### in order to take into account the progress of technical knowledge and new scientific evidence , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend section 2 of part b and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values and to the froude and p / d ratio values , and annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to take into account the progress of technical knowledge and new scientific evidence , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend section 2 of part b of annex i , in particular to include test cycles for hybrid engines and to introduce biofuel blended test fuels in the table of test fuels once these test fuels have been internationally accepted , and section 1 of part c of annex i , with the exception of direct or indirect modifications to exhaust or noise emission values and to the froude and p / d ratio values , and annexes v , vii and ix . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### member states should lay down rules on penalties applicable to infringements of this directive and ensure that they are implemented . those penalties should be effective , proportionate and dissuasive . ### member states should lay down rules on penalties applicable to infringements of this directive and ensure that they are implemented by services clearly designated for that purpose or by the competent national authorities . those penalties should be effective , proportionate and dissuasive , and they should be applied without undue delay .


### the fact that the same watercraft could be used for charter or for recreational boating training shall not prevent it being covered by this directive when it is placed on the union market for recreational purposes . ### watercraft also used for charter or for recreational boating training shall be covered by this directive .


### ‘ personal watercraft’ means a watercraft intended for sports and leisure purposes of less than 4 m in length which uses an internal combustion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting , standing or kneeling on , rather than within the confines of , a hull ; ### ' personal watercraft ' means a vessel less than 4 m in length which uses an internal combustion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting , standing or kneeling on , rather than within the confines of , a hull ;


### ‘ major craft conversion’ means a conversion of a watercraft which changes the means of propulsion of the watercraft , involves a major engine modification , or alters the watercraft to such an extent that it is considered a new watercraft ; ### ‘ major craft conversion’ means a conversion of a watercraft which changes the means of propulsion of the watercraft , involves a major engine modification , or alters the watercraft to such an extent that the essential safety and environmental requirements laid down in this directive which apply are affected ;


### ‘ manufacturer’ means any natural or legal person who manufactures a product or has such a product designed or manufactured and markets that product under his name or trademark ; ### ‘ manufacturer’ means any natural or legal person who manufactures a product or has such a product designed or manufactured and markets that product under his name or trademark ; this shall include any natural or legal person who adapts engines for marine use where the source engine is already type - approved in accordance with directive 97 / 68 / ec or directive 2005 / 55 / ec without altering the exhaust emissions characteristics of the engine ;


### the provisions of this directive shall not prevent member states from adopting provisions concerning navigation on certain waters for the purpose of protection of the environment , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to watercraft conforming to this directive . ### the provisions of this directive shall not prevent member states from adopting provisions concerning navigation on certain waters for the purpose of protection of the environment , including from noise pollution , the fabric of waterways , and ensuring safety of waterways , provided that those provisions do not require modification to watercraft conforming to this directive and that those provisions are justified and proportionate . the commission shall facilitate the exchange of best practices between member states and set up an adequate system for such exchange .


### member states shall not impede the making available on the market or putting into service of any of the following : propulsion engines , whether or not installed in watercraft , complying with this directive ; engines type - approved in accordance with directive 97 / 68 / ec of the european parliament and the council23 which are in compliance with stage iiia , iiib or stage iv emission limits for ci engines used in other applications than propulsion of inland waterway vessels , locomotives and railcars , as provided for in point 4 . 1 . 2 . of annex i to that directive ; engines type - approved in accordance with directive 2005 / 55 / ec of the european parliament and the council24 where the manufacturer declares in accordance with point 9 of annex iv that the engine will meet the exhaust emission requirements of this directive when installed in a watercraft in accordance with the manufacturer ' s supplied instructions . ### member states shall not impede the making available on the market or putting into service of propulsion engines , whether or not installed in watercraft , complying with this directive .


### obligations of private importers ### obligations of private importers where post - construction assessment applies


### inboard engines and stern drive engines without integral exhaust which are regarded as meeting the exhaust emission requirements set out in parts b and c of annex i . ### inboard engines and stern drive engines without integral exhaust which are regarded as meeting the exhaust emission requirements set out in part b of annex i .


### – where the harmonised standards relating to points 3 . 2 and 3 . 3 of part a of annex i are complied with : module a1 , module b together with module c , d , e or f , module g ; or module h ; ### – where the harmonised standards relating to points 3 . 2 and 3 . 3 of part a of annex i are complied with : module b together with module c , d , e or f , module g ; or module h ;


### a production type referred to in module b may cover several versions of the product provided that the differences between the versions do not affect the level of safety and the other requirements concerning the performance of the product . ### a production type referred to in module b may cover several versions of the product provided that : the differences between the versions do not affect the level of safety and the other requirements concerning the performance of the product ; and b ) versions of a product are referred to in the corresponding eu - type examination certificate , if necessary through amendments to the original certificate .


### the amendments referred to in point may include amendments to reference fuels and to the requirements for exhaust and noise emissions testing and to durability criteria . ### the amendments referred to in point may include amendments to reference fuels and to the requirements for exhaust and noise emissions testing and to durability criteria . in particular such amendments may include test cycles for hybrid engines and introduce biofuel blended test fuels in the table of test fuels set out in section 2 of part b of annex i once those test fuels have been agreed in the form of internationally accepted standards .


### the delegation of power referred to in article 49 shall be conferred for an indeterminate period of time from the date specified in article 60 . ### the delegation of power referred to in article 49 shall be conferred for seven years from the date specified in article 60 . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### design category a – ’ocean’ b – ’offshore’ c – ’inshore’ d – ’sheltered waters’ ### design category a b c d


### recreational craft in each category must be designed and constructed to withstand the parameters in respect of stability , buoyancy , and other relevant essential requirements listed in annex i , and to have good handling characteristics . ### watercraft in each category must be designed and constructed to withstand the parameters in respect of stability , buoyancy , and other relevant essential requirements listed in annex i , and to have good handling characteristics .


### the watercraft shall be constructed as to ensure that it has buoyancy characteristics appropriate to its design category according to point 1 . 1 , and the manufacturer ' s maximum recommended load according to point 3 . 6 . all habitable multihull craft shall be so designed that it is either not susceptible to inversion or it has sufficient buoyancy to remain afloat in the inverted position . ### the watercraft shall be constructed as to ensure that it has buoyancy characteristics appropriate to its design category according to point 1 . 1 , and the manufacturer ' s maximum recommended load according to point 3 . 6 . habitable multihull craft that are susceptible to hull inversion shall be so designed as to have sufficient buoyancy to remain afloat in the inverted position .


### all watercraft of categories a and b , and watercraft of categories c and d longer than six metres shall be provided with one or more stowage points for a life raft large enough to hold the number of persons the boat was designed to carry as recommended by the manufacturer . life raft stowage point shall be readily accessible at all times . ### all recreational craft of categories a and b , and recreational craft of categories c and d longer than six metres shall be provided with one or more stowage points for a life raft large enough to hold the number of persons the boat was designed to carry as recommended by the manufacturer . life raft stowage point shall be readily accessible at all times .


### attention shall be paid to the provision of overload and short - circuit protection of all circuits , except engine starting circuits , supplied from batteries . ### attention shall be paid to the provision of adequate overload and short - circuit protection of all circuits , except engine starting circuits supplied from batteries . electric propulsion circuits shall be designed and installed to prevent any unwanted interaction with all other circuits . the installation shall ensure that devices which store electrical energy do not exceed the manufacturer ' s recommended maximum temperature limits .


