible , take into account the national reform programme of the country concerned in the context of the europe 2020 strategy for growth and jobs .


### a member state receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb - a draft adjustment programme aimed at re - establishing a sound and sustainable economic and financial situation and restoring its capacity to finance itself fully on the financial markets . the draft adjustment programme shall take due account of the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures . ### a member state requesting or&#160 ; receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb - a draft adjustment programme aimed at re - establishing a sound and sustainable economic and financial situation and restoring its capacity to finance itself fully on the financial markets . the draft adjustment programme shall take due account of the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures . any macro - economic adjustment programme shall , where possible , take into account&#160 ; the national reform programme of the country concerned in the context of the europe 2020 strategy for growth and jobs .


### a member state shall be under post - programme surveillance as long as a minimum of 75% of the financial assistance received from one or several other member state , the efsm , the efsf or the esm has not been repaid . the council , acting on a qualified majority on a proposal from the commission , may extend the duration of the post programme surveillance . ### a member state shall be under post - programme surveillance as long as a minimum of 75% of the financial assistance received from one or several other member state , the efsm , the efsf or the esm has not been repaid . the council , acting on a proposal from the commission , may extend the duration of the post programme surveillance . &#160 ; when taking this decision , the commission ' s recommendation shall be deemed to have been adopted by the council , unless it decides , by qualified majority , to reject the recommendation within 10 days of its adoption by the commission . the member state concerned may request that a meeting of the council be convened within that period to take a vote on the decision .


### the council , acting by qualified majority on a proposal from the commission , may recommend to the member state under post programme surveillance to adopt corrective measures . ### the council , acting on a proposal from the commission , may recommend to the member state under post programme surveillance to adopt corrective measures . when taking this decision , the commission ' s recommendation shall be deemed to have been adopted by the council , unless it decides , by qualified majority , to reject the recommendation within 10 days of its adoption by the commission . the member state concerned may request that a meeting of the council be convened within that period to take a vote on the decision .


### for the measures referred to in articles 2 , 3 , 6 , 6 and 11 , only members of the council representing member states whose currency is the euro shall vote and the council shall act without taking into account the vote of the member of the council representing the member state concerned . ### for the measures referred to in this regulation , only members of the council representing member states whose currency is the euro shall vote and the council shall act without taking into account the vote of the member of the council representing the member state concerned .


### venture capital provides finance to undertakings that are generally very small , in the initial stages of their corporate existence and display a strong potential for growth and expansion . in addition , venture capital funds provide these undertakings with valuable expertise and knowledge , business contacts , brand - equity and strategic advice . by providing finance and advice to these undertakings , venture capital funds stimulates economic growth , contribute to the creation of jobs , boost innovative undertakings , increase their investment in research and development and foster entrepreneurship , innovation and competitiveness in the union . ### venture capital provides finance to undertakings that are generally very small , in the initial stages of their corporate existence and display a strong potential for growth and expansion . although venture capital funds often invest in start - up undertakings , there are instances where it is appropriate to make transformative investments in undertakings that have been established for more than five years . in addition , venture capital funds provide these undertakings with valuable expertise and knowledge , business contacts , brand - equity and strategic advice . by providing finance and advice to these undertakings , venture capital funds stimulate economic growth , contribute to the creation of jobs , boost innovative undertakings , increase their investment in research and development and foster entrepreneurship , innovation and competitiveness in the union .


### to facilitate re - use , public sector bodies should make documents available through machine readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community . ### to facilitate re - use , public sector bodies should make documents permanently available online in machine readable , searchable and current formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### the basic principle should be that public sector information is freely available for re - use , because this ensures the highest economic returns . where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### in paragraph 1 , the words ' through electronic means ' are replaced by ' permanently available online in machine - readable , searchable and current format and together with their metadata . ' .


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ### the basic principle is that documents may be re - used freely , unless there are significant economic costs which are incurred in order to make the information freely available in a specific case . where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination .


### detailed information on assistance provided by both the public and private sectors , as appropriate , to developing countries that are particularly vulnerable to the effects of climate change in adapting to those climate change effects ; ### detailed information on assistance provided by both the public and private sectors , as appropriate , to developing countries that are particularly vulnerable to the effects of climate change in adapting to those climate change effects , specifying recipient country , sector and type of activity ;


### detailed information on assistance provided by both the public and private sectors , as appropriate , to developing countries to mitigate greenhouse gas emissions ; ### detailed information on assistance provided by both the public and private sectors , as appropriate , to developing countries to mitigate greenhouse gas emissions , specifying recipient country , sector and type of activity ;


### information on the use of revenues during the year x - 1 generated by the member state by auctioning allowances pursuant to article 10 of directive 2003 / 87 / ec . this information shall also include specific and detailed information on the use of 50 % of the revenues , and resulting action taken , specifying the category of such actions taken in accordance with article 10 of directive 2003 / 87 / ec and indicating the relevant beneficiary country or region ; ### information on the use of revenues during the year x - 1 generated by the member state by auctioning allowances pursuant to article 10 of directive 2003 / 87 / ec . this information shall also include specific and detailed information on the use of 50 % of the revenues , and resulting action taken , specifying the category and additionality of such actions taken in accordance with article 10 of directive 2003 / 87 / ec and indicating the relevant beneficiary country or region ;


### information referred to in point of article 6 of decision no 406 / 2009 / ec and information on how their purchasing policy enhances the achievement of an international agreement on climate change . ### information referred to in point of article 6 of decision no 406 / 2009 / ec and information on how their purchasing policy enhances the achievement of an international agreement on climate change . in the case of hydroelectric power production project activities with a generating capacity exceeding 20mw , member states shall , when approving such project activities , ensure that relevant international criteria and guidelines , in particular the hydropower sustainability assessment protocol 2010 , will be respected during the development of such project activities .


### the purpose of this directive is , to contribute to sustainable production and consumption by as a first priority , the prevention of waste electrical and electronic equipment , and in addition , the reuse , recycling and other forms of recovery of such wastes so as to reduce the disposal of waste and contribute to the efficient use of resources . it also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment , e . g . producers , distributors and consumers and in particular those operators directly involved in the collection and treatment of waste electrical and electronic equipment . in particular , different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators . having different national policies on the management of weee hampers the effectiveness of recycling policies . for that reason the essential criteria should be laid down at community level . ### the purpose of this directive is , to contribute to sustainable production and consumption by as a first priority , the prevention of waste electrical and electronic equipment , and in addition , the reuse , recycling and other forms of recovery of such wastes so as to reduce the disposal of waste and contribute to the efficient use of resources and the retrieval of strategic raw materials . it also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment , e . g . producers , distributors and consumers and in particular those operators directly involved in the collection and treatment of waste electrical and electronic equipment . in particular , different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators . having different national policies on the management of weee hampers the effectiveness of recycling policies . for that reason the essential criteria should be laid down at community level .


### the purpose of this directive is , to contribute to sustainable production and consumption by as a first priority , the prevention of waste electrical and electronic equipment , and in addition , the reuse , recycling and other forms of recovery of such wastes so as to reduce the disposal of waste and contribute to the efficient use of resources . it also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment , e . g . producers , distributors and consumers and in particular those operators directly involved in the collection and treatment of waste electrical and electronic equipment . in particular , different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators . having different national policies on the management of weee hampers the effectiveness of recycling policies . for that reason the essential criteria should be laid down at community level . ### the purpose of this directive is , to contribute to sustainable production and consumption by as a first priority , the prevention of waste electrical and electronic equipment , and in addition , the reuse , recycling and other forms of recovery of such wastes so as to reduce the disposal of waste and contribute to the efficient use of resources . it also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment , e . g . producers , distributors and consumers and in particular those operators directly involved in the collection and treatment of waste electrical and electronic equipment . in particular , different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators . having different national policies on the management of weee hampers the effectiveness of recycling policies . for that reason the essential criteria should be laid down at community level and harmonised standards for the collection and handling should be developed .


