### adding value , creating jobs , and promoting innovation at all stages of the fisheries and aquaculture supply chain ; ### adding value , creating jobs , and promoting innovation at all stages of the fisheries , aquaculture and processing supply chain ;


### promoting social well being and cultural heritage in fisheries areas including maritime cultural heritage ; ### promoting social well being and cultural heritage in fisheries areas including fisheries , aquaculture and maritime cultural heritage ;


### apart from other flags , the partners of a flag under the emff may be a local public - private partnership that is implementing a local development strategy within or outside the union . ### for the purposes of this article , apart from other flags , the partners of a flag under the emff may be a local public - private partnership that is implementing a local development strategy within or outside the union .


### approval of cooperation projects shall take place no later than four months after the date of submission of the project . ### administrative decisions on cooperation projects shall take place no later than four months after the date of submission of the project .


### the emff may support the preparation and implementation of production and marketing plans referred to in article 32 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] . ### in accordance with article 20 , the emff shall support the preparation and implementation of production and marketing plans referred to in article 32 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] .


### the emff may support the preparation and implementation of production and marketing plans referred to in article 32 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] . ### the emff may support the preparation and implementation of production and marketing plans referred to in article 32 of [ regulation no on the common organisation of the markets in fishery and aquaculture products ] . where the production and marketing plans contain a section on management of fishing rights granted to a producer organisation or its members , giving details of the means employed to ensure rational management and the means deployed for monitoring , the emff shall support their preparation and implementation .


### the emff may support marketing measures for fishery and aquaculture products which aim at : ### the emff may support marketing measures for fishery , aquaculture and inland fishery products which aim at :


### the emff may support marketing measures for fishery and aquaculture products which aim at : ### the emff may support marketing measures for fishery and aquaculture products which aim at promoting a policy of quality , adding value to products and conducting promotional campaigns for such fishery and aquaculture products :


### improving the conditions for the placing on the market of : ### improving the conditions for the placing on the market of any fishing or aquaculture species , including :


### promoting the quality by facilitating : ### promoting the quality and added value by facilitating :


### certification and promotion including of sustainable fishery and aquaculture products and of environmentally friendly processing methods ; ### quality certification and promotion , including the creation of specific labelling , including of sustainable fishery and aquaculture products and of environmentally friendly processing methods ;


### direct marketing of fishery products by small scale coastal fishermen ; ### direct marketing of fishery products by coastal fishermen ;


### contributing to the transparency of production and the markets and conducting market surveys ; ### contributing to the transparency of production and the markets and conducting market surveys and studies on the union ' s trade dependency ;


### for the processing of organic aquaculture products as regulated in article 6 and 7 of council regulation no 834 / 2007 . ### for the processing of sustainable aquaculture products ;


### each member state concerned shall determine for the regions referred to in paragraph 1 the list of fishery and aquaculture products and the quantity of those products eligible for the compensation . ### each member state concerned shall determine for the regions referred to in paragraph 1 the list of additional costs incurred by operators engaged in the activities of fishing and farming . it shall also draw up the list of fishery and aquaculture products and the quantity of those products eligible for the compensation .


### the commission shall be empowered to adopt delegated acts in accordance to article 150 in order to define the content of the compensation plan , including the criteria for the calculation of the additional costs resulting from the specific handicaps of the regions concerned . ### the commission shall be empowered to adopt implementing acts in accordance with the examination procedure referred to in article 151 in order to define the content of the compensation plan , including the criteria for the calculation of the additional costs resulting from the specific handicaps of the regions concerned .


### purchase or development of technology , including hardware and software , vessel detection systems , cctv systems and it networks enabling the gathering , administration , validation , analysis and exchange of , and the development of sampling methods for , data related to fisheries , as well as interconnection to cross - sectoral data exchange systems ; ### purchase or development of technology , including hardware and software , vessel detection systems , cctv systems and it networks enabling the gathering , administration , validation , analysis , risk management , submission and exchange of , and the development of sampling methods for , data related to fisheries , as well as interconnection to cross - sectoral data exchange systems ;


### purchase and installation of the components necessary to ensure data transmission from actors involved in fishing and the marketing of fishery products to the relevant member state and eu authorities , including the necessary components for electronic recording and reporting systems , vessel monitoring systems , and automatic identification systems used for control purposes ; ### development , purchase and installation of the components , including computer hardware and software , necessary to ensure data transmission from actors involved in fishing and the marketing of fishery products to the relevant member state and eu authorities , including the necessary components for electronic recording and reporting systems , vessel monitoring systems , and automatic identification systems used for control purposes ;


### purchase and installation of the components necessary to ensure traceability of fishery and aquaculture products , as defined in art . 58 of council regulation no 1224 / 2009 ; ### development , purchase and installation of the components , including computer hardware and software , necessary to ensure traceability of fishery and aquaculture products , as defined in art . 58 of council regulation no 1224 / 2009 ;


### modernisation and purchase of patrol vessels , aircrafts and helicopters , provided they are used at least 60% of the time for fisheries control ; ### modernisation and purchase of patrol vessels , aircrafts and helicopters , provided they are used for fisheries control at least 60% of the total time the equipment is used , calculated on an annual basis ;


### modernisation and purchase of patrol vessels , aircrafts and helicopters , provided they are used at least 60% of the time for fisheries control ; ### modernisation and purchase of patrol vessels , aircrafts and helicopters , provided they are used at least 60% per year of the time for fisheries control ;