### all watercraft with a permanently installed gas system shall be fitted with an enclosure to contain all gas cylinders . the enclosure shall be separated from the living quarters , accessible only from the outside and ventilated to the outside so that any escaping gas drains overboard . ### all watercraft with a permanently installed gas system shall be fitted with an enclosure to contain all gas cylinders . the enclosure shall be separated from the living quarters , accessible only from the outside and ventilated to the outside so that any escaping gas drains overboard . any permanent gas system shall be tested after installation .


### 3 . test cycles and reference fuels : ### 3 . test cycles :


### the health warning shall be printed on the front and back external surface of the unit packet and on any outside packaging . ### the health warning shall be printed on the front , bottom or back external surface of the unit packet and on any outside packaging .


### member states shall not prohibit or restrict the import , sale or consumption of tobacco or related products which comply with this directive . ### subject to paragraphs 2 and 3 , member states shall not prohibit or restrict the import , sale or consumption of tobacco or related products which comply with this directive .


### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in compliance with community law . ### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in order to ensure compliance with union law .


### the authority shall ensure that no decision adopted under articles 10 or 11 impinges in any way on the fiscal responsibilities of member states . ### the authority shall ensure that no decision adopted under articles 10 , 11 or 12a impinges in any way on the fiscal responsibilities of member states .


### the authority shall ensure that no decision adopted under articles 10 or 11 impinges in any way on the fiscal responsibilities of member states . ### the authority shall ensure that no decision adopted under articles 6 , paragraph 3 , 10 or 11 impinges in any way on the fiscal responsibilities of member states .


### in its notification , the member state shall justify why and clearly demonstrate how the decision impinges on its fiscal responsibilities . ### in its notification , the member state shall justify why and clearly demonstrate how the decision impinges on its fiscal responsibilities . in that case , the decision of the authority shall be suspended .


### it has also proven necessary to clarify what should be understood as a single procurement , with the effect that the aggregate value of all contracts concluded for the purpose of this procurement has to be taken into account with regard to the thresholds of this directive , and that the procurement should be advertised as a whole , possibly split into lots . the concept of single procurement encompasses all supplies , works and services needed to carry out a particular project , for instance a works project or an entirety of works , supplies and / or services . indications for the existence of one single project can for instance consist in overall prior planning and conception by the contracting authority , the fact that the different elements purchased fulfil a single economic and technical function or that they are otherwise logically interlinked and carried out in a narrow time frame . ### the concept of single procurement encompasses all supplies , works and services needed to carry out a particular project , for instance a works project or an entirety of works , supplies and / or services . the aggregate value of all contracts concluded for the purpose of this procurement has to be taken into account with regard to the thresholds of this directive , and the procurement should be advertised as a whole , possibly split into lots .


### there is a widespread need for additional flexibility and in particular for wider access to a procurement procedure providing for negotiations , as is explicitly foreseen in the agreement , where negotiation is allowed in all procedures . contracting authorities should , unless otherwise provided in the legislation of the member state concerned , be able to use a competitive procedure with negotiation as provided for in this directive , in various situations where open or restricted procedures without negotiations are not likely to lead to satisfactory procurement outcomes . this procedure should be accompanied by adequate safeguards ensuring observance of the principles of equal treatment and transparency . this will give greater leeway to contracting authorities to buy works , supplies and services perfectly adapted to their specific needs . at the same time , it should also increase cross - border trade , as the evaluation has shown that contracts awarded by negotiated procedure with prior publication have a particularly high success rate of cross - border tenders . ### contracting authorities require additional flexibility to choose procurement procedures which provide for negotiations . the union rules on public procurement should align to the government procurement agreement , which allows for negotiation in all procedures . a greater use of these procedures is also likely to increase cross - border trade , as the evaluation has shown that contracts awarded by negotiated procedure with prior publication have a particularly high success rate in attracting cross - border tenders . member states should be able to provide for the use of the competitive procedure with negotiation or the competitive dialogue in various situations where the classic open or restricted procedures without negotiations are unlikely to deliver satisfactory outcomes .


### research and innovation , including eco - innovation and social innovation , are among the main drivers of future growth and have been put at the centre of the europe 2020 strategy for smart , sustainable and inclusive growth . public authorities should make the best strategic use of public procurement to spur innovation . buying innovative goods and services plays a key role in improving the efficiency and quality of public services while addressing major societal challenges . it contributes to achieving best value for public money as well as wider economic , environmental and societal benefits in terms of generating new ideas , translating them into innovative products and services and thus promoting sustainable economic growth . this directive should contribute to facilitating public procurement of innovation and help member states in achieving the innovation union targets . a specific procurement procedure should therefore be provided for which allows contracting authorities to establish a long - term innovation partnership for the development and subsequent purchase of a new , innovative product , service or works provided it can be delivered to agreed performance levels and costs . the partnership should be structured in such a way that it can provide the necessary ‘ market - pull’ , incentivising the development of an innovative solution without foreclosing the market . ### research and innovation , including eco - innovation and social innovation , are among the main drivers of future growth and have been put at the centre of the europe 2020 strategy for smart , sustainable and inclusive growth . public authorities should make the best strategic use of public procurement to drive innovation . buying innovative goods and services plays a key role in improving the efficiency and quality of public services while addressing major societal challenges . it contributes to achieving best value for public money as well as wider economic , environmental and societal benefits in terms of generating new ideas , translating them into innovative products and services and promoting sustainable economic growth . an innovative procurement model is detailed in the commission ' s communication on pre - commercial procurement 1 . this model promotes the take up in the procurement of research and development services which do not fall within the scope of this directive . this model , which has been written into this directive , is recognised and will be available for all contracting authorities to consider . this directive should however contribute to facilitating the public procurement of innovation more generally , and help member states in achieving the innovation union targets . where a need for the development of an innovative product , service or works and the subsequent purchase of the resulting output cannot be met by solutions already available on the market , contracting authorities should have access to a specific procurement procedure in respect of contracts falling within the scope of this directive . this new procedure should allow contracting authorities to establish an innovation partnership for the development and subsequent purchase of new , innovative products , services or works , provided that these can be delivered to agreed performance levels and costs . the procedure should be based on the rules applying to the competitive procedure with negotiations and contracts should be awarded on the sole basis of the most economically advantageous tender , which is the most suited to comparing tenders for innovative solutions . whether the innovation partnership concerns a very large project or a smaller project , it should be structured in such as a way that it can provide the necessary ' market pull ' , incentivising the development of innovative solutions without foreclosing the market . contracting authorities should therefore not misuse innovation partnerships to prevent , restrict or distort competition . __________________ 1 com 799 final : communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions on pre - commercial procurement : driving innovation to ensure sustainable high quality public services in europe .


### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions so as to obtain a sufficient level of competition . consequently , technical specifications should be drafted in such a way to avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works habitually offered by that economic operator . drawing up the technical specifications in terms of functional and performance requirements generally allows this objective to be achieved in the best way possible and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence ; however , other appropriate means of proof such as a technical dossier of the manufacturer should also be allowed where the economic operator concerned has no access to such certificates or test reports , or no possibility of obtaining them within the relevant time limits . ### the technical specifications drawn up by public purchasers need to allow public procurement to be opened up to competition . to that end , it must be possible to submit tenders that reflect the diversity of technical solutions , standards and specifications in the marketplace so as to obtain a sufficient level of competition . consequently , technical specifications should avoid artificially narrowing down competition through requirements that favour a specific economic operator by mirroring key characteristics of the supplies , services or works commonly offered by that economic operator , or that disadvantage economic operators on the basis of a business or development model or on the basis of specific standards or specifications implemented in a given solution or service . drawing up the technical specifications in terms of functional and performance requirements generally circumvents these problems and favours innovation . where reference is made to a european standard or , in the absence thereof , to a national standard , tenders based on equivalent arrangements must be considered equally by contracting authorities . to demonstrate equivalence , tenderers can be required to provide third - party verified evidence . however , other appropriate means of proof such as a manufacturers ' technical dossier should also be allowed where the economic operator concerned has no access to relevant certificates or test reports , or no possibility of obtaining them within the applicable time limits . contracting authorities must be able to provide justification for not granting equivalence in all cases .


