### within the framework of their respective competences , the authority should cooperate with other agencies of the union , in particular those established in the area of employment and social policy , building on their expertise and maximising synergies : the european foundation for the improvement of living and working conditions , the european centre for the development of vocational training , the european agency for safety and health at work , and the european training foundation , as well as , as regards the fight against organised crime and trafficking in human beings , with the european union agency for law enforcement cooperation and european union agency for criminal justice cooperation . ### within the framework of their respective competences , the authority should cooperate with other agencies of the union , in particular those established in the area of employment and social policy , building on their expertise and maximising synergies , such as : the european foundation for the improvement of living and working conditions , the european centre for the development of vocational training , the european agency for safety and health at work , and the european training foundation , as well as , as regards the fight against organised crime and trafficking in human beings , with the european union agency for law enforcement cooperation , european union agency for criminal justice cooperation and the european border and coast guard agency .


### the authority shall provide services to individuals and employers to facilitate labour mobility across the union . to that end , the authority shall : ### without duplicating already existing mechanisms , the authority shall provide services to facilitate labour mobility across the union . to that end , the authority shall :


### the authority shall manage the eures european coordination office and ensure that it fulfils its responsibilities in accordance with article 8 of regulation 2016 / 589 , except for the technical operation and development of the eures portal and related it services , which shall continue to be managed by the commission . the authority , under the responsibility of the executive director as set out in article 23 , shall ensure that this activity fully complies with requirements of the applicable data protection legislation , including the requirement to appoint a data protection officer , in accordance with article 37 . ### the authority shall manage the eures european coordination office and ensure that it fulfils its responsibilities in accordance with article 8 of regulation 2016 / 589 , except for the technical operation and development of the eures portal and related it services , which shall continue to be managed by the commission . it shall be evaluated if this separation of powers is not resulting in a more complex structure . the authority , under the responsibility of the executive director as set out in article 23 , shall ensure that this activity fully complies with requirements of the applicable data protection legislation , including the requirement to appoint a data protection officer , in accordance with article 37 .


### the authority shall promote the use of electronic tools and procedures for message exchange between national authorities , including the internal market information system and the electronic exchange of social security information system . ### the authority shall promote the use of electronic tools and procedures for message exchange between national authorities , including the internal market information system and the electronic exchange of social security information system , while fully respecting data protection regulation .


### where operations falling under point of the first subparagraph also have a benefit for the programme area in which they are implemented , expenditure shall be allocated to these programme areas on a pro rata basis based on objective criteria other than the budget allocation to the programme areas . ### where operations falling under point of the first subparagraph also have a benefit for the programme area in which they are implemented , expenditure shall be allocated to these programme areas on a pro rata basis based on objective criteria .


### with regard to single - use plastic products for which there are no readily available suitable and more sustainable alternatives , member states should , in line with the polluter pays principle , also introduce extended producer responsibility schemes to cover the costs of waste management and clean - up of litter as well as the costs of awareness - raising measures to prevent and reduce such litter . ### with regard to single - use plastic products for which there are no affordable , readily available and more sustainable alternatives , member states should always act in line with the polluter pays principle when covering the costs of waste management , the clean - up of litter and the costs of awareness - raising measures to prevent and reduce such litter . where consumers are the polluters , these costs may be recovered as charges at the point of final sale . producer extended responsibility schemes may be applied if it can be ensured that no competitive distortion arises and imported products and domestically produced products are treated with equal effect on market prices .


### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , in particular recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec . ### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system is , however , not sufficiently effective . it should be strengthened and supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec .


### member states shall ensure that extended producer responsibility schemes are established for all single - use plastic products listed in part e of the annex placed on the union market , in accordance with the provisions on extended producer responsibility in directive 2008 / 98 / ec . ### member states shall establish extended producer responsibility schemes for all single - use plastic products listed in part e of the annex placed on the union market , provided that no competitive distortion arises and imported products and domestically produced products are treated with equal effect on market prices . accordance with the provisions on extended producer responsibility in directive 2008 / 98 / ec shall be ensured .


### reflecting the important contribution that research and innovation should make to address challenges in food , agriculture , rural development and the bioeconomy , and to seize the corresponding research and innovation opportunities in close synergy with common agricultural policy , relevant actions under the specific programme will be supported with eur 10 billion for the cluster ' food and natural resources ' for the period 2021 - 2027 . ### reflecting the important contribution that research and innovation make to address challenges in food , agriculture , rural development and the bioeconomy , and to seize the corresponding research and innovation opportunities in close synergy with common agricultural policy , relevant actions under the specific programme will be supported with eur 10 billion for the cluster ' food and natural resources ' for the period 2021 - 2027 . notes that precision farming is an important tool in increasing yields and productivity while creating a sustainable future for farming .


### reinforcing and spreading excellence ; ### strengthening europe ' s scientific base and reinforcing and spreading excellence ;


### connecting and developing research infrastructures across the european research area ; ### connecting , developing and facilitating wide access to research infrastructures across the european research area ;


### reinforcing the link between research and innovation and other policies , including sustainable development goals ; ### reinforcing the link between research , innovation and education , and other policies , including sustainable development goals ;


### improving skills for innovation ; ### improving skills for research and innovation ;


### for each mission , a mission board may be established . it shall be composed of around 15 high level individuals including relevant end - users ' representatives . the mission board shall advise upon the following : ### for each mission , a mission board may be established . it shall be composed of around 15 high level individuals including relevant end - users ' representatives , stakeholders and academic experts from different disciplines . each mission board should be established following an open call for nominations or for expressions of interest . the mission board shall advise upon the following :


### the eic board shall be composed of 15 to 20 high level individuals drawn from various parts of europe ' s innovation ecosystem , including entrepreneurs , corporate leaders , investors and researchers . it shall contribute to outreach actions , with eic board members striving to enhance the prestige of the eic brand . ### the eic board shall be composed of 15 to 20 high level individuals drawn from various parts of europe ' s innovation ecosystem , including entrepreneurs , corporate leaders , investors , academic experts and researchers . it shall contribute to outreach actions , with eic board members striving to enhance the prestige of the eic brand .


### it will include extensive consultations and exchanges with member states , the european parliament as appropriate , and with various stakeholders about priorities , including missions , under the ' global challenges and industrial competitiveness ' pillar , and the suitable types of action to use , in particular european partnerships . ### it will include extensive consultations and exchanges with member states , the european parliament as appropriate , and with various stakeholders , including the private sector , about priorities , including missions , under the ' global challenges and industrial competitiveness ' pillar , and the suitable types of action to use , in particular european partnerships .


### research funded by the erc is expected to lead to advances at the frontier of knowledge , with scientific publications of the highest quality , to research results with high societal and economic potential impact and with the erc setting a clear and inspirational target for frontier research across the eu , europe and internationally . aiming to make the eu a more attractive environment for the world ' s best scientists , the erc will target a measurable improvement in the eu ' s share of the world ' s top 1 % most highly cited publications , and aim at a substantial increase in the number of excellent researchers from outside europe which it funds . erc funding shall be awarded in accordance with the following well - established principles . scientific excellence shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ' bottom - up ' basis without predetermined priorities . ### research funded by the erc is expected to lead to advances at the frontier of knowledge , with scientific publications of the highest quality , to research results with high societal and economic potential impact and with the erc setting a clear and inspirational target for frontier research across the eu , europe and internationally . aiming to make the eu a more attractive environment for the world ' s best scientists , the erc will target a measurable improvement in the eu ' s share of the world ' s top 1 % most highly cited publications , and aim at a substantial increase in the number of excellent researchers from outside europe which it funds . erc funding shall be awarded in accordance with the following well - established principles . scientific excellence shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ' bottom - up ' basis without predetermined priorities . there should be a balance of fundamental , applied and transnational research and development to ensure efficient , fast translation of new discoveries into actual technologies and commercial products .