### national multi - annual sampling programmes ; ### national and sub - national multi - annual sampling programmes ;


### support under this chapter shall contribute to the development and implementation of the union’s integrated maritime policy . it shall : ### support under this chapter shall contribute to enhance the development and implementation of the union’s integrated maritime policy . it shall :


### promoting actions which encourage member states and eu regions to develop introduce or implement integrated maritime governance ; ### promoting actions which encourage member states and their regions to develop introduce or implement integrated maritime governance ;


### promoting dialogue and cooperation with and among member states and stakeholders on marine and maritime issues , including by developing sea - basin strategies ; ### promoting dialogue and cooperation with and among member states and stakeholders on marine and maritime issues , including by developing and implementing integrated sea - basin strategies , taking into account a balanced approach in all sea basins , as well as the specific characteristics of maritime basins and sub - basins and the relevant macroregional strategies , where appropriate ;


### promoting cross - sectoral cooperation platforms and networks , including representatives of public authorities , regional and local authorities , industry , the tourism sector , research stakeholders , citizens , civil society organisations and the social partners ; ### promoting cross - sectoral cooperation platforms and networks , including representatives of national public authorities , regional and local authorities , industry , the tourism sector , research stakeholders , citizens , civil society organisations and the social partners ;


### promoting the exchange of best practices and dialogue at international level , including bilateral dialogue with third countries without prejudice to other agreements or arrangements which may exist between the eu and the third countries concerned ; ### promoting the exchange of best practices and dialogue at international level , including bilateral dialogue with third countries , taking into account the united nations convention on the law of the sea and the relevant existing international conventions based on unclos , without prejudice to other agreements or arrangements which may exist between the eu and the third countries concerned ; such dialogue shall include , as appropriate , effective discussion on the ratification and the implementation of unclos ;


### the progressive development of a comprehensive and publicly accessible high quality marine knowledge base which shall facilitate sharing , re - use and dissemination of these data and knowledge among various user groups . ### the progressive development of a comprehensive and publicly accessible high quality marine knowledge database which shall facilitate sharing , re - use and dissemination of these data and knowledge among various user groups , therefore avoiding duplication of efforts ; for such recourse must be made whenever possible to existing programmes at the level of member states and the european union ;


### the progressive development of a comprehensive and publicly accessible high quality marine knowledge base which shall facilitate sharing , re - use and dissemination of these data and knowledge among various user groups . ### the progressive development of a comprehensive and publicly accessible high quality marine knowledge base which shall reduce duplication , facilitate sharing , re - use and dissemination of these data and knowledge among various user groups .


### 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 .


### public information and sharing best practice , awareness raising campaigns and associated communication and dissemination activities such as publicity campaigns , events , the development and maintenance of websites , stakeholder platforms , including corporate communication of the political priorities of the union as far as they are related to the general objectives of this regulation ; ### public information and sharing best practice and relevant effective european research programmes , awareness raising campaigns and associated communication and dissemination activities such as publicity campaigns , events , the development and maintenance of websites , stakeholder platforms , including corporate communication of the political priorities of the union as far as they are related to the general objectives of this regulation ;


### conferences , seminars and workshops ; ### conferences , seminars , forums and workshops ;


### the development , operation and maintenance of it - systems and networks enabling the gathering , administration , validation , analysis and exchange of , and the development of sampling methods for , data related to fisheries , as well as interconnection to cross - sectoral data exchange systems ; ### the development , operation and maintenance of it - systems and networks enabling the gathering , administration , validation , analysis and exchange of , and the development of sampling methods for , data , as well as interconnection to cross - sectoral data exchange systems ;


### in order to achieve the specific objective of developing cross - sectoral operations set out in article 81 b ) , the emff may support : ### in order to achieve the specific objective of developing cross - border and cross - sectoral operations set out in article 81 b ) and ba ) , the emff may support :


### in order to achieve the specific objective of developing cross - sectoral operations set out in article 81 b ) , the emff may support : ### in order to achieve the specific objective of developing cross - border and cross - sectoral operations set out in article 81 b ) , the emff may support :


### the preparation and provision of scientific opinions and advice by scientific bodies , including international advisory bodies in charge of stock assessments , by independent experts and by research institutions ; ### the preparation and provision of scientific opinions and advice by scientific bodies , including international advisory bodies in charge of stock assessments , by experts and by research institutions ;


### cooperation activities between the member states in the field of data collection , including the setting - up and running of regionalized databases for storage , management and use of data which will benefit regional cooperation and improve data collection and management activities as well as the scientific expertise in support of fisheries management . ### cooperation activities between the member states in the field of data collection , including the various regional stakeholders and including the setting - up and running of regionalized databases for storage , management and use of data which will benefit regional cooperation and improve data collection and management activities as well as the scientific expertise in support of fisheries management .


### joint purchase by several member states belonging to the same geographical area , of patrol vessels , aircrafts and helicopters , provided they are used at least 60% of the time for fisheries control ; ### joint purchase by several member states belonging to the same geographical area , of patrol vessels , aircrafts and helicopters , provided they are used for fisheries control at least 60% of the total time the equipment is used , calculated on an annual basis ;


### the implementation of sustainable fisheries agreements and the union participation in regional fisheries management organisations ; ### the preparation , monitoring and evaluation of sustainable fisheries agreements and the union participation in regional fisheries management organisations ; the measures in question consist of studies , meetings , expert involvement , temporary staff costs , information activities and any other administrative costs or costs arising from scientific or technical assistance by the commission .


