### arrangements for suspension or revocation of either the notified identification scheme or authentication possibility or the compromised parts concerned . ### arrangements for suspension or revocation of either the notified authentication scheme or the compromised parts concerned .


### the commission shall , by means of implementing acts , establish the necessary modalities to facilitate the cooperation between the member states referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the peer review of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission shall , by means of implementing acts , establish the necessary modalities to facilitate the cooperation between the member states and the publication and peer - review mechanisms referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the independent , third - party auditing of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### it is not competent to deal with the request ; or ### it is not in possession of the required expertise to deal with the request ; or


### trust service providers who are established in the territory of the union shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust services they provide . having regard to state of the art , these measures shall ensure that the level of security is appropriate to the degree of risk . in particular , measures shall be taken to prevent and minimise the impact of security incidents and inform stakeholders of adverse effects of any incidents . ### trust service providers who are established in the territory of the union shall take appropriate technical and organisational measures to manage the risks posed to the security of the trust services they provide . having regard to state of the art , these measures shall ensure that the level of security is appropriate to the degree of risk . measures shall be taken to prevent and minimise the impact of security incidents and to inform stakeholders , including both signatories and relying parties , of all security breaches that might affect them . trust service providers must also take , at their own costs , appropriate and immediate measures to remedy any new , unforeseen security risks and restore the normal security level of the service .


### without prejudice to article 16 , any trust service provider may submit the report of a security audit carried out by a recognised independent body to the supervisory body to confirm that appropriate security measures have been taken . ### without prejudice to article 16 , any trust service provider shall publish the report of a security audit carried out by an independent body whose competence to carry out the audit has been demonstrated to confirm that appropriate security measures have been taken .


### trust service providers shall , without undue delay and where feasible not later than 24 hours after having become aware of it , notify the competent supervisory body , the competent national body for information security and other relevant third parties such as data protection authorities of any breach of security or loss of integrity that has a significant impact on the trust service provided and on the personal data maintained therein . ### in case of a breach of the security of the network , the provider of a trust service must inform both signatories and relying parties and , where the risk lies outside the scope of the measures to be taken by the service provider , of any possible remedies , including an indication of the likely costs involved . trust service providers shall , without undue delay and where feasible not later than 24 hours after having become aware of it , notify , the competent supervisory body , the competent national body for information security and , where personal data is involved in the incident , the data protection authorities of any breach of security or loss of integrity that has an impact on the trust service provided and on the personal data maintained therein . they shall notify not just security breaches in their own systems but any security breaches they observe in the systems of other trust service providers .


### the supervisory body concerned may also inform the public or require the trust service provider to do so , where it determines that disclosure of the breach is in the public interest . ### the supervisory body concerned shall also inform the public or require the trust service provider to do so . publication shall normally be as soon as reasonably practical ; however the trust service provider may request a delay so that vulnerabilities can be fixed . if the supervisory body grants this , it may be for no longer than 45 days and the trust service provider must agree to indemnify all relying parties , wherever in the world they are located , against losses directly arising from the delay in notification .


### qualified trust service providers shall be audited by a recognised independent body once a year to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and shall submit the resulting security audit report to the supervisory body . ### trust service providers shall be audited once a year by an independent body whose competence to carry out the audit has been demonstrated to confirm that they and the trust services provided by them fulfil the requirements set out in this regulation , and shall make the resulting security audit report public and transmit it to the supervisory body . in the event that the audit may contain confidential business information , the publication of sensitive sections may be delayed by the supervisory body , but for no more than one year .


### without prejudice to paragraph 1 , the supervisory body may at any time audit the qualified trust service providers to confirm that they and the qualified trust services provided by them still meet the conditions set out in this regulation , either on its own initiative or in response to a request from the commission . the supervisory body shall inform the data protection authorities of the results of its audits , in case personal data protection rules appear to have been breached . ### without prejudice to paragraph 1 , the supervisory body may at any time audit the trust service providers to confirm that they and the trust services provided by them still meet the conditions set out in this regulation , either on its own initiative or in response to a request from the commission . the trust service provider shall inform the data protection authorities of the results of its audits , in case personal data protection rules appear to have been breached .


### the supervisory body shall have the power to issue binding instructions to qualified trust service providers to remedy any failure to fulfil the requirements indicated in the security audit report . ### the supervisory body shall have the power to issue binding instructions to trust service providers to remedy any failure to fulfil the requirements indicated in the security audit report . such instructions shall be published .


### qualified electronic signature creation devices may be certified by appropriate public or private bodies designated by member states provided that they have been submitted to a security evaluation process carried out in accordance with one of the standards for the security assessment of information technology products included in a list that shall be established by the commission by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### electronic signature creation devices may be certified by appropriate public or private bodies designated by member states provided that they have been submitted to a security evaluation process in accordance with one of the standards for the security assessment of information technology products included in a list that shall be established by the commission by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union


### it is necessary to develop strong and coherent eu - wide networks for the digital delivery of public - good actions , involving both public and civil society actors at national and regional level , and to this end it is essential to ensure the structured eu financing of the costs of the system and software design , as well as maintenance of a resilient hub for such networks , leaving only in - country costs for national operator budgets . ### it is necessary to develop strong and coherent eu - wide networks for the digital delivery of public - good actions , involving both public and civil society actors at national , regional and local level , and to this end it is essential to ensure the structured eu financing of the costs of the system and software design , as well as maintenance of a resilient hub for such networks , leaving only in - country costs for national operator budgets .


