### when the trader has either refused or has more than once failed to remedy the lack of conformity the consumer should be entitled to choose freely any of the available remedies . the trader ' s refusal can be either explicit or implicit , meaning in the latter case that the trader does not respond or ignores the consumer ' s request to remedy the lack of conformity . ### when various circumstances are relevant the consumer should be entitled to choose freely any of the available remedies . this would be the case in particular where the trader has either refused or has failed or will fail to remedy the lack of conformity or the trader has in remedying the defect caused significant inconvenience or will do so . the trader’s refusal can be either explicit or implicit , meaning in the latter case that the trader does not respond or ignores the consumer’s request to remedy the lack of conformity . the question of whether a trader will cause significant inconvenience in remedying a defect or is likely to fail to be able to remedy a defect is to be judged on objective grounds , such as , the poor after sale service that has been provided to the consumer .


### formal requirements for off - premises contracts ### pre - contractual formal requirements for off - premises contracts .


### formal requirements for distance contracts ### pre - contractual formal requirements for distance contracts


### if the contract is concluded through a medium which allows limited space or time to display the information , the trader shall provide at least the information regarding the main characteristics of the product and the total price referred to in articles 5 and on that particular medium prior to the conclusion of such a contract . the other information referred to in articles 5 and 7 shall be provided by the trader to the consumer in an appropriate way in accordance with paragraph 1 . ### if the contract is concluded via telephone or through a medium which allows limited space or time to display the information , the trader shall provide at least the information regarding the main characteristics of the product and the total price referred to in articles 5 and on that particular medium prior to the conclusion of such a contract . the other information referred to in articles 5 shall be provided by the trader to the consumer in an appropriate way in accordance with paragraph 1 .


### draft legislative resolution ### - a . whereas the fiscalis and customs programmes have divergent and distinctive aims , objectives and contexts , and were working well as separate programmes according to the evaluations executed by independent consultants ,


### draft legislative resolution ### - 1 . points out that the financial envelope specified in the legislative proposal constitutes only an indication to the legislative authority and cannot be fixed until agreement is reached on the proposal for a regulation laying down the multiannual financial framework for the years 2014 - 2020 ;


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


### implementing the international dimension of the ' europe 2020 ' strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change and environment . this objective shall be measured by the uptake of the ' europe 2020 ' policies and objectives by key partner countries ; ### implementing the international dimension of the ' europe 2020 ' strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change , job creation and environment . this objective shall be measured by the uptake of the ' europe 2020 ' policies and objectives by key partner countries ;


### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation and outreach activities to promote union ' s values and interests . this objective may be measured , inter alia , by opinion surveys or evaluations . ### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation and outreach activities to promote union ' s values and interests . projects carried out in this regard should , however , meet results - based criteria and deliver demonstrable value for money .


### all third countries , regions and territories may be eligible for cooperation under this regulation . ### all third countries , regions and territories may be eligible for cooperation under this regulation . relevant best practices and lessons learned from the previous instruments should be taken into account when deciding on the eligibility of countries and sectors .


### 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 the receiving competent authority 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 receiving competent authority 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 one month 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 specified 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 .


### 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 .


### a biocidal product shall be considered a low - risk biocidal product if both the following conditions are fulfilled : for any given environmental compartment , the ratio of the predicted environmental concentration to predicted no - effect concentration may be derived and does not exceed 0 . 1 ; for any effect to human health , the margin of exposure and exposure concentration ) is higher than 1 , 000 . however , a biocidal product shall not be considered a low - risk biocidal product if at least one of the following conditions is present : it contains one or more active substances which fulfil the criteria for being persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ; it contains one or more active substances qualified as endocrine disrupters ; it contains one or more active substances which have been classified in accordance with regulation no 1272 / 2008 as or which meets the criteria to be classified as one of the following : carcinogenic ; mutagenic ; neurotoxic ; immunotoxic ; toxic to reproduction ; sensitising . 2 . notwithstanding paragraph 1 , a biocidal product shall be considered a low - risk biocidal product if the active substances in the biocidal product are contained in such way that only a negligible exposure can take place under normal conditions of use and the product is handled under strictly controlled conditions during all other stages of its lifecycle . 3 . for a low - risk biocidal product it shall be demonstrated that the potential for the development of resistance in target organisms due to the use of the biocidal product is low . 4 . in addition to the active substances referred to in article 15 of regulation no 1907 / 2006 , active substances manufactured or imported for use in low - risk biocidal products that are authorised for placing on the market in accordance with article 15 shall be regarded as being registered and the registration as completed for manufacture or import for use in a low - risk biocidal product and therefore as fulfilling the requirements of chapters 1 and 5 of title ii of that regulation . ### a biocidal product shall be considered a low - risk biocidal product if at least one of the following conditions is fulfilled : the biocidal product is not classified for human health or environmental hazards under regulation no 1272 / 2008 ; the classification of the biocidal product is not associated with the signal word ‘ danger’ on the label required under regulation no 1272 / 2008 ; and under normal and reasonably foreseeable conditions of use of the product without the use of personal protective equipment , the requirements in article 16 , and are met ; c ) the active substance in the biocidal product are contained in such a way that under normal or reasonably foreseeable conditions of use the exposure is negligible and the product is handled under strictly controlled conditions during all other stages of its lifecycle . 2 . however , a biocidal product shall not be considered a low - risk biocidal product if it contains an active substance or a substance of concern that : fulfils the criteria for being persistent , bio - accumulative and toxic or very persistent and very bio - accumulative in accordance with annex xiii of regulation no 1907 / 2006 ; is identified as endocrine disrupters under article 57 of regulation no 1907 / 2006 ; has been classified in accordance with regulation no 1272 / 2008 as , or which meets the criteria to be classified as , one of the following : carcinogenic ; mutagenic ; neurotoxic ; immunotoxic ; toxic to reproduction ; sensitising . 4 . in addition to the active substances referred to in article 15 of regulation no 1907 / 2006 , active substances manufactured or imported for use in low - risk biocidal products that are authorised for placing on the market in accordance with article 15 shall be regarded as being registered and the registration as completed for manufacture or import for use in a low - risk biocidal product and therefore as fulfilling the requirements of chapters 1 and 5 of title ii of that regulation .


### if it appears that additional information is necessary in order to carry out a full evaluation of the application , the receiving competent authority shall request the applicant to submit such information . the twelve - month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received . ### if it appears that additional information is necessary in order to carry out a full evaluation of the application , the receiving competent authority shall request the applicant to submit such information within a specified 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 twelve - month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received .


