### the number of non - executive director positions necessary to meet the objective laid down in paragraph 1 shall be the number closest to the proportion of 40 per cent , but not exceeding 49 per cent . ### the number of non - executive director positions necessary to meet the objective laid down in paragraph 1 shall be at least 40 per cent . if the non - executive board consists of only three board members , the proportion one to two shall suffice .


### the proportion of women on company boards is progressing very slowly , with an average annual increase of just 0 . 6 percentage points during the past years . the rate of improvement has differed in individual member states and has led to highly divergent results . much more significant progress was noted in the member states where binding measures have been introduced . growing discrepancies between member states are likely to increase given the very different approaches pursued by individual member states to increase the representation of females on boards that are being pursued by individual member states . ### the proportion of women on company boards is progressing very slowly , with an average annual increase of just 0 . 6 percentage points during the past years . the rate of improvement has differed in individual member states and has led to highly divergent results . much more significant progress was noted in the member states where binding measures have been introduced . growing discrepancies between member states are likely to increase given the very different approaches pursued by individual member states to increase the representation of females on boards that are being pursued by individual member states . member states should therefore exchange information and good practices designed to achieve better results through the adoption of measures to promote gender equality .


### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements . ### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies by establishing effective measures aimed at accelerated progress towards equal representation of men and women while allowing companies sufficient time to conclude the necessary agreements .


### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements . ### this directive lays down minimum requirements on positive action to ensure a more balanced representation of men and women within companies at all levels .


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should aim to reach the objective of having at least 40 per cent of non - executive directors of the under - represented sex at the latest by 1 january 2020 . for the purpose of reaching this objective , those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should carry out the pre - selection or selection procedure for appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria .


### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executives directors . only an eu - level measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life . ### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executive directors . only a binding measure at union level can effectively help to ensure a competitive level - playing field throughout the union , avoid practical complications in business life and allow executives and directors to make full use of the opportunities the internal market has to offer .


### determining the number of non - executive director positions necessary to meet the objective requires further specification since for most board sizes it is mathematically possible only to go beyond or remain below the exact share of 40 per cent . therefore , the number of board positions necessary to meet the objective should be the number closest to 40 per cent . at the same time , in order to avoid discrimination of the initially over - represented sex , listed companies should not be obliged to appoint members of the under - represented sex to half or more of the non - executive board positions . thus , for example , members of the under - represented sex should hold at least one position on boards with three or four non - executive directors , at least two positions on boards with five or six non - executive directors , and at least three positions on boards with seven or eight non - executive directors . ### where the non - executive board consists of only three members , it is mathematically impossible to go beyond a share of 40 per cent for both genders . therefore , in such cases , members of the underrepresented sex should hold at least one position on boards with three non - executive directors .


### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises , even if they are listed companies . ### these requirements should not apply to family businesses , micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises .


### the current lack of transparency of the selection procedures and qualification criteria for board positions in most member states represents a significant barrier to more gender diversity among board members and negatively affects both the board candidates ' careers and freedom of movement , as well as investor decisions . such lack of transparency prevents potential candidates for board positions from applying to boards where their qualifications would be most required and from challenging gender - biased appointment decisions , thus restricting their freedom of movement within the internal market . on the other hand , investors have different investment strategies that require information linked also to the expertise and competence of the board members . more transparency in the qualification criteria and the selection procedure for board members enables investors to better assess the company ' s business strategy and to take informed decisions . ### the current lack of transparency of the selection procedures and qualification criteria for board positions in most member states represents a significant barrier to more gender diversity among board members and negatively affects both the board candidates ' careers and freedom of movement , as well as investor decisions . such lack of transparency prevents potential candidates for board positions from applying to boards where their qualifications would be most required and from challenging gender - biased appointment decisions , thus restricting their freedom of movement within the internal market . on the other hand , investors have different investment strategies that require information linked also to the expertise and competence of the board members . more transparency in the qualification criteria and the selection procedure for board members enables investors to better assess the company ' s business strategy and to take informed decisions . it is therefore important for board appointment procedures to be clear and transparent and for applicants to be assessed objectively on their individual merits , irrespective of gender .


### the union should therefore aim to increase the presence of women on company boards , in order both to boost economic growth and the competitiveness of european companies and to achieve effective gender equality on the labour market . this aim should be pursued through minimum requirements on positive action in the form of binding measures aiming at attaining a quantitative objective for the gender composition of boards of listed companies , in the view of the fact that member states and other countries which have chosen this or a similar method have achieved the best results in reducing the under - representation of women in economic decision - making positions . ### the union should therefore aim to increase the presence of women on company boards , in order both to boost economic growth and the competitiveness of european companies and to achieve effective gender equality on the labour market . this aim should be pursued through minimum common union requirements on positive action in the form of binding measures aiming at attaining a quantitative objective for the gender composition of boards of listed companies , in the view of the fact that member states and other countries which have chosen this or a similar method have achieved the best results in reducing the under - representation of women in economic decision - making positions .


### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published and , where the company in question has not met the objective , it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objective . ### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published and , where the company in question has not met the objective , it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objective . furthermore , companies that have failed to comply with the objectives or commitments should provide a justification of their reasons for not doing so , as well as a description of the concrete measures that they have taken so far , and that they intend to take in the future , in order to meet the objective .


### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the non - executive director positions make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states shall ensure that companies where the gender balance needs to be improved , apply the following minimum requirements for positive action by 1 january 2015 or at the latest by 1 january 2018 .


### in accordance with the principle of proportionality , the objective to be met by listed companies should be limited in time and remain in force only until sustainable progress has been achieved in the gender composition of boards . for that reason , the commission should regularly review the application of this directive and report to the european parliament and the council . the directive is due to expire on 31 december 2028 . the commission should assess , in its review , if there is a need to extend the duration of the directive beyond that period . ### in order to achieve the aims of this directive , member states should cooperate with social partners and the management oft the company with the elected representatives of the employees . the commission should regularly review the application of this directive and report to the european parliament and the council .


### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance and the quality of decision - making are enhanced due to a more diverse and collective mind - set incorporating a wider range of perspectives and therefore reaching more balanced decisions . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union can therefore have a positive impact on the performance of companies concerned . ### at company level , it is widely acknowledged that the presence of women on boards improves corporate governance , because team performance and the quality of decision - making are enhanced due to a more diverse and collective mind - set incorporating a wider range of perspectives as well as a more proactive business model and therefore reaching more balanced decisions , with a view to better reflecting societal and consumers ' realities . numerous studies have also shown that there is a positive relationship between gender diversity at top management level and a company ' s financial performance and profitability . enhancing female representation on the boards of publicly listed companies in the union , given the significant economic and social responsibility of such companies , can therefore have a positive impact on the economic performance of companies concerned . measures to encourage career progression for women at all levels of management should therefore be introduced and reinforced .


### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and accessible manner on their website . ### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the following : the gender representation on their boards , distinguishing between non - executive and executive directors , b ) presentation and analysis of the specific measures taken in view of the objectives laid down in article 4 and in paragraph 1 and 1a of this article , c ) the specific measures planned for the following year , d ) the progress with regard to the objectives laid down in article 4 and paragraph 1 of this article . listed companies shall publish that information in an appropriate and accessible manner on their website and in their annual report .


### the efficient use of human capital is the most important determinant of an economy ' s competitiveness and is key to addressing the eu ' s demographic challenges , to competing successfully in a globalised economy and to ensuring a comparative advantage vis - à - vis third countries . the pool of highly trained and qualified women is constantly growing as evidenced by the fact that 60 per cent of university graduates are female . a continued failure to draw on this pool in appointments to economic decision - making positions would amount to a failure to fully exploit skilled human capital . ### the efficient use of human capital is an important determinant to compete successfully in a globalised economy and to ensure a comparative advantage vis - à - vis third countries . the pool of highly trained and qualified women is constantly growing as evidenced by the fact that 60 per cent of current university graduates are female . by drawing on this pool in future appointments to economic decision - making positions at all levels would contribute to better exploitation of capital .


### where a listed company does not meet the objectives laid down in article 4 or its own individual commitments taken pursuant to paragraph 1 of this article , the information referred to in paragraph 2 of this article shall include the reasons for not reaching the objectives or commitments and a description of the measures which the company has adopted or intends to adopt in order to meet the objectives or commitments . ### where a listed company does not meet the objectives laid down in article 4 or its own individual commitments taken pursuant to paragraph 1 of this article , it shall provide a statement of the reasons for not reaching the objectives or commitments and a description of the measures which the company has adopted or intends to adopt in order to meet the objectives or commitments . that explanation shall form part of the information referred to in paragraph 2 .


### the response depends on excellence in research to improve our fundamental understanding of health , disease , disability , development and ageing , and on the seamless and widespread translation of the resulting and existing knowledge into innovative , scalable and effective products , strategies , interventions and services . furthermore , the pertinence of these challenges across europe and in many cases , globally , demands a response characterised by long term and coordinated support for co - operation between excellent , multidisciplinary and multi - sector teams . ### the response depends on excellence in research and on the efficient dissemination of research results to improve our fundamental understanding of health , disease , disability , development and ageing , and on the seamless and widespread translation of the resulting and existing knowledge into innovative , scalable and effective products , strategies , interventions and services . furthermore , the pertinence of these challenges across europe and in many cases , globally , demands a response characterised by long term and coordinated support for co - operation between excellent , multidisciplinary and multi - sector teams , not only at union but also at global level , by supporting for instance research and development capacity in endemic areas .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; improving disease treatment with an emphasis on the development of stratified / personalised medicine and orphan medicinal products ; transferring knowledge stemming from basic research to clinical practice and scalable innovation actions in a more timely and efficient manner , by fostering high - quality translational research ; using advanced it solutions to improve collection , sharing , comparison and use of health data ; promoting active ageing , independent and assisted living ; improving palliative medicine , better reproductive health , individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems , including by the development and wider implementation of e - health solutions , and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches .


### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 27 million people in the union suffer from diabetes and the total cost of brain disorders has been estimated at eur 800 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these . ### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 27 million people in the union suffer from diabetes and the total cost of brain disorders has been estimated at eur 800 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these . however , for other conditions - in particular neurodegenerative diseases - effective prevention strategies will first require a considerable boost in research into their causes and the development of better early diagnosis and treatment options .


### the focus of activities shall be to reduce resource consumption and greenhouse gas emissions and improve vehicle efficiency , to accelerate the development and deployment of a new generation of electric and other low or zero emission vehicles , including through breakthroughs in engines , batteries and infrastructure ; to explore and exploit the potential of alternative fuels and innovative and more efficient propulsion systems , including fuel infrastructure ; to optimise the use of infrastructures , by means of intelligent transport systems and smart equipment ; and to increase the use of demand management and public and non - motorised transport , particularly in urban areas . ### the focus of activities shall be to reduce resource consumption and greenhouse gas emissions and improve vehicle efficiency , to accelerate the development and deployment of a new generation of low emission vehicles at affordable market prices , including through breakthroughs in engines , batteries and infrastructure ; to explore and exploit the potential of alternative fuels and innovative and more efficient propulsion systems , including fuel infrastructure ; to optimise the use of infrastructures , by means of intelligent transport systems and smart equipment ; and to increase the use of demand management and public and non - motorised transport , particularly in urban areas .