### many of the challenges which confront the eu are also global challenges . the scale and complexity of the problems are vast , and need to be matched by the appropriate money , resources and effort in order to find solutions . these are precisely the areas where the eu must work together ; smart , flexible and joined - up for the benefit and well - being of our citizens . ### many of the challenges which confront the eu are also global challenges . the scale and complexity of the problems are vast , and need to be matched by the appropriate money , resources and effort in order to find solutions . these are precisely the areas where the eu must work collaboratively and with global partners ; smart , flexible and joined - up for the benefit and well - being of our citizens .


### they will also foster participatory approaches to research and innovation , including the multi - actor approach and develop knowledge and innovation systems at local , regional , national and european levels . social innovation with citizens ' engagement and trust in innovation will be crucial to encourage new governance , production and consumption patterns . ### they will also foster participatory approaches to research and innovation , including the multi - actor approach and develop knowledge and innovation systems at local , regional , national and european levels . social innovation with citizens ' engagement and trust in innovation will be crucial to encourage new governance , production and consumption patterns . through this multi - actor approach they will work towards guaranteeing that all important knowledge is transferred to end - users and will involve farmers and other users of agricultural technologies and products , including small farms in innovative developments .


### activities will contribute directly to the following sustainable development goals in particular : sdg 2 – zero hunger ; sd 6 - clean water and sanitation ; sdg 11 – sustainable cities and communities ; sdg 12 - responsible consumption and production ; sdg 13 – climate action ; sdg 14 – life below water ; sdg 15 - life on land . ### activities will contribute directly to the following sustainable development goals in particular : sdg 2 – zero hunger ; sdg 3 - good health and well - being ; sd 6 - clean water and sanitation ; sdg 11 – sustainable cities and communities ; sdg 12 - responsible consumption and production ; sdg 13 – climate action ; sdg 14 – life below water ; sdg 15 - life on land .


### –land use , rural development and territorial linkages ; capitalising on the social , cultural , economic and environmental assets of rural areas for new services , business models , value chains and public goods ; ### –land use , rural development and territorial linkages ; capitalising on the social , cultural , economic and environmental assets of rural areas for new services , business models , value chains and public goods ; identifying opportunities to support skill development and knowledge transfer in these areas , including by means of training and apprenticeships for young and new entrants .


### –agricultural knowledge and innovation systems and their interconnection at various scales ; advice , building skills and information sharing . ### –agricultural knowledge and innovation systems and their interconnection at various scales ; advice , building skills , information sharing and knowledge transfer , especially to end - users .


### the combined effects of population growth , resource scarcity and overexploitation , environmental degradation , climate change and migration create unprecedented challenges which require food system transformation . 20 current food production and consumption are largely unsustainable while we are confronted with the double burden of malnutrition , characterised by the coexistence of undernutrition and obesity . future food systems need to deliver sufficient safe , healthy and quality food for all , underpinned by resource efficiency , sustainability , linking land and sea , reducing food waste , enhancing food production from the seas and oceans and encompassing the entire ' food value chain ' from producers to consumers – and back again . this needs to go hand in hand with development of the food safety system of the future and the design , development and delivery of tools , technologies and digital solutions that provide significant benefits for consumers and improve the competitiveness and sustainability of the food value chain . furthermore , there is a need to foster behavioural changes in food consumption and production patterns as well as to engage primary producers , industry , retailers , food service sectors , consumers , and public services . _________________ 20 swd 319 final : european research and innovation for food and nutrition security ### the combined effects of population growth , resource scarcity and overexploitation , environmental degradation , climate change and migration create unprecedented challenges which require food system transformation . 20 current food production and consumption are largely unsustainable while we are confronted with the double burden of malnutrition , characterised by the coexistence of undernutrition and obesity . future food systems need to deliver sufficient safe , healthy and quality food for all , underpinned by resource efficiency , sustainability , linking land and sea , reducing food waste , enhancing food production from the seas and oceans and encompassing the entire ' food value chain ' from producers to consumers – and back again . this needs to go hand in hand with development of the food safety system of the future and the design , development and delivery of tools , technologies and digital solutions that provide significant benefits for consumers and improve the competitiveness and sustainability of the food value chain . agricultural technologies , including genetic , mechanical and digital , can provide sustainable solutions across all farming types whether conventional , organic or otherwise . furthermore , there is a need to foster behavioural changes in food consumption and production patterns as well as to engage primary producers , industry , retailers , food service sectors , consumers , and public services . _________________ 20 swd 319 final : european research and innovation for food and nutrition security


### based on the experience with the interregional cooperation programmes under interreg and the lack of such cooperation within programmes under the investment for jobs and growth goal during the programming period 2014 - 2020 , the interregional cooperation component should focus more specifically on boosting the effectiveness of cohesion policy . that component should therefore be limited to two programmes , one to enable all kind of experience , innovative approaches and capacity building for programmes under both goals and to promote european groupings of territorial cooperation set up or to be set up pursuant to regulation no 1082 / 2006 of the european parliament and of the council24 and one to improve the analysis of development trends . project - based cooperation throughout the union should be integrated into the new component on interregional innovation investments and closely linked to the implementation of the communication from the commission ' strengthening innovation in europe ' s regions : strategies for resilient , inclusive and sustainable growth ' 25 , in particular to support thematic smart specialisation platforms on fields such as energy , industrial modernisation or agrifood . finally , integrated territorial development focusing on functional urban areas or urban areas should be concentrated within programmes under the investment for jobs and growth goal and in one accompanying instrument , the ‘ european urban initiative” . the two programmes under the interregional cooperation component should cover the whole union and should also be open for the participation of third countries . _________________ 24 regulation no 1082 / 2006 of the european parliament and of the council of 5 july 2006 on a european grouping of territorial cooperation . 25 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions : strengthening innovation in europe ' s regions : strategies for resilient , inclusive and sustainable growth ' - com 376 final , 18 . 7 . 2017 . ### based on the experience with the interregional cooperation programmes under interreg and the lack of such cooperation within programmes under the investment for jobs and growth goal during the programming period 2014 - 2020 , the interregional cooperation component should focus more specifically on boosting the effectiveness of cohesion policy . that component should therefore be limited to two programmes , one to enable all kind of experience , innovative approaches and capacity building for programmes under both goals and to promote european groupings of territorial cooperation set up or to be set up pursuant to regulation no 1082 / 2006 of the european parliament and of the council24 and one to improve the analysis of development trends . project - based cooperation throughout the union should be integrated into the new component on interregional innovation investments and closely linked to the implementation of the communication from the commission ' strengthening innovation in europe ' s regions : strategies for resilient , inclusive and sustainable growth ' 25 , in particular to support thematic smart specialisation platforms on fields such as energy , industrial modernisation or agrifood . finally , integrated territorial development focusing on functional urban areas or urban areas should be concentrated within programmes under the investment for jobs and growth goal and in one accompanying instrument , the ‘ european urban initiative” . the two programmes under the interregional cooperation component should cover the whole union , and should also be open for the participation of third countries ; in addition , again based on the experience of etc programming in the 2014 - 2020 period , the development of natural and cultural resources should be the priority of these two programmes . _________________ 24 regulation no 1082 / 2006 of the european parliament and of the council of 5 july 2006 on a european grouping of territorial cooperation . 25 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions : strengthening innovation in europe ' s regions : strategies for resilient , inclusive and sustainable growth ' - com 376 final , 18 . 7 . 2017 .


### 7 % for cross - border cooperation ; ### 75% for cross - border land and maritime cooperation ;


### procedures for the registration , modification and possible cancellation of union or third country geographical indications in accordance with the trips agreement should be laid down whilst automatically recognising the status of existing protected geographical indications of the union . in view of making procedural rules on geographical indications consistent through all the sectors concerned , such procedures for spirit drinks should be modelled on the more exhaustive and well tested procedures for agricultural products and foodstuffs laid down in regulation no 1151 / 2012 while taking into account specificities of spirit drinks . in order to simplify the registration procedures and to ensure that information for food business operators and consumers is electronically available an electronic register of geographical indications should be established . ### procedures for the registration , modification and possible cancellation of union or third country geographical indications in accordance with the trips agreement should be laid down whilst automatically recognising the status of existing protected registered geographical indications of the union . in view of making procedural rules on geographical indications consistent through all the sectors concerned , such procedures for spirit drinks should be modelled on similar procedures used for agricultural products and foodstuffs laid down in regulation no 1151 / 2012 while taking into account specificities of spirit drinks . in order to simplify the registration procedures and to ensure that information for food business operators and consumers is electronically available , a transparent and easily accessible electronic register of geographical indications should be established , provided it has the same legal value as annex iii of regulation no 110 / 2008 . .


