### by 31 august 2017 , companies shall submit to the verifiers a monitoring plan indicating the method chosen to monitor and report emissions and other climate - relevant information for each of their ships above 5000 gt . ### by 31 august 2015 , companies shall submit to the verifiers a monitoring plan indicating the method chosen to monitor and report emissions and other climate - relevant information for each of their ships above 400 gt .


### from 2019 , by 30 april of each year , companies shall submit to the commission and to the authorities of the flag states concerned , an emission report concerning the emissions and other climate - relevant information during the entire reporting period for each ship under their responsibility , which has been verified as satisfactory by a verifier in accordance with the requirements referred to in article 14 . ### from 2017 , by 30 april of each year , companies shall submit to the commission and to the authorities of the flag states concerned , an emission report concerning the emissions and other climate - relevant information during the entire reporting period for each ship under their responsibility , which has been verified as satisfactory by a verifier in accordance with the requirements referred to in article 14 .


### in order to minimise the administrative burden for ship owners and operators , in particular for small and medium sized enterprises , and to optimise the benefits - costs - ratio of the mrv system without jeopardising the objective to cover a widely predominant share of greenhouse gas emissions from maritime transport , the rules for mrv should only apply to large emitters . a threshold of 5000 gross tonnage has been selected after detailed objective analysis of sizes and emissions of ships going to and coming from union ports . ships above 5000 gt account for around 55% of the number of ships calling into union ports and represent around 90% of the related emissions . this non - discriminatory threshold would ensure that that the most relevant emitters are covered . a lower threshold would result in higher administrative burden while a higher threshold would limit the coverage of emissions and thus the environmental effectiveness of the system . ### in order to ensure coherence with the existing international law , in particular with marpol vi , the mrv system should apply to ships of 400 gt and above .


### by way of derogation from paragraph 1 , for ships falling under the scope of this regulation for the first time after 1 january 2018 , the company shall submit a monitoring plan to the verifier without undue delay and no later than two months after their first call in a port under the jurisdiction of a member state . ### by way of derogation from paragraph 1 , for ships falling under the scope of this regulation for the first time after 1 january 2016 , the company shall submit a monitoring plan to the verifier without undue delay and no later than two months after their first call in a port under the jurisdiction of a member state .


### the power to adopt delegated acts in order to supplement and amend the provisions of annexes i and ii to take into account up - to - date scientific evidence available , as well as the relevant data available on board of ships and the relevant international rules and internationally accepted standards , to identify the most accurate and efficient methods for monitoring of emissions , and to improve the accuracy of the information requested related to the monitoring and reporting of emissions is conferred on the commission subject to the conditions laid down under article 24 to the extent it concerns non - essential elements of this regulation . ### the commission shall be empowered to adopt delegated acts in accordance to article 24 amending annex i to adapt the monitoring methods to scientific and technical progress and internationally accepted standards in order to improve the reliability , validity and accuracy of the emission data . the commission shall be empowered to adopt delegated acts in accordance to article 24 amending annex ii to further specify and adapt the monitoring of climate - relevant information methods to scientific and technical progress and internationally accepted standards in order to improve the reliability , validity and accuracy of the emission data .


### the rules should take into account existing requirements and data already available on board of ships ; therefore , ship owners should be given the opportunity to select one out of the following four monitoring methods : the use of bunker fuel delivery notes , bunker fuel tank monitoring , flow meters for applicable combustion processes or direct emission measurements . a ship specific monitoring plan should document the choice made and provide further details on the application of the selected method . ### ship owners should be given the opportunity to select one out of the following two monitoring methods to ensure accuracy : flow meters for applicable combustion processes or direct emission measurements . a ship specific monitoring plan should document the choice made and provide further details on the application of the selected method .


### companies shall use standardised monitoring plans based on templates . technical rules establishing the templates for the monitoring plans referred to in paragraph 1 shall be determined by means of implementing acts . those implementing acts shall be adopted by the commission in accordance with the procedure referred to in article 25 of this regulation . ### companies shall use standardised templates to submit their monitoring plans . presentation and content of the templates for the monitoring plans referred to in paragraph 1 shall be determined by means of delegated acts . those delegated acts shall be adopted by the commission in accordance with the procedure referred to in article 24 of this regulation .


### in order to reduce carbon dioxide emissions from shipping at union level the best possible option remains setting up a system for monitoring , reporting and verification of co2 emissions based on the fuel consumption of ships as a first step of a staged approach for the inclusion of maritime transport emissions in the union ' s greenhouse gas reduction commitment . ### in order to reduce carbon dioxide emissions from shipping at union level the best possible option remains setting up a system for monitoring , reporting , verification and reduction of climate and health - relevant emissions based on the fuel consumption of ships or on direct measurement in order to include maritime transport emissions in the union ' s greenhouse gas reduction commitment .


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


### improving market access and developing trade , investment and business opportunities for european companies by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union ' s share in foreign trade with key partner countries and by trade and investments flows to partner countries specifically targeted by actions , programmes and measures under this regulation ; ### promoting fair and equitable trade and investment , founded on a rights - based approach which takes into account the international covenant on economic , social and cultural rights as well as respect for international treaties on the environment . this objective shall be measured by reference to the above - mentioned rights - based policy for the implementation of actions , programmes and measures under this regulation ;


### it is important to define , in accordance with the nagoya protocol , that use of genetic resources refers to research and development on the genetic or biochemical composition of samples of genetic material , which includes research and development on isolated compounds extracted from genetic material that was accessed in a party to the nagoya protocol . ### it is important to define , in accordance with the nagoya protocol , that utilisation of genetic resources refers to research and development on the genetic or biochemical composition of samples of genetic material , which includes research and development on isolated compounds extracted from genetic resources that was accessed in a party to the nagoya protocol . research and development should be understood to mean the investigation and study of the genetic or biochemical composition of genetic resources in order to establish facts and reach conclusions , including the creation of innovations and practical applications .


