### operations under this article must be carried out in collaboration with a scientific or technical body as recognised by the national law of each member state which shall validate the results of such operations . ### operations under this article shall be carried out by or in collaboration with public or private scientific or technical bodies as recognised by the national law of each member state which shall validate the results of such operations .


### new forms of income combined with aquaculture activities have already shown their added value for business development . therefore the emff should support these complementary activities outside aquaculture such as angling - tourism , educational or environmental activities . ### new forms of income combined with aquaculture activities have already shown their added value for business development . therefore the emff should support these complementary activities outside aquaculture such as angling - tourism , aquaculture tourism for promoting the aquaculture sector and its products , educational or environmental activities .


### aquaculture contributes to growth and jobs in coastal and rural regions . therefore , it is crucial that the emff is accessible to aquaculture enterprises , in particular smes and contributes to bringing new aquaculture farmers into the business . in order to increase the competitiveness and economic performance of aquaculture activities it is vital to stimulate innovation and entrepreneurship . therefore the emff should support innovative operations and business development , in particular non - food and off - shore aquaculture . ### aquaculture contributes to growth and jobs in coastal and rural regions . therefore , it is crucial that the emff is accessible to aquaculture enterprises , regardless of their size , and contributes to bringing new aquaculture farmers into the business . in order to increase the competitiveness and economic performance of aquaculture activities it is vital to stimulate innovation and entrepreneurship . therefore the emff should support innovative operations and the business development of aquaculture enterprises in general , including non - food and off - shore aquaculture .


### in addition to article 134 of [ regulation no [ . . . ] laying down common provisions ] , the commission may suspend , by means of an implementing act , all or part of the interim payments of the operational programme where the commission has adopted a decision by means of an implementing act recognising that a member state has failed to comply with its obligations under the common fisheries policy . such non compliance shall be liable to affect the expenditure contained in a certified statement of expenditure for which the interim payment is requested . ### in addition to article 134 of [ regulation no [ . . . ] laying down common provisions ] , the commission may suspend , by means of an implementing act , all or part of the interim payments of the operational programme where it has been ascertained that a member state has failed to comply with its obligations under the common fisheries policy .


### – eur 5 800 000 for the canary islands ; ### – eur 11 600 000 for the canary islands ;


### diseases in aquaculture or destruction of production facilities . ### diseases in aquaculture , predation , mechanical failures or destruction of production facilities , for which the operator is not responsible .


### sudden water quality changes ; ### sudden water quality changes , including oil spills , chemical and biological contamination , for which the operator is not responsible ;


### support under this chapter shall be limited to aquaculture enterprises unless otherwise expressly established . ### support under this chapter shall be intended for aquaculture enterprises , organisations of aquaculture prodcuers and fishermen and legal persons .


### the technical tools for setting up and running of an operational european marine observation and data network aiming to facilitate the collection , assembling , quality control , re - use and distribution of marine data through cooperation between the member states institutions involved in the network . ### the technical tools for setting up and running of an operational european marine observation and data network aiming to facilitate the collection , acquisition , assembling , quality control , re - use and distribution of marine data and knowledge through cooperation between the member states institutions involved in the network .


### in order to improve working conditions on board for fishermen the emff may support investments on board or in individual equipments providing that these investments go beyond standards required under national or union law . ### in order to improve the safety , health and living conditions of vessels , the emff may support investments on board or in individual equipments providing that these investments go beyond standards required under national or union law .


### for the purposes of the emff , the integrated local development strategy referred to in article 28 of [ regulation no [ &#8230 ; ] laying down common provisions ] shall be based on the interaction between actors and projects of different sectors of the local economy , in particular the fisheries and aquaculture sectors ; ### for the purposes of the emff , the integrated local development strategy referred to in article 28 of [ regulation no [ &#8230 ; ] laying down common provisions ] shall be based on the interaction between actors and projects of the fisheries and aquaculture sectors , as well as other sectors of the local economy ;


### the management and use of data for the purpose of scientific analysis and cfp implementation ; ### the collection , management and use of data for the purpose of scientific analysis and cfp implementation ;


### for the purpose of increasing the quality of the product landed , increasing energy efficiency , contributing to environmental protection or improving safety and working conditions , the emff may support investments improving fishing port infrastructure or landing sites , including investments in facilities for waste and marine litter collection . ### for the purpose of increasing the quality of the product landed , increasing energy efficiency , contributing to environmental protection or improving safety and working conditions , the emff may support investments to construct and modernise fishing port infrastructure or landing sites and auctions , including investments in related infrastructure in the processing and marketing industry and in facilities for waste and marine litter collection .


### the support referred to in paragraph 1 shall be granted to operators or organisations of fishermen , recognised by the member state , who commissioned the feasibility study referred to in paragraph 1 . ### the support referred to in paragraph 1 shall be granted to operators or organisations of fishermen , recognised by the member state , who commissioned the feasibility study or requested the financial engineering and technical assistance services referred to in paragraph 1 .


### for the purpose of increasing the quality of the product landed , increasing energy efficiency , contributing to environmental protection or improving safety and working conditions , the emff may support investments improving fishing port infrastructure or landing sites , including investments in facilities for waste and marine litter collection . ### the emff may support investments improving fishing port infrastructure , landing sites and fish markets .


### the overall objective of the common fisheries policy is to ensure that fishing and aquaculture activities contribute to long - term sustainable environmental conditions which are necessary for economic and social development . it should contribute moreover to increased productivity , a fair standard of living for the fisheries sector , stable markets , ensure the availability of resources and that supplies reach consumers at reasonable prices . ### the overall objective of the common fisheries policy is to ensure that fishing and aquaculture activities are carried out under long - term environmentally sustainable conditions , also contributing to economic and social development . it should contribute moreover to increased productivity , a fair standard of living for the fisheries sector , stable markets , ensure the availability of resources and that supplies reach consumers at reasonable prices .


### activities referred to in paragraph 1 may cover data collection activities , studies , dissemination of knowledge and best practices . ### activities referred to in paragraph 1 may cover data collection activities , studies , pilot projects , dissemination of knowledge and best practices , in particular through seminars .


### an amount of eur 1 047 000 000 of the emff shall allocated to measures under direct management as specified in chapter i and ii of title vi . this amount includes technical assistance under article 91 . ### an amount of eur x of the emff shall allocated to measures under direct management as specified in chapter i and ii of title vi . this amount includes technical assistance under article 91 .


