### health research and innovation research and innovation have played a significant part in this achievement but also in improving productivity and quality in the health and care industry . however , the eu continues to face novel , newly emerging or persisting challenges that are threatening its citizens and public health , the sustainability of its health care and social protection systems , as well as the competitiveness of its health and care industry . major health challenges in the eu include : the lack of effective health promotion and disease prevention ; the rise of non - communicable diseases ; the spread of antimicrobial drug resistance and the emergence of infectious epidemics ; increased environmental pollution ; the persistence of health inequalities among and within countries affecting disproportionally people that are disadvantaged or in vulnerable stages of life ; the detection , understanding , control , prevention and mitigation of health risks in a rapidly changing social , urban and natural environment ; the increasing costs for european health care systems and the progressive introduction of personalised medicine approaches and digitalisation in health and care ; and the increasing pressure on the european health and care industry to remain competitive in and by developing health innovation vis - a - vis new and emerging global players . ### health research and innovation research and innovation have played a significant part in this achievement but also in improving productivity and quality in the health and care industry . however , the eu continues to face novel , newly emerging or persisting challenges that are threatening its citizens and public health , the sustainability of its health care and social protection systems , as well as the competitiveness of its health and care industry . major health challenges in the eu include : the lack of effective health promotion and disease prevention ; the rise of non - communicable diseases ; the spread of antimicrobial drug resistance and the emergence of infectious epidemics ; increased environmental pollution ; poor diets or inadequate nutrition ; the persistence of health inequalities among and within countries affecting disproportionally people that are disadvantaged or in vulnerable stages of life ; the detection , understanding , control , prevention and mitigation of health risks in a rapidly changing social , urban and natural environment ; the increasing costs for european health care systems and the progressive introduction of personalised medicine approaches and digitalisation in health and care ; and the increasing pressure on the european health and care industry to remain competitive in and by developing health innovation vis - a - vis new and emerging global players .


### resilient and sustainable farming and forestry systems provide economic , environmental and social benefits in a changing context for primary production . in addition to contributing to food and nutrition security , they feed into dynamic value chains , manage land and natural resources as well as deliver a range of vital public goods including carbon sequestration , biodiversity preservation , pollination and public health . integrated approaches are needed to promote the multiple functions of agro - and forest systems taking into account the changing context for primary production , notably in relation to climate and environment , resource availability , demography and consumption patterns . it is also necessary to address the spatial and socio - economic dimension of agriculture and forestry activities and mobilise the potential of rural areas . ### resilient and sustainable farming and forestry systems provide economic , environmental and social benefits in a changing context for primary production . in addition to ensuring food and nutrition security , they feed into dynamic value chains , manage land and natural resources as well as deliver a range of vital public goods including carbon sequestration , biodiversity preservation , pollination and public health . integrated approaches are needed to promote the multiple functions of agro - and forest systems taking into account the changing context for primary production , notably in relation to climate and environment , resource availability , competitiveness , demography and consumption patterns . it is also necessary to address the spatial and socio - economic dimension of agriculture and forestry activities and mobilise the potential of rural areas . farmers also need continued access to innovation , to new technology and to research in order to produce food in a sustainable way so that we can both feed the world and protect the environment for future generations .


### –methods , technologies and tools for sustainable and resilient production in farming and forestry ; ### –methods , technologies and tools for sustainable and resilient production in farming , forestry and plant and animal breeding ;


### resilient and sustainable farming and forestry systems provide economic , environmental and social benefits in a changing context for primary production . in addition to contributing to food and nutrition security , they feed into dynamic value chains , manage land and natural resources as well as deliver a range of vital public goods including carbon sequestration , biodiversity preservation , pollination and public health . integrated approaches are needed to promote the multiple functions of agro - and forest systems taking into account the changing context for primary production , notably in relation to climate and environment , resource availability , demography and consumption patterns . it is also necessary to address the spatial and socio - economic dimension of agriculture and forestry activities and mobilise the potential of rural areas . ### resilient and sustainable farming and forestry systems provide economic , environmental and social benefits in a changing context for primary production . in addition to ensuring food and nutrition security , they feed into dynamic value chains , manage land and natural resources as well as deliver a range of vital public goods including carbon sequestration , biodiversity preservation , pollination and public health . integrated approaches are needed to promote the multiple functions of agro - and forest systems taking into account the changing context for primary production , notably in relation to climate and environment , resource availability , demography and consumption patterns . it is also necessary to address the spatial and socio - economic dimension of agriculture and forestry activities and mobilise the potential of rural areas .


### directive 2006 / 1 / ec does not enable undertakings to fully benefit from the advantages of using hired vehicles . that directive allows member states to restrict the use by their undertakings of hired vehicles with a maximum permissible laden weight of more than six tonnes for own account operations . moreover , member states are not required to allow the use of a hired vehicle on their respective territories if the vehicle has been registered or put into circulation in compliance with the laws in a member state other than the one of establishment of the undertaking hiring it . ### directive 2006 / 1 / ec allows member states to restrict the use by their undertakings of hired vehicles with a maximum permissible laden weight of more than six tonnes for own account operations . in addition , member states are not required to allow the use of a hired vehicle on their respective territories if the vehicle has been registered or put into circulation in compliance with the laws in a member state other than the one of establishment of the undertaking hiring it .


### support from the erdf shall be granted to individual external cross - border interreg programmes provided that equivalent amounts are provided by ipa iii cbc and ndici cbc under the relevant strategic programming document . that equivalence shall be subject to a maximum amount set out in the ipa iii or ndici legislative act . ### support from the erdf shall be granted to individual external cross - border interreg programmes provided that at least equivalent amounts are provided by ipa iii cbc and ndici cbc under the relevant strategic programming document . that contribution shall be subject to a maximum amount set out in the ipa iii or ndici legislative act .


### the resources referred to in paragraph 1 shall be allocated as follows : ### the resources referred to in paragraph 1 , for components 1 to 4 , shall be allocated as follows :


### 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 . .


### by terms indicated in the relevant product specification . ### by any terms permitted by the relevant product specification .