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


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


### competent authorities shall transmit to the commission every two years the information received on the basis of paragraphs 1 and 2 . the commission shall summarise the information received and make it available to the access and benefit - sharing clearing house . ### competent authorities shall verify the information provided under points to and transmit to the commission within three months the information received pursuant to this article . the commission shall within three months summarise the information received and make the information required for the internationally recognised certificate available to the access and benefit - sharing clearing house as well as to the public in an easily accessible open , internet - based , format .


### best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user ' s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol . ### best practices developed by users or organisation with interest and expertise in the utilisation of genetic resources and access and benefit sharing should be evaluated . when found useful and consistent with the nagoya protocol and this regulation , they should be drawn upon in the identification of due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries provided that they facilitate users ' compliance with their obligations , which will include fair and equitable benefit - sharing . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice for facilitating compliance with user obligations . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user ' s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol .


### users should declare at identified points in the chain of activities that constitute use that they have exercised due diligence . suitable points for such declarations are the receiving of public research funds , when a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required . notably , the declaration made upon occasion of requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this regulation . ### users should declare at identified points in the chain of activities that they have exercised due diligence , and provide evidence to that effect . suitable points for such declarations are the establishment of prior informed consent and mutually agreed terms , the receipt of research funding , when applying for intellectual property rights at relevant national , regional or international institutions , where a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required . notably , the declaration made upon occasion of applying for intellectual property rights or requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this regulation .


### users shall declare to the competent authorities established under article 6 that they exercised due diligence in accordance with article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources , or at the time of commercialisation where a market approval is not required . ### users shall declare to the competent authorities established under article 6 that they have complied with article 4 and shall submit the related information on the occasion of : establishing prior informed consent and mutually agreed terms ; receiving research funding involving utilisation of genetic resources and traditional knowledge associated with genetic resources ; applying for patents or for new plant variety rights at relevant national , regional or international institutions covering , inter alia , the accessed genetic resources , products , including derivates , and processes derived from the use of biotechnology , or traditional knowledge associated with the genetic resources ; requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources , or at the time of commercialisation where a market approval is not required .


### ' use of genetic resources ' means to conduct research and development on the genetic or biochemical composition of genetic resources ; ### ' utilisation of genetic resources ' means to conduct research and development on the genetic or biochemical composition of genetic resources including through the application of biotechnology ;


### traditional knowledge that is held by indigenous and local communities may provide important lead information for the scientific discovery of interesting genetic or biochemical properties of genetic resources . ### traditional knowledge that is held by indigenous and local communities may provide important lead information for the scientific discovery of potentially valuable genetic or biochemical properties of genetic resources , including knowledge , innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity . the rights of such communities , as laid down in convention no . 169 of the international labour organisation on indigenous and tribal peoples and also set out in the un declaration on the rights of indigenous peoples adopted by the un general assembly in 2007 should be respected and union implementing measures should facilitate that aim .


### genetic resources represent the gene pool in both natural and cultivated or domesticated stocks and play a significant and growing role in many economic sectors including food production , forestry , development of medicines , or development of bio - based sources of renewable energy . ### genetic resources represent the gene pool in both natural and cultivated or domesticated stocks and play a significant and growing role in many economic sectors including food production , forestry , biotechnology , development and production of medicines , cosmetics or development of bio - based sources of energy .


### collections are major suppliers of genetic resources and traditional knowledge associated with genetic resources used in the union . a system of union trusted collections should be set in place . it would ensure that collections included in the register of union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms , where required . a system of union trusted collections should substantially lower the risk that illegally acquired genetic resources are used in the union . competent authorities of member states would verify if a collection meets the requirements for recognition as union trusted collection . users that acquire a genetic resource from a collection listed in the union register should be considered to have exercised due diligence as regards the seeking of all necessary information . this should prove particularly beneficial for academic researchers as well as small and medium sized enterprises . ### collections are the most accessible suppliers of genetic resources and traditional knowledge associated with genetic resources utilised in the union . as suppliers they can play an important role in helping other users to comply with their obligations . in order to do so a system of union trusted collections should be set in place . it would ensure that collections included in the register of union trusted collections effectively apply measures to only supply samples of genetic resources to third persons with documentation providing evidence of legal acquisition and the establishment of mutually agreed terms , where required . a system of union trusted collections should substantially lower the risk that illegally acquired genetic resources are utilised in the union . competent authorities of member states would verify if a collection meets the requirements for recognition as union trusted collection . users that acquire a genetic resource from a collection listed in the union register should be considered to have exercised due diligence as regards the seeking of all necessary information . this should prove particularly beneficial for academic researchers as well as small and medium sized enterprises .


### users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit - sharing legislation or regulatory requirements and that , where relevant , benefits are fairly and equitably shared upon mutually agreed terms . users shall seek , keep , and transfer to subsequent users information relevant for access and benefit - sharing . ### users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed with prior informed consent and based on mutually agreed terms as defined by applicable access and benefit - sharing legislation or regulatory requirements and that , benefits are fairly and equitably shared upon those agreed terms . users shall seek , keep , and transfer to subsequent users all information and documents relevant for access and benefit - sharing and compliance with the provisions of this regulation .


### best practices developed by users should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user’s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol . ### best practices , developed by users or organisations with an interest , and expertise , in the utilisation of genetic resources and access and benefit - sharing , should play an important role in identifying due diligence measures that are particularly suitable for achieving compliance with the system of implementation of the nagoya protocol with high legal certainty and at low costs . users should be enabled to build on existing access and benefit - sharing codes of conduct developed for the academic sector and different industries as long as they are consistent with the nagoya protocol and this regulation . associations of users should be able to request that the commission determines whether a specific combination of procedures , tools or mechanisms overseen by an association may be recognised as best practice . competent authorities of the member states should consider that the implementation of a recognised best practice by a user reduces that user’s risk of non - compliance and justifies a reduction in compliance checks . the same should apply to best practices adopted by the collective of the parties to the nagoya protocol .


