### information on financial support committed and disbursed to developing countries under the unfccc for the year x - 1 , on financial support committed for the year x and on the planned provision of support . the information reported shall include : ### information on financial support committed and disbursed to developing countries , in accordance with the provisions of the unfccc for the year x - 1 , on financial support allocated for the year x and , if available , on planned financial support for subsequent years . the information reported shall include :


### whether the financial resources that the member state has provided to developing countries are new and additional in the context of the unfccc and how this was calculated ; ### what proportion of financial resources that the member state has provided or allocated to developing countries are new and additional to the target of raising official development assistance to 0 , 7 % of gross national income , in accordance with the unfccc , and how this was calculated ;


### information on any financial resources allocated by the member state related to the implementation of the unfccc by type of channel such as bilateral , regional or other multilateral channels ; ### information on any financial resources allocated by the member state related to the implementation of the unfccc by type of financial instrument and channel such as bilateral , regional or other multilateral channels ;


### partial access may be rejected if such rejection is justified by an overriding reason of general interest , such as public health , it would secure the attainment of the objective pursued and it would not go beyond what is strictly necessary . ### partial access may be rejected if such rejection is justified by an overriding reason relating to the public interest , it would secure the attainment of the objective pursued and it would not go beyond what is necessary .


### with a view to grant access to a regulated profession , the home member state shall recognise the remunerated traineeship pursued in another member state and certified by a competent authority of that member state . ### with a view to grant access to a regulated profession , the home member state shall recognise the traineeship pursued in another member state and certified by a competent authority of that member state .


### directive 2005 / 36 / ec already provides for clear obligations for professionals to have the necessary language skills . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients ' safety . language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host member state . ### directive 2005 / 36 / ec already provides for clear obligations for professionals to have the language skills that are necessary for pursuing their profession in the host member state . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients ' safety . language controls for the jobs in question should not constitute grounds for excluding professionals from the labour market in the host member state and should therefore be reasonable and necessary .


### at least four years of full - time study at a university or comparable teaching institution leading to successful completion of a university - level examination and at least two years of remunerated traineeship ; ### at least four years of full - time study at a university or comparable teaching institution leading to successful completion of a university - level examination and at least two years of traineeship ;


### this directive also establishes rules concerning partial access to a regulated profession and access to and recognition of remunerated traineeships pursued in another member state . ### this directive also establishes rules concerning partial access to a regulated profession and access to and recognition of traineeships pursued in another member state .


### graduates wishing to pursue a remunerated traineeship in another member state where such traineeship is possible should be covered by directive 2005 / 36 / ec in order to foster their mobility . it is also necessary to provide for the recognition of their traineeship by the home member state . ### graduates wishing to pursue a traineeship in another member state where such traineeship is possible should be covered by directive 2005 / 36 / ec in order to foster their mobility . it is also necessary to provide for the recognition of their traineeship by the home member state .


### this directive shall apply to all nationals of a member state wishing to pursue a regulated profession or a remunerated traineeship in a member state , including those belonging to the liberal professions , other than that in which they obtained their professional qualifications , on either a self - employed or employed basis . ### this directive shall apply to all nationals of a member state wishing to pursue a regulated profession or a traineeship in a member state , including those belonging to the liberal professions , other than that in which they obtained their professional qualifications , on either a self - employed or employed basis .


### applications for establishment in the host member state shall be examined in accordance with chapters i and iv of title iii in case of establishment in the host member state . ### in case of establishment in the host member state , applications for establishment shall be examined in accordance with chapters i and iv of title iii by the competent authorities of the member state in close cooperation with the national social partners representing the sectoral professions .


### recognition of remunerated traineeship ### recognition of traineeship


### ‘ remunerated traineeship’ : the pursuit of supervised and remunerated activities , with a view to access to a regulated profession granted on the basis of an examination ; ### ‘ traineeship’ : the pursuit of supervised activities , with a view to access to a regulated profession granted on the basis of an examination ;


### where it is aware of any violation of obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xi . compliance with union legislation or with international provisions also includes compliance in an equivalent manner . ### deleted


