### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisage opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . ### when a member state enters into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations .


### decision 1 / cp . 15 of the conference of the parties to the unfccc and decision 1 / cp . 16 of the conference of the parties to the unfccc contributed significantly to progress in addressing the challenges raised by climate change in a balanced manner . those decisions introduced new monitoring and reporting requirements that apply to the implementation of ambitious emission reductions to which the union and its member states have committed , and provided support to developing countries . those decisions also recognised the importance of addressing adaptation with the same priority as mitigation . decision 1 / cp . 16 also requires that developed countries elaborate low - carbon development strategies or plans . such strategies or plans are expected to contribute towards building a low - carbon society and ensure continued high growth and sustainable development . this regulation should facilitate , through its delegated acts , the implementation of these and future monitoring and reporting requirements arising from further decisions or the approval of an international agreement under the unfccc . ### decision 1 / cp . 15 of the conference of the parties to the unfccc and decision 1 / cp . 16 of the conference of the parties to the unfccc contributed significantly to progress in addressing the challenges raised by climate change in a balanced manner . those decisions introduced new monitoring and reporting requirements that apply to the implementation of ambitious emission reductions to which the union and its member states have committed , and provided support to developing countries . those decisions also recognised the importance of addressing adaptation with the same priority as mitigation . decision 1 / cp . 16 also requires that developed countries elaborate low - carbon development strategies or plans . such strategies or plans are expected to contribute towards building a low - carbon society and ensure continued high growth and sustainable development in a cost - effective manner . according to the commission communication of 8 march 2011 entitled ' a roadmap for moving to a competitive low carbon economy in 2050 ' , domestic emission reductions of the order of 40 % and 60 % below 1990 levels would be a cost - effective pathway by 2030 and 2040 . this regulation should facilitate , through its delegated acts , the implementation of these and future monitoring and reporting requirements arising from further decisions or the approval of an international agreement under the unfccc .


### member states , and the commission on behalf of the union , shall each devise and implement a low - carbon development strategy to contribute to : the transparent and accurate monitoring of the actual and projected progress made by member states , including the contribution made by union measures , in fulfilling the union ' s and the member states ' commitments under the unfccc to limit or reduce anthropogenic greenhouse gas emissions ; meeting the greenhouse gas emission reduction commitments of member states under decision no 406 / 2009 / ec and achieving long - term emission reductions and enhancements of removals by sinks in all sectors in line with the union’s objective to reduce emissions by 80 to 95% by 2050 compared to 1990 levels , in the context of necessary reductions , according to the ipcc , by developed countries as a group . ### member states , and the commission on behalf of the union , shall each devise and implement a low - carbon development strategy to contribute to : the transparent and accurate monitoring of the actual and projected progress made by member states , including the contribution made by union measures , in fulfilling the union ' s and the member states ' commitments under the unfccc to limit or reduce anthropogenic greenhouse gas emissions ; meeting the greenhouse gas emission reduction commitments of member states under decision no 406 / 2009 / ec and achieving long - term emission reductions and enhancements of removals by sinks in all sectors in line with the union ' s objective to reduce emissions by 80 to 95% by 2050 compared to 1990 levels and with a cost - effective trajectory , including milestones for domestic reductions for 2030 and 2040 , in the context of necessary reductions , according to the ipcc , by developed countries as a group .


### the general arrangement should be granted to all those developing countries which share a common developing need and are in a similar stage of economic development . countries which are classified by the world bank as high - income or upper - middle income countries have per capita income levels allowing them to attain higher levels of diversification without the scheme ' s tariff preferences and include economies which have successfully completed their transition from centralised to market economies . those countries do not share the same development , trade and financial needs as the remaining developing countries ; they are at a different stage of economic development , i . e they are not similarly - situated as the more vulnerable developing countries ; and , so as to prevent unjustified discrimination , they need to be treated differently . furthermore , the use of tariff preferences provided under the scheme by high - income or upper - middle income countries increases the competitive pressure on exports from poorer , more vulnerable countries and therefore could impose unjustifiable burden on those more vulnerable developing countries . the general arrangement takes account of the fact that the development , financial and trade needs are subject to change and assures that the arrangement remains open if the situation of a country changes . ### the general arrangement should be granted to all those developing countries which share a common developing need and are in a similar stage of economic development . countries which are classified by the world bank as high - income or upper - middle income countries have per capita income levels allowing them to attain higher levels of diversification without the scheme ' s tariff preferences and include economies which have successfully completed their transition from centralised to market economies . some countries which are classified by the world bank as upper - middle income countries however , are still vulnerable due to the lack of diversification and their insufficient integration in the world economy . high - income countries and non - vulnerable upper - middle income countries do not share the same development , trade and financial needs as the remaining developing countries ; they are at a different stage of economic development , i . e they are not similarly - situated as the more vulnerable developing countries ; and , so as to prevent unjustified discrimination , they need to be treated differently . furthermore , the use of tariff preferences provided under the scheme by high - income or non - vulnerable upper - middle income countries increases the competitive pressure on exports from poorer , more vulnerable countries and therefore could impose unjustifiable burden on those more vulnerable developing countries . the general arrangement takes account of the fact that the development , financial and trade needs are subject to change and assures that the arrangement remains open if the situation of a country changes .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate representation and consultations during its preparatory work , including experts at both european and national level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely , transparent and appropriate transmission of relevant documents to the european parliament and to the council .