### in order to ensure legal certainty , it is important that the rules implementing the nagoya protocol should only apply to genetic resources and traditional knowledge associated with genetic resources that are accessed after the entry into force of the nagoya protocol for the union . ### in order to ensure legal certainty , it is important that the rules implementing the nagoya protocol should only apply to new acquisition or new utilisation of genetic resources and traditional knowledge associated with genetic resources that take place or commence after the entry into force of the nagoya protocol for the union .


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


### competent authorities shall transmit to the commission every two years the information received on the basis of paragraphs 1 and 2 . the commission shall summarise the information received and make it available to the access and benefit - sharing clearing house . ### competent authorities shall verify the information provided under points to and transmit to the commission within three months the information received pursuant to this article . the commission shall within three months summarise the information received and make the information required for internationnally recognised certificate available to the access and benefit - sharing clearing house as well as to the public in an easily accessible open format .


### the union platform shall contribute to the streamlining of access conditions at union level by discussing related issues , including the design and performances of access regimes established in member states , simplified access for non - commercial research , access practices of collections in the union , access of union stakeholders in third countries and the sharing of best practices . ### the union platform shall contribute to the streamlining of access conditions at union level by discussing related issues , including the design and performances of access regimes established in member states , the promotion of research which contributes to the conservation and sustainable use of biological diversity , particularly in developing countries , including simplified access for non - commercial research , access practices of collections in the union , access of union stakeholders in third countries and the sharing of best practices .


### the union platform shall contribute to the streamlining of access conditions at union level by discussing related issues , including the design and performances of access regimes established in member states , simplified access for non - commercial research , access practices of collections in the union , access of union stakeholders in third countries and the sharing of best practices . ### the union platform shall contribute to the streamlining of access conditions at union level by discussing related issues , including the design and performances of access regimes established in member states , the promotion of research which contributes to the conservation and sustainable use of biological diversity , particularly in developing countries , including simplified access for non - commercial research , access practices of collections in the union , access of union stakeholders in third countries on mutually agreed terms after the obtainment of prior informed consent , benefit - sharing practices , the implementation and further development of best practices and the functioning of dispute settlement arrangements . .


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


### users shall declare to the competent authorities established under article 6 that they exercised due diligence in accordance with article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources , or at the time of commercialisation where a market approval is not required . ### users shall declare to the competent authorities established under article 6 that they have complied with provisions of article 4 and shall submit the related information on the occasion of : :


### the nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the convention on biological diversity is an international treaty adopted on 29 october 2010 by the parties to the convention . the nagoya protocol significantly expands the general rules of the convention on access and benefit - sharing for the use of genetic resources and traditional knowledge associated with genetic resources . ### the nagoya protocolon access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the convention on biological diversity is an international treaty adopted on 29 october 2010 by the parties to the convention . the nagoya protocol significantly expands the general rules of the convention on access and benefit - sharing for the utilisation and subsequent commercialisation of genetic resources and traditional knowledge associated with genetic resources .


### the competent authorities shall cooperate with each other , with the administrative authorities of third countries and with the commission sin order to ensure compliance of users with this regulation . ### the competent authorities shall cooperate with each other , with the administrative authorities of third countries and with the commission in order to reinforce effective coordination and ensure compliance of users with this regulation . cooperation shall also be conducted with other relevant actors , including collections , non - governmental organisations and representatives of indigenous and local communities when important for the correct implementation of the nagoya protocol and this regulation .


### fines ; ### fines proportional to the value of the use activities related to genetic resources concerned and at least effectively depriving those responsible of the economic benefits derived from the infringement , increasing for repeated infringements ;


### ' user ' means a natural or legal person using genetic resources or traditional knowledge associated with genetic resources ; ### ' user ' means a natural or legal person utilising genetic resources or traditional knowledge associated with genetic resources or who subsequently commercialises genetic resources or products based on genetic resources or traditional knowledge associated with genetic resources ;


### the convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources . the convention imposes an obligation on all parties to facilitate access to genetic resources over which they hold sovereign rights . it also makes it mandatory for all parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the party providing these resources . such sharing shall be upon mutually agreed terms . the convention also addresses access and benefit - sharing in relation to the knowledge , innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity . ### the convention recognises that states have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources . the convention imposes an obligation on all parties to facilitate access to genetic resources , for environmentally sound uses by other parties , over which they hold sovereign rights . it also makes it mandatory for all parties to take measures to share in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the party providing these resources . such sharing shall be upon mutually agreed terms . the convention also addresses access and benefit - sharing in relation to the knowledge , innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity .


### access decisions and mutually agreed terms , where applicable ; ### access decisions and mutually agreed terms , including benefit - sharing arrangements , where applicable ;


### additionally , depending on the nature of the shortcomings detected , member states may take immediate interim measures , including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities . ### if no positive or satisfactory response is given by the user , and depending on the nature of the shortcomings detected , member states may take immediate interim measures , including inter alia seizure of illegally acquired genetic resources and suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge .


### the information referred to in paragraph 1 shall be made available in accordance with directive 2003 / 4 / ec . ### the information referred to in paragraph 1 shall be made available in accordance with directive 2003 / 4 / ec in an easily accessible open , internet - based , format .


### ' genetic resources ' means genetic material of actual or potential value ; ### ' genetic resources ' means genetic material of actual or potential value , or derivatives thereof ;


### users should declare at identified points in the chain of activities that constitute use that they have exercised due diligence . suitable points for such declarations are the receiving of public research funds , when a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required . notably , the declaration made upon occasion of requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this regulation . ### users should declare at identified points in the chain of activities that they have exercised due diligence , and provide evidence to that effect . suitable points for such declarations are the establishment of prior informed consent and mutually agreed terms , the receipt of research funding , when applying for intellectual property rights at relevant national , regional or international institutions , where a market approval for a product developed on the basis of genetic resources is requested or at the time of commercialisation where a market approval is not required . notably , the declaration made upon occasion of applying for intellectual property rights or requesting market approval would not constitute part of the approval procedure as such and would be directed to competent authorities established under this regulation .