### at least five tenders have been submitted . ### at least three tenders have been submitted .


### public contracts should not be awarded to economic operators that have participated in a criminal organisation or have been found guilty of corruption , fraud to the detriment of the union’s financial interests or money laundering . non - payment of taxes or social security contributions should also be sanctioned by mandatory exclusion at the level of the union . furthermore , contracting authorities should be given the possibility to exclude candidates or tenderers for violations of environmental or social obligations , including rules on accessibility for disabled persons or other forms of grave professional misconduct , such as violations of competition rules or of intellectual property rights . ### public contracts should not be awarded to economic operators that have participated in a criminal organisation or have been found guilty of corruption , fraud to the detriment of the union’s financial interests or money laundering . non - payment of taxes or social security contributions , as well as violations of environmental or social obligations , including rules on accessibility for disabled persons , should also be sanctioned by mandatory exclusion at the level of the union . furthermore , contracting authorities should be given the possibility to exclude candidates or tenderers for forms of grave professional misconduct , such as violations of competition rules or of intellectual property rights .


### costs may be assessed , on the choice of the contracting authority , on the basis of the price only or using a cost - effectiveness approach , such as a life - cycle costing approach , under the conditions set out in article 67 . ### deleted


### where tenders appear to be abnormally low for other reasons , contracting authorities may also request such explanations . ### in any case , where tenders appear to be abnormally low for other reasons , contracting authorities must also request such explanations .


### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as : ### the most economically advantageous tender from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs , which the contracting authority shall assess , as it prefers , either on the basis of the price alone or by using a cost - effectiveness approach , such as a life - cycle costing approach under the conditions set out in article 67 , other criteria linked to the subject - matter of the public contract in question , such as :


### the card or device is used to pay goods and services ; ### the card or device is used to pay goods and services to a company within professional trade or business ;


### the intermediary payment service provider shall have effective procedures in place in order to detect whether the following information on the payer and the payee is missing : ### the intermediary payment service provider shall have effective procedures in place in order to detect whether the following information on the payer and the payee is missing or incomplete :


### however , by way of derogation from paragraph 3 , in the case of transfers of funds not made from an account , the payment service provider of the payer shall not verify the information referred to in paragraph 1 if the amount does not exceed eur 1 000 and it does not appear to be linked to other transfers of funds which , together with the transfer in question , exceed eur 1 000 . ### however , by way of derogation from paragraph 3 , in the case of transfers of funds not made from an account , the payment service provider of the payer is required to verify at least the name of the payer for transfers of funds of up to eur 1 000 , but shall verify the complete information relating to the payer and the payee referred to in paragraph 1 where the transaction is carried out in several operations that appear to be linked or where they exceed eur 1 000 .


### if the payment service provider of the payee becomes aware , when receiving transfers of funds , that information on the payer and the payee required under articles 4 and , 5 and 6 is missing or incomplete , it shall either reject the transfer or ask for complete information on the payer and the payee . ### if the payment service provider becomes aware , when receiving transfers of funds , that information on the payer and the payee required under articles 4 and , 5 and 6 is missing or incomplete or has not been completed using the characters or inputs admissible within the conventions of the messaging or payment and settlement system , it shall either reject the transfer or suspend it and ask for complete information on the payer and the payee before executing the payment transaction .


### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data19 . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent e with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . the fight against money laundering and terrorist financing is recognised as an important public interest ground by all member states . hence , in the application of this regulation , the transfer of personal data to a third country which does not ensure an adequate level of protection in the meaning of article 25 of directive 95 / 46 / ec should be permitted according to article 26 of the same directive . __________________ 19 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the provisions of this regulation apply without prejudice to national legislation implementing directive 95 / 46 / ec of the european parliament and of the council19 . for example , personal data collected for the purpose of complying with this regulation should not be further processed in a way inconsistent e with directive 95 / 46 / ec . in particular , further processing for commercial purposes should be strictly prohibited . the fight against money laundering and terrorist financing is recognised as an important public interest ground by all member states . hence , in the application of this regulation , the transfer of personal data to a third country which does not ensure an adequate level of protection in the meaning of article 25 of directive 95 / 46 / ec should be permitted according to article 26 of the same directive . it is important that payment service providers operating in multiple jurisdictions with branches or subsidiaries located outside the union are not unreasonably prevented from sharing information on suspicious transactions within the same organisation . this is without prejudice to international agreements concluded between the union and third countries on combating money laundering including appropriate safeguards for citizens ensuring an equivalent or adequate level of protection . __________________ 19 directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data .


