### marketing authorisation holders shall be required to submit electronically to the eudravigilance database information on all non - serious suspected adverse reactions that occur in the community , within 90 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . ### marketing authorisation holders shall be required to submit electronically to the eudravigilance database information on all non - serious suspected adverse reactions that occur in the community , within 90 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . marketing authorisation holders of medicines authorised on the basis of article 10a and holders of registrations for medicinal products referred to in articles 14 to 16a shall be exempted from the above requirement .


### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which does not include any marketing authorisation granted in accordance with regulation no 726 / 2004 , the coordination group shall , within 30 days of receipt of the report of the pharmacovigilance risk assessment advisory committee , consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned , including a timetable for the implementation of the opinion . ### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which does not include any marketing authorisation granted in accordance with regulation no 726 / 2004 , the coordination group shall , within 30 days of receipt of the report of the pharmacovigilance risk assessment advisory committee , consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned , including a timetable for the implementation of the opinion . the opinion shall be published immediately , indicating any minority views .


### the pharmacovigilance risk assessment advisory committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing . ### the pharmacovigilance risk assessment committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing , if objective criteria are met on the basis of scientific data , taking account of the effectiveness and benefits of the product concerned and of earlier risk / benefit assessments conducted by the committee for medicinal products for human use or the coordination group in accordance with the procedure for granting marketing authorisations described in article 107l , which must involve the rapporteur of the committee for medicinal products for human use on the product in question , or the rapporteur of the coordination group . the agency , in consultation with the parties concerned , shall draw up guidelines on the organisation and conduct of public hearings .


### within 60 days of the information submitted , the pharmacovigilance risk assessment advisory committee shall make a recommendation , stating the reasons on which it is based . the recommendation shall be any or a combination of the following : ### within 60 days of the information submitted , the pharmacovigilance risk assessment advisory committee shall make a recommendation , stating the reasons on which it is based , and also taking account of the benefits of the medicinal product as assessed by the committee for medicinal products for human use or the coordination group in accordance with the procedure for granting marketing authorisations described in article 107l . the recommendation shall be any or a combination of the following :


### investing in education , skills and life - long learning through : ### investing in education and training , cooperation from education and youth welfare services , skills and life - long learning through :


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


### for more developed regions , member states shall concentrate 80 % of the esf allocation to each operational programme on up to four of the investment priorities set out in article 3 . ### for more developed regions , member states shall concentrate at least 80 % of the total amount of the esf resources at the national level to the thematic objectives set out in point 8 , 9 , and 10 in article 9 of the regulation no [ . . . ] / 2012 [ cpr ] .


### for transition regions , member states shall concentrate 70 % of the esf allocation to each operational programme on up to four of the investment priorities set out in article 3 . ### for transition regions , member states shall concentrate at least 70 % of the total amount of the esf resources at the national level to the thematic objectives set out in point 8 , 9 , and 10 in article 9 of the regulation no [ . . . ] / 2012 [ cpr ] .


### for less developed regions , member states shall concentrate 60 % of the esf allocation to each operational programme on up to four of the investment priorities set out in article 3 . ### for less developed regions , member states shall concentrate at least 60 % of the total amount of the esf resources at the national level to the thematic objectives set out in point 8 , 9 , and 10 in article 9 of the regulation no [ . . . ] / 2012 [ cpr ] .


### by way of derogation from article 110 of regulation no [ … ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both . ### by way of derogation from article 109 of regulation no [ . . . ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both , or in the case of parts of programmes managed by non - governmental organisations or social partners .


### the capacities registered in the european emergency response capacity shall be available for emergency response operations under the mechanism at the request of the commission through the erc . member states shall inform the commission as soon as possible of any compelling reasons that prevent them from making these capacities available in a specific emergency . ### the capacities registered in the european emergency response capacity shall be available for emergency response operations under the mechanism at the request of the commission through the erc . member states shall inform the commission as soon as possible of any compelling reasons that prevent them from making these capacities available in a specific emergency . member states shall provide the commission with a brief description of these compelling reasons .


### where reference is made to this paragraph , article 5 of regulation no 182 / 2011 shall apply . where the committee delivers no opinion , the commission shall not adopt the draft implementing act and the third subparagraph of article 5 of regulation no 182 / 2011 shall apply . ### where reference is made to this paragraph , article 5 of regulation no 182 / 2011 shall apply . where the committee delivers no opinion , including on national security issues , the commission shall not adopt the draft implementing act and the third subparagraph of article 5 of regulation no 182 / 2011 shall apply .


### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results and stimulate training and mobility . ### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results , stimulate training and mobility and take measures to promote gender equality and the gender dimension in research and innovation .


### the implementation of horizon 2020 should respond to the evolving opportunities and needs from science and technology , industry , policies and society . as such , the agendas should be set in close liaison with stakeholders from all sectors concerned , and sufficient flexibility should be allowed for new developments . external advice should be sought on a continuous basis during horizon 2020 , also making use of relevant structures such as european technology platforms , joint programming initiatives and the european innovation partnerships . ### the implementation of horizon 2020 should respond to the evolving opportunities and needs from science and technology , industry , policies and society . as such , the agendas should be set in close liaison with stakeholders from all sectors concerned , including civil society organisations working in the field of gender equality and women ' s rights . sufficient flexibility should be allowed for new developments . external advice should be sought on a continuous basis during horizon 2020 , also making use of relevant structures such as european technology platforms , joint programming initiatives and the european innovation partnerships . the commitment to gender mainstreaming of all union policies should be duly observed in policy , planning and evaluation of projects .


### horizon 2020 should promote cooperation with third countries based on common interest and mutual benefit . international cooperation in science , technology and innovation should be targeted to contribute to achieving the europe 2020 objectives to strengthen competitiveness , contribute to tackling societal challenges and support union external and development policies , including by developing synergies with external programmes and contributing to the union ' s international commitments such as the achievement of millennium development goals . ### horizon 2020 should promote cooperation with third countries based on common interest and mutual benefit . international cooperation in science , technology and innovation should be targeted to contribute to achieving the europe 2020 objectives to strengthen competitiveness , contribute to tackling societal challenges and support union external and development policies , including by developing synergies with external programmes and contributing to the union ' s international commitments such as the achievement of millennium development goals , and the overarching priority of gender equality .