### in some cases , food business operators may be required or may want to indicate the origin of spirit drinks to draw consumers’ attention to the qualities of their product . such origin indications should comply with harmonised criteria . therefore , specific provisions on the indication of the country of origin or place of provenance in the presentation and labelling of spirit drinks should be laid down . ### in some cases , food business operators may be required or may want to indicate the origin of spirit drinks to draw consumers’ attention to the qualities of their product . therefore , specific provisions on the indication of the country of origin or place of provenance in the presentation and labelling of spirit drinks should be laid down .


### inhalation of harmful substances ; ### substances and mixtures which are hazardous to health ;


### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec . in order to ensure as high level of protection for the user of those products as for the ppe covered by directive 89 / 686 / eec , the scope of this regulation should include ppe for private use against damp , water and heat , in line with similar ppe for professional use which is already covered by directive 89 / 686 / eec . artisanal products , such as handmade gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they are therefore not concerned by this inclusion . it is also appropriate to clarify the exclusion list set out in annex i to directive 89 / 686 / eec by adding a reference to products covered by other legislation and therefore are excluded from the ppe regulation . ### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec where they are only intended for private use . in order to provide a high level of protection , items for protecting the hands against extreme heat in a domestic environment should be included within the scope of this regulation if they specifically make a protective claim . artisanal products , such as handmade gloves and oven gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they should therefore not be included in the scope of this regulation . instead , self - certification should be encouraged for those products . many manufacturers are already doing this today .


### ' placing on the market ' means the first making available of ppe on the union market ; ### ' placing on the market ' means the first making available of the ppe type on the union market ;


### 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 .


### manufacturers shall ensure that procedures are in place for series production to remain in conformity with this regulation . changes in the design or characteristics of the ppe and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the ppe is declared shall be adequately taken into account . ### manufacturers shall ensure that procedures are in place for series production to remain in conformity with this regulation . when deemed appropriate with regard to the risks presented by a ppe , manufacturers shall , to protect the health and safety of consumers and other end users , carry out sample testing of ppe made available on the market , investigate , and , if necessary , keep a register of complaints , of non - conforming ppe and ppe recalls , and shall keep distributors informed of any such monitoring .


### before making ppe available on the market , distributors shall verify that it bears the ce marking , is accompanied by the eu declaration of conformity or a simplified eu declaration of conformity , and that it is accompanied by the instructions set out in point 1 . 4 of annex ii in a language which can be easily understood by end - users in the member state in which ppe is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in article 8 and and article 10 . ### before making ppe available on the market , distributors shall verify that it bears the ce marking , is accompanied by the required documents , by the instructions and other information set out in point 1 . 4 of annex ii in a language which can be easily understood by consumers and other end - users in the member state in which ppe is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in article 8 and and article 10 .


### an importer or distributor shall be considered a manufacturer for the purposes of this regulation and he shall be subject to the obligations of the manufacturer set out in article 8 where he places ppe on the market under his name or trademark or modifies ppe already placed on the market in such a way that the conformity with the applicable essential health and safety requirements set out in annex ii may be affected . ### an importer or distributor shall be considered a manufacturer for the purposes of this regulation and he shall be subject to the obligations of the manufacturer set out in article 8 where he places ppe on the market under his name or trademark or modifies ppe already placed on the market in such a way that compliance with this regulation may be affected .


### a conformity assessment body shall be established under national law and have legal personality . ### a conformity assessment body shall be established under national law of a member state and have legal personality .


### conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 , 3 , 5 . 2 and 6 , and ensures and declares on his sole responsibility that the ppe , which has been subject to the provisions of point 4 , is in conformity with the type described in the eu type - examination certificate and satisfies the applicable essential health and safety requirements referred to in article 5 and set out in annex ii . ### conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 , 3 , 5 . 2 and 6 , and ensures and declares on his sole responsibility that the ppe , which has been subject to the provisions of point 4 , is in conformity with the type described in the eu type - examination certificate and satisfies the applicable requirements of this regulation .


### to this end , protective glasses must be so designed and manufactured as to possess , for each harmful wave length , a spectral transmission factor such that the radiant - energy illumination density capable of reaching the user ' s eye through the filter is minimized and , under no circumstances , exceeds the maximum permissible exposure value . ### to this end , eye protective equipment must be so designed and manufactured as to possess , for each harmful wave length , a spectral transmission factor such that the radiant - energy illumination density capable of reaching the user ' s eye through the filter is minimized and , under no circumstances , exceeds the maximum permissible exposure value . ppe designed to protect the skin against non - ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths .


### keep the eu declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for at least 10 years after the ppe has been placed on the market ; ### keep the eu declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for at least 10 years after the ppe has been&#160 ; made available&#160 ; on the market ;


### in order to ensure compliance with the essential safety requirements , it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer . directive 89 / 686 / eec classifies ppe into three categories that are subject to different conformity assessment procedures . in order to ensure a consistently high level of safety for all ppe , the list of products subject to one of the conformity assessment procedures relating to the production phase should be enlarged . the conformity assessment procedures for each category of ppe should be set , as far as possible , on the basis of the conformity assessment modules laid down in decision no 768 / 2008 / ec . ### in order to ensure compliance with the essential health and safety requirements laid down in this regulation , it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer . directive 89 / 686 / eec classifies ppe into three categories that are subject to different conformity assessment procedures . in order to ensure a consistently high level of safety for all ppe , the list of products subject to one of the conformity assessment procedures relating to the production phase should be enlarged . the conformity assessment procedures for each category of ppe should be set , as far as possible , on the basis of the conformity assessment modules laid down in decision no 768 / 2008 / ec .


### ppe : ### identification of the ppe , it may , where useful for the identification of the ppe include an image of sufficient clarity :


### during demonstrations , adequate measures shall be taken to ensure the protection of persons . ### during demonstrations , and field tests , adequate measures shall be taken to ensure the protection of persons .


### aggressive chemicals ; ### harmful biological agents ;


### at trade fairs , exhibitions , and demonstrations , member states shall not prevent the showing of ppe which does not comply with this regulation provided that a visible sign clearly indicates that the ppe does not comply with this regulation and is not available on the market until it has been brought into conformity . ### at trade fairs , exhibitions , demonstrations or field tests , member states shall not prevent the showing of ppe which does not comply with this regulation and is not available on the market . field tests shall not be designed to test the protection performance of the ppe , but to evaluate other non - protective aspects such as comfort , ergonomics and design .