### owing to the potential terrorist financing threat posed by anonymous transfers , it is appropriate to require payment service providers to request information on the payer and the payee . in line with the risk based approach developed by fatf , it is appropriate to identify areas of higher and lower risk with a view to better targeting money laundering and terrorist financing risks . accordingly , the payment service provider of the payee and the intermediary service provider should establish effective risk - based procedures for cases where a transfer of funds lacks the required payer and payee information , in order to decide whether to execute , reject or suspend that transfer and what appropriate follow - up action to take . where the payment service provider of the payer is established outside the territory of the union , enhanced customer due diligence should be applied , in accordance with directive [ xxxx / yyyy ] , in respect of cross - border correspondent banking relationships with that payment service provider . ### owing to the potential terrorist financing threat posed by anonymous transfers , it is appropriate to require payment service providers to request information on the payer and the payee . in line with the risk based approach developed by fatf , it is appropriate to identify areas of higher and lower risk with a view to better targeting money laundering and terrorist financing risks . accordingly , the payment service provider of the payee and the intermediary service provider should establish effective risk - based procedures and assess and weigh risks so that resources can be explicitly steered towards high - risk areas of money laundering . such effective risk - based procedures for cases where a transfer of funds lacks the required payer and payee information will help payment service providers to better decide whether to execute , reject or suspend that transfer and what appropriate follow - up action to take . where the payment service provider of the payer is established outside the territory of the union , enhanced customer due diligence should be applied , in accordance with directive [ xxxx / yyyy ] , in respect of cross - border correspondent banking relationships with that payment service provider .


### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector and threaten the internal market . terrorism shakes the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes . ### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector , threaten the internal market and directly or indirectly undermine the confidence of citizens in the rule of law . the funding of terrorism and organised crime remains a significant problem which should be addressed at union level . terrorism and organised crime shake the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes .


### ‘ a person - to - person’ transfer of funds means a transaction between two natural persons . ### ' a person - to - person ' transfer of funds means a transaction between two natural persons , who , as consumers , act for purposes other than their trade , business or profession .


### ‘ payer’ means a natural or legal person who either carries out a transfer of funds from his or her own account or who places an order for a transfer of funds ; ### ' payer ' means a payer as defined in article 4 of directive 2007 / 64 / ec of the european parliament and of the council24a ; _______________ 24a directive 2007 / 64 / ec of the european parliament and of the council of 13 november 2007 on payment services in the internal market amending directives 97 / 7 / ec , 2002 / 65 / ec , 2005 / 60 / ec and 2006 / 48 / ec and repealing directive 97 / 5 / ec .


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


### in order to check whether the required information on the payer and the payee accompanies transfers of funds , and to help to identify suspicious transactions , the payment service provider of the payee and the intermediary payment service provider should have effective procedures in place in order to detect whether information on the payer and the payee is missing . ### in order to check whether the required information on the payer and the payee accompanies transfers of funds , and to help to identify suspicious transactions , the payment service provider of the payee and the intermediary payment service provider should have effective procedures in place in order to detect whether information on the payer and the payee is missing or incomplete . effective checks of the presence and completeness of information , in particular where several payment service providers are involved , can help make investigation procedures less time consuming and more effective , which , in turn , improves the traceability of transfers of funds . competent authorities in the member states should thus ensure that payment service providers include the required transaction information with the wire transfer or related message throughout the payment chain .


### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or it device is used in order to effect a person - to - person transfer of funds . ### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or prepaid or postpaid it device is used in order to effect a person - to - person transfer of funds .


### ‘ payment service provider’ means a natural or legal person who provides the service of transferring funds in his or her professional capacity ; ### ' payment service provider ' means a payment service provider as defined in article 4 of directive 2007 / 64 / ec ;


### the payment service providers shall establish appropriate procedures for their employees to report breaches internally through a specific channel . ### the payment service providers shall establish appropriate procedures for their employees to report breaches internally through a specific , independent and anonymous channel .


### ‘ payee’ means a natural or legal person who is the intended recipient of transferred funds ; ### ' payee ' means a payee as defined in article 4 of directive 2007 / 64 / ec ;


### the payment service provider of the payee shall consider missing or incomplete information on the payer and the payee as a factor in assessing whether the transfer of funds , or any related transaction , is suspicious , and whether it must be reported to the financial intelligence unit . ### the payment service provider of the payee shall consider missing or incomplete information on the payer and the payee as one of the factors in assessing whether the transfer of funds , or any related transaction , is suspicious , and whether it must be reported to the financial intelligence unit . the payment service provider shall , in its effective risk - based procedures , also focus on , and take appropriate measures regarding , other risk factors as identified in the article 16 and in annex iii to directive [ xxxx / yyyy ] .