### 50 % of the eligible public expenditure for the support referred to in article 78 ; ### 50 % of the eligible public expenditure for the support referred to in articles 33 , 33 , 39 and 78 ;


### 50 % of the eligible public expenditure for the support referred to in article 78 ; ### 50 % of the eligible public expenditure for the support referred to in article 39 and 78 ;


### by way of derogation from paragraph 1 , member states may apply an intensity of public aid between 50% and maximum100% of the total eligible expenditure when the operation is implemented under chapter iii of title v and fulfils one of the following criteria : ### by way of derogation from paragraph 1 , member states may apply an intensity of public aid between 50% and maximum 100% of the total eligible expenditure when the operation is implemented under chapter i , ii and iv of title v and fulfils all of the following criteria :


### for the cases of financial corrections applied on expenditure directly linked to the non - compliance with article 98 , the member states shall decide the amount of a correction taking into account the gravity of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary . ### the member state shall decide the amount of a correction taking into account the gravity of the non compliance by the beneficiary with cfp rules , the economic advantage derived from the non - compliance with cfp rules or the importance of the emff contribution to the economic activity of the beneficiary .


### ensuring the establishment of a single website or a single website portal providing information on , and access to , the operational programme in each member state ; ### ensuring the establishment of a single website or a single website portal providing information on , and access to , the operational programme in each member state ; that website or portal shall be updated promptly in the event of any changes being made ;


### ensuring the establishment of a single website or a single website portal providing information on , and access to , the operational programme in each member state ; ### ensuring the establishment of a single website or a single website portal providing information on , and easy access to , the operational programme in each member state ;


### type of operations located in the outermost regions may benefit from an increase by type of operations located in the outermost regions may benefit from an increase by ### percentage points 35 percentage points 40


### implemented by producer organisation or associations of producer organisations may benefit from an increase by 10 percentage points ### implemented by producer organisation , an association of producer organisations , a professional fishermen ' s organisation recognised by the member state or an interbranch organisation , may benefit from an increase by 30 percentage points .


### 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 , 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 statutory auditor or the audit firm shall comply with the international auditing standards referred to in article 26 of directive 2006 / 43 / ec when carrying out the statutory audit of public - interest entities as long as those standards are in conformity with the requirements of this regulation . ### the statutory auditor or the audit firm shall comply with the international auditing standards referred to in article 26 of directive 2006 / 43 / ec when carrying out the statutory audit of public - interest entities .


### give an opinion which shall state clearly the opinion of the statutory auditor or the audit firm as to whether the annual or consolidated financial statements give a true and fair view and have been prepared in accordance with the relevant financial reporting framework and , where appropriate , whether the annual or consolidated financial statements comply with statutory requirements ; the audit opinion shall be either unqualified , qualified , an adverse opinion or , if the statutory auditor or audit firm are unable to express an audit opinion , a disclaimer of opinion . in case of a qualified or an adverse opinion or a disclaimer of opinion , the report shall explain the reasons of such decision ; ### give an opinion which shall state clearly the opinion of the statutory auditor or the audit firm as to whether the annual or consolidated financial statements give a true and fair view and have been prepared in accordance with the relevant financial reporting framework and , where appropriate , whether the annual or consolidated financial statements comply with statutory requirements ; in accordance with international standards on auditing the audit opinion shall be either unqualified , qualified , an adverse opinion or , if the statutory auditor or audit firm are unable to express an audit opinion , a disclaimer of opinion . in case of a qualified or an adverse opinion or a disclaimer of opinion , the report shall explain the reasons of such decision ;


### refer to any matters to which the statutory auditor or the audit firm draw attention by way of emphasis without qualifying the audit opinion ; ### refer in accordance with international standards on auditing to any matters to which the statutory auditor or the audit firm draw attention by way of emphasis without qualifying the audit opinion ;


### give an opinion concerning the consistency or otherwise of the annual report with the annual financial statements for the same fiscal year ; ### give an opinion in accordance with international standards on auditing concerning the consistency or otherwise of the annual report with the annual financial statements for the same fiscal year ;


### when more than one statutory auditor or audit firm have been appointed to carry out the statutory audit of the public - interest entity , they shall agree on the results of the statutory audit and submit a joint report and opinion . in case of disagreement , each statutory auditor or audit firm shall submit his , her or its opinion separately . if one statutory auditor or audit firm qualifies his , her or its opinion , submits an adverse opinion or a disclaimer of opinion , the overall opinion shall be considered as qualified , adverse opinion or a disclaimer of opinion . in a separate paragraph each statutory auditor or audit firm shall state the reasons of disagreement . ### when more than one statutory auditor or audit firm have been appointed to carry out the statutory audit of the public - interest entity , they shall agree on the results of the statutory audit and submit a joint report and opinion . in case of disagreement , each statutory auditor or audit firm shall submit his , her or its opinion separately . if one statutory auditor or audit firm qualifies his , her or its opinion , submits an adverse opinion or a disclaimer of opinion , the overall opinion shall be considered as qualified , adverse opinion or a disclaimer of opinion , in accordance with international standards on auditing . in a separate paragraph each statutory auditor or audit firm shall state the reasons of disagreement .


