### the competent authorities shall consult and cooperate , whenever appropriate , with the relevant law enforcement national authorities and data protection authorities . ### the competent authorities shall consult with the data protection authorities as a matter of course and cooperate , whenever appropriate , with the relevant national law enforcement authorities .


### the cert shall act under the supervision of the competent authority , which shall regularly review the adequacy of its resources , its mandate and the effectiveness of its incident - handling process . ### the certs shall act under the supervision of the competent authority or the single point of contact , which shall regularly review the adequacy of their resources , mandates and the effectiveness of their incident - handling process .


### the competent authorities and the commission shall form a network to cooperate against risks and incidents affecting network and information systems . ### the single points of contact and the commission , together with enisa if it so requests , shall form a network to cooperate in the development of detection , analysis and response procedures in dealing with security issues and risks or incidents affecting network and information systems .


### jointly discuss and assess , at the request of one member state or of the commission , one or more national nis strategies and national nis cooperation plans referred to in article 5 , within the scope of this directive . ### jointly discuss and assess one or more national nis strategies and national nis cooperation plans referred to in article 5 , within the scope of this directive .


### jointly discuss and assess , at the request of a member state or the commission , the effectiveness of the certs , in particular when nis exercises are performed at union level ; ### jointly discuss and assess the effectiveness of the certs , in particular when nis exercises are performed at union level ;


### cooperate and exchange information on all relevant matters with the european cybercrime centre within europol , and with other relevant european bodies in particular in the fields of data protection , energy , transport , banking , stock exchanges and health ; ### cooperate and exchange expertise on relevant matters on network and information security , in particular in the fields of data protection , energy , transport , banking , financial markets and health with the european cybercrime centre within europol , and with other relevant european bodies ;


### within the cooperation network the competent authorities shall : ### within the cooperation network the single points of contact shall :


### the commission shall establish , by means of implementing acts , the necessary modalities to facilitate the cooperation between competent authorities and the commission referred to in paragraphs 2 and 3 . those implementing acts shall be adopted in accordance with the consultation procedure referred to in article 19 . ### the commission shall establish , by means of implementing acts , the necessary modalities to facilitate the cooperation between single points of contact and the commission referred to in paragraphs 2 and 3 . those implementing acts shall be adopted in accordance with the consultation procedure referred to in article 19 .


### the competent authorities or the commission shall provide early warnings within the cooperation network on those risks and incidents that fulfil at least one of the following conditions : ### the points of single contact , the commission or enisa shall provide early warnings within the cooperation network on those risks and incidents that fulfil at least one of the following conditions :


### they exceed or may exceed national response capacity ; ### the single point of contact assesses that the risk or incident potentially exceeds national response capacity ;


### they affect or may affect more than one member state . ### the single points of contact or the commission assess that the risk or incident affects more than one member state .


### in the early warnings , the competent authorities and the commission shall communicate any relevant information in their possession that may be useful for assessing the risk or incident . ### in the early warnings , the single points of contact and the commission shall communicate any relevant information in their possession that may be useful for assessing the risk or incident .


### where the risk or incident subject to an early warning is of a suspected criminal nature , the competent authorities or the commission shall inform the european cybercrime centre within europol . ### where the risk or incident subject to an early warning is of a suspected serious criminal nature and where the concerned market operator has reported incidents of a suspected serious criminal nature as referred to in article 15 , the member states shall ensure that the european cybercrime centre within europol is informed , where appropriate .


### following an early warning referred to in article 10 the competent authorities shall , after assessing the relevant information , agree on a coordinated response in accordance with the union nis cooperation plan referred to in article 12 . ### following an early warning referred to in article 10 the single points of contact shall , after assessing the relevant information , agree without undue delay on a coordinated response in accordance with the union nis cooperation plan referred to in article 12 .


### the union nis cooperation plan shall be adopted no later than one year following the entry into force of this directive and shall be revised regularly . ### the union nis cooperation plan shall be adopted no later than one year following the entry into force of this directive and shall be revised regularly . results of each revision shall be reported to the european parliament .


### without prejudice to the possibility for the cooperation network to have informal international cooperation , the union may conclude international agreements with third countries or international organisations allowing and organizing their participation in some activities of the cooperation network . such agreement shall take into account the need to ensure adequate protection of the personal data circulating on the cooperation network . ### without prejudice to the possibility for the cooperation network to have informal international cooperation , the union may conclude international agreements with third countries or international organisations allowing and organizing their participation in some activities of the cooperation network . these agreements shall set out the monitoring procedure that must be followed to guarantee the protection of personal data circulating on the cooperation network . the european parliament shall be informed on the negotiation of the agreements , the transparency of which shall be guaranteed . any transfer of personal data to recipients located in countries outside the union shall be conducted in accordance with articles 25 and 26 of directive 95 / 46 / ec and article 9 of regulation no 45 / 2001 .


### member states shall ensure that public administrations and market operators take appropriate technical and organisational measures to manage the risks posed to the security of the networks and information systems which they control and use in their operations . having regard to the state of the art , these measures shall guarantee a level of security appropriate to the risk presented . in particular , measures shall be taken to prevent and minimise the impact of incidents affecting their network and information system on the core services they provide and thus ensure the continuity of the services underpinned by those networks and information systems . ### member states shall ensure that market operators listed in annex ii take appropriate and proportionate technical and organisational measures to manage the risks posed to the security of the networks and information systems which they control and use in their operations . having regard to the state of the art , those measures shall guarantee a level of security appropriate to the risk presented . in particular , measures shall be taken to prevent and minimise the impact of incidents affecting their network and information system on the core services they provide and thus ensure the continuity of the services underpinned by those networks and information systems .


### member states shall ensure that public administrations and market operators notify to the competent authority incidents having a significant impact on the security of the core services they provide . ### member states shall ensure that market operators notify to the competent authority or to the single point of contact incidents having a significant impact on the continuity of the core services they provide . to determine the significance of the impact of an incident , the following parameters shall inter alia be taken into account :


### member states shall ensure that the competent authorities have all the powers necessary to investigate cases of non - compliance of public administrations or market operators with their obligations under article 14 and the effects thereof on the security of networks and information systems . ### member states shall ensure that the competent authorities and the single points of contact have the powers necessary to examine cases of non - compliance of market operators with their obligations under article 14 and the effects thereof on the security of networks and information systems .