### whilst the directive already provides for detailed obligations for member states to exchange information , such obligations should be reinforced . member states should not only react to request for information but also alert other member states in a proactive manner . such alert system should be similar to that of directive 2006 / 123 / ec . a specific alert mechanism is however necessary for health professionals benefiting from automatic recognition under directive 2005 / 36 / ec . this should also apply to veterinary surgeons unless the member states have already triggered the alert mechanism provided for in directive 2006 / 123 / ec . all member states should be alerted if a professional due to a disciplinary action or criminal conviction is no longer entitled to move to another member state . this alert should be activated through the imi regardless of whether the professional has exercised any of the rights under directive 2005 / 36 / ec or of whether he has applied for recognition of his professional qualifications through the issuance of a european professional card or through any other method provided for by that directive . the alert procedure should comply with union law on the protection of personal data and other fundamental rights . ### whilst the directive already provides for detailed obligations for member states to exchange information , such obligations should be reinforced . member states should not only react to request for information but also alert other member states in a proactive manner . such alert system should be similar to that of directive 2006 / 123 / ec . a specific alert mechanism is however necessary for health professionals regulated under directive 2005 / 36 / ec . this should also apply to veterinary surgeons unless the member states have already triggered the alert mechanism provided for in directive 2006 / 123 / ec . all member states should be alerted if a professional , due to a disciplinary action or criminal conviction related to the exercise of his or her profession , is no longer entitled to move to another member state , or if a professional is temporarily or permanently removed from the right to practice in their home or host member state . this alert should be activated through the imi regardless of whether the professional has exercised any of the rights under directive 2005 / 36 / ec or of whether he has applied for recognition of his professional qualifications through the issuance of a european professional card or through any other method provided for by that directive . the alert procedure should comply with union law on the protection of personal data and other fundamental rights .


### in case of professions with patient safety implications , member states may confer to the competent authorities the right to carry out language checking covering all professionals concerned if it is expressly requested by the national health care system , or in case of self - employed professionals not affiliated to the nationals health care system , by representative national patient organisations . ### in case of professions with public health and patient safety implications , member states may confer to the competent authorities the right to carry out language checking covering all professionals concerned if it is expressly requested by the national health care system , or in case of self - employed professionals not affiliated to the nationals health care system , by representative national patient organisations .


### the commission shall adopt implementing acts specifying european professional cards for specific professions , establishing the format of the european professional card , the translations necessary to support any application for issuing a european professional card and details for the assessment of applications , taking into account the particularities of each profession concerned . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 58 . ### the commission shall adopt implementing acts specifying european professional cards for specific professions , following the request of the european sectoral social partners and professional associations representing the sectoral professions to establish a card for a specific profession , establishing the format of the european professional card , the translations necessary to support any application for issuing a european professional card and details for the assessment of applications , taking into account the particularities of each profession concerned . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 58 . the commission shall consult competent authorities and european and national level social partners and professional associations representing the sectoral professions of the related professions on the precise technicalities of the cards of specific professions .


### directive 2005 / 36 / ec only applies to professionals who want to pursue the same profession in another member state . there are cases where the activities concerned are part of a profession with a larger scope of activities in the host member state . if the differences between the fields of activity are so large that in reality a full programme of education and training is required from the professional to compensate for shortcomings and if the professional so requests , a host member state should under these particular circumstances grant partial access . however , in case of overriding reasons of general interest , such as in the case of a doctor of medicine or other health professionals , a member state should be able to refuse partial access . ### directive 2005 / 36 / ec only applies to professionals who want to pursue the same profession in another member state . there are cases where the activities concerned are part of a profession with a larger scope of activities in the host member state . if the differences between the fields of activity are so large that in reality a full programme of education and training is required from the professional to compensate for shortcomings and if the professional so requests , a host member state should under these particular circumstances grant partial access . however , in case of overriding reasons of general interest , a member state should be able to refuse partial access . partial access should not be granted for professions providing health services or otherwise related to public health .


### the commission shall be assisted by a committee on the recognition of professional qualifications . that committee shall be a committee within the meaning of regulation no 182 / 2011 . ### the commission shall be assisted by a committee on the recognition of professional qualifications , ensuring appropriate representation and consultation at both european and national expert level . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following two years . ### in sectors others than health and social care , the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . the competent authority of the host member state shall ensure the prior check of the complete application of the professional for temporary provision of service whether his or her qualifications are in conjunction with the national requirements of the host country on qualifications to provide the same service . member states shall provide a list to the commission on certain professions where working with the temporary mobility card and under the prior declaration regime must require a prior check of application . the host member state may not require a further declaration under article 7 for the following two years , unless overriding concerns are expressed .


### the competent authority of the host member state shall grant partial access to a professional activity in its territory provided that the following conditions are fulfilled : ### the competent authority of the host member state shall grant partial access to a professional activity in its territory , after consulting with the relevant national social partners and professional associations representing the sectoral professions of the sector the profession of the applicant belongs to , provided that the following conditions are fulfilled :


### the competent authorities of a member state shall inform the competent authorities of all other member states and the commission about the identity of a professional who has been prohibited by national authorities or courts from pursuing , even temporarily , on the territory of that member state the following professional activities : ### the competent authorities of a member state shall inform the competent authorities of all other member states and the commission about the identity of a professional who has been temporarily or permanently removed from the right to practice in their home or host member state the following professional activities :


### in case of professions with patient safety implications , member states may confer to the competent authorities the right to carry out language checking covering all professionals concerned if it is expressly requested by the national health care system , or in case of self - employed professionals not affiliated to the nationals health care system , by representative national patient organisations . ### in case of professions with public health and patient safety implications , member states may confer to the competent authorities the right to carry out language checking covering all professionals concerned .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate representation and consultation including experts at both european and national level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely , transparent and appropriate transmission of relevant documents to the european parliament and to the council .