### competent authorities supervising credit institutions and insurance undertakings shall establish regular a dialogue with the statutory auditors and audit firms carrying out the statutory audit of those institutions and undertakings . ### competent authorities supervising credit institutions and insurance undertakings shall establish regular a dialogue with the statutory auditors and audit firms carrying out the statutory audit of those institutions and undertakings . the competent authority and the statutory auditor or audit firm shall inform each other about relevant facts or decisions referred to in paragraph 1 .


### a majority of the members of the audit committee shall be independent . the chairman of the audit committee shall be appointed by its members and shall be independent . ### a majority of the members of the audit committee shall be independent . the chairperson of the audit committee shall be elected annually by the general meeting of shareholders of the audited entity and shall be independent . the chairperson shall report directly to the shareholders .


### market monitoring ### monitoring of audit quality


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


### the risks arising from high concentration , including the demise of audit firms with significant market share , the disruption in the provision of statutory audit services whether in a specific sector or across sectors , the further accumulation of risk in the market and the impact on the overall stability of the financial sector ; ### the risks arising from high concentration of quality deficiencies of a statutory auditor or audit firm , including systematic deficiencies within an audit firm network , which may lead to the demise of audit firms , the disruption in the provision of statutory audit services whether in a specific sector or across sectors , the further accumulation of risk of audit deficiencies and the impact on the overall stability of the financial sector ;


### 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 .


### 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 who 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 or those of 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 .


### 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 .


### ' substance of concern ' means any substance , other than the active substance , which has an inherent capacity to cause an adverse effect on humans , animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect ; ### ' substance of concern ' means any substance , other than the active substance , which has an inherent capacity to cause an adverse effect on humans , animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect . such a substance , unless there are other grounds for concern , should normally be a substance classified as dangerous within the meaning of directive 67 / 548 / eec and be present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of directive 1999 / 45 / ec or regulation no 1272 / 2008 ;


### ' treated material or article ' means any substance , mixture , material or article which was treated with or incorporates one or more biocidal products with the intention to protect the substance , mixture , material or article from deterioration caused by harmful organisms ; ### ' treated material or article ' means any substance , mixture , material or article which was treated with or incorporates one or more biocidal products with the intention that it should perform the biocidal function for which it is intended ;


### ' 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 representative , 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 for the benefit of a third party ;


### 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 .


### an active substance shall , where appropriate , be included in annex i together with any of the following conditions : ### an active substance and a statement of the reference source of the active substance , for determining technical equivalence referred to in article 3 , shall , where appropriate , be included in annex i together with any of the following conditions :


### 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 ;


### active substances identified under article 57 of regulation no 1907 / 2006 as having endocrine disrupting properties . ### active substances identified under article 57 of regulation no 1907 / 2006 as having endocrine disrupting properties . the scientific criteria for determining endocrine disrupting properties pursuant to regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec1 shall apply . ______ oj l 309 , 24 . 11 . 2009 , p . 1 .


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


### 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 of the receipt of an application , the agency shall validate the application if it complies with the following requirements :


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


### 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 . ### 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 . when the commission decides to include the active substance in annex i , the name of the applicant shall be indicated .


### an active substance fulfilling at least one of the following criteria shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2 : its acceptable daily intake , acute reference dose or acceptable operator exposure level is significantly lower than those of the majority of the active substances included in annex i for the same product type ; b ) 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 ; c ) 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 ; d ) it contains a significant proportion of non - active isomers ; e ) it is classified or meets the criteria to be classified , in accordance with regulation no 1272 / 2008 , as carcinogen category 1a or 1b , mutagen category 1a or 1b or toxic for reproduction category 1a or 1b ; f ) 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 . ### active substances shall be considered candidates for substitution in accordance with the procedure referred to in paragraph 2 , if : they are persistent , bio - accumulative and toxic as defined in annex xiii to regulation no 1907 / 2006 ; b ) they are very persistent and bio - accumulative in accordance with the criteria set out in annex xiii to regulation no 1907 / 2006 ; c ) they meet the criteria to be classified , in accordance with regulation no 1271 / 2008 , as category 1a or 1b carcinogens , category 1a or 1b mutagens or toxic for reproduction category 1a or 1b ; d ) they are active substances , such as those with endocrine disrupting properties or persistent , bioaccumulative and toxic properties or and very bioaccumulative properties which do not comply with the criteria referred to in points or – for which scientific evidence exists of probable serious effects on public health or the environment giving rise to a level of concern equivalent to that applicable to the substances referred to in points or .


### 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 .


### 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 .


### the active substances included therein are listed in annex i and any conditions included in that annex together with those active substances are complied with ; ### the active substances included therein are listed in annex i , a registration number is assigned to them in accordance with article 8 , paragraph 5a , and any conditions included in that annex together with those active substances are complied with ;


### s ### the evaluation of the compliance of the biocidal products with the criteria set out in point of paragraph 1 should be based as far as possible on existing information on the substances of concern contained in the biocidal product in order to keep tests on animals to a minimum , in accordance with the procedures laid down in directive 1999 / 45 / ec or regulation no 1272 / 2008 on identifying the danger posed by biocidal products and consequent risk assessment .