### however , where the amendment applications involve one or more amendments to the product specification that relate to the essential characteristics of the product , alter the link referred to in point of article 19 , include a change to the name , or to any part of the name of the spirit drink , affect the defined geographical area or represent an increase in restrictions on trade in the product or its raw materials , the member state shall submit the amendment application to the commission for approval and the application shall follow the procedure laid down in articles 21 to 27 . ### however , where the amendment applications involve one or more amendments to the product specification that relate to the essential characteristics of the product , alter the link referred to in point of article 19 , include a change to the name , or to any part of the name of the spirit drink , affect the defined geographical area or represent an increase in restrictions on trade in the product or its raw materials , the member state shall submit the amendment application to the commission for approval and the application shall follow the procedure laid down in articles 21 and 23 to 27 . as regards third countries , the amendment shall be approved according to the system in place in those third countries .


### the scrutiny of the application shall focus on the proposed amendment . ### the scrutiny of the application shall focus solely on the proposed amendment .


### regulation no 765 / 2008 of the european parliament and of the council16 lays down horizontal provisions on the accreditation of conformity assessment bodies and on the ce marking . __________________ 16 regulation no 765 / 2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products . ### regulation no 765 / 2008 of the european parliament and of the council16 lays down rules on the accreditation of conformity assessment bodies , provides a framework for the market surveillance of products and for controls on products from third countries , and lays down the general principles of the ce marking . __________________ 16 regulation no 765 / 2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products .


### decision no 768 / 2008 / ec of the european parliament and of the council17 provides common principles and reference provisions for the purposes of legislation based on the new approach principles . in order to ensure consistency with other sectoral product legislation , it is appropriate to align certain provisions of this regulation to that decision , in so far as sectoral specificities do not require a different solution . therefore , certain definitions , the general obligations of economic operators , the presumption of conformity , eu declaration of conformity , rules on ce marking , requirements for conformity assessment bodies and notification procedures , the conformity assessment procedures and the provisions concerning procedures to deal with products presenting a risk should be aligned to that decision . __________________ 17 decision no 768 / 2008 / ec of the european parliament and of the council of 9 july 2008 on a common framework for the marketing of products , and repealing council decision 93 / 465 / eec . ### decision no 768 / 2008 / ec of the european parliament and of the council1lays down common principles and reference provisions intended to apply across sectoral legislation . in order to ensure consistency with other sectoral product legislation , it is appropriate to align certain provisions of this regulation to that decision , in so far as sectoral specificities do not require a different solution . therefore , certain definitions , the general obligations of economic operators , the presumption of conformity , eu declaration of conformity , rules on ce marking , requirements for conformity assessment bodies and notification procedures , the conformity assessment procedures and the provisions concerning procedures to deal with products presenting a risk should be aligned to that decision . __________________ 17 decision no 768 / 2008 / ec of the european parliament and of the council of 9 july 2008 on a common framework for the marketing of products , and repealing council decision 93 / 465 / eec .


### economic operators should be responsible for the compliance of products , in relation to their respective roles in the supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the protection of users and to guarantee fair competition on the union market . ### economic operators should be responsible for the compliance of the ppe , in relation to their respective roles in the supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the protection of users and , where appropriate , other persons , and to guarantee fair competition on the union market .


### economic operators should be responsible for the compliance of products , in relation to their respective roles in the supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the protection of users and to guarantee fair competition on the union market . ### economic operators should be responsible for the compliance of the ppe , in relation to their respective roles in the whole supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the proper information and protection of users and , where appropriate , other persons , to guarantee fair competition on the union market .


### all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that ppe protects the health and safety of persons and that they make available on the market only products which comply with this regulation . this regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution chain . ### all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only ppe which is in conformity with this regulation . this regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain .


### all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that ppe protects the health and safety of persons and that they make available on the market only products which comply with this regulation . this regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution chain . ### all economic operators intervening in the supply and distribution chain should take appropriate measures to ensure they make available on the market only ppe which is in conformity with this regulation . this regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain .


### ensuring traceability of ppe throughout the supply chain helps to make market surveillance simpler and more efficient . an efficient traceability system facilitates the market surveillance authorities ' task of tracing economic operators who made non - compliant product available on the market . ### ensuring traceability of ppe throughout the whole supply chain helps to make market surveillance simpler and more efficient . an efficient traceability system facilitates the market surveillance authorities ' task of tracing economic operators who made non - compliant product available on the market . when keeping the information required under this regulation for the identification of other economic operators , economic operators should not be required to update such information in respect of other economic operators who have either supplied them with ppe or to whom they have supplied ppe unless such updated information has been supplied to them .


### the requirement in other internal market legislation to supply an eu declaration of conformity with the equipment has been found to facilitate and to enhance the efficiency of market surveillance and should therefore also be introduced into this regulation . it should be possible to provide a simplified eu declaration of conformity in order to reduce the burden associated with this requirement without reduction of its effectiveness . both possibilities should therefore be provided for in this regulation . ### market surveillance authorities should have easy access to the declaration of conformity . in order to fulfil that requirement , manufacturers should ensure ppe is accompanied either by a full copy of the declaration of conformity or the internet address where the eu declaration of conformity can be accessed . alternatively , the manufacturer should be able to choose to provide a simplified declaration of conformity .


### this regulation lays down requirements for the design and manufacture of personal protective equipment in order to ensure the health and safety protection of users and rules on its free movement in the union . ### this regulation lays down requirements for the design and manufacture of personal protective equipment which is being made available on the market in order to ensure the protection of users and rules on its free movement in the union .


### specifically designed for use by the armed forces or for the maintenance of law and order ; ### specifically designed for use by the armed forces or in the maintenance of law and order ;


### for head , face or eye protection of users , subject to the relevant regulation of the united nations economic commission for europe , of two - or three - wheeled motor vehicles . ### for head , face or eye protection of users , subject to regulation 22 of the united nations economic commission for europe , on uniform provisions concerning the approval of protective helmets and of their visors for drivers and passengers of motor cycles and mopeds ;


### ' individually adapted ppe ' means ppe produced in series where each item is manufactured to fit an individual user ; ### ' ppe type ' means the series of ppe that is equal to the ppe described in the technical documentation and to the ppe subject to the eu type examination ;


### free movement ### free movement , demonstrations and field tests


### manufacturers shall ensure that the ppe which they place on the market bears a type , batch or serial number or other element allowing its identification or , where the size or nature of the ppe does not allow it , that the required information is provided on the packaging or a document accompanying the ppe . ### manufacturers shall ensure that the ppe which they place on the market bears either a type , batch or serial number or other element allowing its identification or , where the size or nature of the ppe does not allow it , that the required information is provided on the packaging or a document accompanying the ppe .


### manufacturers shall ensure that the ppe is accompanied by a copy of the eu declaration of conformity referred to in article . manufacturers may choose to fulfil this requirement by accompanying the ppe with the simplified eu declaration of conformity referred to in article . where only the simplified eu declaration of conformity is provided , it shall be immediately followed by the exact internet address where the full text of the eu declaration of conformity can be obtained . ### manufacturers shall ensure that the ppe is accompanied by a copy of the eu declaration of conformity referred to in article . manufacturers may choose to fulfil this requirement by accompanying the ppe with the simplified eu declaration of conformity referred to in article or include in the instructions and information the internet address where the eu declaration of conformity can be accessed . where only the simplified eu declaration of conformity is provided , it shall contain the exact internet address where the full text of the eu declaration of conformity can be obtained .