### in order to foster the involvement of small and medium - sized enterprises in the public procurement market , contracting authorities should be encouraged to divide contracts into lots , and be obliged to state the reasons for not doing so . where contracts are divided into lots , contracting authorities may , for instance in order to preserve competition or to ensure security of supply , limit the number of lots for which an economic operator may tender ; they may also limit the number of lots that may be awarded to any one tenderer . ### public procurement should be adapted to the needs of smes . contracting authorities should make use of the code of best practice providing guidance on how they may apply the public procurement framework in a way that facilitates sme participation . in order to foster the involvement of small and medium - sized enterprises in the public procurement market , contracting authorities should in particular give consideration to dividing contracts into lots and ensure transparency in access to information on their reasons for doing so or choosing not to . member states should introduce measures to promote the access of smes to public procurement , in particular through improved information and guidance on tendering and on the new opportunities offered by the modernised eu legal framework , and to foster the exchange of best practice and the organisation of training and events involving public procurers and smes .


### monitoring , oversight and support structures or mechanisms exist already at national level and can of course be used to ensure monitoring , implementation and control of public procurement and to provide the required support to contracting authorities and economic operators . ### traceability and transparency of decision - making in procurement procedures is essential for ensuring sound procedures , including effectively fighting corruption and fraud . contracting authorities should keep copies of concluded contracts for high - value contracts to be able to provide access to these documents to interested parties in accordance with applicable rules on access to documentation . furthermore , the essential elements and decisions of individual procurement procedures should be documented in a procurement report . to limit administrative burdens , the procurement report should refer to information already contained in the relevant contract award notices . the electronic systems for publication of these notices , managed by the commission , should also be improved in view of facilitating data entry while making it easier to extract reports and exchange data between systems .


### they are established for or have the specific purpose of meeting needs in the general interest , not having an industrial or commercial character ; for that purpose , a body which operates in normal market conditions , aims to make a profit , and bears the losses resulting from the exercise of its activity does not have the purpose of meeting needs in the general interest , not having an industrial or commercial character ; ### established for , or which have the specific purpose of , meeting needs in the general interest ; these needs should not have an industrial or commercial character ;


### at least 90 % of the activities of that legal person are carried out for the controlling contracting authority or for other legal persons controlled by that contracting authority ; ### at least 80% of the activities of that legal person are carried out for the controlling contracting authority or for other legal persons controlled by that contracting authority ;


### at least 90 % of the activities of that legal person are carried out for the controlling contracting authorities or other legal persons controlled by the same contracting authorities ; ### at least 80% of the activities of that legal person are carried out for the controlling contracting authorities or other legal persons controlled by the same contracting authorities ;


### subject to article 346 of the treaty on the functioning of the european union , this directive shall apply to the awarding of public contracts and to design contests organised in the fields of defence and security , with the exception of the following contracts : ### subject to article 1 , this directive shall apply to the awarding of public contracts and to design contests organised in the fields of defence and security , with the exception of the following contracts :


### this directive shall not apply to public contracts and design contests other than those referred to in paragraph 1 to the extent that the protection of the essential security interests of a member state cannot be guaranteed in a procurement procedure as provided for in this directive . ### this directive shall not apply to public contracts and design contests not otherwise exempted under paragraph 1 where : the protection of the essential security interests of a member state cannot be guaranteed in a procurement procedure as provided for in this directive ; the application of this directive would oblige the member state to supply information the disclosure of which it considers contrary to its essential security interests ; or the procurement and performance of the contract or contest must be accompanied by special security measures in accordance with the laws , regulations or administrative provisions in force in the member state concerned .


### member states shall provide for rules to effectively prevent , identify and immediately remedy conflicts of interests arising in the conduct of procurement procedures that are subject to this directive , including the design and preparation of the procedure , the drawing - up of the procurement documents , the selection of candidates and tenderers and the award of the contract , so as to avoid any distortion of competition and ensure equal treatment of all tenderers . ### member states shall put in place mechanisms to effectively prevent , identify and immediately remedy actual , potential or perceived conflicts of interests arising in the conduct of procurement procedures that are subject to this directive , including the design and preparation of the procedure , the drawing - up of the procurement documents , the selection of candidates and tenderers , the award of the contract and the implementation phase , so as to avoid any distortion of competition and ensure equal treatment of all tenderers .


### the call for competition may be made by one of the following means : ### the call for competition shall be made by a contract notice pursuant to article 47 .


### in the case referred to in point , economic operators having expressed their interest following the publication of the prior information notice shall subsequently be invited to confirm their interest in writing by means of an ‘ invitation to confirm interest’ in conformity with article 52 . ### where the contract is awarded by restricted or competitive procedure with negotiation by a sub - central contracting authority , member states shall provide , notwithstanding the 1st subparagraph , that the call for competition may be made by means of a prior information notice pursuant to article 46 . they may also reserve this possibility to specific categories of sub - central contracting authorities . where the call for competition is made by means of a prior information notice pursuant to article 46 , economic operators , having expressed their interest following the publication of the prior information notice , shall subsequently be invited to confirm their interest in writing by means of an ' invitation to confirm interest ' in conformity with article 52 .


### member states may provide that contracting authorities may apply a negotiated procedure without prior publication only in the specific cases and circumstances referred to expressly in article 30 . ### in the specific cases and circumstances referred to expressly in article 30 , member states shall provide that contracting authorities may apply a negotiated procedure without prior publication . member states shall not allow the use of this procedure in any other cases than those referred to in article 30 .


### sub - central contracting authorities may set the time limit for the receipt of tenders by mutual agreement between the contracting authority and the selected candidates , provided that all candidates have the same time to prepare and submit their tenders . where it is not possible to reach agreement on the time limit for the receipt of tenders , the contracting authority shall fix a time limit which shall be at least 10 days from the date of the invitation to tender . ### member states shall provide that all or specific categories of sub - central contracting authorities may set the time limit for the receipt of tenders by mutual agreement between the contracting authority and the selected candidates , provided that all candidates have the same time to prepare and submit their tenders . in the absence of an agreement on the time limit for the receipt of tenders , the contracting authority shall fix a time limit which shall be at least 10 days from the date of the invitation to tender .


### in competitive procedures with negotiation , any economic operator may submit a request to participate in response to a call for competition by providing the requested information for qualitative selection . ### in competitive procedures with negotiation , any economic operator may submit a request to participate in response to a call for competition containing the information set out in annex vi parts b and c by providing the information for qualitative selection that is requested by the contracting authority .


### in the contract notice or in the invitation to confirm interest contracting authorities shall describe the procurement and the minimum requirements to be met and specify the award criteria so as to enable economic operators to identify the nature and scope of the procurement and decide whether to request to participate in the negotiations . in the technical specifications , contracting authorities shall specify which parts thereof define the minimum requirements . ### in the procurement documents , contracting authorities shall indicate which elements define the minimum requirements to be met . the indications shall be sufficiently precise as to enable economic operators to identify the precise nature and scope of the procurement and decide whether to request to participate in the procedure .