### effective health promotion , supported by a robust evidence base , prevents disease , improves wellbeing and is cost effective . health promotion and disease prevention also depend on an understanding of the determinants of health , on effective preventive tools , such as vaccines , on effective health and disease surveillance and preparedness , and on effective screening programmes . ### effective health promotion and raising awareness of risk factors prevent disease , improve wellbeing and are cost effective . health promotion and disease prevention also depend on an understanding of the determinants of health , on european data based on common indicators , on effective preventive tools , such as vaccines , on effective health and disease surveillance and preparedness , and on effective screening programmes .


### chronic conditions such as cardiovascular disease , cancer , diabetes , neurological and mental health disorders , overweight and obesity and various functional limitations are major causes of disability , ill - health and premature death , and present considerable social and economic costs . ### chronic conditions such as cardiovascular disease , cancer , diabetes , neurological and mental health disorders , overweight and obesity , infertility disorders and various functional limitations are major causes of disability , ill - health and premature death , and present considerable social and economic costs .


### chronic conditions such as cardiovascular disease , cancer , diabetes , neurological and mental health disorders , overweight and obesity and various functional limitations are major causes of disability , ill - health and premature death , and present considerable social and economic costs . ### chronic conditions are major causes of disability , ill - health and premature death , and present considerable social and economic costs .


### all of these activities shall be undertaken in such a way as to provide support throughout the research and innovation cycle , strengthening the competitiveness of the european based industries and development of new market opportunities . ### all of these activities shall be undertaken in such a way as to provide support throughout the research and innovation cycle , strengthening the competitiveness of the european based industries and development of new market opportunities . emphasis will also be placed on engaging all health stakeholders –including patient and patient organisations– in order to develop a research and innovation agenda that actively involves citizens and reflects their needs and expectations .


### successful efforts to prevent , manage , treat and cure disease , disability and reduced functionality are underpinned by the fundamental understanding of their determinants and causes , processes and impacts , as well as factors underlying good health and wellbeing . effective sharing of data and the linkage of these data with large scale cohort studies is also essential , as is the translation of research findings into the clinic , in particular through the conduct of clinical trials . ### successful efforts to prevent , manage , treat and cure disease , disability and reduced functionality are underpinned by improved molecular knowledge of diseases through biomedical research , the fundamental understanding of their determinants and causes , processes and impacts , as well as of factors underlying good health and wellbeing . building on the results of biomedical research in developing stratified and personalised medicine is a powerful tool for providing disease treatment that is tailored to the patient ' s genetic make - up and to the specific disease type , thus increasing the efficiency of care and saving unnecessary costs for the healthcare systems . effective collection and sharing of data and the linkage of these data with large scale cohort studies is also essential , as is the timely translation of research findings into the clinic , in particular through the conduct of clinical trials .


### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention , treatment and management of disease and disability . ### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on reinforcing effective prevention and awareness - raising of the factors posing a health risk and enabling the treatment and management of disease and disability .


### an increasing disease and disability burden in the context of an aging population places further demands on health and care sectors . if effective health and care is to be maintained for all ages , efforts are required to improve decision making in prevention and treatment provision , to identify and support the dissemination of best practice in the health and care sectors , and to support integrated care and the wide uptake of technological , organisational and social innovations empowering in particular older persons as well as disabled persons to remain active and independent . doing so will contribute to increasing , and lengthening the duration of their physical , social , and mental well - being . ### an increasing disease and disability burden in the context of an aging population places further demands on health and care sectors . if effective health and care is to be maintained for all ages , efforts are required to improve decision making in prevention and treatment provision , to identify and support the dissemination of best practice in the health and care sectors , and to support integrated care and the wide uptake of technological , organisational and social innovations empowering in particular older persons , persons with chronic diseases as well as disabled persons to remain active and independent . doing so will contribute to increasing , and lengthening the duration of their physical , social , and mental well - being .


### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention , treatment and management of disease and disability . ### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention , treatment and management of disease and disability . currently , member states spend too little on prevention while concentrating expenditure on treatment . this approach prevents reducing the disease burden and thus , the expenditure on disease treatment , and generates economic loss for society as a whole . ensuring the sustainability of health and social care systems requires an approach that takes into account the long term benefits in terms of savings and wellbeing of a bolder support for research aiming at the development of efficient preventive tools .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis especially linked to potential therapy or prevention ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches .


### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention , treatment and management of disease and disability . ### the cost of union health and social care systems is rising with care and prevention measures in all ages increasingly expensive , the number of europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060 , and those over 80 to rise from 22 to 61 million in the same period . reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention , treatment and management of disease and impairments .


### the aim is to meet the requirements of citizens for safe , healthy and affordable food , and to make food and feed processing and distribution more sustainable and the food sector more competitive . the activities shall focus on healthy and safe foods for all , informed consumer choices , and competitive food processing methods that use less resources and produce less by - products , waste and green - house gases . ### the aim is to meet the requirements of citizens for good quality , safe , healthy and affordable food , and to make food and feed processing and distribution more sustainable and the food sector more competitive . the activities shall focus on good quality , healthy and safe foods for all , informed consumer choices , and competitive food processing methods that use less resources and produce less by - products , waste and green - house gases .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; addressing infertility disorders ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches .


### a contracting authority , which does not exercise over a legal person control within the meaning of paragraph 1 , may nevertheless award a public contract without applying this directive to a legal person which it controls jointly with other contracting authorities , where the following conditions are fulfilled : ### a contracting authority , which does not exercise over a legal person control within the meaning of paragraph 1 , may nevertheless award a public contract without applying this directive to a legal person which it controls jointly with other contracting authorities , and the legal person over which the contracting authority or authorities exercise control may acquire goods and services from those public owners without applying this directive , where the following conditions are fulfilled :


### compliance , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xi or , where not applicable , with other provisions ensuring an equivalent level of protection ; ### compliance , at least in an equivalent manner , with obligations established by union and national legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xi or , where not applicable , with other provisions ensuring an equivalent level of protection ;


### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 , other criteria linked to the subject - matter of the public contract in question , such as : ### the most economically advantageous tender referred to in point of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject - matter of the public contract in question . those criteria shall include , in addition to the price or costs referred to in point of paragraph 1 and basic respect for social standards , other criteria linked to the subject - matter of the public contract in question , such as :


### the decision - making bodies of the controlled legal person are composed of representatives of all participating contracting authorities ; ### the decision - making bodies of the controlled legal person are composed of representatives of all participating contracting authorities , while one representative may represent one or many participating contracting authorities ;


### other categories of services continue by their very nature to have a limited cross - border dimension , namely what are known as services to the person , such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for public contracts for these services , with a higher threshold of eur 500 000 . services to the person with values below this threshold will typically not be of interest to providers from other member states , unless there are concrete indications to the contrary , such as union financing for trans - border projects . contracts for services to the person above this threshold should be subject to union - wide transparency . given the importance of the cultural context and the sensitivity of these services , member states should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate . the rules of this directive take account of that imperative , imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities are able to apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee . member states and / or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of public contracts , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority , without any limits or quotas , provided such a system ensures sufficient advertising and complies with the principles of transparency and non - discrimination . ### other categories of services continue by their very nature to have a limited cross - border dimension , namely what are known as services to the person , such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for public contracts for these services , with a higher threshold of eur 500 000 . services to the person with values below this threshold will typically not be of interest to providers from other member states , unless there are concrete indications to the contrary , such as union financing for trans - border projects . contracts for services to the person above this threshold should be subject to union - wide transparency . given the importance of the cultural context and the sensitivity of these services , member states should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate . the rules of this directive take account of that imperative , imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities are able to apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee and particularly criteria relating to social and employment conditions , health and safety at the workplace , social security and working conditions . member states and / or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of public contracts , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority , without any limits or quotas , provided such a system ensures sufficient advertising and complies with the principles of transparency and non - discrimination .


### member states shall put in place appropriate procedures for the award of contracts subject to this chapter , ensuring full compliance with the principles of transparency and equal treatment of economic operators and allowing contracting authorities to take into account the specificities of the services in question . ### member states shall put in place appropriate procedures for the award of contracts subject to this chapter , ensuring full compliance with the principles of transparency , non - discrimination and equal treatment of economic operators and allowing contracting authorities to take into account the specificities of the services in question .


### there is no private participation in any of the contracting authorities involved . ### there is no active private participation in any of the contracting authorities involved .


### paragraph 1 also applies where a controlled entity which is a contracting authority awards a contract to its controlling entity , or to another legal person controlled by the same contracting authority , provided that there is no private participation in the legal person being awarded the public contract . ### paragraph 1 also applies where a controlled entity which is a contracting authority awards a contract to its controlling entity or entities , or to another legal person controlled by the same contracting authority , provided that there is no private participation in the legal person being awarded the public contract , with the exception of legally enforced forms of private participation .


### member states shall ensure that contracting authorities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation . member states may also provide that the choice of the service provider shall not be made solely on the basis of the price for the provision of the service . ### member states shall ensure that contracting authorities may take into account the need to ensure a high level of quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , including disadvantages and vulnerable groups , the necessity to promote the participation of smes , the involvement and empowerment of users and innovation . member states may also provide that the choice of the service provider shall not be made solely on the basis of the price for the provision of the service .


### there is no private participation in the controlled legal person . ### there is no active private participation in the controlled legal person .


### the exclusions provided for in paragraphs 1 to 4 shall cease to apply from the moment any private participation takes place , with the effect that ongoing contracts need to be opened to competition through regular procurement procedures . ### the exclusions provided for in paragraphs 1 to 4 shall cease to apply from the moment any active private participation takes place , with the effect that ongoing contracts need to be opened to competition through regular procurement procedures .


### the absence of private participation referred to in paragraphs 1 to 4 shall be verified at the time of the award of the contract or of the conclusion of the agreement . ### the absence of active private participation referred to in paragraphs 1 to 4 shall be verified at the time of the award of the contract or of the conclusion of the agreement .


### where contracting authorities choose to award a contract to the most economically advantageous tender , they must determine the award criteria on the basis of which they will assess tenders in order to identify which one offers the best value for money . the determination of these criteria depends on the subject - matter of the contract since they must allow the level of performance offered by each tender to be assessed in the light of the subject - matter of the contract , as defined in the technical specifications , and the value for money of each tender to be measured . furthermore , the chosen award criteria should not confer an unrestricted freedom of choice on the contracting authority and they should ensure the possibility of effective competition and be accompanied by requirements that allow the information provided by the tenderers to be effectively verified . ### where contracting authorities choose to award a contract to the most economically advantageous tender , they must determine the award criteria on the basis of which they will assess tenders in order to identify which one offers the best value for money , economic and social sustainability . the determination of these criteria depends on the subject - matter of the contract since they must allow the level of performance offered by each tender to be assessed in the light of the subject - matter of the contract , as defined in the technical specifications , and the value for money of each tender to be measured . furthermore , the chosen award criteria should not confer an unrestricted freedom of choice on the contracting authority and they should ensure the possibility of effective competition and be accompanied by requirements that allow the information provided by the tenderers to be effectively verified .


