### a parcel delivery service provider which employs fewer than 50 persons shall not be subject to the obligations under paragraph 1 and 2 , unless that provider is established in more than one member state . ### this article shall not apply to parcel delivery service providers which employed on average fewer than 50 persons over the course of the previous calendar year . the number of persons shall be calculated on the basis of the average annual number of full - time , part - time , temporary employees and self - employed , as well as persons working for sub - contracting companies in parcel delivery services . a breakdown of the calculations shall be made available upon request ;


### transparency of tariffs and terminal rates ### transparency of cross - border tariffs and terminal rates


### universal service providers providing parcel delivery services shall provide the national regulatory authority of the member state in which they are established with the public list of tariffs applicable on 1 january of each calendar year for the delivery of postal items falling within the categories listed in the annex . that information shall be provided by 31 january of each calendar year at the latest . ### all cross - border parcel delivery service providers falling within the scope of article 3 shall provide the national regulatory authority of the member state in which they are established with the public list of tariffs applicable on 1 january of each calendar year for the delivery of postal items falling within the categories listed in the annex . that information shall be provided by 28 february of each calendar year at the latest .


### universal service providers providing parcel delivery services shall provide the national regulatory authority of the member state in which they are established with the public list of tariffs applicable on 1 january of each calendar year for the delivery of postal items falling within the categories listed in the annex . that information shall be provided by 31 january of each calendar year at the latest . ### all parcel delivery service providers shall provide the national regulatory authority of the member state where they are established with the public list of tariffs applicable on 1 january of each calendar year to postal items falling within the categories listed in the annex . that information shall be provided by 31 january of each calendar year at the latest .


### the national regulatory authority shall submit its assessment , including any information and / or justification provided in accordance with paragraph 3 , to the commission , the national regulatory authorities of the other member states and the national authorities within the member state of the submitting national regulatory authority entrusted with the implementation of competition law . a non - confidential version of that assessment shall also be provided to the commission . that information shall be provided by 31 march of each calendar year at the latest . ### the parcel delivery service provider shall provide the national regulatory authority with the justification referred to in paragraph 3 within one month of receipt of the request .


### whenever universal service providers providing parcel delivery services conclude multilateral agreements on terminal rates they shall meet all reasonable requests for access to all network elements and associated facilities as well as relevant services and information systems , necessary for the provision of cross - border parcel delivery services . ### whenever parcel service providers with more than 5% of the national market share or established in more than one member state conclude multilateral agreements on terminal rates they shall meet all reasonable requests that are made by parcel delivery service providers defined as small and medium sized enterprises , in accordance with commission recommendation 2003 / 361 / ec and that concern access to all network elements and associated facilities as well as relevant services and information systems , necessary for the provision of cross - border parcel delivery services . any refusal of access shall be justified in a clear and objective way , and notified to national regulatory authorities .


### universal service providers referred to in paragraph 1 shall publish a reference offer . the reference offer shall contain all the relevant associated terms and conditions , including prices . ### parcel delivery service providers referred to in paragraph 1 shall publish a reference offer following a request by the sme seeking access . the reference offer shall contain all the relevant sales associated terms and conditions , including prices .


### universal service providers referred to in paragraph 1 shall upon request , and based on a reference offer , make an individual offer available to a parcel delivery service provider requesting access within the meaning of that paragraph at the latest one month after the receipt of the request . universal service providers receiving an access request and providers requesting access shall negotiate in good faith . ### parcel delivery service providers referred to in paragraph 1 shall upon request , and based on a reference offer , make an individual offer available to the smes seeking access within the meaning of that paragraph at the latest one month after the receipt of the request . parcel delivery service providers receiving an access request and providers requesting access shall negotiate in good faith .


### when no agreement is reached on the basis of the individual offer referred to in paragraph 6 , the parcel delivery service provider requesting access may submit the individual offer made by the universal service provider to the national regulatory authority . if necessary , the national regulatory authority shall change the individual offer to give effect to the obligations laid down in this article . ### when no agreement is reached on the basis of the individual offer referred to in paragraph 6 , the sme seeking access may submit the individual offer made by the parcel delivery service provider to the national regulatory authority . if necessary , the national regulatory authority shall change the individual offer to give effect to the obligations laid down in this article .


### transparent and non - discriminatory cross - border access ### transparent and non - discriminatory cross - border access for small and medium - sized enterprises


### whenever universal service providers providing parcel delivery services conclude multilateral agreements on terminal rates they shall meet all reasonable requests for access to all network elements and associated facilities as well as relevant services and information systems , necessary for the provision of cross - border parcel delivery services . ### whenever universal service providers providing parcel delivery services conclude multilateral agreements on terminal rates they shall meet all reasonable requests that are made by parcel delivery service providers defined as small and medium sized enterprises , in accordance with commission recommendation 2003 / 361 / ec1a and that concern access to all network elements and associated facilities as well as relevant services and information systems , necessary for the provision of cross - border parcel delivery services . any refusal of access shall be justified in a clear and objective way , and notified to national regulatory authorities . __________________ 1a commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises .


### universal service providers referred to in paragraph 1 shall publish a reference offer . the reference offer shall contain all the relevant associated terms and conditions , including prices . ### universal service providers referred to in paragraph 1 shall publish a reference offer following a request by the sme seeking access . the reference offer shall contain all the relevant associated sales terms and conditions , including prices .


### the reference offer shall include all components necessary for access as referred to in paragraph 1 , including any conditions limiting access to and / or use of services where such conditions are allowed by member states in conformity with union law . ### the reference offer shall include any conditions necessary for access as referred to in paragraph 1 , including any conditions limiting access to and / or use of services where such conditions are allowed by member states in conformity with union law . the reference offer shall include , as a minimum , standard conditions , a monthly forecast of traffic for each period of 12 calendar months , public reference prices and public discounts , a bank guarantee , conditions relating to the confidentiality of information exchange and any required authorisation of the access seeker as parcel delivery service provider . the reference offer shall be published on the website of the universal service provider and shall be sent to the national regulatory authority for its information .


### universal service providers referred to in paragraph 1 shall upon request , and based on a reference offer , make an individual offer available to a parcel delivery service provider requesting access within the meaning of that paragraph at the latest one month after the receipt of the request . universal service providers receiving an access request and providers requesting access shall negotiate in good faith . ### universal service providers referred to in paragraph 1 shall upon request , and based on a reference offer , make an individual offer available to the smes seeking access within the meaning of that paragraph at the latest one month after the receipt of the request . universal service providers receiving an access request and providers requesting access shall negotiate in good faith .