### 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 or more 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 .


### 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 .


### 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 ; ### e ) 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 ;


### manufacturers of the active substances ; ### g ) manufacturers of the active substances and registration number of the active substance , in accordance with article 8 ;


### 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 ;


### 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 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 results of the comparative assessment shall be forwarded , without delay , to the competent authorities of other member states and the agency and , in the case of evaluation of an application for a community authorisation , also to the commission . ### the results of the comparative assessment shall be forwarded , without delay , to the competent authorities of other member states and the agency and , in the case of evaluation of an application for renewal of a community authorisation , also to the commission .


### the receiving competent authority or , in the case of a decision on an application for a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met : ### the receiving competent authority , or in the case of a decision on an application for a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met :


### the receiving competent authority or , in the case of a decision on an application for a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met : ### the receiving competent authority or , in the case of a decision on an application for renewal of a community authorisation , the commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with annex vi demonstrates that all the following criteria are met :


### 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 ;


### 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 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 ;


### 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 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 : 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 .


### 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 forwarding 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 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 .


### 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 .


### 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 .


### 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 .


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


### the reference competent authority and the competent authorities of the other concerned member states shall authorise the biocidal product on the basis of the approved assessment report and the summary of the biocidal product characteristics within one month after the end of the period referred to in paragraph 7 . ### the reference competent authority and the competent authorities of the other concerned member states shall authorise the biocidal product on the basis of the approved assessment report and the summary of the biocidal product characteristics within one month after the end of the period referred to in paragraph 7 . a single authorisation number shall be used in all the member states involved .


### 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 , following consultation of 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 .


### within nine months from the receipt of the conclusions of the evaluation , the agency shall prepare and submit to the commission an opinion on the authorisation of the biocidal product . ### within three months from the receipt of the conclusions of the evaluation , the agency shall prepare and submit to the commission an opinion on the authorisation of the biocidal product .


### 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 .


### 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 .


### name and address of the authorisation holder in the member state of origin ; ### name and address of the authorisation holder in the member state of origin and , where appropriate , the letter of access in accordance with article 50 ;


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


### by way of derogation from article 15 , an experiment or a test for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process - oriented research and development , and under the conditions laid down in the second and third subparagraphs . ### by way of derogation from article 15 , an experiment or a test for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product may only take place in the case of scientific research and development or in the case of product and process - oriented research and development .


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


### 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 . if the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects on human or animal health or any unacceptable adverse effect on the environment , the competent authority of the member state concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences . the competent authority shall without delay inform the commission and other competent authorities about such measures . ### the manufacturer of a biocidal product shall ensure that his product is handled in such a way as not to cause damage to health and the environment .


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


### any hazard statement or precautionary statement set out in the authorisation for the biocidal product . ### any hazard statement or precautionary statement set out in the authorisation for the biocidal product if the biocidal product is intended to come into direct contact with humans and the environment .


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


### the labelling shall be clearly visible , easily legible and appropriately durable . where this is necessary because of the size or the function of the treated article or material , the labelling shall be printed on the packaging , on the instructions for use or on the warranty of the treated article or material . ### the labelling may be printed on the treated article or material , on the packaging , on the instructions for use or on the warranty of the treated material or product , provided that it is clearly visible , easily legible and appropriately durable .


### 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 , as provided for by article 50 ,


### the list referred to in paragraph 2 shall be entered by the agency in the biocides data sharing register . ### all information contained in the list referred to in paragraph 2 shall be entered by the agency in the biocides data sharing register , identified by a single code and complete with all identifying details and with a link to the identity of the first applicant and of the owner of the information .


### information submitted for the purposes of directive 98 / 8 / ec or of this regulation shall benefit from data protection under the conditions laid down in this article . the protection period for this information shall start when the information is submitted . 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 submitted for the purposes of directive 98 / 8 / ec or of this regulation shall benefit from data protection under the conditions laid down in this article . the protection period for this information shall start when the information is submitted . a date of submission shall be assigned separately to each document , identified with the single code pursuant to article 48 .


### where no such agreement is reached two months after the request was made according to article 51 , the prospective applicant shall without delay inform the agency and the owner of the information thereof . within two months of being informed about the failure to reach an agreement , the agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals . national courts shall decide on the proportionate share of the cost that the prospective applicant shall pay to the data owner . ### where no such agreement is reached two months after the request was made according to article 51 , both the data owner and the prospective applicant shall without delay inform the agency thereof . within two months of being informed about the failure to reach an agreement , the agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals . an arbitration body within the agency shall decide on the proportionate share of all costs associated with the production and use of the information that the prospective applicant shall pay to the data owner .


### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities . ### in the case of a biocidal product which has already been authorised in accordance with articles 15 , 25 or 28 , and where all periods of protection of information according to article 49 have expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant , and if the periods of protection of information according to article 49 have not expired , the receiving competent authority or the agency may agree that a subsequent applicant for authorisation may share the data provided by the first applicant pursuant to article 52 , in both cases in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised , including degree of purity and nature of impurities .


### 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 2020 . the commission shall submit the report to the european parliament and the council . on the basis of the report , the commission shall assess the desirability of proposing amendments to this regulation .