### member states shall ensure that the competent authorities have the power to require market operators and public administrations to : ### member states shall ensure that the competent authorities and the single points of contact have the power to require market operators to :


### undergo a security audit carried out by a qualified independent body or national authority and make the results thereof available to the competent authority . ### provide evidence of effective implementation of security policies , such as the results of a security audit carried out by a qualified independent body or national authority , and make the evidence available to the competent authority or to the single point of contact .


### undergo a security audit carried out by a qualified independent body or national authority and make the results thereof available to the competent authority . ### provide evidence of effective implementation of security policies , such as results of a security audit carried out by internal auditors , a qualified independent body or national authority , and make the evidence available to the competent authority or to the single point of contact . where necessary , the competent authority or the single point of contact may require additional evidence or carry out an additional audit .


### member states shall ensure that competent authorities have the power to issue binding instructions to market operators and public administrations . ### member states shall ensure that the competent authorities and the single points of contact have the power to issue binding instructions to market operators .


### the competent authorities shall notify incidents of a suspected serious criminal nature to law enforcement authorities . ### the competent authorities and the single point of contact shall inform the market operators concerned about the possibility of reporting incidents of a suspected serious criminal nature to the law enforcement authorities .


### the competent authorities shall work in close cooperation with personal data protection authorities when addressing incidents resulting in personal data breaches . ### the competent authorities and single points of contact shall work in close cooperation with personal data protection authorities when addressing incidents resulting in personal data breaches . the single points of contact and personal data protection authorities shall cooperate through enisa to develop information exchange mechanisms and a single model for notifications under article 14 of this directive and under regulation of the european parliament and of the council on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data .


### the competent authorities shall work in close cooperation with personal data protection authorities when addressing incidents resulting in personal data breaches . ### the competent authorities and the single points of contact shall work in close cooperation with personal data protection authorities when addressing incidents resulting in personal data breaches . the single points of contact and the data protection authorities shall develop , in cooperation with enisa , information exchange mechanisms and a single template to be used both for notifications under article 14 of this directive and regulation [ xxx ] of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data .


### member states shall ensure that any obligations imposed on public administrations and market operators under this chapter may be subject to judicial review . ### member states shall ensure that any obligations imposed on market operators under this chapter may be subject to judicial review .


### the delegation of powers referred to in articles 9 , 10 and 14 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the powers specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated act already in force . ### the delegation of power referred to in article 9 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the powers specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated act already in force .


### a delegated act adopted pursuant to articles 9 , 10 and 14 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to article 9 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### requirements and tasks of the computer emergency response team ### requirements and tasks of the computer emergency response teams


### the cert shall ensure high availability of its communications services by avoiding single points of failure and have several means for being contacted and for contacting others . furthermore , the communication channels shall be clearly specified and well known to the constituency and cooperative partners . ### the certs shall ensure high availability of its communications services by avoiding single points of failure and have several means for being contacted and for contacting others at all times . furthermore , the communication channels shall be clearly specified and well known to the constituency and cooperative partners .


### the offices of the cert and the supporting information systems shall be located in secure sites . ### the offices of the certs and the supporting information systems shall be located in secure sites with secured network information systems .


### – monitoring incidents at a national level , ### – detection and monitoring incidents at a national level ,


### financial market infrastructures : stock exchanges and central counterparty clearing houses ### financial market infrastructures : regulated markets , multilateral trading facilities , organised trading facilities and central counterparty clearing houses


### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . therefore , in order to regulate the processing of employees ‘ personal data in the employment context , member states should be able , within the limits of this regulation , to adopt by law specific rules for the processing of personal data in the employment sector . ### in order to regulate the processing of employees ' personal data in the employment context . member states should be able to adopt by legal provisions specific rules for the processing of personal data in the employment sector . the processing of personal data in the employment context should qualify for exemption from the requirements of this regulation . therefore , when adopting by legal provisions specific rules for the processing of personal data in employment context . member states may adopt legal provisions which should lay down exemptions and derogations . it should be also possible for the member states to provide for that the matters referred to in article 82 can be defined also by collective agreements negotiated and concluded at national level by social partners .


### in the case referred to in point of paragraph 1 , a group of undertakings may appoint a single data protection officer . ### a group of organizations referred to in point and of paragraph 1 may appoint a single data protection officer .


### the proportion of women on company boards is progressing very slowly , with an average annual increase of just 0 . 6 percentage points during the past years . the rate of improvement has differed in individual member states and has led to highly divergent results . much more significant progress was noted in the member states where binding measures have been introduced . growing discrepancies between member states are likely to increase given the very different approaches pursued by individual member states to increase the representation of females on boards that are being pursued by individual member states . ### the proportion of women on company boards is progressing very slowly , with an average annual increase of just 0 . 6 percentage points during the past years . the rate of improvement has differed in individual member states and has led to highly divergent results . much more significant progress was noted in the member states where binding measures have been introduced . growing discrepancies between member states are likely to increase given the very different approaches pursued by individual member states to increase the representation of females on boards that are being pursued by individual member states . member states should therefore exchange information and good practices designed to achieve better results through the adoption of measures to promote gender equality .


### the current lack of transparency of the selection procedures and qualification criteria for board positions in most member states represents a significant barrier to more gender diversity among board members and negatively affects both the board candidates ' careers and freedom of movement , as well as investor decisions . such lack of transparency prevents potential candidates for board positions from applying to boards where their qualifications would be most required and from challenging gender - biased appointment decisions , thus restricting their freedom of movement within the internal market . on the other hand , investors have different investment strategies that require information linked also to the expertise and competence of the board members . more transparency in the qualification criteria and the selection procedure for board members enables investors to better assess the company ' s business strategy and to take informed decisions . ### the current lack of transparency of the selection procedures and qualification criteria for board positions in most member states represents a significant barrier to more gender diversity among board members and negatively affects both the board candidates ' careers and freedom of movement , as well as investor decisions . such lack of transparency prevents potential candidates for board positions from applying to boards where their qualifications would be most required and from challenging gender - biased appointment decisions , thus restricting their freedom of movement within the internal market . on the other hand , investors have different investment strategies that require information linked also to the expertise and competence of the board members . more transparency in the qualification criteria and the selection procedure for board members enables investors to better assess the company ' s business strategy and to take informed decisions . it is therefore important for board appointment procedures to be clear and transparent and for applicants to be assessed objectively on their individual merits , irrespective of gender .