### the identification markings or indicators directly or indirectly relating to health and safety affixed to these types of ppe must , if possible , take the form of harmonized pictograms or ideograms . they must be perfectly visible and legible and remain so throughout the foreseeable useful life of the ppe . in addition , these markings must be complete , precise and comprehensible so as to prevent any misinterpretation ; in particular , when such markings include words or sentences , the latter must be written in the official language of the member state where the equipment is to be used . ### the identification markings or indicators directly or indirectly relating to health and safety affixed to these types of ppe must , if possible , take the form of harmonized pictograms or ideograms . they must be perfectly visible and legible and remain so throughout the foreseeable useful life of the ppe . in addition , these markings must be complete , precise and comprehensible so as to prevent any misinterpretation ; in particular , when such markings include words or sentences , the latter must be written in a language easily understood by consumers and end - users , as determined by the member state where the equipment is made available on the market .


### 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 .


### connexion systems for equipment referred to in point that are not held or worn by a person , that are intended to connect that equipment to an external device or structure , that are removable and not intended to be permanently fixed to a structure ; ### connexion systems for equipment referred to in point that are not held or worn by a person , but which are essential to the equipment ' s function , that are intended to connect that equipment to an external device or structure , that are removable and not intended to be permanently fixed to a structure ;


### appropriate knowledge and understanding of the essential health and safety requirements set out in annex ii , of the corresponding harmonised standards and of the relevant provisions of union harmonisation legislation ; ### appropriate knowledge and understanding of the essential health and safety requirements set out in annex ii , of the corresponding harmonised standards and of the relevant provisions of union harmonisation legislation and of relevant national legislation ;


### intended for private use to protect against atmospheric conditions that are not of an extreme nature ; ### intended for private use to protect against :


### manufacturers shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of the ppe , in a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by ppe which they have placed on the market . ### manufacturers shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of the ppe , in paper or electronic form , in a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by ppe which they have placed on the market .


### ppe materials and other components which may accidentally come into contact with flame and those used in the manufacture of fire - fighting equipment must also possess a degree of non - flammability corresponding to the risk class associated with the foreseeable conditions of use . they must not melt when exposed to flames nor contribute to flame propagation . ### ppe materials and other components which may accidentally come into contact with flame and those used in the manufacture of industrial or fire - fighting equipment must also possess a degree of non - flammability and thermal or arc heat protection corresponding to the risk class associated with the foreseeable conditions of use . they must not melt when exposed to flames nor contribute to flame propagation .


### the manufacturer ' s instructions accompanying ppe intended for brief use in high - temperature environments must in particular provide all relevant data for the determination of the maximum permissible user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose . ### the manufacturer ' s instructions accompanying ppe intended for limited time use in high - temperature environments must in particular provide all relevant data for the determination of the maximum permissible user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose .


### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec . in order to ensure as high level of protection for the user of those products as for the ppe covered by directive 89 / 686 / eec , the scope of this regulation should include ppe for private use against damp , water and heat , in line with similar ppe for professional use which is already covered by directive 89 / 686 / eec . artisanal products , such as handmade gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they are therefore not concerned by this inclusion . it is also appropriate to clarify the exclusion list set out in annex i to directive 89 / 686 / eec by adding a reference to products covered by other legislation and therefore are excluded from the ppe regulation . ### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec where they are only intended for private use . in order to provide a high level of protection , items for protecting the hands against extreme heat in a domestic environment should be included within the scope of this regulation if they specifically make a protective claim . artisanal products , such as handmade gloves and oven gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they should therefore not be included in the scope of this regulation . instead , self - certification should be encouraged for those products . many manufacturers are already doing this today .


### it is necessary to ensure that ppe entering the union market complies with this regulation and , in particular , that appropriate assessment procedures have been carried out by manufacturers . provision should therefore be made for importers to make sure that the ppe they place on the market complies with the requirements of this regulation and that they do not place on the market ppe which does not comply with such requirements or which present a risk . provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the ce marking and technical documentation drawn up by manufacturers are available for inspection by the market surveillance authorities . ### it is necessary to ensure that ppe entering the union market complies with this regulation and , in particular , that appropriate conformity assessment procedures have been carried out by manufacturers . provision should therefore be made for importers to make sure that the ppe they place on the market complies with the requirements of this regulation and that they do not place on the market ppe which does not comply with such requirements or which present a risk . provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the ce marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities .


### it is necessary to clearly specify the relationship and scope of this regulation with the entitlement of member states to lay down requirements for the use of ppe at workplace , in particular pursuant to council directive 89 / 656 / eec19 , in order to avoid any confusion and ambiguity and hence ensure the free movement of compliant ppe . __________________ 19 council directive 89 / 656 / eec of 30 november 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace . ### it is necessary to clearly specify the relationship and scope of this regulation with the entitlement of member states to lay down requirements for the use of ppe at workplace , in particular pursuant to council directive 89 / 656 / eec19 , in order to avoid any confusion and ambiguity and hence ensure the free movement of compliant ppe . article 4 of that directive obliges employers to provide ppe which complies with the relevant union provisions on design and manufacture with respect to safety and health . pursuant to that article , manufacturers of ppe who provide that ppe to their employees must ensure that such ppe fulfils the requirements laid down in this regulation . __________________ 19 council directive 89 / 656 / eec of 30 november 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace .


### ' 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 ;


### for category iii ppe , the ce marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process . ### for category iii ppe , the ce marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process . the identification number of the notified body shall be affixed under its instructions , by the manufacturer or his authorised representative .


### when placing ppe on the market , importers should indicate on the product their name and the address at which they can be contacted . exceptions should be provided for in cases where the size or nature of the ppe does not allow for such an indication . this includes cases where the importer would have to open the packaging to put his name and address on the product . ### when placing ppe on the market , importers should indicate on the ppe their name , registered name or trademark and the postal address at which they can be contacted . exceptions should be provided for in cases where the size or nature of the ppe does not allow for it . this includes cases where the importer would have to open the packaging to put his name and address on the ppe .


### the relevant protection factor number must be marked on all specimens of filtering glasses by the manufacturer . ### the relevant protection factor number must be marked on all specimens of filtering eye protective equipment by the manufacturer .