### when no agreement is reached on the basis of the individual offer referred to in paragraph 6 , the parcel delivery service provider requesting access may submit the individual offer made by the universal service provider to the national regulatory authority . if necessary , the national regulatory authority shall change the individual offer to give effect to the obligations laid down in this article . ### when no agreement is reached on the basis of the individual offer referred to in paragraph 6 , the sme seeking access may submit the individual offer made by the universal service provider to the national regulatory authority . if necessary , the national regulatory authority shall change the individual offer to give effect to the obligations laid down in this article .


### before xx / xx / 2019 , and thereafter every four years , the commission shall submit to the european parliament , the council and the economic and social committee an evaluation report on the application of this regulation accompanied where appropriate by a proposal for its review . ### before xx / xx / 2019 , and thereafter every three years , the commission shall submit to the european parliament , the council and the economic and social committee an evaluation report on the application of this regulation accompanied where appropriate by a legislative proposal for its review . the report shall be produced following consultation with all appropriate stakeholders , including the social dialogue committee for the postal sector .


### whether the affordability of cross - border parcel delivery services has improved , including for users located in remote or sparsely populated areas ; ### whether the efficiency and affordability of cross - border parcel delivery services has improved , including for users located in remote or sparsely populated areas ;


### the tariffs above shall correspond to items delivered at the home or premises in the member state of destination . ### the tariffs above shall correspond to items delivered at the home or premises of the addressee in the member state of destination .


### for the achievement of a genuine digital single market , the harmonisation of certain aspects concerning contracts for supply of digital content , taking as a base a high level of consumer protection , is necessary . ### for the achievement of a genuine digital single market , the harmonisation of certain aspects concerning contracts for supply of digital content , taking as a base a high level of consumer protection and the need to improve accessibility , is necessary .


### consumers will benefit from fully harmonised rights for digital content at a high level of protection . they will have clear rights when they receive or access digital content from anywhere in the eu . this will increase their confidence in buying digital content . this will also contribute to reducing the detriment consumers currently suffer , since there will be a set of clear rights that will enable them to address problems they face with digital content . ### consumers will benefit from fully harmonised rights for digital content at a high level of protection . they will have clear rights when they receive or access digital content from anywhere in the eu . this will increase their confidence in buying digital content . this will also contribute to reducing the detriment consumers currently suffer , since there will be a set of clear rights that will enable them to address problems they face with digital content and its accessibility .


### the directive should address problems across different categories of digital content and its supply . in order to cater for fast technological developments and to maintain the future - proof nature of the notion of digital content , this notion as used in this directive should be broader than in directive 2011 / 83 / eu of the european parliament and of the council . 30 in particular it should cover services which allow the creation , processing or storage of data . while there are numerous ways for digital content to be supplied , such as transmission on a durable medium , downloading by consumers on their devices , web - streaming , allowing access to storage capabilities of digital content or access to the use of social media , this directive should apply to all digital content independently of the medium used for its transmission . differentiating between different categories in this technologically fast changing market is not desirable because it would hardly be possible to avoid discriminations between suppliers . a level - playing field between suppliers of different categories of digital content should be ensured . however this directive should not apply to digital content which is embedded in goods in such a way that it operates as an integral part of the goods and its functions are subordinate to the main functionalities of the goods . _________________ 30 oj l 304 , 22 . 11 . 2011 , p . 64 . ### the directive should address problems across different categories of digital content and its supply . in order to cater for fast technological developments and to maintain the future - proof nature of the notion of digital content , this notion as used in this directive should be broader than in directive 2011 / 83 / eu of the european parliament and of the council30 . in particular it should cover services which allow the creation , processing or storage of data , as well as the mechanisms that facilitate accessibility . while there are numerous ways for digital content to be supplied , such as transmission on a durable medium , downloading by consumers on their devices , web - streaming , allowing access to storage capabilities of digital content or access to the use of social media , this directive should apply to all digital content independently of the medium used for its transmission . differentiating between different categories in this technologically fast changing market is not desirable because it would hardly be possible to avoid discriminations between suppliers . a level - playing field between suppliers of different categories of digital content should be ensured . however this directive should not apply to digital content which is embedded in goods in such a way that it operates as an integral part of the goods and its functions are subordinate to the main functionalities of the goods . _________________ 30 oj l 304 , 22 . 11 . 2011 , p . 64


### the protection of individuals with regard to the processing of personal data is governed by directive 95 / 46 / ec of the european parliament and of the council1 and by directive 2002 / 58 / ec of the european parliament and of the council2 which are fully applicable in the context of contracts for the supply of digital content . those directives already establish a legal framework in the field of personal data in the union . the implementation and application of this directive should be made in full compliance with that legal framework . __________ oj l 281 , 23 / 11 / 1995 , p . 31 - 50 ) [ to be replaced by the general data protection regulation , once adopted ] . 2 . oj l 201 , 31 . 7 . 2002 , p . 37–47 . ### the pursuit of activities falling within the scope of this directive involves the processing of personal data . this directive is without prejudice to the rules of union law applicable to the processing of personal data within the union , in particular regulation 2016 / 679 of the european parliament and of the council1 and directive 2002 / 58 / ec of the european parliament and of the council2 , which govern the processing of personal data carried out in the member states under the supervision of the member states ' competent authorities , in particular the public independent authorities designated by the member states . those legal acts already establish a legal framework in the field of personal data in the union and are fully applicable in the context of contracts for the supply of digital content . the implementation and application of this directive should be made in full compliance with that legal framework . __________ regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . 2 . oj l 201 , 31 . 7 . 2002 , p . 37–47 .


### in cases where the contract does not stipulate sufficiently clear and comprehensive benchmarks to ascertain the conformity of the digital content with the contract , it is necessary to set objective conformity criteria to ensure that consumers are not deprived of their rights . in such cases the conformity with the contract should be assessed considering the purpose for which digital content of the same description would normally be used . ### in cases where the contract does not stipulate sufficiently clear and comprehensive benchmarks to ascertain the conformity of the digital content with the contract , or where it cannot be assumed that consumers could sufficiently comprehend and assess those benchmarks , it is necessary to set conformity criteria to ensure that consumers are not deprived of their rights . in such cases , the conformity with the contract should be assessed considering the purpose for which digital content of the same description would normally be used , as well as consumers ' legitimate expectations .


### while data - driven services and technologies bring significant benefits , they also create some vulnerabilities . as recognised by the digital single market strategy a high level of network and information security is essential across the european union to ensure respect of fundamental rights such as the right to privacy and personal data , to increase user confidence and strengthen their trust in the digital economy . as software becomes pervasive , qualities such as reliability , security and adaptability to evolving needs are also becoming a prime concern . it is therefore increasingly important that those data - driven services and technologies ensure that those qualities are guaranteed , to the extent that is proportionate to the role and function those technologies play . in particular , quality in terms of security and reliability is becoming an important concern for innovative , composite services that have to rely on the interconnection of diverse systems in different domains . ### while data - driven services and technologies bring significant benefits , they also create some vulnerabilities . as recognised by the digital single market strategy a high level of network and information security is essential across the european union to ensure respect of fundamental rights , such as the right to the protection of online privacy and personal data , to increase user confidence and strengthen their trust in the digital economy . as software becomes pervasive , qualities such as reliability , security and adaptability to evolving needs are also becoming a prime concern . it is therefore increasingly important that those data - driven services and technologies ensure that those qualities are guaranteed to the greatest possible extent . in particular , quality in terms of security and reliability is becoming an important concern for innovative , composite services that have to rely on the interconnection of diverse systems in different domains .