### only those economic operators invited by the contracting authority following their assessment of the requested information may submit a written tender which shall be the basis for the subsequent negotiations . contracting authorities may limit the number of suitable candidates to be invited to participate in the procedure in accordance with article 64 . ### only those economic operators invited by the contracting authority following their assessment of the requested information may submit an initial tender which shall be the basis for the subsequent negotiations . contracting authorities may limit the number of suitable candidates to be invited to participate in the procedure in accordance with article 64 .


### the following shall not be changed in the course of the negotiations : ### the minimum requirements and the award criteria shall not be subject to negotiations .


### during the negotiations , contracting authorities shall ensure the equal treatment of all tenderers . to that end , they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others . they shall take particular care to ensure that all tenderers , whose tenders have not been eliminated pursuant to paragraph 5 , are informed in writing of any changes to the technical specifications other than those setting out the minimum requirements , in adequate time to allow such tenderers to modify and re - submit amended tenders following these changes , as appropriate . ### during the negotiations , contracting authorities shall ensure the equal treatment of all tenderers . to that end , they shall not provide information in a discriminatory manner which may give some tenderers an advantage over others . they shall take particular care to ensure that all tenderers , whose tenders have not been eliminated pursuant to paragraph 5 , are informed in writing of any changes to the technical specifications or other procurement documents , other than those setting out the minimum requirements , providing sufficient time for such tenderers to modify and re - submit amended tenders following these changes .


### contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the negotiations without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other confidential information . ### in accordance with article 18 , contracting authorities shall not reveal to the other participants confidential information communicated by a candidate participating in the negotiations without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific information .


### contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific solutions or other specific confidential information . ### in accordance with article 18 , contracting authorities shall not reveal to the other participants solutions proposed or other confidential information communicated by a candidate participating in the dialogue without its agreement . such agreement shall not take the form of a general waiver but shall be given with reference to the intended communication of specific information .


### in innovation partnerships , any economic operator may submit a request to participate in response to a contract notice with a view to establishing a structured partnership for the development of an innovative product , service or works and the subsequent purchase of the resulting supplies , services or works provided that they correspond to the agreed performance levels and costs . ### in innovation partnerships , any economic operator may submit a request to participate in response to a contract notice with a view to establishing a structured partnership for the development of an innovative product , service or works and the subsequent purchase of the resulting supplies , services or works , provided that they correspond to the agreed performance levels and costs . the contract setting up the innovation partnership shall be awarded on the sole basis of the award criterion of the most economically advantageous tender in accordance with article 66 .


### the partnership shall be structured in successive stages following the sequence of steps in the research and innovation process , possibly up to the manufacturing of the supply or the provision of the services . it shall provide for intermediate targets to be attained by the partner and provide for payment of the remuneration in appropriate instalments . based on those targets , the contracting authority may decide after each stage to terminate the partnership and launch a new procurement procedure for the remaining phases , provided that it has acquired the relevant intellectual property rights . ### the partnership shall be structured in successive stages following the sequence of steps in the research and innovation process , which may include the manufacturing of the supply , or the provision of the services or the completion of the works . the partnership shall set intermediate targets to be attained by the partner and provide for remuneration in appropriate instalments . based on those targets , the contracting authority may decide after each stage to terminate the partnership and launch a new procurement procedure for the remaining phases , provided that the contracting authority has indicated in the procurement documents under which conditions it may make use of this discretion to terminate the partnership .


### in selecting candidates , contracting authorities shall pay particular attention to criteria concerning the tenderers ' capacity and experience in the field of research and development and of developing innovative solutions . they may limit the number of suitable candidates to be invited to participate in the procedure in accordance with article 64 . ### in selecting candidates , contracting authorities shall pay particular attention to criteria concerning the candidates ' capacity in the field of research and development and of developing innovative solutions . they may limit the number of suitable candidates to be invited to participate in the procedure in accordance with article 64 .


### the structure of the partnership and , in particular , the duration and value of the different phases shall reflect the degree of innovation of the proposed solution and the sequence of the research and innovation activities required for the development of an innovative solution not yet available on the market . the value and duration of a contract for the purchase of the resulting supply , service or works shall remain within appropriate limits , taking into account the need to recover the costs , including those incurred in developing an innovative solution , and to achieve an adequate profit . ### the contracting authority shall ensure that the structure of the partnership and , in particular , the duration and value of the different phases shall reflect the degree of innovation of the proposed solution and the sequence of the research and innovation activities required for the development of an innovative solution not yet available on the market . the estimated value of supplies , services or works shall not be disproportionate in relation to the investment required for their development .


### the negotiated procedure without prior publication may be foreseen for public works contracts , public supply contracts and public service contracts in any of the following cases : ### the negotiated procedure without prior publication may be used for public works contracts , public supply contracts and public service contracts in any of the following cases :


### the negotiated procedure without prior publication may be foreseen for public service contracts , where the contract concerned follows a design contest organised in accordance with this directive and is to be awarded , under the applicable rules , to the winner or one of the winners of the design contest ; in the latter case , all winners must be invited to participate in the negotiations . ### the negotiated procedure without prior publication may be used for public service contracts , where the contract concerned follows a design contest organised in accordance with this directive and is to be awarded , under the applicable rules , to the winner or one of the winners of the design contest ; in the latter case , all winners must be invited to participate in the negotiations .


### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as : ### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question and , wherever possible , on the basis of the monetisation of the life cycle as defined in article 2 , point 22 . those criteria may include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as :


### centralized data about reported cases of fraud , corruption , conflict of interests and other serious irregularities in the field of public procurement , including those affecting projects cofinanced by the budget of the union . ### centralized data about reported cases of fraud , corruption , conflict of interests and other serious irregularities in the field of public procurement , including those affecting projects cofinanced by the budget of the union , as well as , when possible , on outcome of referral to competent administrative , law enforcement or judicial authorities .


### 1 000 000 eur in the case of public supply contracts or public service contracts ; ### 800 000 eur in the case of public supply contracts or public service contracts ;


### 10 000 000 eur in the case of public works contracts . ### 5 000 000 eur in the case of public works contracts .


### without prejudice to the national law concerning access to information , and in accordance with national and eu legislation on data protection , the oversight body shall , upon written request , give unrestricted and full direct access , free of charge , to the concluded contracts referred to in paragraph 6 . access to certain parts of the contracts may be refused where their disclosure would impede law enforcement or otherwise be contrary to the public interest , would harm the legitimate commercial interests of economic operators , public or private , or might prejudice fair competition between them . ### without prejudice to the national law concerning access to information , and in accordance with national and eu legislation on data protection , the oversight body shall , upon request , give unrestricted and full direct access , free of charge , to the concluded contracts referred to in paragraph 6 . access to certain parts of the contracts may be refused only when their disclosure would impede law enforcement or otherwise be contrary to the public interest , would harm the legitimate commercial interests of economic operators , public or private , or might prejudice fair competition between them . decisions to deny access to certain parts of the public contracts on these grounds should be duly motivated and published .


### the names of the successful candidates or tenderers and the reasons for their selection ; ### where applicable , the results of the qualitative selection and / or reduction of numbers pursuant to article 64 and 65 , namely : the names of the selected candidates or tenderers and the reasons for their selection ; the names of the candidates or tenderers rejected and the reasons for their rejection ;


### national reporting and lists of contracting authorities ### national reporting


### the bodies established or appointed in accordance with article 84 shall forward to the commission an implementation and statistical report on each year , based on a standard form , not later than 31 october of the following year . ### member states shall forward to the commission a statistical report on each year , based on a standard form , not later than 31 october of the following year .


### for all contracts above the thresholds laid down in article 4 of this directive : ### for all contracts above the thresholds laid down in article 4 of this directive , the estimated number and value of contracts awarded during the year concerned , broken down for each type of authority by procedure and by works , supplies and services .