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . however , owing to the diversity of the company law system in the member states , member states may decide not to apply the procedural rules of article 4 in cases where the shareholders meeting has proposed candidates for board election during the shareholders meeting where the election is carried out . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders .


### this directive aims to improve the gender balance among directors of companies listed on stock exchanges and thus to contribute to the realisation of the principle of equal treatment between men and women , recognised as a fundamental right of the union . listed companies should therefore be required to disclose , upon the request of an unsuccessful candidate , not only the qualification criteria upon which the selection was based , but also the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate who is not of the under - represented sex . these limitations to the right to respect for private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter , and the obligation for listed companies to supply that information , upon request , to the unsuccessful candidate , are necessary and , in conformity with the principle of proportionality , genuinely meet recognised objectives of general interest . they are therefore in line with the requirements for such limitations laid down in article 52 of the charter and with the relevant case - law of the court of justice . ### this directive aims to improve the gender balance among directors of companies listed on stock exchanges and thus to contribute to the realisation of the principle of equal treatment between men and women , recognised as a fundamental right of the union . listed companies should therefore be required to disclose , where possible , upon the request of an unsuccessful candidate , not only the qualification criteria upon which the selection was based , but also the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate who is not of the under - represented sex . this disclosure obligation does not apply where such disclosure would endanger trade secrets or would be impossible because the elected board member was proposed by the shareholders . these limitations to the right to respect for private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter , and the obligation for listed companies to supply that information , upon request , to the unsuccessful candidate , are necessary and , in conformity with the principle of proportionality , genuinely meet recognised objectives of general interest . they are therefore in line with the requirements for such limitations laid down in article 52 of the charter and with the relevant case - law of the court of justice .


### member states may have already taken measures providing for means to ensure a more balanced representation of women and men in company boards before the entry into force of this directive . such member states should have an opportunity to apply those measures in place of the procedural requirements relating to appointments where they can demonstrate that the measures taken are of equivalent efficacy in order to attain the objective of a presence of the under - represented sex of at least 40 per cent among non - executive directors of listed companies at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states may have already taken measures providing for means to ensure a more balanced representation of women and men in company boards before the entry into force of this directive . such member states should have an opportunity to apply those measures in place of the procedural requirements relating to appointments where they can demonstrate that the measures taken are of equivalent efficacy in order to attain the objective of a presence of the under - represented sex of at least 40 per cent among non - executive directors of listed companies or the one third objective referred to in article 4 of this directive at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . also e . g . self - regulatory measures aiming to ensure a more balanced representation of women and men among the non - executive directors of listed companies must be considered as relevant measures in this regard .


### this directive shall not apply to small and medium - sized enterprises . ### this directive shall not apply to small and medium - sized enterprises or to smallcap listed companies as defined in article 2 .


### in order to attain the objective laid down in paragraph 1 , member states shall ensure that , in the selection of non - executive directors , priority shall be given to the candidate of the under - represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability , competence and professional performance , unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex . ### in order to attain the objective laid down in paragraph 1 , member states shall ensure that , in the selection of non - executive directors , priority shall be given to the candidate of the under - represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability , competence and professional performance , unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex . to this end , the selection criteria must above all be clear , transparent and non - discriminatory .


### member states shall ensure that listed companies are obliged to disclose , on the request of an unsuccessful candidate , the qualification criteria upon which the selection was based , the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate of the other sex . ### member states shall ensure that listed companies are obliged to disclose , on the request of an unsuccessful candidate , the qualification criteria upon which the selection was based , the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate of the other sex . the obligation to disclose shall not apply where disclosure would endanger trade secrets or where the elected board member was proposed by the shareholders , thereby rendering disclosure impossible .


### without prejudice to article 4 and , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the non - executive directors of listed companies may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and , provided that it can be shown that those measures enable members of the under - represented sex to hold at least 40 per cent of the non - executive director positions of listed companies by at the latest 1 january 2020 , or at the latest 1 january 2018 for listed companies which are public undertakings . ### without prejudice to article 4 , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the non - executive directors of listed companies or member states where other e . g . self - regulatory measures aiming to ensure a more balanced representation of women and men among the non - executive directors of listed companies exist may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and and the application of article 5 , provided that it can be shown that those measures enable members of the under - represented sex to hold either at least 40 per cent of the non - executive director positions of listed companies or the one - third objective referred to in article 4 by at the latest 1 january 2020 , or at the latest 1 january 2018 for listed companies which are public undertakings . the member state in question shall notify this information to the commission .


### member states having suspended pursuant to article 8 the application of the procedural requirements relating to appointments contained in article 4 , , and shall include information in the reports mentioned in paragraph 1 demonstrating the concrete results obtained by the national measures referred to in article 8 . the commission shall then issue a specific report ascertaining whether those measures effectively enable members of the under - represented sex to hold at least 40 per cent of the non - executive director positions by 1 january 2018 for listed companies which are public undertakings , and by 1 january 2020 for listed companies which are not public undertakings . the first such report shall be issued by the commission by 1 july 2017 , and subsequent reports shall be issued within six months after notification of the respective national reports under paragraph 1 . ### member states having suspended pursuant to article 8 the application of the procedural requirements relating to appointments contained in article 4 , , and shall include information in the reports mentioned in paragraph 1 demonstrating the concrete results obtained by the national or self - regulatory measures referred to in article 8 . the commission shall then issue a specific report ascertaining whether those measures effectively enable members of the under - represented sex to hold at least 40 per cent of the non - executive director positions by 1 january 2018 for listed companies which are public undertakings , and by 1 january 2020 for listed companies which are not public undertakings . the first such report shall be issued by the commission by 1 july 2017 , and subsequent reports shall be issued within six months after notification of the respective national reports under paragraph 1 .