### as a second step , the consumer should be entitled to have the price reduced or the contract terminated . the right of a consumer to have the contract terminated should be limited to those cases where for instance bringing the digital content to conformity is not possible and the non - conformity impairs the main performance features of the digital content . where the consumer terminates the contract , the supplier should reimburse the price paid by the consumer or , where the digital content is supplied not in exchange for a price but against access to data provided by the consumer , the supplier should refrain from using it , from transferring that data to third parties or allowing third parties to access it after termination of the contract . fulfilling the obligation to refrain from using data should mean in the case when the counter - performance consists of personal data , that the supplier should take all measures in order to comply with data protection rules by deleting it or rendering it anonymous in such a way that the consumer cannot be identified by any means likely reasonably to be used either by the supplier or by any other person . without prejudice to obligations of a controller under directive 95 / 46 / ec the supplier should not be obliged to undertake any further steps in relation to data which the supplier has lawfully provided to third parties in the course of the duration of the contract for the supply of the digital content . ### as a second step , the consumer should be entitled to have the price reduced or the contract terminated . the right of a consumer to have the contract terminated should be limited to those cases where for instance bringing the digital content to conformity is not possible and the non - conformity impairs the main performance features of the digital content . where the consumer terminates the contract , the supplier should reimburse the price paid by the consumer or , where the digital content is supplied not in exchange for a price but against access to the consumer ' s data , the supplier should refrain from using it , from transferring that data to third parties or allowing third parties to access it after termination of the contract . fulfilling the obligation to refrain from using data should mean in the case when the counter - performance consists of personal data , that the supplier should take all measures in order to comply with data protection rules by deleting it or rendering it anonymous in such a way that the consumer cannot be identified by any means likely reasonably to be used either by the supplier or by any other person .


### the principle of the supplier ' s liability for damages is an essential element of the contracts for supply of digital content . in order to increase consumers ' trust in digital content this principle should thus be regulated at union level to ensure that consumers do not suffer a detriment if their hardware or software is damaged by digital content which is not in conformity with the contract . therefore , consumers should be entitled to a compensation for damages caused to the consumer ' s digital environment by a lack of conformity with the contract or a failure to supply the digital content . however , it should be for member states to lay down the detailed conditions for the exercise of the right to damages while taking into account that discounts on prices for future supplies of the digital content , especially when offered by suppliers as an exclusive compensation for losses , do not necessarily put the consumer as nearly as possible into the position in which the consumer would have been if the digital content had been duly supplied and been in conformity with the contract . ### the principle of the supplier ' s liability for damages is an essential element of the contracts for supply of digital content . in order to increase consumers ' trust in digital content this principle should thus be regulated at union level to ensure that consumers do not suffer a detriment if they sustain damage by digital content which is not in conformity with the contract . therefore , consumers should be entitled to a compensation for damages caused to the consumer by a lack of conformity with the contract or a failure to supply the digital content . however , it should be for member states to lay down the detailed conditions for the exercise of the right to damages while taking into account that discounts on prices for future supplies of the digital content , especially when offered by suppliers as an exclusive compensation for losses , do not necessarily put the consumer as nearly as possible into the position in which the consumer would have been if the digital content had been duly supplied and been in conformity with the contract . it should be possible for member states , when laying down the rules in that regard , to provide for a reduced or increased degree of liability for damages in order to differentiate between suppliers that have done everything in their power to limit the possibility of damage , for example by observing industry codes of best practice , security baselines or international standards , and those that have been negligent in this respect .


### this directive shall apply to any contract where the supplier supplies digital content to the consumer or undertakes to do so and , in exchange , a price is to be paid or the consumer actively provides counter - performance other than money in the form of personal data or any other data . ### this directive shall apply to any contract under which the supplier supplies or undertakes to supply digital content or a digital service to the consumer in exchange for payment or the provision of data as counter - performance .


### to the extent that the contract does not stipulate , where relevant , in a clear and comprehensive manner , the requirements for the digital content under paragraph 1 , the digital content shall be fit for the purposes for which digital content of the same description would normally be used including its functionality , interoperability and other performance features such as accessibility , continuity and security , taking into account : ### to the extent that the contract does not stipulate , where relevant , in a clear and comprehensive manner , the requirements for the digital content under paragraph 1 , or where it cannot be assumed that consumers could sufficiently comprehend and assess these requirements , the digital content shall be fit for the purposes for which digital content of the same description would normally be used including its functionality , interoperability and other performance features such as accessibility , continuity and security , taking into account :


### whether the digital content is supplied in exchange for a price or other counter - performance than money ; ### whether the digital content is supplied in exchange for money or other counter - performance pursuant to article 3 ;


### member states shall ensure that adequate and effective means exist to ensure compliance with this directive . ### member states shall ensure that effective and dissuasive means exist to ensure compliance with this directive .


### the economic and financial crisis has led to a lowering of the level of investments within the union . investment has fallen by approximately 15% since its peak in 2007 . the union suffers in particular from a lack of investment as a consequence of market uncertainty regarding the economic future and the fiscal constraints on member states . this lack of investment slows economic recovery and negatively affects job creation , long - term growth prospects and competitiveness . ### the economic and financial crisis has led to a lowering of the level of investments within the union . investment has fallen by approximately 15% since its peak in 2007 . the union suffers in particular from a lack of investment as a consequence of market uncertainty regarding the economic future and the fiscal constraints on member states . this lack of investment slows economic recovery and negatively affects job creation , long - term growth prospects and internal and external competitiveness . investment is a crucial component that will not only stimulate rapid economic and social recovery from the crisis , but also stimulate the creation of more and better jobs across the eu .


### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion . ### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased and fair access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion .


### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion . ### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union , to overcome the current investments gap among member states and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises , notably innovative companies and start - ups . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s internal and external competitiveness , innovation potential , and economic , social and territorial cohesion .


### the efsi should support strategic investments with high economic value added contributing to achieving union policy objectives . ### the efsi should support strategic investments with high economic and social value added , promoting quality jobs and innovation , integrating and completing the single market , boosting the competitiveness of the eu and contributing to achieving union policy objectives .