### the common training framework has been prepared following a transparent due process , including with stakeholders from member states where the profession is not regulated ; ### the common training framework has been prepared following a transparent due process , including with national social partners , professional associations representing the sectoral professions , and stakeholders from member states where the profession is regulated or not regulated ;


### the common training test has been prepared following a transparent due process , including with stakeholders from member states where the profession is not regulated ; ### the common training test has been prepared following a transparent due process , including with national social partners , professional associations representing the sectoral professions , and stakeholders from member states where the profession is regulated or not regulated ;


### any fees which applicants may incur in relation to administrative procedures to issue a european professional card shall be reasonable , proportionate and commensurate with the costs incurred by the home and host member states and shall not act as a disincentive to apply for a european professional card . the commission shall be empowered to adopt delegated acts in accordance with article 58a concerning the setting of criteria for the calculation and distribution of fees . ### the administrative procedure to issue a european professional card shall not represent any additional cost for the individual professional .


### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data19 . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent e with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . the fight against money laundering and terrorist financing is recognised as an important public interest ground by all member states . hence , in the application of this regulation , the transfer of personal data to a third country which does not ensure an adequate level of protection in the meaning of article 25 of directive 95 / 46 / ec should be permitted according to article 26 of the same directive . __________________ 19 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data19 and regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . __________________ 19 oj l 281 , 23 . 11 . 1995 , p . 31 .


### the payer ' s address , or national identity number , or customer identification number , or date and place of birth . ### the payer ' s address , or customer identification number , or date and place of birth .


### the payment service provider of the payer and the payment service provider of the payee shall keep records of the information referred to in articles 4 , 5 , 6 and 7 for five years . in the cases referred to in article 14 and , the intermediary payment service provider must keep records of all information received for five years . upon expiry of this period , personal data must be deleted , unless otherwise provided for by national law , which shall determine under which circumstances payment service providers may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period following carrying - out of the transfer of funds shall not exceed ten years . ### information on the payer or / and the payee must not be kept any longer than strictly necessary ; the payment service provider of the payer and the payment service provider of the payee shall keep records of the information referred to in articles 4 , 5 , 6 and 7 for a maximum period of five years . in the cases referred to in article 14 and , the intermediary payment service provider must keep records of all information received for five years . upon expiry of this period , personal data must be deleted . member states may allow or require further retention only in exceptional situations which are duly justified and motivated and only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period following carrying - out of the transfer of funds shall not exceed ten years .


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members or owned in whole or in part , by one or more collecting societies provided that these entities manage copyright or related rights ;


### information provided to rightholders , members , other collecting societies and users on request ### information provided to rightholders , members , other collecting societies and users


### member states shall ensure that a collecting society makes the following information available at the request of any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay : ### member states shall ensure that a collecting society makes the following information available to any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay :


### in addition , a collecting society shall make available at the request of any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders . ### in addition , a collecting society shall make available to any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders .


### articles 18 , 18 , 22 , 23 , 24 , 25 , 26 , 27 , 32 and 36 shall also apply to entities owned , in whole or in part , by a collecting society and which offer or grant multi - territorial licences for online rights in musical works . ### this title as well as articles 36 and 40 shall also apply to entities owned , in whole or in part , by a collecting society and which offer or grant multi - territorial licences for online rights in musical works .


### in the waters up to 100 nautical miles from the baselines of the azores , madeira and the canary islands , the member states concerned may from 1 january 2013 to 31 december 2022 restrict fishing to vessels registered in the ports of those islands . such restrictions shall not apply to union vessels that traditionally fish in those waters , in so far as those vessels do not exceed the fishing effort traditionally exerted . member states shall inform the commission of the restrictions put in place under this paragraph . ### in the waters up to 100 nautical miles from the baselines of the azores , madeira , the canary islands , guadeloupe , french guiana , martinique , mayotte and reunion , the member states concerned may from 1 january 2013 to 31 december 2022 restrict fishing to vessels registered in the ports of those territories . such restrictions shall not apply to union vessels that traditionally fish in those waters , and can prove that they have done so without interruption for more than 50 years , in so far as those vessels do not exceed the fishing effort traditionally exerted . member states shall inform the commission of the restrictions put in place under this paragraph .