### separate collection is a precondition to ensure specific treatment and recycling of weee and is necessary to achieve the chosen level of protection of human health and the environment in the community . consumers have to actively contribute to the success of such collection and should be encouraged to return weee . for this purpose , convenient facilities should be set up for the return of weee , including public collection points , where private households should be able to return their waste at least free of charge . distributors have an important role in contributing to the success of weee collection . ### separate collection is a precondition to ensure specific treatment and recycling of weee and is necessary to achieve the chosen level of protection of human health and the environment in the community . consumers have to actively contribute to the success of such collection and should be encouraged to return weee . for this purpose , convenient facilities should be set up for the return of weee , including public collection points , where private households should be able to return their waste at least free of charge . distributors , municipalities and recyclers all have an important role in contributing to the success of weee collection and treatment and thus should be subject to the requirements of this directive .


### in order to attain the chosen level of protection and harmonised environmental objectives of the community , member states should adopt appropriate measures to minimise the disposal of weee as unsorted municipal waste and to achieve a high level of separate collection of weee . in order to ensure that member states strive to set up efficient collection schemes , they should be required to achieve a high level of collection of weee , particularly for cooling and freezing equipment containing ozone depleting substances and fluorinated greenhouse gases , given their high environmental impact and in view of obligations contained in regulation 2037 / 2000 and regulation 842 / 2006 . data included in the impact assessment shows that 65% of electrical and electronic equipment placed on the market is already separately collected today , but more than half of this potentially leaks to improper treatment and illegal exports . this leads to losses of valuable secondary raw materials and environmental degradation . to avoid this , it is necessary to set an ambitious collection target . ### in order to attain the chosen level of protection and harmonised environmental objectives of the community , member states should adopt appropriate measures to minimise the disposal of weee as unsorted municipal waste and to achieve a high level of separate collection of weee . in order to ensure that member states strive to set up efficient collection schemes , they should be required to achieve a high level of collection of weee , particularly for cooling and freezing equipment containing ozone depleting substances and fluorinated greenhouse gases , given their high environmental impact and in view of obligations contained in regulation 2037 / 2000 and regulation 842 / 2006 . data included in the impact assessment shows that 65% of electrical and electronic equipment placed on the market is already separately collected today , but more than half of this potentially leaks to improper treatment and illegal exports , or is treated properly but the amounts treated were not reported . this leads to losses of valuable secondary raw materials , environmental degradation and provision of inconsistent data . to avoid this , it is necessary to set an ambitious collection target , to oblige all actors that collect weee to ensure its environmentally sound treatment , and to require them to report the volumes collected , handled and treated . it is of fundamental importance that member states ensure that the directive is effectively enforced , in particular as regards checks on used eee shipped out of the eu .


### the recovery , preparation for re - use and recycling of equipment can be counted into the targets defined in article 7 of this directive only if that recovery or preparation for re - use or recycling is not in contradiction to other european and member states legislation applicable to the equipment . ### the recovery , preparation for re - use and recycling of equipment can be counted into the targets defined in article 7 of this directive only if that recovery or preparation for re - use or recycling is not in contradiction to other european and member states legislation applicable to the equipment . ensuring proper recovery and preparation for re - use and recycling of equipment will account for sound resource management and will optimise the resources supply .