### requirements governing the use of the eu guarantee , including within specific time frames and key performance indicators ; ### requirements governing the use of the eu guarantee , including within specific time frames , key projects and fields of financing set out in article 5 , and key performance indicators ;


### the efsi agreement shall provide for the creation of a european investment advisory hub within the eib . the eiah shall have as its objective to build upon existing eib and commission advisory services in order to provide advisory support for investment project identification , preparation and development and act as a single technical advisory hub for project financing within the union . this shall include support on the use of technical assistance for project structuring , use of innovative financial instruments , use of public - private partnerships and advice , as appropriate , on relevant issues of eu legislation . ### the efsi agreement shall provide for the creation of a european investment advisory hub within the eib . the eiah shall have as its objective to build upon existing eib and commission advisory services in order to provide advisory support for investment project identification , preparation and development and act as a single technical advisory hub for project financing within the union . this shall include support on the use of technical assistance for project structuring , use of innovative financial instruments , use of public - private partnerships and advice , as appropriate , on fields and areas of eu legislation and policies with particular relevance for the objectives set out in article 5 .


### the investment committee shall be composed of six independent experts and the managing director . independent experts shall have a high level of relevant market experience in project finance and be appointed by the steering board for a renewable fixed term of three years . ### the investment committee shall be composed of six independent experts . independent experts shall have a high level of relevant market experience in project finance and be selected by the steering board . they shall be appointed by the european parliament , after an appropriate hearing by the competent committees of the european parliament , for a renewable fixed term of three years .


### infrastructure projects in the environmental , natural resources , urban development and social fields ; ### infrastructure and innovation projects in the digital single market , digital public administrations and public procurement , the environmental , natural resources , urban development and social fields ;


### the commission and the eib , with support from the member states , shall promote the creation of a transparent pipeline of current and potential future investment projects in the union . the pipeline is without prejudice to the final projects selected for support according to article 3 . ### the commission and the eib , with support from the member states , shall establish&#160 ; a transparent pipeline of current and potential future investment projects in the union . the pipeline is without prejudice to the final projects selected for support according to article 3 .


### the commission and the eib shall develop , update and disseminate , on a regular and structured basis , information on current and future investments which significantly contribute to achieving eu policy objectives . ### the commission and the eib shall develop , update and disseminate , on a regular , transparent and structured basis , information on current and future investments which significantly contribute to achieving eu policy objectives .


### member states shall develop , update and disseminate , on a regular and structured basis , information on current and future investment projects in their territory . ### member states shall develop , update and disseminate , on a regular , transparent and structured basis , information on current and future investment projects in their territory .


### an assessment of the quality of eib financing and investment operations ; ### an assessment of the quality and effectiveness of eib financing and investment operations ;


### the eip should incorporate the union commitment under the addis ababa action agenda on financing for development . it should also allow european investors and private companies , including small and medium - sized enterprises , to participate more effectively to sustainable development in partner countries . ### the eip should incorporate the union commitment under the addis ababa action agenda on financing for development . it should also allow european investors and private companies , including small and medium - sized enterprises , to contribute more effectively to sustainable development in partner countries .


### furthermore , the efsd should operate as ' one - stop - shop ' to receive financing proposals from financial institutions and public or private investors and deliver a wide range of financial support to eligible investments . the efsd guarantee should be backed by the efsd guarantee fund . the efsd should deploy innovative instruments to support investments and involve the private sector . ### furthermore , the efsd should operate as ' one - stop - shop ' to receive financing proposals from financial institutions and public or private investors and deliver a wide range of support to eligible investments and guidance for investors . the efsd guarantee should be backed by the efsd guarantee fund . the efsd should deploy innovative instruments to support investments in sustainable development in partner countries and involve the private sector .


### moreover , the strategic board should support the commission in setting strategic guidance and overall investment goals . the strategic board should also support coordination and coherence between the regional platforms . this should ensure complementarity of the various instruments in external action . the strategic board should be co - chaired by the commission and the high representative of the union for foreign affairs and security policy to ensure consistency and coherence with union external policy objectives and partnership frameworks with third countries . ### moreover , the strategic board should support the commission in setting strategic guidance and overall investment goals . the strategic board should also support coordination and coherence between the regional platforms . this should ensure complementarity and strengthen synergies of the various instruments in external action . the strategic board should be co - chaired by the vice - president of the commission and the high representative of the union for foreign affairs and security policy to ensure consistency and coherence with union external policy objectives and partnership frameworks with third countries .


### in order to increase the impact of the efsd guarantee in view of the needs in the regions concerned , member states should have the possibility of providing contributions in the form of a guarantee or cash . those contributions could be earmarked by region , sector or investment window . ### in order to increase the impact of the efsd guarantee in view of the needs for increasing investments and funding for projects that contribute to sustainable development and create decent employment opportunities in the regions concerned , member states should have the possibility of providing contributions in the form of a guarantee or cash . those contributions could be earmarked by region , sector or investment window .


### the commission should report annually to the european parliament and the council on the financing and investment operations covered by the efsd guarantee with a view to ensuring accountability to the european citizens . the report should be made public in order to allow relevant stakeholders , including civil society , to express their views . the commission should also report annually to the european parliament and the council on the management of the efsd guarantee fund so that accountability and transparency are ensured . ### the commission should report annually to the european parliament and the council on the financing and investment operations covered by the efsd guarantee with a view to ensuring accountability to the european citizens . the report should be made public in order to allow relevant stakeholders , including civil society , to express their views . the commission should also report annually to the european parliament and the council on the management of the efsd guarantee fund so that accountability , transparency and effectiveness of the management are ensured .


### the efsd shall contribute to the achievement of the sustainable development goals of the 2030 agenda with a particular focus on sustainable growth , job creation , socio - economic sectors and on the support to micro , small and medium sized enterprises , thus addressing root causes of migration and contributing to sustainable reintegration of returned migrants in their countries of origin while maximising additionality , delivering innovative products and crowding in private sector funds . ### the efsd shall contribute to the achievement of the sustainable development goals of the 2030 agenda with a particular focus on sustainable growth , eradication of poverty , decent job creation , socio - economic sectors , improving access to public services , on climate change mitigation and adaptation and on the support to micro , small and medium sized enterprises , thus addressing root causes of migration and contributing to sustainable reintegration of returned migrants in their countries of origin while maximising additionality , delivering innovative products and crowding in private sector funds .


### it shall provide strategic guidance and support the commission in setting overall investment goals as regards the use of the efsd guarantee . the strategic board shall also support overall coordination and coherence between the regional investment platforms and with the external lending mandate operations managed by the eib , including the eib resilience initiative . ### it shall provide strategic guidance and support the commission in setting overall investment goals as regards the use of the efsd guarantee , the criteria of eligibility of investment to the regional platforms and operating policies and procedures . the strategic board shall also support overall coordination , cooperation and coherence between the regional investment platforms and with the external lending mandate operations managed by the eib , including the eib resilience initiative . the strategic board activity will be overseen by a steering committee on a permanent basis within the european parliament .