### horizon 2020 shall contribute to building an economy based on knowledge and innovation across the whole union by leveraging sufficient additional research , development and innovation funding . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area . the relevant performance indicators are set out in the introduction of annex i . ### horizon 2020 shall contribute to building an economy based on gender equality , knowledge and innovation across the whole union by leveraging sufficient additional research , development and innovation funding and using the full potential and scientific excellence of all european scientists , including women scientists . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area . the relevant performance indicators are set out in the introduction of annex i .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to achieving gender balance , enhancing the attractiveness of the research profession , especially amongst young women and facilitating cross - border and cross - sector mobility of researchers , with particular attention to female researchers . each work programme shall contain a dedicated section describing the action planned to address gender imbalances and to integrate a gender dimension . this shall be reflected also at a project level within the provisions of grant agreements .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , broad collaboration between research , public authorities , civil society and business , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession among women and men , and to facilitating cross - border and cross - sector mobility of researchers .


### horizon 2020 shall ensure the effective promotion of gender equality and the gender dimension in research and innovation content . ### horizon 2020 shall ensure the effective promotion and inclusion of gender equality and the gender dimension in research and innovation content and in any and all decision - making bodies . to this end , targets will be set and efficient plans to reach those targets will be developed and implemented .


### horizon 2020 may be implemented through public - private partnerships where all the partners concerned commit to support the development and implementation of research and innovation activities of strategic importance to the union ' s competitiveness and industrial leadership or to address specific societal challenges . ### horizon 2020 may be implemented through public - private partnerships where all the partners concerned commit to support the development and implementation of research and innovation activities of strategic importance to the union ' s competitiveness and industrial leadership or to tackle effectively global societal challenges , with particular attention to existing gender inequalities .


### horizon 2020 shall contribute to the strengthening of public - public partnerships where actions at regional , national or international level are jointly implemented within the union . ### horizon 2020 shall contribute to the strengthening of public - public partnerships , including civil society , where actions at regional , national or international level are jointly implemented within the union .


### supporting the union ' s external and development policy objectives , complementing external and development programmes . ### supporting the union ' s external and development policy objectives , complementing external and development programmes , and international commitments such as the achievement of the mdgs and the overarching priority of gender equality .


### activities to disseminate information and carry out communication activities shall be an integral task under all of the actions supported by horizon 2020 . ### activities to disseminate information and carry out communication activities shall be an integral task under all of the actions supported by horizon 2020 , and should incorporate a sufficient gender dimension emphasizing the positive role and contribution of women scientists to research and innovation .


### activities to disseminate information and carry out communication activities shall be an integral task under all of the actions supported by horizon 2020 . ### activities to disseminate information and carry out communication activities shall be an integral task under all of the actions supported by horizon 2020 . all disseminated information and communication activities shall include a gender dimension and be preceded by a gender analysis .


### initiatives aimed at widening awareness and facilitating access to funding under horizon 2020 , in particular for those regions or types of participant that are underrepresented ; ### initiatives aimed at widening awareness and facilitating access to funding under horizon 2020 , in particular for those regions or types of participant that are underrepresented ; the importance of an increased participation of women in science should be promoted and the objective of gender balance in science and research should be viewed as an assertion of the principle of social equity and an essential means for the full utilisation of the existing scientific potential in society ;


### the control system shall ensure an appropriate balance between trust and control , taking into account administrative and other costs of controls at all levels , so that the objectives of horizon 2020 can be achieved and the most excellent researchers and the most innovative enterprises can be attracted to it . ### the control system shall ensure an appropriate balance between trust and control , taking into account administrative and other costs of controls at all levels , so that the objectives of horizon 2020 can be achieved and the most excellent researchers , irrespective of gender , and the most innovative enterprises can be attracted to it .


### not later than end 2017 , and taking into account the ex - post evaluation of the seventh framework programme to be completed by the end of 2015 and the review of the european institute of innovation and technology , the commission shall carry out , with the assistance of independent experts , an interim evaluation of horizon 2020 , its specific programme , including the european research council , and the activities of the european institute of innovation and technology , on the achievements of the objectives of horizon 2020 and continued relevance of all the measures , the efficiency and use of resources , the scope for further simplification , and union added value . that evaluation shall also take into consideration aspects relating to access to funding opportunities for participants in all regions , for smes and for promoting gender balance . that evaluation shall additionally take into account the contribution of the measures to the union priorities of smart , sustainable and inclusive growth and results on the long - term impact of the predecessor measures . ### not later than end 2017 , and taking into account the ex - post evaluation of the seventh framework programme to be completed by the end of 2015 and the review of the european institute of innovation and technology , the commission shall carry out , with the assistance of independent experts , an interim evaluation of horizon 2020 , its specific programme , including the european research council , and the activities of the european institute of innovation and technology , on the achievements of the objectives of horizon 2020 and continued relevance of all the measures , the efficiency and use of resources , the scope for further simplification , and union added value . that evaluation shall also take into consideration aspects relating to access to funding opportunities for participants in all regions , for smes and for promoting gender balance . in addition , the evaluation should take into account achieved gender balance in decision - making bodies , committees and advisory boards , gender dimension in processes , participation and allocation of resources . that evaluation shall additionally take into account the contribution of the measures to the union priorities of smart , sustainable and inclusive growth and results on the long - term impact of the predecessor measures .


### inclusive , innovative and secure societies ### inclusive , equal , innovative and secure societies


### the specific objective ‘ inclusive , innovative and secure societies’ also includes an activity to close the research and innovation divide with specific measures to unlock excellence in less developed regions of the union . ### the specific objective ' inclusive , equal , innovative and secure societies ' shall also include activities aiming at promoting gender balance in research and integration of gender dimension in research and innovation content , and at closing the research and innovation divide with specific measures to unlock excellence in less developed regions of the union .


### another major part of the challenge is that in many european countries the public sector still does not offer sufficiently attractive conditions for the best researchers . it can take many years before talented young researchers are able to become independent scientists in their own right . this leads to a dramatic waste of europe ' s research potential by delaying the emergence of the next generation of researchers , who bring new ideas and energy , and by enticing excellent researchers starting their career to seek advancement elsewhere . ### another major part of the challenge is that in many european countries the public sector still does not offer sufficiently attractive conditions for the best researchers . it can take many years before talented young researchers are able to become independent scientists in their own right . this leads to a dramatic waste of europe ' s research potential by delaying the emergence of the next generation of researchers , who bring new ideas and energy , and by enticing excellent researchers starting their career to seek advancement elsewhere . particular attention should be paid to women scientists , who represent only 18 % of grade a researchers , as compared to 27 % in the usa . attention should be paid to tackling the gender bias in recruitment for scientific jobs and supporting the career of female researchers .