### users of electrical and electronic equipment from private households should have the possibility of returning weee at least free of charge . producers should finance at least the collection from collection facilities , and the treatment , recovery and disposal of weee . member states should encourage producers to take full ownership of the weee collection in particular by financing the collection of weee throughout the whole waste chain , including from private households , in order to avoid leakage of separately collected weee to sub - optimal treatment and illegal exports , to create a level playing field by harmonising producer financing across the eu , to shift payment for the collection of this waste from general tax payers to the consumers of eee in line with the polluter pays principle . in order to give maximum effect to the concept of producer responsibility , each producer should be responsible for financing the management of the waste from his own products . the producer should be able to choose to fulfil this obligation either individually or by joining a collective scheme . each producer should , when placing a product on the market , provide a financial guarantee to prevent costs for the management of weee from orphan products from falling on society or the remaining producers . the responsibility for the financing of the management of historical waste should be shared by all existing producers in collective financing schemes to which all producers , existing on the market when the costs occur , contribute proportionately . collective financing schemes should not have the effect of excluding niche and low - volume producers , importers and new entrants . ### users of electrical and electronic equipment from private households should have the possibility of returning weee at least free of charge . producers should finance at least the collection from collection facilities , and the treatment , recovery and disposal of weee . member states should encourage producers to take full ownership of the weee collection in particular by financing the collection of weee throughout the whole waste chain , including from private households , in order to avoid leakage of separately collected weee to sub - optimal treatment and illegal exports , to create a level playing field by harmonising producer financing across the eu , to shift payment for the collection of this waste from general tax payers to the consumers of eee in line with the polluter pays principle . in order to give maximum effect to the concept of producer responsibility , each producer should be responsible for financing the management of the waste from his own products . the producer should be able to choose to fulfil this obligation either individually or by joining a collective scheme . each producer , or third party contracted to act on their behalf , should , when placing a product on the market , provide a financial guarantee to prevent costs for the management of weee from orphan products from falling on society or the remaining producers . the responsibility for the financing of the management of historical waste should be shared by all existing producers in collective financing schemes to which all producers , existing on the market when the costs occur , contribute proportionately . collective financing schemes should not have the effect of excluding niche and low - volume producers , importers and new entrants .


### this directive lays down measures to protect the environment and human health by preventing or reducing the adverse impacts of the generation and management of waste from electrical and electronic equipments and by reducing overall impacts of resource use and improving the efficiency of such use . ### this directive lays down measures to protect the environment and human health by preventing or reducing the adverse impacts of the generation and management of waste from electrical and electronic equipments and by reducing overall negative impacts of resource use and improving the efficiency of such use .


### member states shall prohibit the disposal of untreated separately collected weee . ### member states shall prohibit and monitor the disposal of untreated separately collected weee .


### member states shall ensure that the collection and transport of separately collected weee is carried out in a way which optimises re - use and recycling and the confinement of hazardous substances . ### member states shall ensure that the collection and transport of separately collected weee is carried out in a way which optimises reuse and recycling and the confinement of hazardous substances . in order to maximise reuse of whole appliances , member states shall also ensure that collection schemes allow for the segregation of reusable appliances from separately collected weee at the collection points , prior to any transportation .


### member states shall ensure that all separately collected weee undergoes treatment . ### member states shall ensure that all separated collected weee undergoes treatment in accordance with the waste hierarchy priority order established by directive 2008 / 98 / ec . to give priority to preparation for reuse , a check should be implemented prior to any treatment , to ascertain whether the waste equipment or individual components thereof are reusable . this check should be carried out by accredited repair and reuse centres , established according to article 11 . 1 and annex iv of directive 2008 / 98 / ec , or similarly qualified personnel


### weee exported out of the community in line with regulation no 1013 / 2006 on shipments of waste , and commission regulation no 1418 / 2007 of 29 november 2007 concerning the export for recovery of certain waste listed in annex iii or annex iiia to regulation no 1013 / 2006 of the european parliament and of the council to certain countries to which the oecd decision on the control of transboundary movements of wastes does not apply shall only count for the fulfilment of obligations and targets of article 11 of this directive if the exporter can prove that the treatment took place under conditions that are equivalent to the requirements of this directive . ### weee exported out of the community in line with regulation no 1013 / 2006 on shipments of waste , and commission regulation no 1418 / 2007 of 29 november 2007 concerning the export for recovery of certain waste listed in annex iii or annex iiia to regulation no 1013 / 2006 of the european parliament and of the council to certain countries to which the oecd decision on the control of transboundary movements of wastes does not apply shall only take place if the exporter can prove that the recovery took place under conditions that are equivalent to the requirements of this directive , and in particular to annexes ii and iii .