### contribute to economic and social development , with particular focus on sustainability and job creation , thus addressing root causes of migration and contributing to sustainable reintegration of returned migrants in their countries of origin ; ### contribute to economic and social development , with particular focus on sustainability , eradication of poverty and decent job creation , thus addressing root causes of migration and contributing to sustainable reintegration of returned migrants in their countries of origin ;


### detailed information on calls on the efsd guarantee , losses , returns , amounts recovered and any other payments received ; ### detailed information on calls on the efsd guarantee , losses , returns , amounts recovered and any other payments received as well as indication of risks of future calls on the efsd guarantee ;


### the results of the mutual evaluation process revealed a lack of clarity as regards the criteria to be used by national competent authorities when assessing the proportionality of requirements restricting access to or pursuit of regulated professions , as well as uneven scrutiny of such measures at all levels of regulation . to avoid fragmentation of the internal market and eliminate barriers to taking - up and pursuit of certain employed or self - employed activities , it is therefore necessary to establish a common approach at union level , preventing disproportionate measures from being adopted . ### the results of the mutual evaluation process revealed a lack of clarity as regards the criteria to be used by national competent authorities when assessing the proportionality of requirements restricting access to or pursuit of regulated professions , as well as uneven scrutiny of such measures at all levels of regulation . to avoid fragmentation of the internal market and eliminate barriers to taking - up and pursuit of certain employed or self - employed activities , there should be a common approach at union level , preventing disproportionate measures from being adopted .


### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession . ### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec . for the purpose of this directive , the term “regulated profession” should refer to both existing regulated professions as defined in directive 2005 / 36 / ec and professions that member states are considering to regulate with the result that they will fall under the definition of “regulated profession” in directive 2005 / 36 / ec . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession .


### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession . ### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec , without prejudice to recital . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession .


### it is appropriate to monitor the proportionality of the provisions restricting access to or pursuit of regulated professions on a regular basis and with a frequency appropriate to the regulation concerned . a review of the proportionality of restrictive national legislation in the area of regulated professions should be based not only on the objective of that legislation at the time of its adoption , but also on the effects of the legislation , assessed after its adoption . the assessment of the proportionality of the national legislation should be based on developments found to have occurred in the area since the legislation was adopted . ### it is appropriate to monitor the non - discrimination , justification and proportionality of the essential provisions restricting access to or pursuit of regulated professions after adoption . a review of the non - discrimination , justification and proportionality of restrictive national legislation in the area of regulated professions should be based not only on the objective of that legislation at the time of its adoption , but also on the effects of the legislation , assessed after its adoption . such assessment of the national legislation should be based on significant developments found to have occurred in the area since the legislation was adopted .


### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , there is particular reason for concern in cases where the policy choice made by those authorities or bodies provides benefits to established operators at the expense of new market entrants . ### member states should carry out the non - discrimination , justification and proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so .


### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , there is particular reason for concern in cases where the policy choice made by those authorities or bodies provides benefits to established operators at the expense of new market entrants . ### member states should carry out proportionality assessments in an objective manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , the policy choice made by those authorities or bodies should not be discriminatory .


### where a member state intends to regulate a profession or to amend existing rules , account should be taken of the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals display a high level of technical knowledge which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them . ### when assessing the proportionality of the provisions , member states should consider the criteria which are relevant for the provisions being analysed . where a member state intends to regulate a profession or to amend existing rules , account should be taken , where relevant , of the nature of the risks related to the public interest objectives pursued , in particular the risks to service recipients , including consumers , to professionals or third parties , also where those risks are not certain or not fully apparent , taking into account the precautionary principle . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals display a high level of technical knowledge which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them .


### to meet the requirement of proportionality , the measure should be suitable for securing the attainment of the objective pursued . a measure should only be considered suitable for securing the attainment of the objective pursued , if it genuinely reflects a concern to attain that objective in a consistent and systematic manner , for instance where similar risks related to certain activities are addressed in a comparable way and where any exceptions to the restrictions involved are applied in line with the stated objective . furthermore , the national measure should contribute to achieving the objective pursued and therefore , where it has no effect on the ground for justification , it should not be considered as suitable . ### to meet the requirement of proportionality , the measure should be suitable for securing the attainment of the objective pursued . a measure should only be considered suitable for securing the attainment of the objective pursued , if it genuinely reflects a concern to attain that objective in a consistent and systematic manner . furthermore , the national measure should contribute to achieving the objective pursued and therefore , where it has no effect on the ground for justification , it should not be considered as suitable .


### among the elements to be taken into account by national authorities , the following are of most relevance : the link between the scope of professional activities covered by a profession and the professional qualification required ; the complexity of the tasks in particular as regards the level , the nature and the duration of the training or experience required ; the existence of different routes to obtain the professional qualification ; the scope of the professional activities , reserved to holders of a particular professional qualification , and in particular whether the activities reserved to certain professionals can be shared with other professionals ; the degree of autonomy in exercising a regulated profession in particular where the activities relating to a regulated profession are pursued under the control and responsibility of a duly qualified professional . ### among the elements to be taken into account , where relevant , by member states , the following are of relevance : the link between the scope of professional activities covered by a profession and the professional qualification required ; the complexity of the tasks in particular as regards the level , the nature and the duration of the training or experience required ; the existence of different routes to obtain the professional qualification ; whether the activities reserved to certain professionals can be shared with other professionals ; the degree of autonomy in exercising a regulated profession in particular where the activities relating to a regulated profession are pursued under the control and responsibility of a duly qualified professional .


### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be duly taken into account by the competent authorities ; based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains . ### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be taken into consideration by the competent authorities ; this analysis should not be the sole evaluation criterion for the proportionality of a measure aimed at protecting an objective of general interest .


### member states should carry out a comparison between the national measure at issue and the alternative and less restrictive solutions that would allow the same objective to be attained but would impose fewer restrictions . where the measures are justified by consumer protection and where the risks identified are limited to the relationship between the professional and the consumer without negatively affecting third parties , the objective could be attained by less restrictive means than reserving activities to professionals , such as protection of the professional title or enrolment on a professional register . regulation by way of reserved activities should be used only in cases where the measures aim at preventing a risk of serious harm to public interest objectives . ### member states should consider , where relevant , the possibility to use less restrictive solutions to achieve the same public interest objective .


### the national authorities should carry out a global assessment of the circumstances in which the restrictive measure is adopted and implemented and examine in particular the cumulative effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with certain provisions such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the cumulative effect of the measures , the competent authorities should also take into account other existing requirements , such as continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession . a measure introduced by a member state cannot be regarded as necessary to achieve the objective pursued if it essentially duplicates requirements which have already been introduced in the context of other rules or procedures . ### where relevant , member states should carry out an assessment of the circumstances in which the measure is adopted and implemented and examine in particular the effect of the new or amended provisions when combined with other requirements restricting access to or pursuit of the profession . the taking - up and pursuit of certain activities may be conditional on complying with certain provisions such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional supervision and liability . therefore , when assessing the effect of the new or amended measures , member states should also take into account , where relevant , the effects of those measures combined with other existing requirements , such as compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession . in carrying out this assessment , existing requirements which are not being amended should not be subject to the proportionality assessment .