### erc funding shall be awarded in accordance with the following well - established principles . scientific excellence shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ‘ bottom - up’ basis without predetermined priorities . the erc grants shall be open to individual teams of researchers of any age and from any country in the world , working in europe . and the erc shall aim to foster healthy competition across europe . ### erc funding shall be awarded in accordance with the following well - established principles . scientific excellence shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ‘ bottom - up’ basis without predetermined priorities . the erc grants shall be open to individual teams of researchers of any age , gender and from any country in the world , working in europe . and the erc shall aim to foster healthy competition across europe .


### the erc ' s scientific council shall continuously monitor the erc ' s operations and consider how best to achieve its objectives by means of grant schemes that emphasise clarity , stability and simplicity , both for applicants and in their implementation and management , and , as necessary , to respond to emerging needs . it shall endeavour to sustain and further refine the erc ' s world - class peer - review system which is based on transparent , fair and impartial treatment of proposals so that it can identify ground - breaking scientific excellence and talent regardless of a researcher ' s gender , nationality or age . finally , the erc shall continue conducting its own strategic studies to prepare for and support its activities , maintain close contacts with the scientific community and other stakeholders and look to make its activities complement research conducted at other levels . ### the erc ' s scientific council shall continuously monitor the erc ' s operations and consider how best to achieve its objectives by means of grant schemes that emphasise clarity , stability and simplicity , both for applicants and in their implementation and management , and , as necessary , to respond to emerging needs . it shall endeavour to sustain and further refine the erc ' s world - class peer - review system which is based on transparent , fair and impartial treatment of proposals so that it can identify ground - breaking scientific excellence and talent regardless of a researcher ' s gender , nationality or age . finally , the erc shall continue conducting its own strategic studies to prepare for and support its activities , maintain close contacts with the scientific community and other stakeholders and look to make its activities complement research conducted at other levels . the council shall seek gender balance in its composition .


### key activities shall be to provide excellent and innovative training to early - stage researchers at post - graduate level via interdisciplinary projects or doctoral programmes involving universities , research institutions , businesses , smes and other socio - economic groups from different countries . this will improve career prospects for young post - graduate researchers in both the public and private sectors . ### key activities shall be to provide excellent and innovative training to early - stage researchers at post - graduate level via interdisciplinary projects or doctoral programmes involving universities , research institutions , businesses , smes and other socio - economic groups from different countries . this will improve career prospects for young post - graduate researchers in both the public and private sectors . special attention should be given to gender balance regarding participation .


### key activities shall be , with the aid of a co - funding mechanism , to encourage regional , national and international organisations to create new programmes and to open existing ones to international and intersectoral training , mobility and career development . this will increase the quality of research training in europe at all career stages , including at doctoral level , will foster free circulation of researchers and scientific knowledge in europe , will promote attractive research careers by offering open recruitment and attractive working conditions and will support research and innovation cooperation between universities , research institutions and enterprises and cooperation with third countries and international organisations . ### key activities shall be , with the aid of a co - funding mechanism , to encourage regional , national and international organisations to create new programmes and to open existing ones to international and intersectoral training , mobility and career development . this will increase the quality of research training in europe at all career stages , including at doctoral level , will foster free circulation of researchers and scientific knowledge in europe , will promote attractive research careers by offering open recruitment and attractive working conditions and will support research and innovation cooperation between universities , research institutions and enterprises and cooperation with third countries and international organisations . special attention should be given to gender balance regarding participation .


### 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 . special attention shall be given broad cooperation between public authorities , research , civil society and business .


### 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 ; 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 gender dimension should be integrated in the activities described above and should be preceded by a gender analysis .


### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies in the context of globalisation . particular support will be provided for the development of the era and the development of framework conditions for innovation . ### the aim is to foster the development of innovative societies and policies in europe through the engagement of citizens , civil society , enterprises and users in research and innovation and the promotion of coordinated research and innovation policies in the context of globalisation . particular support will be provided for the development of the era and the development of framework conditions for innovation .


### ensure societal engagement in research and innovation ; ### ensure societal engagement and participation in research and innovation ;


### development of talented , skilled and entrepreneurial people with the aid of education and training ### development of talented , skilled and entrepreneurial people , both women and men , with the aid of education and training ;


### creating a legal framework to facilitate the digitisation and dissemination of works for which no author is identified or , even if identified , is not located , so called orphan works , is a key action of the digital agenda for europe , as set out in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of regions – a digital agenda for europe . ### creating a legal framework to facilitate the digitisation and dissemination of works for which no rightholder or rightholders are identified or , even if identified , are not located , so called orphan works , is a key action of the digital agenda for europe , as set out in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of regions – a digital agenda for europe .


### the exclusive rights for authors of reproduction and of making available to the public of their works , as harmonised under directive 2001 / 29 / ec of the european parliament and council of 22 may 2001 on the harmonisation of certain aspects of copyright and related rights in the information society , require the consent of the author prior to the digitisation and making available of a work . ### the exclusive rights for rightholders of reproduction and of making available to the public of their works , as harmonised under directive 2001 / 29 / ec of the european parliament and of the council of 22 may 2001 on the harmonisation of certain aspects of copyright and related rights in the information society , require the consent of the rightholder or rightholders prior to the digitisation and making available of a work .


### for the purposes of this directive , cinematographic , audio and audiovisual works in the archives of public service broadcasting organisations should be understood as including works commissioned by such organisations for their exclusive exploitation . ### for the purposes of this directive , cinematographic , audio and audiovisual works in the archives of broadcasting organisations should be understood as including productions commissioned and funded by broadcasting organisations and over which they had editorial control .


### this directive applies to works first published or broadcast in a member state and which are : ### this directive applies to orphan works first published or broadcast or fixed in a member state and which are :


### a work shall be considered an orphan work if the rightholder in the work is not identified or , even if identified , is not located after a diligent search for the rightholder has been carried out and recorded in accordance with article 3 . ### a work shall be considered an orphan work if one or more of the holders of the copyright or related rights are not identified or , even if identified , are not located after a good faith and diligent search for the rightholder has been carried out and recorded in accordance with article 3 .


### the sources that are appropriate for each category of works shall be determined by each member state , in consultation with rightholders and users , and include , the sources listed in the annex . ### the sources that are appropriate for each category of works or any other protected subject - matter shall be determined by each member state , in consultation with rightholders and users , and may include the sources listed in the annex .


### for audiovisual works contained in the collections of film heritage institutions and public service broadcasting organisations : ### for audiovisual works contained in the collections of film heritage institutions and broadcasting organisations :


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report on the co2 emission targets for new passenger cars for the period beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications for the period beyond 2020 . this should be done by setting a target for 2025 . that target should be based on the necessary rate of reduction in line with the union ' s long term climate goals and should enhance the development of cost effective co2 reducing technology for cars . it is therefore desirable for the commission to make a report and propose targets which are consistent with the cost - effective pathway to achieving the union ' s long - term climate goals for 2050 and which ensure the european union ' s continued leadership in fuel economy and co2emissions . the report should take into consideration co2 emissions over the whole life cycle of cars .