### for weee falling under categories 1 and 10 of annex i to directive 20xx / xx / ec , – 85% shall be recovered , and – 80% shall be prepared for reuse and recycled ; ### for weee falling under categories 1 and 10 of annex i to directive 20xx / xx / ec , – 85% shall be recovered , and – 80% of components , materials and substances thereof shall be prepared for reuse and recycled ;


### for weee falling under categories 1 and 10 of annex i to directive 20xx / xx / ec , - 85% shall be recovered and - 80% shall be prepared for reuse and recycled ; ### for weee falling under categories 1 and 4 of annex ia - 85% shall be recovered , - 75% shall be recycled and - 5% shall be prepared for reuse ;


### for weee falling under categories 3 and 4 of annex i to directive 20xx / xx / ec , - 80% shall be recovered , and - 70% shall be prepared for reuse and recycled ; ### for weee falling under category 2 of annex ia - 80% shall be recovered , - 65% shall be recycled and - 5% shall be prepared for reuse ;


### for weee falling under categories 3 and 4 of annex i to directive 20xx / xx / ec , – 80% shall be recovered , and – 70% shall be prepared for reuse and recycled ; ### for weee falling under categories 3 and 4 of annex i to directive 20xx / xx / ec , – 80% shall be recovered , and – 70% of components , materials and substances thereof shall be prepared for reuse and recycled ;


### for weee falling under categories 2 , 5 , 6 , 7 , 8 and 9 of annex i to directive 20xx / xx / ec , - 75% shall be recovered , and - 55% shall be prepared for reuse and recycled ; ### for weee falling under category 5 of annex ia , - 75% shall be recovered , - 50% shall be recycled and - 5% shall be prepared for reuse ;


### for weee falling under categories 2 , 5 , 6 , 7 and 9 of annex i to directive 20xx / xx / ec , – 75% shall be recovered , and – 55% shall be prepared for reuse and recycled ; ### for weee falling under categories 2 , 5 , 6 , 7 and 9 of annex i to directive 20xx / xx / ec , – 75% shall be recovered , and – 55% of components , materials and substances thereof shall be prepared for reuse and recycled ;


### member states shall ensure that , for the purpose of calculating these targets , producers or third parties acting on their behalf keep records on the mass of weee , their components , materials or substances when entering and leaving the treatment facility and / or when entering the recovery or recycling facility . ### member states shall ensure that , for the purpose of calculating these targets , producers or third parties acting on their behalf keep records on the mass of used eee , weee , their components , materials or substances when entering and leaving the treatment or recycling facility and / or when entering the recovery facility .


### member states shall ensure thatproducers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . member states , where appropriate , shall encourage producers to finance all the cost occurring for collection facilities for weee from private households . ### member states shall ensure that producers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . in addition , member states , where appropriate , shall ensure that , to improve the collection of weee , sufficient financial resources are raised according to the polluter pays principle to cover the cost of collection of weee from households , including the cost of running the collection facilities and associated awareness - raising campaigns on the management of weee . these financial resources shall be available only to operators legally obliged to collect weee . where receiving full coverage for their costs , municipalities and private operators obliged by law to act as collection points shall hand over all the weee collected to producers or producer responsibility schemes . the financing of the collection of weee from households for removal to collection facilities should not fall under the individual producer responsibility for financing provided for in article&#160 ; 12 . 2 .