### the union is a contracting party to the united nations convention on the law of the sea of 10 december 1982 and it has ratified the united nations agreement for the implementation of the provisions of the united nations convention on the law of the sea of 10 december 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks of 4 august 1995 . it has also accepted the agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas of 24 november 1993 of the food and agriculture organisation of the united nations . these international instruments predominantly foresee conservation obligations , including among other things obligations to take conservation and management measures designed to maintain or restore marine resources at levels which can produce the maximum sustainable yield both within sea areas under national jurisdiction and on the high seas , and to cooperate with other states to this end , obligations to apply the precautionary approach widely to conservation , management and exploitation of fish stocks , obligations to ensure compatibility of conservation and management measures where marine resources occur in sea areas of different jurisdictional status and obligations to have due regard to other legitimate uses of the seas . the common fisheries policy should contribute to the union ' s proper discharge of its international obligations under these international instruments . where member states adopt conservation and management measures , for which they have been empowered in the framework of the common fisheries policy , they should also act in a manner which is fully consistent with the international conservation and cooperation obligations under the said international instruments . ### the union is a contracting party to the united nations convention on the law of the sea of 10 december 1982 and it has ratified the united nations agreement for the implementation of the provisions of the united nations convention on the law of the sea of 10 december 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks of 4 august 1995 . it has also accepted the agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas of 24 november 1993 of the food and agriculture organisation of the united nations . these international instruments predominantly foresee conservation obligations , including among other things obligations to take conservation and management measures designed to maintain or restore marine resources at levels which can produce the maximum sustainable yield both within sea areas under national jurisdiction and on the high seas , and to cooperate with other states to this end , obligations to apply the precautionary approach widely to conservation , management and exploitation of fish stocks , obligations to ensure compatibility of conservation and management measures where marine resources occur in sea areas of different jurisdictional status and obligations to have due regard to other legitimate uses of the seas . in this connection , the establishment of an advisory committee for the outermost regions , comprising three subcommittees could also make a positive contribution to achieving these objectives in international waters where overfishing and illegal fishing are real problems on a global scale . the common fisheries policy should contribute to the union ' s proper discharge of its international obligations under these international instruments . where member states adopt conservation and management measures , for which they have been empowered in the framework of the common fisheries policy , they should also act in a manner which is fully consistent with the international conservation and cooperation obligations under the said international instruments .


### the common fisheries policy shall apply the precautionary approach to fisheries management , and shall aim to ensure , by 2015 , that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield . ### the common fisheries policy shall apply the precautionary approach to fisheries management , and shall aim to ensure , by 2017 , that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield .


### in a multiannual plan established pursuant to articles 9 , 10 and 11 member states may be authorised to adopt measures , in accordance with that multiannual plan , which specify the conservation measures applicable to vessels flying their flag in relation to stocks in union waters for which they have been allocated fishing opportunities . ### in a multiannual plan established pursuant to articles 9 , 10 and 11 member states shall be authorised , after consulting the regional fisheries management bodies , to adopt measures , in accordance with that multiannual plan , which specify the conservation measures applicable to vessels flying their flag in relation to stocks in union waters for which they have been allocated fishing opportunities .


### clear definition of responsibilities at the union , national , regional and local levels ; ### clear definition of responsibilities at the union , national , regional and local levels , with the objective always being to achieve vertical multilevel governance ;


### measures are needed to reduce and eliminate the current high levels of unwanted catches and discards . indeed , unwanted catches and discards constitute a substantial waste and affect negatively the sustainable exploitation of marine biological resources and marine ecosystems as well as the financial viability of fisheries . an obligation to land all catches of managed stocks caught during fishing activities in union waters or by union fishing vessels should be established and gradually implemented . ### measures are needed to reduce as far as possible the current high levels of unwanted catches and discards . indeed , unwanted catches and discards constitute a substantial waste and affect negatively the sustainable exploitation of marine biological resources and marine ecosystems as well as the financial viability of fisheries . an obligation to land – or if unable to land , strict and rigorous counting prior to being discarded – all catches of managed stocks caught during fishing activities in union waters or by union fishing vessels should be established and gradually implemented .


### in a technical measures framework established pursuant to article 14 member states may be authorised to adopt measures , in accordance with that framework , which specify the technical measures applicable to vessels flying their flag in relation to stocks in their waters for which they have been allocated fishing opportunities . member states shall ensure that such technical measures : ### in a technical measures framework established pursuant to article 14 member states shall be authorised , after consulting the relevant regional fisheries management bodies , to adopt measures , in accordance with that framework , which specify the technical measures applicable to vessels flying their flag in relation to stocks in their waters for which they have been allocated fishing opportunities . member states shall ensure that such technical measures :


### experience with the current financial framework shows that many member states , which are eligible to the cohesion fund , are facing significant obstacles in delivering on time complex cross - border transport infrastructure projects with a high union added value . therefore , in order to improve the delivery of transport projects , in particular cross - border ones , with a high union added value , part of the cohesion fund allocation should be transferred to finance transport projects on the transport core network in the member states eligible to the cohesion fund under the connecting europe facility . the commission should support member states eligible to the cohesion fund to develop an adequate pipeline of projects in order to give greatest possible priority to the national allocations under the cohesion fund . ### experience with the current financial framework shows that many member states , which are eligible to the cohesion fund , are facing significant obstacles in delivering on time complex cross - border transport infrastructure projects with a high union added value . therefore , in order to improve the delivery of transport projects , in particular cross - border ones , with a high union added value , part of the cohesion fund allocation should be transferred to finance transport projects on the transport core network in the member states eligible to the cohesion fund under the connecting europe facility . the commission should support member states eligible to the cohesion fund to develop an adequate pipeline of projects . the commission should ensure during the different phases of the projects selection procedure , the genuine application of the principle of respecting the national allocations .


### the principle of fair processing requires that the data subjects should be informed in particular of the existence of the processing operation and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data . ### the principle of fair and transparent processing requires that the data subjects should be informed in particular of the existence of the processing operation and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data .