### ensuring sustainable and efficient transport in the long run , to be measured by the length of the conventional railway network in the eu - 27 and the length of high - speed railway network in the eu - 27 ; ### ensuring sustainable and efficient transport in the long run . this shall take into account the socio - economic impact , regional integration , the demographic situation , spread and not just profitability . the achievement of this objective will be measured by the length of the conventional railway network in the eu - 27 and the length of high - speed railway network in the eu - 27 ;


### enhancing union security of supply , to be measured by the evolution of system resiliance and security of system operations as well as number of projects allowing diversification of supply sources , supplying counterparts and routes ; ### enhancing union security of supply and efficiency of supply by means of infrastructure modernisation , to be measured by the evolution of system resiliance and security of system operations as well as number of projects allowing diversification of supply sources , supplying counterparts and routes ;


### promoting the interconnection and interoperability of national public services on - line as well as access to such networks , to be measured by the percentage of citizens and businesses using public services on - line and the availability of such services across borders . ### promoting the interconnection and interoperability of national public services on - line , by means of the facilities offered by e - government , as well as access to such networks , to be measured by the percentage of citizens and businesses using public services on - line and the availability of such services across borders .


### actions implementing the core network according to chapter iii of regulation no xxxx / 2012 [ ten - t guidelines ] , including the deployment of new technologies and innovation according to article 39 of regulation no xxxx / 2012 [ ten - t guidelines ] ; ### actions implementing the core network according to chapter iii of regulation no xxxx / 2012 [ ten - t guidelines ] , including the deployment of new technologies and innovation according to article 39 of regulation no xxxx / 2012 [ ten - t guidelines ] , as well as studies into the socio - economic impact implementing and structuring these objectives may have ;


### actions to reduce rail freight noise by retrofitting of existing rolling stock ; ### actions to reduce rail freight noise by the retrofitting and modernisation of existing rolling stock ;


### proposals may be submitted by one or several member states , international organisations , joint undertakings , or public or private undertakings or bodies established in member states . ### proposals may be submitted by one or several member states , subnational bodies endowed with law - making powers , international organisations , joint undertakings , or public or private undertakings or bodies established in member states .


### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable . ### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify or single out the individual . this directive should not apply to anonymous data , meaning any data that can not be related , directly or indirectly , alone or in combination with associated data , to a natural person or where establishing such a relation would require a disproportionate amount of time , expense , and effort , taking into account the state of the art in technology at the time of the processing and the possibilities for development during the period for which the data will be processed .


### in order to exercise their rights , any information to the data subject should be easily accessible and easy to understand , including the use of clear and plain language . ### in order to exercise their rights , any information to the data subject should be easily accessible and easy to understand , including the use of clear and plain language , especially when the data subject is a child .


### ‘ personal data breach’ means a breach of security leading to the accidental or unlawful destruction , loss , alteration , unauthorised disclosure of , or access to , personal data transmitted , stored or otherwise processed ; ### ' personal data breach ' means the accidental or unlawful destruction , loss , alteration , unauthorised disclosure of , or access to , personal data transmitted , stored or otherwise processed ;


### processed fairly and lawfully ; ### processed fairly and lawfully and in a transparent manner in relation to the data subject ;


### accurate and , where necessary , kept up to date ; every reasonable step must be taken to ensure that personal data that are inaccurate , having regard to the purposes for which they are processed , are erased or rectified without delay ; ### accurate and kept up to date ; every reasonable step must be taken to ensure that personal data that are inaccurate are erased or rectified without delay ;


### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language . ### member states shall provide that any information and any communication relating to the processing of personal data are provided by the controller to the data subject in an intelligible form , using clear and plain language , adapted to the data subject , in particular where that information is addressed specifically to a child .


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


### member states shall ensure that the controller or the processor consults the supervisory authority prior to the processing of personal data which will form part of a new filing system to be created where : ### member states shall ensure that the controller or the processor consults the supervisory authority prior to the processing of personal data which will form part of a new type of filing system to be created .


### member states may provide that the supervisory authority establishes a list of the processing operations which are subject to prior consultation pursuant to paragraph 1 . ### member states shall provide that the supervisory authority establishes a list of the processing operations which are subject to prior consultation pursuant to paragraph 1 .


### investigative powers , such as powers of access to data forming the subject matter of processing operations and powers to collect all the information necessary for the performance of its supervisory duties ; ### investigative powers , such as powers of access to all personal data and to all the information necessary for the performance of its supervisory duties and access to any of a data controller ' s premises , including to any data processing equipment and means .


### member states shall provide that each supervisory authority draws up an annual report on its activities . the report shall be made available to the commission and the european data protection board . ### member states shall provide that each supervisory authority draws up a report on its activities at least every two years . the report shall be presented to the national parliament , and be made available to the commission , the european data protection board , and the public . it shall include information on the extent to which competent authorities in their jurisdiction have accessed data held by private parties to investigate or prosecute criminal offences .


### the reports shall , in particular , include details of the names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 . ### the reports shall , in particular , include details of the type , the class of assets , the names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . additionally , for transactions related to commodity derivatives , the report shall indicate whether such transactions qualify as bona - fide hedging transactions . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 .