### importers who consider or have reason to believe that ppe which they have placed on the market is not in conformity with this regulation shall immediately take the corrective measures necessary to bring the ppe into conformity , to withdraw it or to recall it , as appropriate . furthermore , where the ppe presents a risk , importers shall immediately inform the market surveillance authorities of the member states in which they made the ppe available on the market to that effect , giving details , in particular , of the non - conformity and of any corrective measures taken . ### importers who consider or have reason to believe that ppe which they have placed on the market is not in conformity with this regulation shall immediately take the corrective measures necessary to bring the ppe into conformity , to withdraw it or to recall it , as appropriate . furthermore , where the ppe presents a risk , importers shall immediately inform the manufacturer and the competent national authorities of the member states in which they made the ppe available on the market to that effect , giving details , in particular , of the non - conformity and of any corrective measures taken .


### the eu declaration of conformity shall have the structure and shall contain the elements set out in annex ix and shall be continuously updated . it shall be translated into the language or languages required by the member state in which the ppe is made available on the market . ### the eu declaration of conformity shall be based on the model structure set out in annex ix , shall contain the elements specified in the relevant modules set out in annexes iv , vi , vii and viii and shall be continuously updated . it shall be translated into the language or languages required by the member state in which the ppe is placed or made available on the market .


### a simplified eu declaration of conformity shall contain the elements set out in annex x and it shall be continuously updated . it shall be translated into the language or languages required by the member state in which the ppe is made available on the market . the eu declaration of conformity accessible through internet address shall be available in the language or languages required by the member state in which the ppe is made available on the market . ### a simplified eu declaration of conformity shall be based on the model structure set out in annex x and it shall be continuously updated . it shall be translated into the language or languages required by the member state in which the ppe is made available on the market . the eu declaration of conformity accessible through internet address shall be available in the language or languages required by the member state in which the ppe is placed or made available on the market .


### by drawing up the eu declaration of conformity , the manufacturer shall assume the full responsibility for the conformity of the ppe with the requirements of this regulation . ### by drawing up the eu declaration of conformity , the manufacturer shall assume the full responsibility for the compliance of the ppe with the requirements laid down in this regulation .


### the application for notification shall be accompanied by a description of the conformity assessment activities , the conformity assessment procedure and the kinds of ppe for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 23 . ### the application for notification shall be accompanied by a description of the conformity assessment activities , the conformity assessment module or modules and the kinds of ppe for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 23 .


### in the event of restriction , suspension or withdrawal of notification , or where the notified body has ceased its activity , the notifying member state shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request . ### in the event of restriction , suspension or withdrawal of notification , or where the notified body has ceased its activity , the notifying member state shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request . the notifying member state shall inform the concerned manufacturers and give them the possibility to select another notified body of their choice .


### the commission shall be empowered to adopt delegated acts in accordance with article 37 to amend annex i with respect to the category of a specific risk , in response to technical progress and knowledge or new scientific evidence and by taking into account the conformity assessment procedure that need to be followed for each category , in accordance with article 18 . ### in order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk , the commission shall be empowered to adopt delegated acts in accordance with article 37 to amend annex i by reclassifying the risk from one category to another . a member state which has concerns about the classification of a risk into a specific risk category referred to in article 17 shall immediately inform the commission of its concerns and provide reasons in support . prior to adopting a delegated act the commission shall carry out a thorough assessment of the risks that require reclassification and of its impacts .


### member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ### member states shall lay down the rules on penalties applicable to infringements by economic operators of the provisions of this regulation and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] at the latest and shall notify it without delay of any subsequent amendment affecting them .


### however , articles 19 to 35 shall apply from [ six months after entry into force ] . ### however , articles 19 to 35 and articles 38 and 39 shall apply from [ six months after entry into force ] .


### ionising radiation ; ### ionising radiation , laser radiation and radioactive contamination ;


### bullet wounds or knife stabs ; ### bullet wounds , explosive fragments or knife stabs ;


### the materials of which the ppe is made , including any of their possible decomposition products , must not adversely affect the health or safety of users . ### the materials , of which the ppe is made , including any of their possible decomposition products , must not adversely affect the health or safety of users or result in the ppe no longer complying with the essential health and safety requirements laid down in this regulation .


### if the same manufacturer places on the market several models of ppe models of different types in order to ensure the simultaneous protection of adjacent parts of the body , they must be compatible . ### if the same manufacturer places on the market several models of ppe of different types in order to ensure the simultaneous protection of adjacent parts of the body , they must be compatible .


### accessories that may be used with the ppe and the characteristics of appropriate spare parts ; ### where applicable , accessories that may be used with the ppe and the characteristics of appropriate spare parts ;


### the classes of protection appropriate to different levels of risk and the corresponding limits of use ; ### where applicable , the classes of protection appropriate to different levels of risk and the corresponding limits of use ;


### the date or period of obsolescence of the ppe or of certain of its components ; ### where applicable , the date or period of obsolescence of the ppe or of certain of its components ;


### the type of packaging suitable for transport ; ### where applicable , the type of packaging suitable for transport ;


### the name , address and identification number of the notified body or bodies involved in the conformity assessment of the ppe . ### reference to the relevant harmonised standard used , including the date of the standard or references to the other technical specification used :


### these instructions , which must be precise and comprehensible , must be provided at least in the official language of the member state of destination . ### these instructions , which must be precise and comprehensible , must be provided at least in the official language of the member state of destination . any additional relevant instructions for selection , use , care and maintenance of the ppe must be made available in a way that is easily accessible to any concerned person .


### materials and other components of equipment intended for brief use in high - temperature environments and of ppe which may be splashed by hot products such as large quantities of molten material must also possess sufficient thermal capacity to retain most of the stored heat until after the user has left the danger area and removed his ppe . ### materials and other components of equipment intended for brief use in high - temperature environments and of ppe which may be splashed by hot products such as large quantities of molten material must also possess sufficient thermal capacity to protect from burns until after the user has left the danger area and removed his ppe .


### 10 . protection against dangerous substances and infectious agents ### 10 . protection against substances and mixtures which are hazardous to health and against biological agents


### ppe intended to prevent the surface contact of all or part of the body with dangerous substances and infective agents must be capable of preventing the penetration or permeation of such substances and agents through the protective integument under the foreseeable conditions of use for which the ppe is intended . ### ppe intended to prevent the surface contact of all or part of the body with substances and mixtures which are hazardous to health or biological agents must be capable of preventing the penetration or permeation of such substances and mixtures and agents through the protective integument under the foreseeable conditions of use for which the ppe is intended .


### where , by virtue of their nature and the foreseeable conditions of their use , certain dangerous substances or infectious agents possess high penetrative power which limits the duration of the protection provided by the ppe in question , the latter must be subjected to standard tests with a view to their classification on the basis of their performance . ppe which is considered to be in conformity with the test specifications must bear a marking indicating , in particular , the names or , failing this , the codes of the substances used in the tests and the corresponding standard period of protection . the manufacturer ' s instructions must also contain , in particular , an explanation of the codes , a detailed description of the standard tests and all appropriate information for the determination of the maximum permissible period of wear under the different foreseeable conditions of use . ### where , by virtue of their nature and the foreseeable conditions of their use , certain health hazardous substances and mixtures which are hazardous to health or biological agents possess high penetrative power which limits the duration of the protection provided by the ppe in question , the latter must be subjected to standard tests with a view to their classification on the basis of their performance . ppe which is considered to be in conformity with the test specifications must bear a marking indicating , in particular , the names or , failing this , the codes of the substances used in the tests and the corresponding standard period of protection . the manufacturer ' s instructions must also contain , in particular , an explanation of the codes , a detailed description of the standard tests and all appropriate information for the determination of the maximum permissible period of wear under the different foreseeable conditions of use .