### if , when the application for renewal is evaluated , it appears that additional information is necessary in order to carry out a full evaluation of the application , the receiving competent authority shall ask that the applicant submits such information . the six - month period referred to in paragraph 6 shall be suspended from the date of the request until the date the information is received . ### if , when the application for renewal is evaluated , it appears that additional information is necessary in order to carry out a full evaluation of the application , the receiving competent authority shall ask that the applicant submits such information within a specified 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 six - month period referred to in paragraph 6 shall be suspended from the date of the request until the date the information is received .


### 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 . ### within three months following the notification , 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 .


### if the commission decision dismisses the grounds presented for refusing or restricting the national authorisation the competent authority that proposed to refuse to recognise the authorisation , or to restrict the authorisation , shall without delay authorise the biocidal product concerned in accordance with the national authorisation issued by the reference competent authority ### if the commission decision confirms the grounds presented for refusing or restricting the subsequent authorisation , the competent authority that had previously authorised the biocidal product shall without delay review its national authorisation to comply with that decision . if the commission decision confirms the initial national authorisation , the competent authority that proposed to refuse to recognise a national authorisation , or to recognise the national authorisation subject to certain conditions , shall without delay authorise the biocidal product concerned in accordance with the initial authorisation


### if the evaluating competent authority that carried out the initial evaluation of the application for community authorisation decides that a full evaluation of the application is not necessary , it shall , within twelve months after the validation , prepare and submit to the agency a recommendation on the renewal of the authorisation . ### if the evaluating competent authority that carried out the initial evaluation of the application for community authorisation decides that a full evaluation of the application is not necessary , it shall , within six months after the validation , prepare and submit to the agency a recommendation on the renewal of the authorisation .


### a biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met : the source of the active substances it contains is the same in terms of manufacturer and location of the production plant ; it is either the same or similar with regard to the non - active substances present and the type of formulation ; it is either the same or equivalent in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment . ### a biocidal product shall be considered as substantially identical to the reference product if : the source of the active substances it contains is the same in terms of manufacturer and location of the production plant ; and ; it is either the same or similar with regard to the non - active substances present and the type of formulation ; and ; it is either the same or equivalent in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment .


### 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 .


### where any experiment or test takes place in a member state other than the member state where placing on the market of the biocidal product occurs , the applicant shall obtain experiment or test authorisation from the competent authority of the member state in the territory of which the experiments or tests are to be conducted . ### where any experiment or test takes place in a member state other than the member state where placing on the market of the biocidal product occurs , the applicant shall notify the competent authority of the member state in the territory of which the experiments or tests are to be conducted . the applicant 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 applicant shall , if requested , make this information available to the competent authority .


### treated articles or materials shall be labelled with the following information : the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials ; where relevant , the biocidal property attributed to treated articles or materials ; the authorisation number of all biocidal products that were used for the treatment or were incorporated in the articles or materials ; any hazard statement or precautionary statement set out in the authorisation for the biocidal product . ### treated articles or materials shall be labelled with the following information : the names , using wherever possible common nomenclature , of all active substances that were used to treat the articles or materials or that were incorporated in the articles or materials , unless there are already labelling requirements under existing sector - specific legislation ; where relevant , the biocidal property attributed to treated articles ; the authorisation number of all biocidal products that were used for the treatment or were incorporated in the articles or materials ; only for treated articles and where relevant , any hazard statement or precautionary statement set out in the authorisation for the biocidal product .


### the labelling shall be clearly visible , easily legible and appropriately durable . ### the labelling shall be clearly visible , easily legible , appropriately durable and in the national language or languages of the member state on whose market the treated article or material is to be placed .


### the labelling shall be clearly visible , easily legible and appropriately durable . ### the labelling shall be clearly visible , easily legible , appropriately durable and in the national language or one of the national languages of the member state on whose market the treated article or material shall be placed .


### the commission shall draw up a report on the implementation of this regulation and , in particular , on the functioning of the community authorisation procedure and mutual recognition , by 1 january 2023 . the commission shall submit the report to the european parliament and the council ### the commission shall draw up a report on the implementation of this regulation and , in particular , on the functioning of the community authorisation procedure and mutual recognition , by 1 january 2016 . the commission shall submit the report to the european parliament and the council


### member states may require that biocidal products placed on the market of their territories are labelled in their national language or languages . ### member states shall require that biocidal products placed on the market of their territories are labelled in their national language or one of their national languages , in the case of more than one .


### providing advice and assistance to applicants for the inclusion of an active substance in annex i or for a community authorisation ; ### providing advice and assistance to applicants , and in particular to smes , for the inclusion of an active substance in annex i or for a community authorisation ;


### a reduced fee shall be set for small and medium - sized enterprises within the meaning of recommendation 2003 / 361 / ec concerning the definition of micro , small and medium - sized enterprises ### a reduced fee shall be set for smes


### with a view to ensuring an effective implementation of the nagoya protocol , all users of genetic resources and traditional knowledge associated with such resources should have to exercise due diligence to ascertain that the genetic resources and associated traditional knowledge used were accessed in accordance with applicable legal requirements and to ensure that , where relevant , benefits are shared . however , given the diversity of users within the union it is not appropriate to oblige all users to take the same measures for exercising due diligence . therefore , only minimum features of due diligence measures should be set out . the specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct , model contractual clauses , and guidelines with a view to increasing legal certainty and reducing costs . the obligation on users to keep information relevant for access and benefit - sharing should be limited in time , consistent with the time - span for an eventual innovation . ### with a view to ensuring an effective implementation of the nagoya protocol , all users of genetic resources should have to exercise due diligence to ascertain that the genetic resources used were accessed in accordance with applicable legal requirements and to ensure that , where relevant , benefits are shared . however , given the diversity of users within the union it is not appropriate to oblige all users to take the same measures for exercising due diligence . therefore , only minimum features of due diligence measures should be set out . the specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct , model contractual clauses , and guidelines with a view to increasing legal certainty and reducing costs . the obligation on users to keep information relevant for access and benefit - sharing should be limited in time , consistent with the time - span for an eventual innovation .