### at trade fairs , exhibitions , and demonstrations , member states shall not prevent the showing of ppe which does not comply with this regulation provided that a visible sign clearly indicates that the ppe does not comply with this regulation and is not available on the market until it has been brought into conformity . ### at trade fairs , exhibitions , demonstrations or field tests , member states shall not prevent the showing of ppe which does not comply with this regulation and is not available on the market until it has been brought into conformity . field tests shall not be designed to test the protection performance of the ppe , but to evaluate other non - protective aspects such as comfort , ergonomics and design .


### conformity assessment bodies shall participate in , or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of , the relevant standardisation activities and the activities of the notified body coordination group established under this regulation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group . ### conformity assessment bodies shall participate in , or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of , the relevant standardisation activities and the activities of the notified body coordination group established under article 35 of this regulation and shall apply the decisions and documents produced as a result of the work of that group .


### 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 .


### 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 .


### conformity assessment bodies shall take out liability insurance unless liability is assumed by the state in accordance with national law , or the member state itself is directly responsible for the conformity assessment . ### conformity assessment bodies shall take out liability insurance unless liability is assumed by the member state in accordance with national law , or the member state itself is directly responsible for the conformity assessment .


### the identification markings or indicators directly or indirectly relating to health and safety affixed to these types of ppe must , if possible , take the form of harmonized pictograms or ideograms . they must be perfectly visible and legible and remain so throughout the foreseeable useful life of the ppe . in addition , these markings must be complete , precise and comprehensible so as to prevent any misinterpretation ; in particular , when such markings include words or sentences , the latter must be written in the official language of the member state where the equipment is to be used . ### the identification markings or indicators directly or indirectly relating to health and safety affixed to these types of ppe must , if possible , take the form of harmonized pictograms or ideograms . they must be perfectly visible and legible and remain so throughout the foreseeable useful life of the ppe . in addition , these markings must be complete , precise and comprehensible so as to prevent any misinterpretation ; in particular , when such markings include words or sentences , the latter must be written in a language easily understood by consumers and end - users , as determined by the member state where the equipment is made available on the market .


### internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 , 3 and 4 , and ensures and declares on his sole responsibility that the ppe concerned satisfies the applicable essential health and safety requirements referred to in article 5 and set out in annex ii . ### internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 , 3 and 4 , and ensures and declares on his sole responsibility that the ppe concerned satisfies the applicable requirements of this regulation .


### intended to be used for self - defence ; ### designed to be used for self - defence , with the exception of ppe intended for sporting activities ;


### 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 .


### 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 .


### ppe materials and other components which may accidentally come into contact with flame and those used in the manufacture of fire - fighting equipment must also possess a degree of non - flammability corresponding to the risk class associated with the foreseeable conditions of use . they must not melt when exposed to flames nor contribute to flame propagation . ### ppe materials and other components which may accidentally come into contact with flame and those used in the manufacture of industrial or fire - fighting equipment must also possess a degree of non - flammability and thermal or arc heat protection corresponding to the risk class associated with the foreseeable conditions of use . they must not melt when exposed to flames nor contribute to flame propagation .


### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec . in order to ensure as high level of protection for the user of those products as for the ppe covered by directive 89 / 686 / eec , the scope of this regulation should include ppe for private use against damp , water and heat , in line with similar ppe for professional use which is already covered by directive 89 / 686 / eec . artisanal products , such as handmade gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they are therefore not concerned by this inclusion . it is also appropriate to clarify the exclusion list set out in annex i to directive 89 / 686 / eec by adding a reference to products covered by other legislation and therefore are excluded from the ppe regulation . ### some products on the market that provide a protective function to the user are excluded from the scope of directive 89 / 686 / eec where they are only intended for private use . in order to provide a high level of protection , items for protecting the hands against extreme heat in a domestic environment should be included within the scope of this regulation if they specifically make a protective claim . artisanal products , such as handmade gloves and oven gloves , for which the manufacturer does not explicitly claim a protective function are not personal protective equipment ; they should therefore not be included in the scope of this regulation . instead , self - certification should be encouraged for those products . many manufacturers are already doing this today .


### the ce marking shall be affixed before the ppe is placed on the market . it may be followed by a pictogram or other marking indicating the risk against which the ppe is intended to protect . ### the ce marking shall be affixed before the ppe is placed on the market .


### ppe intended to protect users against very serious risks . category iii includes exclusively ppe intended to protect users against the following risks : ### ppe intended to protect users against very serious risks , such as death or irreversible damage to health . category iii includes exclusively ppe intended to protect users against the following risks :


### 1 . the manufacturer shall affix the ce marking to each individual ppe that satisfies the applicable essential health and safety requirements . ### 1 . the manufacturer shall affix the ce marking to each individual ppe that satisfies the applicable requirements of this regulation .


### equipment intended to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non - protective equipment ; ### equipment designed and manufactured to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non - protective equipment ;


### at trade fairs , exhibitions , and demonstrations , member states shall not prevent the showing of ppe which does not comply with this regulation provided that a visible sign clearly indicates that the ppe does not comply with this regulation and is not available on the market until it has been brought into conformity . ### at trade fairs , exhibitions , demonstrations or field tests , member states shall not prevent the showing of ppe which does not comply with this regulation and is not available on the market . field tests shall not be designed to test the protection performance of the ppe , but to evaluate other non - protective aspects such as comfort , ergonomics and design .


### before making ppe available on the market , distributors shall verify that it bears the ce marking , is accompanied by the eu declaration of conformity or a simplified eu declaration of conformity , and that it is accompanied by the instructions set out in point 1 . 4 of annex ii in a language which can be easily understood by end - users in the member state in which ppe is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in article 8 and and article 10 . ### before making ppe available on the market , distributors shall verify that it bears the ce marking , is accompanied by the required documents , by the instructions and other information set out in point 1 . 4 of annex ii in a language which can be easily understood by consumers and other end - users in the member state in which ppe is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in article 8 and and article 10 .