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### regulation no 443 / 2009 requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . current implementation of the union’s regulatory procedure for the measurement of specific co2 emissions is leading to the recording of lower emission levels than occur in the actual performance of vehicles on the road . the measurement procedures referred to in regulation no 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information and its implementing measures therefore need to be amended as a matter of urgency . review of the test procedures is currently proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , and given that the existing test cycle does not sufficiently reflect the actual emissions of cars and vans on the road , the swift development of an improved test cycle is crucial . in order to enable manufacturers to plan in full knowledge of the provisions they will have to comply with the existing test procedure until it is replaced by the wltp . when the current test procedures , set out in annex i to regulation no 443 / 2009 , which establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 , are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles .


### the commission shall adopt detailed provisions for a procedure to approve the innovative technologies referred to in paragraph 1 by way of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 14 of this regulation . ### the commission shall adopt detailed provisions for a procedure to approve the innovative technologies or innovative technology package referred to in paragraph 1 by way of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 14 of this regulation .


### bis 31 . by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new passenger cars for the period beyond 2020 . ’ ### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new passenger cars for the period beyond 2020 . ’ the purpose of this review shall be to set , for the period beyond 2025 , an average emissions target for the fleet of new cars of between 65 and 75 g co2 / km . on the basis of this review , which shall include an overall assessment of the impact on the car industry and its dependent industries , the commission shall , if appropriate , make a proposal to amend this regulation in a way which is cost - effective and as neutral as possible from the point of view of competition and ensures the achievement of the union ' s long - term objectives in combating climate change .


### as from 2020 : specific emissions of co2 = 95 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 0333 . ### as from 2020 one of the following formulae shall apply : specific emissions of co2 = 95 + b &#215 ; where : f = footprint of vehicle in square meters f0 = the value b = 17 . 6 adopted pursuant to article 13 . ” specific emissions of co2 = 95 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 0333 .


### in order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship . therefore the emff should support innovative operations and business development . ### in order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship . eco - innovation shall aim to improve the long term ecological sustainability of fishing operations and reduce the impact of fisheries on the marine ecosystems . therefore the emff should support innovative operations and business development that are environmentally sustainable and apply the precautionary principle and adhere to the ecosystem based approach .


### in order to address health and safety needs on board , the emff should support investments covering safety and hygiene on board . ### in order to address health and safety needs on board , the emff should only support investments covering safety and hygiene on board for vessels that operate in fisheries where it is demonstrated that there is no overcapacity ; these investments shall not increase the ability of the vessel to catch fish .


### investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to improve the overall performance and competitiveness of operators . ### investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to improve methodologies aiming at lower environmental impact activity , the overall performance and competitiveness of operators .


### the sustainable development of fisheries areas should contribute to the eu2020 objectives of promoting social inclusion and poverty reduction and to fostering innovation at local level as well as to the objective of territorial cohesion , a main priority in the lisbon treaty . ### the sustainable development of fisheries areas should contribute to the eu2020 objectives of promoting social inclusion and poverty reduction and to fostering eco - innovation at local level as well as to the objective of territorial cohesion , a main priority in the lisbon treaty .


### in order to stimulate innovation in fisheries , the emff may support projects aiming at developing or introducing new or substantially improved products compared to the state of art , new or improved processes , new or improved management and organisation systems . ### in order to stimulate innovation in fisheries , the emff may support projects aiming at developing or introducing new or substantially improved products compared to the state of art , new or improved processes , new or improved management and organisation systems , provided such projects contribute to the achievement of the objectives referred to in article 2 and 3 of [ the cfp regulation ] .


### when providing information , sufficient detail should be given to ensure that victims are treated in a respectful manner and to enable them to make informed decisions about their participation in proceedings and how to access their rights . in this respect , information allowing the victim to know about the current status of any proceedings and their progress is particularly important . this is equally relevant for information to enable a victim to decide whether to request a review of a decision not to prosecute . ### when providing information , sufficient detail should be given to ensure that victims are treated in a respectful manner and to enable them to make informed decisions about their participation in proceedings and how to access their rights . in this respect , information allowing the victim to know about the current status of any proceedings and their progress is particularly important . this is equally relevant for information to enable a victim to decide whether to request a review of a decision not to prosecute . when providing information about the release of the offender , effective support and assistance , where appropriate through victims support services , should be given to the victims and their family members , in order to minimise the risk of secondary victimisation and help victims cope with the psychological stress resulting from such information .


### support , whether provided by governmental or non - governmental organisations , should be made available from the moment a crime takes place as well as throughout criminal proceedings and after such proceedings in accordance with the needs of the victim . support should be provided through a variety of means , without excessive formalities and through a sufficient geographical distribution to allow all victims the opportunity to access such services . certain groups of victims such as victims of sexual violence , gender , race hate or other bias crimes or victims of terrorism may require specialist support services due to the particular characteristics of the crime they have fallen victim to . ### support , whether provided by suitably identified governmental or non - governmental organisations , should be made available from the moment a crime takes place as well as throughout criminal proceedings and after such proceedings in accordance with the needs of the victim . support should be provided through a variety of means , without excessive formalities and through an appropriate geographical distribution to allow all victims the opportunity to access such services . certain groups of victims such as victims of sexual violence , gender , race hate or other bias crimes or victims of terrorism or organised crime may require specialist support services due to the particular characteristics of the crime they have fallen victim to . member states should supply the resources necessary for the support , assistance and protection of victims , and the proceeds seized in the context of various forms of common , organised or terrorist - related crime should be set aside for this purpose as a matter of priority .


### some victims are particularly vulnerable during criminal proceedings to secondary and repeat victimisation and to intimidation by the offender or his associates . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , victims of sexual violence and victims of human trafficking are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters . ### some victims are particularly vulnerable during criminal proceedings to secondary victimisation and can easily be intimidated by the offender or his associates . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , victims of sexual violence , victims of organised crime , by terrorists , mafia organisations and drug traffickers for example , and victims of human trafficking are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters .


### some victims are particularly vulnerable during criminal proceedings to secondary and repeat victimisation and to intimidation by the offender or his associates . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , victims of sexual violence and victims of human trafficking are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters . ### some victims are particularly vulnerable during criminal proceedings to secondary and repeat victimisation and to intimidation by the offender or his associates and therefore have specific needs . such vulnerability can broadly be identified from the personal characteristics of the victim and the type or nature of the crime . on this basis some victims such as children , persons with disabilities , victims of sexual violence , victims of gender - based violence , victims of violence in close relationships , victims of terrorism and organised crime , and victims of human trafficking are in most cases vulnerable to further victimisation and in need of special protection measures . only in exceptional circumstances , such as balancing the fundamental rights of the accused or suspected person , or where the victim so wishes , should access to such protection measures be limited . in the case of victims of human trafficking and victims of child sexual abuse , sexual exploitation and child pornography , where specific and more detailed provisions are already included in separate instruments adopted or in course of negotiation this directive does not deal with those same matters .


### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . ### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include training on the specific services to which victims should be referred and specialist training where their work focuses on victims with special needs .


### any officials in criminal proceedings likely to come into contact with victims should be trained to identify and meet the needs of victims both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . ### any officials in criminal proceedings likely to come into contact with victims should be able to access and receive appropriate training so they are able to identify victims , to deal with them , to identify their needs and meet these both through initial and ongoing training and to a level appropriate to their contact with victims . this should include specialist training as appropriate . member states should promote this training requirement for the following : police services , lawyers , health services , social services and social workers , judges and staff within the judicial authorities , staff responsible for the protection of children’s rights and any other person likely to come into contact with victims in the course of their duties .


### the complaint of the criminal offence to the competent authority ; ### the essential parts of the complaint of the criminal offence to the competent authority ;


### member states shall ensure that victims receive written acknowledgement of any complaint made by them to an appropriate authority of the member state . ### member states shall ensure that victims receive written acknowledgement and a copy of any complaint made by them to a competent authority of the member state .


### all interviews with victims of sexual violence are conducted by a person of the same sex . ### all interviews with victims of sexual violence , gender - based violence and violence in close relationships are conducted by a person of the sex chosen by the victim .


### member states shall ensure that judicial authorities may adopt during the court proceedings , appropriate measures to protect the privacy and photographic images of victims and their family members . ### member states shall ensure that judicial authorities may adopt during the court proceedings , appropriate measures to protect the privacy , personal data and photographic images of victims and their family members .


### member states shall take measures to ensure that those providing victim support and restorative justice services receive adequate training to a level appropriate to their contact with victims and observe professional standards to ensure such services are provided in an impartial , respectful and professional manner . ### member states shall take measures to ensure that those providing victim support and restorative justice services receive adequate training to a level appropriate to their contact with victims and observe professional standards to ensure such services are provided in an impartial , respectful , personalised and professional manner . they will also ensure that especially vulnerable victims are cared for by specialist staff .


### the agency shall keep the list up to date . ### the agency shall keep the list up to date . medicinal products included on the above - mentioned list of medicinal products for human use must be clearly identified as such on the package in order to provide patients and healthcare professionals with a source of information separate from the list .


### the agency , in collaboration with the member states , shall develop standard web - based structured forms for the reporting of suspected adverse reactions by health - care professionals and patients . ### the agency , in collaboration with the member states and relevant stakeholders , shall develop standard content , formats and procedures for the reporting of suspected adverse reactions by health - care professionals and patients and the traceability of biological medicinal products prescribed , dispensed , or sold on eu territory .


### the pharmacovigilance risk assessment advisory committee shall be composed of the following : ten members and ten alternates appointed by the management board , on the basis of proposals by the national competent authorities ; five members and five alternates appointed by the commission , on the basis of a public call for expressions of interest , after consulting the european parliament . the alternates shall represent and vote for the members in their absence . the commission may adapt the number of members and alternates in the light of technical and scientific needs . those measures , designed to amend non - essential elements of this regulation , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 87 . ### the pharmacovigilance risk assessment advisory committee shall be composed of the following : one member and one alternate per member state , appointed by the national competent authority in consultation with the management board ; two additional members and two alternates , one a representative of healthcare professionals and one a representative of patients , appointed by the commission , on the basis of a public call for expressions of interest , after consulting the european parliament . a member state may request another member state to take its place in the committee . the alternates shall represent and vote for the members in their absence .


### direct financial contributions from the budget may be awarded to european political parties in view of their contribution to forming european political awareness and to expressing the political will of the citizens of the union . ### direct financial contributions from the budget may be awarded to european political parties in view of their contribution to forming european political awareness and to expressing the political will of the citizens of the union in accordance with the provisions of regulation no [ . . . ] of the european parliament and of the council on the statute and funding of european political parties and european political foundations* . ____________ * oj l . . .


### the member states should take all necessary measures to enable air carriers to fulfil their obligations under this directive . dissuasive , effective and proportionate penalties , including financial ones , should be provided for by member states against those air carriers failing to meet their obligations regarding the transfer of pnr data . where there are repeated serious infringements which might undermine the basic objectives of this directive , these penalties may include , in exceptional cases , measures such as the immobilisation , seizure and confiscation of the means of transport , or the temporary suspension or withdrawal of the operating licence . ### the member states should take all necessary measures to enable air carriers to fulfil their obligations under this directive . dissuasive , effective and proportionate penalties , including financial ones , should be provided for by member states against those air carriers failing to meet their obligations regarding the transfer of pnr data . however , in cases of deficient technical architecture , the commission should consider options that ensure the smooth operation of international air traffic and avoid individual member states imposing disparate sanctions . where there are repeated serious infringements which might undermine the basic objectives of this directive , these penalties may include , in exceptional cases , measures such as the immobilisation , seizure and confiscation of the means of transport , or the temporary suspension or withdrawal of the operating licence .


### taking into consideration the right to the protection of personal data , the rights of the data subjects to processing of their pnr data , such as the right of access , the right of rectification , erasure and blocking , as well as the rights to compensation and judicial remedies , should be in line with framework decision 2008 / 977 / jha . ### taking into consideration the right to the protection of personal data , the rights of the data subjects to processing of their pnr data , such as the right of access , the right of rectification , erasure and blocking , as well as the rights to compensation and judicial remedies , should be in line with framework decision 2008 / 977 / jha . such rights should apply equally to union citizens and third country nationals .


### a member state may transfer pnr data and the results of the processing of pnr data to a third country , only on a case - by - case basis and if : the conditions laid down in article 13 of council framework decision 2008 / 977 / jha are fulfilled , the transfer is necessary for the purposes of this directive specified in article 1 , and the third country agrees to transfer the data to another third country only where it is necessary for the purposes of this directive specified in article 1 and only with the express authorisation of the member state . ### a member state may transfer pnr data and the results of the processing of pnr data to a third country , only on a case - by - case basis and if : the union has concluded an international agreement with that third country or is party , with that third country , to an international convention which provides for safeguards compatible with the requirements of this directive , such an international agreement provides for , or the third country specifically agrees to , the transfer of data to another third country where : the third country has justified the necessity of such transfer for the purposes of this directive specified in article 1 , the safeguards provided by the destination country are compatible with the requirements of this directive the member state has given prior express authorisation ; the conditions laid down in article 13 of council framework decision 2008 / 977 / jha are fulfilled .


### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data , the length of the data retention period and the quality of the assessments . it shall also contain the statistical information gathered pursuant to article 18 . ### undertake a review of the operation of this directive and submit a report to the european parliament and the council within four years after the date mentioned in article 15 . such review shall cover all the elements of this directive , with special attention to the compliance with standard of protection of personal data including in cases of transfers of data to third countries , the length of the data retention period and the quality of the assessments . it shall also contain a review of the transitional provisions in article 16 and advice on any problems regarding air carriers’ provision of pnr data according to the push method , including the impact on third - country carriers and their flag states , and the statistical information gathered pursuant to article 18 .


### member states shall prepare a set of statistical information on pnr data provided to the passenger information units . such statistics shall as a minimum cover the number of identifications of any persons who may be involved in a terrorist offence or serious crime according to article 4 and the number of subsequent law enforcement actions that were taken involving the use of pnr data per air carrier and destination . ### member states shall prepare a set of statistical information on pnr data provided to the passenger information units . such statistics shall as a minimum cover the number of identifications of any persons who may be involved in a terrorist offence or serious crime according to article 4 , the number of subsequent law enforcement actions that were taken involving the use of pnr data per air carrier and destination and the number of cases by country and by purpose , as specified in article 1 , of data transferred to third countries in accordance with article 8 .


### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union’s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20% and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 . ### accelerating the refurbishment of existing and deployment of new energy infrastructure is vital to achieve the union’s energy and climate policy objectives , consisting in completing the internal market in energy , guaranteeing security of supply , notably for gas and oil , reducing greenhouse gas emissions by 20% , increasing the share of renewable energy in the final energy consumption to 20% and achieving a 20% increase in energy efficiency by 2020 . at the same time , the union has to prepare its infrastructure for further decarbonisation of its energy system in the longer term towards 2050 . all these targets make a future interconnected european electricity grid and long - distance electricity highways a priority in energy infrastructure .


### there should be effective , speedy and accurate exchange of information among the member states and between the member states and the commission . it is therefore necessary to provide for effective tools for such exchange . the union rapid information system has proved its effectiveness and efficiency . rapex enables measures to be taken across the union in relation to products that present a risk beyond the territory of a single member state . to avoid unnecessary duplication , this system should be used for all alert notifications required by this regulation relating to products presenting a risk . ### there should be effective , speedy and accurate exchange of information among the member states and between the member states and the commission . it is therefore necessary to provide for effective tools for such exchange . the union rapid information system has proved its effectiveness and efficiency . rapex enables measures to be taken across the union in relation to products that present a serious risk beyond the territory of a single member state . to avoid unnecessary duplication , this system should be used for all alert notifications required by this regulation relating to products presenting a serious risk .


### follow and keep up to date with developments in scientific and technical knowledge concerning the safety of products . ### follow and keep up to date with developments in scientific and technical knowledge concerning the safety and compliance of products with union harmonised legislation .


### the general and sector - specific programmes and their updates shall be communicated to the other member states and the commission and , subject to article 6 , shall be made accessible to the public electronically and , where appropriate , by other means . ### the general and sector - specific programmes and their updates shall be drawn up after consultation with relevant stakeholders and shall be communicated to the other member states and the commission . subject to article 6 , they shall be made accessible to the public electronically and , where appropriate , by other means .


### economic operators shall provide all necessary information to market surveillance authorities including information that enables the precise identification of the product and facilitates the tracing of the product . ### economic operators shall cooperate with market surveillance authorities at their request , on any action taken to eliminate the risks presented by products that they have placed or made available on the market .


### on the basis of the results of the evaluation conducted pursuant to paragraph 3 , the commission may decide by implementing acts whether the national measures are justified and similar measures should be taken by all member states that have not already done so . in this case , it shall address the decision to the member states concerned and immediately communicate it to all member states and the relevant economic operator or operators . ### on the basis of the results of the evaluation conducted pursuant to paragraph 3 , the commission shall decide without undue delay by implementing acts whether the national measures are justified and similar measures should be taken by all member states that have not already done so . in this case it shall address the decision to the member states concerned and immediately communicate it to all member states and the relevant economic operator or operators .


### compliance with the requirements of any union harmonisation legislation that apply to the product upon its release which relate to the potential risk under consideration , taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body , shall raise a presumption on the part of market surveillance authorities that the product does not present a risk . however , this shall not prevent those authorities from instructing the authorities in charge of external border controls not to release the product where there is evidence that , despite such compliance , the product does in fact present a risk . ### compliance with the requirements of any union harmonisation legislation that apply to the product upon its release which relate to the potential risk under consideration , taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body , shall raise a presumption on the part of market surveillance authorities that the product does not present a risk .


### it is necessary to lay down methods for the sampling and analysis of textile products in order to exclude any possibility of objections to the methods used . the methods used for official tests carried out in the member states to determine the fibre composition of textile products composed of binary and ternary fibre mixtures should be uniform , as regards both the pre - treatment of the sample and its quantitative analysis . it is appropriate that the methods set out to that end in this regulation be turned into harmonised standards . therefore , the commission should manage the transition from the current system , which is based on the methods set out in this regulation , to a harmonised standard - based system . the use of uniform methods of analysis of textile products composed of binary and ternary fibre mixtures will facilitate the free movement of those products , and thereby improve the functioning of the internal market . ### it is necessary to lay down methods for the sampling and analysis of textile products in order to exclude any possibility of objections to the methods used . the methods used for official tests carried out in the member states to determine the fibre composition of textile products composed of binary and ternary fibre mixtures should be uniform , as regards both the pre - treatment of the sample and its quantitative analysis . in order to simplify this regulation and adapt the uniform methods set out therein to technical progress , it is appropriate that those methods be turned into harmonised standards . to that end , the commission should manage the transition from the current system , which is based on the methods set out in this regulation , to a harmonised standard - based system . the use of uniform methods of analysis of textile products composed of binary and ternary fibre mixtures will facilitate the free movement of those products , and thereby improve the functioning of the internal market .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union concerning the adoption of technical criteria and procedural rules for the authorisation of higher tolerances , the amendment of annexes ii , iv , v , vi , vii , viii and ix in order to adapt them to technical progress and the amendment of annex i in order to include new textile fibre names in the list set out in that annex . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union concerning the adoption of technical criteria and procedural rules for the authorisation of higher tolerances , the labelling or marking of non - textile parts of animal origin , the form and use of language - independent symbols or codes for textile fibre names , the indication of origin of textile products , the amendment of annexes ii , iv , v , vi , vii , viii and ix in order to adapt them to technical progress and the amendment of annex i in order to include new textile fibre names in the list set out in that annex . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### since the objective of this regulation , namely the adoption of uniform rules for the use of textile fibre names and related labelling and marking of fibre composition of textile products , cannot be sufficiently achieved by the member states and can therefore , by reason of its scale , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective . ### since the objectives of this regulation cannot be sufficiently achieved by the member states and can therefore , by reason of its scale , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve those objectives .


