### it is also appropriate to provide definitions of ‘ watercraft built for own use’ and of ‘ private importer’ specific to this sector in order to facilitate the understanding and uniform application of this directive . ### it is also appropriate to provide definitions of ' watercraft built for own use ' and of ' private importer ' specific to this sector in order to facilitate the understanding and uniform application of this directive . it is necessary to extend the current definition of ' propulsion engine ' so that it also covers innovative propulsion solutions .


### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list set out in annex iii to include other products and equipment that contain fluorinated greenhouse gases with a global warming potential of 150 or more , or that rely on them to work , if it has been established that alternatives to the use of fluorinated greenhouse gases or to the use of specific types of fluorinated greenhouse gases are available , and their use would result in lower overall greenhouse gas emissions and to exclude , where appropriate for a specified period of time , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical , economic or safety reasons . ### the commission may , following a request by a competent authority of a member state , by means of implementing acts authorise a time - limited exemption to exclude certain categories of products or equipment listed in annex iii where alternative substances are not available or cannot be used for technical , economic or safety reasons . those implementing acts shall be adopted in accordance with the examination procedure in article 21 .


### the training programmes provided for in paragraph 1 shall cover the following : ### the certification programmes and training provided for in paragraph 1 shall cover the following :


### certificates under the certification programmes provided for in paragraph 1 shall be issued on condition of the applicant having completed a training programme established in accordance with paragraphs 1 and 2 . ### certificates under the certification programmes provided for in paragraph 1 shall be issued on condition of the applicant having successfully completed an evaluation process established in accordance with paragraphs 1 and 2 .


### member states shall notify the commission of their training and certification programmes by 1 january 2015 . they shall recognise certificates issued in another member state . they shall not restrict the freedom to provide services or the freedom of establishment because a certificate was issued in another member state . ### member states shall notify the commission of their certification programmes by 1 january 2017 . they shall recognise certificates issued in another member state . they shall not restrict the freedom to provide services or the freedom of establishment because a certificate was issued in another member state .


### this article shall not apply to hydrofluorocarbons imported into the union to be destroyed . it shall not apply to producers or importers of less than 1 000 tonnes of co2 equivalent of hydrofluorocarbons per year . ### this article shall not apply to the following : hydrofluorocarbons imported into the union for destruction ; hydrofluorocarbons supplied for direct export outside the union ; hydrofluorocarbons supplied for use in feedstock applications ; hydrofluorocarbons supplied for repackaging and subsequent export outside the union ; hydrofluorocarbons produced or imported into the union for use in medical applications .


### unless the records referred to in paragraph 1 are registered in a database set up by the competent authorities of the member states , the operators referred to in paragraph 1 shall keep the records until at least two years after decommissioning the equipment . ### unless the records referred to in paragraph 1 are registered in a database set up by the competent authorities of the member states , the operators referred to in paragraph 1 shall keep the records for at least five years .


### the use of fluorinated greenhouse gases , or of mixtures that contain fluorinated greenhouse gases , with a global warming potential of 2500 or more , to service or maintain refrigeration equipment with a charge size equivalent to 5 tonnes of co2 or more , shall be prohibited from 1 january 2020 . for the purpose of this provision , the global warming potential of mixtures that contain fluorinated greenhouse gases shall be calculated pursuant to annex iv . ### the use of fluorinated greenhouse gases , or of mixtures that contain fluorinated greenhouse gases , with a global warming potential of 2500 or more , to service or maintain refrigeration equipment with a charge size equivalent to 40 tonnes of co2 or more , shall be prohibited from 1 january 2020 . this provision shall not apply to equipment intended for applications until 1 january 2025 , this provision shall not apply to reclaimed fluorinated greenhouse gases with a global warming potential of 2500 or more used for the maintenance or servicing of existing refrigeration equipment , provided that they have been labelled in accordance with article 10 . until 1 january 2025 this provision shall not apply to recycled fluorinated greenhouse gases with a global warming potential of 2500 or more used for the maintenance or servicing of existing refrigeration equipment provided they have been recovered from such equipment . such recycled gases may only be used by the undertaking which carried out their recovery as part of maintenance or servicing or the undertaking for which the recovery was carried out as part of maintenance or servicing .


### this article shall not apply to hydrofluorocarbons imported into the union to be destroyed . ### this article shall not apply to the following : hydrofluorocarbons imported into the union for destruction ; hydrofluorocarbons supplied for direct export outside the union ; hydrofluorocarbons supplied for use in feedstock applications ; hydrofluorocarbons supplied for repackaging and subsequent export outside the union ; hydrofluorocarbons produced or imported into the union for use in medical applications .


### this regulation sets out a system of sanctions for enhancing the enforcement of the preventive and corrective parts of the stability and growth pact in the euro area . ### this regulation sets out a system of incentives and sanctions for enhancing the enforcement of the preventive and corrective parts of the stability and growth pact in the euro area .


### efficient and effective implementation of actions supported by the esf depends on good governance and partnership between all relevant territorial and socio - economic actors , in particular the social partners and non - governmental organisations . it is therefore necessary that member states encourage the participation of social partners and non - governmental organisations in the implementation of the esf . ### efficient and effective implementation of actions supported by the esf depends on good governance and partnership between all relevant territorial and socio - economic actors , in particular local and regional authorities , the social partners and non - governmental organisations . it is therefore necessary that member states encourage the participation of social partners and non - governmental organisations in the implementation of the esf .


### integration of marginalised communities such as the roma ; ### integration of marginalised communities ;


### ' standard ' means a technical specification for repeated or continuous application , with which compliance is not compulsory , and which is one of the following : ### ' standard ' means a technical specification established by consensus and approved by a recognised organisation for repeated or continuous use , with which compliance is not compulsory , and which is one of the following :


### recognition of technical specifications in the field of ict ### recognition and use of technical specifications in the field of ict


### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications which are not national , european or international standards and meet the requirements set out in annex ii , as ict standards . ### either on proposal from a member state or on its own initiative the commission may decide , after consultation with the european standardisation organisations , to use ict technical specifications which are not national , european or international standards and meet the requirements set out in annex ii .