### other categories of services continue by their very nature to have a limited cross - border dimension , namely what are known as services to the person , such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for public contracts for these services , with a higher threshold of eur 500 000 . services to the person with values below this threshold will typically not be of interest to providers from other member states , unless there are concrete indications to the contrary , such as union financing for trans - border projects . contracts for services to the person above this threshold should be subject to union - wide transparency . given the importance of the cultural context and the sensitivity of these services , member states should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate . the rules of this directive take account of that imperative , imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities are able to apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee . member states and / or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of public contracts , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority , without any limits or quotas , provided such a system ensures sufficient advertising and complies with the principles of transparency and non - discrimination . ### other categories of services continue by their very nature to have a limited cross - border dimension , namely what are known as services to the person , such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . by their very nature they are in general difficult to reconcile with internal market rules applying to public procurement . therefore , public authorities should prefer other ways of providing these services and must ensure high quality for the social services provided if they decide nevertheless to apply public procurement procedures . for a better protection of the quality of these services in public contracts , a specific regime should be established , with a higher threshold of eur 500 000 . services to the person with values below this threshold will typically not be of interest to providers from other member states , unless there are concrete indications to the contrary , such as union financing for trans - border projects . contracts for services to the person above this threshold should be subject to union - wide transparency . given the importance of the cultural context and the sensitivity of these services , member states should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate . the essential role and wide discretion of national , regional and local authorities in providing , commissioning and organizing services of general interest is also in line with protocol 26 on services of general interest , article 14 of the treaty on the functioning of the european union and article 36 of the charter of fundamental rights . the rules of this directive take account of that imperative , imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities apply specific quality criteria for the choice of service providers , such as the criteria set out in the voluntary european quality framework for social services of the european union ' s social protection committee , ensuring a high level of quality , safety and affordability , equal treatment and the promotion of universal access and of user rights . this means that principles such as quality , continuity , accessibility , availability and comprehensiveness of services , as well as democratic control and accountability are particularly important . member states and / or public authorities remain free to provide these services themselves , including vertical ' in - house ' provision or horizontal inter - municipal cooperation , or to organise social services in any other way that does not entail the conclusion of public contracts , for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority , without any limits or quotas , provided such a system ensures sufficient advertising and complies with the principles of transparency and non - discrimination . according to case law of the court , in particular the judgement in case c - 70 / 95 , contracting authorities may be allowed to reserve contracts to non - profit organisation , if such a restriction is provided for by national law and compatible with european law , if it is necessary and proportionate to attain certain societal goals of the national welfare system .


### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination and equal treatment . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ‘ the most economically advantageous tender’ or ‘ the lowest cost’ , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions . ### contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency , non - discrimination , equal treatment and the conscientious application of social standards . these criteria should guarantee that tenders are assessed in conditions of effective competition , also where contracting authorities require high - quality works , supplies and services that are optimally suited to their needs , for instance where the chosen award criteria include factors linked to the production process . as a result , contracting authorities should be allowed to adopt as award criteria either ‘ the most economically advantageous tender’ or ‘ the lowest cost’ , added to that of basic respect for national , european and international social standards , taking into account that in the latter case they are free to set adequate quality standards by using technical specifications or contract performance conditions .


### the award of public contracts by or on behalf of member states authorities has to comply with the principles of the treaty on the functioning of the european union , and in particular the free movement of goods , freedom of establishment and the freedom to provide services as well as the principles deriving therefrom , such as equal treatment , non - discrimination , mutual recognition , proportionality and transparency . however , for public contracts above a certain value , provisions should be drawn up coordinating national procurement procedures so as to ensure that these principles are given practical effect and public procurement is opened up to competition . ### the award of public contracts by or on behalf of member states authorities has to comply with the principles of the treaty on the functioning of the european union , and in particular the free movement of goods , freedom of establishment and the freedom to provide services as well as the principles deriving therefrom , such as equal treatment , non - discrimination , mutual recognition , proportionality , openness and transparency . however , for public contracts above a certain value , provisions should be drawn up coordinating national procurement procedures so as to ensure that these principles are given practical effect and public procurement is opened up to competition , always ensuring that public funds are used effectively .


### contracting authorities may authorise tenderers to submit variants . they shall indicate in the contract notice or , where a prior information notice is used as a means of calling for competition , in the invitation to confirm interest whether or not they authorise variants . variants shall not be authorised without such indication . ### contracting authorities shall authorise tenderers to submit variants .


### there is a widespread need for additional flexibility and in particular for wider access to a procurement procedure providing for negotiations , as is explicitly foreseen in the agreement , where negotiation is allowed in all procedures . contracting authorities should , unless otherwise provided in the legislation of the member state concerned , be able to use a competitive procedure with negotiation as provided for in this directive , in various situations where open or restricted procedures without negotiations are not likely to lead to satisfactory procurement outcomes . this procedure should be accompanied by adequate safeguards ensuring observance of the principles of equal treatment and transparency . this will give greater leeway to contracting authorities to buy works , supplies and services perfectly adapted to their specific needs . at the same time , it should also increase cross - border trade , as the evaluation has shown that contracts awarded by negotiated procedure with prior publication have a particularly high success rate of cross - border tenders . ### there is a widespread need for additional flexibility and in particular for wider access to a procurement procedure providing for negotiations , as is explicitly foreseen in the agreement , where negotiation is allowed in all procedures . contracting authorities should be able to use a competitive procedure with negotiation as provided for in this directive . this procedure should be accompanied by adequate safeguards ensuring observance of the principles of equal treatment and transparency . this will give greater leeway to contracting authorities to buy works , supplies and services perfectly adapted to their specific needs . at the same time , it should also increase cross - border trade , as the evaluation has shown that contracts awarded by negotiated procedure with prior publication have a particularly high success rate of cross - border tenders .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements — applicable during performance of the contract — to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are directly related to the subject - matter of the contract and are indicated in the contract notice , the prior information notice used as a means of calling for competition or the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for instance , mention may be made , amongst other things , of the requirements — applicable during performance of the contract — to recruit long - term job - seekers or to implement training measures for the unemployed or young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation .


### it is of utmost importance to fully exploit the potential of public procurement to achieve the objectives of the europe 2020 strategy for sustainable growth . in view of the important differences between individual sectors and markets , it would however not be appropriate to set general mandatory requirements for environmental , social and innovation procurement . the union legislature has already set mandatory procurement requirements for obtaining specific goals in the sectors of road transport vehicles and office equipment no 106 / 2008 of the european parliament and the council of 15 january 2008 on a community energy - efficiency labelling programme for office equipment ) . in addition , the definition of common methodologies for life cycle costing has significantly advanced . it therefore appears appropriate to continue on that path , leaving it to sector - specific legislation to set mandatory objectives and targets in function of the particular policies and conditions prevailing in the relevant sector and to promote the development and use of european approaches to life - cycle costing as a further underpinning for the use of public procurement in support of sustainable growth . ### it is of utmost importance to fully exploit the potential of public procurement to achieve the objectives of the europe 2020 strategy for sustainable growth . in particular public procurement is key to driving innovation , which is of great importance for future growth in europe . in view of the important differences between individual sectors and markets , it would however not be appropriate to set general mandatory requirements for environmental , social and innovation procurement . the union legislature has already set mandatory procurement requirements for obtaining specific goals in the sectors of road transport vehicles and office equipment no 106 / 2008 of the european parliament and the council of 15 january 2008 on a community energy - efficiency labelling programme for office equipment ) . in addition , the definition of common methodologies for life cycle costing has significantly advanced . it therefore appears appropriate to continue on that path , leaving it to sector - specific legislation to set mandatory objectives and targets in function of the particular policies and conditions prevailing in the relevant sector and to promote the development and use of european approaches to life - cycle costing as a further underpinning for the use of public procurement in support of sustainable growth .


### contracting authorities shall limit any conditions for participation to those that are appropriate to ensure that a candidate or tenderer has the legal and financial capacities and the commercial and technical abilities to perform the contract to be awarded . all requirements shall be related and strictly proportionate to the subject - matter of the contract , taking into account the need to ensure genuine competition . ### contracting authorities shall limit any conditions for participation to those that are appropriate to ensure that a candidate or tenderer has the legal and financial capacities and the commercial and technical abilities to perform the contract to be awarded . all requirements shall be directly related and strictly proportionate to the subject - matter of the contract , taking into account the need to ensure genuine competition .


### contracting authorities shall treat economic operators equally and without discrimination and shall act in a transparent and proportionate way . ### contracting authorities shall treat economic operators in accordance with the principles of equality , non - discrimination , free competition and openness . they shall also act in a transparent and proportionate way , always ensuring that public funds are used effectively .


### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender . ### furthermore , in technical specifications and in award criteria , contracting authorities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are directly linked to the subject - matter of the public contract . in order to better integrate social considerations in public procurement , procurers may also be allowed to include , in the award criterion of the most economically advantageous tender , characteristics related to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . for service contracts and for contracts involving the design of works , contracting authorities should also be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the contract in question , as this may affect the quality of contract performance and , as a result , the economic value of the tender .


### the funding of european political parties and european political foundations from the general budget of the european union or from any other source shall not be used to finance national , regional or local referenda campaigns . ### the funding of european political parties and european political foundations from the general budget of the european union or from any other source shall not be used to finance national , regional or local referendum campaigns unless the matter at issue in such referendums is european union legislation or a referendum relates directly to the functioning of a european union institution .


### inspections shall whenever possible be coordinated with inspections under other union legislation and combined , where appropriate . ### inspections shall be coordinated with inspections under other union legislation , in particular directive 2010 / 75 / eu of the european parliament and of the council of 24 november 2010 on industrial emissions 1 , and combined , to the extent possible . 1 oj l 334 , 17 . 12 . 2010 , p . 17 .


### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year . ### member states shall ensure that the information referred to in part 1 and 2 of annex v is permanently available to the public , including in an electronic format and that the information referred to in part 3 of annex v is at least made available to the public upon request . the information shall be reviewed and where necessary updated at least once a year .


### the immediate environment of the establishment , elements liable to cause a major accident or to aggravate the consequences thereof , including details of neighbouring establishments , whether or not those are covered by this directive , as well as other sites , areas and developments that could increase the risk or consequences of a major accident and of domino effects . ### the immediate environment of the establishment , elements liable to cause a major accident or to aggravate the consequences thereof , including details , where available to the operator , of neighbouring establishments , as well as of other sites , areas and developments that could increase the risk or consequences of a major accident and of domino effects .


### summary details of the inspections carried out pursuant to article 19 and of the main findings from the latest inspection conclusions , together with a reference or / link to the related inspection plan . ### information on when the last inspections have been carried out pursuant to article 19 , together with information on where the main findings from the inspections and the related inspection plan can be requested .


### where it is demonstrated to the satisfaction of a competent authority , on the basis of the criteria referred to in paragraph 4 of this article , that particular substances present at an individual establishment or any part thereof and listed in parts 1 or 2 of annex i are incapable of creating a major accident hazard , due to the specific conditions pertaining in the establishment such as the nature of the packaging and containment of the substance or the location and quantities involved , the member state of the competent authority may decide not to apply the requirements set out in articles 7 to 19 of this directive to the establishment concerned . ### without prejudice to paragraph 1 , where it is demonstrated on the basis of the criteria referred to in annex vii , that particular substances present at an individual establishment or any part thereof and listed in parts 1 or 2 of annex i are incapable of creating a major accident hazard , due to the specific conditions pertaining in the establishment regarding the nature of the packaging and containment of the substance or the location and quantities involved , the competent authority of the member state may decide not to apply the requirements set out in article 9 , point of article 10 , article 11 and article 13 of this directive to the establishment concerned .


### inspections shall whenever possible be coordinated with inspections under other union legislation and combined , where appropriate . ### inspections shall be coordinated with inspections under other union legislation , in particular directive 2010 / 75 / eu of the european parliament and of the council of 24 november 2010 on industrial emissions 1 , and , to the extent possible , combined . ______________ 1 oj l 334 , 17 . 12 . 2010 , p . 17 .


### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year . ### member states shall ensure that the information referred to in parts 1 and 2 of annex v is permanently available to the public , including in electronic format and that the information referred to in part 3 of annex v is made available to the public upon request . the information shall be reviewed and where necessary updated at least once a year .