### esma powers to temporarily intervene ### esma intervention powers


### after analysing the information obtained , require any such person to take steps to reduce the size of the position or exposure ; ### after analysing the information obtained , require any such person or class of investors to take steps to reduce the size of the position or exposure ;


### limit the ability of a person from entering into a commodity derivative . ### limit the ability of a person from entering into a commodity derivative or prohibit new classes of contracts .


### esma shall only take a decision under paragraph 1 if all of the following conditions are fulfilled : ### without prejudice to the measures foreseen in article 59 of directive new mifid , esma shall only take a decision under paragraph 1 if one or more of the following conditions are fulfilled :


### the measures listed in points to of paragraph 1 address a threat to the orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union ; ### the measures listed in points to of paragraph 1 address a threat to the efficient and orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , consisting in excessive speculation and market manipulation , increased volatility or distortion of price discovery , or a threat to the stability of the whole or part of the financial system in the union or a distortion of risk management functions of commodity markets ;


### does significantly address the threat to the orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat ; ### addresses the threat to the efficient and orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or improve the ability of competent authorities to monitor the threat ;


### does not have a detrimental effect on the efficiency of financial markets , including reducing liquidity in those markets or creating uncertainty for market participants , that is disproportionate to the benefits of the measure . ### does not have a detrimental effect on the efficiency of financial markets , including reducing liquidity required by bona fide hedging transactions in those markets or creating uncertainty for market participants , that is disproportionate to the benefits of the measure .


### the commission shall adopt by means of delegated acts in accordance with article 41 measures specifying criteria and factors to be taken into account by esma in determining when a threat to the orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union referred to in paragraph 2 arise . ### esma shall develop drafts for regulatory technical standards specifying the measures , criteria and factors that it shall take into account in determining whether the circumstances referred to in paragraph 2 arise .


### any company that issues transferable securities which are admitted to trading on regulated markets shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form . ### any legal entity that issues transferable securities or units in collective investment undertakings as defined in article&#160 ; 2 which are admitted to trading on regulated markets or traded in trading venues shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form .


### the authorities of the member state where the company that issues securities is established shall be competent for ensuring that article 3 is applied . ### the authorities of the member state where the legal entity that issues securities is established shall be competent for ensuring that article&#160 ; 3 is applied .


### annual statistical data on demography are fundamental for the study and definition of a wide range of policies , with particular regard to social and economic issues , at national and regional level . statistics on population are an important denominator for a wide range of policy indicators . ### annual statistical data on demography are fundamental for the study and definition of a wide range of policies , with particular regard to social , economic and territorial issues , at national and regional level . statistics on population are an important denominator for a wide range of policy indicators , such as the ‘ demographic vulnerability index’ , particularly in exploring the severe and permanent demographic handicaps of some eu regions .


### demographic statistics on population constitute an essential component for the estimation of total population in the framework of the european system of accounts . ### demographic statistics on population constitute an essential component for the estimation of total population in the framework of the european system of accounts . the updating and purging of data are an important element for the production of statistics at european level .


### the free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , and to their social and economic interests . ### that food is safe is an essential prerequisite for its free movement within the internal market in order to ensure the health and well - being of citizens .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . taking into account technical and scientific progress , notably in regard to risk assessment , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , 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 . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the results of new risk assessments and the precautionary principle , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### subject to the requirements of articles 7 and 9 and taking into account relevant technical and scientific progress , the commission shall update the delegated regulations mentioned in paragraph 2 in accordance with article 15 . ### subject to the requirements of articles 7 and 9 and taking into account relevant technical and scientific progress , the results of new risk assessments and the precautionary principle , the commission shall update the delegated regulations mentioned in paragraph 2 in accordance with article 15 .


### no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of implementing regulations . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified grounds of extreme urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14 . ### no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of delegated acts pursuant to article 15 . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria .


### the delegation of power referred to in articles 2 and 10 of this regulation shall be conferred for an indeterminate period of time from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ] ### the delegation of power referred to in articles 10 and 11 of this regulation shall be conferred for a period of 5 years from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ]


### the member state referred to in paragraph 2 shall immediately notify other member states and the european securities and markets authority established by regulation… / …of the european parliament and of the council and shall communicate to the latter all information essential to achieve its tasks . ### the member state referred to in paragraph 2 shall immediately notify the european systemic risk board , other member states and the european securities and markets authority established by regulation… / …of the european parliament and of the council and shall communicate to the latter all information essential to achieve its tasks .


### member states shall establish a register of all investment firms . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . the european securities and markets authority established by regulation… / …of the european parliament and of the council shall establish a list of all investment firms in the community . the european securities and markets authority shall publish that list and shall keep it up to date . ### member states shall register all investment firms which provide services or carry out activities within their sphere of authority . a systematically updated list of those firms shall be transferred to the european securities and markets authority established by regulation… / …of the european parliament and of the council . the european supervisory authority shall establish a register of all investment firms in the union . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . where a competent authority has withdrawn an authorisation in accordance with article 8 to , the withdrawal shall be published in the register for a period of two years .


### if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached . ### if , at the end of the two month period following receipt of a request under the first subparagraph any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall await the decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with eu law , and shall take their final decision in conformity with the authority ' s decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of that two month period or after a joint decision has been reached .