### – sector skills alliances between education and training providers and enterprises promoting employability , creating new sector - specific curricula , developing innovative ways of vocational teaching and training and putting the union wide recognition tools in practice . ### – sector skills alliances between education and training providers and the world of work aimed at promoting employability , creating new sector - specific or cross - sectoral curricula , developing innovative ways of vocational teaching and training and putting the union transparency and recognition tools into practice . these should operate respecting member state domestic policy arrangements .


### support to non - commercial european sport events involving several european countries ; ### support to european grassroot sport events involving sport organisations from several european countries ;


### eur 238 827 000 for actions relating to sport , as referred to in chapter iii . ### eur 438 827 000 for actions relating to sport , as referred to in chapter iii .


### to tackle transnational threats to sport such as doping , match fixing , violence , racism and intolerance ; ### to tackle transnational threats to the integrity of sport such as doping , match fixing , violence , homophobia , xenophobia racism and related intolerance ;


### in line with the general objective , the programme shall pursue the following specific objectives in the area of sport : ### in addition to the objectives set out in article 4 and article 5 , the programme shall mainly focus on grassroots sport and shall pursue the following specific objectives in the field of sport :


### to promote the emergence of a european lifelong learning area , trigger policy reforms at national level , support the modernisation of education and training systems , including non - formal learning , and support european cooperation in the youth field , notably through enhanced policy cooperation , better use of recognition and transparency tools and the dissemination of good practices ; ### to promote the emergence of a european lifelong learning area with special focus on vocational education and training , trigger policy reforms at national level , support the modernisation of education and training systems , including informal and non - formal learning and skills training , and support european cooperation in the youth field and in lifelong learning , notably through enhanced policy cooperation , better use of recognition and transparency tools and the dissemination of good practices ;


### ' lifelong learning ' means all general education , vocational education and training , non - formal education and informal learning undertaken throughout life , resulting in an improvement in knowledge , skills and competences within a personal , civic , social and / or employment - related perspective , including the provision of counselling and guidance services ; ### ' lifelong learning ' means all general education , vocational education and training , higher education , continued professional development , non - formal education and informal learning undertaken throughout life , resulting in an improvement in knowledge , skills and competences within a personal , civic , social and / or employment - related perspective , including the provision of counselling and guidance services ;


### ‘ content of websites’ means information to be communicated to the user by means of a user agent , including code or mark - up that defines the content ' s structure , presentation , and interactions . ### ‘ content of websites’ means information to be communicated to the user by means of a user agent , including code or mark - up that defines the content ' s structure , presentation , and interactions , and any hardware or software system that allows users to log in and communicate with the website . it includes textual as well as non - textual information , as well as documents and forms that users can download and interact with online and offline . it also includes the processing of digital forms as well as completion of identification , authentication and payment processes . content also includes social media content embedded in those websites and authoring tools dedicated to create user - generated content .


### to raise general awareness of the value of active ageing in order to highlight the useful contribution older persons make to society and the economy , to promote active ageing and to do more to mobilise the potential of older persons ; ### to raise general awareness of the value of healthy and active ageing in order to highlight the useful contribution older persons make to the family , society and the economy , to promote and permit active participation in the labour market by people over the age of 55 , to support mentoring in relations with the younger generations and generally to do more to mobilise the potential of older persons ;


### – conferences , events and initiatives to promote debate , raise awareness and foster the making of specific commitments ; ### – conferences , events and initiatives , in which the business sector and smes will be closely involved , to promote debate , raise awareness and foster the making of specific commitments contributing to sustainable and long - lasting outcomes through evaluation of effective methods and measures for future initiatives and activities in the field of active ageing ;


### the overall purpose of the european year shall be to encourage and support the efforts of member states , their regional and local authorities , social partners and civil society to promote active ageing and to do more to mobilise the potential of the rapidly growing population in their late 50s and above , thereby preserving solidarity between generations . active ageing means creating better opportunities and working conditions to enable older workers to play their part in the labour market , combating social exclusion by fostering active participation in society , and encouraging healthy ageing . on this basis , the objectives shall be : ### the overall purpose of the european year shall be to encourage and support the efforts of member states , their regional and local authorities , social partners and civil society to promote active ageing and to do more to mobilise the potential of the rapidly growing population in their late 50s and above , thereby preserving solidarity between generations . good health is a precondition for active ageing . support for healthy ageing and measures to promote health ageing should therefore be an integral part of the european year . active ageing means creating better opportunities and working conditions to enable older workers to play their part in the labour market , by means of greater flexibility in labour relations , among other things , combating social exclusion by fostering active participation in society and by providing high - quality and accessible social services that permit ageing with dignity , and encouraging healthy ageing . on this basis , the objectives shall be :


### a person selling an investment product to retail investors shall provide them with the key information document in good time before the conclusion of a transaction relating to the investment product . ### a person selling a packaged retail investment product to retail investors shall provide them with the key information document in good time before the conclusion of a transaction relating to the packaged retail investment product . where a packaged retail investment product is recommended to a client , the key information document shall be provided without delay .


### under a section titled ‘ how has it done in the past ? ’ , the past performance of the investment product , if this is relevant having regard to the nature of the product and the length of its track record ; ### under a section titled ‘ how has it done in the past ? ’ , the past performance of the packaged retail investment product , if this is relevant having regard to the nature of the product and the length of its track record ;


### where investment product manufacturers subject to this regulation are also subject to directive 2009 / 138 / ec , this regulation and directive 2009 / 138 / ec shall both apply . ### information contained in the key information document shall be regarded by competent authorities as appropriate information with respect to information on the risks underlying the contract which are assumed by the policy holder and shall be deemed as satisfying the requirements laid down in article 185 of directive 2009 / 138 / ec .


### to meet the needs of retail investors , it is necessary to ensure that information on investment products is accurate , fair , clear and not misleading for those investors . this regulation should therefore lay down common standards for the drafting of the key information document , in order to ensure that it is comprehensible for retail investors . given the difficulties many retail investors have in understanding specialist financial terminology , particular attention should be paid to the vocabulary and style of writing used in the document . rules should also be laid down on the language in which it should be drawn up . furthermore , retail investors should be able to understand the key information document on its own without referring to other information . ### to meet the needs of retail investors , it is necessary to ensure that information on packaged retail investment products is accurate , fair , clear and not misleading for those investors . this regulation should therefore lay down common standards for the drafting of the key information document , in order to ensure that it is comprehensible for retail investors . given the difficulties many retail investors have in understanding specialist financial terminology , particular attention should be paid to the vocabulary and style of writing used in the document . rules should also be laid down on the language in which it should be drawn up .