### member states in question shall ensure that listed companies , which by applying the national measures referred to in article 8 have not appointed or elected members of the under - represented sex for at least 40 per cent of the non - executive director positions of their boards by 1 january 2018 , where they are public undertakings , or by 1 january 2020 , where they are not public undertakings , apply the procedural requirements relating to appointments contained in article 4 , , and with effect respectively from those dates . ### member states in question shall ensure that listed companies , which by applying the national or self - regulatory measures referred to in article 8 have not appointed or elected members of the under - represented sex for at least 40 per cent of the non - executive director positions of their boards by 1 january 2018 , where they are public undertakings , or by 1 january 2020 , where they are not public undertakings , apply the procedural requirements relating to appointments contained in article 4 , , and with effect respectively from those dates .


### at its 14th special meeting in 2004 , iccat acknowledged the efforts made by cambodia , equatorial guinea and sierra leone to address its concerns and adopted recommendations for the lifting of trade - restrictive measures against those three countries . ### at its 14th special meeting in 2004 , iccat acknowledged the efforts made by cambodia , equatorial guinea and sierra leone to address its concerns and adopted recommendations for the lifting of trade - restrictive measures against those three countries in relation to atlantic bigeye tuna and its products .


### as a consequence , regulation no 827 / 2004 has been amended by regulation no 919 / 2005 , so that it continues prohibiting such imports only from bolivia and georgia , whereas imports from cambodia , equatorial guinea and sierra leone are permitted again . __________________ 6 oj l 156 , 18 . 6 . 2005 , p . 1 . ### as a consequence , regulation no 827 / 2004 has been amended by regulation no 919 / 2005 , so that it continues prohibiting imports of atlantic bigeye tuna and its products only from bolivia and georgia , whereas imports from cambodia , equatorial guinea and sierra leone are permitted again . __________________ 6 oj l 156 , 18 . 6 . 2005 , p . 1 .


### the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions ' roadmap to a resource efficient europe ' has set forth the milestones and actions that are needed to put the union on a path to a resource - efficient and sustainable growth . therefore , the priority area environment and resource efficiency should support effective implementation of union environmental policy by the public and private sectors , in particular in the environmental sectors covered by the roadmap to a resource efficient europe , by facilitating the development and sharing of new solutions and best practices . however , it should exclude those eco - innovation activities that overlap with horizon 2020 . ### the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions ' roadmap to a resource efficient europe ' has set forth the milestones and actions that are needed to put the union on a path to a resource - efficient and sustainable growth . therefore , the priority area environment and resource efficiency should support effective implementation of union environmental policy by the public and private sectors , in particular in the environmental sectors covered by the roadmap to a resource efficient europe , by facilitating the development and sharing of new solutions and best practices . the life programme should provide funding for eco - innovation and demonstration activities in synergy with the horizon 2020 initiative and without prejudice to the specific features of each programme . it would thus help to boost the eco - technology sector and the green economy , in accordance with the europe 2020 strategy .


### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , carbon capture and storage , renewable energy , energy efficiency , transport and fuels , ozone layer protection and fluorinated gases . ### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , carbon capture and storage , renewable energy in urban , agricultural , mountainous or remote areas , waste recovery and biogas production , energy efficiency , public lighting , transport and fuels , in particular third - generation fuels , ozone layer protection and fluorinated gases .


### the first consequences of climate change can already be seen in europe and worldwide , such as extreme weather conditions leading to floods and droughts , and rising temperatures and sea levels . the priority area climate change adaptation should therefore contribute to adapt to such impacts across populations , economic sectors and regions to ensure a more resilient union through specific adaptation measures and strategies . actions in this field should be complementary to actions eligible for funding under the civil protection financial instrument . ### the first consequences of climate change can already be seen in europe and worldwide , such as extreme weather conditions leading to floods and droughts , rising temperatures and sea levels , and the proliferation of exotic invasive species . the priority area climate change adaptation should therefore contribute to adapt to such impacts across populations , economic sectors and regions to ensure a more resilient union through specific adaptation measures and strategies . actions in this field should be complementary to actions eligible for funding under the civil protection financial instrument and under the prospective specific instrument concerning exotic invasive species which is provided for in the eu biodiversity strategy to 2020 .


### in order to secure the best possible use of union funds and to ensure european added value , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of eligibility criteria for project selection , criteria for the application of geographical balance to “integrated projects” , and performance indicators applicable to specific thematic priorities . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to secure the best possible use of union funds and to ensure european added value , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of eligibility criteria for project selection , and performance indicators applicable to specific thematic priorities . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the financial envelope for implementing the life programme shall be eur 3 618 000 000 . ### the financial envelope for implementing the life programme shall be eur 3 618 000 000 . at least 78% of the budgetary resources allocated to life shall be used for action grants for projects .


### participation of third countries in the life programme the life programme shall be open to the participation of the following countries : european free trade association countries which are parties to the agreement on the european economic area ; candidate countries , potential candidates and acceding countries to the union ; countries to which the european neighbourhood policy applies ; countries which have become members of the european environmental agency in accordance with council regulation no 993 / 1999 of 29 april 1999 amending regulation no 1210 / 90 on the establishment of the european environmental agency and the european environment information and observation network . such participation shall be done in accordance with the conditions laid down in the respective bilateral or multilateral agreements establishing the general principles for their participation in union programmes . ### participation of overseas countries and territories and third countries in the life programme the life programme shall be open to the participation of the following countries and territories : - the overseas countries and territories referred to in decision 2001 / 822 / ec ; european free trade association countries which are parties to the agreement on the european economic area ; candidate countries , potential candidates and acceding countries to the union ; countries to which the european neighbourhood policy applies ; countries which have become members of the european environmental agency in accordance with council regulation no 993 / 1999 of 29 april 1999 amending regulation no 1210 / 90 on the establishment of the european environmental agency and the european environment information and observation network . such participation shall be done in accordance with the conditions laid down in decision 2001 / 822 / ec and the respective bilateral or multilateral agreements establishing the general principles for their participation in union programmes .