### where an emergency situation , including adverse developments in financial markets , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority and the authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 25 and 126 and to the competent authority identified under article 129 . ### where a potential or effective emergency situation , including any potential adverse developments in financial markets or in real economy , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority , the european systemic risk board and other authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 125 and 126 and to the competent authority identified under article 129 .


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


### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions . ### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets , flagship initiatives and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions .


### networking and cooperation among specialist bodies , national , regional and local authorities , and employment services at european level ; ### networking and cooperation among specialist bodies , national , regional and local authorities , civil society and social partner organisations and employment services at european level ;


### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea to protect rockall haddock , cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks . ### in the light of advice from ices and stecf certain technical conservation measures in the celtic sea and irish sea to protect cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks .


### the fishing gear used incorporates a sorting grid in accordance with annex xiva ; or a square - mesh panel as described in annex xivc ; ### the fishing gear used incorporates a sorting grid in accordance with annex xiva ; or a combination of a square - mesh panel as described in annex xivc and highly selective gear that has been approved by stecf ;


### it is in the union’s interest to deepen its relations with partners who are playing an increasingly important role in the international economy and trade , in south - south trade and cooperation , in multilateral fora including group of twenty finance ministers and central bank governors , in global governance and in addressing challenges of global concern . the union needs to build comprehensive partnerships with new players on the international scene , in order to promote a stable and inclusive international order , pursue common global public goods , defend core interests of the union and increase knowledge of the union in these countries . ### it is in the union’s interest to deepen its relations with partners who are playing an increasingly important role in the international economy and trade , in south - south trade and cooperation , in multilateral fora including group of twenty finance ministers and central bank governors , in global governance and in addressing challenges of global concern . the union needs to build comprehensive partnerships with new players on the international scene , in order to promote a stable and inclusive international order , pursue common global public goods , promote the core values of the union and increase knowledge of the union in these countries .


### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where the union has significant interests in accordance with the objectives of this regulation . ### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where there are significant mutual interests in accordance with the objectives of this regulation .


### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional or multilateral relationships with third countries and address challenges of global concern . ### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu values and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional or multilateral relationships with third countries and address challenges of global concern .


### improving market access and developing trade , investment and business opportunities for european companies by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union’s share in foreign trade with key partner countries and by trade and investments flows to partner countries specifically targeted by actions , programmes and measures under this regulation ; ### promoting high social and environmental standards for fair and equitable trade and investment relations , by means of economic partnerships and business and regulatory cooperation . this objective shall be measured , inter alia , by the union’s share in foreign trade with key partner countries , by the balance of trade and investment flows with partner countries , and the uptake of trade qualification measures specifically targeted by actions , programmes and measures under this regulation ;


### in implementing this regulation , the union shall aim to ensure coherence and consistency with other areas of its external action , in particular the development cooperation instrument for developing countries , and with other relevant union’s policies when formulating policy , strategic planning and programming and implementing measures . ### in implementing this regulation , the union shall aim to ensure coherence and consistency with other areas of its external action , in particular the development cooperation instrument for developing countries , guided by the union principle of policy coherence for development as enshrined in article 208 tfeu , and with other relevant union policies when formulating policy , strategic planning and programming and implementing measures .


### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and shall also relate to areas linked to the union ' s specific interests , policy priorities and strategies . ### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and shall also relate to areas linked to the union ' s specific values , policy priorities and strategies .


### an expert committee , the medical device coordination group , composed of persons designated by the member states , based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices , should be established in accordance with the conditions and modalities defined in article 78 of regulation [ ref . of future regulation on medical devices ] on medical devices to fulfil the tasks conferred on it by this regulation and by regulation [ ref . of future regulation on medical devices ] on medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation . ### an expert committee , the medical device coordination group , composed of persons designated by the member states , based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices , should be established in accordance with the conditions and modalities defined in article 78 of regulation [ ref . of future regulation on medical devices ] on medical devices to fulfil the tasks conferred on it by this regulation and by regulation [ ref . of future regulation on medical devices ] on medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation . prior to taking up their duties , members of the mdcg shall make available a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be prejudicial to their independence . those declarations shall be verified by the commission .


### ‘ device for self - testing’ means any device intended by the manufacturer to be used by lay persons ; ### ‘ device for self - testing’ means any device intended by the manufacturer to be used by lay persons , including testing services offered to lay persons by means of information society services ;


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


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that , within the limits of its respective activities , the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken .


### the commission , in collaboration with the member states , shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and , where applicable , the authorised representative and the importer . the details regarding the information to be submitted by the economic operators are laid down in part a of annex v . ### the commission , in collaboration with the member states , shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and , where applicable , the authorised representative and the importer , and to ensure transparency and safe and effective use by making available to users current evidence concerning the clinical validity and , where applicable , utility of the device . the details regarding the information to be submitted by the economic operators are laid down in part a of annex v .


### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body . ### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a extensive report of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this extensive report shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body .


### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . ### member states shall provide the commission , the other member states and the public with all information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto .


### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed authorities , and submit it to the commission . the commission may participate in the review . the outcome of the peer - review shall be communicated to all member states and to the commission and a summary of the outcome shall be made publicly available . ### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed authorities , and submit it to the commission for scrutiny . the commission may participate in the review . the outcome of the peer - review shall be communicated to all member states and to the commission and a summary of the outcome shall be made publicly available .


### within 14 days of the submission referred to in paragraph 2 , the commission shall designate a joint assessment team , made up of at least two experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies . the list shall be drawn up by the commission in cooperation with the mdcg . at least one of these experts shall be a representative of the commission who shall lead the joint assessment team . ### within 14 days of the submission referred to in paragraph 2 , the commission shall designate a joint assessment team , made up of at least three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies . the list shall be drawn up by the commission in cooperation with the mdcg . at least one of these experts shall be a representative of the commission who shall lead the joint assessment team .


### within 90 days after designation of the joint assessment team , the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with article 29 and conduct an on - site assessment of the applicant conformity assessment body and , where relevant , of any subsidiary or sub - contractor , located inside or outside the union , to be involved in the conformity assessment process . such on - site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in article 29 , unless the commission representative mentioned in article 30 requests the on - site assessment . ### within 90 days after designation of the joint assessment team , the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with article 29 and conduct an on - site assessment of the applicant conformity assessment body and , where relevant , of any subsidiary or sub - contractor , located inside or outside the union , to be involved in the conformity assessment process . such on - site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in article 29 , unless a member of the joint assessment team mentioned in article 30 requests the on - site assessment .


### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body . ### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a binding recommendation with regard to the draft notification . the relevant national authority shall fully respect this binding recommendation for its decision on the designation of the notified body .


### the commission shall make accessible to the public the list of the bodies notified under this regulation , including the identification numbers that have been assigned to them and the activities for which they have been notified . the commission shall ensure that the list is kept up to date . ### the commission shall make accessible to the public the list of the bodies notified under this regulation , including the identification numbers that have been assigned to them , the activities for which they have been notified and all documents for the notification procedure as referred to in article 31 . the commission shall ensure that the list is kept up to date .


### the member states shall report to the commission and to the other member states , at least once a year , on their monitoring activities . this report shall contain a summary which shall be made publicly available . ### the member states shall report to the commission and to the other member states , at least once a year , on their monitoring activities . this report shall be made publicly available .


### in addition , where a reference laboratory is designated in accordance with article 78 , the notified body performing the conformity assessment shall request that reference laboratory to verify compliance of the device with the applicable cts , when available , or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix . ### in addition , where a reference laboratory is designated in accordance with article 78 , the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable cts , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix . laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and specificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established infection .


### the commission shall , in collaboration with the member states , set up and manage an electronic system on interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies to create the single identification numbers for such clinical performance studies referred to in article 49 and to collate and process the following information : ### the commission shall , in collaboration with the member states , set up and manage an electronic system on interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies . the existence of this database will allow the public to be able to search for specific performance studies and citizens and professionals to make informed decisions about in - vitro devices . to ensure this , the electronic system will help to create the single identification numbers for such clinical performance studies referred to in article 49 and to collate and process the following information :


### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ ref . of future regulation on clinical trials ] . with the exception of the information referred to in article 50 , the information collated and processed in the electronic system shall be accessible only to the member states and to the commission . ### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ ref . of future regulation on clinical trials ] . the information collated and processed in the electronic system shall be accessible to the member states , to the commission , and the commission shall also ensure that healthcare professionals and patients have access to the electronic system


### the member states shall take all appropriate measures to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up . ### the member states shall take all appropriate measures to encourage healthcare professionals , including doctors and pharmacists , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up .


### sanctions in the preventive part of the stability and growth pact ### sanctions and incentives in the preventive part of the stability and growth pact


### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec . ### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec . these criteria should be supplemented with safeguards to ensure cascade of use and respect of waste - hierarchy .


### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land . ### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , this also has an impact on the non - fuel products previously grown there . it is important to maintain sufficient crop diversification on agricultural land to secure current production also when bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land .


### ' for the purpose of compliance with target referred to in the first subparagraph , the maximum joint contribution from biofuels and bioliquids produced from cereal and other starch rich crops , sugars and oil crops shall be no more than the energy quantity corresponding to the maximum contribution as set out in article 3d . ' ### ' for the purpose of compliance with target referred to in the first subparagraph , the maximum joint contribution from biofuels and bioliquids produced from cereal and other starch rich crops , sugars and oil crops shall be conditional to the raw material being obtained from land managed in a manner which enhances overall carbon sink capacity of the land and protects soil fertility , and shall be no more than 3% of the final consumption of energy in transport in 2020 . '


### in point , the following phrase is added : ### point is replaced by the following :


### ' this indent shall be without prejudice to articles 17a and 3d ; ' ### ' for the calculation of the numerator , that is the amount of energy from advanced transport energy sources consumed for the purposes of the first subparagraph , renewable electricity and the types of advanced renewable energy specified in annex ix consumed in all forms of transport shall be taken into account . this indent shall be without prejudice to articles 17a and 3d ; '


### only articles 30 to 39 on consumer rights concerning unfair contract terms , read in conjunction with article 4 on full harmonisation , shall apply to contracts which fall within the scope of directive 94 / 47 / ec of the european parliament and of the council12 and of council directive 90 / 314 / eec13 . ### only articles 30 to 39 on consumer rights concerning unfair contract terms , read in conjunction with article 4 on minimum harmonisation , shall apply to contracts which fall within the scope of directive 94 / 47 / ec of the european parliament and of the council12 and of council directive 90 / 314 / eec13 .