### the commission shall be empowered to adopt delegated acts in accordance with article 23 specifying the details of the presentation and the content of each of the elements of information referred to in paragraph 2 , the presentation and details of the other information the product manufacturer may include within the key information document as referred to in paragraph 3 , and the details of the common format and the common symbol referred to in paragraph 4 . the commission shall take into account the differences between investment products and the capabilities of retail investors as well as the features of investment products that allow the retail investor to select between different underlying investments or other options provided for by the product , including where this selection can be undertaken at different points in time , or changed in the future . ### the commission shall be empowered to adopt delegated acts in accordance with article 23 specifying the details of the presentation and the content of each of the elements of information referred to in paragraph 2 , the presentation and details of the other information the packaged retail investment product manufacturer may include within the key information document as referred to in paragraph 3 , and the details of the common format and the common symbol referred to in paragraph 4 . the commission shall take into account the differences between packaged retail investment products and the capabilities of retail investors as well as the features of packaged retail investment products that allow the retail investor to select between different underlying investments or other options provided for by the product , including where this selection can be undertaken at different points in time , or changed in the future .


### where successive transactions regarding the same investment product are carried out on behalf of a retail investor in accordance with instructions given by that investor to the person selling the investment product prior to the first transaction , the obligation to provide a key information document under paragraph 1 shall only apply to the first transaction . ### in the event a person selling a packaged retail investment product to retail investors either : fails to provide investors with a key information document ; or provides investors with a key information document in respect of which it has not obtained the permission required under paragraph 2 above , the sole responsibility for this breach will lie with the person selling such a packaged retail investment product and , unless the packaged retail investment product manufacturer is the person making such sale , no liability shall arise for the packaged retail investment product manufacturer .


### ‘ this document provides you with key information about this investment product . it is not marketing material . the information is required by law to help you understand the nature of this investment product and the risks of investing in it . you are advised to read it so that you can take an informed decision about whether to invest . ’ ### ‘ this document provides you with key information about this investment product . it is not marketing material . the information is required by law to help you understand the nature , benefits and risks of this investment product and to assist you in making comparisons between this product and alternative investment products . before making a final decision to invest you should carefully consider all of the relevant documents that set out the terms and conditions of your investment , alongside this document . this document only provides information and as such it does not indicate whether a product is suitable for your specific , personal circumstances . ’


### the key information document should be drawn up in a format which allows retail investors to compare different investment products , since consumer behaviours and capabilities are such that the format , presentation and content of information must be carefully calibrated to maximise understanding and use of information . the same order of items and headings for these items should be followed for each document . in addition , the details of the information to be included in the key information document for different products and the presentation of this information should be further harmonised through delegated acts that take into account existing and on - going research on consumer behaviour , including results from testing the effectiveness of different ways of presenting information with consumers . in addition , some investment products give the retail investor a choice between multiple underlying investments . those products should be taken into account when drawing up the format . ### the key information document should be drawn up in a standardised format which allows retail investors to compare different packaged retail investment products , since consumer behaviours and capabilities are such that the format , presentation and content of information must be carefully calibrated to maximise understanding and use of information . the same order of items and headings for these items should be followed for each document . in addition , the details of the information to be included in the key information document for different products and the presentation of this information should be further harmonised through delegated acts that take into account existing and on - going research on consumer behaviour , including results from testing the effectiveness of different ways of presenting information with consumers . in addition , some packaged retail investment products give the retail investor a choice between multiple underlying investments . those products should be taken into account when drawing up the format .


### the erdf shall support , within operational programmes , sustainable urban development through strategies setting out integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas . ### the erdf shall support , within operational programmes , sustainable urban development through strategies setting out integrated actions to tackle the economic , environmental , climate , transport and social challenges affecting urban areas .


### however , member states shall not limit this number to fewer than two suppliers for each category of groundhandling services or , for airports whose annual traffic has been not less than 5 million passengers or 100 000 tonnes of freight for at least the previous three years , to fewer than three suppliers for each category of groundhandling services . ### however , member states shall not limit this number : - to fewer than two suppliers for each category of groundhandling services or ; - for airports whose annual traffic has been not less than 5 million passengers or 100 000 tonnes of freight for at least the previous three years , to fewer than three suppliers for each category of groundhandling services or ; - for airports whose annual traffic has been not less than 15 million passengers or 150 000 tonnes of freight for at least the previous three years , to fewer than four suppliers for each category of groundhandling services .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or prevent or impede serious crimes ; b ) preserve the integrity and security of the network , services provided via this network , and the end - users ' terminals ; c ) prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures ; d ) minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph . ### providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by discriminating against , restricting , or otherwise interfering with the transmission of specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures to prevent or minimise the effects of network congestion , provided that equivalent types of traffic are treated equally , or to implement a court order . such measures shall be set by transparent procedures and they shall not be maintained longer than what is strictly necessary and provide adequate safeguards , in particular to ensure that any restrictions are limited to what is necessary , they are non - discriminatory and proportionate . those safeguards shall include the possibility of judicial redress . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this article .


### ‘ internet access service’ means a publicly available electronic communications service that provides connectivity to the internet , and thereby connectivity between virtually all end points connected to the internet , irrespective of the network technology used ; ### ‘ internet access service ' means a publicly available electronic communications service that provides connectivity to the internet , and between virtually all end points connected to the internet , irrespective of the network technologies or terminal equipment used ;


### as regards the other main substantive conditions which may be attached to rights of use of radio spectrum for wireless broadband , the convergent application by individual member states of the regulatory principles and criteria set down in this regulation would be favoured by a coordination mechanism whereby the commission and the competent authorities of the other member states have an opportunity to comment in advance of the granting of rights of use by a given member state and whereby the commission has an opportunity , taking into account the views of the member states , to forestall implementation of any proposal which appears to be non - compliant with union law . ### as regards the other main substantive conditions which may be attached to rights of use of radio spectrum for wireless broadband , the convergent application by individual member states of the regulatory principles and criteria set down in this regulation would be favoured by a coordination mechanism whereby the commission and the competent authorities of the other member states have an opportunity to comment in advance of the granting of rights of use by a given member state .