### this regulation lays down rules concerning the use of textile fibre names and related labelling and marking of fibre composition of textile products as well as rules concerning the determination of the fibre composition of textile products by quantitative analysis of binary and ternary textile fibre mixtures with a view to improving the functioning of the internal market and to providing accurate information to consumers . ### this regulation lays down rules concerning the use of textile fibre names and related labelling and marking of fibre composition of textile products , rules concerning the determination of the fibre composition of textile products by quantitative analysis of binary and ternary textile fibre mixtures as well as rules concerning the labelling or marking of non - textile parts of animal origin and the indication of the country of origin of textile products , with a view to improving the functioning of the internal market and to providing accurate information to consumers .


### a textile product composed of two or more fibres , one of which accounts for at least 85 % of the total weight , shall be labelled or marked by one of the following : the name of the fibre which accounts for at least 85 % of the total weight immediately preceded or followed by its percentage by weight ; the name of the fibre which accounts for at least 85 % of the total weight immediately preceded or followed by the words ' 85 % minimum ' ; the full percentage composition of the product . 2 . a textile product composed of two or more fibres , none of which accounting for as much as 85 % of the total weight , shall be labelled or marked with at least the name and percentage by weight of the fibres with the highest and next highest percentage by weight of the product , immediately followed by the names of the other constituent fibres in descending order of the percentage by weight , with or without an indication of their percentage by weight . 3 . without prejudice to paragraph 2 , fibres which separately account for less than 10 % of the total weight of a product may be collectively designated by the term ' other fibres ' , immediately preceded or followed by the total percentage by weight . where the name of a fibre which accounts for less than 10 % of the total weight of a product is specified , the full percentage composition of that product shall be given . ### a textile product shall be labelled with the name and percentage by weight of all constituent fibres in descending order . 2 . by way of derogation from paragraph 1 , and without prejudice to article 7 , a fibre which accounts for up to 3 % of the total weight of the textile product , or fibres which collectively account for up to 10 % of the total weight , may be designated by the term ' other fibres ' , immediately followed by their percentage by weight , provided that they cannot easily be stated at the time of the manufacture .


### the labelling and marking of textile products shall be durable , easily legible , visible and accessible and , in the case of a label , securely attached . ### the labelling and marking of textile products shall be durable , easily legible , throughout the product ' s normal or reasonably foreseeable period of use , visible and accessible and , in the case of a label , securely attached .


### abbreviations shall not be used with the exception of a mechanised processing code , provided that code is explained in the same commercial document . ### abbreviations shall not be used with the exception of a mechanised processing code , or where they are defined in internationally recognised standards , provided that the abbreviations are explained in the same commercial document .


### when making a textile product available on the market , the textile fibre composition descriptions referred to in articles 5 , 7 , 8 and 9 shall be indicated in catalogues and trade literature , on packaging , labels and markings in a manner that is easily legible , visible , clear and in uniform print or font . this information shall be clearly visible to the consumer before the purchase , including in cases where the purchase is made by electronic means . ### when making a textile product available on the market , the textile fibre composition descriptions referred to in articles 5 , 7 , 8 and 9 shall be indicated in catalogues and trade literature , on packaging , labels and markings in a manner that is easily legible , visible and clear . the names of the fibres and their percentage by weight shall be indicated in uniform letter / number size , style and font . this information shall be clearly visible to the consumer before the purchase , including in cases where the purchase is made by electronic means .


### the labelling or marking shall be provided in the official language or languages of the member state on the territory of which the textile products are made available to the consumer , unless the member state concerned provides otherwise . ### the labelling or marking shall be provided in any official language of the union which is easily understood by the end consumer in the member state on the territory of which the textile products are made available .


### any laboratory responsible for the testing of textile mixtures for which there is no uniform method of analysis at union level shall determine the fibre composition of such mixtures , indicating in the analysis report the result obtained , the method used and its degree of accuracy . ### any laboratory approved by a member state for the testing of textile mixtures for which there is no uniform method of analysis at union level shall determine the fibre composition of such mixtures , indicating in the analysis report the result obtained , the method used and its degree of accuracy .


### by…* , the commission shall submit a report to the european parliament and to the council on the application of this regulation , with an emphasis on the requests for and adoption of new textile fibre names . ___________ * five years after the entry into force of this regulation ### by …* , the commission shall submit a report to the european parliament and to the council on the application of this regulation , with an emphasis on the requests for and adoption of new textile fibre names and submit , where appropriate , a legislative proposal . ___________ * 3 years after the entry into force of this regulation


### textile products which are in accordance with directive 2008 / 121 / ec and which are placed on the market before …* may continue to be made available on the market until …** . ___________ * 6 months after the date of entry into force of this regulation ___________ ** 2 years after the date of entry into force of this regulation ### textile products which comply with directive 2008 / 121 / ec and which are placed on the market before . . . * may continue to be made available on the market until …** ___________ * 6 months after the date of entry into force of this regulation ___________ ** 2 years and 6 months after the date of entry into force of this regulation


### the rate of building renovation needs to be increased , as the existing building stock represents the single biggest potential sector for energy savings . moreover , buildings are crucial to achieving the eu objective of reducing greenhouse gas emissions by 80 - 95% by 2050 compared to 1990 . buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life . it is therefore appropriate to set an annual rate of renovation of all buildings owned by public bodies to upgrade their energy performance . this renovation rate should be without prejudice to the obligations with regard to nearly - zero energy buildings set in directive 2010 / 31 / eu of the european parliament and of the council of 19 may 2010 on the energy performance of buildings . the obligation to renovate public buildings complements the provisions of that directive , which requires member states to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements . ### the rate of building renovation needs to be increased , as the existing building stock represents the single biggest potential sector for energy savings . moreover , buildings are crucial to achieving the eu objective of reducing greenhouse gas emissions by 80 - 95% by 2050 compared to 1990 . buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life . it is therefore appropriate for each member state to adopt its own measures , which should be cost - effective and otherwise appropriate , with the aim of increasing energy saving and rendering energy use more efficient , for buildings owned by public bodies to upgrade their energy performance . this renovation rate should be without prejudice to the obligations with regard to nearly - zero energy buildings set in directive 2010 / 31 / eu of the european parliament and of the council of 19 may 2010 on the energy performance of buildings . energy saving and energy efficiency measures applicable to public buildings complement the provisions of that directive , which requires member states to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements . building materials also play a crucial role , as an increasingly substantial proportion of the total energy consumption accounted for by buildings arises at the construction stage . promoting the use of low - emission building materials , such as wood , on a europe - wide scale would reduce the environmental burden resulting from construction .