### full harmonisation ### minimum harmonisation


### member states shall ensure that contract terms , as set out in the list in annex ii , are considered unfair in all circumstances . that list of contract terms shall apply in all member states and may only be amended in accordance with articles 39 and 40 . ### member states shall ensure that contract terms , as set out in the list in annex ii , are considered unfair in all circumstances . that list of contract terms shall apply in all member states . member states may adopt or maintain additional contract terms in addition to those included in that list .


### member states shall ensure that contract terms , as set out in the list in point 1 of annex iii , are considered unfair , unless the trader has proved that such contract terms are fair in accordance with article 32 . that list of contract terms shall apply in all member states and may only be amended in accordance with articles 39 and 40 . ### member states shall ensure that contract terms , as set out in the list in point 1 of annex iii , are considered unfair , unless the trader has proved that such contract terms are fair in accordance with article 32 . that list of contract terms shall apply in all member states . member states may adopt or maintain additional contract terms in addition to those included in that list .


### in order to ensure that redress is possible where this regulation has been incorrectly applied , member states should establish adequate and effective out - of - court complaint and redress procedures for settling any dispute arising therefrom . ### in order to ensure that redress is possible where this regulation has been incorrectly applied , member states should establish adequate and effective out - of - court complaint and redress procedures for settling any dispute arising between payment service users and payment service providers .


### directive of the european parliament and of the council amending council directives 78 / 660 / eec and 83 / 349 / eec as regards disclosure of non - financial and diversity information by certain large companies and groups ### directive of the european parliament and of the council amending council directives 78 / 660 / eec and 83 / 349 / eec as regards disclosure of financial , non - financial and diversity information by certain large companies and groups


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing information on their compliance with rights and values protected by norms of international law , companies shall apply the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework and the oecd guidelines for multinational enterprises , companies may also rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and other international frameworks such as the united nations global compact , the international organisation for standardisation 26000 standard , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative .


### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 500 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million . ### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 250 , and exceed either a balance sheet total of eur 17 , 5 million or a net turnover of eur 35 million .


### for companies whose average number of employees during the financial year exceeds 500 and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including : ### for companies whose average number of employees during the financial year exceeds 250 and , on their balance sheet dates , exceed either a balance sheet total of eur 17 , 5 million or a net turnover of eur 35 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , taking into account the company ' s complete supply chain , including :


### where a company does not pursue policies in relation to one or more of these matters , it shall provide an explanation for not doing so . ### where a company does not pursue policies in relation to one or more of these matters , it shall provide a reasoned explanation based on assessment of risks for not doing so .


### in providing such information the company may rely on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon . ### in providing such information , the company shall take into account its responsibility to respect rights and values protected by norms of international law . in this respect the company shall apply the guiding principles on business and human rights implementing the united nations “protect , respect and remedy” framework and the organisation for economic co - operation and development guidelines for multinational enterprises . the company may , in addition , rely on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon . this provision shall apply without prejudice to the requirements of this directive or to other european union legislation or guidance containing more specific rules for companies’ non - financial disclosure .


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing such information , the company shall take into account its responsibility to respect rights and values protected by norms of international law . in this respect the company shall apply the guiding principles on business and human rights implementing the united nations ' ' protect , respect and remedy ' framework and the organisation for economic cooperation and development guidelines for multinational enterprises . in addition , the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . this provision shall apply without prejudice to the requirements of this directive or to other european union legislation or guidance containing more specific rules for companies ' non - financial disclosure .


### to the extent necessary for an understanding of the company ' s development , performance or position , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . ### to the extent necessary for an understanding of the company ' s development , performance or position , and human rights , social and environmental impacts , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 250 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 17 , 5 million or a net turnover of eur 35 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , taking into account the company ' s complete supply chain , including the following :


### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , the company shall provide an explanation for not doing so . ### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , the company shall provide a reasoned explanation based on assessment of risks for not doing so .


### for the partnership contract and each programme respectively , a member state should organise a partnership with the representatives of competent regional , local , urban and other public authorities , economic and social partners , and bodies representing civil society , including environmental partners , non - governmental organisations , and bodies responsible for promoting equality and non - discrimination . the purpose of such a partnership is to respect the principle of multi - level governance , ensure the ownership of planned interventions by stakeholders and build on the experience and know - how of relevant actors . the commission should be empowered to adopt delegated acts providing for a code of conduct in order to ensure that partners are involved in the preparation , implementation , monitoring and evaluation of partnership contracts and programmes in a consistent manner . ### for the partnership contract and each programme respectively , a member state should organise a partnership with the representatives of competent regional , local , urban and other public authorities , economic and social partners , and bodies representing civil society , including environmental partners and partners active in areas such as culture , education and youth policy , non - governmental organisations , and bodies responsible for promoting equality and non - discrimination . the purpose of such a partnership is to respect the principle of multi - level governance , ensure the ownership of planned interventions by stakeholders and build on the experience and know - how of relevant actors . the commission should be empowered to adopt delegated acts providing for a code of conduct in order to ensure that partners are actively involved in the preparation , implementation , monitoring and evaluation of partnership contracts and programmes .