### in order to prevent the general impairment of quality of service for internet access services or to safeguard the ability of end - users to access and distribute content or information or to run applications and services of their choice , national regulatory authorities shall have the power to impose minimum quality of service requirements on providers of electronic communications to the public . national regulatory authorities shall , in good time before imposing any such requirements , provide the commission with a summary of the grounds for action , the envisaged requirements and the proposed course of action . this information shall also be made available to berec . the commission may , having examined such information , make comments or recommendations thereupon , in particular to ensure that the envisaged requirements do not adversely affect the functioning of the internal market . the envisaged requirements shall not be adopted during a period of two months from the receipt of complete information by the commission unless otherwise agreed between the commission and the national regulatory authority , or the commission has informed the national regulatory authority of a shortened examination period , or the commission has made comments or recommendations . national regulatory authorities shall take the utmost account of the commission’s comments or recommendations and shall communicate the adopted requirements to the commission and berec . ### in order to prevent the general impairment of quality of service for internet access services or to safeguard the ability of end - users to access and distribute content or information or to run applications , services and software of their choice , national regulatory authorities shall have the power to impose minimum quality of service requirements , and where appropriate , other quality of service parameters , as defined by the national regulatory authorities on providers of electronic communications to the public . national regulatory authorities shall , in good time before imposing any such requirements , provide the commission with a summary of the grounds for action , the envisaged requirements and the proposed course of action . this information shall also be made available to berec . the commission may , having examined such information , make comments or recommendations thereupon , in particular to ensure that the envisaged requirements do not adversely affect the functioning of the internal market . national regulatory authorities shall take the utmost account of the commission’s comments or recommendations and shall communicate the adopted requirements to the commission and berec . national regulatory authorities shall put in place appropriate complaint procedures for issues concerning the performance of internet access service provided for end - users and providers of content , applications and services . by . . . * berec , after consulting stakeholders and in close cooperation with the commission , shall lay down general guidelines defining uniform conditions for the implementation of the obligations of national regulatory authorities under this article , including in particular the application of reasonable traffic management measures . _________________ *oj : please insert the date of application of this regulation .


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


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or prevent or impede serious crimes ; b ) preserve the integrity and security of the network , services provided via this network , and the end - users ' terminals ; c ) prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures ; d ) minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph . ### providers of internet access services shall specifically not restrict the provisions of paragraph 1 by : - deleting , blocking , slowing down , degrading or discriminating against specific content , applications , services or terminal devices , or specific classes thereof , - prioritising specific content , applications , services or terminal devices , or specific classes thereof , or - concluding special pricing agreements with the end - user which make accessing particular content , applications , services or terminal devices or specific classes thereof seem less economically attractive , except in cases where it is necessary to apply justified and reasonable data traffic management measures . data traffic management measures shall be regarded as justified and reasonable where they : - preserve the integrity and security of the network , services provided via this network , and the end - users ' terminals , or - minimise the effects of proven temporary and exceptional network congestion and manage traffic in the event of such acute network congestion , provided that all content , applications and services are treated in accordance with the best effort principle . they must not be maintained any longer than is strictly necessary . data traffic management measures shall be transparent , non - discriminatory , proportionate , necessary , and subject to clear , comprehensible and accessible redress mechanisms .


### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality which are not impaired by specialised services . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with specialised services , and quality as perceived by end - users . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services . ### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with enhanced quality services , and quality as perceived by end - users . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services .


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . end - users shall be free to enter into agreements on data volumes and speeds with providers of internet access services and , in accordance with any such agreements relative to data volumes , to avail of any offers by providers of internet content , applications and services . ### end - users shall be free to access and distribute information and content , run applications , and use devices , services and software of their choice , irrespective of their origin or destination , via their internet access service . internet access service providers shall not restrict or prevent the use by end - users of any terminal equipment to access and distribute information and content via their internet access service . this is in accordance with directive of the european parliament and of the council 2014 / . . . / eu1a*and without prejudice to the rights of member states to grant individual rights of use under article 5 of directive 2002 / 20 / ec . _________________ 1a directive 2014 / . . . / eu of the european parliament and of the council of . . . on the harmonisation of the laws of the member states relating to the making available on the market of radio equipment and repealing directive 1999 / 5 / ec . * oj : please insert number of the directive and the number , date of adoption and publication reference of the directive in footnote 33a .


### the exercise of the freedoms provided for in paragraphs 1 and 2 shall be facilitated by the provision of complete information in accordance with article 25 , article 26 , and article 27 and . ### end - users shall be provided with complete information in accordance with article 20 , article 21 and article 21a of directive 2002 / 22 / ec , including information on any reasonable traffic management measures applied that might affect access to and distribution of information , content , applications and services as specified in paragraphs 1 and 2 of this article .


### ‘ specialised service’ means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ; ### ' specialised service ' means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof at a guaranteed capacity , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ;


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . ### in exercising their powers under article 30a with respect to article 23 , national regulatory authorities shall closely monitor the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology . they shall , in cooperation with other competent national authorities , also monitor the effects on cultural diversity and innovation . national regulatory authorities shall publish reports on an annual basis regarding their monitoring and findings , and provide those reports to the commission and berec .


### to favour investment and innovation in new and enhanced high - capacity infrastructures which reach throughout the union and which can cater for evolving end - user demand ; ### to favour investment and innovation in new and enhanced high - capacity infrastructures and to ensure that they reach throughout the union and can cater for evolving end - user demand , wherever they may be located in the union ;