### the intermediary payment service provider shall establish effective risk - based procedures for determining when to execute , reject or suspend a transfer of funds lacking the required payer and payee information and the appropriate follow up action . ### the intermediary payment service provider shall establish effective risk - based procedures for determining whether the received information on the payer and the payee is missing or incomplete and shall put in place an appropriate follow up action .


### since in criminal investigations it may not be possible to identify the data required or the individuals involved until many months , or even years , after the original transfer of funds and in order to be able to have access to essential evidence in the context of investigations , it is appropriate to require payment service providers to keep records of information on the payer and the payee for the purposes of preventing , investigating and detecting money laundering or terrorist financing . this period should be limited . ### since in criminal investigations it may not be possible to identify the data required or the individuals involved until many months , or even years , after the original transfer of funds and in order to be able to have access to essential evidence in the context of investigations , it is appropriate to require payment service providers to keep records of information on the payer and the payee for the purposes of preventing , investigating and detecting money laundering or terrorist financing . this period should be limited to five years , after which all personal data should be deleted , unless otherwise provided for by national law . further retention should be granted only if necessary for the prevention , detection or investigation of money laundering and terrorist financing and should not exceed ten years . payment service providers should ensure that data retained under this regulation is used only for the purposes described herein .


### repeated non - inclusion of required information on the payer and payee , in breach of articles 4 , 5 and 6 ; ### repeated non - inclusion of required information on the payer and payee by a payment service provider , in breach of articles 4 , 5 and 6 ;


### administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 shall be published without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets . ### the competent authorities shall publish administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 without undue delay including information on the type and nature of the breach and the identity of persons responsible for it .


### payment service providers shall respond fully and without delay , in accordance with the procedural requirements established in the national law of the member state in which they are established , to enquiries from the authorities responsible for combating money laundering or terrorist financing of that member state concerning the information required under this regulation . ### payment service providers shall respond fully and without delay , in accordance with the procedural requirements established in the national law of the member state in which they are established , to enquiries exclusively from the authorities responsible for combating money laundering or terrorist financing of that member state concerning the information required under this regulation . specific safeguards shall be put in place in order to ensure that such exchanges of information respect data protection requirements .


### in order not to impair the efficiency of payment systems , the verification requirements for transfers of funds made from an account should be separate from those for transfers of funds not made from an account . in order to balance the risk of driving transactions underground by imposing overly strict identification requirements against the potential terrorist threat posed by small transfers of funds , the obligation to check whether the information on the payer is accurate should , in the case of transfers of funds not made from an account , be imposed only in respect of individual transfers of funds that exceed eur 1 000 , . for transfers of funds made from an account , payment service providers should not be required to verify information on the payer accompanying each transfer of funds , where the obligations under directive [ xxxx / yyyy ] have been met . ### payment service providers should ensure that the information on the payer and the payee is not missing or incomplete . in order not to impair the efficiency of payment systems , the verification requirements for transfers of funds made from an account should be separate from those for transfers of funds not made from an account . in order to balance the risk of driving transactions underground by imposing overly strict identification requirements against the potential terrorist threat posed by small transfers of funds , the obligation to check whether the information on the payer is accurate should , in the case of transfers of funds not made from an account , be restricted only to the name of the payer for individual transfers of funds of up to eur 1 000 . for transfers of funds made from an account , payment service providers should not be required to verify information on the payer accompanying each transfer of funds , where the obligations under directive [ xxxx / yyyy ] have been met .


### diversity of competences and views of the members of administrative , management and supervisory bodies of companies facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards . ### diversity of competences and views of the members of administrative , management and supervisory bodies of undertakings facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the undertaking . it would therefore be important to enhance transparency regarding the diversity policy undertakings have in place . this would inform the market of corporate governance practices and thus put indirect pressure on undertakings to have more diversified boards .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to gender and other aspects such as age , geographical diversity , disability , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social , gender and employment matters , including at least social dialogue , compliance with collective agreements and respect of trade unions ' rights , and respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , significant incidents occurred during the reporting period and the risks related to those matters .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , undertakings should be required to include in their management report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . the non - financial statement should also include , where appropriate , a reference to the due diligence processes implemented by the undertaking in order to identify , prevent and mitigate existing and potential adverse impacts as appropriate to the their size and the nature and context of operations .