### the manufacturer shall establish the technical documentation described in annex iii . the documentation shall make it possible to assess the conformity of the ppe to the applicable requirements , and shall include an adequate analysis and assessment of the risk . the technical documentation shall specify the applicable requirements and cover , as far as relevant for the assessment , the design , manufacture and operation of the ppe . ### the manufacturer shall establish the technical documentation described in annex iii .


### the technical documentation described in annex iii . the documentation shall make it possible to assess the conformity of the ppe to the applicable requirements , and shall include an adequate analysis and assessment of the risk . the technical documentation shall specify the applicable requirements and cover , as far as relevant for the assessment , the design , manufacture and operation of the ppe ; ### the technical documentation described in annex iii ;


### for individually adapted ppe , a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of ppe complies with the approved type and with the applicable essential health and safety requirements . ### for made - to - measure ppe , a description of the possible variations and the measures to be taken by the economic operator during the production process to ensure that each item of ppe complies with the approved ppe type and with the applicable health and safety requirements laid down in annex ii .


### the date of issue and , where appropriate , the date of renewal ; ### the date of issue and , where appropriate , the date of renewal or expiry .


### for made - to - measure ppe the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured made - to - measure ppe with the basic model described in the eu type - examination certificate and with the applicable essential health and safety requirements . ### for made - to - measure ppe the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured made - to - measure ppe with the basic model described in the eu type - examination certificate and with the applicable requirements of this regulation .


### 1 . the notified body shall provide the manufacturer with a test report , and shall authorise the manufacturer to affix the notified body ' s identification number to each individual ppe that is in conformity with the type described in the eu type - examination certificate and satisfies the applicable essential health and safety requirements . ### 1 . the notified body shall provide the manufacturer with a test report .


### eu declaration of conformity ### eu declaration of conformity the eu declaration of conformity shall contain the following elements :


### name and address of the manufacturer or his authorised representative [ the authorised representative must also give the business name and address of the manufacturer ] : ### name and address of the manufacturer or , where applicable , his authorised representative .


### references to the relevant harmonised standards , including the date of the standard , or references to the other technical specifications , including the date of the specification , in relation to which conformity is declared : ### references to the applied harmonised standards , including the date of the standard , or references to the other technical specifications , including the date of the specification , in relation to which conformity is declared :


### the resulting ineffective enforcement of cross - border infringements , in particular in the digital environment , enables traders to evade enforcement by relocating within the union , giving rise to a distortion of competition for law - abiding traders operating either domestically or cross - border , and thus directly harming consumers and undermining consumer confidence in cross - border transactions and the single market . an increased level of harmonisation setting effective and efficient enforcement cooperation among competent public enforcement authorities is therefore necessary to detect , investigate and order the cessation of intra - union infringements and widespread infringements , ### the resulting ineffective enforcement of cross - border infringements , in particular in the digital environment , enables traders to evade enforcement by relocating within the union , giving rise to a distortion of competition for traders operating either domestically or cross - border , and thus directly harming consumers and undermining consumer confidence in cross - border transactions and the single market . an increased level of harmonisation setting effective and efficient enforcement cooperation among competent public enforcement authorities is therefore necessary to detect , investigate and order the cessation of intra - union infringements and widespread infringements ,


### consumers should also be protected from short - lived intra - union infringements and widespread infringements that only last for a short period of time but whose harmful effects may continue long after the infringement has stopped . competent authorities should have the necessary powers to investigate and order a cessation of such infringements in the future , ### consumers should also be protected from short - lived intra - union infringements and widespread infringements that only last for a short period of time but whose harmful effects may continue long after the infringement has stopped . competent authorities should have the necessary powers to investigate and order a cessation of such infringements in the future , so as to ensure consumer protection ,


### in the digital environment in particular , the competent authorities should be able to stop infringements quickly and effectively , notably where the trader selling goods or services conceals its identity or relocates within the union or to a third country to avoid enforcement . in cases where there is a risk of serious and irreparable harm to consumers , the competent authorities should to be able to adopt interim measures to prevent such harm or reduce it , including , where necessary , the suspension of a website , domain or a similar digital site , service or account . furthermore , the competent authorities should have the power to take down or have a third party service provider take down a website , domain or a similar digital site , service or account , ### in the digital environment in particular , the competent authorities should be able to prevent infringements quickly and effectively , notably where the trader selling goods or services conceals his identity or relocates within the union or to a third country to avoid enforcement . in cases where there is a risk of serious and irreparable harm to consumers , the competent authorities should to be able to adopt interim measures to prevent such harm or reduce it , including , where necessary , the suspension of a website , domain or a similar digital site , service or account . furthermore , the competent authorities should have the power to take down or have a third party service provider take down a website , domain or a similar digital site , service or account ,


### in order to ensure that traders are sufficiently deterred from committing or repeating infringements and that they will not profit from those infringements , the rules on penalties which have been adopted by member states in accordance with the requirements of union laws that protect consumers’ interests should also be applied to intra - union infringements and widespread infringements . for those same reasons , consumers should be entitled to redress for harm caused by such infringements . ### in order to ensure that traders are sufficiently deterred from committing or repeating infringements and that they will not profit from those infringements , the rules on penalties which have been adopted by member states in accordance with the requirements of union laws that protect consumers ' interests should also be applied to intra - union infringements and widespread infringements , and competent authorities should always take into account the overall harm resulting from the infringement in all member states affected ,


### in order to ensure that traders are sufficiently deterred from committing or repeating infringements and that they will not profit from those infringements , the rules on penalties which have been adopted by member states in accordance with the requirements of union laws that protect consumers’ interests should also be applied to intra - union infringements and widespread infringements . for those same reasons , consumers should be entitled to redress for harm caused by such infringements . ### in order to ensure that traders are sufficiently deterred from committing or repeating infringements and that they will not profit from those infringements , the rules on penalties which have been adopted by member states in accordance with the requirements of union laws that protect consumers’ interests should also be observed and applied to intra - union infringements and widespread infringements . for those same reasons , consumers should be entitled to redress for harm caused by such infringements .


### the effectiveness and efficacy of the mutual assistance mechanism should be improved . information requested should be provided in a timely manner and the necessary enforcement measures should be adopted in a timely manner . the commission should therefore set binding time periods for competent authorities to reply to information and enforcement requests , and clarify procedural and other aspects of handling information and enforcement requests , by means of implementing measures , ### the effectiveness and efficacy of the mutual assistance mechanism should be improved immediately . information requested should be provided in a timely manner and the necessary enforcement measures should be adopted in a timely manner . the commission should therefore set binding time periods for competent authorities to reply to information and enforcement requests , and clarify procedural and other aspects of handling information and enforcement requests , by means of implementing measures ,


### if a trader responsible for the widespread infringement or the widespread infringement with a union dimension fails to cease the infringement voluntarily , the competent authorities of the member states concerned should designate one competent authority in a member state to take the enforcement action adapted to preserve the rights of consumers residing in the other member states concerned by the infringement . that competent authority should be designated , taking into account its capacity to take effective action against the trader , for instance where the trader is established in the member state of that authority . the designated competent authority should act as if the consumers of the other member states were its own consumers . where necessary , to avoid extraterritorial application of the law , several or all the member states concerned by the infringement should be allowed to adopt enforcement measures at the same time to protect their own consumers or consumers residing in other member states . this may be needed , for instance , to stop infringements of a similar nature by subsidiaries of a company , established in more than one member state , which affect the consumers of those member states only , without an apparent cross - border element , ### if a trader responsible for the widespread infringement or the widespread infringement with a union dimension fails to cease the infringement voluntarily , the competent authorities of the member states concerned should designate one competent authority in a member state to take the enforcement action adapted to protect the rights of consumers residing in the other member states concerned by the infringement . that competent authority should be designated , taking into account its capacity to take effective action against the trader , for instance where the trader is established in the member state of that authority . the designated competent authority should act as if the consumers of the other member states were its own consumers . where necessary , to avoid extraterritorial application of the law , several or all the member states concerned by the infringement should be allowed to adopt enforcement measures at the same time to protect their own consumers or consumers residing in other member states . this may be needed , for instance , to stop infringements of a similar nature by subsidiaries of a company , established in more than one member state , which affect the consumers of those member states only , without an apparent cross - border element ,