### with a view to strengthening accessibility and transparency of information about funding opportunities and project beneficiaries , in each member state a single website or website portal providing information on all the operational programmes , including the lists of operations supported under each operational programme , should be made available . ### with a view to strengthening accessibility and transparency of information about funding opportunities and project beneficiaries and explaining more clearly the thinking behind the european integration process in the areas of regional development and cross - sectoral action , in each member state a single website or website portal using clear and comprehensible language and providing information on all the operational programmes , including the lists of operations supported under each operational programme , should be made available .


### investing in education , skills and lifelong learning ; ### investing in education , skills , qualifications and lifelong learning ;


### designed taking into consideration local needs and potential , and include innovative features in the local context , networking and , where appropriate , cooperation . ### designed taking into consideration local needs and potential , and include innovative , social , cultural and educational features in the local context and the promotion of cooperation projects and the development of trans - territorial networks .


### building the capacity of local actors to develop and implement operations ; ### building the capacity of local actors to develop and implement operations , taking account of the social and cultural characteristics of a given region in order to develop innovative know - how which can generate new types of jobs at local level ;


### monitoring the implementation of the local development strategy and the operations supported and carrying out specific evaluation activities linked to the local development strategy . ### monitoring the implementation of the local development strategy and the operations supported and carrying out specific evaluation activities linked to the local development strategy , taking account of the qualitative aspect of the measures and their long - term results .


### eligible population , regional prosperity , national prosperity and unemployment rate for less developed regions and transition regions ; ### eligible population , regional prosperity , national prosperity and unemployment rate by age group for less developed regions and transition regions ;


### eligible population , regional prosperity , unemployment rate , employment rate , educational level and population density for more developed regions ; ### eligible population , regional prosperity , unemployment rate and employment rate by age group , educational level and population density for more developed regions ;


### the contribution to the integrated approach set out in the partnership contract to address the specific needs of geographical areas most affected by poverty or target groups at highest risk of discrimination or exclusion , with special regard to marginalised communities , and the indicative financial allocation ; ### the contribution to the integrated approach set out in the partnership contract to address the specific needs of geographical areas most affected by poverty or target groups at highest risk of discrimination or exclusion , with special regard to marginalised communities , young people and persons with disabilities , and the indicative financial allocation ;


### criteria for fulfilment ### criteria for fulfilment - training measures which provide people with the cross - disciplinary skills they need to find long - term employment more easily .


### criteria for fulfilment – cuts across - sectors , and involves and coordinates all policy sectors and stakeholders that are relevant to address esl . ### criteria for fulfilment – cuts across - sectors , and involves and coordinates all policy sectors and stakeholders , in particular in the areas of culture , the arts and sport , that are relevant to address esl .


### ‘ contingent commission’ means a remuneration in the form of a commission where the amount payable is based on the achievement of agreed targets relating to the business placed by the intermediary with that insurer ; ### ‘ contingent commission’ means a remuneration in the form of a commission where the amount payable is based on the achievement of any kind of agreed targets relating to the activities run by the intermediary with that insurer ;


### the authorities referred to in paragraph 1 shall be either public authorities or bodies recognised by national law or by public authorities expressly empowered for that purpose by national law . they shall not be insurance or reinsurance undertakings . ### the authorities referred to in paragraph 1 shall be either public authorities or bodies recognised by national law or by public authorities expressly empowered for that purpose by national law . they shall not be insurance or reinsurance undertakings or associations whose members directly or indirectly include insurance or reinsurance undertakings or insurance or reinsurance intermediaries .


### it gives advice on the basis of a fair analysis , or ### it gives advice on the basis of an assessment in the interest of the customer ,


### it is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice on the basis of a fair analysis . in that case , it shall provide the names of the insurance undertakings with which it may and does conduct business ; ### it is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice on the basis of an assessment based on the needs of the customer . in that case , it shall provide the names of the insurance undertakings with which it may and does conduct business ;


### where steps taken by the insurance intermediary or insurance undertaking in compliance with articles 15 , 16 and 17 are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature or sources of conflicts of interest to the customer before undertaking business on the customer ' s behalf . ### an insurance intermediary or insurance undertaking shall maintain and operate effective organisational and administrative arrangements with a view to taking all reasonable steps designed to prevent conflicts of interest from adversely affecting the interests of its customers . where steps taken by the insurance intermediary or insurance undertaking are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature or sources of conflicts of interest to the customer before undertaking business on the customer ' s behalf .


### when providing advice the insurance intermediary or insurance undertaking shall obtain the necessary information regarding the customer ' s or potential customer ' s knowledge and experience in the field relevant to the specific type of product or service , as well as regarding the customer ' s or potential customer ' s financial situation and his investment objectives , on the basis of which the insurance intermediary or insurance undertaking should recommend the insurance products that are suitable for the customer or potential customer . ### when providing advice the insurance intermediary or insurance undertaking shall obtain the necessary information regarding the customer ' s or potential customer ' s needs , knowledge and experience in the field relevant to the specific type of product or service , as well as regarding the customer ' s or potential customer ' s financial interest and his investment objectives , on the basis of which the insurance intermediary or insurance undertaking should recommend the insurance products that are in the best interest for the customer or potential customer .