### for all contracts which fall below the thresholds laid down in article 4 of this directive , but would be covered by this directive if their value exceeded the threshold , the number and value of contracts awarded broken down by each type of authority . ### for procurement below the thresholds laid down in article 4 of this directive , but which would be covered by this directive if its value exceeded the threshold , an estimation of the aggregated total value of the procurement during the year concerned . this estimation may in particular be based on data available under national publication requirements .


### the commission shall establish the standard form for the annual implementation and statistical report referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 91 . ### the commission shall establish the standard form for the annual statistical report referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 91 .


### the scope of the emff should cover the support of the cfp which extends to conservation , management and exploitation of marine biological resources , fresh water biological resources and - aquaculture , as well as to the processing and marketing of fishery and aquaculture products , where such activities take place on the territory of member states , or in union waters , including by fishing vessels flying the flag of , and registered in , third countries , or by union fishing vessels , or by nationals of member states , without prejudice to the primary responsibility of the flag state , bearing in mind the provisions of article 117 of the united nations convention on the law of the sea . ### the scope of the emff should cover the support of the cfp which extends to conservation , management and sustainable exploitation of marine biological resources , fresh water biological resources and - aquaculture , as well as to the processing and marketing of fishery and aquaculture products , where such activities take place on the territory of member states , or in union waters , including by fishing vessels flying the flag of , and registered in , third countries , or by union fishing vessels , or by nationals of member states , without prejudice to the primary responsibility of the flag state , bearing in mind the provisions of article 117 of the united nations convention on the law of the sea .


### it is paramount to better integrate environmental concerns into the cfp which should deliver on the objectives and targets of the union ' s environmental policy and the europe 2020 strategy . the cfp is aimed at an exploitation of living marine biological resources that restores and maintains fish stocks at levels which can produce the maximum sustainable yield , not later than 2015 . the cfp shall implement the precautionary and eco - system approaches to fisheries management . consequently the emff should contribute to the protection of the marine environment as set out in the directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . ### it is paramount to make reference to eu environmental legislation in the cfp which should deliver on the objectives and targets of the union ' s environmental policy and the europe 2020 strategy . the cfp is aimed at an exploitation of living marine biological resources that restores and maintains fish stocks at levels which can produce the maximum sustainable yield , not later than 2015 . the cfp shall implement the precautionary and eco - system approaches to fisheries management . consequently the emff should contribute to the protection of the marine environment as set out in the directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy .


### it is paramount to better integrate environmental concerns into the cfp which should deliver on the objectives and targets of the union ' s environmental policy and the europe 2020 strategy . the cfp is aimed at an exploitation of living marine biological resources that restores and maintains fish stocks at levels which can produce the maximum sustainable yield , not later than 2015 . the cfp shall implement the precautionary and eco - system approaches to fisheries management . consequently the emff should contribute to the protection of the marine environment as set out in the directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . ### it is paramount to better integrate environmental concerns into the cfp which should deliver on the objectives and targets of the union ' s environmental policy and the europe 2020 strategy . the cfp is aimed at a sustainable exploitation of living marine biological resources that restores and maintains fish stocks at levels which can produce the maximum sustainable yield , not later than 2015 . the cfp shall implement an ecosystem - based approach to fisheries and aquaculture management . consequently the emff should contribute to the protection of the marine environment as set out in the directive 2008 / 56 / ec of the european parliament and the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy .


### the consequences laid down for the failure to fulfil the eligibility conditions should apply in case of infringements of the cfp rules by the beneficiaries . in order to determine the amount of ineligible expenditure , the gravity of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary should be taken into account . ### the consequences laid down for the failure to fulfil the eligibility conditions should apply in case of infringements of the cfp rules by the beneficiaries . in order to determine the amount of ineligible expenditure , the severity , extent , duration and re - occurrence of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary should be taken into account .


### new forms of income combined with aquaculture activities have already shown their added value for business development . therefore the emff should support these complementary activities outside aquaculture such as angling - tourism , educational or environmental activities . ### new forms of income combined with aquaculture activities have already shown their added value for business development . therefore the emff should support these complementary activities outside aquaculture such as angling - tourism , educational or environmental activities . in particular innovations that contribute to the use of waste materials including dissolved nutrients , the production of renewable energy and the integration of different trophic levels such as fish alongside shellfish and algae should be supported .


### another important form of increasing the income of aquaculture enterprises is adding value to their products by processing and marketing their own production , as well as introducing new species with good market prospects and thus diversifying their production . ### another important form of increasing the income of aquaculture enterprises is adding value to their products by processing and marketing their own production , as well as introducing new species with good market and environmental prospects and thus diversifying their production .


### investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to improve the overall performance and competitiveness of operators . ### investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to minimise the environmental impact of aquaculture and to improve the overall performance and competitiveness of operators .


### it is paramount that member states and operators are equipped in such a way that controls can be carried out to a high standard and therefore ensure compliance with the rules of the common fisheries policy while providing for the sustainable exploitation of living aquatic resources ; the emff should therefore support member states and operators in conformity with council regulation no 1224 / 2009 . by creating a culture of compliance , this support should contribute to sustainable growth . ### it is paramount that member states and operators are equipped in such a way that controls can be carried out regularly and to a high standard and therefore ensure compliance with the rules of the common fisheries policy while providing for the sustainable exploitation of living aquatic resources ; the emff should therefore support member states and operators in conformity with council regulation no 1224 / 2009 . by creating a culture of compliance , this support should contribute to sustainable growth .


### provisions should be laid down for support to collect , manage and use of fisheries data as specified in the multiannual union programme , in particular to support national programmes and the management and use of data for scientific analysis and cfp implementation . the support granted to member states on the basis of the regulation no . 861 / 2006 for the expenditure incurred relating to the collection , management and use of fisheries data should be continued under the emff pursuing the logic of a single fund . ### provisions should be laid down for support to collect , manage and use of fisheries data as specified in the multiannual union programme , in particular to support national programmes and the management and use of data for scientific analysis and cfp implementation . the support granted to member states on the basis of the regulation no . 861 / 2006 for the expenditure incurred relating to the collection , management and use of fisheries data should be continued under the emff pursuing the logic of a single fund . the data referred to in this paragraph should be made publicly available .


### it is also necessary to support the cooperation among member states , as well as with third countries where relevant , with respect to the collection of data within the same sea basin , as well as with the relevant international scientific bodies . ### it is also necessary to support the cooperation among member states , as well as with third countries where relevant , with respect to the collection of data within the same sea basin , as well as with the relevant international scientific bodies . the data referred to in this paragraph should be publically available .


### in order to address the specific needs of the cfp mentioned in articles 50 and 51 of the [ cfp regulation ] and contribute to the compliance with the cfp rules , additional provisions to the rules on interruption of the payment deadline [ regulation no [ … ] laying down common provisions ] should be laid down . where a member state or an operator has failed to comply with its obligations under the cfp or where the commission has evidence to suggest this lack of compliance , as a precautionary measure , the commission should be allowed to interrupt payments . ### in order to address the specific needs of the cfp mentioned in articles 50 and 51 of the [ cfp regulation ] and contribute to the compliance with the cfp rules , additional provisions to the rules on interruption of the payment deadline [ regulation no [ … ] laying down common provisions ] should be laid down . where a member state or an operator has failed to comply with its obligations under the cfp or where the commission has strong and convincing evidence to suggest this lack of compliance , as a precautionary measure , the commission should be allowed to interrupt payments .