### 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 this information , undertakings should rely , as a general rule , on 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 and the ilo tripartite declaration of principles concerning multinational enterprises and social policy . undertakings may also rely on national frameworks , union - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the international organisation for standardisation 26000 , the global reporting initiative , the carbon disclosure project and the climate disclosure standards board .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , undertakings should be required to include in their management report and annual reports as required , a non - financial statement containing information relating to at least environmental matters , gender equality , social and employment - related matters , respect for human rights , anti - corruption and bribery matters . such statement should refer to the company ' s supply chains , subcontractors and business relationships . the statement should include a description of the policies and results as well as an assessment of all current and potential the risks related to those matters , taking into account the companies ' complete supply chain .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency , transparency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report , without prejudice to audit requirements determined by member states , a non - financial statement containing information relating to at least environmental matters , gender balance , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters and the precise purpose of social investments .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . those companies should be encouraged to consult the diversity charters of the eu .


### 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 non - financial - information undertakings should rely on the guidelines adopted by means of delegated acts by the european commission . before these guidelines are available , undertakings should rely as minimum on 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 undertakings may additionally rely also on national , eu - based or international frameworks and , if so , should specify which frameworks they have relied upon .


### 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 , balance sheet total and net turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the management report should only apply to large undertakings and parent undertakings of large groups , following the categorisation set out in article 3 of directive 2013 / 34 / eu .


### 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 , balance sheet total and net turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the management report should only apply to those large undertakings and groups , whose average number of employees exceeds 500 .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , integration of persons with a disability , educational and professional background should only apply to large listed undertakings . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 20 of directive 2013 / 34 / eu . undertakings not having such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case .


### diversity of competences and views of the members of administrative , management and supervisory bodies of companies facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards . ### diversity of competences and views of the members of administrative , management and supervisory bodies of undertakings , including gender diversity , facilitates a good understanding of the business organisation and affairs . it has been acknowledged that gender diversity , especially in top positions , contributes to corporate governance , quality of decision - making and to the company ' s performance . moreover , board diversity represents a benefit for the companies as board composition reflects demographic characteristics of key stakeholder groups such as employee , customer and investor . furthermore , it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the undertakings . it would therefore be important to enhance transparency regarding the diversity policy undertakings have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards .


### in order to alleviate those problems and to speed up the implementation of the operational programmes and projects , as well as to strengthen the economic recovery , it is appropriate that the managing authorities of the member states having experienced serious difficulties with respect to financial stability and which have been granted financial assistance according to one of the financial assistance mechanisms set out above may contribute financial resources from operational programmes to the establishment of risk sharing instruments providing loans or guarantees or other financial facilities , in support of projects and operations foreseen under an operational programme . ### in order to alleviate those problems and to speed up the implementation of the operational programmes and projects , as well as to strengthen the economic recovery , it is appropriate that the managing authorities of the member states having experienced serious difficulties with respect to financial stability and which have been granted financial assistance according to one of the financial assistance mechanisms set out above may contribute financial resources from operational programmes to the establishment of risk sharing instruments providing loans or guarantees or other financial facilities , in support of projects and operations foreseen under an operational programme . in addition , infrastructure and productive investment relevant to the economic recovery and job creation in the member states concerned and compliance with the objectives of the europe 2020 strategy can also be supported .


### the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at eur 3 . 182 , 230 million the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope . ### within the meaning of point [ 17 ] of the interinstitutional agreement of . . . / . . . . between the european parliament , the council and the commission on cooperation in budgetary matters and on sound financial management , the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at a maximum of eur 3 . 182 , 230 million . this amount shall constitute the prime reference for the budgetary authority during the annual budgetary procedure . the annual appropriations shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and to the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management . the eit financial contribution to the kics shall be provided under this financial envelope .


### the power to adopt delegated acts referred to in article 10 shall be conferred on the commission for an indeterminate period of time from the date of adoption of this regulation . ### the power to adopt delegated acts referred to in article 10 shall be conferred on the commission for a period of five years from the date of entry into force . the commission shall draw up a report on the delegation of power no 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 .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative , the decision shall contain a statement of reasons based on objective and verifiable criteria , including any evaluation , expert opinion or recommendation on which it is based . the decision shall be communicated to the holder of the marketing authorisation , who shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies . ### if the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative , the decision shall contain a statement of reasons based on objective and verifiable criteria . the decision shall be communicated to the holder of the marketing authorisation , who shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a reasoned and objectively justified decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted or , where appropriate , of the formal receipt of the marketing authorisation , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states . ### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic or biosimilar medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information .


### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january and 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : ### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information :


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . with respect to generic medicinal products , that time limit shall be 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt or , where appropriate , of the formal receipt of the marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 30 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 . ### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 60 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 .


### any decision to exclude a medicinal product from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the product concerned , shall contain a statement of reasons based on objective and verifiable criteria . such decisions shall include any evaluation , expert opinion or recommendation on which they are based . the applicant shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies . ### any decision to exclude a medicinal product from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the product concerned , shall contain a statement of reasons based on objective and verifiable criteria . such decisions shall include assessments of unmet medical needs , the clinical impact and social costs , the protection of the most vulnerable groups of the population and any evaluation , expert opinion or recommendation on which they are based . the applicant shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies .


### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall guarantee that the marketing authorisation holder has the possibility to introduce an application to increase the price of a medicinal product . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . these reasons must be drawn from a pre - defined list determined and published in an appropriate publication by the member state . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 60 days of its receipt . ### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 90 days of its receipt .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products and the similarity of biosimilar products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy , bioequivalence or biosimilarity of the medicinal product . the marketing authorisation of an orphan medicinal product is also based on the evaluation of several criteria , including the significant benefit of the product over any available existing alternatives in the union , in accordance with regulation no 141 / 2000 , which should not be re - assessed in the framework of pricing and reimbursement procedures .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products , are ascertained in the framework of marketing authorisation procedures , and member states should have full access to the data used in the marketing authorisation procedure so that they can assess the relative safety and efficacy of a medicinal product in the context of pricing and reimbursement procedures .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### having regard to the treaty on the functioning of the european union , and in particular article 114 thereof , ### having regard to the treaty on the functioning of the european union , and in particular articles 114 and 168 thereof ,


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states should not be seeking to re - assess the essential elements on which the marketing authorisation is based . however , member states must be guaranteed full access to the data used by the authorities responsible for granting the marketing authorisation so that they can assess the relative safety , efficacy and efficiency of a medicinal product in the context of its inclusion in the scope of the mandatory health insurance system . the competent authorities should also be able to include or generate additional relevant data for the purposes of assessing medicinal products .


### any decision to exclude a category of medicinal products from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the category concerned , shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication . ### any decision to exclude a category of medicinal products from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the category concerned , shall contain a statement of reasons based on objective and verifiable criteria .


### the decisions referred to in this paragraph shall also include any evaluation , expert opinion or recommendation on which they are based . the applicant shall be informed of all remedies available , including judicial remedies , and the remedies procedure set out article 8 , of the time limits for applying for such remedies . ### the decisions referred to in this paragraph shall also include any evaluation , expert opinion or recommendation on which they are based . the applicant shall be informed of all remedies available , including judicial remedies , of the time limits for applying for such remedies .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### with due regard for the general principles of the protection of the health and safety of workers , member states may authorise or register collective agreements permitting exceptions to the required hours of rest in paragraph 4 and 5 provided that the rest period is no less than 70 hours in any 7 - day period . such exceptions shall , in accordance with directive 1999 / 63 / ec , as far as possible , follow the standards set out but may take account of more frequent or longer leave periods , or the granting of compensatory leave and should equally , as far as possible , take into account the guidance regarding prevention of fatigue laid down in section b - viii / 1 of the stcw code . ### exceptions to the required hours of rest provided for in paragraphs 4 and 5 for seafarers who are assigned duty as officer in charge of a watch or as rating forming part of a watch or those whose duties involve designated safety , prevention of pollution and security duties may be allowed in accordance with directive 1999 / 63 / ec . with due regard for the general principles of the protection of the health and safety of workers , member states may have national laws , regulations or a procedure for the competent authority to authorise or register collective agreements permitting exceptions to the required hours of rest . such exceptions shall , as far as possible , follow the standards set out but may take account of more frequent or longer leave periods , or the granting of compensatory leave for watchkeeping seafarers or seafarers working on board ship on short voyages . however , for the purpose of preventing the danger posed by fatigue , exceptions to the minimum hours of rest provided for in paragraph 4 shall not be allowed and exceptions to the required hours of rest in paragraphs 4 and 5 shall respect the limits set in paragraphs 12 and 13 . such exceptions should equally take into account the guidance regarding prevention of fatigue laid down in section b - viii / 1 of the stcw code .


### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of gmos on their territory . in addition one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes . ### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonise the conditions of cultivation in member states but to grant freedom to member states to restrict or ban cultivation of gmos on their territory because of health and environmental risks or other legitimate factors , such as , for example , on socio - economic grounds . in addition one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes .


### in this context , it appears appropriate to grant to member states , in accordance with the principle of subsidiarity , more freedom to decide whether or not they wish to cultivate gmo crops on their territory without changing the system of union authorisations of gmos and independently of the measures that member states are entitled to take by application of article 26a of directive 2001 / 18 / ec to avoid the unintended presence of gmos in other products . ### in this context , it appears appropriate to grant to member states , in accordance with the principle of subsidiarity , more flexibility to decide whether or not they wish to cultivate gmo crops on their territory without changing the system of union authorisations of gmos and in parallel with the measures that member states must take by application of article 26a of directive 2001 / 18 / ec , as amended by this regulation , to avoid the unintended presence of gmos in other products .


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 ; the requirements and conditions for the granting of the registration referred to in paragraph 6 . the requirements and conditions for listing operators and users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . ### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 , and the categories of data , including of personal data , to be provided ; the requirements and conditions for the granting of the registration referred to in paragraph 6 and the categories of data , including of personal data , to be provided ; and the requirements and conditions for listing operators and users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . the categories of personal data referred to in points and of the first subparagraph shall not include sensitive data within the meaning of article 8 of directive 95 / 46 / ec .


### regulation no 273 / 2004 envisages the processing of data . such processing of data may also cover personal data which should be carried out in accordance with union law . ### regulation no 273 / 2004 envisages the processing of information , including the processing of personal data , for the purposes of enabling the competent authorities to monitor the placing on the market of drug precursors and preventing the diversion of scheduled substances . the processing of personal data should be carried out in accordance with union law on data protection and , in particular , with requirements relating to data quality , proportionality , purpose limitation , and with rights to information , access , rectification of data , erasure and blocking , organisational and technical measures and international transfers of personal data . data should be adequate , accurate , relevant and not excessive in relation to the purpose for which it is collected . it should not be processed for longer than necessary in relation to the purpose for which it is collected and its accuracy should be regularly reviewed . processing of data should be carried out under the supervision of the member states ' competent authorities , in particular the public independent authorities designated by the member states , as regards processing of personal data carried out in the member states . it should also be carried out under the supervision of the european data protection supervisor , as regards the processing of personal data carried out by the commission within the framework of this regulation . in order to enable law enforcement authorities to detect , prevent , investigate or prosecute drug trafficking criminal offences , member states may be allowed to adopt legislative measures to grant their competent authorities access to personal data processed pursuant to this regulation for the above mentioned purposes and in so far it is necessary , proportionate and subject to adequate safeguards . since this processing constitutes a restriction to the fundamental right to the protection of personal data , it should be interpreted restrictively and in compliance with the requirements set out by the charter of fundamental rights of the european union and by the european convention of human rights . this processing should only take place on a case - by - case basis and provided that the competent law enforcement authorities have reasonable grounds to believe that this processing will substantially assist them in preventing , detecting , or investigating drug trafficking criminal offences .


### the processing of personal data by the commission , including for the purpose of the european database provided for in article 13a , shall be carried out in accordance with regulation no 45 / 2001 of the european parliament and of the council and under the supervision of the european data protection supervisor . ### the processing of personal data by the commission , including for the purpose of the european database provided for in article 13a , shall be carried out in accordance with regulation no 45 / 2001 of the european parliament and of the council and under the supervision of the european data protection supervisor . the european data protection supervisor shall ensure that the rights of data subjects relating to the processing in the european database are protected in accordance with regulation no 45 / 2001 .


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 ; the requirements and conditions for the granting of the registration referred to in paragraph 6 the requirements and conditions for listing operators an users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . ### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 , and the categories of data , including of personal data , to be provided ; the requirements and conditions for the granting of the registration referred to in paragraph 6 and the categories of data , including of personal data , to be provided ; and the requirements and conditions for listing operators an users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . the categories of personal data referred to in points and of the first subparagraph shall not include sensitive data within the meaning of article 8 of directive 95 / 46 / ec .


### the commission shall develop a european database on drug precursors with the following functions : ### following the adoption of the delegated acts referred to in article 3 , the commission shall establish a european database on drug precursors with the following functions :


### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration their toxicity or addictiveness . ### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration scientific development and internationally agreed standards to assess their toxicity or addictiveness .


### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity . filters and capsules shall not contain tobacco . ### member states shall prohibit the use of characterising flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity . filters and capsules shall not contain tobacco .


### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . ### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . it is of particular importance that the commission carry out appropriate consultation 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 the council .


### it is important to ensure that consumers can have confidence in the integrity of electricity and gas markets and that prices set on wholesale energy markets reflect a fair interplay between supply and demand . ### it is important that prices set on wholesale energy markets reflect a fair interplay between supply and demand to ensure that consumers pay a fair price for electricity and gas in the entire european economic area .


### energy markets are increasingly interlinked across the union . market abuse in one member state affects wholesale prices for electricity and gas across national borders . therefore the concern to ensure the integrity of markets cannot be a matter only for individual member states . ### energy markets are increasingly interlinked across the union . market abuse in one member state affects not only wholesale prices for electricity and gas across national borders but also retail prices to consumers and micro - enterprises . therefore the concern to ensure the integrity of markets cannot be a matter only for individual member states .


### it is important to ensure that consumers can have confidence in the integrity of electricity and gas markets and that prices set on wholesale energy markets reflect a fair interplay between supply and demand . ### it is important that prices set on wholesale energy markets reflect a fair interplay between supply and demand to ensure that consumers pay a fair price for electricity and gas in the entire european economic area , which in long term would increase consumer confidence in the electricity and gas markets and would ensure affordable , accessible and available energy for all citizens .


### a qualified electronic signature shall have the equivalent legal effect of a handwritten signature . ### an electronic signature shall have the equivalent legal effect of a handwritten signature .


### the commission may , by means of implementing acts , define circumstances , formats and procedures applicable for the purpose of paragraph 1 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define formats and procedures applicable for the purpose of paragraph 1 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the power to adopt delegated acts referred to in articles 8 , 13 , 15 , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . ### the power to adopt delegated acts referred to in articles 8 , 15 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for a period of five years beginning on date of the entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power not later than six 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 .


### 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 , where it determines that disclosure of the breach is in the public interest .


### the electronic identification means are issued by , on behalf of or under the responsibility of the notifying member state ; ### the electronic identification means are either issued by the member state , or issued by another entity as mandated by the member state or issued independently but recognised by the notifying member state ;


### ‘ qualified trust service’ means a trust service that meets the applicable requirements provided for in this regulation ; ### ‘ qualified trust service’ means a trust service that meets the applicable requirements laid down in this regulation ;


### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers . ### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu and consistently with the commission proposal for a directive of the european parliament and the council on the accessibility of public sector bodies ' websites , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers .


### the commission shall report to the european parliament and to the council on the application of this regulation . the first report shall be submitted no later than four years after the entry into force of this regulation . subsequent reports shall be submitted every four years thereafter . ### the commission shall report to the european parliament and to the council on the application of this regulation , in particular with a view to reaching the aim of the regulation to develop the digital single market by strengthening confidence and trust in secure cross - border electronic transactions . the report shall take account of , amongst others , market developments as well as legal and technological developments . it shall further be accompanied by appropriate legislative proposals if necessary . the first report shall be submitted no later than two years after the entry into force of this regulation . subsequent reports shall be submitted every four years thereafter .


### the notifying member state ensures the availability of an authentication possibility online , at any time and free of charge so that any relying party can validate the person identification data received in electronic form . member states shall not impose any specific technical requirements on relying parties established outside of their territory intending to carry out such authentication . when either the notified identification scheme or authentication possibility is breached or partly compromised , member states shall suspend or revoke without delay the notified identification scheme or authentication possibility or the compromised parts concerned and inform the other member states and the commission pursuant to article 7 ; ### the notifying member state ensures the availability of an authentication possibility online , at any time so that any relying party can validate the person identification data received in electronic form . member states shall impose such specific technical requirements only on relying parties established outside of their territory intending to carry out such authentication , which have been agreed in accordance with the procedures laid out in article 8 . when either the notified identification scheme or authentication possibility is breached or partly compromised , member states shall suspend or revoke without delay the notified identification scheme or authentication possibility or the compromised parts concerned and inform the other member states and the commission pursuant to article 7 ;


### it is signed using an advanced electronic signature or an advanced electronic seal of the qualified trust service provider , or by some equivalent method . ### it is signed using an advanced electronic signature or an advanced electronic seal of the qualified trust service provider .