### biodiversity ; ### – nature and biodiversity ;


### to support the application , development , testing and demonstration of integrated approaches for the implementation of plans and programmes pursuant to union environmental policy and legislation , primarily in the areas of water , waste and air ; ### to support the application , development , testing and demonstration of integrated approaches for the implementation of plans and programmes pursuant to union environmental policy and legislation , primarily in the areas of water , waste , air , noise and the urban environment ;


### specific objectives for the priority area biodiversity ### specific objectives for the priority area nature and biodiversity


### the specific objectives of the sub - programme for environment for the priority area biodiversity shall in particular be : ### the specific objectives of the sub - programme for environment for the priority area nature and biodiversity shall in particular be :


### to support the further development , implementation and management of the natura 2000 network set up in article 3 of directive 92 / 43 / eec , in particular the application , development , testing and demonstration of integrated approaches for the implementation of the prioritised action frameworks referred to in article 8 of directive 92 / 43 / eec ; ### to support the further development , implementation and management of the natura 2000 network set up in article 3 of directive 92 / 43 / eec , in particular the application , development , testing and demonstration of integrated approaches for the implementation of the prioritised action frameworks referred to in article 8 of directive 92 / 43 / eec ; to help preserve ecological corridors ;


### integrated projects primarily in the areas of nature , water , waste , air , and climate change mitigation and adaptation ; ### integrated projects primarily in the areas of nature , water , waste , air , noise , the urban environment and climate change mitigation and adaptation ;


### the commission shall ensure geographical balance in line with the principles of solidarity and effort sharing in the award process for integrated projects . the commission shall be empowered to adopt delegated acts in accordance with article 30 concerning criteria for the application of geographical balance in each thematic area referred to in article 18 point . ### the commission shall ensure , in the award process for integrated projects , that projects are selected on merit .


### the thematic priorities for projects to be financed for the period covered by the multiannual work programme ; ### the indicative thematic priorities for projects to be financed for the period covered by the multiannual work programme ;


### although directive 2009 / 21 / ec governs the flag state responsibilities by incorporating the imo ' s flag state audit scheme into union law and by introducing the certification of quality of national maritime authorities ; a separate directive covering the maritime labour standards is deemed more appropriate and clearer to reflect the different purposes and procedures , ### although directive 2009 / 21 / ec governs the flag state responsibilities by incorporating the imo ' s flag state audit scheme into union law and by introducing the certification of quality of national maritime authorities ; a separate directive covering the maritime labour standards is deemed more appropriate and clearer to reflect the different purposes and procedures . therefore , directive 2009 / 21 / ec , the provisions of which apply only to imo conventions , should not be affected by the present directive . in any case , member states could develop , implement and maintain a quality management system for the operational parts of the flag state - related activities of its maritime administration falling within the scope of this directive .


### directive 2009 / 13 / ec applies to seafarers on board ships flying the flag of a member state . member states should therefore monitor compliance with all the provisions of that directive by ships flying their flag . ### directive 2009 / 13 / ec applies to seafarers on board ships flying the flag of a member state . member states should ensure the effective discharge of their obligations as flag states with respect to the implementation of the relevant parts of mlc 2006 which correspond to the elements as set out in the annex to directive 2009 / 13 / ec by ships flying their flag . in establishing an effective system for monitoring mechanisms , including inspections , a member state could grant authorization to public institutions or other organisations within the meaning of mlc 2006 .


### compliance monitoring ### compliance monitoring and certification


### staff in charge of compliance monitoring ### recognised organisations and their staff in charge of compliance monitoring


### a ' public works concession ' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works , where the consideration for the the works to be carried out consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment . ### a ' works concession ' means a contract for pecuniary interest concluded in writing , under which one or more contracting authorities or bodies entrust the execution of the works for which they are responsible to one or more economic operators , where the consideration for this delegation consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment ; ‘ ’services concession’ means a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or bodies entrusts the operation of a service for which they are responsible to one or more economic operators , where the consideration for this delegation consists either solely in the right to exploit the services that are the subject of the contract or in that right together with payment . the right to exploit the works or services shall imply the transfer to the concessionaire of the substantial economic risk in exploiting these works or services , defined as the risk of exposure to the vagaries of the market . the concessionaire shall be deemed to assume the substantial operating risk where , under normal conditions of exploitation , it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject - matter of the concession .


### the duration of the concession shall be limited to the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a resonable return on invested capital . ### the duration of the concession shall be limited to the time – specified precisely in the concession – estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a resonable return on invested capital .


### concessions shall be awarded on the basis of objective criteria which ensure compliance with the principles of transparency , non - discrimination and equal treatment and which ensure that tenders are assessed in conditions of effective competition permitting to identify an overall economic advantage for the contracting authority or the contracting entity . ### concessions shall be awarded on the basis of objective criteria , precisely defined by the concession provider , which ensure compliance with the principles of transparency , non - discrimination and equal treatment and which ensure that tenders are assessed in conditions of effective competition permitting to identify an overall economic advantage for the contracting authority or the contracting entity .


### in the concession documents , the contracting authority or contracting entity may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subconcessionaires . ### in the concession documents , the grantor may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subconcessionaires . the selection of subcontractors shall be updated in the course of the concession contract , subject to replacements and changes .


### draft legislative resolution ### recalls , in particular , that in the same resolution the european parliament calls for a significant increase in relevant expenditure from 2013 , in order to enhance , stimulate and secure the financing of research , development and innovation in the union .


### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence . ### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence thereby the importance of fostering stronger synergies and complementarity with the structural funds .


### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence . ### the union is committed to achieving the europe 2020 strategy , which has set the objectives of smart , sustainable and inclusive growth , highlighting the role of research and innovation as key drivers of social and economic prosperity and of environmental sustainability and setting itself the goal to increase spending on research and development to reach 3 % of gross domestic product by 2020 while developing an innovation intensity indicator . in this context , the innovation union flagship initiative sets out a strategic and integrated approach to research and innovation , setting the framework and objectives to which future union research and innovation funding should contribute . research and innovation are also key factors for other europe 2020 flagship initiatives , notably on resource efficient europe , an industrial policy for the globalisation era , and a digital agenda for europe . moreover , for achieving the europe 2020 objectives relating to research and innovation , cohesion policy has a key role to play through building capacity and providing a stairway to excellence . however , the selection of projects funded under the concept ' stairway to excellence ' needs to be based on certain quality standards . in order to ensure their durable success , specific attention should be paid to projects funded under the concept ' stairway to excellence ' need to be paid specific attention and have to be closely monitored .