### competent authorities of member states should check whether users comply with their obligations . in that context , competent authorities should accept internationally recognised certificates of compliance as evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established . competent authorities should also keep records of the checks made and relevant information should be made available in accordance with directive 2003 / 4 / ec of the european parliament and of the council of 28 january 2003 on public access to environmental information . 13 ### competent authorities of member states should check whether users comply with their obligations . in that context , competent authorities should accept internationally recognised certificates of compliance as evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established . when an international certificate is not available , other legally acceptable forms of compliance should be considered evidence that the genetic resources covered were legally acquired and that mutually agreed terms were established . competent authorities should also keep records of the checks made and relevant information should be made available in accordance with directive 2003 / 4 / ec of the european parliament and of the council of 28 january 2003 on public access to environmental information . 13


### this regulation establishes rules governing access and benefit - sharing for genetic resources and traditional knowledge associated with genetic resources , in accordance with the provisions of the nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the convention on biological diversity . ### this regulation establishes rules governing compliance with access and benefit - sharing for genetic resources , in accordance with the provisions of the nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation to the convention on biological diversity .


### this regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the nagoya protocol for the union . it also applies to the benefits arising from the use of such genetic resources and to traditional knowledge associated with genetic resources . ### this regulation applies to genetic resources over which states exercise sovereign rights that are accessed after the entry into force of the nagoya protocol for the union . it also applies to the benefits arising from the use of such genetic resources .


### the date and place of access of genetic resources and traditional knowledge associated with such resources ; ### the date and place of access of genetic resources ;


### the description of genetic resources or traditional knowledge associated with such resources used , including available unique identifiers ; ### the description of genetic resources used , including available unique identifiers ;


### checks may be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning non - compliance of a user with this regulation . ### checks shall be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning a user ' s non - compliance of a user with this regulation .


### competent authorities shall accept an internationally recognised certificate of compliance as evidence that the genetic resource it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established , as required by the domestic access and benefit - sharing legislation or regulatory requirements of the party to the nagoya protocol providing the prior informed consent . ### competent authorities shall accept an internationally recognised certificate of compliance as evidence that the genetic resource it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established , as required by the domestic access and benefit - sharing legislation or regulatory requirements of the party to the nagoya protocol providing the prior informed consent . in the event that an internationally recognised certificate is not available , other legally acceptable forms of compliance should be considered enough evidence that the genetic resources covered were legally obtained and that mutually agreed terms were established .


### users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1 , notably as regards access to premises and the presentation of documentation or records . ### users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1 .


### additionally , depending on the nature of the shortcomings detected , member states may take immediate interim measures , including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities . ### depending on the nature of the shortcomings detected , member states may take immediate appropriate interim measures , including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities .


### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force of this directive ] . ### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for 5 years from [ the date of entry into force of this directive ] with the possibility of lengthening this period .


### the transmission system operators shall enable permanent physical capacity to transport gas in both directions on all interconnections within two years from the entry into force of this regulation , except in cases where at the request of a competent authority , the commission decides that the addition of a bi - directional flow capacity would not enhance the security of supply of any member state . such decision may be reviewed if circumstances change . the level of the bi - directional flow capacity shall be reached in a cost efficient way and at least take into account the capacity required to meet the supply standard set in article 7 . within that two year period , the gas transmission system operator shall adapt the functioning of the transmission system as a whole so as to enable bi - directional gas flows . ### if necessary according to the risk and impact assessment carried out in accordance with article 8 , taking into account technical feasibility and a cost - benefit analysis , the transmission system operators shall within three years from the entry into force of this regulation enable permanent physical capacity to transport gas in both directions on those interconnections where at the addition of a bi - directional flow capacity would enhance the security of supply , in particular during an emergency . the assessment may be reviewed if circumstances change . within that three - year period , the gas transmission system operator shall , in accordance with the risk and impact assessment carried out in accordance with article 8 , taking into account technical feasibility and a cost - benefit analysis , adapt the functioning of the transmission system as a whole so as to enable bi - directional gas flows .


### by [ 30 september 2010 ; 6 months after entry into force ] each competent authority shall fully assess the risks affecting the security of gas supply in its member state by : using the standards specified in articles 6 and 7 ; b ) taking into account all relevant national and regional circumstances ; c ) running various scenarios of exceptionally high demand and supply disruption , such as failure of main transmission infrastructures , storages , lng terminals , and disruption of supplies from third country suppliers ; d ) identifying the interaction and correlation of risks with other member states . ### by [ 30 march 2011 ; 12 months after entry into force ] each competent authority shall undertake a risk and impact assessment that shall be the basis for : the establishment of the risk profile of the member state concerned , taking into account all relevant national and regional circumstances ; b ) the establishment of the preventive action plan of the member state concerned ; c ) the establishment of the emergency plan of the member state concerned ; the risk and impact assessment shall be based on the standards specified in articles 6 and 7 and shall include running various scenarios of exceptionally high demand and / or supply disruption , such as failure of main transmission infrastructures , storages , lng terminals , and disruption of supplies from third - country producers . account shall be taken of the interaction and correlation of risks with other member states .


### mutual learning , cooperation , awareness raising and dissemination activities , such as identification of , and exchanges on , good practices , innovative approaches and experiences , organisation of peer review and mutual learning ; organisation of conferences and seminars ; organisation of awareness - raising and information campaigns , media campaigns and events , including corporate communication of the political priorities of the european union ; compilation and publication of materials to disseminate information as well as results of the programme ; development , operation and maintenance of systems and tools using information and communication technologies ; ### mutual learning , inter - agency coordination and collaboration , cooperation , awareness raising and dissemination activities , such as identification of , and exchanges on good practices , innovative approaches and experiences , organisation of peer review and mutual learning ; organisation of conferences and seminars ; organisation of awareness - raising and information campaigns , media campaigns and events , including corporate communication of political priorities of the european union ; compilation and publication of materials to disseminate information as well as results of the programme ; development , operation and maintenance of systems and tools using information and communication technologies ;


### contractual arrangements may play a role in fostering the digitisation of european cultural heritage , it being understood that libraries , educational establishments , museums or archives and film heritage institutions may , with a view to undertake the uses permitted under this directive , conclude agreements with commercial partners for the digitisation and making available of orphan works . these agreements may include financial contributions by such partners . ### contractual arrangements may play a role in fostering the digitisation of european cultural heritage , it being understood that libraries , educational establishments , museums or archives and film heritage institutions may , with a view to undertake the uses permitted under this directive , conclude agreements with commercial partners for the digitisation and making available of orphan works . these agreements may include financial contributions by such partners but shall not vest in them any exploitation rights of the works .