### ‘ article 21 ‘ 1 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to publish transparent , comparable , adequate and up - to - date information on applicable prices and tariffs , on any charges due on termination of a contract and on standard terms and conditions in respect of access to , and use of , services provided by them to end - users and consumers in accordance with annex ii . such information shall be published in a clear , comprehensive and easily accessible form . national regulatory authorities may specify additional requirements regarding the form in which such information is to be published . 2 . national regulatory authorities shall encourage the provision of comparable information to enable end - users and consumers to make an independent evaluation of the cost of alternative usage patterns , for instance by means of interactive guides or similar techniques . where such facilities are not available on the market free of charge or at a reasonable price , member states shall ensure that national regulatory authorities are able to make such guides or techniques available themselves or through third party procurement . third parties shall have a right to use , free of charge , the information published by undertakings providing electronic communications networks and / or publicly available electronic communications services for the purposes of selling or making available such interactive guides or similar techniques . 3 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to inter alia : provide applicable tariff information to subscribers regarding any number or service subject to particular pricing conditions ; with respect to individual categories of services , national regulatory authorities may require such information to be provided immediately prior to connecting the call ; inform subscribers of any change to access to emergency services or caller location information in the service to which they have subscribed ; inform subscribers of any change to conditions limiting access to and / or use of services and applications , where such conditions are permitted under national law in accordance with community law ; provide information on any procedures put in place by the provider to measure and shape traffic so as to avoid filling or overfilling a network link , and on how those procedures could impact on service quality ; inform subscribers of their right to determine whether or not to include their personal data in a directory , and of the types of data concerned , in accordance with article 12 of directive 2002 / 58 / ec ; and regularly inform disabled subscribers of details of products and services designed for them . if deemed appropriate , national regulatory authorities may promote self or co - regulatory measures prior to imposing any obligation . 4 . member states may require that the undertakings referred to in paragraph 3 distribute public interest information free of charge to existing and new subscribers , where appropriate , by the same means as those ordinarily used by them in their communications with subscribers . in such a case , that information shall be provided by the relevant public authorities in a standardised format and shall , inter alia , cover the following topics : the most common uses of electronic communications services to engage in unlawful activities or to disseminate harmful content , particularly where it may prejudice respect for the rights and freedoms of others , including infringements of copyright and related rights , and their legal consequences ; and the means of protection against risks to personal security , privacy and personal data when using electronic communications services . ’ ### article 21 is replaced by the following : ‘ article 21 ‘ 1 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to publish transparent , comparable , adequate and up - to - date information on applicable prices and tariffs , on any charges due on early termination of a contract and on standard terms and conditions in respect of access to , and use of , services provided by them to end - users in accordance with annex ii . such information shall be published in a clear , comprehensive and easily accessible form and shall be updated regularly . any differentiation in the conditions applied to consumers and other end - users so requesting shall be made explicit . national regulatory authorities may specify additional requirements regarding the form in which such information is to be published , which may in particular include the introduction of language requirements so as to ensure that such information is easily understood by consumers and other end - users so requesting . member states shall ensure that providers of electronic communications to the public are obliged upon request to supply the information , to the relevant national regulatory authorities , in advance of its publication . 2 . national regulatory authorities shall ensure that consumers and other end - users so requesting have access to independent evaluation tools to enable them to compare the performance of electronic communications network access and services and the cost of alternative usage patterns . where such facilities are not available on the market free of charge or at a reasonable price , member states shall ensure that national regulatory authorities are able to make such guides or techniques available themselves or through third party procurement . third parties shall have a right to use , free of charge , the information published by undertakings providing electronic communications networks and / or publicly available electronic communications services for the purposes of selling or making available such independent evaluation tools . 2a . member states shall ensure that national regulatory authorities , under guidance from berec and following consultation with relevant stakeholders , establish a voluntary certification scheme for interactive comparison websites , guides or similar tools , based on objective , transparent and proportionate requirements , including in particular independence from any provider of electronic communications to the public . 3 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to inter alia : provide end - users with applicable tariff information regarding any number or service subject to particular pricing conditions ; with respect to individual categories of services , national regulatory authorities may require such information to be provided immediately prior to connecting the call ; provide end - users with information on access to emergency services and caller location for all relevant services offered , and any limitations on the provision of emergency services under article 26 , and to ensure that any changes are notified without delay ; provide information on internet access services , where offered , specifying the following : for fixed data links , the normally available and minimum download and upload speed in the end - user ' s member state of residence ; for mobile data links , the estimated and minimum download and upload speed when connected through the provider ' s wireless network in the end - user ' s member state of residence ; details of unit data pricing plans , pricing plans for bulk data and any applicable thresholds . for data volumes above thresholds : unit or bulk pricing on an ad hoc or lasting basis and any data speed limitations that may be applied ; how end - users can monitor the current level of their consumption , whether and how any voluntary limitations can be set ; a clear and comprehensible explanation as to how any data volume limitation , the speed and other quality of service parameters may in practice have an impact on the use of internet access services , in particular the use of content , applications and services ; information on any procedures put in place by the provider to measure and shape traffic as defined in article 23 of regulation . . . / . . . * including an indication of the underlying communication inspection methods used for reasonable traffic management measures and information on how those procedures could impact on service quality , end - users’ privacy and the protection of personal data ; inform consumers , and other end - users where applicable , of their right to determine whether or not to include their personal data in a directory , and of the types of data concerned , in accordance with article 12 of directive 2002 / 58 / ec ; and regularly inform disabled consumers , and other end - users , where applicable , of details of products and services designed for them and the measures taken to ensure equivalence of access ; if deemed appropriate , national regulatory authorities may promote self - or co - regulatory measures prior to imposing any obligation . member states may specify additional requirements on the content , form and manner of the information to be published , taking utmost account of the berec guidelines referred to in paragraph 3a of this article . 3a . by . . . * , berec , after consulting stakeholders and in close cooperation with the commission , shall lay down general guidelines for the methods of measuring the speed , the quality of service parameters to be measured , and the methods for measuring them over time , as well as the content , form and manner of the information to be published , including possible quality certification mechanisms , in order to ensure that end - users , including disabled end - users , have access to comprehensive , comparable , reliable and user - friendly information . where appropriate , the parameters , definitions and measurement methods set out in annex iii may be used . 4 . member states may require that the undertakings referred to in paragraph 3 distribute public interest information free of charge to end - users , where appropriate , by the same means as those ordinarily used by them in their communications with end - users . in such a case , that information shall be provided by the relevant public authorities to the providers of electronic communications to the public in a standardised format and may , inter alia , cover the following topics : the most common uses of electronic communications services to engage in unlawful activities or to disseminate harmful content , particularly where it may prejudice respect for the rights and freedoms of others , including infringements of data protection rights , copyright and related rights , and their legal consequences ; and the means of protection against risks to personal security , privacy and personal data when using electronic communications services . _________________ * oj : please insert the number of this regulation . ** oj : please insert the date of application of this regulation . ’


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23&#160 ; and , compliance with article 23&#160 ; , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . ### national regulatory authorities , in cooperation with national data protection authorities and other competent authorities , where appropriate , shall have the power and obligation to monitor , in compliance with article 23 , the application of reasonable traffic management measures and , through the availability of affordable non - discriminatory internet access services , ensure the ability of end - users to benefit from the freedoms provided for in article 23 and . they shall take the utmost account of the berec guidelines referred to in the fourth subparagraph of paragraph 2 of this article and in article 21 of directive 2002 / 22 / ec . the criteria for defining reasonable traffic management measures shall be subject to periodic review . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring , findings and measures taken . those reports shall be made public .