### consumer organisations play an essential role in informing consumers about their rights and educating them and protecting their interests , including the settlement of disputes . consumers should be encouraged to cooperate with the competent authorities to strengthen the application of this regulation . consumer organisations , in particular consumer organisations that may be delegated enforcement tasks under this regulation and european consumer centres , should be in a position to notify competent authorities of suspected infringements and share information needed to detect , investigate and stop intra - union infringements and widespread infringements with them , ### consumer organisations play a role in informing consumers about their rights and educating them and protecting their interests , including the settlement of disputes . consumer organisations and european consumer centres should be in a position to notify competent authorities of suspected infringements and share with them information needed to detect , investigate and stop infringements ,


### this regulation respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union67 . accordingly this regulation should be interpreted and applied with respect to those rights and principles . when exercising the minimum powers set out in this regulation , the competent authorities should strike an appropriate balance between the interests protected by fundamental rights such as a high level of consumer protection , the freedom to conduct business and freedom of information . _________________ 67 oj c 364 , 18 . 12 . 2000 , p . 1 . ### this regulation respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union67 . accordingly this regulation must be interpreted and applied with respect to those rights and principles . when exercising the minimum powers set out in this regulation , the competent authorities should strike an appropriate balance between the interests protected by fundamental rights such as a high level of consumer protection , the freedom to conduct business and freedom of information . _________________ 67 oj c 364 , 18 . 12 . 2000 , p . 1 .


### any acts or omissions contrary to the laws that protect consumers interests that have common features , such as the same unlawful practice , the same interest being infringed or that are occurring concurrently , in at least two member states ; ### any acts or omissions contrary to the union laws that protect consumers ' interests that harmed , harm , or are likely to harm the collective interests of consumers and have common features , such as the same unlawful practice or the same interest being infringed , and that are occurring concurrently , committed by the same trader or his or her agents or distributors , in at least three member states ;


### consult consumers , consumer organisations , designated bodies and other persons concerned about the effectiveness of the proposed commitments in ceasing the infringement and removing the harm caused by it . ### consult consumer organisations , traders associations and , where applicable , designated bodies .


### the competent authorities shall exercise the powers set out in article 8 in accordance with this regulation and national law either : ### the powers set out in article 8 shall be exercised either :


### the competent authorities shall exercise the powers set out in article 8 in accordance with this regulation and national law either : ### the competent authorities shall exercise the powers in a proportionate manner and ensure that the powers exercised are adequate taking into account the nature and overall harm of the infringement in question . those powers are set out in article 8 in accordance with this regulation and national law and shall be exercised either :


### directly under their own authority ; or ### directly by competent authorities under their own authority ;


### in applying a quality policy and in order to allow for a high level of quality of spirit drinks and diversity in the spirit drinks sector , member states should be allowed to adopt rules on the definition , presentation and labelling of spirit drinks produced in their territory that are stricter than those laid down in this regulation . ### in applying a quality policy and in order to allow for a high level of quality of spirit drinks and diversity in the spirit drinks sector , member states should be allowed to adopt rules on the production , definition , presentation and labelling of spirit drinks produced in their territory that are stricter than those laid down in this regulation .


### a mixture shall bear the sales denomination ‘ spirit drink’ . ### a mixture shall bear the sales denomination ‘ spirit drink’ which shall be displayed clearly in a prominent place on the label .


### any other false or misleading indication as to the provenance , origin , nature or essential qualities of the product , on the inner or outer packaging , advertising material or documents relating to the product concerned , and the packing of the product in a container liable to convey a false impression as to its origin ; ### any other false or misleading indication as to the provenance , origin , nature or essential qualities of the product , on the labelling of the product , on the inner or outer packaging , advertising material or documents relating to the product concerned , and the packing of the product in a container liable to convey a false impression as to its origin ;


### ‘ addition of alcohol’ means the addition of ethyl alcohol of agricultural origin or distillates of agricultural origin or both to a spirit drink . ### ' addition of alcohol ' means the addition of ethyl alcohol of agricultural origin or distillates of agricultural origin or both to a spirit drink . the use of alcohol of agricultural origin for dilute or dissolution of colours , flavouring or any other authorised additives used in the preparation of spirit drinks shall not be considered as addition of alcohol .


### hefebrand or lees spirit is a spirit drink produced exclusively by the distillation at less than 86 % vol . of lees of wine or of fermented fruit . ### hefebrand or lees spirit is a spirit drink produced exclusively by the distillation at less than 86 % vol . of lees of wine or of lees of fermented fruit .


### maximum levels of residue for ethyl alcohol of agricultural origin shall meet those set out in point of annex i , except that the methanol content shall not exceed 10 grams per hectolitre of 100 % vol . alcohol . ### maximum levels of residue for ethyl alcohol of agricultural origin used to produce vodka shall meet those set out in point of annex i , except that the methanol content shall not exceed 10 grams per hectolitre of 100 % vol . alcohol .


### the minimum alcoholic strength by volume of vodka shall be 37 . 5 % . ### the alcoholic strength by volume of vodka shall be not less than 37 . 5 % and no more than 80 % .


### at union level , reports by whistleblowers are one upstream component of enforcement of union law : they feed national and union enforcement systems with information leading to effective detection , investigation and prosecution of breaches of union law . ### at union level , reports by whistleblowers are one upstream component of enforcement of union law : they feed national and union enforcement systems with information often leading to effective detection , investigation and prosecution of breaches of union law .


### whistleblower protection currently provided in the european union is fragmented across member states and uneven across policy areas . the consequences of breaches of union law with cross - border dimension uncovered by whistleblowers illustrate how insufficient protection in one member state not only negatively impacts on the functioning of eu policies in that member state but can also spill over into other member states and the union as a whole . ### whistleblower protection currently provided in the european union is diverse across member states , depending on the national provisions already in place or the overall national legislative structure . the consequences of breaches of union law with cross - border dimension uncovered by whistleblowers highlight the challenges with regard to the effective implementation of eu policies and the need for improving cross - border cooperation mechanisms where needed .


### accordingly , common minimum standards ensuring effective whistleblower protection should apply in those acts and policy areas where i ) there is a need to strengthen enforcement ; ii ) under - reporting by whistleblowers is a key factor affecting enforcement , and iii ) breaches of union law cause serious harm to the public interest . ### accordingly , a set of common minimum standards , unanimously agreed by all eu member states , ensuring effective whistleblower protection should apply in those acts and policy areas where i ) there is a need to strengthen enforcement ; ii ) under - reporting by whistleblowers is a key factor affecting enforcement , and iii ) breaches of union law cause serious harm to the public interest .


### accordingly , common minimum standards ensuring effective whistleblower protection should apply in those acts and policy areas where i ) there is a need to strengthen enforcement ; ii ) under - reporting by whistleblowers is a key factor affecting enforcement , and iii ) breaches of union law cause serious harm to the public interest . ### accordingly , common minimum standards ensuring effective whistleblower protection should only apply in those acts , policy areas and member states where there is evidence that i ) there is a need to strengthen enforcement ; ii ) under - reporting by whistleblowers is a key factor affecting enforcement , and iii ) breaches of union law cause serious harm to the public interest .