### where the insurance intermediary or insurance undertaking considers , on the basis of the information received under the previous subparagraph , that the product or service is not appropriate to the customer or potential customer , the insurance intermediary or insurance undertaking shall warn the customer or potential customer . this warning may be provided in a standardised format . ### where the insurance intermediary or insurance undertaking considers , on the basis of the information asked under the previous subparagraph , that the product or service is not in the best interest of the customer or potential customer , the insurance intermediary or insurance undertaking shall inform the customer or potential customer why . this warning shall be provided in a standardised format .


### in order to take into account the progress of technical knowledge and new scientific evidence , 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 to amend section 2 of part b and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values and to the froude and p / d ratio values , and annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to take into account the progress of technical knowledge and new scientific evidence , 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 to amend section 2 of part b and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values with the effect of reducing the level of protection of the environment , and to the froude and p / d ratio values , and annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### amphibious craft ; ### amphibious craft able to operate on both water and dry land ;


### national provisions concerning navigation the provisions of this directive shall not prevent member states from adopting provisions concerning navigation on certain waters for the purpose of protection of the environment , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to watercraft conforming to this directive . ### national provisions concerning navigation the provisions of this directive shall not prevent member states from adopting provisions concerning navigation on certain waters for the purpose of protection of the environment , including from noise pollution , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to watercraft conforming to this directive .


### watercraft shall be designed to minimise the risks of falling overboard and to facilitate reboarding . ### watercraft shall be designed to minimise the risks of falling overboard and to facilitate reboarding shall be accessible to or deployable by a person in the water unaided .


### gradually reducing the placing on the market of hydrofluorocarbons has been identified as the most effective , cost - efficient way of reducing emissions of those substances in the long term . ### the regulatory approach used for ozone - depleting substances under regulation no 2037 / 2000 and regulation no 1005 / 2009 of the european parliament and of the council of 16 september 2009 on substances that deplete the ozone layer1 , should also be used to regulate hydrofluorocarbons . in addition to bans on the placing on the market of hydrofluorocarbon - based equipment , containment measures and recovery requirements , the gradual reduction of the placing on the market of hydrofluorocarbons has been identified as the most effective , cost - efficient way of reducing emissions of those substances in the long term . ________________ 1 oj l 286 , 31 . 10 . 2009 , p . 1


### operators of equipment that contains fluorinated greenhouse gases shall take precautions to prevent their unintentional release . ### operators of equipment that contains fluorinated greenhouse gases shall take precautionary measures to prevent their unintentional release . without prejudice to the obligation to take precautionary measures to prevent leakages , operators shall ensure that maximum leakage rates are not exceeded .


### the quantities of fluorinated greenhouse gases added and the reasons for adding them ; ### the quantities of fluorinated greenhouse gases added and the reasons for adding them ; in the case of servicing or maintenance of refrigeration equipment pursuant to the third subparagraph of article 11 also indicating whether the substance had been recycled or reclaimed , as well as the name and address of the undertaking having carried out the recycling or reclamation ;


### 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 . ### the records referred to in paragraph 1 shall be registered in a database set up by the competent authorities of the member states . the commission shall provide operational guidance and technical assistance to member states on the establishment and maintenance of the database . member states shall ensure the public has access to relevant information in the database in accordance with directive 2003 / 4 / ec of the european parliament and of the council of 28 january 2003 on public access to environmental information1 . _____________ 1 oj l 41 , 14 . 2 . 2003 , p . 26


### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list of equipment in paragraph 1 to include other types of equipment in view of their increasing relevance due to the commercial or technological development . ### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list of equipment in paragraph 1 to include other types of equipment in view of their increasing relevance due to the commercial or technological development , and to adopt detailed rules regarding the recovery schemes referred to in paragraph 1a .


### the placing on the market of specific products and equipment listed in annex iii shall be prohibited from the date specified in that annex , where applicable differentiating according to the type or global warming potential of the fluorinated greenhouse gas contained . ### the placing on the market and export of specific products and equipment listed in annex iii shall be prohibited from the date specified in that annex , where applicable differentiating according to the type or global warming potential of the fluorinated greenhouse gas contained .


### as of 1 january 2017 , the quantity of greenhouse gases contained in the product or equipment , expressed in weight and in co2 equivalent . ### as of 1 january 2017 , the quantity of greenhouse gases contained in the product or equipment , expressed in weight and in co2 equivalent and the gwp .


### the power to adopt delegated acts referred to in articles 3 , 7 , 8 , 9 , 10 , 13 , 14 , 17 , 18 and 19 and shall be conferred on the commission for an indeterminate period of time from [ dd / mm / yyyy ] [ insert date of entry into force of this regulation ] . ### the power to adopt delegated acts referred to in articles 3 , 7 , 8 , 9 , 10 , 13 , 14 , 17 , 18 and 19 and shall be conferred on the commission for a period of five years from . . . 1 . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . _______________________ 1 please insert the date of entry into force of this regulation .


### 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 sanctions and incentives for enhancing the enforcement of the preventive and corrective parts of the stability and growth pact in the euro area .


### sanctions in the preventive part of the stability and growth pact ### sanctions and incentives in the preventive part of the stability and growth pact