### exchange of best practices , coordination activities including information sharing networks and steering mechanisms for sea - basin strategies ; ### exchange of best practices , coordination activities including information sharing networks and development support for sea - basin strategies ;


### introducing new technical or organisational knowledge in aquaculture farms which reduces their impact on the environment or fosters a more sustainable use of resources in aquaculture ; ### developing technical innovation or knowledge in aquaculture which in particular reduces the impact on the environment , fosters a more sustainable use of resources , improves animal welfare , facilitates new sustainable production methods ;


### conscious of the weak presence of small scale coastal fishermen in the social dialogue , the emff should support organisations promoting this dialogue in the appropriate fora ### conscious of the social and territorial importance of coastal fishermen , the emff should support organisations promoting the social dialogue of the coastal fishing sector in the appropriate fora


### member states shall require that operators submitting an application under the emff provide to the managing authority a signed statement confirming that they respect the criteria listed in paragraph 1 and have not committed an irregularity under the eef or the emff as referred to in paragraph 2 . member states shall verify the veracity of the statement before the approval of the operation . ### member states shall require that operators submitting an application under the emff provide to the managing authority a signed statement confirming that they respect the criteria listed in paragraph 1 . member states shall verify the veracity of the statement before the approval of the operation .


### in view of the different marketing conditions in the outermost regions concerned , the fluctuations in captures and stocks and of market demands , it should be left to the member states concerned to determine the fishery products eligible for compensation , their respective maximum quantities and the compensation amounts within the overall allocation per member state . ### in view of the different fishing , rearing and marketing conditions in the outermost regions concerned , the fluctuations in captures and stocks and of market demands , it should be left to the member states concerned to determine the list of additional costs and the fishery products eligible for compensation , their respective maximum quantities and the compensation amounts within the overall allocation per member state .


### the owner of a fishing vessel having received support under articles 32 , 36 , 39 , or 40 of this regulation shall not transfer the vessel to a third country outside the union during at least 5 years following the date of actual payment to the beneficiary . ### the owner of a fishing vessel having received support under articles 32 , 36 , 39 , or 40 of this regulation shall not transfer that vessel to an operator established in a third country outside the union during at least 5 years following the date of actual payment of this support to the beneficiary . in the event that a vessel is transferred within this term , the member state shall recover the amounts paid in error under that operation , in proportion to the period in which the requirements were not met .


### the feasibility studies and advice referred to respectively in paragraph 1 and shall be provided by recognised scientific or technical bodies with the required advisory competences as recognised by the national law of each member state . ### the feasibility studies and advice referred to in paragraph 1 shall be provided by scientific or technical bodies or by economic advisory entities equipped with the required competences .


### member states shall require that operators submitting an application under the emff provide to the managing authority a signed statement confirming that they respect the criteria listed in paragraph 1 and have not committed an irregularity under the eef or the emff as referred to in paragraph 2 . member states shall verify the veracity of the statement before the approval of the operation . ### member states shall require that operators submitting an application under the emff provide to the managing authority a signed statement confirming that they respect the criteria listed in paragraph 1 and have not committed any fraud under the eef or the emff as referred to in paragraph 2 . member states shall verify the veracity of the statement before the approval of the operation , by reference to the information provided in the national register of infringements established under article 93 of regulation no 1224 / 2009 , or other data provided for this purpose .


### the occurrence of an adverse climatic event or the outbreak of disease in aquaculture shall be formally recognised as such by the member state concerned . ### the occurrence of an adverse climatic event , the outbreak of disease or extensive pollution in aquaculture shall be formally recognised as such by the member state concerned .


### in order to improve the quality of the fish caught the emff may support investments on board for this purpose . ### in order to improve the quality of the fish caught the emff may support investments on board , in the processing and marketing process , for this purpose .


### ensure a significant representation of fisheries and aquaculture sectors . ### ensure a significant representation of the fisheries and / or aquaculture sector .


### investment in human capital is also vital to increase the competitiveness and economic performance of fishing and maritime activities . therefore , the emff should support lifelong learning , co - operation between scientists and fishermen stimulating the dissemination of knowledge as well as for advisory services helping to improve the overall performance and competitiveness of operators . ### investment in human capital is also vital to increase the competitiveness and economic performance of fishing and maritime activities . therefore , the emff should support lifelong learning , vocational training , young people’s access to careers in fishing , co - operation between scientists and fishermen stimulating the dissemination of knowledge as well as for advisory services helping to improve the overall performance and competitiveness of operators .


### in order to address health and safety needs on board , the emff should support investments covering safety and hygiene on board . ### in order to address health and safety needs on board , the emff should support investments covering improved safety and hygiene standards on board .


### diversification of the income of aquaculture enterprises through the development of new aquaculture species with good market prospects ; ### diversification of the income of aquaculture enterprises through the development of new aquaculture species with good profitability , added value and market prospects ;


### in order to maintain the competitiveness of certain fishery products from the outermost regions of the european union compared with that of similar products from other european union ' s regions , the european union introduced measures in 1992 to compensate for the related additional costs in the fisheries sector . the measures applying for the period 2007 - 2013 are laid down in council regulation no 791 / 2007 . it is necessary to continue providing support to offset the additional costs for the marketing of certain fishery products as of 1 january 2014 . ### in order to maintain the competitiveness of certain fishery products from the outermost regions of the european union compared with that of similar products from other european union ' s regions , the european union introduced measures in 1992 to compensate for the related additional costs in the fisheries sector . the measures applying for the period 2007 - 2013 are laid down in council regulation no 791 / 2007 . it is necessary to continue providing support to offset the additional costs for the marketing of certain fishery products as of 1 january 2014 and to extend this to all additional costs incurred by operators engaged in fishing , rearing , processing and marketing activities .


### having regard to the treaty on the functioning of the european union , and in particular article 42 , article 43 , article 91 , article 100 , article 173 , article 175 , article 188 , article 192 , article 194 and article 195 thereof , ### having regard to the treaty on the functioning of the european union , and in particular article 42 , article 43 , article 91 , article 100 , article 173 , article 175 , article 188 , article 192 , article 194 , article 195 and article 349 thereof ,


### the design and development of technical and administrative means necessary for the implementation of conservation measures in the meaning of articles 17 and 21 of the [ regulation on common fisheries policy ] ; ### the design , development and monitoring of technical and administrative means necessary for the development and the implementation of conservation measures in the meaning of articles 17 and 21 of the [ regulation on common fisheries policy ] ;


### eur 4 535 000 000 of the resources referred to in paragraph shall be allocated to the sustainable development of fisheries , aquaculture and fisheries areas under chapters i , ii and iii of title v . ### eur 4 535 000 000 of the resources referred to in paragraph shall be allocated to the sustainable development of fisheries and aquaculture , of the processing and marketing of fish and aquaculture products , and of fisheries areas under chapters i , ii and iii of title v .