### the controller shall implement mechanisms for ensuring that , by default , only those personal data which are necessary for the purposes of the processing are processed . ### the controller shall implement mechanisms for ensuring that , by default ; only those personal data which are necessary for the purposes of the processing are processed and are especially not collected or retained beyond the minimum necessary for those purposes , both in terms of the amount of the data and the time of their storage . this shall be ensured using technical and / or organisational measures , as appropriate . in particular , those mechanisms shall ensure that by default personal data are not made accessible to an indefinite number of individuals .


### any person should have the right to have inaccurate personal data concerning them rectified and the right of erasure where the processing of such data is not in compliance with the main principles laid down in this directive . where the personal data are processed in the course of a criminal investigation and proceedings , , rectification , the rights of information , access , erasure and restriction of processing may be carried out in accordance with national rules on judicial proceedings . ### any person should have the right to have inaccurate or unlawfully processed personal data concerning them rectified and the right of erasure where the processing of such data is not in compliance with the provisions laid down in this directive . where the personal data are processed in the course of a criminal investigation and proceedings , rectification , the rights of information , access , erasure and restriction of processing may be carried out in accordance with national rules on judicial proceedings .


### member states shall provide that the processing of personal data is lawful only if and to the extent that processing is necessary : for the performance of a task carried out by a competent authority , based on law for the purposes set out in article 1 ; or for compliance with a legal obligation to which the controller is subject ; or in order to protect the vital interests of the data subject or of another person ; or for the prevention of an immediate and serious threat to public security . ### member states shall provide that the processing of personal data is lawful only if and to the extent that processing is necessary for the performance of a task carried out by a competent authority , based on union or national law for the purposes set out in article 1 .


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a reasonable fee for providing the information or taking the action requested . in that case , the controller shall bear the burden of proving the excessive character of the request .


### every natural person should have the right not to be subject to a measure which is based solely on automated processing if it produces an adverse legal effect for that person , unless authorised by law and subject to suitable measures to safeguard the data subject ' s legitimate interests . ### every natural person should have the right not to be subject to a measure which is based on profiling . processing which produces a legal effect for that person or otherwise affects him or her should be prohibited , unless strictly necessary in a democratic society , proportionate to the legitimate aim pursued , explicitly authorised by law and subject to suitable measures to safeguard the data subject ' s fundamental rights and legitimate interests , including the right to be provided with meaningful information about the logic used in the profiling . such processing should in no circumstances contain , generate , or discriminate based on special categories of data .


### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or marking of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . ### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or restriction of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent and for the period that such partial or complete restriction constitutes a necessary and strictly proportionate measure in a democratic society with due regard for the legitimate interests and fundamental rights of the person concerned , based on a concrete and individual examination of each specific case :


### member states shall ensure that records are kept of at least the following processing operations : collection , alteration , consultation , disclosure , combination or erasure . the records of consultation and disclosure shall show in particular the purpose , date and time of such operations and as far as possible the identification of the person who consulted or disclosed personal data . ### member states shall ensure that records are kept of at least the following processing operations : collection , alteration , consultation , disclosure , combination or erasure . the records of consultation and disclosure shall show in particular the purpose , date and time of such operations and the identification of the person who consulted or disclosed personal data , and the identity of the recipient of such data .


### the recipients or categories of recipients to whom the personal data have been disclosed , in particular the recipients in third countries ; ### the recipients to whom the personal data have been disclosed , including all the recipients in third countries ;


### in order to ensure a comprehensive and coherent protection of personal data in the union , international agreements concluded by member states prior to the entry force of this directive should be amended in line with this directive . ### in order to ensure a comprehensive and coherent protection of personal data in the union , international agreements concluded by the union or by the member states prior to the entry force of this directive should be amended in line with this directive .


### third parties to the criminal offence , such as persons who might be called on to testify in investigations in connection with criminal offences or subsequent criminal proceedings , or a person who can provide information on criminal offences , or a contact or associate to one of the persons mentioned in and ; and ### persons who might be called on to testify in investigations in connection with criminal offences or subsequent criminal proceedings ;


### the decision for transfers under paragraph 1 must be made by duly authorised staff . these transfers must be documented and the documentation must be made available to the supervisory authority on request . ### these transfers must be documented and the documentation must be made available to the supervisory authority on request .


### member states shall provide that the carrying out of processing by a processor must be governed by a legal act binding the processor to the controller and stipulating in particular that the processor shall act only on instructions from the controller , in particular , where the transfer of the personal data used is prohibited . ### member states shall provide that the carrying out of processing by means of a processor must be governed by a contract or legal act binding the processor to the controller and stipulating in particular that the processor shall : act only on instructions from the controller ; employ only staff who have agreed to be bound by an obligation of confidentiality or are under a statutory obligation of confidentiality ; take all required measures pursuant to article 28 ; engage another processor only with the permission of the controller and therefore inform the controller of the intention to engage another processor in such a timely fashion that the controller has the possibility to object ; insofar as it is possible given the nature of the processing , adopt in agreement with the controller the necessary technical and organisational requirements for the fulfilment of the controller’s obligation to respond to requests for exercising the data subject’s rights laid down in chapter iii ; assist the controller in ensuring compliance with the obligations pursuant to articles 28 to 32 ; hand all results over to the controller after the end of the processing and not otherwise process the personal data ; make available to the controller and the supervisory authority all the information necessary to verify compliance with the obligations laid down in this article ; take into account the principle of data protection by design and default .