### promoting sustainable and competitive fisheries and aquaculture ; ### promoting sustainable and competitive fisheries and aquaculture ; including extensive aquaculture ;


### the achievement of the objectives of the emff shall contribute to the europe 2020 strategy for smart , sustainable and inclusive growth . it shall be pursued through the following six union priorities , which translate the relevant thematic objectives of the common strategic framework : ### the achievement of the objectives of the emff shall contribute to the implementation of the common fisheries policy and to the europe 2020 strategy for smart , sustainable and inclusive growth . it shall be pursued through the following six union priorities , which translate the relevant thematic objectives of the common strategic framework :


### – an evaluation of the effects of the fishing sector on the ecosystem . ### – an evaluation of the effects of the fishing and aquaculture sectors on the ecosystem .


### support to systems of transferable fishing concessions of the cfp ### support to systems of allocation of fishing opportunities


### support to systems of transferable fishing concessions of the cfp ### support to voluntary systems of transferable fishing concessions of the cfp


### in order to establish or modify systems of transferable fishing concessions under article 27 of the [ regulation on the cfp ] , the emff may support : ### the emff may support the establishment or modification of systems that improve the allocation of fishing opportunities among operators , such as :


### in order to establish or modify systems of transferable fishing concessions under article 27 of the [ regulation on the cfp ] , the emff may support : ### in order to establish or modify voluntary systems of transferable fishing concessions under article 27 of the [ regulation on the cfp ] , the emff may support :


### the design and development of technical and administrative means necessary for the creation or functioning of a transferable fishing concessions system ; ### the design and development of technical and administrative means necessary for the creation or functioning of a innovative system for the allocation of fishing opportunities ;


### stakeholder participation in designing and developing transferable fishing concessions systems ; ### stakeholder participation in designing and developing innovative systems as referred to in paragrahp 1 ;


### the monitoring and evaluation of transferable fishing concessions systems ; ### the monitoring and evaluation of systems referred to in paragraph 1 ;


### the management of transferable concessions systems . ### the management of systems referred to in paragraph 1 .


### support under paragraph 1 , and shall only be granted to public authorities . support under paragraph 1 of this article shall be granted to public authorities legal or natural persons or recognized producer organizations involved in collective management of pooled transferable fishing concessions in accordance with article 28 of the regulation on common fisheries . ### support under paragraph 1 shall only be granted to public authorities .


### stakeholder participation in designing and implementing conservation measures in the meaning of articles 17 and 21 of the [ regulation on common fisheries policy ] ### stakeholder participation and cooperation between member states in designing and implementing conservation measures in the meaning of articles 17 and 21 of the [ regulation on common fisheries policy ]


### in order to reduce the impact of fishing on the marine environment , foster the elimination of discards and facilitate the transition to exploitation of living marine biological resources that restores and maintains populations of harvested species above levels which can produce the msy , the emff may support investments in equipment : ### in order to reduce the impact of fishing on the marine environment , foster the elimination of discards and facilitate the transition to the exploitation of living marine biological resources at levels capable of restoring and maintaining populations of harvested species above levels which can produce the msy , the emff may support research and investments in equipment aimed at :


### collection of waste from the sea such as the removal of lost fishing gears and marine litter ; ### collection of waste from the sea by fishermen , such as the removal of lost fishing gears and marine litter ;


### aquaculture methods compatible with specific environmental needs and subject to specific management requirements resulting from the designation of natura 2000 areas in accordance with council directive 92 / 43 / eec and council and european parliament directive 2009 / 147 / ec ; ### aquaculture methods that use existing structures like natural ponds , and aim to create an activity that is semi - natural and compatible with specific environmental needs subject to specific management requirements resulting from the designation of natura 2000 areas in accordance with council directive 92 / 43 / eec and council and european parliament directive 2009 / 147 / ec ;


### the emff may support the implementation of a union control , inspection and enforcement system as provided for in article 46 of the [ regulation on the common fisheries policy ] and specified in council regulation no 1224 / 2009 of 20 november 2009 establishing a union control system for ensuring compliance with the rules of the common fisheries policy . ### the emff may support the implementation of a union control , inspection and enforcement system as provided for in article 46 of the [ regulation on the common fisheries policy ] and specified in council regulation no 1224 / 2009 of 20 november 2009 establishing a union control system for ensuring compliance with the rules of the common fisheries policy . such system should result in a number of controls based on the size of fleets in different member states .


### market intelligence ; ### market intelligence ; including the establishment of electronic markets


### the emff may support the development and dissemination of market intelligence for fishery and aquaculture products by the commission in accordance with article 49 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] . ### the emff may support the development and dissemination of market intelligence for fishery and aquaculture products by the commission in accordance with article 49 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] , including establishing electronic markets better to coordinate information between market operators and processors ;


### for the cases of financial corrections applied on expenditure directly linked to the non - compliance with article 105 , the member states shall decide the amount of a correction taking into account the gravity of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary . ### for the cases of financial corrections applied on expenditure directly linked to the non - compliance with article 105 , the member states shall decide the amount of a correction taking into account the severity , extent , duration and re - occurrence of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary .


### the financial sector is evolving and new categories of financial institutions are created by union law . the importance of new entities and activities outside the regular banking system is growing and their impact on financial stability has become greater . therefore , it is appropriate that the definition of public - interest entity also encompasses other financial institutions and entities such as investment firms , payment institutions , undertakings for collective investments in transferable securities , electronic money institutions and alternative investment funds . ### the financial sector is evolving and new categories of financial institutions have developed in response to regulatory and technological developments . the importance of new entities and activities outside the traditional banking system that were previously unregulated at union level is growing and their impact on financial stability has become greater . therefore , it is appropriate that the definition of public - interest entity also encompasses investment firms and payment institutions , while certain aspects of the regulation also apply to undertakings for collective investments in transferable securities , electronic money institutions and alternative investment funds .


### audit of annual and consolidated financial statements is intended as a statutory safeguard for investors , lenders and business counterparties who have a stake or a business interest in public - interest entities . hence , statutory auditors and audit firms should be completely independent when carrying out statutory audits of such entities and conflicts of interest should be avoided . in order to determine the independence of auditors and audit firms , the concept of network in which auditors and firms operate has to be taken into account . ### audit of annual and consolidated financial statements is intended as a statutory safeguard for investors , lenders and business counterparties who have a stake or a business interest in public - interest entities . hence , statutory auditors and audit firms should be completely independent when carrying out statutory audits of such entities and conflicts of interest should be avoided . they may inform the audited entity of matters arising from the audit , but should abstain from the internal decision processes of the audited entity . if they find themselves in a situation where the significance of the threats to their independence , even after application of safeguards to mitigate those threats , is too high , they should resign or abstain from the audit engagement . in order to determine the independence of auditors and audit firms , the concept of network in which auditors and firms operate has to be taken into account .


### in order to ensure a high level of investor and consumer confidence in the internal market by avoiding conflicts of interests , statutory auditors and audit firms should be subject to appropriate supervision by competent authorities which are independent from the audit profession and which have adequate capacity , expertise and resources . the national competent authorities should have the necessary powers to undertake their supervisory tasks , including the capacity to access documents , demand information from any person and carry out inspections . they should specialize in the supervision of financial markets , of compliance with financial reporting obligations or in statutory audit oversight . however , it should be possible that the supervision of the compliance with the obligations set on public - interest entities is carried out by the competent authorities responsible for the supervision of those entities . the funding of the competent authorities should be free from any possible undue influence by statutory auditors or audit firms . ### in order to ensure a high level of investor and consumer confidence in the internal market by avoiding conflicts of interests , statutory auditors and audit firms should be subject to appropriate supervision by competent authorities which are independent from the audit profession and which have adequate capacity , expertise and resources . the national competent authorities should have the necessary powers to undertake their supervisory tasks , including the capacity to access documents , demand information from any person and carry out inspections . they should specialize in the supervision of compliance with financial reporting obligations or in statutory audit oversight . however , it should be possible that the supervision of the compliance with the obligations set on public - interest entities is carried out by the competent authorities responsible for the supervision of those entities . the funding of the competent authorities should be free from any possible undue influence by statutory auditors or audit firms .