### when placing ppe on the market , importers should indicate on the product their name and the address at which they can be contacted . exceptions should be provided for in cases where the size or nature of the ppe does not allow for such an indication . this includes cases where the importer would have to open the packaging to put his name and address on the product . ### when placing ppe on the market , importers should indicate on the ppe their name , registered name or trademark and the postal address at which they can be contacted . exceptions should be provided for in cases where the size or nature of the ppe does not allow for it . this includes cases where the importer would have to open the packaging to put his name and address on the ppe .


### to this end , protective glasses must be so designed and manufactured as to possess , for each harmful wave length , a spectral transmission factor such that the radiant - energy illumination density capable of reaching the user ' s eye through the filter is minimized and , under no circumstances , exceeds the maximum permissible exposure value . ### to this end , eye protective equipment must be so designed and manufactured as to possess , for each harmful wave length , a spectral transmission factor such that the radiant - energy illumination density capable of reaching the user ' s eye through the filter is minimized and , under no circumstances , exceeds the maximum permissible exposure value . ppe designed to protect the skin against non - ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths .


### 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 .


### 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 .


### it is necessary to ensure that ppe entering the union market complies with this regulation and , in particular , that appropriate assessment procedures have been carried out by manufacturers . provision should therefore be made for importers to make sure that the ppe they place on the market complies with the requirements of this regulation and that they do not place on the market ppe which does not comply with such requirements or which present a risk . provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the ce marking and technical documentation drawn up by manufacturers are available for inspection by the market surveillance authorities . ### it is necessary to ensure that ppe entering the union market complies with this regulation and , in particular , that appropriate conformity assessment procedures have been carried out by manufacturers . provision should therefore be made for importers to make sure that the ppe they place on the market complies with the requirements of this regulation and that they do not place on the market ppe which does not comply with such requirements or which present a risk . provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the ce marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities .


### manufacturers shall ensure that the ppe is accompanied by the instructions set out in point 1 . 4 of annex ii in a language which can be easily understood by end - users , as determined by the member state concerned . ### manufacturers shall ensure that ppe is accompanied by the instructions set out in point 1 . 4 of annex ii in a language which can be easily understood by consumers and end - users , as determined by the member state concerned in which the ppe is made available on the market . such instructions , as well as any labelling , shall be clear , understandable and intelligible . where ppe is available in packages containing multiple units , such instructions shall accompany each smallest commercially available unit .


### member states shall ensure that an appeal procedure against decisions of the notified bodies is available . ### member states shall ensure that a transparent and accessible appeal procedure against decisions of the notified bodies is available .


### manufacturers shall ensure that procedures are in place for series production to remain in conformity with this regulation . changes in the design or characteristics of the ppe and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the ppe is declared shall be adequately taken into account . ### manufacturers shall ensure that procedures are in place for series production to remain in conformity with this regulation . when deemed appropriate with regard to the risks presented by a ppe , manufacturers shall , to protect the health and safety of consumers and other end users , carry out sample testing of ppe made available on the market , investigate , and , if necessary , keep a register of complaints , of non - conforming ppe and ppe recalls , and shall keep distributors informed of any such monitoring .


### distributors who consider or have reason to believe that ppe which they have made available on the market is not in conformity with the requirements of this regulation shall make sure that the necessary corrective measures are taken to bring it into conformity , to withdraw it or to recall it , as appropriate . furthermore , where the ppe presents a risk , distributors shall immediately inform the market surveillance authorities of the member states in which they have made the ppe available on the market to that effect , giving details , in particular , of the non - conformity and of any corrective measures taken . ### distributors who consider or have reason to believe that ppe which they have made available on the market is not in conformity with the requirements of this regulation shall make sure that the necessary corrective measures are taken to bring it into conformity , to withdraw it or to recall it , as appropriate . furthermore , where the ppe presents a risk , distributors shall immediately inform the manufacturer or importer and the competent national authorities of the member states in which they have 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 shall ensure that the ppe is accompanied by the instructions referred to in point 1 . 4 of annex ii in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . ### importers shall ensure that ppe is accompanied by the instructions and other information as set out in point 1 . 4 of annex ii in a language which can be easily understood by consumers and other end - users , as determined by the member state in which the ppe is available on the market . where ppe is available in packages containing multiple units , such instructions shall accompany each smallest commercially available unit .


### start investigations or procedures to bring about the cessation or prohibition of intra - union infringements or widespread infringements of its own initiative and where appropriate to publish information about this ; ### start investigations or procedures to bring about the cessation or prohibition of intra - union infringements or widespread infringements of its own initiative ;


### directly under their own authority ; or ### directly under their own authority ;


### 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 an essential 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 ,


### obtain a commitment from the trader responsible for the intra - union infringement or widespread infringement to cease the infringement and where appropriate to compensate consumers for the harm caused ; ### seek to obtain or accept a commitment from the trader responsible for the intra - union infringement or widespread infringement ;


### in the context of widespread infringements and widespread infringement with a union dimension , the rights of defence of the traders concerned should be respected . this requires , in particular , giving the trader the right to be heard and to use the language of its choice during the proceedings , ### in the context of widespread infringements and widespread infringement with a union dimension , the rights of defence of the traders concerned must be respected . this requires , in particular , giving the trader the right to be heard and to use the language of its choice during the proceedings ,


### publish any final decisions , interim measures or orders , including the publication of the identity of the trader responsible for the intra - union infringement or widespread infringement ; ### publish any final decisions , trader ' s commitments or orders adopted pursuant to this regulation , including the publication of the identity of the trader responsible for the intra - union infringement or widespread infringement in cases where the infringement is serious and has caused harm ;


### 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 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 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 :


### 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 stop 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 , where there are no other means available to prevent or mitigate such harm , including , where necessary , the suspension of a website , service or account , or putting a fully qualified domain name on hold for a specific period of time . furthermore , the competent authorities should have the power to close down or have a third party service provider close down a website , service or account or a part of it , delete a fully qualified domain name and allow the competent authority concerned to register it ,


### 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 union laws that protect consumers interests that harmed , harm , or are likely to harm consumers ' collective interests and that have common features , such as the same unlawful practice or the same interest being infringed , or that are occurring concurrently , in at least two member states ;