### the rate of building renovation needs to be increased , as the existing building stock represents the single biggest potential sector for energy savings . moreover , buildings are crucial to achieving the eu objective of reducing greenhouse gas emissions by 80 - 95% by 2050 compared to 1990 . buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life . it is therefore appropriate to set an annual rate of renovation of all buildings owned by public bodies to upgrade their energy performance . this renovation rate should be without prejudice to the obligations with regard to nearly - zero energy buildings set in directive 2010 / 31 / eu of the european parliament and of the council of 19 may 2010 on the energy performance of buildings . the obligation to renovate public buildings complements the provisions of that directive , which requires member states to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements . ### the rate of building renovation needs to be increased , as the existing building stock represents the single biggest potential sector for energy savings . moreover , buildings are crucial to achieving the eu objective of reducing greenhouse gas emissions by 80 - 95% by 2050 compared to 1990 . buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life . it is therefore appropriate to set an annual rate of renovation of all buildings owned by public bodies to upgrade their energy performance . this renovation rate should be without prejudice to the obligations with regard to nearly - zero energy buildings set in directive 2010 / 31 / eu of the european parliament and of the council of 19 may 2010 on the energy performance of buildings . the obligation to renovate public buildings complements the provisions of that directive , which requires member states to ensure that when existing buildings undergo major renovation their energy performance is upgraded so that they meet minimum energy performance requirements . specific attention shall be paid to ensuring good indoor air quality through e . g . adequate ventilation requirements and the use of low - emission building materials , equipment and products . where energy efficiency measures concern public buildings such as day care centres , kindergartens or schools a health impact assessment shall be carried out .


### an assessment of the possibility of establishing a ‘ white certificate’ scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the latter objective can better be achieved , at least at this stage , by means of national energy efficiency obligation schemes or other alternative measures that achieve the same amount of energy savings . the commission should however define , by a delegated act , the conditions under which a member state could in future recognise the energy savings achieved in another member state . it is appropriate for the level of ambition of such schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities the option of offering energy services to all final customers , not only to those to whom they sell energy . this increases competition in the energy market because energy utilities can differentiate their product by providing complementary energy services . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication ‘ small business act’ sets out principles that should be taken into account by member states that decide to abstain from applying this possibility . ### an assessment of the possibility of establishing a ' white certificate ' scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the objective of 20% energy saving by 2020 can better be achieved by means of national energy efficiency obligation schemes or other alternative measures that achieve the same amount of energy savings , thus ensuring that every member state benefits from the economic and social advantages accruing from improved energy efficiency . however , it is appropriate for the level of ambition of energy efficiency obligation schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities the option of offering energy services to all final customers , not only to those to whom they sell energy . this increases competition in the energy market because energy utilities can differentiate their product by providing complementary energy services . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication “small business act” sets out principles that should be taken into account by member states that decide to abstain from applying this possibility .


### an assessment of the possibility of establishing a ‘ white certificate’ scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the latter objective can better be achieved , at least at this stage , by means of national energy efficiency obligation schemes or other alternative measures that achieve the same amount of energy savings . the commission should however define , by a delegated act , the conditions under which a member state could in future recognise the energy savings achieved in another member state . it is appropriate for the level of ambition of such schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities the option of offering energy services to all final customers , not only to those to whom they sell energy . this increases competition in the energy market because energy utilities can differentiate their product by providing complementary energy services . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication ‘ small business act’ sets out principles that should be taken into account by member states that decide to abstain from applying this possibility . ### an assessment of the possibility of establishing a ‘ white certificate’ scheme at union level has shown that , in the current situation , such a system would create excessive administrative costs and that there is a risk that energy savings would be concentrated in a number of member states and not introduced across the union . the latter objective can better be achieved , at least at this stage , by means of national energy efficiency obligation schemes or other alternative measures that achieve the same amount of energy savings . the commission should however define , by a delegated act , common criteria according to which energy efficiency measures could be measured and verified as well as the conditions under which a member state could in future recognise the energy savings achieved in another member state . it is appropriate for the level of ambition of such schemes to be established in a common framework at union level while providing significant flexibility to member states to take full account of the national organisation of market actors , the specific context of the energy sector and final customers ' habits . the common framework should give energy utilities and other eligible actors the option of offering energy services to all final customers . the common framework should allow member states to include requirements in their national scheme that pursue a social aim , notably in order to ensure that vulnerable customers have access to the benefits of higher energy efficiency . it should also allow member states to exempt small companies from the energy efficiency obligation . the commission communication ‘ small business act’ sets out principles that should be taken into account by member states that decide to abstain from applying this possibility .


### when designing energy efficiency improvement measures , account should be taken of efficiency gains and savings obtained through the widespread application of cost - effective technological innovations such as smart meters . to maximise the saving benefits of these innovations , final customers should be able to visualise indicators of cost and consumption and have regular individual billing based on actual consumption . ### when designing energy efficiency improvement measures , account should be taken of efficiency gains and savings obtained through the widespread application of cost - effective technological innovations such as smart meters . to maximise the saving benefits of these innovations , final customers should be able to see indicators of cost and consumption and have regular individual billing based on actual consumption .


### when member states put in place the roll - out of smart meters foreseen by directives 2009 / 72 / ec and 2009 / 73 / ec concerning electricity and gas markets , they shall ensure that the objectives of energy efficiency and final customer benefits are fully taken into account when establishing the minimum functionalities of the meters and obligations imposed on market participants . ### when member states put in place the roll - out of smart meters foreseen by directives 2009 / 72 / ec and 2009 / 73 / ec concerning electricity and gas markets , they shall ensure that the smart meters deployed facilitate energy savings within the home and that the general overall objectives of energy efficiency and final customer benefits are fully taken into account when establishing the minimum functionalities of the meters and obligations imposed on market participants . minimum functionalities should enable communication of smart metering components with devices or gateways within the home or building used in the provision of energy saving and demand - side management services .