### where the commission has taken no decision pursuant to article 34 , member states shall provide that a transfer of personal data to a recipient in a third country or an international organisation may take place where : appropriate safeguards with respect to the protection of personal data have been adduced in a legally binding instrument ; or the controller or processor has assessed all the circumstances surrounding the transfer of personal data and concludes that appropriate safeguards exist with respect to the protection of personal data . ### where the commission has taken no decision pursuant to article 34 , member states shall provide that a transfer of personal data to a competent public authority in a third country or an international organisation may take place where appropriate safeguards with respect to the protection of personal data have been adduced in a legally binding instrument .


### the commission should equally be able to recognise that a third country , or a territory or a processing sector within a third country , or an international organisation , does not offer an adequate level of data protection . consequently the transfer of personal data to that third country should be prohibited except when they are based on an international agreement , appropriate safeguards or a derogation . provision should be made for procedures for consultations between the commission and such third countries or international organisations . however , such a commission decision shall be without prejudice to the possibility to undertake transfers on the basis of appropriate safeguards or on the basis of a derogation laid down in the directive . ### the commission should equally be able to recognise that a third country , or a territory or a processing sector within a third country , or an international organisation , does not offer an adequate level of data protection . consequently the transfer of personal data to that third country should be prohibited except when they are based on an international agreement which ensures the minimum level of protection set out in this directive , or a derogation . provision should be made for procedures for consultations between the commission and such third countries or international organisations .


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , depending on the individual case , the data subject ' s right of access to the extent and for the period that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned :


### instead of erasure , the controller shall mark the personal data where : ### instead of erasure , the controller shall restrict the processing of the personal data where :


### member states shall provide that measures which produce an adverse legal effect for the data subject or significantly affect them and which are based solely on automated processing of personal data intended to evaluate certain personal aspects relating to the data subject shall be prohibited unless authorised by a law which also lays down measures to safeguard the data subject ' s legitimate interests . ### member states shall provide that measures which produce a legal effect for the data subject or significantly affect them and which are based on automated processing of personal data intended to evaluate certain personal aspects relating to the data subject shall be prohibited unless authorised by a law which also lays down measures to safeguard the data subject ' s legitimate interests .


### where requests are vexatious , in particular due to their repetitive character , the supervisory authority may charge a fee or not take the action required by the data subject . the supervisory authority shall bear the burden of proving of the vexatious character of the request . ### where requests are vexatious , in particular due to their repetitive character , the supervisory authority may charge a reasonable fee . the supervisory authority shall bear the burden of proving of the vexatious character of the request .


### member states shall provide for the right of any body , organisation or association which aims to protect data subjects’ rights and interests concerning the protection of their personal data and is being properly constituted according to the law of a member state to lodge a complaint with a supervisory authority in any member state on behalf of one or more data subjects , if it considers that a data subject’s rights under this directive have been infringed as a result of the processing of personal data . the organisation or association must be duly mandated by the data subject . ### member states shall provide for the right of any body , organisation or association acting in the public interest which has been properly constituted according to the law of a member state to lodge a complaint with a supervisory authority in any member state on behalf of one or more data subjects , if it considers that a data subject’s rights under this directive have been infringed as a result of the processing of personal data .


### in the course of an activity which falls outside the scope of union law , in particular concerning national security ; ### in the course of an activity which falls outside the scope of union law ;


### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ; ### ' data subject ' means an identified natural person or a natural person who can be identified or singled out , directly or indirectly , alone or in combination with associated data , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to a unique identifier , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural , social or gender identity or sexual orientation of that person ;


### member states should ensure that a transfer to a third country only takes place if it is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and the controller in the third country or international organisation is an authority competent within the meaning of this directive . a transfer may take place in cases where the commission has decided that the third country or international organisation in question ensures an adequate level or protection , or when appropriate safeguards have been adduced . ### member states should ensure that a transfer to a third country only takes place if this specific transfer is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and the controller in the third country or international organisation is a public authority competent within the meaning of this directive . a transfer may take place in cases where the commission has decided that the third country or international organisation in question ensures an adequate level or protection , or when appropriate safeguards have been adduced , or where appropriate safeguards have been adduced by way of a legally binding instrument .


### member states shall provide that , having regard to the state of the art and the cost of implementation , the controller shall implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . ### member states shall provide that , having regard to the state of the art , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . this shall include both : technical measures relating to the technical design and architecture of the product or service ; and organisational measures which relate to operational policies of the controller .


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a reasonable fee for providing the information or taking the action requested . in that case , the controller shall bear the burden of proving the excessive character of the request .


### where the commission has taken no decision pursuant to article 34 , member states shall provide that a transfer of personal data to a recipient in a third country or an international organisation may take place where : appropriate safeguards with respect to the protection of personal data have been adduced in a legally binding instrument ; or the controller or processor has assessed all the circumstances surrounding the transfer of personal data and concludes that appropriate safeguards exist with respect to the protection of personal data . 2 . the decision for transfers under paragraph 1 must be made by duly authorised staff . these transfers must be documented and the documentation must be made available to the supervisory authority on request . ### where the commission has taken no decision pursuant to article 34 , member states shall provide that a transfer of personal data to a recipient in a third country or an international organisation may take place where appropriate safeguards with respect to the protection of personal data have been adduced in a legally binding instrument . 2 . these transfers must be documented and the documentation must be made available to the supervisory authority on request .