### competent authorities should have access to all necessary evidence , data and information to determine whether an intra - union infringement or widespread infringement has occurred , and in particular to identify the trader responsible , irrespective of who possesses this evidence , information or data , of where it is located and of its format . competent authorities should be able to directly request that third parties in the digital value chain provide all the evidence , data and information necessary , ### competent authorities should have access to all necessary evidence , data and information to determine whether an intra - union infringement or widespread infringement has occurred , and in particular to identify the trader responsible , irrespective of who possesses this evidence , information or data , of where it is located and of its format . competent authorities should be able to directly request that third parties in the digital value chain provide all the evidence , data and information necessary , while consistently respecting the principles of personal data 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 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 ,


### ‘ distillate of agricultural origin’ means an alcoholic liquid which is obtained by the distillation , after alcoholic fermentation , of agricultural products listed in annex i to the treaty which does not have the properties of ethyl alcohol or of a spirit drink but still retains the aroma and taste of the raw materials used . ### ‘ distillate of agricultural origin’ means an alcoholic liquid which is obtained by the distillation , after alcoholic fermentation , which does not have the properties of ethyl alcohol or of a spirit drink but still retains the aroma and taste of the raw materials used .


### in some cases , food business operators may be required or may want to indicate the origin of spirit drinks to draw consumers’ attention to the qualities of their product . such origin indications should comply with harmonised criteria . therefore , specific provisions on the indication of the country of origin or place of provenance in the presentation and labelling of spirit drinks should be laid down . ### in some cases , food business operators may be required or may want to indicate the origin of spirit drinks to draw consumers’ attention to the qualities of their product . therefore , specific provisions on the indication of the country of origin or place of provenance in the presentation and labelling of spirit drinks should be laid down .


### whistleblower protection is necessary to enhance the enforcement of union law on public procurement . in addition to the need of preventing and detecting fraud and corruption in the context of the implementation of the eu budget , including procurement , it is necessary to tackle insufficient enforcement of rules on public procurement by national public authorities and certain public utility operators when purchasing goods , works and services . breaches of such rules create distortions of competition , increase costs for doing business , violate the interests of investors and shareholders and , overall , lower attractiveness for investment and create an uneven level playing field for all businesses across europe , thus affecting the proper functioning of the internal market . ### whistleblower protection is necessary to enhance the enforcement of union law on public procurement . in addition to the need of preventing and detecting fraud and corruption in the context of the implementation of the eu budget , including procurement , it is necessary to tackle insufficient enforcement of rules on public procurement by national public authorities and certain public utility operators when purchasing goods , works and services . breaches of such rules create distortions of competition , increase costs for doing business , violate the interests of investors and shareholders and , overall , lower attractiveness for investment and create an uneven level playing field for all businesses across europe , thus affecting the proper functioning of the internal market . attention must also be paid to protecting those reporting misuse or misconduct regarding the eu budget and eu institutions .


### protection should , firstly , apply to persons having the status of ' workers ' , within the meaning of article 45 tfeu , as interpreted by the court of justice of the european union52 , i . e . persons who , for a certain period of time , perform services for and under the direction of another person , in return of which they receive remuneration . protection should thus also be granted to workers in non - standard employment relationships , including part - time workers and fixed - term contract workers , as well as persons with a contract of employment or employment relationship with a temporary agency , which are types of relationships where standard protections against unfair treatment are often difficult to apply . _________________ 52 judgments of 3 july 1986 , lawrie - blum , case 66 / 85 ; 14 october 2010 , union syndicale solidaires isère , case c - 428 / 09 ; 9 july 2015 , balkaya , case c - 229 / 14 ; 4 december 2014 , fnv kunsten , case c - 413 / 13 ; and 17 november 2016 , ruhrlandklinik , case c - 216 / 15 . ### protection should , firstly , apply to persons having the status of ' workers ' , within the meaning of article 45 tfeu , as interpreted by the court of justice of the european union52 , i . e . persons who , for a certain period of time , perform services for and under the direction of another person , in return of which they receive remuneration . protection should thus also be granted to workers in non - standard employment relationships , including part - time workers and fixed - term contract workers , as well as persons with a contract of employment or employment relationship with a temporary agency , which are types of relationships where standard protections against unfair treatment are often difficult to apply . considering the report by transparency international published in the summer of 2018 underscoring the need for whistleblower protection within eu institutions as well , protection should extend similarly to eu staff . _________________ 52 judgments of 3 july 1986 , lawrie - blum , case 66 / 85 ; 14 october 2010 , union syndicale solidaires isère , case c - 428 / 09 ; 9 july 2015 , balkaya , case c - 229 / 14 ; 4 december 2014 , fnv kunsten , case c - 413 / 13 ; and 17 november 2016 , ruhrlandklinik , case c - 216 / 15 .


### the exemption of small and micro undertakings from the obligation to establish internal reporting channels should not apply to private undertakings active in the area of financial services . such undertakings should remain obliged to establish internal reporting channels , in line with the current obligations set forth in the union acquis on financial services . ### the exemption of small and micro undertakings from the obligation to establish internal reporting channels should not apply to private undertakings active in or closely linked to the area of financial services . such undertakings should remain obliged to establish internal reporting channels , in line with the current obligations set forth in the union acquis on financial services .


### 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 .


### this directive should be without prejudice to the protection of national security and other classified information which union law or the laws , regulations or administrative provisions in force in the member state concerned require , for security reasons , to be protected from unauthorised access . in particular , moreover , the provision of this directive should not affect the obligations arising from commission decision 2015 / 444 of 13 march 2015 on the security rules for protecting eu classified information or council decision of 23 september 2013 on the security rules for protecting eu classified information . ### this directive should be without prejudice to the protection of national security and other classified information which union law or the laws , regulations or administrative provisions in force in the member state concerned require , for security reasons , to be protected from unauthorised access . moreover , the provision of this directive should not affect the obligations arising from commission decision 2015 / 444 of 13 march 2015 on the security rules for protecting eu classified information or council decision of 23 september 2013 on the security rules for protecting eu classified information .


### 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 .


### 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 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 .


### the obligations of member states as regards convictions of third country nationals should also include fingerprints to secure identification . this obligation includes to store information , including fingerprints , to reply to requests on information from other central authorities , to ensure that a criminal record extract requested by a third country national is supplemented as appropriate with information from other member states , and to make the technical changes to apply state - of - the - art technologies necessary to make the information exchange system work . ### the obligations of member states as regards convictions of third country nationals should also include an obligation to take , store and exchange fingerprints to secure identification . this obligation includes storing information , including fingerprints ; replying fully and effectively to requests on information from other central authorities ; ensuring that a criminal record extract requested by a third country national is supplemented as appropriate with information from other member states , to provide a complete picture of a person’s previous criminal convictions ; making the technical changes to apply state - of - the - art technologies necessary to make the information exchange system work ; and ensuring the highest levels of data protection and security .