### since the objectives of this directive , namely the removal of disproportionate restrictions on access to or pursuit of regulated professions cannot be sufficiently achieved by the member states but can rather , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives , ### since the objectives of this directive , namely the removal of disproportionate restrictions on access to or pursuit of regulated professions cannot be sufficiently achieved by the member states but can rather , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of non - discrimination , and with the principle of proportionality as set out in that article , this directive does not go beyond what is necessary , in order to achieve those objectives ,


### this directive lays down rules on a common framework for conducting proportionality assessments before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , with a view to ensuring the proper functioning of the internal market . ### this directive lays down rules on a common framework for conducting proportionality assessments before introducing new , or amending existing , legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions with a view to ensuring the proper functioning of the internal market . it does not affect member states’ prerogative and margin of discretion to decide , in the absence of harmonisation at eu level , whether and how to regulate a profession while respecting the principles of non - discrimination , justification and proportionality .


### this directive lays down rules on a common framework for conducting proportionality assessments before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , with a view to ensuring the proper functioning of the internal market . ### this directive lays down criteria on a common framework for conducting proportionality assessments before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , with a view to ensuring the proper functioning of the internal market .


### for the purpose of this directive , the definitions of directive 2005 / 36 / ec shall apply . ### for the purpose of this directive , the definitions of directive 2005 / 36 / ec shall apply with the understanding that the term “regulated professions” shall refer to both existing regulated professions and professions member states are considering to regulate .


### ' protected professional title ' means a form of regulating a profession where the use of the title in a professional activity or group of professional activities is subject to a particular professional qualification in the relevant field by virtue of legislative , regulatory or administrative provisions , either directly , or indirectly , and where the improper use of this title is subject to sanctions or other measures . ### ' protected professional title ' means a form of regulating a profession where the use of the title in a professional activity or group of professional activities is subject to a particular professional qualification in the relevant field by virtue of legislative , regulatory or administrative provisions , either directly , or indirectly , and where the improper use of this title is subject to sanctions or other measures . the ' protected professional title ' is the cornerstone of the individual responsibility of professionals , of their independence , and of the qualitative and quantitative requirements with regard to knowledge , training and competence .


### member states shall ensure that before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , the relevant competent authorities undertake an assessment of their proportionality in accordance with the rules laid down in this directive . ### member states shall undertake an assessment of non - discrimination , justification and proportionality in accordance with the rules laid down in this directive before introducing new , or amending existing , essential legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , taking into account the reasonable margin of appreciation allowed to member states . the extent of the assessment shall be proportionate to the nature , the content and the impact of the provisions being introduced .


### member states shall monitor the proportionality of legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions on a regular basis and with a frequency appropriate to the regulation concerned , having due regard to any developments that have occurred since the measure concerned was adopted . ### member states shall monitor the compliance of essential legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions with the principles of non - discrimination , justification and proportionality after adoption , having due regard to any significant developments that have occurred since the measure concerned was adopted .


### grounds of a purely economic nature having essentially protectionist aim or effects or purely administrative reasons shall not constitute overriding reasons in the public interest , justifying a restriction on access to or pursuit of regulated professions . ### grounds of a purely economic nature having essentially protectionist aim or effects or purely administrative reasons shall not constitute overriding reasons in the public interest , justifying a restriction on access to or pursuit of regulated professions . control measures shall be considered justified if they are needed in order to ensure compliance with provisions justified by public interest objectives .


### the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties ; ### the nature of the risks related to the public interest objectives pursued , in particular the risks to service recipients , including consumers , to professionals or third parties , also where the risks may be uncertain or not fully apparent , taking into account the precautionary principle ;


### the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties ; ### the nature of the risks and costs related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties ;


### the necessity of the provision and in particular whether existing rules of a specific or more general nature , such as product safety legislation or consumer protection law , are insufficient to protect the objective pursued ; ### whether existing rules of a specific or more general nature , such as product safety legislation or consumer protection law , are insufficient to protect the objective pursued ;


### rules relating to the organisation of the profession , professional ethics and supervision ; ### rules relating to the organisation and supervision of the profession ;


### territorial restrictions , in particular where the profession is regulated in parts of a member state’s territory in a different manner ; ### territorial restrictions , including where the profession is regulated in parts of a member state’s territory in a different manner ;


### member states shall , by appropriate means , inform citizens , service recipients , representative associations and relevant stakeholders other than the members of the profession before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , and give them the opportunity to make known their views . ### before introducing new , or amending existing , legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , member states shall , by appropriate means , publicly disclose the relevant information on the provisions , adequately consult citizens , service recipients , including consumers , representative associations , social partners and other relevant stakeholders , including those who are not members of the profession , and give them the opportunity to make known their views .


### exchange of information between competent authorities ### exchange of information between member states


### for the purposes of the efficient application of this directive , before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall encourage the exchange of information with competent authorities of other member states on matters covered by this directive , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis . ### for the purposes of the efficient application of this directive and of directive 2005 / 36 / ec , the commission shall encourage and facilitate the exchange of information between member states on matters covered by this directive and by directive 2005 / 36 / ec , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis .


### member states shall inform the commission of the competent authorities responsible for transmitting and receiving information for the purposes of applying paragraph 1 . ### member states shall inform the commission of the public authorities responsible for transmitting and receiving information for the purposes of applying paragraph 1 .


### the reasons for considering that provisions , assessed in accordance with this directive , are justified , necessary and proportionate , and which are communicated to the commission pursuant to paragraphs 5 and 6 of article 59 of directive 2005 / 36 / ec , shall be recorded by the relevant competent authorities in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter made publicly available by the commission . ### the reasons for considering that provisions , assessed in accordance with directive 2005 / 36 / ec and with this directive , are non - discriminatory , justified and proportionate , and which are communicated to the commission pursuant to paragraphs 5 of article 59 of directive 2005 / 36 / ec , shall be recorded by the member states in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter made publicly available by the commission .


### member states and other interested parties may submit comments to the commission or to the member state which has notified the provisions . ### member states and other interested parties may submit comments concerning the provisions and the reasons referred to in paragraph 1 to the commission , or to the member state which has communicated the provisions .