### at its meeting of 4 february 2011 , the european council supported the concept of the common strategic framework for union research and innovation funding to improve the efficiency of research and innovation funding at national and union levels and called on the union to rapidly address remaining obstacles to attracting talent and investment in order to complete the era by 2014 and achieve a genuine single market for knowledge , research and innovation . ### at its meeting of 4 february 2011 , the european council supported the concept of the common strategic framework for union research and innovation funding to improve the efficiency of research and innovation funding at national and union levels and called on the union to rapidly address remaining obstacles to attracting talent and investment in order to complete the era by 2014 and achieve a genuine single market for knowledge , research and innovation . this requires increasing significantly the budget for the next 7 - year period to reinforce the innovation capacity of the eu while attracting significant private sector funds for its activities .


### smes constitute a significant source of innovation and growth in europe . therefore a strong participation of smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 , is needed in horizon 2020 . this should support the aims of the small business act . ### smes constitute a significant source of innovation and growth in europe . therefore a strong participation of smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 , is needed in horizon 2020 . this should support the aims of the small business act . horizon 2020 should offer the necessary incentives to attract smes to this type of funding at eu level and provide for a set of rules and instruments that significantly improve the access of smes to finance .


### excellent science , eur 27818 million ; ### excellent science , 32 , 3% ;


### the maximum overall amount for the union financial contribution from horizon 2020 to the non - nuclear direct actions of the joint research centre shall be eur 2212 million . ### the maximum overall amount for the union financial contribution from horizon 2020 to the non - nuclear direct actions of the joint research centre shall be 2 , 3% .


### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur 3194 million as set out in annex ii . a first allocation of eur 1542 million shall be provided to the european institute of innovation and technology for activities under title xvii of the treaty on the functioning of the european union . a second allocation of up to eur 1652 million shall be provided , subject to the review set out in article 26 . this additional amount shall be provided on a pro - rata basis , as indicated in annex ii , from the amount for the specific objective ‘ leadership in enabling and industrial technologies’ within the priority on industrial leadership set out in paragraph 2 and from the amount for the priority on societal challenges set out in 2 . ### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of 3 % of the total budget as set out in annex ii .


### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the commission may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 10 % of the total initial allocation of each priority and up to 10 % of the initial indicative breakdown of each specific objective . this does not concern the amount set out for the direct actions of the joint research centre in paragraph 2 or the contribution to the european institute of innovation and technology set out in paragraph 3 . ### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the budgetary authority may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure and on the basis of a proposal by the commission review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 10 % of the total initial allocation of each priority and up to 10 % of the initial indicative breakdown of each specific objective . this does not concern the amount set out for the direct actions of the joint research centre in paragraph 2 .


### particular attention shall be paid to ensuring the adequate participation of , and innovation impact on , small and medium - sized enterprises in horizon 2020 . quantitative and qualitative assessments of sme participation shall be undertaken as part of the evaluation and monitoring arrangements . ### particular attention shall be paid to ensuring the adequate participation of , and innovation impact on , small and medium - sized enterprises in horizon 2020 . quantitative and qualitative assessments of sme participation shall be undertaken as part of the evaluation and monitoring arrangements . the commission , in particular , shall ensure to the largest possible extent the participation of smes in horizon 2020 by also providing the necessary assistance that will allow them to fulfil the requirements and improve their access to finance under this programme .


### not later than end 2017 , the commission shall carry out , with the assistance of independent experts , a review of the european institute of innovation and technology . the second allocation of funds to the european institute of innovation and technology as set out in article 6 shall be made available following this review . the review shall assess the progress of the european institute of innovation and technology against all of the following : ### not later than end of 2016 , the commission shall carry out , with the assistance of independent experts , a review of the european institute of innovation and technology . the second allocation of funds to the european institute of innovation and technology as set out in article 6 shall be made available following this review . the review shall assess the progress of the european institute of innovation and technology against all of the following :


### a common information sharing environment for the eu maritime domain which promotes cross - sectoral and cross - border surveillance activities and reinforces the safe and secure use of marine space , taking into account the relevant developments of sectoral policies as regards surveillance and contributing , as appropriate , to their necessary evolutions ; ### a common information sharing environment for the eu maritime domain which promotes cross - sectoral and cross - border surveillance activities and reinforces the safe , secure and environmentally friendly use of marine space , taking into account the relevant developments of sectoral policies as regards surveillance and contributing , as appropriate , to their necessary evolutions ;


### third countries including those bordering a european sea basin , ### third countries bordering a european sea basin ,


### third countries including those bordering a european sea basin , ### third countries including those bordering a european sea basin , especially with regard to ensuring the application of environmental standards in those countries , which shall not be lower than those applicable in the eu ;


### actors in third countries , ### actors in third countries operating in or bordering on a european sea basin ,


### the requirements and standards referred to in paragraphs 1 and 2 shall be implemented in a uniform manner , in accordance with article 35 and . ### the requirements and standards referred to in paragraphs 1 and 2 shall be implemented in a uniform manner , in accordance with article 35 and . manufacturers must be able to access the text of these requirements and standards free of charge .


### compliant products which present a risk to maritime safety or to the protection of the environment ### compliant products which present a risk to maritime safety , to the protection of the environment or to health


### ‘ sub - assembly’ means a hardware device , mentioned as such in the specific annexes , that functions independently and makes up a measuring instrument together with other sub - assemblies with which it is compatible , or with a measuring instrument with which it is compatible ; ### ‘ sub - assembly’ means a hardware device , mentioned as such in the instrument - specific annexes , that functions independently and makes up a measuring instrument together with other sub - assemblies with which it is compatible , or with a measuring instrument with which it is compatible ;


### ‘ putting into use’ means the first use of an instrument intended for the end user for the purposes for which it was intended ; ### ‘ putting into use’ means the first use of a measuring instrument intended for the end user for the purposes for which it was intended ;


### ’placing on the market ' means the first making available of a measuring instrument on the union market ### ' making available on the market ' means the supply of a measuring instrument for distribution or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ;


### ‘ making available on the market’ means any supply of a measuring instrument for distribution or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ; ### ' placing on the market ' means the first making available of a measuring instrument on the union market


### ‘ economic operators’ means the manufacturer , the authorised representative , the importer and the distributor ; ### ‘ economic operators’ means a manufacturer , an authorised representative , a importer or a distributor ;


### ‘ harmonised standard’ means harmonised standard as defined in article 2 of regulation no [ … / … ] [ on european standardisation ] ; ### ‘ harmonised standard’ means a standard as defined in article 2 of regulation no [ … / … ] [ on european standardisation ] ;


### where specific annexes exist , laying down the essential requirements for sub - assemblies , this directive shall apply mutatis mutandis to such sub - assemblies . ### where instrument - specific annexes exist , laying down the essential requirements for sub - assemblies , this directive shall apply mutatis mutandis to such sub - assemblies .