### the ecris legal framework , however , does not sufficiently cover the particularities of requests concerning third country nationals . although it is now possible to exchange information on third country nationals through ecris , there is no procedure or mechanism in place to do so efficiently . ### the existing ecris legal framework , however , does not sufficiently cover the particularities of requests concerning third country nationals . although it is now possible to exchange information on third country nationals through ecris , there is no common or european - wide procedure or mechanism in place to do so efficiently .


### since the objective of this directive , namely to enable rapid and efficient exchange of criminal record information on third country nationals , cannot be sufficiently achieved by the member states , but can rather , by reason of the necessary synergy and interoperability , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve that objective . ### since the objective of this directive , namely to enable rapid and efficient exchange of criminal record information on third country nationals , cannot be sufficiently achieved by the member states , but can rather , by putting in place common rules and interoperable systems , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve that objective .


### such blanket requests impose an administrative burden on all member states , including those not holding information on the particular third country national . in practice , this negative effect deters member states from requesting information on third country nationals and leads to member states limiting the criminal record information on information stored in their national register . ### such blanket requests impose a disproportionate administrative burden on all member states , including those not holding information on the particular third country national . in practice , this negative effect deters member states from requesting information on third country nationals and leads to member states limiting the criminal record information on information stored in their national register . as a consequence , the risk of information exchanges between member states being inefficient and incomplete is increased , which in turn affects the level of security and safety provided to union citizens and persons residing within the union .


### to increase the access to and the availability of microfinance and finance to social enterprises , support financing and investment operations related to social investment and skills and develop and consolidate social investment markets , in the areas referred to in point of article 7 . ### to increase the access to and the availability of microfinance and finance to social enterprises , educational institutions and cultural and creative industries , support financing and investment operations related to social investment skills and competences and develop and consolidate social investment markets , in the areas referred to in point of article 7 .


### the investeu fund should support investments in tangible and intangible assets to foster growth , investment and employment , and thereby contributing to improved well - being and fairer income distribution in the union . intervention through the investeu fund should complement union support delivered through grants . ### the investeu fund should support investments in tangible and intangible assets to foster growth and cohesion , sustainable investment in strategic areas and long term employment , and thereby contributing to improved well - being and equal opportunities in the union . intervention through the investeu fund should complement union support delivered through grants .


### as set out in the reflection paper on the social dimension of europe16 and the european pillar of social rights17 , building a more inclusive and fairer union is a key priority for the union to tackle inequality and foster social inclusion policies in europe . inequality of opportunities affects in particular access to education , training and health . investment in the social , skills and human capital - related economy , as well as in the integration of vulnerable populations in the society , can enhance economic opportunities , especially if coordinated at union level . the investeu fund should be used to support investment in education and training , help increase employment , in particular among the unskilled and long - term unemployed , and improve the situation with regard to intergenerational solidarity , the health sector , homelessness , digital inclusiveness , community development , the role and place of young people in society as well as vulnerable people , including third country nationals . the investeu programme should also contribute to the support of european culture and creativity . to counter the profound transformations of societies in the union and of the labour market in the coming decade , it is necessary to invest in human capital , microfinance , social enterprise finance and new social economy business models , including social impact investment and social outcomes contracting . the investeu programme should strengthen nascent social market eco - system , increasing the supply of and access to finance to micro - and social enterprises , to meet the demand of those who need it the most . the report of the high - level task - force on investing in social infrastructure in europe18 has identified investment gaps in social infrastructure and services , including for education , training , health and housing , which call for support , including at the union level . therefore , the collective power of public , commercial and philanthropic capital , as well as support from foundations , should be harnessed to support the social market value chain development and a more resilient union . __________________ 16 com 206 . 17 com 250 . 18 published as european economy discussion paper 074 in january 2018 . ### as set out in the reflection paper on the social dimension of europe16 and the european pillar of social rights17 , building a more inclusive and fairer union is a key priority for the union to tackle inequality and foster social inclusion policies in europe . inequality of opportunities affects in particular access to education , training and health . investment in the social , skills and human capital - related economy , as well as in the integration of vulnerable populations in the society , can enhance economic opportunities , especially if coordinated at union level . the investeu fund should be used to support investment in education and training , help increase employment , in particular among the unskilled and long - term unemployed . the investeu programme should also contribute to the support of european culture and creativity . to counter the profound transformations of societies in the union and of the labour market in the coming decade , it is necessary to invest in human capital , microfinance and new social economy business models . the investeu programme should strengthen nascent market eco - systems , increasing the supply of and access to finance to micro - and social enterprises . the report of the high - level task - force on investing in social infrastructure in europe18 has identified investment gaps in social infrastructure and services , including for education , training , health and housing , which call for support , including at the union level . therefore , the collective power of public , commercial and philanthropic capital , as well as support from foundations , should be harnessed to support the social market value chain development and a more resilient union . __________________ 16 com 206 . 17 com 250 . 18 published as european economy discussion paper 074 in january 2018 .


### social investment and skills policy window : comprises microfinance , social enterprise finance and social economy ; skills , education , training and related services ; social infrastructure ; social innovation ; health and long - term care ; inclusion and accessibility ; cultural activities with a social goal ; integration of vulnerable people , including third country nationals . ### social investment and skills policy window : comprises microfinance , social enterprise finance and social economy ; skills , education , training and related services ; social infrastructure ; social innovation ; health and long - term care ; accessibility and cultural activities with a social goal ; cultural and creative industries with intercultural dialogue and cohesion goals .