### in the area of financial services , the added value of whistleblower protection was already acknowledged by the union legislator . in the aftermath of the financial crisis , which exposed serious shortcomings in the enforcement of the relevant rules , measures for the protection of whistleblowers were introduced in a significant number of legislative instruments in this area34 . in particular , in the context of the prudential framework applicable to credit institutions and investment firms , directive 2013 / 36 / eu35 provides for protection of whistleblowers , which extends also to regulation no 575 / 2013 on prudential requirements for credit institutions and investment firms . _________________ 34 communication of 8 . 12 . 2010 ' reinforcing sanctioning regimes in the financial services sector ' . 35 directive 2013 / 36 / eu of the european parliament and of the council of 26 june 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms , amending directive 2002 / 87 / ec and repealing directives 2006 / 48 / ec and 2006 / 49 / ec . ### in the area of financial services , the added value of sectoral whistleblower protection was already acknowledged by the union legislator . in the aftermath of the financial crisis , which exposed serious shortcomings in the enforcement of the relevant rules , measures for the protection of whistleblowers were introduced in a significant number of legislative instruments in this area34 . in particular , in the context of the prudential framework applicable to credit institutions and investment firms , directive 2013 / 36 / eu35 provides for protection of whistleblowers , which extends also to regulation no 575 / 2013 on prudential requirements for credit institutions and investment firms . however , a number of high profile cases involving european financial institutions have proven , that protection of whistleblowers within the full range of financial institutions still remain unsatisfactory and that fears of reprisals from both employers and authorities still prevent whistleblowers from coming forward with information on breaches of law . _________________ 34 communication of 8 . 12 . 2010 ' reinforcing sanctioning regimes in the financial services sector ' . 35 directive 2013 / 36 / eu of the european parliament and of the council of 26 june 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms , amending directive 2002 / 87 / ec and repealing directives 2006 / 48 / ec and 2006 / 49 / ec .


### the importance of whistleblower protection in terms of preventing and deterring breaches of union rules on transport safety which can endanger human lives has been already acknowledged in sectorial union instruments on aviation safety38and maritime transport safety39 , which provide for tailored measures of protection to whistleblowers as well as specific reporting channels . these instruments also include the protection from retaliation of the workers reporting on their own honest mistakes . it is necessary to complement the existing elements of whistleblower protection in these two sectors as well as to provide such protection to enhance the enforcement of safety standards for other transport modes , namely road and railway transport . _________________ 38 regulation no 376 / 2014 of the european parliament and of the council , of 3 april 2014 , on the reporting , analysis and follow - up of occurrences in civil aviation . 39 directive 2013 / 54 / eu , of the european parliament and of the council , of 20 november 2013 , concerning certain flag state responsibilities for compliance with and enforcement of the maritime labour convention , directive 2009 / 16 / ec of the european parliament and of the council , of 23 april 2009 , on port state control . ### the importance of whistleblower protection in terms of preventing and deterring breaches of union rules on transport safety which can endanger human lives has been already acknowledged in sectorial union instruments on aviation safety38 and maritime transport safety39 , which provide for tailored measures of protection to whistleblowers as well as specific reporting channels . these instruments also include the protection from retaliation of the workers reporting on their own honest mistakes . it is necessary to complement the existing elements of whistleblower protection in these two sectors as well as to provide such protection to enhance the enforcement of safety standards for other transport modes , namely special , inland waterway , road and railway transport . _________________ 38 regulation no 376 / 2014 of the european parliament and of the council , of 3 april 2014 , on the reporting , analysis and follow - up of occurrences in civil aviation . 39 directive 2013 / 54 / eu , of the european parliament and of the council , of 20 november 2013 , concerning certain flag state responsibilities for compliance with and enforcement of the maritime labour convention , directive 2009 / 16 / ec of the european parliament and of the council , of 23 april 2009 , on port state control .


### the importance of whistleblower protection in terms of preventing and deterring breaches of union rules on transport safety which can endanger human lives has been already acknowledged in sectorial union instruments on aviation safety38and maritime transport safety39 , which provide for tailored measures of protection to whistleblowers as well as specific reporting channels . these instruments also include the protection from retaliation of the workers reporting on their own honest mistakes . it is necessary to complement the existing elements of whistleblower protection in these two sectors as well as to provide such protection to enhance the enforcement of safety standards for other transport modes , namely road and railway transport . _________________ 38 regulation no 376 / 2014 of the european parliament and of the council , of 3 april 2014 , on the reporting , analysis and follow - up of occurrences in civil aviation . 39 directive 2013 / 54 / eu , of the european parliament and of the council , of 20 november 2013 , concerning certain flag state responsibilities for compliance with and enforcement of the maritime labour convention , directive 2009 / 16 / ec of the european parliament and of the council , of 23 april 2009 , on port state control . ### the importance of whistleblower protection in terms of preventing and deterring breaches of union rules on transport safety which can endanger human lives has been already acknowledged in sectorial union instruments on aviation safety38 and maritime transport safety39 , which provide for tailored measures of protection to whistleblowers as well as specific reporting channels . these instruments also include the protection from retaliation of the workers reporting on their own honest mistakes . it is necessary to complement the existing elements of whistleblower protection in these two sectors as well as to provide such protection to enhance immediately the enforcement of safety standards for other transport modes , namely road and railway transport . _________________ 38 regulation no 376 / 2014 of the european parliament and of the council , of 3 april 2014 , on the reporting , analysis and follow - up of occurrences in civil aviation . 39 directive 2013 / 54 / eu , of the european parliament and of the council , of 20 november 2013 , concerning certain flag state responsibilities for compliance with and enforcement of the maritime labour convention , directive 2009 / 16 / ec of the european parliament and of the council , of 23 april 2009 , on port state control .


### evidence - gathering , detecting and addressing environmental crimes and unlawful conduct against the protection of the environment remain a challenge and need to be reinforced as acknowledged in the commission communication ' eu actions to improve environmental compliance and governance ' of 18 january 201840 . whilst whistleblower protection rules exist at present only in one sectorial instrument on environmental protection41 , the introduction of such protection appears necessary to ensure effective enforcement of the union environmental acquis , whose breaches can cause serious harm to the public interest with possible spill - over impacts across national borders . this is also relevant in cases where unsafe products can cause environmental harm . _________________ 40 com 10 final . 41 directive 2013 / 30 / eu of the european parliament and of the council , of 12 june 2013 , on safety of offshore oil and gas operations . ### evidence - gathering , detecting and addressing environmental crimes and unlawful conduct against the protection of the environment unfortunately remain a challenge and need to be reinforced as acknowledged in the commission communication ' eu actions to improve environmental compliance and governance ' of 18 january 201840 . whilst whistleblower protection rules exist at present only in one sectorial instrument on environmental protection41 , the introduction of such protection appears necessary to ensure effective enforcement of the union environmental acquis , whose breaches can cause serious harm to the public interest with possible spill - over impacts across national borders . this is also relevant in cases where unsafe products can cause environmental harm . _________________ 40 com 10 final . 41 directive 2013 / 30 / eu of the european parliament and of the council , of 12 june 2013 , on safety of offshore oil and gas operations .


### the protection of privacy and personal data is another area where whistleblowers are in a privileged position to disclose breaches of union law which can seriously harm the public interest . similar considerations apply for breaches of the directive on the security of network and information systems45 , which introduces notification of incidents and security requirements for entities providing essential services across many sectors and providers of key digital services . whistleblowers ' reporting in this area is particularly valuable to prevent security incidents that would affect key economic and social activities and widely used digital services . it helps ensuring the continuity of services which are essential for the functioning of the internal market and the wellbeing of society . _________________ 45 directive 2016 / 1148 of the european parliament and of the council of 6 july 2016 concerning measures for a high common level of security of network and information systems across the union . ### the protection of privacy and personal data is another area where whistleblowers are in a privileged position to disclose breaches of union law which can seriously harm the public interest . similar considerations apply for breaches of the directive on the security of network and information systems45 , which introduces notification of incidents and security requirements for entities providing essential services across many sectors and providers of key digital services . whistleblowers ' reporting in this area is particularly valuable in order to prevent security incidents that would affect key economic and social activities and widely used digital services . it helps ensuring the continuity of services which are essential for the functioning of the internal market and the wellbeing of society . _________________ 45 directive 2016 / 1148 of the european parliament and of the council of 6 july 2016 concerning measures for a high common level of security of network and information systems across the union .