### labels shall not be misleading and , in any case , shall not mention the indications ‘ low - risk biocidal product’ , ‘ non - toxic’ , ‘ harmless’ or similar indications . in addition , the label must show clearly and indelibly the following information : ### labels shall not be misleading and , in any case , shall not mention the indications ‘ non - toxic’ , ‘ harmless’ or similar indications . in addition , the label must show clearly and indelibly the following information :


### directions for use and the dose rate , expressed in metric units , for each use provided for under the terms of the authorisation ; ### directions for use and the dose rate , expressed in metric units and / or in a manner which is meaningful and comprehensible to the user , for each use provided for under the terms of the authorisation ;


### advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment . in any case , the advertising of a biocidal product shall not mention ‘ low - risk biocidal product’ , ‘ non - toxic’ , ‘ harmless’ or any similar indication . ### advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment . in any case , the advertising of a biocidal product shall not mention ‘ non - toxic’ , ‘ harmless’ or any similar indication .


### 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 .


### 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 .


### 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 .


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


### in line with the goal of simplification , all activities of the emff which fall under shared management , including control and data collection , should take the form of one single operational programme per member state , in accordance with its national structure . the programming exercise shall cover the period from 1 january 2014 to 31 december 2020 . each member state should prepare a single operational programme . each programme should identify a strategy for meeting targets in relation to the union priorities for the emff and a selection of measures . programming should comply with union priorities , while being adapted to national contexts and complement the other union policies , in particular rural development policy and cohesion policy . ### in line with the goal of simplification and decentralisation , all activities of the emff which fall under shared management , including control and data collection , should take the form of one single operational programme per member state , in accordance with its national structure . the programming exercise shall cover the period from 1 january 2014 to 31 december 2020 . each member state should prepare a single operational programme integrating the various sub - national operational programmes . each programme should identify a strategy for meeting targets in relation to the union priorities for the emff and a selection of measures . programming should comply with union priorities , while being adapted to national contexts and complement the other union policies , in particular rural development policy and cohesion policy .


### 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 training , education and lifelong learning , co - operation between scientists and fishermen stimulating the dissemination of knowledge and promoting career opportunities in maritime professions , as well as for advisory services helping to improve the overall performance and competitiveness of operators .


### conscious of the need to identify the most suitable areas for developing aquaculture taking into account access to waters and space , the emff should support national authorities in making their strategic choices at national level . ### conscious of the need to identify the most suitable areas for developing aquaculture taking into account access to waters and space , the emff should support national and sub - national authorities in making their strategic choices in line with their respective powers .


### in order to promote environmentally sustainable aquaculture , the emff should support aquaculture activities which are highly respectful of the environment , the conversion of aquaculture enterprises to eco - management , the use of audit schemes as well as the conversion to organic aquaculture . in the same vein , the emff should also support aquaculture providing for special environmental services . ### in order to promote environmentally sustainable aquaculture , the emff should support aquaculture activities which are highly respectful of the environment , the conversion of aquaculture enterprises to eco - management , the use of audit schemes as well as the conversion to sustainable aquaculture .


### 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 other representative fishing organisations , in particular fishermen ' s associations , and associations of producer organisations by granting them support .


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


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


### the objective of the imp is to support sustainable use of seas and oceans and to develop coordinated , coherent and transparent decision - making in relation to the policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , in accordance with the commission communication ‘ an integrated maritime policy of the european union . ### the objective of the imp is to support sustainable use of seas and oceans and to develop coordinated , coherent and transparent decision - making in relation to the policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , in accordance with regulation no 1255 / 2011 of the european parliament and of the council of 30 november 2011 establishing a programme to support the further development of an integrated maritime policy1 and the commission communication ‘ an integrated maritime policy of the european union . __________________ 1 oj l321 , 5 . 12 . 2011 , p . 1


### sustained funding is needed for the implementation and further development of the integrated maritime policy for the european union as reflected in the statements of the council , the european parliament and the committee of the regions . ### sustained funding is needed for the implementation and further development of the integrated maritime policy for the european union as reflected in regulation no 1255 / 2011 of the european parliament and of the council of 30 november 2011 establishing a programme to support the further development of an integrated maritime policy1 and the statements of the council , the european parliament and the committee of the regions . the development of maritime affairs through financial support for imp measures will have a significant impact in terms of economic , social and territorial cohesion . __________________ 1 oj l321 , 5 . 12 . 2011 , p . 1


### the emff should support the promotion of integrated maritime governance at all levels especially through exchanges of best practices and the further development and implementation of sea basin strategies . these strategies aim at setting up an integrated framework to address common challenges in european sea basins and strengthened co - operation between stakeholders to maximise the use of union financial instruments and funds and contribute to the economic , social and territorial cohesion of the union . ### the emff should support the promotion of integrated maritime governance at all levels especially through exchanges of best practices and the further development and implementation of sea basin strategies . these strategies aim at setting up an integrated framework to address common challenges in european sea basins and strengthened co - operation between stakeholders to maximise the use of union financial instruments and funds and contribute to the economic , social and territorial cohesion of the union . it is therefore very important to improve and enhance external cooperation and coordination in relation to the objectives of the imp , on the basis of the united nations convention on the law of the sea ;


### the emff should also support sustainable economic growth , employment , innovation and competitiveness within maritime sectors and in coastal regions . it is particularly important to identify regulatory barriers and skill deficiencies hindering growth in emerging and prospective maritime sectors , as well as operations aimed at fostering investment in technological innovation necessary to enhance the business potential of marine and maritime applications . ### the emff should also support sustainable economic growth , employment , innovation and competitiveness within maritime sectors and in coastal , insular and outermost regions in the union . it is therefore significant to promote the development of coastal , maritime and island tourism . it is particularly important to identify regulatory barriers and skill deficiencies hindering growth in emerging and prospective maritime sectors , as well as operations aimed at fostering investment in technological innovation necessary to enhance the business potential of marine and maritime applications .