### in the case of corporate entities : the natural person who ultimately owns or controls a legal entity through direct or indirect ownership of a sufficient percentage of the shares or voting rights or ownership interest in that entity , including through bearer shareholdings , or through control via other means , other than a company listed on a regulated market that is subject to disclosure requirements consistent with union law or subject to equivalent international standards which ensure adequate transparency of ownership information . a shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a natural person shall be an indication of direct ownership . a shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a corporate entity , which is under the control of a natural person , or by multiple corporate entities , which are under the control of the same natural person , shall be an indication of indirect ownership . this applies without prejudice to the right of member states to decide that a lower percentage may be an indication of ownership or control . control through other means may be determined , inter alia , in accordance with the criteria in article 22 to of directive 2013 / 34 / eu of the european parliament and of the council ; if , after having exhausted all possible means and provided there are no grounds for suspicion , no person under point is identified , or if there is any doubt that the person identified are the beneficial owner , the natural person who hold the position of senior managing official , the obliged entities shall keep records of the actions taken in order to identify the beneficial ownership under point and this point ; ' _________________ directive 2013 / 34 / eu of the european parliament and of the council of 26 june 2013 on the annual financial statements , consolidated financial statements and related reports of certain types of undertakings , amending directive 2006 / 43 / ec of the european parliament and of the council and repealing council directives 78 / 660 / eec and 83 / 349 / eec . ### in point , point is replaced by the following : ‘ in the case of corporate entities : all the natural persons who ultimately own or control a legal entity through direct or indirect ownership of a sufficient percentage of the shares or voting rights or ownership interest in that entity , including through bearer shareholdings , or through control via other means , other than a company listed on a regulated market that is subject to disclosure requirements consistent with union law or subject to equivalent international standards which ensure adequate transparency of ownership information . a shareholding of 5 % plus one share or an ownership interest of more than 5 % in the customer held by a natural person shall be an indication of direct ownership . a shareholding of 5 % plus one share or an ownership interest of more than 5 % in the customer held by a corporate entity , which is under the control of a natural person , or by multiple corporate entities , which are under the control of the same natural person , shall be an indication of indirect ownership . this applies without prejudice to the right of member states to decide that a lower percentage may be an indication of ownership or control . control through other means may be determined , inter alia , in accordance with the criteria in article 22 to of directive 2013 / 34 / eu of the european parliament and of the council ; if the entity fails to provide the identity of any natural person that meets the criteria under point , or if there is any doubt that the person identified are the beneficial owner , the obliged entities shall record that no beneficial owner exists and keep records of the actions taken in order to identify the beneficial ownership under point . in addition , the obliged entities should identify and verify the identity of the relevant natural person who holds the position of senior managing official , who should be identified as ' senior manager ' , and record details of all legal owners of the entity ; _________________ directive 2013 / 34 / eu of the european parliament and of the council of 26 june 2013 on the annual financial statements , consolidated financial statements and related reports of certain types of undertakings , amending directive 2006 / 43 / ec of the european parliament and of the council and repealing council directives 78 / 660 / eec and 83 / 349 / eec . ’


### in point , the following subparagraph is added : ' for the purposes of article 13 and article 30 of this directive , the indication of ownership or control set out in the second paragraph is reduced to 10% whenever the legal entity is a passive non - financial entity as defined in directive 2011 / 16 / eu . ' ; ### in point , second subparagraph is replaced by the following : a shareholding of 10% plus one share or an ownership interest of more than 10% in the customer held by a natural person shall be an indication of direct ownership . a shareholding of 10 % plus one share or an ownership interest of more than 10% in the customer held by a corporate entity , which is under the control of a natural person , or by multiple corporate entities , which are under the control of the same natural person , shall be an indication of indirect ownership . this applies without prejudice to the right of member states to decide that a lower percentage may be an indication of ownership or control . control through other means may be determined , inter alia , in accordance with the criteria in article 22 to of directive 2013 / 34 / eu of the european parliament and of the council .


### in the case of trusts : the settlor ; the trustee ; the protector , if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means ; ### in point 6 , point is replaced by the following : ‘ in the case of trusts : the settlor ; the trustee ; the protector if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means . with regard to trusts that are designated by characteristics or by class , the trust deed or related document should provide sufficient information concerning the beneficiary so that any person would be able to establish the identity of the beneficiary at the time of the distribution or when the beneficiary intends to exercise vested rights . ’


### ' in the case of trusts : the settlor ; the trustee ; the protector , if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means ; ' ### in point , point is replaced by the following : ' in the case of trusts : the settlor ; the trustee ; the protector , if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other person mentioned in the trust deed or related document any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means ; '


### the effective implementation of the requirements referred to in point is supervised at group level by a competent authority of the home member state or of the third country . ### in article 28 , point c is replaced by the following : ' the effective implementation of the requirements referred to in point is supervised at group level by a competent authority of the home member state . '


### member states shall require that the information held in the central register referred to in paragraph 3 is adequate , accurate and current . ### paragraph 4 is replaced by the following : ‘ 4 . member states shall require that the information held in the central register referred to in paragraph 3 is adequate , accurate and current . member states shall require that the obliged entities report cases of missing or inaccurate disclosures . ’


### member states shall require that the information held in the central register referred to in paragraph 3 is adequate , accurate and current . ### paragraph 4 is replaced by the following : 4 . member states shall require that the information held in the central register referred to in paragraph 3 is adequate , accurate and current . obliged entities , fius and competent authorities shall report any discrepancy they find between the beneficial ownership information held in the central registers and the beneficial ownership information collected as part of their customer due diligence procedures or investigations .


### member states shall require that the information held in the central register referred to in paragraph 4 is adequate , accurate and up - to - date . ### paragraph 5 is replaced by the following : ' 5 . member states shall require that the information held in the central register referred to in paragraph 4 is adequate , accurate and up - to - date . member states shall require that the obliged entities report cases of missing or inaccurate disclosures . '


### member states shall ensure that the information on the beneficial ownership is accessible in all cases to : competent authorities and fius , without any restriction ; obliged entities , within the framework of customer due diligence in accordance with chapter ii ; any person or organisation that can demonstrate a legitimate interest ; the persons or organisations referred to in point shall access at least the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . for the purposes of this paragraph , access to the information on beneficial ownership shall be in accordance with data protection rules and may be subject to online registration and to the payment of a fee . the fees charged for obtaining the information shall not exceed the administrative costs thereof . ### paragraph 5 is replaced by the following : ‘ 5 . member states shall ensure that the information on the beneficial ownership is accessible in all cases to : competent authorities and fius , without any restriction ; obliged entities , within the framework of customer due diligence in accordance with chapter ii ; the public the information accessible to the public shall consist of at least the name , the date of birth , the nationality , a business or service address and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . for the purposes of this paragraph , access to the information on beneficial ownership shall be in accordance with both data protection rules and open data standards . ’ ;


### “9 . in exceptional circumstances to be laid down in national law , where the access referred to in point of paragraph 5 would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions granted pursuant to this paragraph shall not apply to credit institutions and financial institutions , and to the obliged entities as referred to in point of article 2 that are public officials . ### “9 . in exceptional circumstances to be laid down in national law , where the access referred to in point and of paragraph 5 would expose the beneficial owner to the risk of kidnapping , blackmail , violence or intimidation , in particular when the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions shall never be indefinite and shall be reassessed at regular intervals to avoid abuse . where an exemption is granted , it must be clearly noted in the register accessible to entities referred to in point and of paragraph 5 . exemptions granted pursuant to this paragraph shall not apply to credit institutions and financial institutions , and to the obliged entities as referred to in point of article 2 that are public officials .