### sustainable audit capacity and a competitive market for statutory audit services in which there is a sufficient choice of audit firms capable of carrying out statutory audits of public - interest entities are required in order to ensure a smooth functioning of capital markets . esma should report on the changes brought in the audit market structure by this regulation . when carrying such analysis , esma should take into account the impact of the national civil liability rules for statutory auditors on the structure of the audit market . based on such report and other appropriate evidence , the commission should present a report on the impact of the national liability rules for statutory auditors on the audit market structure and should take the steps it considers appropriate as a result of its findings . ### sustainable audit capacity and a competitive market for statutory audit services in which there is a sufficient choice of audit firms capable of carrying out statutory audits of public - interest entities are required in order to ensure a smooth functioning of capital markets . the european competition network should report on the changes brought in the audit market structure by this regulation . when carrying such analysis , the ecn should take into account the impact of the national civil liability rules for statutory auditors on the structure of the audit market . based on such report and other appropriate evidence , the commission should present a report on the impact of the national liability rules for statutory auditors on the audit market structure and should take the steps it considers appropriate as a result of its findings .


### for the purposes of this regulation , the definitions laid down in article 2 of directive 2006 / 43 / ec shall apply , except for the definitions of ' audit report ' and ' competent authority ' . ### for the purposes of this regulation , the definitions laid down in article 2 of directive 2006 / 43 / ec shall apply , except for the definitions of ' audit report ' , ' competent authority ' and ' public - interest entities ' . for the purpose of this regulation ' public - interest entities ' shall cover : entities governed by the law of a member state whose transferable securities are admitted to trading on a regulated market of any member state within the meaning of point 14 of article 4 of directive 2004 / 39 / ec ; credit institutions as defined in point 1 of article 4 of directive 2006 / 48 / ec of the european parliament and of the council* ; insurance undertakings within the meaning of article 13 of directive 2009 / 138 / ec of the european parliament and of the council** ; entities governed by the law of a member state which are payment institutions as defined in point 4 of article 4 of directive 2007 / 64 / ec of the european parliament and of the council*** , unless article 15 of that directive applies ; entities governed by the law of a member state which are electronic money institutions as defined in point 1 of article 2 of directive 2009 / 110 / ec of the european parliament and of the council**** , unless article 15 of directive 2007 / 64 / ec applies ; investment firms as defined in point 1 of article 4 of directive 2004 / 39 / ec ; entities governed by the law of a member state which are central securities depositories ; central counterparties as defined in article 2 of regulation x / xxxx of the european parliament and of the council***** [ see proposal for a regulation on otc derivatives , central counterparties and trade repositories , com484 ) ] ; _________________ * oj l 177 , 30 . 6 . 2006 , p . 1 ** oj l 335 , 17 . 12 . 2009 , p . 1 *** oj l 187 , 18 . 7 . 2009 , p . 5 **** oj l 267 , 10 . 10 . 2009 , p . 7 *****


### competent authorities supervising credit institutions and insurance undertakings shall establish regular a dialogue with the statutory auditors and audit firms carrying out the statutory audit of those institutions and undertakings . ### competent authorities supervising credit investment firms , institutions and insurance undertakings shall establish regular a dialogue with the statutory auditors and audit firms carrying out the statutory audit of those institutions and undertakings at least once a year , a trilateral meeting between competent authorities supervising credit institutions and insurance undertakings , the statutory auditors and audit firms carrying out the statutory audit and the institutions and undertakings themselves shall take place .


### the public - interest entities referred to in points and shall explain to the public the reasons for which it considers it not appropriate to have either an audit committee or an administrative or supervisory body entrusted to carry out the functions of an audit committee . ### the public - interest entities referred to in point shall explain to the national competent authority the reasons for which it considers it not appropriate to have either an audit committee or an administrative or supervisory body entrusted to carry out the functions of an audit committee .


### esma shall consolidate this information and make it public . ### the commission shall consolidate this information and make it public .


### the competent authorities referred to in article 35 shall regularly monitor the developments in the market for providing statutory audit services to public - interest entities . ### the european competition network shall regularly monitor the developments in the market for providing statutory audit services to public - interest entities .


### the competent authorities shall in particular assess the following : ### the authorities referred to in the first sub paragraph shall in particular assess the following :


### by x x 20xx [ 2 years after the entry into force of the regulation ] , and at least on a two - year basis thereafter , each competent authority shall draw up a report on this issue and submit it to esma , eba and eiopa . ### by . . . * , and at least on a four - year basis thereafter , each competent authority shall draw up a report on this issue and submit it to the commission . * oj : please insert date : four years after the entry into force of the regulation .


### esma , eba and eiopa shall use those reports to draw up a joint report on the situation at union level . the report shall be submitted to the commission , the european central bank and the european systemic risk board . ### the commission shall use those reports to draw up a joint report on the situation at union level . the report shall be submitted to the european parliament , the european central bank and the european systemic risk board .


### esma ### egaob


### esma shall provide advice to the competent authorities in the cases provided for in this regulation . the competent authorities shall consider that advice before taking any final decision under this regulation . ### the egaob shall provide advice to the competent authorities in the cases provided for in this regulation . the competent authorities shall consider that advice before taking any final decision under this regulation .


### in a report to be prepared by x x 20xx [ two years after the entry into force of the regulation ] , esma shall undertake an evaluation of the structure of the audit market . ### in a report to be prepared by . . . * , the commission shall undertake an evaluation of the structure of the audit market . * oj : please insert date : four years after the entry into force of the regulation .


### in a report to be prepared by esma by x x 20xx [ four years after the entry into force of the regulation ] , shall examine whether the competent authorities referred to in article 35 are sufficiently empowered and have adequate resources to carry out their tasks . ### in a report to be prepared by the commission by . . . * , shall examine whether the competent authorities referred to in article 35 are sufficiently empowered and have adequate resources to carry out their tasks . * oj : please insert date : four years after the entry into force of the regulation .


### in a report to be prepared by esma by x x 20xx [ six years after the end of the transitional period ] , shall examine the following issues : ### in a report to be prepared by the commission , following the advice of the european competition network and the egaob , by . . . * , shall examine the following issues : * oj : please insert date : six years after the end of the transmission period .


### the competent authority making any such request shall inform esma of any request referred to in the first and second subparagraphs . ### the competent authority making any such request shall inform the commission of any request referred to in the first and second subparagraphs .


### within 15 working days of the establishment of the college of competent authorities with regard to a specific network , its members shall select a facilitator . in the absence of agreement , esma shall appoint a facilitator . ### within 15 working days of the establishment of the college of competent authorities with regard to a specific network , its members shall select a facilitator .


### taking into consideration that some products were not previously covered by the community legislation in the field of biocidal products , it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances , treated articles and materials and food contact materials . ### taking into consideration that some products were not previously covered by the community legislation in the field of biocidal products , it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances and treated articles and materials .


### in the case of scientific research and development , the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start . the person shall draw up and maintain written records detailing the identity of the biocidal product or active substance , labelling data , quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment . the persons concerned shall , if requested , make this information available to the competent authority . ### in the case of scientific research and development , including product and process - oriented research and development , the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start . the person shall draw up and maintain written records detailing the identity of the biocidal product or active substance , labelling data and quantities supplied , and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment . the persons concerned shall , if requested , make this information available to the competent authority .