### promoting the social dialogue at national , regional or local level involving fishermen and other relevant stakeholders . ### promoting the social dialogue at european , national , regional or local level involving fishermen , the social partners and other relevant stakeholders .


### supporting sustainable economic growth , employment , innovation and new technologies within emerging and prospective maritime sectors in coastal regions , in complementarity with established sectoral and national activities . ### supporting sustainable economic growth , employment , innovation and new technologies within maritime sectors , as well as in coastal areas , islands and outermost regions of the european union , in complementarity with established sectoral and national activities .


### in order to reduce the impact of inland fishing on the environment , increase energy efficiency , increase the quality of fish landed , or to improve safety or working conditions , the emff may support the following investments : ### in order to reduce the impact of inland fishing on the environment , increase energy efficiency , increase the quality of fish landed , to improve safety or working conditions and the sustainable development of local communities , the emff , taking account of the specific nature and characteristics of the fishing concerned , may support the following investments :


### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union statutory audit services or related financial audit services . ### where the statutory auditor or audit firm belongs to a network , no other member of such network may , within the european union , provide to the audited organisation , to its parent undertaking or to the undertakings which it directs the non - audit services which are prohibited pursuant to paragraph 3 below .


### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union statutory audit services or related financial audit services . ### where the statutory auditor or audit firm belongs to a network , no other member of such network may provide to the audited entity , to its parent undertaking within the union and to its controlled undertakings within the union the non - audit services that are prohibited under paragraph 3 below .


### the audit report shall not be longer than four pages or 10000 characters . it shall not contain any cross - references to the additional report to the audit committee referred to in article 23 . ### the audit report shall not contain any cross - references to the additional report to the audit committee referred to in article 23 , and shall be in clear and unambiguous language .


### the absence of a reply by the competent authority within the prescribed time - limit following submission of the audit committee ' s recommendation shall be considered as constituting an implied consent to the recommendation . ### the absence of a reply by the competent authority or esma within the prescribed time - limit following submission of the audit committee ' s recommendation shall be considered as constituting an implied consent to the recommendation .


### the audit committee of the public - interest entity shall monitor the work of the statutory auditor or audit firm carrying out the statutory audit . ### the audit committee of the public - interest entity shall monitor the work of the statutory auditor or audit firm carrying out the statutory audit , and , when more than one statutory auditor or audit firm have been appointed , the distribution of tasks between them and their rotation .


### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services and related financial audit services . ### the individual statutory auditor or audit firm entrusted with the task of carrying out a statutory audit of the public - interest organisation concerned may not – either directly or indirectly – provide to the audited organisation , to undertakings directed by the organisation or to its parent undertaking the non - audit services which are prohibited pursuant to paragraph 3 below .


### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union statutory audit services or related financial audit services . ### where the statutory auditor or audit firm belongs to a network , no other member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union non - audit services which are compromising the independence of the statutory audit or audit firm .


### in order to ensure legal certainty and the smooth transition to the regime introduced by this regulation , it is important to introduce a transitional regime regarding the entry into force of the obligation to rotate audit firms , the obligation to organise a selection procedure for the choice of audit firm and the conversion of audit firms into firms that only provide audit services . ### in order to ensure legal certainty and the smooth transition to the regime introduced by this regulation , it is important to introduce a transitional regime regarding the entry into force of certain of the obligations in this regulation .


### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services and related financial audit services . ### a statutory auditor or an audit firm carrying out a statutory audit of a public - interest entity shall not provide to the audited entity or its controlled undertakings , either directly or indirectly , any non - audit services that are prohibited in paragraph 3 below .


### an audit plan setting out the probable scope and method of the statutory audit ; ### an audit plan setting out the probable scope and method of the statutory audit and , where more than one statutory auditor or audit firm have been appointed , the distribution of tasks among the appointed statutory auditors or audit firms and the rotation plan established in accordance with article 33 .


### the public - interest entity shall appoint a statutory auditor or audit firm for an initial engagement that shall not be shorter than two years . ### the public - interest entity shall appoint statutory auditor or audit firm for an initial engagement that shall not be shorter than three years . the maximum duration of an engagement shall not exceed 6 years .


### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the services referred to in article 10 and of this regulation to the audited entity . ### approve the provision by the statutory auditor or audit firm of all non - audit services other than the prohibited services referred to in article 10 and the audit related and other assurance services referred to in article 10 , to the audited entity and its controlled undertakings in the union .


### in the case of a credit institution or insurance undertaking , the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified . ### in the case of a credit institution or insurance undertaking , the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 and esma . esma will consult on such proposals with eba and eiopa . the competent authority referred to in article 35 and esma shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified .


### authorise , on a case by case basis , the provision by the statutory auditor or audit firm of the services referred to in article 10 and of this regulation to the audited entity . ### approve the provision by the statutory auditor or audit firm to the audited entity and its controlled undertakings in the union of all non - audit services other than those prohibited services referred to in article 10 and those audit related and other assurance services referred to in article 10 .


### the public - interest entity shall appoint a statutory auditor or audit firm for an initial engagement that shall not be shorter than two years . ### the public - interest entity shall appoint a statutory auditor or audit firm for an initial engagement that shall not be shorter than three years .


### a statutory auditor or an audit firm carrying out statutory audit of public - interest entities may provide to the audited entity , to its parent undertaking and to its controlled undertakings statutory audit services and related financial audit services . ### a statutory auditor or an audit firm carrying out a statutory audit of a public interest entity shall only provide non - audit services to the audited entity , to its parent undertaking and to its controlled undertakings after having properly assessed threats and potential safeguards in accordance with article 11 . non - audit services listed in paragraph 2 shall not be provided under any circumstance to the audited entity .


### the public - interest entity may renew this engagement only once . ### the public - interest entity may renew the audit engagement providing that such renewal is proposed by the audit committee and is approved by the shareholders’ meeting .


### where the statutory auditor belongs to a network , a member of such network may provide to the audited entity , to its parent undertaking and to its controlled undertakings within the union statutory audit services or related financial audit services . ### where the statutory auditor or audit firm belongs to a network , no other member of such network may , within the european union , provide to the audited organisation , to its parent undertaking or to the undertakings which it directs the non - audit services which are prohibited pursuant to paragraph 3 below .


### the disclosure in good faith to the competent authorities , by the statutory auditor or audit firm , of any fact or decision referred to in paragraph 1 or of any fact during the dialogue foreseen in paragraph 2 shall not constitute a breach of any contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind . ### the disclosure in good faith to the competent authorities , by the statutory auditor or audit firm shall not constitute a breach of any contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind .


### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions . the competent authority shall without delay inform the commission and other competent authorities about the issued national authorisation . ### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a positive opinion for this purpose which may impose further conditions . in the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1 , the biocidal product or active substance may be placed on the market for the purpose of the notified experiment or test .


### 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 .


### the exposure of humans to that active substance in a biocidal product , under normal conditions of use , is negligible , in particular where the product is used in closed systems or strictly controlled conditions ; ### the exposure of humans to that active substance in a biocidal product , under prescribed conditions of use , is negligible or adequately controlled , taking account of the intrinsic hazards presented by the substance , in particular where the product is used in closed systems or strictly controlled conditions ;


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


### 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 ; b ) it is either the same or similar with regard to the non - active substances present and the type of formulation ; c ) 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 identical to the reference product if : it has been produced by the same manufacturer or a manufacturer associated with him or under licence , on the basis of the same manufacturing process ; b ) it is the same with regard to the specifications and content of the active substances and the type of formulation ; c ) it is the same or equivalent in the co - formulants present and the packaging size , material or form , in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment .


### where relevant , the biocidal property attributed to treated articles or materials ; ### where relevant , the biocidal property attributed to treated articles or materials if the biocidal product is intended to come into direct contact with humans and the environment ;


### direct restocking , unless explicitly foreseen as a conservation measure by a union legal act or in the case of experimental restocking . ### direct restocking , unless explicitly foreseen as a conservation measure by a union legal act .


### in order to ensure the viability of fisheries and aquaculture in a highly competitive market , it is necessary to lay down provisions granting support for the implementation of the [ regulation no on the common organisation of the markets in fishery and aquaculture products ] as well as for marketing and processing activities carried by operators to maximise the value of fisheries and aquaculture products . particular attention should be paid to the promotion of operations which integrate producing , processing and marketing activities of the supply chain . in order to adapt to the new discard ban policy , the emff should also support the processing of unwanted catches . ### in order to ensure the viability of fisheries and aquaculture in a highly competitive market , it is necessary to lay down provisions granting support for the implementation of the [ regulation no on the common organisation of the markets in fishery and aquaculture products ] as well as for marketing and processing activities carried by operators to maximise the value of fisheries and aquaculture products . particular attention should be paid to the promotion of operations which integrate producing , processing and marketing activities of the supply chain .


### in line with the discard ban introduced by the cfp , the emff should support investments on board aiming at make the best use of unwanted fish caught and valorise underused components of the fish caught . considering the scarcity of the resources , in order to maximise the value of the fish caught , the emff should also support investments on board aiming at adding commercial value to fish caught . ### in line with the discard reduction introduced by the cfp , the emff should support investments on board aiming at gradually reducing unwanted catches , making the best use of unwanted fish caught and valorising underused components of the fish caught . considering the scarcity of the resources , in order to maximise the value of the fish caught , the emff should also support investments on board and in processing and marketing aiming at adding commercial value to fish caught .


### support shall not contribute to the replacement or modernisation of main or ancillary engines . support shall only be granted to owners of fishing vessels and not more than once during the programming period for the same fishing vessel . ### support shall not contribute to the replacement or modernisation of main or ancillary engines . support shall be granted to owners of fishing vessels , fishermen ' s organisations and administrations .


### conducting regional , national or transnational promotional campaigns for fishery and aquaculture products . ### conducting regional , national or transnational promotional campaigns for fishery and aquaculture products that , in accordance with regulation no 834 / 2007 , are considered organic or to have a low environmental impact .


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


### it is paramount to integrate environmental concerns into the emff and support the implementation of conservation measures under the cfp taking however into account the diverse conditions throughout the union waters . for this purpose it is essential to develop a regionalised approach to conservation measures . ### it is paramount to integrate environmental concerns into the emff and promote actions for the mitigation of the effects of , and adaptation to , climate change on the marine , coastal and insular environment , with a particular emphasis on those areas that are most vulnerable in that respect , support the implementation of conservation measures under the cfp taking however into account the diverse conditions throughout the union waters . for this purpose it is essential to develop a regionalised approach to conservation measures .


### priority should be given to producer organisations and associations of producer organisations by granting them support . the compensation for storage aid and aid for production and marketing plans should gradually be phased out as the importance of this particular kind of support has lost its interest in the light of the evolving structure of the union market for this kind of products and the growing importance of strong producer ' s organisations . ### priority should be given to producer organisations and associations of producer organisations by granting them support . the compensation for storage aid and aid for production and marketing plans should be phased out as the importance of this particular kind of support has lost its interest in the light of the evolving structure of the union market for this kind of products and the growing importance of strong producer ' s organisations .


### operations financed under this article must be carried out in collaboration with a scientific or technical body recognised by the member state which shall validate the results of such operations . ### operations financed under this article must be carried out in collaboration with a scientific or technical body recognised by the member state which shall validate the results of such operations and make them available for the public .


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


### a new application shall be submitted for these sites on the basis of the new criteria and procedures laid down in articles 6 to 9 and shall be transmitted to the commission by the relevant member states at the latest on 31 january [ of the year in question ] . ### new applications for these sites shall be subject to the new criteria and procedures laid down in articles 6 to 9 and shall be transmitted to the commission by the relevant member states at the latest on 31 january [ of the year in question ] .


### – taking part in the activities of networks of sites awarded the european heritage label in order to exchange experiences and initiate common projects ; ### – taking part in the activities of networks of sites awarded the european heritage label in order to exchange experiences , facilitate networking and initiate common projects ;


### the commission shall establish a union - wide list of projects of common interest . the list shall be reviewed and updated as necessary every two years . the first list shall be adopted by 31 july 2013 at the latest . ### the commission adopts delegated acts concerning the establishment and&#160 ; reviewing of the union - wide list of projects of common interest . the list shall be reviewed and updated every two years on the basis of the regional lists adopted and reviewed by the groups following the provisions set out in this article . the first list shall be adopted by 31 july 2013 at the latest .


### except in the cases foreseen in paragraphs 3 and 4 , the commission shall register without delay the proposed initiative under a unique registration number and send a confirmation to the organiser . ### the commission shall , within two months from the request for registration referred to in paragraph 1 , take a decision on admissibility . the proposed citizens ' initiative shall be considered admissible and therefore registered if it satisfies the following conditions : – it cannot be reasonably regarded as improper because it is abusive or devoid of seriousness ; – it does not run counter to the values of the union ; – it concerns a matter where a legal act of the union can be adopted for the purpose of implementing the treaties ; and – it falls within the framework of the powers of the commission to make a proposal .