### where appropriate , the commission may list the substances referred to in the first subparagraph of this paragraph in part 1 or part 2 of annex i by delegated acts in accordance with article 24 . ### in the event that the commission considers that the non - listed dangerous substance which has prompted a measure as referred to in the first subparagraph of this paragraph should be listed in part 1 or part 2 of annex i it shall present to that effect a legislative proposal to the european parliament and to the council .


### without prejudice to article 4 , in order to adapt annexes i to vii to technical progress , the commission shall adopt delegated acts in accordance with article 24 . ### without prejudice to article 4 , in order to adapt part 3 of annex i and annexes ii to vi to technical and scientific progress , the commission shall adopt delegated acts in accordance with article 24 .


### member states shall require the operator to draw up a document setting out the major - accident prevention policy and to ensure that it is properly implemented . the mapp shall be established in writing . it shall be designed to guarantee a high level of protection for human health and the environment . it shall be proportionate to the major - accident hazards . it shall include the operator ' s overall aims and principles of action , the role and responsibility of management and shall address safety culture with respect to the control of major - accident hazards . ### member states shall require the operator to draw up a document setting out the major - accident prevention policy and to ensure that it is properly implemented . the mapp shall be established in writing . it shall be designed to guarantee a high level of protection for human health and the environment . it shall be proportionate to the major - accident hazards . it shall include the operator ' s overall aims and principles of action and the role and responsibility of management with respect to the control of major - accident hazards .


### requests for information obtained by the competent authorities under this directive may be refused where the conditions down in article 4 of directive 2003 / 4 / ec are fulfilled . ### access to information under this directive may be restricted where the conditions laid down in article 4 of directive 2003 / 4 / ec are fulfilled .


### ‘ new establishment’ means an establishment that is newly constructed or has yet to enter into operation ; ### ' new establishment ' means an establishment that is newly constructed or enters into operation after 31 may 2015 ;


### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year . ### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . that information shall be worded clearly and in a way that is intelligible to the public . the information shall be reviewed and where necessary updated at least once a year . upon request from any natural or legal person , member states shall ensure that more detailed and additional information going beyond the information referred to in annex v , and without prejudice to article 21 , is made available to that person .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect of the adoption of criteria for derogations and amendments to the annexes of this directive . ### in order to adapt this directive to technical and scientific progress , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of amendments to part 3 of annex i , and the annexes ii to vi of this directive . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### safety culture — measures to assess and improve safety culture ; ### continuously high level of protection — measures to continuously ensure a high level of protection with respect to major - accident hazards ;


### member states shall ensure that , members of the public concerned are able to seek a review in accordance with article 6 of directive 2003 / 4 / ec of the acts or omissions of a competent authority in relation to any request for information pursuant to article 13 or article 21 of this directive . member states shall ensure that , in accordance with the relevant national legal system , members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions , acts or omissions relating to cases subject to article 14 where : ### member states shall ensure that , members of the public concerned are able to seek a review in accordance with article 6 of directive 2003 / 4 / ec of the acts or omissions of a competent authority in relation to any request for information pursuant to article 13 or article 21 of this directive . member states shall ensure that , in accordance with the relevant national legal system , members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the procedural legality of decisions , acts or omissions relating to cases subject to article 14 where :


### cooperate in informing the public and neighbouring establishments that fall outside the scope of this directive , and in supplying information to the authority responsible for the preparation of external emergency plans . ### supply details to the authority responsible so as to facilitate cooperation with the public and with neighbouring establishments , as well as the preparation of external emergency plans .


### cooperate in informing the public and neighbouring establishments that fall outside the scope of this directive , and in supplying information to the authority responsible for the preparation of external emergency plans . ### cooperate in informing the public and neighbouring sites that fall outside the scope of this directive , and in supplying information to the authority responsible for the preparation of external emergency plans .


### participation of the operator in the union eco - management and audit scheme , pursuant to regulation no 1221 / 2009 of the european parliament and of the council . ### participation of the operator in the union eco - management and audit scheme , pursuant to regulation no 1221 / 2009 of the european parliament and of the council15 or in a recognised equivalent environmental management system .


### member states shall ensure that the information referred to in annex v is permanently available to the public , including in an electronic format . the information shall be reviewed and where necessary updated at least once a year . ### the information shall be reviewed every three years and , where necessary , repeated and updated , at least if there is any modification within the meaning of article 10 . it shall also be permanently available to the public . the maximum period between the repetition of the information to the public shall , in any case , be no longer than five years . such information shall contain , at least , the information listed in annex v .


### any fire or explosion or accidental discharge of a dangerous substance involving a quantity of at least 1 % of the qualifying quantity laid down in column 3 of annex i . ### any fire or explosion or accidental discharge of a dangerous substance involving , a quantity of at least 5 % of the qualifying quantity laid down in column 3 of annex i .


### any fire or explosion or accidental discharge of a dangerous substance involving a quantity of at least 1 % of the qualifying quantity laid down in column 3 of annex i . ### any fire or explosion or accidental discharge of a dangerous substance involving , a quantity of at least 3 % of the qualifying quantity laid down in column 3 of annex i .


### criteria for derogations pursuant to article 4 ### criteria for derogations pursuant to article 4 a derogation in accordance with article 4 and 4 may be granted if at least one of the following generic criteria is fulfilled : physical form of substance substances in solid form , such that , under both normal conditions and any abnormal conditions which can reasonably be foreseen , a release of matter or of energy , which could create a major - accident hazard , is not possible . 2 . containment and quantities substances packaged or contained in such a fashion and in such quantities that the maximum release possible under any circumstances cannot create a major - accident hazard . 3 . location and quantities substances present in such quantities and at such distances from other dangerous substances that they can neither create a major - accident hazard by themselves nor initiate a major accident involving other dangerous substances . 4 . classification substances which are defined as dangerous substances by virtue of their generic classification in part 1 of annex i to this directive , but which cannot create a major - accident hazard , and for which therefore the generic classification is inappropriate for this purpose .