### the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials ; ### the name , using wherever possible common nomenclature of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials , where relevant and for all active substances which are intended to be released under normal or foreseeable conditions of use from the treated article or material , unless labelling requirements or alternative means to meet information requirements already exist under sector - specific legislation .


### any hazard statement or precautionary statement set out in the authorisation for the biocidal product . ### only for treated articles and where relevant , any hazard statement or precautionary statement set out in the authorisation for the biocidal product .


### product - type 20 : - ### product - type 20 : food and feed disinfectants products used for disinfecting food or feedstocks by the control of harmful organisms .


### article 3 of the treaty on european union provides that the union ' shall work for the sustainable development of europe based on balanced economic growth and price stability , a highly competitive social market economy , aiming at full employment and social progress , and a high level of protection and improvement of the quality of the environment . ### article 3 of the treaty on european union provides that the union ' shall work for the sustainable development of europe based on balanced economic growth and price stability , a highly competitive social market economy , aiming at full employment and social progress , and a high level of protection and improvement of the quality of the environment ' , taking into consideration that these goals may be best achieved through open markets .


### the need to supplement already existing indicators with data that incorporate environmental and social aspects in order to allow more coherent and comprehensive policy making has been recognised in commission communication com 433 of august 2009 on gdp and beyond . to this end , environmental accounts offer a means of monitoring the pressures exerted by the economy on the environment and of exploring how these might be abated . in line with the tenets of sustainable development and the drive to achieve a low - carbon economy , embedded in the lisbon strategy and various major initiatives , developing a data framework that consistently includes environmental issues along with economic ones becomes all the more imperative . ### the need to supplement already existing indicators with data that incorporate environmental and social aspects in order to allow more coherent and comprehensive policy making has been recognised in commission communication com 433 of august 2009 on gdp and beyond . to this end , environmental accounts offer a means of monitoring all the effects of the economy on the environment and of exploring how these might be abated . in line with the polluter - pays principle , the tenets of sustainable development and the drive to achieve a low - carbon economy , embedded in the lisbon strategy and various major initiatives , developing a data framework that consistently includes environmental issues along with economic ones becomes all the more imperative .


### the european heritage label should seek synergies and complementarities with other initiatives such as the unesco world heritage list and the council of europe ' s ' european cultural routes ' . the added value of the new european heritage label should be based on the contribution made by the selected sites to european history and culture , on a clear educational dimension reaching out to citizens , including young people , and on networking between the sites to share experiences and best practices . the main focus of the initiative should be on the promotion and the access of the sites , and on the quality of the explanations given and of the activities proposed , rather than on the conservation of the sites , which should be guaranteed by existing protection regimes . ### the european heritage label should seek to supplement but not duplicate initiatives such as the unesco world heritage list and the council of europe ' s ' european cultural routes ' . the added value of the new european heritage label should be based on the contribution made by the selected sites to european history and culture , on a clear educational dimension reaching out to citizens , including young people , and on networking between the sites to share experiences and best practices . the main focus of the initiative should be on the promotion and the access of the sites , and on the quality of the explanations given and of the activities proposed , rather than on the conservation of the sites , which should be guaranteed by existing protection regimes .


### – and / or the place and role of a site in european history and european integration , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological or industrial movements ; ### – and / or the place and role of a site in european history , and its links with key european events or personalities , as well as with cultural , artistic , political , social , scientific , technological or industrial movements ;


### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union ' s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20%20 and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 . ### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union ' s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20%20 and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 . these energy and climate objectives should be met in the most cost - effective way as possible ;


### the investment needs up to 2020 in electricity and gas transmission infrastructures of european relevance have been estimated at about eur 200 billion . the significant increase in investment volumes compared to past trends and the urgency to implement the energy infrastructure priorities requires a new approach in the way energy infrastructures , and notably those of cross - border nature , are regulated and financed . ### the investment needs up to 2020 in electricity and gas transmission infrastructures of european relevance have been estimated at about eur 200 billion . the significant increase in investment volumes compared to past trends and the urgency to implement the energy infrastructure priorities requires a new approach in the way energy infrastructures , and notably those of cross - border nature , are regulated and financed . this approach nonetheless takes account of fiscal consolidation mechanisms taking place across the eu , prioritises those projects of common interest providing genuine european added value , and recognises where member state authorities and the market are better placed to intervene .


### in pursuing its objectives , the agency should take full account of the process of enlargement of the union and of the specific constraints relating to rail links with third countries . the agency should have sole responsibility for the functions and powers assigned to it . ### in pursuing its objectives , the agency should take full account of the process of enlargement of the union and of the specific constraints relating to rail links with third countries .


### a dossier for the active substance satisfying the requirements set out in annex ii ; ### a dossier for the active substance satisfying the requirements set out in annex ii or a letter of access ;


### if the agency considers that the application is incomplete , it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information . ### if the agency considers that the application is incomplete , it shall inform the applicant as to what additional information is required for the validation of the application and shall set a time limit of up to two months for the submission of that information .


### if , when the dossiers are evaluated , it appears that additional information is necessary to carry out the evaluation , the evaluating competent authority shall ask the applicant to submit such information within a specified time limit , and shall inform the agency thereof . ### if , when the dossiers are evaluated , it appears that additional information is necessary to carry out the evaluation , the evaluating competent authority shall ask the applicant to submit such information within a time limit that shall not exceed six months . in exceptional circumstances and following proper justification , the time limit may be extended by up to a further six months . the evaluating competent authority shall inform the agency thereof .


### at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt a decision concerning a renewal of the inclusion of the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### at the end of the period referred to in paragraph 3 or on receipt of the opinion of the agency , the commission shall adopt a decision concerning a renewal of the inclusion of the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . if the commission decides to renew the inclusion of the active substance in annex i , mention should be made of the name of the applicant .


### the commission may consult the agency on any questions of a scientific or technical nature related to the review of inclusion of an active substance in annex i . the agency shall , within nine months from the request , prepare an opinion and submit it to the commission . ### the commission may consult the agency on any questions of a scientific or technical nature related to the review of inclusion of an active substance in annex i . the agency shall , within six months from the request , prepare an opinion and submit it to the commission .


### in the case of a frame formulation , a reduction in the percentage of the active substance in the reference biocidal product may be allowed , and / or an alteration in percentage composition of one or more non - active substances , and / or the replacement of one or more non - active substances by others presenting the same or lower risk . ### in the case of a frame formulation , the following variations are permitted in respect of one or more reference biocidal products : elimination of an active substance in respect of a reference biocidal product with at least two active substances ; reduction in the percentage of the active substances ; elimination of one or more non - active substances ; variation in the percentage composition of one or more non - active substances ; replacement of one or more non - active substances .


### the reference biocidal product within the group of products comprising the frame formulation that has the highest allowed concentration of the active substances ; ### the reference biocidal product within the group of products comprising the frame formulation ;


### the receiving competent authority may require a translation of the national authorisation and application into one or several of the official languages of the member state where that competent authority is situated . ### the receiving competent authority may require a translation of the national authorisation and application into one of the official languages of the member state where that competent authority is situated .


### the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . ### after consulting the applicant , the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 .


### the commission shall adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . ### within three months following the notification , the commission shall , after consultation with the applicant , adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise , or restriction of , the national authorisation in accordance with the procedure referred to in article 72 . should the commission ask the agency for an opinion under the procedure set out in article 30 , the three - month period shall be suspended until the agency has forwarded its opinion .