### it is appropriate to ensure that statements of support for a citizens ' initiative are collected within a specific time - limit . in order to ensure that proposed citizens ' initiatives remain relevant , whilst taking account of the complexity of collecting statements of support across the european union , that time - limit should not be longer than 12 months from the date of registration of the proposed initiative . ### it is appropriate to ensure that statements of support for a citizens ' initiative are collected within a specific time - limit . in order to ensure that proposed citizens ' initiatives remain relevant , whilst taking account of the complexity of collecting statements of support across the european union , that time - limit should not be longer than 24 months from the date of registration of the proposed initiative .


### ' citizens ' initiative ' means an initiative , submitted to the commission in accordance with the present regulation , inviting the commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties , which has received the support of at least one million eligible signatories coming from at least one third of all member states ; ### ' citizens ' initiative ' means an initiative , submitted to the commission in accordance with the present regulation , inviting the commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties , which has received the support of at least one million eligible signatories coming from at least one fifth of all member states ;


### signatories shall be considered as coming from the member state which issued the identification document indicated in their statement of support . ### signatories shall be considered as coming from the member state where they have their permanent residence . a signatory who is not a national of the member state in which he or she permanently resides may choose to be considered as coming either from the member state in which he or she permanently resides or from the member state of which he or she is a national . a signatory permanently resident in a third country shall be considered as coming from the member state of which he or she is a national .


### box 3 : name of signatory : first name* : ……family name* : 2 . address : street : postcode : city* : country* : 3 . e - mail address : 4 . date and place of birth* : date of birth : place and country : 5 . nationality* : 6 . personal identification number* : type of identification number / identity document : national identity card : passport : social security : member state , which issued the identification number / identity document : 7 . i hereby certify that the information provided in this form is correct and that i have only supported this proposed citizens ' initiative once* . date and signature of the signatory* ♦ : ……… . . ### box 3 : nationality* : 2 . name of signatory : first name* : ……family name* : 3 . address : street : postcode : city* : country* : 4 . e - mail address : 5 . date and place of birth* : date of birth : place and country : 6 . personal identification number : type of identification number / identity document : national identity card : passport : social security : member state , which issued the identification number / identity document : 7 . i hereby certify that the information provided in this form is correct and that i have only supported this proposed citizens ' initiative once* . date and signature of the signatory* ♦ : ……… . .


### ' organiser ' means a natural or legal person or organisation responsible for the preparation and submission of a citizens ' initiative to the commission . ### ' organiser ' means a natural person responsible for the preparation and submission of a citizens initiative to the commission .


### it is necessary to establish the minimum number of member states from which citizens must come . in order to ensure that a citizens ' initiative is representative of a union interest , this number should be set at one third of member states . ### it is necessary to establish the minimum number of member states from which citizens must come . in order to ensure that a citizens ' initiative is representative of a union interest , this number should be set at one fifth of member states .


### a proposed citizens ' initiative that has been registered shall be made public in the register . ### the decision on admissibility shall be notified to the organisers of the proposed citizens ' initiative and shall be made public . it shall also include an indication as to which legal act or measures the commission considers that it is appropriate to take if one million statements of support are collected in favour of that citizens ' initiative . the commission may always modify that indication at the moment when it adopts its decision on whether or not to go forward with a citizens ' initiative .


### the full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative ; ### the full name , postal address and e - mail address of the organiser ;


### the signatories of a citizens ' initiative shall come from at least one third of member states . ### the signatories of a citizens ' initiative shall come from at least one fifth of member states .


### the commission should examine a citizens ' initiative and set out its conclusions and the actions it envisages to take in response to it , within a period of four months . ### the commission should examine a citizens ' initiative and set out its conclusions and the actions it envisages to take in response to it , within a period of three months .


### all statements of support shall be collected after the date of registration of the proposed initiative and within a period that shall not exceed 12 months . ### all statements of support shall be collected after the date of registration of the proposed initiative and within a period that shall not exceed 18 months .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### the organiser shall be a citizen of the union and be of the age to be entitled to vote in the european elections .


### the commission shall reject the registration of proposed citizens ' initiatives which are manifestly against the values of the union . ### the commission shall reject the registration of proposed citizens ' initiatives which are manifestly against human rights and the value system of the union .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### the organisers shall be citizens of the union and be of the age to be entitled to vote in the european elections . they should not be currently serving as directly elected politicians . the organisers shall form a citizens ' committee of at least seven persons coming from at least one fourth of the member states . the organisers shall designate a contact person for the organising committee .


### the organiser shall submit statements of support to the member state that issued the identification document indicated therein . ### the organiser shall submit statements of support to the member state where the signatories have their permanent residence . a signatory who is not a national of the member state in which he or she permanently resides may choose to be considered either as coming either from the member state in which he or she permanently resides or from the member state of which he or she is a national . in cases where signatories have their permanent residence in a third country , the organiser shall submit statements of support to the member state of which they are nationals .


### in one third of member states , signatories shall comprise at least the minimum number of citizens set out in annex i . ### in one fifth of member states , signatories shall comprise at least the minimum number of citizens set out in annex i .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### organisers shall be citizens of the union and at least 16 years old .


### according to article 153 of the treaty , the european parliament and the council may adopt , by means of directives , minimum requirements for encouraging improvements , especially in the working environment , to ensure a better level of protection of the health and safety of workers . such directives must avoid imposing administrative , financial and legal constraints in a way which would hold back the creation and development of small and medium - sized undertakings . ### according to article 153 of the treaty , the european parliament and the council may adopt , by means of directives , minimum requirements for encouraging improvements , especially in the working environment , to ensure a better level of protection of the health and safety of workers . such directives must avoid imposing administrative , financial and legal constraints in a way which would hold back the creation and development of small and medium - sized undertakings and their potential to create jobs .


### the receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority . ### the receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority . a single authorisation number shall be used in all the member states involved .


### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product used for treating the materials or articles are authorised for this use in the community or in at least one member state . ### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the active substances used for treating the materials or articles are authorised for this use in the community .


### applicants that have invested in supporting the inclusion of an active substance in annex i or in the authorisation of a biocidal product in accordance with the provisions of this regulation should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants . ### applicants that have invested in supporting the inclusion of an active substance in annex i or in the authorisation of a biocidal product in accordance with the provisions of this regulation and / or in accordance with directive 98 / 8 / ec should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants .


### 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 2023 . the commission shall submit the report to the european parliament and the council . on the basis of this report the commission shall perform an assessment in order to verify whether or not the regulation needs to be amended .


### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . ### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product . comparative assessment shall be applied to all biocidal products for the same purpose when there is sufficient experience , and a minimum of three years , in use .


### the receiving competent authority shall , within twelve months after the validation referred to in article 22 , decide on the application in accordance with article 16 . ### the receiving competent authority shall , within six months after the validation referred to in article 22 , decide on the application in accordance with article 16 .


### where relevant , the biocidal property attributed to treated articles or materials ; ### the biocidal property attributed to treated articles or materials , if the biocidal product contained therein will come into direct contact with people and the environment ;


### an active substance shall be included in annex i for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point of article 16 . ### an active substance shall be included in annex i for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point of article 16 .


### the receiving competent authority may require that applications for a national authorisation be submitted in one or more of the official languages of the member state where that competent authority is situated . ### the receiving competent authority may require that applications for a national authorisation be submitted in one of the official languages of the member state where that competent authority is situated .


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


### if the receiving competent authority , on basis of the validation made pursuant to paragraph 1 , considers that the application is complete , it shall without delay inform the applicant thereof . ### 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 . the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant does not submit the required additional information on time , and shall notify the applicant and the evaluating competent authority of the rejection . in such cases , part of the fees payable to the agency under article 70 shall be reimbursed .


### commission proposal the commission may review the inclusion of an active substance in annex i at any time where there are serious indications that the requirements referred to in article 4 are no longer complied with . where those indications are confirmed , the commission shall adopt a decision amending the inclusion of an active substance in annex i or removing it from that annex . ### the commission may review the inclusion of an active substance in annex i at any time where there are serious indications that the requirements referred to in article 4 are no longer complied with . it shall review inclusion also in cases where there are indications that the objectives of article&#160 ; 4 and and article 7 and of directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy1 may not be achieved . where those indications are confirmed , the commission shall adopt a decision amending the inclusion of an active substance in annex i or removing it from that annex . 1 oj l 327 , 22 . 12 . 2000 , p . 1 .


### ' placing on the market ' means the first supply of a biocidal product for distribution or for use on the community market in the course of a commercial activity , whether in return for payment or free of charge ; ### ' placing on the market ' means the supply of a biocidal product to third parties , whether in return for payment or free of charge , or the making available of a biocidal product to third parties . importation shall be deemed to be placing on the market . no supply to third parties is involved , for example , when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer .


### the authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 18 months before the expiry date of the authorisation . ### the authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 12 months before the expiry date of the authorisation .


### ' letter of access ' means an original document , signed by the owner or owners of information , which states that the information may be used by the competent authorities , the european chemicals agency , or the commission for the purpose of evaluating an active substance or granting an authorisation ; ### ' letter of access ' means an original document , signed by the owner or owners of information or their authorised representative , which states that the information may be used by the designated competent authority , the european chemicals agency , or the commission for the purpose of evaluating an active substance or granting an authorisation for the benefit of a third party ;


### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions . the competent authority shall without delay inform the commission and other competent authorities about the issued national authorisation . ### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and delivered a favourable opinion for this purpose which may impose further conditions . in the absence of an opinion from the competent authority delivered within 30 days after notification of the information required in paragraph 1 , the biocidal product or active substance should be placed on the market for the purposes of the notified experiment or test .


### for the uses specified in the application , another authorised biocidal product or a non - chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment ; ### for the uses specified in the application , another authorised biocidal product or a non - chemical control or prevention method already exists which presents significantly lower or reduced risk for human or animal health or the environment and which proves equally effective and involves no significant increase in the risks for any other parameter ;


### 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 . the receiving competent authority shall , within one month from the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and inform the applicant thereof . ### within three weeks after the receipt of an application , the agency shall validate the application if it complies with the following requirements : the information referred to in article 18&#160 ; has been submitted ; it is accompanied by the fees payable under article 70 . the validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted .


### commission proposal 6 . in the case of a frame formulation , a reduction in the percentage of the active substance in the reference biocidal product may be allowed , and / or an alteration in percentage composition of one or more non - active substances , and / or the replacement of one or more non - active substances by others presenting the same or lower risk . ### in the case of a frame formulation , the following variations in composition with regard to a reference biocidal product are possible : authorisation of an active substance in a reference biocidal product with at least two active substances ; a reduction in the percentage of the active substances ; authorisation of one or more non - active substances ; alteration in percentage composition of one or more non - active substances ; the replacement of one or more non - active substances .


### commission proposal within one month after the receipt of an application for a national authorisation referred to in article 15 , the receiving competent authority shall validate the application if it complies with the following requirements : the information referred to in article 18 has been submitted ; it is accompanied by the fees payable under article 70 . the validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted . ### the person responsible for the placing of a biocidal product on the market , or his representative , shall submit an application for a national or community authorisation to the agency and inform the agency of the name of the competent authority of the member state of his choice which shall be responsible for the evaluation of the application . the agency shall , within three weeks after the receipt of the application , notify the evaluating competent authority that the application is available in the agency database .


### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products that are authorised in different member states . ### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trade of identical biocidal products that are authorised in different member states .


### the subsequent applicant has written agreement in the form of a letter of access from the first applicant that he can use that information , ### the subsequent applicant has written agreement in the form of a letter of access in accordance with article&#160 ; 50 that he can use that information ,


### the authorisation holder or his representative shall submit an application for renewal of a community authorisation to the agency at least 18 months before the expiry date of the authorisation . ### the authorisation holder or his representative shall submit an application for renewal of a community authorisation to the agency at least 12 months before the expiry date of the authorisation .


### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product used for treating the materials or articles are authorised for this use in the community or in at least one member state . ### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the active substances used for treating the materials or articles are authorised for this use in the community .


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


### the commission shall adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in article 72 . the competent authority of the concerned member state shall without delay adopt all appropriate measures to comply with that decision . ### the commission shall , after consultation with the applicant , adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in article 72 . the competent authority of the concerned member state shall without delay adopt all appropriate measures to comply with that decision .


### ' frame formulation ' means a group of biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products ; ### ' frame formulation ' means a group of biocidal products having similar uses and presenting variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where the risk with regard to the reference biocidal product does not increase despite the variations and the stated efficacy in relation to the target organisms is guaranteed ;


### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisation for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions . the competent authority shall without delay inform the commission and other competent authorities about the issued national authorisation . ### an unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve , or result in , release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a positive opinion for this purpose which may impose further conditions . in the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1 , the biocidal product or active substance may be placed on the market for the purpose of the notified experiment or test .