### essential requirements and assessment of conformity ### essential requirements


### manufacturers shall ensure that their measuring instruments bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the measuring instrument does not allow it , that the required information is provided on the packaging or in a document accompanying the measuring instrument . ### manufacturers shall ensure that their measuring instruments bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the measuring instrument does not allow it , that the required information is provided on the packaging or in a document accompanying the measuring instrument in accordance with point 9 . 2 of annex i .


### manufacturers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or , where that is not possible , on its packaging or in a document accompanying the measuring instrument . the address must indicate a single point at which the manufacturer can be contacted . ### manufacturers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by end - users and market surveillance authorities , and the address at which they can be contacted on the measuring instrument or , where that is not possible , on its packaging or in a document accompanying the measuring instrument in accordance with point 9 . 2 of annex i . the address must indicate a single point at which the manufacturer can be contacted .


### manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned . ### manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned . such instructions and safety information as well as any labelling shall be clear , understandable and intelligible .


### importers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned . ### importers shall ensure that the measuring instrument is accompanied by the required documentation , and by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned .


### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or , where that is not possible , on its packaging or in a document accompanying the measuring instrument in accordance with point 9 . 2 of annex i . ### importers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by end - users and market surveillance authorities , and the address at which they can be contacted on the measuring instrument or , where that is not possible , on its packaging or in a document accompanying the measuring instrument in accordance with point 9 . 2 of annex i .


### economic operators shall , on request , identify the following to the market surveillance authorities , for 10 years : ### economic operators shall , on request , specify the following to the market surveillance authorities , for 10 years :


### economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the measuring instrument and for a period of 10 years after they have supplied the measuring instrument . ### economic operators shall present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the measuring instrument and for a period of 10 years after they have supplied the measuring instrument . economic operators shall not be required to update that information after supply is finalised .


### where a normative document satisfies the requirements which it covers and which are set out in annex i and in the relevant instrument specific annexes , the commission may ### on request by a member state or on its own initiative , the commission shall , where appropriate


### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the measuring instrument is placed or made available . ### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the measuring instrument is placed or made available . upon the request of the market surveillance authorities , the economic operator shall provide a copy of the eu declaration of conformity in paper form or by electronic means .


### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the measuring instrument . ### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the measuring instrument with the requirements laid down this directive .


### member states shall notify the commission and the other member states of bodies authorised to carry out third - party conformity assessment tasks under this directive . that notification shall include information on the kind of measuring instrument for which each body has been designated and , where relevant , the instrument accuracy classes , the measuring range , the measurement technology , and any other instrument characteristic limiting the scope of the notification . ### member states shall notify the commission and the other member states of bodies authorised to carry out third - party conformity assessment tasks under this directive .


### member states shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with the provisions of article 30 . ### member states shall designate a single notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with the provisions of article 30 .


### the notification shall include full details of the conformity assessment activities , the conformity assessment module or modules and measuring instrument or measuring instruments concerned and the relevant attestation of competence . ### the notification shall include information on the kinds of measuring instruments for which each body has been designated and , where relevant , the instrument accuracy classes , the measuring range , the measurement technology , and any other instrument characteristic limiting the scope of the notification . the notification shall include full details of the conformity assessment activities , the conformity assessment module or modules and measuring instrument or measuring instruments concerned and the relevant attestation of competence .


### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that a measuring instrument covered by this directive presents a risk to the aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the measuring instrument concerned covering all the requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities . ### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that a measuring instrument covered by this directive presents a risk to the aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the measuring instrument concerned covering all the relevant requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities .


### where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1 , the market surveillance authorities shall take all appropriate provisional measures to prohibit the measuring instrument ' s being made available on their national market , to withdraw the measuring instrument from that market or to recall it . ### where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1 , the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the measuring instrument ' s being made available on their national market , to withdraw the measuring instrument from that market or to recall it .


### member states shall ensure that appropriate restrictive measures are taken in respect of the measuring instrument concerned . ### member states shall ensure that appropriate restrictive measures are taken in respect of the measuring instrument concerned , such as withdrawal of the measuring instrument from their market , without delay .


### a delegated act adopted pursuant to article 46 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 47 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council .


### member states shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . ### member states shall build upon existing mechanism to ensure correct application of the regime governing the ce marking and shall take appropriate action in the event of improper use of the marking . member states shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements .


### the penalties provided for shall be effective , proportionate and dissuasive . ### the penalties referred to in the first paragraph shall be effective , proportionate to the seriousness of the offence , and dissuasive .


### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 51 ] at the latest and shall notify to it without delay any subsequent amendment affecting them . ### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 51 ] and shall notify to it without delay any subsequent amendment affecting them . the commission shall make those provisions publicly available by publishing them on the internet .


### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . the commission shall make those texts publicly available by publishing them on the internet .


### 2 . an instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging , if any , and the accompanying documents required by the provisions of this directive suitably marked . ### 2 . an instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging , if any , or the accompanying documents required by the provisions of this directive suitably marked .


### a notified body , chosen by the manufacturer , shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks of the instrument , taking into account inter alia the technological complexity of the instruments and the quantity of production . an adequate sample of the final measuring instruments , taken on site by the body before the placing on the market , shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard , normative document and / or technical specifications , or equivalent tests , shall be carried out to check the conformity of the instruments with the relevant requirements of this directive . in the absence of a relevant document , the notified body concerned shall decide on the appropriate tests to be carried out . ### an accredited in - house body or a notified body , chosen by the manufacturer , shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks of the instrument , taking into account inter alia the technological complexity of the instruments and the quantity of production . an adequate sample of the final measuring instruments , taken on site by the body before the placing on the market , shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard , normative document and / or technical specifications , or equivalent tests , shall be carried out to check the conformity of the instruments with the relevant requirements of this directive . in the absence of a relevant document , the notified body concerned shall decide on the appropriate tests to be carried out .