### this directive applies to works first published or broadcast in a member state and which are : ### this directive applies to works first published or broadcast in a member state or , where relevant , in the country most associated with the work , and which are :


### ' construction product ' means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof so that the dismantling of the product alters the performance of the construction works with respect to the basic requirements for construction works ; ### ' construction product ' means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and for which the performance of the product alters the performance of the construction works with respect to the basic requirements for construction works ;


### when a construction product is covered by a harmonised standard or a european technical assessment has been issued for it , the manufacturer shall draw up a declaration of performance when such a product is placed on the market . ### when a construction product conforms to a harmonised standard or a european technical assessment has been issued for it , the manufacturer shall draw up a declaration of performance when such a product is placed on the market .


### the release of dangerous substances into ground water , marine waters or soil ; ### the release of dangerous substances into ground water , lakes , rivers , marine waters or soil ;


### ‘ child pornography’ shall mean ### ‘ child pornography’ is a form of child abuse and shall mean


### causing , for sexual purposes , a child who has not reached the age of sexual consent under national law to witness sexual abuse or sexual activities , even without having to participate , shall be punishable by a maximum term of imprisonment of at least two years . ### causing , for sexual purposes , a child who has not reached the age of sexual consent under national law to witness sexual abuse or sexual activities , even without having to participate , shall be punishable by a term of imprisonment .


### engaging in sexual activities with a child who has not reached the age of sexual consent under national law shall be punishable by a maximum term of imprisonment of at least five years . ### engaging in sexual activities with a child who has not reached the age of sexual consent under national law shall be punishable by a term of imprisonment .


### abuse is made of a recognised position of trust , authority or influence over the child shall be punishable by a maximum term of imprisonment of at least eight years ; or ### there is abuse of a recognised position of trust , authority or influence over the child ; or


### abuse is made of a particularly vulnerable situation of the child , notably because of a mental or physical disability or a situation of dependence shall be punishable by a maximum term of imprisonment of at least eight years ; or ### there is abuse of the child ' s situation which is particularly vulnerable , notably because of mental or physical disability or a situation of dependence ; or


### use is made of coercion , force or threats shall be punishable by a maximum term of imprisonment of at least ten years . ### use is made of coercion , force or threats ; shall be punishable by a term of imprisonment


### coercing a child into sexual activities with a third party shall be punishable by a maximum term of imprisonment of at least ten years . ### coercing a child to participate in sexual activities with a third party shall be punishable by a term of imprisonment .


### coercing a child into child prostitution shall be punishable by a maximum term of imprisonment of at least ten years . ### coercing a child into child prostitution shall be punishable by a term of imprisonment .


### causing a child to participate in pornographic performances shall be punishable by a maximum term of imprisonment of at least two years . ### causing a child to participate in pornographic performances shall be punishable by a term of imprisonment .


### profiting from or otherwise exploiting a child participating in pornographic performances shall be punishable by a maximum term of imprisonment of at least two years . ### profiting from or otherwise exploiting a child participating in pornographic performances shall be punishable by a term of imprisonment .


### recruiting a child to participate in pornographic performances shall be punishable by a maximum term of imprisonment of at least five years . ### recruiting a child to participate in pornographic performances shall be punishable by a term of imprisonment .


### causing a child to participate in child prostitution shall be punishable by a maximum term of imprisonment of at least five years . ### causing a child to participate in child prostitution shall be punishable by a term of imprisonment .


### coercing a child to participate in pornographic performances shall be punishable by a maximum term of imprisonment of at least eight years . ### coercing a child to participate in pornographic performances shall be punishable by a term of imprisonment .


### recruiting a child to participate in child prostitution shall be punishable by a maximum term of imprisonment of at least eight years . ### recruiting a child to participate in child prostitution shall be punishable by a term of imprisonment .


### profiting from or otherwise exploiting a child participating in child prostitution shall be punishable by a maximum term of imprisonment of at least five years . ### profiting from or otherwise exploiting a child participating in child prostitution shall be punishable by a term of imprisonment .


### knowingly attending pornographic performances involving the participation of children shall be punishable by a maximum term of imprisonment of at least two years . ### knowingly attending pornographic performances involving the participation of children shall be punishable by a term of imprisonment .


### engaging in sexual activities with a child , where recourse is made to child prostitution shall be punishable by a maximum term of imprisonment of at least five years . ### engaging in sexual activities with a child where recourse is made to child prostitution shall be punishable by a term of imprisonment .


### member states shall take the necessary measures to encourage any person who knows about or suspects , in good faith , offences referred to in articles 3 to 7 to report these facts to the competent services . ### member states shall adopt the necessary measures to encourage any person who knows about the offences referred to in articles 3 to 7 or who suspects in good faith that they may have been committed to report these facts to the competent services . any person reporting such offences will be covered by data protection and anonymity .


### member states shall take the necessary measures to ensure that effective intervention programmes or measures are made available with a view to preventing and minimising the risks of repeated offences of a sexual nature against children . these programmes or measures shall be accessible at any time during the criminal proceedings , inside and outside prison , according to the conditions laid down in national law . ### member states shall take the necessary measures to ensure that effective accredited sex offender treatment programmes are made available or measures put in place with a view to preventing and minimising the risks of repeated offences of a sexual nature against children . these accredited sex offender treatment programmes or measures shall be accessible at any time during the criminal proceedings , inside and outside prison , in accordance with the conditions laid down in national law . member states shall offer counselling and advice programmes to support the perpetrator ' s immediate family .


### in article 4 , the following points and are inserted : ' ' re - securitisation ' means a securitisation where one or more of the underlying exposures meet the definition of a securitisation position ; ' re - securitisation position ' means an exposure to a re - securitisation ; ' ### in article 4 , the following points are inserted : ' ' re - securitisation ' means a securitisation where the risk associated with an underlying pool of exposures is tranched and at least one of the underlying exposures is a securitisation position ; ' re - securitisation position ' means an exposure to a re - securitisation ; '


### the following shall not , with a view to reducing potential or actual losses to investors , provide support to the securitisation beyond its contractual obligations : any originator credit institution which , in respect of a securitisation , has done any of the following : made use of article&#160 ; 95 in the calculation of risk - weighted exposure amounts ; sold instruments from its trading book to an sspe to the effect that it does not hold capital for the specific risk of these instruments anymore ; a sponsor credit institution . ### a sponsor credit institution , or an originator credit institution which in respect of a securitisation has made use of article 95 in the calculation of risk - weighted exposure amounts or has sold instruments from its trading book to an sspe to the effect that it is no longer required to hold own funds for the risks of these instruments , shall not , with a view to reducing potential or actual losses to investors , provide support to the securitisation beyond its contractual obligations .


### the credit assessment shall not be based or partly based on unfunded support provided by the credit institution itself . ### the credit assessment shall not be based or partly based on unfunded support provided by the credit institution itself unless the support cannot be regarded in any way , an enhancement to the credit risks .