### users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit - sharing legislation or regulatory requirements and that , where relevant , benefits are fairly and equitably shared upon mutually agreed terms . users shall seek , keep , and transfer to subsequent users information relevant for access and benefit - sharing . ### users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed with prior informed consent and based on mutually agreed terms as defined by applicable access and benefit - sharing legislation or regulatory requirements and that , benefits are fairly and equitably shared upon those agreed terms . users shall seek , keep , and transfer to subsequent users all information and documents relevant for access and benefit - sharing and compliance with the provisions of this regulation .


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


### collecting of genetic resources in the wild is mostly undertaken for non - commercial purposes by university - based researchers or collectors . in the vast majority of cases and in almost all sectors , access to newly collected genetic resources is gained through intermediaries , collections , or agents that acquire genetic resources in third countries . ### collecting of genetic resources in the wild is mostly undertaken for non - commercial purposes by university - based researchers or collectors . in the vast majority of cases and in almost all sectors , access to newly collected genetic resources is gained through intermediaries , collections , or agents that acquire genetic resources in third countries . this regulation should ensure that the provisions of mutually agreed terms for the initial access relevant for third party transfer are followed by all parties involved . in many cases subsequent utilisation or commercialisation might require new prior informed consent and mutually agreed terms .


### every ten years after its first report the commission shall , on the basis of reporting on and experience with the application of this regulation , review the functioning and effectiveness of this regulation . in its reporting the commission shall in particular consider the administrative consequences for public research institutions , small or medium - sized enterprises and micro - enterprises . it shall also consider the need for further union action on access to genetic resources and traditional knowledge associated with genetic resources . ### every five years after its first report the commission shall , on the basis of reporting on and experience with the application of this regulation , review the functioning and effectiveness of this regulation . in its reporting the commission shall in particular consider the administrative consequences for public research institutions , small or medium - sized enterprises and micro - enterprises . it shall also consider the need for further union action on access to genetic resources and traditional knowledge associated with genetic resources .


### users shall declare to the competent authorities established under article 6 that they exercised due diligence in accordance with article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources , or at the time of commercialisation where a market approval is not required . ### users shall declare to the competent authorities established under article 6 that they have complied with article 4 and shall submit the related information on the occasion of : establishing prior informed consent and mutually agreed terms ; receiving research funding involving utilisation of genetic resources and traditional knowledge associated with genetic resources ; applying for patents or for new plant variety rights at relevant national , regional or international institutions covering , inter alia , the accessed genetic resources , products , including derivates , and processes derived from the use of biotechnology , or traditional knowledge associated with the genetic resources ; requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources , or at the time of commercialisation where a market approval is not required .


### immediate suspension of specific use activities ; ### immediate suspension of specific use activities including commercialisation of products based on genetic resources and associated traditional knowledge ;


### a union platform on access to genetic resources and traditional knowledge associated with genetic resources is hereby established . ### a union platform on access to genetic resources and traditional knowledge associated with genetic resources and on fair and equitable benefit - sharing is hereby established .


### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact , which could include the introduction of estimated indirect land - use change emission factors in the sustainability scheme as of 1st january 2021 . ### the commission should review the effectiveness of the measures introduced by this directive , based on the best and latest available scientific evidence , in limiting indirect land - use change greenhouse gas emissions and addressing ways to further minimise that impact .


### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . in order to reduce such emissions , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly . ### based on forecasts of biofuel demand provided by the member states and estimates of indirect land - use change emissions for different biofuel feedstocks , greenhouse gas emissions linked to indirect land use change are significant , and could negate some or all of the greenhouse gas savings of individual biofuels . this is because land - based biofuels have received a large amount of public subsidies and therefore , almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets . indirect land - use changes therefore need to be taken into account so as to prevent these potential sources of emissions from undermining efforts to meet the union ' s renewable energy and greenhouse gas emission targets . in order to reduce indirect land - use change , it is appropriate to distinguish between crop groups such as oil crops , cereals , sugars and other starch containing crops accordingly .


### whereas the drug prevention and information programme was based on a public health legal basis and therefore covered health considerations , notably the reduction of health harms associated with drug use , the justice programme should approach anti - drugs policy via the angle of crime prevention . illicit drug trafficking and other illegal activities related to drugs should be the main focus of drug - related funding under the new programme . ### the justice programme should approach anti - drugs policy via the angle of both crime prevention and health considerations .


### an agreement laying down the terms and conditions of the detailed rules for use of the prs by the non - member country or international organisation has been concluded between the european union and the non - member country or international organisation in accordance with the procedure provided for in article 128 of the treaty on the functioning of the european union . ### an agreement laying down the terms and conditions of the detailed rules for use of the prs by the non - member country or international organisation has been concluded between the european union and the non - member country or international organisation in accordance with the procedure provided for in article 218 of the treaty on the functioning of the european union , with the consent of the european parliament .


### support for the production of cow’s milk in madeira and réunion has not been sufficient to maintain the balance between domestic and external supply , chiefly because of the serious structural difficulties affecting the sector and its poor capacity to adapt to new economic environments . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder on the sales labelling . ### support for the production of cow’s milk in madeira and réunion is essential , chiefly because of the serious structural difficulties affecting the sector . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully , without losing sight of the need to secure the sector’s long - term future . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder and the percentages of fresh milk and milk powder used on the sales labelling .


### where applicable , the performance of the construction product , by levels or classes , or in a description , in relation to all essential characteristics for which there are provisions related to the declared intended use or uses where the manufacturer intends to place the construction product on the market ; ### where applicable , the performance of the construction product , by levels or classes , or in a description , in relation to all essential characteristics related to the declared intended use or uses ;


### by way of derogation from article 4 and in the absence of union or national provisions requiring the declaration of essential characteristics where a manufacturer intends to place a product on the market , a manufacturer may refrain from drawing up a declaration of performance when placing a construction product covered by a harmonised standard on the market where : ### by way of derogation from article 4 and in the absence of union or national provisions requiring the declaration of essential characteristics where the products will be used , a manufacturer may refrain from drawing up a declaration of performance when placing a construction product covered by a harmonised standard on the market where :


### the construction product , covered by a harmonised technical specification , which the manufacturer places on the market is a system made of components , which the manufacturer assembles duly following precise instructions given by the provider of such a system or of a component thereof , who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification . when these conditions are fulfilled , the manufacturer is entitled to declare performance corresponding to all or part of the test results for the system or the component provided to him . the manufacturer may use the test results obtained by another manufacturer or system provider only after having obtained an authorisation of that manufacturer or system provider , who remains responsible for the accuracy , reliability and stability of those test results . ### the construction product , covered by a harmonised standard , which the manufacturer places on the market is a system made of components , which the manufacturer assembles duly following precise instructions given by the provider of such a system or of a component thereof , who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised standard . when these conditions are fulfilled , the manufacturer is entitled to declare performance corresponding to all or part of the test results for the system or the component provided to him . the manufacturer may use the test results obtained by another manufacturer or system provider only after having obtained an authorisation of that manufacturer or system provider , who remains responsible for the accuracy , reliability and stability of those test results .