### as regards the other main substantive conditions which may be attached to rights of use of radio spectrum for wireless broadband , the convergent application by individual member states of the regulatory principles and criteria set down in this regulation would be favoured by a coordination mechanism whereby the commission and the competent authorities of the other member states have an opportunity to comment in advance of the granting of rights of use by a given member state and whereby the commission has an opportunity , taking into account the views of the member states , to forestall implementation of any proposal which appears to be non - compliant with union law . ### the convergent application by individual member states of the regulatory principles and criteria set down in the union regulatory framework would be favoured by a coordination mechanism whereby the commission and the competent authorities of the other member states have an opportunity to comment in advance of the granting of rights of use by a given member state and whereby the commission has an opportunity , taking into account the views of the member states , to forestall implementation of any proposal which appears to be non - compliant with union law .


### in order to avoid bill shocks , - users should be able to define maximum financial limits for the charges related to their usage of calls and internet access services . this facility should be available free of charge , with an appropriate notification that can be consulted again subsequently , when the limit is being approached . upon reaching the maximum limit , end - users should no longer receive or be charged for those services unless they specifically request the continued provision as agreed with the provider . ### in order to avoid bill shocks , for all post - paid services , end - users should be able to set a predefined maximum financial limit for the charges related to their usage of calls and internet access services . this facility should include an appropriate notification that can be consulted again subsequently , when the limit is being approached .


### for the purposes of the uniform implementation of the general authorisation regime for the deployment , connection and operation of small - area wireless access points pursuant to paragraph 1 , the commission may , by means of an implementing act , specify technical characteristics for the design , deployment and operation of small - area wireless access points , compliance with which shall ensure their unobtrusive character when in use in different local contexts . the commission shall specify those technical characteristics by reference to the maximum size , power and electromagnetic characteristics , as well as the visual impact , of the deployed small - area wireless access points . those technical characteristics for use of small - area wireless access points shall at a minimum comply with the requirements of directive 2013 / 35 / eu30 and with the thresholds defined in council recommendation no 1999 / 519 / ec . 31 __________________ 30 directive 2013 / 35 / eu of the european parliament and of the council of 26 june 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents of directive 89 / 391 / eec ) and repealing directive 2004 / 40 / ec . 31 recommendation 1999 / 519 / ec of the council of 12 july 1999 on the limitation of exposure of the general public to electromagnetic fields . ### for the purposes of the uniform implementation of the deployment , connection and operation of small - area wireless access points pursuant to paragraph 1 , the commission may , by means of an implementing act , specify technical characteristics for the design , deployment and operation of small - area wireless access points , compliance with which shall ensure their unobtrusive character when in use in different local contexts . the operation of small - area wireless access points in spectrum with dedicated granted usage rights shall be managed by the respective authorised person or undertaking . the commission shall specify those technical characteristics by reference to the maximum size , power and electromagnetic characteristics , as well as the visual impact , of the deployed small - area wireless access points . those technical characteristics for use of small area wireless access points shall at a minimum comply with the requirements of directive 2013 / 35 / eu and directive 1999 / 5 / ec taking into account the thresholds defined in council recommendation no 1999 / 519 / ec . 31 __________________ 30 directive 2013 / 35 / eu of the european parliament and of the council of 26 june 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents of directive 89 / 391 / eec ) and repealing directive 2004 / 40 / ec . 31 recommendation 1999 / 519 / ec of the council of 12 july 1999 on the limitation of exposure of the general public to electromagnetic fields .


### the exercise of the freedoms provided for in paragraphs 1 and 2 shall be facilitated by the provision of complete information in accordance with article 25 , article 26 , and article 27 and . ### end - users as well as content , application , and service providers , including the media and cultural industries and governments at all levels , shall be provided with complete information in accordance with article 20 , article 21 and article 21a of directive 2002 / 22 / ec and article 25 , article 26 , and article 27 and of this regulation , including information on any reasonable traffic management measures applied that might affect access to and distribution of information , content , applications and services as specified in paragraphs 1 and 2 .


### articles 20 , 21 , 22 and 30 are deleted . ### article 22 is deleted .


### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 500 new passenger cars registered in the eu in the previous calendar year . ’ ### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 1000 new passenger cars registered in the eu in the previous calendar year . ’


### in recognition of the disproportionate impacts on the smallest manufacturers resulting from compliance with specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of avoided co2 from the vehicles sold by these manufacturers , producers responsible annually for less than 500 new passenger cars are excluded from the scope of the specific emissions target and the excess emissions premium . ### in recognition of the disproportionate impacts on the smallest manufacturers resulting from compliance with specific emissions targets defined on the basis of the utility of the vehicle , high administrative burden of the derogation procedure and only marginal benefit in terms of avoided co2 from the vehicles sold by these manufacturers , producers responsible annually for less than 1000 new passenger cars are excluded from the scope of the specific emissions target and the excess emissions premium .


### the competent authority may allow non - practitioners who are knowledgeable in the areas relevant to statutory audit to be involved in the governance of the public oversight system , provided that they are selected in accordance with an independent and transparent nomination procedure . practitioners shall not be allowed to be involved in the governance of the public oversight system . ### the competent authority may allow non - practitioners who are knowledgeable in the areas relevant to statutory audit to be involved in the governance of the public oversight system , provided that they are selected in accordance with an independent and transparent nomination procedure .


### in article 77 , paragraph 6 is deleted . ### article 77 is amended as follows : paragraph 6 is deleted .


### where provided for in this regulation , the commission shall adopt a decision determining the financial responsibility of the member state concerned in accordance with the criteria laid down in paragraph 1 . ### where provided for in this regulation , the commission shall adopt a decision determining the financial responsibility of the member state concerned in accordance with the criteria laid down in paragraph 1 . the european parliament and council shall be informed about such decision .