### in order to ensure that enterprises play a central role in delivering economic growth in europe , the commission adopted a communication , entitled ‘ an integrated industrial policy for the globalization era , putting competitiveness and sustainability at centre stage’12 in october 2010 , which was endorsed by the european council on its conclusions of december 2010 . this is a flagship initiative of the europe 2020 strategy . the communication sets out a strategy that aims to boost growth and jobs by maintaining and supporting a strong , diversified and competitive industrial base in europe , notably through improving framework conditions for enterprises , as well as through strengthening several aspects of the single market , including business - related services . ### in order to ensure that enterprises play a central role in delivering economic growth in europe , which is a top priority , the commission adopted a communication , entitled ' an integrated industrial policy for the globalization era , putting competitiveness and sustainability at centre stage ' 12 in october 2010 , which was endorsed by the european council on its conclusions of december 2010 . this is a flagship initiative of the europe 2020 strategy . the communication sets out a strategy that aims to boost growth and jobs by maintaining and supporting a strong , diversified and competitive industrial base in europe , notably through improving framework conditions for enterprises , as well as through strengthening several aspects of the single market , including business - related services .


### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises . the added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a pan - european sme finance market . the union ' s actions should be complementary to the member states ' use of financial instruments for smes . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources . ### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises . the added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a simplified and more transparent pan - european sme finance market . the union ' s actions should be complementary to the member states ' use of financial instruments for smes . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources .


### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises . the added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a pan - european sme finance market . the union ' s actions should be complementary to the member states ' use of financial instruments for smes . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources . ### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises . the added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a pan - european sme finance market . the union ' s actions and programmes should be coherent , consistent and complementary to the member states ' use of financial instruments for smes . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources .


### the enterprise europe network has proven its added value for european smes as a one - stop - shop for business support by helping enterprises to improve their competitiveness and explore business opportunities in the single market and beyond . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners , get advice on sources of financing , and on intellectual property and on eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions . ### the enterprise europe network needs to continue to prove its added value for european smes in identifying appropriate union business support programmes to improve their competitiveness and explore business opportunities in the single market and beyond . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners , get advice on sources of union financing , and on intellectual property and on union programmes to encourage eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions .


### to improve the competitiveness of european enterprises , notably smes , the member states and the commission need to create a favourable business environment . the interests of smes and the sectors in which they are most active need particular attention . initiatives at union level are necessary in order to develop a level playing field for smes and to exchange information and knowledge on a european scale . ### to improve the competitiveness of european enterprises , notably smes , the member states and the commission need to create a favourable business environment by reducing the burden of legislation . the interests of smes and the sectors in which they are most active need particular attention . initiatives at union level are necessary in order to develop a level playing field for smes and to exchange information and knowledge on a european scale . digital services can be particularly cost - effective in this area .


### as outlined in the commission communication of 30 june 2010 , entitled ‘ europe , the world ' s no 1 tourist destination – a new political framework for tourism in europe’ , which was endorsed by the european council conclusions of october 2010 , tourism is an important sector of the union economy . enterprises in this sector substantially contribute to the union ' s gross domestic product and job creation and have significant potential for the development of entrepreneurial activity , since it is run mainly by smes . the lisbon treaty acknowledges the importance of tourism outlining the union specific competences in this field which complement the actions of member states . there is clear added value for the tourism initiative at union level , especially in providing data and analysis , in developing transnational promotion strategies and in exchanging best practices . ### as outlined in the commission communication of 30 june 2010 , entitled ‘ europe , the world ' s no 1 tourist destination – a new political framework for tourism in europe’ , which was endorsed by the european council conclusions of october 2010 , tourism is an important sector of the union economy . the treaty on the functioning of the european union outlines the union ' s supporting competences in this field . enterprises in this sector substantially contribute to the union ' s gross domestic product and job creation and have significant potential for the development of entrepreneurial activity , since it is run , like the majority of business sectors , mainly by smes .


### the programme should indicate actions for the objectives , the total financial envelope for pursuing those objectives , different types of implementing measures , and the arrangements for monitoring and evaluation and for protection of the union ' s financial interests . ### the programme should indicate actions for the objectives , the total financial envelope for pursuing those objectives , how access to finance could be simplified , how transparency could be enhanced , different types of implementing measures , and the arrangements for monitoring and evaluation and for protection of the union ' s financial interests .


### encouraging an entrepreneurial culture and promoting the creation and growth of smes . ### encouraging an entrepreneurial spirit and culture and promoting the creation and growth of smes .


### changes in administrative burden on smes , ### reduction in administrative and regulatory burdens on smes ,


### change of administrative burden on smes ### reduction of administrative and regulatory burdens on smes


### to promote entrepreneurship , including among specific target groups ; ### to promote entrepreneurship , including among specific target groups , such as young people and women ;


### to improve access to finance for smes in the form of equity and debt ; ### to improve access to finance for smes in the form of equity , venture capital and debt ;


### to improve access to markets inside the union and globally . ### to improve access to markets , particularly inside the union and also globally .


### measures to improve the design , implementation and evaluation of policies affecting the competitiveness and sustainability of enterprises , including disaster resilience , and to secure the development of appropriate infrastructures , world class clusters and business networks , framework conditions and development of sustainable products , services and processes ; ### measures to improve the design , implementation and evaluation of policies affecting the competitiveness and sustainability of enterprises , sharing best practices regarding world class clusters , business networks and framework conditions and promoting the development of sustainable products , services and processes ;


### the commission shall support actions which aim to improve access to finance for smes in their start - up and growth phases , being complementary to the member states ' use of financial instruments for smes at national and regional level . in order to ensure complementarity , these actions will be closely coordinated with those undertaken in the framework of cohesion policy and at national level . such actions shall aim to stimulate the supply of both equity and debt finance . ### the commission shall support actions which aim to improve access to finance for smes , and reduce and simplify time - consuming barriers for smes in their start - up and growth phases , being complementary to the member states ' use of financial instruments for smes at national and regional level . in order to ensure complementarity , these actions will be closely coordinated with those undertaken in the framework of cohesion policy and at national level . such actions shall aim to stimulate the supply of both equity and debt finance .


### in order to continue improving the competitiveness and access to markets of union enterprises , the commission shall maintain its support for the enterprise europe network . ### in order to continue improving the competitiveness and access to markets of union enterprises , the commission shall fund the enterprise europe network to identify appropriate union programmes which could help to improve their competitiveness and explore business opportunities , notably within the single market ; while avoiding duplicating the efforts made by the member states .