### member states should be allowed to adopt legislative measures delaying , restricting or omitting the information of data subjects or the access to their personal data to the extent that and as long as such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned , to avoid obstructing official or legal inquiries , investigations or procedures , to avoid prejudicing the prevention , detection , investigation and prosecution of criminal offences or for the execution of criminal penalties , to protect public security or national security , or , to protect the data subject or the rights and freedoms of others . ### member states should be allowed to adopt legislative measures delaying or restricting information of data subjects or the access to their personal data to the extent that and as long as such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the fundamental rights and legitimate interests of the person concerned , to avoid obstructing official or legal inquiries , investigations or procedures , to avoid prejudicing the prevention , detection , investigation and prosecution of criminal offences or for the execution of criminal penalties , to protect public security , or to protect the data subject or the rights and freedoms of others .


### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable . ### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely to be used either by the controller or by any other person to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable taking full account of the technological ' state of the art ' and technological trends .


### member states shall prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life . ### member states shall prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or philosophical beliefs , sexual orientation or gender identity , trade - union membership and activities , of genetic data or of data concerning health or sex life .


### member states shall provide for the right of any body , organisation or association referred to in article 50 to exercise the rights referred to in articles 51 and 52 on behalf of one or more data subjects . ### member states shall provide for the right of any body , organisation or association referred to in article 50 to exercise the rights referred to in articles 51 , 52 and 54 on behalf of one or more data subjects .


### member state shall provide that the controller informs the data subject of the right to request the intervention of the supervisory authority pursuant to paragraph 1 . ### member states shall provide that the controller informs the data subject of the right to request the intervention of the supervisory authority pursuant to paragraph 1 .


### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should as far as possible be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals . ### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals .


### member states shall provide that the processing of personal data is lawful only if and to the extent that processing is necessary : for the performance of a task carried out by a competent authority , based on law for the purposes set out in article 1 ; or for compliance with a legal obligation to which the controller is subject ; or in order to protect the vital interests of the data subject or of another person ; or for the prevention of an immediate and serious threat to public security . ### member states shall provide that the processing of personal data is lawful only if and to the extent that processing is necessary for the performance of a task carried out by a competent authority , based on union or national law for the purposes set out in article 1 .


### the communication to the data subject may be delayed , restricted or omitted on the grounds referred to in article 11 . ### the communication to the data subject may be delayed or restricted on the grounds referred to in article 11 .


### member states may adopt legislative measures delaying , restricting or omitting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures delaying or restricting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the fundamental rights and the legitimate interests of the person concerned :


### member states shall provide for the right of the data subject to obtain from the controller a copy of the personal data undergoing processing . ### member states shall provide for the right of the data subject to obtain from the controller a copy of the personal data undergoing processing . where the data subject makes the request in electronic form , the information shall be provided in electronic form , unless otherwise requested by the data subject .


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a fee for providing the information or taking the action requested . in that case , the controller shall bear the burden of proving the manifestly excessive character of the request .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament , the council and the member states shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent , at the same time as the members of the committees and on the same terms , all information referred to in paragraph 1 .


### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified as class a , b and c , in accordance with the rules set out in annex vii , and manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution’s single quality management system , and the health institution is compliant with standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements . ### with the exception of article 59 , the requirements of this regulation shall not apply to laboratory - developed tests manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution’s single quality management system , and the health institution is accredited to standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements .


### this regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription . ### this regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription . direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal . the following devices may only be supplied on a medical prescription : class d devices 2 ) class c devices in the following categories : devices for genetic testing ; companion diagnostics . the commission shall be empowered to adopt delegated acts in accordance with article 85 to decide on other category c tests after consultation with stakeholders .


### if the council decides in accordance with article 126 of the treaty that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 of the treaty that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission , shall decide that the member state shall pay a fine . in respect of article 153 of the treaty , no fine will be levied if the fine is related to a recommendation concerning the issue of pay and / or collective bargaining in the public sector . the decision shall be adopted by the council acting by qualified majority . the council may amend the proposal in accordance with article 293 of the treaty .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to reduce the amount of the non - interest - bearing deposit or to cancel it . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic or social circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 tfeu , propose to reduce the amount of the non - interest - bearing deposit or to cancel it .


### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 tfeu that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council addresses to a member state a recommendation in accordance with article 121 tfeu to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### sanctions for member states whose currency is the euro in the preventive part of the stability and growth pact should provide incentives for prudent fiscal policy - making . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a prudent medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure . ### assistance and incentives for member states whose currency is the euro in the preventive part of the stability and growth pact should ensure appropriate and prudent fiscal policy - making . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a prudent medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure .


### in order to allow the costs of the programmes and of the different phases of the programmes to be clearly identified , the commission , in accordance with the principle of transparent management , shall inform the committee referred to in article 35 annually of the allocation of union funds to each of the activities specified in paragraphs 1 and 2 . ### in order to allow the costs of the programmes and of the different phases of the programmes to be clearly identified , the commission , in accordance with the principle of transparent management , shall inform the budgetary authority and the committee referred to in article 35 annually of the allocation of union funds to each of the activities specified in paragraphs 1 and 2 .