### it is likely that similar claims will be brought under the same agreement against treatment afforded by other member states and the commission is best placed to ensure an effective and consistent defence ; or , ### a similar claim has been lodged , and it is likely that other similar claims may be brought , under the same agreement against treatment afforded by other member states and the commission is best placed to ensure an effective and consistent defence ; or ,


### regulation of the european parliament and of the council establishing a framework for managing financial responsibility linked to investor - state dispute settlement tribunals established by international agreements to which the european union is party ### regulation of the european parliament and of the council establishing a framework for managing financial responsibility linked to investor - to - state dispute settlement tribunals established by international agreements to which the european union is party


### it is appropriate that the commission decide , within the framework set down in this regulation , whether the union should be the respondent or whether a member state should act as respondent . ### in order to create a workable system , the commission should decide , within the framework set down in this regulation , whether the union should be the respondent or whether a member state should act as respondent and inform the european parliament and the council of any such decision as part of its annual reporting on the implementation of this regulation .


### the commission should consult closely with the member state concerned in order to reach agreement on the apportionment of financial responsibility . where the commission determines that a member state is responsible , and the member state does not accept that determination , the commission should pay the award , but should address a decision to the member state requesting it to provide the amounts concerned to the budget of the european union , together with applicable interest . the interest payable should be that set down pursuant to [ article 71 of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities as amended ] . article 263 of the treaty is avalable in cases where a member state considers that the decision falls short of the criteria set out in this regulation . ### the commission should consult closely with the member state concerned in order to reach agreement on the apportionment of financial responsibility . where the commission determines that a member state is responsible , and the member state does not accept that determination , the commission should pay the award , but should address a decision to the member state requesting it to provide the amounts concerned to the budget of the european union , together with applicable interest . the interest payable should be that set down pursuant to article 78 of regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union1 . article 263 of the treaty is available in cases where a member state considers that the decision falls short of the criteria set out in this regulation . ––––––––––––––––– 1 oj l 298 , 26 . 10 . 2012 , p . 1 .


### in the event that the member state does not consent to settle the dispute , the commission may settle the dispute where overriding interests of the union so require . ### in the event that the member state does not consent to settle the dispute , the commission may settle the dispute where overriding interests of the union so require . the european parliament and the council shall be informed without delay about the commission ' s decision to settle the dispute and the justification underpinning it .


### the commission may adopt a decision requiring the member state concerned to make financial contributions to the budget of the union in respect of any costs arising from the arbitration where it considers that the member state will be liable to pay any award pursuant to the criteria set down in article 3 . ### the commission may adopt a decision requiring the member state concerned to make financial contributions to the budget of the european union in respect of any costs arising from the arbitration where it considers that the member state will be liable to pay any award pursuant to the criteria set down in article 3 .


### equally , when a member state acts as respondent it is appropriate that it keep the commission informed of developments in the case and that the commission can , where appropriate , require that the member state acting as respondent takes a specific position on matters having a union interest . ### equally , when a member state acts as respondent it is appropriate that it keeps the commission informed of developments in the case and that the commission can , where appropriate , require that the member state acting as respondent takes a specific position on matters having an impact on the overriding interests of the union .


### the commission may , at any time , require the member state concerned to take a particular position as regards any point of law raised by the dispute or any other element having a union interest . ### where overriding interests of the union so require , the commission may , at any time after consultations with the member state concerned , require that member state to take a particular position as regards any point of law raised by the dispute or any other issue of law , the resolution of which may affect the future interpretation of the agreement in question or other agreements .


### financial responsibility should be allocated to the entity responsible for the treatment found to be inconsistent with the relevant provisions of the agreement . this means that the union should bear the financial responsibility where the treatment concerned is afforded by an institution , body or agency of the union . the member state concerned should bear the financial responsibility where the treatment concerned is afforded by a member state . however , where the member state acts in a manner required by the law of the union , for example in transposing a directive adopted by the union , the union should bear financial responsibility in so far as the treatment concerned is required by union law . the regulation also needs to foresee the possibility that an individual case could concern both treatment afforded by a member state and treatment required by union law . it will cover all actions taken by member states and by the european union . ### financial responsibility should be allocated to the entity responsible for the treatment found to be inconsistent with the relevant provisions of the agreement . this means that the union itself should bear the financial responsibility where the treatment concerned is afforded by an institution , body or agency of the union or any other legal entity acting on behalf of the union . the member state concerned should bear the financial responsibility where the treatment concerned is afforded by that member state . however , where the member state acts in a manner required by the law of the union and fully complies with its obligations under the union law , for example in transposing a directive adopted by the union , the union itself should bear financial responsibility in so far as the treatment concerned is required by union law . the regulation also needs to foresee the possibility that an individual case could concern both treatment afforded by a member state and treatment required by union law . it will cover all actions taken by member states and by the european union . in such a case , the member states and the union should bear financial responsibility for the specific treatment afforded by either of them .


### conduct , where relevant for that particular listed disease , surveillance in the wild animal population ; ### conduct , where relevant for that particular listed disease , surveillance in the wild animal population and if relevant in kept animals ; ;


### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects . ### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects trying to minimize animal suffering and provide pro - active solutions to disease risks .


### where the amounts due to rightholders cannot be distributed , after five years from the end of the financial year in which the collection of the rights revenue occurred , and provided that the collecting society has taken all necessary measures to identify and locate the rightholders , the collecting society shall decide on the use of the amounts concerned in accordance with article 7 , without prejudice to the right of the rightholder to claim such amounts from the collecting society . ### where the amounts due to rightholders cannot be distributed , after three years from the end of the financial year in which the collection of the rights revenue occurred , and provided that the collecting management organisation has taken all necessary measures to identify and locate the rightholders , member states shall be responsible for deciding on how best to allocate undistributed monies , including allowing the collecting management organisations to distribute the monies among their members .


### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no 1760 / 2000 , no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply . ### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply .


### operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment , taking into account : ### operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian . those animal health visits shall be at frequencies that are proportionate to the risks posed by the establishment . taking into account :


### optimal animal health management can only be achieved in cooperation with animal keepers , operators , other stakeholders and trading partners . to secure their support it is necessary to organise decision making procedures and the application of the measures provided for in this regulation in a clear and transparent manner . therefore the competent authority should take appropriate steps to keep the public informed , especially when there are reasonable grounds to suspect that animals or products may present a risk for animal or public health and when a case is of public interest . ### optimal animal health management can only be achieved in cooperation with animal keepers , operators , veterinarians , animal health professionals , other stakeholders and trading partners . to secure their support it is necessary to organise decision making procedures and the application of the measures provided for in this regulation in a clear and transparent manner . therefore the competent authority should take appropriate steps to keep the public informed , especially when there are reasonable grounds to suspect that animals or products may present a risk for animal or public health , food safety or the environment and when a case is of public interest .


### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects . ### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , food security , economic , social and cultural aspects , and especially animal welfare , given the interdependency of animal welfare and animal health , trying to minimize animal suffering and provide pro - active solutions to disease risks .


### however , those control strategies may substantially vary between different listed diseases . thus this regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of listed diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines , hyper - immune sera and antimicrobials . in order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the restrictions , prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain listed diseases . in the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health , economy , society or environment , it should be possible for these measures to be adopted by the urgency procedure . ### however , those control strategies may substantially vary between different listed diseases . thus this regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of listed diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines , hyper - immune sera and antimicrobials . for example , routine administering of vaccines , hyper - immune sera , antimicrobials and other veterinary medicines to animals by animal keepers , operators , veterinarians and animal health professionals should only be tolerated when there are no adverse effects on public health , animal health and animal welfare , both by the practice or the consumption of products of these animals . in order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the restrictions , prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain listed diseases . in the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health , economy , society or environment , it should be possible for these measures to be adopted by the urgency procedure .


### the detection of any signs indicative of the occurrence of listed diseases or emerging diseases ; ### the detection of any signs indicative of the occurrence of listed diseases or emerging diseases and / or of risk factors leading thereto ;


### listed diseases ; ### diseases listed in annex - ia ;


### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects . ### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , food security , economic , social , cultural aspects and especially animal welfare , given the interdependency of animal welfare and animal health .


### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority . those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed . ### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority . those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed . member states should ensure that operators and animal professionals are adequately informed of their obligations under this regulation .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the qualifications of veterinarians and aquatic animal health professionals undertaking activities which fall within the scope of this regulation . ### the commission shall adopt guidance concerning the qualifications of veterinarians , aquatic animal health professionals and bee health professionals undertaking activities which fall within the scope of this regulation .


### in order to guarantee the free movement of products within the union , it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union goods market can thrive . rules are therefore necessary on market surveillance and on controls of products entering the union from third countries . ### in order to guarantee the free movement of products within the union , it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , fair trading practices , protection of consumers , protection of the environment , protection of intellectual property right and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union goods market , online and offline , can thrive . rules are therefore necessary on market surveillance , online and offline , and on controls of products entering the union from third countries .


### member states and the agency shall ensure that railway safety is generally maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . ### member states and the agency shall ensure , each within their respective fields of responsibility , that railway safety is maintained and , where practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . the commission may request the agency to deliver ad hoc technical opinions .


### applications for single safety certificates shall be submitted to the agency . the agency shall take a decision on an application without delay and in any event not more than four months after all required information and any supplementary information requested by the agency has been submitted . if the applicant is requested to submit supplementary information , such information shall be submitted promptly . ### applications for a safety certificate shall be submitted to the agency or in the case of article 10 , and , to the national safety agency . the agency or the national safety authority , where appropriate , shall take a decision on an application without delay and in any event not more than four months after all required information and any supplementary information requested by the agency or the national safety authority , where appropriate , has been submitted . if the applicant is requested to submit supplementary information , such information shall be submitted promptly .


### member states and the agency shall ensure that railway safety is generally maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . ### member states and the agency each for their own missions shall ensure that railway safety is maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents .


### articles 10 and 11 shall apply from [ specific date to be inserted by opoce - two years after the date of entry into force ] . ### articles 10 and 11 shall apply from [ specific date to be inserted by opoce - five years after the date of entry into force ] .


### the holder of the single safety certificate shall inform the agency without delay of any major changes in the conditions of the single safety certificate . it shall furthermore notify the agency whenever new categories of staff or new types of rolling stock are introduced . ### the holder of the safety certificate shall inform the agency or the national safety authority , where appropriate , without delay of any major changes in the conditions of the safety certificate . it shall furthermore notify the agency or the national safety authority , where appropriate , whenever new categories of staff or new types of rolling stock are introduced .


### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . ### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . the safety certificate may also include sidings owned by the railway undertaking if they were included in its safety management system .


### when drafting the recommandations , the agency shall take account of the opinion of the users and of the stakeholders . the recommendations shall enclose a report on the results of this consultation and a report assessing the impact of the new csm to be adopted . ### when drafting the recommendations , the agency shall take account of the opinion of the users , the social partners and of other stakeholders . the recommendations shall enclose a report on the results of this consultation and a report assessing the impact of the new csm to be adopted .


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


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


### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights . ### the measures referred to in this paragraph shall take due account at least all of the following : the cost - effectiveness of the system , in order to guarantee that any measure that is applied is based on a cost - benefit analysis ; the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned ; the independence of the system and the legitimate interests to protect information of commercially confidential nature and the protection of industrial and commercial property rights and personal data .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice and good distribution , trading and brokering practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorisation holder , the wholesale distributor who has undergone the inspection or the trading or brokering authorisation holder . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorisation holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


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


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicines sold directly by producers , without any brokering , to establishments at which they are provided to patients . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### member states shall enter the certificates of good manufacturing practice and good distribution practice which they issue in a community database managed by the agency on behalf of the community . ### member states shall enter the certificates of good manufacturing practice , good distribution practice , good trading practice and good brokering practice which they issue in a union database managed by the agency on behalf of the union .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ’ ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice , good distribution practice , good trading practice , or good brokerage practice referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , wholesale distributor , trading authorisation holder or brokerage authorisation holder who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 . ### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices , good distribution practices , good trading practices or good brokering practices as provided for by union legislation , the information shall be entered in the union database referred to in paragraph 6 and the manufacturing and distribution processes shall cease forthwith .