### effective whistleblower protection implies protecting also further categories of persons who , whilst not relying on their work - related activities economically , may nevertheless suffer retaliation for exposing breaches . retaliation against volunteers and unpaid trainees may take the form of no longer making use of their services , or of giving a negative reference for future employment or otherwise damaging their reputation . ### effective whistleblower protection implies protecting also further categories of persons who , whilst not relying on their work - related activities economically , may nevertheless suffer retaliation for exposing breaches . retaliation against volunteers and unpaid trainees may take the form of no longer making use of their services , or of giving a negative reference for future employment or otherwise damaging their reputation or career prospects .


### it is for the member states to identify the authorities competent to receive and give appropriate follow up to the reports on breaches falling within the scope of this directive . these may be regulatory or supervisory bodies in the areas concerned , law enforcement agencies , anti - corruption bodies and ombudsmen . the authorities designated as competent shall have the necessary capacities and powers to assess the accuracy of the allegations made in the report and to address the breaches reported , including by launching an investigation , prosecution or action for recovery of funds , or other appropriate remedial action , in accordance with their mandate . ### it is for the member states to identify the authorities competent to receive and give appropriate follow up to the reports on breaches falling within the scope of this directive , to ensure proper implementation and to ensure full , loyal and expeditious cooperation between competent authorities both within the member state itself and with relevant authorities in other member states . these may be regulatory or supervisory bodies in the areas concerned , law enforcement agencies , anti - corruption bodies and ombudsmen . the authorities designated as competent shall have , in addition to the necessary capacities and powers , suitably qualified staff to assess the accuracy of the allegations made in the report and to address the breaches reported , including by launching an investigation , prosecution or action for recovery of funds , or other appropriate remedial action , in accordance with their mandate .


### for the effective detection and prevention of breaches of union law it is vital that the relevant information reaches swiftly those closest to the source of the problem , most able to investigate and with powers to remedy it , where possible . this requires that legal entities in the private and the public sector establish appropriate internal procedures for receiving and following - up on reports . ### for the effective detection and prevention of breaches of union law it is vital that the relevant information reaches swiftly those closest to the source of the problem , most able to investigate and with powers to remedy it , where possible . this requires that legal entities in the private and the public sector establish appropriate internal procedures for receiving , analysing and following - up on reports .


### where retaliation occurs undeterred and unpunished , it has a chilling effect on potential whistleblowers . a clear prohibition of retaliation in law has an important dissuasive effect , further strengthened by provisions for personal liability and penalties for the perpetrators of retaliation . ### where retaliation occurs undeterred and unpunished , it has a chilling effect on potential whistleblowers . a clear prohibition of retaliation in law may among other possible instruments have an important dissuasive effect , further strengthened by provisions for personal liability and penalties for the perpetrators of retaliation .


### member states shall designate the authorities competent to receive and handle reports . ### member states shall designate the authorities competent to receive , handle reports and set the hierarchical procedural structure .


### by [ six months after the entry into force of this regulation — opoce , please replace with the actual date ] and every six months thereafter during the development phase of the interoperability components , eu - lisa shall submit a report to the european parliament and the council on the state of play of the development of the interoperability components . once the development is finalised , a report shall be submitted to the european parliament and the council explaining in detail how the objectives , in particular relating to planning and costs , were achieved as well as justifying any divergences . ### by [ six months after the entry into force of this regulation — opoce , please replace with the actual date ] and every six months thereafter during the development phase of the interoperability components , eu - lisa shall submit a report to the european parliament and the council on the state of play of the development of the interoperability components . that report shall include an overview of the current development of costs and progress of the project , a financial impact assessment , and information on any technical problems and risks that may impact the overall costs of the system to be borne by the general budget of the union in accordance with article 60 .


### four years after the start of operations of each interoperability component and every four years thereafter , eu - lisa shall submit to the european parliament , the council and the commission a report on the technical functioning of the interoperability components , including the security thereof . ### two years after the start of operations of each interoperability component and every two years thereafter , eu - lisa shall submit to the european parliament , the council and the commission a report on the technical functioning of the interoperability components , including their security and costs .


### in addition , one year after each report from eu - lisa , the commission shall produce an overall evaluation of the components , including : ### in addition , six months after each report from eu - lisa , the commission shall produce an overall evaluation of the components , including :


### an examination of the results achieved against objectives and the impact on fundamental rights ; ### an examination of the results achieved against objectives and the impact on fundamental rights , as well as the associated costs ;


### an assessment of any implications , including any disproportionate impact on the flow of traffic at border crossing points and those with a budgetary impact on the union budget . ### an assessment of any implications on future operations , including those with a significant impact on the flow of traffic at border crossing points and those with a budgetary impact on the union budget .


### any additional conditions set by the competent authority in the relevant permit pursuant to points and of article 7 , as regards water quality . ### any well - founded additional conditions set by the competent authority in the relevant permit pursuant to points and of article 7 , as regards water quality .


### the competent authority shall verify compliance of the reclaimed water with the conditions set out in the permit , at the point of compliance . the compliance check shall be performed using the following means : ### before issuing a permit , the competent authority shall verify compliance of the reclaimed water with the conditions set out in the permit , at the point of compliance . the compliance check shall be performed using the following means :


### if an incident affecting compliance with the permit ' s conditions occurs , the reclamation plant operator shall immediately inform the competent authority and the end - user which may be potentially affected , and communicate to the competent authority the information necessary for assessing the impacts of such an incident . ### if an incident affecting compliance with the permit ' s conditions occurs , the reclamation facility operator shall immediately inform the competent authority and all reclaimed water distributors and end - user and communicate to the competent authority the information necessary for assessing the impacts of such an incident .


### the union has set itself the objective of offering its citizens an area of freedom , security and justice without internal frontiers , in which the free movement of persons is ensured in conjunction with appropriate measures with respect to the prevention and combating of crime . ### the union has set itself the objective of offering its citizens an area of freedom , security and justice without internal frontiers , in which the free movement of persons is ensured in conjunction with appropriate measures with respect to the prevention and combating of crime , and providing internal security .


### the exchange of information on criminal convictions is important in any strategy to combat crime and counter terrorism . it would contribute to the criminal justice response to radicalisation leading to terrorism and violent extremism if member states used ecris to its full potential . ### the exchange of information on criminal convictions is important in any strategy to combat crime and counter terrorism and to ensure security within the union . if member states used ecris to its full potential , it would bolster the criminal justice response of member states to the radicalisation that leads to acts of terrorism and violent extremism , increase the protection offered to vulnerable persons , and help counter the persistent and serious effects of cross - border organised criminal networks .


### in order to compensate the lack of a single member state where information on a particular third country national is stored , decentralised information technology should enable the central authorities of the member states to find out in which other member state criminal record information is stored . for this purpose , each central authority should distribute to the other member states an index - filter which includes , in an anonymised form , the identification data of the third country nationals convicted in its member state . the personal data should be rendered anonymous in such a way that the data subject is not identifiable . the receiving member state may then match these data with their own information on a ‘ hit’ / ‘ no hit’ basis , thus finding out whether or not criminal record information is available in other member states and , in case of a ‘ hit’ , in which member states . the receiving member state should then follow up a ‘ hit’ using the ecris framework . with respect to third country nationals who also hold the nationality of a member state , the information included in the index should be limited to information available as regards nationals of member states . ### in order to compensate for the lack of a centralised union database where information on a particular third country national is stored , decentralised information technology should enable the central authorities of the member states to find out in which other member state criminal record information is stored . for this purpose , each designated central authority should distribute to the other member states an index - filter which includes , in pseudonymised form , the identification data of the third country nationals convicted in its member state . the personal data related to the information in the index should be pseudonymised in such a way that the data subject is not identifiable . the receiving member state may then match these data with their own information on a ‘ hit’ / ‘ no hit’ basis , thus finding out whether or not criminal record information is available in other member states and , in case of a ‘ hit’ , in which member states . the receiving member state should then follow up a ‘ hit’ using the ecris framework . with respect to third country nationals who also hold the nationality of a member state , the information included in the index should be limited to information available as regards nationals of member states .