### where applicable , the performance of the construction product , by levels or classes , or in a description , in relation to all essential characteristics for which there are provisions related to the declared intended use or uses where the manufacturer intends to place the construction product on the market ; ### where applicable , the performance of the construction product , by levels or classes , or in a description , or based on a calculation , in relation to all essential characteristics related to the declared intended use or uses ;


### the construction product is manufactured in a traditional manner and in a non - industrial process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit , in compliance with the applicable national rules . ### the construction product is manufactured in a manner appropriate to heritage conservation and in a non - industrial process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit , in compliance with the applicable national rules .


### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investments forms should disclose information on their remuneration policies and practices for those staff whose professional activities have a material impact on the risk profile of the institution . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . ### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investments forms should disclose detailed information on their remuneration policies , practices and , for reasons of confidentiality , aggregated amounts for those members of staff and managers whose professional activities have a material impact on the risk profile of the institution . that information should be made available to all stakeholders . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . the role of the european works councils should be respected in regard to the provision of information to and consultation of employees .


### member states shall ensure that suspects and accused persons are granted access to a lawyer as soon as possible and in any event : ### member states shall ensure that suspects and accused persons are granted access to a lawyer in person as soon as possible and in any event :


### the lawyer shall have the right to be present at any other investigative or evidence - gathering act at which the suspect or accused person’s presence is required or permitted as a right , in accordance with national law , unless this would prejudice the acquisition of evidence . ### the lawyer shall have the right to be present at any other investigative or evidence gathering act , save where and only in so far as the person carrying out that investigative or evidence gathering act reasonably believes that evidence will be altered , removed or destroyed pending the lawyer ' s arrival .


### member states shall ensure that statements made by the suspect or accused person or evidence obtained in breach of his right to a lawyer or in cases where a derogation to this right was authorised in accordance with article 8 , may not be used at any stage of the procedure as evidence against him , unless the use of such evidence would not prejudice the rights of the defence . ### member states shall ensure that statements made by the suspect or accused person or evidence obtained in breach of his right to a lawyer or in cases where a derogation from that right was authorised in accordance with article 8 , are not used at any stage of the procedure as evidence against him or her .


### union support under this regulation shall , in principle , be established in partnership with the beneficiaries . the partnership shall involve as appropriate , national , regional and local authorities , other stakeholders , civil society , social partners and other non - state actors in preparing , implementing and monitoring union support . ### union support under this regulation shall be established in partnership with the beneficiaries . the partnership shall , in a transparent and verifiable way and through an institutionalised mechanism , involve the following stakeholders in preparing , implementing , monitoring and evaluating union support : national , regional and local authorities ; civil society organisations ; social partners ; other non - state actors . the commission , and in particular the union ' s delegations in partner countries , shall ensure that appropriate steps are taken to enhance the capacities of civil society organisations and other stakeholders to play a meaningful part in that process .


### union support under this regulation shall , in principle , be established in partnership with the beneficiaries . the partnership shall involve as appropriate , national , regional and local authorities , other stakeholders , civil society , social partners and other non - state actors in preparing , implementing and monitoring union support . ### union support under this regulation shall be established in partnership with the beneficiaries . the partnership shall , in a transparent and verifiable way and through an institutionalised mechanism , involve the following stakeholders in preparing , implementing , monitoring and evaluating union support : civil society organisations ; social and environmental partners ; other non - state actors . the commission , and in particular the union ' s delegations in partner countries , shall ensure that appropriate steps are taken to set up this mechanism aimed at enhancing the capacities of civil society organisations and other stakeholders to play a meaningful part in that process and to grant an effective domestic accountability over public policies and programmes .


### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , including employment levels . ### the achievement of these objectives shall be measured using notably the relevant union annual progress reports on the implementation of the policy and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the union regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the objectives of deep democracy as developed in the renewed european neighbourhood policy must be dully assessed in the overall evaluation of the achievement , among others , adequately monitored democratic elections and free and fair elections , freedom of association , expression and assembly and a free press and media , gender equality , fight against discrimination , the rule of law , an independent judiciary and the right to a fair trial , fighting against corruption , security and law enforcement sector reform and the establishment of democratic control over armed and security forces .


### promoting confidence building and other measures contributing to security and the prevention and settlement of conflicts ; ### promoting confidence building and other measures contributing to human and civil security , peace - building and the prevention and settlement of conflicts ;


### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the eu regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , level of corruption , trade flows , indicators enabling measuring internal economic disparities , including employment levels . ### the achievement of these objectives shall be measured using notably the relevant eu periodic reports on the implementation of the policy , and for paragraphs 2 , and , the relevant indicators established by international organisations and other relevant bodies ; for paragraphs 2 , and the uptake of the union regulatory framework by the partner countries as relevant ; for paragraphs 2 and , the number of relevant agreements and cooperation actions . the indicators will include , among others , adequately monitored democratic elections , pluralism or concentration of the media , level of corruption , trade flows and investments , indicators enabling measuring tendencies in internal economic and social disparities , including employment levels .