### specific measures shall aim to facilitate smes access to markets outside the union , and to strengthening existing support services in those markets . smes may receive support through the programme as regards standards and intellectual property rights in priority third countries . ### specific measures shall aim to facilitate smes access to markets outside the union , and to strengthening existing support services in those markets . smes may receive support , advice and information through the programme on , inter alia , market entry barriers , business opportunities , standards and intellectual property rights in priority third countries . these measures shall complement but not duplicate core trade promotion activities of member states .


### the commission shall draw up an annual monitoring report examining the efficiency and effectiveness of supported actions in terms of financial implementation , results and , where possible , impact . the report shall include information on the amount of climate - related expenditure and the impact of support to climate - change objectives to the extent that the collection of this information does not create unjustified administrative burden for smes . ### the commission shall draw up an annual monitoring report examining the efficiency and effectiveness of supported actions in terms of financial implementation , results and impact , including especially job creation and growth . the report shall include information on the amount of climate - related expenditure and the impact of support to climate - change objectives to the extent that the collection of this information does not create unjustified administrative burden for smes .


### by 2018 at the latest , the commission shall establish an evaluation report on the achievement of the objectives of all the actions supported under the programme at the level of results and impacts , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation report shall also address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor measures ; ### by 2018 at the latest , the commission shall establish an evaluation report , which shall be published every three years , on the achievement of the objectives of all the actions supported under the programme at the level of results and impacts , especially on job creation and economic growth ; the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation report shall also address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor measures ;


### number of member states using sme test ### number of member states using sme test and competitiveness - proofing test


### about 7 simplification measures per year ### at least 7 simplification measures adopted per year


### support under this regulation shall promote enhanced political cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed action plans . ### support under this regulation shall promote enhanced political and social cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed action plans .


### support under this regulation shall promote enhanced political cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed action plans . ### support under this regulation shall promote enhanced political cooperation and progressive economic integration between the union and the partner countries and , in particular , the implementation of partnership and cooperation agreements , association agreements or other existing and future agreements , and jointly agreed macro - regional strategies and action plans .


### promoting confidence building and other measures contributing to security and the prevention and settlement of conflicts ; ### actively promoting confidence building and other measures contributing to security and the prevention and settlement of conflicts , especially frozen conflicts , including support in post - crisis situations and during the nation - building process ;


### the partnership and cooperation agreements , the association agreements and other existing or future agreements that establish a relationship with partner countries , corresponding communications , council conclusions and european parliament resolutions as well as relevant conclusions of ministerial meetings with the partner countries shall constitute the overall policy framework for programming and implementing union support under this regulation . ### the partnership and cooperation agreements , the association agreements and other existing or future agreements that establish a relationship with partner countries , corresponding communications , council conclusions , resolutions of the european parliament , the euro - mediterranean parliamentary assembly , the euro - mediterranean regional and local assembly and the euronest parliamentary assembly , as well as relevant conclusions of ministerial meetings with the partner countries shall constitute the overall policy framework for programming and implementing union support under this regulation .


### the partnership and cooperation agreements , the association agreements and other existing or future agreements that establish a relationship with partner countries , corresponding communications , council conclusions and european parliament resolutions as well as relevant conclusions of ministerial meetings with the partner countries shall constitute the overall policy framework for programming and implementing union support under this regulation . ### the partnership and cooperation agreements , the association agreements and other existing or future agreements that establish a relationship with partner countries , with particular emphasis on the energy community treaty and the energy charter treaty and its transit protocol , corresponding communications , council conclusions and european parliament resolutions as well as relevant conclusions of ministerial meetings with the partner countries shall constitute the overall policy framework for programming and implementing union support under this regulation .


### in implementing this regulation , coherence shall be ensured with other areas of the union external action as well as other relevant union policies . to this end , measures financed under this regulation , including those managed by the european investment bank , shall be based on the cooperation policy documents described in article 3 and as well as on the union ' s specific interests , policy priorities and strategies . such measures shall respect the commitments under multilateral agreements and international conventions to which the union and partner countries are parties . ### in implementing this regulation , coherence shall be ensured with other areas of the union external action as well as other relevant union policies , as enshrined in article 208 of the treaty on the functioning of the european union with regard to policy coherence for development . to this end , measures financed under this regulation , including those managed by the european investment bank , shall be based on the cooperation policy documents described in article 3 and as well as on the union ' s specific interests , policy priorities and strategies . such measures shall respect the commitments under multilateral agreements and international conventions to which the union and partner countries are parties , and the obligations in respect of policy coherence for development , as enshrined in article 208 of the treaty on the functioning of the european union .


### in the event of crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption . ### in the event of crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . as part of such an emergency review , measures may be introduced to fund activities to facilitate the transition from emergency aid to long - term development activities , including activities intended to enhance beneficiaries ' resilience to crises . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments , such as the european instrument for democracy and human rights or the european endowment for democracy , is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption .


### in the event of crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption . ### in the event of economic , political or energy crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption .


### this regulation should also apply to consumer products which , although not foodstuff , resemble foodstuff and are likely to be confused with foodstuff in a way that consumers , especially children , may place them in their mouths , suck or ingest them , which might cause , for example , suffocation , poisoning , the perforation or obstruction of the digestive tract . those food - imitating products have so far been regulated by council directive 87 / 357 / eec of 25 june 1987 on the approximation of the laws of the member states concerning products which , appearing to be other than they are , endanger the health or safety of consumers which should be repealed . ### this regulation should also apply to consumer products which , although not foodstuff , resemble foodstuff and are likely to cause persons , in particular young children , to confuse them with food and to consequently place them in their mouths , suck or ingest them , which by doing so may cause death or personal injury . those food - imitating products have so far been regulated by council directive 87 / 357 / eec of 25 june 1987 on the approximation of the laws of the member states concerning products which , appearing to be other than they are , endanger the health or safety of consumers which should be repealed .


### member states should lay down rules on penalties applicable to infringements of this regulation and ensure that they are implemented . those penalties must be effective , proportionate and dissuasive . ### member states should lay down rules on penalties applicable to infringements of this regulation and ensure that they are implemented . those penalties must be effective , harmonised to the extent possible , proportionate in terms of quantity , the value of the good and the length of time it has been available on the market , and dissuasive .


### subject matter ### subject matter and objective .


### this regulation shall apply to products obtained through a manufacturing process placed or made available on the market , whether new , used or reconditioned , and which comply with any of the following criteria : ### this regulation shall apply to products obtained through a manufacturing process placed or made available on the market , including the online market , whether new , used or reconditioned , and which comply with any of the following criteria :


### to which consumers are exposed in the context of a service provided to them . ### which are provided to a consumer in the course of a service , whether or not the product is used by the consumer himself .