### a biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met : ### a biocidal product shall be considered as substantially identical to the reference product if all of the following conditions are met :


### where relevant , the biocidal property attributed to treated articles or materials ; ### the biocidal property attributed to treated articles or materials , if the biocidal product contained therein will come into direct contact with people and the environment ;


### within two months after the receipt of an application , the agency shall validate the application if it complies with the following requirements : ### within three weeks after the receipt of an application , the agency shall validate the application if it complies with the following requirements :


### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product used for treating the materials or articles are authorised for this use in the community or in at least one member state . ### treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product used for treating the materials or the articles are authorised for this use in the community or in at least one member state , or the biocidal product is present in those articles in transit in a concentration of less than 0 . 01% weight by weight .


### application for authorisation shall be made by , or on behalf of , the person who shall be responsible for the placing on the market of a biocidal product in a particular member state or in the community . ### application for authorisation shall be made by , or on behalf of , the person who will be the holder of the authorisation . this person may be , but is not necessarily , the person responsible for the placing on the market of a biocidal product in a particular member state or in the community .


### the receiving competent authority or , in the case of evaluation of an application for a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 . ### the receiving competent authority or , in the case of evaluation of an application for renewal of a community authorisation , the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with article 9 .


### the exposure of humans to that active substance in a biocidal product , under normal conditions of use , is negligible , in particular where the product is used in closed systems or strictly controlled conditions ; ### the exposure of humans to that active substance in a biocidal product , under normal conditions of use , is negligible or properly managed through sustainable use measures and taking into account the intrinsic properties of the active substance , in particular where the product is used in closed systems or strictly controlled conditions ;


### a competent authority of a member state may grant a parallel trade permit for a biocidal product that is authorised in another member state to be placed on the market and used in the member state of introduction , if it determines that the biocidal product is substantially identical in composition to a biocidal product already authorised in that member state . ### a competent authority of a member state may grant a parallel trade permit for a biocidal product that is authorised in another member state to be placed on the market and used in the member state of introduction , if it determines that the biocidal product is identical in composition to a biocidal product already authorised in that member state .


### there are reasons for concern linked to the nature of the critical effects , in particular developmental neurotoxic or immunotoxic effects , which , in combination with the use patterns , amount to use that could still cause concern , even with very restrictive risk management measures ; ### it is considered as a persistent , bio - accumulative and toxic substance in accordance with the criteria set out in annex xiii of regulation no 1907 / 2006 ;


### commission proposal within one month after the receipt of an application for a national authorisation referred to in article 15 , the receiving competent authority shall validate the application if it complies with the following requirements : the information referred to in article 18 has been submitted ; it is accompanied by the fees payable under article 70 . the validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted . ### the person responsible for the placing of a biocidal product on the market , or his representative , shall submit an application for a national or community authorisation to the agency and inform the agency of the name of the competent authority of the member state of his choice which shall be responsible for the evaluation of the application . the agency shall , within three weeks after the receipt of the application , notify the evaluating competent authority that the application is available in the agency database .


### if the receiving competent authority , on basis of the validation made pursuant to paragraph 1 , considers that the application is complete , it shall without delay inform the applicant thereof . ### 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 . the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant does not submit the required additional information on time , and shall notify the applicant and the evaluating competent authority of the rejection . in such cases , part of the fees payable to the agency under article 70 shall be reimbursed .


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


### by way of derogation from article 47 , treated articles and materials that incorporate biocidal products which are not authorised in the community or in at least one member state and which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] may , until the date of a decision granting authorisation to these biocidal products , continue to be placed on the market if the application for authorisation is submitted at the latest by 1 january 2017 . in the case of a refusal to grant an authorisation to place a biocidal product on the market , treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision . ### by way of derogation from article 47 , treated articles and materials that incorporate biocidal products which are not authorised in the community or in at least one member state and which were available on the market on . . . [ oj : insert the date referred to in the first subparagraph of article 85 ] may , until the date of a decision granting authorisation to these biocidal products , continue to be placed on the market if the application for authorisation is submitted at the latest by 1 january 2015 . in the case of a refusal to grant an authorisation to place a biocidal product on the market , treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision .


### biocidal products , for which an application for a product authorisation has not been submitted in accordance with the second subparagraph , shall no longer be placed on the market with effect from six months after the date on which the inclusion becomes effective . disposal , storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until eighteen months after the date on which the inclusion becomes effective . ### biocidal products , for which an application for a product authorisation has not been submitted in accordance with the second subparagraph , shall no longer be placed on the market after the date on which the inclusion becomes effective . disposal , storage and use of existing stocks of biocidal products for which an application for authorisation has not been submitted in accordance with the second subparagraph are allowed until six months after the date on which the inclusion becomes effective .


### the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials ; ### does not affect the english version .


### the permitted alteration of the composition of this reference biocidal product expressed in percentage of the non - active substances contained in the biocidal products which are considered to belong to that frame formulation ; ### the permitted alteration of the composition of this reference biocidal product expressed as a percentage reduction in the active substances or as a percentage alteration of the non - active substances contained in the biocidal products which are considered to belong to that frame formulation ;


### qualitative and quantitative composition in terms of the active substances and non - active substances , knowledge of which is essential for proper use of the biocidal product ; ### qualitative and quantitative composition in terms of the active substances and non - active substances , taking into consideration the concentration limit values given in article 16 , in so far as knowledge of these is essential for proper use of the biocidal product ;


### it is either the same or similar with regard to the non - active substances present and the type of formulation ; ### it is identical with regard to the specification and content of the active substances and in the type of formulation ;


### commission proposal the agency shall , within two months after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . ### the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application .


### ' placing on the market ' means the first supply of a biocidal product for distribution or for use on the community market in the course of a commercial activity , whether in return for payment or free of charge ; ### ' placing on the market ' means the supply of a biocidal product to third parties , whether in return for payment or free of charge , or the making available of a biocidal product to third parties . importation shall be deemed to be placing on the market . no supply to third parties is involved , for example , when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer .


### an active substance shall be included in annex i for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point of article 16 . ### an active substance shall be included in annex i for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point of article 16 .


### the receiving competent authority may require that applications for a national authorisation be submitted in one or more of the official languages of the member state where that competent authority is situated . ### the receiving competent authority may require that applications for the sole purpose of a national authorisation be submitted in one of the official languages of the member state where that competent authority is situated . applications for a national authorisation which involve a mutual recognition procedure may be submitted , along with the documents referred to in paragraph 1 , to the competent authority in english .


### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products that are authorised in different member states . ### in view of the benefits for the internal market and for the consumer , it is desirable to establish harmonised rules for parallel trading of identical biocidal products which are authorised in different member states .