### a notified body , chosen by the manufacturer , shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks on the instrument , taking into account inter alia the technological complexity of the measuring instruments and the quantity of production . an adequate sample of the final measuring instrument , taken on site by the notified body before the placing on the market , shall be examined and appropriate tests , as identified by the relevant parts of the harmonised standards , normative documents and / or technical specifications , or equivalent tests , shall be carried out to check the conformity of the instrument with the type as described in the eu - type examination certificate and relevant requirements of this directive . ### an accredited in - house body or a notified body , chosen by the manufacturer , shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks on the instrument , taking into account inter alia the technological complexity of the measuring instruments and the quantity of production . an adequate sample of the final measuring instrument , taken on site by the notified body before the placing on the market , shall be examined and appropriate tests , as identified by the relevant parts of the harmonised standards , normative documents and / or technical specifications , or equivalent tests , shall be carried out to check the conformity of the instrument with the type as described in the eu - type examination certificate and relevant requirements of this directive .


### intellectual property rights are vital business assets that help to ensure that innovators and creators get a fair return for their work and that their investment in research and new ideas is protected . ### intellectual property rights are vital business assets that help to ensure that innovators and creators get a fair return for their work and that their investment in research and new ideas is protected . they also allow for innovation and enhance consumers’ access to knowledge and information .


### the constant rise of infringements of intellectual property rights constitutes a genuine threat not only to the union economy , but also to the health and safety of union consumers . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon . ### the constant rise of infringements of intellectual property rights constitutes a genuine threat not only to the union economy , but also to the health and safety of union consumers . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon , and efforts should be intensified in sectors that are sensitive from the health and safety point of view , especially where medicines and foodstuffs are concerned .


### the european parliament , in its resolution of 22 september 2010 on enforcement of intellectual property rights in the internal market , called on the member states and the commission to extend the cooperation between the office and national intellectual property offices to also include the fight against infringements of intellectual property rights . ### the european parliament , in its resolution of 22 september 2010 on enforcement of intellectual property rights in the internal market , called on the member states and the commission to extend the cooperation between the office and national intellectual property offices to also include the fight against infringements of intellectual property rights . it proposed in addition that the observatory should carry out a detailed analysis of the problem of online data theft and put forward proposals for combating that problem .


### raising citizens’ awareness of the impact of infringements of intellectual property rights ; ### raising citizens’ awareness of the impact of infringements of intellectual property rights by continuing and intensifying awareness campaigns on the risks that counterfeit products pose to consumer health and safety and on the adverse impact that counterfeiting and piracy have on the economy and society ;


### the office shall invite to the meetings referred to in point of article 2 representatives from public administrations , bodies and organisations dealing with the protection of intellectual property rights and representatives from the private sector . ### the office shall invite to the meetings referred to in point&#160 ; of article&#160 ; 2 representatives from public administrations , bodies and organisations dealing with the protection of intellectual property rights , representatives from the private sector and representatives of consumer organisations and small and medium&#160 ; sized enterprises .


### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 . ### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; training needs to be promoted and developing countries ' capacities stepped up ; the integration of european national programmes should be further improved ; cooperation with other major public and private partners , including the pharmaceutical industry , public - private partnerships such as product development partnerships , non - governmental organisations and foundations , and civil society needs to be strengthened and extended and respond to clear and transparent rules of governance ; synergies with european external policy actions should be developed , specifically with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . ____________________ 8 van velzen et al . , independent external evaluation report , december 2009 .


### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 . ### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; training should be promoted and the capacities of developing countries reinforced ; the integration of european national programmes should be further improved ; collaboration with public and private partners , including the pharmaceutical industry , and public - private partnerships such as the pdps , non - governmental organisations and foundations , needs to be strengthened and extended ; synergies with european external policy actions should be developed , specifically with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 .


### according to council decision … / 2013 / eu of … 2013 establishing the specific programme implementing horizon 2020 - the framework programme for research and innovation 9 further support may be provided to the edctp2 programme . __________________ 9 oj l … [ horizon 2020 specific programme ] . ### according to regulation no . . . / 2013 of the european parliament and of the council of . . . 2013 establishing horizon 20208a and council decision … / 2013 / eu of … 2013 establishing the specific programme implementing horizon 2020 - the framework programme for research and innovation 9 further support may be provided to the edctp2 programme . __________________ 8a oj l . . . [ horizon 2020 ] . 9 oj l … [ horizon 2020 specific programme ] .


### despite the considerable results and achievements of edctp1 , poverty - related diseases still represent a major obstacle to the sustainable development of developing countries due to their social and economic burden , especially in sub - saharan africa . effective , safe and affordable medical treatments still do not exist for most poverty - related diseases and investment in clinical research remains inadequate as conducting clinical trials is costly and the return on investment is limited due to market failure . moreover , european research activities and programmes are still often fragmented and thus either subcritical in scale or overlapping , whereas research capacity and investment in developing countries are inadequate . ### despite the considerable results and achievements of edctp1 , poverty - related diseases still represent a major obstacle to the sustainable development of developing countries due to their social and economic burden , especially in sub - saharan africa . effective , safe , suitable , accessible and affordable medical treatments tailored to developing countries ' specific circumstances still do not exist for most poverty - related diseases and investment in clinical research remains inadequate as conducting clinical trials is costly and the return on investment is limited due to market failure . it should be pointed out that only 10% of global research funding is allocated for the diseases which account for 90% of the world ' s pathologies . moreover , european research activities and programmes are still often fragmented and thus either subcritical in scale or overlapping , whereas research capacity and investment in developing countries are inadequate .


### the commission presented a communication on 31 march 201010 on the union’s role in global health which calls for a more coordinated approach among member states and across relevant policies to identify and jointly address shared global priorities for health research . ____________ 10 com 128 final . ### the commission presented a communication on 31 march 201010 on the union’s role in global health which calls for a more coordinated approach among member states and across relevant policies to identify and jointly address shared global priorities for health research . in that communication , the commission also restates the need to promote equitable and universal coverage of quality health services plus effective and fair financing of research that benefits the health of all people . ________________ 10 com 128 final .