### in exceptional circumstances to be laid down in national law , where the access referred to in point of paragraph 5 would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . ### in exceptional circumstances to be laid down in national law , where the access referred to in point of paragraph 5 and paragraph 5a would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions shall be reassessed at regular intervals to avoid abuse . when an exemption is granted , this has to be clearly indicated in the register and legal appeal against the exemption shall always be possible . member states shall publish annual statistical data on the amount of exemptions granted and reasons stated and report the data to the commission .


### “in exceptional circumstances laid down in national law , where the access referred to in paragraphs 4 and 4a would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . ### “in exceptional circumstances laid down in national law , where the access referred to in paragraphs 4 and 4a would expose the beneficial owner to the risk of kidnapping , blackmail , violence or intimidation , in particular when the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions shall never be indefinite and shall be reassessed at regular intervals .


### in exceptional circumstances laid down in national law , where the access referred to in paragraphs 4 and 4a would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . ### in exceptional circumstances laid down in national law , where the access referred to in paragraphs 4 and 4a would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from such access to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions shall be reassessed at regular intervals to avoid abuse . when an exemption is granted , this has to be clearly indicated in the register and legal appeal against the exemption shall always be possible . member states shall publish annual statistical data on the amount of exemptions granted and reasons stated and report the data to the commission .


### “1 . member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand or fideicomiso . each member state shall require that trustees of any express trust administered in that member state obtain and hold adequate , accurate and up - to - date information on beneficial ownership regarding the trust . that information shall include the identity of : the settlor ; the trustee ; the protector ; the beneficiaries or class of beneficiaries ; any other natural person exercising effective control of the trust . ' ; ### “1 . member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand , waqf or fideicomiso , and all other similar , in terms of structure or function , existing or future legal arrangements . member states shall require that trustees of any express trust created , administered and / or operating in that member state obtain and hold adequate , accurate and up - to - date information on beneficial ownership regarding the trust . that information shall include the identity of : the settlor ; the trustee ; the protector ; the beneficiaries or class of beneficiaries ; and any other natural person exercising effective control over the trust . ” ;


### “3a . the information referred to in paragraph 1 shall be held in a central register set up by the member state where the trust is administered . ” ; ### “3a . the information referred to in paragraph 1 shall be held in a central register set up by the member state where the trust is created , administered or operates . member states shall notify to the commission the characteristics of the national central register . ” ;


### whenever entering into a new customer relationship with a trust or other legal arrangement subject to registration of beneficial ownership information pursuant to paragraph 3a , the obliged entities shall collect proof of registration whenever applicable . ” ; ### whenever entering into a new customer relationship with a trust or other legal arrangement subject to registration of beneficial ownership information pursuant to paragraph 3a , the obliged entities shall collect proof of registration whenever applicable and report any discrepancy they find between the beneficial ownership information held in the central register and the beneficial ownership information collected as part of their customer due diligence procedures . ” ;


### the information shall consist of the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . ### the information shall consist of at least the name , the date of birth , the nationality , the country of residence and contact details of the beneficial owner as well as the nature and extent of the beneficial interest held .


### health technology assessment is an evidence - based process that allows competent authorities to determine the relative effectiveness of new or existing technologies . hta focuses specifically on the added value of a health technology in comparison with other new or existing health technologies . ### health technology assessment is an evidence - based , multidisciplinary process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and should be carried out in a systematic , independent and transparent manner . hta focuses specifically on the added value of a health technology in comparison with other new or existing health technologies .


### hta covers both clinical and non - clinical aspects of a health technology . the eu co - funded joint actions on hta have identified nine domains by reference to which health technologies are assessed . of these nine domains , four are clinical and five are non - clinical . the four clinical domains of assessment concern the identification of a health problem and current technology , the examination of the technical characteristics of the technology under assessment , its relative safety , and its relative clinical effectiveness . the five non - clinical assessment domains concern cost and economic evaluation of a technology , its ethical , organisational , social , and legal aspects . the clinical domains are therefore more suited to joint assessment at eu - level on their scientific evidence base , while the assessment of non - clinical domains tends to be more closely related to national and regional contexts and approaches . ### hta covers both clinical and non - clinical aspects of a health technology . the eu co - funded joint actions on hta have identified nine domains by reference to which health technologies are assessed . of these nine domains , four are clinical and five are non - clinical . the four clinical domains of assessment concern the identification of a health problem and current technology , the examination of the technical characteristics of the technology under assessment , its relative safety , and its relative clinical effectiveness . the five non - clinical assessment domains concern cost and economic evaluation of a technology , its ethical , organisational , social , and legal aspects . the clinical domains are therefore more suited to joint assessment at eu - level on their scientific evidence base . the assessment of non - clinical domains should closely related to national and regional contexts , approaches and competences .


### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients . ### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable and comprehensive healthcare systems while stimulating quality innovation and increasing sector competitivity , which will ultimately deliver better outcomes for patients .


### the european parliament , in its resolution of 2 march 2017 on eu options for improving access to medicines , 9 called on the commission to propose legislation on a european system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of medicines . _________________ 9 european parliament resolution of 2 march 2017 on eu options for improving access to medicines – 2016 / 2057 . ### the european parliament , in its resolution of 2 march 2017 on eu options for improving access to medicines , 9 called on the commission to propose legislation on a european system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of health technologies compared with the best available alternative taking into account the level of innovation and value for the patients . _________________ 9 european parliament resolution of 2 march 2017 on eu options for improving access to medicines – 2016 / 2057 .


### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology , and in particular , to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology . the outcome of such assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . ### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology . in this connection , the joint clinical assessment provided for by this regulation , which will be mandatory for member states , constitutes a scientific analysis of the relative effects of health technology on clinical outcomes , evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of patients , taking into account the hta core model criteria . this will include consideration of the degree of certainty on the relative outcomes , based on the available evidence . the outcome of such joint clinical assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . the assessment conducted by each member state as part of its national appraisal therefore falls outside the scope of this regulation . such appraisals must include : the joint clinical assessment ; the data specific to each member state ; the medical need within their health system ; information on a national early - access programme , if available ; the target group , therapeutic strategy , clinical use ) ; context - specific analyses ; additional context - specific considerations for each member state .