### in order to facilitate the preparation for reuse and the correct and environmentally sound treatment of weee , including maintenance , upgrade , refurbishment and recycling , member states shall take the necessary measures to ensure that producers provide reuse and treatment information for each type of new eee placed on the market within one year after the equipment is placed on the market . this information shall identify , as far as it is needed by reuse centres , treatment and recycling facilities in order to comply with the provisions of this directive , the different eee components and materials , as well as the location of dangerous substances and preparations in eee . it shall be made available to reuse centres , treatment and recycling facilities by producers of eee in the form of manuals or by means of electronic media . ### in order to facilitate the use and the correct and environmentally sound treatment of weee , including maintenance , upgrade , reuse , preparation for reuse , refurbishment and recycling , member states shall take the necessary measures to ensure that producers provide free of charge reuse and treatment information for each type of new eee placed on the market within one year after the equipment is placed on the market . this information shall identify , as far as it is needed by reuse centres , treatment and recycling facilities in order to comply with the provisions of this directive , the different eee components and materials , as well as the location of dangerous substances and preparations in eee . it shall be made available to reuse centres , treatment and recycling facilities by producers of eee in the form of manuals or by means of electronic media .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with articles 2 , 3 , 5 , 6 , 7 , 11 , 14 , 16 , 19 , 20 and annex i by at the latest [ 18 months after the day of this directive ' s publication in the official journal of the european union ] . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with articles 2 , 3 , 5 , 6 , 7 , 11 , 14 , 16 , 19 , 20 and annex i by at the latest [ 18 months after the day of this directive ' s publication in the official journal of the european union ] . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . member states shall bring into force the laws , regulations and administrative provisions necessary to comply with article 12of this directive so that that each producer only finances the operations relating to the waste from his own products placed on the market later than 13&#160 ; august 2005 , and that the appropriate financial guarantees , as required by article 12of this directive , are provided .


### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the core electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 . in addition to these minimum requirements , the commission should determine , in its request to the relevant european standardisation organisation , further requirements as to the content of such european standard and a deadline for its adoption . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the core electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 and the principles of data protection by design , proportionality and data minimisation . in addition , s mall and medium - sized enterprises as well as smaller contracting authorities and contracting entities , which have only limited staff and financial resources , should be able to apply the standard without incurring excessive costs . furthermore , the standard should also be suitable for use in commercial transactions between private companies , in order to avoid additional costs . finally , the standard should be compatible with relevant international standards in order to prevent suppliers from third countries encountering technical market access barriers . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 .


### the marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products , recorded in a pharmacovigilance system master file permanently accessible for inspection . the competent authorities should undertake the supervision of those systems . a summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the pharmacovigilance system master file for the medicinal product concerned is maintained and accessible for inspection . ### the marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products , recorded in a pharmacovigilance system master file permanently accessible for inspection . the competent authorities should undertake the supervision of those systems . a summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the pharmacovigilance system master file for the medicinal product concerned is maintained and accessible for inspection by the competent authorities .


### after the granting of a marketing authorisation , the national competent authority may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification and include the objectives and timeframe for submission and conduct of the study . ### after the granting of a marketing authorisation , the national competent authority may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed scientific justification and include the objectives and timeframe for submission and conduct of the study .


### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the national competent authority decides , on justified grounds relating to pharmacovigilance or to insufficient exposure to the product , to proceed with one additional five - year renewal in accordance with paragraph 2 . ” ### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal in accordance with paragraph 2 . ”


### through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of an adverse reaction report is identifiable ; ### through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with article 25 of regulation no 726 / 2004 and implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients ;


### the marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system . he shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and , based on the audit findings , ensure that an appropriate corrective action plan is prepared and followed . ### the marketing authorisation holder shall be required to perform an annual audit of his pharmacovigilance system . he shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and communicate them to the competent national authority before 31 december each year . based on the audit findings , the marketing authorisation holder shall ensure that an appropriate corrective action plan is prepared and followed .


### the requirement shall be made in writing , provide a detailed justification , and include the timeframe for submission of the detailed description of the risk - management system . ### the requirement shall be made in writing , provide a detailed justification and include the timeframe for submission of the detailed description of the risk - management system . it shall be made public without delay .