### ' letter of access ' means an original document , signed by the owner or owners of information , which states that the information may be used by the competent authorities , the european chemicals agency , or the commission for the purpose of evaluating an active substance or granting an authorisation ; ### ' letter of access ' means an original document , signed by the owner or owners of information or their authorised representative , which states that the information may be used by the designated competent authority , the european chemicals agency , or the commission for the purpose of evaluating an active substance or granting an authorisation for the benefit of a third party ;


### commission proposal the nature , the quantity and the technical equivalence of active substances in the biocidal product and , where appropriate , any toxicologically or ecotoxicologically significant impurities and non - active substances , and its residues of toxicological or environmental significance , which result from uses to be authorised , can be determined according to the relevant requirements in annexes ii and iii ; ### the chemical identity , the quantity and the technical equivalence of active substances in the biocidal product and , where appropriate , any toxicologically or ecotoxicologically significant impurities and non - active substances , and its residues of toxicological or environmental significance , which result from uses to be authorised , can be determined according to the relevant requirements in annexes ii and iii ;


### application for community authorisation shall be submitted to the agency . ### application for authorisation shall be submitted to the agency . the applicant may , in agreement with a member state , have his application validated by that member state and must identify the evaluating competent authority in the application itself , as laid down in article 22 .


### a biocidal product shall be considered as substantially identical to the reference product if one of the following conditions is met : ### a biocidal product shall be considered as substantially identical to the reference product if all of the following conditions are met :


### during the work programme , the commission shall decide pursuant to the procedure laid down in article 72 that an active substance shall be included in annex i of this regulation and under which conditions , or , in cases where the requirements of article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period , that such active substance shall not be included in annex i of this regulation . the decision shall specify the date on which the inclusion in annex i becomes effective . ### during the work programme , the commission shall decide pursuant to the procedure laid down in article 72 that an active substance shall be included in annex i of this regulation and under which conditions , or , in cases where the requirements of article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period , that such active substance shall not be included in annex i of this regulation . the decision shall specify the date on which the inclusion in annex i becomes effective , which shall be two years after the adoption of the decision .


### it meets two of the criteria to be considered as a persistent , bio - accumulative and toxic substance as set out in annex xiii of regulation no 1907 / 2006 ; ### it is considered as a persistent , bio - accumulative and toxic substance in accordance with the criteria set out in annex xiii of regulation no 1907 / 2006 ; , and , and .


### when preparing an opinion on the inclusion or renewal of the inclusion of an active substance in annex i , the agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion . ### when preparing an opinion on the inclusion or renewal of the inclusion of an active substance in annex i , the agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and whether exposure is not adequately controlled , bearing in mind the intrinsic hazards of the substance , and shall address the matter in its opinion .


### the commission shall adopt the measures designed to set the criteria defining what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2 . ### in order to define what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2 , the commission shall adapt the criteria by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c .


### on receipt of the opinion of the agency , the commission shall adopt a decision on the application to include the active substance in annex i . that decision , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 72 . ### in order to keep the list of authorised active substances updated , on receipt of the opinion of the agency , the commission shall adopt , by means of delegated acts in accordance with article 71 a and subject to the conditions of articles 71 b and 71 c , a decision to include the active substance in annex i . if the commission decides to include the substance in annex i , the name of the applicants shall be given .


### commission proposal within one month after the receipt of an application for a national authorisation referred to in article 15 , the receiving competent authority shall validate the application if it complies with the following requirements : the information referred to in article 18 has been submitted ; it is accompanied by the fees payable under article 70 . the validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted . ### the person responsible for the placing of a biocidal product on the market , or his representative , shall submit an application for a national or community authorisation to the agency and inform the agency of the name of the competent authority of the member state of his choice which shall be responsible for the evaluation of the application . the agency shall , within three weeks after the receipt of the application , notify the evaluating competent authority that the application is available in the agency database .


### a dossier for at least one representative biocidal product that contains the active substance satisfying the requirements set out in annex iii . ### a dossier or a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in annex iii .


### it is considered to have endocrine disrupting properties that may cause adverse effect on humans on the basis of the assessment of community or internationally agreed test guidelines or other available data . ### it is a substance , such as those with endocrine disrupting properties or persistent , bioaccumulative and toxic properties or very persistent , very bioaccumulative properties which do not comply with the criteria referred to in points and – for which scientific evidence exists of possible serious effects on public health or the environment giving rise to a level of concern equivalent to that applicable to other substances referred to in points and .


### if the receiving competent authority , on basis of the validation made pursuant to paragraph 1 , considers that the application is complete , it shall without delay inform the applicant thereof . ### 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 . the agency shall , within three weeks after the receipt of the additional information , determine whether the additional information submitted is sufficient to validate the application . the agency shall reject the application if the applicant does not submit the required additional information on time , and shall notify the applicant and the evaluating competent authority of the rejection . in such cases , part of the fees payable to the agency under article 70 shall be reimbursed .


### application for national authorisation in a member state shall be submitted to the competent authority of that member state . application for community authorisation shall be submitted to the agency . ### application for authorisation shall be submitted to the agency . when an application for national authorisation in a member state is submitted , the applicant , in agreement with the member state concerned , shall identify the evaluating competent authority in the application itself , as laid down in article 22 .


### annex ii – paragraph 2 – subparagraph 3 b ) the permitted alteration of the composition of this reference biocidal product expressed in percentage of the non - active substances contained in the biocidal products which are considered to belong to that frame formulation ; ### the permitted alteration of the composition of this reference biocidal product expressed as a reduction in the percentage of the active substance and / or as an alteration in the percentage of the non - active substances contained in the biocidal products which are considered to belong to that frame formulation ;


### the list referred to in paragraph 2 shall be entered by the agency in the biocides data sharing register . ### each item of information in the list referred to in paragraph 2 shall be identified by a unique code and entered by the agency – with all relevant details and linked to the identity of the initial applicant and the information owner – in the biocides data sharing register .


### any person submitting information related to an active substance to the agency or a competent authority for the purposes of this regulation can request that the information in article 56 shall not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party ' s commercial interests . ### any person submitting information related to an active substance or a biocidal product to the agency or a competent authority for the purposes of this regulation can request that the information in article 56 shall not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party ' s commercial interests .


### information protected under directive 98 / 8 / ec or under this article or for which the protection period expired under directive 98 / 8 / ec or under this article shall not be protected again . ### information protected under directive 98 / 8 / ec or under this article for which the protection period expired under directive 98 / 8 / ec shall , on application , be protected again .