### with 1 . 8% of eu gdp , down from 2 . 2% in 2009 , infrastructure investment activities in the union in 2016 were about 20% below investment rates before the global financial crisis . thus , while a recovery in investment - to - gdp ratios in the union can be observed , it remains below what might be expected in a strong recovery period and is insufficient to compensate years of underinvestment . more importantly , the current investment levels and forecasts do not cover the union ' s structural investment needs in the face of technological change and global competitiveness , including for innovation , skills , infrastructure , small and medium - sized enterprises and the need to address key societal challenges such as sustainability or population ageing . consequently , continued support is necessary to address market failures and sub - optimal investment situations to reduce the investment gap in targeted sectors to achieve the union ' s policy objectives . ### with 1 . 8% of eu gdp , down from 2 . 2% in 2009 , infrastructure investment activities in the union in 2016 were about 20% below investment rates before the global financial crisis . thus , while a recovery in investment - to - gdp ratios in the union can be observed , it remains below what might be expected in a strong recovery period and is insufficient to compensate years of underinvestment . more importantly , the current investment levels and forecasts do not cover the union ' s structural investment needs in the face of technological change and global competitiveness , including for innovation , professional skills and competences , including investment in human capital , infrastructure , small and medium - sized enterprises and the need to address key societal challenges such as sustainability or demographic change . consequently , continued support is necessary to address market failures and sub - optimal investment situations to reduce the investment gap in targeted sectors to achieve the union ' s policy objectives .


### estimate the impact on the social inclusion of certain areas or populations . ### estimate the impact on the social inclusion of certain areas or populations , with particular focus to young people and neets .


### the eib shall target that at least 40 % of efsi financing under the infrastructure and innovation window supports projects with components that contribute to climate action , in line with the cop21 commitments . the steering board shall provide detailed guidance to that end . ### whilst recognizing the demand driven nature of efsi , the eib shall aim that at least 40% of efsi financing in the combined objectives under the infrastructure and innovation window contributes to climate action in line with the cop21 commitments . efsi financing for smes and mid - cap companies shall not be included in that computation .


### the commission shall provide detailed guidance , where needed ; ### the commission shall provide detailed guidance , where needed . in addition , the commission shall draw up standard criteria and definitions to ensure transparency on issues related to tax governance ;


### the eib and eif shall inform or shall oblige financial intermediaries to inform the final beneficiaries , including smes , of the existence of efsi support . ; ### ' the eib and eif shall inform or shall oblige financial intermediaries to inform the final beneficiaries of the existence of efsi support and to place the efsi logo in a prominent place on the financing agreement , particularly in the case of smes , on every contract that includes efsi support , thereby increasing public awareness and expanding visibility ' ;


### it shall also support the preparation of climate action and circular economy projects or components thereof , in particular in the context of cop21 , the preparation of projects in the digital sector , as well as the preparation of projects referred to in the fifth subparagraph of article 5 . ; ### it shall also support the preparation of climate action and circular economy projects or components thereof , in particular in the context of cop21 , the preparation of ambitious projects in the digital and telecommunications sectors , as well as the preparation of projects referred to in the fifth subparagraph of article 5 ;


### leveraging local knowledge to facilitate efsi support across the union and contributing where possible to the objective of sectorial and geographical diversification of the efsi referred to in section 8 of annex ii by supporting the eib to originate operations ; ### leveraging local and regional knowledge to facilitate efsi support across the union and contributing where possible to the objective of sectorial and geographical diversification of the efsi referred to in section 8 of annex ii by supporting the eib as well as the project promoters to originate operations ;


### due to their potential to increase the efficiency of the efsi intervention , blending operations combining non - reimbursable forms of support and / or financial instruments from the union budget , such as those available under the connecting europe facility , and financing from eib group , including eib financing under the efsi , as well as other investors should be encouraged . blending aims to enhance the value added of union spending by attracting additional resources from private investors and to ensure the actions supported become economically and financially viable . ### due to their potential to increase the efficiency of the efsi intervention , blending operations combining non - reimbursable forms of support and / or financial instruments from the union budget , such as those available under the connecting europe facility , and financing from eib group , including eib financing under the efsi , as well as other investors should be encouraged . blending aims to enhance the value added of union spending by attracting additional resources from private investors and to ensure the actions supported become economically and financially viable . in view of the inherent complexity of those instruments , the eiah should also give guidance on the optimal choice of funding instruments and blending . moreover , the eiah , being a market - driven instrument providing advice on investment in various market sectors , should where appropriate also provide access to expertise other advisory entities with relevant specialised knowledge of specific market sectors . encouragement of further collaboration between the eiah and other advisory entities will be critical for the success of the efsi , especially in market areas and niches where higher specialisation and deeper know - how is needed .


### providing advice on the combination of other sources of union funding with the efsi ; ### providing advice on the combination of other sources of union funding with the efsi , thus facilitating the optimal blending of relevant union resources ,


### eib projects carrying a risk lower than the minimum risk under eib special activities may also be supported by the efsi if the use of the eu guarantee is required to ensure additionality as defined in the first subparagraph of this paragraph . ### eib projects carrying a risk lower than the minimum risk under eib special activities cannot be supported by the efsi unless the use of the eu guarantee is necessary to ensure additionality , as defined in the first subparagraph of this paragraph and provided that those projects cannot be better funded through more appropriate eib funds .


### eib projects carrying a risk lower than the minimum risk under eib special activities may also be supported by the efsi if the use of the eu guarantee is required to ensure additionality as defined in the first subparagraph of this paragraph . ### eib projects carrying a risk lower than the minimum risk under eib special activities cannot be supported by the efsi unless the use of the eu guarantee is necessary to ensure additionality , as defined in the first subparagraph of this paragraph and provided that those projects cannot be funded at better terms through other sources of financing .


### to better address market failures or sub - optimal investment situations , eib special activities supported by the efsi shall typically have features such as subordination , participation in risk - sharing instruments , cross - border characteristics , exposure to specific risks or other identifiable aspects as further described in annex ii . ### to better address economic and financial inefficiencies , including market failures , sub - optimal investment situations , discrepancies in the investment capacity of the member states as reflected in diverse risk premiums , leveraging frictions or weak investment multipliers , and including also complicated multinational and cross border projects , and lack of risk - taking , especially in research , innovation , new technologies as well as in new and traditional infrastructures , eib ' s special activities supported by the efsi shall typically have features such as subordination , participation in risk - sharing instruments , as well as first - loss guarantees , cross - border characteristics , exposure to specific risks or other identifiable aspects as further described in annex ii .