### the characteristics of the product , including its composition , packaging , instructions for assembly and , where applicable , for installation and maintenance ; ### the characteristics of the product , including its composition , authenticity , packaging , instructions for assembly and , where applicable , for installation and maintenance ;


### further to a request from a market surveillance authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of a product ; ### further to a reasoned request from a market surveillance authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of a product ;


### proportionate to the possible risks presented by a product , importers shall , to protect the health and safety of persons , carry out sample testing of marketed products , investigate complaints , and keep a register of complaints , of non - conforming products and of product recalls , and shall keep the manufacturer and distributors informed of such monitoring . ### proportionate to the possible risks presented by a product as assessed on the basis of article 6 , importers shall , to protect the health and safety of persons , carry out sample testing of marketed products , investigate complaints , and keep a register of complaints , of non - conforming products and of product recalls , and shall keep the manufacturer and distributors informed of such monitoring .


### distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with article 8 , and and article 10 and , as applicable , shall make sure that the corrective action necessary to bring that product into conformity is taken , to withdraw it or recall it , if appropriate . furthermore , where the product is not safe , distributors shall immediately inform the manufacturer or importer , as applicable as well as market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken . ### distributors who consider or have reason to believe that a product which they have made available on the union or on - line market is not safe or is not in conformity with article 8 , and and article 10 and , as applicable , shall make sure that the corrective action necessary to bring that product into conformity is taken , to withdraw it or recall it . furthermore , where the product is not safe , distributors shall immediately inform the manufacturer or importer , as applicable as well as market surveillance authorities of the member states in which they made the product available to that effect , giving details , in particular , of the risk to health and safety and of any corrective action taken .


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ insert date - 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation , on the basis of the common minimum levels proposed by the commission , and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ insert date - 3 months from the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them . the penalties provided for must be harmonised , proportionate to the length of time , the value and the quantity of non - compliant products placed on the market .


### in order to encourage the involvement of small and medium - sized enterprises in the procurement market , it should be provided explicitly that contracts may be divided into lots , whether homogenous or heterogeneous . where contracts are divided into lots , contracting entities 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 encourage the involvement of small and medium - sized enterprises in the procurement market , contracting authorities should in particular give consideration to dividing contracts into lots , whether homogenous or heterogeneous , and ensure transparency in access to information on their reasons for doing so or choosing not to do so .


### groups of economic operators may submit tenders or put themselves forward as candidates . contracting entities shall not establish specific conditions for participation of such groups in procurement procedures which are not imposed on individual candidates . in order to submit a tender or a request to participate , those groups shall not be required by the contracting entities to assume a specific legal form . ### groups of economic operators may submit tenders or put themselves forward as candidates . contracting entities shall not establish specific conditions for participation of such groups in procurement procedures which are additional or different to those conditions imposed on individual candidates . in order to submit a tender or a request to participate , those groups shall not be required by the contracting entities to assume a specific legal form .


### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union . the esf should in particular increase its support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited . ### the esf should contribute to the europe 2020 strategy and should allow sufficient flexibility to enable member states to use the fund to address their own europe 2020 bottlenecks , thereby ensuring greater concentration of support on the priorities of the european union . the esf should in particular increase its support for the fight against social exclusion and poverty , by refocusing the fund on growth , creating employment opportunities and addressing important skills mismatches . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited .


### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information across union river basins . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative data that are fit for the purpose of the union prioritisation process . the list should be dynamic , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . ### a new mechanism is needed to provide the commission with targeted high - quality monitoring information on the concentration of substances in the aquatic environment , with a focus on emerging pollutants and substances for which available monitoring data are not of sufficient quality for the purpose of risk assessment . the new mechanism should facilitate the gathering of that information complemented by monitoring data from programmes under articles 5 and 8 of directive 2000 / 60 / ec across union river basins . in order to maintain the monitoring costs at reasonable levels , the mechanism should focus on a limited number of substances , included temporarily in a watch list , and a limited number of monitoring sites , but deliver representative data that are fit for the purpose of the union prioritisation process . the list should be dynamic , to respond to new information on the potential risks posed by emerging pollutants and avoid monitoring substances for longer than necessary . the validity of the list should be limited to a specific time frame . based on the results obtained from the member states and pre - defined criteria , the commission should justify to concerned stakeholders the continued monitoring of the substance for every 12 months thereafter while the substance is kept on the list . the substance should be removed from the watch list if the risk assessment in accordance with article 16 of directive 2000 / 60 / ec confirms that the substance does not pose a significant risk at union level to or via the aquatic environment .


### the commission may adopt implementing acts laying down technical specifications for the monitoring of the substances in the watch list and technical formats for the reporting to the commission of the monitoring results and related information . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 9 . ### the commission may adopt implementing acts laying down technical specifications for the monitoring of the substances in the watch list and technical formats for the reporting to the commission of the monitoring results and related information . in the preparation of technical specifications , the commission shall take into account the recommendations of experts as stated in article 16 of directive 2000 / 60 / ec . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 9 . technical specifications should only be implemented if there is a union - level harmonized scientifically validated method , conforming to appropriate international standards , in accordance with directive 2009 / 90 / ec , for the monitoring of the relevant substance .


### the watch list shall contain no more than 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance . the substances shall be selected from among those for which the available information indicates that they may pose a significant risk at union level to or via the aquatic environment . in selecting the substances for the watch list the commission shall take into account all available information including research projects , member states ' characterisation and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec and information on production volumes , use patterns , concentrations in the environment and effects , including that gathered in accordance with directives 98 / 8 / ec , 2001 / 82 / ec and 2001 / 83 / ec of the european parliament and of the council , and with regulation no 1907 / 2006 and regulation no 1107 / 2009 of the european parliament and of the council . ### the watch list shall contain no more than 25 substances at any given time , and shall indicate the monitoring matrix for each substance . the substances shall be selected in accordance with transparent and objective criteria from emerging pollutants and from among those for which the available information indicates that they may pose a significant risk at union level to or via the aquatic environment and insufficient monitoring data for the purposes of prioritisation is available . in selecting the substances for the watch list the commission shall take into account all available information including the results of the prioritisation procedure carried out in the context of the preparation of the present directive , research projects , member states ' characterisation and monitoring programmes under articles 5 and 8 of directive 2000 / 60 / ec and information on production volumes , use patterns , concentrations and natural presence in the environment and effects , including results of robust risk assessment based on widely accepted , validated methodology and scientific data from state - of - the - art studies , taking into account technical and scientific progress and internationally established guidelines , gathered in accordance with directives 98 / 8 / ec , 2001 / 82 / ec and 2001 / 83 / ec of the european parliament and of the council , and with regulation no 1907 / 2006 and regulation no 1107 / 2009 of the european parliament and of the council .