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### inclusive and sustainable development in all aspects , poverty reduction , environmental protection , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience . this regulation contributes to the objectives of dedicating at least 20 percent of the union budget to move towards a low carbon and climate resilient society . actions in these areas , wherever possible , will be mutually supportive in order to reinforce each other ' s impacts ;


### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles . ### a number of major developments in the neighbourhood has led to a comprehensive strategic review of the european neighbourhood policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building deep and sustainable democratic societies and undertaking reforms , in line with the ' more for more ' and ' mutual accountability ' principles . these include a deepening of the relationship with the partners and civil society of the countries involved if the requirements based on the deep democracy approach are met , the launch of regional initiatives and a strong support to democratic transition processes in the region .


### the union aims to establish an area of prosperity and good neighbourliness involving the european union and the countries and territories listed in the annex to this regulation by developing a special relationship . ### the union aims to establish an area of democracy , respect for human rights and the rule of law , prosperity , stability and good neighbourliness involving the union and the countries and territories listed in the annex to this regulation by developing a special relationship based on those common values and cooperation .


### the categories of consumers at risk when using the product , in particular vulnerable consumers ; ### the categories of consumers at risk when using the product under reasonably foreseeable conditions , in particular vulnerable consumers such as children , the elderly and the disabled , while taking into account vulnerability due to specific product categories ;


### handling unwanted catches of commercial stocks ; ### minimising and , where possible , eliminating unwanted catches of commercial stocks marine organisms , ensuring the landing of all unwanted catches of fish species referred to article 15 of the regulation on the common fisheries policy , and handling any unwanted catches ;


### the producer organisation is considered to be representative of production and marketing in one member state and makes an application to the competent national authorities ; ### the producer organisation is considered to be representative of production and marketing , including , where relevant , the small scale and artisanal sector , in one member state and makes an application to the competent national authorities ;


### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union . the esf should in particular increase its support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited . ### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union . a minimum share for the esf for each category of regions should be established in accordance with article 83 of the common provisions regulation , resulting in a minimum overall share for the esf of 25% of the budget allocated to cohesion policy . the esf should in particular increase its support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation of 20 % of the entire esf resources of each member state . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited .


### member states shall ensure that the strategy and actions set out in the operational programmes are consistent and focused on addressing the challenges identified in the national reform programmes and the relevant council recommendations made under article 148 of the treaty , in order to contribute to achieving the headline targets of the europe 2020 strategy on employment , education and poverty reduction . ### member states shall ensure that the strategy and actions set out in the operational programmes are consistent and focused on addressing the challenges identified by their regions and sub - national authorities , in the national reform programmes and the relevant council recommendations made under article 148 of the treaty , in order to contribute to achieving the headline targets of the europe 2020 strategy on employment , education and poverty reduction .


### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing and revising existing instruments rather than establishing new controls . the inclusion of a substance in annex x to directive 2000 / 60 / ec is without prejudice to the application of the provisions of 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 / eec . ### numerous union acts have been adopted since the adoption of directive 2000 / 60 / ec , which constitute emission control measures in accordance with article 16 of that directive for individual priority substances . moreover , many environmental protection measures fall under the scope of other existing union legislation . therefore , priority should be given to implementing , fully applying and , where necessary , revising the provisions of existing sectorial instruments governing priority substances rather than establishing new controls in the context of directive 2000 / 60 / ec . however , this requires that the actions necessary to achieve the objectives laid down in article 16 of directive 2000 / 60 / ec be effectively taken in the context of those other existing union instruments . the inclusion of a substance in annex x to directive 2000 / 60 / ec , or monitoring data showing that additional eu - level measures are necessary , should therefore trigger appropriate follow - up action under the corresponding union instruments by the commission and member states , without prejudice to the application of the provisions of those instruments .


### community financing shall support economic , financial and technical cooperation and other forms of cooperation falling within its spheres of competence with industrialised and other high - income countries and territories and with developing countries falling under regulation no 1905 / 2006 . ### community financing under this regulation shall support socio - economic , financial , technical , cultural and academic cooperation in the areas set out in article 4 , falling within its spheres of competence , with developing countries as listed in annex ii and with industrialised and other high - income countries and territories as listed in annex i . in principle , this regulation shall serve to finance measures which do not fulfil the official development assistance criteria of the oecd .


### the cooperation shall be aimed at engaging with partners which share similar political , economic and institutional structures and values to the community and which are important bilateral partners and players in multilateral fora and in global governance . the cooperation also covers partners with which the community has a strategic interest in promoting links . ### the cooperation shall be aimed at engaging with partner countries towards the achievement of the following goals : – mitigating conflict and enhancing dialogue and rapprochement ; – sharing and promoting similar political , economic and institutional structures and values ; – increasing exchanges with important bilateral partners and players in multilateral fora and in global governance .


### community financing shall support economic , financial and technical cooperation and other forms of cooperation falling within its spheres of competence with industrialised and other high - income countries and territories and with developing countries falling under regulation no 1905 / 2006 . ### community financing under this regulation shall support socio - economic , financial , technical , cultural , academic and other forms of cooperation falling within its spheres of competence , with developing countries as listed in annex ii and with industrialised and other high - income countries and territories as listed in annex i . in principle , this regulation shall serve to finance measures which do not fulfil the official development assistance criteria of the oecd .


### council regulation no 1934 / 2006 of 21 december 2006 establishing a financing instrument for cooperation with industrialised and other high - income countries and territories , and with developing countries falling under regulation no 1905 / 2006 . ### council regulation no 1934 / 2006 of 21 december 2006 establishing a financing instrument for cooperation with countries in the middle east , asia , the americas and south africa


### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of reunion of uht milk reconstituted from milk powder originating in the community shall be authorised within the limits of local consumption requirements , insofar as this measure does not hinder that locally produced milk is collected and finds outlets . this product shall be used for local consumption only . ### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of réunion of uht milk reconstituted from milk powder originating in the community shall be authorised within the limits of local consumption requirements , in so far as this measure does not hinder locally produced milk from being collected and finding outlets or impede efforts to encourage the development of that production . this product shall be used for local consumption only .


### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of reunion of uht milk reconstituted from milk powder originating in the community shall be authorised within the limits of local consumption requirements , insofar as this measure does not hinder that locally produced milk is collected and finds outlets . this product shall be used for local consumption only . ### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of réunion of uht milk reconstituted from milk powder originating in the community shall be authorised within the limits of local consumption requirements , in so far as this measure does not hinder locally produced milk from being collected and finding outlets . this product , whose quality must be maintained , shall be used for local consumption only .


### the second subparagraph of article 18 of regulation no 247 / 2006 foresees gradual elimination , by 31 december 2013 , of vineyards planted with prohibited direct - producer hybrid vine varieties in the azores and madeira . the third subparagraph of article 18 of that regulation obliges portugal to notify each year progress made in converting and restructuring areas planted with such vine varieties . these provisions are stricter than the rules laid down in article 120a of regulation no 1234 / 2007 , namely that prohibited direct - producer hybrid vine varieties shall be grubbed up except when the resulting wine is intended exclusively for the wine producers ' family . therefore article 18 and 18 of regulation no 247 / 2006 should be deleted in order to eliminate the disparity of treatment between the regions of the azores and madeira on one hand and the rest of the community on the other . ### the second subparagraph of article 18 of regulation no 247 / 2006 foresees gradual elimination , by 31 december 2013 , of vineyards planted with prohibited direct - producer hybrid vine varieties in the azores and madeira . the third subparagraph of article 18 of that regulation obliges portugal to notify each year progress made in converting and restructuring areas planted with such vine varieties . these provisions are stricter than the rules laid down in article 120a of regulation no 1234 / 2007 , namely that prohibited direct - producer hybrid vine varieties shall be grubbed up except when the resulting wine is intended exclusively for the wine producers ' family . therefore the date of 31 december 2013 in article 18 of regulation no 247 / 2006 should be deleted in order to eliminate the disparity of treatment between the regions of the azores and madeira on one hand and the rest of the community on the other .


### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised european statistics and ensuring the proper functioning of the european statistical system as a whole . appropriate measures shall be taken to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of administrative burden on statistical respondents . national authorities and the union statistical authority shall ensure that european statistics comply with the european quality standards and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public . ### the programme shall be implemented in accordance with the principles of the european statistics code of practice with a view to producing and disseminating high - quality , harmonised european statistics and ensuring the proper functioning of the european statistical system as a whole . appropriate measures shall be taken to ensure good coordination and effective priority setting within the ess in order to contribute to the reduction of administrative burden on statistical respondents . national authorities and the union statistical authority shall ensure that european statistics comply with the european quality standards and serve the needs of european union institutional users , governments , regional authorities , research institutions , civil society organisations , enterprises and the public . moreover , eurostat shall disclose systematically and publicly whether it has doubts concerning the accuracy of information across all types of statistics . eurostat shall also look at ways to make its publications , particularly those online , more user - friendly to the average citizen and non - professionals especially with regard to the use of graphs . likewise , eurostat ' s website shall allow easier access to complete long - term data series and include intuitive comparative graphs in order to give more added value to citizens ; adds , furthermore , that its periodic updates should provide , where possible , information on each member state and offer year - on - year and month - on - month series and , where possible and useful , long - term data series . furthermore , the european statistical system shall focus on improving the production and provision of statistics on economic activity in the third sector . this can be achieved through strengthening the cooperation between the national statistical institutes and through an improved classification of the aforementioned economic activity , based on the provisions of the un handbook on statistics .


### statistics developed , produced and disseminated under this programme should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value . ### statistics developed , produced and disseminated under this programme should be available promptly and should contribute to the implementation of the policies of the european union , as reflected in the treaty on the functioning of the european union , the europe 2020 strategy for smart , sustainable and inclusive growth and other policies addressed in the commission ' s strategic priorities for 2010 - 2014 and should be fostered through actions financed under this programme where the european union can bring a clear added value . the necessity for a prompt availability of statistics is specifically crucial in relation to the indicators underpinning the eu2020 objectives , since even until now certain data on these indicators for the year 2010 are still not available .


### assess a sufficiently large number of insurance products available on the market . the insurance products should be diversified with regard to their type and issuers or product providers and should not be limited to insurance products issued or provided by entities having close links with the insurance intermediary or insurance undertaking ; and ### assess a range of insurance products available on the market . the insurance products should be diversified with regard to their type and issuers or product providers and should not be limited to insurance products issued or provided by entities having close links with the insurance intermediary or insurance undertaking ; and


### where steps taken by the insurance intermediary or insurance undertaking in compliance with articles 15 , 16 and 17 are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature or sources of conflicts of interest to the customer before undertaking business on the customer ' s behalf . ### an insurance intermediary or insurance undertaking shall maintain and operate effective organisational and administrative arrangements with a view to taking all reasonable steps designed to prevent conflicts of interest from adversely affecting the interests of its customers . where steps taken by the insurance intermediary or insurance undertaking are not sufficient to ensure , with reasonable confidence , that risks of damage to the interests of customers and potential customers arising from conflicts of interest will be prevented , the insurance intermediary or insurance undertaking shall clearly disclose the general nature or sources of conflicts of interest to the customer before undertaking business on the customer ' s behalf .


### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 3 months at the initiative of the european parliament or the council .


### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 8 , 17 , 23 , 24 and 25 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 3 months at the initiative of the european parliament or the council . when a delegated act is delivered just before or during a holiday , the time shall be deemed to run from the date of the first plenary following the holiday . in all instances , including extension , the time period shall be extendible to encompass three full plenary sessions .


### costs and associated charges . ### all costs and any associated charges .


### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . ### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics , composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . the assessment shall take into account the precautionary principle .