### the powers to adopt the delegated acts referred to in articles 4 and 23 shall be conferred on the commission for an indeterminate period of time . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in articles 25 and 26 . ### - 1 . the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article the power to adopt delegated acts referred to in articles 4 and 23 shall be conferred on the commission for an indeterminate period of time from* . 1a . the delegation of power referred to in articles 4 and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . a delegated act adopted pursuant to articles 4 and 23 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . _____________ * oj : please enter the date of entry into force of this directive .


### ' new establishment ' means an establishment that is newly constructed or has yet to enter into operation ; ### ‘ new establishment’ means an establishment that has yet to enter into operation ;


### for new establishments , a reasonable period of time prior to the start of construction or operation , ### for new establishments , a reasonable period of time prior to the start of construction , operation or modifications ,


### what constitutes a sufficient interest and impairment of a right shall be determined by the member states , consistently with the objective of giving the public concerned wide access to justice . to this end , the interest of any non - governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed sufficient for the purpose of paragraph 2 . the organisations referred to in the first subparagraph shall also be deemed to have rights capable of being impaired for the purpose of paragraph 2 . ### what constitutes a sufficient interest and impairment of a right shall be determined by the member states , consistently with the objective of giving the public concerned wide access to justice . to this end , the interest of any non - governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed sufficient for the purpose of point of the first subparagraph of paragraph 1 . the organisations referred to in the first subparagraph shall also be deemed to have rights capable of being impaired for the purpose of point of the first subparagraph of paragraph 1 .


### ‘ operator’ means any natural or legal person who operates or controls an establishment or installation or , where this is provided for by national legislation , to whom decisive economic power over the technical functioning of the establishment or installation has been delegated ; ### ‘ operator’ means any natural or legal person who operates or controls an establishment or installation or , where this is provided for by national legislation , to whom decisive economic and / or decision - making power over the technical functioning of the establishment or installation has been delegated ;


### in the event of the modification of an installation , establishment , storage facility , or process or of the nature or quantity of dangerous substances which could have significant repercussions on major - accident hazards , the member states shall ensure that the operator : ### in the event of the modification of an installation , establishment , storage facility , or process or of the nature or physical form or quantity of dangerous substances which could have significant repercussions on major - accident hazards , the member states shall ensure that the operator :


### where appropriate , the commission may list the substances referred to in the first subparagraph of this paragraph in part 1 or part 2 of annex i by delegated acts in accordance with article 24 . ### in the event that the commission considers that the non - listed dangerous substance which has prompted a measure as referred to in the first subparagraph of this paragraph should be listed in part 1 or part 2 of annex i it shall present to that effect a legislative proposal to the european parliament and to the council .


### where it is demonstrated to the satisfaction of a competent authority , on the basis of the criteria referred to in paragraph 4 of this article , that particular substances present at an individual establishment or any part thereof and listed in parts 1 or 2 of annex i are incapable of creating a major accident hazard , due to the specific conditions pertaining in the establishment such as the nature of the packaging and containment of the substance or the location and quantities involved , the member state of the competent authority may decide not to apply the requirements set out in articles 7 to 19 of this directive to the establishment concerned . ### without prejudice to paragraph 1 , where it is demonstrated on the basis of the criteria referred to in annex vii , that particular substances present at an individual establishment or any part thereof and listed in parts 1 or 2 of annex i are incapable of creating a major accident hazard , due to the specific conditions pertaining in the establishment regarding the nature of the packaging and containment of the substance or the location and quantities involved , the competent authority of the member state may decide not to apply the requirements set out in article 9 , point of article 10 , article 11 and article 13 of this directive to the establishment concerned .


### without prejudice to paragraph 4 , the operator shall periodically review and where necessary update the notification , at least every five years . the operator shall send the updated notification to the competent authority without delay . ### without prejudice to paragraph 4 , the operator shall periodically review and wherever necessary update the notification . the operator shall send the updated notification to the competent authority without delay .


### where it is demonstrated , on the basis of the criteria referred to in paragraph 4 of this article , that particular substances covered by parts 1 or 2 of annex i are incapable of creating a major accident hazard , in particular due to their physical form , properties , classification , concentration or generic packaging , the commission may list those substances in part 3 of annex i by delegated acts in accordance with article 24 . ### where it is demonstrated , on the basis of the criteria set out in annex vii to this directive , that particular substances or mixtures covered by parts 1 or 2 of annex i are under specific conditions incapable of creating a major accident hazard , due to their physical form , properties , classification , concentration or generic packaging , and should thus benefit from a derogation , the commission may adopt delegated acts in accordance with article 24 in order to list those substances and mixtures together with the applicable conditions in part 3 of annex i .


### where it is demonstrated , on the basis of the criteria referred to in paragraph 4 of this article , that particular substances covered by parts 1 or 2 of annex i are incapable of creating a major accident hazard , in particular due to their physical form , properties , classification , concentration or generic packaging , the commission may list those substances in part 3 of annex i by delegated acts in accordance with article 24 . ### where it is demonstrated , on the basis of the criteria referred to in paragraph 4 of this article , that particular substances covered by parts 1 or 2 of annex i are incapable of creating a major accident hazard , in particular due to their physical form , properties , classification , concentration or generic packaging , the commission may submit a legislative proposal to list those substances in part 3 of annex i .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect of the adoption of criteria for derogations and amendments to the annexes of this directive . ### in order to adapt this directive to technical and scientific progress , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of amendments to part 3 of annex i , and the annexes ii to vi of this directive . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### in the event of the modification of an installation , establishment , storage facility , or process or of the nature or quantity of dangerous substances which could have significant repercussions on major - accident hazards , the member states shall ensure that the operator : ### does not affect english version