### the commission shall be empowered to adopt delegated acts in accordance with article 10 concerning the drawing up of the watch list referred to in paragraph 1 of this article . ### the commission shall define a transparent technical procedure and relevant criteria concerning the drawing up of the watch list referred to in paragraph 1 of this article , and be empowered to adopt delegated acts in accordance with article 10 concerning the inclusion and removal of substances on the watch list referred to in paragraph 1 of this article . the watch list shall be valid for a maximum of two years from the date of its adoption , or until a new list is drawn up by the commission if this happens before the end of the two year period . in exercising its power pursuant to this paragraph , the commission shall ensure that the recommendations mentioned in article 16 of directive 2000 / 60 / ec are taken into account .


### the financial reference amount for the implementation of this regulation for the period from 2007 to 2013 shall be eur 172 million for countries listed in annex i and eur 176 million for countries listed in annex ii . the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . ### the financial reference amount for the implementation of this regulation for the period from 2007 to 2013 shall be eur 172 million for countries listed in annex i and eur 176 million for countries listed in annex ii . the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the measures in countries listed in annex ii shall be financed from the margin under heading 4 of the financial framework or other means available in the context of financing external actions . appropriations programmed for use under regulation no 1905 / 2006 shall not be used for this purpose .


### draft legislative resolution ### points out that the financial envelope specified in the legislative proposal for the period 2014 - 2017 constitutes only an indication to the legislative authority and cannot be fixed until agreement is reached on the proposal for a regulation laying down the multiannual financial framework for the years 2014 - 2020 ;


### motion for a resolution ### recalls its resolution of 8 june 2011 on investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; points out that even with an increase in the level of resources for the next mff of at least 5 % compared to the 2013 level only a limited contribution can be made to the achievement of the union’s agreed objectives and commitments and the principle of union solidarity ; challenges the council , if it does not share this approach , to clearly identify which of its policy priorities or projects could be dropped altogether , despite their proven european added value ; _____________ texts adopted , p7_ta0266 .


### statistics developed , produced and disseminated under this programme should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission’s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value . ### statistics developed , produced and disseminated under this programme should be available promptly and should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union demonstrably brings a clear added value . the necessity for a prompt availability of statistics is specifically crucial in relation to the indicators underpinning the eu2020 objectives .


### - firstly , the need for european statistics has been constantly increasing , and this trend is unlikely to change in future . ### - secondly , the need for european statistics has been constantly increasing , and this trend is unlikely to change in future .


### - secondly , the nature of statistics has changed — evidence - based decision making requires statistics that meet high quality criteria linked to the specific purposes they are serving , and there is an increasing need for complex multidimensional statistics supporting composite policy areas . ### - thirdly , the nature of statistics has changed — statistics are no longer merely one source of information for policy - making purposes , but are now at the very heart of the decision - making process . evidence - based decision making requires statistics that meet high quality criteria linked to the specific purposes they are serving , and there is an increasing need for complex multidimensional statistics supporting composite policy areas .


### - thirdly , due to the appearance of new actors on the information market , including those providing information in nearly real time , the priority for the ess in future is high quality and , in the case of short - term statistics , timeliness in particular . ### - fourthly , due to the appearance of new actors on the information market , including those providing information in nearly real time , the priority for the ess in future is high quality and , in the case of short - term statistics , timeliness in particular .


### - fourthly , budget constraints at both national and european level as well as the need to further reduce the burden on enterprises and citizens make the situation even more challenging . ### - fifthly , budget constraints at both national and european level as well as the need to further reduce the burden on enterprises and citizens make the situation even more challenging .


### in the context of the implementation of the programme , where appropriate , cooperation with third countries not participating in the programme should be encouraged , taking into account any relevant agreements between those countries and the union . ### in the context of the implementation of the programme , where appropriate , cooperation with third countries not participating in the programme should be encouraged , taking into account any relevant agreements , or any envisaged agreements between those countries and the union .


### in order to be considered as financing decisions according to article [ ] of regulation [ . . . ] on the financial rules applicable to the general budget of the european union [ new financial regulation ] , the annual work programmes adopted by the commission for implementation of the programme have to set out the objectives pursued , the expected results , the method of implementation and their total amount . they should also contain a description of the actions to be financed , an indication of the amount allocated to each action and an indicative implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing . ### in order to be considered as financing decisions according to article [ ] of regulation [ . . . ] on the financial rules applicable to the general budget of the european union [ new financial regulation ] , the annual work programmes adopted by the commission for implementation of the programme have to set out the objectives pursued , the results specified , the method of implementation and their total amount . they should also contain a description of the actions to be financed , an indication of the amount allocated to each action and a specific project plan and implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing .


### an ex - ante evaluation has been performed in accordance with the principle of sound financial management , in order to focus the programme established by this regulation on the need for effectiveness in achieving the objectives and in order to incorporate budgetary constraints from the design phase of the programme onwards . the value and impact of the measures taken under the programme should be regularly monitored and evaluated , including by independent external evaluators . for the purpose of evaluating the programme , measurable objectives have been formulated and indicators developed . ### an ex - ante evaluation has been performed in accordance with the principle of sound financial management , in order to focus the programme established by this regulation on the need for effectiveness and efficiency in achieving the objectives and in order to incorporate budgetary constraints from the design phase of the programme onwards . the value and impact of the measures taken under the programme should be regularly monitored and evaluated , including by independent external evaluators . for the purpose of evaluating the programme , measurable objectives have been formulated and indicators developed .


### this regulation lays down a financial allocation for the entire duration of the programme which is to be the prime reference for the budgetary authority , within the meaning of point 37 of the inter - institutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management , in the framework of the annual budgetary procedure . ### for 2013 , this regulation lays down a financial allocation for the programme which is to be the prime reference for the budgetary authority , within the meaning of point 37 of the inter - institutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management , in the framework of the annual budgetary procedure . for 2014 - 2017 , this regulation lays down a financial allocation for the entire duration of the programme which is to be the prime reference for the budgetary authority , within the meaning of point [ 17 ] of the interinstitutional agreement of xx / 201y between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management .