### ‘ roadworthiness test’ means a verification that the parts and components of a vehicle comply with its safety and environmental characteristics at the time of approval , first registration or entry into service , or at the time of retrofitting ; ### ‘ roadworthiness test’ means a verification that a vehicle is safe to be used on public roads , that it meets required environmental characteristics and that its parts and components comply , where applicable , with the its safety and environmental characteristics in force at the time of approval , first registration or entry into service or retrofitting ;


### a european organisation representing sme in european standardisation activities which : ### a european horizontal organisation representing crafts and sme in european standardisation activities which :


### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications which are not national , european or international standards and meet the requirements set out in annex ii , as ict standards . ### either on proposal from a public authority referred to in directive 2004 / 18 / ec or on its own initiative the commission may decide to recognise technical specifications in the field of ict which are not national , european or international standards and meet the requirements set out in annex ii . 2 . the decision referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in article 18 ; moreover , european standardisation organisations shall be included in the adoption process .


### the commission shall inform the relevant european standardisation body , within three months following the receipt of the acceptance referred to in paragraph 2 , about the award of a grant for drafting a european standard or european standardisation deliverable . ### the commission shall inform the relevant european standardisation organisation , within one month following the receipt of the acceptance referred to in paragraph 2 , about the award of a grant for drafting a european standard or european standardisation deliverable .


### the agency carries out inspections in order to assist the commission in the assessment of the effective implementation of eu law . the roles of the agency , the commission , the member states and the administrative board should be clearly defined . ### in particular , the agency should assist the commission in carrying out inspections in third countries in the mediterranean and black sea regions in whose waters oil and gas exploration and production is taking place , and in assisting those third countries in strengthening their capacity to improve the safety of their offshore operations .


### in addition , the agency shall carry out inspections on behalf of the commission in third countries as required by eu legislation , in particular regarding organisations recognised by the union in accordance with regulation 391 / 2009 of the european parliament and of the council and the training and certification of seafarers in accordance with directive 2008 / 106 / ec of the european parliament and of the council . ### in addition , the agency shall carry out inspections on behalf of the commission in third countries as required by eu legislation , in particular regarding organisations recognised by the union in accordance with regulation 391 / 2009 of the european parliament and of the council and the training and certification of seafarers in accordance with directive 2008 / 106 / ec of the european parliament and of the council , and also in third countries in the mediterranean and black sea region in whose waters oil and gas exploration is taking place .


### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution . ### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover prevention of and response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and by offshore oil and gas installations and response to marine pollution . the agency should in particular , through its existing satellite monitoring and surveillance service , assist the commission and the member states in detecting and dealing with the effects of oil spills emanating from offshore oil and gas installations .


### for the purposes of point of the first subparagraph , the competent authority referred to in article 35 shall make public a list of the auditors and audit firms concerned which shall be updated on an annual basis . the competent authority shall use the information provided by statutory auditors and audit firms pursuant to article 28 to make the relevant calculations . ### for the purposes of point of the first subparagraph , the competent authority referred to in article 35 shall make public a list of the auditors and audit firms concerned which shall be updated on an annual basis . the competent authority shall use the information provided by statutory auditors and audit firms pursuant to article 28 to make the relevant calculations . this shall be provided in aggregated from to esma .


### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . the recommendation of the audit committee should include at least two possible choices for the audit engagement and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory selection procedure organised by the audited entity , under the responsibility of the audit committee . in such selection procedure , the audited entity should invite statutory auditors or audit firms , including smaller ones , to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this selection procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation . ### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . the recommendation of the audit committee should include at least two possible choices for the audit engagement and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory selection procedure organised by the audited entity , under the responsibility of the audit committee . in such selection procedure , the audited entity should invite statutory auditors or audit firms , including non - dominant ones , to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this selection procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation .


### the public - interest entity shall inform the competent authorities referred to in article 35 of any attempt by a third party to impose such a contractual clause or to otherwise influence the decision of the general meeting of shareholders on the selection of a statutory auditor or audit firm . ### the public - interest entity shall inform directly and without delay the competent authorities referred to in article 35 of any attempt by a third party to impose such a contractual clause or to otherwise influence the decision of the general meeting of shareholders on the selection of a statutory auditor or audit firm .


### where article 37 of directive 2006 / 43 / ec applies , the public - interest entity shall inform the competent authority of the use of the alternative systems or modalities referred to in that article . ### where article 37 of directive 2006 / 43 / ec applies , the public - interest entity shall only inform the competent authority of the use of the alternative systems or modalities referred to in that article ; in this case paragraphs 2 to 6 of this article shall not apply .


### the statutory auditor or audit firm shall establish an appropriate gradual rotation mechanism with regard to the most senior personnel involved in the statutory audit , including at least the persons who are registered as statutory auditors . the gradual rotation mechanism shall be undertaken in phases on the basis of individuals rather than of a complete team . it shall be proportionate in view of the scale and the dimension of the activity of the statutory auditor or audit firm . ### the statutory auditor or audit firm shall establish a four year gradual rotation mechanism with regard to personnel involved in the statutory audit , including at least the persons who are registered as statutory auditors . the gradual rotation mechanism shall be undertaken in phases on the basis of individuals rather than of a complete team . it shall be proportionate in view of the scale and the dimension of the activity of the statutory auditor or audit firm .


### the statutory auditor or the audit firm shall maintain professional scepticism in particular when reviewing management estimates relating to fair values and the impairment of goodwill and other intangible and future cash flow relevant to the consideration of the going concern . ### the statutory auditor or the audit firm shall maintain professional scepticism in particular when reviewing management estimates relating to valuation methods such as fair value , overall risks and the impairment of goodwill and other intangible and future cash flow relevant to the consideration of the going concern


### member states shall require that all conditions in the law , regulations or administrative provisions and / or universally applicable collective agreements applicable to posted workers in a similar situation in the relevant occupational branches are met with regard to the remuneration granted during the transfer . in the absence of a system for declaring collective agreements to be of universal application , member states may , if they so decide , base themselves on collective agreements which are generally applicable to all similar undertakings in the geographical area and in the profession or industry concerned , and / or collective agreements which have been concluded by the most representative employers ' and labour organisations at national level and which are applied throughout national territory . ### member states shall require that all conditions in the law , regulations or administrative provisions and / or collective agreements in a comparable situation in the relevant occupational branches at the place of work are met with regard to the working conditions including in respect of benefits and pay granted during the transfer . particular attention shall be paid to consistency with relevant binding acts of the union .