### conscious of the importance of ensuring conservation of marine biological and protecting fish stocks in particular from illegal fishing and in the spirit of the conclusions drawn in the green paper on the reform of the cfp , those operators who do not comply with the rules of the cfp , and particularly jeopardise the sustainability of the stocks concerned and constitute therefore a serious threat to the sustainable exploitation of living marine biological resources that restores and maintains populations of harvested species above levels which can produce the msy , and those who are involved in iuu fishing should be excluded from support under the emff . union funding should not at any stage from the selection to the implementation of an operation be used to undermine the public interest of conservation of marine biological resources expressed in the objectives of the cfp regulation . ### conscious of the importance of ensuring conservation of marine biological and protecting fish stocks in particular from illegal fishing , those operators who do not comply with the rules of the cfp and those who are involved in iuu fishing should be excluded from support under the emff . union funding should not at any stage from the selection to the implementation of an operation be used to undermine the public interest of conservation of marine biological resources expressed in the objectives of the cfp regulation .


### ' inland fishing ' means fishing carried out for commercial purposes by vessels operating exclusively in inland waters or by other devices used for ice fishing ; ### ' inland fishing ' means fishing carried out for commercial purposes , from a vessel or otherwise , exclusively in inland waters or by other devices used for ice fishing ;


### enhancement of the competitiveness and viability of fisheries , in particular of small scale coastal fleet , and improvement of safety or working conditions ; ### enhancement of the competitiveness and viability of fisheries , in particular of the coastal fleet , and improvement of safety or working conditions ;


### fostering innovative , competitive and knowledge based fisheries through the focus on the following areas : ### fostering innovative , competitive and knowledge based fisheries including related processing through the focus on the following areas :


### 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 must be carried out in collaboration with a scientific or technical body as recognised in the business classification provided for in national public procurement legislation .


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


### 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 working conditions on board for fishermen related to health , safety and hygiene 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 reduce the impact of fishing on the marine environment , foster the elimination of discards and facilitate the transition to exploitation of living marine biological resources that restores and maintains populations of harvested species above levels which can produce the msy , the emff may support investments in equipment : ### in order to reduce the impact of fishing on the marine environment , foster the elimination of discards and facilitate the transition to exploitation of living marine biological resources that restores and maintains populations of harvested species at least at levels which can produce the msy , the emff may support investments in equipment :


### the support referred to in paragraph 1 shall only be granted to owners of union fishing vessels whose vessels are which have carried a fishing activity for at least 60 days at sea during the two years preceding the date of submission of the application . ### the support referred to in paragraph 1 shall be granted to owners of union fishing vessels whose vessels are which have carried a fishing activity for at least 60 days at sea during the two years preceding the date of submission of the application , and to fishermen ' s organisations .


### adding value to aquaculture products , in particular by allowing the aquaculture enterprise to carry out the processing , marketing and direct sale of its own aquaculture production ; ### adding value to aquaculture products , in particular by allowing the aquaculture sector to carry out the processing , marketing and direct sale of its own aquaculture production ;


### diversification of the income of aquaculture enterprises through the development of complementary activities outside aquaculture . ### diversification of the income of the aquaculture sector through the development of complementary activities outside aquaculture .


### submit a business plan for the development of their new activities ; ### submit a business plan for the development of their activities ;


### submit a business plan for the development of their aquaculture activities . ### submit an economically credible business plan for the development of their aquaculture activities .


### support may only be granted where the suspension of harvesting due to contamination of molluscs is the result of the proliferation of toxin - producing plankton or the presence of plankton containing biotoxins , and when : ### support may only be granted where the suspension of harvesting due to contamination of molluscs is the result of the proliferation of toxin - producing plankton or the presence of plankton containing biotoxins , or the proliferation of coliforms and when :


### for the processing of organic aquaculture products as regulated in article 6 and 7 of council regulation no 834 / 2007 . ### for the processing of sustainable aquaculture products .


### 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 ;


### promoting the exchange of best practices and dialogue at international level , including bilateral dialogue with third countries without prejudice to other agreements or arrangements which may exist between the eu and the third countries concerned ; ### promoting the exchange of best practices and dialogue at international level , including bilateral dialogue with third countries , taking into account the united nations convention on the law of the sea and the relevant existing international conventions based on unclos , without prejudice to other agreements or arrangements which may exist between the eu and the third countries concerned ; such dialogue shall include , as appropriate , effective discussion on the ratification and the implementation of unclos ;


### the progressive development of a comprehensive and publicly accessible high quality marine knowledge base which shall facilitate sharing , re - use and dissemination of these data and knowledge among various user groups . ### the progressive development of a comprehensive and publicly accessible high quality marine knowledge base which facilitates sharing , re - use and dissemination of these data and knowledge among various user groups , thus avoiding duplication of the databases ; for this purpose , the best use will be made of existing union and member state programmes , including inspire and gmes .


### 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 emerging and prospective maritime sectors and in coastal , insular and outermost regions in the union , in complementarity with established sectoral and national activities .


### in order to achieve the specific objective of developing cross - sectoral operations set out in article 81 b ) , the emff may support : ### in order to achieve the specific objective of developing cross - border and cross - sectoral operations set out in article 81 b ) and ba ) , the emff may support :


### 65 % of the eligible expenditure for the support referred to in article 79 . ### 75 % of the eligible expenditure for the support referred to in article 79 .


### in addition to the general rules of article 72 of [ regulation no [ . . . ] laying down common provisions ] , and following the commission decision approving the operational programme , an initial pre - financing amount for the whole programming period shall be paid by the commission . this shall represent 4% of the contribution from the union budget to the operational programme concerned . it may be split into two instalments depending on budget availability . ### in addition to the general rules of article 72 of [ regulation no [ . . . ] laying down common provisions ] , and following the commission decision approving the operational programme , an initial pre - financing amount for the whole programming period shall be paid by the commission . this shall represent 7% of the contribution from the union budget to the operational programme concerned . it may be split into two instalments depending on budget availability .


### it is important to ensure high quality statutory audits within the union . all statutory audits should therefore be carried out on the basis of the international auditing standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to statutory audits . member states should be allowed to impose additional national audit procedures or requirements only if they stem from specific national legal requirements relating to the scope of the statutory audit of annual or consolidated financial statements , meaning that those requirements have not been covered by the adopted international auditing standards , and only if they add to the credibility and quality of annual financial statements and consolidated financial statements and are conducive to the union public good . the commission should continue to be involved in the monitoring of the content and adoption process of the international auditing standards by the ifac . ### it is important to ensure high quality statutory audits within the union . all statutory audits should therefore be carried out on the basis of the international auditing standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to statutory audits . member states should avoid imposing additional national audit procedures or requirements , with the proviso that this should be permissible only if they stem from specific national legal requirements relating to the scope of the statutory audit of annual or consolidated financial statements , meaning that those requirements have not been covered by the adopted international auditing standards , and only if they add to the credibility and quality of annual financial statements and consolidated financial statements and are conducive to the union public good . the commission should continue to be involved in the monitoring of the content and adoption process of the international auditing standards by the ifac .


### some member states have replaced the statutory audit of small undertakings with a limited review of their financial statements . it is appropriate to allow those member states to maintain this practice instead of providing for a proportionate application of auditing standards to small undertakings . ### some member states have replaced the statutory audit of small undertakings with a limited review of their financial statements . it is appropriate to allow those member states to maintain this practice instead of providing for a proportionate application of auditing standards to small undertakings . member states within whose territory a statutory audit requirement still exists for small undertakings should assess possibilities of replacing it with a limited review of their financial statements .


### the competent authorities referred to in article 32 shall establish procedures for the approval of statutory auditors who have been approved in other member states . those procedures shall comply with articles 11 and 12 of directive 2005 / 36 / ec and shall not go beyond the requirements contained in articles 13 and 14 of that directive . ### the member states shall establish procedures for the approval of statutory auditors who have been approved in other member states . those procedures shall comply with articles 11 and 12 of directive 2005 / 36 / ec and shall not go beyond the requirements contained in articles 13 and 14 of that directive .


### for the purposes of paragraph 1 , ' international auditing standards ' means international standards on auditing and related statement and standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to the statutory audit . ### for the purposes of paragraph 1 , ' international auditing standards ' means international standards on auditing and related statements and standards adopted and published by the international federation of accountants insofar as they are relevant to the statutory audit and are available in the working languages of the european union .


### the competent authority may allow non - practitioners who are knowledgeable in the areas relevant to statutory audit to be involved in the governance of the public oversight system , provided that they are selected in accordance with an independent and transparent nomination procedure . practitioners shall not be allowed to be involved in the governance of the public oversight system . ### the competent authority may allow non - practitioners who are knowledgeable in the areas relevant to statutory audit to be involved in the governance of the public oversight system , provided that they are selected in accordance with an independent and transparent nomination procedure . member states may , however , allow a minority of practitioners to be involved in the governance of the public oversight system .


### the competent authority shall have the right , where necessary , to initiate and conduct investigations in relation to statutory auditors and audit firms and the right to take appropriate action . it shall have adequate resources to initiate and conduct such investigations . ### the competent authority shall have the right , where necessary , to initiate and conduct investigations in relation to statutory auditors and audit firms and the right to take appropriate action . it shall have adequate resources to initiate and conduct such investigations , which may take the form of a compulsory contribution by statutory auditors and audit firms in proportion to their audit activity .


### the treaty aims at an ever closer union among the peoples of europe and article 167 in particular gives the european union the task of contributing to the flowering of the cultures of the member states , while respecting their national and regional diversity and at the same time bringing the common cultural heritage to the fore . ### the treaty aims at an ever closer union among the peoples of europe and article 167 in particular gives the european union the task of contributing to the flowering of the cultures of the member states , while respecting their national and regional diversity and at the same time bringing the common cultural heritage to the fore . furthermore , article 167 specifies that , in accordance with the principle of proportionality , the union shall contribute to improvement of the knowledge and dissemination of the culture and history of the european peoples .