### member states shall ensure that in their contractual and commercial information , payment service providers use , where relevant , the terms and definitions contained in the list of the most representative payment services referred to in article 3 , paragraph 5 . ### member states shall ensure that in their contractual and commercial information , payment service providers use , where relevant , the terms and definitions contained in the list of all services linked to the payment account , referred to in article 3 , paragraph 1 .


### member states shall ensure that before entering into a contract for a payment account with a consumer , payment service providers provide the consumer with a fee information document containing the list of the most representative services referred to in paragraph 5 of article 3 and the corresponding fees for each service . ### member states shall ensure that in an appropriate time prior to entering into a contract for a payment account with a consumer , payment service providers provide and inform the consumer with a fee information document containing the list of the most representative services referred to in paragraph 5 of article 3 and the corresponding fees for each service . in the case of changes , the consumer shall be informed comprehensively .


### member states shall ensure that any financial loss incurred by the consumer resulting from the non - compliance of a payment service provider involved in the switching process with its obligations under article 10 is refunded by that payment service provider . ### member states shall ensure that any financial loss incurred by the consumer resulting from the non - compliance of a payment service provider involved in the switching process with its obligations under article 10 is immediately refunded by that payment service provider . the burden of proof shall rest with the payment service provider , which shall demonstrate that the conditions laid down in article 10 have been respected .


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


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , gender equality , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy .


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


### additional bans on the placing on the market of new equipment for refrigeration , air - conditioning and fire protection that operate using specific fluorinated greenhouse gases should be introduced where suitable alternatives to the use of those substances are available . in the light of future technical developments and the availability of cost - efficient alternatives to the use of fluorinated greenhouse gases , the commission should be empowered to include other products and equipment or to exclude , also temporarily , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical or economic reasons , including insufficient supply of alternative substances on the market to meet the demand , or due to applicable safety standards excluding the use of relevant alternatives . ### additional bans on the placing on the market of new equipment for refrigeration , air - conditioning , foams , aerosols , solvents and fire protection that operate using specific fluorinated greenhouse gases should be introduced where suitable alternatives to the use of those substances are available to send clear market signals to invest in production facilities to achieve economies of scale while also encouraging innovation . in the light of the availability of replacement technologies today and future technical developments and the availability of cost - efficient alternatives to the use of fluorinated greenhouse gases , the commission should be empowered to include other products and equipment or to exclude , also temporarily , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical or economic reasons , including insufficient supply of alternative substances on the market to meet the demand , or due to applicable safety standards excluding the use of relevant alternatives .


### operators of equipment that contains fluorinated greenhouse gases with a global warming potential equivalent to 5 tonnes of co2 not contained in foams shall ensure that the equipment is checked for leakage . however , equipment with hermetically sealed systems which are labelled as such , containing fluorinated greenhouse gases with a global warming potential equivalent to less than 10 tonnes co2 , shall not be subject to leak checks under this article . ### operators of equipment that contains 1 . 5 kg or more fluorinated greenhouse gases not contained in foams shall ensure that the equipment is checked for leakage .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to reduce the amount of the non - interest - bearing deposit or to cancel it . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional or social economic circumstances or following a request by the member state concerned addressed to the commission within 50 days of adoption of the council decision in accordance with article 126 of the treaty , propose to reduce the amount of the non - interest - bearing deposit or to cancel it .


### distribution of the interest and fines ### use of the interest and fines


### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 tfeu that an excessive deficit or excessive government debt exist in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### additional sanctions are necessary to make the enforcement of budgetary surveillance more effective in the euro area . those sanctions should enhance the credibility of the fiscal surveillance framework of the union . ### additional assistance is necessary to make the enforcement of budgetary surveillance more effective in the euro area . eventual sanctions should not harm political solidarity of the union and social cohesion in its member states . incentives should enhance the credibility of the monetary union and reduce excessive costs of sovereign debt and public investment .


### if the council decides in accordance with article 126 of the treaty that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 of the treaty that the member state has nor taken effective action in response to a council recommendation and has neither given explanation for deviating from the recommendations , the council , acting on a proposal from the commission and after consulting the european parliament , may decide that the member state shall pay a non - interest bearing deposit . in respect of article 153 of the treaty , no sanction will be enforced if it is related to a recommendation concerning the issue of pay and / or collective bargaining in the public sector . the decision shall be adopted by the council by qualified majority . the council may amend the proposal in accordance with article 293 of the treaty .


### a possibility should be provided for the council to reduce or to cancel the sanctions imposed on member states whose currency is the euro on the basis of a commission proposal following a reasoned request by the member state concerned . in the corrective part of the stability and growth pact , the commission should also be able to propose to reduce the size of a sanction or to cancel it on grounds of exceptional economic circumstances . ### a feasible possibility should be provided for the council to reduce or to cancel the sanctions imposed on member states whose currency is the euro on the basis of a proposal made by the commission or the european parliament or on the basis of following a request by the member state concerned . in the corrective part of the stability and growth pact , the commission should also be able to propose to reduce the size of a sanction or to cancel it on grounds of exceptional economic circumstances or negative social effects .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to cancel or to reduce the amount of the fine . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic or social circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 tfeu , propose to cancel or to reduce the amount of the fine . the european parliament shall be kept involved .


### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from sustainable fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , and whenever credits referred to in article 2a reach a negative value the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by simple majority to reject the proposal within thirty days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty .